Controversies in Geriatric Cardiology: Management of Heart Failure in Older Adults

Protagonist

Wilbert S. Aronow, MD, AGSF, Clinical Professor of Medicine, Divisions of Cardiology and Geriatrics, New York Medical College, Valhalla, presented the protagonist viewpoint on the use of cardiac resynchronization therapy (CRT) in older adults with advanced heart failure and intraventricular conduction delay. According to the speaker, CRT optimizes ventricular contractility by decreasing areas of focal dyssynchrony through atrial synchronized biventricular pacing, coordinating right and left ventricular contraction. Cardiac resynchronization therapy has been shown to improve distance walked, functional class, quality of life, treadmill exercise duration, and left ventricular ejection fraction. It also reduces hospitalization for worsening heart failure and use of intravenous drugs for treatment of worsening heart failure. For instance, in a meta-analysis of four randomized controlled studies of CRT in 1634 patients (mean age, 65), CRT reduced death from progressive heart failure by 51%, hospitalization for heart failure by 29%, and all-cause mortality by 23%.¹

In the MIRACLE ICD study,² 369 patients (mean age, 67) received devices with combined CRT and implantable cardioverter defibrillator (ICD) capabilities; 187 were randomized to an ICD with CRT, and 182 control patients were randomized to an ICD with the CRT turned off.¹ Participants had New York Heart Association class III or IV heart failure due to ischemic or nonischemic heart disease, a left ventricular ejection fraction of < 35%, a QRS duration of > 130 milliseconds, and were at high risk for life-threatening ventricular arrhythmias. At 6-month follow-up, CRT significantly improved the quality of life, functional status, peak oxygen consumption, and treadmill exercise duration.

In the COMPANION trial, which was presented at the 2003 American College of Cardiology Annual Meeting but has not yet been published, 1520 patients were randomized to medical therapy alone, CRT, and CRT-plus-backup ICD therapy.³ Participants suffered from New York Heart Association class III or IV heart failure, a left ventricular ejection fraction of < 35%, a left ventricular and end-diastolic diameter of > 6 cm, a QRS duration of > 120 milliseconds, and a PR interval of > 150 milliseconds. Compared to medical therapy, at 1-year follow-up, the primary endpoint (ie, the total hospitalization plus total mortality) was significantly reduced by 19% in the CRT group and by 20% in the CRT-plus-ICD group. Death from and hospitalization for heart failure were significantly reduced by 34% in the CRT group and by 40% in the CRT-plus-ICD group, and all-cause mortality was insignificantly reduced by 24% in the CRT group, but significantly reduced by 36% in the CRT-plus-ICD group.

In the Sudden Cardiac Death in Heart Failure Trial (SCD-HEFT), which was presented at the 2004 American College of Cardiology Annual Meeting but has not yet been published, 2521 patients (mean age, 60) were randomized to placebo, amiodarone, or ICD therapy.⁴ Participants suffered from New York Heart Association class II or III heart failure due to ischemic or nonischemic heart disease, a left ventricular ejection fraction of < 35%, and a mean electrocardiographic (ECG) QRS duration of 112 milliseconds. Compared with placebo, at 46-month median follow-up amiodarone insignificantly increased mortality by 6%, and ICD therapy significantly reduced all-cause mortality by 23% (95% confidence interval, 4-38%). All-cause mortality was reduced by 33% and 16%, respectively, in the groups with an ECG QRS duration of > 120 milliseconds and an ECG QRS duration of < 120 milliseconds. Dr. Aronow pointed out that the rate of unsuccessful implants ranges from 8-13%, and CRT has not been investigated in patients with diastolic heart failure. Regarding complications, the speaker claimed that complications increase if a CRT is placed in a patient beyond the point of no return. “I would consider CRT plus an ICD (I would not use CRT without an ICD) in elderly patients with severe systolic heart failure, despite optimal medical therapy.” In addition, Dr. Aronow stated that patients must not have end-stage heart failure, they must be in sinus rhythm, they must have limited exercise capacity, and they must have evidence of ventricular dyssynchrony, which he prefers to evaluate by tissue Doppler or magnetic resonance imaging.

The speaker concluded by stating that studies exemplify the significant improvements that CRT has on functional status, exercise duration, and left ventricular ejection fraction in appropriately selected patients; the significant reductions of death from or hospitalization for progressive heart failure in appropriately selected patients; the insignificant reduction of all-cause mortality; and the significant reduction that CRT-plus-ICD therapy has on all-cause mortality in appropriately selected patients. Dr. Aronow has found that in the older population (over 80 years), there is a significant increase in quality of life. “In my opinion, approximately 10% of elderly patients with heart failure may benefit from CRT,” Dr. Aronow said, “but you must appropriately select them,” as the procedure is unsuccessful in 9-13% of patients.

Antagonist

George E. Taffet, MD, Associate Professor, Department of Medicine, Sections of Cardiovascular Sciences and Geriatrics, Baylor College of Medicine, Houston, TX, described the patients who others have suggested would benefit from CRT: those with functional New York Heart Association class III or IV heart failure, a QRS duration of at least 130 (sometimes > 150) milliseconds, left ventricular ejection fractions of < 35%, left ventricular and diastolic diameter of > 55 mm, on the maximum medical therapy, and who are not “past the point of no return.” Complications with all pacemakers include pneumothorax, hemothorax, perforation, pocket hematoma, pocket infection, and lead infection. Additionally, biventricular pacers can lead to significant difficulties in lead placement in at least 10% of patients, coronary sinus dissection or coronary perforation in approximately 4%, extra cardiac stimulation in the diaphragm in at least 2%, perforations of the heart in 1%, and lead dislodging in 2-6%. In addition, software dysfunction occurs in about 5% of patients, procedure-related complications occur in 5%, unsuccessful procedures in 8-12%, and acute heart failure decompensation may occur even after successful procedures. “I think that survival is not really a good outcome for most of the patients that geriatricians deal with,” Dr. Taffet said. “Remember, congestive heart failure is a horribly morbid disease in these patients, and therefore, the things that you really need to think about are the quality of life, that’s functional.”

The speaker also recommended that physicians review the Minnesota Living With Heart Failure Questionnaire,⁵ as it may be helpful in treating patients with other diseases in addition to heart failure. Dr. Taffet agreed with the benefits that studies have shown such as arrhythmia prevention, increased survival, reduced hospitalizations from worsening CHF or death, improved systolic function at lower energy cost, increased exercise performance, and improved quality of life. The speaker also noted the benefit of upward titration of beta-blockers. However, relatively few patients over the age of 75 and even fewer older women are included in these studies, and approximately one-third of patients do not respond to CRT. The speaker conducted an informal survey among researchers who have published material on CRT, and learned from the 10 responses received that all agree there was essentially nothing in the literature to guide decision-making for the patient over age 80. Participants also reported a significant selection bias toward “healthier” patients in this age group who underwent the procedure of CRT. Some reviewed their experiences systemically and think that there is no difference in efficacy between younger and older patients; others believe that the effects would decrease in their older patients.

The verdict of whether they think there is an increase in complications was divided evenly. Many of them mentioned financial issues, and a few participants called for studies that were specific to this age group. In the United States, the cost for pacemakers ranges from $25,000 to $40,000; however, the total cost including hospital and professional fees may reach up to $100,000. Dr. Taffet spoke of palliative care challenges that include the reticence of families and physicians to turn off pacemakers of all types, and the painful, uncomfortable death that may occur in patients with an ICD due to the shocks that they receive during the experience. Dr. Taffet stated that many patients with CHF who have systolic dysfunction also have diastolic dysfunction. In fact, diastolic heterogeneity occurs as part of normal aging.⁶ According to the speaker, while CRT prolongs systole by decreasing heterogeneity, it increases filling time which should help diastolic filling. Dr. Taffet pointed out that the study in which these conclusions were made examined young patients,⁷ and that while we now have some knowledge about systolic asynchrony, diastolic asynchrony is intrinsic to aging. “I have a feeling when [the author] looks at older patients, he’s going to have even worse diastolic function,” he said. In conclusion, Dr. Taffet claimed that CRT should be used in a very small subset of older people, “although I think there’s no evidence to directly choose which ones those are.” He also recommended that studies be conducted on older patients with low ejection fraction heart failure alone to examine efficacy and complication rate.