Results of a new trial suggest that an implanted device that provides continuous wireless sensing of pulmonary artery pressures can reduce hospitalizations in patients with heart failure (HF). In a report published online in the Lancet, William Abraham and members of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) Trial Study Group randomized 550 patients with NYHA class III HF to receive either the CardioMEMS heart sensor or conventional therapy.

After six months, there were 83 HF-related hospitalizations in the treatment group versus 120 in the control group — a 30% reduction. At 15 months, the reduction in HF-related hospitalizations reached 39%. There were no pressure-sensor failures and 8 patients had a complication related to the device.

The authors concluded that the “trial represents the first positive, randomized, adequately powered clinical trial of implantable hemodynamic monitoring in patients with moderately symptomatic HF. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved HF management and leads to a reduction in HF-related hospitalizations.”

In an accompanying comment, Henry Krum wrote that “the CardioMEMS device seems to be a simple but ingenious piece of bioengineering. Its simplicity lies in its smallness and ability to derive and transmit clinically useful data (continuous pulmonary artery pressures), via an implantation procedure that seems to add very little in terms of time or risk to that of standard right-heart catheterization.” Nevertheless, he questioned whether there should be “rapid uptake” of the device and said that “we are still some way off” from “widespread or routine” use of the device.

Here is the press release from the Lancet:

WIRELESS MONITORING REDUCES HOSPITALISATION FOR HEART FAILURE BY NEARLY 40% (CHAMPION study)

**Embargo 1830H New York time Wed 9 Feb**

Use of an implanted device to remotely monitor the condition of patients with heart failure* could reduce the rate of hospitalisation due to the condition by 39%.  The findings of the CHAMPION study, published Online First by The Lancet, also show a low device failure rate, suggesting that such devices can be safely used in heart failure patients and thus significantly reduce the costs of care. The Article is by Dr William T Abraham, Ohio State University, Columbus, OH, USA, and colleagues.

The implanted device works by measuring the pressures within the pulmonary arteries (those connecting the heart to the lungs). In the study, patients with moderately serious heart failure (New York Heart Association [NYHA] class III) and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. Patients were assigned to either use of the wireless device,that measured pulmonary artery pressure daily in addition to standard care (treatment group); or to standard care only (monitoring of patient-reported changes in symptoms and daily weights) in the control group.

In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (270 patients) compared with 120 in the control group (280 patients), giving a 30% reduction in hospitalisation in the treatment group. During the entire follow-up, the treatment group had a 39% reduction in heart-failure related hospitalisation compared with the control group (153 vs 253 events). Only three patients in each group had device-related or system-related complications, none of which led to serious consequences. No patients experienced pressure-sensor failures in their devices.

The authors conclude: “The CHAMPION trial represents the first positive, randomised, adequately powered clinical trial of implantable haemodynamic monitoring in patients with moderately symptomatic heart failure. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart-failure management and leads to a reduction in heart-failure-related hospitalisations.”

In a linked Comment, Dr Henry Krum, Monash University and Alfred Hospital, Melbourne, VIC, Australia, says: “Going forward, a key issue is how rapid the uptake of this new device-based approach to heart-failure management might be. A right-heart catheter might be indicated in many patients with NYHA class III heart failure for routine diagnostic work-up, assessment for transplantation, or both, but overall these patients would be in the minority. Therefore, in terms of insertion of this device becoming a widespread or routine procedure, we are still some way off. Nevertheless, the risk versus benefit profile of the CardioMEMS device, as reported in CHAMPION, suggests that strong consideration should be given to its implantation in appropriate patients, even in the absence of a standard indication for right-heart catheterisation. With increasing clinical use of these devices will come further technological advances. We are only at the beginning of this revolution in patient monitoring.”

Here is the press release from CardioMEMS:

CHAMPION Study Published in The Lancet

CardioMEMS Sensor Significantly Reduces Heart Failure Hospitalizations

ATLANTA — February 10, 2011 — The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial was published online today in The Lancet. CHAMPION demonstrated a 30% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 39% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment. The CHAMPION Trial also met all of its safety and secondary efficacy endpoints.

The CHAMPION trial was a randomized, prospective, multicenter, controlled trial that enrolled 550 patients at 64 leading heart centers in the U.S. The trial was led by Dr. William Abraham at the Ohio State University Medical Center and Dr. Philip Adamson at the Oklahoma Heart Hospital. It evaluated the safety and effectiveness of CardioMEMS’ heart failure pressure measurement system in New York Heart Association Class III (NYHA Class III) heart failure patients. NYHA Class III patients represent approximately 30% of the over six million heart failure patients in the U.S. and account for nearly half of all heart failure hospitalizations.

All subjects in the CHAMPION trial had the CardioMEMS heart failure sensor permanently implanted in the pulmonary artery using a simple, catheter-based technique. All patients took daily pulmonary artery pressure readings from home that were transmitted to CardioMEMS’ secure patient database. For patients in the treatment group only, healthcare providers were provided access to the pressure readings which were used in the treatment of their heart failure condition. For control group patients, health care providers were denied access to the pressure readings and they continued to receive standard care.

“The results from the CHAMPION study are very significant and provide a valuable new tool in the battle against heart failure. Pulmonary artery pressure monitoring is the first major device breakthrough in heart failure since CRT therapy,” said William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.

Dr. Adamson, director of the Heart Failure Institute at the Oklahoma Heart Hospital, added, “The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life. These results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The ‘Hemodynamic Era’ is a major advancement with promise for profound long-term impact on heart failure morbidity.”

“Hospitalizations are very traumatic for heart failure patients and costly to the health care system,” said Jay Yadav, M.D., founder and CEO of CardioMEMS and a cardiologist at the Piedmont Heart Institute. “With the CardioMEMS heart failure monitoring system, frequent hemodynamic monitoring can allow doctors and nurses to more efficiently manage their patients and produce meaningful reductions in their patients’ heart failure related hospitalizations.”

In September of 2010, St. Jude Medical (NYSE: STJ) invested $60 million in CardioMEMS in exchange for a 19% equity ownership interest and an exclusive option to acquire the remaining 81% of CardioMEMS for an additional $375 million during a period that extends through the completion of certain commercialization milestones.

Caution: Investigational device limited by federal law to investigational use.

About CardioMEMS, Inc.

CardioMEMS is a medical device company that has developed and is commercializing proprietary wireless sensing and communication technology for the human body. Its technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. CardioMEMS miniature wireless sensors can be implanted using minimally invasive techniques and transmit cardiac output, blood pressure and heart rate data, which are critical to the management of patients. The sensors can be permanently implanted into the heart and blood vessels due to their small size, durability and lack of wires and batteries. Using radiofrequency (RF) energy, the sensors transmit real-time data to external electronic readers, which then communicate this information to the patient’s physician. Previous lead investors in CardioMEMS include Arcapita Ventures, Boston Millennia Partners and Foundation Medical Partners. More information about CardioMEMS is located at www.cardiomems.com.

CardioMEMS and the CardioMEMS logo are registered trademarks of CardioMEMS, Inc.

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