Transcatheter aortic valve implantation (TAVI) is considered a safe procedure and is endorsed by the 2020 American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease for select patients.¹ However, up to 68-93% of patients had perfusion defects identified on diffusion-weighted perfusion imaging following the procedure, which was lower in the cerebral embolic protection (CEP) groups in trials.² Yet these trials were small and underpowered for meaningful clinical outcomes.

As such, the PROTECTED TAVR (Stroke PROTECTion with Sentinel During Transcatheter Aortic Valve Replacement) trial³ was designed to investigate whether CEP would reduce the risk of periprocedural stroke. Patients were evaluated both at baseline and after the procedure to determine their neurological status. The primary endpoint of stroke within 72 hours of TAVI or before discharge was 2.3% with CEP versus 2.9% without CEP (p = 0.3). Disabling stroke (0.5 vs. 1.3% [p < 0.05]), death (0.5% vs. 0.3%), and transient ischemic attack (3.1% vs. 3.7%) were also reported. The routine use of a CEP device did not lower the risk of stroke in patients undergoing transfemoral TAVI. Given that this is the largest trial to date, these results will likely impact guidelines and practice. The significant reduction in disabling strokes is only hypothesis generating but needs to be considered in light of the negative primary endpoint of this trial.

Huded et al. reported stroke rates in the United States from the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry.⁴ The 30-day stroke rate was higher in those with a previous stroke, known peripheral arterial disease, hypertension, porcelain aorta, carotid stenosis, general anesthesia and self-expanding TAVI devices, and in-hospital atrial fibrillation after TAVI, as well as in women. The PROTECTED TAVR trial did not specifically examine these subgroups, particularly for alternate access. It is intuitive to consider CEP in individuals at high risk to reduce disabling stroke, which comes at a cost to patients and the health care system.

References

1. Otto CM, Nishimura RA, Bonow RO, et al.; Writing Committee Members. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2021;77:e25-e197.
2. Haussig S, Mangner N, Dwyer MG, et al. Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI randomized clinical trial. JAMA 2016;316:592-601.
3. Kapadia SR, Makkar R, Leon M, et al.; on behalf of the PROTECTED TAVR Investigators. Cerebral Embolic Protection During Transcatheter Aortic-Valve Replacement. N Engl J Med 2022;387:1253-63.
4. Huded CP, Tuzcu EM, Krishnaswamy A, et al. Association between transcatheter aortic valve replacement and early postprocedural stroke. JAMA 2019;321:2306-15.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Transcatheter Aortic Valve Replacement, Patient Discharge, Aortic Valve Stenosis, Ischemic Attack, Transient, Intracranial Embolism, Stroke, Registries, Aorta, Peripheral Arterial Disease, Perfusion, Perfusion Imaging, Surgeons

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