In April 2024, the Dutch Healthcare Institute (ZIN) announced two projects awarded under round 9 of the subsidy scheme for promising care:
Targeted muscle reinnervation during leg amputation in patients with peripheral artery disease (Prevent PAP trial), starting in June 2024 for four years and five months. Research results will be submitted to ZIN by November 2028, with a reimbursement decision expected in May 2029.
Thrombectomy by catheterization in adult patients with high-risk pulmonary embolism (TORPEDO-NL), initiated on April 01, 2024, and lasting four years and five months. Research findings will be submitted to ZIN by September 2028, with a reimbursement decision anticipated in March 2029.**Project 1: Targeted Muscle Reinnervation during Leg Amputation for Peripheral Artery Disease (Prevent PAP trial)**
Introduction:
The Prevent PAP trial, funded by the Promising Care Grant Scheme, aims to assess the effectiveness and cost-effectiveness of Targeted Muscle Reinnervation (TMR) during leg amputation in patients with peripheral artery disease (PAD). This project, set to commence in June 2024 and span over four years and five months, will evaluate whether TMR can alleviate Post-Amputation Pain (PAP), a common complication of leg amputation.
Condition and Treatment:
Peripheral artery disease (PAD) often necessitates leg amputation, affecting over 3,300 individuals annually in the Netherlands. Post-amputation pain (PAP) presents a significant challenge for these patients, impacting their quality of life. TMR, a nerve surgical technique, involves connecting severed nerves to leg muscles during amputation to potentially mitigate PAP.
Research Design:
The Prevent PAP trial is a multicentre randomized controlled trial (RCT) involving 242 PAD patients undergoing leg amputation. Half of the participants will receive TMR during the procedure. The study aims to determine whether TMR reduces or prevents PAP, as measured by a reduction of 2 or more points on the NRS pain score and assess its safety and cost-effectiveness.
Assessment of State of Science and Practice:
Upon completion, the National Health Care Institute will evaluate whether TMR during leg amputation aligns with the current state of science and practice. This assessment, expected within six months of study completion, will consider published research findings and the acceptability of associated costs.
Project 2: Thrombectomy by Catheterization for High-Risk Pulmonary Embolism (TORPEDO-NL)
Introduction:
TORPEDO-NL, another initiative under the Promising Care Grant Scheme, investigates the efficacy and cost-effectiveness of thrombectomy by catheterization in adult patients with high-risk pulmonary embolism (PE). This project, which began in April 2024 and will extend for four years and five months, aims to improve outcomes for PE patients.
Condition and Treatment:
Pulmonary embolism (PE), characterized by blood clots in pulmonary arteries, poses significant risks, including mortality and disabilities. Thrombolysis, the current standard treatment, carries bleeding risks. Thrombectomy offers an alternative, potentially reducing mortality and severe bleeding.
Research Design:
The TORPEDO-NL trial is a multicentre randomized trial involving 111 adult PE patients with hemodynamic instability. Seventy-four patients will undergo thrombectomy by catheterization. The study will assess whether thrombectomy reduces mortality, treatment failure, bleeding, and cerebral infarction compared to thrombolysis.
Assessment of State of Science and Practice:
Following completion, the National Health Care Institute will evaluate whether thrombectomy by catheterization meets the state of science and practice. This assessment will consider published study results and the acceptability of associated costs.
In both projects, the National Health Care Institute’s assessments will guide decisions regarding potential reimbursement from the basic health insurance package, impacting future healthcare delivery and patient outcomes in the Netherlands.