Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Hase, Hiromu; Yoshijima, Nobuhiro; Yanagisawa, Ryoji; Tanaka, Makoto; Tsuruta, Hikaru; Shimizu, Hideyuki; Fukuda, Keiichi; Naganuma, Toru; Mizutani, Kazuki; Yamawaki, Masahiro; Tada, Norio; Yamanaka, Futoshi; Shirai, Shinichi; Tabata, Minoru; Ueno, Hiroshi; Takagi, Kensuke; Watanabe, Yusuke; Yamamoto, Masanori; Hayashida, Kentaro; Investigators, Ocean-Tavi

doi:10.1002/ccd.29259

Cited by 42 publications

(28 citation statements)

References 29 publications

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“…Compared with the balloon-expandable SAPIEN 3 valve, 7/10 https://e-kcj.org https://doi.org/10.4070/kcj.2020.0409 the self-expanding Evolut R valve showed superior hemodynamic outcomes (iEOA, 1.08 vs. 1.2 cm 2 /m 2 , p<0.001; mean aortic valve pressure gradient, 12.0 vs. 9.0 mmHg, p<0.001). 15) However, no significant difference was noted in the incidence of moderate and severe PPM which was different from our study. This may be due to the difference in study population with smaller BSA compared to the study of ours and Mauri et al 5) Clinically significant PPM was identified as a predictor of adverse clinical outcomes after TAVR.…”

Section: Tavr In Patients With Small Aortic Annuluscontrasting

confidence: 99%

“… 5) 6) The main factor to achieve better hemodynamic benefits and larger EOA may be driven by supra-annular location in the self-expanding valve compared with intra-annular location in the balloon-expandable valve. Recently, Hase et al 15) focused on Japanese patients with small aortic annulus defined as mean annulus diameter ≤23 mm on computed tomography. Compared with the balloon-expandable SAPIEN 3 valve, the self-expanding Evolut R valve showed superior hemodynamic outcomes (iEOA, 1.08 vs. 1.2 cm 2 /m 2 , p<0.001; mean aortic valve pressure gradient, 12.0 vs. 9.0 mmHg, p<0.001).…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Transcatheter Aortic Valve Replacement between Self-Expanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

Lee

Hong

et al. 2021

Korean Circ J

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Background and Objectives Transcatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus. Methods A total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared. Results Between the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm 2 , p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm 2 /m 2 , p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up. Conclusions TAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.

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Section: Tavr In Patients With Small Aortic Annuluscontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Comparison of Transcatheter Aortic Valve Replacement between Self-Expanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

Lee

Hong

et al. 2021

Korean Circ J

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“…obesity and impaired left ventricular function), a small native aortic annulus was associated with increased rates of PPM [7]. Recent analyses favored supra-annular transcatheter heart valves (THV) for the treatment of patients with severe aortic stenosis and a small aortic annulus (SAA) [8][9][10]. However, several additional THV designs have become commercially available in the meantime and optimal valve selection for patients with SAA remains unclear.…”

Section: Introductionmentioning

confidence: 99%

Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves

et al. 2021

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Background A small aortic annulus is associated with increased risk of prosthesis–patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI). Whether specific transcatheter heart valve (THV) designs yield superior hemodynamic performance in these small anatomies remains unclear. Methods Data from 8411 consecutive patients treated with TAVI from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as multidetector computed tomography-derived annulus area < 400 mm2. TAVI was performed with a balloon-expanding intra-annular (Sapien-3, n = 288), self-expanding intra-annular (Portico, n = 110), self-expanding supra-annular (Evolut, n = 179 and Acurate-Neo, n = 428) and mechanically expanding infra-annular (Lotus, n = 64) THV according to local practice. PPM was defined as indexed effective orifice area ≤ 0.85cm2/m2. Results A small annulus was found in 1069 (12.7%) patients. PPM was detected in 38.3% overall with a higher prevalence after implantation of a balloon-expanding intra-annular or mechanically expanding infra-annular THV compared to self-expanding intra- and supra-annular THV. Multivariable analysis linked self-expanding THV (Evolut: Odds ratio [OR] 0.341, Acurate-Neo: OR 0.436, Portico: OR 0.291), postdilatation (OR 0.648) and age (OR 0.968) to lower rates of PPM, while aortic valve calcification was associated with an increased risk (OR 1.001). Paravalvular regurgitation > mild was more frequent after TAVI with self-expanding THV (p = 0.04). Conclusion In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy were left with PPM after TAVI. Self-expanding supra- and intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation. Graphic abstract

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“…Schofer et al reported data from 1,309 patients undergoing TAVI with intraannular BEV, supra-annular SEV, intra-annular SEV, cusp-fixated SEV, mechanically expandable infra-annular valve, and nonmetallic valve: the lowest rate of severe PPM was present with supra-annular SEV (4%), whereas the highest rate of severe PPM was detected in patients with self-expandable cusp-fixated (25%) and intra-annular BEV (24%) (38). In a recent further analysis of propensity score-matched patients from the OCEAN-TAVI registry treated with third-generation THV, Evolut R seemed to be superior to Sapien 3 in hemodynamic performance in terms of mean pressure gradient and iEOA (78).…”

Section: Self-expandable Valvesmentioning

confidence: 94%

Clinical and Technical Challenges of Prosthesis–Patient Mismatch After Transcatheter Aortic Valve Implantation

Fazzari¹,

Cannata²,

Sánchez³

et al. 2021

Front. Cardiovasc. Med.

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Prosthesis–patient mismatch (PPM) is present when the effective area of a prosthetic valve inserted into a patient is inferior to that of a normal human valve; the hemodynamic consequence of a valve too small compared with the size of the patient's body is the generation of higher than expected transprosthetic gradients. Despite evidence of increased risk of short- and long-term mortality and of structural valve degeneration in patients with PPM after surgical aortic valve replacement, its clinical impact in patients subject to transcatheter aortic valve implantation (TAVI) is yet unclear. We aim to review and update on the definition and incidence of PPM after TAVI, and its prognostic implications in the overall population and in higher-risk subgroups, such as small aortic annuli or valve-in-valve procedures. Last, we will focus on the armamentarium available in order to reduce risk of PPM when planning a TAVI procedure.

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Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Cited by 42 publications

References 29 publications

Comparison of Transcatheter Aortic Valve Replacement between Self-Expanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

Comparison of Transcatheter Aortic Valve Replacement between Self-Expanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves

Clinical and Technical Challenges of Prosthesis–Patient Mismatch After Transcatheter Aortic Valve Implantation

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