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Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

Publication ,  Journal Article
Sherwood, MW; Xiang, K; Matsouaka, R; Li, Z; Vemulapalli, S; Vora, AN; Fanaroff, A; Harrison, JK; Thourani, VH; Holmes, D; Kirtane, A; Rao, SV ...
Published in: Circ Cardiovasc Interv
January 2020

BACKGROUND: Vascular and bleeding complications were commonly reported in transcatheter aortic valve replacement clinical trials. Little is known about complication rates in contemporary US clinical practice or clinical outcomes associated with these complications. METHODS: In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we evaluated patients undergoing transcatheter aortic valve replacement from November 1, 2011 to June 30, 2016. The primary outcomes were in-hospital vascular complications and bleeding events. Secondary outcomes included all-cause mortality, stroke, and rehospitalization at 1 year. P values for trends were calculated for rates over time, and multivariable logistic regression was used to determine the association between vascular/bleeding complications and in-hospital clinical outcomes. RESULTS: Overall, 34 893 patients undergoing transcatheter aortic valve replacement at 445 hospitals were analyzed. Of these, 9.3% (n=3257) experienced a vascular complication while 7.6% (n=2651) had an in-hospital bleeding event. Rates of both vascular complications and bleeding events decreased over time (P value for trend test <0.0001); however, there was significant variation in rates across hospital sites (adjusted median rate, 11.4%; IQR, 8.9-14.5). Vascular complications were independently associated with 30-day death (adjusted HR, 2.23 [95% CI, 1.80-2.77]) and death (adjusted HR, 1.17 [95% CI, 1.05-1.30]) and rehospitalization (adjusted HR, 1.14 [95% CI, 1.07-1.22]) at 1 year. Bleeding events were also associated with 30-day death (adjusted HR, 3.71 [95% CI, 2.94-4.69]), and with death (adjusted HR, 1.39 [95% CI, 1.23-1.56]) and hospital readmission (adjusted HR, 1.19 [95% CI, 1.11-1.27]) at 1 year. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement in the US, vascular complications and in-hospital bleeding events were common, but rates have declined over time with significant variation in complication rates across hospital sites. Vascular and bleeding complications are both associated with worse short- and long-term clinical outcomes including all-cause mortality. Further innovation to reduce sheath sizes and optimize antithrombotic therapy is necessary to reduce the incidence of these detrimental complications.

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Published In

Circ Cardiovasc Interv

DOI

EISSN

1941-7632

Publication Date

January 2020

Volume

13

Issue

1

Start / End Page

e008227

Location

United States

Related Subject Headings

  • Vascular Diseases
  • United States
  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Time Factors
  • Stroke
  • Risk Factors
  • Risk Assessment
  • Registries
  • Postoperative Hemorrhage
 

Citation

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Chicago
ICMJE
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Sherwood, M. W., Xiang, K., Matsouaka, R., Li, Z., Vemulapalli, S., Vora, A. N., … Rao, S. V. (2020). Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry. Circ Cardiovasc Interv, 13(1), e008227. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008227
Sherwood, Matthew W., Katelyn Xiang, Roland Matsouaka, Zhuokai Li, Sreekanth Vemulapalli, Amit N. Vora, Alexander Fanaroff, et al. “Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.Circ Cardiovasc Interv 13, no. 1 (January 2020): e008227. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008227.
Sherwood MW, Xiang K, Matsouaka R, Li Z, Vemulapalli S, Vora AN, Fanaroff A, Harrison JK, Thourani VH, Holmes D, Kirtane A, Pineda AM, Peterson ED, Rao SV. Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry. Circ Cardiovasc Interv. 2020 Jan;13(1):e008227.

Published In

Circ Cardiovasc Interv

DOI

EISSN

1941-7632

Publication Date

January 2020

Volume

13

Issue

1

Start / End Page

e008227

Location

United States

Related Subject Headings

  • Vascular Diseases
  • United States
  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Time Factors
  • Stroke
  • Risk Factors
  • Risk Assessment
  • Registries
  • Postoperative Hemorrhage