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Purpose: To limit the ever-increasing healthcare costs, strategies to minimize hospitalization length are warranted. In this perspective, early discharge (the same day or after < 24 h) post-cardiac implantable electronic device (CIED) implantation might represent a useful strategy; nevertheless, it is imperative first to understand the timing of (potentially lethal) complications and evaluate whether this is not only an effective but also a safe clinical decision., Methods: A retrospective cohort analysis of all patients undergoing new CIED implantation from Jan 2008 to Dec 2014 was conducted. Patient demographics, comorbidities, and timing of complications post CIED implantation were evaluated, and the timing of complications was divided into intra-operative, 0-6 h (h), 6 to 24 h, and > 24 h post-implant. One-year post-implant follow-up (FU) was performed in our CIED clinic., Results: A total of 1868 patients (68% men, average age 70 years, 85% hypertension, 39% diabetes, 57% coronary artery disease, and average left ventricular ejection fraction (LVEF) 41%) received 703 (38%) pacemaker, 448 (24%) implantable cardioverter-defibrillator (ICD), 639 (34%) cardiac resynchronization therapy (CRT) devices, and 78 (4.2%) cardiac contractility modulation. A total of 199 (11%) patients experienced 214 complications. Most (75%) occurred > 24 h post-implantation (with a median of 7 days). At univariate analysis, complications occurred more often in patients with a lower LVEF, on anticoagulation/antiplatelet therapy, and undergoing ICD/CRT-D implantation (p < 0.05 for all)., Conclusion: Most complications occur > 24 h after first time CIED implantation. Therefore, it might not be optimal to discharge patients in ≤ 24 h, unless extensive ambulatory monitoring for complications is available.

Purpose: We sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT)., Methods: We enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection., Results: We included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16-0.94) and Premofix® (HR: 0.37 (95% CI 0.15-0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma., Conclusions: In patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.

Aims: Inadvertent lead malposition (ILM) in the left heart is a potential cause of thromboembolism and, therefore, a complication of heart rhythm device implantation [HRDI: pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)]. The aim of the study was to report the incidence and clinical outcome of ILM., Methods and Results: Postoperative lateral and posterior-anterior chest X-rays of all consecutive patients undergoing HRDI from 2007 through 2012 were retrospectively analysed. During the study period, 2579 patients underwent HRDI at our institution. ILM was present in six patients (0.34%, 50% male, mean age 71.5 ± 9.4 years). In one and four patients, malposition was in the left atrium and ventricle, respectively. In one case, the RV-lead was placed in a coronary sinus branch. In four patients, ILM was detected intra-operatively or in the early postoperative period. In the remaining two patients, malposition was not recognized and they suffered cerebral embolism 4 months and 1 year after implantation. ILM was corrected during the same hospital stay (four cases), or during follow-up by percutaneous extraction (two cases). Patients with ILM had significantly more scoliosis (16.7 vs. 0.17%; P = 0.01), congenital heart disease (CHD: 33.3 vs. 0.4%; P = 0.003), or prior surgery for CHD (16.7 vs. 0.5%; P = 0.03). The likelihood of ILM was also increased when HRDI was performed by an inexperienced operator (<100 HRDI; P < 0.01)., Conclusion: The incidence of ILM was 0.34% in our series. Scoliosis, CHD, prior correction of CHD, and limited operator experience were identified as risk factors., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: Pocket hematoma is a common complication after heart rhythm device implantation (HRD) in patients receiving anticoagulation and/or dual antiplatelet therapy (DAPT)., Methods: We conducted a prospective case-control study and enrolled all patients admitted for HRD receiving anticoagulation or DAPT. Participants received D-Stat (a mixture of collagen and thrombin) into the pectoral pocket and were compared with an age- and gender-matched group receiving a vacuum drainage system. The primary endpoint was a composite of hematoma needing evacuation and pocket infection., Results: We included a total of 164 patients (mean age 73 ± 10.7 years; 118 [72 %] men). In all, 82 patients (50 %) received D-stat and 82 (50 %) vacuum drainage. There were 83 (51 %) patients who were treated with anticoagulation, 69 (42 %) patients received DAPT, and 11 (7 %) patients both. The primary endpoint occurred in 14.5 % (12/82) of patients in the D-Stat group and 0 % (0/82) of patients in the drainage group (p < 0.01). The use of D-Stat solution was associated with an increased incidence of pocket hematoma requiring evacuation (8.5 % versus 0 %; p = 0.01), and tended to an increased rate of pocket infections (6.1 % versus 0 %; p = 0.06). Postoperative immunoglobulin E levels (106 ± 219 IU/ml [D-Stat] versus 117 ± 189 IU/ml [drainage]) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus drainage: ∆21 mg/l) were similar in both groups (p = 0.7 and p = 0.5, respectively)., Conclusions: Administration of D-Stat solution is associated with a higher rate of pocket hematoma requiring reoperation in a high risk population receiving anticoagulation and/or DAPT. The observed rate of pocket infections in the D-Stat group is a matter of concern.

Background: Pericardial effusion (PE) may complicate permanent heart rhythm device (HRD: pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) placement. Incidence of and risk factors for this complication have never been prospectively evaluated., Methods and Results: The subjects of this prospective observational study were 968 consecutive patients undergoing HRD implantation or upgrade, and underwent echocardiographic evaluation before and 24h after the operation. PE was documented in 98 patients (10%), 14 (1.5%) of whom progressed to cardiac tamponade requiring pericardiocentesis (n=12; 86%) or surgical treatment (n=2; 14%). In 70% (10/14) of those patients a bloody effusion suggested cardiac perforation of an implanted lead; acute pericarditis was observed in the remaining 30% (4/14). At multivariate analysis, female gender (hazard ratio [HR], 2.7; 95% confidence interval [CI]: 1.4-3.5, P=0.01) was predictive in the case of any post-procedural PE, whereas intake of antiplatelet medication (HR, 3.1; 95% CI: 2.1-3.8, P=0.01) was predictive for cardiac tamponade. Previous cardiac surgery (HR, 0.70; 95% CI: 0.50-0.92, P=0.02) was a protective factor in any PE and cardiac tamponade. None of the 84 patients with small or moderate PE required pericardial drainage. After 3.1±0.5 months, a PE was no longer observed at echocardiography in 71% of those patients., Conclusions: PE is frequently seen after HRD implantation, but rarely requires any therapy. Female gender and antiplatelet therapy are risk factors, whereas previous cardiac surgery was a protective factor.

Background: Pocket hematoma is a common complication after cardiac rhythm device implantation (CRDI) in patients receiving anticoagulation or dual antiplatelet therapy (DAPT). We sought to assess the safety and effectiveness of D-Stat Flowable Hemostat ([D-Stat]-a mixture of thrombin and collagen) in these patients., Methods: We conducted a prospective case control study and enrolled all patients admitted for CRDI receiving anticoagulation or DAPT. Participants received either D-Stat into the pectoral pocket as an adjunct to standard of care versus the standard of care (UC) alone. The primary endpoint was a composite of hematoma needing evacuation, and pocket infection., Results: We included a total of 163 patients (mean age 72 ± 8 years). 119 (73%) were male. 82 patients (50%) received D-stat and 81 (50%) usual care; 82 patients (50%) were treated with anticoagulation, 62 patients (38%) received DAPT, and 19 patients (12%) both. The primary endpoint occurred in 12/82 patients from the D-Stat group and 3/81 patients of the control group (14.6% versus 3.7%; p=0.03). The use of D-Stat tended for a higher incidence of pocket hematoma requiring evacuation (8.5% versus 2.4%; p=0.12), and an increased rate of pocket infections (6.1% versus 1.2%; p=0.21). Postoperative Immunoglobulin E levels (86 ± 147 IU/ml (D-Stat) versus 120 ± 231 IU/ml (UC)) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus UC: 14 mg/l) were similar in both groups (p=0.26 and p=0.4, respectively)., Conclusions: Administration of D-Stat does not decrease the frequency of clinically relevant pocket hematomas. The observed rate of pocket infections in the D-Stat group is a matter of concern., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Aims: Efficacy of pace-termination of atrial arrhythmias (ATP) may depend on atrial cycle length and regularity. Whether device programming of ATP therapies can improve ATP efficacy and alter atrial tachyarrhythmia burden is unknown., Methods and Results: ATP efficacy was evaluated in 61 patients (39 males; 66 +/- 10 years) with a standard indication for pacing, 95% with a history of AT/AF. Each patient was implanted with a novel DDDRP pacemaker capable of delivering ATP therapy. ATP efficacy and AT/AF frequency and burden were compared within each patient during a period of nominal ATP programming (NP) followed by a period of aggressive incremental programming (IP). Adjusted ATP-termination efficacy was higher during IP than during NP (54.8% vs 37.9%, P < 0.05). No differences in AT/AF frequency (3.3 +/- 5.9 vs 3.2 +/- 6.9 day(-1)) or burden (18 +/- 28% vs 18 +/- 29%) were observed comparing NP with IP. The majority of episodes during both the NP (81%) and IP (77%) periods terminated within 10 min. Episodes lasting 24 h or more accounted for only 0.4% of the episodes in both groups. but accounted for 38% of the average burden during NP and 51% during IP., Conclusions: Device programming of ATP therapies can influence the number of treated episodes and the efficacy of ATP therapies although arrhythmic frequency and burden may not change. Total atrial arrhythmia burden is disproportionately influenced by long (>24 h) episodes.