- New Study Is First Randomized Clinical Trial Comparing Conventional Sternotomy Mitral Valve Repair.
- Researchers reported that recovery from baseline to 6 weeks was superior with mini mitral valve surgery, but recovery of physical function at 12 weeks was better with mini mitral valve surgery and sternotomy. is the same for both.
- High rates of mitral valve repair were seen with both surgical approaches, with no difference in primary safety outcomes.
- The researchers say the finding that mini mitral valve surgery is as safe and effective as a traditional sternotomy should give patients confidence when performed by an experienced surgeon.
The mitral valve of the heart acts like a door between the two chambers of the heart (left atrium and left ventricle).
It allows blood to flow from the left atrium (upper atrium) to the left ventricle (lower atrium).
Mitral regurgitation is a condition in which the mitral valve does not close properly and some blood flows backward.
This causes the heart to struggle to pump enough blood to the body. Symptoms include fatigue and shortness of breath.
In some cases, doctors may prescribe drugs to treat mitral regurgitation.
Another option is mitral valve repair surgery. This can be done in various ways, such as:
- Traditional surgery via sternotomy – This involves opening the chest completely from the collarbone to the bottom of the sternum. The healing process after surgery is long.
- Minimally invasive mitral valve repair via mini-thoracotomy, also called “mini-mitral valve”. This involves making an incision about 2 inches long in the chest to access the heart and using a camera and special instruments to repair the valve. Recovery time is shorter, but the procedure is more complicated.
The cardiac surgery community has widely debated which of the two approaches is best. Although patients prefer the minimally invasive mini-mitral valve approach, there have been concerns about its clinical efficacy compared to conventional sternotomy.
There were also questions about its safety.
To answer these questions, researchers at the University of Newcastle in the UK designed a randomized clinical trial comparing two surgical techniques, led by Professor of Cardiac Surgery Dr. Enoch Akoua.
The results of the UK mini mitral valve study, not yet published in a peer-reviewed journal, were presented at the 2023 Scientific Sessions of the American College of Cardiology.
Dr. Donald Grower, professor of surgery at Duke University School of Medicine, who was not involved in the study, said: medical news today This was a “rare randomized trial” and “both approaches yielded comparable results, suggesting faster recovery with the use of the mini mitral valve.”
James S. Gammie, Ph.D., senior professor of cardiac surgery at Johns Hopkins Medicine in Maryland, who was not involved in the study, commented: [this] A rigorous, prospective, randomized trial. ”
This study recruited adults who needed to undergo mitral valve repair and were eligible for either surgical approach.
Researchers randomly assigned study participants from 10 locations in England and Scotland to undergo mini mitral valve surgery or sternotomy.
The procedure was performed by 28 surgeons who were considered experts based on a history of at least 50 completed surgeries.
The main question Akowuah’s team tried to answer was whether there was an improvement in physical function and return to normal activity after mini mitral valve surgery compared to conventional surgery.
At weeks 6 and 12, study participants were asked to wear a Fitbit-like device called an accelerometer for one week at a time to measure physical activity and sleep efficiency. .
Other important secondary outcomes measured in this study were: Mitral valve repair rate. quality of mitral valve repair (moderate or severe mitral regurgitation rate at 12 weeks and his 1 year); adverse events (death, stroke, hospitalization for heart failure, repeated mitral valve interventions).
In total, 329 people were randomized to either treatment. The average age of study participants he was 67 years old and 30% were female.
For those who underwent conventional surgery, physical function did not improve 6 weeks after surgery compared to baseline. Researchers report that it takes 12 weeks to observe significant improvement from baseline.
In contrast, people who underwent mini mitral valve surgery had significantly higher physical function scores compared to baseline at six weeks, indicating they were already recovering from surgery, the researchers noted. bottom.
At 12 weeks, both groups recovered from surgery. This means that there were no significant differences between groups in changes in physical function from baseline to his 12 weeks.
The researchers found that people in the mini mitral valve surgery group spent significantly more time doing moderate, vigorous physical activity, such as running, walking, and swimming, and had better sleep efficiency than those in the sternotomy group. observed.
Additionally, those who had mini mitral valve surgery had shorter hospital stays and were twice as likely to be discharged early.
High rates of mitral valve repair were seen with both approaches. 97% for sternotomy and 95% for mini mitral valve.
The two approaches had similar safety profiles, with 12-week mortality of 2.5% for sternotomy and 0.6% for mini-mitral valve.
At 1 year, both groups had good echocardiographic results (92% had no or mild mitral regurgitation) and demonstrated good valve repair durability.
There were no differences in key safety outcomes (death, hospitalization for heart failure, reoperation) at 1 year.
Globally, the majority of people undergoing mitral valve repair undergo sternotomy and a small percentage undergo mini mitral valve surgery.
“Over 30% of isolated mitral valve surgeries in North America are performed using the right breast,” Gammie said. [mini-mitral] approach. “
One of the factors limiting the popularity of mini mitral valve surgery is the uncertainty regarding the safety and efficacy of this technique.
The UK Mini Mitral Valve Study is the first randomized clinical trial to show that mini mitral valve surgery is as safe and effective as conventional sternotomy. Akowuah and his colleagues hope that this new knowledge will increase adoption of the mini-mitral technique internationally.
Gummies say “[t]This trial did not show that right thoracotomy was superior to conventional sternotomy. In his opinion, “The most important measure of the success of mitral valve surgery is the degenerative disease repair rate, which should be nearly 100%. brings.”
“I have seen many patients who have had both a right thoracotomy and a sternotomy (simultaneous or simultaneous), and patients generally report that the right chest approach is more painful. added Gammie.
Mini-mitral valve surgery is a complex technique and the surgeon requires considerable experience to gain expertise.
Gammy described it as “an art that requires considerable experience to develop”. He said that surgeons usually
“The UK Mini Mitral Valve Trial, in an experienced hand, reassures the community that a right-sided open-chest approach to mitral valve repair can deliver results comparable to traditional sternotomy. For shallow hands, concentrating on repair through a sternotomy is probably the safest approach,” he said.
Glower agreed that the surgeon’s expertise determined the outcome.
“[T]His trials with experienced teams were low in volume with either approach, and it doesn’t mean that less experienced teams can reproduce the results,” he said.