User login
General surgeons getting less vascular training
Vascular surgery fellow case logs reflect an increase in endovascular interventions, but general surgery residents may be missing out on training opportunities, according to a study of national case data.
In addition, general surgery residents saw a decrease in open vascular surgery cases, which was not reflected among the vascular surgery fellows, according to Dr. Rose C. Pedersen and colleagues in the department of surgery, Kaiser Permanente Los Angeles Medical Center. The report was published online in Annals of Vascular Surgery (doi: 10.1016/j.avsg.2016.02.008).
The paper was originally presented at the 2105 annual meeting of the Southern California Vascular Society. The study reports findings of a review of the Accreditation Council for Graduate Medical Education national case log reports from 2001 to 2012.
During that period, the number of general surgery residents increased from 1,021 to 1,098, while the number of vascular surgery fellows increased from 96 to 121. The total number of vascular cases logged by the vascular fellows significantly increased by 161%, from an average of 298 cases to 762 cases over the time period assessed. During that same period, vascular cases done by general surgery residents significantly decreased by 40%, from an average of 186 to 116 cases.
In terms of open cases. vascular fellows saw a significant 43% decrease in open abdominal aortic aneurysm (AAA) cases, going from 26 to 15, and a slight but significant increase in carotid endarterectomy cases logged (44 to 49). Hemodialysis access and major amputations also both increased significantly. A decreases in open surgery for peripheral obstructive disease was small and not significant.
General surgery residents saw decreases in all open surgery areas over the time period: AAA cases fell significantly by 78% (9 cases to 2 cases); carotid endarterectomies decreased significantly from 23 to 12 cases; and surgery for peripheral obstructive disease fell significantly from 21 to 8). Hemodialysis access cases and major amputations both decreased as well, but not significantly.
Endovascular cases increased from 2001 to 2012 for both vascular fellows and general surgery residents. Vascular fellows saw endovascular AAA repair significantly increase from an average of 17 to 46 cases, while those for general surgery residents rosed from roughly 1 to 3 cases. Similarly, endovascular interventions for peripheral obstructive disease significantly increased for vascular fellows from 17 to 85, and from 1.3 to 4 for general surgery residents.
“The contemporary management of abdominal aortic aneurysmal diseases and peripheral obstructive diseases has been particularly changed by endovascular therapies that have been adopted into the training experience of vascular surgery fellows, but not those of general surgery residents. Open surgery experience has decreased overall for general surgery residents in all major categories, a change not seen in vascular fellows,” the researchers concluded.
The authors reported no relevant disclosures.
Vascular surgical practice has evolved with the introduction of minimally invasive technology and advancement of endovascular techniques, and as such, the training of the vascular surgical specialist too has evolved. This article highlights the effect of these technological advancements on the vascular surgical fellowship training experience and points out the effect of this embracing of endovascular techniques by academic centers in their general surgery trainee vascular surgical experience. Open operative case numbers are declining and endovascular case numbers are increasing significantly.
As traditionally performed open procedures are being substituted for endovascular repairs, the open operative experience for vascular surgery trainees is declining or staying stable at the expense of the general surgery resident experience. Open cases (open aneurysm repairs, aortofemoral artery bypasses, visceral artery bypasses, carotid endarterectomies), because they are performed infrequently now, have become fellow cases.
 |
Dr. Erica L. Mitchell |
Endovascular cases, which have increased over 300%-400%, too are essentially fellow cases (or in 0+5 programs, which are not discussed in this manuscript, vascular surgery resident cases) because the endovascular skill set does not appear to translate or transfer (and therefore is not considered relevant to the general surgery resident planning on a fellowship or career in the traditional surgical specialties) into open and laparoscopic skills desired by general surgery trainees.
Unfortunately, this open to endovascular operative experience shift will only increase with the introduction and early adoption (in academic centers) of complex endovascular techniques for the management of complex obstructive and aneurysmal arterial disease. A review of case log data for 0+5 and 5+2 residents completing programs in 2014-2015 reveals the operative experience and continued decline in open operative case numbers and increases in endovascular case numbers.
Vascular surgery training programs and their faculties have a responsibility to make sure the operative experience of general surgery residents is a worthwhile one. We, the faculty, need to keep encouraging general surgery residents to come to the operating room, even if they are not the primary surgeons. To make this worthwhile for them (because residents will not come to the operating room if there is nothing to be gained for themselves), we have to let them participate in the case somehow. One of the most critical aspects of a vascular surgical procedure is the operative exposure.
Having the general surgery residents participate in the vascular exposure is not only formative to their understanding of surgical anatomy, and applicable to all aspects of surgical practice, it is also critical to trainee development of decision making, judgment, and situational awareness. These exposures can and should be logged, using the e-code, to receive ACGME case log credit for vascular surgical procedures. E-codes, additionally, allow more than one resident to take credit for an arterial exposure and repair. We must also encourage trainees to come to the angio suite, while these cases, on the outset do not seem relevant to general surgery training, they do provide the learner with a greater appreciation of the complexity of vascular anatomy.
Importantly, as long as we continue to train vascular surgery specialists via the traditional 5+2 paradigm, we must keep general surgery residents, rotating through our services, interested and engaged in the management of vascular diseases. The simplest way to engage them is to make them feel relevant and to make them feel relevant they have to participate, both inside and outside of the operating room. It is, after all, our duty as surgical educators and advocates for our specialty to train the next generation of vascular surgical specialists!
Dr. Erica L. Mitchell is professor of surgery, program director for vascular surgery, and vice-chair of quality, department of surgery, Oregon Health & Science University, Portland. She is an associate medical editor of Vascular Specialist.
Vascular surgical practice has evolved with the introduction of minimally invasive technology and advancement of endovascular techniques, and as such, the training of the vascular surgical specialist too has evolved. This article highlights the effect of these technological advancements on the vascular surgical fellowship training experience and points out the effect of this embracing of endovascular techniques by academic centers in their general surgery trainee vascular surgical experience. Open operative case numbers are declining and endovascular case numbers are increasing significantly.
As traditionally performed open procedures are being substituted for endovascular repairs, the open operative experience for vascular surgery trainees is declining or staying stable at the expense of the general surgery resident experience. Open cases (open aneurysm repairs, aortofemoral artery bypasses, visceral artery bypasses, carotid endarterectomies), because they are performed infrequently now, have become fellow cases.
|
Dr. Erica L. Mitchell |
Endovascular cases, which have increased over 300%-400%, too are essentially fellow cases (or in 0+5 programs, which are not discussed in this manuscript, vascular surgery resident cases) because the endovascular skill set does not appear to translate or transfer (and therefore is not considered relevant to the general surgery resident planning on a fellowship or career in the traditional surgical specialties) into open and laparoscopic skills desired by general surgery trainees.
Unfortunately, this open to endovascular operative experience shift will only increase with the introduction and early adoption (in academic centers) of complex endovascular techniques for the management of complex obstructive and aneurysmal arterial disease. A review of case log data for 0+5 and 5+2 residents completing programs in 2014-2015 reveals the operative experience and continued decline in open operative case numbers and increases in endovascular case numbers.
Vascular surgery training programs and their faculties have a responsibility to make sure the operative experience of general surgery residents is a worthwhile one. We, the faculty, need to keep encouraging general surgery residents to come to the operating room, even if they are not the primary surgeons. To make this worthwhile for them (because residents will not come to the operating room if there is nothing to be gained for themselves), we have to let them participate in the case somehow. One of the most critical aspects of a vascular surgical procedure is the operative exposure.
Having the general surgery residents participate in the vascular exposure is not only formative to their understanding of surgical anatomy, and applicable to all aspects of surgical practice, it is also critical to trainee development of decision making, judgment, and situational awareness. These exposures can and should be logged, using the e-code, to receive ACGME case log credit for vascular surgical procedures. E-codes, additionally, allow more than one resident to take credit for an arterial exposure and repair. We must also encourage trainees to come to the angio suite, while these cases, on the outset do not seem relevant to general surgery training, they do provide the learner with a greater appreciation of the complexity of vascular anatomy.
Importantly, as long as we continue to train vascular surgery specialists via the traditional 5+2 paradigm, we must keep general surgery residents, rotating through our services, interested and engaged in the management of vascular diseases. The simplest way to engage them is to make them feel relevant and to make them feel relevant they have to participate, both inside and outside of the operating room. It is, after all, our duty as surgical educators and advocates for our specialty to train the next generation of vascular surgical specialists!
Dr. Erica L. Mitchell is professor of surgery, program director for vascular surgery, and vice-chair of quality, department of surgery, Oregon Health & Science University, Portland. She is an associate medical editor of Vascular Specialist.
Vascular surgical practice has evolved with the introduction of minimally invasive technology and advancement of endovascular techniques, and as such, the training of the vascular surgical specialist too has evolved. This article highlights the effect of these technological advancements on the vascular surgical fellowship training experience and points out the effect of this embracing of endovascular techniques by academic centers in their general surgery trainee vascular surgical experience. Open operative case numbers are declining and endovascular case numbers are increasing significantly.
As traditionally performed open procedures are being substituted for endovascular repairs, the open operative experience for vascular surgery trainees is declining or staying stable at the expense of the general surgery resident experience. Open cases (open aneurysm repairs, aortofemoral artery bypasses, visceral artery bypasses, carotid endarterectomies), because they are performed infrequently now, have become fellow cases.
|
Dr. Erica L. Mitchell |
Endovascular cases, which have increased over 300%-400%, too are essentially fellow cases (or in 0+5 programs, which are not discussed in this manuscript, vascular surgery resident cases) because the endovascular skill set does not appear to translate or transfer (and therefore is not considered relevant to the general surgery resident planning on a fellowship or career in the traditional surgical specialties) into open and laparoscopic skills desired by general surgery trainees.
Unfortunately, this open to endovascular operative experience shift will only increase with the introduction and early adoption (in academic centers) of complex endovascular techniques for the management of complex obstructive and aneurysmal arterial disease. A review of case log data for 0+5 and 5+2 residents completing programs in 2014-2015 reveals the operative experience and continued decline in open operative case numbers and increases in endovascular case numbers.
Vascular surgery training programs and their faculties have a responsibility to make sure the operative experience of general surgery residents is a worthwhile one. We, the faculty, need to keep encouraging general surgery residents to come to the operating room, even if they are not the primary surgeons. To make this worthwhile for them (because residents will not come to the operating room if there is nothing to be gained for themselves), we have to let them participate in the case somehow. One of the most critical aspects of a vascular surgical procedure is the operative exposure.
Having the general surgery residents participate in the vascular exposure is not only formative to their understanding of surgical anatomy, and applicable to all aspects of surgical practice, it is also critical to trainee development of decision making, judgment, and situational awareness. These exposures can and should be logged, using the e-code, to receive ACGME case log credit for vascular surgical procedures. E-codes, additionally, allow more than one resident to take credit for an arterial exposure and repair. We must also encourage trainees to come to the angio suite, while these cases, on the outset do not seem relevant to general surgery training, they do provide the learner with a greater appreciation of the complexity of vascular anatomy.
Importantly, as long as we continue to train vascular surgery specialists via the traditional 5+2 paradigm, we must keep general surgery residents, rotating through our services, interested and engaged in the management of vascular diseases. The simplest way to engage them is to make them feel relevant and to make them feel relevant they have to participate, both inside and outside of the operating room. It is, after all, our duty as surgical educators and advocates for our specialty to train the next generation of vascular surgical specialists!
Dr. Erica L. Mitchell is professor of surgery, program director for vascular surgery, and vice-chair of quality, department of surgery, Oregon Health & Science University, Portland. She is an associate medical editor of Vascular Specialist.
Vascular surgery fellow case logs reflect an increase in endovascular interventions, but general surgery residents may be missing out on training opportunities, according to a study of national case data.
In addition, general surgery residents saw a decrease in open vascular surgery cases, which was not reflected among the vascular surgery fellows, according to Dr. Rose C. Pedersen and colleagues in the department of surgery, Kaiser Permanente Los Angeles Medical Center. The report was published online in Annals of Vascular Surgery (doi: 10.1016/j.avsg.2016.02.008).
The paper was originally presented at the 2105 annual meeting of the Southern California Vascular Society. The study reports findings of a review of the Accreditation Council for Graduate Medical Education national case log reports from 2001 to 2012.
During that period, the number of general surgery residents increased from 1,021 to 1,098, while the number of vascular surgery fellows increased from 96 to 121. The total number of vascular cases logged by the vascular fellows significantly increased by 161%, from an average of 298 cases to 762 cases over the time period assessed. During that same period, vascular cases done by general surgery residents significantly decreased by 40%, from an average of 186 to 116 cases.
In terms of open cases. vascular fellows saw a significant 43% decrease in open abdominal aortic aneurysm (AAA) cases, going from 26 to 15, and a slight but significant increase in carotid endarterectomy cases logged (44 to 49). Hemodialysis access and major amputations also both increased significantly. A decreases in open surgery for peripheral obstructive disease was small and not significant.
General surgery residents saw decreases in all open surgery areas over the time period: AAA cases fell significantly by 78% (9 cases to 2 cases); carotid endarterectomies decreased significantly from 23 to 12 cases; and surgery for peripheral obstructive disease fell significantly from 21 to 8). Hemodialysis access cases and major amputations both decreased as well, but not significantly.
Endovascular cases increased from 2001 to 2012 for both vascular fellows and general surgery residents. Vascular fellows saw endovascular AAA repair significantly increase from an average of 17 to 46 cases, while those for general surgery residents rosed from roughly 1 to 3 cases. Similarly, endovascular interventions for peripheral obstructive disease significantly increased for vascular fellows from 17 to 85, and from 1.3 to 4 for general surgery residents.
“The contemporary management of abdominal aortic aneurysmal diseases and peripheral obstructive diseases has been particularly changed by endovascular therapies that have been adopted into the training experience of vascular surgery fellows, but not those of general surgery residents. Open surgery experience has decreased overall for general surgery residents in all major categories, a change not seen in vascular fellows,” the researchers concluded.
The authors reported no relevant disclosures.
Vascular surgery fellow case logs reflect an increase in endovascular interventions, but general surgery residents may be missing out on training opportunities, according to a study of national case data.
In addition, general surgery residents saw a decrease in open vascular surgery cases, which was not reflected among the vascular surgery fellows, according to Dr. Rose C. Pedersen and colleagues in the department of surgery, Kaiser Permanente Los Angeles Medical Center. The report was published online in Annals of Vascular Surgery (doi: 10.1016/j.avsg.2016.02.008).
The paper was originally presented at the 2105 annual meeting of the Southern California Vascular Society. The study reports findings of a review of the Accreditation Council for Graduate Medical Education national case log reports from 2001 to 2012.
During that period, the number of general surgery residents increased from 1,021 to 1,098, while the number of vascular surgery fellows increased from 96 to 121. The total number of vascular cases logged by the vascular fellows significantly increased by 161%, from an average of 298 cases to 762 cases over the time period assessed. During that same period, vascular cases done by general surgery residents significantly decreased by 40%, from an average of 186 to 116 cases.
In terms of open cases. vascular fellows saw a significant 43% decrease in open abdominal aortic aneurysm (AAA) cases, going from 26 to 15, and a slight but significant increase in carotid endarterectomy cases logged (44 to 49). Hemodialysis access and major amputations also both increased significantly. A decreases in open surgery for peripheral obstructive disease was small and not significant.
General surgery residents saw decreases in all open surgery areas over the time period: AAA cases fell significantly by 78% (9 cases to 2 cases); carotid endarterectomies decreased significantly from 23 to 12 cases; and surgery for peripheral obstructive disease fell significantly from 21 to 8). Hemodialysis access cases and major amputations both decreased as well, but not significantly.
Endovascular cases increased from 2001 to 2012 for both vascular fellows and general surgery residents. Vascular fellows saw endovascular AAA repair significantly increase from an average of 17 to 46 cases, while those for general surgery residents rosed from roughly 1 to 3 cases. Similarly, endovascular interventions for peripheral obstructive disease significantly increased for vascular fellows from 17 to 85, and from 1.3 to 4 for general surgery residents.
“The contemporary management of abdominal aortic aneurysmal diseases and peripheral obstructive diseases has been particularly changed by endovascular therapies that have been adopted into the training experience of vascular surgery fellows, but not those of general surgery residents. Open surgery experience has decreased overall for general surgery residents in all major categories, a change not seen in vascular fellows,” the researchers concluded.
The authors reported no relevant disclosures.
FROM ANNALS OF VASCULAR SURGERY
Robotic vascular surgery: Ready for prime time?
A single-center experience using the da Vinci robotic system to perform vascular procedures demonstrated the safety and feasibility of this technique in different areas of vascular surgery.
Dr. Petr Štádler and his colleagues at the No Homolce Hospital in Prague reported on 310 robotic-assisted vascular procedures performed between November 2005 and May 2014 with the aid of the da Vinci system. They concluded that robotic-assisted vascular procedures added to the speed and relative simplicity of construction of vascular anastomoses.
The patient cohort had procedures consisting of 224 robotic occlusive disease treatments (group 1), 65 robotic aorto-illiac aneurysm surgeries (group II), and 21 other robotic procedures (group III) as reported online in the European Journal of Vascular and Endovascular Surgery (2016. doi: 10.1016/j.ejvs.2016.02.016).
A total of 298 cases (96.1%) were successfully completed robotically, with conversion required in 10 cases; 2 patients were inoperable. The overall 30-day mortality rate was 0.3% for the entire cohort, and only two (0.6%) late prosthetic infections were seen. The median operating time was 204 min, the median anastomosis time was 29 min, and median blood loss was 571 mL.
In comparing groups I and II, group I required an operative time of 194 min, compared with 253 min in group II. Mean aortic cross-clamp time was 37 min in group I and 93 min in group II, while the mean blood loss was greater in group II (1,210 mL) as compared with group 1 (320 mL).
“The robotic system provides a real opportunity for minimally invasive surgery in the field of vascular surgery ... with all its advantages. Robotic AAA [abdominal aortic aneurysm] and aortofemoral bypass represent the standard operations in vascular surgery and they are not only possible, but safe and effective,” said Dr. Štádler and his colleagues. They added, however, that “further randomized studies are needed to ensure its benefits and the cost-effectiveness of robotic vascular surgery, compared with open and laparoscopic repair.”
Dr, Štádler and his colleagues reported that they had no disclosures.
When we examine the data presented by the authors of this paper closely, we see vast differences between the group I patients (bypasses for aortoiliac occlusive disease) and the group II patients (repair of aortoiliac aneurysms). In the occlusive group (group I), the operative time averaged 194 minutes. However, in the aneurysm group, the surgical repair of an aneurysm took over 4 hours. Another broad discrepancy between groups I and II is evident in examining cross-clamp time. In the occlusive group, the cross-clamp was 37 minutes; however, aneurysm patients required 93 minutes of cross-clamp to complete the proximal anastomosis. Similar disparities are seen in mean blood loss. Patients with occlusive disease lost an average of 320 mL of blood, while aneurysm patients lost 1,210 mL
 |
Dr. Mark A. Adelman |
The authors have been clever in combining these two groups as a single cohort.
However, I might argue that by segregating the groups, we might find that occlusive disease is well treated with robotically assisted surgery, but aneurysm repair should be left to open or endovascular techniques.
In addition to the data disparities, there are several practical limitations to performing robotic aortic surgery. Learning robotic techniques requires significant additional surgical training that is typically not within the skill set of a vascular surgeon. Who will devote the time and resources toward training vascular surgeons? Presently, there are increased hardware and operating room times associated with robotic-assisted surgeries. Because of the bulkiness of the robotic system and need for space for mechanical arms, large operating rooms must be utilized to perform robotic procedures.
Although I have not performed robotic surgery, I understand the tactile feedback, or haptics are significantly reduced when operating with the robot. Lastly, during this era of value-based medicine, is robotic surgery too expensive? The current cost of a robot approaches $2 million, and robotic arms have a limited life expectancy.
In summary, the authors have not demonstrated that this procedure is safe in aneurysm patients, or generalizable across all vascular surgeons given the lack of training paradigm. Further, robotic procedures are probably not cost effective in this very cost-sensitive health care environment. When I was training under Dr. Frank Cole Spencer in general surgery, he was fond of saying “just because you can teach a dog to ride a bicycle, it does not mean that you should.” As Dr. Juan Parodi will remind us, if the technology becomes more affordable, and changes significantly, we must all remain open minded. But currently, this technology is not yet ready for prime time. In its current state, this dog will not be learning to ride this robotic bike.
Dr. Mark A. Adelman is the Frank J. Veith, MD Professor, chief of vascular and endovascular surgery, and vice chair for strategy and business development, department of surgery, NYU Langone Medical Center, New York.
When we examine the data presented by the authors of this paper closely, we see vast differences between the group I patients (bypasses for aortoiliac occlusive disease) and the group II patients (repair of aortoiliac aneurysms). In the occlusive group (group I), the operative time averaged 194 minutes. However, in the aneurysm group, the surgical repair of an aneurysm took over 4 hours. Another broad discrepancy between groups I and II is evident in examining cross-clamp time. In the occlusive group, the cross-clamp was 37 minutes; however, aneurysm patients required 93 minutes of cross-clamp to complete the proximal anastomosis. Similar disparities are seen in mean blood loss. Patients with occlusive disease lost an average of 320 mL of blood, while aneurysm patients lost 1,210 mL
|
Dr. Mark A. Adelman |
The authors have been clever in combining these two groups as a single cohort.
However, I might argue that by segregating the groups, we might find that occlusive disease is well treated with robotically assisted surgery, but aneurysm repair should be left to open or endovascular techniques.
In addition to the data disparities, there are several practical limitations to performing robotic aortic surgery. Learning robotic techniques requires significant additional surgical training that is typically not within the skill set of a vascular surgeon. Who will devote the time and resources toward training vascular surgeons? Presently, there are increased hardware and operating room times associated with robotic-assisted surgeries. Because of the bulkiness of the robotic system and need for space for mechanical arms, large operating rooms must be utilized to perform robotic procedures.
Although I have not performed robotic surgery, I understand the tactile feedback, or haptics are significantly reduced when operating with the robot. Lastly, during this era of value-based medicine, is robotic surgery too expensive? The current cost of a robot approaches $2 million, and robotic arms have a limited life expectancy.
In summary, the authors have not demonstrated that this procedure is safe in aneurysm patients, or generalizable across all vascular surgeons given the lack of training paradigm. Further, robotic procedures are probably not cost effective in this very cost-sensitive health care environment. When I was training under Dr. Frank Cole Spencer in general surgery, he was fond of saying “just because you can teach a dog to ride a bicycle, it does not mean that you should.” As Dr. Juan Parodi will remind us, if the technology becomes more affordable, and changes significantly, we must all remain open minded. But currently, this technology is not yet ready for prime time. In its current state, this dog will not be learning to ride this robotic bike.
Dr. Mark A. Adelman is the Frank J. Veith, MD Professor, chief of vascular and endovascular surgery, and vice chair for strategy and business development, department of surgery, NYU Langone Medical Center, New York.
When we examine the data presented by the authors of this paper closely, we see vast differences between the group I patients (bypasses for aortoiliac occlusive disease) and the group II patients (repair of aortoiliac aneurysms). In the occlusive group (group I), the operative time averaged 194 minutes. However, in the aneurysm group, the surgical repair of an aneurysm took over 4 hours. Another broad discrepancy between groups I and II is evident in examining cross-clamp time. In the occlusive group, the cross-clamp was 37 minutes; however, aneurysm patients required 93 minutes of cross-clamp to complete the proximal anastomosis. Similar disparities are seen in mean blood loss. Patients with occlusive disease lost an average of 320 mL of blood, while aneurysm patients lost 1,210 mL
|
Dr. Mark A. Adelman |
The authors have been clever in combining these two groups as a single cohort.
However, I might argue that by segregating the groups, we might find that occlusive disease is well treated with robotically assisted surgery, but aneurysm repair should be left to open or endovascular techniques.
In addition to the data disparities, there are several practical limitations to performing robotic aortic surgery. Learning robotic techniques requires significant additional surgical training that is typically not within the skill set of a vascular surgeon. Who will devote the time and resources toward training vascular surgeons? Presently, there are increased hardware and operating room times associated with robotic-assisted surgeries. Because of the bulkiness of the robotic system and need for space for mechanical arms, large operating rooms must be utilized to perform robotic procedures.
Although I have not performed robotic surgery, I understand the tactile feedback, or haptics are significantly reduced when operating with the robot. Lastly, during this era of value-based medicine, is robotic surgery too expensive? The current cost of a robot approaches $2 million, and robotic arms have a limited life expectancy.
In summary, the authors have not demonstrated that this procedure is safe in aneurysm patients, or generalizable across all vascular surgeons given the lack of training paradigm. Further, robotic procedures are probably not cost effective in this very cost-sensitive health care environment. When I was training under Dr. Frank Cole Spencer in general surgery, he was fond of saying “just because you can teach a dog to ride a bicycle, it does not mean that you should.” As Dr. Juan Parodi will remind us, if the technology becomes more affordable, and changes significantly, we must all remain open minded. But currently, this technology is not yet ready for prime time. In its current state, this dog will not be learning to ride this robotic bike.
Dr. Mark A. Adelman is the Frank J. Veith, MD Professor, chief of vascular and endovascular surgery, and vice chair for strategy and business development, department of surgery, NYU Langone Medical Center, New York.
A single-center experience using the da Vinci robotic system to perform vascular procedures demonstrated the safety and feasibility of this technique in different areas of vascular surgery.
Dr. Petr Štádler and his colleagues at the No Homolce Hospital in Prague reported on 310 robotic-assisted vascular procedures performed between November 2005 and May 2014 with the aid of the da Vinci system. They concluded that robotic-assisted vascular procedures added to the speed and relative simplicity of construction of vascular anastomoses.
The patient cohort had procedures consisting of 224 robotic occlusive disease treatments (group 1), 65 robotic aorto-illiac aneurysm surgeries (group II), and 21 other robotic procedures (group III) as reported online in the European Journal of Vascular and Endovascular Surgery (2016. doi: 10.1016/j.ejvs.2016.02.016).
A total of 298 cases (96.1%) were successfully completed robotically, with conversion required in 10 cases; 2 patients were inoperable. The overall 30-day mortality rate was 0.3% for the entire cohort, and only two (0.6%) late prosthetic infections were seen. The median operating time was 204 min, the median anastomosis time was 29 min, and median blood loss was 571 mL.
In comparing groups I and II, group I required an operative time of 194 min, compared with 253 min in group II. Mean aortic cross-clamp time was 37 min in group I and 93 min in group II, while the mean blood loss was greater in group II (1,210 mL) as compared with group 1 (320 mL).
“The robotic system provides a real opportunity for minimally invasive surgery in the field of vascular surgery ... with all its advantages. Robotic AAA [abdominal aortic aneurysm] and aortofemoral bypass represent the standard operations in vascular surgery and they are not only possible, but safe and effective,” said Dr. Štádler and his colleagues. They added, however, that “further randomized studies are needed to ensure its benefits and the cost-effectiveness of robotic vascular surgery, compared with open and laparoscopic repair.”
Dr, Štádler and his colleagues reported that they had no disclosures.
A single-center experience using the da Vinci robotic system to perform vascular procedures demonstrated the safety and feasibility of this technique in different areas of vascular surgery.
Dr. Petr Štádler and his colleagues at the No Homolce Hospital in Prague reported on 310 robotic-assisted vascular procedures performed between November 2005 and May 2014 with the aid of the da Vinci system. They concluded that robotic-assisted vascular procedures added to the speed and relative simplicity of construction of vascular anastomoses.
The patient cohort had procedures consisting of 224 robotic occlusive disease treatments (group 1), 65 robotic aorto-illiac aneurysm surgeries (group II), and 21 other robotic procedures (group III) as reported online in the European Journal of Vascular and Endovascular Surgery (2016. doi: 10.1016/j.ejvs.2016.02.016).
A total of 298 cases (96.1%) were successfully completed robotically, with conversion required in 10 cases; 2 patients were inoperable. The overall 30-day mortality rate was 0.3% for the entire cohort, and only two (0.6%) late prosthetic infections were seen. The median operating time was 204 min, the median anastomosis time was 29 min, and median blood loss was 571 mL.
In comparing groups I and II, group I required an operative time of 194 min, compared with 253 min in group II. Mean aortic cross-clamp time was 37 min in group I and 93 min in group II, while the mean blood loss was greater in group II (1,210 mL) as compared with group 1 (320 mL).
“The robotic system provides a real opportunity for minimally invasive surgery in the field of vascular surgery ... with all its advantages. Robotic AAA [abdominal aortic aneurysm] and aortofemoral bypass represent the standard operations in vascular surgery and they are not only possible, but safe and effective,” said Dr. Štádler and his colleagues. They added, however, that “further randomized studies are needed to ensure its benefits and the cost-effectiveness of robotic vascular surgery, compared with open and laparoscopic repair.”
Dr, Štádler and his colleagues reported that they had no disclosures.
FROM EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Key clinical point: Robotic-assisted vascular surgery procedures appeared safe and provided benefits in speed and simplicity for vascular anastomoses.
Major finding: A total of 298 (96.1%) cases were successfully completed robotically, with a 30-day mortality of 0.3% and two (0.6%) late prosthetic infections seen.
Data source: A prospective study was performed assessing 310 robotic-assisted vascular procedures.
Disclosures: The authors reported that they had no disclosures.
Endovascular surges over surgery for patients hospitalized for CLI
Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.
In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.
The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].
Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.
A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).
Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).
Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.
Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.
In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.
“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.
The authors reported that they had no relevant disclosures.
Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.
Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.
Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.
Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.
Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.
Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.
Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.
Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.
Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.
Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.
Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.
Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.
Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.
In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.
The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].
Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.
A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).
Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).
Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.
Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.
In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.
“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.
The authors reported that they had no relevant disclosures.
Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.
In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.
The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].
Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.
A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).
Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).
Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.
Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.
In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.
“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.
The authors reported that they had no relevant disclosures.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Surgery in hospitalized CLI patients decreased and endovascular treatment increased from 2003 to 2011 with a concomitant decrease in in-hospital mortality and major amputation.
Major finding: Surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%.
Data source: A retrospective database analysis of 642,433 patients hospitalized with CLI from 2003 to 2011 who were included in the Nationwide Inpatient Sample.
Disclosures: The authors reported that they had no relevant disclosures.
Lies, damn lies, and research: Improving reproducibility in biomedical science
The issue of scientific reproducibility has come to the fore in the past several years, driven by noteworthy failures to replicate critical findings in several much-publicized reports coupled to a series of scandals calling into question the role of journals and granting agencies in maintaining quality and oversight.
In a special Nature online collection, the journal assembled articles and perspectives from 2011 to the present dealing with this issue of research reproducibility in science and medicine. These articles were supplemented with current editorial comment.
Seeing these broad spectrum concerns pulled together in one place makes it difficult not to be pessimistic about the current state of research investigations across the board. The saving grace, however, is that these same reports show that a lot of people realize that there is a problem – people who are trying to make changes and who are in a position to be effective.
According to the reports presented in the collection, the problems in research accountability and reproducibility have grown to an alarming extent. In one estimate, irreproducibility ends up costing biomedical research some $28 billion wasted dollars per year (Nature. 2015 Jun 9. doi: 10.1038/nature.2015.17711).
A litany of concerns
In 2012, scientists at AMGEN (Thousand Oaks, Calif.) reported that, even cooperating closely with the original investigators, they were able to reproduce only 6 of 53 studies considered to be benchmarks of cancer research (Nature. 2016 Feb 4. doi: 10.1038/nature.2016.19269).
Scientists at Bayer HealthCare reported in Nature Reviews Drug Discovery that they could successfully reproduce results in only a quarter of 67 so-called seminal studies (2011 Sep. doi: 10.1038/nrd3439-c1).
According to a 2013 report in The Economist, Dr. John Ioannidis, an expert in the field of scientific reproducibility, argued that in his field, “epidemiology, you might expect one in ten hypotheses to be true. In exploratory disciplines like genomics, which rely on combing through vast troves of data about genes and proteins for interesting relationships, you might expect just one in a thousand to prove correct.”
This increasing litany of irreproducibility has raised alarm in the scientific community and has led to a search for answers, as so many preclinical studies form the precursor data for eventual human trials.
Despite the concerns raised, human clinical trials seem to be less at risk for irreproducibility, according to an editorial by Dr. Francis S. Collins, director, and Dr. Lawrence A. Tabak, principal deputy director of the U.S. National Institutes of Health, “because they are already governed by various regulations that stipulate rigorous design and independent oversight – including randomization, blinding, power estimates, pre-registration of outcome measures in standardized, public databases such as ClinicalTrials.gov and oversight by institutional review boards and data safety monitoring boards. Furthermore, the clinical trials community has taken important steps toward adopting standard reporting elements,” (Nature. 2014 Jan. doi: 10.1038/505612a).
The paucity of P
Today, the P-value, .05 or less, is all too often considered the sine qua non of scientific proof. “Most statisticians consider this appalling, as the P value was never intended to be used as a strong indicator of certainty as it too often is today. Most scientists would look at [a] P value of .01 and say that there was just a 1% chance of [the] result being a false alarm. But they would be wrong.” The 2014 report goes on to state how, according to one widely used calculation by authentic statisticians, a P value of .01 corresponds to a false-alarm probability of at least 11%, depending on the underlying probability that there is a true effect; a P value of .05 raises that chance of a false alarm to at least 29% (Nature. 2014 Feb. doi: 10.1038/506150a).
Beyond this assessment problem, P values may allow for considerable researcher bias, conscious and unconscious, even to the extent of encouraging “P-hacking”: one of the few statistical terms to ever make it into the Urban Dictionary. “P-hacking is trying multiple things until you get the desired result” – even unconsciously, according to one researcher quoted.
In addition, “unless statistical power is very high (and much higher than in most experiments), the P value should be interpreted tentatively at best” (Nat Methods. 2015 Feb 26. doi: 10.1038/nmeth.3288).
So bad is the problem that “misuse of the P value – a common test for judging the strength of scientific evidence – is contributing to the number of research findings that cannot be reproduced,” the American Statistical Association warns in a statement released in March, adding that the P value cannot be used to determine whether a hypothesis is true or even whether results are important (Nature. 2016 Mar 7. doi: 10.1038/nature.2016.19503).
And none of this even remotely addresses those instances where researchers report findings that “trend towards significance” when they can’t even meet the magical P threshold.
A muddling of mice (and more)
Fundamental to biological research is the vast array of preliminary animal studies that must be performed before clinical testing can begin.
Animal-based research has been under intense scrutiny due to a variety of perceived flaws and omissions that have been found to be all too common. For example, in a report in PLoS Biology, Dr. Ulrich Dirnagl of the Charité Medical University in Berlin reviewed 100 reports published between 2000 and 2013, which included 522 experiments using rodents to test cancer and stroke treatments. Around two-thirds of the experiments did not report whether any animals had been dropped from the final analysis, and of the 30% that did report rodents dropped from analysis, only 14 explained why (2016 Jan 4. doi: 10.1371/journal.pbio.1002331). Similarly, Dr. John Ioannidis and his colleagues assessed a random sample of 268 biomedical papers listed in PubMed published between 2000 and 2014 and found that only one contained sufficient details to replicate the work (Nature. 2016 Jan 5. doi: 10.1038/nature.2015.19101).
A multitude of genetic and environmental factors have also been found influential in animal research. For example, the gut microbiome (which has been found to influence many aspects of mouse health and metabolism) varies widely in the same species of mice fed on different diets or obtained from different vendors. And there can be differences in physiology and behavior based on circadian rhythms, and even variations in cage design (Nature. 2016 Feb 16. doi: 10.1038/530254a).
But things are looking brighter. By the beginning of 2016, more than 600 journals had signed up for the voluntary ARRIVE (Animals in Research: Reporting of In Vivo Experiments) guidelines designed to improve the reporting of animal experiments. The guidelines include a checklist of elements to be included in any reporting of animal research, including animal strain, sex, and adverse events (Nature. 2016 Feb 1. doi: 10.1038/nature.2016.19274).
Problems have also been reported in the use of cell lines and antibodies in biomedical research. For example, a report in Nature indicated that too many biomedical researchers are lax in checking for impostor cell lines when they perform their research (Nature. 2015 Oct 12. doi: 10.1038/nature.2015.18544). And recent studies have shown that improper or misused antibodies are a significant source of false findings and irreproducibility in the modern literature (Nature. 2015 May 19. doi: 10.1038/521274a).
Reviewer, view thyself
The editorial in The Economist also discussed some of the failures of the peer-reviewed scientific literature, usually considered the final gateway of quality control, to provide appropriate review and correction of research errors. The editorial cites a damning test of lower-tier research publications by Dr. John Bohannon, a biologist at Harvard, who submitted a pseudonymous paper on the effects of a chemical derived from lichen cells to 304 journals describing themselves as using peer review. The paper was concocted wholesale with manifold and obvious errors in study design, analysis, and interpretation of results, according to Dr. Bohannon. This fictitious paper from a fictitious researcher based at a fictitious university was accepted for publication by an alarming 147 of the journals.
The problem is not new. In 1998, Dr. Fiona Godlee, editor of the British Medical Journal, sent an article with eight deliberate mistakes in study design, analysis, and interpretation to more than 200 of the journal’s regular reviewers. None of the reviewers found all the mistakes, and on average, they spotted fewer than two. And another study by the BMJ showed that experience was an issue, not in improving quality of reviewers, but quite the opposite. Over a 14-year period assessed, 1,500 referees, as rated by editors at leading journals, showed a slow but steady drop in their scores.
Such studies prompted a profound reassessment by the journals, in part pushed by some major granting agencies, including the National Institutes of Health.
Not taking grants for granted
The National Institutes for Health are advancing efforts to expand scientific rigor and reproducibility in their grants projects.
“As part of an increasing drive to boost the reliability of research, the NIH will require applicants to explain the scientific premise behind their proposals and defend the quality of their experimental designs. They must also account for biological variables (for example, by including both male and female mice in planned studies) and describe how they will authenticate experimental materials such as cell lines and antibodies.”
Whether current efforts by scientists, societies, granting organizations, and journals can lead to authentic reform and a vast and relatively quick improvement in reproducibility of scientific results is still an open question. In discussing a 2015 report on the subject by the biomedical research community in the United Kingdom, neurophysiologist Dr. Dorothy Bishop had this to say: “I feel quite upbeat about it. ... Now that we’re aware of it, we have all sorts of ideas about how to deal with it. These are doable things. I feel that the mood is one of making science a much better thing. It might lead to slightly slower science. That could be better” (Nature. 2015 Oct 29. doi: 10.1038/nature.2015.18684).
In the recent Nature editorial, “Repetitive flaws,” comments are offered regarding the new NIH guidelines that require grant proposals to account for biological variables and describe how experimental materials may be authenticated (2016 Jan 21. doi: 10.1038/529256a). It is proposed that these requirements will attempt to improve the quality and reproducibility of research. Many concerns regarding scientific reproducibility have been raised in the past few years. As the editorial states, the NIH guidelines “can help to make researchers aspire to the values that produced them” and they can “inspire researchers to uphold their identity and integrity.”
To those investigators who strive to report only their best results following exhaustive and sincere confirmation, these guidelines will not seem threatening. Providing experimental details of one’s work is helpful in many ways (you can personally reproduce them with new and different lab personnel or after a lapse of time, you will have excellent experimental records, you will have excellent documentation when it comes time to write another grant, and so on), and I have personally been frustrated when my laboratory cannot duplicate published work of others. However, questions raised include who will pay for reproducing the work of others and how will the sacrifice of additional animals or subjects be justified? Many laboratories are already financially strapped due to current funding challenges and time is also extremely valuable. In addition, junior researchers are on tenure and promotion timelines that provide stress and need for publications to establish independence and credibility, and established investigators must document continued productivity to be judged adequate to obtain continued funding.
The quality of peer review of research publications has also been challenged recently, adding to the concern over the veracity of published research. Many journals now have mandatory statistical review prior to acceptance. This also delays time to publication. In addition, the generous reviewers who perform peer review often do so at the cost of their valuable, uncompensated time.
Despite these hurdles and questions, those who perform valuable and needed research to improve the lives and care of our patients must continue to strive to produce the highest level of evidence.
Dr. Jennifer S. Lawton is a professor of surgery at the division of cardiothoracic surgery, Washington University, St. Louis. She is also an associate medical editor for Thoracic Surgery News.
In the recent Nature editorial, “Repetitive flaws,” comments are offered regarding the new NIH guidelines that require grant proposals to account for biological variables and describe how experimental materials may be authenticated (2016 Jan 21. doi: 10.1038/529256a). It is proposed that these requirements will attempt to improve the quality and reproducibility of research. Many concerns regarding scientific reproducibility have been raised in the past few years. As the editorial states, the NIH guidelines “can help to make researchers aspire to the values that produced them” and they can “inspire researchers to uphold their identity and integrity.”
To those investigators who strive to report only their best results following exhaustive and sincere confirmation, these guidelines will not seem threatening. Providing experimental details of one’s work is helpful in many ways (you can personally reproduce them with new and different lab personnel or after a lapse of time, you will have excellent experimental records, you will have excellent documentation when it comes time to write another grant, and so on), and I have personally been frustrated when my laboratory cannot duplicate published work of others. However, questions raised include who will pay for reproducing the work of others and how will the sacrifice of additional animals or subjects be justified? Many laboratories are already financially strapped due to current funding challenges and time is also extremely valuable. In addition, junior researchers are on tenure and promotion timelines that provide stress and need for publications to establish independence and credibility, and established investigators must document continued productivity to be judged adequate to obtain continued funding.
The quality of peer review of research publications has also been challenged recently, adding to the concern over the veracity of published research. Many journals now have mandatory statistical review prior to acceptance. This also delays time to publication. In addition, the generous reviewers who perform peer review often do so at the cost of their valuable, uncompensated time.
Despite these hurdles and questions, those who perform valuable and needed research to improve the lives and care of our patients must continue to strive to produce the highest level of evidence.
Dr. Jennifer S. Lawton is a professor of surgery at the division of cardiothoracic surgery, Washington University, St. Louis. She is also an associate medical editor for Thoracic Surgery News.
In the recent Nature editorial, “Repetitive flaws,” comments are offered regarding the new NIH guidelines that require grant proposals to account for biological variables and describe how experimental materials may be authenticated (2016 Jan 21. doi: 10.1038/529256a). It is proposed that these requirements will attempt to improve the quality and reproducibility of research. Many concerns regarding scientific reproducibility have been raised in the past few years. As the editorial states, the NIH guidelines “can help to make researchers aspire to the values that produced them” and they can “inspire researchers to uphold their identity and integrity.”
To those investigators who strive to report only their best results following exhaustive and sincere confirmation, these guidelines will not seem threatening. Providing experimental details of one’s work is helpful in many ways (you can personally reproduce them with new and different lab personnel or after a lapse of time, you will have excellent experimental records, you will have excellent documentation when it comes time to write another grant, and so on), and I have personally been frustrated when my laboratory cannot duplicate published work of others. However, questions raised include who will pay for reproducing the work of others and how will the sacrifice of additional animals or subjects be justified? Many laboratories are already financially strapped due to current funding challenges and time is also extremely valuable. In addition, junior researchers are on tenure and promotion timelines that provide stress and need for publications to establish independence and credibility, and established investigators must document continued productivity to be judged adequate to obtain continued funding.
The quality of peer review of research publications has also been challenged recently, adding to the concern over the veracity of published research. Many journals now have mandatory statistical review prior to acceptance. This also delays time to publication. In addition, the generous reviewers who perform peer review often do so at the cost of their valuable, uncompensated time.
Despite these hurdles and questions, those who perform valuable and needed research to improve the lives and care of our patients must continue to strive to produce the highest level of evidence.
Dr. Jennifer S. Lawton is a professor of surgery at the division of cardiothoracic surgery, Washington University, St. Louis. She is also an associate medical editor for Thoracic Surgery News.
The issue of scientific reproducibility has come to the fore in the past several years, driven by noteworthy failures to replicate critical findings in several much-publicized reports coupled to a series of scandals calling into question the role of journals and granting agencies in maintaining quality and oversight.
In a special Nature online collection, the journal assembled articles and perspectives from 2011 to the present dealing with this issue of research reproducibility in science and medicine. These articles were supplemented with current editorial comment.
Seeing these broad spectrum concerns pulled together in one place makes it difficult not to be pessimistic about the current state of research investigations across the board. The saving grace, however, is that these same reports show that a lot of people realize that there is a problem – people who are trying to make changes and who are in a position to be effective.
According to the reports presented in the collection, the problems in research accountability and reproducibility have grown to an alarming extent. In one estimate, irreproducibility ends up costing biomedical research some $28 billion wasted dollars per year (Nature. 2015 Jun 9. doi: 10.1038/nature.2015.17711).
A litany of concerns
In 2012, scientists at AMGEN (Thousand Oaks, Calif.) reported that, even cooperating closely with the original investigators, they were able to reproduce only 6 of 53 studies considered to be benchmarks of cancer research (Nature. 2016 Feb 4. doi: 10.1038/nature.2016.19269).
Scientists at Bayer HealthCare reported in Nature Reviews Drug Discovery that they could successfully reproduce results in only a quarter of 67 so-called seminal studies (2011 Sep. doi: 10.1038/nrd3439-c1).
According to a 2013 report in The Economist, Dr. John Ioannidis, an expert in the field of scientific reproducibility, argued that in his field, “epidemiology, you might expect one in ten hypotheses to be true. In exploratory disciplines like genomics, which rely on combing through vast troves of data about genes and proteins for interesting relationships, you might expect just one in a thousand to prove correct.”
This increasing litany of irreproducibility has raised alarm in the scientific community and has led to a search for answers, as so many preclinical studies form the precursor data for eventual human trials.
Despite the concerns raised, human clinical trials seem to be less at risk for irreproducibility, according to an editorial by Dr. Francis S. Collins, director, and Dr. Lawrence A. Tabak, principal deputy director of the U.S. National Institutes of Health, “because they are already governed by various regulations that stipulate rigorous design and independent oversight – including randomization, blinding, power estimates, pre-registration of outcome measures in standardized, public databases such as ClinicalTrials.gov and oversight by institutional review boards and data safety monitoring boards. Furthermore, the clinical trials community has taken important steps toward adopting standard reporting elements,” (Nature. 2014 Jan. doi: 10.1038/505612a).
The paucity of P
Today, the P-value, .05 or less, is all too often considered the sine qua non of scientific proof. “Most statisticians consider this appalling, as the P value was never intended to be used as a strong indicator of certainty as it too often is today. Most scientists would look at [a] P value of .01 and say that there was just a 1% chance of [the] result being a false alarm. But they would be wrong.” The 2014 report goes on to state how, according to one widely used calculation by authentic statisticians, a P value of .01 corresponds to a false-alarm probability of at least 11%, depending on the underlying probability that there is a true effect; a P value of .05 raises that chance of a false alarm to at least 29% (Nature. 2014 Feb. doi: 10.1038/506150a).
Beyond this assessment problem, P values may allow for considerable researcher bias, conscious and unconscious, even to the extent of encouraging “P-hacking”: one of the few statistical terms to ever make it into the Urban Dictionary. “P-hacking is trying multiple things until you get the desired result” – even unconsciously, according to one researcher quoted.
In addition, “unless statistical power is very high (and much higher than in most experiments), the P value should be interpreted tentatively at best” (Nat Methods. 2015 Feb 26. doi: 10.1038/nmeth.3288).
So bad is the problem that “misuse of the P value – a common test for judging the strength of scientific evidence – is contributing to the number of research findings that cannot be reproduced,” the American Statistical Association warns in a statement released in March, adding that the P value cannot be used to determine whether a hypothesis is true or even whether results are important (Nature. 2016 Mar 7. doi: 10.1038/nature.2016.19503).
And none of this even remotely addresses those instances where researchers report findings that “trend towards significance” when they can’t even meet the magical P threshold.
A muddling of mice (and more)
Fundamental to biological research is the vast array of preliminary animal studies that must be performed before clinical testing can begin.
Animal-based research has been under intense scrutiny due to a variety of perceived flaws and omissions that have been found to be all too common. For example, in a report in PLoS Biology, Dr. Ulrich Dirnagl of the Charité Medical University in Berlin reviewed 100 reports published between 2000 and 2013, which included 522 experiments using rodents to test cancer and stroke treatments. Around two-thirds of the experiments did not report whether any animals had been dropped from the final analysis, and of the 30% that did report rodents dropped from analysis, only 14 explained why (2016 Jan 4. doi: 10.1371/journal.pbio.1002331). Similarly, Dr. John Ioannidis and his colleagues assessed a random sample of 268 biomedical papers listed in PubMed published between 2000 and 2014 and found that only one contained sufficient details to replicate the work (Nature. 2016 Jan 5. doi: 10.1038/nature.2015.19101).
A multitude of genetic and environmental factors have also been found influential in animal research. For example, the gut microbiome (which has been found to influence many aspects of mouse health and metabolism) varies widely in the same species of mice fed on different diets or obtained from different vendors. And there can be differences in physiology and behavior based on circadian rhythms, and even variations in cage design (Nature. 2016 Feb 16. doi: 10.1038/530254a).
But things are looking brighter. By the beginning of 2016, more than 600 journals had signed up for the voluntary ARRIVE (Animals in Research: Reporting of In Vivo Experiments) guidelines designed to improve the reporting of animal experiments. The guidelines include a checklist of elements to be included in any reporting of animal research, including animal strain, sex, and adverse events (Nature. 2016 Feb 1. doi: 10.1038/nature.2016.19274).
Problems have also been reported in the use of cell lines and antibodies in biomedical research. For example, a report in Nature indicated that too many biomedical researchers are lax in checking for impostor cell lines when they perform their research (Nature. 2015 Oct 12. doi: 10.1038/nature.2015.18544). And recent studies have shown that improper or misused antibodies are a significant source of false findings and irreproducibility in the modern literature (Nature. 2015 May 19. doi: 10.1038/521274a).
Reviewer, view thyself
The editorial in The Economist also discussed some of the failures of the peer-reviewed scientific literature, usually considered the final gateway of quality control, to provide appropriate review and correction of research errors. The editorial cites a damning test of lower-tier research publications by Dr. John Bohannon, a biologist at Harvard, who submitted a pseudonymous paper on the effects of a chemical derived from lichen cells to 304 journals describing themselves as using peer review. The paper was concocted wholesale with manifold and obvious errors in study design, analysis, and interpretation of results, according to Dr. Bohannon. This fictitious paper from a fictitious researcher based at a fictitious university was accepted for publication by an alarming 147 of the journals.
The problem is not new. In 1998, Dr. Fiona Godlee, editor of the British Medical Journal, sent an article with eight deliberate mistakes in study design, analysis, and interpretation to more than 200 of the journal’s regular reviewers. None of the reviewers found all the mistakes, and on average, they spotted fewer than two. And another study by the BMJ showed that experience was an issue, not in improving quality of reviewers, but quite the opposite. Over a 14-year period assessed, 1,500 referees, as rated by editors at leading journals, showed a slow but steady drop in their scores.
Such studies prompted a profound reassessment by the journals, in part pushed by some major granting agencies, including the National Institutes of Health.
Not taking grants for granted
The National Institutes for Health are advancing efforts to expand scientific rigor and reproducibility in their grants projects.
“As part of an increasing drive to boost the reliability of research, the NIH will require applicants to explain the scientific premise behind their proposals and defend the quality of their experimental designs. They must also account for biological variables (for example, by including both male and female mice in planned studies) and describe how they will authenticate experimental materials such as cell lines and antibodies.”
Whether current efforts by scientists, societies, granting organizations, and journals can lead to authentic reform and a vast and relatively quick improvement in reproducibility of scientific results is still an open question. In discussing a 2015 report on the subject by the biomedical research community in the United Kingdom, neurophysiologist Dr. Dorothy Bishop had this to say: “I feel quite upbeat about it. ... Now that we’re aware of it, we have all sorts of ideas about how to deal with it. These are doable things. I feel that the mood is one of making science a much better thing. It might lead to slightly slower science. That could be better” (Nature. 2015 Oct 29. doi: 10.1038/nature.2015.18684).
The issue of scientific reproducibility has come to the fore in the past several years, driven by noteworthy failures to replicate critical findings in several much-publicized reports coupled to a series of scandals calling into question the role of journals and granting agencies in maintaining quality and oversight.
In a special Nature online collection, the journal assembled articles and perspectives from 2011 to the present dealing with this issue of research reproducibility in science and medicine. These articles were supplemented with current editorial comment.
Seeing these broad spectrum concerns pulled together in one place makes it difficult not to be pessimistic about the current state of research investigations across the board. The saving grace, however, is that these same reports show that a lot of people realize that there is a problem – people who are trying to make changes and who are in a position to be effective.
According to the reports presented in the collection, the problems in research accountability and reproducibility have grown to an alarming extent. In one estimate, irreproducibility ends up costing biomedical research some $28 billion wasted dollars per year (Nature. 2015 Jun 9. doi: 10.1038/nature.2015.17711).
A litany of concerns
In 2012, scientists at AMGEN (Thousand Oaks, Calif.) reported that, even cooperating closely with the original investigators, they were able to reproduce only 6 of 53 studies considered to be benchmarks of cancer research (Nature. 2016 Feb 4. doi: 10.1038/nature.2016.19269).
Scientists at Bayer HealthCare reported in Nature Reviews Drug Discovery that they could successfully reproduce results in only a quarter of 67 so-called seminal studies (2011 Sep. doi: 10.1038/nrd3439-c1).
According to a 2013 report in The Economist, Dr. John Ioannidis, an expert in the field of scientific reproducibility, argued that in his field, “epidemiology, you might expect one in ten hypotheses to be true. In exploratory disciplines like genomics, which rely on combing through vast troves of data about genes and proteins for interesting relationships, you might expect just one in a thousand to prove correct.”
This increasing litany of irreproducibility has raised alarm in the scientific community and has led to a search for answers, as so many preclinical studies form the precursor data for eventual human trials.
Despite the concerns raised, human clinical trials seem to be less at risk for irreproducibility, according to an editorial by Dr. Francis S. Collins, director, and Dr. Lawrence A. Tabak, principal deputy director of the U.S. National Institutes of Health, “because they are already governed by various regulations that stipulate rigorous design and independent oversight – including randomization, blinding, power estimates, pre-registration of outcome measures in standardized, public databases such as ClinicalTrials.gov and oversight by institutional review boards and data safety monitoring boards. Furthermore, the clinical trials community has taken important steps toward adopting standard reporting elements,” (Nature. 2014 Jan. doi: 10.1038/505612a).
The paucity of P
Today, the P-value, .05 or less, is all too often considered the sine qua non of scientific proof. “Most statisticians consider this appalling, as the P value was never intended to be used as a strong indicator of certainty as it too often is today. Most scientists would look at [a] P value of .01 and say that there was just a 1% chance of [the] result being a false alarm. But they would be wrong.” The 2014 report goes on to state how, according to one widely used calculation by authentic statisticians, a P value of .01 corresponds to a false-alarm probability of at least 11%, depending on the underlying probability that there is a true effect; a P value of .05 raises that chance of a false alarm to at least 29% (Nature. 2014 Feb. doi: 10.1038/506150a).
Beyond this assessment problem, P values may allow for considerable researcher bias, conscious and unconscious, even to the extent of encouraging “P-hacking”: one of the few statistical terms to ever make it into the Urban Dictionary. “P-hacking is trying multiple things until you get the desired result” – even unconsciously, according to one researcher quoted.
In addition, “unless statistical power is very high (and much higher than in most experiments), the P value should be interpreted tentatively at best” (Nat Methods. 2015 Feb 26. doi: 10.1038/nmeth.3288).
So bad is the problem that “misuse of the P value – a common test for judging the strength of scientific evidence – is contributing to the number of research findings that cannot be reproduced,” the American Statistical Association warns in a statement released in March, adding that the P value cannot be used to determine whether a hypothesis is true or even whether results are important (Nature. 2016 Mar 7. doi: 10.1038/nature.2016.19503).
And none of this even remotely addresses those instances where researchers report findings that “trend towards significance” when they can’t even meet the magical P threshold.
A muddling of mice (and more)
Fundamental to biological research is the vast array of preliminary animal studies that must be performed before clinical testing can begin.
Animal-based research has been under intense scrutiny due to a variety of perceived flaws and omissions that have been found to be all too common. For example, in a report in PLoS Biology, Dr. Ulrich Dirnagl of the Charité Medical University in Berlin reviewed 100 reports published between 2000 and 2013, which included 522 experiments using rodents to test cancer and stroke treatments. Around two-thirds of the experiments did not report whether any animals had been dropped from the final analysis, and of the 30% that did report rodents dropped from analysis, only 14 explained why (2016 Jan 4. doi: 10.1371/journal.pbio.1002331). Similarly, Dr. John Ioannidis and his colleagues assessed a random sample of 268 biomedical papers listed in PubMed published between 2000 and 2014 and found that only one contained sufficient details to replicate the work (Nature. 2016 Jan 5. doi: 10.1038/nature.2015.19101).
A multitude of genetic and environmental factors have also been found influential in animal research. For example, the gut microbiome (which has been found to influence many aspects of mouse health and metabolism) varies widely in the same species of mice fed on different diets or obtained from different vendors. And there can be differences in physiology and behavior based on circadian rhythms, and even variations in cage design (Nature. 2016 Feb 16. doi: 10.1038/530254a).
But things are looking brighter. By the beginning of 2016, more than 600 journals had signed up for the voluntary ARRIVE (Animals in Research: Reporting of In Vivo Experiments) guidelines designed to improve the reporting of animal experiments. The guidelines include a checklist of elements to be included in any reporting of animal research, including animal strain, sex, and adverse events (Nature. 2016 Feb 1. doi: 10.1038/nature.2016.19274).
Problems have also been reported in the use of cell lines and antibodies in biomedical research. For example, a report in Nature indicated that too many biomedical researchers are lax in checking for impostor cell lines when they perform their research (Nature. 2015 Oct 12. doi: 10.1038/nature.2015.18544). And recent studies have shown that improper or misused antibodies are a significant source of false findings and irreproducibility in the modern literature (Nature. 2015 May 19. doi: 10.1038/521274a).
Reviewer, view thyself
The editorial in The Economist also discussed some of the failures of the peer-reviewed scientific literature, usually considered the final gateway of quality control, to provide appropriate review and correction of research errors. The editorial cites a damning test of lower-tier research publications by Dr. John Bohannon, a biologist at Harvard, who submitted a pseudonymous paper on the effects of a chemical derived from lichen cells to 304 journals describing themselves as using peer review. The paper was concocted wholesale with manifold and obvious errors in study design, analysis, and interpretation of results, according to Dr. Bohannon. This fictitious paper from a fictitious researcher based at a fictitious university was accepted for publication by an alarming 147 of the journals.
The problem is not new. In 1998, Dr. Fiona Godlee, editor of the British Medical Journal, sent an article with eight deliberate mistakes in study design, analysis, and interpretation to more than 200 of the journal’s regular reviewers. None of the reviewers found all the mistakes, and on average, they spotted fewer than two. And another study by the BMJ showed that experience was an issue, not in improving quality of reviewers, but quite the opposite. Over a 14-year period assessed, 1,500 referees, as rated by editors at leading journals, showed a slow but steady drop in their scores.
Such studies prompted a profound reassessment by the journals, in part pushed by some major granting agencies, including the National Institutes of Health.
Not taking grants for granted
The National Institutes for Health are advancing efforts to expand scientific rigor and reproducibility in their grants projects.
“As part of an increasing drive to boost the reliability of research, the NIH will require applicants to explain the scientific premise behind their proposals and defend the quality of their experimental designs. They must also account for biological variables (for example, by including both male and female mice in planned studies) and describe how they will authenticate experimental materials such as cell lines and antibodies.”
Whether current efforts by scientists, societies, granting organizations, and journals can lead to authentic reform and a vast and relatively quick improvement in reproducibility of scientific results is still an open question. In discussing a 2015 report on the subject by the biomedical research community in the United Kingdom, neurophysiologist Dr. Dorothy Bishop had this to say: “I feel quite upbeat about it. ... Now that we’re aware of it, we have all sorts of ideas about how to deal with it. These are doable things. I feel that the mood is one of making science a much better thing. It might lead to slightly slower science. That could be better” (Nature. 2015 Oct 29. doi: 10.1038/nature.2015.18684).
CABG with ITA for moderate stenosis improved long-term survival
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Grafting moderately stenosed coronary arteries using with internal thoracic arteries improved long-term survival.
Major finding: ITA grafting, compared with no grafting or use of a saphenous vein graft, yielded a 22% lower long-term mortality.
Data source: Researchers performed a prospective study of 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry who had a single coronary artery with moderate stenosis.
Disclosures: The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
NSQIP calculator shown inadequate to stratify risk in stage I non–small cell lung cancer.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: The current NSQIP Surgical Risk Calculator does not adequately estimate risk among patients with clinical stage I non–small cell lung cancer.
Major finding: The NSQIP risk calculator significantly underestimated serious complication risk in operative patients (16.6% actual risk vs. 8.8% predicted) and did not adequately stratify risk between surgical and stereotactic body radiation therapy (SBRT) patients.
Data source: Researchers retrospectively assessed 279 NSCLC stage I lung cancer patients who underwent surgery vs. 206 patients who underwent SBRT from 2009 to 2012.
Disclosures: The study was supported by grants from the National Institutes of Health. The authors had no relevant financial disclosures.
MRI assessment of pulmonary vein stenosis predicts outcomes
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
 |
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Survival after pulmonary vein stenosis repair was adversely affected by smaller upstream cross-sectional area indexed to body surface area.
Major finding: Smaller upstream total cross-sectional area indexed for body surface area (P = .30) and greater number of stenotic pulmonary veins (P = .007) were associated with increased early risk of death.
Data source: Researchers reviewed the outcomes of 31/145 patients who underwent surgical repair of pulmonary stenosis who had preoperative computed tomography and magnetic resonance imaging between 1990 and 2012.
Disclosures: The authors reported that they had no conflicts of interest.
FDA approves marketing of sutureless aortic valve
LivaNova announced that the U.S. Food and Drug Administration has announced the approval of their Perceval Sutureless Heart Valve. The approval was issued Jan. 8 and is effective immediately, and LivaNova indicated that it will begin commercial distribution of the device in the United States over the coming quarter.
According to an FDA summary document, the Perceval Sutureless Heart Valve is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The self-expanding stent frame consists of a tissue component made from bovine pericardium and a self-expandable nitinol stent, along with a dedicated delivery system that allows physicians to position and anchor the valve suturelessly.
The Perceval heart valve is supplied unmounted and must be loaded onto an accompanying holder by reducing the valve size using a supplied polycarbonate collapser. The holder is used for sternal approaches and includes a rigid shaft with an end section that houses the valve prosthesis during delivery. A separate holder, approximately 3 cm longer, is also available for minimally invasive procedures. After implantation, the physician uses the a post-dilation catheter to expand the valve in situ.
Perceval’s approval was based upon the results of a pivotal European study performed to assess the device, the CAVALIER (Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark) trial. The prospective, multicenter, nonrandomized clinical study was conducted at 26 investigational sites in Austria, Belgium, England, France, Germany, and the Netherlands.
Patients were treated between Feb. 23, 2010, and Sept. 30, 2013, and the database for the PDA-assessed data collected through Nov. 5, 2014, and included 658 patients.
The differences between the New York Heart Association (NYHA) class at 12 months and the baseline were calculated. In total, 77.5% of patients showed a decrease of NYHA equal to at least one class, whereas 19.7% of patients remained stable over the time. Only 2.8% of patients showed a worsened clinical status.
Reduction in mean gradients and increase in effective orifice area were both observed at 1 year follow-up, according to the FDA report.
At the 1-, 2-, and 3-year follow-up time points, 75.1% or greater of the implanted patients with available data had improved by one to three classes and at the 4-year follow-up time point 72.6% of the patients had improved by one to three classes, according to the report. In addition, at the 1-, 2-, and 3-year follow-up time points, 92.9% or greater of the patients were in NYHA Class I and Class II, and at the 4-year follow-up time point, 86.3% of the patients were in NYHA Class I and Class II.
Although there was a predominance of women in the study population (64.4%), patients of both sexes demonstrated acceptable hemodynamic outcomes and significant improvement in functional status, according to the FDA summary.
Sutureless valves are considered to have a promising future according to a recent international consensus panel recommendationpublished online in the European Journal of Cardio-Thoracic Surgery (2015 Oct 29. doi: 10.1093/ejcts/ezv369). The report assessed various benefits of sutureless and rapid deployment technology, and concluded these devices “may represent a helpful tool in aortic valve replacement for patients requiring a biological valve.” However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves, they concluded.
LivaNova announced that the U.S. Food and Drug Administration has announced the approval of their Perceval Sutureless Heart Valve. The approval was issued Jan. 8 and is effective immediately, and LivaNova indicated that it will begin commercial distribution of the device in the United States over the coming quarter.
According to an FDA summary document, the Perceval Sutureless Heart Valve is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The self-expanding stent frame consists of a tissue component made from bovine pericardium and a self-expandable nitinol stent, along with a dedicated delivery system that allows physicians to position and anchor the valve suturelessly.
The Perceval heart valve is supplied unmounted and must be loaded onto an accompanying holder by reducing the valve size using a supplied polycarbonate collapser. The holder is used for sternal approaches and includes a rigid shaft with an end section that houses the valve prosthesis during delivery. A separate holder, approximately 3 cm longer, is also available for minimally invasive procedures. After implantation, the physician uses the a post-dilation catheter to expand the valve in situ.
Perceval’s approval was based upon the results of a pivotal European study performed to assess the device, the CAVALIER (Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark) trial. The prospective, multicenter, nonrandomized clinical study was conducted at 26 investigational sites in Austria, Belgium, England, France, Germany, and the Netherlands.
Patients were treated between Feb. 23, 2010, and Sept. 30, 2013, and the database for the PDA-assessed data collected through Nov. 5, 2014, and included 658 patients.
The differences between the New York Heart Association (NYHA) class at 12 months and the baseline were calculated. In total, 77.5% of patients showed a decrease of NYHA equal to at least one class, whereas 19.7% of patients remained stable over the time. Only 2.8% of patients showed a worsened clinical status.
Reduction in mean gradients and increase in effective orifice area were both observed at 1 year follow-up, according to the FDA report.
At the 1-, 2-, and 3-year follow-up time points, 75.1% or greater of the implanted patients with available data had improved by one to three classes and at the 4-year follow-up time point 72.6% of the patients had improved by one to three classes, according to the report. In addition, at the 1-, 2-, and 3-year follow-up time points, 92.9% or greater of the patients were in NYHA Class I and Class II, and at the 4-year follow-up time point, 86.3% of the patients were in NYHA Class I and Class II.
Although there was a predominance of women in the study population (64.4%), patients of both sexes demonstrated acceptable hemodynamic outcomes and significant improvement in functional status, according to the FDA summary.
Sutureless valves are considered to have a promising future according to a recent international consensus panel recommendationpublished online in the European Journal of Cardio-Thoracic Surgery (2015 Oct 29. doi: 10.1093/ejcts/ezv369). The report assessed various benefits of sutureless and rapid deployment technology, and concluded these devices “may represent a helpful tool in aortic valve replacement for patients requiring a biological valve.” However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves, they concluded.
LivaNova announced that the U.S. Food and Drug Administration has announced the approval of their Perceval Sutureless Heart Valve. The approval was issued Jan. 8 and is effective immediately, and LivaNova indicated that it will begin commercial distribution of the device in the United States over the coming quarter.
According to an FDA summary document, the Perceval Sutureless Heart Valve is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The self-expanding stent frame consists of a tissue component made from bovine pericardium and a self-expandable nitinol stent, along with a dedicated delivery system that allows physicians to position and anchor the valve suturelessly.
The Perceval heart valve is supplied unmounted and must be loaded onto an accompanying holder by reducing the valve size using a supplied polycarbonate collapser. The holder is used for sternal approaches and includes a rigid shaft with an end section that houses the valve prosthesis during delivery. A separate holder, approximately 3 cm longer, is also available for minimally invasive procedures. After implantation, the physician uses the a post-dilation catheter to expand the valve in situ.
Perceval’s approval was based upon the results of a pivotal European study performed to assess the device, the CAVALIER (Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark) trial. The prospective, multicenter, nonrandomized clinical study was conducted at 26 investigational sites in Austria, Belgium, England, France, Germany, and the Netherlands.
Patients were treated between Feb. 23, 2010, and Sept. 30, 2013, and the database for the PDA-assessed data collected through Nov. 5, 2014, and included 658 patients.
The differences between the New York Heart Association (NYHA) class at 12 months and the baseline were calculated. In total, 77.5% of patients showed a decrease of NYHA equal to at least one class, whereas 19.7% of patients remained stable over the time. Only 2.8% of patients showed a worsened clinical status.
Reduction in mean gradients and increase in effective orifice area were both observed at 1 year follow-up, according to the FDA report.
At the 1-, 2-, and 3-year follow-up time points, 75.1% or greater of the implanted patients with available data had improved by one to three classes and at the 4-year follow-up time point 72.6% of the patients had improved by one to three classes, according to the report. In addition, at the 1-, 2-, and 3-year follow-up time points, 92.9% or greater of the patients were in NYHA Class I and Class II, and at the 4-year follow-up time point, 86.3% of the patients were in NYHA Class I and Class II.
Although there was a predominance of women in the study population (64.4%), patients of both sexes demonstrated acceptable hemodynamic outcomes and significant improvement in functional status, according to the FDA summary.
Sutureless valves are considered to have a promising future according to a recent international consensus panel recommendationpublished online in the European Journal of Cardio-Thoracic Surgery (2015 Oct 29. doi: 10.1093/ejcts/ezv369). The report assessed various benefits of sutureless and rapid deployment technology, and concluded these devices “may represent a helpful tool in aortic valve replacement for patients requiring a biological valve.” However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves, they concluded.
AHA/ACC: Consensus recommendations for young athletes with congenital heart disease
Most children and young adult patients with congenital heart disease can and should engage in some form of physical activity and should avoid a sedentary lifestyle, according to a task force scientific statement from the American Heart Association and the American College of Cardiology (AHA/ACC).
This recommendation comes despite the fears of sudden cardiac death (SCD) in young athletes, which formed the initial impetus of the entire series of task force reports.
The recommended level of sports participation for patients with treated or untreated congenital heart defect, however, should consider the training and the competitive aspects of the sport itself and must be individualized to the patient. This means taking into account the patient’s current functional status, history of surgery, and the presence of implanted cardiac devices, according to the report by Dr. George F. Van Hare of Washington University, St. Louis, and his colleagues, which was published online in the Journal of the American College of Cardiology.
The report breaks down its specific recommendations based upon the various types of congenital heart defect (CHD). Full details and nuances of the recommendations and their specific levels of evidence for each individual condition and the many variants can be found in the online publication. Below is a brief and selected summary for some of the most common defects and some of those most pertinent to sudden cardiac death in young athletes.
Simple shunting lesions (atrial septal defect, ventricular septal defect, patent ductus arteriosus): Treated and untreated
In addressing the three most common subtypes of CHD – ventricular septal defect (VSD, 34%), atrial septal defect (ASD, 13%), and patent ductus arteriosus (PDA, 10%) – the committee found no data that children with these lesions are related to acknowledged episodes of sudden cardiac death (SCD). This applied whether the defects were closed or remained open. “With rare exceptions, patients with hemodynamically insignificant CHD such as VSD, ASD, and PDA may participate competitively in all sports,” it concluded. These recommendations fall under class I; level of evidence C for almost all of these patients, according to the writing committee.
Congenital coronary anomalies: Treated and untreated
Anomalies of coronary arteries are the second-most commonly identified structural causes of SCD in competitive athletes, accounting for about 17% of such deaths in the United States, according to the report. The vast majority of sudden deaths associated with coronary anomalies occur during or shortly after exercise. Despite being less commonly represented in patients, among athletes who have died suddenly, anomalous origin of the left main or left anterior descending coronary artery from the right sinus of Valsalva is far more prevalent. In addition, SCDs are most strongly associated with the pattern in which the anomalous left coronary artery passes between the aorta and main pulmonary artery. Recommended return to intense athletic activities is only to be permitted at least 3 months after surgery, and with a demonstration of the absence of ischemia on postoperative stress testing, with evidence levels depending on the type of anomaly. Of note, in contrast, the committee indicated that athletes with an anomalous origin of a right coronary artery from the left sinus of Valsalva should simply be evaluated by an exercise stress test, and for those without symptoms or a positive exercise stress test, permission to compete can be considered after adequate counseling (class IIa; level of evidence C).
Pulmonary valve stenosis: Treated and untreated
The committee determined that athletes with mild pulmonary stenosis (PS) and normal right ventricular (RV) function can participate in all competitive sports, although annual reevaluation also is recommended (class I; level of evidence B). In addition, athletes treated by operation or balloon valvuloplasty who have achieved adequate relief of PS (gradient less than 40 mm Hg by Doppler) can participate in all competitive sports (class I; level of evidence B). Other patients should be restricted to low-intensity sports, according to the committee.
Aortic valve stenosis: Treated and untreated
Children and adolescents with aortic stenosis (AS) are differentiated between those with mild, moderate, and severe AS by physical examination, ECG, and Doppler echocardiography. In all cases, regardless of the degree of stenosis, patients with a history of fatigue, light-headedness, dizziness, syncope, chest pain, or pallor on exercise deserve a full evaluation. Annual re-evaluation is required for all patients with AS because the disease can progress. Patients with severe AS are at risk of sudden death, particularly with exercise. The committee determined that athletes with mild AS can participate in all competitive sports (class I; level of evidence B), but that athletes with severe AS should be restricted from all competitive sports, with the possible exception of low-intensity sports (class III; level of evidence B).
Coarctation of the aorta: Treated and untreated
Before a decision is made regarding exercise participation, a detailed evaluation should be conducted, including a physical examination, ECG, chest radiograph, exercise testing, transthoracic echocardiographic evaluation of the aortic valve and aorta, and either magnetic resonance imaging or computed tomography angiography, according to the committee. The determination as to the level of sports participation permitted requires a complex assessment of these various test results and can range from full participation in the case of the least affected to restrictions to low-intensity sports in those more severely affected.
Cyanotic CHD, including tetralogy of Fallot
Full clinical assessment, including laboratory and exercise testing, should be considered before any physical activity because this population is at very high risk of sudden death, according to the committee. Recommendations are complex and depend on the level of repair and its success, but, in general, significant restrictions are recommended for all but the most effectively treated patients.
Transposition of the great arteries after atrial switch (Mustard or Senning operation)
This is a population highly at risk, according to the committee. They appear to have a unique response to exercise with reports that a high proportion of sudden death events occur during exertion. In addition, evidence of exercise-induced arrhythmias on routine clinical testing has not been shown to reliably predict exercise-induced SCD events. Although recommendations vary, including strong restrictions for many, at best the most successful of these patients should only be considered for low- to moderate-intensity competitive sports, according to the committee.
Other conditions assessed and evaluated by the committee included congenitally corrected TGA, TGA after the arterial switch, Fontan procedure, elevated pulmonary vascular resistence in CHD, ventricular dysfunction after CHD surgery, and Ebstein anomaly of the tricuspid valve.
In all cases, complete physical assessment of these patients is recommended, especially due to the often highly individualized nature of the patient’s presentation of these conditions and the variety and variability of interventions that may have been performed. Such differentials make recommendations regarding sports participation a complex calculus, which the committee attempts to provide, listing whatever evidence is available.
The majority of these patients, however, will not be considered for the highest levels of competitive sports participation. Although, in almost all cases, the need for physical activity as a contributor to patient health and well-being is stressed at whatever level of performance is possible.
The report ”Eligibility and disqualification recommendations for competitive athletes with cardiovascular abnormalities: Task Force 4: congenital heart disease: a scientific statement from the American Heart Association and American College of Cardiology,” was prepared by Dr. Van Hare and his colleagues on behalf of the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, Council on Cardiovascular Disease in the Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and the American College of Cardiology (doi: 10.1016/j.jacc.2015.09.032).
This report is one of the assessments and recommendations of 15 task forces on eligibility and disqualification recommendations for young athletes, nine of which are disease or multidisease related. The other six task forces focus on a variety of relevant topics and issues regarding the risks of young athletes on the field, including screening, the use of automated external defibrillators on the field, the use of dietary supplements and performance-enhancing drugs, sudden death, and the medical-legal perspectives involved.
All 15 task force reports were simultaneously published online in the Journal of the American College of Cardiology and the journal Circulation.
Dr. Van Hare and all but one member of the writing group had no disclosures. One member disclosed consultant/advisory committee associations with a variety of medical device companies.
For many busy clinicians, societal guidelines, task force recommendations, expert consensus statements, and similar authoritative tomes are resources that are scarcely ever read carefully. This is likely not a reflection of the inherent value of such documents, but rather related to the observation that updated guidelines generally reflect, at most, a small change from predecessor versions. (It also should be mentioned that many such contributions are fairly heavy going for even the most determined reader.)
Occasionally, however, a new guideline may signal a dramatic shift in practice, and the recently published AHA/ACC Scientific Statement on Eligibility and Disqualification Recommendations for Competitive Athletes with Cardiovascular Abnormalities (Congenital Heart Disease) contains such a change.
 |
Dr. Robert Jaquiss |
In particular, the new recommendation suggests that athletes with anomalous aortic origin of the right coronary from the left coronary sinus, who have neither symptoms nor a positive stress test, may be allowed to participate in competitive athletics without undergoing surgical repair. As before, those with anomalous left coronary should not be allowed to participate until after surgical treatment.
Prior guidelines suggested that all patients, both anomalous left from right sinus and right from left sinus, be restricted prior to surgery. Because anomalous right coronary is five to six times more common than anomalous left coronary and because it is certainly much less ominous, the previous “one size fits all” approach almost certainly resulted in overtreatment, unnecessary restriction of participation, or both. Furthermore, because anomalous aortic of a coronary artery is so common, occurring in 0.1%-0.2% of the population (300,000 to 600,000 people in the United States), many thousands of competitive athletes will be impacted by the changed guidelines.
Most cardiologists, surgeons, and, most especially, patients will welcome the updated recommendations. Nonetheless, it must be emphasized that anomalous coronary arteries, even anomalous right coronary arteries, may indicate an increased risk of sudden death and that a complete assessment, including stress testing when feasible, and thorough discussion with expert clinicians is still absolutely necessary for such patients and their families.
Dr. Robert Jaquiss of Duke University, Durham, N.C., is the congenital heart section associate medical editor for Thoracic Surgery News.
For many busy clinicians, societal guidelines, task force recommendations, expert consensus statements, and similar authoritative tomes are resources that are scarcely ever read carefully. This is likely not a reflection of the inherent value of such documents, but rather related to the observation that updated guidelines generally reflect, at most, a small change from predecessor versions. (It also should be mentioned that many such contributions are fairly heavy going for even the most determined reader.)
Occasionally, however, a new guideline may signal a dramatic shift in practice, and the recently published AHA/ACC Scientific Statement on Eligibility and Disqualification Recommendations for Competitive Athletes with Cardiovascular Abnormalities (Congenital Heart Disease) contains such a change.
|
Dr. Robert Jaquiss |
In particular, the new recommendation suggests that athletes with anomalous aortic origin of the right coronary from the left coronary sinus, who have neither symptoms nor a positive stress test, may be allowed to participate in competitive athletics without undergoing surgical repair. As before, those with anomalous left coronary should not be allowed to participate until after surgical treatment.
Prior guidelines suggested that all patients, both anomalous left from right sinus and right from left sinus, be restricted prior to surgery. Because anomalous right coronary is five to six times more common than anomalous left coronary and because it is certainly much less ominous, the previous “one size fits all” approach almost certainly resulted in overtreatment, unnecessary restriction of participation, or both. Furthermore, because anomalous aortic of a coronary artery is so common, occurring in 0.1%-0.2% of the population (300,000 to 600,000 people in the United States), many thousands of competitive athletes will be impacted by the changed guidelines.
Most cardiologists, surgeons, and, most especially, patients will welcome the updated recommendations. Nonetheless, it must be emphasized that anomalous coronary arteries, even anomalous right coronary arteries, may indicate an increased risk of sudden death and that a complete assessment, including stress testing when feasible, and thorough discussion with expert clinicians is still absolutely necessary for such patients and their families.
Dr. Robert Jaquiss of Duke University, Durham, N.C., is the congenital heart section associate medical editor for Thoracic Surgery News.
For many busy clinicians, societal guidelines, task force recommendations, expert consensus statements, and similar authoritative tomes are resources that are scarcely ever read carefully. This is likely not a reflection of the inherent value of such documents, but rather related to the observation that updated guidelines generally reflect, at most, a small change from predecessor versions. (It also should be mentioned that many such contributions are fairly heavy going for even the most determined reader.)
Occasionally, however, a new guideline may signal a dramatic shift in practice, and the recently published AHA/ACC Scientific Statement on Eligibility and Disqualification Recommendations for Competitive Athletes with Cardiovascular Abnormalities (Congenital Heart Disease) contains such a change.
|
Dr. Robert Jaquiss |
In particular, the new recommendation suggests that athletes with anomalous aortic origin of the right coronary from the left coronary sinus, who have neither symptoms nor a positive stress test, may be allowed to participate in competitive athletics without undergoing surgical repair. As before, those with anomalous left coronary should not be allowed to participate until after surgical treatment.
Prior guidelines suggested that all patients, both anomalous left from right sinus and right from left sinus, be restricted prior to surgery. Because anomalous right coronary is five to six times more common than anomalous left coronary and because it is certainly much less ominous, the previous “one size fits all” approach almost certainly resulted in overtreatment, unnecessary restriction of participation, or both. Furthermore, because anomalous aortic of a coronary artery is so common, occurring in 0.1%-0.2% of the population (300,000 to 600,000 people in the United States), many thousands of competitive athletes will be impacted by the changed guidelines.
Most cardiologists, surgeons, and, most especially, patients will welcome the updated recommendations. Nonetheless, it must be emphasized that anomalous coronary arteries, even anomalous right coronary arteries, may indicate an increased risk of sudden death and that a complete assessment, including stress testing when feasible, and thorough discussion with expert clinicians is still absolutely necessary for such patients and their families.
Dr. Robert Jaquiss of Duke University, Durham, N.C., is the congenital heart section associate medical editor for Thoracic Surgery News.
Most children and young adult patients with congenital heart disease can and should engage in some form of physical activity and should avoid a sedentary lifestyle, according to a task force scientific statement from the American Heart Association and the American College of Cardiology (AHA/ACC).
This recommendation comes despite the fears of sudden cardiac death (SCD) in young athletes, which formed the initial impetus of the entire series of task force reports.
The recommended level of sports participation for patients with treated or untreated congenital heart defect, however, should consider the training and the competitive aspects of the sport itself and must be individualized to the patient. This means taking into account the patient’s current functional status, history of surgery, and the presence of implanted cardiac devices, according to the report by Dr. George F. Van Hare of Washington University, St. Louis, and his colleagues, which was published online in the Journal of the American College of Cardiology.
The report breaks down its specific recommendations based upon the various types of congenital heart defect (CHD). Full details and nuances of the recommendations and their specific levels of evidence for each individual condition and the many variants can be found in the online publication. Below is a brief and selected summary for some of the most common defects and some of those most pertinent to sudden cardiac death in young athletes.
Simple shunting lesions (atrial septal defect, ventricular septal defect, patent ductus arteriosus): Treated and untreated
In addressing the three most common subtypes of CHD – ventricular septal defect (VSD, 34%), atrial septal defect (ASD, 13%), and patent ductus arteriosus (PDA, 10%) – the committee found no data that children with these lesions are related to acknowledged episodes of sudden cardiac death (SCD). This applied whether the defects were closed or remained open. “With rare exceptions, patients with hemodynamically insignificant CHD such as VSD, ASD, and PDA may participate competitively in all sports,” it concluded. These recommendations fall under class I; level of evidence C for almost all of these patients, according to the writing committee.
Congenital coronary anomalies: Treated and untreated
Anomalies of coronary arteries are the second-most commonly identified structural causes of SCD in competitive athletes, accounting for about 17% of such deaths in the United States, according to the report. The vast majority of sudden deaths associated with coronary anomalies occur during or shortly after exercise. Despite being less commonly represented in patients, among athletes who have died suddenly, anomalous origin of the left main or left anterior descending coronary artery from the right sinus of Valsalva is far more prevalent. In addition, SCDs are most strongly associated with the pattern in which the anomalous left coronary artery passes between the aorta and main pulmonary artery. Recommended return to intense athletic activities is only to be permitted at least 3 months after surgery, and with a demonstration of the absence of ischemia on postoperative stress testing, with evidence levels depending on the type of anomaly. Of note, in contrast, the committee indicated that athletes with an anomalous origin of a right coronary artery from the left sinus of Valsalva should simply be evaluated by an exercise stress test, and for those without symptoms or a positive exercise stress test, permission to compete can be considered after adequate counseling (class IIa; level of evidence C).
Pulmonary valve stenosis: Treated and untreated
The committee determined that athletes with mild pulmonary stenosis (PS) and normal right ventricular (RV) function can participate in all competitive sports, although annual reevaluation also is recommended (class I; level of evidence B). In addition, athletes treated by operation or balloon valvuloplasty who have achieved adequate relief of PS (gradient less than 40 mm Hg by Doppler) can participate in all competitive sports (class I; level of evidence B). Other patients should be restricted to low-intensity sports, according to the committee.
Aortic valve stenosis: Treated and untreated
Children and adolescents with aortic stenosis (AS) are differentiated between those with mild, moderate, and severe AS by physical examination, ECG, and Doppler echocardiography. In all cases, regardless of the degree of stenosis, patients with a history of fatigue, light-headedness, dizziness, syncope, chest pain, or pallor on exercise deserve a full evaluation. Annual re-evaluation is required for all patients with AS because the disease can progress. Patients with severe AS are at risk of sudden death, particularly with exercise. The committee determined that athletes with mild AS can participate in all competitive sports (class I; level of evidence B), but that athletes with severe AS should be restricted from all competitive sports, with the possible exception of low-intensity sports (class III; level of evidence B).
Coarctation of the aorta: Treated and untreated
Before a decision is made regarding exercise participation, a detailed evaluation should be conducted, including a physical examination, ECG, chest radiograph, exercise testing, transthoracic echocardiographic evaluation of the aortic valve and aorta, and either magnetic resonance imaging or computed tomography angiography, according to the committee. The determination as to the level of sports participation permitted requires a complex assessment of these various test results and can range from full participation in the case of the least affected to restrictions to low-intensity sports in those more severely affected.
Cyanotic CHD, including tetralogy of Fallot
Full clinical assessment, including laboratory and exercise testing, should be considered before any physical activity because this population is at very high risk of sudden death, according to the committee. Recommendations are complex and depend on the level of repair and its success, but, in general, significant restrictions are recommended for all but the most effectively treated patients.
Transposition of the great arteries after atrial switch (Mustard or Senning operation)
This is a population highly at risk, according to the committee. They appear to have a unique response to exercise with reports that a high proportion of sudden death events occur during exertion. In addition, evidence of exercise-induced arrhythmias on routine clinical testing has not been shown to reliably predict exercise-induced SCD events. Although recommendations vary, including strong restrictions for many, at best the most successful of these patients should only be considered for low- to moderate-intensity competitive sports, according to the committee.
Other conditions assessed and evaluated by the committee included congenitally corrected TGA, TGA after the arterial switch, Fontan procedure, elevated pulmonary vascular resistence in CHD, ventricular dysfunction after CHD surgery, and Ebstein anomaly of the tricuspid valve.
In all cases, complete physical assessment of these patients is recommended, especially due to the often highly individualized nature of the patient’s presentation of these conditions and the variety and variability of interventions that may have been performed. Such differentials make recommendations regarding sports participation a complex calculus, which the committee attempts to provide, listing whatever evidence is available.
The majority of these patients, however, will not be considered for the highest levels of competitive sports participation. Although, in almost all cases, the need for physical activity as a contributor to patient health and well-being is stressed at whatever level of performance is possible.
The report ”Eligibility and disqualification recommendations for competitive athletes with cardiovascular abnormalities: Task Force 4: congenital heart disease: a scientific statement from the American Heart Association and American College of Cardiology,” was prepared by Dr. Van Hare and his colleagues on behalf of the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, Council on Cardiovascular Disease in the Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and the American College of Cardiology (doi: 10.1016/j.jacc.2015.09.032).
This report is one of the assessments and recommendations of 15 task forces on eligibility and disqualification recommendations for young athletes, nine of which are disease or multidisease related. The other six task forces focus on a variety of relevant topics and issues regarding the risks of young athletes on the field, including screening, the use of automated external defibrillators on the field, the use of dietary supplements and performance-enhancing drugs, sudden death, and the medical-legal perspectives involved.
All 15 task force reports were simultaneously published online in the Journal of the American College of Cardiology and the journal Circulation.
Dr. Van Hare and all but one member of the writing group had no disclosures. One member disclosed consultant/advisory committee associations with a variety of medical device companies.
Most children and young adult patients with congenital heart disease can and should engage in some form of physical activity and should avoid a sedentary lifestyle, according to a task force scientific statement from the American Heart Association and the American College of Cardiology (AHA/ACC).
This recommendation comes despite the fears of sudden cardiac death (SCD) in young athletes, which formed the initial impetus of the entire series of task force reports.
The recommended level of sports participation for patients with treated or untreated congenital heart defect, however, should consider the training and the competitive aspects of the sport itself and must be individualized to the patient. This means taking into account the patient’s current functional status, history of surgery, and the presence of implanted cardiac devices, according to the report by Dr. George F. Van Hare of Washington University, St. Louis, and his colleagues, which was published online in the Journal of the American College of Cardiology.
The report breaks down its specific recommendations based upon the various types of congenital heart defect (CHD). Full details and nuances of the recommendations and their specific levels of evidence for each individual condition and the many variants can be found in the online publication. Below is a brief and selected summary for some of the most common defects and some of those most pertinent to sudden cardiac death in young athletes.
Simple shunting lesions (atrial septal defect, ventricular septal defect, patent ductus arteriosus): Treated and untreated
In addressing the three most common subtypes of CHD – ventricular septal defect (VSD, 34%), atrial septal defect (ASD, 13%), and patent ductus arteriosus (PDA, 10%) – the committee found no data that children with these lesions are related to acknowledged episodes of sudden cardiac death (SCD). This applied whether the defects were closed or remained open. “With rare exceptions, patients with hemodynamically insignificant CHD such as VSD, ASD, and PDA may participate competitively in all sports,” it concluded. These recommendations fall under class I; level of evidence C for almost all of these patients, according to the writing committee.
Congenital coronary anomalies: Treated and untreated
Anomalies of coronary arteries are the second-most commonly identified structural causes of SCD in competitive athletes, accounting for about 17% of such deaths in the United States, according to the report. The vast majority of sudden deaths associated with coronary anomalies occur during or shortly after exercise. Despite being less commonly represented in patients, among athletes who have died suddenly, anomalous origin of the left main or left anterior descending coronary artery from the right sinus of Valsalva is far more prevalent. In addition, SCDs are most strongly associated with the pattern in which the anomalous left coronary artery passes between the aorta and main pulmonary artery. Recommended return to intense athletic activities is only to be permitted at least 3 months after surgery, and with a demonstration of the absence of ischemia on postoperative stress testing, with evidence levels depending on the type of anomaly. Of note, in contrast, the committee indicated that athletes with an anomalous origin of a right coronary artery from the left sinus of Valsalva should simply be evaluated by an exercise stress test, and for those without symptoms or a positive exercise stress test, permission to compete can be considered after adequate counseling (class IIa; level of evidence C).
Pulmonary valve stenosis: Treated and untreated
The committee determined that athletes with mild pulmonary stenosis (PS) and normal right ventricular (RV) function can participate in all competitive sports, although annual reevaluation also is recommended (class I; level of evidence B). In addition, athletes treated by operation or balloon valvuloplasty who have achieved adequate relief of PS (gradient less than 40 mm Hg by Doppler) can participate in all competitive sports (class I; level of evidence B). Other patients should be restricted to low-intensity sports, according to the committee.
Aortic valve stenosis: Treated and untreated
Children and adolescents with aortic stenosis (AS) are differentiated between those with mild, moderate, and severe AS by physical examination, ECG, and Doppler echocardiography. In all cases, regardless of the degree of stenosis, patients with a history of fatigue, light-headedness, dizziness, syncope, chest pain, or pallor on exercise deserve a full evaluation. Annual re-evaluation is required for all patients with AS because the disease can progress. Patients with severe AS are at risk of sudden death, particularly with exercise. The committee determined that athletes with mild AS can participate in all competitive sports (class I; level of evidence B), but that athletes with severe AS should be restricted from all competitive sports, with the possible exception of low-intensity sports (class III; level of evidence B).
Coarctation of the aorta: Treated and untreated
Before a decision is made regarding exercise participation, a detailed evaluation should be conducted, including a physical examination, ECG, chest radiograph, exercise testing, transthoracic echocardiographic evaluation of the aortic valve and aorta, and either magnetic resonance imaging or computed tomography angiography, according to the committee. The determination as to the level of sports participation permitted requires a complex assessment of these various test results and can range from full participation in the case of the least affected to restrictions to low-intensity sports in those more severely affected.
Cyanotic CHD, including tetralogy of Fallot
Full clinical assessment, including laboratory and exercise testing, should be considered before any physical activity because this population is at very high risk of sudden death, according to the committee. Recommendations are complex and depend on the level of repair and its success, but, in general, significant restrictions are recommended for all but the most effectively treated patients.
Transposition of the great arteries after atrial switch (Mustard or Senning operation)
This is a population highly at risk, according to the committee. They appear to have a unique response to exercise with reports that a high proportion of sudden death events occur during exertion. In addition, evidence of exercise-induced arrhythmias on routine clinical testing has not been shown to reliably predict exercise-induced SCD events. Although recommendations vary, including strong restrictions for many, at best the most successful of these patients should only be considered for low- to moderate-intensity competitive sports, according to the committee.
Other conditions assessed and evaluated by the committee included congenitally corrected TGA, TGA after the arterial switch, Fontan procedure, elevated pulmonary vascular resistence in CHD, ventricular dysfunction after CHD surgery, and Ebstein anomaly of the tricuspid valve.
In all cases, complete physical assessment of these patients is recommended, especially due to the often highly individualized nature of the patient’s presentation of these conditions and the variety and variability of interventions that may have been performed. Such differentials make recommendations regarding sports participation a complex calculus, which the committee attempts to provide, listing whatever evidence is available.
The majority of these patients, however, will not be considered for the highest levels of competitive sports participation. Although, in almost all cases, the need for physical activity as a contributor to patient health and well-being is stressed at whatever level of performance is possible.
The report ”Eligibility and disqualification recommendations for competitive athletes with cardiovascular abnormalities: Task Force 4: congenital heart disease: a scientific statement from the American Heart Association and American College of Cardiology,” was prepared by Dr. Van Hare and his colleagues on behalf of the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, Council on Cardiovascular Disease in the Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and the American College of Cardiology (doi: 10.1016/j.jacc.2015.09.032).
This report is one of the assessments and recommendations of 15 task forces on eligibility and disqualification recommendations for young athletes, nine of which are disease or multidisease related. The other six task forces focus on a variety of relevant topics and issues regarding the risks of young athletes on the field, including screening, the use of automated external defibrillators on the field, the use of dietary supplements and performance-enhancing drugs, sudden death, and the medical-legal perspectives involved.
All 15 task force reports were simultaneously published online in the Journal of the American College of Cardiology and the journal Circulation.
Dr. Van Hare and all but one member of the writing group had no disclosures. One member disclosed consultant/advisory committee associations with a variety of medical device companies.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Recommendations for sports participation should consider the activity itself and take into account the patient’s functional status, history of surgery, and implanted devices.
Major finding: Congenital heart disease is the most common form of serious birth defect (8 per 1,000 live births) and, with dramatic improvements in survival, the issue of youth and young-adult participation in competitive sports must be addressed.
Data source: The AHA/ACC expert consensus recommendations were developed using the experience of the writing-group members and the available scientific evidence in the literature.
Disclosures: The review was sponsored by the AHA and the ACC. Dr. Van Hare and all but one member of the writing group had no disclosures. One member disclosed consultant/advisory committee associations with a variety of medical device companies.
Low incidence of DVT reported after percutaneous EVAR
Completely percutaneous endovascular aortic aneurysm repair (PEVAR) has become more common, using the suture-mediated “preclose” technique. The rate of periprocedural, iatrogenic, acute deep vein thrombosis (DVT), hitherto unknown, was found to be low for this approach, according to a study reported by Dr. Courtney E. Morgan and her colleagues at the Northwestern University, Chicago.
The researchers assessed 52 consecutive patients (44 men) with a mean age of 73 years, who underwent PEVAR at their center. Only 6% had a prior history of DVT (J Vasc Surg. 2015 Aug; 62:351-4).
Acute DVT was seen in four patients on postoperative day 1. These four DVTs comprised one femoropopliteal, and three calf DVTs. Three of these patients had associated risk factors: history of DVT (two patients); active smokers (one patient); and obesity (body mass index greater than 30 kg/m2 in all three patients).
At 2 weeks postoperatively, 75% of the DVTs had resolved.
“We found an overall rate of proximal DVT of 4% after PEVAR, which increased to 13% when calf-vein DVTs were included. Most patients with postoperative DVT had preexisting risk factors, which suggests that routine duplex ultrasound screening after PEVAR is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT,” the authors concluded.
Two of the researchers have received funding and/or served as speakers/consultants for device companies involved in EVAR.
Read the full study online in the Journal of Vascular Surgery.
Completely percutaneous endovascular aortic aneurysm repair (PEVAR) has become more common, using the suture-mediated “preclose” technique. The rate of periprocedural, iatrogenic, acute deep vein thrombosis (DVT), hitherto unknown, was found to be low for this approach, according to a study reported by Dr. Courtney E. Morgan and her colleagues at the Northwestern University, Chicago.
The researchers assessed 52 consecutive patients (44 men) with a mean age of 73 years, who underwent PEVAR at their center. Only 6% had a prior history of DVT (J Vasc Surg. 2015 Aug; 62:351-4).
Acute DVT was seen in four patients on postoperative day 1. These four DVTs comprised one femoropopliteal, and three calf DVTs. Three of these patients had associated risk factors: history of DVT (two patients); active smokers (one patient); and obesity (body mass index greater than 30 kg/m2 in all three patients).
At 2 weeks postoperatively, 75% of the DVTs had resolved.
“We found an overall rate of proximal DVT of 4% after PEVAR, which increased to 13% when calf-vein DVTs were included. Most patients with postoperative DVT had preexisting risk factors, which suggests that routine duplex ultrasound screening after PEVAR is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT,” the authors concluded.
Two of the researchers have received funding and/or served as speakers/consultants for device companies involved in EVAR.
Read the full study online in the Journal of Vascular Surgery.
Completely percutaneous endovascular aortic aneurysm repair (PEVAR) has become more common, using the suture-mediated “preclose” technique. The rate of periprocedural, iatrogenic, acute deep vein thrombosis (DVT), hitherto unknown, was found to be low for this approach, according to a study reported by Dr. Courtney E. Morgan and her colleagues at the Northwestern University, Chicago.
The researchers assessed 52 consecutive patients (44 men) with a mean age of 73 years, who underwent PEVAR at their center. Only 6% had a prior history of DVT (J Vasc Surg. 2015 Aug; 62:351-4).
Acute DVT was seen in four patients on postoperative day 1. These four DVTs comprised one femoropopliteal, and three calf DVTs. Three of these patients had associated risk factors: history of DVT (two patients); active smokers (one patient); and obesity (body mass index greater than 30 kg/m2 in all three patients).
At 2 weeks postoperatively, 75% of the DVTs had resolved.
“We found an overall rate of proximal DVT of 4% after PEVAR, which increased to 13% when calf-vein DVTs were included. Most patients with postoperative DVT had preexisting risk factors, which suggests that routine duplex ultrasound screening after PEVAR is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT,” the authors concluded.
Two of the researchers have received funding and/or served as speakers/consultants for device companies involved in EVAR.
Read the full study online in the Journal of Vascular Surgery.
FROM THE JOURNAL OF VASCULAR SURGERY
