title: Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation: Insights From the Brazilian Transcatheter Aortic Valve Replacement Registry.
abstract: Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to support this approach.
  
  
  
  Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372; direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similar between groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% versus 10%; P=0.25 and 18.1% versus 24.5%; P=0.07, respectively) and stroke (2.8% versus 3.8%; P=0.85 and 5.5% versus 6.8%; P=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7% versus 35.1%; P=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (11% versus 13.3%; P=0.57 and 9.8±5.5 versus 8.7±4.3; P=0.09, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use of CoreValve were independent predictors of new onset persistent left bundle branch block.
  
  
  
  The 2 TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a midterm follow-up although BAVP was associated with a higher rate of new onset persistent left bundle branch block, particularly in patients receiving a CoreValve.
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Fernando L M
authors: FL
authors: Bernardi
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Henrique B
authors: HB
authors: Ribeiro
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Luiz A
authors: LA
authors: Carvalho
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Rogerio
authors: R
authors: Sarmento-Leite
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: José A
authors: JA
authors: Mangione
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Pedro A
authors: PA
authors: Lemos
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Alexandre
authors: A
authors: Abizaid
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Eberhard
authors: E
authors: Grube
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.).
authors: Josep
authors: J
authors: Rodés-Cabau
authors: From the Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, Brazil (F.L.M.B., H.B.R., P.A.L.); Department of Interventional Cardiology, TotalCor Hospital, Sao Paulo, Brazil (H.B.R.); Department of Interventional Cardiology, Hospital Pro-Cardiaco, Rio de Janeiro, Brazil (L.A.C.); Department of Interventional Cardiology, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (R.S.-L.); Department of Interventional Cardiology, Hospital Beneficencia Portuguesa, Sao Paulo, Brazil (J.A.M.); Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.); Department of Cardiology, University Hospital of Bonn, Germany (E.G.); Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Canada (J.R.-C.); and Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil (F.S.d.B.). fabio.brito@einstein.br.
authors: Fábio S
authors: FS
authors: de Brito
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D002037:Bundle-Branch Block / Q000209:etiology; D002423:Cause of Death; D005260:Female; D006801:Humans; D008297:Male; D057216:Propensity Score; D012042:Registries; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality
keywords: aortic valve stenosis; balloon valvuloplasty; left bundle branch block; propensity score; transcatheter aortic valve replacement