Long-Term Intracoronary Structural and Vasomotor Assessment of the ABSORB Bioresorbable Vascular Scaffold.

We systematically categorized the longer-term (≥3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 ± 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised in-segment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p <0.03 for all) were each independently associated with abnormal BVS endothelium-dependent vasomotor function. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction.

Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants.

OBJECTIVE: To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk. METHODS: Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR. RESULTS: We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant. CONCLUSIONS: In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs.