Durability of De Vega Tricuspid Valve Annuloplasty for Severe Tricuspid Regurgitation During Left Ventricular Assist Device Implantation Shahab A. Akhter, MD, M. Reza Salabat, MD, Jennifer L. Philip, MD, Tracy B. Valeroso, RN, MSN, Mark J. Russo, MD, MS, Jonathan D. Rich, MD, and Valluvan Jeevanandam, MD Department of Surgery, University of Chicago Medical Center, Chicago, Illinois, and Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin
Background. Correction of significant tricuspid regurgitation (TR) at the time of continuous-flow (CF) left ventricular assist device (LVAD) implantation has been shown to be beneficial in several recently published studies. The most common technique is ring annuloplasty followed by valve replacement. Our center has primarily used the De Vega annuloplasty, and the durability of this repair is the focus of this study. Methods. This was a retrospective review of 35 consecutive patients who underwent CF LVAD implantation and De Vega tricuspid valve annuloplasty (TVA) for severe TR and were alive at 1 year. Echocardiograms were obtained preoperatively, intraoperatively, at discharge, and at 1 year after operation. Results. The TR in 32 of 35 patients (91.4%, group A) improved from severe preoperatively to insignificant at the time of discharge after De Vega TVA, and 3 patients
(8.6%, group B) had moderate residual TR. At 1-year follow-up, 29 of 32 (90.6%) patients in group A had insignificant TR, 2 (6.3%) had moderate TR, and 1 (3.1%) had severe TR. In group B, 2 of 3 patients had no progression of their moderate TR at 1 year and 1 had severe TR. Overall, 2 of 35 (5.7%) patients had severe TR at 1 year after De Vega TVA and LVAD implantation. Conclusions. We conclude from this consecutive cohort of patients undergoing CF LVAD implantation and De Vega TVA that this technique is very durable at 1 year and has the advantages of a shorter operative time relative to ring annuloplasty and decreased cost because a prosthetic implant is not used.
C
annuloplasty ring or valve replacement are shorter operative time and lower cost.
ontinuous-flow (CF) left ventricular assist devices (LVADs) are now standard therapy for patients with advanced heart failure. A large proportion of this patient population has significant functional tricuspid regurgitation (TR), and there appears to be general consensus that surgically addressing the TR at the time of LVAD implantation is beneficial. There are several approaches to correcting TR, including the use of a formal tricuspid annuloplasty ring, performing tricuspid valve replacement, and performing a suture annuloplasty procedure such as the De Vega technique. Our center has been very aggressive about correcting moderate or severe TR at the time of CF LVAD implantation, and we have been performing a modified De Vega annuloplasty in nearly all cases of functional TR. The objective of this study was to evaluate the short- and intermediate-term durability of De Vega tricuspid valve annuloplasty (TVA) in patients with severe TR undergoing CF LVAD implantation. The primary advantages of this technique compared with an
(Ann Thorac Surg 2014;-:-–-) Ó 2014 by The Society of Thoracic Surgeons
Patients and Methods This study was approved by the Institutional Review Board of the University of Chicago Medical Center. This is a retrospective study of 35 consecutive patients who underwent CF LVAD implantation and De Vega TVA for severe TR between January and December of 2012 and were alive at 1-year follow-up. None of the patients underwent ring annuloplasty. The surgical approach to LVAD implantation as well as TVA was through a median sternotomy, and all patients underwent implantation of the device using cardiopulmonary bypass. None of these patients had a concomitant mitral valve repair. Thirty patients had a HeartMate II device (Thoratec, Pleasanton, CA) implanted and 5 underwent Heartware HVAD (Heartware, Framingham, MA) implantation. All LVAD implantations were performed by 2 surgeons at the
Accepted for publication March 20, 2014. Address correspondence to Dr Akhter, Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, CSC H4/340, Madison, WI 53792; e-mail: akhter@surgery. wisc.edu.
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
Dr Jeevanandam discloses financial relationships with HeartWare and Thoratec.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2014.03.022
2
AKHTER ET AL DE VEGA TV REPAIR WITH LVAD IMPLANTATION
Ann Thorac Surg 2014;-:-–-
University of Chicago Medical Center, and the De Vega TVA was performed in an identical manner in all cases. A double-layer suture annuloplasty was performed as described by De Vega [1] using a pledgeted 2-0 polypropylene suture with the annuloplasty sized to a 26-mm dilator. Transthoracic echocardiograms were obtained for all patients preoperatively, before discharge, and 1 year after implantation. In addition, intraoperative transesophageal echocardiography was used in all cases to grade TR after weaning from cardiopulmonary bypass. TR was graded as insignificant (none, trivial, or mild) or significant (moderate or severe). TR grades were assigned according to the American Society of Echocardiography guidelines. Fig 1. De Vega technique for tricuspid valve annuloplasty.
Results Table 1 details the preoperative characteristics of this group of patients who underwent CF LVAD implantation and De Vega TVA. The technique for TVA that we used is illustrated in Fig 1. Thirty-two of 35 (91.4%, group A) patients improved from severe TR preoperatively to insignificant TR at the time of discharge after De Vega TVA, and 3 (8.6%, group B) patients had moderate residual TR. At 1-year follow-up, 29 of 32 (90.6%) patients in group A had insignificant TR, 2 (6.3%) had moderate TR, and 1 (3.1%) had severe TR. In group B, 2 of 3 patients had no progression of their moderate TR at 1 year and 1 had severe TR. Overall, 2 of 35 (5.7%) patients had severe TR at 1 year after De Vega TVA and LVAD implantation. The data are summarized in Table 2. None of these patients had significant clinical evidence of right heart failure during the implantation hospitalization or during the follow-up period of 1 year. Extended use of inotropic agents or temporary right ventricular assist device support was not required in this group of patients.
and that significant TR is associated with longer inotropic support and hospital length of stay after transplantation. A follow-up study from this group compared patients with significant TR undergoing LVAD þ TVA ring repair/ replacement versus those undergoing LVAD implantation alone [3]. Postoperative TR was markedly reduced in the group that had a TV procedure compared with LVAD alone, and there was a lower incidence of right ventricular assist device support and extended inotrope use. Addition of a TV procedure also led to a lower incidence of renal dysfunction and shorter length of hospital stay. Most recently, the Duke group studied the utility of concomitant TV procedures for patients undergoing CF LVAD implantation [4] and again demonstrated significant reduction in postoperative TR, a lower incidence of right ventricular failure, and shorter length of hospitalization with surgical correction of TR. Of this group of 33 patients who had a concomitant TV procedure, 29 had an undersized ring annuloplasty repair and 4 underwent TV replacement with a bioprosthesis.
Comment Several recent studies have demonstrated a significant benefit for surgical correction of moderate or severe TR at the time of CF LVAD implantation. The group at Duke University Medical Center has conducted many of these studies. Piacentino and colleagues [2] showed that TR is not reduced immediately after LVAD implantation alone Table 1. Patient Characteristics Before LVAD Implantation (N ¼ 35) Age (y) Sex (% male) Cause of heart failure (% NICM) CVP (mm Hg) Mean PAP (mm Hg) Cardiac index (L/min/m2) INTERMACS classification
56 66 57 19 40 1.7 2
CVP ¼ central venous pressure; INTERMACS ¼ Interagency Registry for Mechanically Assisted Circulatory Support; NICM ¼ nonischemic cardiomyopathy; PAP ¼ pulmonary artery pressure.
Table 2. Tricuspid Regurgitation Grade After De Vega TVA With CF LVAD Implantation Overall Cohort (N ¼ 35) TR Grade Preoperative Discharge 1y Group A (n ¼ 32) Preoperatively Discharge 1y Group B (n ¼ 3) Preoperative Discharge 1y
Insignificant
Moderate
Severe
... 32 (91.4%) 29 (82.9%)
... 3 (8.6%) 4 (11.4%)
35 (100%) ... 2 (5.7%)
32 (100%) 29 (90.6%)
... 2 (6.3%)
32 (100%) ... 1 (3.1%)
... ... ...
... 3 (100%) 2 (66.6%)
3 (100%) ... 1 (33.3%)
CF LVAD ¼ continuous-flow left ventricular assist device; tricuspid regurgitation; TVA ¼ tricuspid valve annuloplasty.
TR ¼
Ann Thorac Surg 2014;-:-–-
Importantly, Krishan and associates [5] have shown, in a group of 37 patients who underwent LVAD implantation and TV ring annuloplasty, that there is no increase in perioperative risk and make a strong case for a more liberal approach to TV repair at the time of LVAD implantation [5]. A recent publication from the Mayo Clinic showed no significant difference in the estimated long-term survival between TV repair and TV replacement during LVAD implantation [6]. Forty-eight patients in this study underwent TV repair that was performed using suture annuloplasty (modified Kay technique or De Vega) in 37 of 48 patients and a prosthetic ring in the remaining 11 of 48. A total of 16 patients underwent TV replacement. The reduction in TR grade in the early postoperative period was maintained at 12 months after LVAD implantation, and among the TV repair subgroup, the mean TR grade was comparable for suture annuloplasty (1.7 1.2) and the prosthetic annuloplasty cohort (2.2 1.5) on a scale of 0 to 5. This study also provides strong evidence to support the use of a suture annuloplasty technique at the time of LVAD implantation in the setting of significant TR. Our study group all underwent De Vega TVA for severe TR at the time of CF LVAD implantation, with 32 of 35 (91.4%) patients having insignificant TR at the time of discharge from their index hospitalization. At 1 year, 29 of these 32 (90.6%) patients continued to have insignificant TR, 2 (6.3%) had moderate TR, and 1 (3.1%) progressed to severe TR. In the group of 3 patients who had moderate TR at the time of discharge from LVAD/TVA surgical procedures, 2 patients had no progression of TR and 1 had severe TR at 1 year. Overall, there was a 5.7% incidence of severe TR at 1 year. None of these patients had overt clinical evidence of right heart failure at this time point. A study from the Cleveland Clinic examined the durability of TV ring annuloplasty versus De Vega suture annuloplasty in conventional cardiac operations and
AKHTER ET AL DE VEGA TV REPAIR WITH LVAD IMPLANTATION
3
found that the De Vega TVA had significantly inferior durability to a ring annuloplasty [7]. We propose that the excellent durability of this suture annuloplasty technique in the CF LVAD population is, in part, likely related to the decreased pulmonary artery pressures and pulmonary vascular resistance resulting from unloading the left ventricle. We conclude from this consecutive cohort of patients undergoing CF LVAD implantation and De Vega TVA that this technique for TV repair is very durable at 1 year and has the advantages of shorter operative time relative to ring annuloplasty as well as decreased cost associated with a prosthetic implant not being used.
References 1. De Vega NG. Selective, adjustable and permanent annuloplasty. An original technic for the treatment of tricuspid insufficiency [in Spanish] Rev Esp Cardiol 1972;25:555–6. 2. Piacentino V 3rd, Williams ML, Depp T, et al. Impact of tricuspid valve regurgitation in patients treated with implantable left ventricular assist devices. Ann Thorac Surg 2011;91:1342–6. 3. Piacentino V 3rd, Troupes CD, Ganapathi AM, et al. Clinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation. Ann Thorac Surg 2011;92:1414–8. 4. Piacentino V 3rd, Ganapathi AM, Stafford-Smith M, et al. Utility of concomitant tricuspid valve procedures for patients undergoing implantation of a continuous-flow left ventricular device. J Thorac Cardiovasc Surg 2012;144:1217–21. 5. Krishan K, Nair A, Pinney S, Adams DH, Anyanwu AC. Liberal use of tricuspid-valve annuloplasty during left-ventricular assist device implantation. Eur J Cardiothorac Surg 2012;41: 213–7. 6. Deo SV, Hasin T, Altarabsheh SE, et al. Concomitant tricuspid valve repair or replacement during left ventricular assist device implant demonstrates comparable outcomes in the long term. J Card Surg 2012;27:760–6. 7. McCarthy PM, Bhudia SK, Rajeswaran J, et al. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg 2004;127:674–85.
Background. Correction of significant tricuspid regurgitation (TR) at the time of continuous-flow (CF) left ventricular assist device (LVAD) implantation has been shown to be beneficial in several recently published studies. The most common technique is ring annuloplasty followed by valve replacement. Our center has primarily used the De Vega annuloplasty, and the durability of this repair is the focus of this study. Methods. This was a retrospective review of 35 consecutive patients who underwent CF LVAD implantation and De Vega tricuspid valve annuloplasty (TVA) for severe TR and were alive at 1 year. Echocardiograms were obtained preoperatively, intraoperatively, at discharge, and at 1 year after operation. Results. The TR in 32 of 35 patients (91.4%, group A) improved from severe preoperatively to insignificant at the time of discharge after De Vega TVA, and 3 patients
(8.6%, group B) had moderate residual TR. At 1-year follow-up, 29 of 32 (90.6%) patients in group A had insignificant TR, 2 (6.3%) had moderate TR, and 1 (3.1%) had severe TR. In group B, 2 of 3 patients had no progression of their moderate TR at 1 year and 1 had severe TR. Overall, 2 of 35 (5.7%) patients had severe TR at 1 year after De Vega TVA and LVAD implantation. Conclusions. We conclude from this consecutive cohort of patients undergoing CF LVAD implantation and De Vega TVA that this technique is very durable at 1 year and has the advantages of a shorter operative time relative to ring annuloplasty and decreased cost because a prosthetic implant is not used.
C
annuloplasty ring or valve replacement are shorter operative time and lower cost.
ontinuous-flow (CF) left ventricular assist devices (LVADs) are now standard therapy for patients with advanced heart failure. A large proportion of this patient population has significant functional tricuspid regurgitation (TR), and there appears to be general consensus that surgically addressing the TR at the time of LVAD implantation is beneficial. There are several approaches to correcting TR, including the use of a formal tricuspid annuloplasty ring, performing tricuspid valve replacement, and performing a suture annuloplasty procedure such as the De Vega technique. Our center has been very aggressive about correcting moderate or severe TR at the time of CF LVAD implantation, and we have been performing a modified De Vega annuloplasty in nearly all cases of functional TR. The objective of this study was to evaluate the short- and intermediate-term durability of De Vega tricuspid valve annuloplasty (TVA) in patients with severe TR undergoing CF LVAD implantation. The primary advantages of this technique compared with an
(Ann Thorac Surg 2014;-:-–-) Ó 2014 by The Society of Thoracic Surgeons
Patients and Methods This study was approved by the Institutional Review Board of the University of Chicago Medical Center. This is a retrospective study of 35 consecutive patients who underwent CF LVAD implantation and De Vega TVA for severe TR between January and December of 2012 and were alive at 1-year follow-up. None of the patients underwent ring annuloplasty. The surgical approach to LVAD implantation as well as TVA was through a median sternotomy, and all patients underwent implantation of the device using cardiopulmonary bypass. None of these patients had a concomitant mitral valve repair. Thirty patients had a HeartMate II device (Thoratec, Pleasanton, CA) implanted and 5 underwent Heartware HVAD (Heartware, Framingham, MA) implantation. All LVAD implantations were performed by 2 surgeons at the
Accepted for publication March 20, 2014. Address correspondence to Dr Akhter, Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, CSC H4/340, Madison, WI 53792; e-mail: akhter@surgery. wisc.edu.
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
Dr Jeevanandam discloses financial relationships with HeartWare and Thoratec.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2014.03.022
2
AKHTER ET AL DE VEGA TV REPAIR WITH LVAD IMPLANTATION
Ann Thorac Surg 2014;-:-–-
University of Chicago Medical Center, and the De Vega TVA was performed in an identical manner in all cases. A double-layer suture annuloplasty was performed as described by De Vega [1] using a pledgeted 2-0 polypropylene suture with the annuloplasty sized to a 26-mm dilator. Transthoracic echocardiograms were obtained for all patients preoperatively, before discharge, and 1 year after implantation. In addition, intraoperative transesophageal echocardiography was used in all cases to grade TR after weaning from cardiopulmonary bypass. TR was graded as insignificant (none, trivial, or mild) or significant (moderate or severe). TR grades were assigned according to the American Society of Echocardiography guidelines. Fig 1. De Vega technique for tricuspid valve annuloplasty.
Results Table 1 details the preoperative characteristics of this group of patients who underwent CF LVAD implantation and De Vega TVA. The technique for TVA that we used is illustrated in Fig 1. Thirty-two of 35 (91.4%, group A) patients improved from severe TR preoperatively to insignificant TR at the time of discharge after De Vega TVA, and 3 (8.6%, group B) patients had moderate residual TR. At 1-year follow-up, 29 of 32 (90.6%) patients in group A had insignificant TR, 2 (6.3%) had moderate TR, and 1 (3.1%) had severe TR. In group B, 2 of 3 patients had no progression of their moderate TR at 1 year and 1 had severe TR. Overall, 2 of 35 (5.7%) patients had severe TR at 1 year after De Vega TVA and LVAD implantation. The data are summarized in Table 2. None of these patients had significant clinical evidence of right heart failure during the implantation hospitalization or during the follow-up period of 1 year. Extended use of inotropic agents or temporary right ventricular assist device support was not required in this group of patients.
and that significant TR is associated with longer inotropic support and hospital length of stay after transplantation. A follow-up study from this group compared patients with significant TR undergoing LVAD þ TVA ring repair/ replacement versus those undergoing LVAD implantation alone [3]. Postoperative TR was markedly reduced in the group that had a TV procedure compared with LVAD alone, and there was a lower incidence of right ventricular assist device support and extended inotrope use. Addition of a TV procedure also led to a lower incidence of renal dysfunction and shorter length of hospital stay. Most recently, the Duke group studied the utility of concomitant TV procedures for patients undergoing CF LVAD implantation [4] and again demonstrated significant reduction in postoperative TR, a lower incidence of right ventricular failure, and shorter length of hospitalization with surgical correction of TR. Of this group of 33 patients who had a concomitant TV procedure, 29 had an undersized ring annuloplasty repair and 4 underwent TV replacement with a bioprosthesis.
Comment Several recent studies have demonstrated a significant benefit for surgical correction of moderate or severe TR at the time of CF LVAD implantation. The group at Duke University Medical Center has conducted many of these studies. Piacentino and colleagues [2] showed that TR is not reduced immediately after LVAD implantation alone Table 1. Patient Characteristics Before LVAD Implantation (N ¼ 35) Age (y) Sex (% male) Cause of heart failure (% NICM) CVP (mm Hg) Mean PAP (mm Hg) Cardiac index (L/min/m2) INTERMACS classification
56 66 57 19 40 1.7 2
CVP ¼ central venous pressure; INTERMACS ¼ Interagency Registry for Mechanically Assisted Circulatory Support; NICM ¼ nonischemic cardiomyopathy; PAP ¼ pulmonary artery pressure.
Table 2. Tricuspid Regurgitation Grade After De Vega TVA With CF LVAD Implantation Overall Cohort (N ¼ 35) TR Grade Preoperative Discharge 1y Group A (n ¼ 32) Preoperatively Discharge 1y Group B (n ¼ 3) Preoperative Discharge 1y
Insignificant
Moderate
Severe
... 32 (91.4%) 29 (82.9%)
... 3 (8.6%) 4 (11.4%)
35 (100%) ... 2 (5.7%)
32 (100%) 29 (90.6%)
... 2 (6.3%)
32 (100%) ... 1 (3.1%)
... ... ...
... 3 (100%) 2 (66.6%)
3 (100%) ... 1 (33.3%)
CF LVAD ¼ continuous-flow left ventricular assist device; tricuspid regurgitation; TVA ¼ tricuspid valve annuloplasty.
TR ¼
Ann Thorac Surg 2014;-:-–-
Importantly, Krishan and associates [5] have shown, in a group of 37 patients who underwent LVAD implantation and TV ring annuloplasty, that there is no increase in perioperative risk and make a strong case for a more liberal approach to TV repair at the time of LVAD implantation [5]. A recent publication from the Mayo Clinic showed no significant difference in the estimated long-term survival between TV repair and TV replacement during LVAD implantation [6]. Forty-eight patients in this study underwent TV repair that was performed using suture annuloplasty (modified Kay technique or De Vega) in 37 of 48 patients and a prosthetic ring in the remaining 11 of 48. A total of 16 patients underwent TV replacement. The reduction in TR grade in the early postoperative period was maintained at 12 months after LVAD implantation, and among the TV repair subgroup, the mean TR grade was comparable for suture annuloplasty (1.7 1.2) and the prosthetic annuloplasty cohort (2.2 1.5) on a scale of 0 to 5. This study also provides strong evidence to support the use of a suture annuloplasty technique at the time of LVAD implantation in the setting of significant TR. Our study group all underwent De Vega TVA for severe TR at the time of CF LVAD implantation, with 32 of 35 (91.4%) patients having insignificant TR at the time of discharge from their index hospitalization. At 1 year, 29 of these 32 (90.6%) patients continued to have insignificant TR, 2 (6.3%) had moderate TR, and 1 (3.1%) progressed to severe TR. In the group of 3 patients who had moderate TR at the time of discharge from LVAD/TVA surgical procedures, 2 patients had no progression of TR and 1 had severe TR at 1 year. Overall, there was a 5.7% incidence of severe TR at 1 year. None of these patients had overt clinical evidence of right heart failure at this time point. A study from the Cleveland Clinic examined the durability of TV ring annuloplasty versus De Vega suture annuloplasty in conventional cardiac operations and
AKHTER ET AL DE VEGA TV REPAIR WITH LVAD IMPLANTATION
3
found that the De Vega TVA had significantly inferior durability to a ring annuloplasty [7]. We propose that the excellent durability of this suture annuloplasty technique in the CF LVAD population is, in part, likely related to the decreased pulmonary artery pressures and pulmonary vascular resistance resulting from unloading the left ventricle. We conclude from this consecutive cohort of patients undergoing CF LVAD implantation and De Vega TVA that this technique for TV repair is very durable at 1 year and has the advantages of shorter operative time relative to ring annuloplasty as well as decreased cost associated with a prosthetic implant not being used.
References 1. De Vega NG. Selective, adjustable and permanent annuloplasty. An original technic for the treatment of tricuspid insufficiency [in Spanish] Rev Esp Cardiol 1972;25:555–6. 2. Piacentino V 3rd, Williams ML, Depp T, et al. Impact of tricuspid valve regurgitation in patients treated with implantable left ventricular assist devices. Ann Thorac Surg 2011;91:1342–6. 3. Piacentino V 3rd, Troupes CD, Ganapathi AM, et al. Clinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation. Ann Thorac Surg 2011;92:1414–8. 4. Piacentino V 3rd, Ganapathi AM, Stafford-Smith M, et al. Utility of concomitant tricuspid valve procedures for patients undergoing implantation of a continuous-flow left ventricular device. J Thorac Cardiovasc Surg 2012;144:1217–21. 5. Krishan K, Nair A, Pinney S, Adams DH, Anyanwu AC. Liberal use of tricuspid-valve annuloplasty during left-ventricular assist device implantation. Eur J Cardiothorac Surg 2012;41: 213–7. 6. Deo SV, Hasin T, Altarabsheh SE, et al. Concomitant tricuspid valve repair or replacement during left ventricular assist device implant demonstrates comparable outcomes in the long term. J Card Surg 2012;27:760–6. 7. McCarthy PM, Bhudia SK, Rajeswaran J, et al. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg 2004;127:674–85.
