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Need for Embolic Protection During Transcatheter Aortic Valve Implantation: An Interventionalist's Perspective on Histopathology Findings.

ABSTRACT: Transcatheter aortic valve implantation (TAVI) is a less invasive aortic valve replacement technique and is indicated for patients with symptomatic severe aortic stenosis and a high operative risk. Cerebral embolisation seems inherent to TAVI, as illustrated by the consistent appearance of new brain lesions on post-procedural MRI studies. Embolic protection devices may capture or deflect embolised material en route to the brain and thus reduce TAVI-related brain injury. Histopathology studies of captured debris revealed a diverse aetiology including recent or organised thrombotic material, tissue originating from the aortic valve, atherosclerotic plaques or myocardium and foreign body components. In this overview we provide a perspective on current evidence and implications for embolic protection devices in the dynamic TAVI field.

SUBMITTER: Kroon HG

PROVIDER: S-EPMC5808741 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Need for Embolic Protection During Transcatheter Aortic Valve Implantation: An Interventionalist's Perspective on Histopathology Findings.

Kroon Herbert G HG Van Mieghem Nicolas Mda NM

Interventional cardiology (London, England) 20170501 1

Transcatheter aortic valve implantation (TAVI) is a less invasive aortic valve replacement technique and is indicated for patients with symptomatic severe aortic stenosis and a high operative risk. Cerebral embolisation seems inherent to TAVI, as illustrated by the consistent appearance of new brain lesions on post-procedural MRI studies. Embolic protection devices may capture or deflect embolised material en route to the brain and thus reduce TAVI-related brain injury. Histopathology studies of ...[more]

PMID: 29588728

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Project description:BackgroundThe use of cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) reveals conflicting data.AimsThis updated meta-analysis aims to evaluate the efficacy and safety of the SENTINEL Cerebral Protection System.MethodsA literature search for relevant studies up to September 2022 was performed. Study outcomes were divided based on time period - overall (up to 30 days) and short (≤7 days). The outcomes studied include stroke (disabling, non-disabling), mortality, neuroimaging findings, transient ischaemic attack, acute kidney injury and major vascular and bleeding complications.ResultsA total of 15 studies involving 294,134 patients were included. Regarding overall outcomes, significant reductions were noted for mortality (odds ratio [OR] 0.60, 95% confidence interval [CI]: 0.41-0.88; p=0.008), all stroke (OR 0.64, 95% CI: 0.46-0.88; p=0.006) and disabling stroke (OR 0.42, 95% CI: 0.23-0.74; p=0.003) using the SENTINEL device. No significant differences were noted for other outcomes. There was significant heterogeneity across the studies for mortality (p=0.013) and all stroke (p=0.003). Including only randomised data (n=4), there was only significant reduction in the incidence of disabling stroke (OR 0.39, 95% CI: 0.17-0.89; p=0.026) in the SENTINEL group. In studies reporting ≤7-day outcomes (n=8), use of the SENTINEL device demonstrated significantly lower rates of all stroke (p<0.001), disabling stroke (p<0.001) and major bleeding complications (p=0.02). No differences in neuroimaging outcomes were noted.ConclusionsIn this updated meta-analysis, use of the SENTINEL Cerebral Protection System was associated with lower rates of mortality, all stroke and disabling stroke, although significant heterogeneity was noted for mortality and all stroke. Including exclusively randomised data, there was only significant reduction in the incidence of disabling stroke. No significant adverse outcomes with device use were noted.

Project description:BackgroundStroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited.MethodsWe performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights.ResultsOur analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses.ConclusionsIn this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.

Project description:BackgroundIn the treatment of valvular heart diseases, transcatheter therapies have changed the rules of the game, especially in the case of aortic stenosis and mitral regurgitation. Since the first in man transcatheter aortic valve intervention (TAVI) performed by Dr. Alain Cribier in 2002 in a non-operable aortic stenosis (AS) patient, TAVI has changed the lives of so many patients for whom medical treatment was, up to then, the only option.ObjectiveThis article outlines patient selection and pre-procedure evaluation, current perspectives, recent advances, current and future devices, current guidelines informing the use of TAVI, expanding indications for TAVI, ongoing challenges and the future of TAVI.MethodsThe use of these percutaneous techniques has also increased significantly in the past few years with its first application in 2002, transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis and has become the standard of care for patients with AS at prohibitively high surgical risks, as well as a preferred treatment for elderly patients with intermediate and high-risk AS.ResultsSince the first pioneering procedure was performed 22 years ago, transcatheter aortic valve implantation (TAVI) has evolved into a routine procedure increasingly performed under conscious sedation via transfemoral access. On a global market worth $2 billion per year, over 300 000 patients have received a transcatheter aortic valve, demonstrating its clinical and market impact. TAVI may be used in lower risk, younger, asymptomatic populations with ongoing studies using an expanding portfolio of devices. Also, for patients deemed unsuitable for cardiac surgery, mitral transcatheter therapies represent the treatment of choice. Percutaneous repair techniques have had the most clinical experience to date.ConclusionDuring this 20-year period, the increased knowledge on pre-procedural planning, the important technological improvements in transcatheter valves, the increased experience and the numerous studies that have been carried out have permitted an expansion of the indications for TAVI, from inoperable patients to high- and intermediate-risk patients. This article outlines patient selection and pre-procedure evaluation, current perspectives, recent advances, current and future devices, current guidelines informing the use of TAVI, expanding indications for TAVI, ongoing challenges and the future of TAVI.

Dataset Information

Need for Embolic Protection During Transcatheter Aortic Valve Implantation: An Interventionalist's Perspective on Histopathology Findings.

Publications

Need for Embolic Protection During Transcatheter Aortic Valve Implantation: An Interventionalist's Perspective on Histopathology Findings.

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