Comparing short-term outcomes between the Evolut Pro valve and older generation self-expandable valves for transcatheter aortic valve replacement

Itamar Loewenstein ¹ Ilan Merdler ¹ Aviram Hochstadt ¹ Zahler David ¹ Ariel Finkelstein ¹ Shmuel Banai ¹ Yann Topilsky ¹ Amir Halkin ¹ Maayan Konigstein ¹ Shmuel Bazan ² Issy Barbash ² Amit Segev ² Victor Guetta ³ Haim Danenberg ³ David Planner ⁴ Katia Orvin ⁴ Vaknin Assa Hana ⁴ Abed Assali ⁴ Ran Kornowski ² Arie Steinvil ¹

¹Cardiology department, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
²Leviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
³Cardiology department, Hadassah Medical Center, Jerusalem, Hebrew University of Jerusalem, Jerusalem, Israel
⁴Cardiology department, Rabin Medical Center, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Background: The Medtronic Evolut Pro valve (EPV) is a novel self-expandable valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in trans-aortic valvular replacement (TAVR). Paravalvular leak and need for permanent pacemaker (PPM) implantation are still the principal limitations of TAVR in comparison to surgical aortic valve replacement. Existing evidence demonstrating an advantage in comparison to other SEVs regarding PVL and PPM rates is either limited or conflicting. We aimed to compare EPV to older generation SEVs, regarding post-procedural PVL and PPM rates and other safety and efficacy outcomes.

Methods: We performed an independent, non-funded, retrospective, multi-center propensity matched analysis of the Israeli TAVR database for patients treated with Medtronic SEVs between September 2008 and June 2019. We performed two separate propensity score matched comparisons to examine procedural efficacy and safety outcomes: One comparing EPV with the first generation CoreValve (CV) and the other comparing EPV with the second generation Evolut R valve (ERV).

Results: 2591 patients were propensity-matched, creating final cohorts of 222 patients in the ERV group and 217 patients in both CV and ERV groups. Mild and above PVL rates were lower for EPV [angiographic PVL (aPVL): 9.6%, echocardiographic PVL (ePVL): 42.9%] as compared to both CV (aPVL: 47.0%, ePVL: 78.3%, P

Conclusion: The new Medtronic Evolut Pro valve demonstrates excellent procedural safety and efficacy outcomes. Mild and above PVL rates are significantly reduced in comparison to both older generation SEVs as opposed to need for PPM implantation rates which were not significantly improved.

*Drs. Loewenstein and Merdler contributed equally to this article.