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Review
. 2023 May 25:10:1130354.
doi: 10.3389/fcvm.2023.1130354. eCollection 2023.

The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis

Nagendra Boopathy Senguttuvan  1   2 , Hemal Bhatt  2   3 , Vinod Kumar Balakrishnan  1 , Parasuram Krishnamoorthy  3 , Sunny Goel  3 , Pothireddy M K Reddy  1 , Vinodhini Subramanian  1 , Bimmer E Claessen  2   4 , Ashish Kumar  5 , Monil Majmundar  6 , Richard Ro  2 , Stamatios Lerakis  2 , Ramamoorthi Jayaraj  7 , Ankur Kalra  5   8 , Marcus Flather  9 , George Dangas  2 , Gilbert H L Tang  10
Affiliations
Review

The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis

Nagendra Boopathy Senguttuvan et al. Front Cardiovasc Med. .

Erratum in

Abstract

Aim: Transfemoral Trans-catheter Aortic Valve Replacement (TF-TAVR) is a safe and effective therapy compared with surgical aortic valve replacement (SAVR) in patients across all risk profiles using balloon-expandable valves (BEV) and self-expanding valves (SEV). Our aim was to compare safety and efficacy of BEV vs. SEV in high-risk patients undergoing TF-TAVR.

Methods and results: We searched PubMed, EMBASE, Clinicaltrials.gov, Scopus, and Web of sciences for studies on patients with severe aortic stenosis undergoing TAVR. Primary outcome was 30-day all-cause mortality. Secondary outcomes defined by Valve Academic Research Consortium 2 (VARC-2) criteria were also examined. Six studies with 2,935 patients (1,439 to BEV and 1,496 to SEV) were included. BEV was associated with lower risk of all-cause mortality (2.2% vs. 4.5%; RR: 0.51; 95% CI: 0.31-0.82; p < 0.006) and cardiovascular mortality [(2.5% vs. 4.3%; RR: 0.54; 95% CI: 0.32-0.90; p = 0.01) at 30 days compared with SEV. Implantation of more than one valve per procedure (0.78% vs. 5.11%; RR: 0.15; 95% CI: 0.07-0.31; p < 0.00001), and moderate/severe AR/PVL (2.5% vs. 9.01%; RR: 0.3; 95% CI: 0.17-0.48); p < 0.00001) were also lower in the BEV arm.

Conclusion: BEV TAVR is associated with reduced all-cause mortality (High level of GRADE evidence), cardiovascular mortality (very low level) at 30 days compared with SEV TAVR in high surgical risk patients. Data are necessary to determine if the difference in outcomes persists in longer-term and if the same effects are seen in lower-risk patients.

Systematic review registration: identifier, CRD42020181190.

Keywords: aortic stenosis; balloon expandable; self-expanding; trans catheter aortic valve replacement; valve.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
The preferred reporting items for systematic reviews and meta-analyses (PRISMA) Chart. Electronic search from databases and study selection.
Figure 2
Figure 2
Comparison of balloon expandable platform vs. self-expanding platforms in high risk patients undergoing TAVR, BEV is associated with reduced risk of all-cause mortality at 30 days compared with SEV (A). The sub-group difference was not significant when the studies were stratified for the type of study (B). BEV, balloon expandable valve; SEV, self-expanding valve; TAVR, transcatheter aortic valve replacement; M-H, Mantel-Haenszel; CI, confidence interval.
Figure 3
Figure 3
Comparison of balloon expandable platform with old generation self-expanding platforms for to assess the role of study type (RCTs comparing BEV vs. SEV head to head with post-hoc and pre-specified analyses of RCTs) showing no between-the-group difference on the result. BEV, balloon expandable valve; SEV, self-expanding valve; TAVR, trans-catheter aortic valve replacement; M-H, Mantel-Haenszel; CI, confidence interval.
Figure 4
Figure 4
Comparison of balloon expandable platform vs. self-expanding platforms for cardiovascular mortality (A), stroke (B) and early safety (C) at 30 days in high risk patients undergoing TAVR. BEV, balloon expandable valve; SEV, self-expanding valve; TAVR, transcatheter aortic valve replacement; M-H, Mantel-Haenszel; CI, confidence interval.
Figure 5
Figure 5
Comparison of balloon expandable platform vs. self-expanding platforms for implantation of >1 valve per procedure (A), moderate to severe AR/PVL (B), new PPM requirement (C), and device success as defined by VARC (D) at 30 days in high risk patients undergoing TAVR. BEV, balloon expandable valve; SEV, self-expanding valve; AR, aortic regurgitation; PVL, para valvular leak; PPM, permanent pacemaker; TAVR, transcatheter aortic valve replacement; VARC, valve academic research consortium; M-H, Mantel-Haenszel; CI, confidence interval.
Figure 6
Figure 6
Comparison of balloon expandable platform vs. self-expanding platforms for life-threatening bleeding (A), major vascular complications (B), acute kidney injury (C), and atrial fibrillation (D) at 30 days in high risk patients undergoing TAVR. BEV, balloon expandable valve; SEV, self-expanding valve; TAVR, transcatheter aortic valve replacement; M-H, Mantel-Haenszel; CI, confidence interval.
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Comment in

References

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