Transcatheter Aortic Valve Replacement Comparable with Surgery

New Orleans—A randomized study of patients with symptomatic aortic stenosis and at high risk for surgery found that those undergoing transcatheter aortic valve replacement (TAVR) had similar survival at 1 year compared with those undergoing aortic valve replacement (AVR), which is the standard of care. The authors noted that TAVR is the standard of care in patients who cannot undergo surgery, but that the results indicated that TAVR could also be an alternative to AVR in high-risk patients. Craig R. Smith, MD, the study’s lead author, presented the findings of the PARTNER (Placement of Aortic Transcatheter Valves) trial at the ACC meeting. He said the study was the first to compare TAVR with AVR. There are 2 types of TAVR: transfemoral and transapical. The primary end point (all-cause mortality at 1 year) was met, with 24.2% of patients in the TAVR group dying compared with 26.8% of patients in the TAVR group (noninferiority P=.001). Major strokes at 1 year and major vascular complications were significantly more frequent in the TAVR group, while major bleeding and new-onset atrial fibrillation were significantly more frequent in the AVR group. The authors initially screened 3105 patients and further reduced the cohort to 1057 patients: 699 in the high-risk group and 358 in the inoperable group. Patients were assessed at 26 sites by a surgeon and cardiologist: 22 in the United States, 3 in Canada, and 1 in Germany. They were included in the study if they had severe AS (defined as echo-derived aortic valve area <0.8 cm2 and mean aortic valve graft >40 mm Hg or peak jet velocity >4.0 m/sec), cardiac symptoms (defined as New York Heart Association functional classification ≥2), and high surgical risk (defined as the surgeon and cardiologist predicting a risk of operative mortality ≥15%). The 699 patients who were at high risk were assessed based on transfemoral or transapical access, and the 2 groups were each randomized in a 1:1 ratio. The transfemoral group included 244 patients who underwent transfemoral TAVR and 248 who underwent AVR, while the transapical group included 104 patients who underwent transfemoral TAVR and 103 who underwent AVR. The study utilized the Edwards SAPIEN transcatheter heart valve, a retroflex catheter, and the Ascendra aortic heart valve replacement system. Of the 699 patients, a total of 42 were not treated because they died, refused to participate, or withdrew from the study. Patients in the AVR and TAVR groups had similar baseline demographics: approximately 57% were males, and their median age was approximately 84 years. At 30 days, 3.4% of patients in the TAVR group had died compared with 6.5% of patients in the AVR group (P=.07). In addition, 7.2% of patients in the TAVR group had died or been rehospitalized compared with 9.7% of patients in the AVR group (P=.24). Furthermore, 3.8% of patients in the TAVR group had sustained a major stroke compared with 2.1% of patients in the AVR group (P=.20). At 1 year, 34.6% of patients in the TAVR group had died or been rehospitalized compared with 35.9% of patients in the AVR group (P=.73). In addition, 5.1% of patients in the TAVR group had sustained a major stroke compared with 2.4% of patients in the AVR group (P=.07). The authors cited several study limitations: in the control group (those undergoing AVR), 8% of patients withdrew or refused therapy; 5% of patients in the TAVR group did not receive therapy; the AVR group had a significantly longer interval between randomization and treatment; doctors at most sites did not have experience with TAVR; and the researchers could not assess the durability of TAVR because there was no long-term follow-up.