Uncertainty About the Generalizability of Results
Discussants reported that the COMPANION results generated uncertainty about which patients would receive the most benefit from CRT. COMPANION had enrolled predominantly NYHA class III patients, and experts were divided on whether the results might also apply to non–class III patients. Conflicting messages on this point may have blunted efforts to educate primary care providers about CRT. To date, no primary care professional society has produced guidelines regarding referral for CRT, and according to our discussants, primary-care providers have little knowledge of the cardiology-specialty guidelines. Some stakeholders believe that primary-care physicians may also hesitate to refer patients, because of incorrect views regarding the costs, risks, and side effects of CRT-D therapy. According to one estimate, only 45 percent of patients that meet guideline criteria are ever referred.
Use of CER Results to Treat Noncomparable Patients
It is not clear that the patients actually receiving CRT and CRT-D therapies are comparable to those treated in the CER studies. In fact, registry data indicate that HF patients in the community differ from the CER study population in at least two important respects: Registry patients are, on average, a decade older than those in trials, and they have many more comorbid conditions. For example, one in five patients in the American Heart Association’s Get With the Guidelines–Heart Failure registry (GWTG) who received CRT had a history of COPD, which has been associated with a 50-percent increased risk of death in HF patients (Piccini, Hernandez, et al., 2008). Patients with right-bundle branch block and atrial fibrillation also commonly receive CRT-D despite not being comparable to the study groups. Based on the limited available evidence, the outcomes of CRT in these noncomparable patients appear to differ from the COMPANION results. Despite this, the COMPANION results are frequently used as a rationale for treating this group. Guidelines leave these areas open, and as one discussant put it, “The fuzzier the guidelines are, the happier the medical device industry is.”
Financial Incentives Are Poorly Aligned with CER Evidence
There are no effective limitations on reimbursement by payers for CRT-D procedures. Stakeholders report that these procedures are more or less revenue-neutral for hospitals (especially CRT-D, with its longer operating-room time), so hospitals have no strong incentive to either encourage or discourage their use. The main financial driver is physician reimbursement. Without appropriateness criteria to guide reimbursement, some CRT-D devices have been implanted in patients without clear indications for the device. One critical driver of CRT-D use is Medicare reimbursement policy. CMS pays for ICD implantations but not CRT. (CMS approved ICDs for primary prevention of sudden cardiac death in 2003 but has yet to issue a national coverage determination for CRT.) Thus, despite the low marginal cost-effectiveness of CRT-D over CRT alone, virtually all implantations in Medicare-covered HF patients involve CRT-D devices. Many ICD implantations appear to be inappropriate: Recent studies reveal that use of CRT-D therapy is off-label in up to 30 percent of all implantations (Piccini, Hernandez, et al., 2008; Farmer, Kirkpatrick, et al., 2009; Fein, Wang, et al., 2010; Al-Khatib, Hellkamp, et al., 2011), while 70 percent of patients referred for CRT were not on OPT, as recommended by guidelines (Friedewald, Boehmer, et al., 2007). When medical therapy is maximized, up to one-third of patients may improve to a point at which they are no longer candidates for CRT, suggesting that another 20 percent or more of implantations may also be premature.
Lack of Patient Decision Aids
While CER-based guidelines regarding CRT-D are available for physicians (as discussed below), there are currently no decision aids for patients. Given the challenges of projecting and interpreting the risk of sudden death and the technical details of this largely preventive treatment, patients who do not have well-designed educational materials are unlikely to have much voice in the treatment decision. The experience with creating decision aids for coronary angioplasty suggests that effective tools could certainly also be produced for patients considering CRT therapy. The main implementation barrier is lack of incentives for physicians to offer decision aids to patients. Neither specialists who perform the procedure nor referring generalists have a triggering motivation to acquire decision aids or to encourage patients to use them if they are available. Limited research in other clinical areas suggests that decision aids may reduce the use of more-invasive treatment options. The most appropriate single point for employing decision aids in the pathway leading to CRT implantation is likely to be referring primary care physicians or cardiologists (rather than interventional cardiologists), because these physicians may have greater equipoise in deciding whether or not to recommend the procedure.
Limited CER Detailing Efforts
Stakeholders report that detailing of the results from COMPANION and similar studies was tailored to interventional cardiologists. Device manufacturers with a limited budget and sales force focused their resources on physicians most likely to actually perform CRT implantation procedures, to the exclusion of referring physicians, including general cardiologists and primary-care physicians. The device manufacturers may have relied on indirect marketing of the devices to these other physicians by interventional cardiologists. Academic detailing to specialists or generalists was limited and mostly resulted from informal “water-cooler” conversations with colleagues. The result appears to have been limited awareness of the CER results among referring physicians and a dependence on referral to interventionists to evaluate whether patients were appropriate candidates for therapy.
The Importance of Referring Physicians in the Treatment Decision
Most stakeholders reported that HF patients, once referred to an electrophysiologist, were very likely to receive a device. However, many primary-care physicians and some general cardi-ologists are reportedly not familiar with the COMPANION CER results. This may result in failure to refer patients with appropriate indications. At the same time, referring physicians may use referral to an electrophysiologist as an opportunity for assessment when they are unsure whether the patient is an appropriate CRT candidate. As noted, many of these patients are not yet on optimal medications. Nevertheless, the assumption among many interventional cardiologists is that the referral was actually a decision that the patient needs the procedure and the referring physician will be disappointed if the patient does not receive one. As a consequence, many patients who are appropriate candidates for CRT therapy are apparently never referred (especially by primary-care providers), while others who may not be appropriate candidates undergo CRT implantations simply because they were referred for evaluation.
Lack of Clinical Decision Support Tools
Stakeholders report that clinical decision support tools would probably improve appropriate referrals of HF patients for CRT therapy. They note that primary-care physicians, in particular, would probably identify more patients for referral if they had such tools. They emphasize that decision support must be integrated into the flow of care, and that a “stand-alone” CRT tool is not likely to be used. As one discussant put it, “You’ve got to make it easy for physicians to do the right thing.” Integrating decision support into quality improvement programs that include feedback on a physician’s performance might provide a further incentive. For example, one discussant reported that two cardiology practices that implemented a “hard stop” and required physicians to identify whether each HF patient met criteria for use of CRT achieved 100-percent compliance, meaning that all of the patients referred for CRT met the guidelines.
Few Restrictions on Which Interventionists Can Perform Implantation of CRT
There is currently no binding restriction on which physicians or centers can offer CRT. Stakeholders report that the only real restriction is whether a hospital will credential a given physician to perform the procedure, and hospital credentialing criteria reportedly vary widely. The COMPANION study “hand picked” only high-volume electrophysiology centers to participate in the study group. Most procedures are not currently performed at such centers. This is significant because even for patients who meet the CER appropriateness criteria, implantations by non-electrophysiologists were associated with a higher risk of procedural complications and lower likelihood of receiving a CRT-D device (when indicated) than those for patients whose ICD was implanted by an electrophysiologist (Curtis, Luebbert, et al., 2009). Less-experienced operators and centers with low procedure volumes were also associated with more complications and poorer outcomes. Voluntary certification procedures (discussed below) may help alter this landscape.
Inattention to Cost-Effectiveness Results
Cost-effectiveness studies have raised significant questions regarding the relative cost of CRT therapy for some patients and even more questions about the marginal cost-benefit of adding ICD treatment to CRT for primary prevention of sudden cardiac death. Despite this, stakeholders reported that the decision to recommend CRT virtually never includes consideration of cost-effectiveness. Stakeholders report that until recently, doctors paid little attention to cost-effectiveness, and it still does not appear to significantly affect their clinical decisions regarding CRT.