Author + information
- Hasan Rehman1,
- Ankur Kalra2,
- John Cochran3,
- Leif Peterson4,
- Rishi Puri5,
- Sahil Khera6,
- Tanush Gupta7,
- Dhaval Kolte8,
- Colin Barker9,
- Deepak Bhatt10,
- Michael J. Reardon11 and
- Neal Kleiman12
- 1Houston Methodist Hospital, Houston, Texas, United States
- 2Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States
- 3Baylor College of Medicine, Houston, Texas, United States
- 4Houston Methodist Research Institute, Houston, Texas, United States
- 5Quebec Heart & Lung Institute, Quebec City, Quebec, Canada
- 6Westchester Medical Center, Valhalla, New York, United States
- 7Albert Einstein College of Medicine/ Montefiore Medical Center, Bronx, New York, United States
- 8Brown University, Providence, Rhode Island, United States
- 9Houston Methodist, Houston, Texas, United States
- 10Brigham and Women's Hospital, Boston, Massachusetts, United States
- 11Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, United States
- 12Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, United States
The utility of routine balloon predilation in transcatheter aortic valve replacement (TAVR) with balloon-expandable or self-expanding valves is being called into question. We compared clinical outcomes at 30 days and 1 year in the “no balloon predilation” vs. conservative or aggressive balloon predilation groups in patients undergoing TAVR with self-expanding valves (CoreValve®, Medtronic, Inc., Minneapolis, MN).
Between October 2011 - September 2016, 548 patients who underwent TAVR with CoreValve® were stratified into no predilation (n=148; 27%), conservative predilation (predilation balloon size ≤ minimum annulus diameter) (n=292; 53%) and aggressive predilation (predilation balloon size > minimum annulus diameter) (n=108; 20%) groups (Table 1).
The need for balloon postdilation post TAVR was lower in the aggressive (23.1%) and conservative predilation (32.9%) groups compared with the no predilation group (37.2%), although the association was not statistically significant after adjusting for covariates (adjusted Odds Ratio [aOR]: 0.95, 95% Confidence Interval [CI]: 0.52 -1.74 for conservative vs. none; aOR 0.53, 95% CI: 0.25 - 1.16 for aggressive vs. none). Paravalvular leak (PVL) was lowest in the aggressive predilation group (38.5%) compared with conservative (44.0%) and no predilation (42.3%) groups. Compared with no predilation, after adjusting for covariates, conservative predilation was significantly more likely to be associated with PVL (aOR: 1.83, 95% CI: 1.03 - 3.24), while there was no significant association with aggressive predilation (aOR: 1.27, 95% CI: 0.63 - 2.54). Pacemaker implantation was higher with predilation (22.2% in aggressive; 20.5% in conservative groups) compared with no predilation group (18.2%) (aOR 1.82, 95% CI: 0.71 – 4.68 for aggressive vs. none; aOR 2.48, 95% CI: 1.09 – 5.67 for conservative vs. none). There were no differences in 30-day or 1-year rates of stroke and death between the 3 groups.
Conservative predilation was associated with more PVL and permanent pacemaker requirement rates at discharge. Stroke and death rates at 30 days and 1 year weren't different between the 3 groups after adjusting for covariates.
STRUCTURAL: Valvular Disease: Aortic