Justus Strauch1, Daniel Wendt2, Anno Diegeler3, Martin Heimeshoff4, Steffen Hofmann5, David Holzhey6, Frank Oertel7, Thorsten Wahlers8, Jana Kurucova9, Martin Thoenes9, Cornelia Deutsch10, Peter Bramlage10, Holger Schröfel11. 1. Clinic for Cardiosurgery and Thoracic Surgery, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum, Germany. 2. Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center, Essen, Germany. 3. Department of Cardiovascular Surgery, Cardiovascular Clinic Bad Neustadt, Bad Neustadt, Germany. 4. Helios Klinik für Herzchirurgie Karlsruhe, Karlsruhe, Germany. 5. Schuechtermann-Klinik, Cardiac Centre Osnabrück-Bad Rothenfelde, Rothenfelde, Germany. 6. Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany. 7. Heart Centre Augsburg, Augsburg, Germany. 8. Department of Cardiothoracic Surgery, Heart Center, University of Cologne, Cologne, Germany. 9. Edwards Lifesciences, Nyon, Switzerland. 10. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. 11. Department of Cardiovascular Surgery, University Heart Center Freiburg, Bad Krozingen, Germany.
Abstract
OBJECTIVES: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates. METHODS: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI. RESULTS: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment. CONCLUSIONS: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.
OBJECTIVES: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates. METHODS: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI. RESULTS: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment. CONCLUSIONS: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.
Authors: Jannik Ole Ashauer; Nikolaos Bonaros; Markus Kofler; Gerhard Schymik; Christian Butter; Mauro Romano; Vinayak Bapat; Justus Strauch; Holger Schröfel; Andreas Busjahn; Cornelia Deutsch; Peter Bramlage; Jana Kurucova; Martin Thoenes; Stephan Baldus; Tanja K Rudolph Journal: BMC Cardiovasc Disord Date: 2019-07-19 Impact factor: 2.298
Authors: Gerhard Schymik; Tanja Rudolph; Claudius Jacobshagen; Jürgen Rothe; Hendrik Treede; Sebastian Kerber; Derk Frank; Lenka Sykorova; Maki Okamoto; Martin Thoenes; Cornelia Deutsch; Peter Bramlage; Christian Butter Journal: Open Heart Date: 2019-10-03