CLINICAL TRIALS OF THE ABDOMINAL LEFT VENTRICULAR ASSIST DEVICE (ALVAD): PROGRESS REPORT.

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Critical Care Medicine

Background:

• The abdominal left ventricular assist device (ALVAD) is a novel pneumatic pump designed for severe heart failure.
• Conventional treatments like intraaortic balloon pumping have limitations in supporting cardiac function.

Purpose of the Study:

• To evaluate the safety and efficacy of the ALVAD in patients with profound ventricular dysfunction.
• To assess the potential for ventricular recovery and the device's performance in critical cardiac scenarios.

Main Methods:

• Controlled clinical trials involving ALVAD implantation between the left ventricle apex and infrarenal abdominal aorta.
• Pneumatic actuation, synchronous or asynchronous with an external console.
• Monitoring of patient demographics, bypass duration, plasma hemoglobin, and platelet counts.

Main Results:

• ALVAD demonstrated superior effectiveness compared to intraaortic balloon pumping.
• Successfully implanted in 21 patients (average age 50) with an average support duration exceeding one day.
• Observed ventricular recovery in two patients and facilitated cardiac allografting in one.
• Device functioned effectively during ventricular fibrillation/standstill and supported biventricular function.

Conclusions:

• The ALVAD can facilitate recovery of severely depressed ventricles.
• It is a viable option for patients with impending multiple organ failure due to cardiac dysfunction.
• Early intervention with ALVAD is crucial to prevent irreversible organ damage.