Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement

Leclercq, Florence; Robert, Pierre; Akodad, Mariama; Macia, Jean‐Christophe; Gandet, Thomas; Delseny, Delphine; Chettouh, Marine; Schmutz, Laurent; Robert, Gabriel; Lévy, G.; Targosz, Frédéric; Maupas, Eric; Roubille, François; Marin, Grégory; Nagot, Nicolas; Albat, Bernard; Lattuca, Benoît; Cayla, Guillaume

doi:10.1016/j.jcin.2019.12.006

Cited by 36 publications

(33 citation statements)

References 25 publications

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“…We included eight studies in qualitative synthesis and eight in the meta‐analysis (Figure 1). There were a total of 3078‬ patients from eight studies 10‐12,14‐18 . Three studies were RCTs, three studies were propensity‐matched cohorts, and two studies were matched cohorts.…”

Section: Resultsmentioning

confidence: 99%

“…There were a total of 3078 patients from eight studies. [10][11][12][14][15][16][17][18] Three studies were RCTs, three studies were propensity-matched cohorts, and two studies were matched cohorts. Three studies were multicentre and five studies were single-center.…”

Section: Study Selection and Baseline Characteristicsmentioning

confidence: 99%

“…11 Recently published randomized controlled trials (RCTs) showed promise that direct was noninferior to preimplantation balloon valvuloplasty in both balloon-expandable valves and self-expandable valves. 10,12 In this systematic review and meta-analysis, we aim to evaluate the efficacy and safety of direct vs preimplantation balloon valvuloplasty (predilatation) before TAVR. This study will only include RCT and prospective-matched cohorts to reduce potential bias.…”

Section: Introductionmentioning

confidence: 99%

“…By reducing maneuvers, it is hoped that temporary hypoperfusion can be reduced, and the mechanical complications can be avoided 11 . Recently published randomized controlled trials (RCTs) showed promise that direct was noninferior to preimplantation balloon valvuloplasty in both balloon‐expandable valves and self‐expandable valves 10,12 . In this systematic review and meta‐analysis, we aim to evaluate the efficacy and safety of direct vs preimplantation balloon valvuloplasty (predilatation) before TAVR.…”

Section: Introductionmentioning

confidence: 99%

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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: Resultsmentioning

confidence: 99%

Section: Study Selection and Baseline Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…The ever-growing number of TAVI procedures benefit from improved pre-procedural assessment, with dedicated protocols of computed tomography (CT) image acquisition and reconstruction, including sophisticated but still experimental 3D software simulating procedural outcome as severity of aortic regurgitation and need of pacemaker (PM) implantation (FEops HEART Guide™, Gent, Belgium) [ 4 ]. The procedural technique itself has been refined and aims, in selected patients, to a ‘minimalistic’ approach, which consists of percutaneous femoral primary access route–now used in more than 95% of patients [ 3 ] secondary radial access for supravalvular aortic angiography to guide valve deployment and check optimal closure of the primary access [ 5 ], direct implantation without pre-dilatation [ 6 ], vascular and transthoracic echocardiography with no transoesophageal echocardiography and the increasing use of conscious sedation and local anaesthesia [ 7 ]. Engineering advances on transcatheter valves’ design led to catheter miniaturization and lower paravalvular leaks (PVL), thanks to optimized sealing “skirts”, applied on both balloon-expandable and self-expanding valves.…”

Section: Introduction Extended Indications: a Powerful Stimulus To Reduce All Complicationsmentioning

confidence: 99%

Advancements in Transcatheter Aortic Valve Implantation: A Focused Update

et al. 2021

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Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65–75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).

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One‐year clinical and echocardiographic outcomes of direct implantation of a self‐expanding valve

Benetos

Karmpalioti

Drakopoulou

et al. 2020

Cathet Cardio Intervent

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Objective: To present 1 year clinical and echocardiographic outcomes of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial.Background: Intermediate-term data from randomized studies investigating the safety and efficacy of direct implantation are lacking.Methods: DIRECT trial randomized 171 consecutive patients with severe aortic stenosis at four tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. All patients underwent a clinical and echocardiographic follow-up at 1 year. All-cause and cardiac mortality, stroke, heart failure hospitalization, and new pacemaker implantation were recorded.Results: At 1 year, four deaths were recorded in pre-BAV group (4.7%) and three deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality at 1 year (log-rank p = .72). Similarly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at 1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group, log-rank p = .24). There was no significant difference between pre-BAV and no BAV group in aortic valve area (1.84 ± 0.39 cm 2 vs. 1.85 ± 0.44 cm 2 , p = .90), mean aortic valve gradient (8.36 ± 5.04 vs. 8.00 ± 4.04 mmHg, p = .65) and moderate or severe paravalvular regurgitation Georgios Benetos and Maria Karmpalioti contributed equally to this study.

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Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement

Cited by 36 publications

References 25 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

Advancements in Transcatheter Aortic Valve Implantation: A Focused Update

One‐year clinical and echocardiographic outcomes of direct implantation of a self‐expanding valve

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