TY - JOUR
T1 - Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement
T2 - Insights from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry
AU - Sherwood, Matthew W.
AU - Xiang, Katelyn
AU - Matsouaka, Roland
AU - Li, Zhuokai
AU - Vemulapalli, Sreekanth
AU - Vora, Amit N.
AU - Fanaroff, Alexander
AU - Harrison, J. Kevin
AU - Thourani, Vinod H.
AU - Holmes, David
AU - Kirtane, Ajay
AU - Pineda, Andres M.
AU - Peterson, Eric D.
AU - Rao, Sunil V.
N1 - Publisher Copyright:
© 2020 Lippincott Williams and Wilkins. All rights reserved.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - bleeding
KW - cardiology
KW - hospital
KW - incidence
KW - transcatheter aortic valve replacement
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U2 - 10.1161/CIRCINTERVENTIONS.119.008227
DO - 10.1161/CIRCINTERVENTIONS.119.008227
M3 - Article
C2 - 31937138
AN - SCOPUS:85077903272
SN - 1941-7640
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
M1 - e008227
ER -