Patients with aortic stenosis who were at high surgical risk had better outcomes if they underwent transcatheter aortic valve replacement (TAVR) than if they had surgical aortic valve replacement (SAVR), according to an analysis of a randomized trial.
Lead researcher Vincent Gaudiani, MD, of Pacific Coast Cardiac and Vascular Surgeons in Redwood City, Calif., presented the results on May 16 during a plenary session at the American Association for Thoracic Surgery annual meeting in Baltimore.
“We think that the physiologic effect of operation is a very important feature and that there are so many entry points into getting into trouble after operation that a population this small couldn’t define them,” Gaudiani said. “I still believe that quicker operations are better, but this trial doesn’t prove it.”
Gaudiani cited a study from April that found patients who received the CoreValve TAVR system (Medtronic) had lower rates of all-cause mortality after three years compared with patients in the SAVR group.
In this trial, 750 high risk patients were randomized to receive TAVR with the CoreValve system or SAVR. All of the patients had enrolled in the pivotal CoreValve trial, for which Gaudiani was a co-author.
Medtronic funded the study, and the company’s personnel performed all statistical analyses and verified the data’s accuracy.
The heart team considered patients at high risk if they had a mortality or irreversible morbidity rate between 15 percent and 50 percent at 30 days. The centers in this study were new to TAVR but were experienced in aortic valve replacements.
At baseline, the groups were similar. The mean age was approximately 83 years old, and approximately 53 percent of patients were males. Significantly more patients in the SAVR group had diabetes, but the differences were not statistically significant with any other comorbidity or area.
After one year, 14.2 percent of patients in the TAVR group and 19.1 percent of patients in the SAVR group had died. The mortality rates were 21.9 percent and 29.0 percent, respectively, at two years and 32.9 percent and 39.1 percent, respectively, at three years.
The difference at three years was not statistically significant.
Within the first 30 days after the procedures, 3.3 percent of patients in the TAVR group and 4.5 percent of patients in the SAVR group had died. The mortality rates were 4.0 percent and 7.9 percent, respectively, from day 31 through 120 and 7.5 percent and 7.7 percent, respectively, from day 121 through 365.
The difference from day 31 through 120 was statistically significant, but the differences at the other two time points were not statistically significant.
The researchers examined each of the deaths and divided the deaths into the following areas:
- Technical problems with the procedure – injury to cardiac structure, lack of myocardial protection, induced ischemia and vascular complications requiring intervention and transfusion of more than three months.
- Failure to repair the disease adequately – mean gradient of more than 20 mm Hg, moderate or worse paravalvular aortic leak and failure to correct known significant coronary issues.
- Complications linked to death – acute kidney injury, major or life-threatening bleeding with transfusion and new atrial fibrillation, which does not resolve by discharge.
- Failure to recover – not able to spend 14 or more consecutive days at home.
- Other reasons not directly linked to the procedure or disease repair such as malignancy, late falls, late surgeries and accidents.
Within 30 days, nine patients in the TAVR group and six patients in the SAVR group died due to technical problems, three patients in the TAVR group and two patients in the SAVR group died of complications and one patient in the TAVR group and eight patients in the SAVR group died due to a failure to recover.
“In the early period, no recovery is a bigger factor in the surgical patients,” Gaudiani said. “There were some patients that did die within the 30-day period who just never could put up with the physiologic stresses of surgery, at least the way we looked at it.”
From days 31 to 120, seven patients in each group died due to complications and two patients in the TAVR group and nine patients in the SAVR group died due to a failure to recover. During that same time period, six patients in the TAVR group died due to other reasons, six patients in the SAVR group died due to technical problems and five patients in the SAVR group died due to failure to repair the disease adequately.
“Even after 30 days out to a 120-day period, there were many more patients who just could not recover from the stress of operation,” Gaudiani said.
From days 121 to 365, one patient in each group died due to technical problems, one patient in each group died due to repair failure and two patients in each group died due to complications. In addition, four patients in the TAVR group and seven patients in the SAVR group died due to a failure to recover, while 19 patients in the TAVR group and 13 patients in the SAVR group died due to other reasons.
“I think the most important thing this paper shows is that this new technology has challenged us surgeons to put in larger valves with less morbidity,” Gaudiani said. “I think we need to spend considerable time thinking about how to do that on behalf of those people who require surgical aortic valve replacement in the future.”
The researchers also found that 66.9 percent of patients in the TAVR group and 39.7 percent of patients in the SAVR group were discharged to home, which was a statistically significant difference. In addition, 23.8 percent and 45.8 percent, respectively, were sent to rehabilitation clinics.
“I think this has important implications for the future as to how we think about surgical mortality,” Gaudiani said. “It must have been the days of hernias and colostomies that we decided 30 days was the period after which a patient could be said to have recovered from the acute phase of the operation. Everybody who operates in this room knows that’s not true anymore. We should probably stop thinking about morbidity and mortality as a 30-day indicator because very few patients are really recovered from what we do for a living in 30 days.”