title: Incidence and predictors of clinically relevant cardiac perforation associated with systematic implantation of active-fixation pacing and defibrillation leads: a single-centre experience with over 3800 implanted leads.
abstract: OBJECTIVE
  Active-fixation leads have been associated with higher incidence of cardiac perforation. Large series specifically evaluating this complication are lacking. We sought to evaluate the incidence and predictors of clinically relevant cardiac perforation in a consecutive series of patients implanted with active-fixation pacing and defibrillation leads.
  
  
  RESULTS
  We conducted a retrospective observational study including all consecutive patients implanted with an active-fixation pacing/defibrillation lead at our institution from July 2008 to July 2015. The incidence of clinically relevant cardiac perforation and cardiac tamponade was evaluated. Univariate and multivariate analyses were used to identify predictors of cardiac perforation. Acute and long-term management of these patients was also investigated. A total of 3822 active-fixation pacing (n = 3035) and defibrillation (n = 787) leads were implanted in 2200 patients. Seventeen patients (0.8%) had clinically relevant cardiac perforation (13 acute and 4 subacute perforations), and 13 (0.5%) had cardiac tamponade resolved with pericardiocentesis. None of the patients with cardiac perforation required surgical treatment. In multivariate analysis, an age >80 years (OR 3.84, 95% CI 1.14-12.87, P = 0.029), female sex (OR 3.14, 95% CI 1.07-9.22, P = 0.037), and an apical position of the right ventricular lead (OR 3.37, 95% CI 1.17-9.67, P = 0.024) were independent predictors of cardiac perforation.
  
  
  CONCLUSIONS
  Implantation of active-fixation leads is associated with a low incidence of clinically relevant cardiac perforation. Older and female patients have a higher risk of perforation as well as those patients receiving the ventricular lead in an apical position.
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain cano_osc@gva.es.
authors: Óscar
authors: Ó
authors: Cano
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.|Instituto Investigación Sanitaria La Fe, Valencia, Spain.
authors: Ana
authors: A
authors: Andrés
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.|Instituto Investigación Sanitaria La Fe, Valencia, Spain.
authors: Pau
authors: P
authors: Alonso
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
authors: Joaquín
authors: J
authors: Osca
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
authors: María-José
authors: MJ
authors: Sancho-Tello
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
authors: José
authors: J
authors: Olagüe
authors: Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
authors: Luis
authors: L
authors: Martínez-Dolz
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects*; D002305:Cardiac Tamponade / Q000453:epidemiology / Q000601:surgery; D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004554:Electric Countershock / Q000009:adverse effects* / Q000295:instrumentation; D005260:Female; D006335:Heart Injuries / Q000175:diagnosis / Q000209:etiology* / Q000601:surgery; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D020519:Pericardiocentesis; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012737:Sex Factors; D013030:Spain / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
keywords: Active-fixation leads; Cardiac perforation; Cardiac tamponade; Implantable cardioverter defibrillator; Pacemaker