Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation

Jeffrey J. Popma, Michael J. Reardon, Steven J. Yakubov, James B. Hermiller, J. Kevin Harrison, Thomas G. Gleason, John V. Conte, G. Michael Deeb, Stanley Chetcuti, Jae Kuen Oh, Michael J. Boulware, Jian Huang, David H. Adams

Research output: Contribution to journalArticle

14 Citations (Scopus)

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)

Original languageEnglish (US)
Pages (from-to)973-981
Number of pages9
JournalJACC: Cardiovascular Imaging
Volume9
Issue number8
DOIs
StatePublished - Aug 1 2016

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Safety
Aortic Valve Insufficiency
Aortic Valve Stenosis
Aortic Valve
Surgical Instruments
Aorta
Dilatation
Clinical Trials
Equipment and Supplies
Mortality
Transcatheter Aortic Valve Replacement
Therapeutics

Keywords

  • aortic valve
  • replacement
  • self-expanding
  • transcatheter

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Popma, J. J., Reardon, M. J., Yakubov, S. J., Hermiller, J. B., Harrison, J. K., Gleason, T. G., ... Adams, D. H. (2016). Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation. JACC: Cardiovascular Imaging, 9(8), 973-981. https://doi.org/10.1016/j.jcmg.2016.06.002

Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation. / Popma, Jeffrey J.; Reardon, Michael J.; Yakubov, Steven J.; Hermiller, James B.; Harrison, J. Kevin; Gleason, Thomas G.; Conte, John V.; Deeb, G. Michael; Chetcuti, Stanley; Oh, Jae Kuen; Boulware, Michael J.; Huang, Jian; Adams, David H.

In: JACC: Cardiovascular Imaging, Vol. 9, No. 8, 01.08.2016, p. 973-981.

Research output: Contribution to journalArticle

Popma, JJ, Reardon, MJ, Yakubov, SJ, Hermiller, JB, Harrison, JK, Gleason, TG, Conte, JV, Deeb, GM, Chetcuti, S, Oh, JK, Boulware, MJ, Huang, J & Adams, DH 2016, 'Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation', JACC: Cardiovascular Imaging, vol. 9, no. 8, pp. 973-981. https://doi.org/10.1016/j.jcmg.2016.06.002
Popma JJ, Reardon MJ, Yakubov SJ, Hermiller JB, Harrison JK, Gleason TG et al. Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation. JACC: Cardiovascular Imaging. 2016 Aug 1;9(8):973-981. https://doi.org/10.1016/j.jcmg.2016.06.002
Popma, Jeffrey J. ; Reardon, Michael J. ; Yakubov, Steven J. ; Hermiller, James B. ; Harrison, J. Kevin ; Gleason, Thomas G. ; Conte, John V. ; Deeb, G. Michael ; Chetcuti, Stanley ; Oh, Jae Kuen ; Boulware, Michael J. ; Huang, Jian ; Adams, David H. / Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation. In: JACC: Cardiovascular Imaging. 2016 ; Vol. 9, No. 8. pp. 973-981.
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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{\circledR} System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve{\circledR} U.S. Pivotal Trial]; NCT01240902)",
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AU - Popma, Jeffrey J.

AU - Reardon, Michael J.

AU - Yakubov, Steven J.

AU - Hermiller, James B.

AU - Harrison, J. Kevin

AU - Gleason, Thomas G.

AU - Conte, John V.

AU - Deeb, G. Michael

AU - Chetcuti, Stanley

AU - Oh, Jae Kuen

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AU - Huang, Jian

AU - Adams, David H.

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N2 - 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)

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