Temporary medical electrical lead

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator

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A61N 105

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058490337

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BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to the field of cardiac stimulation and specifically to the field of temporary stimulation of cardiac tissue through a medical electrical lead.


BACKGROUND OF THE INVENTION

Atrial arrhythmias and supra ventricular tachycardias, such as atrial fibrillation, atrial flutter and atrio-ventricular reentries, are a common postoperative complication among patients who have had heart surgery. See, for example, Cardiac Surg. Kirklin J W, Barrat-Boyes B C (Eds.): NY 1993, pg. 210. During the first 10 days after heart surgery it is estimated postoperative supra ventricular tachycardia occurs in up to 63 percent of patients. See, for example, "The Importance of Age as a Predicator of Atrial Fibrillation and Flutter After Coronary Artery Bypass Grafting", Leitch et al., J. Thorac. Cardiovasc. Surg., 1990:100:338-42; "Atrial Activity During Cardioplegia and Postoperative Arrhythmias", Mullen et al., J. Thorac. Cardiovasc. Surg., 1987:94:558-65.
The presence of these arrhythmias, which in an otherwise healthy patient may not be unduly serious, may be especially harmful to heart surgery patients. The hemodynamic condition of these patients is often already compromised by either the surgery itself or the effects of prolonged anaesthesia or both. Supra ventricular tachycardias may further cause a very irregular ventricular rate which may even further deteriorate their hemodynamic condition. Such further deterioration is especially serious for patients with a compromised left ventricular function. These complications may present a serious impediment to the recovery of the patient. See, for example, "Maintenance of Exercise Stroke Volume During Ventricular Versus Atrial Synchronous Pacing: Role of Contractility", Ausubel et al., Circ., 1985:72(5):1037-43; "Basic Physiological Studies on Cardiac Pacing with Special Reference to the Optimal Mode and Rate After Cardiac Surgery", Baller et al., Thorac. Cardiovasc. Surg., 1981:29:168-73.
Due to the serious and potentially life threatening nature of these conditions, postoperative treatment is often aimed at preventing arrhythmias, such as through drugs. Drugs, however, have been found to not always be effective at preventing arrhythmias. Thus it is often necessary to provide a means for terminating any arrhythmias which may occur. One common method used has been through over-pacing.
For example Waldo et al. in "Use of Temporarily Placed Epicardial Atrial Wire Electrodes For The Diagnosis and Treatment of Cardiac Arrhythmias Following Open-Heart Surgery," J. Thorac. Cardiovasc. Surg., 1978, vol. 76, no. 4, pgs. 558-65 discloses the use of a pair of temporary heart wires placed on the atrium to diagnose and treat arrhythmias by antitachy overdrive pacing. Specifically the temporary heart wires were sutured to the atrial wall at the time of the heart surgery. Once the patient was ready to be released the wires were removed by traction or pulling upon their external end.
Temporary postoperative atrial and ventricular pacing with temporary heart wires has been found to successfully treat many of the potential post-operative arrhythmias. As such the procedure has become widespread at least 100,000 procedures per year. Several problems, however, were encountered with the system disclosed by Waldo et al., referred to above. One problem was the stability of the heart wire within the atrial wall. Because the wall undergoes constant motion, the temporary heart wire lead was found to dislodge an unacceptable amount. Secondly, the relatively thin atrial wall, especially on elderly patients, was sometimes torn by traction upon the lead for removal.
An improved method of temporarily affixing heart wires onto the atrium was achieved with the introduction of the Medtronic Model 6500 Temporary Myocardial Pacing Lead System. That lead system featured a silicone atrial fixation disk to fasten the lead to the atrium. Specifically the silicone atrial fixation disk was permanently sutured to the atrium. The lead was positioned so that it was trappe

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Medtronic Model 6500 Temporary Myocardial Pacing Lead Brochure (MC 873026).
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Waldo, et al., "Use of Atrial Epicardial Wire Electrodes in the Diagnosis and Treatment of Arrhythmias Following Open Heart Surgery", Advances In The Management of Arrhythmias, D.T. Kelly, ED Lane Cove, Australia: Telectronics Pty., 1978 pp. 287-306.

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