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Medscape
05-05-2025
- Health
- Medscape
New Safety Questions Over Mechanical Circulatory Support
For circulatory support in cardiogenic shock, the best choice between Impella and intra-aortic balloon pump (IABP) has been controversial. Now, new data is complicating the debate. Presenting at the Society for Cardiovascular Angiography and Interventions in Washington, DC, Godbless Ajenaghughrure, MD, an internist and resident at Trihealth Good Samaritan Hospital in Cincinnati, Ohio, reported that Impella use is associated with higher 30-day mortality compared to IABP. The new propensity-matched analysis shows that Impella use at 1 month is linked to significantly higher all-cause mortality (42.3%) compared with IABP (29.6%; hazard ratio [HR], 1.594; 95% CI, 1.396-1.820; P < .001). Cardiac Arrest and Sepsis Patients treated with Impella also had higher rates of cardiac arrest (33.9% vs 26.8%; HR, 1.310; 95% CI, 1.135-1.511; P < .001) and sepsis (14.6% vs 12.3%; HR, 1.410; 95% CI, 1.070-1.858; P = .024). There were no significant differences in rates of acute kidney injury (14.6% vs 12.3%; P = .090), cerebral infarction (10.1% vs 8.4%; P = .130), atrial fibrillation (27.7% vs 27.1%; P = .754), ventricular tachycardia (21.8% vs 23.7%; P = .254), or gastrointestinal bleeding (12.8% vs 12.4%; P = .689). Researchers used the large healthcare database TriNetX to conduct the analysis comparing 30-day outcomes between patients who received either Impella (n = 1256) or IABP (n = 1256) support for cardiogenic shock. Patients were well-matched for heart failure, atrial fibrillation, diabetes, chronic kidney disease, and prior myocardial infarction, the authors report. Cardiogenic shock affects between 40,000 and 50,000 people in the US a year and is the leading cause of in-hospital mortality after acute myocardial infarction. One-year mortality rates are as high as 50%. In interventional cardiology, specialists use several types of mechanical circulatory support devices for patients in cardiogenic shock, especially after an acute coronary syndrome or myocardial infarction. Impella and IABP are two devices inserted percutaneously, typically through the femoral artery, and occasionally through the axillary artery. More Support, Not Necessarily Better Impella, a temporary rotary heart pump, provides stronger circulatory support than the traditional balloon pump, explained Diljon Chahal, MD, a cardiologist at University of Maryland Medical Center in Baltimore. However, he said, the Impella catheter is significantly larger than the IABP catheter, which can increase the risk of bleeding, vascular injury, and infection. "There has been ongoing controversy over which device may be better for patients in cardiogenic shock. Several prior studies, including the IMPRESS and ISAR-SHOCK trials, showed no significant difference in 30-day mortality between Impella and IABP in this setting," he pointed out. "While Impella does provide greater immediate hemodynamic support, this new propensity-matched analysis shows that greater support does not necessarily translate into better outcomes," he said. "The findings of higher 30-day mortality, more cardiac arrests, and higher rates of sepsis suggest that device-related complications may offset the intended benefits, particularly when used broadly without careful patient selection." This current analysis "is thought-provoking and reinforces the need for more randomized trials with longer-term follow-up," he said. "Until we have stronger prospective data, mechanical support decisions must be individualized, carefully balancing risks and benefits, rather than assuming that more support is always better. Although this study is valuable, the jury is still out on whether Impella offers a true survival advantage over IABP in cardiogenic shock."
Medscape
05-05-2025
- Health
- Medscape
Single Antiplatelet After TAVR Lowers Risk
Patients who received a single antiplatelet drug therapy— usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease. Francesco Pelliccia, MD, PhD 'This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,' said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC. Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry. In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant. Balancing Risks and Benefits The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel. A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke. Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year's follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy. Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy. By the Numbers Randomized trials are generally considered the best evidence for medical questions such as this one. 'But randomized trials often do not reflect real-world reality. We have to look at what really happens,' Pelliccia said. Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials. 'The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,' Pelliccia said.
