Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database
| Autor: | Giuseppe Boriani, Saverio Iacopino, Sergio Valsecchi, Maurizio Lunati, Antonello Vado, Massimo Santini, Carlo Bonanno, Chantal Zucchiatti, Alessandro Capucci, Alessandro Proclemer, Renato Pietro Ricci, Maurizio Landolina, Maurizio Gasparini |
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| Rok vydání: | 2011 |
| Předmět: |
Long term complications
Male Reoperation medicine.medical_specialty Time Factors Databases Factual Defibrillation medicine.medical_treatment Cardiac resynchronization therapy MEDLINE Cardiac Resynchronization Therapy Postoperative Complications Physiology (medical) medicine Humans In patient Aged Heart Failure business.industry Middle Aged medicine.disease Surgery Defibrillators Implantable Clinical trial Survival Rate Treatment Outcome Italy Heart failure Biventricular defibrillator Female Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Circulation. 123(22) |
| ISSN: | 1524-4539 |
| Popis: | Background— Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and Results— We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P =0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P =0.682). Conclusions— In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01007474. |
| Databáze: | OpenAIRE |
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