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Moderate TR Should be Repaired at the Time of LVAD – Con
James Kirklin MD
James K. Kirklin, MD
Disclosure: I am Director of the Data Coordinating Center for the INTERMACS
project and receive support through an Institutional Contract
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
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
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, MDAnn Thor Surg,2016;101:2168-75
"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. HHSN268201100025C"
Incidence of Tricuspid Regurgitation at time of LVAD Implant
Percentof Patients
Degree of Tricuspid Regurgitation
CONTINUOUS FLOW DEVICES
• Adults (age ≥ 19 years at implant)
• Destination Therapy at time of implant
• Implant dates: 2006-2013
• Patients: n=2527 from INTERMACS
39% mod or sev TR
Song et al, Ann Thor Surg.2016;101:2165
Chart1
Unknown
None
Mild
Moderate
Severe
Series 1
14.5
8.4
38
28.6
14.5
Sheet1
Series 1Series 2Series 3
Unknown14.52.42
None8.4
Mild384.42
Moderate28.61.83
Severe14.52.85
To resize chart data range, drag lower right corner of range.
Use of Tricuspid Valve Repair at time of LVAD Implant
Percent with Tricuspid Repair
Degree of Tricuspid Regurgitation
17%
35%
Song et al, Ann Thor Surg.2016;101:2165
Chart1
None
Mild
Moderate
Severe
Series 1
2.3
6.7
16.7
35
Sheet1
Series 1Series 2Series 3
None2.32.42
Mild6.7
Moderate16.74.42
Severe351.83
2.85
To resize chart data range, drag lower right corner of range.
Months post implant
% S
urvi
val
Tricuspid Regurg % Survival (preimplant) n deaths 1mo 12mo None/Mild 1171 278 95% 78%Mod/Severe 989 294 94% 74%
P = 0.009
Survival Following LVAD Implant: None/Mild vs. Moderate/Severe TR
Song et al, Ann Thor Surg.2016;101:2165
Months post implant
% S
urvi
val
Concomitant Tricuspid Surgery n deathsNone 757 225Repair 215 60
Overall p = 0.83
Survival with Moderate/Severe TR: No TVR vs TVR
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%
21%25% 26%
29%23%
19%
30%
100%
42%
30%
39% 39% 37%40%
33%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre-implant 1 week 1 month 3 month 6 month 12 month 18 month 24 month
TV Repair No TV Procedure
No TV ProcedureTV Repair
Song et al, Ann Thor Surg.2016;101:2165
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)
Chart1
Pre-implantPre-implant
1 week1 week
1 month1 month
3 month3 month
6 month6 month
12 month12 month
18 month18 month
24 month24 month
TV Repair
No TV Procedure
1
1
0.21
0.42
0.25
0.3
0.26
0.39
0.29
0.39
0.23
0.37
0.19
0.4
0.3
0.33
Sheet1
TV RepairNo TV Procedure
Pre-implant100%100%
1 week21%42%
1 month25%30%
3 month26%39%
6 month29%39%
12 month23%37%
18 month19%40%
24 month30%33%
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. 2014 Jun 1;33(6):609-17
STS Database Study• Propensity Score matching• TV Repair with mod-sev TR
did NOT reduce early mortality
Concomitant tricuspid valve surgery during implantation of continuous-flow left ventricular assist devices: a Society of Thoracic Surgeons database analysis.
13
Sub-study from HVAD BTT Trial
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. 2014 Sep 9;130(11 suppl 1):S3-11
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)
Heartware BTT Trial:N=382
15
Single Institution Studies
16
Fujita et al, Right Heart Failure and Benefits of Adjuvant TV Repair in patients undergoing LVAD ImplantationEJCTS, 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.
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. 2015 Apr 1;34(4):S194.
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
TV Repair
No TV Repair
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 p
CVP (mm Hg) 12.4 ± 5.9 8.7 ± 4.5 7.4 ± 5.2
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%
Atluri P, Fairman AS, MacArthur JW, Goldstone AB, Cohen JE, Howard JL, ZalewskiCM, 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. 2013 Nov 1;28(6):770-5.
Variable Preimplant Postimplant P-ValueHeart rate (beats/min) 88 + 14 96 + 12 0.0004Arterial blood pressure (mean, mmHg) 72.5 + 9.1 76.0 + 9.5 0.03Central venous pressure (mmHg) 12.1 + 5.1 12.0 + 4.0 0.8Pulmonary artery pressure (mean, mmHg) 30.2 + 7.4 26.6 + 4.9
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 ventriculadysf.(all patients)
2.09 ± 0.64 1.65 ± 0.71 1.67 ± 0.77 1.36 ± 0.88 1.64 ± 0.79 0.001
Right ventriculadysfun. (pre-op moderate or severe, n = 58)
2.46 ± 0.49 1.89 ± 0.55 1.79 ± 0.74 1.48 ± 0.80 1.75 ± 0.80
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.
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
Thank you!
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 Jul 1;98(1):81-3
Slide Number 1 �James K. Kirklin, MDChallenges in Understanding the Appropriate Role of Tricuspid Valve Repair During LVAD ImplantChallenges in Understanding the Appropriate Role of Tricuspid Valve Repair During LVAD ImplantSlide Number 5Slide Number 6Incidence of Tricuspid Regurgitation at time of LVAD ImplantUse of Tricuspid Valve Repair at time of LVAD ImplantSlide Number 9Slide Number 10Incidence of Moderate/Severe Tricuspid Regurgitation �after LVAD implant: TV Repair vs. No TV RepairSlide Number 12Slide Number 13Slide Number 14Slide Number 15Slide Number 16Slide Number 17Slide Number 18Slide Number 19Slide Number 20Slide Number 21My Conclusions based on Available EvidenceDespite my “assignment”, TV Repair Should be Considered in the following Situations If TR is Severe at Operation Given the Low Surgical RiskThank you!Slide Number 25