Heart Beat: August 2018
Benefits of Statin Therapy Far Outweigh Risk of Side Effects for Most Patients
After a careful review of 17 years of statin studies, the European Atherosclerosis Society concluded that the potential benefits of statins outweigh the risks. Their consensus document, published online April 27, 2018, in the European Heart Journal, examined the incidence of several serious side effects attributed to statins and weighed them against the drugs’ benefits. Statins were associated with one case of new-onset diabetes per 1,000 patients per year, but prevent three to five new cardiovascular events per year in the same population. They found no evidence that statins have an adverse effect on cognitive function or cause Parkinson’s disease, Alzheimer’s disease or any other form of dementia. Risk of harm to the kidneys is minor, because statins are largely metabolized by the liver. There was a small increased risk of hemorrhagic stroke in patients with a history of ischemic stroke who take high-dose atorvastatin, yet statin therapy significantly reduces the risk of ischemic stroke. Moreover, its effectiveness increases as LDL cholesterol levels drop. They were unable to discern whether statin-associated muscle symptoms were real or the result of expectations—a reverse placebo effect, as it were. According to the principal author, “There is no doubt that the benefit [of statins] is largely above the risk, which is small but there.”
New Device Strengthens the Pumping Power of a Failing Heart
Patients with class III and ambulatory class IV heart failure may soon have access to an implantable device designed to strengthen the heart’s contractions. In clinical trials, the OptimizerTM device for cardiac contractility modulation improved the ability to exercise in patients with an ejection fraction of 25 to 45 percent or narrow QRS intervals, which can cause rapid, weak, heart rhythms. Additionally, patients with the device reported a substantial 11-point improvement in quality of life. As explained in the May 5, 2018, issue of JACC: Heart Failure, the combined data from two trials revealed a significant reduction in heart failure hospitalizations and cardiovascular death. Like a pacemaker, the rechargeable Optimizer device has a pulse generator and leads. Unlike a pacemaker, it does not initiate new heartbeats, but rather enhances existing contractions. When the device receives regulatory approval by the Food and Drug Administration, it will be the only treatment option for patients with moderate-to-severe heart failure who remain symptomatic despite optimal medical therapy.
A Close Look at Atrial Fibrillation Shows Ablation to Be Safe and Effective
A trial of patients with symptomatic atrial fibrillation (Afib) has shed new light on the benefits of catheter ablation. Ablation is generally reserved for patients on anti-arrhythmia medications who continue to experience Afib. The trial randomized 2,200 Afib patients age 65 and older, or younger than 65 with at least one stroke risk factor, to ablation or medical therapy and followed them for a median of four years. The primary endpoint was the combination of death, hospitalization, disabling stroke, cardiac arrest or serious bleeding. In the randomized group (“intention-to-treat”), the two treatments were nearly equivalent, with a suggestion of greater benefit for ablation. But during the trial, 9 percent of patients randomized to ablation never underwent the procedure, and 27 percent of those randomized to medical treatment crossed over to ablation. When patients were examined as they had been treated, those who underwent ablation were 33 percent less likely to meet the primary endpoint and 40 percent less likely to die from any cause than those on medical therapy. These results are causing cardiologists to debate whether ablation and medical therapy are equivalent or ablation is superior. One outcome that cannot be debated is that ablation was superior in patients with New York Heart Association class II or higher heart failure and in those younger than age 65. Ablation significantly reduced the chance Afib would recur, with 60 percent of patients maintaining a normal heart rhythm four years after their ablation. This should provide reassurance that ablation is a safe, long-lasting treatment for younger patients who would otherwise face a lifetime on anti-arrhythmia medications, and help heart failure patients live longer and have fewer heart-failure hospitalizations.