The five-year mortality rate following a diagnosis of heart failure (HF) is 50 percent, even with optimal medical therapy. HF is also associated with a poor functional status (Friedewald, Boehmer, et al., 2007). For patients with both HF and delayed electrical conduction in the ventricles (wide QRS), treatment with cardiac resynchronization therapy (CRT), using an implantable pacemaker to stimulate both ventricles, has been shown to be effective in improving functional status (Abraham, Fisher, et al., 2002). However, the efficacy of CRT had not been established for those HF patients who also require an implantable cardiac defibrillator (ICD) to treat intermittent life-threatening abnormal heart rhythms.
CRT-device implantation has been described as “a complex and rapidly developing clinical science” that requires a broad range of new skills (Burkhardt and Wilkoff, 2007). The implantation procedure and the optimization of device functioning are both technically challenging, and there are no standards for device optimization. CRT devices may be implanted by a range of physicians, including cardiologists, thoracic surgeons, and electrophysiologists. Race and sex disparities in ICD use have been well documented and may influence the uptake of CRT-D (combined CRT and ICD therapy).
Many risks are associated with CRT procedures. Acute dislodgements during the initial procedure are associated with increased odds of other adverse events, including cardiac arrest, cardiac tamponade, device infection, pneumothorax, and in-hospital death (Cheng, Wang, et al., 2010). Anecdotal evidence suggests that infection rates relating to the devices are rising (Poole, Gleva, et al., 2010). The initial implantation of a CRT-D device can have a 10-percent or greater in-hospital complication rate than implanting an ICD alone (Reynolds, Cohen, et al., 2006). Among patients who undergo generator replacement and lead addition, the six-month major complication rate among those who upgraded from ICD to CRT-D or underwent revision of a CRT device is nearly 19 percent (Poole, Gleva, et al., 2010) Complication rates and procedure times appear to decrease somewhat with the experience of the physician (Leon, Abraham, et al., 2005).
Failure rates for CRT therapy can be up to 40 percent, even for patients who have a wide QRS interval (Burkhardt and Wilkoff, 2007; Friedewald, Boehmer, et al., 2007), and the device may last only ten years before needing replacement. The implant failure rate is approximately 5 percent per year, and failure is more common at low-volume facilities, particularly community hospitals (Friedewald, Boehmer, et al., 2007). According to anecdotal reports, a physician’s decision to refer a patient for CRT may depend on the outcomes of the first several patients he or she refers (Friedewald, Boehmer, et al., 2007).
The costs of implantation and follow-up of CRT-D therapy over a roughly seven-year period are more than $13,000 higher than those of CRT therapy alone (Budde, 2006). The nonsurgical medical care of HF is time-intensive and underreimbursed (Fonarow, Yancy, et al., 2008), and the decision to proceed with device therapy often requires multiple, in-depth discussions with patients. Virtual (electronic) follow-up of outcomes with these devices is also currently unreimbursed (Friedewald, Boehmer, et al., 2007).