A Medical Device Daily

New research shows that cardiac resynchronization therapy (CRT) devices equipped with Medtronic's (Minneapolis) OptiVol Fluid Status Monitoring identified patients who were at a significantly higher risk (3.5 times) of having a heart failure event in the near future. It also showed that CRT reduced the time to first heart failure hospitalization or death by nearly half in patients with mild heart failure.

The study results were presented at this week's Heart Failure Society of America (HFSA) annual scientific meeting in Toronto

The findings from the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) and PARTNERS HF (Multi-site Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients with Heart Failure) trials, both sponsored by Medtronic, were presented as late-breaking clinical trials, and, according to the company, "demonstrate the value of CRT and device diagnostics in managing heart failure patients and their hospitalizations."

European patient data shows that CRT, in combination with optimal medical therapy (OMT), significantly reduced the risk of heart failure hospitalizations or death in the first 18 months over OMT alone in patients with asymptomatic or mild heart failure. Currently, CRT is indicated for patients with moderate or severe heart failure. Optimal medical therapy is considered to be beta blockers and ACE inhibitors or aldosterone-receptor blockers.

At 18 months, 15.7% of study patients without CRT were hospitalized for heart failure or died vs. 7.5% of heart failure patients studied with CRT, a reduction of about 50% reduction. CRT also is shown to help improve the heart's pumping efficiency and reduce its size.

Presented by William Abraham, MD, chief of cardiovascular medicine at Ohio State University (Columbus), the 610-patient REVERSE study is the first large-scale, global, randomized, double-blind trial to demonstrate the benefits of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms.

"Even in patients who generally have mild or no symptoms of heart failure, CRT can have a positive impact and delay the time to first heart failure hospitalization or death," said Abraham. "Preventing the progression of heart failure with device therapy can lead to better patient outcomes and reduce economic burden to the hospital and healthcare system."

Twelve-month REVERSE data previously has been presented at a number of scientific congresses in Europe and the U.S. These latest results represent findings at 18-months for the European blinded cohort, which will be followed for 24 months.

Despite the trial not meeting statistical significance for its primary endpoint (percentage of patients worsened at 12 months using a heart failure Clinical Composite Score, which includes subjective and objective measures of heart failure status), more patients in the trial improved with CRT, and this trend continues at 18 months.

Medtronic said PARTNERS HF data demonstrated that monitoring fluid trends in the chest cavity using OptiVol identified patients more likely to have subsequent heart failure events, such as shortness of breath, fatigue, tissue swelling due to fluid build up, and decompensation or deterioration of the heart.

Patients with a fluid index crossing above a threshold of 100 ohm days during the 21 days prior to their six-month visit were two times more likely to have a heart failure event in the following six months independent of other clinical variables. Another analysis that simulated more frequent monitoring demonstrated patients with a fluid index crossing were about 3.5 times more likely to have subsequent heart failure events independent of other clinical variables.

"These findings demonstrate that continuous device monitoring of heart failure patients in addition to periodic office visits can identify patients at increased risk for future heart failure events," said David Whellan, MD, associate professor of medicine at Thomas Jefferson University Hospital (Philadelphia). "Ongoing fluid monitoring can help me better manage my heart failure patients and intervene earlier before symptoms worsen."

Whellan presented the initial findings from this 12-month prospective, multi-center, observational, unblinded study, which includes 707 CRT with defibrillation (CRT-D) patients.

OptiVol Fluid Status Monitoring is found only on Medtronic cardiac resynchronisation therapy-defibrillators and implantable cardioverter-defibrillators. It uses low electrical pulses that travel across the thoracic cavity to measure the level of resistance, indicating fluid in the chest – a common sign of heart failure.

Also at HFSA:

• CVRx's (Minneapolis) Rheos System significantly improved heart structure and function in treating early-stage heart failure patients, according to data presented in a poster session. John Bisognano, MD, PhD, associate professor of medicine at the University of Rochester School of Medicine and Dentistry (Rochester, New York), presented the study data.

The company noted that in heart failure patients, the heart becomes enlarged and functions inefficiently, increasing the risk of death and poor quality of life. Reducing heart size lowers these risks, CVRx said.

The Rheos System uses the company's Baroreflex Activation Therapy technology, which is designed to activate the carotid baroreceptors, central components of the body's natural cardiovascular regulation system. When the baroreceptors are activated, signals are sent through neural pathways to the brain and interpreted as a rise in blood pressure.

The brain works to counteract this perceived rise in blood pressure by sending signals to other parts of the body — heart, blood vessels and kidneys — that relax the blood vessels and inhibit the production of stress-related hormones. These changes enable the heart to increase blood output, while maintaining or reducing its workload, thereby reducing blood pressure when it is elevated and alleviating the symptoms of heart failure.

Clinical data presented as a poster at HFSA showed that continuous use of Rheos therapy in early-stage heart failure patients remodels cardiac structure and improves heart function. The Rheos System was implanted in 18 patients at five medical centers in Europe and the U.S.

The patients had early-stage heart failure and high blood pressure, and were on optimal medication levels. After one year of Rheos therapy, left ventricular mass and left atrial dimension were reduced toward normal levels. In addition, blood pressure was lowered.

"We believe the Rheos System can have significant therapeutic value in heart failure patients," said Bisognano. "The current clinical trial evaluating the Rheos System will help us further understand how Rheos therapy addresses heart failure."

The first study evaluating Rheos therapy in diastolic heart failure patients has begun in Europe.

"With one year of Rheos therapy, the improvements in cardiac structure and function were significant in heart failure patients, and have not been seen with aggressive medical therapy currently available," said CVRx President/CEO Nadim Yared. "We are excited about the possible clinical benefits of Rheos therapy as a new approach to treating heart failure patients."

He added, "With our recent financing, we have the resources to launch clinical research initiatives for the use of Rheos therapy in heart failure patients. Heart failure represents a large unmet clinical need and a significant market opportunity for our company."

* New analysis from the largest outpatient study of heart failure patients in the U.S. shows they are receiving inconsistent care. These findings from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF), sponsored by Medtronic, were presented as posters.

IMPROVE HF was designed to quantify and improve quality of care for heart failure patients by promoting the use of evidence-based, guideline-recommended therapies.

"These new data represent novel observations obtained in the outpatient environment and demonstrate that patients suffering from heart failure are not receiving consistent care in accordance with recommended evidence-based guidelines," said Clyde Yancy, MD, co-chair of the IMPROVE HF Scientific Steering Committee, and medical director at the Baylor Heart and Vascular Institute, Baylor University Medical Center (Dallas).

He added, "Previously we could only speculate on the quality of heart failure care in the outpatient arena. Now we know and there are reasons for concern."

IMPROVE HF is the first of its kind, large-scale, prospective study involving roughly 40,000 heart failure patients from some 160 U.S. cardiology practices. This new release of baseline data includes 15,381 patients and 167 clinics. The study is assessing seven performance measures including four on drug therapy, three on device therapy and heart failure education.

Chart reviews were conducted at baseline, and then again at six, 12, 18 and 24 months as part of the ongoing study and performance improvement initiative. All study data is being collected and analyzed by an independent clinical research organization.