Moderate TR Should be Repaired at the Time of LVAD Con. James Kirklin MD

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1 Moderate TR Should be Repaired at the Time of LVAD Con James Kirklin MD

2 Disclosure: I am Director of the Data Coordinating Center for the INTERMACS project and receive support through an Institutional Contract James K. Kirklin, MD

3 Challenges in Understanding the Appropriate Role of Tricuspid Valve Repair During LVAD Implant Lack of uniformity of decision process among surgeons and centers Many of the favorable reports from single centers may not be readily generalizable Quantification of TR by echo is imprecise and severity of TR is highly dependent on loading conditions Challenging for available studies to differentiate favorable effects of TV repair from VAD-induced reduction of RV afterload Paucity of late functional outcome/qol data to evaluate effect of TV repair

4 Challenges in Understanding the Appropriate Role of Tricuspid Valve Repair During LVAD Implant If Echo is used as the indicator, when is the most reliable time to perform the study? If signs of advanced RH failure ( ascites, high pra/la, overt RH failure) is used as indication for TV repair, RVAD may be a preferable option

5 2 Large Multi-institutional Studies INTERMACS STS Database 5

6 Impact of Tricuspid Regurgitation and Tricuspid Valve Repair on Outcomes Following VAD Implantation in INTERMACS Howard Song, MD, PhD Co-authors James Mudd, MD; Jill Gelow, MD, MPH; Christopher Chien, MD; Fred Tibayan, MD; Kathryn Hollifield, BSN, RN; David Naftel, PhD; and James Kirklin, MD Ann Thor Surg,2016;101: "This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN C"

7 Song et al, Ann Thor Surg.2016;101:2165 Incidence of Tricuspid Regurgitation at time of LVAD Implant Percent of Patients CONTINUOUS FLOW DEVICES Adults (age 19 years at implant) Destination Therapy at time of implant Implant dates: Patients: n=2527 from INTERMACS 39% mod or sev TR Degree of Tricuspid Regurgitation

8 Song et al, Ann Thor Surg.2016;101:2165 Use of Tricuspid Valve Repair at time of LVAD Implant 35% Percent with Tricuspid Repair 17% Degree of Tricuspid Regurgitation

9 Song et al, Ann Thor Surg.2016;101:2165 Survival Following LVAD Implant: None/Mild vs. Moderate/Severe TR Tricuspid Regurg % Survival (preimplant) n deaths 1mo 12mo None/Mild % 78% Mod/Severe % 74% % Survival P = Months post implant

10 Song et al, Ann Thor Surg.2016;101:2165 Survival with Moderate/Severe TR: No TVR vs TVR Concomitant Tricuspid Surgery n deaths None Repair % Survival Overall p = 0.83 Months post implant

11 Song et al, Ann Thor Surg.2016;101:2165 Incidence of Moderate/Severe Tricuspid Regurgitation after LVAD implant: TV Repair vs. No TV Repair 100% 90% 80% 70% 60% 100% 100% Authors concluded: TVR does not confer survival advantage among VAD pts with mod-sev TR For many pts, LVAD alone relieves pre-0p TR as effectively as TVR By multivariable analysis, worsening TR a risk factor for early mortality (not neutralized by TVR) 50% 40% 30% 20% 10% 0% 42% 21% 30% 25% 26% 39% 39% 29% No TV Procedure TV Repair Pre-implant 1 week 1 month 3 month 6 month 12 month 18 month 24 month TV Repair No TV Procedure 37% 23% 40% 19% 33% 30%

12 Concomitant tricuspid valve surgery during implantation of continuous-flow left ventricular assist devices: a Society of Thoracic Surgeons database analysis. STS Database Study Propensity Score matching TV Repair with mod-sev TR did NOT reduce early mortality Robertson JO, Grau-Sepulveda MV, Okada S, O Brien SM, Brennan JM, Shah AS, Itoh A, Damiano RJ, Prasad S, Silvestry SC. Concomitant tricuspid valve surgery during implantation of continuous-flow left ventricular assist devices: a Society of Thoracic Surgeons database analysis. The Journal of Heart and Lung Transplantation Jun 1;33(6):609-17

13 Sub-study from HVAD BTT Trial 13

14 Heartware BTT Trial: N=382 By multivariable analysis, Strongest predictors of early death/rhf: more severe TR ( but not TV Repair), females; but patients with m-sev pre-op TR had lower rate of late RHF with TVR than without (p=0.024) Milano C, Pagani FD, Slaughter MS, Pham DT, Hathaway DR, Jacoski MV, Najarian KB, Aaronson KD. Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures. Circulation Sep 9;130(11 suppl 1):S3-11

15 Single Institution Studies 15

16 Fujita et al, Right Heart Failure and Benefits of Adjuvant TV Repair in patients undergoing LVAD Implantation EJCTS, 2014 Single Institution Study N=141 Policy of TV repair for mod-to-severe TR or marked annular dilatation (>40mm) Annuloplasty ring (n=48) or De Vega (n=21) Marked decrease in TR that was maintained out to 2 yr. 16

17 TV Repair No TV Repair Durability and Clinical Impact of Tricuspid Valve Procedures Columbia, n=336 Authors conclude that TV repairs (with annuloplasty ring) are protective against future mod-sev TR out to 2 years No data on functional impact Han J, Takeda K, Takayama H, Kurlansky PA, Colombo PC, Yuzefpolskaya M, Fukuhara S, Truby LK, Topkara VK, Mancini DM, Naka Y. Durability and Clinical Impact of Tricuspid Valve Procedures in Patients Receiving Continuous-Flow Left Ventricular Assist Device. The Journal of Heart and Lung Transplantation Apr 1;34(4):S194.

18 Hemodynamics Pre- and Post-LVAD Implantation ( All patients(n=21) with TV Repair Excluded; n=105) Pre-LVAD 1 month post- LVAD 6 months post- LVAD CVP (mm Hg) 12.4 ± ± ± 5.2 <0.001 PAPs (mm Hg) 52.3 ± ± ± 10.4 <0.001 PAPd (mm Hg) 24.9 ± ± ± 7.1 <0.001 PAPm (mm Hg) 35.5 ± ± ± 7.6 <0.001 PCWP (mm Hg) 23.0 ± ± ± 6.5 <0.001 TPG (mm Hg) 12.3 ± ± ± CI (liters/min m2) RVSWI (liters/min m2) 1.8 ± ± ± 0.5 < ± ± ± <0.001 Single Center Study Henry Ford Hospital Morgan JA, Paone G, Nemeh HW, Murthy R, Williams CT, Lanfear DE, Tita C, Brewer RJ. Impact of continuous-flow left ventricular assist device support on right ventricular function. The Journal of Heart and Lung Transplantation Apr 1;32(4): p

19 TR Pre-LVAD vs 1 and 6 Months Post-LVAD ( All patients with TV Repair Excluded) Single Center (n= 106) TR Mild Moderate or severe p Pre-LVAD 88.6% 11.4% 1 month post-op 95.2% 4.8% <0.001 a 6 months post-op 94.3% 5.7% <0.766 LVAD, left ventricular assist device; TR, tricuspid regurgitation. *Statistically significant. Morgan JA, Paone G, Nemeh HW, Murthy R, Williams CT, Lanfear DE, Tita C, Brewer RJ. Impact of continuous-flow left ventricular assist device support on right ventricular function. The Journal of Heart and Lung Transplantation Apr 1;32(4):

20 Pre- and Postoperative Hemodynamic and Laboratory Variables Univ. of Pa (n=114) ( No patient in study received TV Repair) Variable Preimplant Postimplant P-Value Heart rate (beats/min) Arterial blood pressure (mean, mmhg) Central venous pressure (mmhg) Pulmonary artery pressure (mean, mmhg) < Cardiac index (L/min -1 m -2 ) < Right ventricular dysfunction 0.02 None 7.07% 12.50% Mild 23.89% 36.46% Moderate 43.37% 39.58% Severe 25.67% 11.45% Right ventricular stroke work index (g m 2 /beat) Tricuspid regurgitation (%) None 9.26% 4.35% Mild 36.11% 65.22% Moderate 44.44% 27.17% Severe 10.19% 3.26% Sodium Total bilirubin Aspartate aminotransferase Alanine aminotransferase Creatinine Postoperative hemodynamic variables were acquired immediately upon arrival to the intensive care unit. Postoperative echocardiographic parameters were determined immediately prior to leaving the operating room (n=114). Atluri P, Fairman AS, MacArthur JW, Goldstone AB, Cohen JE, Howard JL, Zalewski CM, Shudo Y, Woo YJ. Continuous flow left ventricular assist device implant significantly improves pulmonary hypertension, right ventricular contractility, and tricuspid valve competence. Journal of cardiac surgery Nov 1;28(6):770-5.

21 Mean Preoperative, Immediate Postoperative, and Follow-Up Right Ventricular Dysfunction and Tricuspid Regurgitation Following Continuous Flow Left Ventricular Assist Device Implant. Univ. of Pa (n=114) ( No patient in study received TV Repair). Conclusion: On average, the immediate improvement in TR was sustained long term without TV Repair Pre-Operative (n = 114) Post-Operative (n = 114) 3-Month Follow-Up (n = 71) 6-Month Follow-Up (n = 63) 12-Month Follow- Up(n=52) P = (Post-Op vs. Pre-Op) Right ventricula dysf.(all patients) Right ventricula dysfun. (pre-op moderate or severe, n = 58) Tricuspid regurg. (all patients) Tricuspid regurg. (pre-op moderat or severe, n = 59) 2.09 ± ± ± ± ± ± ± ± ± ± 0.80 < ± ± ± ± ± ± ± ± ± ± 0.57 < Atluri P, Fairman AS, MacArthur JW, Goldstone AB, Cohen JE, Howard JL, Zalewski CM, Shudo Y, Woo YJ. Continuous flow left ventricular assist device implant significantly improves pulmonary hypertension, right ventricular contractility, and tricuspid valve competence. Journal of cardiac surgery Nov 1;28(6): Authors Conclude: CF LVAD implant improves pulm. HTN, RV fnc., and TR. TR ( unless torrential) may be managed nonoperatively during LVAD implant

22 My Conclusions based on Available Evidence Moderate-to-severe tricuspid regurgitation at the time of LVAD implantation is associated with reduced short and long-term survival. The 2 largest multi-institutional studies suggest that in general, TV repair for moderate/severe TR does not increase early or midterm survival. A number of smaller cohort studies suggest benefit, in terms of improvement in late TR, with TV repair at implant. Other studies indicate important improvement in mod-severe TR with LVAD alone. TV repair adds to complexity of the operation to a modest degree. Given available evidence, I recommend No TV repair if, at operation, TR is moderate or less.

23 . Despite my assignment, TV Repair Should be Considered in the following Situations If TR is Severe at Operation Given the Low Surgical Risk If functional TR is severe with CVP/PCWP>0.5 and TV annulus >40 mm If PAP is only moderately elevated with normal TPG and severe TR (less likely to have marked reduction of RV afterload post LVAD) If structural damage to a TV leaflet ( for example a non functioning AICD lead) is causing severe TR and surgeon is experienced with TV reconstruction Severe TR without these criteria should include TV repair only if surgeon feels it does not importantly increase surgical complexity. REMEMBER, A PERFECT IMPLANT OF THE LVAD AND MINIMAL BLEEDING IS MUCH MORE IMPORTANT THAN THE TRICUSPID VALVE REPAIR

24 Thank you!

25 Table 7 De Vega technique for tricuspid valve annuloplasty Akhter SA, Salabat MR, Philip JL, Valeroso TB, Russo MJ, Rich JD, Jeevanandam V. Durability of De Vega tricuspid valve annuloplasty for severe tricuspid regurgitation during left ventricular assist device implantation. The Annals of thoracic surgery. 2014

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