Dataset Information

Incidence and Risk Assessment of Infolding Using Self-Expandable Devices in TAVR.

ABSTRACT:

Background

Transcatheter aortic valve replacement is an evolving interventional therapy for patients with symptomatic severe aortic stenosis. Infolding (INF) as wrinkling along the valve frame is only seen in self-expandable transcatheter valves or surgical sutureless prostheses and is known to be a very rare event during delivery but probably underreported. Therefore, we aimed to (1) determine the frequency of events, (2) identify potential predictors of INF, and (3) evaluate the potential clinical impact of this adverse event.

Methods

INF cases of 2 centers were retrospectively analyzed in an all-comer cohort of 1416 patients with older- and newer-generation self-expandable (SEV) devices. The underlying functional, anatomical, and procedural conditions were evaluated by univariate analysis.

Results

INF+ was observed in 14 patients (1.0%) with the following valve size distribution: SEV-26: 14.3%, SEV-29: 28.6%, and SEV-34: 57.4%. Several dependent predictors of INF were pointed out, such as severe peripheral kinking, severe aortic calcification, resheathing maneuvers, valve-in-valve procedures, and the use of the largest valve size. INF+ patients showed a higher incidence of acute kidney injury (INF- vs. INF+: 12.3% vs. 35.7%; p = 0.008), of a new atrioventricular block (INF- vs. INF+: 14.8% vs. 42.9%; p = 0.003), and a higher need of permanent pacemaker implantation (INF- vs. INF+: 14.9% vs. 35.7%; p = 0.031).

Conclusions

Identifying potential predictors of INF can probably influence the implantation strategy and improve safety algorithms and clinical outcomes. Even being a rare but potentially life-threatening and underreported event, safety rules must be established when expanding transcatheter aortic valve replacement treatment to younger patients.

SUBMITTER: Veulemans V

PROVIDER: S-EPMC10236850 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Incidence and Risk Assessment of Infolding Using Self-Expandable Devices in TAVR.

Veulemans Verena V Piuhola Jarrko J Niemelä Matti M Maier Oliver O Piayda Kerstin K Polzin Amin A Jung Christian C Westenfeld Ralf R Kelm Malte M Zeus Tobias T

Structural heart : the journal of the Heart Team 20220404 1

<h4>Background</h4>Transcatheter aortic valve replacement is an evolving interventional therapy for patients with symptomatic severe aortic stenosis. Infolding (INF) as wrinkling along the valve frame is only seen in self-expandable transcatheter valves or surgical sutureless prostheses and is known to be a very rare event during delivery but probably underreported. Therefore, we aimed to (1) determine the frequency of events, (2) identify potential predictors of INF, and (3) evaluate the potent ...[more]

PMID: 37273474

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Project description:ObjectivesOptimizing valve implantation depth (ID) plays a crucial role in minimizing conduction disturbances and achieving optimal functional integrity. Until now, the impact of intraprocedural fast (FP) or rapid ventricular pacing (RP) on the implantation depth has not been investigated. Therefore, we aimed to (1) evaluate the impact of different pacing maneuvers on ID, and (2) identify the independent predictors of deep ID.Methods473 TAVR patients with newer-generation self-expanding devices were retrospectively enrolled and one-to-one propensity-score-matching was performed, resulting in a matching of 189 FP and RP patients in each cohort. The final ID was analyzed, and the underlying functional, anatomical, and procedural conditions were evaluated by univariate and multivariate analysis.ResultsThe highest ID was reached under RP in severe aortic valve calcification and valve size 26 mm. Multivariate analysis identified left ventricular outflow (LVOT) calcification [OR 0.50 (0.31-0.81) p = 0.005*], a "flare" aortic root [OR 0.42 (0.25-0.71), p = 0.001*], and RP (OR 0.49 [0.30-0.79], p = 0.004*) as independent highly preventable predictors of a deep ID. In a model of protective factors, ID was significantly reduced with the number of protective criteria (0-2 criteria: - 5.7 mm ± 2.6 vs. 3-4 criteria - 4.3 mm ± 2.0; p < 0.0001*).ConclusionData from this retrospective analysis indicate that RP is an independent predictor to reach a higher implantation depth using self-expanding devices. Randomized studies should prove for validation compared to fast and non-pacing maneuvers during valve delivery and their impact on implantation depth.Trail registrationClinical Trial registration: NCT01805739.Study designEvaluation of the impact of different pacing maneuvers (fast ventricular pacing-FP vs. rapid ventricular pacing-RP) on implantation depth (ID). After one-to-one-propensity-score-matching, independent protective and risk factors for a very deep ID beneath 6 mm toward the LVOT (< - 6 mm) were identified. Stent frame pictures as a courtesy by Medtronic®. AVC aortic valve calcification.

Project description:Background: Transcatheter aortic valve replacement (TAVR) has emerged as a well-established option for patients with severe aortic stenosis who present high or extreme surgical risk. Direct comparisons of outcomes between different valve prostheses are important to assist operators in making an informed device selection. We aimed to perform a comparative analysis of early clinical outcomes at 30 days and long-term outcomes up to 3 years after TAVR using self-expandable Portico or CoreValve Evolut R valve prostheses. Methods: Out of 396 patients treated with either Portico or CoreValve Evolut R valves from January 2018 to December 2021, 79 patients were assigned to each group after 1:1 propensity score matching based on baseline parameters. Peri- and postprocedural outcomes at 30 days and up to a 3-year follow-up period were retrospectively collected according to the Valve Academic Research Consortium (VARC-2) criteria. Results: The immediate survival rate was 100% in both groups. The 30-day mortality was 0.0% in the Portico group and 1.3% in the CoreValve Evolut group (p = 1). Minor postprocedural bleeding was more frequent in the Evolut group both at 30 days (8.9% vs. 0%, p = 0.02) and at 3 years (11.4% vs. 3.8%, p = 0.133). There were no statistically significant differences regarding the combined safety endpoint (p = 1), acute kidney injury (AKIN 2 or AKIN 3) (p = 1; p = 0.477), or new pacemaker implantation (p = 0.31), at either 30 days or 3 years. Postprocedural myocardial infarction and stroke showed comparable rates in both groups. Conclusions: In terms of early clinical outcomes, no statistically significant differences were observed between the two groups of self-expandable valve prostheses, except for a significantly higher rate of minor bleeding in the Evolut group at 30 days. Notably, this trend of increased minor bleeding in the Evolut group persisted over the 3-year follow-up period, although the difference did not reach statistical significance. Both groups demonstrated low rates of all-cause mortality and clinical complications at long-term follow-up. The choice of valve should be customized to the individual characteristics of each patient.

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Dataset Information

Incidence and Risk Assessment of Infolding Using Self-Expandable Devices in TAVR.

Background

Methods

Results

Conclusions

Publications

Incidence and Risk Assessment of Infolding Using Self-Expandable Devices in TAVR.

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