Galician Agency for Health Technology Assessment (AVALIA-T) released four Med Tech-related health technology assessments in the first half of 2017

In the first half of 2017, Galician Agency for Health Technology Assessment (AVALIA-T) published 4 HTAs for medical technologies and procedures including Impella ventricular assist device in cardiogenic shock, microwave ablation for tumors of the liver, microsurgery in limb lymphedema and intravitreal injections. Read high-level conclusions from these assessments below.

Percutaneous circulatory support Impella® CP (4.0) in patients with cardiogenic shock

The health technology assessment was performed with a systematic literature review of efficacy and safety evidence for technology and review of clinical guidelines and economic evaluations.

Published evidence for Impella® CP in the management of cardiogenic shock was found limited. Analysis of safety evidence demonstrated that Impella® CP devices have similar rates of adverse events in comparison with intra-aortic balloon counterpulsation except severe bleeding that may be more frequent in patients treated with Impella® CP. Efficacy data showed that mortality rate in the short-term period (<30 days) and medium-term period (6 months) was similar in both groups, standing around 40-50%. No economic evaluations were identified.

Review of ongoing clinical trials identified phase III study where Impella® CP is compared to standard treatment in the management of acute myocardial infarction complicated by cardiogenic shock. It was stated that new evidence after completion of this study could provide further information on safety, effectiveness, and cost-effectiveness for these devices.

Microwave ablation for treatment of tumors of liver

The work for assessment of microwave ablation begun after the request of the Xerence Integrated Management of A Coruña and the Radiodiagnostic / Ultrasound Service (Hospital Clínico Universitario de A Coruña) to evaluate available evidence of safety and effectiveness compared to radiofrequency ablation in the treatment of hepatocellular carcinoma and liver metastases. Systematic literature review demonstrated that evidence for technology is limited and based mainly on observational studies of low methodological quality. Efficacy and safety of procedure were similar to radiofrequency ablation. Microwave ablation was considered as more effective than radiofrequency ablation in patients with the size of liver tumor about 3-6 cm. In conclusion, conduction of randomized controlled trial was recommended for collecting data with high methodological quality and results from this study can be extrapolated in clinical practice.

Effectiveness and safety of microsurgery in limb lymphedema

This assessment report was carried out at the request of the National Health System Interterritorial Council’s Services, Insurance & Finance Committee and was aimed to assess microsurgical reconstructive techniques via lymphatic venous anastomosis (LVA) and via autologous lymph node transfer (ALNT) in secondary lymphedema among patients who do not respond to conservative treatment.

Review of evidence showed that there are no studies of sufficient quality which would allow definitive conclusions to be drawn. However, available data suggested the hypothesis that ALNT may achieve better results than LVA and that such results, in turn, could be better in the upper than in the lower extremities.

Intravitreal injections. Effectiveness and safety based on the place of the procedure

The objective was to evaluate safety and effectiveness of intravitreal injections, depending on the location of administration, operating theatre vs. consulting or clean room. Authors concluded that intravitreal injections could be administered both in operating theatres and in consulting or clean rooms, provided that a series of aseptic measures are implemented in line with the indications contained in the company core data sheets. However, costs generated by IVI administered in operating theatres were higher than those administered in consulting or rooms due, above all, to the increase in staff.

See the full list of reports for the 2017 year here.

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