Eur J Cardiothorac Surg 2007;32:201. doi:10.1016/j.ejcts.2007.05.002
Copyright © 2007, European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved
Editorial comment
Fontan completion without surgery
Marc R. de Leval*
84 Harley Street, London W1G 7HW, United Kingdom
* Corresponding author. Tel.: +44 20 7034 8806; fax: +44 20 7034 8808. (Email: marc.deleval{at}hcahealthcare.co.uk).
Completing a total cavopulmonary connection (TCPC) by interventional cardiac catheterisation has been suggested more than 10 years ago. Its feasibility has been demonstrated by a few animal and clinical studies. The article by Sallehuddin et al. [1] published in this issue of the journal provides some refinement and additional support for this evolving line of management. It also raises a number of questions related to the introduction of new interventional technologies. The feasibility of the procedure has been demonstrated and further technical innovations are expected to make it more reproducible and more effective. Where do we go from now? In this day and age of evidence-based medicine, some would argue that making arbitrary decisions about the effectiveness of interventions based on observational evidence is not acceptable. Should a multi-institutional randomised controlled trial (RCT) comparing surgical and catheter-based completion of the TCPC be initiated? Should a trial take place, with what should the interventional TCPC completion be compared? Lateral tunnel and/or extracardiac conduit? The interventional procedure is a completion of the lateral tunnel which is currently performed in a minority of TCPCs. A scientific comparison between the surgically created lateral tunnel and extracardiac conduit is not available. The confounding variables, such as the underlying cardiac diagnosis, may have a greater impact on the long-term results than the type of procedure performed to complete the TCPC.
Should an RCT take place, when should it start in the context of comparing an evolving technology with an established surgical procedure? If the RCT is undertaken too early, the result of the trial may become obsolete. If undertaken later, equipoise may be lost as the technique becomes established (or rejected) in clinical practice. Randomisation should begin as soon as it is feasible. It is possible to extend a trial in the light of new developments and conduct tracker trials which include randomised comparison of two generic technologies and an observational study of differences within these broad types of treatment [2,3]. The endovascular aneurysm repair trial, which would not be very dissimilar to an interventional Fontan completion trial, was based on the tracker trial concept [4].
Should an RCT take place, what should be the end points? Amongst others they should certainly include detailed short-term and long-term flow dynamics, the incidence of reinterventions, the incidence of thromboembolic complications, arrhythmias, residual defects, etc. One can assume that refinement in the technologies will abolish the residual shunts. Incidentally, it is interesting to note that in two short published clinical series the incidence of pleural effusions seems to be less than following surgical completion of TCPCs. Could there be an analogy with the higher incidence of pericardial effusion following surgical closure of secundum atrial septal defects compared to interventional closure?
This article also highlights the ever-increasing importance of the multi-disciplinarity in the management of cardiovascular disorders. Progress and success rely on a harmonious collaboration between interventional cardiologists and surgeons. This medical/surgical collaboration comes under various caveats. In this instance, the surgeon, as John the Baptist, paves the way for the cardiologists. In other instances, the interventional and surgical procedures take place during the same session. Those are often referred to as hybrid procedures. The development of rescue procedures for failed interventional procedures has opened a new surgical field. The most subtle and critical part of this collaboration resides in the selection between catheter based or surgically based procedures when they are both available and established. Too often, the decision is made by those who possess the technical skills of one procedure rather than by a multidisciplinary team, and consequently the best interest of the patient is not necessarily served.
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References
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- Sallehuddin A, Al Mesned A, Al Barakati M, Al Fayyadh M, Al Fadley F, Al Halees Z. Fontan completion without surgery. Eur J Cardiothorac Surg 2007;32:195-200.[Abstract/Free Full Text]
- Lilford R, Braunholtz D, Greenhalgh R, Edwards S. Trials and fast changing technologies: the case for tracker studies. BMJ 2000;320:43-46.[Free Full Text]
- Lilford R, Braunholtz D, Harris J, Gill T. Trials in surgery. Br J Surg 2004;91:6-16.[Medline]
- EVAR Trial Participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR Trial 1): randomised controlled trial. Lancet 2005;365:2179-2186.[CrossRef][Medline]
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