California Pacific Medical Center’s Advanced Heart Failure, Transplant and Ventricular Assist Device (VAD) program cares for people throughout the entire spectrum of heart disease, from chronic to end stage. As a referring provider, here’s what you need to know about the advanced therapies and devices that we offer.
Mechanical Circulatory Support Services
Durable Mechanical Circulatory Support
Intended to provide longer term support for a patient’s failing heart, these devices serve either as a bridge to cardiac transplant or as a permanent treatment, known as destination therapy. Options include:
- HeartMate 2 Left Ventricular Assist Device
- Heartware LVAS (available soon)
- HeartMate 3 LVAS (currently in investigational/clinical trial stage)
Temporary Mechanical Circulatory Support
These devices are intended to provide short-term cardiac support to patients until heart function recovers, or as a bridge to durable ventricular assist devices or urgent cardiac transplant. Options include:
- Impella (CP and 5.0) — This device can be placed urgently in the catheterization lab or as a surgical procedure, allowing for temporary ventricular support for the failing heart.
- Extracorporeal Membrane Oxygenation (ECMO) — An external device that provides full support for the heart and lungs for the sickest patients, such as those who have had a cardiac arrest or have severe respiratory failure.
- CentriMag — A temporary, external ventricular assist device to assist the right and/or left ventricle during critical illness, allowing for transition to recovery, more durable support or transplantation.
CardioMEMS HF System
The CardioMEMS Heart Failure (HF) system is an implantable hemodynamic monitoring device that assesses cardiac hemodynamics, allowing for proactive and tailored medical therapy for patients. By providing information on pulmonary artery pressure, an important marker of clinical status in heart failure patients, this device helps with decision-making for medication adjustments. The CardioMEMS HF system is clinically proven to reduce hospital admissions for heart failure by up to 37 percent.
The device is small, roughly the thickness of a dime, does not require battery power and is implanted in the patient’s pulmonary artery. Implantation is quite simple and is very similar to a routine right-heart catheterization procedure. Complications are rare and in general the procedure does not require a hospital stay.
Patient qualifications for the CardioMEMS HF system include:
- Symptomatic heart failure (NYHA Functional Class III) regardless of ejection fraction.
- Hospital admission for heart failure within the last 12 months.
Innovation and Clinical Research Trials
1. Comparison of Sacubitril/Valsartan versus Enalapril on Effect on NT-pro-BNP in Patients stabilized from an Acute Heart Failure Episode (PIONEER-HF)
- Multicenter, randomized, double-blind clinical trial studying the effect of the novel heart failure medication sacubitril/valsartan (Entresto) versus enalapril in the treatment of patients who have been hospitalized for acute decompensated heart failure. Sacubitril/valsartan has been shown to reduce cardiovascular death and all-cause mortality in heart failure patients by 20 percent in the PARADIGM-HF clinical trial.
- ClinicalTrials.gov Identifier: NCT02554890
2. CardioMEMS HF System Post Approval Study
- Nonrandomized, observational trial to evaluate the use of the CardioMEMS HF system in patients with NYHA Class III heart failure in a commercial setting. This trial enrolls patients who have NYHA Class III heart failure regardless of ejection fraction and have been hospitalized within the prior 12 months.
- ClinicalTrials.gov Identifier: NCT02279888
3. MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3, IDE Clinical Study Protocol and Continuing Access Protocol
- Randomized clinical trial of a third-generation LVAD, the HeartMate 3, versus the FDA approved HeartMate II when used for the treatment of advanced heart failure as either destination therapy or as a bridge to transplantation. The continuing access protocol is a non-randomized trial in which all patients receive the HeartMate 3 LVAD for treatment of advanced heart failure as either destination therapy or as a bridge to transplantation.
- ClinicalTrials.gov Identifier: NCT02224755