What is the clinical evidence from this study?

Study design: Observational. Population: Implantable cardioverter defibrillator (ICD) implantation (n=273). Intervention: Heparin bridging vs. No antiplatelet or anticoagulation. Primary outcome: Major bleeding complications (hematoma requiring reoperation, cardiac tamponade, pericardial effusion requiring additional hospital stay, or critical symptomatic bleeding) (OR 7.44, 95% CI 2.06-26.89, p=0.0022).

January 1, 2013Circulation JournalOpen Access

Anticoagulation Management in the Perioperative Phase of Implantable Cardioverter Defibrillator Implantation

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Key result

Heparin bridging significantly increased the risk of major bleeding complications at the time of ICD implantation, with an adjusted odds ratio of 7.44.

Why the study?

Does heparin bridging increase major bleeding complications in patients undergoing ICD implantation?

Population

273 consecutive Japanese patients undergoing initial implantable cardioverter defibrillator implantation…

Comparison

Heparin bridging: warfarin discontinued 3-5 days… vs No antiplatelet or anticoagulation, antiplatelet…

Design

Cohort

Follow-up

at least 1 month

Authors

HYHisashi YokoshikiElectrophysiology HMHirofumi MitsuyamaNakamura Memorial Hospital MWMasaya WatanabeHokkaido Orthopedic Surgery Memorial Hospital

Discussion

Member takes

Implication

Clinicians should avoid heparin bridging at ICD implantation; this Level 3 finding leaves open confirmation by randomized trials.

Study Design

Type

Observational (n=273)

Multicenter

Structured PICO

Does heparin bridging increase major bleeding complications in patients undergoing ICD implantation?

Population

273 consecutive Japanese patients (mean age 58, 22% female) undergoing initial implantable cardioverter defibrillator implantation, evaluated for perioperative complications within 1 month.

Exposure

Heparin bridging (n=34): warfarin discontinued 3-5 days prior, IV heparin started 12h after withholding warfarin, adjusted for aPTT ~60s, withheld 4-6h prior to procedure, restarted 12h after.

Comparator

No antiplatelet or anticoagulation (n=121), antiplatelet only (n=59), or warfarin continuation (n=59, discontinued 1-2 days prior and restarted day of or next day).

Outcome

Major bleeding (hematoma requiring reoperation, cardiac tamponade, pericardial effusion requiring additional hospital stay, or critical symptomatic bleeding) or thromboembolic events (stroke, systemic embolism) during or within 1 month of implantation.safety

Main Result

Odds Ratio: 7.44 (95% CI 2.06–26.89)

Absolute Event Rate: 17.6% vs 1.7%

p-value: p=0.0022

Heparin bridging during ICD implantation significantly increases the risk of major bleeding complications compared to no anticoagulation or warfarin continuation.

Limitations

Hematomas without surgical evacuation were not included as bleeding complications.
Perioperative management of anticoagulation was dependent on the decision by each doctor.
INR on or 1 day after ICD implantation in the warfarin group was variable and less than optimal in most patients.
Heterogeneous patients in terms of antiplatelet potency may have been included in the antiplatelet group.
Hematomas without surgical evacuation were not included as bleeding complications
Perioperative management of anticoagulation was dependent on the decision by each doctor
INR on or 1 day after ICD implantation in the W group was variable and less than optimal
Heterogeneous patients in terms of antiplatelet potency may have been included in the AP group

Cite This Study

Yokoshiki et al. (2013) conducted an observational in Implantable cardioverter defibrillator (ICD) implantation (n=273). Heparin bridging vs. No antiplatelet or anticoagulation was evaluated on Major bleeding complications (hematoma requiring reoperation, cardiac tamponade, pericardial effusion requiring additional hospital stay, or critical symptomatic bleeding) (OR 7.44, 95% CI 2.06-26.89, p=0.0022). Heparin bridging significantly increased the risk of major bleeding complications at the time of ICD implantation, with an adjusted odds ratio of 7.44.

synapsesocial.com/papers/6a902db1e73a4c404fc924b2 https://doi.org/10.1253/circj.cj-12-1507

Topics

Cardiac device therapy Anticoagulation in AF

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Anticoagulation Management in the Perioperative Phase of Implantable Cardioverter Defibrillator Implantation

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Anticoagulation Management in the Perioperative Phase of Implantable Cardioverter Defibrillator Implantation

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider