© AME Publishing Company. All rights reserved.Ann Cardiothorac Surg 2012;1(2):185-189www.annalscts.comIntroductionThe introduction of transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic valve disease in the elderly and high-risk population. Experiences and results around the World have varied widely and the importance of a multidisciplinary and cohesive heart team is mandatory in this challenging group of patients. Our Unit started a TAVI program (Edwards Sapien trans-femoral and trans-apical) some three years ago. We have now performed 70 procedures, with no procedural deaths and only three thirty day deaths, none of which were cardiac related. Some of this was good luck, but a lot of it was good management and a credit to the wider team involved. The aim of this paper is to offer some insight into the successful implementation of a TAVI program into the treatment armamentarium of a cardiovascular unit. Pursuing a TAVI program-a decision not to be taken lightlyTAVI is a highly resource and labor intensive procedure. The impact on other procedures and patients must be considered before embarking on a TAVI program. Intensive care unit pressures and effects on elective cardiac surgical procedures are especially important. The waiting list times for younger cardiac surgical patients may increase and there may be morbidity and mortality associated with this. However you may like to analyze it - TAVI is not cheap. There are multiple health economic models that can be used to justify TAVI, but there is no getting away from the fact that the prostheses are around $30,000 (AUD) and there are significant procedural related costs. The prostheses are not currently reimbursable under private health insurance schemes (in Australia) and the institution must bear the cost. A recent economic analysis of the Partner One Trial medically managed patients showed an almost doubling of costs in the Cohort B (TAVI) patients ($100,000 vs. $50,000) with a cost of $50,000 (USD) per life year extended for the TAVI cohort (1). These are philosophical as well as economic issues and must be weighed up when embarking on a TAV I program. There must be quarantined time for TAVI and this needs to be arranged well in advance. Maintaining communication between the Operating Room, Angiography Suite and Intensive Care to ensure bed availability and appropriate staff are rostered for the procedure is especially important. The procedure is ideally performed in a hybrid operating suite, however it is possible to use an angiography suite. It is imperative that the angiography suite has sufficient space to accommodate a surgical setup and an ECMO circuit (our preference over a full bypass machine). It is also important to have the ability to perform rescue surgery, prior to transfer to the operating room, within the confines of the angiography suite should the need arise.Obtaining permission-ethical and financialPrior to commencing a TAVI program, it is a requirement in most institutions to have the procedure approved by The Ethics Committee, The New Device and Procedures Committee and by The Hospital Administration (who control the finances). We recommend personal presentations to these committees after submitting carefully writtenapplications. It’s then important to educate and inform the wider PerspectiveHow to set up a successful TAVI programMichael P. Vallely1,2,3, Michael K. Wilson1,2, Mark Adams2,3,4, Martin K.C. Ng2,3,41Cardiothoracic Surgical Unit, Royal Prince Alfred Hospital, Sydney, Australia; 2The Baird Institute for Applied Heart and Lung Surgical Research, Sydney, Australia; 3Faculty of Medicine, The University of Sydney, Sydney, Australia; 4Department of Cardiology, Royal Prince Alfred Hospital, Sydney, AustraliaCorresponding to: Michael Vallely, PhD, FRACS. C/- Sydney Cardiothoracic Surgeons, Suite 304/100 Carillon Avenue, NEWTOWN NSW 2042, Australia. Email: michael.vallely@bigpond.com.Submitted May 25. Accepted for publication Jun 08, 2012.DOI: 10.3978/j.issn.2225-319X.2012.06.04
186Vallely et al. Implementation of a TAVI program © AME Publishing Company. All rights reserved.Ann Cardiothorac Surg 2012;1(2):185-189www.annalscts.commedical community on the benefits of TAVI and your group’s intention to pursue the therapy. Presentations involving surgeons and physicians at referring hospitals clinical meetings, to GP groups and a judicious use of the media to advertise the technology is important. Having a single point of referral is also important to make it easy for referring physicians and patients alike. The maintenance of a database to track and report results is extremely important. This should involve contribution to national and international registries. Data collection and management needs to be factored into the program from the outset. Training and proctoringThe two companies (Edwards Lifesciences and Medtronic) involved in the current commercially available TAVI technology are strict in their adherence to a structured training and proctoring algorithm for the teams involved in the delivery of TAVI. Several centers around the World have high volume TAVI workloads and provide a training and subsequent proctoring service (our Unit now provides proctoring for trans-apical TAVI). Training involves lecture and laboratory based education followed by live case observations. A number of proctored cases are then completed before the site is “signed-off” (usually 8-10 cases). The company involved usually allocates the training site and the subsequent proctors. However, it is important that there is a good synergy between the visiting and host teams. Advice and mentorship for the discussion of difficult cases in the initial post-proctored period is also valuable. It’s important that there is not too much delay between the training period and the commencement of the TAVI implants.The high-risk heart valve team-patient selection (and rejection)The concept and importance of the “Heart Team” is no more evident than in a TAVI program. The units that have a successful TAVI program have a high level of cohesion between all parties involved, from the referring physicians through to the procedural specialists. The Heart Team includes an interventional cardiologist, a non-interventional cardiologist, a cardiac surgeon, an anesthetist, an intensive care specialist and a geriatrician. An expert opinion from a vascular surgeon is useful in borderline peripheral access cases and for peripheral access rescue surgery should the need arise. TAVI is a procedure that requires multiple skill sets and it is often unpredictable when there will be significant complications that require the immediate input of all members. Patient selection and rejection can be challenging and is as much art as science. There have been several attempts to quantify “frailty” in the cardiac surgical patient, but much of this is derived from the geriatric literature and can be difficult to apply. All patients need to be assessed and investigated before being discussed at the high-risk heart valve multidisciplinary team meeting (MDT) (Figure 1). In our experience a higher number of patients are rejected rather than accepted for TAVI. We use balloon aortic valvuloplasty (BAV) liberally for several reasons. Firstly, it is a useful discriminator between shortness of breath from respiratory causes ie. it doesn’t improve the symptoms, and patients who improve dramatically with temporary relief of their aortic stenosis. BAV is also a useful bridge to definitive therapy, which allows a planned procedure and time to address other issues (coronary and carotid stenting as an example) and to allow for the considerable (up to six months) waiting time for the procedure. Some patients should be offered open AVR surgery, especially if they are medically fit and have concomitant cardiac issues such as coronary artery or mitral valve disease. Even more importantly, some patients should be offered medical therapy only, as the risk of TAVI may outweigh the benefit or the co-morbidities (particularly respiratory) may negate any benefit in improvement of symptoms that TAVI may confer. Indeed, many patients are referred and have an expectation (as does the referring physician) that “something” will be done, and it can be very difficult to manage patients and their families through a decision that no procedure can be offered. The PARTNER 1 (2) and PARTNER 2 (3) trials were important studies in the defining of patients that are appropriate for TAVI. Firstly, the PARTNER 1 patients were considered too high risk for open AVR and the higher risk patients (logistic EUROSCORE >30) had a very poor long-term survival, questioning the value (financial and affects on other resources) of the procedure in this cohort. The PARTNER 2 patients (potential surgical candidates) had equivalent results between open AVR and TAVI, with significantly less paravalvular leak in the open AVR group, suggesting that open AVR is superior in this population. Therefore it is important to try and find the “sweet spot” for the best use of TAVI (Figure 2). We feel that this is the patient group that has significant co-morbidities that