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Monday, December 24, 2012
Advances, Winter 2013
Left: Left atrial pressure sensor device in a patient with a pre-existing CRT device. Right: Intracardiac echocardiographic display of the left atrial pressure sensor.
Patients with moderate to severe heart failure (HF) often have an adversely remodeled heart accompanied by abnormal electrical and mechanical contraction patterns. One of the most common treatments for this patient population includes cardiac resynchronization therapy (CRT), involving surgical placement of a biventricular pacing device to resynchronize the contraction of both sides of the heart’s ventricles. However, even with CRT, approximately one-third of patients do not respond well and continue to have worsening heart failure.
New research from the Massachusetts General Hospital Institute for Heart, Vascular, and Stroke Care shows that receiving care at a multidisciplinary integrated CRT Program—where the treating subspecialties see patients on the same clinic day to provide coordinated, patient-centered treatment—leads to better clinical outcomes for this patient population. In a research paper published in the September 2012 issue of the European Heart Journal (EHJ), the Mass General CRT team showed that compared with conventional CRT treatment, coordinated multidisciplinary care yielded a 38 percent reduction in the risk of hospitalizations, cardiac transplantation, and mortality over a mean two-year follow-up period.
Patients receiving CRT require the services of several subspecialists, including a heart failure physician, an electrophysiologist, and an imaging echocardiographer. With conventional care, patients access these specialists at separate appointments, sometimes spaced weeks apart. With coordinated care, all the subspecialists deliver care on the same appointment day in one centralized location.
The EHJ study included 254 patients with HF receiving multidisciplinary integrated CRT treatment at Mass General compared with a well-matched control group of 173 others who received conventional care. All patients had echocardiographic-guided device optimization at their one-month visit. Patients were seen again at three and six months in a coordinated care setting. The long-term outcome was measured as a combined endpoint of heart failure hospitalization, cardiac transplantation, or all-cause mortality.
Jagmeet P. Singh, MD, PhD, FHRS, director of the Institute’s CRT Program, founded the multidisciplinary CRT Program in 2005, bringing together all the treating subspecialties including the collaborative efforts of the Institute’s Heart Failure and Cardiac Transplant Program,
Cardiac Arrhythmia Service, and Echocardiography Services. Since then, more than 800 patients have received treatment in the clinic—including many outside of the Massachusetts and New England region, extending to the larger U.S. and Europe. The program's singular aim is to improve the outcome for all patients receiving CRT—including the one-third of patients classified as non-responders.
Conventional medical therapy has been shown to improve the quality of life for HF patients; however, many patients continue to worsen and need alternative treatment strategies. Although CRT may be an appropriate intervention for many of these patients, it adds a level of complexity to the care delivered to this patient group. The benefits seen in the EHJ study show that the multidisciplinary care approach is the difference in obtaining better outcomes using largely the same medicines, devices, and imaging protocols established in conventional treatment.
The study emphasizes that replacing individual treatment silos with one coordinated system of care achieves the best outcomes for patients receiving CRT.
CRT Response Linked to Communication
Some medical conditions that can significantly limit the effectiveness of CRT include the presence of a severely scarred heart from a previous myocardial infarction, coexisting lung disease, or valvular heart disease. Lack of optimal response to CRT may also result from deficient coordination and communication between treating subspecialists. Patients receiving CRT have poorly functioning hearts, are highly symptomatic, and require many medications—necessitating frequent adjustments based on their HF status. These implanted CRT devices provide considerable personalized data and information that helps assess the clinical well-being of the patient. Often, the programming parameters need to be adjusted to provide better individualized therapy. These patients also may need echocardiographic imaging of the heart to provide more objective assessment of the cardiac function and encourage patient-specific programming of the device pacing intervals. Typically with conventional practice, these three treatment modalities: 1) medical management; 2) device implantation and monitoring; and 3) imaging follow-up—are usually delivered independently by physicians at different points, often several weeks apart. And there is no structured means of communication between care providers, so the patient often has to take responsibility for reporting results to other physicians and scheduling appointments.
Dr. Singh founded the CRT Program at Mass General to address these limitations by bringing together the different subspecialties. CRT devices provide a wealth of data that was not being used optimally in the wider community to help treat HF patients. CRT devices provide a host of information regarding the clinical state of the patient, including fluid overload, nocturnal heart rate, and heart rate variability, all of which provide a better understanding of the clinical trajectory of the patient. This information can be shared in real time via a coordinated clinic environment. And Dr. Singh believed that the device settings could be optimized on a more individual basis, according to each patient’s response nuances. This reality led to establishing the CRT Program to improve individual patient outcomes for this vulnerable population.
At its center is the strategy of bringing all the treating subspecialties to the clinic on the same day so that information can be easily generated and shared. The result is the best possible integrated care at one time with proven advantages in morbidity and mortality.
Research and Treatment Connection
Adapted from Altman R. et al., Eur Heart J, 2012.
Research remains a central mission of Mass General's tertiary care academic medical center. Research is also a pillar of the CRT Program within the Institute for Heart, Vascular, and Stroke Care. Approximately 70 percent of the patients passing through the CRT Program clinic are involved in research protocols. Patients who choose to participate in a clinical study also meet with the research staff during their clinic visits.
Currently, there are approximately 15 different clinical research protocols run by nine physician principal investigators within the Mass General CRT Program. Many of these are national or multinational multicenter trials, as well as investigator-initiated studies. This marriage between the CRT Program clinic and research is an effort to simultaneously learn from patients, with the goal of quickly translating science into the delivery of cutting-edge clinical care.
Research linked with the delivery of resynchronization therapy currently falls under three general umbrellas: 1) studies to enhance patient selection for receiving treatment; 2) improving CRT device implantation techniques; and 3) improving and individualizing patient follow-up.
Delivering Multidisciplinary Care
Because the care of patients undergoing CRT is complex, the goal of the CRT Program clinic is primarily to set patients on the best clinical trajectory after their device implantation.
Each patient is seen for a baseline visit prior to surgical implantation with a CRT device. Patients subsequently receive coordinated care at one, three, and six months after device implantation. During each visit, practitioners consult with each other face-to-face regarding each case, sharing clinical, device, and imaging information.
The CRT Program clinic is held one day per week, and approximately eight to 10 patients visit that day. The patient will spend two to three hours being seen by various treating and research professionals, and will also be seen by the nurse practitioner who reads the CRT programmer device information, which contains data related to patient activity level, irregular beats, and heart rhythm changes. Depending on that information, the patient advances through the clinic to be seen by the heart failure/transplant physician, the electrophysiologist, and an echocardiographer. If more time is needed with one particular specialist, the schedule is adjusted to accommodate each patient’s needs at that point. Also in attendance at each clinic visit are technologists and support staff with expertise in heart failure who conduct walk tests, quality-of-life assessments, and device evaluations.
The heart failure physician decides if medications need adjustment. Patients commonly need medication adjustments after the initiation of resynchronization therapy. For example, many patients may need markedly lower doses of diuretics, and some can eliminate their use entirely. In addition, HF-specific medications that help remodel the heart that were previously not tolerated can be maximized. The electrophysiologist determines if the CRT device is functioning well and if the patient’s heart is pacing well. They also look for arrhythmia- or device-related issues that could be causing problems. The role of the imaging echocardiographer is to assess the impact of synchronization therapy on the heart and help the electrophysiologist optimize the CRT device settings based on contractility measures.
The Mass General CRT Program clinic includes the services of four electrophysiologists, three heart failure physicians, two physician echocardiographers, three sonographers, one dedicated CRT nurse practitioner, three study coordinators, four research fellows, and administrative support, among a host of other collaborative efforts with other divisions. Staff rotate through the clinic on assigned days.
Having all the treating professionals centered on the patient at the same point improves real-time, intra-team communication and decision making about device settings and medical management. It also improves communication with patients since they do not have to collect or remember to pass on key information from previous physicians. All the data is centralized within the clinic’s scheduling and patient electronic medical records. Demographic, clinical, and outcome data is entered in real time and on a daily basis into a central database, which allows Mass General physicians to design and conduct a robust research and clinical trials program to further improve outcomes for heart failure patients.
Importantly, patients within the multidisciplinary CRT Program retain their own referring physicians, cardiologists, and/or heart failure specialists. The goal of the clinic is not to replace the care provided by a referring physician, but to complement it and provide a strong bridge with the larger community of referring cardiologists. Updates inclusive of a detailed clinic report as well as imaging and device data are provided to referring physicians after one of their patients receives a clinic visit.
Remote Monitoring Ensures Rapid Response
Another important factor behind the improved outcomes of patients followed in the Institute’s CRT Program is that most patients are also followed via remote monitoring with active alert settings. Implantable devices provide information about heart rate, heart rate variability, patient activity, arrhythmias, defibrillator therapy, and more. When certain changes occur, even if the patient notices nothing, the device immediately sends an alert to the CRT device monitoring staff. Alternatively, if an event is noticed, the patient can press a button on the CRT programmer at home that immediately transmits data from the device.
Mass General’s CRT monitoring group alerts treating physicians and the clinic coordinator to the change 24 hours a day, seven days a week. A response can be made within minutes of signs of trouble. Although many devices are equipped for remote monitoring, having a committed, fully staffed monitoring group is an important component of dealing effectively with live alerts.
The Mass General CRT Program clinic sets all alerts to actively record even the most subtle changes that may indicate a serious abnormality. All the information is immediately stored in an electronic medical records system that helps communications between group members, other disciplines, and referring physicians.
Coordination of care makes the multidisciplinary approach possible. At Mass General, nurse practitioner Mary Orencole, MS, ANP-BC, is the point person for both the patient and the treating professionals on the CRT Program team. Acting as the operational hub of the clinic, Orencole schedules visits for all participants based on the individualized needs of each patient. She also communicates with patients directly, schedules appointments, answers patients’ questions between visits, and is the primary team contact notified following a remote monitoring alert.
Preparatory work is also central to coordinated care. Prior to clinic day, Orencole prepares a summary of each patient. Some of the basic information is gathered from the comprehensive database maintained on every patient participating in the clinic. In this way, all the care providers are equally updated regarding patient medications, heart dimensions, the type of implanted device, the pacing lead location, and a complete patient history. Additional information is included if the patient has been treated elsewhere or if any abnormal results surfaced since the previous visit. This helps ensure that all the treating subspecialists are fully prepared ahead of time.
Once patients have completed treatment in the CRT Program, they usually seek follow-up care with their own cardiologist or heart failure specialist. Yet patients can be referred back to the clinic at any point for re-evaluation for a device lead revision, image-based device optimization, or if they are participating in a research effort at the hospital.
Members of the CRT Program continue to expand their collaborative efforts with basic science researchers as well as cardiothoracic and neurovascular surgeons. In the future, the clinic is also looking to develop a direct flow of communication between the CRT Program and cardiac surgeons within the Institute, realizing that some HF patients may continue to worsen over time. Creating this link with cardiac surgery will facilitate the delivery of collaborative care between the HF physician and the cardiothoracic surgeon, should the patient need either left ventricular assist device (LVAD) therapy or cardiac transplantation.
In the current era of health care reform and the Affordable Health Care Act, health care providers are becoming accountable for patient outcomes. The multidisciplinary CRT Program at Mass General proves this can be accomplished even for patients with serious HF while reducing costs related to hospitalizations. With changes expected in access to health care providers, reimbursement rates, and payment structures, many areas of medical care, including the use of electrophysiology, will be driven by resource optimization, effectiveness research, and the economics of outcomes. In addition to new research strategies in HF, the CRT Program team is studying the economics of the multidisciplinary approach as a model for expanding the synergistic work environment for better patient health outcomes.
Ongoing Research Efforts
Members of the CRT team are also collaborating with other physician scientists within the Institute and the larger Mass General research community on several basic research and advanced therapeutic strategies with significant clinical potential for HF. A few notable examples include the following:
• Harald C. Ott, MD, of cardiothoracic surgery; Sean Wu, MD, PhD, of the Center for Regenerative Medicine; and Antonis Armoundas, PhD, of the Cardiovascular Research Center are working to develop a bioartificial heart using the cardiac scaffold and stem cells.
• Douglas E. Drachman, MD, interventional cardiologist, is working toward studying stem cell strategies to treat patients with ischemic cardiomyopathy.
• Emad Nader Eskandar, MD, director of Stereotactic and Functional Neurosurgery, implanted the first vagal nerve stimulator in collaboration with the HF and electrophysiology groups in August 2012. This was part of the international 650-patient INcrease Of VAgal TonE in chronic Heart Failure (INOVATE-HF) clinical study. This study involves stimulating the vagus nerve in patients with HF, with the goal of helping the heart remodel favorably.
• HF specialist and Institute researcher Kimberly A. Parks, DO, in collaboration with electrophysiologist Conor D. Barrett, MD, is leading the Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF) at Mass General, a trial using implantable sensors in the left atrium to wirelessly measure left atrial pressure. If pressure sensor devices can alert physicians to a rise in left atrial pressure, intervention can be initiated earlier in the disease process and hopefully reduce symptoms and HF-related hospitalizations
Altman RK, et al. (2012). Multidisciplinary care of patients receiving cardiac resynchronization therapy is associated with improved clinical outcomes. Eur Heart J, 33(17): 2181-88. Epub 2012 May 21.
Exner DV, Auricchio A, Singh JP. (2012). Contemporary and future trends in cardiac resynchronization therapy to enhance response. Heart Rhythm, 9(8 Suppl): S27-35. Epub 2012 Apr 20.
Singh JP, et al. (2011). Left ventricular lead position and clinical outcome in the MADIT-CRT trial. Circulation, 123(11): 1159-66.
Singh JP, Gras D. (2011). Biventricular pacing: Current trends and future strategies. Eur Heart J, 33(3): 305-13. Epub 2011 Sep 27.
Massachusetts General Hospital Institute for Heart, Vascular and Stroke CareThe goal of the Massachusetts General Hospital Institute for Heart, Vascular, and Stroke Care is to advance the diagnosis and treatment of heart, vascular, and cerebrovascular conditions by providing comprehensive patient care while shaping the medicine of tomorrow. Under unified leadership from Mass General’s Corrigan Minehan Heart Center, the Vascular Center, and the Stroke Service, the Institute is pioneering a new model that involves complete integration of clinical care and research across disciplines. This patient- and disease-focused model combines basic, translational, and clinical research with the expertise of a multi-specialty panel of expert scientists and clinicians. By bridging multiple disciplines, the leadership of the Mass General Institute for Heart, Vascular, and Stroke Care is developing educational programs that reinforce the opportunities offered through integrated care, while also working to address critical issues of health policy and reform.For more information, visit massgeneral.org/institute
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