Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli

Regazzoli, Damiano; Chiarito, Mauro; Cannata, F.; Pagnesi, Matteo; Miura, Mizuki; Ziviello, Francesca; Picci, Andrea; Reifart, Jörg; Marco, Federico De; Bedogni, Francesco; Adamo, Marianna; Curello, Salvatore; Teles, Rui Campante; Taramasso, Maurizio; Barbanti, Marco; Tamburino, Corrado; Stefanini, Giulio; Mangieri, Antonio; Giannini, Francesco; Pagnotta, Paolo; Maisano, Francesco; Kim, Won-Keun; Mieghem, Nicolás M. Van; Colombo, Antonio; Reimers, Bernhard; Latib, Azeem

doi:10.1016/j.jcin.2019.08.041

Cited by 64 publications

(47 citation statements)

References 36 publications

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“…In our study, the Sapien 3 group tended to have a higher incidence of PPM, but there was no significant difference between the two groups. A recent study analyzed a larger number of patients who used Evolut R than in this study; the Sapien 3 group in our study showed a lower rate of moderate or severe PPM 22 . The reason for this difference is that patients with small BSA were also registered in the OCEAN‐TAVI registry.…”

Section: Discussionmentioning

confidence: 63%

“…A recent study analyzed a larger number of patients who used Evolut R than in this study; the Sapien 3 group in our study showed a lower rate of moderate or severe PPM. 22 The reason for this difference is that patients with small BSA were also registered in the OCEAN-TAVI registry. Miyasaka et al 19 reported that BSA plays an important role in the lower incidence of PPM especially in a small annulus cohort.…”

Section: Discussionmentioning

confidence: 99%

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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

Hase

Yoshijima

Yanagisawa

et al. 2020

Cathet Cardio Intervent

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Objectives To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. Background Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli. Methods In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. Results The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01–1.46] vs. 1.08 [IQR: 0.90–1.28] cm2/m2, p < .001}. However, no significant differences were reported in the incidence of severe prosthesis‐patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all‐cause mortality (log‐lank test, p = .81). Conclusions TAVR for patients with a small annulus using third‐generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all‐cause mortality at 1 year was similar between both groups.

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Section: Discussionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 99%

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

Hase

Yoshijima

Yanagisawa

et al. 2020

Cathet Cardio Intervent

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“…Another supraannular SEV (Acurate Neo, Boston Scientific, Marlborough, Massachussets) similarly resulted in lower gradients and lower rate of severe PPM when compared with Sapien 3 BEV in a multicenter, propensity score-matched study enrolling 246 patients with aortic stenosis and small aortic annuli (81). On the other hand, Portico (St. Jude Medical, Minneapolis, Minnesota) intra-annular SEV showed a rate of PPM similar to Sapien XT intra-annular BEV (10 vs. 13%, p = 0.56) in a comparative study of 62 patients treated with 23-mm valves (82), and a higher proportion of moderate PPM than supraannular SEV in the TAVI-SMALL registry (83). The latter study, a multicenter observational study providing a direct comparison of SEV in a real-world cohort of patients with aortic stenosis and small annuli, provided some insights into the possible mechanism underlying the different hemodynamic behavior of SEV according to prosthetic leaflets position with respect to the native annulus.…”

Section: Small Aortic Annulimentioning

confidence: 98%

“…Similarly, intra-annular SEV and supra-annular SEV designs showed the highest and lowest rate of severe PPM, respectively, in patients from a single center retrospective study receiving small THV sizes (≤23 mm) (38). Finally, the favorable hemodynamics of SEV compared with BEV is also tangible when focusing on patients with very small annuli: the mean post-procedural gradient was 10 ± 0.4 mmHg in 175 patients from TAVI-SMALL registry (defined as area-or perimeter-derived diameter <20 mm) implanted with SEV, and 15.4 ± 4.1 and 12.2 ± 4.8 mmHg in 511 patients from OCEAN-TAVI registry (defined as annular area <314 mm 2 ) implanted with 20-mm Sapien XT and 23-mm Sapien XT, respectively (83,84).…”

Section: Small Aortic Annulimentioning

confidence: 99%

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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“…14) On the other hand, the incidence of more than moderate PPM after self-expanding Evolut valve implantation in our study was considerably lower (8.9%) than a previous study which analyzed the performance of self-expanding valves in European patients with small aortic annulus (Evolut R, 24.5%; Evolut PRO, 20.5%). 17) The greater difference in the incidence of PPM following self-expanding valve implantation may be explained by several factors. Our definition of small aortic annulus was different from previous studies, as we followed the latest proposals for a mean diameter of <23 mm or minimal diameter of ≤21 mm on computed tomography.…”

Section: Tavr In Patients With Small Aortic Annulusmentioning

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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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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Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli

Cited by 64 publications

References 36 publications

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

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

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

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

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