LVADs Can Benefit Many More Patients with Advanced Heart Failure

Left ventricular assist devices (LVADs) need not — and should not — be a therapy of last resort. If there’s one thing about mechanical circulatory support device therapy—of which LVADs represent the vast majority — that goes underappreciated among cardiovascular specialists, that’s it. So say Randall C. Starling, MD, MPH, and Nader Moazami, MD, the medical and surgical directors (respectively) of Cleveland Clinic’s Cardiac Transplantation and Ventricular Assist Device Therapy Program.

“I think there may be a misperception that we have nothing to offer patients with advanced heart failure other than transplantation,” says Dr. Starling. “In fact, there are many such patients not listed for transplant in whom LVAD therapy is currently extending life and substantially improving quality of life.”

Help needed to close the transplant shortfall

He is referring to the use of LVADs as destination therapy, in contrast to their use as a bridge to transplantation, in which LVAD implantation is deemed necessary to provide stability to a patient on the national heart transplant waiting list until a donor heart can be obtained.

Use of LVADs for destination therapy—i.e., without plans for subsequent heart transplant—has increased in recent years, particularly as donor heart shortages have caused national heart transplant volumes to plateau around 2,200 annually. Yet that growth, which has brought the count of U.S. patients living with LVADs to 10,000 to 12,000, has barely made a dent in the population of 100,000 to 250,000 or more U.S. adults with advanced heart failure who stand to benefit from LVAD therapy.

Lifestyle decision vs. last resort

A major reason for that gap, says Dr. Moazami, is that cardiologists are generally not referring patients with advanced heart failure for evaluation for LVAD destination therapy. “Many patients in end-stage heart failure are referred to us for heart transplant evaluation,” he explains. “What we don’t get are patients referred for evaluation for LVAD destination therapy.

We’d really like to see these patients earlier, to discuss their options more fully and perhaps explore LVAD therapy outside the context of transplantation, if that makes sense for them.”

Because those earlier referrals don’t take place, an LVAD is too often considered only when heart failure is much more severe, perhaps after it lands the patient in the ICU. When heart transplant is contraindicated in such patients, they typically view an LVAD as their only alternative to death.

“Instead of this scenario, implantation of an LVAD as destination therapy should be a highly elective procedure,” says Dr. Moazami. “When we can see patients in the outpatient setting and have time to evaluate them and discuss LVAD therapy with them, it becomes more of a lifestyle decision, and patients can really absorb what the therapy will mean for them.”

Extending life for almost all patients

Increasingly, what LVAD therapy means for patients is extended life and dramatically improved quality of life. Cleveland Clinic has seen its LVAD patients’ survival rates rise steadily in recent years (see table below) as its experience in implantation has deepened and as improved continuous-flow LVADs have displaced older pulsatile-flow device models.

And whereas the table includes all LVAD recipients—including bridge-to-transplant patients and destination therapy patients who receive LVADs as essentially a last resort—survival rates are considerably higher for patients who undergo LVAD destination therapy on a more elective basis. “Among those patients, our survival rates are close to 100 percent at one month and three months after LVAD placement,” Dr. Moazami notes.

To date, most experience with chronic LVAD therapy is in patients living with the devices for one to three years, though a small but growing population of patients have lived with LVAD support for five years or more. “Mechanical failure of LVAD pumps is very rare,” says Dr. Moazami. “Theoretically, these devices should be good to last for at least 10 to 15 years.”

Quality of life may be biggest differentiator

Even more noteworthy is the devices’ effects on patient quality of life. “We have nothing medically that compares with an LVAD as far as ability to improve the quality as well as quantity of life,” notes Dr. Starling. He cites the six-minute walk test as a prime example. “Multiple studies have shown the average improvement in the six-minute walk test with LVAD therapy is about 150 meters, far greater than the average improvement of approximately 36 meters with well-established interventions like cardiac resynchronization therapy,” he says.

“When I evaluate patients for LVAD therapy,” adds Dr. Moazami, “I generally say the LVAD is likely to restore them to how they felt and functioned four or five years earlier. Patients tend to be highly satisfied with the strength and activity level they regain”.

Meticulous evaluation and education are musts

That said, LVADs are not for everyone. Patients need to clearly understand what living with an LVAD involves and must have a support system to help them make the most of the device postoperatively. To that end, Cleveland Clinic’s LVAD team meticulously evaluates potential LVAD recipients and spends copious time educating them about LVAD surgery and what they can expect when living with the device.

Patients meet with a full complement of providers — cardiac surgeon, cardiologist, social worker, dedicated VAD nurses and specialized nurse practitioners — as well as a fellow patient now living with an LVAD. “We educate patients at all these levels because each of us provides a different perspective on the LVAD experience,” explains Dr. Moazami.

So what should trigger referral for LVAD evaluation?

To ensure that more patients who would benefit from LVADs actually get the devices, Dr. Starling advises cardiologists to consider referring advanced heart failure patients for possible LVAD evaluation if they meet the following conditions:

• Hospitalized for heart failure once or twice in prior 12 months
• Becoming winded and needing to stop after walking one block or climbing one flight of stairs

He adds that repeated use of inotropic therapy or being discharged on inotropic therapy also signals that a patient with advanced heart failure may be ready for evaluation for LVAD placement. “Additionally, an inability to tolerate ACE inhibitors and beta blockers due to low blood pressure and/or worsening kidney function is another marker that a patient could perhaps benefit from an LVAD,” Dr. Starling notes.

“Not all these patients will be candidates, but they all deserve a chance to learn what can be offered to them,” adds Dr. Moazami. “These are the patients who are not being referred to LVAD programs now.”