Safety and Efficacy of Protamine Administration for Prevention of Bleeding Complications in Patients Undergoing TAVR

Al‐Kassou, Baravan; Kandt, Julian; Lohde, Luisa; Shamekhi, Jasmin; Sedaghat, Alexander; Tabata, Noriaki; Weber, Marcel; Sugiura, Akira; Fimmers, Rolf; Werner, Nikos; Grube, Eberhard; Treede, Hendrik; Nickenig, Georg; Sinning, Jan‐Malte

doi:10.1016/j.jcin.2020.03.041

Cited by 38 publications

(35 citation statements)

References 19 publications

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“…In a recently published retrospective analysis of our own material (186 patients undergoing transfemoral TAVI, 44% via surgical cut-down, 21% received PS at operators' discretion) PS administration did not decrease the rate of bleeding complications [15]. Conversely, in a much larger (873 patients), single-center, prospective observational study, in which 677 patients undergoing TAVI received PS, protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications while not increasing the occurrence of stroke and myocardial infarction [16]. That?…”

Section: Discussionmentioning

confidence: 94%

“…The median age was 82 years (IQR 77-85), there were 48 males (48%), almost 90% of patients had hypertension, 43% -diabetes, and approximately one-third (36%) was in New York Heart Association (NYHA) class III or IV. The median logistic EuroSCORE was 10.5 (IQR,(8)(9)(10)(11)(12)(13)(14)(15)(16). All the procedures were performed via transfemoral access and in all cases, a pre-close system was used.…”

Section: Populationmentioning

confidence: 99%

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Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

et al. 2021

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Background: Bleeding complications after transcatheter aortic valve implantation (TAVI) negatively affect the post-procedural prognosis. Routine use of protamine sulfate (PS) to reverse unfractionated heparin after TAVI was never assessed in a randomized controlled trial. Aims:The aim of this study was to assess the impact of PS on bleeding complications after TAVI.Methods: Between December 2016 and July 2020 311 patients qualified to TAVI in one academic center were screened. Patients that met the inclusion criteria were randomized to either PS or normal saline administration at the moment of optimal valve deployment. Baseline, procedural, and follow-up data for up to 30 days were collected and analyzed. The primary endpoint (PE) was a composite of life-threatening and major bleeding according to Valve Academic Research Consortium within 48 hours after the procedure.Results: Overall, 100 patients (48 males, median age 82 years) met the inclusion criteria and were included in the study. Forty-seven subjects (47%) were randomized to PS. The primary endpoint occurred in 29% of the study population. Despite numerically lower rates of PE in patients randomized to PS, a statistical significance was not reached (21% in the PS group and 36% in the placebo group; odds ratio [OR], 0.48; 95% confidence intervals [CI] 0.2-1.2; P = 0.11). There were no significant differences in secondary endpoints.Conclusions: Routine protamine sulfate administration did not significantly decrease the rate of major and life-threatening bleeding complications after TAVI. Larger studies are required to assess the impact of routine PS use.

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Section: Discussionmentioning

confidence: 94%

Section: Populationmentioning

confidence: 99%

Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

et al. 2021

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“…More over, heparin reversal has recently been reported to reduce significantly rate of major or life-threatening complications, without increasing the risk of thrombo-embolic events (including stroke or myocardial infarction) ( 60 ). However, results should be interpreted cautiously since heparin reversal was performed in presence of vascular complication at the beginning of the study whereas protamine was administered to all patients toward the end of the study.…”

Section: General Complication Prevention and Treatmentmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation: All Transfemoral? Update on Peripheral Vascular Access and Closure

Perrin

Bonnet

Leroux

et al. 2021

Front. Cardiovasc. Med.

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Transfemoral access remains the most widely used peripheral vascular approach for transcatheter aortic valve implantation (TAVI). Despite technical improvement and reduction in delivery sheath diameters of all TAVI platforms, 10–20% of patients remain not eligible to transfemoral TAVI due to peripheral artery disease. In this review, we aim at presenting an update of recent data concerning transfemoral access and percutaneous closure devices. Moreover, we will review peripheral non-transfemoral alternative as well as caval-aortic accesses and discuss the important features to assess with pre-procedural imaging modalities before TAVI.

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“…Despite its neutralization action, protamine may cause severe side effects such as systemic hypotension, anaphylactic reaction, pulmonary hypertension, and tissue damage of the lungs, kidneys, and red blood cells (Sokolowska et al, 2016). Hence, the use of protamine can have a significant difference in short-term and long-term morbidity and mortality (Al-Kassou et al, 2020). As one study reviewed 10,059 CEAs performed in 9,260 patients from 2003 to 2012, protamine use remained stable from 2003 through 2007 at 43%.…”

Section: Introductionmentioning

confidence: 99%

A Meta-Analysis of Using Protamine for Reducing the Risk of Hemorrhage During Carotid Recanalization: Direct Comparisons of Post-operative Complications

et al. 2022

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Background: Protamine can decrease the risk of hemorrhage during carotid recanalization. However, it may cause severe side effects. There is no consensus on the safety and efficacy of protamine during surgery. Thus, we conduct a comprehensive review and meta-analysis to compare the differences between the protamine and the no-protamine group.Method: We systematically obtained literature from Medline, Google Scholar, Cochrane Library, and PubMed electronic databases. All four databases were scanned from 1937 when protamine was first adopted as a heparin antagonist until February 2021. The reference lists of identified studies were manually checked to determine other eligible studies that qualify. The articles were included in this meta-analysis as long as they met the criteria of PICOS; conference or commentary articles, letters, case report or series, and animal observation were excluded from this study. The Newcastle-Ottawa Quality Assessment Scale and Cochrane Collaboration’s tool are used to assess the risk of bias of each included observational study and RCT, respectively. Stata version 12.0 statistical software (StataCorp LP, College Station, Texas) was adopted as statistical software. When I2 < 50%, we consider that the data have no obvious heterogeneity, and we conduct a meta-analysis using the fixed-effect model. Otherwise, the random-effect model was performed.Result: A total of 11 studies, consisting of 94,618 participants, are included in this study. Our analysis found that the rate of wound hematoma had a significant difference among protamine and no-protamine patients (OR = 0.268, 95% CI = 0.093 to 0.774, p = 0.015). Furthermore, the incidence of hematoma requiring re-operation (0.7%) was significantly lower than that of patients without protamine (1.8%). However, there was no significant difference in the incidence of stroke, wound hematoma with hypertension, transient ischemic attacks (TIA), myocardial infarction (MI), and death.Conclusion: Among included participants undergoing recanalization, the use of protamine is effective in reducing hematoma without increasing the risk of having other complications. Besides, more evidence-based performance is needed to supplement this opinion due to inherent limitations.

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Safety and Efficacy of Protamine Administration for Prevention of Bleeding Complications in Patients Undergoing TAVR

Cited by 38 publications

References 19 publications

Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

Transcatheter Aortic Valve Implantation: All Transfemoral? Update on Peripheral Vascular Access and Closure

A Meta-Analysis of Using Protamine for Reducing the Risk of Hemorrhage During Carotid Recanalization: Direct Comparisons of Post-operative Complications

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