Long‐term outcomes of self‐expanding versus balloon‐expandable transcatheter aortic valves: Insights from the <scp>OBSERVANT</scp> study

Costa, Giuliano; D’Errigo, Paola; Rosato, Stefano; Valvo, Roberto; Biancari, Fausto; Tamburino, Corrado; Cerza, Francesco; Cicala, Stefano Domenico; Seccareccia, Fulvia; Barbanti, Marco

doi:10.1002/ccd.29701

Cited by 6 publications

(7 citation statements)

References 30 publications

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“…Although this does not impact on early outcomes and bioprosthesis functioning, comparison of these devices in larger dataset with longer follow-up is needed for a proper evaluation of the eventual clinical relevance of this finding. 22 Unfortunately, the OBSERVANT II study did not provide echocardiographic follow-up of TAVI patients.…”

Section: Discussionmentioning

confidence: 99%

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study

Costa

Barbanti

Rosato

et al. 2022

Circ: Cardiovascular Interventions

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BACKGROUND: Head-to-head comparisons of devices for transcatheter aortic valve implantation (TAVI) are mostly limited to 2-arm studies so far. The aim of this study was to compare simultaneously outcomes of the most used, second- and third-generation transcatheter aortic valves in a real-world population. METHODS: A total of 2728 patients undergoing TAVI with different second- and third-generation devices, and enrolled in the multicenter, prospective OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment) from December 2016 to September 2018 were compared according to the transcatheter aortic valve received. Outcomes were adjudicated through a linkage with administrative databases, and adjusted using inverse propensity of treatment weighting. The primary end point was the composite of all-cause death, stroke and rehospitalization for heart failure at 1-year. Rates were reported consecutively for Evolut R, Evolut PRO, SAPIEN 3, ACURATE neo, and Portico groups. RESULTS: The primary end point did not differ among groups (23.9% versus 24.7% versus 21.5% versus 23.7% versus 27.4%, respectively, P =0.56). Permanent pacemaker implantation was significantly lower for patients receiving SAPIEN 3 (19.9% versus 19.3% versus 12.5% versus 14.7% versus 22.1%, respectively, P <0.01) at 1 year. The SAPIEN 3 had lower rates of paravalvular regurgitation (moderate-to-severe grade 10.1% versus 5.0% versus 2.1% versus 13.1% versus 10.8%, respectively, P <0.01) but higher transprosthetic gradients (median mean gradients 7.0 versus 6.0 versus 10.0 versus 7.0 versus 8.0 mm Hg, respectively, P <0.01) after TAVI. CONCLUSIONS: Data from real-world practice showed low and comparable rates of complications after TAVI considering all the available devices. Patients receiving SAPIEN 3 valve had lower rates of paravalvular regurgitation and permanent pacemaker implantation, but higher transprosthetic gradients.

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Section: Discussionmentioning

confidence: 99%

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study

Costa

Barbanti

Rosato

et al. 2022

Circ: Cardiovascular Interventions

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“…Overall: A total of twenty-one studies 7 – 16 , 18 , 19 , 21 – 23 , 25 – 29 , 31 , 32 were included that assessed mortality. Our analysis found that the results were significant for BEV compared to SEV for overall mortality.…”

Section: Resultsmentioning

confidence: 99%

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis

Khan,

Farrukh,

Belay

et al. 2024

Annals of Medicine &Amp; Surgery

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Background: Aortic stenosis (AS) is a common heart condition categorized into congenital and acquired forms. Transcatheter Aortic Valve Replacement (TAVR) is an innovative method for AS management, and two valve types, Self-Expanding Valves (SEV) and Balloon-Expandable Valves (BEV), are used in TAVR. The objective of this study is to compare the clinical outcomes associated with balloon-expandable and self-expandable valves in transcatheter aortic valve replacement. Methods: The researchers conducted a comprehensive meta-analysis following PRISMA guidelines and AMSTAR 2 tool. The methodology involved a systematic literature search, strict eligibility criteria, unbiased study selection, meticulous data extraction, quality assessment, and rigorous statistical analysis. Results: Our analysis included twenty-six papers and 26553 patients. BEV exhibited significant advantages over SEV in overall mortality across 21 studies, particularly in perioperative and 30-day assessments. However, no substantial disparities emerged between the two valve types in stroke incidence. BEV demonstrated notable benefits in reducing hospitalization rates across 6 studies and significantly fewer instances of permanent pacemaker implantations across 19 studies, particularly evident in the perioperative setting. Other secondary outcomes like bleeding, acute kidney injury, and myocardial infarction showcased non-significant differences between BEV and SEV. Conclusion: The analysis indicates that BEV may offer benefits in specific aspects of TAVR outcomes, but further research is needed to fully understand the factors influencing patient outcomes and mortality in TAVR procedures.

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“…Moderate or severe PVR is associated with increased risk of death and heart failure rehospitalizations. Although the incidence of moderate or even severe PVR has declined considerably with the use of second-generation TAVI devices [25], there is evidence that mild PVR, which is still present in a sizable portion of patients, might negatively affect longterm survival as well [1][2][3] and should be avoided in a lowrisk population, in which surgical aortic valve replacement is a viable alternative.…”

Section: Rationalementioning

confidence: 99%

“…Paravalvular regurgitation (PVR) remains an important drawback of transcatheter aortic valve implantation (TAVI) with negative prognostic implications for the patient [1][2][3]. Apart from procedural causes, its incidence depends on sealing zone anatomy, quantified for example by measures of calcium protrusion into the lumen [4], semiquantitatively graded calcium bulks [5] or landing zone eccentricity or nontubularity [6,7].…”

Section: Introductionmentioning

confidence: 99%

Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation

Stachel

Abdel‐Wahab

Waha‐Thiele

et al. 2022

Int J Cardiovasc Imaging

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To evaluate the prognostic relevance of aortic annulus (AA) and left ventricular outflow tract (LVOT) Fractal dimension (FD). FD is a mathematical concept that describes geometric complexity of a structure and has been shown to predict adverse outcomes in several contexts. Computed tomography (CT) scans from the SOLVE-TAVI trial, which, in a 2 × 2 factorial design, randomized 447 patients to TAVI with the balloon-expandable Edwards Sapien 3 or the self-expanding Medtronic Evolut R, and conscious sedation or general anesthesia, were analyzed semi-automatically with a custom-built software to determine border of AA and LVOT. FD was measured by box counting using grid calibers between 0.8 and 6.75 mm and was compared between patients with none/trivial and mild/moderate paravalvular regurgitation (PVR). Overall, 122 patients had CT scans sufficient for semi-automatic PVR in 30-day echocardiography. PVR was none in 65(53.3%) patients, trace in 9(7.4%), mild in 46(37.7%), moderate in 2(1.6%) and severe in 0 patients. FD determined in diastolic images was significantly higher in patients with mild/moderate PVR (1.0558 ± 0.0289 vs. 1.0401 ± 0.0284, p = 0.017). Annulus eccentricity was the only conventional measure of AA and LVOT geometry significantly correlated to FD (R = 0.337, p < 0.01). Area under the curve (AUC) of diastolic annular FD for prediction of mild/moderate PVR in ROC analysis was 0.661 (0.542–0.779, p = 0.014). FD shows promise in prediction of PVR after TAVI. Further evaluation using larger patient numbers and refined algorithms to better understand its predictive performance is warranted.Trial Registration:www.clinicaltrials.gov, identifier: NCT02737150, date of registration: 13.04.2016.

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Long‐term outcomes of self‐expanding versus balloon‐expandable transcatheter aortic valves: Insights from the OBSERVANT study

Cited by 6 publications

References 30 publications

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis

Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation

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