CHAMPION: HF Hospitalizations Down Long Term Using CardioMEMS PA-Pressure Monitor

Veronica Hackethal, MD

November 24, 2015

LONDON, UK — The drop in heart-failure hospitalizations seen at 6 months was maintained at 18 months in the randomized CHAMPION trial of management guided by remote hemodynamic monitoring using the wireless CardioMEMS implant (St Jude Medical)[1].

The single-blind trial, which had entered more than 500 patients in NYHA class 3 heart failure, is the longest follow-up to date of hemodynamic-guided remote management for heart failure, according to the CHAMPION long-term follow-up analysis published in the Lancet.

The tiny device, implanted via catheter to provide real-time pulmonary-artery-pressure readings to clinicians, is approved for patients in NYHA class 3 with a history of hospitalizations within the past year.

"In the intended population, pulmonary-artery-pressure–guided heart-failure management significantly improves clinical outcomes over a long period of follow-up and should become a standard of care in these patients," commented co–principal investigator Dr William Abraham (Ohio State University, Columbus) to heartwire from Medscape.

"It's important to note that this approach is effective regardless of ejection fraction, so patients with heart failure and a preserved ejection fraction, such as in diastolic heart failure, are also very good candidates," Abraham added.

Six-month results from the CHAMPION trial had shown a 30% reduction in heart-failure hospitalizations in patients managed with the device compared with standard therapy, whereas the current analysis of findings at 18 months points to a 39% reduction.

The randomized phase occurred from September 2007 to October 2009. Patients remained blinded to their treatment group for an average of 18 months. During this time, researchers randomized patients to CardioMEMS-guided management (n=270) or standard guideline-compliant therapy (n=280). Treatment consisted of daily pulmonary-artery-pressure monitoring using the CardioMEMS device, which could be used to guide therapy based on preset protocols.

Those who completed the randomized period (n=347) transitioned to the 13-month open-access period, ending in August 2012. During this time researchers had access to pulmonary-artery pressures for all participants.

During the randomized period, the treatment group experienced a 33% reduction in hospital admissions for heart failure (hazard ratio [HR] 0.67, 95% CI 0.55–0.80; P<0.0001) and a 23% reduction in the risk of death or first hospitalization for heart failure (HR 0.77, 95% CI 0.60–0.98; P=0.0330), compared with controls.

There were significantly more medication adjustments in the CardioMEMS-guided-management group than in the control group.

During the open-access period, the guided-therapy group experienced a 48% reduction in rate of hospitalizations for heart failure (HR 0.52, 95% CI 0.40–0.69; P<0.0001) and 47% decreased risk of death or first hospitalization for heart failure (HR 0.53, 95% CI 0.38–0.73; P<0.0001), compared with rates in the control group. The treatment group also had better quality-of-life scores than the control group.

During the first 6 months of the trial, eight (1%) device-related or system-related complications and seven (1%) procedure-related adverse events occurred. No further events occurred during the remainder of the trial, and there were no CardioMEMS sensor failures.

Writing in an accompanying editorial[2], Drs Nikolaos Dagres and Gerhard Hindricks (University of Leipzig, Germany) questioned whether similar outcomes would be possible in a routine clinical-practice setting and highlighted the trial's intensive monitoring of staff by the sponsor. In addition, they write, increased workloads associated with telemonitoring and insufficient reimbursement may contribute to underutilization.

"Overall, the results reported by Abraham and colleagues provide further strong evidence that telemonitoring can be successfully applied to manage disease in patients with heart failure," they concluded, "However, widespread and meaningful applications of these technologies will require coordinated efforts of all involved parties, as well as proper recognition of their function by the healthcare system."

The study was funded by CardioMems/St Jude Medical, from which Abraham discloses receiving consulting fees and honoraria. Disclosures for the coauthors are listed in the paper. Dagres reports personal fees from Boston Scientific. Hindricks reports grants from Boston Scientific, St Jude Medical, and Biotronik.

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