Dierk Scheinert

Excimer laser-assisted recanalization of long, chronic superficial femoral artery occlusions.

PURPOSE To examine the safety and efficacy of excimer laser-assisted angioplasty (ELA) for recanalization of superficial femoral artery (SFA) occlusions. METHODS Data were analyzed from 318 consecutive patients (207 men; mean age 64.2 +/- 10.7 years, range 33-91) who underwent ELA of 411 SFAs with chronic occlusions averaging 19.4 +/- 6.0 cm in length. More than 75% of patients had severe claudication (category 3). Critical lower limb ischemia with rest pain or minor tissue loss was present in 6 and 15 patients, respectively. The mean ankle brachial index (ABI) before and after exercise was 0.62 +/- 0.15 and 0.40 +/- 0.18, respectively. RESULTS The initial attempt (crossover approach 89.7%, antegrade 6.6%, transpopliteal 3.6%) to cross the occlusion with an excimer laser catheter was successful in 342 (83.2%) of 411 limbs. A secondary attempt performed in 44 of 69 failed cases was successful in 30 limbs, increasing the technical success rate to 90.5% (372/411). Complications included acute reocclusion (4, 1.0%), perforation (9, 2.2%), and distal thrombosis/embolization (16, 3.9%). Postprocedurally, 219 (68.8%) patients were asymptomatic; mild (category 1) or moderate (category 2) claudication remained in 53 (16.6%) and 26 (8.2%) patients, respectively. The primary patency at 1 year was 33.6%. In the majority of patients, reocclusion was treatable on an outpatient basis. The 1-year assisted primary and secondary patency rates were 65.1% and 75.9%, respectively. CONCLUSIONS Long SFA occlusions can be recanalized safely and successfully by ELA. However, to maintain patency and quality of life, intensive surveillance using objective testing followed by prompt repeat intervention are mandatory.

Transradial approach for coronary angioplasty in the setting of acute myocardial infarction: A dual-center registry

Although transradial angioplasty has been shown to have no major entry site–related complications, its clinical applicability for balloon angioplasty and stenting in acute myocardial infarction (AMI) is unclear. In order to assess the feasibility, safety, and clinical outcome of transradial access for coronary angioplasty (PTCA) and stenting during AMI, transradial angioplasty for AMI was registered on a prospective database at two European sites (A and B) with experience in the radial approach (RA); 6 Fr catheters with an inner lumen of at least 0.064″ and low‐profile rapid‐exchange balloons were used. Primary success rates and procedural complications of 6 Fr RA were determined and compared to 6 Fr femoral approach (FA) procedures. A total of 1,224 AMI patients entered the registry. Study site A enrolled 185 RA patients (13.6% AMI) and study site B 92 RA patients (63.4%). Patient baseline demographics were similar in both study centers and showed no differences between RA and FA patients, except a more frequent use of abciximab in study site B compared to A. PTCA was successful in > 95% of both RA and FA patients. Total procedural time did not differ between RA and FA patients. Severe access site–related bleeding complications, however, were observed in FA patients only: study site A used closure devices routinely and found 2% severe bleedings; study site B used no closure device for FA patients and observed 7% severe bleedings. In selected patients and in experienced hands, transradial PTCA in AMI has a high success rate, is clinically safe, and could become an attractive alternative access site for patients being at high or even low risk for bleeding complications. Cathet Cardiovasc Intervent 2002;55:206–211.

Stent-supported recanalization of chronic Iliac artery occlusions

PURPOSE Iliac artery occlusions that are more than a few centimeters in length are normally treated with surgical bypass grafting. The aim of this study was to evaluate the results of primary stent implantation after Excimer laser-assisted recanalization of iliac artery occlusions. SUBJECTS AND METHODS We studied 212 consecutive patients with chronic unilateral iliac artery occlusions (mean [+/- SD] length 8.9 +/- 3.9 cm) who were treated with Excimer laser-assisted recanalization and stent implantation. Based on the criteria of the Society of Cardiovascular and Interventional Radiology, lesions were graded as class III occlusions (<5 cm) in 46 patients and as class IV (> or =5 cm) in 166 patients. A total of 527 stents (Palmaz stent, 346; Wallstent, 94; Strecker stent, 38; covered stents, 49) were implanted. RESULTS Technical success was achieved in 190 (90%) patients. There was a clinical improvement of three grades in 112 (53%) patients and of two grades in 67 (32%) patients. The rate of major complications was 1.4%, which included arterial rupture (1) and embolic events (2). Primary patency rates were 84% at 1 year, 81% at 2 years, 78% at 3 years, and 76% at 4 years. Secondary patency rates were 88% at 1 year, 88% at 2 years, 86% at 3 years, and 85% at 4 years. CONCLUSION Stent-supported angioplasty is an effective treatment for iliac artery occlusions, with less morbidity and mortality than is associated with surgery. However, reported long-term patency rates after bypass surgery are greater than those we observed with interventional treatment. The value of primary stenting as compared with angioplasty alone should be evaluated in a randomized trial.

Treatment of Catheter-Induced Iliac Artery Injuries with Self-Expanding Endografts

Purpose: To evaluate the efficacy of fabric-covered endoprostheses for percutaneous repair of traumatic iliac artery lesions. Methods: Among 47 patients treated for catheter-induced iliac artery injuries, 20 (42%) patients (13 men; mean age 58 ± 10 years, range 41–76) presented with acute (n = 7) or subacute (n = 13) lesions considered inappropriate for bare stent implantation (17 dissecting aneurysms, 2 perforations, and 1 traumatic arteriovenous fistula). The self-expanding Cragg EndoPro System I or Passager devices were deployed percutaneously to exclude the defects. Results: Immediate exclusion of the lesion was achieved in all 20 cases; there were no major procedural complications. However, within 24 hours after implantation, fever (n = 11, 55%) and elevations in white blood cell count (n = 10, 50%) and C-reactive protein (n = 13, 65%) were seen in the majority of patients, which prolonged hospitalization in this group (8.4 versus 4.2 days). During a median 21-month follow-up (range 5–31), 2 angiographically documented restenoses at the outlet of the endografts were treated successfully with balloon angioplasty, achieving primary and secondary patency rates of 87% and 100%, respectively. Conclusions: Early model stent-grafts provided a safe and effective endovascular treatment for iliac perforations and large arterial dissections, showing a high mid-term patency rate. However, postimplantation syndrome appears to occur frequently with this type of Dacroncovered nitinol device.

Sequential vs. kissing balloon angioplasty for stenting of bifurcation coronary lesions

Coronary angioplasty of bifurcation lesions remains a technical challenge and is believed to result in low procedural success associated with the risk of side‐branch occlusion. Furthermore, long‐term results are associated with a high rate of reintervention. The aim of the study was to evaluate the immediate and long‐term clinical and angiographic results of sequential vs. simultaneous balloon angioplasty (kissing balloon technique) for stenting of bifurcation coronary lesions. Between December 1999 and January 2001, 59 patients underwent coronary angioplasty because of symptomatic bifurcation lesions type III (i.e., side branch originates from within the target lesion of the main vessel, and both main and side branch are angiographically narrowed more than 50%). Twenty‐six patients were treated with simultaneous and 33 patients with sequential balloon angioplasty. Main‐vessel stent placement was mandatory; side‐branch stenting and platelet IIb/IIIa antagonists were allowed at the discretion of the operator. Kissing balloon technique offered no advantage in terms of procedural success or need for repeat target vessel revascularization due to restenosis at 6‐month follow‐up. Using sequential balloon angioplasty, permanent or transient side‐branch compromise rate (TIMI flow < 3) was significantly higher than after kissing balloon technique (33% vs. 0%, respectively; P = 0.003). Major clinical events in‐hospital or at 6‐month follow‐up, however, showed no significant differences. Kissing balloon angioplasty reduces the rate of transient side‐branch occlusion compared to sequential PTCA but does not improve immediate or long‐term outcome compared to sequential PTCA for stenting of bifurcation lesions. Cathet Cardiovasc Intervent 2002;55:461–466.

Direct coronary stenting versus predilatation followed by stent placement

Direct stenting without antecedent dilatation may reduce procedural time, costs, and radiation exposure, and may result in less vessel injury. The purpose of this investigation was to compare immediate and long-term clinical and angiographic outcomes of direct stenting with stent placement after initial balloon dilation. Three hundred thirty-five symptomatic patients with single or multiple coronary lesions (diameter reduction 60% to 95%) of < or =30 mm length and with a vessel diameter of 2.5 to 4.0 mm were randomized either to direct stenting (group A, n = 171) or stenting after predilation (group B, n = 164). Patients with vessels with excessive calcification, severe proximal tortuosity, or occlusion were excluded. All patients were asked to return for routine repeat angiography at 6 months, irrespective of symptoms. Feasibility of direct stenting was 95% in group A, with 5% requiring crossover to predilation. Successful stent placement after predilation was performed in all 164 patients in group B. Direct stenting was associated with less procedural duration (group A 42.1 +/- 18.7 minutes vs group B 51.5 +/- 23.8 minutes, p = 0.004), radiation exposure time (group A 10.3 +/- 7.7 minutes vs group B 12.5 +/- 6.4 minutes, p = 0.002), amount of contrast dye used (group A 163 +/- 69 ml vs group B 197 +/- 84 ml, p <0.0001), and lower procedural costs (group A 845 +/- 167 vs group B 1,064 +/- 175, p <0.0001). Immediate angiographic results and in-hospital clinical outcomes (death, Q-wave myocardial infarction, repeat revascularization) were not significantly different between both strategies. However, at 6-month follow-up, direct stenting was associated with a lower angiographic restenosis (group A 20% vs group B 31%, p = 0.048) and target lesion revascularization rates (group A 18% vs group B 28%; p = 0.03). This study demonstrates the feasibility, safety, and outcomes of direct stenting in eligible coronary lesions. In appropriately selected cases, direct stenting has a lower rate of angiographic restenosis up to 6 months after the procedure, resulting in fewer coronary reinterventions compared with the conventional strategy of stenting with antecedent dilatation.

Initial experience with the Endicor X-sizer thrombectomy device in patients with ST segment elevation myocardial infarction

In der vorliegenden Pilotstudie wurden 16 Patienten mit akutem ST-Hebungsmyokardinfarkt (AMI) untersucht. Alle Patienten hatten zum Zeitpunkt der Koronarangiographie ein verschlossenes Koronargefäß (TIMI 0 Fluss). Es war die Absicht, bei allen Patienten eine Thrombektomie (mit dem Endicor X-Sizer) anstelle einer Ballonangioplastie vor der geplanten Stentimplantation durchzuführen. Bei 15 Patienten war die Thrombektomie erfolgreich und resultierte in einem TIMI 3 Fluss. Nach erfolgreicher Stentimplantation blieb bei allen 15 Patienten der TIMI 3 Fluss erhalten. Ein 12 Kanal-EKG wurde unmittelbar vor und nach der Koronarintervention aufgezeichnet. Das Ausmaß der ST-Streckenhebung wurde aus der Summe von acht Ableitungen für anteriore Infarkte und aus fünf Ableitungen für inferiore Infarkte ermittelt. Eine EKG-Analyse war bei 13 Patienten möglich (2 Patienten entwickelten einen Schenkelblock). Bei allen 13 Patienten fand sich nach der Intervention eine >50% Reduktion der ST-Strecke und bei 11 Patienten sogar eine >70% Reduktion. Periprozedurale Komplikationen waren niedrig (1 Koronardissektion nach Thrombektomie) und es traten keine kardialen Ereignisse innerhalb von 30 Tagen auf. Die Thrombusextraktion könnte eine Alternative zur Ballonangioplastie bei Patienten mit AMI werden. We investigated 16 patients with ST segment elevation myocardial infarction who had an occluded coronary artery (TIMI 0) at initial angiogram. Instead of balloon angioplasty and stenting, patients were subjected to thrombectomy (Endicor X-sizer) and stenting. In 15/16 patients the occlusion could be crossed by the thrombectomy device resulting in TIMI flow 3 in all of them. Thereafter, stenting was performed. At final angiogram all 15 patients continued to show TIMI flow grade 3. Twelve-lead ECG was performed prior to and post-intervention. ST elevation was measured as the sum of eight leads for anterior infarction and of five leads for inferior infarction. In 13/15 patients, ECG analysis was possible (2 developed bundle branch block post-intervention). In all 13 patients, a >50% ST decrease of the initial amount of ST elevation was observed reaching a >70% reduction in 11 patients. Procedural complications were low (one coronary dissection after thrombectomy) and 30 days follow-up was uneventful. Thrombectomy using the Endicor X-Sizer device may become an attractive mechanical reperfusion strategy for patients with acute myocardial infarction.

Pseudoaneurysm Formation at the Site of External Iliac Artery Stents: Percutaneous Stent-Graft Treatment:

Purpose: To present a patient who developed an asymptomatic large iliac pseudoaneurysm complicating stent-supported iliac artery recanalization. Case Report: The pseudoaneurysm was detected in an asymptomatic 69-year-old man during routine angiography 6 months after an uncomplicated procedure to implant 3 overlapping Palmaz stents in an occluded external iliac artery. There was no evidence of stent infection. During a second intervention, the pseudoaneurysm was successfully treated by percutaneous implantation of an EndoPro System I stent-graft. Contrast-enhanced spiral computed tomography at 6 and 12 months confirmed the durability of aneurysm exclusion and the patency of the endoprosthesis. Conclusions: Angioplasty-induced pseudoaneurysm is rare and usually asymptomatic, but elective percutaneous stent-graft repair should be considered as the first treatment option.

High-Dose Intracoronary Irradiation after De Novo Stent Implantation

Purpose:This randomized study was designed to compare the efficacy of high-dose coronary β-radiation after intravascular ultrasound-(IVUS-)guided direct stenting with sham treatment in patients with de novo lesions.Patients and Methods:32 patients were enrolled in the study protocol. Following angioplasty procedure, intracoronary brachytherapy was performed with the Novoste™ Beta-Cath System. The prescribed dose was 24 Gy referred to the lamina elastica externa. Quantitative coronary angiography and IVUS were performed to analyze the treated coronary vessel.Results:Angiographic results revealed a significantly smaller minimal lumen diameter compared with the postprocedural minimal lumen diameter within the stented segment (p = 0.004) in the nonirradiated group. The same significant result was observed in the injured segment of the nonirradiated patients (p = 0.011). The IVUS data revealed a significant increase of the plaque volume after 8 months in the nonirradiated group compared to the postprocedural value (irradiated 5.41 ± 8.83 mm3 vs. nonirradiated 21.11 ± 16.08 mm3; p = 0.001). Late luminal loss was significantly greater in the nonirradiated group (p = 0.004). The primary clinical endpoint (death, myocardial infarction, repeat target lesion revascularization, percutaneous revascularization, coronary artery bypass surgery) was reached by seven irradiated (33.3%) and four (18.2%) nonirradiated patients (p = 0.623). Late stent thrombosis was observed in one irradiated patient.Conclusion:The EVEREST trial has demonstrated the feasibility of high-dose intracoronary brachytherapy in de novo coronary lesions. There is a significant reduction of neointimal proliferation within the stented segment. Nevertheless, this benefit is vitiated by an increase of restenotic lesions outside the stent segment.Hintergrund und Ziel:Die intrakoronare Brachytherapie ist eine durch zahlreiche Studien belegte effektive Therapie zur Verhinderung der In-Stent-Restenose. Der Stellenwert der intrakoronaren Brachytherapie bei der Behandlung neu aufgetretener Stenosen, insbesondere nach Stentapplikation, ist bislang nicht eindeutig geklärt. Die EVEREST-Studie (Evaluation of Endoluminal Radiation in Elective Stenting) hatte zum Ziel, die Durchführbarkeit und Effektivität einer intrakoronaren Brachytherapie unmittelbar nach Stentimplantation in De-novo-Stenosen zu überprüfen.Patienten und Methodik:32 Patienten wurden in das Studienprotokoll aufgenommen. Diese Patienten wurden doppelblind entweder in einen Radiotherapiearm mit einer Dosis von 24 Gy oder in einen Plazeboarm randomisiert. Alle Stenosen wurden mit einem Stent versorgt; anschließend wurde eine intrakoronare Brachytherapie mit dem Novoste™-Beta-Cath-System mit 24 Gy oder Plazebo durchgeführt. Im Nachbeobachtungszeitraum wurden eine quantitative Koronaranalyse (QCA) und eine intravaskuläre Ultraschalluntersuchung (IVUS) des behandelten Gefäßabschnitts durchgeführt.Ergebnisse:In der QCA ergab sich im Nachuntersuchungszeitraum ein signifikant kleinerer minimaler Gefäßquerschnitt (p = 0,004) bei den Patienten in der Plazebogruppe. Ebenso zeigen die IVUS-Daten eine signifikante Zunahme des Plaquevolumens in der Kontrollgruppe (p = 0,001). Der späte Lumenverlust war in der Plazebogruppe signifikant höher. Der primäre klinische Endpunkt trat bei sieben bestrahlten (33,3%) und vier nicht bestrahlten (18,2%) Patienten ein (p = 0,623). Eine Patient der Verumgruppe erlitt eine späte Stentthrombose.Schlussfolgerung:Die EVEREST-Studie belegt die Durchführbarkeit einer hochdosierten intrakoronaren Brachytherapie und deren Wirksamkeit mit einer signifikanten Reduktion des Plaquevolumens und des späten Lumenverlusts. Problematisch erscheinen allerdings die höhere Rate an Reinterventionen und das Auftreten einer Stentthrombose bei Patienten der Verumgruppe.

Distal Superficial Femoral Artery (SFA) Access

An endovascular recanalization of chronic total occlusions (CTO) of the superficial femoral artery (SFA) can fail in a substantial number of cases. Retrograde approach for CTOs of the SFA, where an antegrade recanalization has failed, is an alternative technique. The classical transpopliteal recanalization technique however has some drawbacks. We developed another technique as an alternative to the classical transpopliteal approach for those cases where the SFA occlusion does not reach beyond the adductor canal. Retrograde access is attempted distal to the adductor canal (high P1-segment) by leaving the patient in a supine position.