Balloon valvotomy: Cost-effective for Fallot
It leads to a better repair long-term’
Pediatric interventional cardiologists at Cedars-Sinai Medical Center in Los Angeles are finding that their less-invasive alternative for tiny patients with Fallot’s syndrome not only saves money, but also results in much better long-term results than the series of surgeries that these patients traditionally have to undergo. One year after implementing this procedure, the cost of treating a Fallot child at Cedars decreased by 20% to 30%, and the quality of care was the same or better.
The innovative balloon pulmonary valvotomy helps children survive until a complete repair can be performed. "Our approach allows infants with tetralogy of Fallot to grow and remain healthy until their final surgery, which usually is done between eight months of age to a year," says L. Stephen Gordon, MD, director of pediatric cardiac catheterization and intervention at Cedars. "And we’ve found that the results of the final reparative surgery are better."
Complex defect reduces blood flow to lungs
Tetralogy of Fallot is a congenital heart defect that poses unique challenges. The complex condition is characterized by a large ventricular septal defect, an overriding aorta that deviates to the right, infundibular pulmonary stenosis, and right ventricular hypertrophy — all resulting in a flow of unoxygenated blood into the systemic circulation and decreased blood flow to the lungs.
"Overall, there are three types of Fallot children," explains Gordon. "The baby with spells, who needs either two surgeries or balloon dilation and surgery; the baby who does fine on his own without surgery until he reaches 6 months to a year, when he can have a final repair; and the baby who isn’t doing well, so needs repair sometime between 3 and 6 months. That last is a questionable group because morbidity is high. If they need surgery, their hospitalization is long and expensive."
Approximately 12% of patients less than 3 months old do not survive initial complete repair. Therefore, surgeons place a temporary surgical shunt — Gore-Tex sewn from the subclavian artery to the pulmonary artery — to bypass the heart and increase blood flow to the lungs. That has a significant number of side effects including stenosis where the shunt is sewn to the pulmonary artery.
"That procedure results in prolonged hospitalization," says Gordon. "On average, a week, and it can be longer." Additional risks exist as well. Respiratory complications are common.
As an alternative to this temporary operation, Gordon and associate pediatric cardiologists place a balloon across the pulmonary valve, dilating and stretching it.
"Our intervention dilates the whole outflow track to allow some growth and also to improve the saturation," he says. The two-hour procedure is performed through a catheter in the groin, under general anesthesia, and the child can go home the next day. The risks are fewer, the number of lab tests is cut, and patients are weaned from ventilators quickly, reducing the chance of pneumonia.
"That represents a one-night stay vs. a week in the hospital," Gordon says. "Hospitalization and physician costs are less, but the most encouraging aspect of this strategy is that it enhances the ultimate repair."
Track record shows success
Pediatric cardiologists at Cedars have performed more than 300 interventional procedures over the last 11 years without a procedural-related death and with a minimal complications rate. For the team’s first 13 tetralogy patients, they were able to increase the babies’ blood oxygen saturation from 76% to 91%; and each eventually underwent a complete, successful repair.
Gordon is also using innovative interventional cardiology procedures to treat patent ductus arteriosus in 1-year-olds where an opened blood vessel between the pulmonary artery and the aorta does not close after birth, causing the pulmonary artery to widen and placing excess strain on the left side of the heart.
As an alternative to a surgical procedure to close the opening, Gordon inserts a metal coil that springs up into the patent ductus arteriosus and occludes it. Patients leave the hospital six hours after the one-hour procedure, which is done through groin openings. He has performed 15 coil procedures and says they are safe and cost-effective. They save hospital time and eliminate the need for any type of surgical procedure.
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