Alcohol Injections Safer, Less Costly Than Surgery for Thickened Heart Muscle

 

May 10, 2011

Alcohol Injections Safer, Less Costly Than Surgery for Thickened Heart Muscle

May 10, 2011 – In a “real-world” test of treatments for an overly thickened heart muscle, the use of alcohol injections to shrink the unwanted tissue appears to be significantly safer and less expensive than open-heart surgery to cut it away, according to a study presented today at the Society for Cardiovascular Angiography and Interventions (SCAI) 2011 Scientific Sessions.

“This study provides valuable information that will guide clinical decision-making in a vulnerable group of patients,” said Srihari S. Naidu, M.D., FSCAI, director of the cardiac catheterization laboratory at Winthrop University Hospital in Mineola, N.Y. “It appears that a minimally invasive treatment may be an excellent treatment option that can save patients the expense, trauma and associated risk of open-heart surgery."

The study focused on patients with hypertrophic obstructive cardiomyopathy (HOCM), a genetic condition in which the walls of the heart grow excessively muscular and thick, and intrude into the heart’s main pumping chamber, the left ventricle. If the wall between the right and left sides of the heart (the septum) becomes too thick, it can block the valve that allows blood to flow out of the left ventricle to the rest of the body. Patients with HOCM can experience dizziness, fainting, shortness of breath, chest pain, abnormal heart rhythms and heart failure. Blockage of blood flow out of the heart has also been associated with an increased risk of death, including sudden cardiac death.

The new study is the first to compare newer, minimally invasive alcohol injections versus open-heart surgery for treating HOCM, using data from multiple hospitals in the United States and the types of patients doctors see in day-to-day practice. It was led by Dr. Naidu, in collaboration with Yamei Wang, director of biostatistics for The Medicines Company, in Parsippany, N.J.

Whether to perform surgery or alcohol injections has been the subject of intense debate. Most experts agree that both procedures relieve symptoms, but the consensus has been that surgery was safer, with less risk of scar-related rhythm abnormalities and, therefore, less need for a permanent pacemaker or defibrillator.

For the study, the researchers analyzed information entered between 2000 and 2010 into the PREMIER database, which receives data from about one out of six hospitals in the United States. During that time, 246 patients underwent open-heart surgery to remove unwanted heart muscle from the septum that divides the right and left sides of the heart (isolated septal myectomy) and 169 patients had alcohol injections into the obstructing tissue via a slender catheter threaded into the heart (alcohol septal ablation).

The patients who had alcohol injections were older than patients who underwent surgery (nearly 59 years old, on average, as compared with about 54 years, p=0.004). Nonetheless, survival during the initial hospital stay was significantly higher among patients treated with alcohol injections (100 percent vs. 94.7 percent, respectively, p=0.002). In addition, the risk of kidney damage requiring dialysis was significantly lower (0.0 percent vs. 2.4 percent, p=0.041), and length of hospitalization was significantly shorter (3.8 days, on average, vs. 7.7 days, p<0.0001). Patient cost, adjusted for inflation, were less than half that of surgery ($14,154 vs. $33,016, p<0.0001).

There was no significant difference between the two groups in the rates of stroke or the need for a permanent pacemaker or defibrillator,

“In recent years, some of the best surgical centers have published in-hospital survival rates in excess of 99 percent, leading many to believe that surgery is as safe, or perhaps even safer, than the minimally invasive alternative – not just over the long-term, but even up-front while still in the hospital,” Naidu said. “Our data show pretty clearly that the real-world early safety of alcohol septal ablation appears far superior to that of surgery, and that the reported safety of surgery in the best centers isn’t necessarily generalizable to the larger community of HOCM patients.”

Funding for the data analysis was provided by The Medicines Company.

Naidu has no relevant relationship with industry to disclose.

For more information: www.scai.org or www.SecondsCount.org.