Key result
Semi-compliant balloon predilatation shows no difference in device success vs non-compliant balloons in TAVR.
Why the study?
The study evaluated differences in outcomes when using semi-compliant versus non-compliant balloon systems for predilatation during self-expanding TAVR.
Does the use of semi-compliant balloon systems compared to non-compliant balloon systems for predilatation affect procedural device success and adverse events in patients undergoing self-expanding TAVR?
Cohort (n=251)
No
Does the use of semi-compliant balloon systems compared to non-compliant balloon systems for predilatation affect procedural device success and adverse events in patients undergoing self-expanding TAVR?
Although balloon compliance during predilatation for self-expanding TAVR did not impact overall VARC-2 device success or 30-day mortality, semi-compliant balloons were associated with lower rates of postdilatation and conversion to open surgery compared to non-compliant balloons.
Answers are grounded in this paper and cite their sources.
Maintains equipoise for balloon compliance in self-expanding TAVR predilatation; leaves open effects on postdilatation and conversion rates.
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.
No takes yet. Share an insight, caveat, or question.
Mach et al. (2021) conducted a cohort in Severe aortic stenosis undergoing self-expanding transcatheter aortic valve replacement (TAVR) (n=251). Predilatation with semi-compliant balloon (SCB) systems (NuCLEUS-X, Z-MED, Z-MED II, VACS II, VACS III) vs. Predilatation with non-compliant balloon (NCB) systems (TRUE Dilatation) was evaluated on VARC-2 defined device success (composite of absence of procedural mortality, correct valve positioning, adequate valve performance, and absence of moderate or severe paravalvular leak) (OR 0.813, 95% CI 0.355-1.971, p=0.257). Semi-compliant balloon predilatation showed no significant difference in procedural device success compared to non-compliant balloons during self-expanding TAVR (85.5% vs 90.6%, P=0.257).
Synapse has enriched 10 related papers. Consider them for comparative context: