Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty

Bijuklic, Klaudija; Haselbach, Timo; Witt, Julian; Krause, Korff; Hansen, Lorenz; Gehrckens, Ralf; Rieß, Friedrich-Christian; Schöfer, Joachim

doi:10.1016/j.jcin.2015.07.013

Cited by 66 publications

(73 citation statements)

References 16 publications

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“…Among the studied populations, TAVI was performed without preimplantation BAV in 721 patients and with preimplantation BAV in 674 patients. The mean age was 81.3 years, and 49.6% of participants were female in 14 studies that reported both age and sex . The balloon‐expandable Edwards SAPIEN XT or SAPIEN 3 valve was implanted in 10 studies including 793 patients, and the self‐expandable Medtronic CoreValve was used in 7 studies including 602 patients.…”

Section: Resultsmentioning

confidence: 99%

“…The crude incidence of residual moderate or severe aortic regurgitation or PVL was reported in 9 studies and occurred in 16% (124 of 757) of patients. In this regard, 4 studies used the balloon‐expandable valve with a 3% rate (9 of 262 patients), and 5 studies used the self‐expandable valve with a 23% rate (115 of 495 patients). Of note, the need for postimplantation postdilation was reported in 14 studies and occurred in 18% (210 of 1177) of patients; 9 studies used the balloon‐expandable valve with a 14% rate (118 of 864 patients), and 6 studies used the self‐expandable valve with a 29% rate (92 of 313 patients).…”

Section: Resultsmentioning

confidence: 99%

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Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta‐Analysis

Bagur

Kwok

Nombela‐Franco

et al. 2016

JAHA

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BackgroundPreimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV.Methods and ResultsWe conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random‐effects meta‐analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30‐day all‐cause mortality occurred in 6% (72 of 1282) of patients. Meta‐analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32–1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62–1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23–1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66–1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30–1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49–1.30, P=0.37).ConclusionsOur analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta‐Analysis

Bagur

Kwok

Nombela‐Franco

et al. 2016

JAHA

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“…The relatively large proportion of patients treated with direct valve implantation may represent the process of simplifying the TAVI procedure to increase its safety, but more evidence for such an approach is needed [21]. In fact, 33% of Polish centres perform aortic valvuloplasty during TAVI.…”

Section: Discussionmentioning

confidence: 99%

The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland

Parma

Dąbrowski

Ochała

et al. 2017

pwki

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IntroductionFew studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing.AimTo assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making.Material and methodsThe Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively).ResultsThe median TAVI experience per centre was 80 procedures (95% CI: 38.1–154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each.ConclusionsThe PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations.

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“…9 In our study, the need for 11 This is also supported by a recent study showing a higher volume of cerebral ischemic lesions by diffusion-weighted magnetic resonance imaging in patients undergoing direct-TAVR in relation to patients undergoing TAVR with BAVP. 12 Furthermore, preparing the aortic valve with BAVP, especially in those patients with a larger burden of valve calcification, may offer more room and further decrease the risks of hemodynamic instability during device delivery, facilitating the proper position of the THV, potentially leading to a more precise deployment with better outcomes. [13][14][15] In addition, preparation of the aortic valve could facilitate full and symmetrical expansion of the device, ultimately resulting in less paravalvular leak and minimal transaortic gradient.…”

Section: Discussionmentioning

confidence: 99%

Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation

Bernardi

Ribeiro

Carvalho

et al. 2016

Circ: Cardiovascular Interventions

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T ranscatheter aortic valve replacement (TAVR) is a complex multistep procedure that has been established as a treatment option for patients with severe aortic stenosis, considered to be inoperable or at high surgical risk. 1 In experienced centers, there has been a trend toward a simplification of the procedure, moving from general anesthesia and surgical cutdown for the femoral access, to a more minimalistic approach with conscious sedation, local anesthesia, and a fully percutaneous approach.2 Likewise, during the early days of TAVR, balloon aortic valve predilatation (BAVP) was considered an essential step to prepare the calcified aortic valve for the correct positioning and deployment of bulkier transcatheter heart valves (THV). Nonetheless, in line with this trend of making the procedure more straightforward, together with the greater experience of the operators and improvement of devices and technique, the need for predilatation has been questioned. Background-Direct

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Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty

Abstract: The implantation of a balloon-expandable aortic valve without versus with prior BAV, although performed with a shorter procedure time and lower contrast volume, is associated with a significantly higher volume of cerebral ischemic lesions.

Cited by 66 publications

References 16 publications

Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta‐Analysis

Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta‐Analysis

The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland

Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation

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