Abstract

Transcatheter aortic valve replacement (TAVR) is a newer alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. Clinical trials have investigated TAVR's safety and effectiveness. Cerebral embolization is a common complication leading to stroke after TAVR and SAVR; different cerebral protection methods have been studied to prevent this.This paper evaluates the rate of post-procedural stroke rates between TAVR and SAVR and investigates the effect of cerebral protective methods on the stroke risk post-TAVR.Publications on TAVR and SAVR were found using specific criteria on PubMed. The Placement of Aortic Transcatheter Valves 1 (PARTNER 1) and PARTNER 2, the Nordic Aortic Valve Intervention (NOTION), and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trials compared the incidence of complications between TAVR and SAVR. The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCED), CoreValve (Medtronic, Minneapolis, MN), Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (Neuro-TAVI), Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotusTM Valve System (Boston Scientific, Marlborough, MA) - Randomized Clinical Evaluation (REPRISE II), and The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STC/ACC TVT) registry studies further explored the risk of stroke in TAVR. The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVO)-3 MRI, a prospective randomized evaluation of the TriGuardTM HDH (Keystone Heart, Tampa, FL) Embolic Deflection Device During Transcatheter Aortic Valve Replacement (DEFLECT III), Claret Embolic Protection and Transcatheter Aortic Valve Implantation (CLEAN-TAVI), and Cerebral Protection in Transcatheter Aortic Valve Replacement (SENTINEL) trials investigated cerebral protection methods post-TAVR for stroke prevention.In the PARTNER 1 trial, the stroke rate was greater in the TAVR group than in the SAVR group at one year (8.3% vs. 4.3%, P=0.04); the PARTNER 2 trial showed a lower risk of stroke at two years (6.2% and 6.4%, respectively). The NOTION and SURTAVI trials showed no significant difference in stroke rate between TAVR and SAVR at one year (13.1% vs 16.3%, respectively; p = 0.43). An increase in stroke rate after TAVR was found in the ADVANCED trial (5.6% at 31 days - two years) and CoreValve trial (4.3% in the late phase). The Neuro-TAVI trial showed ischemia after TAVR in 20% of patients at discharge. In the STC/ACC TVT Registry, the rate of post-procedure disabling stroke was 1.7% at 30 days. Finally, the BRAVO-3 MRI study showed no advantages between bivalirudin or unfractionated heparin in preventing cerebral lesion formation (65.5% vs 58.1%, respectively; p = 0.55). The DEFLECT III, CLEAN-TAVI, and SENTINEL trials assessed the safety and efficacy of transcatheter cerebral embolic protection devices (CEPDs); their results ranged from 50% improvement (CLEAN-TAVI) to none (DEFLECT III, SENTINEL), therefore, showing non-inferiority of cerebral embolic protection devices for TAVR patients.The clinical trials studied in this paper showed a similar incidence of stroke in both groups, with the majority of TAVR patients developing cerebral lesions. With the addition of cerebral embolic protective devices, this incidence has decreased.

Highlights

  • BackgroundAortic stenosis is a degenerative disease causing left ventricular outflow obstruction, decreased cardiac output, and subsequent mortality [1]

  • The clinical trials studied in this paper showed a similar incidence of stroke in both groups, with the majority of transcatheter aortic valve replacement (TAVR) patients developing cerebral lesions

  • The Bivalirudin on Aortic Valve Intervention Outcomes (BRAVO)-3 MRI study is a part of the BRAVO-3 trial, a double-blind randomized, controlled trial comparing bivalirudin with unfractionated heparin (UFH) in patients undergoing transfemoral TAVR to evaluate whether parenteral procedural anticoagulation affects cerebral embolization

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Summary

Introduction

Aortic stenosis is a degenerative disease causing left ventricular outflow obstruction, decreased cardiac output, and subsequent mortality [1]. The first arm of the trial assessed TAVR vs SAVR outcomes in patients with severe aortic stenosis and high surgical risk. The BRAVO-3 MRI study is a part of the BRAVO-3 trial, a double-blind randomized, controlled trial comparing bivalirudin with unfractionated heparin (UFH) in patients undergoing transfemoral TAVR to evaluate whether parenteral procedural anticoagulation affects cerebral embolization. The DEFLECT III trial utilized the TriGuard HDH (Keystone Heart, Tampa, FL) embolic deflection device in a multi-center, single-blinded randomized control trial This exploratory study evaluated high and extreme risk patients undergoing TAVR. This was not a statistically significant reduction, this trial concluded that the Sentinel device was safe to use These results may have been affected by the variability in committee-driven patient selection at 17 different centers and use of four different valve replacement systems; future studies should control for these variables [17]

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