Article Text

other Versions

PDF
Original article
Clinical outcomes in patients with implantable cardioverter defibrillators and Sprint Fidelis leads
  1. Roberto Verlato1,
  2. Domenico Facchin2,
  3. Domenico Catanzariti3,
  4. Giulio Molon4,
  5. Gabriele Zanotto5,
  6. Giovanni Morani6,
  7. Marco Brieda7,
  8. Francesco Zanon8,
  9. Pietro Delise9,
  10. Loira Leoni10,
  11. Jennifer Comisso11,
  12. Claudia Campo11
  1. 1Department of Cardiology, Ospedale P. Cosma, Camposampiero, Italy
  2. 2Department of Cardiology, Azienda Ospedaliero- Universitaria di Udine, Udine, Italy
  3. 3Department of Cardiology, Ospedale Santa Maria del Carmine, Rovereto, Italy
  4. 4Department of Cardiology, Ospedale Sacro Cuore, Negrar, Italy
  5. 5Department of Cardiology, Ospedale di Legnago, Legnago, Italy
  6. 6Department of Cardiology, Ospedale Borgo Trento, Verona, Italy
  7. 7Department of Cardiology, Ospedale Santa Maria degli Angeli, Pordenone, Italy
  8. 8Department of Cardiology, Ospedale Santa Maria della Misericordia, Rovigo, Italy
  9. 9Department of Cardiology, Ospedale di Conegliano, Conegliano, Italy
  10. 10Department of Cardiology, Ospedale di Padova, Padova, Italy
  11. 11Department of Italia, Medtronic Italia, Milan, Italy
  1. Correspondence to Dr Roberto Verlato, Department of Cardiology, General Hospital Cosma, Via P Cosma 1, Camposampiero 35012, Italy; roberto.verlato{at}libero.it

Abstract

Objective The performances of implantable cardioverter defibrillators and leads are important issues for healthcare providers and patients. In 2007 Sprint Fidelis leads were found to be associated with an increased failure rate and so the purpose of the study was to evaluate long-term mortality and clinical outcomes in patients implanted with Sprint Fidelis leads compared with Sprint Quattro leads.

Design, setting, patients 508 patients with Sprint Fidelis leads and 468 with Sprint Quattro leads were prospectively followed in 12 Italian cardiology centres.

Main outcome measures Information on hospitalisations and other clinical events were collected during scheduled and unscheduled hospital visits. Deaths were identified from medical records or via phone contacts with patients’ family members or through the National Office of Vital Statistics.

Results Over a mean follow-up of 27±18 months 141 deaths occurred in the overall population. No death was observed in patients with diagnosed failing lead. Kaplan-Meier patient survival differed between the two lead groups (80±2% in Fidelis leads vs 70±4% in the Sprint Quattro leads at 4 years, p=0.002). Multivariate analyses showed that mortality was neither associated with lead type nor with diagnosed failed lead. The annual rate of lead failure was 1.8% patient-year for Fidelis leads and 0.2% for the Sprint Quattro leads.

Conclusions In our multicentre research, the clinical outcomes of patients with Fidelis leads differed from those of patients with Sprint Quattro leads. Nevertheless, neither mortality nor the combined endpoint of mortality and heart failure hospitalisations was associated with the lead type.

http://clinicaltrials.gov/ct2/show/NCT01007474.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.