Post-operative pain following cardiac implantable electronic device implantation: insights from the BRUISE CONTROL trials.

AIMS: Post-operative pain following cardiac implantable electronic device (CIED) insertion is associated with patient dissatisfaction, emotional distress, and emergency department visits. We sought to identify factors associated with post-operative pain and develop a prediction score for post-operative pain. METHODS AND RESULTS: All patients from the BRUISE CONTROL-1 and 2 trials were included in this analysis. A validated Visual Analogue Scale (VAS) was used to assess the severity of pain related to CIED implant procedures. Patients were asked to grade the most severe post-operative pain, average post-operative pain, and pain on the day of the first post-operative clinic. Multivariable regression analyses were performed to identify predictors of significant post-operative pain and to develop a pain-prediction score. A total of 1308 patients were included. Multivariable regression analysis found that the presence of post-operative clinically significant haematoma {CSH; P value < 0.001; odds ratio (OR) 3.82 [95% confidence interval (CI): 2.37-6.16]}, de novo CIED implantation [P value < 0.001; OR 1.90 (95% CI: 1.47-2.46)], female sex [P value < 0.001; OR 1.61 (95% CI: 1.22-2.12)], younger age [<65 years; P value < 0.001; OR 1.54 (95% CI: 1.14-2.10)], and lower body mass index [<20 kg/m2; P value < 0.05; OR 2.05 (95% CI: 0.98-4.28)] demonstrated strong and independent associations with increased post-operative pain. An 11-point post-operative pain prediction score was developed using the data. CONCLUSION: Our study has identified multiple predictors of post-operative pain after CIED insertion. We have developed a prediction score for post-operative pain that can be used to identify individuals at risk of experiencing significant post-operative pain.

Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2.

BACKGROUND: Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin. METHODS: We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery. RESULTS: Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (P<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; P=0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; P=0.717). CONCLUSIONS: Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.

Continued vs. interrupted direct oral anticoagulants at the time of device surgery, in patients with moderate to high risk of arterial thrombo-embolic events (BRUISE CONTROL-2).

Aims: Guidelines recommend warfarin continuation rather than heparin bridging for pacemaker and defibrillator surgery, after the BRUISE CONTROL trial demonstrated an 80% reduction in device pocket haematoma with this approach. However, direct oral anticoagulants (DOACs) are now used to treat the majority of patients with atrial fibrillation. We sought to understand the best strategy to manage the DOACs at the time of device surgery and specifically hypothesized that performing device surgery without DOAC interruption would result in a reduced haematoma rate. Methods and results: We randomly assigned patients with atrial fibrillation and CHA2DS2-VASc score ≥2, to continued vs. interrupted DOAC (dabigatran, rivaroxaban, or apixaban). The primary outcome was blindly evaluated, clinically significant device pocket haematoma: resulting in re-operation, interruption of anticoagulation, or prolonging hospital stay. In the continued arm, the median time between pre- and post-operative DOAC doses was 12 h; in the interrupted arm the median time was 72 h. Clinically significant haematoma occurred in of 7 of 328 (2.1%; 95% CI 0.9-4.3) patients in the continued DOAC arm and 7 of 334 (2.1%; 95% CI 0.9-4.3) patients in the interrupted DOAC arm (P = 0.97). Complications were uncommon, and included one stroke and one symptomatic pericardial effusion in each arm. Conclusions: These results suggest that, dependent on the clinical scenario, either management strategy (continued DOAC or interrupted DOAC) might be reasonable, at least for patients similar to those enrolled in our trial.

Ablate and his bundle pace.

Atrioventricular junction (AVJ) ablation and pacing therapy is a safe and effective method to control heart rate in patients with atrial fibrillation and rapid ventricular rates who have failed pharmacologic rate control therapies. Usually, the pacing lead of the pacemaker is located at the right ventricular apex or septum, and sometimes the patient has a cardiac resynchronization therapy device with an additional lead implanted through the coronary sinus for left ventricular pacing. We present a 72-year-old woman with permanent atrial fibrillation who developed tachycardia-induced cardiomyopathy. She underwent AVJ ablation following pacemaker implantation with a single lead located at the His bundle region resulting in significant clinical and hemodynamic improvement at follow-up. .

Prevention of venous thrombosis after electrophysiology procedures: a survey of national practice.

PURPOSE: Femoral venous access is required for most electrophysiology procedures. Limited data are available regarding post-procedure venous thromboembolism (VTE), specifically deep vein thrombosis (DVT) and pulmonary embolism (PE). Potential preventative strategies are unclear. We aimed to survey Canadian centers regarding incidence of VTE and strategies for prevention of VTE after procedures that do not require post-procedure anticoagulation. METHODS: An online survey was distributed to electrophysiologists representing major Canadian EP centers. Participants responded regarding procedural volume, incidence of VTE post-procedure, and their practice regarding pharmacological and non-pharmacological peri-procedural VTE prophylaxis. RESULTS: The survey included 17 centers that performed a total of 6062 procedures in 2016. Ten patients (0.16%) had VTE (including 9 DVTs and 6 PEs) after diagnostic electrophysiology studies and right-sided ablation procedures excluding atrial flutter. Five centers (41.6%) administered systemic intravenous heparin during both diagnostic electrophysiology studies and right-sided ablation procedures. For patients taking oral anticoagulants, 10 centers (58.8%) suspend therapy prior to the procedure. Two centers (11.8%) routinely prescribed post-procedure pharmacologic prophylaxis for VTE. Four centers (23.5%) used compression dressings post-procedure and all prescribed bed rest for a maximum of 6 h. Of the variables collected in the survey, none were found to be predictive of VTE. CONCLUSIONS: VTE is not a common complication of EP procedures. There is significant variability in the strategies used to prevent VTE events. Future research is required to evaluate strategies to reduce the risk of VTE that may be incorporated into EP practice guidelines.

Venous Thrombosis After Electrophysiology Procedures: A Systematic Review.

BACKGROUND: Femoral venous access for catheter introduction represents the cornerstone of electrophysiology (EP) procedures. Limited data are available regarding postprocedure VTE. The aim of this systematic review is to determine the incidence of DVT and pulmonary embolism (PE) associated with femoral vein catheterization during EP procedures. METHODS: An electronic search was conducted for studies documenting the incidence of DVT and PE after EP procedures. Studies were classified as atrial fibrillation (AF) or non-AF ablation procedures. RESULTS: Two thousand eight-hundred sixty-four studies were evaluated, 16 of which were included in the analysis. The incidence of DVT after AF and non-AF ablations reached as high as 0.33% and 2.38%, respectively, with a pooled incidence of 0% (95% CI, 0%-0.0003%) and 0.24% (95% CI, 0.08%-0.39%), respectively. The incidence of PE was 0.29% after AF ablation and ranged from 0% to 1.67% for non-AF procedures; the pooled incidence after non-AF ablations was 0.12% (95% CI, 0%-0.25%). Asymptomatic DVT was documented in up to 21.2% of patients. Hematomas occurred in 1.05% of AF ablations (95% CI, 0.30%-1.8%) and 0.3% of non-AF ablations (95% CI, 0.09%-0.51%). CONCLUSIONS: A lower incidence of symptomatic DVT and PE was observed after AF ablations as opposed to non-AF ablations, likely due to the use of routine periprocedural anticoagulation. Asymptomatic DVTs appear to be common, although their significance is unclear. Future studies are required to weigh the risk of hematoma against the risk of VTE associated with the use of prophylactic anticoagulation after non-AF ablation procedures.

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.

BACKGROUND: The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. OBJECTIVES: The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. METHODS: The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. RESULTS: The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CONCLUSIONS: CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137).

Strategy of continued vs interrupted novel oral anticoagulant at time of device surgery in patients with moderate to high risk of arterial thromboembolic events: The BRUISE CONTROL-2 trial.

BACKGROUND: Patients who require perioperative anticoagulation during cardiac implantable electronic device surgery are at increased risk for bleeding complications. The BRUISE CONTROL trial demonstrated that continuing warfarin was safer than heparin bridging, reducing the incidence of clinically significant pocket hematoma. Novel oral anticoagulants are being increasingly prescribed in place of warfarin. The best perioperative management of these new anticoagulants is unknown. METHODS/DESIGN: A randomized controlled trial to investigate whether a strategy of continued vs interrupted novel oral anticoagulant (dabigatran, rivaroxaban, or apixaban) at the time of device surgery, in patients with moderate to high risk of arterial thromboembolic events, reduces the incidence of clinically significant hematoma (defined as a hematoma requiring reoperation and/or resulting in prolongation of hospitalization, and/or requiring interruption of anticoagulation). The secondary outcomes include components of the primary outcome, composite of all other major perioperative bleeding events, thromboembolic events, all-cause mortality, cost-effectiveness, patient quality of life, perioperative pain, and satisfaction. Planned analyses include descriptive statistics of all baseline variables. For the primary outcome, interrupted vs continued novel oral anticoagulant arms will be compared using the χ(2) test. If any clinically significant differences are identified, a logistic regression analysis will be conducted. Quality of life will be assessed using EuroQol-5D, and perioperative pain using a visual analog scale. DISCUSSION: BRUISE CONTROL-2 is a randomized trial evaluating the best strategy to manage novel oral anticoagulants at the time of device surgery. We hypothesize that device surgery can be performed safely without interruption of these medications.