MedAxiom: When are LVADs the answer?
Douglas-Cooke, director of cardiac surgical services and advanced HF at Sentara Heart Hospital in Norfolk, Va., referenced a Canadian study with “startling results” that looked at mortality following a first HF hospitalization. The study showed 30-day mortality to be 8.6 percent for males and 6.8 percent for females. After five years, mortality rates jumped to 52 percent for males and 47 percent for females.
Additionally, Douglas-Cooke referenced a study that showed transplant survival to be 85 percent at five years; however, she asked whether this is the answer for every advanced HF patient.
“Of the 300 million folks out there, 2.5 percent have heart failure,” she said. “That takes you down to about 7.5 million and of that number, 50 to 55 percent have systolic heart failure, which takes you down to 3.5 million.” Now that patients are living longer, more patients with HF will be eligible for transplant and LVADs. But while there are more than 4,000 patients in the transplant registry, the maximum number that will receive transplants this year is 2,100.
“Many will argue that we need to do a better job using long-term mechanical circulatory support," Douglas-Cooke added.
According to Douglas-Cooke, in advanced HF:
- There is unequal HF distribution;
- Medicines do not work for advanced HF;
- Chronic inotropic therapy carries a high mortality;
- There are not enough donor hearts for transplant;
- The supply of donor hearts is not likely to increase;
- Stem cells are not ready for prime time.
“In 2012, mechanical circulatory support is the most viable option for these patients,” she added.
She called HeartMate II technology a “gamechanger,” saying that device updates have allowed data to be extrapolated. It also is equipped with patient alarms. Additionally, results from the 2012 INTERMACS (Interagency Registry Mechanically Assisted Circulatory Support) study showed that continuous flow device survival at three months was drastically improved when compared with pulsitile flow devices, 91 percent vs. 79 percent, respectively.
“The technology offers great advantages and survivability to these advanced heart failure patients,” she said. Additionally, this technology offers much greater benefits when compared with medical management. In fact, a 2010 study by Park et al showed that in the REMATCH trial 67 percent of patients who received LVADs were alive at 12 to 24 months compared with 24 percent of those being medically managed.
Douglas-Cooke also referenced the use of the INTERMACS system mandated by the Centers for Medicare & Medicaid Services (CMS) to help provide quarterly reports to hospitals. Now hospitals document information at various time periods and mine data on mortality, readmissions and explants.
“We have to pay attention to the INTERMACS score and Seattle Heart Failure model,” she added. “Physicians have a responsibility to refer a patient at the earliest possible time, rather than waiting for cardiogenic shock to occur.”
Physicans may utilize these tools to evaluate when a candidate should be referred and whether LVADs are the best option, she added.
“What we have clearly seen over the last two to three years is that LVAD devices have improved outcomes and improved quality of life,” she said. “It will remain critical for us to refer patients earlier than what we are doing today nationwide. Here we can improve survival, decrease costs and most importantly improve the quality of their lives.”
Lastly, Douglas-Cooke said that the number of multiple hospital readmissions for medically managed patients outweighs the costs of implanting LVAD devices. Thus, this data may squash the argument that the device exceeds the cost-effective threshold.