Long-term results of plaque excision combined with aggressive pharmacotherapy in high-risk patients with advanced peripheral artery disease (SAVE a LEG registry).

BACKGROUND: In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce. METHODS: Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29-93) with SilverHawk(TM) plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR). RESULTS: The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with <30% residual stenosis achieved in 818 (98.9%) lesions. SilverHawk was used alone in 86.7%. No acute limb loss or major perforation occurred. Sixty (26.6%) patients had TLR. Long-term mortality was 16.4%. Seven (3.1%) patients had to undergo major amputations and 7 (3.1%) minor amputations. Seventy (31.1%) patients had a major adverse event. Atorvastatin 80 mg was found to be independent predictor of survival, and major amputation was found to be independent predictor of mortality. CONCLUSIONS: SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care.

Cardiva Catalyst II vascular access management device in percutaneous diagnostic and interventional procedures with same-day discharge (Catalyst II trial).

PURPOSE: To present a prospective, single-center trial of the Cardiva Catalyst II, a vascular closure device that provides temporary hemostasis after the procedure and is removed under manual compression, leaving no material behind. METHODS: During a 16-month period between April 2008 and July 2009, 400 procedures (100 interventions, 300 diagnostic procedures) were performed on 351 nonconsecutive patients (185 men; mean age 60.2 ± 12.0 years, range 27-93). All interventions were performed utilizing bivalirudin for anti-thrombin therapy. Initial follow-up was done at a mean 1.3 ± 0.7 days after the index procedure in all patients. Final follow-up, for diagnostic procedures as well as interventions, was performed at a mean 15.4 ± 7.1 days. The primary and secondary endpoints were the rate of major and minor vascular complications, respectively. RESULTS: Successful deployment of the device was reported in 397 (99.3%) procedures, which were primarily in retrograde fashion (97.0%) from the right groin (92.5%). In most cases (309, 77.2%), a 5-F sheath was used. A major vascular complication occurred after 1 intervention; none was noted after diagnostic procedures. Minor vascular complications were recorded after 2 interventions and 5 diagnostic procedures. Overall vascular complication rates were 0.25% for major sequelae and 1.75% for minor events. Mean time to discharge after diagnostic procedures was 145.0 ± 21.2 minutes versus 295.1 ± 44.1 minutes after interventional procedures (p < 0.05). There was no death, stroke, myocardial infarction, or urgent hospital transfer in the study cohort. CONCLUSION: Cardiva Catalyst is safe and effective device in achieving local hemostasis after percutaneous diagnostic procedures and interventions performed under bivalirudin anticoagulation. The use of this device with an appropriate protocol facilitates same-day discharge.

Image-guided automatic triggering of a fractional CO2 laser in aesthetic procedures.

BACKGROUND: Laser procedures in dermatology and aesthetic medicine are associated with the need for manual laser triggering. This leads to pulse overlapping and side effects. METHODS: Automatic laser triggering based on image analysis can provide a secure fit to each successive doses of radiation. A fractional CO2 laser was used in the study. 500 images of the human skin of healthy subjects were acquired. Automatic triggering was initiated by an application together with a camera which tracks and analyses the skin in visible light. The tracking algorithm uses the methods of image analysis to overlap images. After locating the characteristic points in analysed adjacent areas, the correspondence of graphs is found. The point coordinates derived from the images are the vertices of graphs with respect to which isomorphism is sought. When the correspondence of graphs is found, it is possible to overlap the neighbouring parts of the image. RESULTS: The proposed method of laser triggering owing to the automatic image fitting method allows for 100% repeatability. To meet this requirement, there must be at least 13 graph vertices obtained from the image. For this number of vertices, the time of analysis of a single image is less than 0.5s. CONCLUSIONS: The proposed method, applied in practice, may help reduce the number of side effects during dermatological laser procedures resulting from laser pulse overlapping. In addition, it reduces treatment time and enables to propose new techniques of treatment through controlled, precise laser pulse overlapping.

Treatment of symptomatic coronary artery disease in patients with end-stage renal disease on hemodialysis with paclitaxel-eluting TAXUS stent.

Percutaneous coronary intervention (PCI) utilizing drug-eluting stents is becoming a very common revascularization technique in the dialysis cohort; therefore, we sought to identify the impact of dialysis on outcomes in this group of patients. This is a multicenter registry comparing results of 290 patients (186 with normal kidney function, 104 on dialysis) who underwent PCI with exclusive use of paclitaxel-eluting TAXUS stent. The primary endpoint was an assessment of major adverse cardiac events (MACE) at 1- and 2-year observation. Mean follow-up was 23.3 ± 6.1 months. Results at 12 months showed: MACE 11.8% vs. 7.7% (P = not significant [ns]), composite major adverse cardiac and cerebrovascular events (MACCE) 12.4% vs. 11.5% (P = ns), all-cause death 2.7% vs. 8.6% (P < 0.05), cardiac death 2.7% vs. 1.9% (P = ns), target vessel revascularization (TVR) 9.1% vs. 6.7% (P = ns), acute myocardial infarction (AMI) 3.8% vs. 2.9% (P = ns), cerebrovascular events (CVA) 0.5% vs. 1.0% (P = ns); and results at 24 months showed: MACE 17.7% vs. 18.3% (P = ns), MACCE 21.5% vs. 26.0% (P = ns), all-cause death 4.3% vs. 14.4% (P < 0.01), cardiac death 3.2% vs. 1.9% (P = ns), TVR 14.0% vs. 16.3% (P = ns), AMI 5.4% vs. 5.8% (P = ns), CVA 3.2% vs. 2.9% (P = ns) for non-end-stage renal disease (ESRD) and dialysis group, respectively. Prior coronary artery bypass graft (CABG) was found to be single risk factor for MACE, TVR, and MACCE in patients with ESRD, while dialysis and prior CABG were found to be single risk factors for death in the entire population. PCI with TAXUS is a feasible procedure and presents promising results in dialysis-dependent patients.