Better TAVR Systems, Patient Selection Credited for Drop in Vascular, Bleeding Complications

Larry Hand

November 01, 2016

WASHINGTON, DC — In-hospital vascular complications and in-hospital bleeding remain as common adverse events following transcatheter aortic-valve replacement (TAVR), but the trend is decreasing, according to research presented at TCT 2016; the study was published simultaneously in the Journal of the American College of Cardiology[1].

"The incidence of vascular complications and bleeding is decreasing over time, and what we'd attribute that to, based on data, is improved delivery systems," Dr Matthew Sherwood (Inova Heart and Valvular Institute, Falls Church, VA and Duke University Medical Center, Durham, NC) told heartwire from Medscape.

"But even though the incidence of these complications is decreasing, they're still very important. Vascular complications and in-hospital bleeding are associated with death at 30 days and 1 year. It's important for us to look for ways to reduce the incidence of these complications," he said.

Sherwood and colleagues analyzed data from the STS/ACC TVT Registry on 22,069 patients (mean age 84, most female) who underwent TAVR at 359 hospitals, with 6213 patients having data at 1 year linked to the Centers for Medicare & Medicaid Services (CMS).

They found that the rate of vascular complications decreased from about 19% in late 2011 to about 8% in late 2015 and that the rate of in-hospital bleeding decreased from about 19% to about 7% during the same period.

Significant Predictors of Vascular Complications and In-Hospital Bleeding

Predictor Adjusted odds ratio 95% CI P
Vascular complications
Female sex 1.86 1.69–2.03 <0.01
Cardiogenic shock 1.93 1.08–3.44 0.03
History of peripheral artery disease 1.32 1.19–1.47 <0.01
In-hospital bleeding
Female sex 1.39 1.25-1.54 <0.01
Cardiogenic shock 1.48 0.81-2.70 0.19
History of peripheral artery disease 1.19 1.18-1.45 P <0.01

The researchers found vascular complications to be associated with all-cause mortality (adjusted odds ratio [aOR] 2.23.19; 95% CI, 1.180–2.77) at 30 days and bleeding to be more associated with mortality (aOR 3.71; 95% CI, 3.94–4.93) at 30 days.

At the 1-year mark, vascular complications were associated with all-cause mortality (aOR 1.14; 95% CI 1.18–1.31), hospital readmission (aOR 1.16; 95% CI 1.05–1.28), and stroke (aOR 1.21; 95% CI 0.18–1.63). Bleeding was associated with all-cause mortality (aOR 1.26; 95% CI 1.09–1.47), hospital readmission (aOR 1.15; 95% CI 1.04–1.28), and stroke (aOR 1.63; 95% CI 1.08–2.48).

"Vascular complications and bleeding remain common among TAVR patients in contemporary clinical practice, but the incidence of these events has decreased over time," Sherwood said during the presentation.

He told heartwire ,"Two important [improvements] are that the companies are continuing to innovate and have smaller and better delivery systems, so that will help, and then also patient selection. Patients who have smaller vessels, those are the patients who are at high risk for these complications, so we should think very hard about our device selections."

The American College of Cardiology Foundation and the Society of Thoracic Surgeons supported this research. Sherwood reported no relevant financial relationships.

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