Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement

Kapadia, Samir; Kodali, Susheel; Makkar, Raj; Mehran, Roxana; Lazar, Ronald M.; Zivadinov, Robert; Dwyer, Michael G.; Jilaihawi, Hasan; Virmani, Renu; Anwaruddin, Saif; Thourani, Vinod H.; Nazif, Tamim; Mangner, Norman; Woitek, Felix; Krishnaswamy, Amar; Mick, Stephanie; Chakravarty, Tarun; Nakamura, Mamoo; McCabe, James M.; Satler, Lowell F.; Zajarías, Alan; Szeto, Wilson Y.; Svensson, Lars G.; Alu, Maria; White, Roseann; Kraemer, Carlye; Parhizgar, Azin; Leon, Martin B.; Linke, Axel; Al-Jilaihawi, Hasanian; Tuzcu, E. Murat; Nazif, Tamin; Babaliaros, Vasilis; Devireddy, Chandan; Mavromatis, Kreton; Waksman, Ron; Pichard, Augusto D.; Vallabhajosyula, Prashanth; Giri, Jay; Herrmann, Howard C.; Lasala, John M.; Greenbaum, Adam; O’Neill, William W.; Eng, Marvin H.; Rovin, Joshua D.; Lin, Li Jen; Spriggs, Douglas; Wong, S. Chiu; Bergman, Geoffrey; Salemi, Arash; Smalling, Richard W.; Kar, Biswajit; Loyalka, Pranav; Lim, D. Scott; Ragosta, Michael; Reisman, Mark; Don, Creighton W.; Sharma, Samin K.; Kini, Annapoorna; Dangas, George; Mahoney, Paul; Morse, Andrew C.; Stankewicz, Mark A.; Rodríguez, Evelio; Frerker, Christian; Cohen, David J.

doi:10.1016/j.jacc.2016.10.023

Cited by 408 publications

(288 citation statements)

References 38 publications

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“…Five studies were randomized controlled trials17, 18, 19, 20, 21; the remaining 3 were registries 15, 16, 22. The mean age was 81.7 years, and 50.2% were female.…”

Section: Resultsmentioning

confidence: 99%

“…On the other hand, the availability of these devices spurred the cardiological community to increase the use of MRI to assess patients after TAVI, thus leading to the publication of several randomized studies and/or registries specifically focusing on cerebral embolic protection 15, 16, 17, 18, 19, 20, 21. All these studies, regardless of the design, arterial access, type of prosthesis, and the EPD, consistently showed that the rate of silent new ischemic cerebral lesions (as high as 80%) is much higher than the rate of clinically relevant cerebrovascular events (2–6%) 22.…”

Section: Discussionmentioning

confidence: 99%

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Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Testa

Latib

Casenghi

et al. 2018

JAHA

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BackgroundThe use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation. Available evidence from single studies is inconclusive. The aim of the present meta‐analysis was to assess the safety and efficacy profile of current EPD.Methods and ResultsMajor medical databases were searched up to December 2017 for studies that evaluated patients undergoing transcatheter aortic valve implantation with or without EPD. End points of interest were 30‐day mortality, 30‐day stroke, the total number of new lesions, the ischemic volume per lesion, and the total volume of lesions. Eight studies involving 1285 patients were included. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. The use of EPD was not associated with significant differences in terms of 30‐day mortality (odds ratio 0.43 [0.18–1.05], P=0.3) but it was associated with a lower rate of 30‐day stroke (odds ratio 0.55 [0.31–0.98], P=0.04). No differences were detected with respect to the number of new lesions (standardized mean difference −0.19 [−0.71 to 0.34], P=0.49). The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, −0.52 [−0.85 to −0.20], P=0.002) and smaller total volume of lesions (standardized mean difference, −0.23 [−0.42 to −0.03], P=0.02).ConclusionsThe use of EPD is not associated with a reduced rate of mortality and new ischemic cerebral lesions. The use of EPD during transcatheter aortic valve implantation seems to be associated with a lower 30‐day stroke rate, although this result is driven by a single nonrandomized study. The use of EPD is associated with a smaller volume of ischemic lesions, and smaller total volume of ischemic lesions.

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“…Five studies were randomized controlled trials17, 18, 19, 20, 21; the remaining 3 were registries 15, 16, 22. The mean age was 81.7 years, and 50.2% were female.…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Testa

Latib

Casenghi

et al. 2018

JAHA

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“…8 The recent SENTINEL trial (Cerebral Protection in Transcatheter Aortic Valve Replacement) of the Montage Dual Filter System (Claret Medical, Inc) demonstrated that 99% of deployed filters retrieved periprocedural embolic debris from the cerebral vessels (size range of 0.15 to >1 cm), identified by histopathology as valve-related material (including calcium, thrombus, and valve leaflet tissue), as well as arterial wall and TAVR delivery system catheter fragments. 9 Although these observations have made mechanical reduction of procedural embolization a primary target of periprocedural stroke prevention during TAVR, the complex and multifactorial pathogenesis and variable presentation of neurological injury early and late after these procedures warrants continued attention to additional factors that could modulate the known embolic risk and its clinical consequences.…”

Section: Procedural Stroke Riskmentioning

confidence: 99%

Carotid Disease and Stroke After Transcatheter Aortic Valve Replacement

Lansky

Ghare

Pietras

2018

Circ: Cardiovascular Interventions

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“…Moreover, the device demonstrated retrieval of diverse tissue and material and subsequent reduction of cerebral lesions as assessed by CMRI 8, 9, 10. In TAVR procedures, clinical studies revealed evidence of visible debris removed in up to 100% of cases; the device has also been studied in other endovascular procedures, such as interventional left atrial appendage (LAA) closure, transcatheter valve‐in‐valve procedures, and transcatheter mitral valve repair via MitraClip 11, 12, 13, 14. The aim of the present pilot study was to assess the safety and feasibility of the Sentinel CPS during VT ablation procedures in patients with ischemic heart disease and to provide insight into the histo‐pathomorphologic correlates of periprocedural cerebral embolization.…”

Section: Introductionmentioning

confidence: 99%

Cerebral Protection During Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Heart Disease

Heeger

Metzner

Schlüter

et al. 2018

JAHA

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BackgroundCatheter ablation of ventricular tachycardia (VT) is associated with the risk of cerebral embolism. The origin of periprocedural brain embolism in the setting of VT ablation is often unknown and strategies to avoid it are sparse. The aim of this study was to assess the safety and feasibility of an endovascular 2‐filter‐based cerebral protection system (CPS) in left ventricular VT ablation procedures in patients with ischemic heart disease. Furthermore, histopathological correlates of periprocedural embolization were investigated.Methods and ResultsIn this pilot study, 11 patients with ischemic heart disease and sustained VT underwent left ventricular catheter ablation under CPS surveillance. The placement of the CPS was conducted before the ablation procedure via the right radial artery. The VT ablation procedure was performed via a combined transaortic and transseptal approach. All VTs were successfully ablated. Placement and retrieval of the CPS was successful and safe in all cases. No periprocedural complications related to the CPS were observed and no periprocedural transient ischemic attack or stroke occurred. Debris captured by the CPS was detected in all patients. Histology revealed that acute thrombus was the most common type of debris (91%), followed by arterial wall tissue (73%) and foreign material (55%). Less frequently found were myocardium (27%), calcification (9%), necrotic core (9%), and valve tissue (9%).ConclusionsCerebral protection during VT ablation seems to be safe and feasible. Ablation procedures of VT are associated with embolization of embolic debris, which was found in every patient.

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Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement

Abstract: TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).

Cited by 408 publications

References 38 publications

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Carotid Disease and Stroke After Transcatheter Aortic Valve Replacement

Cerebral Protection During Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Heart Disease

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