Sandru, 85, was the first patient enrolled in a Cedars-Sinai clinical trial for a tiny implant known as the WATCHMAN Device. It reduces the risk of deadly strokes in patients with erratic heartbeats by closing a pouch in the heart where blood pools, preventing clots from traveling out of the heart and into the body.
"It's given me more freedom and less worry," Sandru said.
Now it's his wife's turn.
Maria Sandru, 87, is one of the nation's first two patients to receive the WATCHMAN device since the Food and Drug Administration approved it March 13. The umbrella-shaped implant frees patients from blood thinning medications that pose their own dangers.
"We'll live together with matching parasols," said Maria, who received her implant on Monday.
The WATCHMAN device is designed for patients who suffer from non-valvular atrial fibrillation, an irregular heartbeat that can lead to blood clots, strokes, heart failure and other heart-related complications. The device is placed in the heart via a catheter during a minimally invasive procedure that allows patients to return to their daily activities within a few days.
Gheorghe Sandru said he expects that his wife will soon enjoy the benefits he has experienced since receiving his implant in 2006: No more blood thinners that can cause internal bleeding, no more trips to the doctor to adjust tricky medication levels. No more fretting about strokes.
In place of those worries, the Sandrus are looking forward to celebrating their 64th wedding anniversary later this year.
"We've been waiting and waiting for this treatment," said Gheorghe, noting that both he and his wife have family histories of heart complications.
Cedars-Sinai was among the earliest U.S. hospitals to test the WATCHMAN through the "Protect AF" clinical trial in 2006. The FDA approved the devise based on data from Cedars-Sinai and other medical centers that participated in trials, according to Boston Scientific Corp., the device's manufacturer.
Saibal Kar, MD, the interventional cardiologist who performed the procedure on both Sandruses, has pioneered the treatment in the U.S. and abroad and has performed more WATCHMAN implants than any other U.S. physician. Kar used the implant with more than 130 patients during Cedars-Sinai's clinical trial. He also has performed the procedure and taught it to physicians in Australia, South Korea, Israel and elsewhere.
"This is a transforming technology," said Kar, director of Cardiovascular Intervention Center Research at the Cedars-Sinai Heart Institute. "It provides a new and hopeful alternative to reduce the risk of strokes and the need for long-term blood thinning therapies can cause bleeding."
Kar has a personal motivation as well: Several years ago, his father, a cardiologist in India, suffered a stroke from atrial fibrillation. Kar's father inspired him and his sister, Sheila Kar, MD, an attending cardiologist and past clinical chief at the Heart Institute, to pursue their careers.
That family connection led the Sandrus to the WATCHMAN: Sheila Kar, the couple's longtime cardiologist, recommended Gheorghe for the 2006 clinical trial and also recommended Maria for the device as soon as it won FDA approval.
Now, with the procedure behind her, Maria is thinking about the future with her husband and their adult daughter, Corina, who cares for them. The three joke about taking a cruise, visiting their native Romania or simply enjoying a brisk walk around their Hollywood block.
"It's a huge load off," Maria said. "Now we can take a vacation."
Saibal Kar serves as a national and international trainer for the WATCHMAN Device and has received research grants from Boston Scientific Corp. to study and evaluate the implant. Kar was the co-principal investigator for a company-sponsored national clinical trial of the device. He has not received any compensation for his work.