Irvine Calif.-based Inari Medical Inc. reported results from what it described as the largest prospective study of interventional treatment in high-risk pulmonary embolism (PE), which found a 90% survival improvement in high-risk pulmonary embolism using the company’s Flowtriever System. Data from the FLAME (Flowtriever for Acute Massive Pulmonary Embolism) study in high-risk PE was presented at the 2023 American College of Cardiology (ACC) conference on March 5.
Device durability for transcatheter aortic valve replacement (TAVR) devices remains topical for patients, payers and regulators, but the standard measure of 10-year data were difficult to obtain for the first decade after the FDA first approved a TAVR device in 2011.
Pulsed field ablation (PFA) may not be the final word where energy sources for atrial fibrillation (AF) ablation are concerned, but several companies have adopted development programs that propose the use of PFA as an alternative to conventional energy sources. Dublin-based Medtronic plc appears to have at least a narrow lead over the competition in the PFA space thanks to the results of the PULSED AF pivotal study presented at the 2023 American College of Cardiology Scientific Sessions.
Tricuspid valve regurgitation has lagged mitral regurgitation where device development is concerned, but new one-year data from the TRILUMINATE study of the Triclip device suggests that device therapy is safe and cuts down on regurgitation in a manner that makes the condition much more tolerable for patients. At this point, however, the data do not yet offer much difference when it comes to mortality and rehospitalization compared to medical management, a gap Abbott will have to overcome if it wants to maximize its investment in this underdeveloped area of medical technology.
Abbott Laboratories scored a major win for its Mitraclip device thanks to data from the COAPT study for secondary mitral valve regurgitation. The latest data from this study show a stunning difference in two-year mortality compared to maximized medical management only – 29% on the device versus 46% on medical management – but differences between the COAPT study results and outcomes seen in the MITRA-FR study will force cardiologists to dive into the data to ensure that their patient selection practices account for critical differences in the conduct of these two studies.
As was the case with left atrial appendage closure, renal denervation (RD) as a treatment for hypertension has proven to be difficult to move along into routine clinical usage. New data for a study sponsored by Medtronic plc showed that RD offers a statistically significant improvement over sham treatment in reducing hypertension, but the data do not seem to suggest that patients will be able to drop their antihypertensive medications after RD treatment.
The tricuspid valve at times seems the lost child of the heart’s valves, but new research hints that regurgitation of this valve can be resolved with a transcatheter replacement. Adam Greenbaum, of Emory University School of Medicine, said the early feasibility study of the Pascal valve by Edwards Lifesciences Inc., of Irvine, Calif., demonstrated a large improvement in mortality at one year and significant improvements in heart failure status, a result that offers new hope for these patients.
There has been some skepticism about the value of electronic health records (EHRs) beyond their role as a source of income for EHR developers, but an April 3 presentation at the 2022 America College of Cardiology scientific sessions being held in Washington suggests this type of software offers some real value for heart failure patients. Tariq Ahmad of Yale School of Medicine said a study of EHRs suggests their power lay in part in prompting compliance with heart failure medication regimes, an application of this type of software that can both save lives and cut costs for the Medicare program and Medicare beneficiaries.
Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients.