Heart failure is a chronic and progressive condition that affects millions of people worldwide. When the heart is unable to pump enough blood to meet the body’s needs, patients experience debilitating symptoms and impaired quality of life. For decades, heart transplantation has been the gold standard treatment for end-stage heart failure patients. However, significant advancements have been made in cardiac assist devices, which serve as lifesaving alternatives for patients awaiting transplant or as permanent solutions for those who are not candidates. In this article, we explore the technologies powering this revolution in heart failure treatment.
Ventricular Assist Devices
A ventricular assist device, or VAD, is a mechanical pump that is implanted inside the body to help the weakened heart pump blood to the body. There are two main types of VADs: left ventricular assist devices (LVADs) and right ventricular assist devices (RVADs).
LVADs are the most common type as they aid in pumping blood from the left ventricle to the body. They are used either as a bridge to transplant or as destination therapy for patients not eligible for transplant. Some LVADs completely take over the pumping function of the heart while others work in partial support. There have been significant improvements in device design and biocompatibility over the past two decades, with smaller pulsatile and continuous flow pumps becoming dominant. The HeartMate 3 and HeartWare HVAD are two widely used continuous flow LVADs approved for both bridge to transplant and destination therapy indications.
RVADs help the right ventricle pump blood to the lungs and are used less frequently than LVADs. They serve an important role for patients with bi-ventricular failure or isolated right heart failure. The most commonly implanted RVAD is the CircuLite Synergy Pump. With LVADs and RVADs, many advanced heart failure patients have gained improved quality of life, mobility and survival advantages over medical management alone.
For patients with irreversible bi-ventricular failure, an artificial heart may be the best treatment option. The two FDA approved total artificial hearts available in the US are the SynCardia temporary Total Artificial Heart and the Carmat total bioprosthetic heart. Unlike a VAD, an artificial heart completely replaces the pumping function of the native heart.
The SynCardia device is made of titanium and plastic and is pneumatically driven by an external driver console and control system connected via a pneumatic driveline. It serves as a bridge to transplant, buying patients time until a donor organ becomes available. Over 1,000 patients have been bridged to transplant with the SynCardia device.
The Carmat artificial heart aims to provide a long-term solution through its biologically compatible materials and energy supply. It is made of biomaterials like calf heart tissue and its energy source is hydraulic and self-regulated by the patient’s metabolism. Early clinical trials evaluating the Carmat heart as destination therapy have shown promise. With further developments, total artificial hearts may someday make heart transplantation less necessary.
Research continues into novel technologies promising less invasive solutions. Some early-stage cardiac assist devices under investigation include:
– Minimally Invasive VADs: Smaller, percutaneously implanted VADs that do not require chest surgery for implant. Examples are the HeartMate PHP and HeartWare MVAD.
– Wearable VADs: External VADs worn on the torso that connect percutaneously to the heart, like the CircuLite Portico device.
– Bioartificial Hearts: Made of living cells on a biocompatible scaffold that could potentially restore native heart function over time. Examples still in preclinical testing include the SynCardia bioprosthetic TAH and University of Minnesota bioartificial heart.
– Genetically Engineered Heart Tissue: Using stem cell therapy and gene editing to potentially regenerate diseased heart muscle. Long way from human use currently.
– Neuromodulation Devices: Implantables that deliver targeted electrical or biological stimulation to improve cardiac function in heart failure through pathways like the vagus nerve. Early trials exploring this approach.
Regulatory Challenges and Future Directions
Despite major advances, widespread adoption of Cardiac Assist Devices faces regulatory challenges. Streamlining clinical trial designs and FDA approval processes can accelerate patient access. Areas in need of standardization include long-term outcomes assessment frameworks and reimbursement models. Global harmonization of regulatory guidelines would also be valuable.
Significant research funding remains crucial. Promising areas include durable materials, wireless energy delivery, tissue engineering, integrated sensors and data analytics in digital health. Public-private partnerships are key to tackling the complex scientific and economic hurdles. With continued innovation, cardiac assist technologies hold tremendous potential to transform heart failure management in the decades to come by improving survival rates and quality of life for patients worldwide.
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it