The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial.

BACKGROUND: The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency. METHODS/DESIGN: This is a multicenter randomized controlled trial to evaluate the Luminor® paclitaxel-coated DEB catheter for stenotic or occlusive lesions (length ≤15 cm) in the superficial femoral artery (SFA) and the popliteal artery (PA) up to the P1 segment compared to the noncoated, plain old balloon angioplasty (POBA) catheter. In total 172 subjects will be treated with either the DEB catheter or the POBA catheter in 11 German study centers in a 1:1 randomization study design. The primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with the Walking Impairment Questionnaire (WIQ) and the EQ-5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at the index limb, number of dropouts and all-cause mortality. DISCUSSION: EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of the Luminor® paclitaxel-coated DEB catheter for the reduction of restenosis compared to the POBA catheter for the SFA and the PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying paclitaxel-coated DEBs from different manufacturers with different coating technologies in the same target vessel. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02540018 , registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.

Twelve-month experience with the GORE® TIGRIS® Vascular Stent in the superficial femoral and popliteal arteries.

AIM: The aim of this paper was to report the continued mid-term follow-up of the first patients world-wide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. METHODS: From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up. RESULTS: The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%. The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed. CONCLUSION: The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.

INCRAFT® Stent-Graft System: one-year outcome of the INNOVATION Trial.

AIM: Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA. METHODS: The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device- or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up. RESULTS: Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type Ia endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA. CONCLUSION: The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.

The use of the GORE® TIGRIS® Vascular Stent with dual component design in the superficial femoral and popliteal arteries at 6 months.

AIM: The aim of this study was to collect procedural and clinical data assessing safety and performance of the GORE® TIGRIS® Vascular Stent, a novel dual component stent, made of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. METHODS: This retrospective analysis included 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (occlusions in 5%) who underwent angioplasty and implantation of a GORE® TIGRIS® Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for Duplex ultrasound and assessment of Rutherford Becker class (RBC) and Ankle-Brachial Index (ABI) RESULTS: The mean implanted stent length was 62.3 mm (range 30-100 mm). Procedural success (residual stenosis <30%) was achieved in 100% of the lesions. At 6 months 2 restenosis in 2 patients were observed, resulting in a cumulative primary patency rate (±standard error) of 91.7±8.0%. Between baseline and 6 months the ABI increased from 0.65±0.18 to 0.96±0.12 (P<0.0001) and the median of RBC increased from 3 to 1.5 (P<0.0005). No stent thrombosis was found. CONCLUSION: In this retrospective collection of patients all lesions could be successfully treated with this novel hybrid TIGRIS stent. These preliminary results show promising primary patency rates at 6 months. In addition, significant improvements were observed in symptom classification and hemodynamics.

Cordis INCRAFT™ ultra-low profile AAA stent-graft system.

Endovascular repair was originally introduced as a less invasive alternative in less healthy patients, but potentially lower morbidity has been balanced by limited anatomic applicability, as well as inferior long-term device durability. The INCRAFT™ endograft was developed with surgical repair in mind, in an attempt to capitalize on the anatomic flexibility of traditional procedures. The INCRAFT system was designed to address durability issues of older generation devices. At the same time it provides a solution for a broad range of patients using a limited number of codes needed. The 3-pieces modular system allows precise placement at level of the iliacs and aortic neck reducing the risk of unintentional coverage of the hypogastric and renal arteries. In addition, the ultra-low profile delivery system (13 Fr even for graft main bodies up to 30 mm) contributes to increase patient eligibility for endovascular aortic repair and to decrease the risk for access complications. When desired, the delivery system can be introduced through a percutaneous approach. The initial experience with the new endograft showed a highly versatile device that offers a more individualized endovascular option to a greater number of patients with abdominal aortic aneurysms. The ongoing IN-NOVATION trial and two planned clinical trials (IN-CEPTION and IN-SPIRATION) will build further understanding of the performance of the device allowing for a wider subset of inclusion criteria.

[Endovascular treatment of abdominal aortic aneurysms in octogenarians]. / Die endovaskuläre Behandlung von Bauchaortenaneurysmen bei älteren Patienten (> or = 80 Jahre).

BACKGROUND: The increase in life expectancy results in a higher number of patients with an advanced age over 80 years requiring abdominal aortic aneurysm therapy. The aim of this study was to review the outcome of octogenarians undergoing endovascular treatment for abdominal aortic aneurysms. PATIENTS AND METHODS: Between June 2004 and March 2008 25 patients (24 males, one female), with a mean age of 83 +/- 2.6 years (range: 80-91 years) underwent elective endovascular treatment for abdominal aortic aneurysms. The average preoperative aneurysm diameter was 57 +/- 9.8 mm (range: 40-80 mm). All procedures were carried out in the angiography suite under general anesthesia. RESULTS: Endovascular abdominal aortic aneurysm repair was technically successful in all patients. There was one perioperative death due to an aneurysm-related complication. The perioperative (30 days) mortality rate was 4 %. Intensive care unit admission was required in five patients. The in-hospital morbidity rate was 20 %. Mean follow-up time was 18.7 +/- 14 months (range: 2 to 47 months). Two patients died from unrelated causes. There were no device- or aneurysm-related deaths. A patient with a type I A endoleak underwent correction by additional stent-graft placement four weeks after initial placement. CONCLUSION: Endovascular abdominal aortic aneurysm repair in octogenarians is a valuable alternative to open aortic repair and can be performed safely and successfully. We strongly recommend the endovascular treatment for patients over 80 years of age with an appropriate size of aortic aneurysm.

Endurant stent-graft system: preliminary report on an innovative treatment for challenging abdominal aortic aneurysm.

The evolution of stent-grafts and endovascular delivery systems has substantially improved the application rate for and patient outcomes with endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA), but further development is needed in order to reduce the continuing incidence of complications and secondary re-interventions. Severe angulations at the proximal aneurysm neck and tortuous, calcified, and small iliac arteries are still recognized as important risk factors for successful EVAR of AAA and hence as criteria for exclusion of many potential patients. The Endurant stent-graft is part of a next-generation system that was designed with the clear intention of expanding the applicability of EVAR for AAA while also continuing to improve treatment outcomes and reduce complications. Innovative features of the system design include anchoring pins for ensuring proximal fixation, wire-formed M-shape body stents for improved flexibility and conformability, and a low-profile delivery system with hydrophilic coating that improves trackability and pushability to facilitate the vascular access even in small challenging arteries. Initial clinical experience with the Endurant stent-graft system, including preliminary results from the first-in-human European trial of the device, has demonstrated that the device can be delivered and deployed safely, even in highly angulated anatomies. Technical success was achieved in 90.3% of the patients in the trial. No device-related serious adverse events were seen during the first follow-up period, and no device-related deaths were reported. This new stent-graft will potentially enlarge the patient population suitable for EVAR of AAA.

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results.

AIM: The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent. METHODS: This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents. RESULTS: Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each). CONCLUSION: The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:

The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.

OBJECTIVE: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. BACKGROUND: The Mynx device is an extra-arterial vascular closure technology utilizing a water-soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. METHODS: The Mynx study was a prospective, multicenter, single-arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (+/-7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. RESULTS: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device-precipitated complications associated with serious clinical sequelae were reported. Mean (+/- standard deviation) times to hemostasis and ambulation were 1.3 +/- 2.3 min and 2.6 +/- 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). CONCLUSIONS: The initial experience with the extra-arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures.

Percutaneous transluminal angioplasty for renovascular hypertension in a neonate.

AIM: To report on the first case of successful percutaneous transluminal renal artery angioplasty in a neonate. CASE REPORT: a 5-d-old neonate was admitted with cardiorespiratory failure. Monitoring of blood pressure revealed severe arterial hypertension. Doppler sonography detected stenotic flow in the right renal artery. A (99m)Tc-MAG3 scan revealed highly diminished elimination by the right kidney. Selective renin levels were 23,968 ng/l in the right and 3770 ng/l in the left renal vein and the aorta. Percutaneous transluminal angioplasty using a 2 x 10 mm balloon catheter was performed on the 8th day of life. RESULTS: The patient was discharged from hospital normotensive without anti-hypertensive medication. During 8 mo follow-up the blood pressure remained normal, Doppler sonography revealed no recurrent artery stenosis, and renal function improved. CONCLUSION: Neonatal percutaneous transluminal angioplasty for renal artery stenosis may be feasible in selected patients.

Initial clinical experience with an IVUS-guided transmembrane puncture device to facilitate recanalization of total femoral artery occlusions.

PURPOSE: Failure to recanalize chronic superficial femoral artery occlusions is frequently caused by subintimal passage of the occlusion with inability to re-enter the true lumen with the guide-wire. The present study details our initial experience with the Pioneer crossing device (Medtronic, Menlo Park, CA) to facilitate recanalization of total femoral artery occlusions. MATERIAL AND METHODS: 25 consecutive patients (18 male, mean age 63 years) whose failed recanalization attempts of chronic superficial femoral artery occlusions (mean occlusion length 12.7 cm) with standard techniques were re-scheduled for a secondary recanalization procedure. The Pioneer crossing device is a 6.2F rapid exchange catheter, which tracks over a 0.014"-wire. A 20MHz phased array IVUS transducer is integrated into the tip of the catheter allowing visualization of the vessel morphology. Using the guidance of the IVUS cross-sectional image supported by colour-flow imaging, the true lumen is punctured with an integrated 24G needle allowing delivery of a second 0.014"-wire. RESULTS: Re-entry into the true lumen was successfully accomplished in all cases without complications. In 8 cases with severe calcification predilatation of the false channel was necessary to allow advancement of the Pioneer crossing device. Furthermore, in 7 patients with severe calcification multiple puncture attempts were necessary to penetrate the dissection membrane. A procedural success (<25% residual stenosis) could be achieved in all cases after predilatation and stenting of the occlusion with self-expanding nitinol stents. CONCLUSION: The Pioneer crossing device is an effective and save tool to facilitate true lumen re-entry during recanalization of total superficial femoral artery occlusions.

First clinical experiences with an endovascular clamping system for neuroprotection during carotid stenting.

OBJECTIVES: This report evaluates the feasibility and efficacy of an endovascular blood flow blockage technique to prevent intracerebral embolization of plaque debris during carotid artery stenting. METHODS: Forty-two patients were enrolled in five clinical sites in Germany and Italy with either an asymptomatic internal carotid artery stenosis > or =75% (mean 87%) or a symptomatic stenosis > or =60% (mean 85%). Cerebral protection during the stenting procedure was achieved using an endovascular clamping technique, obtained by occlusion of the external and common carotid artery via two independently inflatable balloons integrated in the Mo.Ma system. Blood with particulate plaque debris was aspirated before flow was restored. The patient's clinical and the neurological status were assessed during intervention, at discharge, and at 3 months follow-up. RESULTS: Stenting was performed in all but one patient. The mean flow occlusion time was 10.6+/-6.5 min. Transient clamping intolerance was observed in five patients (12%). In two patients, neurological deficits persisted for 2 and 12 h, respectively. Two minor strokes (4,7%) occurred at 5 and 72 h after the procedure. No major strokes or deaths were observed at 3 months follow-up. CONCLUSIONS: This first clinical experience with the Mo.Ma device substantiates the feasibility of endovascular clamping in preventing cerebral embolization during carotid artery stenting.

Treatment of long superficial femoral artery occlusions with excimer laser angioplasty: long-term results after 48 months.

PURPOSE: To evaluate clinical and hemodynamical long-term results after laser angioplasty of long occlusions of the superficial femoral artery (SFA). MATERIAL AND METHODS: In a prospective trial of 452 patients with long occlusions of the SFA, excimer percutaneous transluminal laser angioplasty (PTLA) for recanalization was applied. The average occlusion length of the SFA was 25.5 cm (range 16-38 cm). The recanalization attempt was done with the crossover technique in 398 patients, in 36 patients with the antegrade technique and in another 18 patients with the transpopliteal technique. RESULTS: The application of laser angioplasty demonstrated a successful recanalization of the SFA in 386/452 patients (85.5%). Recanalization with PTLA was not possible in 66 patients (14.5%). The main reason for the unsuccessful PTLAs was obstructing calcified material (n = 28) resistant to PTLA application. After a follow-up period of 48 months there was a primary, primary-assisted, and secondary patency rate of 22.3%, 40.9%, and 43.2%, respectively. CONCLUSION: Laser angioplasty of long occlusions of the SFA is a feasible procedure with a low failure rate. Long-term results are promising, but additional interventions are required in most patients if a patency rate of 43.2% is to be achieved after 4 years.

Endoluminal stent-graft placement for acute rupture of the descending thoracic aorta.

AIMS: To investigate the results of endovascular stent-graft placement for the treatment of acute perforating lesions of the descending thoracic aorta. METHODS AND RESULTS: A total of 31 consecutive patients underwent interventional treatment for perforating lesions of the descending aorta. In 21 cases (group A), the aortic perforation was due to rupture of a descending thoracic aneurysm or dissection, whereas 10 patients (group B) were treated for traumatic transection of the descending aorta. A total of 42 endoprostheses were implanted. The implantation procedure was successful in all cases without peri-interventional complications. In one case, implantation of a second endoprosthesis became necessary due to type I endoleak. Overall, the 30-day mortality was 9.7%. As all three deaths occurred in group A, the mortality rate in this group was 14.3% versus 0% in group B. Similarly, postinterventional complications were more prevalent, with 28.6% in group A (renal failure n = 4; stroke n = 2) versus 10.0% in group B (renal failure n = 1). No paraplegia and no further deaths or ruptures occurred during follow-up (mean 17 months). CONCLUSION: Interventional stent-graft placement is an effective treatment option for the emergency repair of descending aortic perforations.

[Intra-arterial lysis therapy in acute limb ischemia. Technical possibilities and limits of indication]. / Intraarterielle Lysetherapie bei akuter Extremitätenischämie. Technische Möglichkeiten und indikatorische Grenzen.

Acute limb ischemia is associated with a high risk of death and loss of the extremity. To restore the blood flow, several percutaneous thrombolytic techniques were developed. To achieve a targeted thrombus infiltration, the continuous application of low-dose urokinase or recombinant tissue plasminogen activator using a specific lysis catheter with sideholes is preferable. Concerning the amputation-free survival, thrombolysis is superior to surgery for occlusions of native vessels or bypass grafts that are not older than 2 weeks. Furthermore, the percutaneous approach permits the simultaneous treatment of the underlying lesion by angioplasty or stent implantation after dissolution of the occluding thrombus. The higher risk of complications must be balanced against risks of surgery in each patient.

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

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.

Short (1-10 cm) superficial femoral artery occlusions: results of treatment with excimer laser angioplasty.

PURPOSE: To evaluate the safety and long-term results after laser angioplasty of short occlusions of the superficial femoral artery (SFA). METHODS: In a prospective trial in 312 patients with short occlusions of the SFA excimer laser angioplasty for recanalization was applied. The average occlusion length of the SFA was 7.5 cm (range 1-10 cm). The recanalization attempt was done using either a cross-over technique from the contralateral femoral artery (278 patients), antegrade technique (16 patients) or transpopliteal technique (18 patients). RESULTS: Percutaneous transluminal laser angioplasty (PTLA) produced successful recanalization of the SFA in 286 of 312 patients (91.7%). In 26 patients (8.3%) recanalization was not possible. The reason for the unsuccessful PTLAs was obstructing calcified materialn = 8) which was resistant to laser application. In nine cases obstructing calcifications resulted in positioning of the laser catheter in subintimal tissue or perforation of the SFA. In another four patients there was an aberrant anatomy of the SFA which resulted in a direct vessel injury after advancing the laser catheter. In five patients subintimal recanalization failed. After a follow-up period of 36 months there was a primary, primary assisted and secondary patency rate of 49.2%, 76.5% and 86.3%. CONCLUSION: Excimer laser angioplasty of short occlusions of the SFA is a feasible procedure with a low failure rate. Long-term results are promising but additional interventions are required in most patients to achieve a patency rate of 86.3% after 3 years. Further studies are needed to compare the clinical outcome of PTLA and PTA in short occlusions of the SFA.

High-dose intravascular beta-radiation after de novo stent implantation induces coronary artery spasm.

BACKGROUND: Intracoronary brachytherapy is effective in preventing restenosis after coronary interventions. However, in vitro and animal studies have shown that irradiation produces immediate and sustained endothelial dysfunction. This study assesses the clinical relevance of impaired vasomotoric function induced by brachytherapy. METHODS AND RESULTS: We analyzed the occurrence of postradiation coronary artery spasms in 1 animal study and 2 clinical trials investigating the effects of high-dose intracoronary beta-radiation after de novo coronary artery stenting. Irradiated segments (IRSs) proximal and distal to the stent were studied by quantitative coronary angiography after stenting, after radiation, and at the end of the procedure. There was an 67% overall incidence of coronary artery spasm in the IRSs immediately after beta-radiation compared with 9% after sham treatment (P<0.001). Whereas in most cases this phenomenon was only minor or moderate, in 12 cases, 4 (22%) animals and 8 (28%) patients, severe coronary spasm (>90% diameter stenosis) with significant ECG-changes or hemodynamic instability was observed. Relief of spasms was protracted (mean time until complete relief of spasm 423+/-122 seconds) and required repetitive intracoronary administration of nitroglycerin (mean dose: 1.2+/-0.6 mg). CONCLUSIONS: Vasoconstriction is a frequent reaction of coronary arteries after high-dose intracoronary beta-radiation, necessitating repetitive administration of vasodilators.