Rapid deployment surgical valves linked to higher rates of stroke, pacemaker implantation
Sutureless valves have recently been developed to streamline surgical aortic valve replacement (SAVR) procedures, with the hope that shorter operations lead to better outcomes. But a new study in the Journal of the American College of Cardiology suggests quicker is not always better.
When comparing nearly 21,000 German patients who received conventional biological valves to 1,125 receiving rapid deployment versions, those implanted with conventional prostheses had significantly lower rates of pacemaker implantation (3.7 versus 8.8 percent) and disabling stroke (0.9 versus 2.2 percent). In-hospital mortality rates were similar despite rapid deployment valves (RDVs) being associated with procedural times that were 10 minutes shorter and aortic cross clamp times that were 16 minutes shorter on average.
Importantly, the results were similar after the researchers matched the groups 1:1 with propensity scoring.
“Data of this GARY (German Aortic Valve Registry) analysis demonstrate that a significant reduction of operating times as well as the utilization of minimally invasive approaches may not translate into a beneficial effect on in-hospital mortality. Moreover, neurological events were even elevated in patients undergoing RDV implantation,” wrote lead researcher Stephan Ensminger, MD, DPhil, and colleagues.
The authors also analyzed differences between three RDVs which were approved for commercial use: the self-expanding, nitinol-based 3F Enable valve (Medtronic); the balloon-expandable Intuity valve (Edwards Lifesciences); and the Perceval S sutureless valve (Sorin/LivaNova group). The Medtronic valve has been pulled from the market, they noted, but the others continue to be implanted.
After propensity matching 102 patients for each device, the Perceval S was associated with a significantly greater proportion of patients with high post-operative pressure gradients. That valve was also linked to the shortest procedure time and was implanted most often during the study, suggesting operator experience played a role in surgery time, the researchers noted.
In a related editorial, Hartzell V. Schaff, MD, with the department of cardiovascular surgery at the Mayo Clinic, suggested the additional prosthetic material in RDVs versus conventional valves may have contributed to their higher embolic risk. This material could hypothetically break off the valve and lead to stroke.
“Additional data on less serious transient neurological events would be helpful in understanding possible mechanisms of injury,” he added.
Schaff noted the study adds evidence RDVs have little to no clinical benefit over traditional biological valves. They actually increase costs, he wrote, but continue to be attractive to many because of “commercial pressure” associated with adopting new technologies.
“The present report from GARY adds important information to the value proposition for use of sutureless prostheses by confirming the higher risk of post-operative pacemaker requirement and identifying a possible association of disabling stroke with the use of rapid deployment prostheses,” Schaff wrote. “Thus, in the absence of any clear advantage with regard to mortality, it seems prudent to reserve use of rapid deployment valves during AVR for special circumstances where additional risk with standard suture fixation of stented bioprosthetic valves is anticipated due to difficulty with exposure or tissue quality.”
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.