CardioMEMS PA-Pressure-Guided Heart Failure Therapy Safe, Reduces Events in Postapproval Study

Marlene Busko

March 27, 2019

NEW ORLEANS — Patients with heart failure (HF) who were implanted with the CardioMEMS (Abbott) pulmonary artery (PA) pressure sensor showed a reduction in hospitalizations after 1 year in the CardioMEMS HF System Post Approval Study (CardioMEMS-HF PAS).

The study's 1200 participants were all in NYHA class 3 at baseline and had been hospitalized for HF at least once in the previous year. Serving as their own control group, they were 58% less likely (P < .0001) to be hospitalized for HF, the primary efficacy outcome, the year after they received the PA-pressure sensor than in the previous year.

The benefit was similar across a range of prespecified subgroups, including patients with reduced, midrange, or preserved ejection fraction (EF), men and women, and black and white patients, observed David M. Shavelle, MD, University of Southern California, Los Angeles, at a press briefing after his presentation of the study here at the American College of Cardiology 68th Annual Scientific Session (ACC.19).

The device is "extremely safe. There were only four device- or system-related safety events among the 1200 patients, and there was only one episode of sensor failure," Shavelle told theheart.org | Medscape Cardiology.

The study adds to the body of evidence suggesting that the device can help reduce hospitalizations, assuming there is good adherence to sending PA-pressure readings to clinicians and that they take effective action, said Anita Deswal, MD, MBBS, Baylor College of Medicine, Houston, a panelist at the late-breaking trial session during which Shavelle presented the study.

"This builds a dataset that's increasing our comfort level and our utility of a very novel strategy," agreed panelist Clyde W. Yancy, MD, Northwestern University, Chicago.

CHAMPION-like Patients

As previously reported, the CHAMPION trial, published in 2011, randomly assigned 550 patients in class 3 HF who were implanted with the CardioMEMS sensor to standard medical care with or without PA-pressure-guided therapy. It revealed significantly lower rates of HF hospitalization in the latter group.

The US Food and Drug Administration approved CardioMEMS in 2014 — largely on the basis of that trial — with the stipulation that the current postapproval study be conducted.

It enrolled 1200 patients, much like those in CHAMPION, who were successfully implanted with the device at 104 centers in the United States from September 2014 through March 2018.

They were instructed to transmit their PA pressures daily, which they did by lying on a special pillow with an embedded antenna that wirelessly captured signals from the sensor, which was located beside an electronic console.

The console relayed PA pressures to a secure website where clinicians could access them and, if they indicated volume retention, make changes to the patient's medications.

The predominantly white patients had a mean age of 69 years and 38% were women. Ejection fractions were reduced (<40%) in 53% of the cohort, midrange (41%–50%) in 17%, and preserved (>50%) in 38%.

Half the patients had already received an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device with or without a defibrillator (CRT or CRT-D).

The rate of hospitalization for HF fell from 1.24 per patient per year in the year before implantation to 0.52 in the year after implantation of the device (hazard ratio [HR], 0.42; 95% CI, 0.38 - 0.47; < .0001).

Similarly, the number of HF hospitalizations or deaths per patient per year declined from 1.24 to 0.69 (HR, 0.56; 95% CI, 0.51 - 0.62; < .0001). The corresponding HR for hospitalization from any cause was 0.72 (95% CI, 0.67 - 0.77; P < .0001).

Freedom from device- or system-related complications at 1 year was 99.7%, and freedom from sensor failure was 99.9%, which was "significantly higher than the prespecified objective performance criteria" of 80% and 90%, respectively, Shavelle noted.

"As far as we know, in 12-plus years in the US, the device doesn't wear out," he said. "There's no battery, so it's dissimilar to a pacemaker or ICD."

Who Are the Optimal Candidates?

"Are there any cautions we need to think about" when selecting class 3 HF patients who might benefit from the device, Deswal asked. She then speculated that the ideal candidate might be those who are "not too sick, not too healthy," who will transmit pressure readings and follow other directions, and are managed at a center that is set up for effective, ongoing monitoring and treatment changes.

Shavelle agreed, and elaborated to theheart.org | Medscape Cardiology that the device is most appropriate "for the patients who are on optimal therapy, patients who are having an issue with volume overload, because the device will tell you when to up- and downtitrate diuretics."

It is also for "patients who are comfortable with interaction with their providers," he added. "So you call a patient and say: 'It's Dr Shavelle calling. I want you to increase your diuretic.' If they say, 'Who's Dr Shavelle?' that's not the right patient. You have to have a relationship with the patient."

In his presentation, Shavelle noted that in the year prior to CardioMEMS implantation, 70% of the patients had one hospital admission for HF; 28% had two to four admissions; and 2% had at least five admissions. Patients in all three groups benefited, he said.

Of the cohort, 105 patients died in the first 6 months and another 86 died in the subsequent 6 months; most of them were in the group with the most frequent admissions, Shavelle said.

"Weekly Is Not Enough"

Yancy pointed out that 76% of the patients transmitted their PA pressure readings every day, and 90% did it at least weekly, which calls for "a fairly intense amount of oversight and data aggregation."

Was daily transmission necessary? he wondered, "because it has direct implications on the infrastructure and resource burden."

The current study was not designed to capture this information, Shavelle replied. But about 120 patients are being followed at his center, and "we like patients to transmit daily, knowing that they're probably going to transmit several times a week. I personally think, for an unstable patient, weekly is not enough."

The Abbott-sponsored Hemodynamic-Guided Management of Heart Failure (GUIDE HF) trial, which started to enroll an estimated 3600 patients last year, is expected to be completed in 2023.

Unlike CHAMPION or the postapproval study, GUIDE-HF is including patients from NYHA class 2 to 4, and not only "patients who were admitted to the hospital, but also patients who were not admitted to the hospital but who have a risk for heart failure hospitalization," Shavelle said.

CardioMEMS-HF PAS was funded by Abbott. Shavelle discloses receiving consulting fees from Abbott and research support from Abbott, Abiomed, the National Institutes of Health, v-wave Medical, and BioCardia. Deswal had no disclosures. Yancy discloses an unspecified relationship with Abbott Laboratories.

American College of Cardiology (ACC) 68th Annual Scientific Session: Abstract 405-16. Presented March 17, 2019.

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