Conference Coverage
TAVR matches surgery in intermediate-risk patients
Transcatheter aortic-valve replacement performed as well as surgical-valve replacement in patients with an intermediate mortality risk in a...
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
Doug Brunk/Frontline Medical News
Dr. Vinod H. Thourani
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.