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