Excellence in Medical Devices

McGowan Institute researchers excel at the development of artificial and biohybrid organs and devices that provide a bridge to organ transplant, and in some cases eliminate the need for transplantation altogether.

Pioneers in Artificial Heart Technology

The Artificial Heart Program has been a world leader in mechanical circulatory support for two decades. Since 1990, when the University of Pittsburgh Medical Center was the first to discharge a patient on a ventricular assist device (VAD), the Artificial Heart Program has since enabled some 90 patients with end-stage heart failure return to their homes – rather than to intensive care – to await a donor heart. The program has placed over 300 implants for a total of over 70 patient year’s experience and over 24 patient days of outpatient support. The McGowan Institute was instrumental in the development of the Thoratec Heartmate II rotary blood pump, now in clinical trials worldwide.

VAD as a Bridge to Recovery

While VADs are critical as a “bridge to transplant” for patients who can no longer be managed medically, Institute researchers have demonstrated that VADs can be used as a bridge to recovery as well -- making heart transplantation unnecessary. Under the leadership of Dr. Robert Kormos, the Artificial Heart Program team has successfully weaned patients with post-partum and viral cardiomyopathies --- and even ischemic heart disease -- off VADs. Weaning requires a level of scrutiny that only this research team can provide: UPMC clinicians and industry partners developed automated border detection echocardiography to look into the heart itself to see how well it performs when the VAD is slowed or temporarily halted. In further weaning trials, a protocol for calculating a power value for the strength of the left ventricle makes it possible to distinguish patients that may be capable of surviving VAD removal without the need for a heart transplant.

VAD Destination Therapy

In summer 2004, UPMC discharged its first patient with a permanent artificial heart. The Heartmate XVE Left Ventricular Assist System is a long-term permanent assist device approved by the US Food and Drug Administration for so-called destination therapy. It is intended for patients with end-stage heart failure who, despite receiving optimal treatment, have a life expectancy of less than two years and are not viable candidates for heart transplantation. As the use of destination therapy expands, the long-term vision for mechanical support is to assist the heart while it repairs itself using novel new cellular therapies.

PediaFlow

To address the critical need for pediatric mechanical circulatory support, the National Institutes of Health has funded the Institute’s efforts to develop PediaFlow, a quarter-sized centrifugal VAD support system that provides left, right, or biventricular assistance for up to six months, either as a bridge to transplant or, in the case of myocarditis, to recovery. The project team is under the leadership of Dr. Harvey Borovetz. PediaFlow is designed for children from birth to 2 years. The heart pump will use a magnetically levitated impeller, technology that increases the life span of the pump, reduces the electrical power and cooling requirements, and drastically reduces blood damage and clotting.

New Studies Seek to Improve Outcomes in Pediatric Heart Transplant Patients

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has awarded a team from Children's Hospital and the University of Pittsburgh a $14.5 million grant to develop novel approaches that seek to improve the outcomes of pediatric heart transplant recipients. The five-year grant establishes the University of Pittsburgh as a Specialized Center of Clinically Oriented Research (SCCOR) in Pediatric Heart Development and Disease. Such a center encourages basic science research findings to be applied more rapidly to address specific clinical problems.

The center grant brings together experts in pediatric cardiology and transplant medicine, transplant surgery, immunology, pharmacology, infectious diseases, molecular genetics and biostatistics from the School of Medicine, Graduate School of Public Health, Starzl Transplantation Institute and Children's Hospital of the University of Pittsburgh Medical Center.

Respiratory Support Technology

Patients with acute lung failure or acute episodes of chronic lung conditions have a better chance of recovering if their lungs have an opportunity to rest. While ventilators can take over the job of breathing, they can also cause lung damage.

The Medical Devices Laboratory, under the leadership of Dr. William Federspiel, is developing several oxygenation systems independent of the lungs. An intravenous respiratory assist catheter oxygenates and removes carbon dioxide before the blood arrives in the lungs, thereby relieving them of duty. While small enough to be inserted into the vena cava via the femoral vein, the catheter can compensate for 40 to 60% of adult lung function: it boosts gas exchange through its hollow polypropylene fibers with “active mixing” of blood. One version of the respiratory assist catheter, which uses a pulsating balloon to promote blood mixing, has been licensed to the Pittsburgh firm ALung Technologies as the Hattler Catheter® and is being readied for clinical trials.

In development are smaller, more efficient versions of the respiratory assist catheter that use bundle rotation to further increase gas exchange. Also under development is a respiratory assist lung that provides a higher level of breathing support. Worn outside the body, it employs a rotational fiber bundle to boost gas exchange and to pump blood through a relatively small dual-channel cannula inserted into the venous system. The enhanced gas exchange allows the device to operate at relatively low blood flow rates outside the body, essentially as respiratory dialysis.

Visit the Medical Devices Lab Web Site

Bioartificial Liver

Patients with acute liver failure need a bridge to transplant or recovery, too. The Modular Extracorporeal Liver Support (MELS) employs active hepatic cells sustained in bioreactor cartridges filled with hollow fibers. These act both as capillaries and an immunoisolation barrier, segregating patient blood from allo- or xenogenic hepatocytes. In this specific configuration, which resembles the natural structure of the liver, the donor cells form liver-like tissue and survive for over two months. In a phase I trial, 80% of those treated with MELS received a transplant or recovered liver function. Under the leadership of Dr. Joerg Gerlach, MELS is now being prepared for testing in a multi-center phase II trial.

Sonic Flashlight

Developed by Dr. George Stetten, the Sonic Flashlight™ can help surgeons can to “look” into a patient rather than up to a monitor. Available in both OR-sized and hand-held versions, the Sonic Flashlight™ projects a real-time sonogram image onto a translucent mirror over the patient. A surgeon looking through the mirror sees both the sonogram and the patient at the same time, using the image as an aide for the guidance of needles and incisions.

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