Author + information
- Wesley Pedersen,
- Mason Hinke,
- Pau Sorajja,
- Aisha Ahmed,
- Michael Mooney and
- Irvin Goldberg
Balloon (bal) aortic valvulopasty (BAV) has reemerged with transcatheter therapy. Cylindrical bal have been the device of choice despite limitations. The V8 (InterValve Inc) bal with broader segments separated by a narrowed waist is designed to permit enhanced fix and better leaflet opening without annular compromise.
Reported are our findings using the V8 bal in 40 consecutive, matched patients (pts) undergoing BAV compared to a subset of 40 pts from a 403 pt BAV database using cylindrical bals. Pts were propensity matched by age, gender, left ventricular ejection fraction (LVEF) and Society of Thoracic Surgeons (STS) risk score. Endpoints included change in AVA by echo, change in aortic insufficiency (AI), new permanent pacemaker implantation (PPM) and major adverse event (MAE) which included procedural death, emergency surgery or stoke. Bal sizes for each pt were recorded. AI was quantitated numerically: 0 none to trace, 1+ mild, 2+ moderate, 3+ severe.
V8 and cylindrical bal groups were similar across age, sex, STS score, LVEF and baseline AVA. The change in AVA from baseline to post procedure strongly trended in favor of V8 bal pts over cylindrical bal pts (0.29cm2±0.17 vs. 0.22cm2±0.15; p=0.058). Maximum bal sizes were significantly larger for V8 pts enabled by the bal shape. There were no significant differences in AI, new PPM or MAE. There was no severe AI in either group post procedure.
Findings in this preliminary experience suggest an advantage for enhancing AVA when using the V8 bal. In addition, there was no increase in AI, new PPM or MAE events in comparison to the cylindrical bal.