Beyond the Short-Term: Clinical Outcome and Valve Performance 2 Years After Transcatheter Aortic Valve Implantation in 227 Patients
What is the long-term follow-up of clinical and echocardiographic results after transcatheter aortic valve implantation (TAVI)?
Patients’ mean age was 81 ± 7 years, 59% were female, mean European System for Cardiac Operative Risk Evaluation was 21% ± 14%, mean Society of Thoracic Surgeons score was 7% ± 5%, and access routes were transfemoral (n = 164), transapical (n = 54), axillary (n = 5), or transaortic (n = 4). A CoreValve (Medtronic Inc., Minneapolis, MN) prosthesis was implanted in 174 patients, and a SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA) was implanted in 53 patients. Clinical and echocardiographic investigations were performed at 6 months, 1 year, and 2 years.
Survival was 88.5% at 30 days, 75.9% at 6 months, 74.5% at 1 year, and 64.4% at 2 years. Patients improved significantly in New York Heart Association class after 6 months (from 3.2 ± 0.5 to 1.7 ± 0.7, p < 0.001) and up to 2 years (1.9 ± 0.7). Cumulative incidences of myocardial infarction, stroke, and life-threatening or major bleeding were 2.7%, 6.2%, and 16.2% at 2 years, respectively. The postprocedural mean transprosthetic gradient was 12 ± 4 mm Hg for all valves and did not change up to 2 years, and the effective orifice area was 1.5 ± 0.4 cm2 with no change over 2 years of follow-up. Moderate or severe prosthetic regurgitation was present in 8% of patients at 2 years. In 6% of patients, the paravalvular or valvular regurgitation grade increased significantly over time.
The authors concluded that with excellent functional recovery of the patients, and overall low morbidity at 2 years, TAVI may be considered the treatment of choice for aortic valve stenosis in elderly patients with an increased risk for surgery.
This study, with a 2-year follow-up of 227 patients after TAVI, suggests a considerable periprocedural mortality but low mortality after 6 months; efficacy of the treatment with persistent symptom relief; a low morbidity rate at 2 years except for bleeding events; and good systolic valve function. Based on this and other studies, TAVI can be considered the treatment of choice for aortic valve stenosis in elderly patients with increased risk for surgery with a heart–lung machine. Because outcomes were not compared with a control group, future studies are indicated to prove an advantage over conventional surgical AVR. In addition, prosthetic regurgitation and bleeding events should be addressed in future studies for evaluation of the impact on long-term outcomes.
Keywords: Myocardial Infarction, Stroke, Follow-Up Studies
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