A combination of improved patient selection and increasing operator expertise may be behind recent strides in some transfemoral transcatheter aortic valve replacement (TAVR) outcomes, according to the PARTNER registry.
Between 2009 and 2012, the -- from 22.7% to 14.4% (P=0.005), and 34.9% to 32.6% (P=0.005), respectively -- , of Mount Sinai Medical Center in Miami Beach, Fla., and colleagues reported in the January issue of JACC: Cardiovascular Interventions.
Moderate-to-severe paravalvular regurgitation fell from 19.2% to 10.1% (P=0.001) over the same period, although there was no improvement in 30-day mortality, peri-procedural stroke, or major vascular complications.
These trends accompanied an increasingly lower risk population: The number of "inoperable" patients declined (39.7% in earlier patients versus 7.6% in later patients, P<0.0001) as did proportion with prior cerebrovascular events (25.9% versus 18.8%, P=0.02) and porcelain aorta (6.8% versus 1.4%, P=0.0006), despite increasing mean age (P=0.0009).
The PARTNER Continued Access (NRCA) Registry included 1,063 patients who got transfemoral TAVR. The cohort was divided into tertiles based on the year of intervention.
It would seem that reducing late mortality after transfemoral TAVR "is highly dependent on strategic case selection, the enrollment of patients with fewer high-risk characteristics and [the] avoidance of 'futile' patients, lowering the frequency of moderate/severe peri-procedural paravalvular regurgitation and reducing non-fatal major procedural complications," researchers concluded.
Additionally, "newer imaging algorithms, especially based on 3D computed tomography aortic annulus measurements," may have "played a key role in lowering paravalvular regurgitation rates, as well as reducing the need for balloon post-dilatation," , of the Cleveland Clinic, and , of the Quebec Heart & Lung Institute, wrote in an accompanying editorial.
For now, Puri and Rodés-Cabau see a "bright" future for the intervention. Yet they still asked: "How much further can TAVR evolve? Are we reaching a threshold in terms of complication rates?"
Since there was no decrease in the rate of peri-procedural stroke or major vascular complications, "additional measures (i.e., embolic protection devices, improved antithrombotic regimes) may be required to systemically further lower peri-procedural stroke rates during TAVR" while "further reductions in sheath sizes are required to incrementally lower peri-TAVR vascular complications," the editorialists noted.
Disclosures
The PARTNER trial was funded by Edwards Lifesciences.
Beohar and Puri reported no relevant conflicts of interests.
Rodes-Cabau disclosed receiving research grants from Edwards Lifesciences and Keystone Heart.
Primary Source
JACC: Cardiovascular Interventions
Beohar, et al "Trends in complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement: experience from the PARTNER continued access registry" J Am Coll Cardiol Intv 2016. DOI: 10.1016/j.jcin.2015.10.050.
Secondary Source
JACC: Cardiovascular Interventions
Puri R, et al "Transcatheter aortic valve replacement: a revolution in evolution" J Am Coll Cardiol Intv 2016. DOI: 10.1016/j.jcin.2015.12.019.