Expanding the Limits: Transapical Transcatheter Aortic Valve for Severe Aortic Regurgitation
What is the safety and efficacy of the self-expandable ACURATE TA device (Symetis SA, Ecublens, Switzerland) in a cohort of patients with pure aortic regurgitation (AR)?
Between April 2012 and December 2013, a total of eight high-risk patients with pure, severe AR were enrolled (grade III+). Clinical and hemodynamic data as well as data on device and procedure parameters and outcomes were collected.
Patient mean age ± standard deviation was 72.5 ± 8.4 years, and 37.5% of patients were female. Logistic EuroSCORE was 34.0 ± 7.9% and the Society of Thoracic Surgeons score was 7.3 ± 3.3% on average. Two patients had undergone emergency aortic operation before due to acute type A aortic dissection, and both were treated by replacement of the ascending aorta (including root reconstruction) and the aortic arch combined with or without E-vita Open stent graft (Jotec GmbH, Hechingen, Germany) (January 2011 and March 2012), whereas the other patients experienced primary AR. All patients underwent successful transapical transcatheter aortic valve replacement (TAVR) with the transapical ACURATE TA device (size small, n = 1; size medium, n = 3; size large, n = 4) without any intraprocedural complications according to the Valve Academic Research Consortium 2 criteria. Post-procedure AR grade I+ or lower, as revealed by transesophageal echocardiography and angiography, was present in all eight patients. At 30 days, the stroke incidence and all-cause mortality rate were 0%.
The authors concluded that small single-center series demonstrates the feasibility of transapical TAVR with the self-expandable ACURATE TA device in high-risk patients with severe AR.
This study reports the first clinical experience and proves the feasibility of TAVR with the ACURATE TA device in high-risk patients presenting with severe AR. The valve hemodynamic findings were satisfactory and comparable to conventional heart valves. Furthermore, the specific architecture of the bioprosthesis lends itself to secure annular placement and alignment in the native anatomy of the noncalcified aortic valve. Larger multicenter studies with longer-term follow-up are needed to assess safety, efficacy, and durability of this device.
Keywords: Stroke, Bioprosthesis, Heart Valve Prosthesis Implantation, Hemodynamics, Echocardiography, Transesophageal, Stents
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