Cardiac ablation

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 15937 of August 4, 2022, Tuscany Regional Healthcare has published assessments of six medical devices in various therapeutic areas, such as cardiovascular and peripheral vascular areas, neurovascular procedures, gastroenterology, and dermatology.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 13241 of July 4, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the cardiovascular area.

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

In January 2021, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (self-expanding implant insertion into the intersphincteric space for faecal incontinence and minimally invasive radical hysterectomy for early stage cervical cancer), two new medical technologies guidance (the PLASMA system for transurethral resection and haemostasis of the prostate, and the VAC Veraflo Therapy system for acute infected or chronic wounds), and six Medtech innovation briefings (Optilume for anterior urethral strictures, AI in mammography, AI for analyzing chest CT images, AcQMap for mapping the heart atria to target ablation treatment, and others). Also, two clinical guidelines were updated.

On September 24, 2020, NHS England opened a consultation on clinical commissioning policy for the use of catheter ablation for paroxysmal and persistent atrial fibrillation. Comments can be submitted until October 24, 2020.

At the end of January 2020, the Decision Forum rejected Focal Impulse and Rotor Mapping ablation approach and workstation RhytmView for the treatment of atrial fibrillation and ex-situ perfusion platform for organ preservation after the brain death of the donor due to its insufficient efficacy evidence.

More than 50 new DRGs were introduced in the Swedish system in 2019, while two have been deleted. The changes affected nursing care, psychiatry, hospital and day case services of different major disease categories. Important changes relate to cardiac ablation, placement of neurostimulator.

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

A 104-page reimbursement report covers percutaneous, thoracoscopic and open in adjunction to heart surgery ablations in hospital settings. Radiofrequency, cryo and microwave ablation sources were considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.