• Cardiology Clinical Trials
• Valvular Disease
• Interventional Techniques & Devices

• Cardiology Clinical Trials
• Valvular Disease
• Cardiology
• Interventional Techniques & Devices

Transcatheter aortic valve replacement (TAVR) is the recommended treatment for “inoperable” patients with severe aortic stenosis (AS). One-, 2-, and 3-year data from the Placement of Aortic Transcatheter Valves study [PARTNER; NCT00530894] showed significant reductions in all-cause mortality, cardiac mortality, and rehospitalization [Kapadia SR et al. Circulation. 2014; Makkar RR et al. N Engl J Med. 2012; Leon MB et al. N Engl J Med. 2010]. Samir R. Kapadia, MD, Cleveland Clinic Foundation, Cleveland, Ohio, USA, reported the 5-year outcomes for the PARTNER trial. Benefits as to all-cause and cardiovascular (CV) mortality, repeat hospitalization, and functional status were sustained in the TAVR-treated patients compared with those given standard therapy. Valve durability was demonstrated with no increase in transvalvular gradient or attrition of valve area.

The PARTNER trial included patients (n = 358) with severe symptomatic AS with aortic value area < 0.8 cm² (effective orifice area index < 0.5 cm²/m²), and mean gradient > 40 mm Hg or jet velocity > 4.0 m/second. Patients deemed “inoperable” (defined as risk of death or serious irreversible morbidity of AVR exceeding 50%) were assessed by a cardiologist and 2 surgeons. Participants were randomly assigned (1:1) to TAVR or standard therapy. After 3 years, 20 patients crossed over to TAVR from standard therapy.

The study's primary end point of all-cause mortality was evaluated when all patients reached 1-year follow-up. Key end points for the 5-year analysis included all-cause and cardiac mortality, rehospitalization, stroke, NYHA functional class, and echo-derived valve areas, transvalvular gradients, and paravalvular leak. Mortality outcomes were stratified by Society of Thoracic Surgeons (STS) risk score, paravalvular leak, and age.

At baseline, subjects were mean age 83 years with mean STS scores between 11.2 and 12.1. Most (> 90%) were NYHA III or IV and about 70% had coronary artery disease; 46% were men. Creatinine values > 2 mg/dL were present in 5.6% of TAVR patients and 9.6% receiving standard therapy. Frailty was 18.1% for TAVR and 28% for standard therapy. A porcelain aorta was present in 19% of TAVR subjects and 11.2% of patients receiving standard therapy (P = .05). The incidence of chronic obstructive pulmonary disease was significantly higher in the standard therapy group (52.5% vs 41.3% in the TAVR group; P = .04). Average chest wall radiation was 8.6%.

At 5 years, all-cause mortality in the intention to treat (ITT) population was 93.6% for standard therapy and 71.8% for TAVR (HR, 0.50; 95% CI, 0.39 to 0.65; P < .0001). Other key end point events are shown in Table 1.

The mortality benefit was similar in elderly (> 85 years) patients compared with those ≤ 85 years. A CV mortality and all-cause mortality benefit was seen even in patients with high STS scores. Beyond early procedural risk of stroke in TAVR-treated patients, there was no persistent risk over 5 years of follow-up. Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Moderate and severe paravalvular leak was associated with a higher CV mortality particularly in patients with less comorbidity.

Despite an increase risk of major stroke, TAVR is a beneficial treatment for patients with severe AS who are not suitable candidates for surgery.

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