Three-year outcome of a nonthoracotomy approach to cardioverter-defibrillator implantation in 189 consecutive patients

doi:10.1016/0002-9149(94)90850-8

The American Journal of Cardiology

Volume 74, Issue 10, 15 November 1994, Pages 1011-1015

https://doi.org/10.1016/0002-9149(94)90850-8 Get rights and content

Abstract

To date, no long-term clinical data have been published in patients undergoing a nonthoracotomy approach to cardioverter-defibrillator system implantation. In the present report, 189 consecutive patients prospectively underwent a standardized approach to cardioverter-defibrillator system implantation in which the nonthoracotomy configurations were tested first. If satisfactory defibrillation thresholds were not obtained, thoracotomy was performed during the same intraoperative session. A nonthoracotomy system was successfully implanted in 149 of 189 patients (79%), with a higher success rate (90%) observed in patients who had more recent implantations. The overall rate of complications associated with these systems was low (11%). Over a mean follow-up of 12.5 ± 9.3 months, 17 patients (9%) died. Three-year total, cardiac, and sudden death-free actuarial survival for all patients was 83 ± 11%, 88 ± 7%, and 94 ± 2%, respectively. Three-year sudden death-free actuarial survival was higher in the nonthoracotomy than in the thoracotomy patients (97 ± 2% vs 87 ± 6%, p = 0.047), although total survival was similar (77 ± 11% vs 83 ± 7%, p = 0.77). These data suggest that a majority of patients (>80%) requiring a cardioverter-defibrillator system can undergo implantation using a nonthoracotomy approach. Patients receiving nonthoracotomy systems have 3-year outcomes comparable to those implanted via thoracotomy. If these results are maintained, a nonthoracotomy approach will supplant thoracotomy-implanted systems as the preferred method because of the simpler implant procedure and lower overall cost involved.

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Cited by (18)

Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial
2001, American Heart Journal
Citation Excerpt :
The overall frequency of patients with complications was 11.5% (62 complications in 539 patients, Table IV). These findings are consistent with the experience of prior reports.2-14 The likelihood of complications was not influenced by device or lead manufacturer, lead material, location of the implant procedure, or any patient-specific factors (eg, age, sex, diabetes mellitus, EF, history of prior thoracotomy, etc).
Background Implantation of transvenous implantable cardioverter defibrillators (ICDs) by use of a nonthoracotomy approach has become routine therapy for survivors of life-threatening tachyarrhythmias. The purpose of this study was to identify and prospectively characterize the frequency of lead- and ICD-related complications from the Antiarrhythmics versus Implantable Defibrillators (AVID) Trial. Methods and Results Between June 1, 1993, and April 7, 1997, 539 patients received nonthoracotomy ICDs either as initial treatment assignment (477) or as crossover from medical management (62). A total of 62 first complications occurred. The subclavian route of insertion resulted in more complications than the cephalic vein route, 46 of 339 (14%) versus 6 of 135 (4%), P =.005, as did the abdominal versus pectoral generator site, 31 of 238 (13%) versus 17 of 291 (6%), P <.02. Most dislodgements and system infections tended to occur in the 3 months after implantation, whereas lead fractures continued to occur throughout follow-up. Failure to use perioperative antibiotics was a predictor of system infection (P =.001). Conclusions These data suggest that cephalic vein access and pectoral generator site may result in fewer complications. The continued occurrence of lead fractures and the need for premature system revision supports the practice of close routine ICD system surveillance. (Am Heart J 2001;141:92-8.)
Multicenter experience with a pectoral unipolar implantable cardioverter-defibrillator
1996, Journal of the American College of Cardiology
The purpose of this study was to prospectively examine in a multicenter study the methods of use, efficacy and complications of a unipolar cardioverter-defibrillator in patients at risk for sudden cardiac death.
Implantation of cardioverter-defibrillators in the pectoral region offers a significant opportunity to improve the management of patients with life-threatening arrhythmias. Unipolar, single-lead, pectoral implantable cardioverterdefibrillators might decrease related mortality, morbidity and costs in the care of such patients.
From November 3, 1993 to May 8, 1995, a unipolar defibrillator (Medtronic model 7219C) was selected for use in 473 patients from 74 centers (386 [82%] men, 87 [18%] women; mean [±sd]age 59 ± 13 years, range 16 to 88). The clinical indication for use was ventricular fibrillation in 157 patients, sustained ventricular tachycardia in 236, both ventricular tachycardia and ventricular fibrillation in 53 and syncope or inducible ventricular tachycardia/ventricular fibrillation in 27. Coronary artery disease was present in 323 patients (68%). The mean left ventricular ejection fraction was 0.36 ± 0.15 (range 0.10 to 0.85). The distribution of New York Heart Association congestive heart failure was class I = 34%; class II = 45%; class III = 17%; and class IV = 2%.
The unipolar cardioverter-defibrillator was inserted successfully in 464 (98%) of 473 candidates. Effective defibrillation occurred with the first shock polarity tested in 88% of patients, after a polarity switch in 8% and after lead or generator repositioning in 2%. The stored energy defibrillation threshold was obtained at implantation in 339 patients (72%) and was 11.5 ± 6.1 J, with 72% of patients having a defibrillation threshold ≤12 J. The mean “skin-to-skin” implantation time was 96 ± 45 min (range 25 to 335 min). Complications occurred in 29 patients (6%). Device therapy for 2,160 spontaneous ventricular tachycardia or fibrillation episodes occurred in 128 patients (27%) over a 2,732 device-month experience (range 0 to 17.2) and was effective in 98.7% of episodes. There were 14 deaths (10 nonsudden cardiac, 3 sudden cardiac, 1 noncardiac). Cumulative survival, on an intention-to-treat basis from all causes of death at 17.2 months, was 94.4%.
Unipolar pectoral implantable cardioverterdefibrillators can be inserted with a high likelihood of success in a relatively brief procedure. Defibrillation thresholds are low, morbidity is modest, and survival rates are good with this new type of implantable cardioverter-defibrillator.
Sensing lead-related complications in patients with transvenous implantable cardioverter-defibrillators
1996, American Journal of Cardiology
The widespread use of the redesigned Endotak^TM lead (CPI, St. Paul, Minnesota), which combines transvenous pacing, sensing, and defibrillation on a single transvenous lead in patients receiving transvenous implantable cardioverter-defibrillators (ICDs), has reduced morbidity and shortened length of hospital stay after ICD implantation. We describe the incidence and management of Endotak sensing lead-related failures in a series of 348 consecutive patients from 4 institutions who underwent implantation between 1990 and 1995. We retrospectively reviewed the databases for patients receiving an ICD with an Endotak lead for the incidence of lead-related sensing abnormalities. Ten patients (2.8%) with lead-related sensing abnormalities were detected at a mean of 15 ± 11 months after ICD implantation. Sensing abnormalities were detected in 6 patients after they received inappropriate shocks. Noise or oversensing was noted in 7 patients from interrogation of the devices' data logs. Eight patients had a new transvenous sensing lead placed, 1 patient had a new Endotak lead placed, and 1 had a chronic pacemaker sensing lead converted to function as a sensing lead. No further sensing problems were noted in 8 of 10 patients during a mean follow-up of 14 ± 8 months. The site of the sensing lead failure was localized to the subrectus pocket in 5 patients and to the clavicle-first rib area in 3 patients; it was undetermined and presumed to be in the clavicle-first rib area in the other 2 patients. One patient had late failure of the defibrillation lead. We conclude that Endotak sensing lead failure does not require insertion of a new Endotak lead, but can be managed with close follow-up and insertion of a new transvenous sensing lead. Endotak lead fractures are frequently localized to the ICD pocket. (Am J Cardiol 1996;78:647–651)
Complications and mortality of single versus dual chamber implantable cardioverter defibrillators
2006, Indian Pacing and Electrophysiology Journal
Ablation for ventricular tachycardia after MI
2002, Cardiology Review
Catheter ablation and antiarrhythmic drugs for haemodynamically tolerated post-infarction ventricular tachycardia: Long-term outcome in relation to acute electrophysiological findings
2002, European Heart Journal

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Three-year outcome of a nonthoracotomy approach to cardioverter-defibrillator implantation in 189 consecutive patients

Abstract

J Am Coll Cardiol

J Am Coll Cardiol

Am Heart J

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Thorac Cardiovasc Surg

Am J Cardiol

Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings

N Engl J Med

Automatic implantable cardioverter defibrillators and survival of patients with left ventricular dysfunction and malignant ventricular arrhythmias

Ann Intern Med

The automatic implantable cardioverter-defibrillator: 5-year clinical experience