Why the study?
Does TAVR using the CoreValve system provide procedural success and safety in high-risk or inoperable patients with severe aortic valve disease?
Does TAVR using the CoreValve system provide procedural success and safety in high-risk or inoperable patients with severe aortic valve disease?
TAVR with the CoreValve system is feasible and safe in high-risk or inoperable patients in the Philippines, demonstrating 100% procedural success and no 30-day cardiac mortality.
BACKGROUND: Symptomatic, severe aortic stenosis (AS) is a potentially life threatening and functionally limiting disease that typically affects the elderly. Transcatheter aortic valve replacement (TAVR) may be an effective, minimally invasive valve replacement technique comparable to surgical aortic valve replacement for high-risk patients with severe, symptomatic AS. METHODS: We report our single-center TAVR experience with the CoreValve system (Medtronic) in 27 high-risk, extra high-risk, or inoperable patients that underwent TAVR using Corevalve at the St. Luke’s Medical Center. All patients underwent computerized tomography angiogram and 2D echocardiography designed to assess vascular access, aortic anatomy, ventricular function and annular dimensions. TAVR was performed at the cardiac catheterization laboratory, under general anesthesia and transesophageal echocardiography guidance. The femoral approach was used whenever possible. Those with unsuitable femoral anatomy underwent subclavian or direct aortic implantation. RESULTS: Since our team performed the first TAVR in the Philippines in February 2012, a total of 27 patients have undergone TAVR. Fourteen (52%) were males. The mean age was 79.96 years (range 52-91). Twenty-six had severe, symptomatic, calcific AS and one had severe, valvar and paravalvar aortic regurgitation (AR) of a Carpentier-Edwards perimount bioprosthetic valve. TAVR was performed via the transfemoral approach in 23 patients (85%); direct aortic approach in three patients (11%); and left subclavian approach in one patient (4%). There were 30 valves implanted. Out of 27 patients, two patients (7%) required 23 mm valves; eight patients (30%) required 26 mm valves; 12 patients (44%) used 29 mm valves; and 5 patients (19%) required 31 mm valves. Three patient required two valves following valve dislocation during implantation. Procedural success was 100% with no cardiac mortality at 30 days. Mean hospital stay was 12.61 days. Five (18%) had permanent pacemaker implantation for high grade atrioventricular block. On follow up, three patients (11%) died of non-cardiac causes. Serial echocardiograms demonstrated no AR in 13 patients (48%) and trivial to mild AR in 14 patients (52%). There were no patients with moderate or severe AR. CONCLUSION: TAVR in high-risk and extra high-risk or inoperable patients can be performed with high procedural success and no 30-day cardiac mortality. There was no follow up evidence of significant AR nor paravalvar leaks. Non-cardiac mortality appears to be a function of multiple, complex comorbidities among extra high-risk or inoperable patients.
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Posas et al. (2013) studied this question.
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