Predictors of pocket hematoma after cardiac implantable electronic device surgery: A nationwide cohort study.

Purpose: Clinically significant pocket hematoma (CSH) is a common complication to cardiac implantable electronic device (CIED) surgery. We aimed to evaluate predictors of CSH after CIED surgery. Methods: We performed a nationwide population-based prospective cohort study with systematic patient chart review of all Danish patients undergoing CIED surgery during a 12-month period. Multiple logistic regression analysis was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals for association between predictors and CSH. Results: We included 5918 consecutive patients, 63% males, mean age 72.6 years. A total of 148 (2.5%) patients experienced CSH, including 10 patients (0.2%) requiring re-operation with hematoma evacuation. The risk of CSH was significantly increased in patients treated with aspirin (aOR 1.8; 1.2-2.7), aspirin and clopidogrel (aOR 3.9; 2.3-6.5), or heparin (aOR 2.1; 1.1-4.1), and in patients with INR≥2.0 (aOR 2.0; 1.2-3.2). Patients operated by low-volume operators (aOR 2.7; 1.6-4.6) or undergoing more complex CIED surgery such as cardiac resynchronization therapy (aOR 2.0; 1.1-3.5) or dual-chamber defibrillator (aOR 2.1; 1.2-3.8) also had significantly increased CSH risk. Conclusion: In a large nationwide cohort of consecutive patients undergoing CIED surgery, the risk of CSH was 2.5%, with 0.2% necessitating evacuation. CSH risk was increased both in patients receiving aspirin, dual antiplatelet therapy or continued vitamin K-antagonist therapy. Dual antiplatelet therapy had the highest risk (aOR) of CSH. Both low operator volume and more complex CIED surgery were independently associated with higher CSH risk. These data should be considered when planning CIED surgery.

Knowledge gaps, lack of confidence, and system barriers to guideline implementation among European physicians managing patients with CIED lead or infection complications: a European Heart Rhythm Association/European Society of Cardiology educational needs assessment survey.

As the number of patients with cardiac implantable electronic devices (CIEDs) grows, they are likely to present with issues to diverse groups of physicians. Guideline-adherent management is associated with improved prognosis in patients with CIED infection or lead problems but is insufficiently implemented in practice. The European Heart Rhythm Association (EHRA) with the support of the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery, performed a multinational educational needs assessment study in ESC member countries, directed at physicians who might be confronted with CIED patients with complications. A total of 336 physicians from 43 countries, reached through the ESC mailing list, participated. They included a mix of electrophysiologists, cardiologists general physicians and cardiac surgeons .One hundred and twenty-nine (38%) of the respondents performed lead extraction. The survey included eight clinical cases and a self-evaluation question of knowledge and skills to apply that knowledge. The survey looked at 14 areas of care across five stages of the patient journey. Of the non-extracting physicians over 50% felt they lacked the knowledge and skills to make the diagnosis and refer for lead extraction and over 75% felt they lacked knowledge and skills to manage aspects of extraction and post-extraction care. Barriers to correct referral were logistic and attitudinal. Extracting physicians reported significantly higher rates of adequate skills and knowledge across all five stages of the patient journey (P < 0.05). We identified major gaps in physicians' knowledge and skills across all stages of CIED care. These gaps should be addressed by targeted educational activities and streamlining referral pathways.

Single lead atrial vs. dual chamber pacing in sick sinus syndrome: extended register-based follow-up in the DANPACE trial.

AIMS: The DANPACE trial randomized patients with sick sinus syndrome (SSS) to single lead atrial (AAIR) or dual chamber (DDDR) pacemaker (PM). After 5 years follow-up, no difference in overall survival, stroke or heart failure (HF) was observed, whereas risk of atrial fibrillation (AF) and PM reoperation were increased in the AAIR group. The present study aimed to investigate very long term risk of death, AF hospitalization, stroke, HF and rate of change in pacing mode using national register-based data. METHODS AND RESULTS: The study population consisted of all 1384 patients included at Danish PM centres in the DANPACE trial randomized to AAIR (n = 696) or DDDR (n = 688). Long-term follow-up data was obtained from Danish national registers. Analysis was intention-to-treat. results: During mean follow-up of 8.9 years, 413 patients (59.3%) died in the AAIR-group compared to 367 (53.3%) in the DDDR-group (adjusted hazard ratio 1.03; 95% confidence interval 0.90-1.19; P = 0.65). We observed no difference in risk of AF hospitalization, stroke or HF. During extended follow-up, annual rate of pacing mode change to DDDR in the AAIR group was 4.5%, and higher than the 2.3% observed during trial conduct. CONCLUSION: This register-based long-term follow-up study indicates that there is no difference in mortality among patients with SSS randomized to AAIR or DDDR pacing, even with very long follow-up. Nor is there any difference in risk of AF hospitalization, stroke or HF. The higher rate of pacing mode-change to DDDR in the AAIR group suggests a different management of patients with an AAIR PM after the DANPACE trial.

Management of Cardiac Electronic Device Infections: Challenges and Outcomes.

Cardiac implantable electronic device (CIED) infection is an increasing problem. Reasons for this are uncertain, but likely relate to an increasing proportion of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices implanted, as well as implantations in 'higher risk' candidates, i.e. patients with heart failure, diabetes and renal failure. Challenges within the field of CIED infections are multiple with prevention being the most important challenge. Careful prescription of CIED treatment and careful patient preparation before implantation is important. Diagnosis is often difficult and delayed by subtle signs of infection. Treatment of CIED infection includes complete system removal in centres experienced in CIED extraction and prolonged antibiotic therapy. Meticulous planning and preparation before system extraction and later CIED re-implantation is essential for better patient outcome. Future strategies for reducing CIED infection should be tested in sufficiently powered, multicentre, randomised controlled trials.

Syncope in paced patients with sick sinus syndrome from the DANPACE trial: incidence, predictors and prognostic implication.

OBJECTIVES: Syncope is a cause of significant morbidity in sick sinus syndrome (SSS) which may not be resolved with permanent pacemaker therapy. We aimed to determine the incidence, predictors and prognostic implication of syncope in paced patients with SSS. METHODS: We studied 1415 patients (mean age 72.9 years, SD 11.1) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing (n=707) or rate-responsive dual chamber pacing (n=708). Main outcome measures were patient-reported syncope after pacemaker implantation and mortality. RESULTS: Mean follow-up was 5.4 years (SD 2.6). A total of 247 (17.5%) patients experienced syncope after pacemaker implantation (135 (19%) from the rate-responsive single chamber pacing group, and 112 (15.8%) from the rate-responsive dual chamber pacing group. Predictors of syncope post pacemaker implantation included: age 0-39 years (HR 2.9, 95% CI 1.4 to 6.3, p=0.01; reference range 60-79 years), age ≥80 years (HR 1.4, 95% CI 1.0 to 1.8, p=0.03), syncope prior to pacemaker implant (HR 1.8, 95% CI 1.4 to 2.3, p<0.001), previous myocardial infarction (HR 1.5, 95% CI 1.1 to 2.1, p=0.03), heart failure (HR 1.4, 95% CI 1.0 to 1.9, p=0.046), and high Charlson comorbidity index (HR 1.6, 95% CI 1.1 to 2.2, p=0.01). Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not (adjusted HR 1.6, 95% CI 1.3 to 2.1, p<0.001). CONCLUSIONS: Syncope in paced patients with SSS is common, and is associated with higher mortality. The predictors identified in this study suggest a multifactorial aetiology of syncope.

Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark.

AIMS: Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. METHODS AND RESULTS: Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1-1.6), underweight (aRR 1.5; 1.1-2.3), implanted in a centre with an annual volume <750 procedures (0-249 procedures: aRR 1.6; 1.1-2.2, 250-499: aRR 2.0; 1.6-2.7, 500-749: aRR 1.5; 1.2-1.8), received a dual-chamber ICD (aRR 2.0; 1.4-2.7) or CRT-D (aRR 2.6; 1.9-3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0-1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4-2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0-2.3). CONCLUSION: CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment.

System upgrade and its complications in patients with a single lead atrial pacemaker: data from the DANPACE trial.

AIMS: To investigate the indications for system upgrade with single lead atrial pacing (AAIR), complications associated with these re-interventions, and possible predictors for system upgrade among patients included in the Danish Multicenter Randomized Trial on AAIR vs. dual-chamber pacing (DDDR) in sick sinus syndrome (DANPACE). METHODS AND RESULTS: A total of 707 of 1415 patients were randomized to AAIR pacing. Mean follow-up was 5.5 ± 2.6 years. Information on indications for system upgrade and complications were collected by reviewing patient charts. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals (CI) for the association between predictors and system upgrade. Sixty-six patients (9.3%) in the AAIR group underwent system upgrade. Fifty-nine of these patients (89.3%) had a documented class I indication for system upgrade. Age (aOR 0.98 for each 1-year increase in age; 95% CI 0.6-1.0), and left atrial enlargement (aOR 1.9; 95% CI 1.0-3.8) were predictors for system upgrade. No single clinically applicable predictor for upgrade was identified. A total of 11 patients (16.7%) experienced at least one major complication after system upgrade. CONCLUSION: The majority of patients with AAIR pacing who underwent system upgrade had a class I indication. The incidence of major complications after system upgrade was high. The present data support the use of DDDR pacing rather than AAIR pacing in sick sinus syndrome.

Pneumothorax in cardiac pacing: a population-based cohort study of 28,860 Danish patients.

AIM: To identify risk factors for pneumothorax treated with a chest tube after cardiac pacing device implantation in a population-based cohort. METHODS AND RESULTS: A nationwide cohort study was performed based on data on 28 860 patients from the Danish Pacemaker Register, which included all Danish patients who received their first pacemaker (PM) or cardiac resynchronization device from 1997 to 2008. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals for the association between risk factors and pneumothorax treated with a chest tube. The median age was 77 years (25th and 75th percentile: 69-84) and 55% were male (n = 15 785). A total of 190 patients (0.66%) were treated for pneumothorax, which was more often in women [aOR 1.9 (1.4-2.6)], and in patients with age >80 years [aOR 1.4 (1.0-1.9)], a prior history of chronic obstructive pulmonary disease [aOR 3.9 (1.6-9.5)], implantation of a dual-chamber PM [aOR 1.5 (1.0-2.2)], venous access with subclavian vein puncture [aOR 7.8 (4.9-12.5)], venous access with both subclavian vein puncture and cephalic vein cut-down [aOR 5.7 (3.0-10.8)], and implantation in a non-university centre [aOR 2.1 (1.6-2.9)]. CONCLUSION: Pneumothorax treated with a chest tube remains a clinically important problem in device therapy. The cephalic vein cut-down technique should be applied whenever possible to avoid this complication.

Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients.

BACKGROUND: Lead complications are the main reason for reoperation after implantation of pacemakers (PM) or cardiac resynchronization therapy (CRT-P) devices. OBJECTIVE: This study sought to describe the incidence of lead complications causing reoperation after device implantation and to identify risk factors for lead complications. METHODS: A nationwide, population-based, historic cohort study was performed based on data from the Danish Pacemaker Register, which includes all Danish patients who received their first PM or CRT-P device from 1997 to 2008. Follow-up occurred 3 months after implantation. RESULTS: The study population consisted of 28,860 patients. The incidence of any lead complication was 3.6%, encompassing right atrial (RA; 2.3%), right ventricular (2.2%), and left ventricular (4.3%) lead complications. The lead complication risk declined during the first part of the study period and remained stable after 2002. Multivariate analysis identified the following significant risk factors: chronic heart failure as indication (adjusted odds ratio (aOR) 3.0; 95% confidence interval [CI] 2.1 to 4.3), implantation in a nonuniversity center (aOR 1.4; 95% CI 1.2 to 1.6), inexperienced operator with <25 implantations (aOR 1.6; 95% CI 1.3 to 2.0), single-lead RA device (aOR 1.4; 95% CI 1.1 to 1.8), dual-chamber pacing device (aOR 1.6; 95% CI 1.4 to 1.9), CRT-P device (aOR 3.3; 95% CI 2.4 to 4.4) and passive-fixation RA lead (aOR 2.2; 95% CI 1.7 to 2.9). CONCLUSION: Lead complications causing reoperation remain a clinically important problem in device therapy. Mainly procedure-related factors were identified as independent risk factors for lead complications.

Very long term follow-up of cardiac resynchronization therapy: clinical outcome and predictors of mortality.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves symptoms, left ventricular ejection fraction (LVEF) and survival in patients with heart failure and wide QRS, however, long term clinical outcome is unknown. AIMS: To identify predictors of mortality and evaluate the effects of CRT after long term follow-up. METHODS: Consecutive patients treated with CRT between 1997 and 2002 were included. We collected clinical information from patient files. Patients who were still alive underwent echocardiography and clinical evaluation. RESULTS: We included 179 patients (median age 65.5 years, 144 male). Median follow-up for survival was 4.0 years. Mortality at one and five years was 15% and 53%, respectively. Predictors of mortality were, ischaemic heart disease (IHD), higher NYHA class and lower LVEF (<22.5%) at baseline, and no improvement in NYHA class at early follow-up. NYHA class remained stable from early to long term follow-up after a median of 5.1 years. In patients with non-IHD median LVEF increased significantly from early to long term follow-up (39% vs. 50% p=0.007). CONCLUSION: Predictors of mortality in patients with CRT are IHD, lower LVEF and higher NYHA class at baseline, and no symptomatic response to CRT. After 5 years follow-up, clinical effects are sustained, and in patients with non-IHD further improvements in LVEF are observed.