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Behind the scenes

Dr. Pir Shah makes a case for a coronary device

The atmosphere is light and social as people bring their coffee to the table and greet one another with the enthusiasm of a reunion. Indeed, for some, it has been a month since they met; others interact daily on the job. The mood shifts as binders are distributed and the meeting is called to order by Chairperson Therese Beauclair, a registered pharmacist and assistant director of Pharmacy at Community Hospital. Participants snap to attention.

This is the monthly meeting of the Institutional Review Board (IRB) for Community Hospital, an assembly of clinical and nonclinical members convened to oversee all research studies conducted through the hospital.

First, the IRB will hear from Dr. Pir Shah, who is presenting the Impella Recoverheart® catheter device protocol for clinical trial. Board members turn to Section 3 in their binders for an overview of the device and its merits, and to find the "Consent Documentation Checklist" they’ll use as a worksheet during the presentation.

It is not the role of the IRB to test or approve the commercial use of this device today. It is the members’ job to scrutinize the information to be shared with potential participants and to judge whether the research, the related documentation, and the protocols are clear, valid, and in compliance with all federal and state regulations.

Their responsibility is not to the drugs, devices, or treatments under consideration, nor to the hospital, per se; rather, they are responsible to the subjects who will participate in any clinical trial conducted at Community Hospital. It is the board’s job to ensure the safety, dignity, and quality of care for every human research subject.

"The Impella Recover device," Shah begins, "is designed to help enable coronary interventions in patients who are too ill to undergo angioplasty or coronary bypass surgery. When angioplasty/coronary intervention is performed, the blood flow in the artery being treated is completely blocked for a short time — from a few seconds up to one to two minutes — making coronary blood flow worse before it gets better or normal.

"Patients with a weak heart can’t tolerate even this very short interruption in blood flow, with a high risk of fibrillation/cardiac arrest."

Most of the time, he says, patients are treated with an intra-aortic balloon pump, a good device if the heart function is reasonably intact. However, because it has no motor to move extra blood through the body during surgery, high-risk patients with poor heart function do not do well.

"The difference between the balloon pump and the Impella Recover," says Shah, "is that the Impella has a motor in itself that pumps blood in addition to what the heart is pumping. This keeps the patient from going into shock and his or her organs from shutting down."

The goal of the clinical trial, Shah says, is to make sure the device is safe and that it’s better than the balloon pump. When the heart pumps, everything moves, but the device must not. This is a self-contained device whose moving parts and motor are contained within the housing, making it very safe, he says.

"How safe is the Impella versus the balloon pump?" asks a board member.

"The safety of the Impella is superior to the pump," Shah says. "With the pump, the heart has to be able to squeeze or contract during surgery. The Impella actively unloads the heart at up to 2.5 liters of blood per minute, reducing the heart’s workload and, therefore, the risk of myocardial infarction or cardiac arrest."

The rate "seems astounding," says the member.

"This is because of the motor inside the device," Shah says.

"How much does this device cost?" asks another member. "And can it be used again?"

"It costs around $10,000 to $20,000," Shah says. "It cannot be used again because it cannot be completely re-sterilized. So, upon FDA recommendation, it is disposed of after use."

"Is it possible," asks a member, "that a patient could become dependent upon the device and need it for longer than the recommended four to five days?"

"This is an ad hoc intervention used when the patient didn’t achieve improved circulation with angioplasty," Shah responds. "It is designed to buy time to make plans and decide what to do next."

"Who is the candidate for this device?"

"Most patients are 70 to 75 years old and have had interventions in the past," Shah says. "They are not happy with their quality of life, their medications are not working, and they are not good candidates for bypass surgery. They understand that this is the only way out. The goal is to improve their outcome."

After Shah concludes his presentation and leaves, the IRB discusses the protocol.

"I think the purpose of the trial appears confusing," says a member.

"It is not clear that it’s being randomized. The technical phrases need to be simplified and shifted from labels to descriptions."

"On page 1," says another, "it says the purpose is to evaluate safety and feasibility, but that was already done in the first study. This is to demonstrate the efficacy of the device, or safety as it relates to adverse events or in comparison to the pump. The language on the consent form is just too technical."

"For the most part," says Dr. Anthony Chavis, vice president of medical affairs and patient safety officer for Community Hospital and an IRB member, "these are very safe, elective procedures. The complication rate is 1 percent to 2 percent. Among those with bad physiology, where the heart doesn’t function well to begin with, the mortality rate is 5 percent to 20 percent. But these are the high-risk patients."

"Impella has gone through the safety trial, but it was not compared to the gold standard, the pump," Chavis continues. "Patients who could benefit from this are easily identifiable and measurable. All in all, the study appears sound."

At the end of the presentation and extensive discussion, the board agrees to approve the research project, with suggested revisions to the information to be shared with prospective research subjects.