Disclosures: Al-Kassou, Brouwer and ten Berg report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
June 24, 2020
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Protamine reduces bleeding complications after TAVR

Disclosures: Al-Kassou, Brouwer and ten Berg report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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Patients who were administered protamine after transcatheter aortic valve replacement had significantly lower rates of major and life-threatening bleeding complications compared with those without heparin reversal, researchers found.

“To our knowledge, this is the first study evaluating patients receiving protamine for heparin reversal in the context of TAVR,” Baravan Al-Kassou, MD, cardiologist at the Heart Center in the department of medicine II at University Hospital Bonn in Germany, told Healio. “Our study demonstrates that protamine administration for heparin reversal after the TAVR procedure may result in significantly lower rates of life-threatening and major bleeding events, without increasing the incidence of thromboembolic events, such as stroke and myocardial infarction. Furthermore, patients with protamine administration had significantly shorter hospital stays as compared to patients without heparin reversal.”

Prevalence of 30-day mortality and major bleeding among patients who underwent TAVR and received protamine compared with patients who did not.

Heparin reversal after TAVR

In the study published in JACC: Cardiovascular Interventions, researchers analyzed data from 873 patients (mean age, 81 years; 50% women) with severe, symptomatic aortic stenosis who underwent TAVR between February 2013 and May 2018. All patients underwent TAVR with next-generation heart valves. Of the patients in this study, 677 (mean age, 81 years; 51% women) were administered protamine for heparin reversal based on the operator’s discretion.

Baravan Al-Kassou

The primary endpoint was a composite of 30-day all-cause mortality and both major and life-threatening bleeding. Secondary endpoints were also included, defined as stroke, 1-year all-cause mortality, major vascular complications, MI and acute kidney injury at 30 days.

The primary endpoint occurred less frequently in patients who were given protamine compared with those who did not (3.2% vs. 8.7%; P = .003), which was driven by lower rates of major bleeding (1% vs. 4.1%; P = .008) and life-threatening bleeding (0.1% vs. 2.6%; P < .001) in patients who were administered protamine.

Patients given protamine also had shorter hospital stays compared with those who were not given the heparin reversal agent (11.1 days vs. 12.7 days; P = .05).

For the overall cohort, stroke occurred in 1.9% of patients and MI was observed in 0.2%, resulting in no significant differences between groups.

Based on multivariate analysis, acute kidney injury (OR = 5.82; 95% CI, 2.02-16.77) and protamine administration (OR = 0.24; 95% CI, 0.1-0.58) were independently linked with the primary endpoint.

“This study presents the results of our single-center experience,” Al-Kassou said in an interview. “An adequately powered randomized controlled trial is needed to confirm the efficacy and safety of protamine administration in the field of TAVR.” 

Protamine timing

In a related editorial, Jurrien M. ten Berg, MD, PhD, director of the St. Antonius Center for Platelet Function Research in Nieuwegein, the Netherlands, and Jorn Brouwer, MD, PhD student at St. Antonius Hospital, wrote: “The timing of protamine administration remains unclear. In this study, protamine was administered after closure of the vascular access. In our opinion, administration before vascular access closure would definitely have prevented even more vascular and bleeding complications. Heparin was continued after TAVR for unclear reasons, which would have increased the overall bleeding rate.”

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Reference:

For more information:

Baravan Al-Kassou, MD, can be reached at baravan.al-kassou@ukbonn.de.