St. Jude Medical Presents Positive Data From Multiple Studies During HRS 2015

St. Paul, Minn.-based cardiovascular device company St. Jude Medical Inc., was prolific in the presentation of new product data at the Heart Rhythm Society’s (HRS) 36th annual scientific meeting in Boston, Mass.

The company presented positive data for its CardioMEMS HF System for the management of class III heart failure patients as well as data supporting what the company calls the “first and only” quadripolar cardiac resynchronization therapy pacemaker (CRT-P) system in the United States—the Allure Quadra CRT-P system, with the Quartet Quadripolar LV Lead.

A presentation during HRS titled “Pulmonary Artery Pressure Management in Heart Failure Patients with Cardiac Resynchronization Therapy or Implantable Cardioverter Defibrillator Devices Significantly Reduces Hospitalizations and Mortality Above and Beyond Background Guideline-Directed Medical Therapy” was presented by William T. Abraham, M.D., co-primary investigator of the Champion clinical trial, which supported U.S. Food and Drug Administration (FDA) approval of the CardioMEMS HF System.

The retrospective analysis showed that heart failure (HF) management using pulmonary artery (PA) pressure monitoring improved outcomes in patients already receiving optimal treatment including both medical management with guideline directed medical therapy and device therapy with an implantable rhythm device, such as an implantable cardioverter defibrillator or cardiac resynchronization therapy device.

“Even in patients being managed in accordance with American College of Cardiology and American Heart Association guidelines for medical management and device therapy, we saw a decrease in all-cause hospitalizations and mortality for class III heart failure patients when we added pulmonary artery pressure monitoring with the CardioMEMS HF System,” said Abraham, chief of cardiovascular medicine at The Ohio State University Wexner Medical Center. “These data show a 43 percent reduction in heart failure hospitalizations and 53 percent reduction in mortality, which demonstrates the added value of PA pressure monitoring in an already well managed patient population.”

A new economic analysis of data from the Champion trial showed an incremental cost-effectiveness ratio (ICER) based on all-cause comprehensive management of heart failure patients of $30,167 per quality adjusted life year gained when the patients were managed by PA pressure monitoring. The ICER is a statistic used to summarize the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible therapeutic interventions, divided by the difference in their effect on quality of life and survival. The analysis—“Cost Effectiveness Assessment of Pulmonary Artery Pressure Monitoring for Heart Failure Management”—was presented by Philip Adamson, M.D., co-primary investigator of the Champion trial.

“These data, presented at HRS, show that the economic value for pulmonary artery pressure monitoring is well below the U.S. acceptable cost effectiveness threshold,” said Adamson, medical director and vice president of medical affairs for St. Jude Medical. “We are encouraged by these analyses indicating that the CardioMEMS HF System is a cost-effective solution.”

Additional Champion trial data analysis presented at HRS by Lee Goldberg, M.D., from the Hospital of the University of Pennsylvania, evaluated patients from Champion and found that heart failure hospitalizations were reduced the most when PA pressures from the CardioMEMS HF System were used rather than clinicians relying on clinical signs and symptoms alone. The findings show that early intervention through the identification of increased PA pressure weeks prior to clinical signs and symptoms, significantly reduce HF hospitalizations. In addition, previously presented data at AHA 2014 showed a 58 percent reduction in 30-day all-cause readmissions when using the CardioMEMS HF System, which can minimize a hospital’s risk of Medicare penalties due to high-readmission rates.

The CardioMEMS system uses a miniaturized, wireless monitoring sensor that is implanted in the PA during a minimally invasive procedure to directly measure PA pressure. Measuring PA pressure allows clinicians to proactively manage treatment with medication changes for patients with worsening HF before visible symptoms, such as weight and blood pressure changes, occur. The system allows patients to transmit PA pressure data from their homes to their health care providers, who then manage appropriate medication changes to reduce the likelihood of hospitalization.

The Center for Disease Control and Prevention reports that more than 5 million Americans suffer from HF with 670,000 new cases diagnosed each year. Roughly 1.4 million patients in the U.S. have New York Heart Association class III HF, and historically these patients account for nearly half of all HF hospitalizations. According to the American Heart Association, the estimated direct and indirect cost of HF in the U.S. for 2012 was $31 billion and that number is expected to more than double by 2030.

Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands and blood pressure within the heart is elevated. Significant HF progression over a period of days is known as acute decompensation and leads to hospitalization. Increased PA pressures often precede indirect measures of worsening HF such as weight and blood pressure changes. The CardioMEMS HF System, approved by the U.S. Food and Drug Administration in May 2014, allows clinicians to stabilize PA pressures by proactively managing medications and other treatment options while also providing an early indication of worsening HF.

St. Jude Medical, which had been an early investor in the company, purchased CardioMEMS outright in 2014 for $375 million. In Sep 2010, St. Jude Medical had acquired a 19 percent stake in CardioMEMS for $60 million.

Quadripolar Pacing
St. Jude Medical also presented data supporting the Allure Quadra CRT-P system, with the Quartet Quadripolar LV (left ventricle) Lead. According to the company, the device is associated with a 63 percent reduction in the need to replace the lead or deactivate CRT following implant.

Quadripolar LV pacing using SJM quadripolar CRT-Ds (defibrillators) or CRT-Ps and a St. Jude Medical (SJM) quadripolar lead provides physicians with multiple pacing options to avoid phrenic nerve stimulation and allow for optimal treatment delivery without the need to replace or deactivate the therapy. An analysis evaluating more than 3,000 patients implanted with a CRT-P (1,325 with a quadripolar lead vs. 1,930 with a bipolar lead) looked at whether the known decreased need to replace or deactivate LV leads associated with SJM quadripolar CRT-Ds and the Quartet LV lead also extends to St. Jude Medical quadripolar CRT-Ps.

The retrospective data analysis was presented in a session titled “Quadripolar Leads are Associated with Fewer LV Lead Replacements and Deactivations in CRT-P Patients” by Mintu P. Turakhia, M.D., who led the investigation. The data show that patients with the Quartet LV lead were 63 percent less likely to undergo lead replacement or deactivation of CRT compared to the patients with bipolar leads.

“There is a strong body of evidence indicating that quadripolar resynchronization leads are associated with fewer complications and better outcomes when used with implantable defibrillators,” said Turakhia, cardiac electrophysiologist and assistant professor of medicine at Stanford University. “However, we didn’t know whether these benefits extended to pacemakers. The current study showed that even in cardiac resynchronization pacemakers, the quadripolar lead was associated with fewer complications in the first three months.”

CRT resynchronizes the beating of the heart’s lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Approximately 23 million people worldwide are afflicted with congestive heart failure and 2 million new cases are diagnosed each year worldwide, according to figures cited by the company. 

St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.