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Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis.

Publication ,  Journal Article
Rogers, T; Waksman, R; Harrison, JK; Deeb, GM; Zhang, AQ; Hermiller, JB; Popma, JJ; Reardon, MJ
Published in: Am J Cardiol
June 1, 2018

The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.

Duke Scholars

Published In

Am J Cardiol

DOI

EISSN

1879-1913

Publication Date

June 1, 2018

Volume

121

Issue

11

Start / End Page

1358 / 1364

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Stroke
  • Severity of Illness Index
  • Pacemaker, Artificial
  • Myocardial Infarction
  • Mortality
  • Male
  • Humans
  • Hemodynamics
 

Citation

APA
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ICMJE
MLA
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Rogers, T., Waksman, R., Harrison, J. K., Deeb, G. M., Zhang, A. Q., Hermiller, J. B., … Reardon, M. J. (2018). Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis. Am J Cardiol, 121(11), 1358–1364. https://doi.org/10.1016/j.amjcard.2018.02.008
Rogers, Toby, Ron Waksman, J Kevin Harrison, G Michael Deeb, Angie Q. Zhang, James B. Hermiller, Jeffrey J. Popma, and Michael J. Reardon. “Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis.Am J Cardiol 121, no. 11 (June 1, 2018): 1358–64. https://doi.org/10.1016/j.amjcard.2018.02.008.
Rogers T, Waksman R, Harrison JK, Deeb GM, Zhang AQ, Hermiller JB, et al. Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis. Am J Cardiol. 2018 Jun 1;121(11):1358–64.
Rogers, Toby, et al. “Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis.Am J Cardiol, vol. 121, no. 11, June 2018, pp. 1358–64. Pubmed, doi:10.1016/j.amjcard.2018.02.008.
Rogers T, Waksman R, Harrison JK, Deeb GM, Zhang AQ, Hermiller JB, Popma JJ, Reardon MJ. Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis. Am J Cardiol. 2018 Jun 1;121(11):1358–1364.
Journal cover image

Published In

Am J Cardiol

DOI

EISSN

1879-1913

Publication Date

June 1, 2018

Volume

121

Issue

11

Start / End Page

1358 / 1364

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Stroke
  • Severity of Illness Index
  • Pacemaker, Artificial
  • Myocardial Infarction
  • Mortality
  • Male
  • Humans
  • Hemodynamics