Heart Failure and Ventricular Device Therapy

September 7, 2017

Basic Device Overview

The incidence and prevalence of heart failure have steadily increased in the United States for the past several years. Currently, an estimated 5.7 million Americans over the age of 20 have heart failure[1]. Projections show that heart failure prevalence will continue to increase during the next several years, with estimates of more than 8 million Americans being affected by 2030.

Heart failure is a chronic, progressive inability of the heart to pump sufficient blood to meet the body’s demands. Heart failure is a broad spectrum of disease and ranges from patients who do well for many years with oral therapy to patients who require cardiac transplantation. For patients with advanced heart failure, multiple options are now available, including inotrope support (both inpatient and outpatient), cardiac transplantation, and long-term mechanical circulatory support (MCS).

Heart transplantation remains the definitive therapy for patients with advanced heart failure. However, owing to limited donor organ availability and long wait times, MCS devices have become standard therapy for the management of advanced heart failure both for patients who will eventually receive a transplant (bridge to transplantation) and as an option for those who may not qualify for transplant but qualify for long-term MCS (destination therapy). When medications can no longer help and other surgical options have been exhausted, a physician may recommend MCS. MCS devices are most often used for patients experiencing New York Heart Association (NYHA) Class III-IV heart failure symptoms.

In 2013 The International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support made a commitment to convene an international and multidisciplinary panel of experts in MCS care and published guidelines that provide an impetus for organized dissemination of best practices from various centers with excellent outcomes into the literature to further the field of MCS.

The guidelines support the following criteria for consideration of MCS:

  • The initial evaluation for MCS or heart transplantation consideration begins with the identification of potentially reversible factors that could contribute to worsening heart failure. The presence and degree of coronary ischemia, valvular heart disease, arrhythmias, or cardiotoxic agents should be determined as well
  • Appropriate candidates should have any reversible causes of heart failure addressed prior to consideration for MCS as well as have their transplant candidacy assessed prior to implant
  • All patients being considered for MCS should also have their NYHA class and Interagency Registry for Mechanically Assisted Support (INTERMACS) profile determined
  • Patients who are inotrope-dependent should be considered for MCS because they represent a group with high mortality with ongoing medical management
  • Patients with end-stage systolic heart failure who do not fall into recommendations 1 and 2 above should undergo routine risk stratification at regular intervals to determine the need for and optimal timing of MCS
  • Heart failure patients who are at high-risk for 1-year mortality using prognostic models should be referred for advanced therapy including heart transplant, or MCS (bridge to transplantation) or destination therapy, as appropriate

An MCS device is more commonly called a Ventricular Assist Device (VAD). A VAD is a mechanical device that helps pump blood from the lower chambers of the heart (ventricles) to the body. While it does not replace the native heart, it does work to prolong the heart’s life.

There are several different types of VAD’s:

  • Left ventricular assist devices (LVAD) help the left side of the heart pump blood to the largest artery of the body, the aorta.
  • Right ventricular assist devices (RVAD) help the right side of the heart pump blood to the lungs.
  • Bi-ventricular assist devices (BVAD) help both sides of the heart pump.
  • Total Artificial Heart (TAH) that replaces the heart and pumps blood to the body.

VADs are primarily used for bridge to transplant, destination therapy and bridge to recovery. The Scientific Registry of Transplant Recipients estimates that approximately 51 percent of all heart transplant patients have a device at the time of transplant which varies widely by state and facility. The usage of VADs will continue to grow, particularly as new devices are tested and approved by the FDA. In this article we will provide information on appropriate candidate selection, the complexity of patient management, clinical outcomes, new technology on the horizon and the associated cost trends with the necessary services needed to manage these costs.

The two primary types of implantable VAD’s are pulsatile and continuous flow. Currently available VAD’s share the same basic configuration regardless of the manufacturer and include the following components:

  • A blood pump which is implanted in the intracorporeal position
  • A motor housed within the pump
  • Cannulas (tubes) that connect the pump to the heart and aorta

The newer devices are smaller, they are more reliable, they last longer and as you’ll see they have better outcomes and fewer adverse events. When we look at INTERMACS, a large national database of approved devices to see what kinds of devices are being implanted it shows that the newer devices have pretty much taken over from the old pulsatile devices.

Listed below are the current types of Ventricular Assist Devices:

Thoratec Heartmate II™

The HeartMate II™ is an intermediate-to-chronic left ventricular assist device. Designed to dramatically improve survival and quality of life, the HeartMate II was developed with the goal of providing up to 10 years of circulatory support for a broad range of advanced heart failure patients. Its small size and quiet operation make the HeartMate II suitable for a wider range of patients, including women and those of smaller stature. This device is FDA approved[2] for bridge to transplant and destination therapy.

HeartWare®

The HeartWare®, or HVAD pump, is a miniaturized, centrifugal pump capable of delivering up to 10 liters/minute of blood flow from the heart to the rest of the body. Like all other VADs, the HeartWare® VAD has a small driveline exiting the abdomen that delivers power to the pump via a controller and two batteries. The impeller inside the pump is suspended using a combination of passive magnets and hydrodynamic thrust bearings offering essentially a “wear-less” system. The HeartWare® VAD is in clinical trials for both bridge to transplantation and destination therapy.

Impella® 2.5 and 5.0

The Impella® 2.5 and 5.0 is a minimally invasive, catheter-based cardiac assist device designed to partially unload the left ventricle thus reducing the heart’s workload and oxygen consumption. The Impella 2.5 and 5.0 can be inserted into the left ventricle in a cath lab through the femoral artery, into the ascending aorta, across the aortic valve, and into the left ventricle. The tip of the catheter contains a “pigtail” that crosses the patient’s heart valve and rests in the left ventricle, generating flows up to 2.5-5.0 L/min.

Thoratec HeartMate 3®

The HeartMate 3® Left Ventricular Assist System (LVAS) is a left ventricular assist device that is currently being studied for use in people with advanced heart failure. The HeartMate 3® is in a category of pumps called centrifugal pumps. The job of the HeartMate 3® is to increase blood flow to the body and can pump up to 10 liters per minute of blood. Increasing blood flow to the body can improve a person’s ability to function and may increase the amount of time a person can live with heart failure. The HeartMate 3® is currently only available through participation in a clinical trial.

Outcomes

What does the outcomes data support? The outcomes are improving per the comparison between the newer continuous flow devices and the older pulsatile devices. With the continuous flow pumps in the blue and the pulsatile flow pumps in the red, you can see the blue outcomes are significantly better throughout the duration of support compared to the old pulsatile devices such that at one year about 82% of the patients were alive with the continuous flow devices with any kind of indication versus 61% for the old pulsatile devices.

SURVIVAL – BTT

Aaronson et al. Circulation 2012;125:3191-3200

And you can see below, the outcomes with the HVAD in blue were virtually identical to patients who got the HeartMate II™ in red. There is no statistically significant difference in terms of survival and overall survival was very, very good. You can see at 30 days, 99% survival in the HVAD group and 97% survival in the HeartMate II group, but by a year 86% survival in essentially both groups; very good survival with both pumps. With overall survival about 85 or 86% of patients are alive at one year, but most of those patients have been transplanted. And when you look at the graph somewhere about 30% of the patients at 6 months have been transplanted. So not all these patients are supported out to a year, but again they still have very good survival rates.

BTT – REAL WORLD

Kirklin et al. J Heart Lung Transplant 2013;32:141-156

The other major use of these pumps is what we call destination therapy. Destination therapy is used for patients who are just as compromised as the patients who are in bridge to transplant so they have advanced heart failure, are very sick but are not transplant candidates. These patients obtain the pump in lieu of transplantation, and are maintained on the pump as an alternative to getting cardiac transplantation. Looking at these pumps as destination therapy below, the only pump currently approved as destination therapy is the HeartMate II. The first slide is data from the trial that was used to approve the HeartMate II as destination therapy. The continuous flow LVAD in the second graph in blue is the HeartMate II and the old pulsatile pumps are in the orange. You can see that the survival is much better for the patients who had the HeartMate II rather than the old pulsatile devices. If patients are critically ill and require a pump but are on inotropic therapy at home, the survival at 6 months is about 50%, and the survival at one year is somewhere only around 10 or 15%. The survival benefit for implanting a pump compared to maintaining a patient on their current therapy is much more optimal.

DT – REAL WORLD

Kirklin et al. J Heart Lung Transplant 2013;32:141-156

Quality of Life

The impact of LVADs on symptom burden and quality of life in patients with severe heart failure has been favorable. In the HeartMate II destination therapy trial, all patients experienced NYHA class III or IV heart failure symptoms at the start of the trial, and by the end, 80% of those undergoing support with a continuous flow LVAD were NYHA class I or II. In addition, patients in this trial demonstrated meaningful improvements in the Minnesota Living with Heart Failure questionnaire and Kansas City Cardiomyopathy questionnaire, with a significant increase in a 6-min walk distance by 12 months. This should be tempered by the understanding that complications following LVAD implantation are often unrelated to heart failure, and therefore, heart failure specific quality of life assessments may overestimate the benefit of LVAD therapy.

Timing of Implantation

How do we know when a patient is ready for one of these devices? To consider implantation, a patient must present with advanced New York Heart Association Class III or Class IV. They have reduced cardiac function with an ejection fraction of less than 30%. They have advanced symptoms being breathless at rest. These patients are frequently hospitalized, often multiple hospitalizations in the past 6 months to 12 months, and this is all despite good medical therapy. They are not able to tolerate their heart failure medicines (ace inhibitors and beta blockers). Patients have renal insufficiency or persistently high brain natriuretic peptide (BNP). This is a test that measures the amount of the BNP hormone in your blood. BNP is made by your heart and shows how well your heart is working. Normally, only a low amount of BNP is found in your blood. But if your heart has to work harder than usual over a long period of time, such as from heart failure, the heart releases more BNP, increasing the blood level of BNP.  In addition, patients who have these advanced symptoms who are treated with Cardiac Resynchronization Therapy (CRT) and don’t respond or feel any better puts a patient at very high risk and deemed a candidate for implantation.  Other profile criteria for implantation timing include an INTERMACS Profile 1, the sickest patients, and even some of the INTERMACS Profile 2s.

However, the current trend in timing for implant is implanting earlier and moving into the more stable patients who are either inotrope dependent or just before inotrope, which is INTERMACS Profile 4, 5 and 6. But the decision to implant earlier depends on the reason why a patient may be getting the pump. For destination therapy it’s a little bit easier decision because a patient is not waiting for another therapy, unlike bridge to transplant where a patient is waiting for a heart and the decision tree is a bit more complicated. But the overall trend of the field given the way the devices have improved is moving to earlier implantation.

Complications following VAD Implants

The most common complications in patients supported with an LVAD are bleeding, LVAD thrombosis, stroke or systemic thromboembolism, and infection.

Bleeding is the most common adverse event after LVAD implantation. Patients with LVADs require antiplatelet and anticoagulant therapy, which predisposes them to bleeding complications. Bleeding that occurs in the first 14 days after the implantation is mostly related to surgery. Causes of later bleeding include the development of arteriovenous malformations, hepatic dysfunction from post-implant right ventricular failure and acquired von Willebrand syndrome. Gastrointestinal (GI) bleeding occurs at a median of 33 days from surgery (range: 1 to 530 days), with the greatest risk within the first post-operative month. It is the most common cause of 30-day readmission. Another important site of bleeding is bleeding into the central nervous system. Central nervous system bleeds occur relatively late.

Despite antithrombotic treatment, thromboembolic events are common. They include cerebrovascular accident, transient ischemic attack, arterial non-central nervous system embolism, or pump thrombosis (PT). Atrial fibrillation is a well-established risk factor for thromboembolic complications and is frequently found in patients with advanced heart failure, including patients undergoing LVAD implantation. Both HeartWare® and HeartMate II™ patients are susceptible to PT. PT can cause life-threatening device malfunction and embolic strokes.

Infections are a common cause of morbidity and are the second most common cause of death in patients who survive the initial six months on CF-LVAD support. Infections are also one of the leading causes of readmission in these patients. The rates of LVAD-related infections are high, ranging from 30 to 50%. Recent data from the INTERMACS registry indicated that pneumonia and sepsis are the most common infectious complications in patients supported with LVADs (23% and 20%, respectively), followed by driveline site infections (DLIs), which occur in approximately 19% of LVAD recipients within one year after implant.

Adverse Event Rates

Kirklin et al. J Heart Lung Transplant 2015;34:1495-1504

Associated Cost Trends

While it can be an essential life-saving option, a VAD comes with a large price tag. Between 2009 and 2015, the average billed charges for the implantation and first-year maintenance of a VAD were $1.05 million with each succeeding year billing up to $500,000 in post-implantation charges[3].

After a VAD procedure, a patient can plan to face extremely high post-discharge and device maintenance costs. These costs are incurred through management services for the device and equipment, typically provided by the hospital or separate vendor. Vendors tend to charge higher rates, costing a patient anywhere from $97,000 to $300,000 annually for device maintenance. Costs are also incurred through complications, follow-up medical services and pharma. A VAD patient can cost from 1.5 times (for a bridge to transplant patient) to greater than 3 times (for a destination therapy patient surviving 10 years) more than a heart transplant patient.

To address the increasing costs, PULSE + Plus™ offers access to VAD Centers of Excellence (COE) networks, which identifies best-in-class programs and contains costs for provider and durable medical equipment. An innovative solution that focuses on superior clinical outcomes, the VAD program identifies, qualifies and contracts with those that demonstrate the best clinical outcomes, providing access to quality providers for VAD implantation as well as post-surgical maintenance.

However, despite optimal contracting, the cost of VAD procedures and post-implant device maintenance can be extremely unpredictable. As the volume of procedures trends upward year after year, the importance of containing VAD costs becomes increasingly apparent. Clinical outcomes are significantly different and lengths of stay are highly variable making it a difficult exercise to predict costs. To help further mitigate unpredictable exposure, it is important to insert a rigorous claim payment integrity review to help control cost variation.

Our claim payment process focuses on the following key areas:

  • Are devices and treatment therapies provided appropriate and a covered plan benefit?
  • Does the room and board acuity match the daily nursing resources provided?
  • Assessment for adverse events or preventable event/condition that are not present when the provider initiates treatment for a patient.
  • Device failure or replacement? What are the underlying causes?
  • Are the patient monitoring/nursing services billed separately from the daily room and board?
  • Are floor stock supplies charged without adequate supporting clinical record documentation?
  • Device charges – were the items actually utilized for the patient?

The strategies for managing cost include understanding the care plan for the patient with a target for the expected length of stay while collaborating and developing ongoing communication with the providers. It is important to expect clinical challenges and barriers to discharge which will can result in higher claim costs which will require a proactive examination of the of the claim for fair and reasonable reimbursement for providers. Utilizing the PULSE + Plus™ resource options affords a custom case specific solution to yield better financial outcomes.

Contact the experts at PartnerRe online, by phone at 415-354-1551 or by email at ali.duerr@partnerre.com.


[1] https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm
[2] http://www.thoratec.com/patients-caregivers/about-heartmateII.aspx
[3] Optum; Sources: 1. Taylor, M. 2Q Cardio Update and Market Models. Barclays. Published August 12, 2016. Accessed November 9, 2016. 2. UnitedHealth Group Claims Database 2009-2015. VAD implant + 1 year N=382.

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