Author + information
- Received January 21, 2020
- Revision received March 23, 2020
- Accepted March 31, 2020
- Published online June 15, 2020.
- Baravan Al-Kassou, MDa,
- Julian Kandt, MDa,
- Luisa Lohde, MDa,
- Jasmin Shamekhi, MDa,
- Alexander Sedaghat, MDa,
- Noriaki Tabata, MDa,
- Marcel Weber, MDa,
- Atsushi Sugiura, MDa,
- Rolf Fimmers, PhDb,
- Nikos Werner, MDa,
- Eberhard Grube, MDa,
- Hendrik Treede, MDc,
- Georg Nickenig, MDa and
- Jan-Malte Sinning, MDa,∗ ()
- aHeart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany
- bDepartment of Medical Biometry, Informatics, and Epidemiology, University Hospital Bonn, Bonn, Germany
- cHeart Center, Department of Cardiac Surgery, University Hospital Bonn, Bonn, Germany
- ↵∗Address for correspondence:
Dr. Jan-Malte Sinning, Heart Center Bonn, Department of Medicine II, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.
Objectives The aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes.
Background Occurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality.
Methods This study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients.
Results The primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
Conclusions Protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration.
Drs. Sinning, Grube, and Nickenig have received speaking honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Grube is a proctor for Boston Scientific and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received January 21, 2020.
- Revision received March 23, 2020.
- Accepted March 31, 2020.
- 2020 American College of Cardiology Foundation
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