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Hybrid procedures may be better option for LVOTO in lower-weight neonates
Little outcomes data have been published comparing hybrid and Norwood stage 1 procedures for newborns with critical left ventricular outflow tract obstruction (LVOTO), but a prospective analysis of more than 500 operations over 9 years reported that while the Norwood has better survival rates overall, hybrid procedures may improve survival in low-birth-weight newborns.
“Although lower birth weight was identified as an important risk factor for death for the entire cohort, the detrimental impact of low birth weight was mitigated, to some degree, for patients who underwent a hybrid procedure,” said Travis Wilder, MD, of the Congenital Heart Surgeons’ Society (CHSS) Data Center, and his coauthors. They reported their findings in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (153:163-72).
Norwood operations involve major surgical reconstruction along with exposure to cardiopulmonary bypass (CPB), with either deep hypothermic circulatory arrest (DHCA) or regional cerebral perfusion, during aortic arch reconstruction. Previous reports have linked CPB to postoperative hemodynamic instability, complications, and death (Ann Thorac Surg. 2009 Jun;87:1885-92). “In addition, the early physiological stress imposed on neonates after Norwood operations raises concerns regarding adverse neurodevelopment,” Dr. Wilder and his coauthors wrote.
Dr. Wilder and his coauthors pointed out that the hybrid procedure has emerged to avoid CPB and DHCA or regional cerebral perfusion and the potential resulting physiologic instability. “In this light, hybrid palliation may be perceived as a lower-risk alternative to Norwood operations, especially for patients considered at high risk for mortality,” the researchers said. Despite that perception, the actual survival “remains incompletely defined,” they said.
The overall average 4-year unadjusted survival for the entire study population was 65%, but those who had the NW-RVPA procedure had significantly improved survival (73%) vs. both the NW-BT (61%) and the hybrid groups (60%).
Those who had the hybrid procedure were older at stage 1 (12 days vs. 8 and 6 days, respectively for NW-BT and NW-RVPA) and had lower birth weight (2.9 kg vs. 3.2 kg and 3.15 kg, respectively). Hybrid patients also had a higher prevalence of baseline right ventricle dysfunction, were more likely to have baseline tricuspid valve regurgitation, and had a lower prevalence of aortic and mitral valve atresia.
For all patients, birth weight of 2.0-2.5 kg had a strong association with poor survival, Dr. Wilder and his coauthors reported, but the drop-off in survival for low-birth-weight neonates was greater in the Norwood group than in the hybrid group. “This finding suggests that hybrid procedures may offer a modest survival advantage over NW-RVPA at birth weight less than or equal to 2.0 kg and over NW-BT at birth weight less than or equal to 3.0 kg,” the researchers said.
Dr. Wilder and his coauthors had no financial relationships to disclose.
While the study by Dr. Wilder and his coauthors may have drawn an accurate conclusion about low-birth-weight newborns possibly benefiting from a hybrid procedure for hypoplastic left heart syndrome, the number of patients in each strategy was small, Carlos M. Mery, MD, MPH, of Texas Children’s Hospital/Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017 Jan;153:173-4).
Dr. Mery noted other limitations of the study, namely the heterogeneity of procedures by participating center. “Of the 20 centers, only 11 performed any hybrid procedures, and 1 center accounted for 42% of all hybrid procedures performed,” he said. “Because centers may be associated with possibly unaccounted risk factors and different learning curves, the conclusions may not be easily generalizable.”
The conclusion that newborns of lower birth weight may benefit from the hybrid procedure helps to bring clarity for which patients may benefit from a specific procedure, Dr. Mery said. “We seem to be getting closer to the ultimate goal of being able to offer each individual patient the management strategy that will lead to the best possible outcome, not only for quantity but also for quality of life,” Dr. Mery said.
Dr. Mery had no financial relationships to disclose.
While the study by Dr. Wilder and his coauthors may have drawn an accurate conclusion about low-birth-weight newborns possibly benefiting from a hybrid procedure for hypoplastic left heart syndrome, the number of patients in each strategy was small, Carlos M. Mery, MD, MPH, of Texas Children’s Hospital/Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017 Jan;153:173-4).
Dr. Mery noted other limitations of the study, namely the heterogeneity of procedures by participating center. “Of the 20 centers, only 11 performed any hybrid procedures, and 1 center accounted for 42% of all hybrid procedures performed,” he said. “Because centers may be associated with possibly unaccounted risk factors and different learning curves, the conclusions may not be easily generalizable.”
The conclusion that newborns of lower birth weight may benefit from the hybrid procedure helps to bring clarity for which patients may benefit from a specific procedure, Dr. Mery said. “We seem to be getting closer to the ultimate goal of being able to offer each individual patient the management strategy that will lead to the best possible outcome, not only for quantity but also for quality of life,” Dr. Mery said.
Dr. Mery had no financial relationships to disclose.
While the study by Dr. Wilder and his coauthors may have drawn an accurate conclusion about low-birth-weight newborns possibly benefiting from a hybrid procedure for hypoplastic left heart syndrome, the number of patients in each strategy was small, Carlos M. Mery, MD, MPH, of Texas Children’s Hospital/Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017 Jan;153:173-4).
Dr. Mery noted other limitations of the study, namely the heterogeneity of procedures by participating center. “Of the 20 centers, only 11 performed any hybrid procedures, and 1 center accounted for 42% of all hybrid procedures performed,” he said. “Because centers may be associated with possibly unaccounted risk factors and different learning curves, the conclusions may not be easily generalizable.”
The conclusion that newborns of lower birth weight may benefit from the hybrid procedure helps to bring clarity for which patients may benefit from a specific procedure, Dr. Mery said. “We seem to be getting closer to the ultimate goal of being able to offer each individual patient the management strategy that will lead to the best possible outcome, not only for quantity but also for quality of life,” Dr. Mery said.
Dr. Mery had no financial relationships to disclose.
Little outcomes data have been published comparing hybrid and Norwood stage 1 procedures for newborns with critical left ventricular outflow tract obstruction (LVOTO), but a prospective analysis of more than 500 operations over 9 years reported that while the Norwood has better survival rates overall, hybrid procedures may improve survival in low-birth-weight newborns.
“Although lower birth weight was identified as an important risk factor for death for the entire cohort, the detrimental impact of low birth weight was mitigated, to some degree, for patients who underwent a hybrid procedure,” said Travis Wilder, MD, of the Congenital Heart Surgeons’ Society (CHSS) Data Center, and his coauthors. They reported their findings in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (153:163-72).
Norwood operations involve major surgical reconstruction along with exposure to cardiopulmonary bypass (CPB), with either deep hypothermic circulatory arrest (DHCA) or regional cerebral perfusion, during aortic arch reconstruction. Previous reports have linked CPB to postoperative hemodynamic instability, complications, and death (Ann Thorac Surg. 2009 Jun;87:1885-92). “In addition, the early physiological stress imposed on neonates after Norwood operations raises concerns regarding adverse neurodevelopment,” Dr. Wilder and his coauthors wrote.
Dr. Wilder and his coauthors pointed out that the hybrid procedure has emerged to avoid CPB and DHCA or regional cerebral perfusion and the potential resulting physiologic instability. “In this light, hybrid palliation may be perceived as a lower-risk alternative to Norwood operations, especially for patients considered at high risk for mortality,” the researchers said. Despite that perception, the actual survival “remains incompletely defined,” they said.
The overall average 4-year unadjusted survival for the entire study population was 65%, but those who had the NW-RVPA procedure had significantly improved survival (73%) vs. both the NW-BT (61%) and the hybrid groups (60%).
Those who had the hybrid procedure were older at stage 1 (12 days vs. 8 and 6 days, respectively for NW-BT and NW-RVPA) and had lower birth weight (2.9 kg vs. 3.2 kg and 3.15 kg, respectively). Hybrid patients also had a higher prevalence of baseline right ventricle dysfunction, were more likely to have baseline tricuspid valve regurgitation, and had a lower prevalence of aortic and mitral valve atresia.
For all patients, birth weight of 2.0-2.5 kg had a strong association with poor survival, Dr. Wilder and his coauthors reported, but the drop-off in survival for low-birth-weight neonates was greater in the Norwood group than in the hybrid group. “This finding suggests that hybrid procedures may offer a modest survival advantage over NW-RVPA at birth weight less than or equal to 2.0 kg and over NW-BT at birth weight less than or equal to 3.0 kg,” the researchers said.
Dr. Wilder and his coauthors had no financial relationships to disclose.
Little outcomes data have been published comparing hybrid and Norwood stage 1 procedures for newborns with critical left ventricular outflow tract obstruction (LVOTO), but a prospective analysis of more than 500 operations over 9 years reported that while the Norwood has better survival rates overall, hybrid procedures may improve survival in low-birth-weight newborns.
“Although lower birth weight was identified as an important risk factor for death for the entire cohort, the detrimental impact of low birth weight was mitigated, to some degree, for patients who underwent a hybrid procedure,” said Travis Wilder, MD, of the Congenital Heart Surgeons’ Society (CHSS) Data Center, and his coauthors. They reported their findings in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (153:163-72).
Norwood operations involve major surgical reconstruction along with exposure to cardiopulmonary bypass (CPB), with either deep hypothermic circulatory arrest (DHCA) or regional cerebral perfusion, during aortic arch reconstruction. Previous reports have linked CPB to postoperative hemodynamic instability, complications, and death (Ann Thorac Surg. 2009 Jun;87:1885-92). “In addition, the early physiological stress imposed on neonates after Norwood operations raises concerns regarding adverse neurodevelopment,” Dr. Wilder and his coauthors wrote.
Dr. Wilder and his coauthors pointed out that the hybrid procedure has emerged to avoid CPB and DHCA or regional cerebral perfusion and the potential resulting physiologic instability. “In this light, hybrid palliation may be perceived as a lower-risk alternative to Norwood operations, especially for patients considered at high risk for mortality,” the researchers said. Despite that perception, the actual survival “remains incompletely defined,” they said.
The overall average 4-year unadjusted survival for the entire study population was 65%, but those who had the NW-RVPA procedure had significantly improved survival (73%) vs. both the NW-BT (61%) and the hybrid groups (60%).
Those who had the hybrid procedure were older at stage 1 (12 days vs. 8 and 6 days, respectively for NW-BT and NW-RVPA) and had lower birth weight (2.9 kg vs. 3.2 kg and 3.15 kg, respectively). Hybrid patients also had a higher prevalence of baseline right ventricle dysfunction, were more likely to have baseline tricuspid valve regurgitation, and had a lower prevalence of aortic and mitral valve atresia.
For all patients, birth weight of 2.0-2.5 kg had a strong association with poor survival, Dr. Wilder and his coauthors reported, but the drop-off in survival for low-birth-weight neonates was greater in the Norwood group than in the hybrid group. “This finding suggests that hybrid procedures may offer a modest survival advantage over NW-RVPA at birth weight less than or equal to 2.0 kg and over NW-BT at birth weight less than or equal to 3.0 kg,” the researchers said.
Dr. Wilder and his coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Norwood procedures have the best survival rates for neonates with critical left ventricular outflow tract obstruction, but hybrid procedures may improve survival for those with lower birth weight.
Major finding: Risk-adjusted 4-year survival was 76% for the Norwood operation with a right ventricle–to-pulmonary artery conduit, 61% for Norwood with a modified Blalock-Taussig shunt and 60% for the hybrid procedure.
Data source: Prospective observational cohort study of 564 neonates admitted to 21 Congenital Heart Surgeons’ Society institutions from 2005 to 2014.
Disclosures: Dr. Wilder and his coauthors had no financial relationships to disclose.
LAA closure during cardiac surgery cuts late mortality
NEW ORLEANS – Surgical left atrial appendage closure at the time of open heart surgery in patients with atrial fibrillation doesn’t decrease patients’ early or late risk of stroke, but it does substantially reduce their risk of late mortality, Masahiko Ando, MD, reported at the American Heart Association scientific sessions.
Solid evidence demonstrates that percutaneous left atrial appendage (LAA) closure using the Watchman or other devices in patients with atrial fibrillation offers a potential alternative to lifelong oral anticoagulation.
In contrast, even though surgical LAA closure at the time of cardiac surgery is commonly done, the data as to its long-term impact are scanty. This was the impetus for Dr. Ando and his coinvestigators at Massachusetts General Hospital in Boston to perform a comprehensive systematic review of the medical literature. They also conducted a meta-analysis that involved 7,466 patients who underwent open-heart surgery with or without surgical LAA closure in 12 studies, 3 of which were randomized controlled trials, 2 propensity-matched comparisons, and the rest cohort studies.
At 30-day follow-up, LAA closure was not associated with any significant effect on the risks of stroke, death, reexploration for bleeding, or postoperative atrial fibrillation.
At the latest follow-up in the studies, however, surgical LAA closure was associated with a highly significant 36% reduction in mortality risk compared with the no–LAA-closure control group. This remained the case even after statistical adjustment for demographics, type of cardiac surgery, and the form of preoperative atrial fibrillation.
“Given that we generally add LAA closure to those who have a higher risk of embolization, which could have negatively affected the efficacy of LAA closure, this preventive effect of LAA closure on late mortality cannot be ignored,” said Dr. Ando.
The most likely explanation for the improved survival in surgical LAA closure recipients, he continued, is that the procedure enabled them to avoid aggressive lifelong oral anticoagulation, with its attendant risks.
Dr. Ando reported having no financial conflicts regarding his study.
NEW ORLEANS – Surgical left atrial appendage closure at the time of open heart surgery in patients with atrial fibrillation doesn’t decrease patients’ early or late risk of stroke, but it does substantially reduce their risk of late mortality, Masahiko Ando, MD, reported at the American Heart Association scientific sessions.
Solid evidence demonstrates that percutaneous left atrial appendage (LAA) closure using the Watchman or other devices in patients with atrial fibrillation offers a potential alternative to lifelong oral anticoagulation.
In contrast, even though surgical LAA closure at the time of cardiac surgery is commonly done, the data as to its long-term impact are scanty. This was the impetus for Dr. Ando and his coinvestigators at Massachusetts General Hospital in Boston to perform a comprehensive systematic review of the medical literature. They also conducted a meta-analysis that involved 7,466 patients who underwent open-heart surgery with or without surgical LAA closure in 12 studies, 3 of which were randomized controlled trials, 2 propensity-matched comparisons, and the rest cohort studies.
At 30-day follow-up, LAA closure was not associated with any significant effect on the risks of stroke, death, reexploration for bleeding, or postoperative atrial fibrillation.
At the latest follow-up in the studies, however, surgical LAA closure was associated with a highly significant 36% reduction in mortality risk compared with the no–LAA-closure control group. This remained the case even after statistical adjustment for demographics, type of cardiac surgery, and the form of preoperative atrial fibrillation.
“Given that we generally add LAA closure to those who have a higher risk of embolization, which could have negatively affected the efficacy of LAA closure, this preventive effect of LAA closure on late mortality cannot be ignored,” said Dr. Ando.
The most likely explanation for the improved survival in surgical LAA closure recipients, he continued, is that the procedure enabled them to avoid aggressive lifelong oral anticoagulation, with its attendant risks.
Dr. Ando reported having no financial conflicts regarding his study.
NEW ORLEANS – Surgical left atrial appendage closure at the time of open heart surgery in patients with atrial fibrillation doesn’t decrease patients’ early or late risk of stroke, but it does substantially reduce their risk of late mortality, Masahiko Ando, MD, reported at the American Heart Association scientific sessions.
Solid evidence demonstrates that percutaneous left atrial appendage (LAA) closure using the Watchman or other devices in patients with atrial fibrillation offers a potential alternative to lifelong oral anticoagulation.
In contrast, even though surgical LAA closure at the time of cardiac surgery is commonly done, the data as to its long-term impact are scanty. This was the impetus for Dr. Ando and his coinvestigators at Massachusetts General Hospital in Boston to perform a comprehensive systematic review of the medical literature. They also conducted a meta-analysis that involved 7,466 patients who underwent open-heart surgery with or without surgical LAA closure in 12 studies, 3 of which were randomized controlled trials, 2 propensity-matched comparisons, and the rest cohort studies.
At 30-day follow-up, LAA closure was not associated with any significant effect on the risks of stroke, death, reexploration for bleeding, or postoperative atrial fibrillation.
At the latest follow-up in the studies, however, surgical LAA closure was associated with a highly significant 36% reduction in mortality risk compared with the no–LAA-closure control group. This remained the case even after statistical adjustment for demographics, type of cardiac surgery, and the form of preoperative atrial fibrillation.
“Given that we generally add LAA closure to those who have a higher risk of embolization, which could have negatively affected the efficacy of LAA closure, this preventive effect of LAA closure on late mortality cannot be ignored,” said Dr. Ando.
The most likely explanation for the improved survival in surgical LAA closure recipients, he continued, is that the procedure enabled them to avoid aggressive lifelong oral anticoagulation, with its attendant risks.
Dr. Ando reported having no financial conflicts regarding his study.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Late mortality risk was reduced by 36% in patients with atrial fibrillation who underwent surgical LAA closure during open heart surgery, compared with those who did not.
Data source: This meta-analysis included 12 published studies and 7,466 patients who either did or did not undergo surgical LAA closure during open heart surgery.
Disclosures: The study presenter reported having no financial conflicts.
More tricuspid valve regurgitation should be fixed
CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.
Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.
A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).
Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.
The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).
“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.
And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.
Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.
Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).
However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).
According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.
For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.
In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.
Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.
[email protected]
On Twitter @karioakes
CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.
Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.
A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).
Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.
The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).
“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.
And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.
Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.
Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).
However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).
According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.
For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.
In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.
Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.
[email protected]
On Twitter @karioakes
CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.
Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.
A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).
Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.
The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).
“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.
And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.
Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.
Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).
However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).
According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.
For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.
In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.
Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM HEART VALVE SUMMIT 2016
Expandable cardiac valve in children found feasible
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: An expandable cardiac valve adapted for infants and children demonstrates acceptable function and can accommodate the child’s growth.
Major finding: At 12 months after implantation of a bovine jugular vein graft reinforced with an external stent modified for surgical valve replacement in pediatric patients, Kaplan-Meier analysis indicated that 83% of those surviving would be free from reoperation at 12 months.
Data source: Single-center study of 42 patients who underwent implantation between 2010 and 2014.
Disclosures: Dr. Emani and his coauthors had no financial relationships to disclose.
Lower-risk approach for aortic arch repair
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Aortic arch reconstruction through a median sternotomy on bypass in newborns and infants had lower rates for recurrent obstruction than did a thoracotomy approach.
Major finding: Of 11 patients who required reintervention, one had a median sternotomy and 10 had a lateral thoracotomy.
Data source: Retrospective review of 183 consecutive newborns and infants with coarctation and hypoplastic aortic arch from 1996 to 2013.
Disclosures: Dr. Tulzer and coauthors had no financial relationships to disclose.
Sutureless aortic valve replacement: Is ease worth the cost?
CHICAGO – Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.
“Why use a sutureless valve?” asked Vinod H. Thourani, MD, speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta. 
Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”
Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.
Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.
Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).
Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.
Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 (J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4).
Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.
Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.
“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.
Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.
Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.
Dr. Thourani reported multiple financial relationships with medical device companies.
[email protected]
On Twitter @karioakes
CHICAGO – Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.
“Why use a sutureless valve?” asked Vinod H. Thourani, MD, speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.
Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”
Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.
Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.
Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).
Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.
Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 (J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4).
Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.
Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.
“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.
Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.
Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.
Dr. Thourani reported multiple financial relationships with medical device companies.
[email protected]
On Twitter @karioakes
CHICAGO – Rapid deployment sutureless valves can be a good option for some patients, providing a highly functional and nearly leakproof valve with less cardiopulmonary bypass and aortic cross-clamp times than those of conventional procedures.
“Why use a sutureless valve?” asked Vinod H. Thourani, MD, speaking at Heart Valve Summit 2016. He said that for many patients, there are abundant good reasons for the choice. The rapidity of the implantation procedure is a huge plus, he said. Cardiopulmonary bypass times are reduced when sutureless valve replacement is a stand-alone procedure, added Dr. Thourani, chief of cardiovascular surgery at Emory Hospital Midtown and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.
Rapid deployment is also of benefit in combined cases, or when patients have multiple comorbidities or poor left ventricular function. Sutureless valves, he said, are “optimal for multiple valve or concomitant procedures.”
Hemodynamics also are favorable, said Dr. Thourani; sutureless valves produce lower gradients than do their sutured alternatives, and work well in patients with a small aortic root.
Both sutureless valves that are currently available use bovine tissue; one, Sorin’s Perceval, uses a nitinol stent, while the Edwards’ Intuity uses stainless steel. The Perceval stent requires no sutures, while the Intuity requires just three. Also, the Perceval is collapsible, while the Intuity is not.
Removal of the pathologic valve in the sutureless procedure, he said, may contribute to the lower paravalvular leak and stroke rates than are seen in transcatheter aortic valve replacement (TAVR).
Expanded indications for sutureless valves include a calcified aortic root or a homograft; sutureless valves also can be used as an aortic valve redo, with patent grafts. Dr. Thourani said that he favors a transverse incision with a high aortotomy, about 2 cm above the sinotubular junction (STJ). In addition, off-label indications have included bicuspid aortic valve, pure aortic insufficiency, a prior mitral prosthesis or a degenerated aortic bioprosthesis, and a rescue procedure for a failed TAVR.
Dr. Thourani cited results of a trial conducted by Theodor Fischlein, MD, of Paracelsus Medical University in Nuremberg, Germany, and coauthors. These 1-year follow-up data from 628 patients participating in CAVALIER (Perceval S Valve Clinical Trial for Extended CE Mark), an international multicenter prospective trial, were presented at AATS 2016 (J Thorac Cardiovasc Surg. 2016 Jun;51[6]:1617-26.e4).
Of the 658 patients who met enrollment criteria and had a Perceval valve placement attempted, 30 wound up with a different prosthesis, most often because the correct valve size was not available. The remaining 628 patients who received the Perceval valve were included in the study. At 1 year, 549 patients remained; 50 had died, 12 had undergone valve explantation, and the remainder withdrew or were lost to follow-up.
Of the original Perceval recipients, 219 had received their valve via minimally invasive access. At 1 year, effective orifice area remained stable at the same mean 1.5 cm2 that was seen at discharge, an improvement from the mean 0.7 cm2 effective orifice area seen preoperatively. The mean pressure gradient, which was 45 mm Hg preoperatively, dropped precipitously to 10.3 mm Hg at discharge, and dropped a bit more at 1 year, to 9.2 mm Hg.
“This is a rapid and reproducible procedure: Over 20,000 implants have been performed worldwide,” said Dr. Thourani. The procedure looks good for low- to medium-risk patients, and may be the first procedure to consider for patients with a small aortic root, who have had prior coronary artery bypass surgery with patent grafts, or those with a calcified aortic root and homografts.
Questions still to be answered, he said, include whether “the cost will justify the decrease in cross-clamp times.” Also, though midrange results are good, longitudinal follow-up to track long-term valve hemodynamics is still ongoing.
Although patient demand seems to be high for a minimally invasive approach, sutureless valves still have low adoption rates, he said.
Dr. Thourani reported multiple financial relationships with medical device companies.
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On Twitter @karioakes
EXPERT ANALYSIS FROM THE HEART VALVE SUMMIT 2016
TAVR valve durability supported in large follow-up
WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”
This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.
This evaluation of 2,404 TAVR patients in the PARTNER 1 trial examined by echocardiography and encompassing 6,493 patient-years of follow-up is the “largest core-lab based study of transcatheter heart valves to date. These data demonstrate excellent durability of transcatheter heart valves, suggesting that the low 5-year survival observed in this cohort is not related to adverse hemodynamics or transcatheter heart valve deterioration,” said Dr. Douglas, professor of medicine at Duke University, Durham, N.C.
Her findings showed that out of the 2,482 patients treated with TAVR (and including those without echo follow-up) either in the trial or during the continued access program and followed for a median of 2.9 years and an average of 2.6 years, 20 patients (0.8%) required a reintervention. Four of these 20 patients (0.2% of the total cohort) showed a “classic pattern” of aortic valve deterioration marked by an increased valve pressure gradient and a reduced valve area, she reported.
“Reintervention was rare, became less frequent over time, and was usually not due to structural deterioration of the transcatheter heart valve,” she said. But Dr. Douglas also cautioned that among the patients who received the first-generation, balloon expandable Sapien valve in this cohort, just 39% survived to 5 years, and a mere 282 patients (11%) actually underwent echocardiographic examination at 5 years.
“This is one of several steps we need to take to figure out the durability of transcatheter valves,” said Jeffrey J. Popma, MD, professor of medicine and an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston. He noted that data are needed from follow-up periods of 8 or 10 years, but these data will not be available until intermediate- or low-risk patients undergo TAVR in controlled circumstances and have long-term follow-up. 
“Ten-year follow-up data will essentially be impossible” for the high-risk or inoperable patients treated with TAVR in the PARTNER 1 trial, which focused on the sickest patients with aortic stenosis, said Dr. Popma, lead investigator for several studies of TAVR using self-expanding aortic valves and marketed as CoreValve devices.
“We obviously need to follow patients longer. The 5-year results look terrific, and so very reassuring, but we need to keep an eye on this as we move TAVR into less sick and younger patients,” said Dr. Robert O. Bonow, professor of cardiology at Northwestern University, Chicago. “Durability is the remaining frontier in terms of moving TAVR into younger patients,” Dr. Bonow said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
These data continue to show that “transcatheter valves have looked hemodynamically superior to surgically-placed valves with respect to the VARC (Valve Academic Research Consortium)–2 criteria” for prosthetic valve function, Dr. Popma noted. “I think the benefits of surgical valves have been overstated and the benefits of transcatheter valves understated,” he said.
“Surgical valves have not been held to the same [very demanding] standard as transcatheter valves,” Dr. Douglas agreed.
The data Dr. Douglas reported contrast with longer-term follow-up reported in May 2016 for 378 patients who underwent TAVR at either of two pioneering centers in a retrospective review. Those data suggested a valve degeneration rate of about 50% after 8 years, Danny Dvir, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. Speaking recently in an interview, Dr. Dvir acknowledged some of the challenges in trying to derive valve durability information from a relatively small number of very-high-risk patients who underwent TAVR very early during development of the procedure.
Some TAVR experts have also questioned the criteria that Dr. Dvir used to identify valve structural valve degeneration for this analysis. “The criteria he used were much more stringent that the criteria we have used to assess surgically-placed valves,” said Michael J. Reardon, MD, professor of cardiovascular surgery at Houston Methodist Hospital. “If surgically-placed aortic valves were subjected to the same criteria Dr. Dvir applied then they would perform even worse,” Dr. Reardon said in an interview.
PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.
[email protected]
On Twitter @mitchelzoler
The data reported by Dr. Douglas are very important and very reassuring. It isn’t easy to evaluate long-term results in patients who underwent TAVR in the early days because that population of patients was old and at very high risk. Even when patients had successful procedures their longevity wasn’t long. Only about 10% of the starting population of 2,482 patients in Dr. Douglas’ study actually had echocardiography done after 5 years. To assess durability you need longer-term echo follow-up, but it will be very challenging to have enough patients to have statistical power to do that.
I am not nervous about long-term durability of TAVR in octogenarian patients, the most typical age for TAVR patients today and since we began using it. Durability is more of an issue for patients who are 75 or younger, and we will need data from 7- to 10-year follow-up of younger patients to have a reasonable answer. Younger patients who undergo TAVR may face more of a threat from valve deterioration simply because of their longer life expectancy. In addition, with surgical valves we know that younger age is one of the strongest predictors of valve degeneration.
Danny Dvir, MD , is an interventional cardiologist at the University of Washington in Seattle. He has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. He made these comments in an interview.
The data reported by Dr. Douglas are very important and very reassuring. It isn’t easy to evaluate long-term results in patients who underwent TAVR in the early days because that population of patients was old and at very high risk. Even when patients had successful procedures their longevity wasn’t long. Only about 10% of the starting population of 2,482 patients in Dr. Douglas’ study actually had echocardiography done after 5 years. To assess durability you need longer-term echo follow-up, but it will be very challenging to have enough patients to have statistical power to do that.
I am not nervous about long-term durability of TAVR in octogenarian patients, the most typical age for TAVR patients today and since we began using it. Durability is more of an issue for patients who are 75 or younger, and we will need data from 7- to 10-year follow-up of younger patients to have a reasonable answer. Younger patients who undergo TAVR may face more of a threat from valve deterioration simply because of their longer life expectancy. In addition, with surgical valves we know that younger age is one of the strongest predictors of valve degeneration.
Danny Dvir, MD , is an interventional cardiologist at the University of Washington in Seattle. He has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. He made these comments in an interview.
The data reported by Dr. Douglas are very important and very reassuring. It isn’t easy to evaluate long-term results in patients who underwent TAVR in the early days because that population of patients was old and at very high risk. Even when patients had successful procedures their longevity wasn’t long. Only about 10% of the starting population of 2,482 patients in Dr. Douglas’ study actually had echocardiography done after 5 years. To assess durability you need longer-term echo follow-up, but it will be very challenging to have enough patients to have statistical power to do that.
I am not nervous about long-term durability of TAVR in octogenarian patients, the most typical age for TAVR patients today and since we began using it. Durability is more of an issue for patients who are 75 or younger, and we will need data from 7- to 10-year follow-up of younger patients to have a reasonable answer. Younger patients who undergo TAVR may face more of a threat from valve deterioration simply because of their longer life expectancy. In addition, with surgical valves we know that younger age is one of the strongest predictors of valve degeneration.
Danny Dvir, MD , is an interventional cardiologist at the University of Washington in Seattle. He has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. He made these comments in an interview.
WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”
This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.
This evaluation of 2,404 TAVR patients in the PARTNER 1 trial examined by echocardiography and encompassing 6,493 patient-years of follow-up is the “largest core-lab based study of transcatheter heart valves to date. These data demonstrate excellent durability of transcatheter heart valves, suggesting that the low 5-year survival observed in this cohort is not related to adverse hemodynamics or transcatheter heart valve deterioration,” said Dr. Douglas, professor of medicine at Duke University, Durham, N.C.
Her findings showed that out of the 2,482 patients treated with TAVR (and including those without echo follow-up) either in the trial or during the continued access program and followed for a median of 2.9 years and an average of 2.6 years, 20 patients (0.8%) required a reintervention. Four of these 20 patients (0.2% of the total cohort) showed a “classic pattern” of aortic valve deterioration marked by an increased valve pressure gradient and a reduced valve area, she reported.
“Reintervention was rare, became less frequent over time, and was usually not due to structural deterioration of the transcatheter heart valve,” she said. But Dr. Douglas also cautioned that among the patients who received the first-generation, balloon expandable Sapien valve in this cohort, just 39% survived to 5 years, and a mere 282 patients (11%) actually underwent echocardiographic examination at 5 years.
“This is one of several steps we need to take to figure out the durability of transcatheter valves,” said Jeffrey J. Popma, MD, professor of medicine and an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston. He noted that data are needed from follow-up periods of 8 or 10 years, but these data will not be available until intermediate- or low-risk patients undergo TAVR in controlled circumstances and have long-term follow-up.
“Ten-year follow-up data will essentially be impossible” for the high-risk or inoperable patients treated with TAVR in the PARTNER 1 trial, which focused on the sickest patients with aortic stenosis, said Dr. Popma, lead investigator for several studies of TAVR using self-expanding aortic valves and marketed as CoreValve devices.
“We obviously need to follow patients longer. The 5-year results look terrific, and so very reassuring, but we need to keep an eye on this as we move TAVR into less sick and younger patients,” said Dr. Robert O. Bonow, professor of cardiology at Northwestern University, Chicago. “Durability is the remaining frontier in terms of moving TAVR into younger patients,” Dr. Bonow said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
These data continue to show that “transcatheter valves have looked hemodynamically superior to surgically-placed valves with respect to the VARC (Valve Academic Research Consortium)–2 criteria” for prosthetic valve function, Dr. Popma noted. “I think the benefits of surgical valves have been overstated and the benefits of transcatheter valves understated,” he said.
“Surgical valves have not been held to the same [very demanding] standard as transcatheter valves,” Dr. Douglas agreed.
The data Dr. Douglas reported contrast with longer-term follow-up reported in May 2016 for 378 patients who underwent TAVR at either of two pioneering centers in a retrospective review. Those data suggested a valve degeneration rate of about 50% after 8 years, Danny Dvir, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. Speaking recently in an interview, Dr. Dvir acknowledged some of the challenges in trying to derive valve durability information from a relatively small number of very-high-risk patients who underwent TAVR very early during development of the procedure.
Some TAVR experts have also questioned the criteria that Dr. Dvir used to identify valve structural valve degeneration for this analysis. “The criteria he used were much more stringent that the criteria we have used to assess surgically-placed valves,” said Michael J. Reardon, MD, professor of cardiovascular surgery at Houston Methodist Hospital. “If surgically-placed aortic valves were subjected to the same criteria Dr. Dvir applied then they would perform even worse,” Dr. Reardon said in an interview.
PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”
This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.
This evaluation of 2,404 TAVR patients in the PARTNER 1 trial examined by echocardiography and encompassing 6,493 patient-years of follow-up is the “largest core-lab based study of transcatheter heart valves to date. These data demonstrate excellent durability of transcatheter heart valves, suggesting that the low 5-year survival observed in this cohort is not related to adverse hemodynamics or transcatheter heart valve deterioration,” said Dr. Douglas, professor of medicine at Duke University, Durham, N.C.
Her findings showed that out of the 2,482 patients treated with TAVR (and including those without echo follow-up) either in the trial or during the continued access program and followed for a median of 2.9 years and an average of 2.6 years, 20 patients (0.8%) required a reintervention. Four of these 20 patients (0.2% of the total cohort) showed a “classic pattern” of aortic valve deterioration marked by an increased valve pressure gradient and a reduced valve area, she reported.
“Reintervention was rare, became less frequent over time, and was usually not due to structural deterioration of the transcatheter heart valve,” she said. But Dr. Douglas also cautioned that among the patients who received the first-generation, balloon expandable Sapien valve in this cohort, just 39% survived to 5 years, and a mere 282 patients (11%) actually underwent echocardiographic examination at 5 years.
“This is one of several steps we need to take to figure out the durability of transcatheter valves,” said Jeffrey J. Popma, MD, professor of medicine and an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston. He noted that data are needed from follow-up periods of 8 or 10 years, but these data will not be available until intermediate- or low-risk patients undergo TAVR in controlled circumstances and have long-term follow-up.
“Ten-year follow-up data will essentially be impossible” for the high-risk or inoperable patients treated with TAVR in the PARTNER 1 trial, which focused on the sickest patients with aortic stenosis, said Dr. Popma, lead investigator for several studies of TAVR using self-expanding aortic valves and marketed as CoreValve devices.
“We obviously need to follow patients longer. The 5-year results look terrific, and so very reassuring, but we need to keep an eye on this as we move TAVR into less sick and younger patients,” said Dr. Robert O. Bonow, professor of cardiology at Northwestern University, Chicago. “Durability is the remaining frontier in terms of moving TAVR into younger patients,” Dr. Bonow said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
These data continue to show that “transcatheter valves have looked hemodynamically superior to surgically-placed valves with respect to the VARC (Valve Academic Research Consortium)–2 criteria” for prosthetic valve function, Dr. Popma noted. “I think the benefits of surgical valves have been overstated and the benefits of transcatheter valves understated,” he said.
“Surgical valves have not been held to the same [very demanding] standard as transcatheter valves,” Dr. Douglas agreed.
The data Dr. Douglas reported contrast with longer-term follow-up reported in May 2016 for 378 patients who underwent TAVR at either of two pioneering centers in a retrospective review. Those data suggested a valve degeneration rate of about 50% after 8 years, Danny Dvir, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. Speaking recently in an interview, Dr. Dvir acknowledged some of the challenges in trying to derive valve durability information from a relatively small number of very-high-risk patients who underwent TAVR very early during development of the procedure.
Some TAVR experts have also questioned the criteria that Dr. Dvir used to identify valve structural valve degeneration for this analysis. “The criteria he used were much more stringent that the criteria we have used to assess surgically-placed valves,” said Michael J. Reardon, MD, professor of cardiovascular surgery at Houston Methodist Hospital. “If surgically-placed aortic valves were subjected to the same criteria Dr. Dvir applied then they would perform even worse,” Dr. Reardon said in an interview.
PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.
[email protected]
On Twitter @mitchelzoler
AT TCT 2016
Key clinical point:
Major finding: During median follow-up of 2.9 years, 0.2% of patients had valves with classic hemodynamic signs of valve deterioration.
Data source: A total of 2,482 TAVR patients either enrolled in the PARTNER 1 trial or who underwent TAVR during a continued access program.
Disclosures: PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.
Can bioprosthetics work for large airway defects?
Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.
Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.
These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.
All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.
Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.
This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.
Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.
All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.
Dr. Udelsman and his coauthors reported having no financial disclosures.
In his invited commentary, Raja Flores, MD, of Mount Sinai Health System in New York said this study demonstrated “modest success” with bioprosthetic materials for repair of large airway deficits – the same level of success he ascribes to human studies of other surgical approaches to large airway deficits (J Thorac Cardiovasc Surg. 2016 Nov;152:1233-4).
But progress has been slow and animal studies of large airway deficit repair have been “wastefully repetitive” without any advances. “We must build on what these human studies have taught us and not continue unsuccessfully to reinvent the same malfunctioning [airways],” Dr. Flores said.
When surgeons encounter such patients, surgery isn’t necessary for their survival, Dr. Flores said. “T-tubes work just fine.” The goal is to improve their quality of life. “Unless we can provide a reliable, long-lasting solution, an unpredictable life-threatening experimental surgical intervention is not justified to treat a stable, functional patient,” he said.
And while Dr. Udelsman and his colleagues have shown “some progress” in their study, he cautioned surgeons to heed the words of a tracheal surgery pioneer Hermes Grillo, MD, at Boston’s Massachusetts General Hospital and Harvard Medical School: “Success has been announced episodically over the decades in each of these categories, but thus far no one replacement method has held for the long term in any safe and practicable manner.” Dr. Flores added: “This still holds true today.”
Dr. Flores reported having no financial disclosures.
In his invited commentary, Raja Flores, MD, of Mount Sinai Health System in New York said this study demonstrated “modest success” with bioprosthetic materials for repair of large airway deficits – the same level of success he ascribes to human studies of other surgical approaches to large airway deficits (J Thorac Cardiovasc Surg. 2016 Nov;152:1233-4).
But progress has been slow and animal studies of large airway deficit repair have been “wastefully repetitive” without any advances. “We must build on what these human studies have taught us and not continue unsuccessfully to reinvent the same malfunctioning [airways],” Dr. Flores said.
When surgeons encounter such patients, surgery isn’t necessary for their survival, Dr. Flores said. “T-tubes work just fine.” The goal is to improve their quality of life. “Unless we can provide a reliable, long-lasting solution, an unpredictable life-threatening experimental surgical intervention is not justified to treat a stable, functional patient,” he said.
And while Dr. Udelsman and his colleagues have shown “some progress” in their study, he cautioned surgeons to heed the words of a tracheal surgery pioneer Hermes Grillo, MD, at Boston’s Massachusetts General Hospital and Harvard Medical School: “Success has been announced episodically over the decades in each of these categories, but thus far no one replacement method has held for the long term in any safe and practicable manner.” Dr. Flores added: “This still holds true today.”
Dr. Flores reported having no financial disclosures.
In his invited commentary, Raja Flores, MD, of Mount Sinai Health System in New York said this study demonstrated “modest success” with bioprosthetic materials for repair of large airway deficits – the same level of success he ascribes to human studies of other surgical approaches to large airway deficits (J Thorac Cardiovasc Surg. 2016 Nov;152:1233-4).
But progress has been slow and animal studies of large airway deficit repair have been “wastefully repetitive” without any advances. “We must build on what these human studies have taught us and not continue unsuccessfully to reinvent the same malfunctioning [airways],” Dr. Flores said.
When surgeons encounter such patients, surgery isn’t necessary for their survival, Dr. Flores said. “T-tubes work just fine.” The goal is to improve their quality of life. “Unless we can provide a reliable, long-lasting solution, an unpredictable life-threatening experimental surgical intervention is not justified to treat a stable, functional patient,” he said.
And while Dr. Udelsman and his colleagues have shown “some progress” in their study, he cautioned surgeons to heed the words of a tracheal surgery pioneer Hermes Grillo, MD, at Boston’s Massachusetts General Hospital and Harvard Medical School: “Success has been announced episodically over the decades in each of these categories, but thus far no one replacement method has held for the long term in any safe and practicable manner.” Dr. Flores added: “This still holds true today.”
Dr. Flores reported having no financial disclosures.
Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.
Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.
These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.
All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.
Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.
This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.
Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.
All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.
Dr. Udelsman and his coauthors reported having no financial disclosures.
Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.
Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.
These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.
All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.
Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.
This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.
Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.
All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.
Dr. Udelsman and his coauthors reported having no financial disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Bioprosthetic materials show progress for reconstruction of large airway defects.
Major finding: Airway defects were successfully closed in all patients, with no postoperative deaths or recurrence of airway defect.
Data source: Eight patients who underwent closure of complex central airway defects with bioprosthetic materials between 2008 and 2015.
Disclosures: Dr. Udelsman and coauthors reported having no relevant financial disclosures.
Evaluating Fontan failure risk after arrhythmia
People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.
“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.
The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).
Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.
The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.
After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.
Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.
“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”
About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.
Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.
When interpreting the data that the Australian and New Zealand researchers analyzed, one must be cautious about viewing arrhythmia as an early indicator for Fontan revision, Mark E. Alexander, MD, of Boston Children’s Hospital and Harvard Medical School, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1364-5).
The outcome of a Fontan revision after an arrhythmia “becomes self-fulfilling,” Dr. Alexander said. He questioned what the revision procedure would be when the initial operation was an extracardiac Fontan. “The complex risks of that procedure continue to keep decisions regarding Fontan revisions challenging,” he said. He also noted the study did not analyze the association of ventricular function and arrhythmias “in a substantive way.”
And Dr. Alexander did not interpret the study results as an endorsement of the extracardiac Fontan or a rejection of the lateral tunnel approach. The early adoption of the extracardiac Fontan by the groups the authors represented is itself a limitation of the study, he said. Challenges with follow-up of extracardiac techniques in this and other studies “limit our ability to declare a ‘victor’ in that debate,” he said. “It does remind the electrophysiologist that he or she needs to master the techniques of entering the pulmonary venous atrium in these patients.”
The precision of calculating risk after an operation grows weaker with time, he said, and at 15-20 years morbidity starts to increase and follow-up becomes “more diffuse,” Dr. Alexander said. “That reality means we look forward to this group continuing to enhance our understanding of how our changing management decisions can aid our patients.”
Dr. Alexander had no financial relationships to disclose.
When interpreting the data that the Australian and New Zealand researchers analyzed, one must be cautious about viewing arrhythmia as an early indicator for Fontan revision, Mark E. Alexander, MD, of Boston Children’s Hospital and Harvard Medical School, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1364-5).
The outcome of a Fontan revision after an arrhythmia “becomes self-fulfilling,” Dr. Alexander said. He questioned what the revision procedure would be when the initial operation was an extracardiac Fontan. “The complex risks of that procedure continue to keep decisions regarding Fontan revisions challenging,” he said. He also noted the study did not analyze the association of ventricular function and arrhythmias “in a substantive way.”
And Dr. Alexander did not interpret the study results as an endorsement of the extracardiac Fontan or a rejection of the lateral tunnel approach. The early adoption of the extracardiac Fontan by the groups the authors represented is itself a limitation of the study, he said. Challenges with follow-up of extracardiac techniques in this and other studies “limit our ability to declare a ‘victor’ in that debate,” he said. “It does remind the electrophysiologist that he or she needs to master the techniques of entering the pulmonary venous atrium in these patients.”
The precision of calculating risk after an operation grows weaker with time, he said, and at 15-20 years morbidity starts to increase and follow-up becomes “more diffuse,” Dr. Alexander said. “That reality means we look forward to this group continuing to enhance our understanding of how our changing management decisions can aid our patients.”
Dr. Alexander had no financial relationships to disclose.
When interpreting the data that the Australian and New Zealand researchers analyzed, one must be cautious about viewing arrhythmia as an early indicator for Fontan revision, Mark E. Alexander, MD, of Boston Children’s Hospital and Harvard Medical School, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1364-5).
The outcome of a Fontan revision after an arrhythmia “becomes self-fulfilling,” Dr. Alexander said. He questioned what the revision procedure would be when the initial operation was an extracardiac Fontan. “The complex risks of that procedure continue to keep decisions regarding Fontan revisions challenging,” he said. He also noted the study did not analyze the association of ventricular function and arrhythmias “in a substantive way.”
And Dr. Alexander did not interpret the study results as an endorsement of the extracardiac Fontan or a rejection of the lateral tunnel approach. The early adoption of the extracardiac Fontan by the groups the authors represented is itself a limitation of the study, he said. Challenges with follow-up of extracardiac techniques in this and other studies “limit our ability to declare a ‘victor’ in that debate,” he said. “It does remind the electrophysiologist that he or she needs to master the techniques of entering the pulmonary venous atrium in these patients.”
The precision of calculating risk after an operation grows weaker with time, he said, and at 15-20 years morbidity starts to increase and follow-up becomes “more diffuse,” Dr. Alexander said. “That reality means we look forward to this group continuing to enhance our understanding of how our changing management decisions can aid our patients.”
Dr. Alexander had no financial relationships to disclose.
People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.
“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.
The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).
Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.
The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.
After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.
Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.
“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”
About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.
Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.
People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.
“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.
The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).
Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.
The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.
After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.
Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.
“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”
About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.
Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: The development of arrhythmia is associated with a heightened risk of failure of Fontan circulation after a Fontan procedure.
Major finding: At 20 years, freedom from any arrhythmia was 66%, and after the onset of any arrhythmia freedom from Fontan failure was 55%.
Data source: 1,034 patients who had undergone a Fontan procedure from 1975 to 2014 as recorded in the Australian and New Zealand Fontan Registry.
Disclosures: Coauthor Andrew Bullock, MBBS, reported receiving consulting fees from Actelion. All other others have no financial relationships to disclose.
Revision technique treats graft dysfunction after esophageal reconstruction
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
Key clinical point: Cervicosternolaparotomy revision surgery for graft dysfunction after esophageal reconstruction for caustic injuries can achieve good results with acceptable morbidity.
Major finding: Functional success rate after revision CSLap was 85% after a mean follow-up of 4.4 years.
Data source: 55 patients who underwent CSLap revision surgery between 1999 and 2015 at a single center.
Disclosures: Dr. Voron and coauthors had no financial relationships to disclose.