Thrombectomy and distal protection devices.

Visible distal embolization is a relatively rare complication during percutaneous coronary interventions but it may occur in 15-20% of angioplasties in saphenous vein grafts (SVG) and in thrombus containing lesions of native coronary arteries, especially in the setting of acute myocardial infarction (AMI). Mechanical thrombectomy devices and distal protection devices have been introduced to reduce the incidence of distal embolisation. Angiojet thrombectomy has shown positive outcomes in thrombus containing lesions when compared with intracoronary thrombolysis but a randomised trial failed to show benefit in the context of AMI. The X-Sizer, Excimer LASER and various simple aspiration thrombectomy catheters show promise in treatment of AMI with improvement shown in surrogate end-points such as resolution of ST-elevation but there have been no randomised trials large enough to demonstrate changes in hard clinical end-points. Distal protection devices have come to be routinely used during SVG treatment and, after the results of the SAFER and FIRE trials; they became a treatment recommendation in the recently issued European Society of Cardiology (ESC) guidelines. For AMI, these devices showed great promise in early single-centre studies which have been offset by the lack of clinical benefit in the multi-centre EMERALD trial. Proximal occlusion devices may further decrease the incidence of distal embolisation, especially in the treatment of totally occluded SVGs or native arteries, by reversing the blood flow and offering protection at a very early stage of the procedure before wire passage. Despite continuous technical improvement and a growing number of miniaturised thrombectomy devices and filters, because of the paucity of controlled large studies, it remains unclear whether these devices will remain limited to niche' applications or will become a regular companion to balloons and stents in mainstream angioplasty procedures.

[Pressure wire guide provisional coronary stent implantation].

OBJECTIVES: Whether coronary artery lesion successfully dilated by balloon angioplasty should be stented or not is unclear. The purpose of this study is to evaluate the provisional stent implantation method assessing residual ischemia by pressure wire. METHODS: Thirty-one patients with de-novo lesions suitable for stenting were enrolled in a pressure wire guided provisional stent study. The pressure wire was used to assess the fractional flow reserve(FFR) before and after balloon angioplasty. When the FFR after angioplasty was less than 0.75, stent implantation was planned. Patients with lesions consisting of an intermediate stenosis proximal to the target lesion, chronic total occlusion, bypass graft and left main lesion were excluded from the study. Stent implantation was permitted even if the FFR was more than 0.75 when the operator thought stenting was necessary. Medical treatment was given with aspirin 162 mg/day, cilostazol 200 mg/day for 6 months and additional ticlopidine 200 mg/day for a month after stenting the lesion. RESULTS: Target vessel was the left anterior descending coronary artery in 19 lesions, the right coronary artery in 3, and the circumflex coronary artery in 9. Stent implantation was performed in seven (23%) of 31 lesions and the other 24(77%) lesions were treated with only balloon angioplasty. The FFR before intervention was 0.58 +/- 0.16, and improved to 0.87 +/- 0.07 (p < 0.0001). Percentage diameter stenosis before intervention was 70.7 +/- 12.6% and improved to 20.1 +/- 13.3% (p < 0.0001) after intervention. There was no major cardiac event (death, coronary artery bypass grafting, myocardial infarction, stent thrombosis). Six months follow-up angiography was performed in 27 patients (87%). Angiographic restenosis (percentage diameter stenosis > or = 50%) was found in four patients (15%). A new lesion was found in two patients. Target vessel revascularization was performed in six patients (21%). CONCLUSIONS: Lesions successfully dilated by balloon angioplasty with FFR > or = 0.75 do not require stenting.

Successful thrombus removal using 6Fr hydrolyser thrombectomy catheter in acute myocardial infarction via radial artery.

The 6Fr Hydrolyser thrombectomy catheter for acute myocardial infarction (AMI) successfully removed a massive thrombus in the coronary artery in three patients. The 6Fr Hydrolyser catheter could be advanced into the right coronary artery with bare-wire methods via a 6Fr sheath at the radial artery. This approach suggests that the device can be an alternative method for thrombolysis in selected AMI patients with massive thrombus in the coronary artery.

Manufacturers' distribution of drug samples to a family medicine clinic.

The distribution of drug product samples by pharmaceutical companies to a family medicine clinic was studied. Data on all deliveries of drug samples to the clinic site of a university-affiliated family medicine residency program from November 1992 through December 1993 were collected. In addition, the 11 faculty family physicians were surveyed about their experiences with the deliveries of samples. Forty-three manufacturers delivered samples of 331 drugs during the 14-month study period. There were 366 visits by the drug company representatives, who made 1117 separate deliveries. The total value of the samples, based on the average whole-sale price, was $240,782. Twenty-nine percent of the drugs were nonformulary, and only 49% were stocked by the pharmacy. The physicians surveyed indicated that they were either usually or always asked to sign for samples they did not in fact request, that they usually did not know what was recorded on the receipts for samples that they signed, and that they seldom verified what was actually delivered. Pharmaceutical manufactures delivered large quantities of drug samples during the study period, and many of the drugs were nonformulary or not stocked by the pharmacy. The physicians indicated that they were not well informed about delivered samples for which they signed receipts.