Preliminary Experience with Nonthoracotomy Implantahle Cardioverter Defihrillators in Young Patients (original) (raw)

1994, Pacing and Clinical Electrophysiology

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.

Acute Efficacy and Chronic Follow-Up of Patients with Non-Thoracotomy Third Generation Implantahle Defibrillators

Pacing and Clinical Electrophysiology, 1994

Third Generation Implantable Defibrillators. Non-thoracotomy implantation 0/implantable cardioverter defibrillators (ICDs) has simplified (he process of device inserfion, promising to decrease associated proceduraJ conipJications whiJe providing sudden death protection at least equal to epicardial systems. This study presents the acute and chronic results 0/110 patients who underwent attempted non-thoracotomy ICD impiuntation wiih the Medtronic Transvene lead system and PCD model 7217 or 7219. Of the no patients attempted, 100 (91 %J had the system successfully implanted without the need for an epicardial patch. One patient died 1 week postoperatively of septic shock related to the implantation (0.9% perioperative mortality). During folloiv-up of 16 ± 11 months, 45% of the patients had an event detected as ventricular tachycardia; 26% of these detections were felt clinically to be due to supraventricular rhythms. Of the remainder, 87% were successfully treated with the first VT therapy, and 98% were terminated by the final therapy; 66% of the patients had at least one episode of ventricular fibrillation, of which 5% were felt to be inappropriate detections; 65% of the appropriate episodes were successfully treated with the first VF therapy, and all were converted by the final therapy. Total mortality at 6, 12, and 24 months was 3%, 11%, and 19% respectively. Only one patient had sudden cardiac death, occurring at 13 months postimplant. Overall, the non-thoracotomy lead system for this ICD displayed infrequent implant complications and proved to be reliable ai terminating arrhythmias and maintaining a low rate 0/sudden cardiac death in this high risk popuiation. fPACE, Vol. 17, March 1994, Part U) implantable defibrillator, non-thoracotomy leads, ventricular tachycardia, ventricular fibrillation Address for reprints: |ohannes Brachmann, M.D.,

Implantable Cardioverter Defibrillator Implanted by Nonthoracotomy Approach: Initial Clinical Experience with the Redesigned Transvenous Lead System

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.

Experience of cardioverter-defibrillators inserted without thoracotomy: evaluation of transvenously inserted intracardiac leads alone or with a subcutaneous axillary patch

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

Implantation by electrophysiologists of 100 consecutive cardioverter defibrillators with nonthoracotomy lead systems

Circulation, 1994

BACKGROUND Traditional lead systems for implantable cardioverter defibrillators (ICDs) require a thoracotomy for placement. Nonthoracotomy lead systems are available and are usually implanted by an electrophysiologist and a surgeon. The purpose of this study was to prospectively evaluate the safety and efficacy of ICD implantation with a nonthoracotomy lead system by electrophysiologists. METHODS AND RESULTS A consecutive series of 100 patients (mean age, 61 +/- 13 years, +/- SD) underwent ICD implantation with a nonthoracotomy lead system while intubated and under general anesthesia. Seventy-seven patients had coronary artery disease, 15 had idiopathic cardiomyopathy, 6 had miscellaneous heart disease, and 2 had structurally normal hearts. The mean ejection fraction was 0.29 +/- 0.13. Sixty-eight patients had suffered a cardiac arrest, and 32 had had ventricular tachycardia or syncope. All patients except 9 underwent electrophysiological testing and had failed 1 +/- 1 drug trials b...

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

Midterm experience with implantable cardioverter-defibrillators in children and young adults

Europace, 2010

This single-centre study was undertaken to review our experience with implantable cardioverter-defibrillator (ICD) implantation in children with relatively different aetiologies. Methods and results We retrospectively reviewed the records of the paediatric patients who underwent ICD implantation between October 2001 and December 2008. The data of these patients were collected by reviewing the patients' medical records and computerized departmental pacemaker databases. A total of 28 patients who underwent ICD implantation during this period were included in this study. The median age was 12 years and median weight was 32 kg. Most of the patients had ion-channel diseases (n ¼ 13) or cardiomyopathy (n ¼ 11). Devices were implanted for either secondary (n ¼ 22) or primary (n ¼ 6) prevention. The selected ICD generator type was single chamber in 22 patients, dual chamber in 5 patients, and biventricular in 1. Nineteen patients received 122 shocks. Fifteen of 22 patients (68.2%) from the secondary prevention group and 2 of 6 patients (33.3%) from the primary prevention group experienced at least one appropriate shock during a median period of 11.3 months (range: 4 days-6.5 years). Forty-two inappropriate shocks were delivered in seven (31.8%) patients from the secondary prophylaxis group during a median period of 11.3 months. The most important reason for inappropriate shocks was T-wave oversensing. In six patients, lead-related acute or chronic complications occurred. Conclusion The ICD was safe and effective in interrupting malignant arrhythmias in children and adolescents with a high risk of sudden cardiac death. However, the occurrence of lead complications is significant. The incidence of therapies delivered by the device, with appropriate and inappropriate shocks, was high and interfered with the quality of life. The most important reason for inappropriate shocks was T-wave oversensing. Careful programming is mandatory to reduce the inappropriate shocks.

Children and young adults treated with transvenous and subcutaneous implantable cardioverter-defibrillators: a 22-year single-center experience and new perspectives

Kardiologia Polska, 2020

BACKGROUND Over the last several years the evolution of transvenous implantable cardioverter-defibrillator (T-ICD) system and the introduction of subcutaneous ICD (S-ICD) have contributed to the development of the sudden cardiac death (SCD) prevention in clinical practice. AIMS To report our clinical experience with ICD therapy in children and young adults during the twenty-two years of the follow-up. METHODS We reviewed the database of ICD recipients choosing 80 consecutive patients (pts) implanted at the age of 6-21 in 1996-2018. We analyzed the rate of appropriate (AT) and inappropriate therapies (IT), mortality, complications and new treatment options. RESULTS A total of 21/80 patients (26.25%) received ≥1 AT for ventricular tachycardia/ventricular fibrillation (anti-tachycardia pacing or shock) and 25/80 patients (31.25%) had one or multiple IT (P = 0.47). Nine patients (11%) had both AT and IT interventions. During follow-up, 2 (2.5%) cardiac resynchronization therapy (CRT) systems, and 8 (10%) S-ICDs were implanted, 3 heart transplantations were performed, and 1 severe tricuspid valve regurgitation occurred. A total of 6/80 patients (7.5%) died. All deaths occurred in the hypertrophic cardiomyopathy group. CONCLUSIONS The mortality rate was 6/80 (7.5%) in the twenty-two-year follow-up. The rate of AT vs. IT was almost equal and remained steady in the long observation period. Severe TR might be a serious clinical problem in some patients. Entirely S-ICD for SCD prevention is a feasible and safe therapy in young recipients.

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