Tell us about the Massachusetts General Hospital (MGH) CRT clinic and its background. Why was it important to integrate multidisciplinary care for your CRT patients?
Orencole: The MGH Multidisciplinary CRT clinic was established in 2005 to incorporate the multidisciplinary care of heart failure (HF) patients who underwent device implantation around the many providers who are specialists in the field and who could focus on the care needs of these patients. It was very important to us that patients coming to MGH had all of their care needs attended to in one visit. The complex nature of these patients requires the participation of their internist, primary cardiologist, electrophysiologist and heart failure specialist, along with specialists in cardiac imaging.
The MGH CRT Multidisciplinary Clinic consists of a team of expert cardiologists including electrophysiologists, heart failure specialists, cardiac imaging specialists, device specialists, researchers, and a dedicated nurse practitioner who collaborate in providing care of the patient at every visit. Having an integrated clinic where patients and families are seen and clinically evaluated together enables us to review their response to both pharmacological and device therapy. In addition, it provides the unique opportunity for enhanced patient education.
The clinic works in conjunction with referring physicians, consisting of cardiologists, heart failure specialists, and electrophysiologists within and outside of our institution who have patients with recent CRT implants or a limited response to CRT therapy.
Describe the population of CRT patients treated in this study.
Orencole: The patients in the study met conventional criteria for CRT implant in that they had NYHA class 3 or 4 heart failure, had LVEF less than or equal to 35%, and QRS duration of >120 ms. The data in the study were prospectively collected from patients in the CRT clinic who underwent CRT device implantation or upgrade from a pacemaker or single chamber ICD to a CRT device between September 2005 and February 2010, who were followed in the multidisciplinary clinic. There were 254 patients included in the multidisciplinary care (MC) cohort. The MC protocol included multidisciplinary clinic visits at one month, three months and six months post-implant, with echo-guided optimizations done at one month and six months. In addition, the patients’ physiologic device parameters were evaluated collaboratively by the nurse practitioner and electrophysiologist in the clinic.
Patients who underwent CRT device implantation and were conventionally followed at MGH between March 2003 and November 2009 but never seen in the multidisciplinary clinic were included as the conventional care (CC) or control group (these were 173 patients for whom data were collected retrospectively). These patients were also seen at our institution and had clinic visits scheduled as needed in varying intervals. Echocardiogram-guided optimizations were dictated by physician discretion and not performed routinely.
The long-term outcome was measured as a combined endpoint of heart failure hospitalization, cardiac transplantation, or all-cause mortality.
I think there is real value in the populations that were analyzed as part of this study, as differences in patient outcomes can be contributed to the type of clinical center where that patient’s care occurs.
Why is it that some patients do not respond adequately or are non-responsive to CRT therapy?
Altman: The reasons for lack of response to CRT are complex and in some ways can be thought of as relating to baseline patient factors, technical aspects of device implantation, as well as the care patients receive in the post-procedural setting. Our study focused on answering the question of whether a systematic multidisciplinary approach in the post-procedural setting could make some headway in improving the response rate. Our data suggest that the type of post-implant care received by patients may impact the response to CRT.
How long has this team been in place at MGH? How is communication optimized between the heart failure, EP, and imaging staff?
Moore: The CRT team has been in place since 2005. It started on the basic principle that good care of a heart failure patient with a complex device deserves to be seen by the doctor managing the chronic disease (heart failure) and the person managing the device (electrophysiologist). Another basic principle was that crosstalk was essential. Imaging played a key role in device optimization and determination of remodeling, so it made good sense to incorporate imaging with echocardiography early in the process. Since we were learning about the who, what, when, and where of device therapy in this complex patient population, we added a research team as well as support for a data repository early in the process. I will say the “glue” of the clinic is and always will be our midlevel provider, or fellows, nurse practitioner, and the research team. They make the crosstalk easy. We utilize real-time meetings during clinic, and the entire care plan is documented within 24 hours in the electronic medical record for our referring physicians.
Tell us about the components of multidisciplinary care for CRT implantation. How does conventional care differ from multidisciplinary care?
Altman: The patients in our study did not differ in the method of implantation of their devices, and thus, we cannot say what impact the multidisciplinary clinic had on CRT implantation. However, in the clinic, those patients who are non-responders undergo a comprehensive evaluation of the reasons for non-response by each component of the multidisciplinary team. At times, these patients may undergo advanced cardiac imaging in order to assess for dyssynchrony or for coronary venous mapping in consideration of LV lead revision to enhance response.
What is significant about this study? How were clinical outcomes affected?
Orencole: The study is significant in that it suggests that post-device implant care can impact the response to CRT. Attention to the device diagnostic trending information including SDANN, heart rate variability, rate histograms, activity trending, transthoracic impedance changes, and defibrillator treatment therapy zones and integrating this into the patient’s clinical presentation all play a part in response and assist in the pharmacological management of heart failure patients with CRT (Figure 1).
The study showed that patients followed in this type of setting had significantly better outcomes than the CC arm (Figure 2). In particular, the MC group demonstrated a lower incidence of death, transplant or heart failure hospitalization and suggested more favorable echocardiographic reverse remodeling in this group.
What has been the response of MGH staff to the multidisciplinary care protocol? What challenges were faced or lessons learned in implementing this protocol?
Orencole: We have conducted follow-up satisfaction surveys with our referring cardiologists and the response has been incredibly favorable. This group of patients tends to be very dynamic with numerous possible complications, which could lead to unnecessary admissions. The adaptation and integration of remote monitoring into this patient population has enabled us to respond very quickly to changes in their clinical status. All patients going through the clinic, with the exception of those without land telephone lines, are followed on a remote monitoring system. I think the expeditious manner in which communications are sent out to the care group as a whole, including their primary care providers, has really enhanced favorable outcomes as well as positive communication. In many outpatient clinical settings, remote monitoring has only been partially adapted to prevent patients from having to come into the clinic to have their device checked. In conversation with general cardiologists and heart failure specialists in the community, there has been some understandable reluctance to “log on” to all of the different device websites and assume the responsibility for these alerts.
It is very important to have highly qualified individuals on these systems to be able to evaluate alerts and device integrity, and also be empowered to make changes quickly. We care for a patient population that does not easily tolerate decreased percentages of biventricular pacing or arrhythmias requiring therapies, so decisive response to home monitoring alerts is essential.
What about the cost-effectiveness of the program?
Moore: As the population eligible for device therapy rapidly expands, the need to be more cognizant of its cost-effectiveness and to refine the selection criteria will become more important. In order to ensure that we accurately select the patient most likely to respond, we recognize potential non-responders early and accordingly make changes to the drug-device therapy. In order to be successful, communication lines between the electrophysiologist, echocardiographer, and HF specialist need to be facilitated.
Orencole: I think that as Medicare moves toward a “bundled fee” reimbursement strategy, programs like this will be very important at keeping overall costs down. The healthcare system has got to function like a well-oiled machine with increased collaboration and more patient-centered focus. It makes sense that integrated care strategies like ours be initiated on more resource-intensive and high-cost disease patient populations. If we can reduce HF hospital readmission rates by having collaborative multidisciplinary clinics be the standard, than that will translate into reduced overall healthcare costs.
Is there anything else you’d like to add?
Orencole: I think as we start to see results from various research studies on heart failure management programs and remote monitoring, that the trends will suggest we are making a difference. These specialized programs have been shown to be successful in improving quality of life and patient satisfaction, while reducing hospital admissions, readmissions, and lengths of stay. The data from the ALTITUDE and CONNECT studies confirmed significant reductions in hospital admissions as well as decreased time to respond to clinical changes in heart failure patient populations.
As we proceed, it is important to examine these populations for clinical characteristics that define clinical non-response to CRT therapy. We can also make better determinations of the patient’s substrate selected for implantation, and that continues to be an evolving clinical paradigm.
Other opportunities include analyzing LV lead implantation strategies as well as lead location when patients present with suboptimal response to CRT. Certainly, if patients are being considered for heart transplant secondary to non-response, there may be other lead option technologies available that could enhance their response as well as undergo echo optimization or a multidisciplinary clinic evaluation. In fact, some of our patients from different parts of the United States have found us through Internet searches and have experienced enhanced clinical response to CRT.
When we initiated the MGH Multidisciplinary CRT clinic, CRT was unique in its real-time window into patient data. There is now a complementary array of other devices, such as impedance sensors, ventricular assist devices, and neurological feedback devices that are used in the care of advanced heart failure patients and also provide real-time data that can be used to tailor decisions. The name of our clinic might have to evolve as we incorporate all of these types of devices and physiologic data into the integrated care of heart failure patients.
- Altman RK, Parks KA, Schlett CL, et al. Multidisciplinary care of patients receiving cardiac resynchronization therapy is associated with improved clinical outcomes. Eur Heart J 2012 May 21. [Epub ahead of print]