M. Mirowski

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

THE development of a clinically applicable, automatic, implantable defibrillator has been described previously.1 This electronic device is designed to monitor cardiac electrical activity, to recogn...

Mortality in Patients with Implanted Automatic Defibrillators

Fifty-two patients who survived several arrhythmic cardiac arrests had implantation of an automatic defibrillator along with additional cardiovascular surgery as indicated. The mean follow-up was 14.4 months and the longest was 3 years. In the hospital, the implanted devices identified and reverted 82 episodes of spontaneous and 81 of 99 episodes of induced malignant tachyarrhythmias. There were 62 automatic resuscitations in 17 patients outside the hospital. Twelve patients died; four of the deaths were not witnessed. These deaths represent a 22.9% total and 8.5% sudden-death 1-year mortality rate. Because the expected 1-year mortality in patients without the automatic defibrillator was calculated to be 48%, there was an estimated 52% decrease in anticipated total deaths. The automatic implantable defibrillator can identify and correct potentially lethal ventricular tachyarrhythmias, leading to a substantial increase in 1-year survival in properly selected high-risk patients.

The automatic implantable defibrillator

The automatic implantable defibrillator is an electronic device programmed to monitor the cardiac rhythm continuously, to recognize ventricular fibrillation and ventricular tachyarrhythmias characterized by sinusoidal waveform, and to deliver corrective difibrillatory discharges when indicated. Three patients suffering from recurrent malignant ventricular arrhythmias refractory to medical therapy underwent permanent implantation of this device. Seven episodes of ventricular tachycardia and flutter-fibrillation were documented during the weeks following the implantations; two were induced at electrophysiologic studies and five occurred spontaneously. All were correctly identified and six were automatically reverted to normal sinus rhythm by the implanted device; one induced episode was cardioverted externally before the unit could recycle. Although many problems remain to be solved and the ultimate value of this therapeutic modality has to be determined, a new approach to prevention of sudden death in patients at high risk of developing lethal ventricular arrhythmias has become available.

A chronically implanted system for automatic defibrillation in active conscious dogs. Experimental model for treatment of sudden death from ventricular fibrillation.

SUMMARY Ventricular defibrillation was achieved in active conscious dogs with a chronically implanted automatic system composed of a defibrillator and an alternating current fibrillator. The hermetically sealed defibrillator is encased in titanium, weighs 250 g and has a volume of 145 ml. The sensor continuously monitors ventricular electrical activity and recognizes fibrillation by the absence of isoelectric potential segments. Fibrillation is induced by placing a magnet over the implanted fibrillator. The resulting syncope closely resembles the clinical entity of sudden death, while the defibrillator automatically restores normal rhythm with a truncated exponential pulse of 30 J, 15 seconds after the onset of the arrhythmia. The operational status of the defibrillator can be tested in vitro and noninvasively in vivo with an external analyzer. This experimental model allows for the first time a long-term study of the automatic implantable defibrillator approach to prevent sudden death from ventricular fibrillation under a variety of physiopathologic conditions.

Clinical evaluation of the internal automatic cardioverter-defibrillator in survivors of sudden cardiac death

An R-wave synchronous implantable automatic cardioverter-defibrillator (IACD) was evaluated in 12 patients with repeated episodes of cardiac arrest who remained refractory to medical and surgical therapy. Seven men and 5 women, average age 61 years, surgically received a complete IACD system. Coronary artery disease was found in 11 and the prolonged Q-T syndrome in 1. The average ejection fraction was 34%, and 6 patients had severe congestive heart failure (New York Heart Association class III or IV). The IACD is a completely implantable unit consisting of 2 bipolar lead systems. One system uses a lead in the superior vena cava and on the left ventricular apex through which the cardioverting pulse is delivered. The second system employs a close bipolar lead implanted in the ventricle for sensing rate. After the onset of ventricular tachycardia or fibrillation, the IACD automatically delivers approximately 25 J. Postoperative electrophysiologic study in 10 and spontaneous ventricular tachycardia in 1 patient demonstrated appropriate IACD function and successful conversion in all with an average of 18 +/- 4 seconds. The induced arrhythmias were ventricular tachycardia (160 to 300 beats/min) in 9 and ventricular fibrillation in 1. These data demonstrate that ventricular tachycardia, not ventricular fibrillation, was the predominant rhythm induced during programmed ventricular stimulation in these survivors of cardiac arrest and that the IACD effectively responded to a wide range of ventricular tachycardia rates as well as ventricular fibrillation. Use of the IACD offers an effective means of therapy for some patients who otherwise may not have survived.

The Automatic Implantable Cardioverter-Defibrillator

The automatic implantable cardioverter‐defibrillator is an electronic device designed to monitor the heart continuously, to identify malignant ventricular tachyarrhythmias, and then to deliver effective countershock to restore normal rhythm. There are two defibrillating electrodes which are also used for waveform analysis; one is located in the superior vena cava, the other is placed over the cardiac apex. A third bipolar right ventricular electrode serves for rate counting and R‐wave synchronization. When ventricular fibrillation occurs, a 25 joule pulse is delivered; when ventricular tachycardia faster than a preset rate is detected, the discharge is R‐wave synchronized. The device can recycle three times if required. Special batteries can deliver over 100 shocks or provide a 3‐year monitoring life. Implantation of the device is made either through a thoracotomy or by a subxiphoid approach. Thus far, the device has been implanted in 160 patients with a follow‐up of 42 months. Acceleration of ventricular tachycardia to a faster rhythm or to ventricular fibrillation occurred only rarely and is dealt with most successfully through recycling. Actuarial analysis of the initial 52 patients has indicated 22.9% one‐year total mortality, a 52% decrease from the 48% mortality that would be expected in the same group of patients without the device: the mortality attributed to arrhythmias was only 8.5%. In conclusion, the automatic cardioverter‐defibrillator can reliably identify and correct potentially lethal ventricular tachyarrhythmias, leading to a substantial increase in survival in properly selected high‐risk patients.

Implantation of the Automatic Defibrillator: The Subxiphoid Approach

The automatic implantable defibrillator is an electronic device capable of diagnosing and correcting malignant venticular arrhythmias. While major thoracic surgery was required in the original 24 implants, a new technique for implanting the device has been developed. The first subxiphoid implantations have been accomplished with the defibrillatory function successfully tested intraoperatively. The advantages and indications of the subxiphoid technique are reviewed.

Treatment of Malignant Ventricular Arrhythmias with Endocardial Resection and Implantation of the Automatic Cardioverter-Defibrillator

Although ventricular resection guided by endocardial mapping has been a successful treatment for drug-refractory ventricular arrhythmias, 20 to 30 percent of patients still have postoperative sustained ventricular tachycardia or sudden death. To improve the outcome of the procedure, we implanted an automatic cardioverter-defibrillator in conjunction with endocardial resection in 28 patients, all of whom had had previous myocardial infarctions and between one and five cardiac arrests. There were three perioperative deaths. During follow-up of 8 to 51 months (mean, 25), 4 of the 25 survivors had recurrences of hypotensive ventricular tachycardia, which in all instances were automatically terminated by the implanted device. One patient, whose automatic cardioverter-defibrillator was not functional, died suddenly. We conclude that patients undergoing mapping-directed endocardial resection can be provided with additional protection against recurrent ventricular tachyarrhythmias or sudden death by implantation of an automatic cardioverter-defibrillator.

The Automatic Implantable Defibrillator.: New Modality for Treatment of Life-Threatening Ventricular Arrhythmias

New Modality for treatment of life‐threatening ventricular arrhythmias. The automatic implantable defibrillator continuously monitors cardiac rhythm, identifies ventricuiar fibrillation and then delivers corrective defibrillatory discharges when indicated: it weighs 250 grams and has a volume of 145 cc. When a suitable arrhythmia is detected, a 25 Joule pulse is delivered through a superior vena cava catheter electrode and another electrode placed over the cardiac apex. As oj March 1981, sixteen survivors of multiple cardiac arrests refractory io antiarrhythmic therapy had undergone implantation of the automatic defibrillator. There was no operative mortality and the morbidity was minimal. Electrophysiologic studies were performed before and after surgery to confirm failure of drug therapy and to ensure the devices ability to terminate malignant arrhythmias. Eight spontaneous and fourteen of the seventeen induced malignant arrhythmias were properly recognized and corrected by the device. The discharges were well tolerated by awake patients. A number of problems including recycling delays and spurious discharges have been identified and corrected. There were three late deaths with pulmonary edema noted in two patients, and asystole in one. The autopsies revealed no myocardial damage attributable to the automatic defibrillator. Although the ultimate role of this approach to prevention of sudden arrhythmic death has yet to be determined, the results obtained to date are encouraging and indicate that a useful modality for treating malignant ventricular arrhythmias has been added to our armamentarium. (PACE, Vol. 5, May‐June, 1982)

Pathologic findings related to the lead system and repeated defibrillations in patients with the automatic implantable cardioverter-defibrillator

The purpose of the present study was to examine at autopsy the effect of multiple defibrillations on the myocardium and the pathologic consequences of short- and long-term placement of the intravascular and interpericardial leads of the automatic implantable cardioverter-defibrillator. Twenty-five patients were examined at autopsy; 8 of them underwent lead implantation only and 17 received both leads and the automatic implantable cardioverter-defibrillator. Twelve patients (48%) died of ventricular tachycardia or ventricular fibrillation; seven (28%) died of other causes. Acute pericarditis occurred in all patients, resulting in a localized, progressive fibrosis around the apical patch lead without giving rise to pericardial restriction. Thrombus formation was associated with the superior vena cava spring electrode in four patients (17%) and the right ventricular rate-sensing electrode in one patient (4%). Asymptomatic pulmonary emboli occurred in two patients (8%). In one patient who underwent defibrillation 59 times, superior vena cava changes consisted of vein wall destruction, fibrosis and thrombus formation. Pathologic changes under the apical patch related to defibrillation were observed in seven patients; two of these had fewer than 5 defibrillations, one had 8 defibrillations and four had 21 to 74 defibrillations. These changes consisted of contraction band necrosis in four patients, vacuolar cytoplasmic clearing and loss of myocytes confined to the myocardium under the patch electrode in five patients who had multiple defibrillations. The observed pathologic changes were estimated to affect less than 2% of the total myocardial mass. Thus, the automatic implantable cardioverter-defibrillator lead system and multiple defibrillations result in localized myocardial injury confined to the tissue under the patch electrode.(ABSTRACT TRUNCATED AT 250 WORDS)