Intracoronary local paclitaxel delivery by X-ray contrast media for in-stent restenosis: a clinical pilot study to assess safety and tolerability.

AIM: Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and clinical trials. In the porcine overstretch model paclitaxel dissolved in the contrast medium iopromide inhibited neointimal proliferation in a dose-dependent manner after intracoronary injection and was well tolerated. METHODS: As a first step entering clinical development, a phase I trial was performed using four ascending paclitaxel dose/concentration levels: samples of up to 100 mL of the contrast medium (iopromide) containing 10, 50, 100 or 200 µM paclitaxel or iopromide (controls) were randomly administered to patients assigned to bare metal stent implantation for single de novo coronary artery lesions. Safety variables, tolerability and angiographic parameters were assessed. RESULTS: Adverse events, ECG, systolic and diastolic blood pressure, left ventricular ejection fraction, leukocyte count, other hematological or clinical chemistry data did not reveal any trend which could be related to the study medication. Short-lasting serum paclitaxel concentrations remained significantly below those known from cancer therapy. Angiographic late lumen loss was 0.72±0.50 mm (N.=7) in controls versus 0.45±0.65 mm (N.=17) in all paclitaxel-treated patients; binary restenosis rate was 5/7(63%) versus 6/17 (35%) and target lesion revascularization rate was 4/8 (50%) versus 4/24 (17%). CONCLUSION: Intracoronary infusion of paclitaxel dissolved in an X-ray contrast medium was well tolerated. The results show restenosis inhibition, but the number of patients examined was too small to demonstrate a statistically significant inhibition.

[Left atrial myxoma: second recurrence 20 years after the first operation]. / Linksatriales Myxom: zweites Rezidiv 20 Jahre nach der ersten Operation.

We report about a 52-year old woman, who underwent a resection of a left atrial myxoma 20 years ago. Twelve years later she suffered from exertional dyspnea. Echocardiography revealed a recurrent myxoma. This was resected. Eight years later the woman suffered from disturbances of heart rhythm and from angina pectoris. The coronary arteries were normal, but a recurrent left atrial myxoma was found and operated. We conclude a long-term follow-up is inevitable in patients after the resection of a myxoma.

[Evaluation of regional wall motion abnormalities of the heart--comparison with doppler tissue echocardiography, MR-tagging and levocardiography]. / Beurteilung regionaler Wandbewegungsstörungen des Herzens--Vergleich von Gewebe-Doppler-Echokardiographie, MR-Tagging und Lävokardiographie.

PURPOSE: To compare the visual analysis of magnetic resonance imaging (MRI) with the tagging technique and Doppler tissue echocardiography with invasive ventriculography in detecting and quantifying regional left ventricular wall motion abnormalities. MATERIALS AND METHODS: Sixteen patients with coronary artery disease and a history of prior myocardial infarction underwent invasive ventriculography, Doppler tissue echocardiography and MR-tagging within one week. Regional wall motion abnormalities (WMA) were detected in all patients. WMA were graded as normal = 1; hypokinetic = 2; akinetic = 3; or dyskinetic = 4. For agreement between MRI, echocardiography, and ventriculography the kappa coefficient (kappa) according to Cohen was calculated. RESULTS: The kappa coefficient (kappa) was 0.962 for agreement between MRI and echocardiography and 0.602 for agreement between MRI and ventriculography as well as between echocardiography and ventriculography. CONCLUSION: Reliable analysis of regional left ventricular wall motion abnormalities is feasible using visual analysis of MR-tagging. MRI and Doppler tissue echocardiography detect more WMA than invasive ventriculography and grade them as more severe.

Multislice CT coronary angiography: evaluation of an automatic vessel detection tool.

PURPOSE: To investigate the potential of a new detection tool for multislice CT (MSCT) coronary angiography with automatic display of curved multiplanar reformations and orthogonal cross-sections. MATERIALS AND METHODS: Thirty-five patients were consecutively enrolled in a prospective intention-to-diagnose study and examined using a MSCT scanner with 16 x 0.5 mm detector collimation and 400 ms gantry rotation time (Aquilion, Toshiba). A multisegment algorithm using up to four segments was applied for ECG-gated reconstruction. Automatic and manual detection of coronary arteries was conducted using the coronary artery CT protocol of a workstation (Vitrea 2, Version 3.3, Vital Images) to detect significant stenoses (> or = 50 %) in all segments of > or = 1.5 mm in diameter. Each detection tool was used by one reader who was blinded to the results of the other detection method and the results of conventional coronary angiography. RESULTS: The overall sensitivity, specificity, nondiagnostic rate, and accuracy of the automatic and manual approach were 90 vs. 94 %, 89 vs. 84 %, 6 vs. 6 %, and 89 vs. 88 %, respectively (p = n. s.). The vessel length detected with the automatic and manual approach were highly correlated for the left main/left anterior descending (143 +/- 30 vs. 146 +/- 24 mm, r = 0.923, p < 0.001), left circumflex (94 +/- 35 vs. 93 +/- 33 mm, r = 0.945, p < 0.001), and right coronary artery (145 +/- 36 vs. 144 +/- 37 mm, r = 0.925, p < 0.001). The time required to create reformations along the coronary arteries was significantly shorter with the automatic tool compared to the manual approach (203 +/- 77 vs. 391 +/- 104 sec, p < 0.005). In 90 % of the coronary branches automatic detection required less time than the manual approach. CONCLUSION: Automatic coronary vessel detection is feasible and reduces the time required to create reformations by a factor of approximately two without deteriorating the diagnostic accuracy.

[Left ventricular pseudoaneurysm after mitral valve replacement]. / Linksventrikuläres Pseudoaneurysma nach Mitralklappenersatz.

We report about a woman with a rare complication after mitral valve replacement 24 years ago. The patient had a massive hemorrhage some hours after operation. We performed invasive diagnostics because of an increasing pressure gradient across the prosthesis and revealed a left ventricular pseudoaneurysm. Before the planned reoperation the patient died suddenly. As the cause of death, we assumed a rupture of the pseudoaneurysm.

Clinical and angiographic acute and follow up results of intracoronary beta brachytherapy in saphenous vein bypass grafts: a subgroup analysis of the multicentre European registry of intraluminal coronary beta brachytherapy (RENO).

OBJECTIVE: To assess clinically and angiographically the feasibility, safety, and effectiveness of vascular brachytherapy (VBT) in saphenous vein bypass grafts (SVG). PATIENTS AND METHODS: 67 of 1098 (6.1%) consecutive patients of the European registry of intraluminal coronary beta brachytherapy underwent treatment for 68 SVG lesions by VBT using a Sr/Y(90) source train (BetaCath). Clinical follow up data were obtained for all of them after a mean (SD) of 6.3 (2.4) months and angiographic follow up was performed in 61 patients (91.0%) after 6.9 (2.0) months. RESULTS: 58 (86.6%) patients were men, their mean (SD) age was 66 (10) years, 28 (41.8%) had unstable angina, and 21 (31.3%) had diabetes. Fifty three (77.9%) lesions were in-stent restenosis, 13 (19.1%) de novo lesions, and 2 (3.0%) non-stented restenotic lesions. Mean (SD) reference diameter before the intervention was 4.19 (0.52) mm, mean (SD) lesion length was 23.56 (20.38) mm, and mean (SD) minimum lumen diameter measured 0.73 (0.62) mm. Mean (SD) acute gain was 3.02 (0.88) mm. The prescribed radiation dose was 20.1 (3.2) Gy. Pullback manoeuvres were performed in 17 (25.0%) of cases. Most patients received combined aspirin and thienopyridin treatment for 6 or 12 months after the procedure. Technical success was obtained in 62 (91.2%) treated lesions and in-hospital major adverse cardiac events occurred in 4.5%. At follow up, mean (SD) reference diameter was 4.20 (0.53) mm, minimum lumen diameter 2.94 (1.50) mm, and late loss 0.86 (1.25) mm. The overall major adverse cardiac events rate was 26.7%. CONCLUSION: VBT of SVG is feasible and safe. At follow up the reintervention rate and cardiac morbidity and mortality seem to be favourable, considering that interventions in SVG usually are associated with the highest risks.

[Communication between nonstenotic coronary arteries]. / Verbindung zwischen nichtstenosierten Herzkranzarterien.

This is the report of a rare intercoronary communication between the right and the circumflex artery.

Successful stent-graft repair of a vertebrojugular arteriovenous fistula.

PURPOSE: To describe an apparently unreported endovascular means of treating a vertebral arteriovenous fistula (AVF) using a small-caliber stent-graft to permanently reconstruct the involved vessels. CASE REPORT: A 13-year-old girl presented with tinnitus caused by a high-flow AVF between the right extracranial vertebral artery and deep jugular vein arising from repeated internal jugular vein catheterization. A 4-mm-diameter balloon-expandable Jostent coronary stent-graft was placed in the vertebral artery via a percutaneous femoral access, with immediate and complete obliteration of the AVF and resolution of the tinnitus. Follow-up duplex ultrasonography at 15 months demonstrated patency and luminal integrity of the vertebral artery. CONCLUSIONS: Vertebrojugular AVFs are rare and usually treated with transcatheter embolization techniques, but percutaneous repair using a small-caliber stent-graft appears feasible. This minimally invasive treatment might become the method of choice for AVFs in other small-bore vessels.

Randomized comparison of coronary stent implantation under ultrasound or angiographic guidance to reduce stent restenosis (OPTICUS Study).

BACKGROUND: Observational studies in selected patients have shown remarkably low restenosis rates after ultrasound-guided stent implantation. However, it is unknown whether this implantation strategy improves long-term angiographic and clinical outcome in routine clinical practice. Methods and Results-- A total of 550 patients with a symptomatic coronary lesion or silent ischemia were randomly assigned to either ultrasound-guided or angiography-guided implantation of

Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.

OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.

Suture closure of the brachial artery access site post-coronary catheterization.

A total of 18 diagnostic and interventional coronary angiographic patients were treated with a suture mediated closure device for achievement of hemostasis at the brachial artery puncture site. One case resulted in crossing over to standard manual compression due to incomplete tissue capture post-closure. One post-procedural bleeding was reported as well as one case of radial artery vasospasm. No late or major complications were reported.

[Coronary artery anomaly and coronary disease. A case report]. / Koronaranomalie und koronare Herzkrankheit. Ein Fallbericht.

We report on a 60 year old man with coronary artery disease and coronary artery anomaly. In this patient a reopening of the occluded right coronary artery was performed and a stenosis of the circumflex artery was successfully dilated.

Reduced procedural risk for coronary catheter interventions in carriers of the coagulation factor VII-Gln353 gene.

OBJECTIVES: We have focused on the role of coagulation factor VII (FVII) Arg353Gln polymorphism as a risk predictor of complications following percutaneous transluminal coronary angioplasty (PTCA), directional coronary atherectomy (DCA), and stenting. BACKGROUND: The FVII Arg353Gln mutation decreases FVII activity, and presence of the Gln353 allele could be protective against thrombus formation during catheter interventions. METHODS: A total of 666 consecutive patients with coronary artery disease who had undergone PTCA (n = 280), DCA (n = 104), or stenting (n = 282) were followed up for a 30-day composite end point, which included need for target vessel revascularization, myocardial infarction, and death. The Arg353Gln polymorphism of FVII was determined by PCR/RFLP assay. RESULTS: Carriers of the Gln353 allele had significantly lower levels of total FVII activity (FVIIc, -20.7%, p < 0.001) and of activated circulating FVII (FVIIa, -32.7%, p = 0.03) compared with Arg353/Arg353. The composite end point occurred in 43 patients: 4 were heterozygous Arg353/Gln353, and 39 were homozygous Arg353/Arg353. The incidence of the composite end point was 2.5% in carriers of the Gln353 allele and 7.7% in Arg353/Arg353 homozygotes (p = 0.013). This corresponds to a 72% risk reduction in carriers of the Gln353 allele (relative risk: 0.28; 95% confidence interval: 0.09-0.81; p = 0.02). CONCLUSIONS: The Gln353 allele of FVII is associated with substantial risk reduction in adverse events that complicate coronary catheter interventions. With the perspective of active site-blocked activated FVII (FVIIai) as conjunctive medication, the results suggest that the FVII genotype should be taken into due consideration in assessment of FVIIai medication and of its dosage.

[Recommendations of the International Cardiology Forum (ICF) 1998 on revision of the current guidelines for the diagnosis and treatment of unstable angina pectoris and nontransmural myocardial infarct]. / Empfehlungen des International Cardiology Forum (ICF) 1998 zur Revision der bestehenden Richtlinien zur Diagnostik und Therapie der instabilen Angina pectoris und des nicht-transmuralen Myokardinfarktes.

Rapid progress in the understanding and treatment of unstable angina and acute coronary syndrome are prompting occasional revisions to current treatment guidelines. The recommendations contained in this paper are based on the consensus reached during discussions at the 'International Cardiology Forum' in September 1998. Consensus was reached on significant major points, although some aspects remain controversial. A substantial body of data accumulated in a host of studies justify changes to current treatment habits.

Immediate stent implantation versus conventional techniques for the treatment of abrupt vessel closure or symptomatic dissections after coronary balloon angioplasty.

BACKGROUND: Coronary stenting was initially designed to treat a bailout scenario. Prospective randomized trials comparing stent implantation with standard techniques, including emergency coronary artery bypass grafting, are lacking. The aim of this trial was to test the superiority of immediate stent implantation compared with standard techniques for the treatment of abrupt or threatening closure after coronary balloon angioplasty. METHODS: In a prospective trial, 100 patients with abrupt vessel closure or symptomatic dissections causing objective signs of ischemia were randomly assigned to treatment with immediate placement of stents (n = 51) versus standard techniques such as prolonged dilatation or emergency bypass surgery (n = 49). The primary end point was the achievement of successful stabilization not requiring crossover to the other study group. Secondary end points included event-free survival and restenosis. RESULTS: Successful stabilization was achieved in 94% of patients in the stent group compared with 78% of patients in the standard treatment group (P =.038). Two patients died in each group, and there was a trend toward a higher incidence of myocardial infarction (16% vs 8%; P =.163) and a significantly increased creatine phosphokinase level (245 IU/L [95% confidence interval, 217-265 IU/L] vs 179 IU/L [confidence interval 140-212 IU/L]; P =.0002) in the standard treatment group. Event-free survival after 250 days was 72% in the stent group compared with 29% in the standard treatment group (P =.001). The angiographic restenosis rate was 30% in the stent group versus 59% in the standard treatment group (P =.01). CONCLUSIONS: Immediate stenting, if technically feasible, shows superior short- and long-term results compared with standard treatment options.

Clinical experience with autologous endothelial cell-seeded polytetrafluoroethylene coronary artery bypass grafts.

OBJECTIVE: Autologous endothelial cell seeding was used to improve the patency of 4-mm polytetrafluoroethylene vascular prostheses. METHODS: Since 1995, 14 patients with coronary artery disease received 21 autologous endothelial cell-seeded polytetrafluoroethylene vascular bypass grafts for coronary artery revascularization. The polytetrafluoroethylene grafts were seeded with the endothelial cells in a multiple step procedure, including cell culture techniques before coronary bypass operation. With the use of extracorporal circulation and cardioplegic arrest, a bypass operation was performed by means of conventional surgical techniques. RESULTS: After a mean postoperative follow-up of 27.7 months (range, 7.5-48 months), the graft patency rate is 90.5%. Follow-up angiograms of the aorta-coronary polytetrafluoroethylene bypass grafts showed patent bypasses in all cases except two. Angiograms of all 19 patent endothelial cell-seeded polytetrafluoroethylene bypass grafts showed a smooth luminal borderline without stenotic regions. The percutaneous transluminal angioscopic evaluation showed a glossy white and smooth endoluminal graft surface without any fibrin, platelet, or erythrocyte deposits. Intravascular ultrasonographic examinations confirmed the results. CONCLUSION: Patency of autologous endothelial cell-seeded 4-mm polytetrafluoroethylene vascular prostheses as coronary artery bypass grafts was much better than that of unseeded polytetrafluoroethylene grafts. Further evaluations and a larger population of patients will prove whether the encouraging patency will last.

Carvedilol for prevention of restenosis after directional coronary atherectomy : final results of the European carvedilol atherectomy restenosis (EUROCARE) trial.

BACKGROUND: In addition to its known properties as a competitive, nonselective beta and alpha-1 receptor blocker, carvedilol directly inhibits vascular myocyte migration and proliferation and exerts antioxidant effects that are considerably greater than those of vitamin E or probucol. This provides the basis for an evaluation of carvedilol for the prevention of coronary restenosis. METHODS AND RESULTS: In a prospective, double-blind, randomized, placebo-controlled trial, 25 mg of carvedilol was given twice daily, starting 24 hours before scheduled directional coronary atherectomy and continuing for 5 months after a successful procedure. The primary end point was the minimal luminal diameter as determined during follow-up angiography 26+/-2 weeks after the procedure. Of 406 randomized patients, 377 underwent attempted atherectomy, and in 324 (88.9%), a

Clinical and angiographic results with the ACS MULTI-LINK DUET trade mark Coronary Stent System - the DUET Study.

BACKGROUND: The DUET Study is a multicenter prospective efficacy and safety evaluation of the ACS MULTI-LINK DUET coronary stainless steel balloon-expandable stent. AIMS: The primary objective was to determine the one-month incidence of MACE (major adverse cardiac events). The secondary objectives were the acute success rate, the restenosis and reocclusion rates (assessed by quantitative coronary angiography (QCA)) at six months and the occurrence of MACE in hospital and at six months. METHODS: Two hundred and ten patients were enrolled between February and June 1998 in 18 European centers. Successful stent placement was achieved in 209 patients. All patients were treated with ticlopidine 500 mg/day for one month and with aspirin >/=100 mg/day. To allow the investigators to gain familiarity with the stent system, the first one to three patients per center formed a separate lead-in population leaving an intention-to-treat population of 157 patients. The majority of the intention-to-treat population were male (79%); 28% had unstable angina, 69% had stable angina, 44% had had a previous myocardial infarction, 15% had had a previous percutaneous transluminal coronary angioplasty, and 3% had a history of stroke. The target vessel was 38.5% left anterior descending artery, 20.5% left circumflex artery and 41.0% right coronary artery. RESULTS: All but one of the intention-to-treat patients were effectively stented (17 required multiple stents). Six-month angiographic follow-up was available in 90% of the intention-to-treat population. Minimal lumen diameter (MLD) postprocedure was 2.61 +/- 0.33 mm, with a residual diameter stenosis of 16%. Six-month follow-up data showed an MLD of 1.87 +/- 0.56 mm with a residual diameter stenosis of 36%. The binary restenosis rate (>/=50% residual stenosis) was 15.6%. Up to one month following the procedure 94.9% of the population was MACE-free, with two subacute occlusions. At six months all patients were alive, of whom 82.8% were MACE-free, and 73% were free of anginal complaints. CONCLUSION: The results observed in the current DUET registry are comparable to data of other balloon-expandable-stent trials, with a low incidence of clinical events at follow-up.