Initial results of the Quanam drug eluting stent (QuaDS-QP-2) Registry (BARDDS) in human subjects.

Thirty-two patients presenting with varied coronary syndromes and anatomy were treated with a new coronary multisleeve drug delivery coronary stent (QuaDS-QP-2) containing up to 4,000 microg of a taxol-derived lipophilic microtubule inhibitor (QP2). The device was successfully implanted in 32 patients who have been followed for up to 2 years. Twenty-five patients have undergone stress ECHO or SPECT Thallium and all are currently asymptomatic. Thirteen patients have already been restudied angiographically, by IVUS and/or by SPECT Thallium testing and are detailed in this report. Angiographic, IVUS, and SPECT Thallium have been controlled at a mean of 11.2 months (range, 6-15 months) in this 13-patient cohort. Although all 13 QuaDS-QP-2 (QDES) stents were angiographically and IVUS patent, two reinterventions have been required in the 32-patient study group thus far, both relate to either new disease or to distal, small-vessel disease beyond the stent. There was no evidence of significant proliferation in the QDES devices. On the basis of this preliminary data and a European pilot study, a controlled randomized trial (SCORE) is currently in progress in western Europe.

Novel drug-delivery stent: intravascular ultrasound observations from the first human experience with the QP2-eluting polymer stent system.

BACKGROUND: The aim of this study was to use serial intravascular ultrasound (IVUS) to evaluate the long-term effect of stent-based 7-hexanoyltaxol (QP2, a taxane analogue) delivery on neointimal tissue growth within the stent and on vessel dimensions at the adjacent reference segments. METHODS AND RESULTS: Serial IVUS analyses (immediately after intervention and at follow-up at 8.3 months) were performed in 15 native coronary lesions treated with the QuaDS-QP2 stent. IVUS measurements were performed at 8 cross-sections in each target segment (4 cross-sections within the stent and 2 cross-sections in each reference segment). At baseline, no significant plaque protrusion or thrombus was detected in the target segment. Mild incomplete stent apposition and edge dissection were observed in one and two cases, respectively. Percent expansion of the stent (minimum stent area/average reference lumen area) was 96.0+/-21.7%. At follow-up, mean neointimal area within the stent was 1.2+/-1.3 mm(2), and mean cross-sectional narrowing (neointimal area/stent area) was 13.6+/-14.9%. At the vessel segments immediately adjacent to the stent, a significant increase in plaque area (1.9+/-2.6 mm(2), P=0.001) was observed, but vessel area remained unchanged. However, no patients showed clinically significant in-stent or edge restenosis (diameter stenosis >/=50%) during the follow-up period. CONCLUSIONS: The first human experience with the new drug-delivery stent showed a minimal amount of neointimal proliferation in the stented segment. Late lumen loss at the reference sites adjacent to the stent was acceptable and predominantly due to plaque proliferation.

Loud systolic and diastolic murmurs originating on a right atrial metastatic tumor.

A 36-year-old asymptomatic man, who two months before had a normal clinical examination, developed two loud, grade 5/6 harsh systolic and diastolic murmurs, audible over the entire precordium. Two-dimensional echocardiography revealed a huge tumoral mass, attached to the right atrium near the tricuspid valve, pedicellated and of great mobility, reaching the right ventricular outflow tract during diastole, and coming back to the atrium in systole. Right-sided angiography confirmed the diagnosis, and after ablation of the tumor, the auscultation was normal again. Two loud murmurs constitute a quite uncommon manifestation of an intracavitary mass, and this unusual finding has not previously reported in the medical literature available to the authors.

Transbrachial selective arteriography of the neck vessels: our experience in 258 cases.

We have developed a catheter that facilitates the study of the neck vessels via a brachial arteriotomy so that other vascular areas (heart, kidneys, etc) can be studied in the same procedure. The catheter has a preformed curvature with a tapered, closed-end distal tip. We have successfully utilized this catheter in 258 consecutive patients, 133 (52%) of whom had undergone concurrent studies of other vascular areas, usually cardiac catheterization with coronary arteriography. No major complications occurred with the use of this catheter. We have found that with this catheter we can study the neck vessels via the brachial approach safely and easily and perform studies of other vascular areas using the same arteriotomy.