The ETTAA study protocol: a UK-wide observational study of 'Effective Treatments for Thoracic Aortic Aneurysm'.

INTRODUCTION: Chronic thoracic aortic aneurysm (CTAA) affecting the arch or descending aorta is an indolent but life-threatening condition with a rising prevalence as the UK population ages. Treatment may be in the form of open surgical repair (OSR) surgery, endovascular stent grafting (ESG) or best medical therapy (BMT). Currently, there is no consensus on the best management strategy, and no UK-specific economic studies that assess outcomes beyond the chosen procedure, but this is required in the context of greater demand for treatment and limited National Health Service (NHS) resources. METHODS AND ANALYSIS: This is a prospective, multicentre observational study with statistical and economic modelling of patients with CTAA affecting the arch or descending aorta. We aim to gain an understanding of how treatments are currently chosen, and to determine the clinical effectiveness and cost-effectiveness of the three available treatment strategies (BMT, ESG and OSR). This will be achieved by: (1) following consecutive patients who are referred to the teams collaborating in this proposal and collecting data regarding quality of life (QoL), medical events and hospital stays over a maximum of 5 years; (2) statistical analysis of the comparative effectiveness of the three treatments; and (3) economic modelling of the comparative cost-effectiveness of the three treatments. Primary study outcomes are: aneurysm growth, QoL, freedom from reintervention, freedom from death or permanent neurological injury, incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: The study will generate an evidence base to guide patients and clinicians to determine the indications and timing of treatment, as well as informing healthcare decision-makers about which treatments the NHS should provide. The study has achieved ethical approval and will be disseminated primarily in the form of a Health Technology Assessment monograph at its completion. TRIAL REGISTRATION NUMBER: ISRCTN04044627.

Midterm experience with modified Cabrol procedure: safe and durable for complex aortic root replacement.

OBJECTIVE: To evaluate the early and late outcomes of the modified Cabrol technique as a method of coronary reimplantation during complex composite graft replacement of the ascending aorta. METHODS: Between 1995 and 2012, 348 patients (mean age, 56 ± 14 years; 283 males and 65 females) underwent composite graft replacement of the ascending aorta, 40 of whom (mean age, 60 ± 12 years; 35 males and 5 females) had one or both coronary ostia reimplanted using a modified Cabrol technique with an 8- to 10-mm Dacron interposition graft. The mean clinical and radiologic (computed tomographic scan) postoperative follow-up was 39 months (range, 1-171 months), via our aortic database, patient interviews, and Social Security Death Index. RESULTS: Cabrol reimplantation was necessitated by reoperations with anatomically fixed coronary ostia (n = 16, 40%), severely displaced coronary arteries (n = 15, 37.5%), button calcification (n = 4, 10%), coronary anomalies (n = 3, 7.5%), and coronary aneurysm (n = 2, 5%). Of the operations, 20% (8 patients) were urgent interventions. Early mortality was 3 (7.5%) of 40, none related to the Dacron interposition graft. Total late mortality was 16.2%, also not related to the coronary graft. Actuarial survivals were 0.88 ± 0.05, 0.79 ± 0.07, and 0.73 ± 0.08 at 1, 3, and 6 years, respectively. Radiologic follow-up was available for 31 (83.8%) of the surviving patients and revealed that the interposition graft was widely patent in all. CONCLUSIONS: The modified Cabrol technique using a Dacron interposition graft showed good survival rates and excellent durability over time, confirmed radiographically. These data confirm that it is appropriate to use the Cabrol technique when technical complexity prevents bringing coronary buttons to the main aortic graft.

Are thromboembolic and bleeding complications a drawback for composite aortic root replacement?

BACKGROUND: Valve-preserving aortic root reconstruction is being performed with increasing frequency. Independent of durability concerns, enthusiasm for retaining the native valve is often championed on the presumption that composite graft replacement of the aorta will be complicated by thromboembolism and bleeding. Our goal in this late follow-up study is to determine if thromboembolism or bleeding, or both, are indeed problematic after composite aortic root replacement. METHODS: Between 1995 and 2011, 306 patients (mean age, 56±14 years) underwent composite graft replacement of the aorta. St. Jude mechanical valve conduits (St. Jude Medical, St Paul, MN) were used in 242 patients, and 64 received a biologic conduit. Long-term postoperative follow-up (mean, 56 months; range, 1 to 97 months) was performed through our Aortic Database, supplemented by patient interviews and use of the Social Security Death Index. RESULTS: Hospital mortality was 2.9% overall and 1.4% in the last 8 years. Kaplan-Meier curves showed freedom (±standard deviation) from bleeding, stroke, and distal embolism as 94.3%±1.7% at 5 years and 91.3%±2.4% at 10 years. Survival was 93.5%±1.8% at 5 years and 80.9%±4.6% at 10 years, which was not statistically different from that for an age- and sex-matched population in Connecticut. Freedom from reoperation of the aortic root was 99% at 10 years. CONCLUSIONS: Patients had excellent survival and few thromboembolic and bleeding complications after composite aortic root replacement. These data supporting minimal morbidity in the setting of well-established durability should be used to put alternative procedures, such as valve-preserving aortic root reconstruction, into context.