Critical Study Baystate Doctor Heads Research That May Improve Surgical Safety

For many patients, cardiovascular complications following major surgery are a significant threat.

 

A team of doctors from Baystate Health System and other area institutions has researched whether lipid-lowering therapy can reduce this risk. The results of the study were published in the May 5 issue of the Journal of the American Medical Association.

The article, titled “Lipid-lowering Therapy and In-hospital Mortality Following Major Non-cardiac Surgery,” is the first large-scale study to suggest that lipid-lowering therapy may be a beneficial treatment for major non-cardiac surgeries, said Dr. Peter K. Lindenauer, the article’s lead author and associate medical director of Baystate’s Division of Healthcare Quality.

Yet, he was quick to stress, the effort was far from the larger-scale, randomized study that needs to be done to determine whether physicians should make changes in the way they prepare patients for surgery.

Learning the Benefits

Lindenauer and his team began their study with the recognition that cardiovascular complications following such surgeries are a notable source of perioperative morbidity and mortality. Although lipid-lowering medications are considered a key component in the prevention of cardiovascular disease, their potential benefit during the perioperative period has been uncertain.

“Cardiovascular complications following surgery are common, but while physicians are generally able to identify who is at risk, few therapies have been proven to be effective at reducing the occurrence of these complications,” Lindenauer said.

Beta blockers are a class of drugs, commonly used to treat hypertension, that have been shown to benefit patients around the time of surgery. However, even patients treated with beta blockers are still at risk for suffering postoperative complications.

“Lipid-lowering drugs are known to be beneficial in the prevention of heart attacks — both in those patients at risk of developing a first heart attack, as well as in preventing the reoccurrence of a heart attack in a patient who has already suffered one,” Lindenauer said.

“Not only do statins reduce cholesterol, they appear to have a number of other effects, including reducing inflammation, improving the function of the cells that line blood vessels, reducing coagulability, and producing a stabilizing effect on atherosclerotic plaques. It is the rupture of these atherosclerotic plaques that are believed to be responsible for most post-operative myocardial infarctions.”

The key objective of the study was to examine the association between using lipid-lowering medications and in-hospital mortality following major, non-cardiac surgery. “We were interested in learning whether lipid-lowering drugs might have a benefit around the time of surgery,” Lindenauer said.

As part of the study, the records of over 750,000 patients who underwent major, non-cardiac surgery at 329 hospitals throughout the United States were examined over a two-year period from hospital discharge and pharmacy records. The investigators compared the mortality of patients who received lipid-lowering drugs in the initial part of their hospitalization with those who had not.

They found a 1{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} difference between the mortality rates of the patients based on whether or not they received lipid-lowering therapy, Lindenauer said. According to those findings, the number of patients who would need to be treated with these medications to prevent a single in-hospital death varied from 30 in the highest risk group to 186 among those at lowest risk.

Piece of the Puzzle

Still, Lindenauer stressed, the results should be taken only as the start of what he hopes will be further studies.

“There are a couple of ways to respond to a new study,” he told The Healthcare News. “You could take the results as truth and start to incorporate that into your practice, and had this been a large, randomized trial, that would be a reasonable approach to dealing with the findings.”

However, he added, although the team’s study was very broad in scope, it was basically observational, based on a study of records. The best type of study would involve a large group of patients randomly divided into groups — those receiving lipid-lowering drugs and those who don’t — and monitored in a controlled way.
“This study, although it was well-designed, is still subject to certain biases that can create what we call ‘confounding’ and fundamentally lead to results which are not true,” Lindenauer said. “Still, this is a very provocative study, even though it’s too early for the medical community to start recommending lipid-lowering therapy as a standard way to reduce the risk of patients going into major, non-cardiac surgery.”

Nevertheless, he said he’s optimistic about the results of the study, which was co-authored by Dr. Evan M. Benjamin, vice president of the Division of Healthcare Quality at Baystate; Dr. Penelope Pekow, also from the division; Dr. Kaijun Wang of the School of Public Health and Health Sciences at UMass in Amherst; and Dr. Benjamin Gutierrez of Premier Healthcare Informatics.

“This is really interesting,” Lindenauer said. “We need more therapies that can prevent complications in surgical patients — in particular, these cardiovascular complications. Perhaps these lipid-lowering drugs can be such an intervention. But the most appropriate response is to say that we need more evidence, stronger evidence, and that evidence needs to come from randomized, controlled trials.”

Making Progress

But to move in that direction, other researchers must take up the idea and run with it, he said.

“Although it is certainly too early to begin recommending these medications to patients routinely, lipid-lowering therapy as an intervention to reduce risk for major surgeries is an emerging area of interest that warrants further investigation,” he said.

“Given the fact that as many as one million operations are complicated by potentially life-threatening perioperative cardiac events, our hope is that others will soon conduct clinical trials to test our observations and determine the optimal timing and duration of therapy.”

Improving patient outcomes is one of Lindenauer’s main goals as part of Baystate’s Division of Healthcare Quality, which was created to integrate patient safety, quality improvement, medical management, case management, infection control, and health sciences research under one umbrella to coordinate those elements of health care delivery.

“This research is only tangentially connected to the division,” he said, “but we’ve done other research that has been published in major journals.”

By putting quality at the core of Baystate’s strategic vision and linking the functions the division oversees, the health system has been able to make quality part of its culture, he said, and in doing so has achieved regional and national recognition.

For example, Baystate Medical Center was named a Distinguished Performer last year in the Premier Award for Quality program, a national award sponsored by Premier Inc., in recognition of the advances Baystate has made in health care quality and patient safety.

Premier is a national alliance of more than 1,500 not-for-profit hospitals committed to improving health care quality, enhancing safety, and reducing costs.