Efficacy and Safety of New Generation Transcatheter Aortic Valves: Insights from the Israeli
Transcatheter Aortic Valve Implantation Registry

Zach Rozenbaum Cardiology, Sourasky Tel Aviv Medical Center, Israel Sackler Faculty of Medicine, Tel Aviv University, Israel Ariel Finkelstein Cardiology, Sourasky Tel Aviv Medical Center, Israel Sackler Faculty of Medicine, Tel Aviv University, Israel Arie Steinvil Cardiology, Sourasky Tel Aviv Medical Center, Israel Sackler Faculty of Medicine, Tel Aviv University, Israel Amir Halkin Cardiology, Sourasky Tel Aviv Medical Center, Israel Sackler Faculty of Medicine, Tel Aviv University, Israel Shmuel Banai Cardiology, Sourasky Tel Aviv Medical Center, Israel Sackler Faculty of Medicine, Tel Aviv University, Israel Israel Barbash Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Sheba Medical Center, Israel Amit Segev Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Sheba Medical Center, Israel Victor Guetta Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Sheba Medical Center, Israel Haim Danenberg Cardiology, Hadassah Hebrew University Medical Center, Israel Katia Orvin Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Rabin Medical Center, Israel Hana Vaknin Assa Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Rabin Medical Center, Israel Abid Assali Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Rabin Medical Center, Israel Ran Kornowski Sackler Faculty of Medicine, Tel Aviv University, Israel Cardiology, Rabin Medical Center, Israel

Background: Direct head-to-head comparison between new generation transcatheter aortic valve implantation (TAVI) valves in a prospective clinical trial has never been performed. It is therefore essential to compare their efficacy and safety in real life practice.
Methods: We performed a retrospective analysis on an Israeli multicenter registry comprised of four tertiary centers, comparing patients outcomes implanted with the Edwards SAPIEN S3 (ES3) versus the Medtronic Evolut-R (MER) valves.
Results: The study population included 735 patients (ES3 n=223; MER n= 512). Patients implanted with MER were more likely to be older (83 vs. 81 years), of female gender (65% vs. 33%), and have renal failure (68% vs. 54%), and higher STS scores (3.5% vs. 3.1%), as compared to ES3, respectively (all p<0.05). The transfemoral approach was used in most patients (MER 97%; ES3 92%). The use of MER was significantly associated with higher rates of post dilatation (35% vs. 10%) the need for a second valve (2.7% vs. 0.5%), however lower rates of pre dilatation (21% vs. 63%). Procedural outcome were comparable between groups including devices success (97% vs. 98%), major vascular complications (3.3% vs. 4.6%), bleeding (3% vs. 5%), permanent pacemaker implantation (17.5% vs. 14.4%), and at least moderate paravalvular regurgitation (4% vs. 1.4%) for MER vs. ES3, respectively (all p>0.05). The use of ES3 was associated however with higher rates of acute kidney injury (19% vs. 10%, p=0.001), however post procedural Dialysis was comparable (1.8 vs 0.8%, p=0.383) to the MER group, respectively. Similar 1-month and 1-year all-cause mortality were observed (1.9% versus 1.3%, p=0.764; and 8% vs. 8.5%, p=0.804; for MER vs. ES3, respectively).
Conclusion: In our contemporary Israeli registry, the overall clinical outcomes were favorable among mostly elderly patients with severe aortic stenosis. Comparable rates of new generation TAVI valves efficacy and safety outcomes measures were observed with the ES3 and MER.

Presentation


Zach Rozenbaum
Zach Rozenbaum
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