Results from the PRAGMATIC Plus analysis of Edwards Lifesciences’ (NYSE:EW) Sapien transcatheter aortic valve implantation system and Medtronic’s (NYSE:MDT) rivaling CoreValve device found few differences between the devices, with the exception of lower rates of permanent pacemaker implantation in patients who received Edwards’ Sapien device.
The so-called "pacemaker issue" has been a recurring topic at healthcare conferences since 1st publication earlier this year in the Journal of the American College of Cardiology, although the problem isn’t considered a safety risk.
"Importantly, there is no association between pacemaker implants and increased mortality, while other complications – such as stroke, PVL, rupture, and vascular complications – are much more worrisome because they can be dangerous and even life-threatening for patients," Medtronic told MassDevice.com today.
Medtronic further noted that findings from the PRAGMATIC Plus study are less significant, given that the study is a non-randomized, retrospective analysis, unlike the more robust clinical studies released by Medtronic. The Minnesota medical device giant plans this week to release a highly anticipated 1st look at data from its U.S. CoreValve pivotal trial.
The pacemaker issue came up several times during TAVI presentations at today’s Transcatheter Cardiovascular Therapeutics symposium in San Francisco. The difference may be a meaningful one for physicians deciding which device to implant, given that the PRAGAMATIC Plus analysis found no other differences reported in 30-day or 1-year mortality or combined safety endpoints between CoreValve and Sapien, according to a morning presentation at TCT.
Findings from the PRAGMATIC Plus study, presented by the San Raffaele Scientific Institute’s Dr. Alaide Chieffo, included pooled clinical and procedural characteristics and outcome data for nearly 800 patients who received TAVI treatment prior to July 2011. Results showed no significant differences at 30 days in all-cause mortality, cardiac mortality, heart attack, stroke, life-threatening bleeding or other safety outcomes.
Researchers did, however, find a statistically significant difference in patients requiring permanent pacemaker implants, with 22.5% of CoreValve patients requiring pacemakers compared with only 5.9% of Sapien patients, an outcome that Dr. Chieffo said was unsurprising.
Luckily the pacemaker issue may be on the decline. Researchers last year released study results finding that post-TAVI pacemaker use, once reported in 1 out of every 3 CoreValve procedures, had dropped as physicians developed strategies to avoid problems during TAVI implantation.
Researchers gathered at last year’s PCR London Valves 2012 meeting reported several methods for combating the need for pacemaker implantation following a CoreValve procedure, including avoiding pre-dilation, positioning the valve slightly higher in the heart and waiting for 10 days following the procedure before determining whether a pacemaker is needed.
A Swedish TAVI study showed that post-procedure pacemaker use was down to 11%, with data coming from a registry that included both CoreValve and Sapien.