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HOUSTON -- Subclavian access for transcatheter aortic valve replacement (TAVR) cases in which the femoral artery isn't suitable was at least as safe as conventional transfemoral procedures, analysis of the CoreValve trial data showed.
Despite treating a somewhat higher risk group with more peripheral vascular disease, the subclavian approach yielded similar all-cause mortality rates to a matched transfemoral TAVR group in the pooled extreme and high-risk cohorts of the trial (23.3% and 24.8%, P=0.70), , of the University of Pittsburgh, and colleagues reported at the Society of Thoracic Surgeons annual meeting.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
The rate of successful vascular access, delivery, and deployment of the device was similar, too, at 97.5% done subclavian and 98.0% transfemoral.
The duration of ICU and hospital stays after the procedure were similar, as were rates of life-threatening or disabling bleeding, major vascular complications, acute kidney injury, major stroke, cardiovascular death, MI, and reintervention. There was a trend for less pacemaker implantation (19.5% subclavian versus 26.4% transfemoral, P=0.09).
"Subclavian access should be the preferred secondary access in patients with prohibitive iliofemoral access," Gleason concluded, noting that direct and transapical routes through the chest are "becoming obsolete."
The analysis included all 202 patients in the CoreValve U.S. Pivotal Trial program treated with TAVR via subclavian access and a propensity-matched group of equal size who had been treated via transfemoral access. All valves were delivered through an 18F delivery catheter system. Patients with an aortic root angulation greater than 70° for the left subclavian artery and more than 30° for the right subclavian artery were not eligible for subclavian access.
Meeting attendee , of East Carolina University in Greenville, N.C., drew attention to the excellent subclavian delivery times achieved in the study, noting that not every center outside the study might be able to achieve the 57-minute procedure time as in the study. That time was actually the same as for transfemoral procedures, although a longer total time in the cath lab or operating room (238 versus 214 minutes).
There are some drawbacks to subclavian access, Gleason noted, such as that it requires surgical cut down, use can potentially jeopardize a left internal mammary artery graft, and is more cumbersome by putting the operator closer to the radiation source.
Still, he said, "For the surgeons and for everyone in this room, this is a great thing for us. This is an area we should be championing."
Session moderator , of the Mayo Clinic in Rochester, Minn., noted in an interview that this isn't a turf issue for surgeons, though, because the access route gets decided as part of the heart team.
Co-moderator, of Houston Methodist, agreed. "In addition to the benefits that may or may not be with TAVR valves, the heart team has done more to improve the care of patients by bringing a wide view and expedience and skill set to the room or right at the patient's bedside.
"In the past, you'd be forced for transfemoral TAVR to try to decide what's the risk, how much of an injury might I create to the femoral vessels. I think having different avenues to more safely do these techniques is better for the patients."
"This is something that does add value to having a surgeon as part of the team, not to replace the cardiologist, but work side by side," he stated.
Disclosures
Gleason disclosed serving on the CoreValve U.S. Trial National Steering and Screening Committees.
Some co-authors are employees of Medtronic.
Primary Source
Society of Thoracic Surgeons
Gleason TG, et al "Subclavian access for self-expanding transcatheter aortic valve replacement renders equivalent outcomes as transfemoral" STS 2017.