Outcomes With Second-Generation Self-Expandable TAVR

Study Questions:

What is the early safety and efficacy of a new generation of self-expanding transcatheter aortic valve replacement (TAVR) in treatment of aortic valve disease?

Methods:

This study evaluated outcomes in 264 unselected patients with aortic valve disease treated with a new generation of self-expanding TAVR device (Evolut R, Medtronic) in the United Kingdom and Ireland. Procedural experience, clinical outcomes at 30 days, and echocardiographic findings were evaluated.

Results:

Aortic valve pathology included stenosis in 72.0%, mixed disease in 17.4%, and dysfunctional aortic valve bioprostheses in 10.6% of patients. Mean age was 81.1 ± 7.8 years, and 58.3% were female. Mean Society of Thoracic Surgeons score was 6.0 ± 5.6. Conscious sedation was used in 39.8% of individuals, with transfemoral access in 93.6%. Post-implant balloon dilatation was performed in 23.0%, while repositioning of the valve was done in 20.5% of individuals. Successful valve deployment was achieved in 91.3% of cases. The absence of moderate or severe aortic regurgitation at 30 days was noted in 92.3% of patients. At 30 days, mortality, stroke, major vascular complications, and need for new pacemaker were 2.3%, 3.8%, 5.3%, and 14.7%, respectively.

Conclusions:

This new generation of self-expandable TAVR device appears safe and effective for treatment of an unselected series of patients with aortic valve disease.

Perspective:

This paper is similar to another study published in this same journal using this device in a more selected US population. In contrast, the present paper evaluates an unselected real-world group of patients treated with TAVR for aortic stenosis, mixed aortic valve disease, and bioprosthetic aortic valve degeneration. This study reports a low rate of death and stroke, with good valve hemodynamics and low rates of significant regurgitation. The need for permanent pacemaker is lower than initial studies with self-expanding devices, but remains a relatively common complication. Overall, these results suggest that this new generation of self-expandable devices has continued incremental improvements.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD & Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD & Pediatrics and Imaging, CHD & Pediatrics and Interventions, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Conscious Sedation, Constriction, Pathologic, Dilatation, Echocardiography, Geriatrics, Heart Defects, Congenital, Heart Valve Diseases, Hemodynamics, Pacemaker, Artificial, Stroke, Transcatheter Aortic Valve Replacement


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