Discontinuation of Pacemaker Therapy

D. Benditt

Discontinuation of Pacemaker Therapy

D. Benditt

1999

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The paper discusses the rationale and experience of discontinuing permanent pacing therapy in selected patients whose condition has improved or in whom symptoms related to pacing have arisen. With a conservative estimate indicating that 2-4% of patients might not require lifelong pacing therapy, the authors argue for a clinical reassessment of the need for pacemaker therapy before generator replacement, suggesting that this may lead to considerable cost savings without compromising patient safety.

Cardiac Electrophysiology Review 1999;2:393–396 © Kluwer Academic Publishers, Boston Discontinuation of Pacemaker Therapy Lurie, Pacemaker Iskos, andRemoval Bend itt Keith G. Lurie, Demos Iskos, and David G. Benditt Cardiac Arrhythmia Center, Cardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN Approximately 120,000 new pacing systems are implanted and 40,000 pacemaker (PM) generators are replaced annually in the U.S. [1,2]. At the time of generator battery depletion or pacing system malfunction, conventional wisdom has been to replace the generator and/or the pacing leads without reexamining the need for pacing therapy. However, the potential health risks and costs of maintaining a functional pacing system for a lifetime can be substantial, especially in young individuals. Furthermore, some patients are occasionally referred for generator replacement in whom there appears to be no apparent need or evidence of reversal of the pathologic process that led to initiation of pacemaker therapy. In such cases termination of permanent pacing therapy may actually be “indicated.” and intractable pain at the site of the implant in the other), we considered generator removal in all 5 individuals. To ascertain that the risk of recurrent bradycardia was low enough to justify discontinuation of pacing, we utilized the following techniques: (a) Holter and/or continuous loop recorders before pacemaker removal while the lower rate had been decreased to approximately 30 beats/min, and/or after the procedure to correlate any recurrent symptoms with the underlying rhythm, (b) an electrophysiology study focusing on assessment of AV conduction in 2 patients with AV block, and (c) review of pacemaker counters to determine the percentage of sensed and paced beats during a speci~c time period in 2 patients. The pacing leads were removed in only 1 patient with a relatively recent implant (9 months). Following pacemaker removal all patients were followed clinically and have not required reinstitution of pacing after a follow-up period of more than 3 years. Termination of Pacing Therapy Discussion We previously reported experience with 5 patients in whom pacemaker generators were permanently removed [2]. These individuals were referred to the University of Minnesota for end-of-life generator replacement (1 case), a pacing system-related complication (3 cases) or both (1 case). They were all relatively young (age range of 32–53 years), but had already been paced for a mean of 11 years (range of 9 months to 18 years). Indications for institution of cardiac pacing included high-degree AV block following cardiac surgery for correction of complex congenital heart disease in 2 patients, third-degree AV block in a patient with clinical suspicion of Lyme’s disease, sinus arrest after motor vehicle accident complicated by myocardial contusion in 1 patient, and symptomatic junctional bradycardia in a patient subsequently diagnosed with neurocardiogenic syncope. At the time of our evaluation all patients exhibited sinus rhythm with a narrow QRS complex and a normal PR interval. Given the apparent improvement in AV conduction in the 3 patients with AV block and the development of complications related to the pulse generator in the remaining 2 patients (skin erosion in one Termination of chronic pacing therapy should be considered in all patients undergoing permanent generator replacement when there is no clinical evidence of electric pacing. The decision to replace the generator should take into consideration the risks and bene~ts of pacemaker removal. The most signi~cant health risk with routine replacement of end-of-life pulse generators infection; it appears to increase with reoperation and has been reported to range from 1–7%. Risks of multiple leads also include thrombosis, emboli, and tricuspid valve insuf~ciency. Furthermore, the cost of maintaining an appropriately functioning pacing system is high, especially in young individuals who need to undergo several procedures for generator replacement and/or lead revision during their lifetime. Introduction Address correspondence to: Keith G. Lurie, M.D., Box 508 UMHC, 420 Delaware St. SE, Minneapolis, MN 55455. E-mail: [email protected] 393 394 Lurie, Iskos, and Benditt The current inability to predict intermittent conduction system failure by means of invasive or non-invasive testing adds to the challenge of this medical decision. Despite the uncertainty, based on our experience termination of pacing appears safe, if not “indicated,” in carefully selected patients. It is crucial for patients to be actively involved in the decision-making and comprehend the pros and cons of the intervention as well as the need for follow-up. How should a busy cardiologist “screen” for potential candidates for device removal in a time and cost-effective manner? It appears reasonable to initially consider this strategy in the subset of pacemaker recipients who: (a) received a pacemaker for an ACC/AHA class III indication [3], (b) continue to experience symptoms such as lightheadedness or syncope despite the presence of a normally functioning pacemaker, suggesting an alternative diagnosis, and (c) exhibit apparent improvement of the conduction system abnormality which led to the original device implantation. Causes of potentially reversible sinus or AV node dysfunction are listed in Table 1. We further stratify patients according to their risk of developing recurrent symptomatic bradycardia, e.g. ECG evidence of conduction system disease such as PR . 0.24 sec, intraventricular conduction delay, and evidence of periodic bradycardia. Each may indicate a “high risk” group. Even more importantly, the physician should evaluate individual patient risk of serious morbidity if bradycardia recurs following pacemaker removal. Elderly patients and those with left ventricular dysfunction are at a greater risk in this regard. Such “high risk” patients may not be appropriate candidates for termination of pacing therapy. A secondary yet important question relates to whether the pacing leads should be removed in a patient in whom a decision to terminate pacing therapy has been reached? As lead explantation can result in Table 1. Potentially reversible causes of sinus and AV node dysfunction Cardiac surgery (post-operatively) Heart transplantation Mitral or aortic valve replacement Congenital heart disease repair Cardiac contusion Drugs Electrolyte disturbances Hypoxia Infections Endocarditis Myocarditis, e.g. Lyme’s disease Myocardial ischemia-infarction Neoplasms Neurocardiogenic re_exes (cardioinhibitory, cough) Rheumatologic syndromes Sleep apnea CEPR 1999; Vol. 2, No. 4 serious complications, especially in patients with chronic implants, our usual ~rst approach has been to cap the leads and follow clinically. If pacing needs to be reinstituted, the addition of a pulse generator would be all that is required to reestablish an operational pacing system. Lead removal might be reasonably attempted 1 to 2 years following generator removal in patients who remain well without a pacemaker. However, increased experience and success with a newer laser lead removal device suggests that lead removal is safer than with older techniques and may be appropriate in some patients at the time the generator is removed. Building upon our experience to date, a reasonable approach to determine whether permanent pacing therapy should be terminated is summarized in Figure 1. This strategy is based upon a cautious approach that involves removing a permanently implanted device once it has been determined to be either no longer indicated or effective. In patients with a high probability of requiring a pacemaker in the future, i.e., elederly patients and those with left ventricular dysfunction, the generator should be replaced. This proposed approach includes a period of time to observe the patient with pacing at heart rates ,40 bpm and time for non-invasive monitoring. A multi-center prospective study using this algorithm is needed before de~ning the “indications” for permanent pacemaker removal. Based upon our experience, we conservatively estimate that approximately 2–4% of patients undergoing generator replacement may not require life-long pacing therapy. Thus, among the 40,000 annual generator replacements in the U.S., approximately 800–1600 patients may be candidates for discontinuation of pacing therapy each year, leading to potential cost savings of several million dollars. Although the risks of terminating pacing therapy can be signi~cant, presence of a permanent pacemaker is not synonymous with a permanent need for cardiac pacing. It is important for cardiologists and cardiovascular surgeons to reassess the need for continuation of pacing therapy prior to generator replacement. In selected patients termination of pacing appears safe. The optimal method and timing of this intervention requires prospective validation by a multicenter randomized study. The authors would like to thank Jenny Hoogenakker for helping to prepare this manuscript. CEPR 1999; Vol. 2, No. 4 Pacemaker Removal 395 Fig. 1. A suggested clinical approach to patient selection for discontinuation of cardiac pacing therapy. LV 5 left ventricle; IVCD 5 intraventricular conduction delay; PM 5 pacemaker 396 Lurie, Iskos, and Benditt References 1. Buckingham TA, Volgman AS, Wimer E. Trends in pacemaker use: Results of a multicenter registry. PACE 1991; 14:1437–1439. 2. Iskos D, Lurie KG, Sakaguchi S, Benditt DG. Termination of implantable pacemaker therapy: Experience in ~ve patients. Ann Int Med 1997;126:787–790. 3. Gregoratos G, Cheitlin MD, Conill A, Epstein AE, Fellows C, Ferguson TB Jr, Freedman RA, Hlatky MA, Naccarelli CEPR 1999; Vol. 2, No. 4 GV, Saksena S, Schlant RC, Silka MJ, Ritchie JL, Gibbons RJ, Eagle KA, Gardner TJ, Lewis RP, O’Rourke RA, Ryan TJ, Garson A Jr. ACC/AHA guidelines for implantation of cardiac pacemakers and antiarrhythmia devices. A report of the ACC/AHA Task Force on practice guidelines (committee on pacemaker implantation). J Am Coll Cardiol 1998; 31:1175–1209.

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