Abstract
Transcatheter aortic valve implantation shortcomings such as relevant paravalvular leakage (PVL) have been shown to negatively impact survival. The Sapien 3 prosthesis has added features to address these problems. We compared the functional performance of the Sapien 3 (S3) and its predecessor Sapien XT (XT), with a particular focus on PVL. We analyzed 601 patients presenting with severe native aortic valve stenosis treated with either Sapien XT (n = 405, 2011 to 2014, mean STS-PROM [Society of Thoracic Surgeons predicted risk of mortality] 11.0%) or Sapien 3 prosthesis (n = 196, 2014 to 2016, mean STS-PROM 9.2%). Beside a propensity score-based comparison, we modeled the likelihood of PVL as a function of oversizing and prosthesis. Primary end points were 1-year survival, degree of oversizing, and occurrence of PVL. One-year survival (stratified log-rank p = 1.00) and 30-day mortality (S3: 10 of 126 vs XT: 10 of 126, p = 1.00) did not differ. In the matched cohort, oversizing was less common in the S3 group (absolute median difference of 7% in oversizing, interquartile range 1.1% to 12.7%, p = 0.025). PVL > = 1° was similar in both groups (S3: 13 of 126 vs XT: 20 of 126, p = 0.296). Mean gradients were lower in the XT group (me...Continue Reading
References
Jan 10, 2002·The Journal of Thoracic and Cardiovascular Surgery·Eugene H Blackstone
Sep 19, 2006·Journal of Clinical Epidemiology·Geert J M G van der HeijdenKarel G M Moons
Oct 31, 2006·Statistics in Medicine·Donald B Rubin
Dec 23, 2008·The Annals of Thoracic Surgery·Thomas WaltherMichael Mack
Sep 8, 2009·Journal of the American Society of Echocardiography : Official Publication of the American Society of Echocardiography·William A ZoghbiUNKNOWN Canadian Society of Echocardiography
May 25, 2010·The Annals of Thoracic Surgery·Miralem PasicRoland Hetzer
Jan 11, 2011·European Heart Journal·Martin B LeonPatrick W Serruys
May 10, 2011·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Jörg KempfertThomas Walther
Mar 27, 2012·The New England Journal of Medicine·Susheel K KodaliUNKNOWN PARTNER Trial Investigators
Mar 29, 2014·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Jörg KempfertThomas Walther
Aug 2, 2014·Clinical Cardiology·Helge MöllmannChristian Hamm
Dec 3, 2014·The American Journal of Cardiology·Arie SteinvilAriel Finkelstein
Aug 14, 2015·Journal of the American College of Cardiology·Giuseppe Bruschi, Federico De Marco
Apr 5, 2016·The New England Journal of Medicine·Martin B LeonUNKNOWN PARTNER 2 Investigators
Jun 12, 2016·Journal of cardiology·Takahide AraiBernard Chevalier
Jan 11, 2017·World Journal of Cardiology·Fadi J SawayaBernard Chevalier
Jan 21, 2017·Circulation·Olaf WendlerAlec Vahanian
May 23, 2017·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Fabio BariliLorenzo Menicanti
Citations
Mar 13, 2020·Expert Review of Medical Devices·Alberto Alperi GarciaJosep Rodés-Cabau
Aug 5, 2021·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Sa'ar MinhaIsrael M Barbash
Aug 19, 2021·Expert Review of Medical Devices·Alberto AlperiJosep Rodés-Cabau