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Minimally invasive treatment for atrial fibrillation by high intensity ultrasound (HIFU) ablation

Source agency:

Agenas (COTE)

Date of Submission:

07/10/2009

Date of Printing:

05/02/2012

Disclaimer:

This report is work in progress and should not be used for external distribution without permission from the originating agency. Users should be aware that reports are based on information available at the time of research and often on a limited literature search.

Technology, Company & Licensing

Technology name:

Epicor LP (TM)

Technology - description:

Ablation consists of causing lesions on heart tissue to electrically isolate certain areas and restore normal heart impulse conduction. The lesions are normally made in specific segments (for example; around the pulmonary veins), using different sources of energy and different approaches (endocardiac or epicadiac) [Aktas, 2008]. The procedure of high intensity focused ultrasound (HIFU) ablation can be performed in open chest procedure, or by means of a small incision between the ribs (mini-thoracotomy). In the second instance the procedure is defined as minimally invasive. The present HS report assess those devices which by means of ultrasound are capable of inducing localised lesions following a minimally invasive approach.

Company or developer:

St Jude Medical Inc.

Reason for database entry:

Minimally invasive treatment for atrial fibrillation by HIFU ablation is an emerging technology in Italy and worldwide. The technology could have high potential for the treatment of atrial fibrillation (AF)in patients who are resistant to pharmacological therapies and/or have undergone unsuccessful transcatheter ablation.

Technology - stage in early warning process:

Assessment complete

Technology - stage of development:

Nearly established

Licensing, reimbursement and other approval:

The Epicor LP system was approved by the FDA in September 2008 and received the CE mark in November 2008.
The Italian NHS reimburses surgical ablation procedures with the DRG 108 tariff (other cardiovascular system interventions) which is € 12.498,25 per admission; if the procedure is concomitant with another only the principal procedure is reimbursed. This could be a negative incentive for the use of the procedure (and the technology).

Technology - type(s):

Device

Technology - use(s):

Therapeutic

Patient Indication & Setting

Patient indications:

The technology is aimed at patients who suffer from atrial fibrillation (AF) and who have shown resistance to other pharmacological therapies and/or have received treatment by transcatheter ablation which was ineffective.

Disease description and associated mortality and morbidity:

AF is a cardiac arrhythmia characterised by irregular electrical activity of the atria, two of the four heart chambers. Normal atrial contractions are replaced by chaotic movements which are not effective in achieving blood propulsion. According to prevalence estimates, some 2.3 million Americans have AF, although this figure seems to be destined to double by 2050 because of different causes, amongst them the ageing of the population [Kannel, 2009].
AF is the most common cardiac arrhythmia in clinical practice and its incidence is age-dependent [Disertori, 2006]. One estimate puts its prevalence in Europe at 4.5 million cases [Fuster, 2006], while in Italy it is estimated that there are 400,000 sufferers and 50,000 new cases every year [Disertori, 2006]. AF is more common in Caucasians than Africans [Ruo 2004]. There has been a 66% increase in hospitalization for AF in the last 20 years. This is due to the ageing population and to the increase in chronic cardiac diseases and an increased diagnostic capability in outpatients [Fuster, 2006].
AF is associated with sizeable increase in morbidity and mortality especially in asymptomatic patients. Risks of stroke, cardiac failure and cardiomiopathy caused by tachycardia are all increased by AF. In the US 15-20% of strokes may be associated with AF [Hart, 2000].
Patients with symptomatic AF have a lower quality of life with palpitations, chest pain, dyspnoea, fatigue and hypotension as main symptoms. On the basis of severity, several types of AF can be described as follows:
- paroxysmal: a patient with episodes lasting up to 7 days with spontaneous conversion to sinus rhythm;
- persistent: a patient with episodes lasting longer than 7 with conversion to sinus rhythm after pharmacological or electrical cardioversion;
- permanent: a patient with permanent AF.

AF presents itself with co-morbidities (such as hypertensive cardiopathy, ischaemic cardiopathy, cardiac failure, cardiomyopathies, mitral valve disease). However it can present itself in the absence of co-morbidities (isolated or idiopathic AF) in an estimated 15 to 30% of cases [www.fibrillazioneatriale.it]. In addition an estimated 50% of patients with mitral valve disease have associated AF. After heart surgery, 15-20% of cases convert into sinus rhythm without any specific anti-arrhythmic treatment [www.fibrillazioneatriale.it].

Number of Patients:

 

Technology - specialities(s):

Cardiovascular disease & vascular surgery

Technology - setting(s):

General hospital and ambulatory care

Setting - further information:

The procedure is carried out in hospital, in the cardiac surgery theatre or in the hybrid theatre (a sterile theatre with the equipment for the procedure).

Impact

Alternative and/or complementary technology:

Additive and substitution

Current Technology:

At present possible comparators are:
- Open chest surgery;
- Pharmacological treatment;
- Electrical cardioversion;
- Catheter ablation.

Health Impact:

The treatment of AF with the Epicor LP system using a mini thoracotomy aims at re-establishing sinus rhythm and cardiac frequency, minimize the risk of blood clots forming and the risk of stroke while intervening on the patient with minimal invasivity. In addition the use of HIFU allows intervention without cardiac arrest and is highly reproducible as the nature of the lesions caused by ablation is less operator-dependent than of those caused using previous devices. If the methods have equal effectiveness the risk of operator dependent failure is less (i.e., due to less dexterity, experience or concentration).

Diffusion:

The Epicor LP system has been on the Italian market since November 2008. At present the manufacturer reports only one centre active in mini-thoracotomy procedures, at the Luigi Sacco Hospital in Milan (10 cases had been operated on by June 2009).

Cost, infrastructure and economic consequences:

The price of the Epicor LP system recommended by St Jude Medical Inc. is based on the number of procedures carried out (approximately € 2.000-2.500 per procedure). The cost of each Epicor LP procedure borne by the user (health authority or hospital) is based on:
- The Epicor LP system made up of disposable items (circular ablation device, straight line ablation device, introducer and link cable) and by the ablation control system (usually provided in service);
- Staff costs.
The Epicor LP system should be used exclusively in cardiac surgery or hybrid theatres; it uses instruments which do not require structural changes. The control system does not occupy a sizeable space.
The procedure must be carried out by a team made up of: a cardiac surgeon, an assistant surgeon and possibly a third operator plus a machine operator (usually a nurse). Team members must undergo 1-2 days’ training in a centre recognized by the manufacturer (St. Jude Medical Inc).

Ethical, social, legal, political and cultural impact:

 

Evidence & Policy

Clinical evidence and safety:

We carried out a review of the literature to identify Horizon Scanning (HS) and rapid Health Technology Assessment (HTA) reports on minimally invasive ultrasound ablation. We only searched for English language documents in two databases CRD (Dare and HTA) and Euroscan. No reports were identified. The only other report [CEDIT, 2006] assessed the use of an ultrasound ablation system during open chest surgery (the device was Epicor by St.Jude Medical Inc). We carried out a review of the literature to identify single studies assessing minimally invasive ultrasound ablation using the main search engines EMBASE, Medline and Cochrane Library. We looked for studies in English published in the last 10 years but found none. As it is an emerging technology we also looked for evidence in grey literature (registers, abstracts and presentations).
We found no studies or evidence. We are aware that a report of the experience gained with the 10 cases is currently being written.

Economic evaluation:

 

Ongoing research:

 

Ongoing or planned HTA:

 

Web link:

http://www.agenas.it/cote.html

References and sources:

Aktas MK, Daubert JP, Hall B. Surgical atrial fibrillation ablation: a review of contemporary techniques and energy sources. Cardiol J. 2008;15(1):87-94.

CEDIT Recommendations, 2006; Ref. 05.13/Re1/06.

Disertori M, Alboni P, Botto G, et al. Linee guida AIAC per il trattamento della fibrillazione atriale. Gennaio 2006.

Fuster et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation.

Groh MA, Binns OA, Burton HG III, et al. Ultrasonic cardiac ablation for atrial fibrillation during concomitant cardiac surgery: long-term clinical outcomes. Ann Thorac Surg. 2007 Dec;84(6):1978-83.

Hart RG. Stroke prevention in atrial fibrillation. Curr Cardiol Rep. 2000 Jan;2(1):51-5.

Kannel WB, Benjamin EJ. Current perceptions of the epidemiology of atrial fibrillation.Cardiol Clin. 2009 Feb;27(1):13-24, vii.

Ninet J, Roques X, Seitelberger R, et al. Surgical ablation of atrial fibrillation with off-pump, epicardial, high-intensity focused ultrasound: results of a multicenter trial. J Thorac Cardiovasc Surg. 2005 Sep;130(3):803-9.

Reddy VY. Atrial fibrillation: unanswered questions and future directions. Cardiol Clin. 2009 Feb;27(1):201-16, x-xi.

Ruo B, Capra AM, Jensvold NG, et al. Racial variation in the prevalence of atrial fibrillation among patients with heart failure: the Epidemiology, Practice, Outcomes, and Costs of Heart Failure(EPOCH) study. J Am Coll Cardiol 2004;43:429 –35.

Schmidt B, Chun KR, Kuck KH, Antz M. Pulmonary vein isolation by high intensity focused ultrasound. Indian Pacing Electrophysiol J. 2007 Apr 1;7(2):126-33.

www.fibrillazioneatriale.it

www.sjm.com/

Notes:

This report is based on information available when the searches were made and does not contain data on subsequent developments or improvements of the evaluated technology. The observations made on effectiveness, safety or cost-effectiveness of the technology evaluated in the report are to be considered temporary.