Continuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: A randomized clinical trial

doi:10.1016/j.hrthm.2010.12.016

Heart Rhythm

Volume 8, Issue 4, April 2011, Pages 536-540

https://doi.org/10.1016/j.hrthm.2010.12.016 Get rights and content

Background

Management of oral anticoagulation in patients undergoing pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation remains controversial. Prior studies demonstrate that continuation of warfarin may be safer when compared with strategies requiring interruption and/or heparin bridging. Limited data from randomized trials exist.

Objective

We conducted a randomized trial to determine whether warfarin continuation is superior to warfarin interruption during PPM or ICD implantation.

Methods

Patients on oral anticoagulation referred for PPM or ICD implantation were randomized to warfarin continuation versus interruption. Patients randomized to warfarin interruption were further stratified into two groups based on their risk for thromboembolic events in the absence of warfarin. Moderate-risk patients were randomized to warfarin continuation versus warfarin interruption. High-risk patients were randomized to warfarin continuation versus warfarin interruption with heparin bridging. The primary combined outcome included thromboembolic events, anticoagulant-related complications, or any significant bleeding necessitating additional intervention or discontinuation of anticoagulation.

Results

We studied 100 patients (average age 70.8 years, 21% female, mean body mass index 28.4) who underwent 64 ICD and 36 PPM implantations. Fifty patients were assigned to continue warfarin. The randomized groups were well matched. Among patients randomized to warfarin interruption, there were two pocket hematomas, one pericardial effusion, one transient ischemic attack, and one patient who developed heparin-induced thrombocytopenia. No events were noted among patients continuing warfarin (P = .056).

Conclusions

While the results were not statistically significant, there was a trend toward reduced complications in patients randomized to warfarin continuation. This strategy should be considered in patients undergoing PPM or ICD implantation.

Introduction

Among patients undergoing pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation, approximately 12.4%–45% are on anticoagulation therapy.1, 2 Given the low risk of thromboembolism with short-term warfarin interruption³ and the concern for increased bleeding while anticoagulated, current guidelines suggest discontinuation of warfarin with and without heparin bridging in the periprocedural period.⁴ While this strategy may be appropriate in cases involving major surgery, this may not be applicable in device-based procedures where implantations typically occur above the pectoral fascia. In fact, significant hematomas have been shown to occur in approximately 30% of patients managed with heparin bridging in these settings.1, 5

Previous studies have demonstrated that continuation of warfarin in the periprocedural period may be safe.6, 7, 8 While the management of warfarin before device implantation varies widely, especially in individuals at high risk for embolic events,9, 10 more recent reports have shown that warfarin discontinuation with heparin bridging is associated with more significant bleeding events.11, 12 These data, coupled with prior systematic reviews,¹³ suggest that warfarin continuation may be superior to warfarin interruption. Unfortunately, no randomized data demonstrating that warfarin continuation is superior to warfarin discontinuation exist.¹⁴

Section snippets

Patient selection and randomization schema

This was a randomized prospective study aimed to determine whether warfarin continuation in the periprocedural period is superior to warfarin interruption with or without heparin bridging (Figure 1). The study was approved by the Johns Hopkins Investigational Review Committee and was registered in the clinicaltrials.gov database (NCT00721136). All patients on oral anticoagulation who were referred for PPM or ICD implantation (including generator exchanges) were approached.

Since patients had

Patient characteristics

A total of 104 patients were randomized in this study. Two patients from each treatment arm were excluded from the analysis. Three of these patients withdrew after being told of the treatment assignment, and one patient's procedure was cancelled owing to need for a left ventricular assist device. Among the 100 patients remaining, 83 were categorized as moderate-risk patients and 17 were in the high-risk group. Atrial fibrillation was the most common indication for warfarin therapy (66%). Other

Discussion

Prior studies have shown that continuing warfarin does not increase bleeding complications. A recent prospective study showed similar bleeding rates between these two treatment arms but was underpowered to demonstrate noninferiority.¹⁴ In another more recent study, individuals who continued warfarin in the periprocedural period (mean INR similar to that reported here) had lower bleeding complications compared with those treated with warfarin interruption and daltaparin bridging.⁸ Our findings

Limitations

Several limitations affected this study. While this randomized study was not blinded, implanting physicians were blinded to the overall study results until enrollment was closed. Second, all cases involved the use of an upper-extremity venogram and avoidance of performing a cephalic vein cut-down. It is not clear how a cephalic vein cut-down would affect bleeding risk on warfarin as the process of “cutting down” may increase the risk for bleeding but direct visualization of the vein may

Conclusion

Previous retrospective analyses suggest that bleeding rates with warfarin continuation may be less than or similar to warfarin interruption. This randomized study demonstrates a trend toward reduced complications when warfarin is continued in the periprocedural period of PPM and ICD implantations. Consideration should be made for continuing warfarin in these procedures.

Acknowledgments

We thank our device nurses, Misty Capps, Kathleen DeVaughn, and Julia Zinski, for help in evaluating patients postoperatively.

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: AC has received an honorarium from Boston Scientific, Medtronic, St. Jude Medical, and Biotronik. DDS has received research support from Boston Scientific. RDB is a consultant to Boston Scientific and has received fellowship support from Medtronic and St. Jude Medical. HC is a consultant to Medtronic, has received an honorarium from Boston Scientific, and receives research support from Boston Scientific, Medtronic, and St. Jude Medical.

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ClinicalDeviceContinuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: A randomized clinical trial

Background

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Patient selection and randomization schema

Patient characteristics

Discussion

Limitations

Conclusion

Acknowledgments

Chest

J Am Coll Cardiol

Am Heart J

Heart Rhythm

J Am Coll Cardiol

Heart Rhythm

J Thromb Haemost

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Post-operative use of heparin increases morbidity of pacemaker implantation

Europace

Clinical
Device
Continuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: A randomized clinical trial