Final report of the European multi-center registry using the Duett vascular sealing device.

Duett, a novel vascular sealing device, was first clinically used in July 1997. A European multi-center registry was established to evaluate the safety and procedural success of the Duett sealing device in a broad range of patients undergoing diagnostic or interventional endovascular procedures. At 25 European sites 1587 patients were enrolled. All patients (> or = 18 years) must have given informed consent for the use of the sealing device after a diagnostic and/or interventional endovascular procedure performed via a femoral arterial approach. Standard length (< or = 10 cm) 5 to 9 F introducer sheaths had to be used. An ACT of < or = 400 s, and any approved GP IIb/IIIa platelet receptor antagonist was permitted. Successful deployment could be achieved in 96.2% (1526/1587 patients) with complete hemostasis within 2 to 5 minutes in over 95% of the patients. The complication-free rate was 96.4%. Arterial occlusions were rare (4 patients) and successfully treated with surgical repair in 1 and with thrombolysis in 3 patients. Pseudoaneurysms occurred in 34 patients, the majority (30/34) were successfully treated with ultrasound-guided compression or resolved spontaneously. The total rate of major complications was 2.6% (41/1587). The final results of the European registry demonstrate that the Duett sealing device can be used with a high procedural success following diagnostic and interventional endovascular procedures. The incidence of major complications is low and comparable to all other approved vascular closure devices and manual compression. CE-mark certification was approved at the end of 1998.

[Angioplasty in acute myocardial infarction]. / Angioplastikk ved akutt hjerteinfarkt.

20 patients with acute myocardial infarction and a medical history of less than six hours were treated with immediate percutaneous transluminal coronary angioplasty. The median time from start of symptoms until establishment of reperfusion of the infarct related artery was 190 minutes, and the time from admission to insertion of the balloon was 52 minutes. Angioplasty was successful in all patients, with no serious complications. All patients experienced pain relief immediately after angioplasty. No patients died or had further infarctions. None needed hospitalization during the first three months of follow up. Eight patients had an exercise test between five and seven days after angioplasty and the other 12 at their six-week check up; there were no signs of ischemia or anginal pain. Measurement of global ejection fraction one week and six weeks after treatment showed median normal values and no significant changes (58% versus 57%). Myocardial perfusion imaging was carried out in eight patients both before hospital discharge and six weeks later. Normalization and improvement was seen in six patients using this method, whereas the perfusion was found unaltered in two patients. Hibernation or stunning, or both are suggested as possible explanations for this. We found the method highly effective and safe in selected patients.

Coronary angioplasty using a low osmolar nonionic contrast medium. A retrospective angiographic and clinical evaluation.

This study was performed to investigate the occurrence of acute angiographic and clinical complications following PTCA using a low osmolar nonionic contrast medium. Five hundred consecutive PTCA procedures were analyzed retrospectively. The incidence of acute in laboratory complications during PTCA as well as complications occurring during the hospital stay 24 to 48 hours after the procedure were recorded. Occlusion of the dilated artery or a side branch was observed in 19 (3.8%) of the procedures, major dissection in 34 (6.8%), and thrombus in 14 (2.8%). One patient died, 6 (1.2%) required emergency coronary artery bypass grafting (CABG), 4 (0.8%) required an emergency PTCA, and 7 (1.4%) suffered myocardial infarction (MI). Our results show that angiographic findings of thrombus, major dissection and occlusion were serious conditions that related to the clinical complications MI, emergency CABG and re-PTCA. Patients with unstable angina were risk patients for both angiographic and clinical complications. Low rates of intraarterial thrombus formation and coronary artery occlusion indicate good angiographic technique and anticoagulant and antiplatelet medication.

[Balloon therapy of mitral stenosis]. / Ballongbehandling av mitralstenose.

The authors describe the technique of percutaneous balloon mitral valvuloplasty and the results in the first 12 patients treated in Norway. One patient experienced a serious complication, but has later been treated successfully. The average maximal gradient and mean gradient were reduced from 21 mm Hg to 8 mm Hg and from 12 mm Hg to 4 mm Hg respectively. The average size of the valve orifice increased from 1.0 cm2 to 2.2 cm2. Echo-cardiographic follow-up after one year revealed no restenoses. The indications and contraindications are discussed.

Influence of renal angiography in living potential kidney donors.

The angiograms of 258 potential kidney donors were retrospectively reviewed to assess the influence of angiography for deciding whether or not to accept the potential donor for nephrectomy and which kidney to use for transplantation. Twenty-five potential donors were rejected. In only 8 of these was angiography necessary to reveal the pathology. Angiography was found to be important in deciding which kidney to donate. In 81 donors the right kidney was used for donation and in 50 this decision was based on findings at angiography.