Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

PURPOSE: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). METHODS: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. RESULTS: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. CONCLUSION: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

The cost-effectiveness of a new percutaneous ventricular assist device for high-risk PCI patients: mid-stage evaluation from the European perspective.

OBJECTIVE: A new and smaller percutaneous ventricular assist device (pVAD, Impella, Abiomed, Danvers, MA) has been developed to provide circulatory support in hemodynamically unstable patients and to prevent hemodynamic collapse during high-risk percutaneous coronary interventions (PCI). The objective of the study was to assess the cost-effectiveness of this specific device compared to the intra-aortic balloon pump (IABP) from the European perspective. Additional analysis on extracorporeal membrane oxygenation was conducted for observational purposes only, given its use in some European countries. METHODS: A combination of a decision tree and Markov model was developed to assess the cost-effectiveness of the small, pVAD. The short-term (30-day) effectiveness and safety (early survival, risk of bleeding, and stroke) were modeled, as well as long-term risk of major adverse cardiovascular events (recurrent myocardial infarction, stroke, and heart failure). The short-term effectiveness and safety data for the device were obtained from two registries (the Europella and USpella), both of which are large multi-center studies in high-risk patient groups. Probabilities of long-term major adverse cardiovascular events were obtained from various published clinical studies. The economic analysis was conducted from a German statutory health insurance perspective and only direct medical costs were included. Cost-effectiveness was estimated over a 10-year time horizon. RESULTS: Compared with IABP, the pVAD generated an incremental quality-adjusted life-year (QALY) of 0.22 (with Euro-registry data) and 0.27 (with US-registry data). The incremental cost-effectiveness ratio (ICER) of the device varied between €38,069 (with Euro-registry data) and €31,727 (with US-registry data) per QALY compared with IABP. KEY LIMITATIONS: Unadjusted, indirect comparisons of short-term effectiveness and safety between the interventions were used in the model. Cost and utility data were retrieved from various sources. Therefore, differences in patient populations may bias the estimated cost-effectiveness. CONCLUSIONS: Compared with IABP, the pVAD is a cost-effective intervention for high-risk PCI patients, with ICERs well-below the conventional cost-effectiveness threshold.