For Some, Hopes for a Heart Grow Dim as LVAD-Only Centers Spread

When it comes to receiving a new heart, some patients with advanced heart failure may be put at a disadvantage by recent policy changes from the US Centers for Medicare & Medicaid Services (CMS), according to a range of experts watching this space with trepidation.

In 2020, CMS revised their national coverage determination (NCD) for durable, intracorporeal left ventricular assist devices (LVADs) by removing the current therapeutic intent-to-treat criteria of bridge-to-transplant and destination therapy. As part of the change, patients with advanced heart failure being considered for an LVAD no longer have to be reviewed by physicians at a Medicare-approved heart transplant center. Additionally, the NCD no longer required patients to be placed on the active transplant waiting list maintained by the Organ Procurement and Transplantation Network (OPTN).

But that policy change may actually have the unintended consequence of widening inequities that already exist in access to cardiovascular transplantation.

Late last year, Thomas Cascino, MD, MSc (University of Michigan Medical School, Ann Arbor), and colleagues delved into the Society of Thoracic Surgeons (STS) Intermacs registry to see who was receiving LVADs, and where.

Their analysis showed that patients treated at a hospital with both LVAD-implanting and heart-transplantation capabilities were more likely to get a subsequent heart transplantation, whereas for those treated at LVAD-only hospitals, their device, rather than being a bridge to transplant or a bridge to decision, proved more likely to be a bridge to nowhere.

“The general driver of the policy was that there was emerging evidence that patients receiving LVADs as bridge-to-transplant or destination therapy did well and there might not be the need to maintain that affiliation [with transplant centers],” senior investigator Donald S. Likosky, PhD (University of Michigan Medical School), told TCTMD. “By removing it, on the one hand, you can imagine it makes it more equitable to receive care at a center that doesn’t offer transplant, but alternatively, you can imagine that it makes it more challenging given that transplant is the gold-standard treatment for patients with advanced heart failure.”

Need for Collaboration, Say Experts

While their analysis was purely observational, Likosky said it does raise important issues, including the clinical question of how to best standardize the evaluation of advanced heart failure across centers. “I think it’s really important to consider that initial evaluation for LVAD and whether or not there may be a need for a transplant in the future,” said Likosky.

Joseph G. Rogers, MD (Texas Heart Institute, Houston), an expert in heart failure, heart transplantation, and mechanically assisted circulation, was also cautious interpreting the new findings, pointing out that it can be difficult to extract explanations for findings in large data sets. “Still, I think there’s a signal in there,” Rogers told TCTMD. “What I take away from it is that we need to take a harder look at [the policy]—we need to be sure that we’re providing equitable access to all available patients.”

Mary N. Walsh, MD (Ascension St. Vincent Heart Center, Indianapolis, IN), medical director of the heart failure and cardiac transplantation program at her center, agreed, adding that she would like to see all LVAD candidates reviewed by transplantation specialists.

We need to be sure that we’re providing equitable access to all available patients. Joseph Rogers

“What’s very, very important is that patients being seen at a VAD-only center be given information about cardiac transplantation and be evaluated for transplant at a transplant center,” she told TCTMD. “If a patient goes to an LVAD-only center, they may say the patient isn’t a transplant candidate, but I would argue that’s not true because if you’re not doing evaluations of patients every day for transplant, the nuances of what makes a patient a candidate or not may elude you. In the past, a transplant center had to be partnered with an LVAD-only center to make sure that didn’t happen.”

Rogers pointed out that LVAD-only centers have a high level of expertise, with a range of surgical heart failure specialists and cardiologists, as well as teams capable of supporting patients, such as social workers and psychologists. Patients go through a rigorous process before LVAD implantation, a process not dissimilar to the evaluation of patients for heart transplantation.

“But I think there is a subtle nuance in that,” said Rogers in reference to the patient workup. “The transplant indications continue to evolve and there are centers transplanting patients who have characteristics that overlap with [destination-therapy] VAD. So, I think that in an ideal ‘patient-centered’ world we would continue to have a very collaborative relationship between LVAD-only centers and transplant centers so that we’re at least being able to have a conversation about what their options are for therapy.”

Change in UNOS Allocation of Hearts

In 2018, the OPTN/United Network for Organ Sharing (UNOS) also made changes to the way hearts were allocated in order to prioritize patients at the highest risk for death. UNOS created six “urgency status” tiers, pushing those with a stable LVAD further down the list (status 4, with status 1 being the most urgent). Only if complications arise with the LVAD or there is evidence of clinical deterioration are such patients given higher urgency status for a new heart.

“With the change in UNOS policy in 2018, patients with durable LVADs are to some extent disadvantaged in the listing criteria,” said Walsh. Today, many transplant centers are now using a strategy of nondurable LVADs to support patients to transplant, she added.

Survival rates with durable LVADs have increased over time and are generally considered excellent, said Walsh, but patients prefer heart transplantation to device therapy. She added that some patients who receive an LVAD—and are then considered less-urgent candidates for heart transplantation—can feel “stuck” with the device. “There are risks and benefits—patients can die after transplant from an infection or [organ] rejection—but overall quality of life long term is generally better with transplant,” she said.

To date, the two therapies—LVAD destination therapy and heart transplantation—have not been compared in a head-to-head clinical trial. Like Walsh, Rogers said there has been a progressive improvement in short-to-intermediate-term outcomes with the device.

If you’re not doing evaluations of patients every day for transplant, the nuances of what makes a patient a candidate or not may elude you. Mary Walsh

“At least in the short term, the outcomes are getting close to those of transplantation in terms of mortality,” he said. “If you look at the data today from Intermacs, the 5-year survival rate is around 50%, which is inferior to transplantation. So, it’s not clear if we look at longer time points, but my guess is that we would still see that transplantation offers a better survival rate than [destination-therapy] VAD.”

Rogers said there have been a number of changes in practice patterns based on the 2018 UNOS policy, noting, like Walsh, that there has been a shift toward more temporary support to bridge patients to transplantation. “It’s requiring all of us to be introspective about how we used VADs in the past and how we should be using them going forward. It’s an area of intense discussion and debate in the heart failure community.” 

Like the others, Michelle Kittleson, MD, PhD (Cedars-Sinai Medical Center, Los Angeles, CA), said she believes there have been unintended consequences resulting from the new CMS policy and UNOS allocation change that deprioritizes stable patients with LVAD support. And also like the others, she said “there is a need to ensure most patients without an obvious contraindication to transplant are evaluated at transplant centers ideally before durable LVAD and definitely following LVAD implant once ambulatory to assess transplant eligibility.”

Different Transplant Rates Between Centers

Speaking with TCTMD, Likosky said the University of Michigan has a multidisciplinary team of heart failure clinicians and surgeons, as well as economists, health policy experts, health services’ researchers, and statisticians, who study current and new policies intended to facilitate access to advanced heart failure treatments. In this study, which was published in November 2022 in JAMA Network Open, the group was interested in examining whether the 2020 policy determination from CMS had a differential impact on cardiac transplantation.     

The retrospective cohort study included 22,221 patients (mean age 59.0 years; 78.4% male) in the STS Intermacs registry who received a durable continuous-flow LVAD between 2012 and 2020. Of these, 14.2% were treated at hospitals that only implanted LVADs while the remainder were treated at centers with both LVAD and transplantation capabilities.

The LVAD-only centers had fewer hospital beds, were more likely to be in smaller cities, and were less likely to be affiliated with a medical school. The number of LVAD-only centers increased over time, as did the number of procedures performed at these hospitals. There was also an increase in the number of LVAD/transplant hospitals, although the rise was smaller, and there was no change in the number of LVADs implanted over time at transplant-capable hospitals.

I think it’s really important to consider that initial evaluation for LVAD and whether or not there may be a need for a transplant in the future. Donald Likosky

At centers with both LVAD and transplant capabilities, 37.7% of patients receiving an LVAD were treated with an intent to bridge to later transplant compared with just 16.9% of patients treated at LVAD-only centers. Overall, those treated at LVAD/transplant hospitals had a significantly higher odds of being considered for transplant (bridging strategy) compared with those treated at LVAD-only centers (OR 1.79; 95% CI 1.35-2.38).

Two years after LVAD transplantation, 25.6% of those treated at LVAD/transplant centers went on to receive a new heart compared with 11.9% of those treated at LVAD-only centers. In a multivariable, cause-specific hazard model, those who received their LVAD at a center with both LVAD and transplantation capabilities were 33% more likely to go on to transplantation compared with those treated at LVAD-only hospitals. In the model, mortality rates while receiving LVAD support were similar at the two types of hospitals at 2 years.

Expanding Cardiovascular Service Lines

Kittleson said the finding that patients undergoing LVAD implantation at a transplant center are more likely to later undergo cardiac transplantation isn’t necessarily surprising, “but it is concerning.”

One of the key questions to answer is whether the association is causal or coincidental. For example, is there something different, possibly related to comorbidities, about patients receiving LVADs at nontransplant sites? Patients treated at the LVAD-only centers were older (63.5 versus 59.0 years; P < 0.001) and were more likely to have transplant-limiting comorbidities (77.2% vs 57.8%; P < 0.001), but the association remained when the analysis was restricted to those younger than 70 years and after using propensity-score matching, said Kittleson.

“Based on these analyses, therefore, it appears that there is a potentially causal relationship between receiving an LVAD at an LVAD-only center and being transplanted,” she said.  

Prior to the CMS revision in 2020, physicians were required to indicate whether the LVAD was intended as a bridge to transplantation or destination therapy. That distinction, however, was somewhat artificial, said Walsh, noting that physicians usually referred to modifiable or nonmodifiable contraindications to transplant.

Modifiable contraindications might include smoking or body mass index while nonmodifiable may include a history of cancer. Walsh said that many patients may not be currently eligible for transplantation but have modifiable contraindications, and in those circumstances the LVAD isn’t destination therapy so much as a “bridge to decision.” The purpose of that designation was to treat the critically ill patient and then later review if they were an eligible candidate for heart transplantation.

Walsh said the CMS policy change emerged for the right reasons—to allow more people access to this lifesaving therapy—but questioned why LVAD-only centers continue to proliferate.

“It’s business,” she said. “People want to expand their cardiovascular service line, and it seems like a great idea, but unless they’re partnered closely with a transplant center, which often is in the same town, the patient isn’t really getting a good look at what their options are.”

Ultimately, she said she believes that CMS put patients at a disadvantage when it no longer required the LVAD-implanting site to receive written permission from the Medicare-approved transplant center. In some circumstances, contraindication to transplant is quite clear, and only a review of the patient’s records is necessary, she said. “If you focus this on the patient, they should really have the opportunity for receiving an evaluation for a primary heart transplant,” said Walsh.