The TAVI Debate

A view from: Dr. A. Sampath Kumar, Editor, Asian Cardiothoracic Annals, Sage Publications.

New technology is fascinating. It is exciting and inviting to participate. Nowhere is this more widespread than in medicine, and, particularly in cardiovascular therapeutics. 

However, it is becoming increasingly important to regulate the spurt in such high technology procedures. The onus lies with our own professional Associations. It is therefore very encouraging to note that a recent publication in all the cardiovascular journals has put forward strict guidelines for Cardiologists, Surgeons and Institutions to be registered for the development of this program of TAVI. These guidelines translate into strict criteria for institutions, departments and for selection of patients for this procedure, with the proviso that those who in breach of these guidelines, including the Industry may be debarred from performing or publishing such results.

Transcatheter Aortic Valve Implantation (TAVI) is here to stay. As a cardiovascular surgeon I acknowledge that it has a place in the management of patients with severe Calcific Aortic Stenosis(AS) who are truly inoperable. Where affordable, this high-tech procedure can offer relief of suffering for the brief life span that such patients are likely to enjoy. It is, however, a high risk procedure. It is technology intensive requiring highly sophisticated imaging instrumentation and skills. Furthermore, it is highly expensive compared to the well-established Gold Standard surgical AVR. It can offer short-term benefits albeit with high risk of mortality and complications such as stroke, embolic phenomenon and peripheral vascular complications. However, it may be the last choice for seriously ill patients with AS. 

The extension of this technology to new indications and to patients who are clearly operable is truly transgressing ethical considerations. The implications are serious and the outcomes affect innocent patients who may be ‘lured’ into accepting the procedure.

So, for who is this procedure appropriate? It is to be reserved for the elderly patient (depending on populations statistics – generally, over 75 yrs) who have co-morbidities such as pulmonary insufficiency, morbid obesity, acute or chronic renal failure or a malignancy and receiving immunosuppressant drugs or chemotherapy. The decision is to be made by a pre-constituted panel for the purpose and includes patients’ relatives. All other patients can be offered surgical AVR with better outcomes and lower mortality and morbidity. TAVI is reported to carry a 20 to 24 % procedural mortality and risk of complications.

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