Perspective Chapter: Delivering LVAD Care to the Local Community

Abstract

Heart failure is a growing pandemic affecting approximately 6.2 million people in the US and 15 million people worldwide. Mechanical circulatory support devices are not only a bridge to transplantation, but have become destination therapy for a large portion of this population. Given its prevalence and high morbidity and mortality leading to significant financial burden on our healthcare system, establishing strategies focused on improving therapeutic outcomes and prognosis should be prioritized. Delivering care to such a large and complex patient population poses unique challenges given the progressive care needs and extensive follow-up. Time and distance traveled are among the limiting factors that disable patients from having access to life sustaining advanced therapies such as the LVAD. This chapter aims to review the traditional care model and expand on the necessary tools and benefits of the LVAD shared care model in delivering care to previously underserved patient populations with advanced heart failure.

1. Introduction

Heart failure (HF) is a condition with high mortality due to decreased cardiac function leading to poor perfusion, exacerbated during high metabolic states. It is a growing pandemic expected to rise by almost 30%, expanding its reach from 6.2 million to 8 million people by 2030 in the US and many more worldwide [1, 2, 3]. It carries significant morbidity and dramatically limits patients’ quality of life. The morbidity is costly, leading to high expenditures of 30.7 billion dollars annually, which is also projected to double by 2030 [4, 5]. The symptoms are debilitating as the disease progresses towards its end stages of advanced heart failure (AdHF) even despite maximally tolerated guideline directed medical therapy. At this stage in the disease process, medical therapy is inadequate and treatment must be advanced to more invasive means [6, 7]. The only viable options are orthotopic heart transplant or durable mechanical support in the form of a left ventricular assist device (LVAD). As the therapy advances, the treatment team must adapt to a multidisciplinary cohort incorporating a multitude of care providers from varying backgrounds [8, 9, 10]. Few places have the resources capable of staffing such a diversity of providers, which comes at great expense, therefore traditionally limiting care to large academic centers. Patients that do not live near these centers face geographic barriers to care coordination and are prohibited from otherwise appropriate life prolonging care. The new shared care model allows for device implantation at a large center with the subsequent transfer of follow up care to a local heart failure program capable of managing LVAD recipients. This concept allows for greater access and thereby increases effective eligibility for advanced therapies. It also improves patient adherence to the rigorous home care regimens that LVADs require. Improved access and adherence ultimately improves patient outcomes and reduces their financial burden [11].

2. Advancing therapies

Worldwide, there are an increasing number of end stage heart failure patients with LVADs which now exceeds 100,000 of which 18,539 are reported in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) [5, 12] and 16,286 reported in the global IMACS registry collecting data from the United States, Europe, Japan, and United Kingdom [13]. As the end-stage heart failure pandemic continues to grow and alter the lives of multiple patients, LVAD advancements provide a viable option for patients as either a bridge to heart transplant or as destination therapy for those who are not transplant candidates.

MOMENTUM 3 is a landmark multicenter trial demonstrating the strides in LVAD technologies and decreasing patient complication rates. The centrifugal-flow LVAD, HeartMate III, demonstrated superior performance to the axial-flow LVAD, HeartMate II. The HeartMate III reduces shear stress, reduces friction, and prevents thrombosis. The primary outcome of the MOMENTUM 3 trial showed that 74.7% of patients with a HeartMate III survived without disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years versus 60.6% of patients with the HeartMate II. Secondary outcomes of the study revealed decreased pump thrombosis, stroke, and bleeding events in the HeartMate III compared to the HeartMate II. The 3 year survival rate when utilizing HeartMate III now rivals that of heart transplantation [14]. This allows LVADs to extend life-prolonging therapy to patients not eligible for heart transplant and give patients an option that they never had before. The prevalence of adHF and life prolonging impact of LVADs worldwide makes the further development of LVAD care networks a pivotal part of delivering adHF care and improving patient outcomes.

3. Traditional LVAD care model

In traditional advanced heart failure centers, the care for these patients was provided by large multidisciplinary teams involving multiple coordinators, nurses, physician assistants, cardiothoracic surgeons, palliative care, and various advanced heart failure specialists. Due to the costs associated with such a large team, LVAD care was historically limited to large, urban medical facilities [15, 16]. Post-transplantation inpatient cardiac rehabilitation allows patients to improve their functional status. This also allowed for adjustment of LVAD settings as vital signs fluctuated with the body’s adjustment to altered hemodynamics. Since patients with LVADs do not have a true systolic blood pressure, their mean arterial pressure (MAP) can be measured with a portable doppler by a trained professional. In addition to the vital signs, the degree of anticoagulation requires close monitoring as early data suggests that direct oral acting agents carry an increased risk of thrombotic events [17, 18, 19].

Patients and caregivers are required to attend extensive educational sessions at all LVAD implantation centers. These sessions evaluate patients’ functional status in an effort to avoid catastrophic errors while performing daily care such as changing batteries, bathing, or responding to device alarms [20]. Training the patients to manage the driveline using sterile technique is extensive. Standardized kits have been generated to aid in the process, but driveline site infections remain a major concern and a cumbersome task for the patient [11, 21]. Driveline care requires significant adjustment to lifestyle, including intimate relationships. Patients are directed to be exceedingly careful to avoid pressure on equipment or excessive body movements near the exit site [22]. Similar to other major cardiac surgeries, after appropriate rehabilitation and wound healing, driving is permitted. Traveling requires additional preparation to ensure back ups to all equipment is available along with a LVAD site at destination [23].

While a multidisciplinary team optimizes care of an LVAD patient, a recent national survey of cardiologists, LVAD advanced practice providers, coordinators, surgeons, and social workers failed to identify the characteristics that would make an ideal patient [24]. Patients with higher education levels (>12 years) had higher survival rates [25]. The Singapore LVAD program has stricter selection criteria, however, the program’s outcomes were similar to the IMACS registry. They did report a higher 3 year survival, but also a higher infection rate [26].

LVAD patients are frequently hospitalized due to complications with as many as 80% of all patients having had at least one admission by the 1 year mark [11]. Most commonly, they present with gastrointestinal bleeding (GIB) or a driveline infection. Optimal social support and meticulous adherence to LVAD management have been noted in conjunction with reduction in unplanned admissions. In 2020, there was a case report noting 4 years as the longest time interval to hospitalization for an LVAD patient. University of Chicago has conducted many trials investigating the infrastructure leading to LVAD success. They suggest the continuation of GDMT to decrease HF recurrence, omega-3 to decrease GIB [27, 28], bi-monthly international normalized ratio (INR) checks to maintain therapeutic anticoagulation [29], and a coordinator team to address all device alarms as measures to prevent adverse events and related unplanned readmissions [30]. The Miami Transplant Institute conducted a CF-LVAD study which showed anticoagulation management by a pharmacist along with self-testing improved the duration of time spent in therapeutic range [31]. With advancing technology, telehealth may serve as an adjunct to improving patient care. A small study utilizing a LVAD specific platform where patients entered their parameters followed by health surveys improved patient satisfaction. This platform gives patients the ability to review LVAD educational materials and track their individual data which has the potential to reduce readmissions [32, 33, 34].

Traditionally, the LVAD patient would remain associated with that implanting facility, regardless of the patient’s distance traveled to the facility, socioeconomic limitations, time constraints and other factors. While this model encourages continuity of care in large cities with multiple healthcare centers, it discourages use of advanced therapies in patients who live outside of large cities [35, 36].

4. A new model: shared care

As the prevalence of end-stage heart disease continues to increase, the concept of “shared care” that focuses on implanting devices at a major institution and subsequently transferring follow up care to local heart failure cardiologists may expand access for LVADs to patients living in remote areas or of lower socioeconomic status who are unable to afford travel. In technical terms, a shared care LVAD center model occurs when a patient undergoes LVAD implantation at an implanting center, but greater than 50% of both the outpatient care and inpatient care alike is delivered locally [37]. This network of shared care sites can offload non-implant related issues from an implant center reducing strain on its resources while also allowing patients quicker access to routine care. In order for this to work, all care sites need to be properly trained in LVADs (Figure 1).

Figure 1.

Shared-care model for LVAD patients.

The shared-care model has been used among various specialties in medicine. In Toronto, it is being used in kidney transplant recipients with optimization of post-transplant care leading to a reduction in financial burden for patients and a reduction in follow up care volume for transplant centers [38]. They have also coordinated extensively in management of complex hematologic disorders which was initiated at Princess Margaret Cancer Centre. These models require training for community partners to ensure patient safety and satisfaction [39]. Later, it carried over to cardiology as the International Society of Heart and Lung Transplantation established guidelines for the principles of shared care after heart transplantation [40]. Now, it can be reiterated for the continuum of LVAD care.

While the model itself has been successfully implemented in complex medical conditions, it had not previously been attempted for LVAD patients. There are several examples demonstrating the success of the shared care model for LVAD patients. The Deborah Heart and Lung Center (DHLC) located in Browns Mills, New Jersey is a non-profit cardiac care specialty hospital which serves a largely underserved population in rural South Jersey. Its advanced heart failure program launched in April 2017 with partnerships and guidance from Thomas Jefferson University Hospitals, Temple University Hospital, and Robert Wood Johnson University Hospital. The shared care team consists of heart failure specialists and advanced practice providers [11]. Patients who lived in this area no longer had to travel over 90 minutes by car each way for their appointments nor did they require transfer to distant hospitals every time they were hospitalized. This allowed for all preop work-up and post-op care to occur in the local community, leading to improved access for patients with financial difficulties. This also improved patient compliance and diligence in attending all appointments, including seeking care as soon as issues arise. Other centers in the U.S. have demonstrated similar favorable outcomes with the shared-care model. A study published in JACC evaluated several key measures for LVAD patients implanted at the University of Utah Hospital. The authors included 336 patients implanted between 2007 and 2018, and categorized them based on level of care and resources utilized for their post implantation care. Overall, the rates of infection, bleeding, death, and pump thromboses were similar between care provided at the implanting institution (traditional care model) and outpatient care with LVAD specific training (the shared-care model). Rates were higher when outpatient services that were utilized did not have LVAD specific training, highlighting the importance of ensuring proper LVAD-specific training and resources are available at shared-care facilities [41].

There are no established criteria for shared care programs. However, a group of authors suggested several criteria that were published in the American Heart Association Journal Circulation, which focused on three broad categories: personnel, education, and equipment (Table 1). It is generally agreed that a shared care center should have an appointed local LVAD specialist—typically a heart failure cardiologist, though formal training in advanced heart failure is not a Joint Commission requirement for LVAD implantation facilities. Moreover, a nurse coordinator is another essential team member, who often serves as the primary contact for patients and other providers in the shared care team. Regarding education, LVAD specific training for all team members is essential. Preceptorships and LVAD vendors can provide the on-site education needed to learn the principles of LVAD management. Basic equipment should be garnered by the shared care facility and appropriate staff trained on its use. Device consoles, spare parts such as controllers, power cables, controller batteries, battery charges, and driveline equipment should ideally be available for timely replacement and troubleshooting [42].

General	Dedicated LVAD Team Physician Supervision—often a Cardiologist Advanced Heart Failure Physician as Medical Director Nurse Coordinator Hotline or other dedicated LVAD patient portal
Education	LVAD evaluation and management training Implanting facility preceptorships Internal review to continuously update best practices Onsite LVAD training VEndor sponsored, hands-on training
Maintenance	Equipment: system monitors, batteries, controllers, driveline dressings Establish policies for common complications Interval reassessment of shared-care providers and patient outcomes

Table 1.

Potential criteria for shared-care partners.

Every follow-up visit starts with a review of systems concerning potential LVAD complications (Table 2). Next, is a blood pressure check which in continuous flow devices is typically taken as a mean arterial pressure obtained via doppler. This is done by inflating the sphygmomanometer to 20 mmHg above flow occlusion and the opening pressure is considered the systolic blood pressure if the patient has pulsatility. In absence of pulsatility, as in most LVAD patients, this is considered the MAP or mean arterial pressure. Recommended MAP is 60–80 mmHg [43] and MAPs outside of this range warrant intervention. One of the common alarms is “low flow” due to decrease in pump flow in both hyper and hypotension. Guideline directed medical therapy or neurohormonal antagonism must be continued to appropriately control blood pressure.

Symptom	Evaluate for
Shortness of breath or leg swelling	Heart failure
Darkened or bloody urine or stools	Coagulation abnormalities—bleeding or pump thrombosis
Fevers, chills, or trauma to driveline site	Infection of driveline site

Table 2.

Symptoms in an LVAD patient.

An ECG is recommended in every LVAD patient to evaluate for ventricular arrhythmias. Prompt attention to any signs and symptoms of right heart failure should warrant further investigation. Alarm interrogation and documentation is also necessary. Critical alarms include “VAD stopped” and “critical battery” of 5 minutes which display as a red triangle. A yellow flashing triangle necessitates evaluation by a LVAD specialist as it suggests the pump exceeds its power threshold. Non-flashing alerts require non-emergent evaluation and can be evaluated at the shared care center.

Additionally, laboratory tests are followed closely to ensure proper function of the LVAD. Regular INR checks, lactate dehydrogenase (LDH), and plasma free hemoglobin or hematocrit are measured regularly to monitor for adequate anticoagulation, as well as to monitor for hemolysis [44]. In addition, echocardiography is used to monitor ventricular function. Aortic valve insufficiency symbolizes inadequate function and leads to adjustment to LVAD parameters [45].

Driveline exit sites must be thoroughly inspected and suspicion of infection should be followed up with site culture, blood cultures, and appropriate imaging studies. This can be performed at the local shared care site as it does not require hardware manipulation. As infection rates are higher in this population and linked to a higher 1-year mortality, prompt treatment of infections with appropriate antibiotics is warranted [46]. GI bleeding is another complication that needs prompt evaluation and can be completed at any shared care site with GI services. As arteriovenous malformations (AVMs) are frequently the source of GI bleeding, urgent endoscopy can serve as diagnostic and therapeutic modality [47]. Reversal of INR is not ideal and requires careful monitoring as subtherapeutic states lead to pump thrombosis and failure. Neurologic complications, both hemorrhagic and cardioembolic strokes account for 19% mortality following an LVAD implant [12]. Due to its increasing prevalence, guidelines for LVAD patients were added to the cardiopulmonary resuscitation (CPR) algorithm in 2017. All staff at shared care centers must be able to recognize situations in which this protocol must be initiated. If the device hum is present, then controller function and adequate power must be confirmed. In the absence of the device hum, with MAP <50 mmHg, CPR should be initiated. However, with increasing time of pump discontinuation, the likelihood of pump thrombosis increases. Extracorporeal membrane oxygenation (ECMO) can be considered in these scenarios if CPR is successful and further care should be transferred to a tertiary center [48].

Follow up care in an LVAD patient is key to a successful outcome (Figure 2). Houston Methodist, another implanting center who successfully employs the shared care model, developed an extensive protocol to be used at shared care sites and specified the steps taken for equipment checks from patient education to clinician verification [49]. Educating the new shared care site on management of LVAD visits and emergencies can be a challenge. There are no current guidelines on the training required by ancillary staff to conduct such visits. Allowing for this care to occur near a patient’s home can prove to be a psychosocial advantage, encouraging family members involvement and support. If a regional center is trained in the basics of LVAD management, it would decrease inpatient transfers for non-LVAD related hospitalizations, thereby improving patient experience while increasing community hospital revenue [50].

Figure 2.

Follow up evaluation of LVAD patient.

The success of the shared care model can also allow former non-implantation sites to naturally evolve into implantation sites themselves. The lessons learned by its participation as a shared care site enabled DHLC to develop its own LVAD transplant program further expanding patient access to needed durable mechanical support. New implant centers will then develop their own selection committee for candidacy in accordance with the International Society of Heart and Lung Transplant Committee standards and guidelines. The patient is scored on the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scale with 1 noting critical cardiogenic shock and 3 as stable on continuous intravenous inotropic support. INTERMACS 4 through 7 are not typically considered for LVAD as they have not yet reached the severity level required and are managed with medications. Once the case is reviewed by the team, patients with an INTERMACS score greater than two can choose the location for further work up for implantation with a plethora of tests such as echocardiograms, CT scans, and colonoscopies which are used to maximize the patient’s status for an optimal outcome. Once a LVAD is implanted, follow up care is transferred back to the referring heart failure specialist who can continue to manage the patient in conjunction with the LVAD team. While heart transplantation remains the goal for some patients, others have been rejected due to age or other comorbidities. With the increasing demand for LVADs as destination therapy, more shared care networks will likely make the transition to implantation centers as well.

5. Discussion

The shared care to destination therapy model is an example of a new milestone in the advancement of care in the face of a growing heart failure pandemic. This model not only expands access to LVAD care, but also provides patients with social, financial, and satisfaction benefits. Shared care centers allow individuals to reach an advanced heart failure specialist quickly and efficiently by eliminating long distance travel and its associated financial expenses, as well as eliminating the excessive time commitment previously required for routine care. Patients are able to continue to reside in their own communities without making a lifelong commitment to either move where resources are available or spend an excessive amount of time traveling. The physician-to-patient ratios will remain lower enabling the physician-patient relationship to grow stronger over the years, which can improve the physician’s ability to deliver personalized care and treat each patient based on their individual needs.

Given the high mortality rates in end stage heart failure and the recent advancements in LVAD technology that now afford a 3 year survival rate comparable to that of heart transplants [12], the demand for LVADs continues to escalate. Just as DHLC implemented the shared care to destination therapy model to eventually become a LVAD implant center, other shared care centers will likely do the same and heart failure cardiologists will be better able to evaluate adHF patients for LVAD candidacy to improve patient outcomes, satisfaction, and quality of life. This involves a multidisciplinary team discussing LVAD selection criteria, action plans, patient support, guideline directed treatment, and comprehensive follow up care.

A successful transition to a destination therapy center consists of a multidisciplinary team made up of an advanced heart failure cardiologist, LVAD surgical director, LVAD medical director, medical critical care director, heart failure nurse practitioners, and two social workers all centered on patient care. Through this period of expansion and development, these multidisciplinary teams are integral to the successful establishment of a shared care center and a LVAD implant center. As former shared care centers transition to destination therapy centers, the network of shared care can then expand outward even more.

6. Limitations

A prospective study interrogating the shared-care model has yet to be performed. While limited data points are available, and retrospective data such as that from the centers mentioned above, the viewpoints in this chapter should be validated in a true prospective study. Such data will better delineate clinical outcomes for shared-care patients, such as adverse events, quality of life, financial impact for patients and healthcare systems. Despite a lack of such studies, the shared-care model is currently being utilized across the country.

7. Conclusion

Traditionally, because LVAD implant facilities are frequently remotely located from the patients that they serve, the shared-care model developed has demonstrated a safe and effective way to care for LVAD patients who live far from their implanting center.

Acknowledgments

The authors would like to acknowledge the contributions of Heart Failure and LVAD teams at DHLC, including but limited to Dr. Cindy Kos D.O., Abroo Muzaffar APN, Jamie McLeod, LPN, Dionne Bademosi APN, and Carlos Lozano APN.

Conflict of interest

The authors declare no conflict of interest.

Thanks

Special thanks to our colleagues, the Cardiovascular Disease Fellows at Deborah Heart and Lung Center.