Seco M, Martinez G, Edelman JJ, Ng HK, Vallely MP, Wilson MK, Ng MK
Int. J. Cardiol. 2015 Mar;201:587-589
PMID: 26334384
Position Statement for the Operator and Institutional Requirements for a Transcatheter Aortic Valve Implantation (TAVI) Program
Walters DL, Webster M, Pasupati S, Walton A, Muller D, Stewart J, Williams M, MacIsaac A, Scalia G, Wilson M, Gamel AE, Clarke A, Bennetts J, Bannon P
Heart Lung Circ 2014 Oct;
PMID: 25488705
Abstract
The Cardiac Society of Australia and New Zealand (CSANZ) and the Australia and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) have joined together to provide recommendations for institutions and individual operators to assess their ability to initiate and maintain a transcatheter valve program. Transcatheter aortic valve replacement has been developed as an alternative to traditional surgical replacement of the aortic valve in high risk patients, particularly the frail elderly. The position paper has endorsed the important role of a multi-disciplinary “Heart Team” in selecting patients for TAVI as fundamental to the establishment of a successful program. The paper outlines recommendations for the cardiologist to have a background in structural intervention and the surgeon to have experience in high-risk aortic valve replacement. It is further recommended that TAVI programs be established in high volume cardiac surgical centres where on site valve surgery is performed. The paper is intended to provide guidance to individual operators and prospective institutions considering the establishment of a successful TAVI program.
Transcatheter Valve-in-Valve Replacement in Complex Cyanotic Congenital Heart Disease With a Single Ventricle
Martínez GJ, Ng BH, Wilson MK, Pasupati S, Robinson DA, Cartwright BL, Adams MR, Celermajer DS, Ng MK
JACC Cardiovasc Interv 2014 Oct;7(10):e133-5
PMID: 25240545
Abstract
Extracorporeal membrane oxygenation for very high-risk transcatheter aortic valve implantation
Seco M, Forrest P, Jackson SA, Martinez G, Andvik S, Bannon PG, Ng M, Fraser JF, Wilson MK, Vallely MP
Heart Lung Circ 2014 Oct;23(10):957-62
PMID: 24954708
Abstract
BACKGROUND: Transcatheter aortic valve implantation (TAVI) can cause profound haemodynamic perturbation in the peri-operative period. Veno-arterial extracorporeal membrane oxygenation (ECMO) can be used to provide cardiorespiratory support during this time, either prophylactically or emergently.
METHOD: 100 TAVI procedures were performed between 2009 and 2013 in our institution. ECMO was used in 11 patients, including eight prophylactic and three rescue cases. Rescue ECMO was required for ventricular fibrillation after valvuloplasty, and aortic annulus rupture. The criteria for prophylactic ECMO included heart failure requiring stabilisation pre-TAVI, haemodynamic instability with balloon aortic valvuloplasty performed to improve heart function pre-TAVI, moderate or severe left and/or right ventricular failure, or borderline haemodynamics at procedure. Differences in preoperative characteristics and postoperative outcomes between ECMO and non-ECMO TAVI patients were compared, and significant results were further assessed controlling for EuroSCORE.
RESULTS: Compared to TAVI patients who did not require ECMO, ECMO patients had significantly higher mean EuroSCORE (51 vs. 30%, p.05). ECMO patients were more likely to develop acute renal failure than non-ECMO patients (36 vs. 8%, p<.05), which was most likely due to haemodynamic collapse and end-organ dysfunction in patients that required ECMO rescue.
CONCLUSIONS: Instituting prophylactic ECMO in selected very high-risk patients may help avoid consequences of intra-operative complications and the need for emergent rescue ECMO.
Systematic review of the cost-effectiveness of transcatheter aortic valve implantation
Indraratna P, Ang SC, Gada H, Yan TD, Manganas C, Bannon P, Cao C
J. Thorac. Cardiovasc. Surg. 2014 Aug;148(2):509-14
PMID: 24280719
Abstract
OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment to aortic valve replacement (AVR) for selected patients with severe aortic stenosis. The present systematic review was conducted to analyze the cost-effectiveness of this novel technique within reimbursed healthcare systems.
METHODS: Two reviewers used 7 electronic databases from January 2000 to November 2012 to identify relevant cost-effectiveness studies of TAVI versus AVR or medical therapy. The primary endpoints were the incremental cost-effectiveness ratio (ICER) and the probability of cost-effectiveness. The eligible studies for the present systematic review included those in which the cost-effectiveness data were measured or projected for TAVI and either medical therapy or AVR. All forms of TAVI were included, and all retrieved publications were limited to the English language.
RESULTS: Eight studies were included for quantitative assessment. The ICER for TAVI compared with medical therapy for surgically inoperable patients ranged from US$26,302 to US$61,889 per quality-adjusted life year gained. The probability of TAVI being cost-effective compared with medical therapy ranged from 0.03 to 1.00. The ICER values for TAVI compared with AVR for high-risk surgical candidates ranged from US$32,000 to US$975,697 per quality-adjusted life year gained. The probability of TAVI being cost-effective in this cohort ranged from 0.116 to 0.709.
CONCLUSIONS: Depending on the ICER threshold selected, TAVI is potentially justified on both medical and economic grounds compared with medical therapy for patients deemed to be surgically inoperable. However, in the high-risk surgical patient cohort, the evidence is currently insufficient to economically justify the use of TAVI in preference to AVR.
Transapical aortic valve implantation – an Australian experience
Seco M, Martinez G, Bannon PG, Cartwright BL, Adams M, Ng M, Wilson MK, Vallely MP
Heart Lung Circ 2014 May;23(5):462-8
PMID: 24315653
Abstract
BACKGROUND: The aim of this study was to report our initial experience with the transapical approach to transcatheter aortic valve implantation (TAVI) at an Australian institution.
METHODS: All patients with severe, symptomatic aortic stenosis were assessed by our multidisciplinary team. A total of 32 patients received a transapical TAVI using an Edwards SAPIEN prosthesis. Data were prospectively collected and analysed according to the Valve Academic Research Consortium version 2 guidelines.
RESULTS: Intraoperative outcomes included: 100% device success with no conversion to surgical valve replacement, extracorporeal membrane oxygenation was used electively in 15.6% and emergently in 6.3%, and no valve migration or malpositioning requiring prosthesis retrieval and re-implantation. Outcomes at 30 days post-TAVI included: No mortality, 3.1% myocardial infarction, no disabling stroke, 3.1% non-disabling stroke, no transient ischaemic attacks, 6.3% life-threatening bleeding, 15.6% major bleeding, 3.1% major vascular complications, and 12.5% postoperative acute kidney injury requiring renal replacement therapy. Mild paravalvular regurgitation was present in 29%, and there was no moderate or severe regurgitation. Mean follow-up time was 28.8±12.9 months. Cumulative results included: 9.4% mortality, 6.3% stroke, 6.3% myocardial infarction, and no repeat procedures. At one year postoperation, echocardiography demonstrated that the mean pressure across the prosthesis was 10.1±1.7mmHg, and the mean aortic valve area was 1.4±0.2cm(2).
CONCLUSION: Good short-term outcomes and low or zero mortality are achievable with transapical TAVI at an Australian institution.
The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): concept, design and rationale
Fanning JP, Wesley AJ, Platts DG, Walters DL, Eeles EM, Seco M, Tronstad O, Strugnell W, Barnett AG, Clarke AJ, Bellapart J, Vallely MP, Tesar PJ, Fraser JF
BMC Cardiovasc Disord 2014;14:45
PMID: 24708720
Abstract
BACKGROUND: The incidence of clinically apparent stroke in transcatheter aortic valve implantation (TAVI) exceeds that of any other procedure performed by interventional cardiologists and, in the index admission, occurs more than twice as frequently with TAVI than with surgical aortic valve replacement (SAVR). However, this represents only a small component of the vast burden of neurological injury that occurs during TAVI, with recent evidence suggesting that many strokes are clinically silent or only subtly apparent. Additionally, insult may manifest as slight neurocognitive dysfunction rather than overt neurological deficits. Characterisation of the incidence and underlying aetiology of these neurological events may lead to identification of currently unrecognised neuroprotective strategies.
METHODS: The Silent and Apparent Neurological Injury in TAVI (SANITY) Study is a prospective, multicentre, observational study comparing the incidence of neurological injury after TAVI versus SAVR. It introduces an intensive, standardised, formal neurologic and neurocognitive disease assessment for all aortic valve recipients, regardless of intervention (SAVR, TAVI), valve-type (bioprosthetic, Edwards SAPIEN-XT) or access route (sternotomy, transfemoral, transapical or transaortic). Comprehensive monitoring of neurological insult will also be recorded to more fully define and compare the neurological burden of the procedures and identify targets for harm minimisation strategies.
DISCUSSION: The SANITY study undertakes the most rigorous assessment of neurological injury reported in the literature to date. It attempts to accurately characterise the insult and sustained injury associated with both TAVI and SAVR in an attempt to advance understanding of this complication and associations thus allowing for improved patient selection and procedural modification.
