AUTOMATIC IMPLANTABLE DEFIBRILLATOR (ICD) OUR EXPERIENCE WITH PHYLAX ICD

American College of Cardiology - May 1, 2002, Volume 39, Number 9 (supplement B)

ICD is by now a routine-practised therapy in patients with life-threatening ventricular tachyarrhythmias to prevent sudden cardiac death. The objective of our prospective study was to evaluate the follow-up of patients implanted with Phylax ICDs.

METHODS

23 patients (20 male, 3 female, mean age 68 ± 6) enrolled in the study were affected by ischemic-dilated cardiomyopathy (11), idiopathic dilated cardiomyopathy (7), valvular disease (2), pulmonary cardiomyopathy (3). All of them were in NYHA class 2-3, with an Ejection Fraction of 36 ± 13 %. Indications for ICD implantation were Sustained Ventricular Tachycardia (18) and Ventricular Fibrillation (5). All the patients were implanted with the single-chamber model (19) or the dual chamber model (4) of the Biotronik Phylax ICD.

RESULTS

21/23 patients (91%) received ICD shocks which were appropriate and successful in 20/21 patients (95%). In 2 patients out of 23 the ICD delivered unsuccessful shocks causing device reprogramming (1) or replacement (1). ICD therapy deliveries were observed within 30 days and one year after implantation; more precisely: in 7 patients within 30 days, 5 within 3 months, 7 within 6 months, 2 within 1 year. In 2 patients ICDs still have not delivered any therapy. ICDs successfully terminated 4 episodes of Ventricular Fibrillation with shocks, 16 episodes of Ventricular Tachycardia with Anti-Tachy-Pacing (ATP) therapies (12 episodes) and with ATP+shocks (4 episodes). During a follow-up period of 18 months 3/23 patients (13%) died due to progressive and refractory congestive heart failure: in all these cases the ICD successfully delivered therapies after implant. In one patient “Arrhythmic Storm” was observed causing 51 maximal shock deliveries in 24 hours: all of them were appropriate and effective. This patient is still alive and in a good clinical condition. The total number of shocks delivered is 127, with a mean number of shocks per patient of 5,5.

CONCLUSIONS

Patients with life-threatening ventricular tachyarrhythmias and pump insufficiency remarkably benefit from the ICD therapy. In our patients the ICD implantation allowed a 18-months arrhythmic death survival of 87%. Phylax ICDs showed to be reliable and safe, with appropriate and successful therapy deliveries in 95% of cases.