Blog

Percutaneous transseptal mitral valve replacement (TMVR) using the SAPIEN M3 system effectively reduced mitral regurgitation (MR) with low rates of complications and mortality in patients who were not candidates for conventional surgery or transcatheter edge-to-edge repair (TEER), according to results of the ENCIRCLE trial presented at TCT 2025 and simultaneously published in The Lancet.

The trial involved a total of 287 patients from the U.S., Canada, Europe, Israel and Australia who had MR ≥3+, NYHA Class ≥II, and were unsuitable for surgery or TEER due to clinical, anatomic or technical considerations. The balloon-expandable, dedicated SAPIEN M3 mitral transcatheter heart valve was implanted in each patient and follow-up was conducted at 30 days, six months and one year.

In overall findings, the primary endpoint – the composite of all-cause mortality and rehospitalization for heart failure at one year compared to a pre-specified performance goal of 45% – was 25.2%. All-cause death and heart failure hospitalization rates were 13.9% and 16.7%, respectively. Additionally, improvements in MR grade were observed across all patients, with more than 95% having ≤1+ total MR at 30 days and one year. Researchers also noted the TMVR system had a procedural safety profile similar to TEER and that patients experienced clinically meaningful and durable improvements in symptoms and quality of life.

“Percutaneous transseptal TMVR had a low mortality rate while providing a significant reduction in [MR] severity and providing meaningful and durable improvements in functional status and quality of life,” said David Daniels, MD. “These findings will help guide clinical practice by providing an alternative treatment option for patients who are not suitable for conventional surgery or TEER procedures.”

Additionally, Daniels and colleagues say their findings could allow for “future reintervention with percutaneous transseptal mitral valve-in-valve implantation in the event of structural valve deterioration,” noting that “reintervention after failed TEER remains a major limitation.”

Clinical Topics:
Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging

Keywords:
Transcatheter Cardiovascular Therapeutics, TCT25, Angiography, Heart Valve Diseases

The figure represents a small percentage of Amazon’s 1.55 million total employees, but nearly 10% of the company’s roughly 350,000 corporate employees. This would represent the largest job cut at Amazon since around 27,000 jobs were eliminated starting in late 2022.

Sign up here.

An Amazon spokesperson declined to comment.

Managers of impacted teams were asked to undergo training on Monday for how to communicate with staff following notifications that will start going out via email on Tuesday morning, the people said.

Amazon CEO Andy Jassy is undertaking an initiative to reduce what he has described as an excess of bureaucracy at the company, including by reducing the number of managers. He installed an anonymous complaint line for identifying inefficiencies that has elicited some 1,500 responses and over 450 process changes, he said earlier this year.

The full scope of this round of job cuts was not immediately clear. The people familiar with the matter said the number could change over time, as Amazon’s financial priorities shift. Fortune earlier reported that the human resources division could be targeted with a cut of roughly 15%.

Amazon shares were up 1.2% at $226.80 on Monday afternoon. The company plans to report third-quarter earnings on Thursday.

Our Standards: The Thomson Reuters Trust Principles., opens new tab