Brian R Lindman1, Hersh S Maniar2, Wael A Jaber2, Stamatios Lerakis2, Michael J Mack2, Rakesh M Suri2, Vinod H Thourani2, Vasilis Babaliaros2, Dean J Kereiakes2, Brian Whisenant2, D Craig Miller2, E Murat Tuzcu2, Lars G Svensson2, Ke Xu2, Darshan Doshi2, Martin B Leon2, Alan Zajarias2. 1. From the Washington University School of Medicine, St. Louis, MO (B.R.L., H.S.M., A.Z.); Cleveland Clinic Foundation, OH (W.A.J., E.M.T., L.G.S.); Emory University School of Medicine, Atlanta, GA (S.L., V.H.T., V.B.); Baylor Scott and White Health, Plano, TX (M.J.M.); Mayo Clinic, Rochester, MN (R.M.S.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Intermountain Heart Center, Murray, UT (B.W.); Stanford University School of Medicine, CA (D.C.M.); Cardiovascular Research Foundation, New York, NY (K.X., M.B.L.); and Columbia University Medical Center/New York Presbyterian Hospital (D.D., M.B.L.). blindman@dom.wustl.edu. 2. From the Washington University School of Medicine, St. Louis, MO (B.R.L., H.S.M., A.Z.); Cleveland Clinic Foundation, OH (W.A.J., E.M.T., L.G.S.); Emory University School of Medicine, Atlanta, GA (S.L., V.H.T., V.B.); Baylor Scott and White Health, Plano, TX (M.J.M.); Mayo Clinic, Rochester, MN (R.M.S.); The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.); Intermountain Heart Center, Murray, UT (B.W.); Stanford University School of Medicine, CA (D.C.M.); Cardiovascular Research Foundation, New York, NY (K.X., M.B.L.); and Columbia University Medical Center/New York Presbyterian Hospital (D.D., M.B.L.).
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 withtranscatheter 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.
RCT Entities:
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 dysfunctionas 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.
Authors: William A Zoghbi; Maurice Enriquez-Sarano; Elyse Foster; Paul A Grayburn; Carol D Kraft; Robert A Levine; Petros Nihoyannopoulos; Catherine M Otto; Miguel A Quinones; Harry Rakowski; William J Stewart; Alan Waggoner; Neil J Weissman Journal: J Am Soc Echocardiogr Date: 2003-07 Impact factor: 5.251
Authors: Roberto M Lang; Michelle Bierig; Richard B Devereux; Frank A Flachskampf; Elyse Foster; Patricia A Pellikka; Michael H Picard; Mary J Roman; James Seward; Jack S Shanewise; Scott D Solomon; Kirk T Spencer; Martin St John Sutton; William J Stewart Journal: J Am Soc Echocardiogr Date: 2005-12 Impact factor: 5.251
Authors: Norbert F Voelkel; Robert A Quaife; Leslie A Leinwand; Robyn J Barst; Michael D McGoon; Daniel R Meldrum; Jocelyn Dupuis; Carlin S Long; Lewis J Rubin; Frank W Smart; Yuichiro J Suzuki; Mark Gladwin; Elizabeth M Denholm; Dorothy B Gail Journal: Circulation Date: 2006-10-24 Impact factor: 29.690
Authors: J P Sun; K B James; X S Yang; N Solankhi; M S Shah; K L Arheart; J D Thomas; W J Stewart Journal: Am J Cardiol Date: 1997-12-15 Impact factor: 2.778
Authors: Ibrahim Sultan; Arturo Cardounel; Islam Abdelkarim; Arman Kilic; Andrew D Althouse; Michael S Sharbaugh; Aman Gupta; Jeff Xu; Miho Fukui; Marc A Simon; John T Schindler; Joon S Lee; Thomas G Gleason; João L Cavalcante Journal: Heart Date: 2018-08-09 Impact factor: 5.994
Authors: Miho Fukui; Aman Gupta; Islam Abdelkarim; Michael S Sharbaugh; Andrew D Althouse; Hesham Elzomor; Suresh Mulukutla; Joon S Lee; John T Schindler; Thomas G Gleason; João L Cavalcante Journal: JAMA Cardiol Date: 2019-03-01 Impact factor: 14.676
Authors: Philippe Unger; Marie-Annick Clavel; Brian R Lindman; Patrick Mathieu; Philippe Pibarot Journal: Nat Rev Cardiol Date: 2016-04-28 Impact factor: 32.419
Authors: Brian R Lindman; Marie-Annick Clavel; Patrick Mathieu; Bernard Iung; Patrizio Lancellotti; Catherine M Otto; Philippe Pibarot Journal: Nat Rev Dis Primers Date: 2016-03-03 Impact factor: 52.329