Cedars-Sinai Medical Center

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Formulary Expanded; FDA Warns About Immune Globulins, Spinal Catheters, Cardiac Drugs

Pharmacy Focus

The Pharmacy and Therapeutics Committee added ticagrelor (Brilinta®) to the formulary and took other actions Oct. 1. Also, the U.S. Food and Drug Administration has cautioned about human immune globulin products, the use of spinal catheters in patients taking anticoagulants and two cardiac stress test agents.

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Grand Rounds

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Upcoming CME Conferences

Click below to view a complete list of all scheduled Continuing Medical Education conferences.

CME Newsletter - November 2013 (PDF)

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Cedars-Sinai Patient Is First in U.S. to Receive Newly Approved Device to Fix Mitral Valve

Cedars-Sinai Heart Institute patient Pearl Segal (seated) celebrates a successful outcome with her family and healthcare team. From left: David Segal, son; cardiologist Saibal Kar, MD; Zalman Segal, husband; senior physician assistant Asma Hussaini, MS, PA-C; and Lee Weinstein, daughter.

A Cedars-Sinai Heart Institute patient is the first in the nation since the procedure's approval to undergo a nonsurgical method to fix a leaky — and life-threatening — heart valve condition.

The first patient in the U.S. to have the MitraClip® procedure following approval by the U.S. Food and Drug Administration was Pearl Segal, 83, of Phoenix. Segal was diagnosed two years ago with mitral valve regurgitation, a backward flow of blood in the heart caused by a leaky valve.

The procedure was performed by Saibal Kar, MD, the Heart Institute's director of Cardiovascular Intervention Center Research. Kar has performed more MitraClip procedures than any other U.S. physician, according to manufacturer Abbott.

Mitral regurgitation is a debilitating, progressive and life-threatening disease that affects more than 4 million in the United States, raising their risk of heart failure, irregular heartbeats, stroke and death. Medication can manage their symptoms, but medication does not stop the progression of mitral regurgitation. But Segal, like many elderly patients with mitral valve regurgitation, was too frail to undergo open-heart mitral valve surgery, which is the standard-of-care treatment.

Before undergoing the procedure, Segal would get out of breath merely walking down the hall of her home. Just hours after her 45-minute mitral valve procedure Nov. 4, Segal's son, David, said, "Her color is better, she's not getting out of breath and she's smiling."

Pearl Segal said undergoing the mitral procedure was much easier than her 2009 experience with open-heart surgery to fix an unrelated heart condition. That surgery required 10 days of hospitalization, followed by two weeks of cardiac rehabilitation and a month of in-home nursing.

"I won this time," she said as she prepared to go home the day after her procedure. "This is better than winning the lottery."

"Mitral valves can become dysfunctional for several reasons, including age," Kar said. "But as we age, we face higher risk from open-heart surgery. Catheter-based, minimally invasive heart procedures are a way we can add years to life and life to years."

During clinical trials, Kar and other Cedars-Sinai Heart Institute physicians performed more catheter-based mitral valve repairs than any other U.S. medical center. Kar receives compensation from Abbott for teaching clinicians how to implant the MitraClip device.

During the procedure, the MitraClip device is delivered to the heart through the femoral vein. Once implanted, the device allows the mitral valve to open and close correctly without leaking, thereby relieving symptoms and improving the patient's quality of life. Patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays.

"This device offers new hope for thousands of patients with leaky valves worldwide," said Eduardo Marbán, MD, PhD, director of the Cedars-Sinai Heart Institute. "We are proud to have been the leading site in the clinical trials that led to approval, and we look forward to offering this innovative therapy to all those in need."