Thoracic Surgery News (Archived)

A device that closes the left atrial appendage to prevent stroke in patients with nonvalvular atrial fibrillation showed a 95.6% procedural success rate in a study of real-world experience since it was approved by the FDA in 2015, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology.

The study was based on data collected by Boston Scientific, the manufacturer of the Watchman device, regarding 3,822 consecutive patients who underwent the implantation during a 14-month period. The “excellent” procedural success rate, together with low short-term complication rates, are especially “remarkable” because 71% of the interventional cardiologists and electrophysiologists who performed these procedures had no experience with the device prior to FDA approval, said Vivek Y. Reddy, MD, of Mount Sinai Medical Center, New York.

A device that closes the left atrial appendage to prevent stroke in patients with nonvalvular atrial fibrillation showed a 95.6% procedural success rate in a study of real-world experience since it was approved by the FDA in 2015, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology.

The study was based on data collected by Boston Scientific, the manufacturer of the Watchman device, regarding 3,822 consecutive patients who underwent the implantation during a 14-month period. The “excellent” procedural success rate, together with low short-term complication rates, are especially “remarkable” because 71% of the interventional cardiologists and electrophysiologists who performed these procedures had no experience with the device prior to FDA approval, said Vivek Y. Reddy, MD, of Mount Sinai Medical Center, New York.

A device that closes the left atrial appendage to prevent stroke in patients with nonvalvular atrial fibrillation showed a 95.6% procedural success rate in a study of real-world experience since it was approved by the FDA in 2015, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology.

The study was based on data collected by Boston Scientific, the manufacturer of the Watchman device, regarding 3,822 consecutive patients who underwent the implantation during a 14-month period. The “excellent” procedural success rate, together with low short-term complication rates, are especially “remarkable” because 71% of the interventional cardiologists and electrophysiologists who performed these procedures had no experience with the device prior to FDA approval, said Vivek Y. Reddy, MD, of Mount Sinai Medical Center, New York.

Training in cardiothoracic surgery is long and arduous. Through it all, one’s chief concerns are generally limited to becoming a proficient physician and surgeon while attending to the basic necessities of life (i.e., sleep and the occasional meal). Then, mercifully, it ends, and you take that first job, typically move to a new city, and, if you’re lucky, get right to work with a full clinic and caseload. On the other hand, as is common for many, you now have an ample amount of time and very few patients or cases. At this point you have two options: Sit and wait, or get out there and do what comes least naturally to most of us; promote yourself.

Full disclosure, I’ve done a lot of this self-promotion; driving around, shaking hands, getting gently rebuffed or offered empty pleasantries. Admittedly, it’s not a lot of fun, and at the end of the day you might come home feeling a bit like Willy Loman in “Death of a Salesman,” with no clear idea if you have accomplished anything or not. Please don’t despair, however, because even in the era of social media there remains no substitute for the face to face, and I can tell you from personal experience that, with persistence and a strategic approach, good things can happen. The following are some key steps in the process of self-promotion and practice building:

• Familiarize yourself with your institution’s marketing department. Each institution typically employs liaisons whose job it is to promote new hires. In addition, they can arrange meetings between you and referring physicians.

• Make yourself available to travel with the liaisons. They can sell you only so much in your absence. The more they hear you speak about your clinical interests, the better equipped they are to discuss your practice when you are not with them.

• Determine how you want to market yourself. It is not enough to say you are a new cardiac surgeon. Make sure marketing and potential referring physicians know exactly what it is you do (i.e., cardiac surgeon with aortic expertise or thoracic surgeon with interest in benign esophageal disease).

• Learn the demographics of your state and/or region. It is important to know the key population centers and their access to care. People of means will usually perform thorough research and seek out the best care, whereas individuals of lesser means will be motivated by proximity. In the case of the latter, consideration for a satellite clinic may be in order.

• Learn the geography of your state and/or region. The physical location of your hospital can heavily influence referral patterns. If patients believe that your hospital/clinic is hard to get to, and they are overwhelmed by the idea of navigating the campus, you may have a problem. In this case, once again a satellite clinic with easy access and parking may go a long way to keeping those patients.

• When you are out and about, take the time to learn who are the new members of the group that you are visiting. These are individuals who have no established referral patterns and would probably be more than happy to send you a patient or two. Older members tend to have their preferences, which they have developed long before you came to town.

• Give out that cellphone. Accessibility is still king and it can’t get any easier for the busy cardiologist or oncologist than to have your phone number. Plus, some hospital systems track the referral patterns of their physicians in an attempt to discourage sending patients outside the system. Thus, the cellphone provides a way around that barrier.

• Make the most of your call! When the outside hospital wants to transfer someone in, take that patient. Even if you don’t operate on them, that patient has an internist or a pulmonologist or an oncologist, and your subsequent phone call lets them know that you are out there and eager to help.

Did I mention that practice building is hard? Some of the bullet points listed above will work well, and others will be less fruitful. If things remain slow, a little introspection and reinvention may be required. Try to think of yourself as the Rolling Stones (or not, your choice, but this is my analogy). The Stones made a couple of nice pop records and could have drifted into oblivion, but instead they escaped to the south of France (for tax reasons mind you) and turned out “Exile on Main Street.” The result was sustained relevance and an album that is forever etched in the rock pantheon.

So ask yourself, What can I do to make myself unique and offer what others want or need and will continue to both want and need into the future? Many times this requires a willingness to take on challenging cases and to develop new skill sets. Not an easy pursuit, mind you, but one that will be recognized by your peers both within your institution and outside of it.

Personally, I recognized a need for the treatment of large paraesophageal hernias. Perhaps not my first choice, but clearly a group of patients who were underserved and an operation I was willing to offer.

Perseverance is in order when you first start out, and it can be easy to get discouraged, but continued belief in oneself and your abilities is tantamount to success. For instance, take F. Scott Fitzgerald. In 1925, he published “The Great Gatsby,” to less than rave reviews, and by 1940 the book was largely forgotten. Despite this setback, Fitzgerald never stopped believing that Gatsby was his masterpiece and promoted it as such. Interestingly, in 1942, a group of publishers began to distribute leftover copies to GIs fighting overseas, who loved it, and now today the book is considered by some to be one of the great American novels. So get out there, tell your story, believe in yourself, deliver good service to your patients and referring physicians, and good things will happen.
 

Dr. Klapper is an assistant professor of surgery in the division of cardiothoracic surgery, Duke University Medical Center, Durham, N.C.

Training in cardiothoracic surgery is long and arduous. Through it all, one’s chief concerns are generally limited to becoming a proficient physician and surgeon while attending to the basic necessities of life (i.e., sleep and the occasional meal). Then, mercifully, it ends, and you take that first job, typically move to a new city, and, if you’re lucky, get right to work with a full clinic and caseload. On the other hand, as is common for many, you now have an ample amount of time and very few patients or cases. At this point you have two options: Sit and wait, or get out there and do what comes least naturally to most of us; promote yourself.

Full disclosure, I’ve done a lot of this self-promotion; driving around, shaking hands, getting gently rebuffed or offered empty pleasantries. Admittedly, it’s not a lot of fun, and at the end of the day you might come home feeling a bit like Willy Loman in “Death of a Salesman,” with no clear idea if you have accomplished anything or not. Please don’t despair, however, because even in the era of social media there remains no substitute for the face to face, and I can tell you from personal experience that, with persistence and a strategic approach, good things can happen. The following are some key steps in the process of self-promotion and practice building:

• Familiarize yourself with your institution’s marketing department. Each institution typically employs liaisons whose job it is to promote new hires. In addition, they can arrange meetings between you and referring physicians.

• Make yourself available to travel with the liaisons. They can sell you only so much in your absence. The more they hear you speak about your clinical interests, the better equipped they are to discuss your practice when you are not with them.

• Determine how you want to market yourself. It is not enough to say you are a new cardiac surgeon. Make sure marketing and potential referring physicians know exactly what it is you do (i.e., cardiac surgeon with aortic expertise or thoracic surgeon with interest in benign esophageal disease).

• Learn the demographics of your state and/or region. It is important to know the key population centers and their access to care. People of means will usually perform thorough research and seek out the best care, whereas individuals of lesser means will be motivated by proximity. In the case of the latter, consideration for a satellite clinic may be in order.

• Learn the geography of your state and/or region. The physical location of your hospital can heavily influence referral patterns. If patients believe that your hospital/clinic is hard to get to, and they are overwhelmed by the idea of navigating the campus, you may have a problem. In this case, once again a satellite clinic with easy access and parking may go a long way to keeping those patients.

• When you are out and about, take the time to learn who are the new members of the group that you are visiting. These are individuals who have no established referral patterns and would probably be more than happy to send you a patient or two. Older members tend to have their preferences, which they have developed long before you came to town.

• Give out that cellphone. Accessibility is still king and it can’t get any easier for the busy cardiologist or oncologist than to have your phone number. Plus, some hospital systems track the referral patterns of their physicians in an attempt to discourage sending patients outside the system. Thus, the cellphone provides a way around that barrier.

• Make the most of your call! When the outside hospital wants to transfer someone in, take that patient. Even if you don’t operate on them, that patient has an internist or a pulmonologist or an oncologist, and your subsequent phone call lets them know that you are out there and eager to help.

Did I mention that practice building is hard? Some of the bullet points listed above will work well, and others will be less fruitful. If things remain slow, a little introspection and reinvention may be required. Try to think of yourself as the Rolling Stones (or not, your choice, but this is my analogy). The Stones made a couple of nice pop records and could have drifted into oblivion, but instead they escaped to the south of France (for tax reasons mind you) and turned out “Exile on Main Street.” The result was sustained relevance and an album that is forever etched in the rock pantheon.

So ask yourself, What can I do to make myself unique and offer what others want or need and will continue to both want and need into the future? Many times this requires a willingness to take on challenging cases and to develop new skill sets. Not an easy pursuit, mind you, but one that will be recognized by your peers both within your institution and outside of it.

Personally, I recognized a need for the treatment of large paraesophageal hernias. Perhaps not my first choice, but clearly a group of patients who were underserved and an operation I was willing to offer.

Perseverance is in order when you first start out, and it can be easy to get discouraged, but continued belief in oneself and your abilities is tantamount to success. For instance, take F. Scott Fitzgerald. In 1925, he published “The Great Gatsby,” to less than rave reviews, and by 1940 the book was largely forgotten. Despite this setback, Fitzgerald never stopped believing that Gatsby was his masterpiece and promoted it as such. Interestingly, in 1942, a group of publishers began to distribute leftover copies to GIs fighting overseas, who loved it, and now today the book is considered by some to be one of the great American novels. So get out there, tell your story, believe in yourself, deliver good service to your patients and referring physicians, and good things will happen.
 

Dr. Klapper is an assistant professor of surgery in the division of cardiothoracic surgery, Duke University Medical Center, Durham, N.C.

Training in cardiothoracic surgery is long and arduous. Through it all, one’s chief concerns are generally limited to becoming a proficient physician and surgeon while attending to the basic necessities of life (i.e., sleep and the occasional meal). Then, mercifully, it ends, and you take that first job, typically move to a new city, and, if you’re lucky, get right to work with a full clinic and caseload. On the other hand, as is common for many, you now have an ample amount of time and very few patients or cases. At this point you have two options: Sit and wait, or get out there and do what comes least naturally to most of us; promote yourself.

Full disclosure, I’ve done a lot of this self-promotion; driving around, shaking hands, getting gently rebuffed or offered empty pleasantries. Admittedly, it’s not a lot of fun, and at the end of the day you might come home feeling a bit like Willy Loman in “Death of a Salesman,” with no clear idea if you have accomplished anything or not. Please don’t despair, however, because even in the era of social media there remains no substitute for the face to face, and I can tell you from personal experience that, with persistence and a strategic approach, good things can happen. The following are some key steps in the process of self-promotion and practice building:

• Familiarize yourself with your institution’s marketing department. Each institution typically employs liaisons whose job it is to promote new hires. In addition, they can arrange meetings between you and referring physicians.

• Make yourself available to travel with the liaisons. They can sell you only so much in your absence. The more they hear you speak about your clinical interests, the better equipped they are to discuss your practice when you are not with them.

• Determine how you want to market yourself. It is not enough to say you are a new cardiac surgeon. Make sure marketing and potential referring physicians know exactly what it is you do (i.e., cardiac surgeon with aortic expertise or thoracic surgeon with interest in benign esophageal disease).

• Learn the demographics of your state and/or region. It is important to know the key population centers and their access to care. People of means will usually perform thorough research and seek out the best care, whereas individuals of lesser means will be motivated by proximity. In the case of the latter, consideration for a satellite clinic may be in order.

• Learn the geography of your state and/or region. The physical location of your hospital can heavily influence referral patterns. If patients believe that your hospital/clinic is hard to get to, and they are overwhelmed by the idea of navigating the campus, you may have a problem. In this case, once again a satellite clinic with easy access and parking may go a long way to keeping those patients.

• When you are out and about, take the time to learn who are the new members of the group that you are visiting. These are individuals who have no established referral patterns and would probably be more than happy to send you a patient or two. Older members tend to have their preferences, which they have developed long before you came to town.

• Give out that cellphone. Accessibility is still king and it can’t get any easier for the busy cardiologist or oncologist than to have your phone number. Plus, some hospital systems track the referral patterns of their physicians in an attempt to discourage sending patients outside the system. Thus, the cellphone provides a way around that barrier.

• Make the most of your call! When the outside hospital wants to transfer someone in, take that patient. Even if you don’t operate on them, that patient has an internist or a pulmonologist or an oncologist, and your subsequent phone call lets them know that you are out there and eager to help.

Did I mention that practice building is hard? Some of the bullet points listed above will work well, and others will be less fruitful. If things remain slow, a little introspection and reinvention may be required. Try to think of yourself as the Rolling Stones (or not, your choice, but this is my analogy). The Stones made a couple of nice pop records and could have drifted into oblivion, but instead they escaped to the south of France (for tax reasons mind you) and turned out “Exile on Main Street.” The result was sustained relevance and an album that is forever etched in the rock pantheon.

So ask yourself, What can I do to make myself unique and offer what others want or need and will continue to both want and need into the future? Many times this requires a willingness to take on challenging cases and to develop new skill sets. Not an easy pursuit, mind you, but one that will be recognized by your peers both within your institution and outside of it.

Personally, I recognized a need for the treatment of large paraesophageal hernias. Perhaps not my first choice, but clearly a group of patients who were underserved and an operation I was willing to offer.

Perseverance is in order when you first start out, and it can be easy to get discouraged, but continued belief in oneself and your abilities is tantamount to success. For instance, take F. Scott Fitzgerald. In 1925, he published “The Great Gatsby,” to less than rave reviews, and by 1940 the book was largely forgotten. Despite this setback, Fitzgerald never stopped believing that Gatsby was his masterpiece and promoted it as such. Interestingly, in 1942, a group of publishers began to distribute leftover copies to GIs fighting overseas, who loved it, and now today the book is considered by some to be one of the great American novels. So get out there, tell your story, believe in yourself, deliver good service to your patients and referring physicians, and good things will happen.
 

Dr. Klapper is an assistant professor of surgery in the division of cardiothoracic surgery, Duke University Medical Center, Durham, N.C.

Traditional open repair for type A aortic dissection in patients with Marfan syndrome and a previous cardiovascular surgery carries a high risk of morbidity and mortality, but a team of surgeons from China have reported on a hybrid technique that combines open and endovascular approaches to repair type A dissection in a patient with Marfan syndrome.

In the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1191-3), Hong-wei Zhang, MD, and colleagues from West China Hospital of Sichuan University, explained their technique using chimney and sandwich grafts to repair a type A dissection in the patient late after Bentall surgery. “With great advancements in recent thoracic endovascular aortic repair technology, innovative hybrid operations combining open and endovascular techniques hold promising potential to expand treatment options,” Dr. Zhang and coauthors said.

They reported on a 33-year-old male with Marfan syndrome (MFS) who had elective aortic root and mechanical valve replacement 10 years earlier. Three days of persistent chest and back pain caused the patient to go to the emergency department, where computed tomography angiography (CTA) confirmed a type A aortic dissection from the distal ascending aorta to the iliac arteries and involving the proximal innominate artery and left common carotid artery (LCCA).

Because the patient refused another open surgery, Dr. Zhang and colleagues executed their hybrid approach, the first step of which was to create an LCCA-left axillar artery bypass with a 6-mm Gore-Tex graft (W.L. Gore & Associates). After they led the graft through the costoclavicular passage, they introduced the first (distal) thoracic stent (Valiant Captivia, Medtronic) from the right femoral artery and deployed it at the proximal descending aorta. They then inserted the second (proximal) thoracic stent graft into the previous ascending synthetic graft.

Next, they delivered the chimney grafts, two Fluency Plus covered stents (Bard Peripheral Vascular), from the right brachial and innominate artery into the ascending graft. Then they delivered two more Fluency grafts from the LCCA into the endolumen of the first (distal) thoracic stent graft.

After they deployed the second (proximal) thoracic stent graft, they deployed the precisely positioned stent grafts from the innominate artery and the LCCA, sandwiching the covered stents for the LCCA between the two thoracic stent grafts. They then occluded the left subclavian artery with a 10-mm double-disk vascular occlude.

Upon angiography at completion, Dr. Zhang and coauthors found an endoleak from the overlap zones between the two thoracic stent grafts.

However, the patient’s postoperative course was uneventful, and CTA 5 days after surgery showed complete sealing of the primary entry tear with patent chimney and sandwich grafts. The patient remained symptom-free at 30 days, when CTA again confirmed patency of the supra-arch grafts.

Dr. Zhang and coauthors acknowledge that carotid-to-carotid bypass could have been an alternative in order to use fewer stent grafts and to reduce the risk of endoleaks in this case, but they opted for this approach because of the dissection of the proximal innominate artery and LCCA and their concern of the long-term patency of a carotid-to-carotid bypass. “To our knowledge, this is the first reported case of a hybrid treatment for new-onset, type A aortic dissection in patients with MFS with a previous Bentall procedure,” Dr. Zhang and coauthors said. “Although further staged repairs are required in our case, this endovascular technique could be an effective and life-saving treatment option for the high-risk repeated surgical patients with MFS.”

Dr. Zhang and coauthors had no financial relationships to disclose.

Traditional open repair for type A aortic dissection in patients with Marfan syndrome and a previous cardiovascular surgery carries a high risk of morbidity and mortality, but a team of surgeons from China have reported on a hybrid technique that combines open and endovascular approaches to repair type A dissection in a patient with Marfan syndrome.

In the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1191-3), Hong-wei Zhang, MD, and colleagues from West China Hospital of Sichuan University, explained their technique using chimney and sandwich grafts to repair a type A dissection in the patient late after Bentall surgery. “With great advancements in recent thoracic endovascular aortic repair technology, innovative hybrid operations combining open and endovascular techniques hold promising potential to expand treatment options,” Dr. Zhang and coauthors said.

They reported on a 33-year-old male with Marfan syndrome (MFS) who had elective aortic root and mechanical valve replacement 10 years earlier. Three days of persistent chest and back pain caused the patient to go to the emergency department, where computed tomography angiography (CTA) confirmed a type A aortic dissection from the distal ascending aorta to the iliac arteries and involving the proximal innominate artery and left common carotid artery (LCCA).

Because the patient refused another open surgery, Dr. Zhang and colleagues executed their hybrid approach, the first step of which was to create an LCCA-left axillar artery bypass with a 6-mm Gore-Tex graft (W.L. Gore & Associates). After they led the graft through the costoclavicular passage, they introduced the first (distal) thoracic stent (Valiant Captivia, Medtronic) from the right femoral artery and deployed it at the proximal descending aorta. They then inserted the second (proximal) thoracic stent graft into the previous ascending synthetic graft.

Next, they delivered the chimney grafts, two Fluency Plus covered stents (Bard Peripheral Vascular), from the right brachial and innominate artery into the ascending graft. Then they delivered two more Fluency grafts from the LCCA into the endolumen of the first (distal) thoracic stent graft.

After they deployed the second (proximal) thoracic stent graft, they deployed the precisely positioned stent grafts from the innominate artery and the LCCA, sandwiching the covered stents for the LCCA between the two thoracic stent grafts. They then occluded the left subclavian artery with a 10-mm double-disk vascular occlude.

Upon angiography at completion, Dr. Zhang and coauthors found an endoleak from the overlap zones between the two thoracic stent grafts.

However, the patient’s postoperative course was uneventful, and CTA 5 days after surgery showed complete sealing of the primary entry tear with patent chimney and sandwich grafts. The patient remained symptom-free at 30 days, when CTA again confirmed patency of the supra-arch grafts.

Dr. Zhang and coauthors acknowledge that carotid-to-carotid bypass could have been an alternative in order to use fewer stent grafts and to reduce the risk of endoleaks in this case, but they opted for this approach because of the dissection of the proximal innominate artery and LCCA and their concern of the long-term patency of a carotid-to-carotid bypass. “To our knowledge, this is the first reported case of a hybrid treatment for new-onset, type A aortic dissection in patients with MFS with a previous Bentall procedure,” Dr. Zhang and coauthors said. “Although further staged repairs are required in our case, this endovascular technique could be an effective and life-saving treatment option for the high-risk repeated surgical patients with MFS.”

Dr. Zhang and coauthors had no financial relationships to disclose.

Traditional open repair for type A aortic dissection in patients with Marfan syndrome and a previous cardiovascular surgery carries a high risk of morbidity and mortality, but a team of surgeons from China have reported on a hybrid technique that combines open and endovascular approaches to repair type A dissection in a patient with Marfan syndrome.

In the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1191-3), Hong-wei Zhang, MD, and colleagues from West China Hospital of Sichuan University, explained their technique using chimney and sandwich grafts to repair a type A dissection in the patient late after Bentall surgery. “With great advancements in recent thoracic endovascular aortic repair technology, innovative hybrid operations combining open and endovascular techniques hold promising potential to expand treatment options,” Dr. Zhang and coauthors said.

They reported on a 33-year-old male with Marfan syndrome (MFS) who had elective aortic root and mechanical valve replacement 10 years earlier. Three days of persistent chest and back pain caused the patient to go to the emergency department, where computed tomography angiography (CTA) confirmed a type A aortic dissection from the distal ascending aorta to the iliac arteries and involving the proximal innominate artery and left common carotid artery (LCCA).

Because the patient refused another open surgery, Dr. Zhang and colleagues executed their hybrid approach, the first step of which was to create an LCCA-left axillar artery bypass with a 6-mm Gore-Tex graft (W.L. Gore & Associates). After they led the graft through the costoclavicular passage, they introduced the first (distal) thoracic stent (Valiant Captivia, Medtronic) from the right femoral artery and deployed it at the proximal descending aorta. They then inserted the second (proximal) thoracic stent graft into the previous ascending synthetic graft.

Next, they delivered the chimney grafts, two Fluency Plus covered stents (Bard Peripheral Vascular), from the right brachial and innominate artery into the ascending graft. Then they delivered two more Fluency grafts from the LCCA into the endolumen of the first (distal) thoracic stent graft.

After they deployed the second (proximal) thoracic stent graft, they deployed the precisely positioned stent grafts from the innominate artery and the LCCA, sandwiching the covered stents for the LCCA between the two thoracic stent grafts. They then occluded the left subclavian artery with a 10-mm double-disk vascular occlude.

Upon angiography at completion, Dr. Zhang and coauthors found an endoleak from the overlap zones between the two thoracic stent grafts.

However, the patient’s postoperative course was uneventful, and CTA 5 days after surgery showed complete sealing of the primary entry tear with patent chimney and sandwich grafts. The patient remained symptom-free at 30 days, when CTA again confirmed patency of the supra-arch grafts.

Dr. Zhang and coauthors acknowledge that carotid-to-carotid bypass could have been an alternative in order to use fewer stent grafts and to reduce the risk of endoleaks in this case, but they opted for this approach because of the dissection of the proximal innominate artery and LCCA and their concern of the long-term patency of a carotid-to-carotid bypass. “To our knowledge, this is the first reported case of a hybrid treatment for new-onset, type A aortic dissection in patients with MFS with a previous Bentall procedure,” Dr. Zhang and coauthors said. “Although further staged repairs are required in our case, this endovascular technique could be an effective and life-saving treatment option for the high-risk repeated surgical patients with MFS.”

Dr. Zhang and coauthors had no financial relationships to disclose.

Using a newer form of MRI to investigate oxygen levels in newborns with congenital heart disease, researchers in Canada reported that these patients may have impaired brain growth and development in the first weeks of life because of significantly lower cerebral oxygen delivery levels.

These findings suggest that oxygen delivery may impact brain growth, particularly in newborns with single-ventricle physiology, reported Jessie Mei Lim, BSc, of the University of Toronto, and her colleagues from McGill University, Montreal, and the Hospital for Sick Children, Toronto. The findings were published in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1095-103). Ms. Lim and her colleagues used cine phase-contrast (PC) MRI to measure cerebral blood flow in newborns with congenital heard disease (CHD). Previous studies used optical measures of tissue oxygenation and MRI arterial spin labeling to suggests that newborns with severe CHD have impaired CBF and cerebral oxygen delivery (CDO₂) and CBF.

This single-center study involved 63 newborns from June 2013 to April 2015 at the Hospital for Sick Children. These subjects received an MRI of the head before surgery at an average of age 7.5 days. The scans were done without sedation or contrast while the infants were asleep. The study compared 31 age-matched controls with 32 subjects with various forms of CHD – 12 were managed surgically along a single-ventricle pathway (SVP), 4 had coarctation of the aorta, 13 had transposition of the great arteries (TGA), and 3 had other forms of CHD.

The researchers validated their method by reporting similarities between flows in the basilar and vertebral arteries in 14 controls, “suggesting good consistency and accuracy of our method for measuring CBF,” Ms. Lim and her coauthors noted. A comparison of CBF measured with an unpaired Student t test revealed no significant differences between the CHD group and controls. The average net CBF in CHD patients was 103.5 mL/min vs. 119.7 mL/min in controls.

However, when evaluating CDO₂ using a Student t test, the researchers found significantly lower levels in the CHD group – an average of 1,1881 mLO₂/min. vs. 2,712 mL O₂/min in controls (P less than .0001). And when the researchers indexed CDO₂ to brain volume yielding indexed oxygen delivery, the difference between the two groups was still significant: an average of 523.1 mL O₂/min-1 .100 g-1 in the CHD group and 685.6 mL O₂/min-1.100 g-1 in controls (P = .0006).

Among the CHD group, those with SVP and TGA had significantly lower CDO₂ than that of controls. Brain volumes were also lower in those with CHD (mean of 338.5 mL vs. 377.7 mL in controls, P = .002).

The MRI findings were telling in the study population, Ms. Lim and her coauthors said. Five subjects in the CHD group had a combination of diffuse excessive high-signal intensity (DEHSI) and white-matter injury (WMI), 10 had an isolated finding of DEHSI, two had WMI alone and five others had other minor brain abnormalities. But the control group had no abnormal findings on conventional brain MRI.

The researchers acknowledged that, while the impact of reduced cerebral oxygen delivery is unknown, “theoretical reasons for thinking it might adversely impact ongoing brain growth and development during this period of rapid brain growth are considered.”

Cardiovascular surgeons should consider these findings when deciding on when to operate on newborns with CHD, the researchers said. “Further support for the concept that such a mechanism could lead to irreversible deficits in brain growth and development might result in attempts to expedite surgical repair of congenital cardiac lesions, which have conventionally not been addressed in the neonatal period,” they wrote.

Ms. Lim and her coauthors had no financial relationships to disclose.

Using a newer form of MRI to investigate oxygen levels in newborns with congenital heart disease, researchers in Canada reported that these patients may have impaired brain growth and development in the first weeks of life because of significantly lower cerebral oxygen delivery levels.

These findings suggest that oxygen delivery may impact brain growth, particularly in newborns with single-ventricle physiology, reported Jessie Mei Lim, BSc, of the University of Toronto, and her colleagues from McGill University, Montreal, and the Hospital for Sick Children, Toronto. The findings were published in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1095-103). Ms. Lim and her colleagues used cine phase-contrast (PC) MRI to measure cerebral blood flow in newborns with congenital heard disease (CHD). Previous studies used optical measures of tissue oxygenation and MRI arterial spin labeling to suggests that newborns with severe CHD have impaired CBF and cerebral oxygen delivery (CDO₂) and CBF.

This single-center study involved 63 newborns from June 2013 to April 2015 at the Hospital for Sick Children. These subjects received an MRI of the head before surgery at an average of age 7.5 days. The scans were done without sedation or contrast while the infants were asleep. The study compared 31 age-matched controls with 32 subjects with various forms of CHD – 12 were managed surgically along a single-ventricle pathway (SVP), 4 had coarctation of the aorta, 13 had transposition of the great arteries (TGA), and 3 had other forms of CHD.

The researchers validated their method by reporting similarities between flows in the basilar and vertebral arteries in 14 controls, “suggesting good consistency and accuracy of our method for measuring CBF,” Ms. Lim and her coauthors noted. A comparison of CBF measured with an unpaired Student t test revealed no significant differences between the CHD group and controls. The average net CBF in CHD patients was 103.5 mL/min vs. 119.7 mL/min in controls.

However, when evaluating CDO₂ using a Student t test, the researchers found significantly lower levels in the CHD group – an average of 1,1881 mLO₂/min. vs. 2,712 mL O₂/min in controls (P less than .0001). And when the researchers indexed CDO₂ to brain volume yielding indexed oxygen delivery, the difference between the two groups was still significant: an average of 523.1 mL O₂/min-1 .100 g-1 in the CHD group and 685.6 mL O₂/min-1.100 g-1 in controls (P = .0006).

Among the CHD group, those with SVP and TGA had significantly lower CDO₂ than that of controls. Brain volumes were also lower in those with CHD (mean of 338.5 mL vs. 377.7 mL in controls, P = .002).

The MRI findings were telling in the study population, Ms. Lim and her coauthors said. Five subjects in the CHD group had a combination of diffuse excessive high-signal intensity (DEHSI) and white-matter injury (WMI), 10 had an isolated finding of DEHSI, two had WMI alone and five others had other minor brain abnormalities. But the control group had no abnormal findings on conventional brain MRI.

The researchers acknowledged that, while the impact of reduced cerebral oxygen delivery is unknown, “theoretical reasons for thinking it might adversely impact ongoing brain growth and development during this period of rapid brain growth are considered.”

Cardiovascular surgeons should consider these findings when deciding on when to operate on newborns with CHD, the researchers said. “Further support for the concept that such a mechanism could lead to irreversible deficits in brain growth and development might result in attempts to expedite surgical repair of congenital cardiac lesions, which have conventionally not been addressed in the neonatal period,” they wrote.

Ms. Lim and her coauthors had no financial relationships to disclose.

Using a newer form of MRI to investigate oxygen levels in newborns with congenital heart disease, researchers in Canada reported that these patients may have impaired brain growth and development in the first weeks of life because of significantly lower cerebral oxygen delivery levels.

These findings suggest that oxygen delivery may impact brain growth, particularly in newborns with single-ventricle physiology, reported Jessie Mei Lim, BSc, of the University of Toronto, and her colleagues from McGill University, Montreal, and the Hospital for Sick Children, Toronto. The findings were published in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1095-103). Ms. Lim and her colleagues used cine phase-contrast (PC) MRI to measure cerebral blood flow in newborns with congenital heard disease (CHD). Previous studies used optical measures of tissue oxygenation and MRI arterial spin labeling to suggests that newborns with severe CHD have impaired CBF and cerebral oxygen delivery (CDO₂) and CBF.

This single-center study involved 63 newborns from June 2013 to April 2015 at the Hospital for Sick Children. These subjects received an MRI of the head before surgery at an average of age 7.5 days. The scans were done without sedation or contrast while the infants were asleep. The study compared 31 age-matched controls with 32 subjects with various forms of CHD – 12 were managed surgically along a single-ventricle pathway (SVP), 4 had coarctation of the aorta, 13 had transposition of the great arteries (TGA), and 3 had other forms of CHD.

The researchers validated their method by reporting similarities between flows in the basilar and vertebral arteries in 14 controls, “suggesting good consistency and accuracy of our method for measuring CBF,” Ms. Lim and her coauthors noted. A comparison of CBF measured with an unpaired Student t test revealed no significant differences between the CHD group and controls. The average net CBF in CHD patients was 103.5 mL/min vs. 119.7 mL/min in controls.

However, when evaluating CDO₂ using a Student t test, the researchers found significantly lower levels in the CHD group – an average of 1,1881 mLO₂/min. vs. 2,712 mL O₂/min in controls (P less than .0001). And when the researchers indexed CDO₂ to brain volume yielding indexed oxygen delivery, the difference between the two groups was still significant: an average of 523.1 mL O₂/min-1 .100 g-1 in the CHD group and 685.6 mL O₂/min-1.100 g-1 in controls (P = .0006).

Among the CHD group, those with SVP and TGA had significantly lower CDO₂ than that of controls. Brain volumes were also lower in those with CHD (mean of 338.5 mL vs. 377.7 mL in controls, P = .002).

The MRI findings were telling in the study population, Ms. Lim and her coauthors said. Five subjects in the CHD group had a combination of diffuse excessive high-signal intensity (DEHSI) and white-matter injury (WMI), 10 had an isolated finding of DEHSI, two had WMI alone and five others had other minor brain abnormalities. But the control group had no abnormal findings on conventional brain MRI.

The researchers acknowledged that, while the impact of reduced cerebral oxygen delivery is unknown, “theoretical reasons for thinking it might adversely impact ongoing brain growth and development during this period of rapid brain growth are considered.”

Cardiovascular surgeons should consider these findings when deciding on when to operate on newborns with CHD, the researchers said. “Further support for the concept that such a mechanism could lead to irreversible deficits in brain growth and development might result in attempts to expedite surgical repair of congenital cardiac lesions, which have conventionally not been addressed in the neonatal period,” they wrote.

Ms. Lim and her coauthors had no financial relationships to disclose.

Recent findings on the incidence and pathophysiology of bioprosthetic valve thrombosis require revisiting existing guidelines against routine echocardiography in the first 5 years after bioprosthetic valve replacement and a longer course of anticoagulation therapy than the current standard of 3 months, investigators from the Mayo Clinic said in an expert opinion article in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152;975-8).

In the expert commentary, Alexander C. Egbe, MBBS, of the departments of cardiovascular diseases and cardiovascular surgery at Mayo Clinic in Rochester, Minn., and coauthors explored the implications of their previous research, published in the Journal of the American College of Cardiology, that reported that bioprosthetic valve thrombosis (BPVT) is “not an uncommon cause of prosthetic valve dysfunction.” They identified BPVT in 46 of 397 (11%) bioprosthetic valves explanted at Mayo Clinic, and estimated the incidence of BPVT at 1% (J Am Coll Cardiol. 2015;66:2285-94), although Dr. Egbe and colleagues acknowledged the true incidence of BPVT is unknown, as is the time to occurrence. They noted that a different study design would be needed to determine that, along with the incidence of BPVT.

“The occurrence of BPVT is not restricted to surgically implanted bioprosthetic valves, but has also been observed after transcatheter aortic valve replacement (TAVR),” Dr. Egbe and colleagues said. They noted an association between BPVT and a lack of anticoagulation therapy in two earlier reports (N Engl J Med. 2015;373:2015-24; J Am Coll Cardiol. 2016;67:644-55). In their own study, 14 of 15 patients (93%) with diagnosed BPVT responded to anticoagulation therapy and avoided reoperation.

Dr. Egbe and coauthors did somewhat define the extent of the problem of misdiagnosis of BPVT. The diagnosis was considered in only 6 of 45 patients (13%) who had transesophageal echocardiography. “A significant proportion of the patients with BPVT were misdiagnosed as having structural failure and referred for reoperation,” Dr. Egbe and coauthors said. “This attests to the low level of awareness of the existence of BPVT and the lack of well-defined diagnostic criteria.”

They proposed a diagnostic model based on the echocardiography characteristics of three findings: a 50% increase in gradient within 5 years of implantation; increased cusp thickness; and abnormal cusp mobility. “The presence of all three echocardiographic features reliably diagnosed BPVT with a sensitivity of 72% and a specificity of 90%,” they said.

Their finding that 85% of BPVT cases occurred within 5 years of implantation flies in the face of clinical guidelines that state routine annual echocardiography is not recommended in that time frame (J Am So Echocardiogr. 2009;22;975-1014). But abnormal physical examination findings as a prerequisite for echocardiography may not be an effective method to diagnose BPVT. “In addition to transthoracic and transesophageal echocardiography, the use of other complementary imaging modalities, such as computed tomography, could be very effective in identifying subtle BPVT,” Dr. Egbe and colleagues said,

But preventing BPVT is more complicated. Clinical guidelines recommend anticoagulation of bioprosthetic valves for 3 months after implantation, but adhering to that guideline showed no protective effect against BPVT in their study, Dr. Egbe and coauthors said. Nor did antiplatelet therapy prove effective in preventing BPVT. However, a Danish study showed stopping anticoagulation within 6 months of surgical aortic valve replacement increased risk of thromboembolic complications and cardiovascular death (JAMA. 2012;308:2118-25). And the role of prosthesis type in BPVT “remains unclear.”

Dr. Egbe and coauthors acknowledged a number of questions persist with regard to BPVT in bioprosthetic valve dysfunction, including the true incidence, best screening method, risk factors, and the duration of anticoagulation, as well as the role of novel oral anticoagulants. “Answers to these questions will come from population-based prospective studies,” Dr. Egbe and colleagues said.

Dr. Egbe and his coauthors had no relationships to disclose.

Recent findings on the incidence and pathophysiology of bioprosthetic valve thrombosis require revisiting existing guidelines against routine echocardiography in the first 5 years after bioprosthetic valve replacement and a longer course of anticoagulation therapy than the current standard of 3 months, investigators from the Mayo Clinic said in an expert opinion article in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152;975-8).

In the expert commentary, Alexander C. Egbe, MBBS, of the departments of cardiovascular diseases and cardiovascular surgery at Mayo Clinic in Rochester, Minn., and coauthors explored the implications of their previous research, published in the Journal of the American College of Cardiology, that reported that bioprosthetic valve thrombosis (BPVT) is “not an uncommon cause of prosthetic valve dysfunction.” They identified BPVT in 46 of 397 (11%) bioprosthetic valves explanted at Mayo Clinic, and estimated the incidence of BPVT at 1% (J Am Coll Cardiol. 2015;66:2285-94), although Dr. Egbe and colleagues acknowledged the true incidence of BPVT is unknown, as is the time to occurrence. They noted that a different study design would be needed to determine that, along with the incidence of BPVT.

“The occurrence of BPVT is not restricted to surgically implanted bioprosthetic valves, but has also been observed after transcatheter aortic valve replacement (TAVR),” Dr. Egbe and colleagues said. They noted an association between BPVT and a lack of anticoagulation therapy in two earlier reports (N Engl J Med. 2015;373:2015-24; J Am Coll Cardiol. 2016;67:644-55). In their own study, 14 of 15 patients (93%) with diagnosed BPVT responded to anticoagulation therapy and avoided reoperation.

Dr. Egbe and coauthors did somewhat define the extent of the problem of misdiagnosis of BPVT. The diagnosis was considered in only 6 of 45 patients (13%) who had transesophageal echocardiography. “A significant proportion of the patients with BPVT were misdiagnosed as having structural failure and referred for reoperation,” Dr. Egbe and coauthors said. “This attests to the low level of awareness of the existence of BPVT and the lack of well-defined diagnostic criteria.”

They proposed a diagnostic model based on the echocardiography characteristics of three findings: a 50% increase in gradient within 5 years of implantation; increased cusp thickness; and abnormal cusp mobility. “The presence of all three echocardiographic features reliably diagnosed BPVT with a sensitivity of 72% and a specificity of 90%,” they said.

Their finding that 85% of BPVT cases occurred within 5 years of implantation flies in the face of clinical guidelines that state routine annual echocardiography is not recommended in that time frame (J Am So Echocardiogr. 2009;22;975-1014). But abnormal physical examination findings as a prerequisite for echocardiography may not be an effective method to diagnose BPVT. “In addition to transthoracic and transesophageal echocardiography, the use of other complementary imaging modalities, such as computed tomography, could be very effective in identifying subtle BPVT,” Dr. Egbe and colleagues said,

But preventing BPVT is more complicated. Clinical guidelines recommend anticoagulation of bioprosthetic valves for 3 months after implantation, but adhering to that guideline showed no protective effect against BPVT in their study, Dr. Egbe and coauthors said. Nor did antiplatelet therapy prove effective in preventing BPVT. However, a Danish study showed stopping anticoagulation within 6 months of surgical aortic valve replacement increased risk of thromboembolic complications and cardiovascular death (JAMA. 2012;308:2118-25). And the role of prosthesis type in BPVT “remains unclear.”

Dr. Egbe and coauthors acknowledged a number of questions persist with regard to BPVT in bioprosthetic valve dysfunction, including the true incidence, best screening method, risk factors, and the duration of anticoagulation, as well as the role of novel oral anticoagulants. “Answers to these questions will come from population-based prospective studies,” Dr. Egbe and colleagues said.

Dr. Egbe and his coauthors had no relationships to disclose.

Recent findings on the incidence and pathophysiology of bioprosthetic valve thrombosis require revisiting existing guidelines against routine echocardiography in the first 5 years after bioprosthetic valve replacement and a longer course of anticoagulation therapy than the current standard of 3 months, investigators from the Mayo Clinic said in an expert opinion article in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152;975-8).

In the expert commentary, Alexander C. Egbe, MBBS, of the departments of cardiovascular diseases and cardiovascular surgery at Mayo Clinic in Rochester, Minn., and coauthors explored the implications of their previous research, published in the Journal of the American College of Cardiology, that reported that bioprosthetic valve thrombosis (BPVT) is “not an uncommon cause of prosthetic valve dysfunction.” They identified BPVT in 46 of 397 (11%) bioprosthetic valves explanted at Mayo Clinic, and estimated the incidence of BPVT at 1% (J Am Coll Cardiol. 2015;66:2285-94), although Dr. Egbe and colleagues acknowledged the true incidence of BPVT is unknown, as is the time to occurrence. They noted that a different study design would be needed to determine that, along with the incidence of BPVT.

“The occurrence of BPVT is not restricted to surgically implanted bioprosthetic valves, but has also been observed after transcatheter aortic valve replacement (TAVR),” Dr. Egbe and colleagues said. They noted an association between BPVT and a lack of anticoagulation therapy in two earlier reports (N Engl J Med. 2015;373:2015-24; J Am Coll Cardiol. 2016;67:644-55). In their own study, 14 of 15 patients (93%) with diagnosed BPVT responded to anticoagulation therapy and avoided reoperation.

Dr. Egbe and coauthors did somewhat define the extent of the problem of misdiagnosis of BPVT. The diagnosis was considered in only 6 of 45 patients (13%) who had transesophageal echocardiography. “A significant proportion of the patients with BPVT were misdiagnosed as having structural failure and referred for reoperation,” Dr. Egbe and coauthors said. “This attests to the low level of awareness of the existence of BPVT and the lack of well-defined diagnostic criteria.”

They proposed a diagnostic model based on the echocardiography characteristics of three findings: a 50% increase in gradient within 5 years of implantation; increased cusp thickness; and abnormal cusp mobility. “The presence of all three echocardiographic features reliably diagnosed BPVT with a sensitivity of 72% and a specificity of 90%,” they said.

Their finding that 85% of BPVT cases occurred within 5 years of implantation flies in the face of clinical guidelines that state routine annual echocardiography is not recommended in that time frame (J Am So Echocardiogr. 2009;22;975-1014). But abnormal physical examination findings as a prerequisite for echocardiography may not be an effective method to diagnose BPVT. “In addition to transthoracic and transesophageal echocardiography, the use of other complementary imaging modalities, such as computed tomography, could be very effective in identifying subtle BPVT,” Dr. Egbe and colleagues said,

But preventing BPVT is more complicated. Clinical guidelines recommend anticoagulation of bioprosthetic valves for 3 months after implantation, but adhering to that guideline showed no protective effect against BPVT in their study, Dr. Egbe and coauthors said. Nor did antiplatelet therapy prove effective in preventing BPVT. However, a Danish study showed stopping anticoagulation within 6 months of surgical aortic valve replacement increased risk of thromboembolic complications and cardiovascular death (JAMA. 2012;308:2118-25). And the role of prosthesis type in BPVT “remains unclear.”

Dr. Egbe and coauthors acknowledged a number of questions persist with regard to BPVT in bioprosthetic valve dysfunction, including the true incidence, best screening method, risk factors, and the duration of anticoagulation, as well as the role of novel oral anticoagulants. “Answers to these questions will come from population-based prospective studies,” Dr. Egbe and colleagues said.

Dr. Egbe and his coauthors had no relationships to disclose.

Teaching minimally invasive robotic surgery to residents can be difficult in a health care environment obsessed with quality outcome measures and under scrutiny by hospital administrators and payers, but researchers at the University of Alabama at Birmingham may have devised a method to instruct residents in robotic lobectomy without compromising patient outcomes, according to a study published in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:991-7).

Robert J. Cerfolio, MD, MBA, and his coauthors divided the procedure into 19 sequential, teachable steps and allowed residents to perform selected steps during operations that Dr. Cerfolio directed. “We then applied simulation training, coaching techniques, and video review of each step to help improve the steps that residents could not complete,” Dr. Cerfolio and his coauthors said.

Teaching minimally invasive robotic surgery to residents can be difficult in a health care environment obsessed with quality outcome measures and under scrutiny by hospital administrators and payers, but researchers at the University of Alabama at Birmingham may have devised a method to instruct residents in robotic lobectomy without compromising patient outcomes, according to a study published in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:991-7).

Robert J. Cerfolio, MD, MBA, and his coauthors divided the procedure into 19 sequential, teachable steps and allowed residents to perform selected steps during operations that Dr. Cerfolio directed. “We then applied simulation training, coaching techniques, and video review of each step to help improve the steps that residents could not complete,” Dr. Cerfolio and his coauthors said.

Teaching minimally invasive robotic surgery to residents can be difficult in a health care environment obsessed with quality outcome measures and under scrutiny by hospital administrators and payers, but researchers at the University of Alabama at Birmingham may have devised a method to instruct residents in robotic lobectomy without compromising patient outcomes, according to a study published in the October issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:991-7).

Robert J. Cerfolio, MD, MBA, and his coauthors divided the procedure into 19 sequential, teachable steps and allowed residents to perform selected steps during operations that Dr. Cerfolio directed. “We then applied simulation training, coaching techniques, and video review of each step to help improve the steps that residents could not complete,” Dr. Cerfolio and his coauthors said.

WASHINGTON – Results from two large, multicenter comparisons of coronary stenting and coronary bypass surgery for treating patients with unprotected left main coronary disease may have superficially shown sharp differences, but the bottom line will likely be greater empowerment of percutaneous coronary intervention as an option for selected patients with less complex coronary disease.

Prior to the results from the EXCEL and NOBLE trials, reported at the Transcatheter Cardiovascular Therapeutics annual meeting, “guidelines put PCI [percutaneous coronary intervention] into a class 1, 2 or 3 status for treating left main coronary disease depending on disease complexity, but in the United States, PCI for patients eligible for CABG [coronary artery bypass grafting] has not been frequently done. I think these results, in a very circumscribed subset of patients and using a state-of-the-art stent, will affect the guidelines,” predicted Gregg W. Stone, MD, lead investigator for EXCEL and professor of medicine at Columbia University in New York.

“What the guidelines have not addressed are the patients with low- or intermediate-complexity disease who have an acceptable risk for undergoing either PCI or CABG. I think the trial results answer this question,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta and an EXCEL investigator.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Results from two large, multicenter comparisons of coronary stenting and coronary bypass surgery for treating patients with unprotected left main coronary disease may have superficially shown sharp differences, but the bottom line will likely be greater empowerment of percutaneous coronary intervention as an option for selected patients with less complex coronary disease.

Prior to the results from the EXCEL and NOBLE trials, reported at the Transcatheter Cardiovascular Therapeutics annual meeting, “guidelines put PCI [percutaneous coronary intervention] into a class 1, 2 or 3 status for treating left main coronary disease depending on disease complexity, but in the United States, PCI for patients eligible for CABG [coronary artery bypass grafting] has not been frequently done. I think these results, in a very circumscribed subset of patients and using a state-of-the-art stent, will affect the guidelines,” predicted Gregg W. Stone, MD, lead investigator for EXCEL and professor of medicine at Columbia University in New York.

“What the guidelines have not addressed are the patients with low- or intermediate-complexity disease who have an acceptable risk for undergoing either PCI or CABG. I think the trial results answer this question,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta and an EXCEL investigator.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Results from two large, multicenter comparisons of coronary stenting and coronary bypass surgery for treating patients with unprotected left main coronary disease may have superficially shown sharp differences, but the bottom line will likely be greater empowerment of percutaneous coronary intervention as an option for selected patients with less complex coronary disease.

Prior to the results from the EXCEL and NOBLE trials, reported at the Transcatheter Cardiovascular Therapeutics annual meeting, “guidelines put PCI [percutaneous coronary intervention] into a class 1, 2 or 3 status for treating left main coronary disease depending on disease complexity, but in the United States, PCI for patients eligible for CABG [coronary artery bypass grafting] has not been frequently done. I think these results, in a very circumscribed subset of patients and using a state-of-the-art stent, will affect the guidelines,” predicted Gregg W. Stone, MD, lead investigator for EXCEL and professor of medicine at Columbia University in New York.

“What the guidelines have not addressed are the patients with low- or intermediate-complexity disease who have an acceptable risk for undergoing either PCI or CABG. I think the trial results answer this question,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta and an EXCEL investigator.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

Routine follow-up coronary angiography after percutaneous coronary intervention leads to increased rates of coronary revascularization but without any significant benefits for outcomes, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously on Nov. 1 in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Hiroki Shiomi, MD, from Kyoto University, and his coauthors reported on ReACT, a prospective, open-label randomized controlled trial of routine follow-up coronary angiography in 700 patients who underwent successful percutaneous coronary intervention (PCI).

Among the 349 patients randomized to follow-up coronary angiography (FUCAG), 12.8% underwent any coronary revascularization within the first year after PCI, compared with 3.8% of the 351 patients randomized to standard clinical follow-up. The routine angiography group also had a higher incidence of target lesion revascularization in the first year after the index PCI (7.0% vs. 1.7%).

In both these cases, the cumulative 5-year incidence of coronary or target lesion revascularization was not significantly different between the routine angiography and control groups. However researchers saw no significant benefit from routine FUCAG in terms of the cumulative 5-year incidence of all-cause death, myocardial infarction, stroke, or emergency hospitalizations for acute coronary syndrome or heart failure, compared with clinical follow-up (22.4% vs. 24.7%; P = 0.70).

Nor were there any significant differences between the two groups in these individual components, or in the cumulative 5-year incidence of major bleeding (JACC Cardiovasc Interv. 2016 Nov 1.)

The authors commented that several previous studies have shown that routine FUCAG does not improve clinical outcomes, although it is still commonly performed in Japan after PCI.

“However, previous studies in the drug-eluting stents (DES) era were conducted in the context of pivotal randomized trials of DES and there have been no randomized clinical trials evaluating long-term clinical impact of routine FUCAG after PCI in the real world clinical practice including high-risk patients for cardiovascular events risk such as complex coronary artery disease and acute myocardial infarction (AMI) presentation,” the authors wrote.

Overall, 85.4% of patients in the routine angiography group and 12% of those in the clinical care group underwent coronary angiography in the first year, including for clinical reasons.

In the clinical follow-up group, coronary angiography was performed because of acute coronary syndrome (14%), recurrence of angina (60%), other clinical reasons (14%), or no clinical reason (12%). The control group also had more noninvasive physiological stress testing such as treadmill exercise test and stress nuclear study.

“Considering the invasive nature of coronary angiography and increased medical expenses, routine FUCAG after PCI would not be allowed as the usual clinical practice, unless patients have recurrent symptoms or objective evidence of ischemia,” the authors wrote.

“On the other hand, there was no excess of adverse clinical events with routine angiographic follow-up strategy except for the increased rate of 1-year repeat coronary revascularization.”

Given this, they suggested that scheduled angiographic follow-up might still be considered acceptable for early in vivo or significant coronary device trials.

While the authors said the trial ended up being underpowered because of a reduced final sample size and lower-than-anticipated event rate, it did warrant further larger-scale studies. In particular, they highlighted the question of what impact routine follow-up angiography might have in higher-risk patients, such as those with left main or multivessel coronary artery disease.

“Finally, because patient demographics, practice patterns including the indication of coronary revascularization, and clinical outcomes in Japan may be different from those outside Japan, generalizing the present study results to populations outside Japan should be done with caution.”

This study was supported by an educational grant from the Research Institute for Production Development (Kyoto). One author declared honoraria for education consulting from Boston Scientific Corporation.
 

Routine follow-up coronary angiography after percutaneous coronary intervention leads to increased rates of coronary revascularization but without any significant benefits for outcomes, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously on Nov. 1 in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Hiroki Shiomi, MD, from Kyoto University, and his coauthors reported on ReACT, a prospective, open-label randomized controlled trial of routine follow-up coronary angiography in 700 patients who underwent successful percutaneous coronary intervention (PCI).

Among the 349 patients randomized to follow-up coronary angiography (FUCAG), 12.8% underwent any coronary revascularization within the first year after PCI, compared with 3.8% of the 351 patients randomized to standard clinical follow-up. The routine angiography group also had a higher incidence of target lesion revascularization in the first year after the index PCI (7.0% vs. 1.7%).

In both these cases, the cumulative 5-year incidence of coronary or target lesion revascularization was not significantly different between the routine angiography and control groups. However researchers saw no significant benefit from routine FUCAG in terms of the cumulative 5-year incidence of all-cause death, myocardial infarction, stroke, or emergency hospitalizations for acute coronary syndrome or heart failure, compared with clinical follow-up (22.4% vs. 24.7%; P = 0.70).

Nor were there any significant differences between the two groups in these individual components, or in the cumulative 5-year incidence of major bleeding (JACC Cardiovasc Interv. 2016 Nov 1.)

The authors commented that several previous studies have shown that routine FUCAG does not improve clinical outcomes, although it is still commonly performed in Japan after PCI.

“However, previous studies in the drug-eluting stents (DES) era were conducted in the context of pivotal randomized trials of DES and there have been no randomized clinical trials evaluating long-term clinical impact of routine FUCAG after PCI in the real world clinical practice including high-risk patients for cardiovascular events risk such as complex coronary artery disease and acute myocardial infarction (AMI) presentation,” the authors wrote.

Overall, 85.4% of patients in the routine angiography group and 12% of those in the clinical care group underwent coronary angiography in the first year, including for clinical reasons.

In the clinical follow-up group, coronary angiography was performed because of acute coronary syndrome (14%), recurrence of angina (60%), other clinical reasons (14%), or no clinical reason (12%). The control group also had more noninvasive physiological stress testing such as treadmill exercise test and stress nuclear study.

“Considering the invasive nature of coronary angiography and increased medical expenses, routine FUCAG after PCI would not be allowed as the usual clinical practice, unless patients have recurrent symptoms or objective evidence of ischemia,” the authors wrote.

“On the other hand, there was no excess of adverse clinical events with routine angiographic follow-up strategy except for the increased rate of 1-year repeat coronary revascularization.”

Given this, they suggested that scheduled angiographic follow-up might still be considered acceptable for early in vivo or significant coronary device trials.

While the authors said the trial ended up being underpowered because of a reduced final sample size and lower-than-anticipated event rate, it did warrant further larger-scale studies. In particular, they highlighted the question of what impact routine follow-up angiography might have in higher-risk patients, such as those with left main or multivessel coronary artery disease.

“Finally, because patient demographics, practice patterns including the indication of coronary revascularization, and clinical outcomes in Japan may be different from those outside Japan, generalizing the present study results to populations outside Japan should be done with caution.”

This study was supported by an educational grant from the Research Institute for Production Development (Kyoto). One author declared honoraria for education consulting from Boston Scientific Corporation.
 

Routine follow-up coronary angiography after percutaneous coronary intervention leads to increased rates of coronary revascularization but without any significant benefits for outcomes, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously on Nov. 1 in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Hiroki Shiomi, MD, from Kyoto University, and his coauthors reported on ReACT, a prospective, open-label randomized controlled trial of routine follow-up coronary angiography in 700 patients who underwent successful percutaneous coronary intervention (PCI).

Among the 349 patients randomized to follow-up coronary angiography (FUCAG), 12.8% underwent any coronary revascularization within the first year after PCI, compared with 3.8% of the 351 patients randomized to standard clinical follow-up. The routine angiography group also had a higher incidence of target lesion revascularization in the first year after the index PCI (7.0% vs. 1.7%).

In both these cases, the cumulative 5-year incidence of coronary or target lesion revascularization was not significantly different between the routine angiography and control groups. However researchers saw no significant benefit from routine FUCAG in terms of the cumulative 5-year incidence of all-cause death, myocardial infarction, stroke, or emergency hospitalizations for acute coronary syndrome or heart failure, compared with clinical follow-up (22.4% vs. 24.7%; P = 0.70).

Nor were there any significant differences between the two groups in these individual components, or in the cumulative 5-year incidence of major bleeding (JACC Cardiovasc Interv. 2016 Nov 1.)

The authors commented that several previous studies have shown that routine FUCAG does not improve clinical outcomes, although it is still commonly performed in Japan after PCI.

“However, previous studies in the drug-eluting stents (DES) era were conducted in the context of pivotal randomized trials of DES and there have been no randomized clinical trials evaluating long-term clinical impact of routine FUCAG after PCI in the real world clinical practice including high-risk patients for cardiovascular events risk such as complex coronary artery disease and acute myocardial infarction (AMI) presentation,” the authors wrote.

Overall, 85.4% of patients in the routine angiography group and 12% of those in the clinical care group underwent coronary angiography in the first year, including for clinical reasons.

In the clinical follow-up group, coronary angiography was performed because of acute coronary syndrome (14%), recurrence of angina (60%), other clinical reasons (14%), or no clinical reason (12%). The control group also had more noninvasive physiological stress testing such as treadmill exercise test and stress nuclear study.

“Considering the invasive nature of coronary angiography and increased medical expenses, routine FUCAG after PCI would not be allowed as the usual clinical practice, unless patients have recurrent symptoms or objective evidence of ischemia,” the authors wrote.

“On the other hand, there was no excess of adverse clinical events with routine angiographic follow-up strategy except for the increased rate of 1-year repeat coronary revascularization.”

Given this, they suggested that scheduled angiographic follow-up might still be considered acceptable for early in vivo or significant coronary device trials.

While the authors said the trial ended up being underpowered because of a reduced final sample size and lower-than-anticipated event rate, it did warrant further larger-scale studies. In particular, they highlighted the question of what impact routine follow-up angiography might have in higher-risk patients, such as those with left main or multivessel coronary artery disease.

“Finally, because patient demographics, practice patterns including the indication of coronary revascularization, and clinical outcomes in Japan may be different from those outside Japan, generalizing the present study results to populations outside Japan should be done with caution.”

This study was supported by an educational grant from the Research Institute for Production Development (Kyoto). One author declared honoraria for education consulting from Boston Scientific Corporation.
 

The largest randomized clinical trial to assess the safety and efficacy of cerebral embolic protection systems during transcatheter aortic valve replacement yielded puzzling and somewhat contradictory results, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology.

Virtually every device in this industry-sponsored study involving 363 elderly patients (mean age, 83.4 years) with severe aortic stenosis trapped particulate debris as intended, the mean volume of new lesions in the protected areas of the brain was reduced by 42%, and the number and volume of new lesions correlated with neurocognitive outcomes at 30 days.

However, the reduction in lesion volume did not achieve statistical significance, and the improvement in neurocognitive function also did not reach statistical significance.

In addition, “the sample size was clearly too low to assess clinical outcomes, and in retrospect, was also too low to evaluate follow-up MRI findings or neurocognitive outcomes.” Nevertheless, the trial “provides reassuring evidence of device safety,” said Samir R. Kapadia, MD, of the Cleveland Clinic (J Am Coll Cardiol. 2016 Nov 1. doi: 10.1016/j.jacc.2016.10.023).

In this prospective study, the investigators assessed patients at 17 medical centers in the United States and 2 in Germany. In addition to being elderly, the study patients were at high risk because of frequent comorbidities, including atrial fibrillation (31.7%) and prior stroke (5.8%).

[email protected]

The largest randomized clinical trial to assess the safety and efficacy of cerebral embolic protection systems during transcatheter aortic valve replacement yielded puzzling and somewhat contradictory results, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology.

Virtually every device in this industry-sponsored study involving 363 elderly patients (mean age, 83.4 years) with severe aortic stenosis trapped particulate debris as intended, the mean volume of new lesions in the protected areas of the brain was reduced by 42%, and the number and volume of new lesions correlated with neurocognitive outcomes at 30 days.

However, the reduction in lesion volume did not achieve statistical significance, and the improvement in neurocognitive function also did not reach statistical significance.

In addition, “the sample size was clearly too low to assess clinical outcomes, and in retrospect, was also too low to evaluate follow-up MRI findings or neurocognitive outcomes.” Nevertheless, the trial “provides reassuring evidence of device safety,” said Samir R. Kapadia, MD, of the Cleveland Clinic (J Am Coll Cardiol. 2016 Nov 1. doi: 10.1016/j.jacc.2016.10.023).

In this prospective study, the investigators assessed patients at 17 medical centers in the United States and 2 in Germany. In addition to being elderly, the study patients were at high risk because of frequent comorbidities, including atrial fibrillation (31.7%) and prior stroke (5.8%).

[email protected]

The largest randomized clinical trial to assess the safety and efficacy of cerebral embolic protection systems during transcatheter aortic valve replacement yielded puzzling and somewhat contradictory results, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology.

Virtually every device in this industry-sponsored study involving 363 elderly patients (mean age, 83.4 years) with severe aortic stenosis trapped particulate debris as intended, the mean volume of new lesions in the protected areas of the brain was reduced by 42%, and the number and volume of new lesions correlated with neurocognitive outcomes at 30 days.

However, the reduction in lesion volume did not achieve statistical significance, and the improvement in neurocognitive function also did not reach statistical significance.

In addition, “the sample size was clearly too low to assess clinical outcomes, and in retrospect, was also too low to evaluate follow-up MRI findings or neurocognitive outcomes.” Nevertheless, the trial “provides reassuring evidence of device safety,” said Samir R. Kapadia, MD, of the Cleveland Clinic (J Am Coll Cardiol. 2016 Nov 1. doi: 10.1016/j.jacc.2016.10.023).

In this prospective study, the investigators assessed patients at 17 medical centers in the United States and 2 in Germany. In addition to being elderly, the study patients were at high risk because of frequent comorbidities, including atrial fibrillation (31.7%) and prior stroke (5.8%).

[email protected]

Patients on extracorporeal membrane oxygenation (ECMO) received relatively low doses of sedatives and analgesics while at a light level of sedation in a single-center prospective study of 32 patients.

In addition, patients rarely required neuromuscular blockade, investigators reported online in the Journal of Critical Care.

This finding contrasts with current guidelines on the management of pain, agitation, and delirium in patients on ECMO. The guidelines are based upon previous research that indicated the need for significant increases in sedative and analgesic doses, as well as the need for neuromuscular blockade, wrote Jeremy R. DeGrado, PharmD, of the department of pharmacy at Brigham and Women’s Hospital, Boston, and his colleagues (J Crit Care. 2016 Aug 10;37:1-6. doi: 10.1016/j.jcrc.2016.07.020).

“Patients required significantly lower doses of opioids and sedatives than previously reported in the literature and did not demonstrate a need for increasing doses throughout the study period,” the investigators said. “Continuous infusions of opioids were utilized on most ECMO days, but continuous infusions of benzodiazepines were used on less than half of all ECMO days.”

Their 2-year, prospective, observational study assessed 32 adult intensive care unit patients on ECMO support for more than 48 hours. A total of 15 patients received VA (venoarterial) ECMO and 17 received VV (venovenous) ECMO. Patients received a median daily dose of benzodiazepines (midazolam equivalents) of 24 mg and a median daily dose of opioids (fentanyl equivalents) of 3,875 mcg.

The primary indication for VA ECMO was cardiogenic shock, while VV ECMO was mainly used as a bridge to lung transplant or in patients with severe acute respiratory distress syndrome. The researchers evaluated a total of 475 ECMO days: 110 VA ECMO and 365 VV ECMO.

On average, patients were sedated to Richmond Agitation Sedation Scale scores between 0 and −1. Across all 475 ECMO days, patients were treated with continuous infusions of opioids (on 85% of ECMO days), benzodiazepines (42%), propofol (20%), dexmedetomidine (7%), and neuromuscular blocking agents (13%).

In total, patients who received VV ECMO had a higher median dose of opioids and trended toward a lower dose of benzodiazepines than those who received VA ECMO, Dr. DeGrado and his associates reported.

In total, patients in the VA arm, compared with those in the VV arm, more frequently received a continuous infusion opioid (96% vs. 82% of days) and a benzodiazepine (58% vs. 37% of days). These differences were statistically significant.

Adjunctive therapies, including antipsychotics and clonidine, were administered frequently, according to the report.

“We did not observe an increase in dose requirement over time during ECMO support, possibly due to a multi-modal pharmacologic approach. Overall, patients were not deeply sedated and rarely required neuromuscular blockade. The hypothesis that patients on ECMO require high doses of sedatives and analgesics should be further investigated,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Patients on extracorporeal membrane oxygenation (ECMO) received relatively low doses of sedatives and analgesics while at a light level of sedation in a single-center prospective study of 32 patients.

In addition, patients rarely required neuromuscular blockade, investigators reported online in the Journal of Critical Care.

This finding contrasts with current guidelines on the management of pain, agitation, and delirium in patients on ECMO. The guidelines are based upon previous research that indicated the need for significant increases in sedative and analgesic doses, as well as the need for neuromuscular blockade, wrote Jeremy R. DeGrado, PharmD, of the department of pharmacy at Brigham and Women’s Hospital, Boston, and his colleagues (J Crit Care. 2016 Aug 10;37:1-6. doi: 10.1016/j.jcrc.2016.07.020).

“Patients required significantly lower doses of opioids and sedatives than previously reported in the literature and did not demonstrate a need for increasing doses throughout the study period,” the investigators said. “Continuous infusions of opioids were utilized on most ECMO days, but continuous infusions of benzodiazepines were used on less than half of all ECMO days.”

Their 2-year, prospective, observational study assessed 32 adult intensive care unit patients on ECMO support for more than 48 hours. A total of 15 patients received VA (venoarterial) ECMO and 17 received VV (venovenous) ECMO. Patients received a median daily dose of benzodiazepines (midazolam equivalents) of 24 mg and a median daily dose of opioids (fentanyl equivalents) of 3,875 mcg.

The primary indication for VA ECMO was cardiogenic shock, while VV ECMO was mainly used as a bridge to lung transplant or in patients with severe acute respiratory distress syndrome. The researchers evaluated a total of 475 ECMO days: 110 VA ECMO and 365 VV ECMO.

On average, patients were sedated to Richmond Agitation Sedation Scale scores between 0 and −1. Across all 475 ECMO days, patients were treated with continuous infusions of opioids (on 85% of ECMO days), benzodiazepines (42%), propofol (20%), dexmedetomidine (7%), and neuromuscular blocking agents (13%).

In total, patients who received VV ECMO had a higher median dose of opioids and trended toward a lower dose of benzodiazepines than those who received VA ECMO, Dr. DeGrado and his associates reported.

In total, patients in the VA arm, compared with those in the VV arm, more frequently received a continuous infusion opioid (96% vs. 82% of days) and a benzodiazepine (58% vs. 37% of days). These differences were statistically significant.

Adjunctive therapies, including antipsychotics and clonidine, were administered frequently, according to the report.

“We did not observe an increase in dose requirement over time during ECMO support, possibly due to a multi-modal pharmacologic approach. Overall, patients were not deeply sedated and rarely required neuromuscular blockade. The hypothesis that patients on ECMO require high doses of sedatives and analgesics should be further investigated,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Patients on extracorporeal membrane oxygenation (ECMO) received relatively low doses of sedatives and analgesics while at a light level of sedation in a single-center prospective study of 32 patients.

In addition, patients rarely required neuromuscular blockade, investigators reported online in the Journal of Critical Care.

This finding contrasts with current guidelines on the management of pain, agitation, and delirium in patients on ECMO. The guidelines are based upon previous research that indicated the need for significant increases in sedative and analgesic doses, as well as the need for neuromuscular blockade, wrote Jeremy R. DeGrado, PharmD, of the department of pharmacy at Brigham and Women’s Hospital, Boston, and his colleagues (J Crit Care. 2016 Aug 10;37:1-6. doi: 10.1016/j.jcrc.2016.07.020).

“Patients required significantly lower doses of opioids and sedatives than previously reported in the literature and did not demonstrate a need for increasing doses throughout the study period,” the investigators said. “Continuous infusions of opioids were utilized on most ECMO days, but continuous infusions of benzodiazepines were used on less than half of all ECMO days.”

Their 2-year, prospective, observational study assessed 32 adult intensive care unit patients on ECMO support for more than 48 hours. A total of 15 patients received VA (venoarterial) ECMO and 17 received VV (venovenous) ECMO. Patients received a median daily dose of benzodiazepines (midazolam equivalents) of 24 mg and a median daily dose of opioids (fentanyl equivalents) of 3,875 mcg.

The primary indication for VA ECMO was cardiogenic shock, while VV ECMO was mainly used as a bridge to lung transplant or in patients with severe acute respiratory distress syndrome. The researchers evaluated a total of 475 ECMO days: 110 VA ECMO and 365 VV ECMO.

On average, patients were sedated to Richmond Agitation Sedation Scale scores between 0 and −1. Across all 475 ECMO days, patients were treated with continuous infusions of opioids (on 85% of ECMO days), benzodiazepines (42%), propofol (20%), dexmedetomidine (7%), and neuromuscular blocking agents (13%).

In total, patients who received VV ECMO had a higher median dose of opioids and trended toward a lower dose of benzodiazepines than those who received VA ECMO, Dr. DeGrado and his associates reported.

In total, patients in the VA arm, compared with those in the VV arm, more frequently received a continuous infusion opioid (96% vs. 82% of days) and a benzodiazepine (58% vs. 37% of days). These differences were statistically significant.

Adjunctive therapies, including antipsychotics and clonidine, were administered frequently, according to the report.

“We did not observe an increase in dose requirement over time during ECMO support, possibly due to a multi-modal pharmacologic approach. Overall, patients were not deeply sedated and rarely required neuromuscular blockade. The hypothesis that patients on ECMO require high doses of sedatives and analgesics should be further investigated,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]