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‘Stepping’ up robotic lobectomy instruction
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, FCCP, 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. 
Surgeons in academic centers face the challenge of teaching “the art and science of surgery,” Dr. Cerfolio and his colleagues said, while maintaining quality outcomes. “Teaching minimally invasive surgery, especially robotic surgery, is challenging given the risks and the limited availability of the robot.”
The researchers acknowledged that other groups have taken a similar approach to training, but this is the first study that included video review, coaching, and instruction tied to time constraints, they said.
“A major concern is that while teaching robotic surgery, patients can be injured, care is worse, and metrics that are increasingly used as surrogates for quality outcomes suffer,” they noted.
They allotted each step in the procedure a set amount of time in which the resident had to complete it, totaling 80 minutes for all 19 steps and ranging from 1 minute to inspect the pleura after placing ports (9 minutes) to 20 minutes to close the five incisions. If the resident completed the task in the allotted time, it was recorded as “performed.”
Between February 2010 and December 2010 Dr. Cerfolio performed 520 robotic lobectomies, and over time the percentage of successful steps per resident improved.
For example, in the first year, 50% of thoracic surgery residents completed the first five steps (mark and place ports, inspect pleura, resect the inferior pulmonary ligament, and remove three lymph nodes), but by the last year of the study 90% of them successfully completed the five steps.
Dr. Cerfolio and coauthors acknowledged “many flaws” in their study, but the study also had strengths: It involved only one operation and corroborated the database with each resident’s own surgical logs.
“Operations such as robotic lobectomy can be successfully taught by dividing them into a series of surgical maneuvers or steps,” the researchers noted. Recording what residents can and can’t do, reviewing video, and coaching contribute to the process to improve their skills. “Further studies that scientifically measure ‘ways to teach’ and ways to coach and mentor are needed,” they said.
Dr. Cerfolio disclosed relationships with Intuitive Surgical, Ethicon, Community Health Services, KCL, Bovie and C-SATS. Coauthor Douglas Minnich, MD, is a consultant to Medtronic. The other co-authors had no financial relationships to disclose.
This in an interesting and clinically relevant study given the emphasis many institutions have placed on becoming “robotic” centers of excellence. The overall cost effectiveness of robotic surgery from a public policy standpoint remains a matter of intense study given the scarcity of resources in many health-care settings.
This in an interesting and clinically relevant study given the emphasis many institutions have placed on becoming “robotic” centers of excellence. The overall cost effectiveness of robotic surgery from a public policy standpoint remains a matter of intense study given the scarcity of resources in many health-care settings.
This in an interesting and clinically relevant study given the emphasis many institutions have placed on becoming “robotic” centers of excellence. The overall cost effectiveness of robotic surgery from a public policy standpoint remains a matter of intense study given the scarcity of resources in many health-care settings.
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, FCCP, 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.
Surgeons in academic centers face the challenge of teaching “the art and science of surgery,” Dr. Cerfolio and his colleagues said, while maintaining quality outcomes. “Teaching minimally invasive surgery, especially robotic surgery, is challenging given the risks and the limited availability of the robot.”
The researchers acknowledged that other groups have taken a similar approach to training, but this is the first study that included video review, coaching, and instruction tied to time constraints, they said.
“A major concern is that while teaching robotic surgery, patients can be injured, care is worse, and metrics that are increasingly used as surrogates for quality outcomes suffer,” they noted.
They allotted each step in the procedure a set amount of time in which the resident had to complete it, totaling 80 minutes for all 19 steps and ranging from 1 minute to inspect the pleura after placing ports (9 minutes) to 20 minutes to close the five incisions. If the resident completed the task in the allotted time, it was recorded as “performed.”
Between February 2010 and December 2010 Dr. Cerfolio performed 520 robotic lobectomies, and over time the percentage of successful steps per resident improved.
For example, in the first year, 50% of thoracic surgery residents completed the first five steps (mark and place ports, inspect pleura, resect the inferior pulmonary ligament, and remove three lymph nodes), but by the last year of the study 90% of them successfully completed the five steps.
Dr. Cerfolio and coauthors acknowledged “many flaws” in their study, but the study also had strengths: It involved only one operation and corroborated the database with each resident’s own surgical logs.
“Operations such as robotic lobectomy can be successfully taught by dividing them into a series of surgical maneuvers or steps,” the researchers noted. Recording what residents can and can’t do, reviewing video, and coaching contribute to the process to improve their skills. “Further studies that scientifically measure ‘ways to teach’ and ways to coach and mentor are needed,” they said.
Dr. Cerfolio disclosed relationships with Intuitive Surgical, Ethicon, Community Health Services, KCL, Bovie and C-SATS. Coauthor Douglas Minnich, MD, is a consultant to Medtronic. The other co-authors had no financial 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, FCCP, 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.
Surgeons in academic centers face the challenge of teaching “the art and science of surgery,” Dr. Cerfolio and his colleagues said, while maintaining quality outcomes. “Teaching minimally invasive surgery, especially robotic surgery, is challenging given the risks and the limited availability of the robot.”
The researchers acknowledged that other groups have taken a similar approach to training, but this is the first study that included video review, coaching, and instruction tied to time constraints, they said.
“A major concern is that while teaching robotic surgery, patients can be injured, care is worse, and metrics that are increasingly used as surrogates for quality outcomes suffer,” they noted.
They allotted each step in the procedure a set amount of time in which the resident had to complete it, totaling 80 minutes for all 19 steps and ranging from 1 minute to inspect the pleura after placing ports (9 minutes) to 20 minutes to close the five incisions. If the resident completed the task in the allotted time, it was recorded as “performed.”
Between February 2010 and December 2010 Dr. Cerfolio performed 520 robotic lobectomies, and over time the percentage of successful steps per resident improved.
For example, in the first year, 50% of thoracic surgery residents completed the first five steps (mark and place ports, inspect pleura, resect the inferior pulmonary ligament, and remove three lymph nodes), but by the last year of the study 90% of them successfully completed the five steps.
Dr. Cerfolio and coauthors acknowledged “many flaws” in their study, but the study also had strengths: It involved only one operation and corroborated the database with each resident’s own surgical logs.
“Operations such as robotic lobectomy can be successfully taught by dividing them into a series of surgical maneuvers or steps,” the researchers noted. Recording what residents can and can’t do, reviewing video, and coaching contribute to the process to improve their skills. “Further studies that scientifically measure ‘ways to teach’ and ways to coach and mentor are needed,” they said.
Dr. Cerfolio disclosed relationships with Intuitive Surgical, Ethicon, Community Health Services, KCL, Bovie and C-SATS. Coauthor Douglas Minnich, MD, is a consultant to Medtronic. The other co-authors had no financial relationships to disclose.
Noncancerous disease has a significant impact on lung cancer surgery survival
After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).
“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”
The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.
In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.
However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.
In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).
“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.
“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.
Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.
Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).
“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”
The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.
Every surgeon performing lung resection comes across elderly patients who are at a higher risk than usual for a formal lung resection. In this era of screening and the abundant use of CT scans, this is increasingly common. Selection of the optimal treatment approach is often done intuitively, balancing the increased risk of surgery vs. the improved cancer-specific survival and the baseline life expectancy of the patient. This manuscript provides more quantitative estimates of this balance and draws attention, through a competing risks analysis, to the importance of non–cancer-related mortality in elderly patients.
The authors point out that non–cancer-related mortality is more common than cancer-related mortality for up to 2.5 years after surgery in patients greater than 75 years of age. This way of examining a situation is different from the usual emphasis on 30-day (and more recently the 90-day) perioperative mortality. The manuscript significantly adds to the decision-making framework of this increasingly important population and is a useful read for all lung cancer surgeons.
Sai Yendamuri, MD, is an attending surgeon in the department of thoracic surgery, the director, Thoracic Surgery Research Laboratory, and associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is associate medical editor for Thoracic Surgery News.
Every surgeon performing lung resection comes across elderly patients who are at a higher risk than usual for a formal lung resection. In this era of screening and the abundant use of CT scans, this is increasingly common. Selection of the optimal treatment approach is often done intuitively, balancing the increased risk of surgery vs. the improved cancer-specific survival and the baseline life expectancy of the patient. This manuscript provides more quantitative estimates of this balance and draws attention, through a competing risks analysis, to the importance of non–cancer-related mortality in elderly patients.
The authors point out that non–cancer-related mortality is more common than cancer-related mortality for up to 2.5 years after surgery in patients greater than 75 years of age. This way of examining a situation is different from the usual emphasis on 30-day (and more recently the 90-day) perioperative mortality. The manuscript significantly adds to the decision-making framework of this increasingly important population and is a useful read for all lung cancer surgeons.
Sai Yendamuri, MD, is an attending surgeon in the department of thoracic surgery, the director, Thoracic Surgery Research Laboratory, and associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is associate medical editor for Thoracic Surgery News.
Every surgeon performing lung resection comes across elderly patients who are at a higher risk than usual for a formal lung resection. In this era of screening and the abundant use of CT scans, this is increasingly common. Selection of the optimal treatment approach is often done intuitively, balancing the increased risk of surgery vs. the improved cancer-specific survival and the baseline life expectancy of the patient. This manuscript provides more quantitative estimates of this balance and draws attention, through a competing risks analysis, to the importance of non–cancer-related mortality in elderly patients.
The authors point out that non–cancer-related mortality is more common than cancer-related mortality for up to 2.5 years after surgery in patients greater than 75 years of age. This way of examining a situation is different from the usual emphasis on 30-day (and more recently the 90-day) perioperative mortality. The manuscript significantly adds to the decision-making framework of this increasingly important population and is a useful read for all lung cancer surgeons.
Sai Yendamuri, MD, is an attending surgeon in the department of thoracic surgery, the director, Thoracic Surgery Research Laboratory, and associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is associate medical editor for Thoracic Surgery News.
After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).
“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”
The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.
In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.
However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.
In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).
“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.
“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.
Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.
Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).
“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”
The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.
After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).
“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”
The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.
In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.
However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.
In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).
“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.
“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.
Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.
Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).
“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”
The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Risk of non-cancer death after curative resection of stage 1 non–small-call lung cancer (NSCLC) exceeded that of lung-cancer deaths 1.5 to 2.5 years after surgery in older patients.
Major finding: In patients aged 75 and older the risk of non–lung-cancer–related death exceeded the risk of death from lung cancer for 2.5 years after surgery, whereas in patients 65 and younger the risk of non–lung cancer death exceeded that of lung-cancer death for 3 months after surgery.
Data Source: Single-center analysis of 5,371 consecutive patients who had curative lung cancer resection from 2000 to 2011, 2,186 of whom had stage 1 NSCLC.
Disclosures: The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial relationships to disclose.
Expandable cardiac valve in children found feasible
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: An expandable cardiac valve adapted for infants and children demonstrates acceptable function and can accommodate the child’s growth.
Major finding: At 12 months after implantation of a bovine jugular vein graft reinforced with an external stent modified for surgical valve replacement in pediatric patients, Kaplan-Meier analysis indicated that 83% of those surviving would be free from reoperation at 12 months.
Data source: Single-center study of 42 patients who underwent implantation between 2010 and 2014.
Disclosures: Dr. Emani and his coauthors had no financial relationships to disclose.
Lower-risk approach for aortic arch repair
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Aortic arch reconstruction through a median sternotomy on bypass in newborns and infants had lower rates for recurrent obstruction than did a thoracotomy approach.
Major finding: Of 11 patients who required reintervention, one had a median sternotomy and 10 had a lateral thoracotomy.
Data source: Retrospective review of 183 consecutive newborns and infants with coarctation and hypoplastic aortic arch from 1996 to 2013.
Disclosures: Dr. Tulzer and coauthors had no financial relationships to disclose.
Can bioprosthetics work for large airway defects?
Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.
Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.
These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.
All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.
Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.
This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.
Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.
All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.
Dr. Udelsman and his coauthors reported having no financial disclosures.
In his invited commentary, Raja Flores, MD, of Mount Sinai Health System in New York said this study demonstrated “modest success” with bioprosthetic materials for repair of large airway deficits – the same level of success he ascribes to human studies of other surgical approaches to large airway deficits (J Thorac Cardiovasc Surg. 2016 Nov;152:1233-4).
But progress has been slow and animal studies of large airway deficit repair have been “wastefully repetitive” without any advances. “We must build on what these human studies have taught us and not continue unsuccessfully to reinvent the same malfunctioning [airways],” Dr. Flores said.
When surgeons encounter such patients, surgery isn’t necessary for their survival, Dr. Flores said. “T-tubes work just fine.” The goal is to improve their quality of life. “Unless we can provide a reliable, long-lasting solution, an unpredictable life-threatening experimental surgical intervention is not justified to treat a stable, functional patient,” he said.
And while Dr. Udelsman and his colleagues have shown “some progress” in their study, he cautioned surgeons to heed the words of a tracheal surgery pioneer Hermes Grillo, MD, at Boston’s Massachusetts General Hospital and Harvard Medical School: “Success has been announced episodically over the decades in each of these categories, but thus far no one replacement method has held for the long term in any safe and practicable manner.” Dr. Flores added: “This still holds true today.”
Dr. Flores reported having no financial disclosures.
In his invited commentary, Raja Flores, MD, of Mount Sinai Health System in New York said this study demonstrated “modest success” with bioprosthetic materials for repair of large airway deficits – the same level of success he ascribes to human studies of other surgical approaches to large airway deficits (J Thorac Cardiovasc Surg. 2016 Nov;152:1233-4).
But progress has been slow and animal studies of large airway deficit repair have been “wastefully repetitive” without any advances. “We must build on what these human studies have taught us and not continue unsuccessfully to reinvent the same malfunctioning [airways],” Dr. Flores said.
When surgeons encounter such patients, surgery isn’t necessary for their survival, Dr. Flores said. “T-tubes work just fine.” The goal is to improve their quality of life. “Unless we can provide a reliable, long-lasting solution, an unpredictable life-threatening experimental surgical intervention is not justified to treat a stable, functional patient,” he said.
And while Dr. Udelsman and his colleagues have shown “some progress” in their study, he cautioned surgeons to heed the words of a tracheal surgery pioneer Hermes Grillo, MD, at Boston’s Massachusetts General Hospital and Harvard Medical School: “Success has been announced episodically over the decades in each of these categories, but thus far no one replacement method has held for the long term in any safe and practicable manner.” Dr. Flores added: “This still holds true today.”
Dr. Flores reported having no financial disclosures.
In his invited commentary, Raja Flores, MD, of Mount Sinai Health System in New York said this study demonstrated “modest success” with bioprosthetic materials for repair of large airway deficits – the same level of success he ascribes to human studies of other surgical approaches to large airway deficits (J Thorac Cardiovasc Surg. 2016 Nov;152:1233-4).
But progress has been slow and animal studies of large airway deficit repair have been “wastefully repetitive” without any advances. “We must build on what these human studies have taught us and not continue unsuccessfully to reinvent the same malfunctioning [airways],” Dr. Flores said.
When surgeons encounter such patients, surgery isn’t necessary for their survival, Dr. Flores said. “T-tubes work just fine.” The goal is to improve their quality of life. “Unless we can provide a reliable, long-lasting solution, an unpredictable life-threatening experimental surgical intervention is not justified to treat a stable, functional patient,” he said.
And while Dr. Udelsman and his colleagues have shown “some progress” in their study, he cautioned surgeons to heed the words of a tracheal surgery pioneer Hermes Grillo, MD, at Boston’s Massachusetts General Hospital and Harvard Medical School: “Success has been announced episodically over the decades in each of these categories, but thus far no one replacement method has held for the long term in any safe and practicable manner.” Dr. Flores added: “This still holds true today.”
Dr. Flores reported having no financial disclosures.
Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.
Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.
These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.
All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.
Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.
This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.
Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.
All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.
Dr. Udelsman and his coauthors reported having no financial disclosures.
Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.
Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.
These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.
All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.
Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.
This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.
Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.
All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.
Dr. Udelsman and his coauthors reported having no financial disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Bioprosthetic materials show progress for reconstruction of large airway defects.
Major finding: Airway defects were successfully closed in all patients, with no postoperative deaths or recurrence of airway defect.
Data source: Eight patients who underwent closure of complex central airway defects with bioprosthetic materials between 2008 and 2015.
Disclosures: Dr. Udelsman and coauthors reported having no relevant financial disclosures.
Evaluating Fontan failure risk after arrhythmia
People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.
“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.
The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).
Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.
The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.
After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.
Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.
“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”
About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.
Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.
When interpreting the data that the Australian and New Zealand researchers analyzed, one must be cautious about viewing arrhythmia as an early indicator for Fontan revision, Mark E. Alexander, MD, of Boston Children’s Hospital and Harvard Medical School, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1364-5).
The outcome of a Fontan revision after an arrhythmia “becomes self-fulfilling,” Dr. Alexander said. He questioned what the revision procedure would be when the initial operation was an extracardiac Fontan. “The complex risks of that procedure continue to keep decisions regarding Fontan revisions challenging,” he said. He also noted the study did not analyze the association of ventricular function and arrhythmias “in a substantive way.”
And Dr. Alexander did not interpret the study results as an endorsement of the extracardiac Fontan or a rejection of the lateral tunnel approach. The early adoption of the extracardiac Fontan by the groups the authors represented is itself a limitation of the study, he said. Challenges with follow-up of extracardiac techniques in this and other studies “limit our ability to declare a ‘victor’ in that debate,” he said. “It does remind the electrophysiologist that he or she needs to master the techniques of entering the pulmonary venous atrium in these patients.”
The precision of calculating risk after an operation grows weaker with time, he said, and at 15-20 years morbidity starts to increase and follow-up becomes “more diffuse,” Dr. Alexander said. “That reality means we look forward to this group continuing to enhance our understanding of how our changing management decisions can aid our patients.”
Dr. Alexander had no financial relationships to disclose.
When interpreting the data that the Australian and New Zealand researchers analyzed, one must be cautious about viewing arrhythmia as an early indicator for Fontan revision, Mark E. Alexander, MD, of Boston Children’s Hospital and Harvard Medical School, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1364-5).
The outcome of a Fontan revision after an arrhythmia “becomes self-fulfilling,” Dr. Alexander said. He questioned what the revision procedure would be when the initial operation was an extracardiac Fontan. “The complex risks of that procedure continue to keep decisions regarding Fontan revisions challenging,” he said. He also noted the study did not analyze the association of ventricular function and arrhythmias “in a substantive way.”
And Dr. Alexander did not interpret the study results as an endorsement of the extracardiac Fontan or a rejection of the lateral tunnel approach. The early adoption of the extracardiac Fontan by the groups the authors represented is itself a limitation of the study, he said. Challenges with follow-up of extracardiac techniques in this and other studies “limit our ability to declare a ‘victor’ in that debate,” he said. “It does remind the electrophysiologist that he or she needs to master the techniques of entering the pulmonary venous atrium in these patients.”
The precision of calculating risk after an operation grows weaker with time, he said, and at 15-20 years morbidity starts to increase and follow-up becomes “more diffuse,” Dr. Alexander said. “That reality means we look forward to this group continuing to enhance our understanding of how our changing management decisions can aid our patients.”
Dr. Alexander had no financial relationships to disclose.
When interpreting the data that the Australian and New Zealand researchers analyzed, one must be cautious about viewing arrhythmia as an early indicator for Fontan revision, Mark E. Alexander, MD, of Boston Children’s Hospital and Harvard Medical School, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1364-5).
The outcome of a Fontan revision after an arrhythmia “becomes self-fulfilling,” Dr. Alexander said. He questioned what the revision procedure would be when the initial operation was an extracardiac Fontan. “The complex risks of that procedure continue to keep decisions regarding Fontan revisions challenging,” he said. He also noted the study did not analyze the association of ventricular function and arrhythmias “in a substantive way.”
And Dr. Alexander did not interpret the study results as an endorsement of the extracardiac Fontan or a rejection of the lateral tunnel approach. The early adoption of the extracardiac Fontan by the groups the authors represented is itself a limitation of the study, he said. Challenges with follow-up of extracardiac techniques in this and other studies “limit our ability to declare a ‘victor’ in that debate,” he said. “It does remind the electrophysiologist that he or she needs to master the techniques of entering the pulmonary venous atrium in these patients.”
The precision of calculating risk after an operation grows weaker with time, he said, and at 15-20 years morbidity starts to increase and follow-up becomes “more diffuse,” Dr. Alexander said. “That reality means we look forward to this group continuing to enhance our understanding of how our changing management decisions can aid our patients.”
Dr. Alexander had no financial relationships to disclose.
People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.
“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.
The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).
Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.
The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.
After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.
Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.
“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”
About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.
Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.
People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.
“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.
The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).
Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.
The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.
After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.
Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.
“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”
About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.
Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: The development of arrhythmia is associated with a heightened risk of failure of Fontan circulation after a Fontan procedure.
Major finding: At 20 years, freedom from any arrhythmia was 66%, and after the onset of any arrhythmia freedom from Fontan failure was 55%.
Data source: 1,034 patients who had undergone a Fontan procedure from 1975 to 2014 as recorded in the Australian and New Zealand Fontan Registry.
Disclosures: Coauthor Andrew Bullock, MBBS, reported receiving consulting fees from Actelion. All other others have no financial relationships to disclose.
Revision technique treats graft dysfunction after esophageal reconstruction
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
Key clinical point: Cervicosternolaparotomy revision surgery for graft dysfunction after esophageal reconstruction for caustic injuries can achieve good results with acceptable morbidity.
Major finding: Functional success rate after revision CSLap was 85% after a mean follow-up of 4.4 years.
Data source: 55 patients who underwent CSLap revision surgery between 1999 and 2015 at a single center.
Disclosures: Dr. Voron and coauthors had no financial relationships to disclose.
SYNTAX analysis: Making the case for CABG over PCI
Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.
Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).
“In fact, there was a significant survival advantage for CABG in the patients with intermediate and high SYNTAX scores, with the death rate of CABG versus PCI being 9.6% versus 16.3% (P less than .047) and 8.8% versus 17.8% (P less than .02), respectively,” they wrote.
The advantages of surgery “have been most striking for patients with intermediate or high SYNTAX scores, but seem to exist for patients with low scores as well, although requiring more follow-up,” Dr. Mack and colleagues said. But the situation is less clear in other subgroups, particularly in patients with less diffuse distal disease and lower SYNTAX scores, they added.
Complete revascularization after the procedure may explain the better outcomes with CABG, as 43.3% of those in the PCI arm had incomplete revascularization vs. 36.8% in the CABG arm. “Incomplete revascularization was associated with increased risk for major adverse cardiac or cerebrovascular events three years after PCI, but incomplete revascularization in the CABG group could not be identified as a predictor for worse outcomes,” Dr. Mack and colleagues noted.
The expert opinion authors debunk one of the recent criticisms of SYNTAX: that its reliance on first-generation drug-eluting stents is dated and not relevant today. They noted the more recent Bypass Surgery Vs. Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease trial found a similarly higher rate of death, heart attack, and target vessel revascularization occurred more frequently in the PCI group (15.3% vs. 10.6% in the CABG group) (N Engl J Med. 2015;372:1204-12).
Nonetheless, Dr. Mack and coauthors found room for improvement for CABG through increased use of atrial revascularization and appropriate measures to minimize stroke.
The latest SYNTAX findings can inform the approach surgeons take with high-risk patients, they said. This should include “a discussion of these data, particularly in regard to survival.” And physicians should base their therapeutic recommendations on these data. “At present, there are data seeming to indicate that the majority of patients with three-vessel disease receiving invasive treatment in the United States are being treated with PCI, an outcome that is not congruent with these outcome findings,” they said.
Taking into consideration other SYNTAX analyses that have shown that completeness of revascularization is a determining factor in post-PCI outcomes, Dr. Mack and coauthors said that physicians should calculate the degree of coronary artery disease (CAD) left untreated after intervention, “and those patients who are likely to have a high residual SYNTAX score should be strongly considered for CABG.” Doctors should also focus “intensive efforts” on adherence to optimal medical therapy after both CABG and PCI.
“Finally, although there is a strong patient preference for a less-invasive treatment of their CAD, patients with advanced disease should be made aware that the choice of PCI puts them at an increased risk of death relative to CABG, and a full and transparent discussion should occur regarding the implications of their decision,” Dr. Mack and coauthors concluded.
They had no relevant financial relationships to disclose.
In their invited editorial commentary, Saswata Deb, MD, and Stephen E. Fremes, MD, of the Schulich Heart Center at the University of Toronto, concurred with the conclusions of Dr. Mack and colleagues (J Thorac Cardiovasc Surg. 2016;152:1241-2). And Joseph F. Sabik III, MD, of the Cleveland Clinic arrived at a similar conclusion in an accompanying editorial (J. Thorac Cardiovasc Surg. 2016;152:1227-8).
Dr. Deb and Dr. Fremes found noteworthy the point Dr. Mack and coauthors raised about cardiologists and internists continuing to recommend PCI to patients with complex multivessel CAD despite evidence from SYNTAX and other trials. “This raises the importance of having a multidisciplinary heart team,” Dr. Deb and Dr. Fremes said.
But they also raised an important question about the difference in outcomes between CABG and PCI in complex multivessel disease. CABG should be the preferred intervention if the high rates of late fatal myocardial infarction after PCI are due to incomplete revascularization; however, if late stent thrombosis was the cause of this disparity in outcomes, then improvements in PCI could close that gap.
In his editorial, Dr. Sabik attributed the difference in outcomes between PCI and CABG to the ability of the former to both treat existing and prevent future stenosis. PCI can be “difficult, dangerous, and even impossible” when the target vessel is totally occluded or the stenosis is complex, hence leading to incomplete revascularization and residual ischemia. “Performing CABG to these vessels is no more difficult than for an isolated, noncomplex stenosis,” Dr. Sabik said.
Dr. Sabik disclosed he is the principal investigator for an Abbott Laboratories–sponsored trial of left main coronary disease, and is on the scientific advisory board of Medtronic.
Dr. Deb and Dr. Fremes had no relationships to disclose.
In their invited editorial commentary, Saswata Deb, MD, and Stephen E. Fremes, MD, of the Schulich Heart Center at the University of Toronto, concurred with the conclusions of Dr. Mack and colleagues (J Thorac Cardiovasc Surg. 2016;152:1241-2). And Joseph F. Sabik III, MD, of the Cleveland Clinic arrived at a similar conclusion in an accompanying editorial (J. Thorac Cardiovasc Surg. 2016;152:1227-8).
Dr. Deb and Dr. Fremes found noteworthy the point Dr. Mack and coauthors raised about cardiologists and internists continuing to recommend PCI to patients with complex multivessel CAD despite evidence from SYNTAX and other trials. “This raises the importance of having a multidisciplinary heart team,” Dr. Deb and Dr. Fremes said.
But they also raised an important question about the difference in outcomes between CABG and PCI in complex multivessel disease. CABG should be the preferred intervention if the high rates of late fatal myocardial infarction after PCI are due to incomplete revascularization; however, if late stent thrombosis was the cause of this disparity in outcomes, then improvements in PCI could close that gap.
In his editorial, Dr. Sabik attributed the difference in outcomes between PCI and CABG to the ability of the former to both treat existing and prevent future stenosis. PCI can be “difficult, dangerous, and even impossible” when the target vessel is totally occluded or the stenosis is complex, hence leading to incomplete revascularization and residual ischemia. “Performing CABG to these vessels is no more difficult than for an isolated, noncomplex stenosis,” Dr. Sabik said.
Dr. Sabik disclosed he is the principal investigator for an Abbott Laboratories–sponsored trial of left main coronary disease, and is on the scientific advisory board of Medtronic.
Dr. Deb and Dr. Fremes had no relationships to disclose.
In their invited editorial commentary, Saswata Deb, MD, and Stephen E. Fremes, MD, of the Schulich Heart Center at the University of Toronto, concurred with the conclusions of Dr. Mack and colleagues (J Thorac Cardiovasc Surg. 2016;152:1241-2). And Joseph F. Sabik III, MD, of the Cleveland Clinic arrived at a similar conclusion in an accompanying editorial (J. Thorac Cardiovasc Surg. 2016;152:1227-8).
Dr. Deb and Dr. Fremes found noteworthy the point Dr. Mack and coauthors raised about cardiologists and internists continuing to recommend PCI to patients with complex multivessel CAD despite evidence from SYNTAX and other trials. “This raises the importance of having a multidisciplinary heart team,” Dr. Deb and Dr. Fremes said.
But they also raised an important question about the difference in outcomes between CABG and PCI in complex multivessel disease. CABG should be the preferred intervention if the high rates of late fatal myocardial infarction after PCI are due to incomplete revascularization; however, if late stent thrombosis was the cause of this disparity in outcomes, then improvements in PCI could close that gap.
In his editorial, Dr. Sabik attributed the difference in outcomes between PCI and CABG to the ability of the former to both treat existing and prevent future stenosis. PCI can be “difficult, dangerous, and even impossible” when the target vessel is totally occluded or the stenosis is complex, hence leading to incomplete revascularization and residual ischemia. “Performing CABG to these vessels is no more difficult than for an isolated, noncomplex stenosis,” Dr. Sabik said.
Dr. Sabik disclosed he is the principal investigator for an Abbott Laboratories–sponsored trial of left main coronary disease, and is on the scientific advisory board of Medtronic.
Dr. Deb and Dr. Fremes had no relationships to disclose.
Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.
Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).
“In fact, there was a significant survival advantage for CABG in the patients with intermediate and high SYNTAX scores, with the death rate of CABG versus PCI being 9.6% versus 16.3% (P less than .047) and 8.8% versus 17.8% (P less than .02), respectively,” they wrote.
The advantages of surgery “have been most striking for patients with intermediate or high SYNTAX scores, but seem to exist for patients with low scores as well, although requiring more follow-up,” Dr. Mack and colleagues said. But the situation is less clear in other subgroups, particularly in patients with less diffuse distal disease and lower SYNTAX scores, they added.
Complete revascularization after the procedure may explain the better outcomes with CABG, as 43.3% of those in the PCI arm had incomplete revascularization vs. 36.8% in the CABG arm. “Incomplete revascularization was associated with increased risk for major adverse cardiac or cerebrovascular events three years after PCI, but incomplete revascularization in the CABG group could not be identified as a predictor for worse outcomes,” Dr. Mack and colleagues noted.
The expert opinion authors debunk one of the recent criticisms of SYNTAX: that its reliance on first-generation drug-eluting stents is dated and not relevant today. They noted the more recent Bypass Surgery Vs. Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease trial found a similarly higher rate of death, heart attack, and target vessel revascularization occurred more frequently in the PCI group (15.3% vs. 10.6% in the CABG group) (N Engl J Med. 2015;372:1204-12).
Nonetheless, Dr. Mack and coauthors found room for improvement for CABG through increased use of atrial revascularization and appropriate measures to minimize stroke.
The latest SYNTAX findings can inform the approach surgeons take with high-risk patients, they said. This should include “a discussion of these data, particularly in regard to survival.” And physicians should base their therapeutic recommendations on these data. “At present, there are data seeming to indicate that the majority of patients with three-vessel disease receiving invasive treatment in the United States are being treated with PCI, an outcome that is not congruent with these outcome findings,” they said.
Taking into consideration other SYNTAX analyses that have shown that completeness of revascularization is a determining factor in post-PCI outcomes, Dr. Mack and coauthors said that physicians should calculate the degree of coronary artery disease (CAD) left untreated after intervention, “and those patients who are likely to have a high residual SYNTAX score should be strongly considered for CABG.” Doctors should also focus “intensive efforts” on adherence to optimal medical therapy after both CABG and PCI.
“Finally, although there is a strong patient preference for a less-invasive treatment of their CAD, patients with advanced disease should be made aware that the choice of PCI puts them at an increased risk of death relative to CABG, and a full and transparent discussion should occur regarding the implications of their decision,” Dr. Mack and coauthors concluded.
They had no relevant financial relationships to disclose.
Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.
Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).
“In fact, there was a significant survival advantage for CABG in the patients with intermediate and high SYNTAX scores, with the death rate of CABG versus PCI being 9.6% versus 16.3% (P less than .047) and 8.8% versus 17.8% (P less than .02), respectively,” they wrote.
The advantages of surgery “have been most striking for patients with intermediate or high SYNTAX scores, but seem to exist for patients with low scores as well, although requiring more follow-up,” Dr. Mack and colleagues said. But the situation is less clear in other subgroups, particularly in patients with less diffuse distal disease and lower SYNTAX scores, they added.
Complete revascularization after the procedure may explain the better outcomes with CABG, as 43.3% of those in the PCI arm had incomplete revascularization vs. 36.8% in the CABG arm. “Incomplete revascularization was associated with increased risk for major adverse cardiac or cerebrovascular events three years after PCI, but incomplete revascularization in the CABG group could not be identified as a predictor for worse outcomes,” Dr. Mack and colleagues noted.
The expert opinion authors debunk one of the recent criticisms of SYNTAX: that its reliance on first-generation drug-eluting stents is dated and not relevant today. They noted the more recent Bypass Surgery Vs. Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease trial found a similarly higher rate of death, heart attack, and target vessel revascularization occurred more frequently in the PCI group (15.3% vs. 10.6% in the CABG group) (N Engl J Med. 2015;372:1204-12).
Nonetheless, Dr. Mack and coauthors found room for improvement for CABG through increased use of atrial revascularization and appropriate measures to minimize stroke.
The latest SYNTAX findings can inform the approach surgeons take with high-risk patients, they said. This should include “a discussion of these data, particularly in regard to survival.” And physicians should base their therapeutic recommendations on these data. “At present, there are data seeming to indicate that the majority of patients with three-vessel disease receiving invasive treatment in the United States are being treated with PCI, an outcome that is not congruent with these outcome findings,” they said.
Taking into consideration other SYNTAX analyses that have shown that completeness of revascularization is a determining factor in post-PCI outcomes, Dr. Mack and coauthors said that physicians should calculate the degree of coronary artery disease (CAD) left untreated after intervention, “and those patients who are likely to have a high residual SYNTAX score should be strongly considered for CABG.” Doctors should also focus “intensive efforts” on adherence to optimal medical therapy after both CABG and PCI.
“Finally, although there is a strong patient preference for a less-invasive treatment of their CAD, patients with advanced disease should be made aware that the choice of PCI puts them at an increased risk of death relative to CABG, and a full and transparent discussion should occur regarding the implications of their decision,” Dr. Mack and coauthors concluded.
They had no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Physicians should clearly communicate to patients with complex multivessel artery disease the key findings of the SYNTAX trial.
Major finding: The SYNTAX trials showed the risk of cardiac death from myocardial infarction after percutaneous coronary intervention (PCI) is 10 times greater than that after coronary artery bypass grafting in higher-risk patients.
Data source: A post hoc analysis of causes of death in all 3,075 trial and registry patients in the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) trial.
Disclosures: Dr. Mack and coauthors reported having no financial disclosures.
Is regional anesthesia safer in CEA?
COLUMBUS, OHIO – General anesthesia during carotid endarterectomy carries almost twice the risk of complications and unplanned intubation as regional anesthesia, but the latter approach, which is not available in all hospitals, has its own issues, an analysis of procedures from a statewide database in Michigan found.
“This study is timely because of CMS [Center for Medicare & Medicaid Services] initiatives tying reimbursement to specific quality measures,” Ahmad S Hussain, MD, of Wayne State University in Detroit said in reporting the study results at the annual meeting of the Midwestern Vascular Surgery Society.
Regional anesthesia in CEA emerged in the 1990s, Dr. Hussain said, and allows for more reliable neurologic monitoring and more direct evaluation of the need for stenting during CEA than general anesthesia, which requires continuous monitoring of cerebral perfusion with carotid stump pressures, electroencephalogram, and transcranial doppler.
The researchers retrospectively analyzed 4,558 patients who had CEA at hospitals participating in the Michigan Surgical Quality Cooperative from 2012 to 2014 – 4,008 of whom had general anesthesia and 550 regional anesthesia.
“Advocates for carotid endarterectomy with regional anesthesia cite a reduction in hemodynamic instability and the ability for neurological monitoring, but many still prefer general anesthesia because the benefits of regional anesthesia have not been clearly demonstrated, allowing that regional anesthesia may not be available in all centers and allowing that a certain amount of patient movement during the procedure may not be uniformly tolerated,” Dr. Hussain said.
General anesthesia patients in the study had more than twice the rate of any morbidity at 30 days than those who had regional, 8.7% vs. 4.2%, and significantly higher rates of unplanned intervention, 2.1% vs. 0.6%. Dr. Hussain said. However, the study could not determine differences in 30-day mortality or other key outcomes, such as rates of pneumonia, sepsis, deep vein thrombosis, or pulmonary embolism, becauseof insufficient sample sizes, Dr. Hussain said
The study found less significant differences between general and regional anesthesia techniques, respectively, in rates of extended length of stay, 12.1% vs. 9.5%; readmissions, 9.2% vs. 6.1%; and reoperation, 4.5% vs. 3%.
The retrospective study used two models to analyze odds ratios: Model 1 adjusted for case mix; and model 2 adjusted for case mix as fixed effects and site as a random effect. While the retrospective nature of the study may be a limitation, the findings support the use of regional anesthesia for CEA when available, Dr. Hussain said.
Dr. Hussain had no relationships to disclose.
COLUMBUS, OHIO – General anesthesia during carotid endarterectomy carries almost twice the risk of complications and unplanned intubation as regional anesthesia, but the latter approach, which is not available in all hospitals, has its own issues, an analysis of procedures from a statewide database in Michigan found.
“This study is timely because of CMS [Center for Medicare & Medicaid Services] initiatives tying reimbursement to specific quality measures,” Ahmad S Hussain, MD, of Wayne State University in Detroit said in reporting the study results at the annual meeting of the Midwestern Vascular Surgery Society.
Regional anesthesia in CEA emerged in the 1990s, Dr. Hussain said, and allows for more reliable neurologic monitoring and more direct evaluation of the need for stenting during CEA than general anesthesia, which requires continuous monitoring of cerebral perfusion with carotid stump pressures, electroencephalogram, and transcranial doppler.
The researchers retrospectively analyzed 4,558 patients who had CEA at hospitals participating in the Michigan Surgical Quality Cooperative from 2012 to 2014 – 4,008 of whom had general anesthesia and 550 regional anesthesia.
“Advocates for carotid endarterectomy with regional anesthesia cite a reduction in hemodynamic instability and the ability for neurological monitoring, but many still prefer general anesthesia because the benefits of regional anesthesia have not been clearly demonstrated, allowing that regional anesthesia may not be available in all centers and allowing that a certain amount of patient movement during the procedure may not be uniformly tolerated,” Dr. Hussain said.
General anesthesia patients in the study had more than twice the rate of any morbidity at 30 days than those who had regional, 8.7% vs. 4.2%, and significantly higher rates of unplanned intervention, 2.1% vs. 0.6%. Dr. Hussain said. However, the study could not determine differences in 30-day mortality or other key outcomes, such as rates of pneumonia, sepsis, deep vein thrombosis, or pulmonary embolism, becauseof insufficient sample sizes, Dr. Hussain said
The study found less significant differences between general and regional anesthesia techniques, respectively, in rates of extended length of stay, 12.1% vs. 9.5%; readmissions, 9.2% vs. 6.1%; and reoperation, 4.5% vs. 3%.
The retrospective study used two models to analyze odds ratios: Model 1 adjusted for case mix; and model 2 adjusted for case mix as fixed effects and site as a random effect. While the retrospective nature of the study may be a limitation, the findings support the use of regional anesthesia for CEA when available, Dr. Hussain said.
Dr. Hussain had no relationships to disclose.
COLUMBUS, OHIO – General anesthesia during carotid endarterectomy carries almost twice the risk of complications and unplanned intubation as regional anesthesia, but the latter approach, which is not available in all hospitals, has its own issues, an analysis of procedures from a statewide database in Michigan found.
“This study is timely because of CMS [Center for Medicare & Medicaid Services] initiatives tying reimbursement to specific quality measures,” Ahmad S Hussain, MD, of Wayne State University in Detroit said in reporting the study results at the annual meeting of the Midwestern Vascular Surgery Society.
Regional anesthesia in CEA emerged in the 1990s, Dr. Hussain said, and allows for more reliable neurologic monitoring and more direct evaluation of the need for stenting during CEA than general anesthesia, which requires continuous monitoring of cerebral perfusion with carotid stump pressures, electroencephalogram, and transcranial doppler.
The researchers retrospectively analyzed 4,558 patients who had CEA at hospitals participating in the Michigan Surgical Quality Cooperative from 2012 to 2014 – 4,008 of whom had general anesthesia and 550 regional anesthesia.
“Advocates for carotid endarterectomy with regional anesthesia cite a reduction in hemodynamic instability and the ability for neurological monitoring, but many still prefer general anesthesia because the benefits of regional anesthesia have not been clearly demonstrated, allowing that regional anesthesia may not be available in all centers and allowing that a certain amount of patient movement during the procedure may not be uniformly tolerated,” Dr. Hussain said.
General anesthesia patients in the study had more than twice the rate of any morbidity at 30 days than those who had regional, 8.7% vs. 4.2%, and significantly higher rates of unplanned intervention, 2.1% vs. 0.6%. Dr. Hussain said. However, the study could not determine differences in 30-day mortality or other key outcomes, such as rates of pneumonia, sepsis, deep vein thrombosis, or pulmonary embolism, becauseof insufficient sample sizes, Dr. Hussain said
The study found less significant differences between general and regional anesthesia techniques, respectively, in rates of extended length of stay, 12.1% vs. 9.5%; readmissions, 9.2% vs. 6.1%; and reoperation, 4.5% vs. 3%.
The retrospective study used two models to analyze odds ratios: Model 1 adjusted for case mix; and model 2 adjusted for case mix as fixed effects and site as a random effect. While the retrospective nature of the study may be a limitation, the findings support the use of regional anesthesia for CEA when available, Dr. Hussain said.
Dr. Hussain had no relationships to disclose.
AT MIDWESTERN VASCULAR 2016
Key clinical point: General anesthesia for carotid endarterectomy carries a higher risk of complications and readmissions than regional anesthesia.
Major finding: Any morbidity after CEA with general anesthesia was 8.7% vs. 4.2% for regional anesthesia, and readmissions rates were 9.2% vs. 6.1%.
Data source: Retrospective analysis of 4,558 patients who had CEA between 2012 and 2014 at hospitals participating in the Michigan Surgical Quality Collaborative database.
Disclosures: Dr. Hussain reported having no financial disclosures.
CEA risk models fit for an app
COLUMBUS, OHIO – Carotid endarterectomy is an effective treatment for people with asymptomatic carotid artery disease when stroke rates are low and they survive long enough to benefit from the treatment. But determining who those patients are can be a challenge for vascular surgeons. A team of vascular specialists from around the country have developed risk prediction models to help surgeons better select asymptomatic patients for the procedure, Randall DeMartino, MD, said at the annual meeting of the Midwestern Vascular Surgical Society.
“These models will be used for mobile apps and web-based applications for point of care patient risk assessment,” said Dr. DeMartino of the Mayo Clinic in Rochester, Minn. He is the lead researcher for the study, which uses data from the Vascular Quality Initiative (VQI).
In developing the models, the researchers sampled asymptomatic patients in the VQI who had first-time elective CEA. There were 31,939 patients in the stroke analysis who had CEA from 2010-2015, and 24,086 patients in the mortality analysis who had procedures from 2010-2014. Dr. DeMartino and his colleagues evaluated all preoperative patient and surgeon characteristics, then used an algorithm to optimize the variables that were selected for the final logistic model.
The researchers also evaluated 30-day stroke rates and 1-year mortality at participating centers and found wide variability: an average of 0.9% for stroke, with a range of 0-8.3%; and 3.2% for mortality, with a range of 0-20%. “Actually, 22% of centers had a 1-year mortality rate that exceeded 5%,” Dr. DeMartino said.
The model for 1-year mortality identified the following variables associated with the highest risk of death 1 year after CEA: age greater than or equal to 80 years; a preoperative hemoglobin less than 10 mg/dL; oxygen-dependent chronic obstructive pulmonary disease; mild to severe congestive heart failure; American Society of Anesthesiologists classification of IV or V; stage 4 or 5 chronic kidney disease; and a contralateral occlusion.
“Conversely, a normal stress test, when performed, and preoperative statin use were associated with reduced risk of death over a year,” Dr. DeMartino said.
“These data have been used to provide Center Opportunity for Improvement reports through VQI where centers can identify if they are selecting patients with risk factors for stroke or mortality more often compared to other centers,” Dr. DeMartino said. “This allows centers to see where opportunities for improvement exist.”
Also, physicians can see the proportion of patients they select with a predicted mortality risk over 5% at one year – “a group of patients who may gain little benefit from prophylactic CEA,” he said. “Physicians can compare their patient selection to those in their region or nationally.”
Dr. DeMartino had no relationships to disclose.
COLUMBUS, OHIO – Carotid endarterectomy is an effective treatment for people with asymptomatic carotid artery disease when stroke rates are low and they survive long enough to benefit from the treatment. But determining who those patients are can be a challenge for vascular surgeons. A team of vascular specialists from around the country have developed risk prediction models to help surgeons better select asymptomatic patients for the procedure, Randall DeMartino, MD, said at the annual meeting of the Midwestern Vascular Surgical Society.
“These models will be used for mobile apps and web-based applications for point of care patient risk assessment,” said Dr. DeMartino of the Mayo Clinic in Rochester, Minn. He is the lead researcher for the study, which uses data from the Vascular Quality Initiative (VQI).
In developing the models, the researchers sampled asymptomatic patients in the VQI who had first-time elective CEA. There were 31,939 patients in the stroke analysis who had CEA from 2010-2015, and 24,086 patients in the mortality analysis who had procedures from 2010-2014. Dr. DeMartino and his colleagues evaluated all preoperative patient and surgeon characteristics, then used an algorithm to optimize the variables that were selected for the final logistic model.
The researchers also evaluated 30-day stroke rates and 1-year mortality at participating centers and found wide variability: an average of 0.9% for stroke, with a range of 0-8.3%; and 3.2% for mortality, with a range of 0-20%. “Actually, 22% of centers had a 1-year mortality rate that exceeded 5%,” Dr. DeMartino said.
The model for 1-year mortality identified the following variables associated with the highest risk of death 1 year after CEA: age greater than or equal to 80 years; a preoperative hemoglobin less than 10 mg/dL; oxygen-dependent chronic obstructive pulmonary disease; mild to severe congestive heart failure; American Society of Anesthesiologists classification of IV or V; stage 4 or 5 chronic kidney disease; and a contralateral occlusion.
“Conversely, a normal stress test, when performed, and preoperative statin use were associated with reduced risk of death over a year,” Dr. DeMartino said.
“These data have been used to provide Center Opportunity for Improvement reports through VQI where centers can identify if they are selecting patients with risk factors for stroke or mortality more often compared to other centers,” Dr. DeMartino said. “This allows centers to see where opportunities for improvement exist.”
Also, physicians can see the proportion of patients they select with a predicted mortality risk over 5% at one year – “a group of patients who may gain little benefit from prophylactic CEA,” he said. “Physicians can compare their patient selection to those in their region or nationally.”
Dr. DeMartino had no relationships to disclose.
COLUMBUS, OHIO – Carotid endarterectomy is an effective treatment for people with asymptomatic carotid artery disease when stroke rates are low and they survive long enough to benefit from the treatment. But determining who those patients are can be a challenge for vascular surgeons. A team of vascular specialists from around the country have developed risk prediction models to help surgeons better select asymptomatic patients for the procedure, Randall DeMartino, MD, said at the annual meeting of the Midwestern Vascular Surgical Society.
“These models will be used for mobile apps and web-based applications for point of care patient risk assessment,” said Dr. DeMartino of the Mayo Clinic in Rochester, Minn. He is the lead researcher for the study, which uses data from the Vascular Quality Initiative (VQI).
In developing the models, the researchers sampled asymptomatic patients in the VQI who had first-time elective CEA. There were 31,939 patients in the stroke analysis who had CEA from 2010-2015, and 24,086 patients in the mortality analysis who had procedures from 2010-2014. Dr. DeMartino and his colleagues evaluated all preoperative patient and surgeon characteristics, then used an algorithm to optimize the variables that were selected for the final logistic model.
The researchers also evaluated 30-day stroke rates and 1-year mortality at participating centers and found wide variability: an average of 0.9% for stroke, with a range of 0-8.3%; and 3.2% for mortality, with a range of 0-20%. “Actually, 22% of centers had a 1-year mortality rate that exceeded 5%,” Dr. DeMartino said.
The model for 1-year mortality identified the following variables associated with the highest risk of death 1 year after CEA: age greater than or equal to 80 years; a preoperative hemoglobin less than 10 mg/dL; oxygen-dependent chronic obstructive pulmonary disease; mild to severe congestive heart failure; American Society of Anesthesiologists classification of IV or V; stage 4 or 5 chronic kidney disease; and a contralateral occlusion.
“Conversely, a normal stress test, when performed, and preoperative statin use were associated with reduced risk of death over a year,” Dr. DeMartino said.
“These data have been used to provide Center Opportunity for Improvement reports through VQI where centers can identify if they are selecting patients with risk factors for stroke or mortality more often compared to other centers,” Dr. DeMartino said. “This allows centers to see where opportunities for improvement exist.”
Also, physicians can see the proportion of patients they select with a predicted mortality risk over 5% at one year – “a group of patients who may gain little benefit from prophylactic CEA,” he said. “Physicians can compare their patient selection to those in their region or nationally.”
Dr. DeMartino had no relationships to disclose.
AT MIDWESTERN VASCULAR 2016
Key clinical point: Risk-prediction models may identify patients at greatest risk of stroke and 1-year death after carotid endarterectomy (CEA).
Major finding: Contralateral occlusion has odds ratios of 2.5 for 30-day stroke after CEA and 1.7 for death at 1 year.
Data source: Sampling of patients from the Vascular Quality Initiative who had first-time CEA: 31,939 in the stroke analysis and 24,086 in the mortality analysis.
Disclosures: Dr. DeMartino reported having no financial disclosures.