This year’s AHA Scientific Sessions in Anaheim, CA provided the cardiology community with a number of important trials. Large clinical studies have the possibility to directly impact clinical practice. In the subspecialty of electrophysiology, there was an important trial with significant relevance to physicians who implant or provide perioperative care for patients with pacemakers/ defibrillators (“EP device procedures”).
A frequent dilemma which implanting physicians face is whether or not to suspend anticoagulation prior to insertion of an EP device. Suspension of anticoagulation raises the risk of stroke for many patients and this cannot be ignored. The obvious postoperative concern is the attendant risk of pocket hematoma which is not only a painful experience for the patient, but can also dramatically increase the risk of infection. The latter is considered a potentially disastrous complication with high morbidity and mortality. In 2013, Birnie et al published the results of BRUISE-CONTROL which was a randomized controlled trial with sought to determine outcomes between continued warfarin use, and suspension of warfarin while bridging with intravenous heparin at the time of surgical implant (NEJM 2013). The results were categorically in favor of continued warfarin use. With that study, patients in the uninterrupted oral anticoagulation arm had a marked reduction of postoperative pocket hematoma (3.5% -16%). For some time, many implanting physicians had observed the benefits of continued oral anticoagulation with warfarin during device implants, however the data from this trial provided validation of this practice.
In the past several years, a group of new oral anticoagulants have emerged (NOACs). While the pharmacological mechanisms vary (e.g. factor ten, direct thrombin inhibition) the clinical effects aim to provide systemic anticoagulation. These agents have increased in popularity as an alternative to warfarin. As experience with these agents (e..g. Apibixan, Rivaroxaban, Dabigatran) grew, a determination of their effects on device implants was needed and to ascertain their risk for postoperative hematoma formation. A new trial was launched: BRUISE CONTROL-2. The clinical question was to determine any difference in the development of a hematoma subsequent to a NOAC’s uninterrupted use versus suspension of the NOAC drug two days prior to the procedure. To further add complexity to the matter, only one of these medications has a commercially available reversal agent (dabigatran), hence there is a natural apprehension of performing a procedure under the influence of anticoagulant whose effects cannot be stopped. BRUISE CONTROL-2 presented by Dr David Birnie on 11/12/17.
Surprisingly, there was no difference in pocket hematoma formation (2.1% vs 2.1%). The study was terminated due to futility. The authors concluded that either approach is reasonable. Since the study was not blinded, one might question whether the implanting physicians modified their surgical approach and perhaps could have used different methods to curtail bleeding (e.g. the use of hemostatic or antithrombotic agents introduced into the pocket).
Overall, there was a low complication rate. A size categorization of the incisional hematomas would be helpful as well: a large tension-creating hematoma clearly does not have the same clinical impact as mild swelling. In my opinion the results further validate the safety of NOAC use perioperatively. A subanalysis of how the individual agents performed would be helpful to further elucidate whether there exists a drug superiority, or better yet a BRUISE CONTROL-3 could help address this.
Christian Perzanowski is an electrophysiologist in Tampa, FL. His main interests are in ablation techniques for atrial fibrillation and device therapy for congestive heart failure.