Transcatheter Aortic Valve Replacement with the CoreValve in High- Risk, Extra-High-Risk, or Inoperable Patients: Midterm Follow-Up, the St. Luke’s Global City Heart Institute Experience

Background: Symptomatic, severe aortic stenosis (AS) is a potentially life-threatening and functionally limiting disease that typically affects the elderly. Such patients often have multiple comorbidities, which adversely influence outcomes of surgical aortic valve replacement (SAVR). As an effective minimally invasive valve replacement technique for high-risk patients with severe symptomatic AS, transcatheter aortic valve replacement (TAVR) is comparable to SAVR. This study reports the authors’ TAVR experience with the CoreValve THV (Medtronic) in 51 high-risk, extra-high-risk, or inoperable patients with severe aortic valve disease. Methods: All patients were assessed and risk stratified by a multidisciplinary team of cardiologists, surgeons, and cardiac anesthetists using the Society of Thoracic Surgeons (STS) score and logistic EuroSCORE (LE), computed tomography angiography (CTA), 2D echocardiography and coronary angiography. Coronary artery revascularization was done when indicated. Echocardiography and clinical follow-up was done at 1, 3, 6 and 12 months; and then every year thereafter or whenever clinically indicated. TAVR was done at the cardiac catheterization laboratory with transesophageal echocardiography (TEE) guidance and mostly under general anesthesia. The femoral approach was used whenever possible. Those with unsuitable femoral anatomy underwent subclavian or direct aortic implantation. Results: A total of 51 patients underwent TAVR. Twenty-seven (53%) were males; mean age was 77.8 years. Forty-nine had severe, symptomatic, calcific AS; two had severe aortic regurgitation (AR). Forty-nine (96%) had congestive heart failure, 34 of which were in New York Heart Association (NYHA) classes III–IV. Two (4%) had recurrent syncope. Fifty-one (100%) had hypertension; 32 (63%) had chronic obstructive pulmonary disorder; and 40 (78%) had coronary artery disease. The mean STS and LE scores were 10.71 and 15.31, respectively. The mean left ventricular ejection fraction (LVEF) was 55%; mean aortic valve area (AVA), 0.65 cm2; peak and mean gradients, 80.19 mmHg and 49.17 mmHg, respectively; and mean pulmonary artery pressure, 45.2 mmHg. Procedural success was 98%, with 30-day all-cause mortality of 8%. Mean hospital stay was 10.13 days. Twelve (23.5%) had permanent pacemaker implantation for high-grade atrioventricular block. Mean follow-up was 446.2 days. On follow-up, 5 (10%) had died of noncardiac causes, 1 (2%) of sudden cardiac death 16 months after implantation. Serial echocardiograms demonstrated no AR in 25 (51%); trivial to mild, 14 (29%); moderate to severe periventricular leucomalacia, 1(2%). Mean and peak follow-up gradients were 17.947 (p≤0.0001) and 9.417 mmHg (p≤0.0001), respectively; mean AVA, 1.84 cm2 (p≤0.0001); mean LVEF, 59.39% (p=0.003); mean pulmonary artery systolic pressure, 43.47 mmHg (p=0.599). Thirty-eight surviving patients remain in NYHA Class I, while 4 are Class II (p=0.002). Conclusion: TAVR in high-risk, extra-high-risk, or inoperable patients can be performed with high procedural success and acceptable 30-day mortality. Valve performance, valve gradients and AVA remain stable and significantly improve on follow-up. Most patients remain in functional Class I. Follow-up noncardiac mortality appears to be a function of multiple complex comorbidities among extra-high risk or inoperable patients.