Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation

Banerjee, Kinjal; Kandregula, Krishna; Sankaramangalam, Kesavan; Anumandla, Anil Kumar Reddy; Kumar, Arnav; Parikh, Parth; Kerrigan, Jimmy; Khubber, Shameer; Krishnaswamy, Amar; Mick, Stephanie; White, Jonathon; Svensson, Lars G.; Kapadia, Samir

doi:10.1016/j.amjcard.2018.04.025

Cited by 17 publications

(12 citation statements)

References 26 publications

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“…This meta‐analysis also differs from another previous meta‐analysis of observational studies, which showed that direct TAVR was associated with less AR, fewer pacemaker implantation, vascular complications 20 . The present meta‐analysis showed that moderate‐severe AR/PVL, new pacemaker implantation, and vascular complications were similar in both groups.…”

Section: Discussioncontrasting

confidence: 99%

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement—Systematic review and meta‐analysis of randomized controlled trials and prospective‐matched cohorts

et al. 2020

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Background This systematic review and meta‐analysis aimed to evaluate the efficacy and safety of direct vs preimplantation balloon valvuloplasty (predilatation) before transcatheter aortic valve replacement (TAVR). Methods We performed a systematic literature search up until March 2020 from PubMed, SCOPUS, EuropePMC, Cochrane Central Database, ProQuest, and http://ClinicalTrials.gov. We included randomized controlled trial (RCT) and prospective‐matched cohorts that compared direct TAVR and preimplantation balloon valvuloplasty before TAVR. The primary outcome was the device success as defined by Valve Academic Research Consortium 2. The secondary outcome was a patient‐prosthesis mismatch, the need for balloon postdilatation, composite adverse events, and 1‐year mortality. Results There were a total of 3078‬ patients from eight studies. This meta‐analysis showed that direct TAVR has a similar device success rate (P = .63), the need for postdilatation (P = .82), and composite adverse events (P = .98) compared with preimplantation balloon valvuloplasty. Subgroup analysis for balloon‐expandable valves showed lower need for balloon postdilatation (risk ratio [RR], 0.63 [0.47, 0.84]; P = .002; I2, 0%) in direct TAVR group but higher incidence of acute kidney injury (RR, 3.23 [1.25, 8.40]; P = .02; I2, 0%) and major/life‐threatening bleeding (RR, 1.54 [1.17, 2.02]; P = .002; I2, 0%). Subgroup analysis for the RCTs alone and RCTs + propensity‐matched cohorts showed similar device success and composite adverse events in both groups. However, pooled RCTs showed a higher need for balloon postdilatation in direct TAVR (RR, 1.83 [1.03, 3.24]; P = .04; I2, 0%). Conclusion Direct TAVR has similar efficacy and safety to preimplantation balloon valvuloplasty. However, better‐designed RCTs are required before drawing a definite conclusion.

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Section: Discussioncontrasting

confidence: 99%

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement—Systematic review and meta‐analysis of randomized controlled trials and prospective‐matched cohorts

et al. 2020

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“…Remarkably, none of the 158 patients with both a balloon-expandable valve and without predilation developed LCP. A recent meta-analysis of the impact of balloon predilation found lower PPI rates in patients without predilation 15. This supports the theory that predilation could result in direct trauma and ischaemia to the conduction system causing early CDs 16.…”

Section: Discussionmentioning

confidence: 57%

Late onset of new conduction disturbances requiring permanent pacemaker implantation following TAVI

Kooistra

Mourik

Rodríguez-Olivares

et al. 2020

Heart

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BackgroundThe timing of onset and associated predictors of late new conduction disturbances (CDs) leading to permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) are still unknown, however, essential for an early and safe discharge. This study aimed to investigate the timing of onset and associated predictors of late onset CDs in patients requiring PPI (LCP) following TAVI.Methods and resultsWe performed retrospective analysis of prospectively collected data from five large volume centres in Europe. Post-TAVI electrocardiograms and telemetry data were evaluated in patients with a PPI post-TAVI to identify the onset of new advanced CDs. Early onset CDs were defined as within 48 hours after procedure, and late onset CDs as after 48 hours. A total of 2804 patients were included for analysis. The PPI rate was 12%, of which 18% was due to late onset CDs (>48 hours). Independent predictors for LCP were pre-existing non-specific intraventricular conduction delay, pre-existing right bundle branch block, self-expandable valves and predilation. At least one of these risk factors was present in 98% of patients with LCP. Patients with a balloon-expandable valve without predilation did not develop CDs requiring PPI after 48 hours.ConclusionsSafe early discharge might be feasible in patients without CDs in the first 48 hours after TAVI if no risk factors for LCP are present.

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“…However, these studies have been mostly limited to the previous generation of SAPIEN XT prosthesis [4]; although, some have been conducted for the currently commercially available SAPIEN 3 prosthesis [9,15]. Larger studies, [6,7,9]. We should, however, acknowledge that there was a trend toward a worse composite safety endpoint in the direct TAVR group, although it was not statistically significant.…”

Section: Impact Of Direct Tavr Vs Pre-bav Tavr On Procedures and 30day Safety Outcomesmentioning

confidence: 99%

Outcomes of transcatheter aortic valve replacement without predilation of the aortic valve: Insights from 1544 patients included in the SOURCE 3 registry

Dumonteil

Terkelsen

Frerker

et al. 2019

International Journal of Cardiology

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Aims: To investigate the impact of transcatheter aortic valve replacement (TAVR) without preliminary balloon aortic valvuloplasty (pre-BAV) on periprocedural outcomes in a large, real-world registry. Methods and results: The SOURCE 3 registry was an observational, multi-center, single-arm study of patients with severe, symptomatic aortic stenosis at high surgical risk treated with the SAPIEN 3 transcatheter heart valve (THV). Procedural and 30-day outcomes were compared between two groups of 772 patients each (retrospectively matched) with or without pre-BAV. All baseline clinical, echocardiographic, and anatomical valve characteristics were comparable between groups except for Society of Thoracic Surgeons (STS) score, which was lower in the direct TAVR group (6.0 ± 5.9 vs 7.8 ± 8.3; p ¼ 0.003). In the direct TAVR group, there were less post-dilatations (8.1% vs. 13.1%, p ¼ 0.002), shorter procedural time (70.9 ± 39.8 min vs 73.0 ± 32.2 min, p ¼ 0.033) and fluoroscopy time (13.4 ± 7.0 min vs 14.9 ± 7.4 min, p < 0.001). Other procedural outcomes and echocardiographic variables at 30 days did not differ significantly between the two groups: safety endpoint (10.4% with pre-BAV vs 13.5% with direct TAVR, p ¼ 0.059), mortality (2.1% vs 2.3%, p ¼ 0.730), disabling strokes (0.4% vs 0.5%, p ¼ 0.704), and moderate to severe paravalvular leak (PVL) (3.2% vs 2.2%, p ¼ 0.40). Unexpectedly, new permanent pacemaker implantation and life-threatening bleeds were less frequently observed with pre-BAV group than with direct TAVR (10.4% vs 13.9%, p ¼ 0.032 and 3.5% vs 6.5%, p ¼ 0.007, respectively). Conclusion:In this large TAVR dataset, direct implantation of the SAPIEN 3 THV without pre-BAV was feasible and safe and resulted in shorter procedures, without impact on 30-day prosthesis function and PVL.

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Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation

Cited by 17 publications

References 26 publications

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement—Systematic review and meta‐analysis of randomized controlled trials and prospective‐matched cohorts

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement—Systematic review and meta‐analysis of randomized controlled trials and prospective‐matched cohorts

Late onset of new conduction disturbances requiring permanent pacemaker implantation following TAVI

Outcomes of transcatheter aortic valve replacement without predilation of the aortic valve: Insights from 1544 patients included in the SOURCE 3 registry

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