Restrictive ruling on cardiac procedure

Source: Edwards Lifesciences

The interdisciplinary G-BA justified a decision to restrict TAVI procedures to hospitals with cardiac surgery departments and wards by stating that complications following the procedure cannot be ruled out, and that in-patient aftercare provided by heart surgeons is therefore a necessity. The decision was taken in the context of a new G-BA guideline that sets minimum standards for minimally invasive aortic valve interventions in German hospitals.

Heart surgeons have therefore asserted themselves over their cardiologist colleagues with a demand that TAVIs should only be carried out in heart centres with cardiac surgery on-site, as per recommendations defined in the European Guidelines on Management of Valvular Heart Disease. In a position paper published last year, the cardiologists had argued in favour of allowing heart centres without cardiac surgery departments on-site to continue performing these interventions under certain conditions and in the presence of a cardiac surgeon (www.healthcare-in-europe.com/en/article/11713-transcatheter-aortic-valve-implantations-tavi.html).

As expected, when the decision was announced Professor Jochen Cremer, President of the German Society for Thoracic and Cardio­vascular Surgery (DGTHG), welcomed this move. Professor Christian Hamm, President of the German Cardiac Society (DGK) also views the G-BA guidelines, along with the mentioned quality criteria listed in the DGK position paper, as a positive contribution towards quality assurance for TAVIs in Germany.

According to Hamm, there are currently 11 Heart Centres without cardiac surgery departments on site that carry out TAVIs - treating fewer than 5% of all patients undergoing this type of procedure. According to the definition of the G-BA interim arrangements, the centres are to continue with the provision of cardiac surgery through cooperation agreements until June 2016.

As for the indication for treatment, the new G-BA guideline confirms the guidelines as well as national and international recommendations currently in force. For patients with a low risk score, open surgery remains the procedure of choice; TAVIs should only be carried out for older patients and those classed as inoperable.

The Federal Ministry of Health is expected to pass the new G-BA guideline in coming months; only then will it be legally binding.

29.04.2015

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