Rapid Integration of CER Evidence into Guidelines
In 2005, following publication of COMPANION and related studies, the ACC/AHA guidelines were modified to include recommendations regarding CRT therapy. Dissemination of the guidelines was reportedly accelerated by publishing them on dedicated patient and physician webpages. The guidelines recommended use of CRT for patients with a left ventricular ejection fraction (LVEF) less than or equal to 35 percent, sinus rhythm, cardiac dyssynchrony (interpreted as a QRS duration greater than 120 ms), and NYHA functional class III or ambulatory class IV symptoms despite being on recommended OPT. They recommended that these patients should receive CRT unless contraindicated and assigned a level of evidence of A (McAlister, Ezekowitz, Dryden, et al., 2007). The guidelines do not address patient age or comorbid conditions, which might also impact the benefit of CRT therapy. They also do not address the question of CRT versus CRT-D, which, according to one discussant “is still a source of contention in the community.” Nevertheless, the guidelines do establish a basis upon which to assess appropriate use and have reportedly significantly increased referrals for CRT by cardiologists, especially HF specialists.
Several CME activities were specifically designed to help disseminate the CER findings on CRT. These include a CME roundtable of key opinion leaders at the American College of Cardiology that discussed the evidence for CRT use as well as lingering clinical questions and the AHA’s GWTG–Heart Failure program, which combined registry and educational activities. Similarly, the IMPROVE-HF registry included decision support tools, utilization reports, and other information on best practice. These were cited by stakeholders as helping disseminate the CER results, although their main impact was only among proceduralists and cardiologists specifically interested in HF management.
Growing Prominence of Clinical Registries
Several registries now collect data on HF patients and CRT use, and they have had a significant impact on dissemination of the CER findings. The IMPROVE-HF registry, launched around 2007, the first large, comprehensive registry for HF in outpatient settings, includes 167 U.S. outpatient cardiology practices. Similarly, the GWTG–Heart Failure registry collects data from 228 participating hospitals. The ACC and AHA also maintain the NCDR, which includes an ICD registry. COMPANION and other CER trials involving CRT were all specifically cited in the rationale for the IMPROVE-HF registry’s CRT performance measure (Fonarow, Yancy, et al., 2007).
These registries are also the only significant source of tracking data on HF patients’ long-term functional and morbidity outcomes and complication rates (McAlister, Ezekowitz, et al., 2007). Very little other information is available regarding CRT use outside of clinical trials (Piccini, Hernandez, et al., 2008). One key finding from the IMPROVE-HF registry is that appropriate use of CRT increased 29.9 percent and use of ICDs increased 27.4 percent (although it should be noted that other studies have shown no such trend in appropriate use between 2005 and 2008) (Fonarow, Albert, et al., 2010).
Current registries have some limitations, including technical and incentive barriers to acquiring necessary information. Documentation of functional status occurred in only 58 percent of the cases in the IMPROVE HF registry, limiting the ability to determine other patients’ suitability for CRT-D (Fonarow, Yancy, et al., 2008). Documentation of patients’ QRS duration, likewise critical, was also often missing (Fonarow, Albert, et al., 2010). Similarly, the AHA registry cannot definitively address underuse of CRT, since it does not include information on potentially eligible patients (such as QRS duration or NYHA classification). Stakeholders also pointed out that the IMPROVE-HF registry is sponsored by a device manufacturer. Finally, while the registries have divergent goals and focus, they are effectively competing with each other for participants, which makes it difficult to get representative overall data. As one stakeholder put it, “We [still] have a long way to go.”
Adoption of CER Results by Specialized Clinics
About 41 percent of the outpatient practices enrolled in the IMPROVE-HF registry were using dedicated HF clinics. These practices had higher utilization rates for CRT and HF education, but not other process measures (Albert, Fonarow, et al., 2010). Some healthcare systems have likewise established dedicated clinics for HF, and similarly, many hospitals maintain “HF units” that use standardized protocols to ensure the use of best-practices guidelines (Arnold and Gula, 2010). Stakeholders reported that physicians specializing in HF treatment are well acquainted with the COMPANION results and are the primary source of appropriate referrals for the procedure.
Professional Certification-Organization Activities
While certification is not compulsory, the Heart Rhythm Society has established a “path to competency” for implantation of CRT and CRT-D devices. Thus, there are now standards for who should undertake the procedure and how it should be performed. At present, however, there appear to be limited incentives to comply with the standards, which blunts their impact. This may be offset in the future by the increasing proportion of physicians trained during their residencies or fellowships to do CRT and CRT-D procedures.
Publication of High Rates of Off-Label and Inappropriate Use
Stakeholders suggest that recently published studies that document the frequent inappropriate use of CRT and ICD therapy (Fein, Wang, et al., 2010; Al-Khatib, Hellkamp, et al., 2011) have had an impact. Practitioners have reportedly reduced the frequency with which they perform procedures not covered by evidence, out of concern that payers such as Medicare will react by establishing reimbursement criteria, refusing to pay for off-label procedures, or even demanding refunds from physicians for already reimbursed procedures that were not performed with an appropriate indication. Interestingly, this use of CER evidence to inform Medicare payment decisions is explicitly limited by legislation (Affordable Care Act, Section 6303).
Experts believe that the development of ACOs will reduce inappropriate CRT use through several mechanisms, including the better alignment of financial incentives with outcomes—i.e., no longer rewarding just the procedure, but rather the thought process and outcome. They are also placing more emphasis on shared decisionmaking by patients and their doctors. Finally, it is anticipated that they will improve evidence-based care through the use of quality improvement and clinical decision support tools.
Integrating Clinical Decision Support into EHRs
Many stakeholders noted that primary care doctors need triggers and an effective alert system more than cardiologists do. Developing and integrating clinical decision support tools with EHRs at the point of care is one approach. Alternatively, EHR systems could be used to mine registries to identify patients who would be candidates for CRT or an ICD. Neither has yet been im-plemented in practice. However, the technology does illustrate what one stakeholder described as “the kind of thing HIT can do when it’s closely coupled to a clinical need and solid science.”