New registry data shows that approximately 1 in 6 patients who undergo percutaneous left atrial appendix (LAA) closure die within a year, suggesting that life expectancy assessment may be needed before this procedure can be performed.
The study also identified five risk factors independently associated with death within a year of LAA closure. These were the elderly (over 78 years of age), low BMI (less than 23), renal dysfunction, prediabetes, and prediabetes. heart failure. Patients with four or more of these risk factors had an approximately 50% risk of death during the first year.
“LAA shutdowns are being made for prevention brain attack In patients with non-valvular atrial fibrillationHowever, patients need to live long enough to see benefit Stroke preventionSenior author, Josep Rodés-Cabau, MD, Quebec Heart and Lung Institute, Quebec City, Canada, commented on theheart.org | Medscape Heart.
“If the patient dies within a few months of the procedure, the benefit is questionable. Our study suggests that if patients have a large number of comorbid diseases and therefore life expectancy, this should make the interventional physician reconsider the procedure based on expected to benefit.”
study was published In the September issue of JACC: Clinical Electrophysiology.
Rodés-Cabau explained that closing the LAA via the catheter is a preventative measure – to prevent stroke in patients with atrial fibrillation. At present, the procedure is generally performed in patients who cannot take oral anticoagulants due to the high risk of bleeding, and these patients often have many other comorbidities.
“While the LAA closure procedure itself is very safe, we noted that many patients were dying within the first year of the procedure. We wanted to look at the factors that were associated with these deaths.”
The researchers analyzed data from a multinational registry including 807 consecutive patients who underwent LAA closure at eight centers from Europe and Canada in a 10-year period from 2009 to 2019. The patients had a mean age of 76 years and a median CHA2DS2– VASc score of 4.5.
The results showed that premature death (within 1 year of the procedure) occurred in 125 patients (15.5%).
In multivariate analysis, factors associated with premature death after LAA closure were older age (78 years or older; heart rate, 1.03 per year), lower body mass index (<23 kg/m2; heart rate, 0.92 per 1 kg/m2 increase), diabetes (heart rate, 1.71), previous heart failure (heart rate, 1.74), decreased estimated glomerular filtration rate (heart rate, 1.09; per 5 ml/min/1.73 m2 decrease) ).
There was a gradual increase in the risk of early death during the first year of LAA closure with a combination of different risk factors, and patients with four or more of these risk factors had a 48.9% risk of death in the first year.
“I think it is reasonable to believe that if a patient is to live for less than a year, the probability of preventing many stroke events with LAA closure is very low. And we have to think about the cost-effectiveness of doing this procedure,” said Rhodes Capo.
He noted that the same principle had been discussed with atrial catheters valve replacement (TAVR). “TAVR unfeasibility is now an accepted phenomenon in high-risk patients. We suggest that the same concept be applied in LAA closure.”
Rodés-Cabau notes that at present LAA closures are generally performed in high-risk patients – those who cannot take anticoagulants long-term. But this may change in the future.
Studies are underway to compare LAA closure with long-term NOAC [novel oral anticoagulant] Treatment and if these studies favor LAA closure, this procedure may become more common in lower-risk patients for whom life expectancy would not be an issue. But at present, the LAA closure procedure is generally performed in high-risk patients who may have a limited number [life] anticipation “.
Asked whether it would be reasonable to prevent this procedure in a patient with four or five identified risk factors, Rhodes Capau said, “That’s the million dollar question.”
“This is the first study to look at factors associated with limited life expectancy after LAA closure. Although the study itself was very large, the number of patients with four or more of these risk factors was very small, so these findings are You need confirmation,” he said.
“With just this one study, I would say that we cannot make definitive decisions at the moment, because this procedure can prevent strokes. But I think we can say that this study highlights the importance of careful evaluation of the patient. Perhaps we should ask the geriatrician. About assessing life expectancy. I don’t think this is being done systematically at the moment.”
He added, “If a patient is in their mid-80s, with heart failure, kidney dysfunction, and diabetes, I think we can consider whether it’s worth doing an LAA closure. At the end of the day, it’s all about resources. If there’s zero cost, then yes we can.” Implementation of the procedure is up to everyone, but unfortunately we have to consider the costs.”
Informed Consent Discussions
in accompanying openingSalvatore Savona, MD, and Emile Daoud, MD, both of Wexner Medical Center, Ohio State University, Columbus, say the study offers an interesting analysis of “real-world” data and a practical approach to identifying risk factors associated with early death.
“Like other predictive models, the authors presented easy-to-measure features that are statistically associated with early death. If validated prospectively, this model could aid discussions of informed consent for patients when considering LAAC. [LAA closure],” they write.
But the editors point out some limitations. These include the fact that this was not a randomized trial, and there was significant variability in patient referral, management, and unmeasured physician bias. In addition, the mortality rate was significantly higher than that seen in recent randomized trials of LAA closure, and 18% of deaths were classified as unknown. They suggest that “although mortality is not in dispute, aetiology may help identify ways to alter outcomes and enhance patient evaluation.”
Savona and David also stress that deeming the procedure unfeasible, even for high-risk patients, has broad implications. They noted, “When evaluating the most severe patients, the estimate for premature mortality is about 50%, which means, of course, that the other 50% are alive.”
They say that caution should be exercised when classifying any aspect of Medicare as unfeasible until systematic data are available to specifically address the potential patient benefit from closing the LAA.
They concluded, “The study ultimately highlights the need for a comprehensive approach to procedural patient selection, as the majority of deaths were neither cardiovascular nor procedural.” “Prospective, randomized studies addressing the fragility of high-risk patient groups, net clinical benefits, and quality of life are needed to address the role of LAAC. Until such studies, consideration of conducting LAAC should be consistent with randomized clinical trials, consensus data, and careful consideration of individual patient care.”
Rhodes Capau holds the “Fondation Famille Jacques Larivière” Research Chair for the Development of Structural Interventions for Cardiology. He received institutional research grants from Boston Scientific.