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Clinical Trial
. 2015 Apr;8(4):10.1161/CIRCINTERVENTIONS.114.002073 e002073.
doi: 10.1161/CIRCINTERVENTIONS.114.002073.

Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valves II inoperable cohort

Brian R Lindman  1 , Hersh S Maniar  2 , Wael A Jaber  2 , Stamatios Lerakis  2 , Michael J Mack  2 , Rakesh M Suri  2 , Vinod H Thourani  2 , Vasilis Babaliaros  2 , Dean J Kereiakes  2 , Brian Whisenant  2 , D Craig Miller  2 , E Murat Tuzcu  2 , Lars G Svensson  2 , Ke Xu  2 , Darshan Doshi  2 , Martin B Leon  2 , Alan Zajarias  2
Affiliations
Clinical Trial

Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valves II inoperable cohort

Brian R Lindman et al. Circ Cardiovasc Interv. 2015 Apr.

Abstract

Background: Tricuspid regurgitation (TR) and right ventricular (RV) dysfunction adversely affect outcomes in patients with heart failure or mitral valve disease, but their impact on outcomes in patients with aortic stenosis treated with transcatheter aortic valve replacement has not been well characterized.

Methods and results: Among 542 patients with symptomatic aortic stenosis treated in the Placement of Aortic Transcatheter Valves (PARTNER) II trial (inoperable cohort) with a Sapien or Sapien XT valve via a transfemoral approach, baseline TR severity, right atrial and RV size and RV function were evaluated by echocardiography according to established guidelines. One-year mortality was 16.9%, 17.2%, 32.6%, and 61.1% for patients with no/trace (n=167), mild (n=205), moderate (n=117), and severe (n=18) TR, respectively (P<0.001). Increasing severity of RV dysfunction as well as right atrial and RV enlargement were also associated with increased mortality (P<0.001). After multivariable adjustment, severe TR (hazard ratio, 3.20; 95% confidence interval, 1.50-6.82; P=0.003) and moderate TR (hazard ratio, 1.60; 95% confidence interval, 1.02-2.52; P=0.042) remained associated with increased mortality as did right atrial and RV enlargement, but not RV dysfunction. There was an interaction between TR and mitral regurgitation severity (P=0.04); the increased hazard of death associated with moderate/severe TR only occurred in those with no/trace/mild mitral regurgitation.

Conclusions: In inoperable patients treated with transcatheter aortic valve replacement, moderate or severe TR and right heart enlargement are independently associated with increased 1-year mortality; however, the association between moderate or severe TR and an increased hazard of death was only found in those with minimal mitral regurgitation at baseline. These findings may improve our assessment of anticipated benefit from transcatheter aortic valve replacement and support the need for future studies on TR and the right heart, including whether concomitant treatment of TR in operable but high-risk patients with aortic stenosis is warranted.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.

Keywords: aortic valve stenosis; echocardiography; heart failure; transcatheter aortic valve replacement; tricuspid valve insufficiency.

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Conflict of interest statement

Disclosures: The other authors report no potential conflicts of interest.

Figures

Figure 1
Figure 1. Time-to-event curves for 1-year death from any cause
One-year time-to-event curves are shown for death from any cause in the as-treated population of the PARTNER II trial inoperable cohort according to tricuspid regurgitation (TR) severity (A), right ventricular (RV) function (B), RV size (C), and right atrial (RA) index (D). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test. Abbreviations: HR, hazard ratio; refer to Table 1.
Figure 1
Figure 1. Time-to-event curves for 1-year death from any cause
One-year time-to-event curves are shown for death from any cause in the as-treated population of the PARTNER II trial inoperable cohort according to tricuspid regurgitation (TR) severity (A), right ventricular (RV) function (B), RV size (C), and right atrial (RA) index (D). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test. Abbreviations: HR, hazard ratio; refer to Table 1.
Figure 1
Figure 1. Time-to-event curves for 1-year death from any cause
One-year time-to-event curves are shown for death from any cause in the as-treated population of the PARTNER II trial inoperable cohort according to tricuspid regurgitation (TR) severity (A), right ventricular (RV) function (B), RV size (C), and right atrial (RA) index (D). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test. Abbreviations: HR, hazard ratio; refer to Table 1.
Figure 1
Figure 1. Time-to-event curves for 1-year death from any cause
One-year time-to-event curves are shown for death from any cause in the as-treated population of the PARTNER II trial inoperable cohort according to tricuspid regurgitation (TR) severity (A), right ventricular (RV) function (B), RV size (C), and right atrial (RA) index (D). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test. Abbreviations: HR, hazard ratio; refer to Table 1.
Figure 2
Figure 2. Effect of clinical and echocardiographic factors on the association between tricuspid regurgitation severity and 1-year death from any cause
Cox proportional hazards models were used to evaluate the hazard ratios for 1-year death from any cause for patients with moderate/severe versus no/trace/mild tricuspid regurgitation (TR) in the clinical and echocardiographic sub-groups shown. Abbreviations: GFR, glomerular filtration rate; LVEF, left ventricular ejection fraction; PA, pulmonary artery.
Figure 3
Figure 3. Time-to-event curves for 1-year death from any cause according to mitral and tricuspid regurgitation severity
One-year time-to-event curves are shown for death from any cause in the as-treated population of the PARTNER II trial inoperable cohort for patients with no/trace/mild TR and no/trace/mild MR (Group A), no/trace/mild TR and moderate/severe MR (Group B), moderate/severe TR and no/trace/mild MR (Group C), and moderate/severe TR and moderate/severe MR (Group D). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
Figure 4
Figure 4. Change in tricuspid regurgitation severity and right ventricular function over time after transcatheter aortic valve replacement
Among patients who survived 1 year after transcatheter aortic valve replacement and had TR assessed at baseline, 30 days, and 1 year, the number and percentages of patients with no/trace/mild, moderate, and severe TR are shown at baseline, 30 days, and 1 year for those with moderate or severe TR at baseline (a) or no/trace/mild TR at baseline (b). Among patients who survived 1 year after transcatheter aortic valve replacement and had RV function assessed at baseline, 30 days, and 1 year, the number and percentages of patients with normal RV function, mild RV dysfunction, and moderate/severe RV dysfunction are shown at baseline, 30 days, and 1 year for those with any RV dysfunction at baseline (c) or normal RV function at baseline (d).
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