Los Robles is 1 of 100 sites World-Wide to Implant Novel Heart Failure Device

Thousand Oaks, CA, February 27, 2020 - Los Robles Health System has initiated a large clinical study RELIEVE-HF designed to help patients with advanced heart failure. Primary investigator Dr. Saibal Kar and Sub investigator Dr. Vishva Dev will be the first in the area to implant the new device. Other Sub investigators on the study are Dr. David Aliabadi and Dr. Gregory Fontana. The V-Wave interatrial shunt may potentially improve symptoms for heart failure patients, irrespective of their ejection fraction (reduced or preserved; also referred to as systolic and diastolic heart failure, respectively). “This procedure is a simple solution for a complex problem. The procedure potentially could dramatically reduce hospitalization for patients with Congestive Heart Failure, who remain symptomatic in spite of adequate medical treatment,” says Dr. Saibal Kar.

In severe heart failure, even with optimized medical therapy, the heart is not able to effectively pump blood out to the body. Fluid pressure builds up in the heart, and in the left atrium. This elevated left atrial pressure can lead to fluid pressure backing up into lungs, causing patients to have difficulty breathing. The fluid pressure buildup in the lungs also leads to more than 90% of heart failure hospitalizations ^(1,2,3).

The V-Wave interatrial shunt device is designed to continuously reduce excess left atrial pressure by allowing movement of a small volume of blood from the left atrium to the right atrium. This is expected to reduce the fluid pressure backing up into the lungs – the primary cause of breathing difficulty and hospital admissions in heart failure. The investigational device is a tiny hourglass shaped shunt that is placed between the two upper chambers of the heart using a minimally invasive procedure through a catheter placed in the femoral vein in the leg. The procedure is performed in a hospital under sedation or anesthesia and typically takes around one hour.

Heart failure is a serious global disease affecting more than 26 million people worldwide with more than 800,000 new cases in the U.S. each year. Even with medication, patients with severe heart failure have a very poor prognosis and a large percentage of patients remain highly symptomatic. New therapies are needed to improve quality of life, exercise capacity, and life-expectancy, and to reduce the high risk of hospitalization.

The RELIEVE-HF study is a global pivotal study designed to evaluate safety, as well as the effectiveness, of the V-Wave interatrial shunt in reducing heart failure symptoms and hospitalizations. The clinical trial will include patients with advanced heart failure who experience symptoms with minimal or no exertion and have either reduced or preserved ejection fractions. The trial will enroll about 500 patients at up to 100 sites world-wide. https://clinicaltrials.gov/ct2/show/NCT03499236

Prior clinical experience with the V-Wave shunt demonstrated the safety of the device and implantation procedure ⁽⁴⁾. At one year, the V-Wave shunt was associated with statistically significant improvements in symptoms, quality of life, and exercise capacity without objective worsening of cardiac function. Follow-up is now available in certain patients for 3 years and results support continued efficacy.

References

1. Schiff GD, et al. Decompensated heart failure: symptoms, patterns of onset, and contributing factors. The American journal of medicine 2003;114(8):625-30.
2. Adamson PB, et al. Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system. JACC 2003;41(4):565-71.
3. Fonarow GC, et al. Risk Stratification for in-hospital mortality in acutely decompensated heart failure. JAMA 2005;293:572-580.
4. Rodés-Cabau J, et al. Interatrial Shunting for Heart Failure: Early and Late Results From the First-in-Human Experience With the V-Wave System. JACC Cardiovasc Interv. 2018;11(22):2300-2310.