Dataset Information

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

ABSTRACT:

Background

This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR).

Methods

251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions.

Results

No significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success.

Conclusion

While the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

SUBMITTER: Mach M

PROVIDER: S-EPMC8459263 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLimited studies have focused on the performance of self-expandable valves (SEVs) and balloon-expandable valves (BEVs) in patients with dilatated ascending aorta (AA) undergoing transcatheter aortic valve replacement (TAVR). The present study compared the performance of widely used Edwards BEVs and domestic SEVs in patients with dilatated AA among Chinese population.MethodsWe identified and reviewed 207 patients who had baseline AA diameter ≥40 mm and underwent transfemoral TAVR. Patients were divided into two groups: SEV and BEV. The SEVs were locally manufactured valves that have received Chinese regulatory approval (Venus-A, Taurus One, and VitaFlow), while the BEVs were Edwards Sapien XT and Sapien3. Procedural device success and post-procedural changes of AA diameters were compared.ResultsThe sample size of SEV group was larger than that of BEV group because BEVs were not available in China in the early clinical practice. The overall device success was slightly lower in SEV group compared with BEV group (84.2% vs. 95.8%, P=0.213). However, in the univariable and multivariable logistic regression analyses, only bicuspid aortic valve (BAV) was found to be an independent risk factor for device failure (OR: 2.632, CI: 1.107-6.257, P=0.029). During the median follow-up of 21 months, no statistical difference was found between the two groups regarding the overall survival (83.1%±4.7% vs. 95.8%±4.1%, P=0.533), and no aortic dissection nor rupture was observed. In a subgroup of patients who had follow-up CTs ≥12-month intervals, the AA diameter appeared to remain stable in SEV group with an aortic expansion rate of 0 (-0.4 to 0.8) mm (P=0.102), while it slightly enlarged in BEV group with an aortic expansion rate of 0.4 (-0.4 to 0.6) mm/y (P=0.038). In addition, the AA diameter also slightly enlarged in patients with BAV [0.2 (0 to 1.0) mm/y, P=0.015], while it remained stable in patients with tricuspid aortic valve (TAV) [0 (-0.8 to 0.6) mm/y, P=0.640].ConclusionsIn patients with dilatated AA who underwent TAVR, the type of THVs did not affect the procedural device success. BAV appeared to be a risk factor for both device failure and higher aortic expansion rate in these patients.

Project description:IntroductionThe effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-TAVR) has recently been subject of debate. We investigate outcomes of patients treated with balloon-expanding (BE) vs. self-expanding (SE) valves in in a cohort of all these procedures performed in Germany in 2018.MethodsAll patients receiving TF-TAVR with either BE (N = 9,882) or SE (N = 7,413) valves in Germany in 2018 were identified. In-hospital outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, permanent pacemaker implantation, mechanical ventilation > 48 h, length of hospital stay, and reimbursement. Since patients were not randomized to the two treatment options, logistic or linear regression models were used with 22 baseline patient characteristics and center-specific variables as potential confounders. As a sensitivity analysis, the same confounding factors were taken into account using the propensity score methods (inverse probability of treatment weighting).ResultsBaseline characteristics differed substantially, with higher EuroSCORE (p < 0.001), age (p < 0.001) and rate of female sex (p < 0.001) in SE treated patients. After risk adjustment, no marked differences in outcomes were found for in-hospital mortality [risk adjusted odds ratio (aOR) for SE instead of BE 0.94 (96% CI 0.76;1.17), p = 0.617] major bleeding [aOR 0.91 (0.73;1.14), p = 0.400], stroke [aOR 1.13 (0.88;1.46), p = 0.347], acute kidney injury [OR 0.97 (0.85;1.10), p = 0.621], postoperative delirium [aOR 1.09 (0.96;1.24), p = 0.184], mechanical ventilation > 48 h [aOR 0.98 (0.77;1.25), p = 0.893], length of hospital stay (risk adjusted difference in days of hospitalization (SE instead of BE): - 0.05 [- 0.34;0.25], p = 0.762) and reimbursement [risk adjusted difference in reimbursement (SE instead of BE): - €72 (- €291;€147), p = 0.519)] There is, however, an increased risk of PPI for SE valves (aOR 1.27 [1.15;1.41], p < 0.001). Similar results were found after application of propensity score adjustment.ConclusionsWe find broadly equivalent outcomes in contemporary TF-TAVR procedures, regardless of the valve type used. Incidence of major complications is very low for both types of valve.