Intra- versus supra-annular self-expanding transcatheter heart valves in small aortic annuli

Masanori Yamamoto¹^,²^,³, MD; Toshinobu Ryuzaki⁴, MD; Hirofumi Hioki⁵, MD; Ai Kagase³, MD; Shinichi Shirai⁶, MD; Yohei Ohno⁷, MD; Fumiaki Yashima⁸, MD; Toru Naganuma⁹, MD; Masahiro Yamawaki¹⁰, MD; Yusuke Watanabe¹¹, MD; Futoshi Yamanaka¹², MD; Kazuki Mizutani¹³, MD; Masahiko Noguchi¹⁴, MD; Masaki Izumo¹⁵, MD; Kensuke Takagi¹⁶, MD; Masahiko Asami¹⁷, MD; Hiroshi Ueno¹⁸, MD; Hidetaka Nishina¹⁹, MD; Hiroto Suzuyama²⁰, MD; Kazumasa Yamasaki²¹, MD; Kenji Nishioka²², MD; Daisuke Hachinohe²³, MD; Yasushi Fuku²⁴, MD; Toshiaki Otsuka²⁵, MD; Kentaro Hayashida⁴, MD; on behalf of the OCEAN-TAVI investigators

1. Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan; 2. Department of Cardiology, Nagoya Heart Center, Nagoya, Japan; 3. Department of Cardiology, Gifu Heart Center, Gifu, Japan; 4. Division of Cardiology, Keio University School of Medicine, Tokyo, Japan; 5. Department of Cardiology, IMS Tokyo Katsushika General Hospital, Tokyo, Japan; 6. Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan; 7. Department of Cardiology, Tokai University School of Medicine, Isehara, Japan; 8. Department of Cardiology, Saiseikai Utsunomiya Hospital, Utsunomiy, Japan; 9. Department of Cardiology, New Tokyo Hospital, Matsudo, Japan; 10. Department of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan; 11. Division of Cardiology, Teikyo University Hospital, Tokyo, Japan; 12. Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan; 13. Department of Cardiology, Kinki University, Osaka, Japan; 14. Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan; 15. Department of Cardiology, St. Marianna University School of Medicine, Kawasaki, Japan; 16. Department of Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan; 17. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan; 18. Department of Cardiology, Toyama University Hospital, Toyama, Japan; 19. Department of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan; 20. Department of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan; 21. Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan; 22. Department of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan; 23. Department of Cardiovascular Medicine, Sapporo Cardiovascular Clinic, Sapporo, Japan; 24. Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan; 25. Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan, and Center for Clinical Research, Nippon Medical School Hospital, Tokyo, Japan

Abstract

Background: Clinical data are scarce comparing supra-annular self-expanding valves (SA-SEVs) and intra-annular (IA)-SEVs after transcatheter aortic valve implantation (TAVI), particularly in patients with a small aortic annulus (SAA).

Aims: We aimed to compare early clinical outcomes, including echocardiographic parameters, between the latest generation of IA-SEV and SA-SEV after TAVI in patients with SAA.

Methods: Focused on patients with SAA, defined as an annulus area ≤430 mm², the data of 919 patients who underwent TAVI with an IA-SEV (n=518, Navitor) or an SA-SEV (n=401, Evolut FX) were retrospectively extracted. Differences in valve design on postprocedural results were investigated between the two groups and in the propensity score-matched (PSM) cohort.

Results: The postprocedural effective orifice area (EOA), indexed EOA, and mean pressure gradient (mPG) were similar in the overall cohort between the two groups (allp>0.05), whereas the mPG was higher with IA-SEVs than with SA-SEVs (8.74±5.01 mmHg vs 7.84±4.43 mmHg; p=0.049) after PSM (n=219 patients/group). There were no significant differences in the incidence of severe prosthesis-patient mismatch (1.9% vs 0.9%; p=0.405) or paravalvular leakage ≥mild (34.1% vs 42.2%; p=0.084) between the 2 groups in the PSM cohort. The rates of technical success (95.9% vs 95.8%), device success at discharge (91.3% vs 87.8%), and in-hospital death (1.4% vs 0.5%) were comparable in the overall cohort (allp>0.05). These results were not changed in the PSM cohort (allp>0.05).

Conclusions: The latest-generation IA-SEV and SA-SEV demonstrated similar clinical results except for a few echocardiographic findings after TAVI in patients with SAA.

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