title: Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy.
abstract: OBJECTIVE
  The long-term impact of implantable device-related complications on the patient outcome has not been thoroughly evaluated. The aims of this retrospective, bi-centre study were to analyse the rate and nature of device-related complications requiring surgical revision in a large series of patients undergoing device implantation, elective generator replacement and pacing system upgrade and to systematically assess the impact of such complications on patient outcome and healthcare utilization.
  
  
  RESULTS
  Data from 2671 consecutive procedures (1511 device implantations, 1034 elective generator replacements, and 126 pacing system upgrades) performed between January 2006 and March 2011 were retrospectively analysed. The outcome measures recorded were complication-related mortality, number of re-operations, need for complex surgical procedures, number of re-hospitalizations, and additional hospital treatment days. Over a median follow-up of 27 months, the overall rate of complications was 2.8% per procedure-year [9.5% in cardiac resynchronisation therapy (CRT) device implantation, 6.1% in pacing system upgrade, 3.5% in implantable cardioverter defibrillator implantation, 1.7% in pacemaker implantation, and 1.7% in generator replacement). The procedure with the highest risk of complications was CRT device implantation (odds ratio: 6.6; P < 0.001); these complications primarily involved coronary sinus lead dislodgement and device infection. Patients with complications had a significantly higher number of device-related hospitalizations (2.3 ± 0.6 vs. 1.0 ± 0.1; P < 0.001) and hospital treatment days (15.7 ± 25.1 vs. 3.6 ± 1.1; P < 0.001) than those without complications. Device infection was the complication with the greatest negative impact on patient outcome.
  
  
  CONCLUSIONS
  Cardiac resynchronisation therapy implantation was the procedure with the highest risk of complications requiring surgical revision. Complications were associated with substantial clinical consequences and a significant increase in the number and length of hospitalizations.
authors: Cardiology Unit, 'Card. G. Panico' Hospital, Tricase (Le), Italy. dr.palmisano@libero.it
authors: Pietro
authors: P
authors: Palmisano
authors: Michele
authors: M
authors: Accogli
authors: Maria
authors: M
authors: Zaccaria
authors: Giovanni
authors: G
authors: Luzzi
authors: Frida
authors: F
authors: Nacci
authors: Matteo
authors: M
authors: Anaclerio
authors: Stefano
authors: S
authors: Favale
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects; D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable / Q000009:adverse effects; D020878:Device Removal / Q000009:adverse effects / Q000401:mortality; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D004868:Equipment Failure; D005260:Female; D006406:Hematoma / Q000209:etiology / Q000401:mortality / Q000601:surgery; D006760:Hospitalization; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000401:mortality / Q000601:surgery; D012086:Reoperation; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000209:etiology / Q000401:mortality / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult