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Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry
Authors:Alberto Alperi  Josep Rodés-Cabau  Matheus Simonato  Didier Tchetche  Gaetan Charbonnier  Henrique B. Ribeiro  Azeem Latib  Matteo Montorfano  Marco Barbanti  Sabine Bleiziffer  Björn Redfors  Mohamed Abdel-Wahab  Abdelhakim Allali  Giuseppe Bruschi  Massimo Napodano  Marco Agrifoglio  Anna Sonia Petronio  Cristina Giannini  Danny Dvir
Affiliation:1. Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada;2. Hospital Clínic de Barcelona, Barcelona, Spain;3. Cardiovascular Research Foundation, New York, New York, USA;4. Escola Paulista de Medicina, São Paulo, Brazil;5. Yale School of Medicine, Yale University, New Haven, Connecticut, USA;6. Clinique Pasteur, Toulouse, France;7. Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil;8. Montefiore Medical Center, New York, New York, USA;9. Istituto di Ricovero e Cura a Carattere Scientifico—San Raffaele Scientific Institute, Milan, Italy;10. Università degli Studi di Catania, Catania, Italy;11. Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany;12. NewYork–Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA;13. Sahlgrenska University Hospital, Gothenburg, Sweden;14. Heart Center Leipzig–University of Leipzig, Leipzig, Germany;15. Segeberger Kliniken, Bad Segeberg, Germany;p. Ospedale Niguarda Ca’ Granda, Milan, Italy;q. Università degli Studi di Padova, Padova, Italy;r. Centro Cardiologico Monzino, Milan, Italy;s. Università di Pisa, Pisa, Italy;t. Royal Columbian Hospital, New Westminster, British Columbia, Canada;u. Rabin Medical Center, Petah Tikva, Israel;v. Uniklinik Köln, Cologne, Germany;w. Azienda Ospedaliera Universitaria Senese, Siena, Italy;x. Hôpitaux Universitaires de Genève, Geneva, Switzerland;y. St. Paul’s Hospital, Vancouver, British Columbia, Canada;z. Deutsches Herzzentrum München, Munich, Germany;11. Deutsches Herzzentrum Berlin, Berlin, Germany;22. Asklepios Klinik St. Georg, Hamburg, Germany;33. Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada;44. Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;55. Universitätsspital Bern, Bern, Switzerland;66. Kerckhoff-Klinik, Bad Nauheim, Germany;77. Istituto di Ricovero e Cura a Carattere Scientifico—Policlinico San Donato, Milan, Italy;88. Sussex Cardiac Centre, Brighton, United Kingdom;99. Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy;1010. Spedali Civili Brescia, Brescia, Italy;1111. Medizinisches Versorgungszentrum, Hamburg, Germany;1212. Helios Klinik für Herzchirurgie Karlsruhe, Karlsruhe, Germany;1313. Médipôle Hôpital Privé, Villeurbanne, France;1414. Università degli Studi di Bologna—Policlinico S. Orsola-Malpighi, Bologna, Italy;1515. Odense Universitetshospital, Odense, Denmark;pp. Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands;qq. Intermountain Heart Institute, Murray, Utah, USA;rr. Universitätsklinikum Bonn, Bonn, Germany;ss. Rigshospitalet, Copenhagen, Denmark;tt. University of Washington, Seattle, Washington, USA;uu. Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel;1. Clinical and Interventional Cardiology Unit, Sant''Ambrogio Cardio-Thoracic Center, Milan, Italy;2. Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy;1. Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada;2. Heart Center Leipzig at University of Leipzig, Leipzig, Germany;3. Heart Center, Segeberger Kliniken, Bad Segeberg, Germany;4. Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany;5. Normandie Univ, UNIROUEN, U1096, CHU Rouen, Department of Cardiology, FHU CARNAVAL, F-76000 Rouen, France;6. Righospitalet, Copenhagen, Denmark;7. Bichat Hôpital, Paris, France;8. Deutsches Herzzentrum München, Munich, Germany;9. Ospedale San Raffaele, Milan, Italy;10. Maria Cecilia Hospital, GVM Care and Research, Cotignola RA, Italy;11. Medical University of Silesia, Katowice, Poland;12. Univ Rennes, CHU Rennes, Inserm, LTSI - UMR1099, F 35000 Rennes, France;13. Heart Center Bonn, Bonn, Germany;14. St Michaels Hospital, Toronto, Ontario, Canada;15. Southlake Hospital, Newmarket, Ontario, Canada;p. Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain;q. Hôpital Européen Georges-Pompidou, Paris, France;r. Hôpital Rangueil, Toulouse, France;s. Hospital Universitario Virgen de la Victoria, Malaga, Spain;t. Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA;u. IRCCS Pol. San Donato, Milan, Italy;v. Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany;w. Hospital Universitario Reina Sofia, Cordoba, Spain;x. Hospital Universitario Central de Asturias, Oviedo, Spain;y. Clinique Pasteur, Toulouse, France;z. Centro Cardiologico Monzino, IRCCS and Department of Biomedical and Clinical Sciences “Luigi Sacco,” University of Milan, Milan, Italy;11. Cleveland Clinic, Cleveland, Ohio, USA;22. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (on behalf of Swiss TAVI);33. CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain;44. Sunnybrook Health Science Center, Toronto, Ontario, Canada;55. Emory University School of Medicine, Atlanta, Georgia, USA;66. Instituto de Investigación Universitaria Gregorio Marañón, Hospital Gregorio Marañon, Madrid, Spain;77. Hospital Vall d''Hebron, Barcelona, Spain;88. Hospital Universitario Ramón y Cajal, Madrid, Spain;99. St Paul’s Hospital, Vancouver, British Columbia, Canada;1010. University Hospital of Udine, Udine, Italy;1111. Cedars-Sinai Heart Institute, Los Angeles, California, USA;1212. Mount Sinai Hospital, New York, New York, USA;1313. Hospital Germans Trias i Pujol, Badalona, Spain;1414. Hospital Clínic de Barcelona, Barcelona, Spain;1515. Hospital de Bellvitge, L''Hospitalet de Llobregat, Spain;pp. A.O.U. Policlinico Vittorio Emanuele, University of Catania, Catania, Italy;qq. Centre Hospitalier de l''Université de Montreal, Montreal, Quebec, Canada;rr. Cliniques Universitaires Saint-Luc, Brussels, Belgium;ss. ASST-Spedali Civili di Brescia, Brescia, Italy;tt. Istituto Clinico Sant''Ambrogio, Milan, Italy;uu. University Hospital Galway, Galway, Ireland;vv. Columbia University Medical Center, New York, New York, USA;ww. InCor, Heart Institute, University of São Paulo Medical School, Sao Paulo, Brazil;xx. Hospital Samaritano Paulista, Sao Paulo, Brazil;yy. Hospital Beneficencia Portuguesa, Sao Paulo, Brazil;zz. Ospedale Mauriziano, Torino, Italy;111. Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy;222. Hospital Naval Marcilio Dias, Rio de Janeiro, Brazil;333. Hospital São Francisco-Santa Casa de Porto Alegre, Porto Alegre, Brazil;444. Hospital Pró-cardíaco, Rio de Janeiro, Brazil;555. Hospital Madre Teresa, Belo Horizonte, Brazil;666. Hospital Sao Luiz, Sao Paulo, Brazil;777. Clínica Sao Vicente, Rio de Janeiro, Brazil;888. Hospital Universitario La Princesa, Madrid, Spain;999. St.-Johannes-Hospital, Dortmund, Germany;101010. Montefiore Medical Center, New York, New York, USA;1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA;2. Division of Infectious Diseases, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA;1. Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan;2. Department of Internal Medicine, Division of Cardiology, University of Michigan, Ann Arbor, Michigan;3. Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas;4. Department of Cardiology, Detroit Medical Center, Detroit, Michigan;5. Department of Cardiology, Yale University School of Medicine, New Haven, Connecticut;6. Department of Cardiology, Aurora Healthcare, Milwaukee, Wisconsin;7. Department of Cardiothoracic Surgery, Aurora Healthcare, Milwaukee, Wisconsin;8. Department of Cardiology, St. Francis Hospital, Roslyn, New York;9. Department of Cardiothoracic and Vascular Surgery, St. Francis Hospital, Roslyn, New York;10. Department of Cardiology, North Shore University Hospital, Manhasset, New York;11. Department of Cardiovascular and Thoracic Surgery, North Shore University Hospital, Manhasset, New York;12. Department of Cardiology, University of Vermont Medical Center, Burlington, Vermont;13. Department of Cardiothoracic Surgery, University of Vermont Medical Center, Burlington, Vermont;14. Department of Cardiac Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts;15. Department of Cardiothoracic Surgery, Riverside Methodist Hospital, Columbus, Ohio;p. Department of Cardiology, Riverside Methodist Hospital, Columbus, Ohio;q. Department of Cardiovascular Diseases, Mayo Clinic Foundation, Rochester, Minnesota;r. Coronary and Structural Heart Clinical Department, Medtronic, Mounds View, Minnesota;s. Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas;t. Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York;u. Department of Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts
Abstract:
BackgroundPermanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs).ObjectivesThe goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures.MethodsData were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs.ResultsA total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups).ConclusionsIn a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.
Keywords:pacemaker  transcatheter aortic valve replacement  valve in valve  BEV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0030"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  balloon-expandable valve  PPI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0040"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  permanent pacemaker implantation  RBBB"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0050"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  right bundle branch block  SEV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0060"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  self-expandable valve  TAVR"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0070"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  transcatheter aortic valve replacement  THV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0080"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  transcatheter heart valve  ViV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0090"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  valve in valve
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