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Predictors of poor outcomes with novel TAVR system identified
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Calcification and other factors were predictors of paravalvular leakage and permanent pacemaker implantation in patients treated with a novel transcatheter aortic valve replacement system, researchers reported at EuroPCR.
Won-Keun Kim, MD, from the department of cardiology at Kerckhoff Heart Center in Bad Nauheim, Germany, and colleagues analyzed 500 patients (median age, 82 years; 65% women) who underwent TAVR with a self-expanding nitinol system (Acurate Neo, Symetis/Boston Scientific). The device is not yet approved for use in the United States.
The researchers stratified patients by device landing zone calcification (mild, moderate or severe) and assessed anatomic and procedural predictors of paravalvular leakage and permanent pacemaker implantation.
Second-degree or greater paravalvular leakage after the procedure was more common the greater degree of landing zone calcification. The mild group had an 0.8% rate compared with 5% for the moderate group and 13% for the severe group (P < .001), Kim and colleagues found.
The rate of permanent pacemaker implantation was not affected by degree of landing zone calcification, according to the researchers.
Kim and colleagues found the following were independent predictors of second-degree or greater paravalvular leakage:
- more severe periannular calcification (OR = 1.007; 95% CI, 1.003-1.01);
- less oversizing (OR = 0.867; 95% CI, 0.773-0.971);
- presence of annular plaque protrusions (OR = 2.756; 95% CI, 1.138-6.67);
- aortic movement of the delivery system after full deployment (OR = 5.593; 95% CI, 1.299-24.076); and
- sinotubular junction height (OR = 1.156; 95% CI, 1.007-1.328).
There were two predictors of permanent pacemaker implantation: pre-existing right bundle branch block (OR = 3.122; 95% CI, 1.261-7.731) and more oversizing (OR = 1.111; 95% CI, 1.009-1.222).
Because the sizing recommendations of the manufacturer were not validated by clinical data, a sizing chart based on the outcomes of the present analysis was devised. According to the researchers, the small size should be used in patients with perimeter-derived annulus in diastole 20 mm to 22 mm and perimeter-derived annulus in systole 20 mm to 22.4 mm; the medium size should be used in patients with perimeter-derived annulus in diastole 22.1 mm to 23.9 mm and perimeter-derived annulus in systole 22.5 mm to 24.3 mm; and the large size should be used in patients with perimeter-derived annulus in diastole 24 mm to 25.8 mm and perimeter-derived annulus in systole 24.4 mm to 26.3 mm.
“Procedural success of transfemoral implantation of the Acurate Neo device requires careful patient selection with appropriate oversizing and recognition that best outcomes may be achieved in cases with only mild to moderate [device landing zone] calcification. Less aggressive pre-dilatation may help reduce [permanent pacemaker implantation] rates,
and maintaining forward pressure on the delivery system during deployment may decrease the likelihood of post-procedural [paravalvular leakage],” Kim and colleagues wrote in a simultaneous publication in JACC: Cardiovascular Interventions. – by Erik Swain
References:
Kim WK, et al. Hot Line TAVI 2. Presented at: EuroPCR; May 22-25, 2018; Paris.
Kim WK, et al. JACC Cardiovasc Interv. 2018;doi:10.1016/j.jcin.2018.04.039.
Disclosure: Kim reports he is a proctor for St. Jude Medical and Symetis and receives lecture honoraria from Edwards Lifesciences, St. Jude Medical and Symetis.