Jeffrey J Popma1, Michael J Reardon2, Steven J Yakubov3, James B Hermiller4, J Kevin Harrison5, Thomas G Gleason6, John V Conte7, G Michael Deeb8, Stanley Chetcuti8, Jae K Oh9, Michael J Boulware10, Jian Huang10, David H Adams11. 1. Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: jpopma@bidmc.harvard.edu. 2. Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas. 3. Riverside Methodist Hospital, Columbus, Ohio. 4. St. Vincent's Heart Center of Indiana, Indianapolis, Indiana. 5. Duke University Medical Center, Durham, North Carolina. 6. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 7. Johns Hopkins Medical Center, Baltimore, Maryland. 8. University of Michigan Medical Center, Ann Arbor, Michigan. 9. Mayo Clinic Foundation, Rochester, Minnesota. 10. Medtronic, Minneapolis, Minnesota. 11. Mount Sinai Health System, New York, New York.
Abstract
OBJECTIVES: The aim of this study was to determine the relationship between aortoventricular (AoV) angulation on clinical outcomes after self-expanding transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who were deemed suboptimal for surgery. BACKGROUND: Multidetector computed tomographic (MDCT) imaging of the aortovalvular complex has become a prerequisite for case planning with self-expanding TAVR. The effect of aortic angulation, an index of an unfolded or "horizontal" aorta, on procedural outcome after self-expanding TAVR is not known. METHODS: The clinical course of 3,578 patients who received implants in the CoreValve US Clinical Trials and who had prospective MDCT estimation of the AoV angle before the procedure was reviewed. Clinical site echocardiogram assessments were used to determine the degree of residual aortic regurgitation 24 to 48 h after the procedure and at 30 days. On the basis of the measurement of the AoV angle on MDCT, patients were categorized into septiles, ranging from the lowest septile of an AoV angle <37.0° to the highest AoV angle septile of >55.0°. RESULTS: Patients were elderly (age 83.3 ± 7.8 years) and were at high risk for surgical valve replacement (Society of Thoracic Surgeons Predicted Risk of Mortality 8.8 ± 4.7). Greater degrees of AoV angulation were correlated with older age (p < 0.0001). Although procedure time was 6.9 min longer in the highest septile (59.4 ± 35.9 min vs. 52.5 ± 35.3 min in the lowest septile; p = 0.004), there were no linear trends (p > 0.05) in the frequencies of device success, procedural success, frequencies of moderate or greater aortic regurgitation at 30 days, number of valves implanted, or need for balloon post-dilation or new pacemakers among the AoV angle septiles. CONCLUSIONS: The degree of AoV angulation does not affect early clinical outcomes self-expanding transcatheter aortic valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve® U.S. Pivotal Trial]; NCT01240902).
OBJECTIVES: The aim of this study was to determine the relationship between aortoventricular (AoV) angulation on clinical outcomes after self-expanding transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who were deemed suboptimal for surgery. BACKGROUND: Multidetector computed tomographic (MDCT) imaging of the aortovalvular complex has become a prerequisite for case planning with self-expanding TAVR. The effect of aortic angulation, an index of an unfolded or "horizontal" aorta, on procedural outcome after self-expanding TAVR is not known. METHODS: The clinical course of 3,578 patients who received implants in the CoreValve US Clinical Trials and who had prospective MDCT estimation of the AoV angle before the procedure was reviewed. Clinical site echocardiogram assessments were used to determine the degree of residual aortic regurgitation 24 to 48 h after the procedure and at 30 days. On the basis of the measurement of the AoV angle on MDCT, patients were categorized into septiles, ranging from the lowest septile of an AoV angle <37.0° to the highest AoV angle septile of >55.0°. RESULTS:Patients were elderly (age 83.3 ± 7.8 years) and were at high risk for surgical valve replacement (Society of Thoracic Surgeons Predicted Risk of Mortality 8.8 ± 4.7). Greater degrees of AoV angulation were correlated with older age (p < 0.0001). Although procedure time was 6.9 min longer in the highest septile (59.4 ± 35.9 min vs. 52.5 ± 35.3 min in the lowest septile; p = 0.004), there were no linear trends (p > 0.05) in the frequencies of device success, procedural success, frequencies of moderate or greater aortic regurgitation at 30 days, number of valves implanted, or need for balloon post-dilation or new pacemakers among the AoV angle septiles. CONCLUSIONS: The degree of AoV angulation does not affect early clinical outcomes self-expanding transcatheter aortic valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve® U.S. Pivotal Trial]; NCT01240902).
Authors: Jordan B Strom; Yuansong Zhao; Kamil F Faridi; Hector Tamez; Neel M Butala; Linda R Valsdottir; Jeptha Curtis; J Matthew Brennan; Changyu Shen; Mike Boulware; Jeffrey J Popma; Robert W Yeh Journal: Circ Cardiovasc Interv Date: 2019-11-07 Impact factor: 6.546