St. Jude's CardioMEMS Showing Results In HF

Results from the CHAMPION study give St. Jude hope that its CardioMEMS system will stem the tide of heart failure.

New long-term data on St. Jude Medical Inc.’s CardioMEMS HF System, taken from prospective findings coming out of the CHAMPION study, show that after 31 months of follow-up, CardioMEMS HF-managed patients had a 48% reduction in heart failure hospitalizations compared with patients managed with the standard of care, ie based on outward signs of worsening HF.

The results, published in online in The Lancet in early November, demonstrate the effectiveness of monitoring pulmonary artery pressure for reducing hospitalizations among heart failure patients, says St. Jude. The CardioMEMS system uses a miniature wireless monitoring sensor implanted in the PA to directly measure blood pressure and heart rate data. Patients transmit this data from home to their health care providers, who are thus able to manage the patient’s medications more effectively.

Speaking to IN VIVO, Philip B. Adamson, MD, St. Jude’s medical director and vice-president of medical affairs, said the results of the long-term study not only further support the real-world applicability of CardioMEMS in reducing HF hospitalizations, but they also demonstrate the long-term benefit of hemodynamic monitoring in reducing HF in high-risk (New York Heart Association Class III) patients.

“We’re very pleased with the results, because they increase our understanding of HF and the unique importance of understanding the syndrome from a hemodynamic perspective,” said Adamson. The CardioMEMS HF System is the first and only FDA-approved (in May 2014) HF monitor that, when used by physicians to monitor their HF patients, has been shown to significantly reduce HF hospital admissions and improve the quality of life in NYHA Class III patients. TheLancet’s article reports results from the second part of the CHAMPION trial (the first part was in 2011) and represented the “open access” element of the trial. The first part of the study demonstrated a statistically and clinically significant 28% reduction in the rate of HF hospitalizations at six months, and a 37% reduction during an average follow-up duration of 15 months.

As to the latest results, Adamson said, “We found that compliance with uploads (of data) by patients was very high, and over nearly three years the data demonstrate a continued reduction the rate of HF hospitalizations.” This underlines the robustness of the intervention, he added.

CardioMEMS is already being used in more than 200 US hospitals, and uptake has exceeded the company’s expectations. The value the current data has is that it broadens the discussion St. Jude can have with reimbursers. “We can see that the second part of the trial has been very helpful to payers,” said Adamson, adding, “In the US we have the US-centric excessive 30-day readmission penalty pressure – and in the CHAMPION Trial hemodynamic monitoring reduced those readmissions by 50% as well.”

Effectiveness Stable Over Time

“The company is very excited by the results and that there has been no evidence of loss of effectiveness over time.” The question now is how long the effect can last. St. Jude is now looking into the trial data, and at how medications were used, how pressures changed and at expanding the subgroup to elderly patients. “We have lots of sub-studies, and are now also looking at mortality in the long-term – although that was not a study endpoint.”

In early October 2015, St. Jude completed the $3.3 billion acquisition of Thoratec Corp., which has brought the HeartMate II VAD, and next-generation HeartMate III and HeartMate PHP devices into the portfolio. These complementary solutions will give St. Jude a more comprehensive HF portfolio and open up further possibilities for widening the application of CardioMEMS.

German Trial Slated for 2016

Next up for St. Jude is the continuation of its post-approval CardioMEMS study for the FDA – with 1,200 patients being followed for two years. The study will also look at outcomes and will be “quite an important contribution to the literature,” according to Adamson.

Elsewhere, while there is “still a lot to find out from the CHAMPION trial,” St. Jude is planning to run other US trials, and some European trials. There have been local site studies of implants done in physician-initiated studies in Italy, Germany and the UK. But a prospective trial is now planned for Germany in early 2016.

The number of US centers will also increase. “We will have more, but we’ve been very careful to ensure these sensors are integrated in a controlled way,” said Adamson. St. Jude wants to be sure that clinicians can implant the device in centers that have an infrastructure to monitor pressures long-term – the system, besides the sensor, consists of the integrated patient system, the website and the cellphone. CardioMEMS has no batteries or leads.

The equipment all combines to support for the life of HF patients, and represents a much-needed new approach to tackling a serious problem. Over the last 20 years, HF has risen by 300% in US hospitals. “It’s a growing population, but we are stemming the tide of HF,” Adamson asserted.

Spending To Save In The Long Term

Long-term outcomes are improving, but it’s hard to say what effect the technology will have on reining in the looming $31 billion cost of US heart failure. The device costs will be offset by a reduction of hospitalizations over time. 80% of hospital costs on HF are spent on the late stages of inpatient care. “It’s an economic modeling exercise, and you spend to save in the long term. CardioMEMS is a one-off cost issue upfront, and we support the device for the rest of the patient’s life,” Adamson said.

CardioMEMS is not for all HF patients, but St. Jude says it is excited by the uptake. And armed with robust data, the company is now moving into high-risk patients, intent on further extending the beneficial effects on HF treatment costs and improving patient outcomes.