Acute Efficacy and Chronic Follow-Up of Patients with Non-Thoracotomy Third Generation Implantahle Defibrillators (original) (raw)
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Pacing and Clinical Electrophysiology, 1991
Standard implantation procedure for the implantable cardioverter defibrillator (ICD) has traditionally required a thoracotomy approach. A newly revised nonthoracotomy defibrillator lead system that uses a single transvenous tripolar endocardial lead alone or in combination with a subcutaneous/submuscular patch lead was introduced into clinical trials in September, 1990. Fourteen patients requiring a cardioverter defibrillator for recurrent sustained ventricular tachycardia (eight patients) or aborted sudden cardiac death (six patients) were evaluated for implantation of this lead system. Primary successful lead system implantation was obtained in nine patients. The remaining five patients had unacceptably high defibrillation thresholds (DFTs) for implantation. One of the nine initially successful implants demonstrated unacceptable DFTs and cross-talk inhibition from a permanent pacemaker necessitating removal of the nonthoracotomy lead system and replacement with a conventional lead system via thoracotomy. All remaining primary implanted patients experienced successful conversion of induced ventricular fibrillation prior to hospital discharge. Continued follow-up and greater experience to confirm the durability and efficacy of the nonthoracotomy AICD lead system are needed.
The subcutaneous implantable cardioverter-defibrillator: A tertiary center experience
Cardiology Journal
Background: The aim of the study was to evaluate subcutaneous implantable cardioverterdefibrillator (S-ICD) patients with regard to underlying etiology, peri-procedural outcome, appropriate/inappropriate shocks, and complications during follow-up. Methods: All patients who underwent S-ICD implantation from February 2013 to March 2017 at an academic hospital in Vienna were included. Medical records were examined and follow-up interrogations of devices were conducted. Results: A total of 79 S-ICD patients (58.2% males) with a mean age of 44.5 ± 17.2 years were followed for a mean duration of 12.8 ± 13.7 months. A majority of patients (58.2%) had S-ICD for primary prevention of sudden cardiac death. The most common of the 16 underlying etiologies were ischemic cardiomyopathy, non-ischemic cardiomyopathy, and idiopathic ventricular fibrillation. The lead was implanted to the left sternal border in 96.2% of cases, between muscular layers in 72.2%. Mean implant time was 45 min, 3 patients were induced, and all patients except one were programmed to two zones. Six (7.6%) patients experienced at least one appropriate therapy for ventricular arrhythmias and the time to first event ranged from 1 to 52 months. Seven patients experienced inappropriate shocks due to Twave oversensing, atrial tachycardia with rapid atrioventricular conduction, external electromagnetic interference, and/or baseline oversensing due to lead movement. Four patients underwent revision for lead repositioning (n = 1), loose device suture (n = 1), and infection (n = 2). Conclusions: While S-ICDs are a feasible and effective treatment, issues remain with inappropriate shock and infection.
Preliminary Experience with Nonthoracotomy Implantahle Cardioverter Defihrillators in Young Patients
Pacing and Clinical Electrophysiology, 1994
in Young Patients. Implantable cardioverter defihrillators represent an important treatment option for patients with life-threatening tachyarrhythinias. However, the requirement for surgical access to the thorax contributes to significant procedural morbidity with ICD implantation. This study was performed to assess an initial experience with a nonthoracotomy approach to ICD lead implantation in young patients. An international survey identified 17 patients, ranging in age from 12-20 years (mean = 16.7 ± 2.4) and weighing from 33-89 kg (mean = 60.6 ± 13.3), who had undergone placement ofthe Medtronic Transvend efibrillator lead system. Implant indications were aborted sudden cardiac death in 15 patients and recurrent ventricular tachycardia or familial sudden death in 2 patients. At a median follow-up of 7.9 months, 9 of 17patients had received at least one ICD therapy. There have been no deaths. Complications included patch or generator erosion (3 patients), lead dislodgement (1 patient), and ICD system infection requiring explanation (1 patient). The initial experience with nonthoracotomy ICDs in young patients appears promising. This approach may be particularly advantageous for patients who have undergone prior thoracotomy. Prospective clinical trials will be required to establish the applicability of these lead systems to select patient populations.
The Implantable Cardioverter-Defibrillator: Clinical Results
Pacing and Clinical Electrophysiology, 1991
PALATIANOS, G.M., ET AL.: The Implantable Cardioverter-Defibrillator: Clinical Results. To evaluate the effectiveness of the automatic implantable cardioverter-defibnllator (AICD), a 7-year experience, from 1983-1990, was revieived. A totai 0/ ^11 patients received an AICD device. Their ages ranged between 8 and 83 years. Mean age was 63.9 years. There were 91 men and 20 women. Eighty of the patients received the AICD following an out-of-hospital cardiac arrest, whiie 31 were suffering from intermittent symptomatic ventricular tachycardio. The underlying etiology in 97 patients (87%) was ischemic coronary artery disease, in 11 patients (10%} dilated cardiomyopathy, and in 3 patients (3%) idiopathic ventricuiar fibrillation. Mean ejection fraction was 33.2%. Implantation 0/ the AICD was performed via a left thoracotomy in 39 patients, median sternotomy in 49 patients and subxiphoidsubcostal approach in 23 patients. Jn-hospitai mortality occurred in one patient who suffered an acute myocardial infarction 4 hours postoperativeiy, Out-of-hospital mortality was observed in 19 patients. There were two arrhythmic deaths. EoUow-up was available for 107 patients. Mean follow-up was 33.1 months. Sixty-six patients (62%J had AICD shocks. The initial appropriate shocks occurred during the first postimplantation year in 91% of the patients. In 53 0/ the survivors, initial AICD shocks took place within 4.4 ± 4.7 months from implantation. Thirteen of the 20 patients who died had received appropriate AICD shocks. In these patients, the time between implantation and first shock was 2.7 ± 3.6 months whereas the time between implantation and death was 11.3 ± 10.3 months (NS). We conclude that the AICD is effective in converting ventricuiar tachyarrhythmias and prolongs survival. [PACE, Vol. 14, February, Part II 1991) sudden cardiac death, automatic impiantabie defibrillator Address for reprints: George M. Palatianos, M,D,. Division of Thoracic and Cardiovascular Surgery |R-114), P,0. Box 016960 Miami, VL 33101,
Implantable Defibrillation: Eight Years Clinical Experience
Pacing and Clinical Electrophysiology, 1988
THOMAS, A.C., ET AL.: Implantable defibrillation: eight years clinical experience. Implantation of the first automatic de/ibriJIator occurred in February 1980. Incorporation o/cardioversion capability in 1982 resulted in the AICD^^ automatic implantabJe cardioverter de^briJJator. Between April 1, 1982 and April 15, 1988, 3610 patients in 236 U.S. and 84 international centers received AICD pulse generators. Patient population consisted of 2904 males and 683 females with recurrent ventricular tachycardia and/or fibrillation, mean age 59 yrs. (range 9-96 yrs.). Primary diagnoses reported for the patient group were: coronary artery disease (63.5%), nonischemic cardiomyopathy (12.9%), other (6.4%) and unspecified {17.2%). Mean reported LV ejection paction was 32.8%. Follow-up averaged 12.2 mo. (range 0-72 mo.). Of 385 deaths, 94 (24%) were sudden. Cumulative percentage survival (±S.E.) from sudden cardiac death (SCD) was 98.0 ± 0.3%, 96.5 ± 0.5%, 95.2 ± 0. 7%, 93.7 ± 1.0%, 93.7 ± 1.0% and 89.7 ± 4.0% at 12, 24, 36, 48, 60 and 72 months, respectively. Operative mortality {^30 days) was 2.5%. Reported side e^ects/compJications were similar to those o/pacemakers. To date, 33% of the patients received spontaneous device countershocks. AICD pulse generator survival from electrical and mechanical failures was 92.8 ± 0. 5%, 88.4 ± 0.7%, 86.7 ± 0.8% and 86.4 ± 0.9% at 12, 18, 24 and 30 mos. Data analysis demonstrates that the AICD has had a significant impact on patient survival from SCD. (PACE, Vol. 11, November Part II1988) automatic impJantabJe cardioverter dejibriJJator, ventricuJar tachyarrhythmias, dejibriJJation techniques
Nonthoracotomy defibrillator implantation: A single-center experience with 200 patients
The Annals of Thoracic Surgery, 1994
Nonthoracotomy leads for defibrillator implantation and biphasic shocking devices are under investigation. Implantation success and mortality and morbidity of the procedure determine the operative course. Lead-associated complications, late infection, and freedom of sudden cardiac death characterize the follow-up period with respect to the implanted device. From October 1989 to March 1993 in 200 patients, 205 (including five infections caused by reimplantations) transvenous or transvenoussubcutaneous lead systems were tested. Mean ejection fraction was 0.40 ± 0.16. In 62.5% (125/200) coronary artery disease and in 19% (38/200) cardiomyopathy was the underlying disease (59 patients with prior cardiac operations). Leads were implanted with defibrillation thresholds less than 25 J in 195 patients, whereas 10 patients received intrathoracal patches. Since biphasic shocks became available, no nonthoracotomy lead system has failed in the last 115 consecutive patients. Peri
Heart, 1993
Objectives-To compare the efficacy of a purely transvenous cardioverter-defibrillator (ICD) system with that of a system with a supplementary subcutaneous patch. To evaluate clinical follow up of these lead arrangements that-do not require thoracotomy. Design-A simplified defibrillation protocol to test two different lead arrangements during implantation, with routine clinical follow up after implantation. Setting-Tertiary referral centre for treatment of arrhythmia. Patients-22 consecutive patients selected for implantation of an ICD because of life-threatening ventricular arrythmias (ventricular fibrillation or sustained ventricular tachycardia) of whom 20 entered the test protocol. Intervention-Implantation of an ICD with transvenously inserted intracardiac leads and a subcutaneous patch and assessment of effective defibrillation followed by testing of the purely transvenous approach. Main outcome measures-Reproducible conversion of ventricular fibrillation to sinus rhythm at a certain energy level, providing a safety margin of at least 10 J for both lead arrangements. Confirmation of efficacy during clinical follow up (mean 6 months). Results-A transvenous lead system combined with a subcutaneous axillary patch was implanted in 20122 patients and it provided adequate and acceptable energy levels. In 10120 tested patients a purely transvenous lead configuration provided an acceptable safety margin as well. Nine patients had clinical recurrences: all these arrhythmias were successfully converted. Conclusion-A transvenous lead system was sufficient in 50% of the patients at the time of implantation. Data on long-term clinical follow up of this arrangement are not available. The