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Early elimination of cyclosporine after heart transplant has renal benefit
SAN FRANCISCO – Use of an everolimus-containing regimen with early stopping of cyclosporine after de novo heart transplantation improves renal function and reduces cardiac allograft vasculopathy, without compromising graft outcomes, new data suggest.
These was among key findings of the randomized, open-label SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance) reported at the 2014 World Transplant Congress.
"Renal dysfunction and cardiac allograft vasculopathy are markers for increased morbidity and mortality after heart transplantation," lead author Dr. Vilborg Sigurdardottir commented when introducing the study.
Patients in the trial were randomized evenly to a three-drug regimen containing the calcineurin inhibitor cyclosporine (Sandimmune) or to a four-drug regimen also containing the mTOR inhibitor everolimus (Zortress) with discontinuation of cyclosporine at week 7-11. Everolimus is currently approved by the Food and Drug Administration to prevent graft rejection in kidney and liver transplant recipients and, under another brand name, to treat some cancers.
Measured glomerular filtration rate (GFR) at 12 months, the trial’s primary outcome, was 30% better in the everolimus group than in the cyclosporine group (79.8 vs. 61.5 mL/min per 1.73 m2; P less than .001), according to results presented at the congress and recently published (Am. J. Transplant. 2014;14:1828-38).
The urinary albumin-creatinine ratio was higher in the everolimus group, but none of the patients had nephrotic levels of proteinuria.
Rates of adverse events were similar, with the exception that the everolimus group had a lower rate of cytomegalovirus infection (5% vs. 30%) and a higher rate of pneumonia (12% vs. 3%), Dr. Sigurdardottir reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The incidence of biopsy-proven acute rejection of at least grade 2R was greater with everolimus (40% vs. 18%, P = .01). However, at 12 months, the groups did not differ with respect to left ventricular function as assessed by echocardiography and biomarkers, and, in a cardiac reserve substudy, with respect to cardiac output and pulmonary capillary wedge pressure.
The incidence of cardiac allograft vasculopathy, defined as a mean media-intima thickness of at least 0.5 mm on intravascular ultrasound (IVUS), was lower in the everolimus group (51% vs. 65%, P less than .01), and progression assessed as the change in percent atheroma volume was slower in that group.
"Everolimus initiation and early cyclosporine elimination in de novo heart transplant recipients showed a highly significant improvement of renal function in terms of measured GFR, a reduced incidence of cytomegalovirus [a confirmatory result of previous large-scale studies], similar numbers of adverse and serious adverse events, and an increased incidence of treated acute rejection, however, without hemodynamic compromise and with preserved cardiac function and preserved cardiac reserve," concluded Dr. Sigurdardottir, who is medical director of heart transplantation at the Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. "We saw also favorable coronary remodeling and less graft vasculopathy, as previously shown."
Among patients whose donor hearts had such disease, the increase in media-intima thickness and percent atheroma volume was less with everolimus than with cyclosporine, Dr. Sigurdardottir said. "Interestingly, we saw here that the total atheroma volume decreased between baseline and 12 months in the everolimus group in the patients who had preexisting donor disease."
An attendee from Norway said, "I am a nephrologist, and if I were to get a new heart, I’d rather have a GFR of 61 and no rejection than a GFR of 73 with rejection. Have you looked at the development of donor-specific antibodies in the ones who had rejection, because I’d like to live for more than a year – I’d like to live 3 years or 5 years or 10 years."
"You are absolutely right. At the time of transplantation, we would be looking at the acute problems, and we often see the kidney dysfunction, so we want to do something about that. But of course these studies need to tell us how patients fare longer term," Dr. Sigurdardottir agreed. None of the patients were found to have donor-specific antibodies, but the trial protocol did not mandate routine measurement, she said.
An attendee from Los Angeles commented, "We tried to do CNI [calcineurin inhibitor] weaning in 2006 and had hemodynamically compromised rejection. Now, I congratulate you on being innovative and having quadruple therapy from the get-go and then taking off the CNI. But the issue of increased rejection is important because ISHLT [International Society for Heart and Lung Transplantation] data show that that does lead to poorer outcome. It is countered by your improvement in renal function, but also your IVUS result, I think, is very important as well."
"Rejection is an important issue, but it is a common issue after transplantation. It was usually manageable. Since we didn’t see any hemodynamic compromise, it was up to each investigator to evaluate what to do. There were nine patients who converted to combination therapy," Dr. Sigurdardottir reported. "The future needs to tell us what the relevance of this rejection is, and we will do a follow-up at 3 and 5 years."
Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
SAN FRANCISCO – Use of an everolimus-containing regimen with early stopping of cyclosporine after de novo heart transplantation improves renal function and reduces cardiac allograft vasculopathy, without compromising graft outcomes, new data suggest.
These was among key findings of the randomized, open-label SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance) reported at the 2014 World Transplant Congress.
"Renal dysfunction and cardiac allograft vasculopathy are markers for increased morbidity and mortality after heart transplantation," lead author Dr. Vilborg Sigurdardottir commented when introducing the study.
Patients in the trial were randomized evenly to a three-drug regimen containing the calcineurin inhibitor cyclosporine (Sandimmune) or to a four-drug regimen also containing the mTOR inhibitor everolimus (Zortress) with discontinuation of cyclosporine at week 7-11. Everolimus is currently approved by the Food and Drug Administration to prevent graft rejection in kidney and liver transplant recipients and, under another brand name, to treat some cancers.
Measured glomerular filtration rate (GFR) at 12 months, the trial’s primary outcome, was 30% better in the everolimus group than in the cyclosporine group (79.8 vs. 61.5 mL/min per 1.73 m2; P less than .001), according to results presented at the congress and recently published (Am. J. Transplant. 2014;14:1828-38).
The urinary albumin-creatinine ratio was higher in the everolimus group, but none of the patients had nephrotic levels of proteinuria.
Rates of adverse events were similar, with the exception that the everolimus group had a lower rate of cytomegalovirus infection (5% vs. 30%) and a higher rate of pneumonia (12% vs. 3%), Dr. Sigurdardottir reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The incidence of biopsy-proven acute rejection of at least grade 2R was greater with everolimus (40% vs. 18%, P = .01). However, at 12 months, the groups did not differ with respect to left ventricular function as assessed by echocardiography and biomarkers, and, in a cardiac reserve substudy, with respect to cardiac output and pulmonary capillary wedge pressure.
The incidence of cardiac allograft vasculopathy, defined as a mean media-intima thickness of at least 0.5 mm on intravascular ultrasound (IVUS), was lower in the everolimus group (51% vs. 65%, P less than .01), and progression assessed as the change in percent atheroma volume was slower in that group.
"Everolimus initiation and early cyclosporine elimination in de novo heart transplant recipients showed a highly significant improvement of renal function in terms of measured GFR, a reduced incidence of cytomegalovirus [a confirmatory result of previous large-scale studies], similar numbers of adverse and serious adverse events, and an increased incidence of treated acute rejection, however, without hemodynamic compromise and with preserved cardiac function and preserved cardiac reserve," concluded Dr. Sigurdardottir, who is medical director of heart transplantation at the Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. "We saw also favorable coronary remodeling and less graft vasculopathy, as previously shown."
Among patients whose donor hearts had such disease, the increase in media-intima thickness and percent atheroma volume was less with everolimus than with cyclosporine, Dr. Sigurdardottir said. "Interestingly, we saw here that the total atheroma volume decreased between baseline and 12 months in the everolimus group in the patients who had preexisting donor disease."
An attendee from Norway said, "I am a nephrologist, and if I were to get a new heart, I’d rather have a GFR of 61 and no rejection than a GFR of 73 with rejection. Have you looked at the development of donor-specific antibodies in the ones who had rejection, because I’d like to live for more than a year – I’d like to live 3 years or 5 years or 10 years."
"You are absolutely right. At the time of transplantation, we would be looking at the acute problems, and we often see the kidney dysfunction, so we want to do something about that. But of course these studies need to tell us how patients fare longer term," Dr. Sigurdardottir agreed. None of the patients were found to have donor-specific antibodies, but the trial protocol did not mandate routine measurement, she said.
An attendee from Los Angeles commented, "We tried to do CNI [calcineurin inhibitor] weaning in 2006 and had hemodynamically compromised rejection. Now, I congratulate you on being innovative and having quadruple therapy from the get-go and then taking off the CNI. But the issue of increased rejection is important because ISHLT [International Society for Heart and Lung Transplantation] data show that that does lead to poorer outcome. It is countered by your improvement in renal function, but also your IVUS result, I think, is very important as well."
"Rejection is an important issue, but it is a common issue after transplantation. It was usually manageable. Since we didn’t see any hemodynamic compromise, it was up to each investigator to evaluate what to do. There were nine patients who converted to combination therapy," Dr. Sigurdardottir reported. "The future needs to tell us what the relevance of this rejection is, and we will do a follow-up at 3 and 5 years."
Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
SAN FRANCISCO – Use of an everolimus-containing regimen with early stopping of cyclosporine after de novo heart transplantation improves renal function and reduces cardiac allograft vasculopathy, without compromising graft outcomes, new data suggest.
These was among key findings of the randomized, open-label SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance) reported at the 2014 World Transplant Congress.
"Renal dysfunction and cardiac allograft vasculopathy are markers for increased morbidity and mortality after heart transplantation," lead author Dr. Vilborg Sigurdardottir commented when introducing the study.
Patients in the trial were randomized evenly to a three-drug regimen containing the calcineurin inhibitor cyclosporine (Sandimmune) or to a four-drug regimen also containing the mTOR inhibitor everolimus (Zortress) with discontinuation of cyclosporine at week 7-11. Everolimus is currently approved by the Food and Drug Administration to prevent graft rejection in kidney and liver transplant recipients and, under another brand name, to treat some cancers.
Measured glomerular filtration rate (GFR) at 12 months, the trial’s primary outcome, was 30% better in the everolimus group than in the cyclosporine group (79.8 vs. 61.5 mL/min per 1.73 m2; P less than .001), according to results presented at the congress and recently published (Am. J. Transplant. 2014;14:1828-38).
The urinary albumin-creatinine ratio was higher in the everolimus group, but none of the patients had nephrotic levels of proteinuria.
Rates of adverse events were similar, with the exception that the everolimus group had a lower rate of cytomegalovirus infection (5% vs. 30%) and a higher rate of pneumonia (12% vs. 3%), Dr. Sigurdardottir reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The incidence of biopsy-proven acute rejection of at least grade 2R was greater with everolimus (40% vs. 18%, P = .01). However, at 12 months, the groups did not differ with respect to left ventricular function as assessed by echocardiography and biomarkers, and, in a cardiac reserve substudy, with respect to cardiac output and pulmonary capillary wedge pressure.
The incidence of cardiac allograft vasculopathy, defined as a mean media-intima thickness of at least 0.5 mm on intravascular ultrasound (IVUS), was lower in the everolimus group (51% vs. 65%, P less than .01), and progression assessed as the change in percent atheroma volume was slower in that group.
"Everolimus initiation and early cyclosporine elimination in de novo heart transplant recipients showed a highly significant improvement of renal function in terms of measured GFR, a reduced incidence of cytomegalovirus [a confirmatory result of previous large-scale studies], similar numbers of adverse and serious adverse events, and an increased incidence of treated acute rejection, however, without hemodynamic compromise and with preserved cardiac function and preserved cardiac reserve," concluded Dr. Sigurdardottir, who is medical director of heart transplantation at the Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. "We saw also favorable coronary remodeling and less graft vasculopathy, as previously shown."
Among patients whose donor hearts had such disease, the increase in media-intima thickness and percent atheroma volume was less with everolimus than with cyclosporine, Dr. Sigurdardottir said. "Interestingly, we saw here that the total atheroma volume decreased between baseline and 12 months in the everolimus group in the patients who had preexisting donor disease."
An attendee from Norway said, "I am a nephrologist, and if I were to get a new heart, I’d rather have a GFR of 61 and no rejection than a GFR of 73 with rejection. Have you looked at the development of donor-specific antibodies in the ones who had rejection, because I’d like to live for more than a year – I’d like to live 3 years or 5 years or 10 years."
"You are absolutely right. At the time of transplantation, we would be looking at the acute problems, and we often see the kidney dysfunction, so we want to do something about that. But of course these studies need to tell us how patients fare longer term," Dr. Sigurdardottir agreed. None of the patients were found to have donor-specific antibodies, but the trial protocol did not mandate routine measurement, she said.
An attendee from Los Angeles commented, "We tried to do CNI [calcineurin inhibitor] weaning in 2006 and had hemodynamically compromised rejection. Now, I congratulate you on being innovative and having quadruple therapy from the get-go and then taking off the CNI. But the issue of increased rejection is important because ISHLT [International Society for Heart and Lung Transplantation] data show that that does lead to poorer outcome. It is countered by your improvement in renal function, but also your IVUS result, I think, is very important as well."
"Rejection is an important issue, but it is a common issue after transplantation. It was usually manageable. Since we didn’t see any hemodynamic compromise, it was up to each investigator to evaluate what to do. There were nine patients who converted to combination therapy," Dr. Sigurdardottir reported. "The future needs to tell us what the relevance of this rejection is, and we will do a follow-up at 3 and 5 years."
Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
FROM THE 2014 WORLD TRANSPLANT CONGRESS
Key clinical point: For post–heart transplant patients, early cessation of cyclosporine when using an everolimus-containing regimen appears to be safe and did not compromise graft outcomes.
Major finding: Compared with patients continued on cyclosporine, patients taken off this agent at 7-11 weeks had a 30% better measured glomerular filtration rate at 12 months.
Data source: A randomized, open-label trial of 115 patients undergoing de novo heart transplantation
Disclosures: Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
Many surgical residents consider quitting during training
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
FROM JAMA Surgery
Major finding: More than half of survey respondents (58%) considered quitting their general surgery residency, an issue more persistent with female respondents.
Data source: Analysis of 288 responses to a survey of general surgery residents in 13 residency programs across different regions (West, Southwest, Midwest, and Northeast) and training centers (university programs, independent programs, or hybrid university-affiliated programs without an onsite university or medical school).
Disclosures: The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
FDA approves ex vivo lung perfusion device that preserves donor organs
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lung to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating the lungs, "which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About one in five donor lungs meet the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage. "Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
This is exciting news given the shortage of available lungs which meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in postoperative complications. Also, how significant will the financial impact be using the device? I look forward to the results of long-term studies and hopefully this will be a viable option for our patients.
Dr. Jennifer Cox is assistant professor of pulmonary and critical care medicine critical care selective, University of South Florida, Tampa.
This is exciting news given the shortage of available lungs which meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in postoperative complications. Also, how significant will the financial impact be using the device? I look forward to the results of long-term studies and hopefully this will be a viable option for our patients.
Dr. Jennifer Cox is assistant professor of pulmonary and critical care medicine critical care selective, University of South Florida, Tampa.
This is exciting news given the shortage of available lungs which meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in postoperative complications. Also, how significant will the financial impact be using the device? I look forward to the results of long-term studies and hopefully this will be a viable option for our patients.
Dr. Jennifer Cox is assistant professor of pulmonary and critical care medicine critical care selective, University of South Florida, Tampa.
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lung to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating the lungs, "which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About one in five donor lungs meet the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage. "Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lung to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating the lungs, "which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About one in five donor lungs meet the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage. "Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
Thoracic radiotherapy backed for extensive SCLC
CHICAGO – Thoracic radiotherapy improved overall survival, progression-free survival, and intrathoracic control in patients with extensive small-cell lung cancer who responded to chemotherapy, according to results from the randomized CREST study.
"Thoracic radiotherapy should be offered in addition to PCI [prophylactic cranial irradiation] to all extensive-stage small-cell lung cancer patients responding to initial chemotherapy," Dr. Ben J. Slotman said at the annual meeting of the American Society of Clinical Oncology.
The rationale for CREST (Chest Radiotherapy Extensive Stage Trial) was based on an earlier trial by Dr. Slotman showing that prophylactic cranial irradiation not only lowered the risk of symptomatic brain metastases but also significantly improved 1-year overall survival compared with no additional therapy in patients with extensive small-cell lung cancer (SCLC) who had any response to chemotherapy (N. Engl. J. Med. 2007;357:664-72).
Most patients, however, had persistent intrathoracic disease after chemotherapy or intrathoracic progression, said Dr. Slotman, professor and head of radiation oncology, VU Medical Center, Amsterdam.
CREST investigators at 42 centers in the Netherlands, the United Kingdom, Norway, and Belgium randomly assigned 498 patients with any response after four to six cycles of initial platinum-based chemotherapy to thoracic radiotherapy (TRT) (30 Gy in 10 fractions) plus PCI or PCI only. Treatment began within 2-7 weeks of their last chemotherapy. Patients with brain or plural metastasis, pleuritis carcinomatosa, or prior radiotherapy (RT) to the brain or thorax were excluded.
About 70% of patients had a partial response to chemotherapy, and almost 90% still had persistent intrathoracic disease at the time of randomization. Their median age was 63 years.
Overall survival at 1 year was not statistically different between the TRT and no TRT arms (33% vs. 28%; hazard ratio, 0.84; P = .066). The survival curves began to diverge after 9 months, however, leading to a significant overall survival benefit favoring TRT at 18 months (P = .03) and 24 months (13% vs. 3%; P = .004), Dr. Slotman said.
A subgroup analysis found no influence on overall survival for treatment factors such as age, sex, response after chemotherapy, or presence of intrathoracic disease at randomization.
Discussant Dr. Walter J. Curran Jr., executive director of the Winship Cancer Institute of Emory University, Atlanta, said CREST was a well-executed and adequately powered trial, but argued that its conclusion that thoracic RT improves overall survival "is not supported by the presented data."
The hazard ratio of 0.84 failed to reach the HR goal of 0.76, and the comparison at 2 years was not the primary end point of the trial, he said.
Dr. Curran said there is a rationale for why sequential chemotherapy-radiation would work for patients with more extensive disease, even though every randomized limited disease small-cell trial has shown a benefit with concurrent vs. sequential chemotherapy-radiation therapy or early vs. delayed concurrent chemoradiation, and little to no benefit with sequential chemoradiation, compared with chemotherapy alone.
"The rationale behind it, and it’s a reasonable one, is that in the noncurative setting, which is what we’re dealing with if you remember the survival curves Dr. Slotman showed us, we really are probably talking about debulking chemoresistant disease," he said. "If one is able to do that with limited toxicity and without long-lasting morbidity, that might extend survival but certainly is not going to procure cure rates as thoracic radiation can do in limited disease."
Progression-free survival was significantly better in patients receiving TRT vs. no TRT (HR, 0.73; P = .001), Dr. Slotman said.
TRT-treated patients also had significantly less intrathoracic progression overall (43.7% vs. 80%; P less than .001), as the first site of relapse (41.7% vs. 78%; P less than .001), and as the only site of relapse (20% vs. 46%; P less than .001).
Going forward, Dr. Curran said it will be important to know whether patients with extensive-stage disease receiving TRT also have less progression of thoracic disease and to better understand quality of life and toxicity associated with the therapy.
Dr. Slotman said grade 3/4 toxicity was similar between groups, although those receiving radiation had a modest increased risk of grade 3 fatigue (11 vs. 8 events) and grade 3 esophagitis (4 events vs. 0 events).
CHICAGO – Thoracic radiotherapy improved overall survival, progression-free survival, and intrathoracic control in patients with extensive small-cell lung cancer who responded to chemotherapy, according to results from the randomized CREST study.
"Thoracic radiotherapy should be offered in addition to PCI [prophylactic cranial irradiation] to all extensive-stage small-cell lung cancer patients responding to initial chemotherapy," Dr. Ben J. Slotman said at the annual meeting of the American Society of Clinical Oncology.
The rationale for CREST (Chest Radiotherapy Extensive Stage Trial) was based on an earlier trial by Dr. Slotman showing that prophylactic cranial irradiation not only lowered the risk of symptomatic brain metastases but also significantly improved 1-year overall survival compared with no additional therapy in patients with extensive small-cell lung cancer (SCLC) who had any response to chemotherapy (N. Engl. J. Med. 2007;357:664-72).
Most patients, however, had persistent intrathoracic disease after chemotherapy or intrathoracic progression, said Dr. Slotman, professor and head of radiation oncology, VU Medical Center, Amsterdam.
CREST investigators at 42 centers in the Netherlands, the United Kingdom, Norway, and Belgium randomly assigned 498 patients with any response after four to six cycles of initial platinum-based chemotherapy to thoracic radiotherapy (TRT) (30 Gy in 10 fractions) plus PCI or PCI only. Treatment began within 2-7 weeks of their last chemotherapy. Patients with brain or plural metastasis, pleuritis carcinomatosa, or prior radiotherapy (RT) to the brain or thorax were excluded.
About 70% of patients had a partial response to chemotherapy, and almost 90% still had persistent intrathoracic disease at the time of randomization. Their median age was 63 years.
Overall survival at 1 year was not statistically different between the TRT and no TRT arms (33% vs. 28%; hazard ratio, 0.84; P = .066). The survival curves began to diverge after 9 months, however, leading to a significant overall survival benefit favoring TRT at 18 months (P = .03) and 24 months (13% vs. 3%; P = .004), Dr. Slotman said.
A subgroup analysis found no influence on overall survival for treatment factors such as age, sex, response after chemotherapy, or presence of intrathoracic disease at randomization.
Discussant Dr. Walter J. Curran Jr., executive director of the Winship Cancer Institute of Emory University, Atlanta, said CREST was a well-executed and adequately powered trial, but argued that its conclusion that thoracic RT improves overall survival "is not supported by the presented data."
The hazard ratio of 0.84 failed to reach the HR goal of 0.76, and the comparison at 2 years was not the primary end point of the trial, he said.
Dr. Curran said there is a rationale for why sequential chemotherapy-radiation would work for patients with more extensive disease, even though every randomized limited disease small-cell trial has shown a benefit with concurrent vs. sequential chemotherapy-radiation therapy or early vs. delayed concurrent chemoradiation, and little to no benefit with sequential chemoradiation, compared with chemotherapy alone.
"The rationale behind it, and it’s a reasonable one, is that in the noncurative setting, which is what we’re dealing with if you remember the survival curves Dr. Slotman showed us, we really are probably talking about debulking chemoresistant disease," he said. "If one is able to do that with limited toxicity and without long-lasting morbidity, that might extend survival but certainly is not going to procure cure rates as thoracic radiation can do in limited disease."
Progression-free survival was significantly better in patients receiving TRT vs. no TRT (HR, 0.73; P = .001), Dr. Slotman said.
TRT-treated patients also had significantly less intrathoracic progression overall (43.7% vs. 80%; P less than .001), as the first site of relapse (41.7% vs. 78%; P less than .001), and as the only site of relapse (20% vs. 46%; P less than .001).
Going forward, Dr. Curran said it will be important to know whether patients with extensive-stage disease receiving TRT also have less progression of thoracic disease and to better understand quality of life and toxicity associated with the therapy.
Dr. Slotman said grade 3/4 toxicity was similar between groups, although those receiving radiation had a modest increased risk of grade 3 fatigue (11 vs. 8 events) and grade 3 esophagitis (4 events vs. 0 events).
CHICAGO – Thoracic radiotherapy improved overall survival, progression-free survival, and intrathoracic control in patients with extensive small-cell lung cancer who responded to chemotherapy, according to results from the randomized CREST study.
"Thoracic radiotherapy should be offered in addition to PCI [prophylactic cranial irradiation] to all extensive-stage small-cell lung cancer patients responding to initial chemotherapy," Dr. Ben J. Slotman said at the annual meeting of the American Society of Clinical Oncology.
The rationale for CREST (Chest Radiotherapy Extensive Stage Trial) was based on an earlier trial by Dr. Slotman showing that prophylactic cranial irradiation not only lowered the risk of symptomatic brain metastases but also significantly improved 1-year overall survival compared with no additional therapy in patients with extensive small-cell lung cancer (SCLC) who had any response to chemotherapy (N. Engl. J. Med. 2007;357:664-72).
Most patients, however, had persistent intrathoracic disease after chemotherapy or intrathoracic progression, said Dr. Slotman, professor and head of radiation oncology, VU Medical Center, Amsterdam.
CREST investigators at 42 centers in the Netherlands, the United Kingdom, Norway, and Belgium randomly assigned 498 patients with any response after four to six cycles of initial platinum-based chemotherapy to thoracic radiotherapy (TRT) (30 Gy in 10 fractions) plus PCI or PCI only. Treatment began within 2-7 weeks of their last chemotherapy. Patients with brain or plural metastasis, pleuritis carcinomatosa, or prior radiotherapy (RT) to the brain or thorax were excluded.
About 70% of patients had a partial response to chemotherapy, and almost 90% still had persistent intrathoracic disease at the time of randomization. Their median age was 63 years.
Overall survival at 1 year was not statistically different between the TRT and no TRT arms (33% vs. 28%; hazard ratio, 0.84; P = .066). The survival curves began to diverge after 9 months, however, leading to a significant overall survival benefit favoring TRT at 18 months (P = .03) and 24 months (13% vs. 3%; P = .004), Dr. Slotman said.
A subgroup analysis found no influence on overall survival for treatment factors such as age, sex, response after chemotherapy, or presence of intrathoracic disease at randomization.
Discussant Dr. Walter J. Curran Jr., executive director of the Winship Cancer Institute of Emory University, Atlanta, said CREST was a well-executed and adequately powered trial, but argued that its conclusion that thoracic RT improves overall survival "is not supported by the presented data."
The hazard ratio of 0.84 failed to reach the HR goal of 0.76, and the comparison at 2 years was not the primary end point of the trial, he said.
Dr. Curran said there is a rationale for why sequential chemotherapy-radiation would work for patients with more extensive disease, even though every randomized limited disease small-cell trial has shown a benefit with concurrent vs. sequential chemotherapy-radiation therapy or early vs. delayed concurrent chemoradiation, and little to no benefit with sequential chemoradiation, compared with chemotherapy alone.
"The rationale behind it, and it’s a reasonable one, is that in the noncurative setting, which is what we’re dealing with if you remember the survival curves Dr. Slotman showed us, we really are probably talking about debulking chemoresistant disease," he said. "If one is able to do that with limited toxicity and without long-lasting morbidity, that might extend survival but certainly is not going to procure cure rates as thoracic radiation can do in limited disease."
Progression-free survival was significantly better in patients receiving TRT vs. no TRT (HR, 0.73; P = .001), Dr. Slotman said.
TRT-treated patients also had significantly less intrathoracic progression overall (43.7% vs. 80%; P less than .001), as the first site of relapse (41.7% vs. 78%; P less than .001), and as the only site of relapse (20% vs. 46%; P less than .001).
Going forward, Dr. Curran said it will be important to know whether patients with extensive-stage disease receiving TRT also have less progression of thoracic disease and to better understand quality of life and toxicity associated with the therapy.
Dr. Slotman said grade 3/4 toxicity was similar between groups, although those receiving radiation had a modest increased risk of grade 3 fatigue (11 vs. 8 events) and grade 3 esophagitis (4 events vs. 0 events).
AT THE ASCO ANNUAL MEETING 2014
Key clinical point: Thoracic radiotherapy may improve survival when delivered after chemotherapy in extensive-stage lung cancer responding to chemotherapy.
Major finding: Overall survival at 1 year was not statistically different between the TRT and no TRT arms (HR, 0.84; P = .066) but was significantly different at 18 months (P = .03) and 24 months (P = .004).
Data source: A randomized study of 498 patients with extensive-stage small-cell lung cancer responding to initial chemotherapy.
Disclosures: Dr. Slotman and his coauthors reported no financial disclosures.
2014 AATS Critical Care Scholarship
The Graham Foundation provides funds for residents to attend the Cardiovascular Thoracic Critical Care Conference Oct. 9-11, in Washington, DC.
• Residents must be enrolled in an ACGME accredited CT surgical training program in the U.S. or RCPSC accredited CT surgical resident program in Canada.
• The AATS Graham Foundation will pay registration and $500 to the resident’s institution for travel and hotel.
• Program Directors may select one resident per institution. Additional residents may be nominated and accepted if vacancies arise.
• The Program Director commitment form is due August 15.
• Up to 75 recipients will be awarded on a first-come, first-served basis.
Visit http://www.aats.org or contact admin@aats.org.
The Graham Foundation provides funds for residents to attend the Cardiovascular Thoracic Critical Care Conference Oct. 9-11, in Washington, DC.
• Residents must be enrolled in an ACGME accredited CT surgical training program in the U.S. or RCPSC accredited CT surgical resident program in Canada.
• The AATS Graham Foundation will pay registration and $500 to the resident’s institution for travel and hotel.
• Program Directors may select one resident per institution. Additional residents may be nominated and accepted if vacancies arise.
• The Program Director commitment form is due August 15.
• Up to 75 recipients will be awarded on a first-come, first-served basis.
Visit http://www.aats.org or contact admin@aats.org.
The Graham Foundation provides funds for residents to attend the Cardiovascular Thoracic Critical Care Conference Oct. 9-11, in Washington, DC.
• Residents must be enrolled in an ACGME accredited CT surgical training program in the U.S. or RCPSC accredited CT surgical resident program in Canada.
• The AATS Graham Foundation will pay registration and $500 to the resident’s institution for travel and hotel.
• Program Directors may select one resident per institution. Additional residents may be nominated and accepted if vacancies arise.
• The Program Director commitment form is due August 15.
• Up to 75 recipients will be awarded on a first-come, first-served basis.
Visit http://www.aats.org or contact admin@aats.org.
2015 AATS Grant Writing Workshop – March 6, Bethesda, MD
Organized by the AATS Scientific Affairs and Government Relations Committee, the Workshop will take place on Friday, March 6, 2015 at the Doubletree Bethesda in Bethesda, MD (9 miles from Washington, DC). This full-day program is designed for all levels of academic CT surgeons.
The workshop will provide attendees a better understanding of the nature of preparing and submitting grant proposals along with the techniques required to ensure submissions are of the highest quality. Attendees will work with well known leaders in CT surgery and NIH Staff to achieve the following:
• Create Career Development and Training Grants
• Analyze Outcomes Research and Clinical Research Networks
• Assess the Structure and Components of a Grant
• Understand the Steps to Becoming an NIH Investigator
The deadline for registration is Friday, February 6, 2015. For additional information on the workshop program, housing, and to register please visit www.aats.org.
Organized by the AATS Scientific Affairs and Government Relations Committee, the Workshop will take place on Friday, March 6, 2015 at the Doubletree Bethesda in Bethesda, MD (9 miles from Washington, DC). This full-day program is designed for all levels of academic CT surgeons.
The workshop will provide attendees a better understanding of the nature of preparing and submitting grant proposals along with the techniques required to ensure submissions are of the highest quality. Attendees will work with well known leaders in CT surgery and NIH Staff to achieve the following:
• Create Career Development and Training Grants
• Analyze Outcomes Research and Clinical Research Networks
• Assess the Structure and Components of a Grant
• Understand the Steps to Becoming an NIH Investigator
The deadline for registration is Friday, February 6, 2015. For additional information on the workshop program, housing, and to register please visit www.aats.org.
Organized by the AATS Scientific Affairs and Government Relations Committee, the Workshop will take place on Friday, March 6, 2015 at the Doubletree Bethesda in Bethesda, MD (9 miles from Washington, DC). This full-day program is designed for all levels of academic CT surgeons.
The workshop will provide attendees a better understanding of the nature of preparing and submitting grant proposals along with the techniques required to ensure submissions are of the highest quality. Attendees will work with well known leaders in CT surgery and NIH Staff to achieve the following:
• Create Career Development and Training Grants
• Analyze Outcomes Research and Clinical Research Networks
• Assess the Structure and Components of a Grant
• Understand the Steps to Becoming an NIH Investigator
The deadline for registration is Friday, February 6, 2015. For additional information on the workshop program, housing, and to register please visit www.aats.org.
Graham Foundation and Edwards Offer Advanced Valve Disease Fellowship
The Edwards Lifesciences Advanced Treatments of Valve Disease Fellowship allows a young CT surgeon to spend a period of three months (minimum) to one year studying clinical techniques at a secondary institution with a focus on enhancing expertise in advanced treatments of valve disease. A $25,000 award will be provided to help defray related travel and living expenses incurred at the secondary institution.
For additional information visit www.AATSGrahamFoundation.org. Applicants should meet the following criteria:
• A candidate should have completed his/her formal training in general surgery and in thoracic and/or cardiovascular surgery, but not yet have reached a senior position.
• Candidate meets all necessary criteria (license, visa, etc. ...) for travel to and from secondary center
• Candidates must have a current academic or hospital appointment
• Candidates must be in their first five years post CT training
Applications must be submitted electronically by November 1, 2014. Applications will be reviewed by the AATS Graham Foundation’s Scientific Review Committee, which includes surgeons with recognized expertise in the treatment of valve disease. Applications will be graded on all aspects of the criteria and notified by December 15.
The Edwards Lifesciences Advanced Treatments of Valve Disease Fellowship allows a young CT surgeon to spend a period of three months (minimum) to one year studying clinical techniques at a secondary institution with a focus on enhancing expertise in advanced treatments of valve disease. A $25,000 award will be provided to help defray related travel and living expenses incurred at the secondary institution.
For additional information visit www.AATSGrahamFoundation.org. Applicants should meet the following criteria:
• A candidate should have completed his/her formal training in general surgery and in thoracic and/or cardiovascular surgery, but not yet have reached a senior position.
• Candidate meets all necessary criteria (license, visa, etc. ...) for travel to and from secondary center
• Candidates must have a current academic or hospital appointment
• Candidates must be in their first five years post CT training
Applications must be submitted electronically by November 1, 2014. Applications will be reviewed by the AATS Graham Foundation’s Scientific Review Committee, which includes surgeons with recognized expertise in the treatment of valve disease. Applications will be graded on all aspects of the criteria and notified by December 15.
The Edwards Lifesciences Advanced Treatments of Valve Disease Fellowship allows a young CT surgeon to spend a period of three months (minimum) to one year studying clinical techniques at a secondary institution with a focus on enhancing expertise in advanced treatments of valve disease. A $25,000 award will be provided to help defray related travel and living expenses incurred at the secondary institution.
For additional information visit www.AATSGrahamFoundation.org. Applicants should meet the following criteria:
• A candidate should have completed his/her formal training in general surgery and in thoracic and/or cardiovascular surgery, but not yet have reached a senior position.
• Candidate meets all necessary criteria (license, visa, etc. ...) for travel to and from secondary center
• Candidates must have a current academic or hospital appointment
• Candidates must be in their first five years post CT training
Applications must be submitted electronically by November 1, 2014. Applications will be reviewed by the AATS Graham Foundation’s Scientific Review Committee, which includes surgeons with recognized expertise in the treatment of valve disease. Applications will be graded on all aspects of the criteria and notified by December 15.
Ethicon Fellowship for Advanced Thoracic MIS
The AATS Graham Foundation Ethicon Fellowship for Advanced Thoracic Minimally Invasive Surgery (MIS) provides young thoracic surgeons from the United States the opportunity to spend a focused period of three months to one year studying clinical techniques at a host institution proficient in MIS. Applicants should meet the following criteria:
• A candidate should have completed his/her formal training in general surgery and in thoracic and/or cardiovascular surgery, but should not yet have started a staff position or have started a staff position within a 12 month period prior to commencing this fellowship.
• Candidate meets all necessary criteria (license, visa, etc...) for travel to and from secondary center
• Candidates must have a current academic or hospital appointment
• Candidates must be in their first five years post thoracic training
Application Process
Applications will be available annually. In addition to a formal online application, candidates will also be required to upload the following:
• Curriculum Vitae
• Letter of support from their home and secondary institutions
• Detailed outline of plans for the duration of stay at secondary center
• One page narrative on what they hope to accomplish during their travel to a secondary training center
• One page statement of future career goals
• One page statement describing the relationship of the planned study to the applicant’s prior work, preparation and professional goals.
Applications for consideration must be submitted electronically by Nov. 1, 2014. Applications will be reviewed by the AATS Graham Foundation’s Scientific Review Committee, which includes surgeons with recognized expertise in minimally invasive surgery and the focus will be to place the recipients in institutions utilizing Ethicon technology for MIS. Notifications of the final decision will be provided by December 15th. For information visit www.AATSGrahamFoundation.org.
The AATS Graham Foundation Ethicon Fellowship for Advanced Thoracic Minimally Invasive Surgery (MIS) provides young thoracic surgeons from the United States the opportunity to spend a focused period of three months to one year studying clinical techniques at a host institution proficient in MIS. Applicants should meet the following criteria:
• A candidate should have completed his/her formal training in general surgery and in thoracic and/or cardiovascular surgery, but should not yet have started a staff position or have started a staff position within a 12 month period prior to commencing this fellowship.
• Candidate meets all necessary criteria (license, visa, etc...) for travel to and from secondary center
• Candidates must have a current academic or hospital appointment
• Candidates must be in their first five years post thoracic training
Application Process
Applications will be available annually. In addition to a formal online application, candidates will also be required to upload the following:
• Curriculum Vitae
• Letter of support from their home and secondary institutions
• Detailed outline of plans for the duration of stay at secondary center
• One page narrative on what they hope to accomplish during their travel to a secondary training center
• One page statement of future career goals
• One page statement describing the relationship of the planned study to the applicant’s prior work, preparation and professional goals.
Applications for consideration must be submitted electronically by Nov. 1, 2014. Applications will be reviewed by the AATS Graham Foundation’s Scientific Review Committee, which includes surgeons with recognized expertise in minimally invasive surgery and the focus will be to place the recipients in institutions utilizing Ethicon technology for MIS. Notifications of the final decision will be provided by December 15th. For information visit www.AATSGrahamFoundation.org.
The AATS Graham Foundation Ethicon Fellowship for Advanced Thoracic Minimally Invasive Surgery (MIS) provides young thoracic surgeons from the United States the opportunity to spend a focused period of three months to one year studying clinical techniques at a host institution proficient in MIS. Applicants should meet the following criteria:
• A candidate should have completed his/her formal training in general surgery and in thoracic and/or cardiovascular surgery, but should not yet have started a staff position or have started a staff position within a 12 month period prior to commencing this fellowship.
• Candidate meets all necessary criteria (license, visa, etc...) for travel to and from secondary center
• Candidates must have a current academic or hospital appointment
• Candidates must be in their first five years post thoracic training
Application Process
Applications will be available annually. In addition to a formal online application, candidates will also be required to upload the following:
• Curriculum Vitae
• Letter of support from their home and secondary institutions
• Detailed outline of plans for the duration of stay at secondary center
• One page narrative on what they hope to accomplish during their travel to a secondary training center
• One page statement of future career goals
• One page statement describing the relationship of the planned study to the applicant’s prior work, preparation and professional goals.
Applications for consideration must be submitted electronically by Nov. 1, 2014. Applications will be reviewed by the AATS Graham Foundation’s Scientific Review Committee, which includes surgeons with recognized expertise in minimally invasive surgery and the focus will be to place the recipients in institutions utilizing Ethicon technology for MIS. Notifications of the final decision will be provided by December 15th. For information visit www.AATSGrahamFoundation.org.
Arch replacement with FET not worse when acute
TORONTO – Operative mortality with total aortic arch replacement using a four-branched graft and frozen elephant trunk implantation (Sun’s procedure) was 6.5%, including those whose type A aortic dissection was defined as acute.
Operative mortality was higher in acute versus chronic type A aortic dissection (TAAD) patients undergoing the procedure (8.1% vs. 4.3%; P = .031), as was the incidence of stroke (2.2% vs. 0.6%; P = .046), and respiratory complications (20.8% vs. 8.6%; P less than .001).
However, although the risk of operative mortality in acute patients was 1.95 times higher than for chronic patients, in multivariate analysis, acuteness was not identified as a significant risk factor for operative mortality (odds ratio, 1.67; P = .152).
The factors identified as increasing risk of operative mortality were coexisting cerebrovascular disease; malperfusion of the brain, kidneys, spinal cord, and viscera; concomitant extra-anatomic bypass; and cardiopulmonary bypass time exceeding 180 minutes.
"This study proves the safety of frozen elephant trunk with total arch replacement," said Dr. Wei-Guo Ma of Yale University, New Haven, Conn.
"Operative mortality was not affected by either the acute or chronic phase. Instead it was affected by seven other factors, such as prior CVD [cerebrovascular disease], malperfusion, and longer CPB [cardiopulmonary bypass] time.
"If a patient comes without those risk factors, surgeons can go ahead and perform this emergent frozen elephant trunk for him without fear of imposing greater risk of mortality," he said.
Standard TAAD remains a highly lethal condition, with the greatest surgical risk seen during the acute phase. Although some progress has been made, surgeons continue to debate the optimal surgical approach to TAAD, in particular the extent of distal aortic repair. Some advocate a more limited approach of hemiarch repair only, while others propose that total arch repair offers better outcomes.
Sun’s procedure is performed with right axillary artery cannulation for cardiopulmonary bypass and selective antegrade cerebral perfusion, under moderate hypothermic circulatory arrest at 25° C.
The frozen elephant trunk (Cronus, MicroPort Medical, Shanghai, China) is implanted into the descending aorta, followed by total arch replacement using a four-branched vascular graft, with a special sequence for aortic reconstruction (i.e., proximal descending aorta to left carotid artery to ascending aorta to left subclavian artery to innominate artery). Associated operations, including coronary artery bypass grafting, are performed during the cooling phase, if needed.
In this case series, presented by Dr. Ma at the annual meeting of the American Association for Thoracic Surgery, acuteness was defined as an interval between onset of symptoms and surgery of 14 days or less.
TAAD was diagnosed preoperatively by transthoracic echocardiography or computed tomographic angiography, with the location of the intimal tear confirmed during surgery.
The surgeons retrospectively compared early outcomes between acute and chronic TAAD patients after Sun’s procedure, seeking to identify risk factors for operative mortality in both groups and seeking to determine whether acuteness significantly affects operative mortality after this extensive surgical approach.
Between April 2003 and September 2012, Sun’s procedure was performed on 803 patients with acute or chronic TAAD. Mean age was 46 years and 80% of the cohort was male. A total of 456 were classified as acute TAAD patients, with a mean of 5.5 days lapsing between onset of symptoms to surgery (median, 4.1 days), and 347 were chronic, with 197 days lapsing between onset of symptoms and surgery (median, 38 days).
Clinically apparent malperfusion was common, seen in 12.6% of cases, 12.3% of the acute arm and 9.2% of the chronic arm. Patients with malperfusion had an overall mortality of 19.3% (25% in the acute arm and 9.4% in the chronic arm; P less than .001).
"Visceral malperfusion tended to be the most lethal, with five of seven patients dying," reported Dr. Ma. He also noted the young age of their cohort as compared to other regions of the world: 88.8% of patients were under 60 years of age.
Acute, minus natural selection
The invited discussant on the abstract, Dr. Malakh L. Shrestha took issue with the study’s conclusion that acuteness did not affect operative mortality. Dr. Shrestha is the division manager of valvular and coronary artery surgery at the Hannover (Germany) Medical School.
"As a high volume center, what we’ve learned is that acute and chronic aortic dissection patients are two totally different subsets of patients in terms of clinical presentation and mortality. The greatest danger in the acute patient is in the first few hours after the dissection, with the majority of patients dying without surgical intervention."
At Dr. Shrestha’s center in Germany, a high-volume aortic center, they often see patients within the first few hours of their dissection and they’ve found a significantly higher mortality in these patients, compared with chronic TAAD whether an ascending aortic replacement or a frozen elephant trunk procedure is done.
With a median of 4.1 days lapsing between onset of symptoms and surgery in the Ma et al. study, Dr. Shrestha argued that "although on the basis of classification, you can still say they’re acute, there has been some sort of natural selection. So, I think that means, at least for your conclusions, that you need to clarify the statement that there is no difference between acute and chronic, because these are obviously not the same subset of patients that we see in the Western world."
Dr. Ma agreed that natural selection was indeed at play in their series, in that about 80% of their patients were referrals that were transferred in some cases from hundreds of miles away, with many dying en route or before surgery. He also concurred that had their mean and median number of days in their acute cohort been less, indeed, mortality might have been higher.
Dr. Ma reported having no conflicts of interest. Dr. Shrestha is a consultant for Edwards Lifesciences.
TORONTO – Operative mortality with total aortic arch replacement using a four-branched graft and frozen elephant trunk implantation (Sun’s procedure) was 6.5%, including those whose type A aortic dissection was defined as acute.
Operative mortality was higher in acute versus chronic type A aortic dissection (TAAD) patients undergoing the procedure (8.1% vs. 4.3%; P = .031), as was the incidence of stroke (2.2% vs. 0.6%; P = .046), and respiratory complications (20.8% vs. 8.6%; P less than .001).
However, although the risk of operative mortality in acute patients was 1.95 times higher than for chronic patients, in multivariate analysis, acuteness was not identified as a significant risk factor for operative mortality (odds ratio, 1.67; P = .152).
The factors identified as increasing risk of operative mortality were coexisting cerebrovascular disease; malperfusion of the brain, kidneys, spinal cord, and viscera; concomitant extra-anatomic bypass; and cardiopulmonary bypass time exceeding 180 minutes.
"This study proves the safety of frozen elephant trunk with total arch replacement," said Dr. Wei-Guo Ma of Yale University, New Haven, Conn.
"Operative mortality was not affected by either the acute or chronic phase. Instead it was affected by seven other factors, such as prior CVD [cerebrovascular disease], malperfusion, and longer CPB [cardiopulmonary bypass] time.
"If a patient comes without those risk factors, surgeons can go ahead and perform this emergent frozen elephant trunk for him without fear of imposing greater risk of mortality," he said.
Standard TAAD remains a highly lethal condition, with the greatest surgical risk seen during the acute phase. Although some progress has been made, surgeons continue to debate the optimal surgical approach to TAAD, in particular the extent of distal aortic repair. Some advocate a more limited approach of hemiarch repair only, while others propose that total arch repair offers better outcomes.
Sun’s procedure is performed with right axillary artery cannulation for cardiopulmonary bypass and selective antegrade cerebral perfusion, under moderate hypothermic circulatory arrest at 25° C.
The frozen elephant trunk (Cronus, MicroPort Medical, Shanghai, China) is implanted into the descending aorta, followed by total arch replacement using a four-branched vascular graft, with a special sequence for aortic reconstruction (i.e., proximal descending aorta to left carotid artery to ascending aorta to left subclavian artery to innominate artery). Associated operations, including coronary artery bypass grafting, are performed during the cooling phase, if needed.
In this case series, presented by Dr. Ma at the annual meeting of the American Association for Thoracic Surgery, acuteness was defined as an interval between onset of symptoms and surgery of 14 days or less.
TAAD was diagnosed preoperatively by transthoracic echocardiography or computed tomographic angiography, with the location of the intimal tear confirmed during surgery.
The surgeons retrospectively compared early outcomes between acute and chronic TAAD patients after Sun’s procedure, seeking to identify risk factors for operative mortality in both groups and seeking to determine whether acuteness significantly affects operative mortality after this extensive surgical approach.
Between April 2003 and September 2012, Sun’s procedure was performed on 803 patients with acute or chronic TAAD. Mean age was 46 years and 80% of the cohort was male. A total of 456 were classified as acute TAAD patients, with a mean of 5.5 days lapsing between onset of symptoms to surgery (median, 4.1 days), and 347 were chronic, with 197 days lapsing between onset of symptoms and surgery (median, 38 days).
Clinically apparent malperfusion was common, seen in 12.6% of cases, 12.3% of the acute arm and 9.2% of the chronic arm. Patients with malperfusion had an overall mortality of 19.3% (25% in the acute arm and 9.4% in the chronic arm; P less than .001).
"Visceral malperfusion tended to be the most lethal, with five of seven patients dying," reported Dr. Ma. He also noted the young age of their cohort as compared to other regions of the world: 88.8% of patients were under 60 years of age.
Acute, minus natural selection
The invited discussant on the abstract, Dr. Malakh L. Shrestha took issue with the study’s conclusion that acuteness did not affect operative mortality. Dr. Shrestha is the division manager of valvular and coronary artery surgery at the Hannover (Germany) Medical School.
"As a high volume center, what we’ve learned is that acute and chronic aortic dissection patients are two totally different subsets of patients in terms of clinical presentation and mortality. The greatest danger in the acute patient is in the first few hours after the dissection, with the majority of patients dying without surgical intervention."
At Dr. Shrestha’s center in Germany, a high-volume aortic center, they often see patients within the first few hours of their dissection and they’ve found a significantly higher mortality in these patients, compared with chronic TAAD whether an ascending aortic replacement or a frozen elephant trunk procedure is done.
With a median of 4.1 days lapsing between onset of symptoms and surgery in the Ma et al. study, Dr. Shrestha argued that "although on the basis of classification, you can still say they’re acute, there has been some sort of natural selection. So, I think that means, at least for your conclusions, that you need to clarify the statement that there is no difference between acute and chronic, because these are obviously not the same subset of patients that we see in the Western world."
Dr. Ma agreed that natural selection was indeed at play in their series, in that about 80% of their patients were referrals that were transferred in some cases from hundreds of miles away, with many dying en route or before surgery. He also concurred that had their mean and median number of days in their acute cohort been less, indeed, mortality might have been higher.
Dr. Ma reported having no conflicts of interest. Dr. Shrestha is a consultant for Edwards Lifesciences.
TORONTO – Operative mortality with total aortic arch replacement using a four-branched graft and frozen elephant trunk implantation (Sun’s procedure) was 6.5%, including those whose type A aortic dissection was defined as acute.
Operative mortality was higher in acute versus chronic type A aortic dissection (TAAD) patients undergoing the procedure (8.1% vs. 4.3%; P = .031), as was the incidence of stroke (2.2% vs. 0.6%; P = .046), and respiratory complications (20.8% vs. 8.6%; P less than .001).
However, although the risk of operative mortality in acute patients was 1.95 times higher than for chronic patients, in multivariate analysis, acuteness was not identified as a significant risk factor for operative mortality (odds ratio, 1.67; P = .152).
The factors identified as increasing risk of operative mortality were coexisting cerebrovascular disease; malperfusion of the brain, kidneys, spinal cord, and viscera; concomitant extra-anatomic bypass; and cardiopulmonary bypass time exceeding 180 minutes.
"This study proves the safety of frozen elephant trunk with total arch replacement," said Dr. Wei-Guo Ma of Yale University, New Haven, Conn.
"Operative mortality was not affected by either the acute or chronic phase. Instead it was affected by seven other factors, such as prior CVD [cerebrovascular disease], malperfusion, and longer CPB [cardiopulmonary bypass] time.
"If a patient comes without those risk factors, surgeons can go ahead and perform this emergent frozen elephant trunk for him without fear of imposing greater risk of mortality," he said.
Standard TAAD remains a highly lethal condition, with the greatest surgical risk seen during the acute phase. Although some progress has been made, surgeons continue to debate the optimal surgical approach to TAAD, in particular the extent of distal aortic repair. Some advocate a more limited approach of hemiarch repair only, while others propose that total arch repair offers better outcomes.
Sun’s procedure is performed with right axillary artery cannulation for cardiopulmonary bypass and selective antegrade cerebral perfusion, under moderate hypothermic circulatory arrest at 25° C.
The frozen elephant trunk (Cronus, MicroPort Medical, Shanghai, China) is implanted into the descending aorta, followed by total arch replacement using a four-branched vascular graft, with a special sequence for aortic reconstruction (i.e., proximal descending aorta to left carotid artery to ascending aorta to left subclavian artery to innominate artery). Associated operations, including coronary artery bypass grafting, are performed during the cooling phase, if needed.
In this case series, presented by Dr. Ma at the annual meeting of the American Association for Thoracic Surgery, acuteness was defined as an interval between onset of symptoms and surgery of 14 days or less.
TAAD was diagnosed preoperatively by transthoracic echocardiography or computed tomographic angiography, with the location of the intimal tear confirmed during surgery.
The surgeons retrospectively compared early outcomes between acute and chronic TAAD patients after Sun’s procedure, seeking to identify risk factors for operative mortality in both groups and seeking to determine whether acuteness significantly affects operative mortality after this extensive surgical approach.
Between April 2003 and September 2012, Sun’s procedure was performed on 803 patients with acute or chronic TAAD. Mean age was 46 years and 80% of the cohort was male. A total of 456 were classified as acute TAAD patients, with a mean of 5.5 days lapsing between onset of symptoms to surgery (median, 4.1 days), and 347 were chronic, with 197 days lapsing between onset of symptoms and surgery (median, 38 days).
Clinically apparent malperfusion was common, seen in 12.6% of cases, 12.3% of the acute arm and 9.2% of the chronic arm. Patients with malperfusion had an overall mortality of 19.3% (25% in the acute arm and 9.4% in the chronic arm; P less than .001).
"Visceral malperfusion tended to be the most lethal, with five of seven patients dying," reported Dr. Ma. He also noted the young age of their cohort as compared to other regions of the world: 88.8% of patients were under 60 years of age.
Acute, minus natural selection
The invited discussant on the abstract, Dr. Malakh L. Shrestha took issue with the study’s conclusion that acuteness did not affect operative mortality. Dr. Shrestha is the division manager of valvular and coronary artery surgery at the Hannover (Germany) Medical School.
"As a high volume center, what we’ve learned is that acute and chronic aortic dissection patients are two totally different subsets of patients in terms of clinical presentation and mortality. The greatest danger in the acute patient is in the first few hours after the dissection, with the majority of patients dying without surgical intervention."
At Dr. Shrestha’s center in Germany, a high-volume aortic center, they often see patients within the first few hours of their dissection and they’ve found a significantly higher mortality in these patients, compared with chronic TAAD whether an ascending aortic replacement or a frozen elephant trunk procedure is done.
With a median of 4.1 days lapsing between onset of symptoms and surgery in the Ma et al. study, Dr. Shrestha argued that "although on the basis of classification, you can still say they’re acute, there has been some sort of natural selection. So, I think that means, at least for your conclusions, that you need to clarify the statement that there is no difference between acute and chronic, because these are obviously not the same subset of patients that we see in the Western world."
Dr. Ma agreed that natural selection was indeed at play in their series, in that about 80% of their patients were referrals that were transferred in some cases from hundreds of miles away, with many dying en route or before surgery. He also concurred that had their mean and median number of days in their acute cohort been less, indeed, mortality might have been higher.
Dr. Ma reported having no conflicts of interest. Dr. Shrestha is a consultant for Edwards Lifesciences.
Key clinical point: Operative mortality risk factors included CVD; malperfusion of the brain, kidneys, spinal cord, and viscera; and CPB time exceeding 180 minutes.
Major finding: After multivariate adjustment, acute and chronic TAAD patients had similar operative mortality after total arch replacement and frozen elephant trunk implantation.
Data source: Case series with 803 TAAD patients, 456 defined as acute (less than 14 days from symptom onset) and 347 chronic (more than 14 days from symptom onset).
Disclosures: Dr. Ma reported having no conflicts of interest. Dr. Shrestha is a consultant for Edwards Lifesciences.
Left ventricular dysfunction common after mitral valve repair
TORONTO – Early postoperative left ventricular dysfunction occurs in about 18% of patients who undergo "early" mitral valve repair for severe degenerative disease and have normal preoperative ejection fractions exceeding 60%.
In two-thirds of these patients, the left ventricular dysfunction is persistent and associated with increased mortality, reported Dr. Rakesh Suri of the Mayo Clinic in Rochester, Minn.
"These results may help redefine what we have held true for the last few decades," Dr. David H. Adams said after hearing the data presented at the annual meeting of the American Association for Thoracic Surgery.
Dr. Adams is program director of the Mitral Valve Repair Center, Mount Sinai Medical Center, New York.
Guidelines from the American College of Cardiology/American Heart Association recommend that, for patients with severe degenerative mitral regurgitation due to leaflet prolapse, mitral valve repair needs to be done before the onset of left ventricular dysfunction.
However, despite this preemptive approach, a proportion of patients experience a profound decrease in left ventricular ejection fraction (LVEF), to less than 50% in the immediate postoperative period.
Dr. Suri and his colleagues studied the incidence, predictors, and short- and long-term consequences of this phenomenon in 1,705 patients with severe degenerative mitral regurgitation but LVEF greater than 60% who underwent mitral valve repair at the Mayo Clinic from Jan. 1, 1993, to June 30, 2012.
Patients were excluded from the study if they were under age 18, had a history of significant coronary artery disease, or were undergoing concomitant cardiac procedures other than Maze, tricuspid valve repair, or closure of a patent foramen ovale, the researchers noted.
After mitral valve repair, 82% of the cohort had normal LVEF (50% or more), and 18% developed early LV dysfunction (less than 50%).
Mean preoperative LVEF was 65.8% in the group that maintained normal ejection fraction post repair and 66.3% in the group that developed LV dysfunction (P less than .001).
In the group of patients in whom an early decline in LV function was noted, the mean fall in LVEF was 36%, compared with a postrepair drop of 11% in patients whose function remained in the normal range (P less than .001).
When the researchers looked at whether or not patients went to surgery with guideline-based class I or IIa triggers for mitral valve repair, those being symptoms of LV dysfunction, atrial fibrillation, or pulmonary hypertension, they found that 37% of patients who did not develop LV dysfunction and 22% of those who did had no class I or IIa triggers.
"In other words, the guidelines were incapable of defining this population prior to the performance of mitral valve repair," Dr. Suri explained.
On multivariate analysis, predictors of early LV dysfunction were higher right ventricular systolic pressure and LV end-systolic dimension (both P less than .001).
Patients with early LV dysfunction continued to have significantly diminished LVEF at less than 5, 5-10, and less than 10 years.
"Examined in terms of the ability to recover a normal ejection fraction with time, we saw that amongst those with no LV dysfunction following mitral valve repair, two-thirds went on to complete recovery," explained Dr. Suri.
"In contrast, among those with early LV dysfunction, only one-third were capable of recovering normal LV function with time. In other words, two-thirds had persistent LV dysfunction despite undergoing ‘early’ mitral valve repair," Dr. Suri said.
Early LVEF of less than 40% was seen to increased late mortality risk by 70%.
According to these data, a "normal" preoperative ejection fraction should not provide false reassurance of the capacity for restoration of LV function late following mitral valve repair, suggesting that surgical intervention prior to the onset of excessive LV dilation or pulmonary hypertension is warranted, Dr. Suri said.
"So much of the evidence base that serves as a foundation for the ACC/AHA guidelines comes from the Mayo experience, and your new data is provocative and will have implications for future guidelines," said Dr. Adams, the invited discussant for the abstract.
Dr. Suri reported having no disclosures related to this presentation.
TORONTO – Early postoperative left ventricular dysfunction occurs in about 18% of patients who undergo "early" mitral valve repair for severe degenerative disease and have normal preoperative ejection fractions exceeding 60%.
In two-thirds of these patients, the left ventricular dysfunction is persistent and associated with increased mortality, reported Dr. Rakesh Suri of the Mayo Clinic in Rochester, Minn.
"These results may help redefine what we have held true for the last few decades," Dr. David H. Adams said after hearing the data presented at the annual meeting of the American Association for Thoracic Surgery.
Dr. Adams is program director of the Mitral Valve Repair Center, Mount Sinai Medical Center, New York.
Guidelines from the American College of Cardiology/American Heart Association recommend that, for patients with severe degenerative mitral regurgitation due to leaflet prolapse, mitral valve repair needs to be done before the onset of left ventricular dysfunction.
However, despite this preemptive approach, a proportion of patients experience a profound decrease in left ventricular ejection fraction (LVEF), to less than 50% in the immediate postoperative period.
Dr. Suri and his colleagues studied the incidence, predictors, and short- and long-term consequences of this phenomenon in 1,705 patients with severe degenerative mitral regurgitation but LVEF greater than 60% who underwent mitral valve repair at the Mayo Clinic from Jan. 1, 1993, to June 30, 2012.
Patients were excluded from the study if they were under age 18, had a history of significant coronary artery disease, or were undergoing concomitant cardiac procedures other than Maze, tricuspid valve repair, or closure of a patent foramen ovale, the researchers noted.
After mitral valve repair, 82% of the cohort had normal LVEF (50% or more), and 18% developed early LV dysfunction (less than 50%).
Mean preoperative LVEF was 65.8% in the group that maintained normal ejection fraction post repair and 66.3% in the group that developed LV dysfunction (P less than .001).
In the group of patients in whom an early decline in LV function was noted, the mean fall in LVEF was 36%, compared with a postrepair drop of 11% in patients whose function remained in the normal range (P less than .001).
When the researchers looked at whether or not patients went to surgery with guideline-based class I or IIa triggers for mitral valve repair, those being symptoms of LV dysfunction, atrial fibrillation, or pulmonary hypertension, they found that 37% of patients who did not develop LV dysfunction and 22% of those who did had no class I or IIa triggers.
"In other words, the guidelines were incapable of defining this population prior to the performance of mitral valve repair," Dr. Suri explained.
On multivariate analysis, predictors of early LV dysfunction were higher right ventricular systolic pressure and LV end-systolic dimension (both P less than .001).
Patients with early LV dysfunction continued to have significantly diminished LVEF at less than 5, 5-10, and less than 10 years.
"Examined in terms of the ability to recover a normal ejection fraction with time, we saw that amongst those with no LV dysfunction following mitral valve repair, two-thirds went on to complete recovery," explained Dr. Suri.
"In contrast, among those with early LV dysfunction, only one-third were capable of recovering normal LV function with time. In other words, two-thirds had persistent LV dysfunction despite undergoing ‘early’ mitral valve repair," Dr. Suri said.
Early LVEF of less than 40% was seen to increased late mortality risk by 70%.
According to these data, a "normal" preoperative ejection fraction should not provide false reassurance of the capacity for restoration of LV function late following mitral valve repair, suggesting that surgical intervention prior to the onset of excessive LV dilation or pulmonary hypertension is warranted, Dr. Suri said.
"So much of the evidence base that serves as a foundation for the ACC/AHA guidelines comes from the Mayo experience, and your new data is provocative and will have implications for future guidelines," said Dr. Adams, the invited discussant for the abstract.
Dr. Suri reported having no disclosures related to this presentation.
TORONTO – Early postoperative left ventricular dysfunction occurs in about 18% of patients who undergo "early" mitral valve repair for severe degenerative disease and have normal preoperative ejection fractions exceeding 60%.
In two-thirds of these patients, the left ventricular dysfunction is persistent and associated with increased mortality, reported Dr. Rakesh Suri of the Mayo Clinic in Rochester, Minn.
"These results may help redefine what we have held true for the last few decades," Dr. David H. Adams said after hearing the data presented at the annual meeting of the American Association for Thoracic Surgery.
Dr. Adams is program director of the Mitral Valve Repair Center, Mount Sinai Medical Center, New York.
Guidelines from the American College of Cardiology/American Heart Association recommend that, for patients with severe degenerative mitral regurgitation due to leaflet prolapse, mitral valve repair needs to be done before the onset of left ventricular dysfunction.
However, despite this preemptive approach, a proportion of patients experience a profound decrease in left ventricular ejection fraction (LVEF), to less than 50% in the immediate postoperative period.
Dr. Suri and his colleagues studied the incidence, predictors, and short- and long-term consequences of this phenomenon in 1,705 patients with severe degenerative mitral regurgitation but LVEF greater than 60% who underwent mitral valve repair at the Mayo Clinic from Jan. 1, 1993, to June 30, 2012.
Patients were excluded from the study if they were under age 18, had a history of significant coronary artery disease, or were undergoing concomitant cardiac procedures other than Maze, tricuspid valve repair, or closure of a patent foramen ovale, the researchers noted.
After mitral valve repair, 82% of the cohort had normal LVEF (50% or more), and 18% developed early LV dysfunction (less than 50%).
Mean preoperative LVEF was 65.8% in the group that maintained normal ejection fraction post repair and 66.3% in the group that developed LV dysfunction (P less than .001).
In the group of patients in whom an early decline in LV function was noted, the mean fall in LVEF was 36%, compared with a postrepair drop of 11% in patients whose function remained in the normal range (P less than .001).
When the researchers looked at whether or not patients went to surgery with guideline-based class I or IIa triggers for mitral valve repair, those being symptoms of LV dysfunction, atrial fibrillation, or pulmonary hypertension, they found that 37% of patients who did not develop LV dysfunction and 22% of those who did had no class I or IIa triggers.
"In other words, the guidelines were incapable of defining this population prior to the performance of mitral valve repair," Dr. Suri explained.
On multivariate analysis, predictors of early LV dysfunction were higher right ventricular systolic pressure and LV end-systolic dimension (both P less than .001).
Patients with early LV dysfunction continued to have significantly diminished LVEF at less than 5, 5-10, and less than 10 years.
"Examined in terms of the ability to recover a normal ejection fraction with time, we saw that amongst those with no LV dysfunction following mitral valve repair, two-thirds went on to complete recovery," explained Dr. Suri.
"In contrast, among those with early LV dysfunction, only one-third were capable of recovering normal LV function with time. In other words, two-thirds had persistent LV dysfunction despite undergoing ‘early’ mitral valve repair," Dr. Suri said.
Early LVEF of less than 40% was seen to increased late mortality risk by 70%.
According to these data, a "normal" preoperative ejection fraction should not provide false reassurance of the capacity for restoration of LV function late following mitral valve repair, suggesting that surgical intervention prior to the onset of excessive LV dilation or pulmonary hypertension is warranted, Dr. Suri said.
"So much of the evidence base that serves as a foundation for the ACC/AHA guidelines comes from the Mayo experience, and your new data is provocative and will have implications for future guidelines," said Dr. Adams, the invited discussant for the abstract.
Dr. Suri reported having no disclosures related to this presentation.
Key clinical point: Guidelines were incapable of defining the at-risk population prior to mitral valve repair.
Major finding: A total of 18% of patients with severe degenerative mitral disease but normal preoperative LVEF who underwent mitral valve repair had early postoperative decreases in LV function (to less than 50%). Two-thirds of these patients had persistent LV dysfunction.
Data source: Retrospective analysis of 1,705 patients with severe degenerative mitral regurgitation who underwent mitral valve repair.
Disclosures: Dr. Suri reported having no disclosures related to this presentation.