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Rationale: Recent research shows that in-stent restenosis (ISR) occurs in half of the patients treated with stenting of femoral and popliteal artery for lower extremity arteriosclerotic occlusive disease (LEASO). Combined therapy is mainly used clinically to obtain better medium- and long-term treatment outcomes and reduce the occurrences of reintervention, among which, the combination of excimer laser ablation (ELA) and drug eluting balloon (DEB) is a new and effective choice., Patient Concerns: A 76-year-old male patient with ISR of right superficial femoral artery after stent implantation was reported., Diagnosis: Rechecking angiography indicated severe occlusion of the right superficial femoral artery. The physical examination showed that bilateral femoral and popliteal arteries were accessible whereas right dorsalis and posterior tibial arteries are unaccessible. Ankleolus brachial index (ABI) was 0.92 for left and 0.58 for right., Interventions: We performed the operation with ELA and drug balloon DEB on the right superficial femoral artery under local anesthesia and treated with oral antiplatelet drugs after operation., Outcomes: The combination treatment was very successful, and postoperative lower extremity arteriogram showed the blood flow was fluent and fast. No recurrence was discovered 3 months after the operation and he had no obvious symptom of claudication., Lessons: The combination of ELA and DEB is useful and effective for ISR of peripheral vessel after stent implantation, and this surgical method is worthwhile but need further clinical research for safety confirmation.

Background: Many patients are subjected to the potential risks and morbidity associated with an indwelling inferior vena cava (IVC) filter when standard methods fail to remove the filter. We evaluated the safety and effectiveness of the excimer laser sheath technique for removing embedded IVC filters., Methods: Over a 5-year period, 251 consecutive patients undergoing laser-assisted filter retrieval were prospectively enrolled. There were 103 men and 148 women (mean, 46 years; range, 15-82 years). Indications for retrieval included symptomatic acute IVC thrombosis, chronic IVC occlusion, and/or pain from filter penetration. Retrieval was also performed to prevent risks from prolonged implantation and potentially to eliminate the need for lifelong anticoagulation. After retrieval failed using three times the standard retrieval force (digitally measured), treatment escalation was attempted using a laser sheath powered by a 308-nm XeCl laser. Success was defined as complete filter detachment and removal from the body. Primary safety outcomes were major procedure-related complications., Results: Laser-assisted retrieval was successful in 249 of 251 patients (99.2%) (95% CI, 97.2%-99.9%), with a mean implantation of 979 days, range: 37-7,098 days (> 19 years), among retrievable-type filters (n = 211) and permanent-type filters (n = 40). Average force during failed attempts without laser was 6.7 vs 3.8 lbs during laser-assisted retrievals (P < .0001). The major complication rate was 1.6% (95% CI, 0.4%-4.0%), and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 45 of 46 patients (98%) (95% CI, 88%-99%) and alleviated filter-related morbidity in 55 of 57 patients (96%) (95% CI, 88%-99%)., Conclusions: The excimer laser sheath technique is safe and effective for removing embedded IVC filters refractory to standard retrieval and high force. This technique can be used to alleviate or prevent filter-related morbidity and may allow cessation of filter-related anticoagulation., Trial Registry: ClinicalTrials.gov; No.: NCT01158482; URL: www.clinicaltrials.gov., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Objectives: To describe our single center experience with the use of laser endartherectomy assisted balloon angioplasty in popliteal and infrapopliteal arterial disease., Background: Peripheral arterial disease (PAD) carries significant morbidity to patients. Some patients may have multiple comorbid conditions potentially limiting therapeutic options for PAD. Endovascular interventions are aimed at decreasing arterial disease symptoms, improve wound healing and ultimately limb salvage. There is limited data on below the knee PAD and simultaneous laser endartherectomy use in this anatomic location., Methods: The cohort comprised 41 patients that underwent laser assisted balloon angioplasty from 2010 to 2013. All patients had popliteal and infrapopliteal arterial disease. Outcomes evaluated were limb salvage and symptom relief 12months following the procedure. A comparison between the patients that underwent amputation and those with limb salvage was also performed., Results: All the patients had TASC II (Trans Atlantic Inter-Society Consensus) type D lesions. Most patients reported persistent PAD symptoms by six months, with 17% remaining symptom free by 12months. Affected limb salvage was 69%. Five patients (12%) died and one third of the patients had a new peripheral angiogram. In the repeat angiogram, most patients showed initial target vessel occlusion. No statistically significant differences were found between the patients that preserved their limb to those who underwent amputation., Conclusions: Laser assisted balloon angioplasty use for complex popliteal and infrapopliteal arterial disease is a therapeutic option when limb salvage is the goal. Despite this, symptom recurrence and the need for repeated angiography continue to be high., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance., Objectives: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF., Methods: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority., Results: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB., Conclusions: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: An innovative xenon-chlorine (excimer) pulsed laser catheter (ELCA X80) has been recently used for the treatment of complex coronary lesions, as calcified stenosis, chronic total occlusions and non-compliant plaques. Such complex lesions are difficult to adequately treat with balloon angioplasty and/or intracoronary stenting. The aim of this study was to examine the acute outcome of this approach on a cohort of patients with coronary lesions., Methods and Results: Eighty patients with 100 lesions were enrolled through four centers, and excimer laser coronary angioplasty was performed on 96 lesions (96%). Safety and effectiveness data were compared between patients treated with standard laser therapy and those treated with increased laser therapy. Laser success was obtained in 90 lesions (93.7%), procedural success was reached in 88 lesions (91.7%), and clinical success in was obtained in 87 lesions (90.6%). There was no perforation, major side branch occlusion, spasm, no-reflow phenomenon, dissection nor acute vessel closure. Increased laser parameters were used successfully for 49 resistant lesions without complications., Conclusions: This study suggests that laser-facilitated coronary angioplasty is a simple, safe and effective device for the management of complex coronary lesions. Furthermore, higher laser energy levels delivered by this catheter improved the device performance without increasing complications., (Copyright © 2015. Published by Elsevier Inc.)

Introduction: Therapeutic options for the treatment of varicosis of the great saphenous vein (gsv) include endoluminal laser therapy, crossectomy/stripping and a combination of both. In this paper we present data for clinical and sonographic inguinal recurrencies up to two years post operation., Material and Methods: In an open multicentre, randomised three-arm trial, sonographic and clinical parameters were compared perioperatively, after 2, 6, 12 and 24 months between endoluminal venous laser therapy, high ligation and invaginating stripping and a combination of both (laser: 980 nm, continuous mode, 30 W, Biolitec®, Jena, Germany). Data of 449 patients were available for the perioperative and 2 months examination. 388 patients were followed up until 6, 380 patients for 12 and 332 patients for 24 months. We compared clinical recurrences, sonographic reflux findings, and reflux side branches in the inguinal region at the saphenofemoral junction., Results: We found significantly more inguinal reflux and reflux side branches in the laser groups (p < 0.0001), however, there was no statistically significant relation between clinical recurrences and sonographic reflux. Over time, there were no intraindividual constant refluxes. Regarding the secondary endpoints oedema, lymphatic oedema, local disturbances of sensibility and irritations of the saphenous nerve, lymphatic oedema and irritations of the saphenous nerve were significantly more present in the two laser groups. After two years pain and restrictions in professional life were no longer relevant in all groups., Discussion: Clinical recurrences developed both in the C/S and in the laser group but reflux into the gsv and into proximal side branches developed significantly more often in the laser group. In a long-term follow-up we have to investigate the importance of reflux side branches for the development of clinical recurrences to reveal differences between the three therapeutic strategies., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: In-stent restenosis (ISR) after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. The purpose of this study is to evaluate the mid-term follow-up of a combination therapy using laser debulking and drug-eluting balloons for ISR., Methods: A prospective cohort of 14 patients (10 female, 4 male) with clinically relevant (Rutherford 3-6) ISR who were treated with excimer-laser angioplasty and drug-eluting balloons and a clinical follow-up of at least 9 months was evaluated., Results: Mean age was 78 ± 6.5 years (range, 67-88 years). The mean lesion length treated was 133.2 ± 107.2 mm (range, 10-380 mm). The mean time to occurrence of restenosis after initial treatment was 8.6 ± 4.7 months (range, 2-18 months). Technical success was 100%. Distal embolization occurred in 2 cases, and was treated successfully by endovascular means. No other periprocedural major adverse events occurred. All patients were available for clinical follow-up and 12 patients were available with Duplex follow-up. At a mean clinical follow-up of 19.1 ± 8.7 months (range, 9-38 months), 1 target lesion revascularization was seen (at 3 years after the ISR treatment). In the patients with critical limb ischemia (n = 7), no major amputations were needed. Twelve patients had Duplex control (mean follow-up, 19.4 ± 9.4 months; range, 9-38 months). Binary restenosis (>50%) was seen in 1 case at 36 months; it was the same patient who had TLR. A 25%-50% stenosis was seen in 4 patients (mean follow-up, 25 months; range, 19-38 months). No sign of neointimal hyperplasia was demonstrated in 7 patients (mean follow-up, 14.3 months; range, 9-19 months)., Conclusion: These mid- to long-term data compare favorably with results obtained with standard balloon angioplasty, cutting-balloon angioplasty, and balloon angioplasty using drug-eluting balloon. Longer follow-up and randomized trials are necessary to further define the role of combined excimer-laser debulking and drug-eluting balloon angioplasty in the treatment of ISR.

Introduction: Balloon catheters have been developed to facilitate pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). We sought to compare the safety and efficacy of the cryoballoon (CB) and the laserballoon (LB) in a pilot study., Methods and Results: One hundred and forty patients with drug-refractory PAF were prospectively allocated in a 1:1 fashion to undergo a PVI procedure with the 28 mm CB or the LB and were followed for 12 months using 3-day Holter ECG recording. The primary efficacy endpoint was a documented AF recurrence ≥ 30 seconds between 90 and 365 days after the index ablation. In total, 269 of 270 PVs (99.6%) and 270 of 273 PVs (98.9%) were acutely isolated in the CB and LB group, respectively. Mean procedural time was 136 ± 30 minutes for the CB group and 144 ± 33 minutes for the LB group (P = 0.13). Mean fluoroscopy time was longer in the CB group (21 ± 9 minutes vs 15 ± 6 minutes; P < 0.001). During 12 months follow-up, 37% of patients in the CB group and 27% in the LB group experienced an AF recurrence (P = 0.18). Phrenic nerve palsies occurred in 5.7% (CB) and 4.2% (LB) of patients, respectively., Conclusion: Balloon catheters are a viable option to safely perform a PVI procedure in patients with drug-refractory PAF. Ninety-nine percent of PVs may be acutely isolated with a single balloon catheter. The AF free survival rate after a single ablation procedure was not statistically different between groups., (© 2013 Wiley Periodicals, Inc.)

Pulmonary vein isolation (PVI) is the basis of all ablation techniques for paroxysmal atrial fibrillation. Performing conventional radiofrequency ablation for PVI is time consuming and sometimes challenging when using point-by-point applications to create continuous lesions. Small electrically conducting gaps evolving in the ablation lines may cause recurrences of atrial fibrillation or regular atrial re-entry tachycardias. Development of novel anatomically designed ablation catheters for PVI aim to facilitate the ablation procedure, to produce continuous and durable lesions with a limited number of ablation impulses and to reduce the complication rate. The endoscopic laser balloon ablation system (HeartLight® EAS, Cardiofocus Inc.) is the first system that allows direct visual guidance of energy delivery at the antral level of each pulmonary vein and uses a completely new energy source for ablation.

The novel approach of using excimer laser in a contrast medium for treating an under-expanded stent in a calcified coronary artery is described. In this first reported case, the laser in a contrast medium was used to treat an under-expanded stent deployed 18 months prior in a calcified non-dilatable coronary artery lesion. The normal laser approach in saline medium flush during lasing to clear any contrast was not effective. The use of concurrent contrast during lasing was effective and successful to help expand the stent with a successful outcome.

Aims: Age is an important determinant of outcomes in patients treated with percutaneous coronary intervention (PCI). This report from the randomised multicentre SPIRIT III trial compares the outcomes in elderly and younger patients treated with everolimus-eluting stent (EES) versus paclitaxel-eluting stent (PES)., Methods and Results: A total of 1,002 patients with stable or unstable angina or inducible ischaemia undergoing PCI were randomised in a 2:1 ratio to receive EES or PES. Outcomes were examined across the randomised groups as a function of age and stent type. Patients ≥65 years of age (elderly) treated with EES vs. PES had lower in-segment late lumen loss (0.11±0.32 mm vs. 0.38±0.55 mm, respectively, p=0.0002) and lower rates of binary in-segment restenosis (3.4% vs. 15.5%, p = 0.004) at eight months, along with a 48% lower incidence of 3-year target vessel failure (TVF=cardiac death, myocardial infarction and ischaemia-driven target vessel revascularisation [TVR]; 10.8% vs. 20.8%, p=0.009), mainly due to a lower incidence of TVR (5.4% vs. 9.2%, p=0.20). Among EES patients, elderly compared to younger patients had comparable rates of binary in-segment restenosis (3.4% vs. 5.6%, p=0.44) at eight months but paradoxically lower rates of TVF (10.8% vs. 17.1%, p=0.03) at three years. Among PES patients, elderly compared to younger patients had a higher rate of binary in-segment restenosis (15.5% vs. 3.4%, p=0.01) at eight months and no difference in the rate of 3-year TVF (20.8% vs. 19.4%, p=0.77) .There was a significant interaction between stent assignment, age ≥65 years and 8-month angiographic in-segment late loss (p=0.001)., Conclusions: Implantation of both EES and PES appeared to be safe in elderly patients, however EES compared to PES was more effective due to enhanced 3-year MACE- and TVF-free outcomes. Further research should clarify age-specific mechanisms of neointimal response after treatment with drug-eluting stents.

Aims: To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) for in-stent restenosis (ISR) in an unselected patient population. Implantation of bare metal stents in native coronary vessels can result in ISR rates exceeding 50%. PES significantly reduces ISR-lesion restenosis and improves event-free survival versus vascular brachytherapy., Methods and Results: The 7,492-patient ARRIVE registry enrolled patients receiving ≥1 TAXUS Express stent at procedure initiation with no inclusion/exclusion criteria, including 489 patients with ISR. Endpoints were independently adjudicated. All major cardiac events were monitored plus a 10%-20% sample per site. ISR patient 2-year follow-up was 94% complete (462/489). Compared to simple-use patients undergoing native coronary intervention (N=2698) or other, non-ISR expanded-use cases (N=4305), ISR patients had significantly more baseline comorbidities/complex disease. They had higher 2-year rates for mortality (8.6% vs. 4.2%, P<0.001), myocardial infarction (5.0% vs. 2.2%, P<0.001), definite/probable stent thrombosis (4.0% vs. 1.4%, P<0.001), and target lesion revascularisation (12.3% vs. 5.4%, P<0.001) versus simple-use. Safety outcomes were comparable between the ISR and non-ISR expanded-use subgroups but target vessel revascularisation (TVR) was significantly higher for ISR (16.0% vs. 10.9%, P=0.003). ISR was independently associated with increased risk for TVR (1.4-fold)., Conclusions: ARRIVE ISR, one of the largest studied cohorts of patients receiving DES for ISR, had higher risk for clinical events versus simple-use patients but comparable safety outcomes versus other expanded-use patients except for significantly higher revascularisation. ARRIVE provides a detailed estimate of 2-year outcomes in these real-world patients.

Background: Intrapericardial mapping and ablation can be utilized to target epicardial arrhythmic circuits. Current epicardial ablation strategies are associated with risk of damage to adjacent structures, including the coronary vasculature and phrenic nerves., Objectives: The purpose of this study was to evaluate the feasibility of an investigational, visually guided laser balloon catheter for manipulation within the pericardial space, visualization of epicardial structures, and delivery of laser ablation lesions to the ventricular myocardium., Methods: Pericardial access was obtained in 4 anesthetized swine by subxyphoid puncture. The laser balloon catheter was introduced into the pericardial space via a deflectable sheath, and was manipulated to predefined regions in all animals. Visually guided laser ablation was performed on the ventricular myocardium, with post mortem examination of lesion size and depth., Results: The laser ablation catheter could be manipulated to all targeted regions in all animals. Associated structures, including epicardial coronary arteries and veins as well as an endocardial catheter in the left atrial appendage, were easily visualized. A total of 9 laser energy applications at varying power/time settings were performed. Ablation utilizing moderate (7-8.5 W) power produced relatively uniform lesions (diameter 5-12 mm, depth 6-9 mm), while high (14 W) power produced a visible "steam pop" with a large, hemorrhagic lesion (22 × 11 × 11 mm)., Conclusions: The investigational laser balloon catheter can be manipulated within the epicardial space, allowing for direct visualization of surrounding structures during ablation. Titration of laser power can be utilized to create moderate-sized ablation lesions while avoiding steam pops., (© 2011 Wiley Periodicals, Inc.)

Aims: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients., Methods and Results: In the DiabeDES III trial, 127 patients were randomised to SES or ZES stent implantation. Angiographic 10-month follow-up data were available in 105 patients, including 48 SES and 57 ZES treated patients. Angiographic endpoints were in-stent late lumen loss and minimal lumen diameter. IVUS endpoints included NIH volume and in-stent percent volume obstruction. Baseline clinical characteristics and lesion parameters were similar in the two groups. At 10-month follow-up, angiographic in-stent late lumen loss (0.14±0.37 mm vs. 0.74±0.45 mm, p<0.001) was reduced and minimum lumen diameter was higher (2.36±0.53 mm vs. 1.96±0.65, p<0.001) in the SES group as compared to the ZES group. As compared to the ZES group, NIH volume was significantly reduced in the SES group (median [interquartile range]: 0.0 mm3 [0.0 to 1.2] vs. 16.5 mm3 [6.2 to 31.1], p<0.001). In-stent% volume obstruction was significantly reduced in SES as compared to ZES (median [interquartile range]: 0.0% [0.0-0.7] vs. 13.0% [6.7-20.8], p<0.001)., Conclusions: In diabetic patients, the SES reduced angiographic late lumen loss and inhibited NIH more effectively than ZES.

Introduction: Calcified coronary lesions may be associated with stent underexpansion, malapposition, and high rates of restenosis. The use of drug-eluting stents (DES) in such lesions has not been fully addressed in the major trials. We sought to examine the outcomes of patients who were treated with plaque modification (PM) to facilitate DES implantation., Methods: We analyzed 164 calcified coronary lesions in 145 consecutive patients who underwent aggressive PM with either rotational atherectomy (RA) and/or cutting balloon (CB) before DES implantation. CB was used in moderate calcified lesions and RA alone or followed by CB in severe calcified lesions., Results: Patients were 68.7 +/- 10.1 years old, 47% were diabetic, 34% had left ventricular ejection fraction (LVEF) < or =50%, and 39% had 3-vessel disease. Ninety-five percent of lesions were classified as B2/C, 100% as moderately/severely calcified. PM was achieved by using CB in 57% and by RA alone or followed by CB in 43%. In 100%, a DES was implanted. There was no failure to deliver a stent. At 15 +/- 11 months follow-up, the overall major adverse cardiac events (MACE) rate was 9.6% (3.4% cardiac death, 2.3% myocardial infarction, and 3.4% target lesion revascularization [TLR]). The only independent predictor of MACE was LVEF < or =50% (odds ratio 3.88; 95% confidence interval: 1.15-13.1; P = 0.03). The incidence of stent thrombosis (ST) was 2.1%. There were no significant differences in MACE and TLR based on the type of PM used., Conclusions: In this population at high risk of restenosis, aggressive PM by CB and/or RA before DES implantation provides excellent mid-term outcomes with only 3.4% TLR and 2.1% ST.

The aim of this study was to investigate the immediate and long-term outcome of patients who were treated with rotational atherectomy (RA) to facilitate the delivery of drug eluting stents (DES) in heavily calcified lesions. We analyzed 150 consecutive patients who underwent RA and subsequently DES implantation in our institution. The patients had heavily calcified coronary artery lesions requiring plaque modification prior to conventional angioplasty and stent implantation. Rotational atherectomy was performed using the standard Boston Scientific Rotablator system. A 2-burr stepped approach was selected in most of the cases. Following successful modification of the plaque, the angioplasty was performed with a balloon at low pressure to avoid dissection and a DES was implanted. The mean follow up period was 3 years (max. 78 months). Follow-up data included all cause death, stroke, myocardial infarction (MI), recurrent angina, re-hospitalization, target lesion revascularization (TLR), target vessel revascularization (TVR), and long-term duration of dual antiplatelet therapy. The rate of recurrent angina and MI during follow up was low (3.3%) and the overall major adverse cardiac events (MACE) rate was 11.3%. No MACE occurred during hospitalization. There was no relationship between discontinuation of clopidogrel and occurrence of death or MI. The combined approach of RA-DES has a favorable effect when dealing with heavily calcified lesions in both the angiographic and clinical outcomes. No safety concerns are observed up to 6 years.

Background: Although efforts have been focused on developing endovascular procedures by which intravascular devices such as stents could be effectively deployed, few data exist regarding devices for the nonsurgical retrieval of deployed stents. Therefore, we designed to enable retrieval of deployed stents without a surgical procedure., Methods: The device consisted of four components: ultra-low profile forceps with 2.0 mm in diameter, conducting shaft with 1.8 mm in diameter, control handle by which the forceps is opened or closed, and a covering sheath. This device was designed to advance into the vessel lumen along a 0.014-inch guidewire by over the wire fashion., Results: The forceps could firmly catch nonexpanded as well as expanded tubular-type stents with open cells in an in vitro model that was 4.0 mm in diameter. Then, we used this device in porcine renal arteries with 2.5-5.0 mm in diameter. At first, a fragmented 0.014-inch guidewire could be safely removed without vessel damage that was confirmed by intravascular ultrasound. This device could successfully remove four of five inappropriately and 11 of 14 appropriately deployed stents. Under these conditions, intravascular ultrasound demonstrated minor vessel wall dissection in two-third of cases., Conclusions: These results demonstrate that the present device can be used for transluminal removal of foreign bodies such as nonexpanded as well as expanded stents in acute phase. Further miniaturization may enable using this type of device in the renal as well as coronary arteries.

Excimer laser has been successfully applied to complex atherosclerotic plaques in acute coronary syndromes; however, its role in debulking in left main coronary artery disease has not been fully explored. Details of a series of 20 patients who underwent excimer laser revascularization of a spectrum of left main coronary artery lesions are presented. Twenty symptomatic patients who received excimer laser debulking were examined for procedural outcome and follow up results. The left main coronary artery was characterized as protected, semi-protected, poorly protected, or unprotected, depending on the presence or absence of patent bypass grafts to the left anterior descending (LAD) and circumflex (CX) arteries. A fully protected left main coronary artery (LMCA) was present in only 20% of the patients. The target lesions included 11(55%) distal LMCA stenoses, six (30%) ostial stenoses, and one (5%) mid-portion lesions. Two (10%) patients had in-stent re-stenosis of the entire length of the LMCA. Small (0.7 mm-1.4 mm) excimer laser catheters were mostly used. A relatively high number of laser energy pulses (1,334 +/- 643) were required to achieve adequate debulking. Successful LMCA intervention was performed in 19 (95%) patients, while in-hospital complications occurred in only one (5%) patient. Subacute/late stent thrombosis developed 3 months after the procedure in one patient, and two patients died from non-cardiac causes during follow-up. Lesions in LMCAs can be revascularized in selected patients by laser debulking and adjunct stenting. Inadequate protection by bypass grafts and decreased left ventricular function do not contradict utilization of excimer laser. Small laser catheters and high energy levels are required during laser debulking of stenoses of left main coronary arteries.

Traditional open surgical repair for aortic rupture from a thoracoabdominal pseudoaneurysm is associated with a high morbidity and mortality. The use of advanced intravascular imaging and endovascular techniques permits selection and customizing endoluminal graft components to treat such catastrophic events in high-risk surgical patients. We report the successful management of a ruptured thoracoabdominal pseudoaneurysm with an endovascular approach.

Conventional percutaneous transluminal angioplasty (PTA) for complex or long segment infrainguinal occlusive arterial disease is limited by elastic recoil, dissection and restenosis, with high rates of intermediate and long term restenosis . Debulking with excimer laser has been advocated as a useful adjunctive strategy to improve procedural success and long term patency. This paper reviews the technological development of excimer laser, the studies supporting its use in infrainguinal arterial disease, effective and safe lasing techniques, its advantages, limitations and disadvantages. Case examples will be presented to illustrate its use in infrainguinal arterial disease. Although randomized controlled trials are lacking, existing registry and case series studies suggest efficacy of the excimer laser-assisted PTA for complex infrainguinal arterial disease, including patients with critical limb ischemia.

Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based endovascular therapies. The diffuse nature of lower extremity atherosclerotic disease, the presence of chronic total occlusions, poor distal runoff, and the presence of critical limb ischemia all have contributed to the disappointing results of balloon angioplasty for complex infrainguinal arterial disease. These challenges have spawned the development of a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for lower extremity peripheral arterial occlusive disease. This review summarizes the recent advances in available technologies, including novel angioplasty balloons; nitinol stents, stent grafts, and drug-eluting stents; excisional, laser, and rotational atherectomy devices; devices for crossing total occlusions; true-lumen reentry devices; thrombectomy catheters; and embolic protection devices.

Background: Results for standard revascularization therapies in acute myocardial infarction (AMI) have been limited in part by distal embolization, a process which might be reduced by the application of ultraviolet laser light. The aim was to assess feasibility and safety of excimer laser coronary angioplasty (ELCA) in a randomized study in AMI., Methods: Twenty-seven consecutive patients with ST-segment elevation AMI (aged 57.8+/-9.2 years) were randomized either to balloon angioplasty and stent implantation alone (n=13) or adjunct ELCA (n=14). Quantitative coronary angiography was analyzed by an independent core laboratory., Results: ELCA was feasible and safe in all cases. No procedure-associated complications were observed. Similar results were found for main parameters in laser (L) and control (C) patients: diameter stenosis decreased from 94.3+/-9.6 to 20.7+/-10.3% (L) and from 82.7+/-16.8 to 18.9+/-5.5% (C) (p=ns; L vs. C). TIMI flow increased from 0.7+/-1.2 to 2.8+/-0.4 and from 1.7+/-1.5 to 3.0+/-0 (p=ns; L vs. C), respectively. The post-procedural myocardial blush score did not differ between the groups (2.1+/-1.3 and 2.7+/-1.0; p=ns; L vs. C) and the final corrected TIMI frame count (cTFC) was also similar in both groups (23+/-7 and 22+/-4; p=ns; L vs. C), but the cTFC gain was higher in the laser group (53+/-14% and 35+/-20%; p<0.05; L vs. C)., Conclusions: Laser angioplasty is feasible and safe for the treatment of patients with ST elevation AMI. Procedural results were at least on par with conventional treatment. Further randomized controlled trials are needed to assess the benefit of laser angioplasty in AMI.

ST-elevation myocardial infarction is due to the occlusion of a coronary artery, mainly due to a rupture of an atherosclerotic plaque with superimposed thrombosis. The main therapeutic goal is to restore the blood flow within the culprit artery as quickly as possible. In this review we discussed the several approaches which have been employed to reach this target. Primary percutaneous coronary intervention (PCI) is considered the best treatment option, as it is associated to lower in-hospital mortality, reduced risk of reinfarction and stroke, lower rate of intracranial bleeding and ventricular rupture from myocardial hemorrhage compared with fibrinolytic therapy. Also, it is superior to facilitated PCI, i.e. immediate planned PCI after i.v. thrombolytic therapy administration, because of lower mortality, reinfarction rate, strokes and bleedings. Rescue PCI after failed thrombolysis was associated with a reduction of early severe heart failure and improved survival at 1 year, in patients with moderate to large infarctions, compared to conservative medical therapy, in a pooled analysis of 9 randomized trials, carried out in the balloon era. Also in the stent era, a meta-analysis of 5 randomized trials found a significant 36% reduction in the risk of 30-day mortality, a trend to lower risk of heart failure, although a marginally increased risk of thromboembolic stroke, in the rescue PCI arm. However, rescue PCI is not associated with a better long-term clinical outcome. Laser thrombectomy before PCI could be a useful additional strategy which might be compared to standard stenting in future randomized studies.

Purpose: To report our experience with excimer laser-facilitated recanalization of acute and subacute thrombotic occlusions of hemodialysis shunts., Methods: Twenty-one patients (16 women; mean age 54+/-19 years, range 31-76) presented with acute and subacute thrombotic occlusions of their hemodialysis shunts (4 Cimino, 17 prosthetic; 18 forearm, 3 upper arm); mean occlusion time was 4.1+/-3 days (range 1-14), and the thrombotic occlusion measured a mean 17.4+/-9 cm (range 5-27). Fresh thrombus was observed in addition to the total shunt occlusion in all cases. All patients were treated initially with a pulsed ultraviolet (308-nm) excimer laser. Eighteen (85.7%) patients received adjunctive local thrombolysis for treatment of residual thrombus. Nineteen (90.5%) patients underwent angioplasty of the underlying anastomotic stenosis., Results: The angiographic occlusion was reduced from 100% to 63%+/-28% after laser treatment and to 36%+/-18% after 1 hour of thrombolytic therapy (20 mg tissue plasminogen activator). TIMI flow increased significantly from grade 0 to 2.7+/-0.5 following laser ablation (p<0.001) and to 3.0+/-0.2 upon completion of the angioplasty procedure (p>0.001 versus baseline). The immediate procedural success was 95.2% (20/21). Detectable thrombotic embolization and laser-related complications were not observed in any case. Primary patency was 85%; 3 patients had abnormal Doppler flow within 6 weeks and underwent reintervention (secondary patency 100%). All successfully treated shunts were usable for further dialysis at the 6-week follow-up., Conclusion: Percutaneous excimer laser-facilitated thrombus vaporization is safe and effective for recanalization of acute and subacute thrombotic occlusions of hemodialysis shunts.

Background: One of the most common complications after mechanical penetrating keratoplasty is the occurrence of irregular astigmatism. We developed a method to prepare donor grafts for transplantation applying excimer laser techniques. The quality of the cut edges and exposure time were evaluated., Materials and Methods: The beam of an experimental excimer laser (OPTex, Lambda Physik) was homogenized and guided by an optical system including lenses and scanner mirrors. A special software was used to conduct the laser beam in a circular mode over the surface of the cornea. Corneas from porcine eyes were stabilized in an artificial anterior chamber. Twenty in vitro explants were trephinated applying our method and subsequently investigated by electron microscopy and histology., Results: All experiments provided regular and smooth cut edges. The average exposure time until perforation was 10.5 min (SD 2.7 min), the diameter of the grafts was 8.0 mm., Conclusion: The experiments showed the possibility of non-contact trephination and generation of smooth cut edges with a rotating focussed excimer laser beam in a porcine cornea model. A major advantage of the system is the possibility of customized "tailored" grafts.

Percutaneous revascularization has become an effective treatment for patients suffering from chronic critical limb ischemia (CLI) due to chronic atherosclerotic obstructions, including total occlusions. Unlike other vascular beds, total chronic occlusions of the femoropopliteal arteries are frequently found in patients with severe claudication or CLI. As a consequence, patients with long chronic total occlusions of the femoropopliteal arteries are generally not considered optimal candidates for percutaneous revascularization and are frequently referred for surgical revascularization. In the present study, we sought to evaluate the feasibility, safety, and outcome of a modified wireless laser ablation technique to recanalize total occlusions in patients with CLI who had failed conventional percutaneous techniques for limb salvage. Procedural success, complications, actuarial freedom of limb loss, and surgical revascularization were evaluated in 25 patients after a mean follow-up of 13 +/- 8 months. Procedural success was achieved in 21 patients (84%). Actuarial freedom from surgical revascularization or limb loss was 72%. There was one vascular perforation. No deaths or distal embolization occurred. Three patients (12%) required limb amputation during follow-up, whereas four patients (16%) had surgical revascularization in the presence of feasible vascular targets. Limb salvage was achieved in 88% of patients when laser recanalization was combined with surgical revascularization. These results suggest that the use of laser ablation is safe and facilitates angioplasty and stenting in patients with CLI that failed conventional endovascular revascularization. This technique might prevent limb loss in patients with CLI due to femoropopliteal total occlusions, particularly in patients with unsuitable anatomy for surgical revascularization.

Two decades after the clinical introduction of percutaneous transluminal angioplasty (PTA), controversy still exists about the role of PTA for the treatment of occlusive disease in the femoropopliteal and infragenicular arteries. For the patient with critical limb ischemia (CLI), where diffuse disease and long occlusions are the rule, the results with PTA have not been optimal. Surgical revascularization has long been considered the gold standard for this patient population, but this procedure is associated with significant morbidity and mortality and up to 37% of patients may be poor surgical candidates. With advances in laser catheter design and refinement of recanalization techniques, improved results have been seen with laser assisted angioplasty of complex peripheral arterial disease. There has been renewed interest in excimer laser angioplasty for the treatment of patients with long total occlusions and diffuse disease who otherwise would have limited options for treatment. Excimer laser assisted angioplasty has been shown to be a successful approach to the treatment of long occlusions in the superficial femoral artery. Data from the recently completed Laser Angioplasty for Critical Limb Ischemia Phase 2 Trial (LACI) suggest that this is a viable treatment strategy for patients with CLI who are otherwise not good candidates for bypass surgery.

Background and Purpose: We present the results of endovascular photoacoustic recanalization (EPAR) treatment for acute ischemic stroke from the Safety and Performance Study at 6 centers in Europe and North America. The objectives of mechanical thrombolysis are rapid vessel recanalization and minimal use of chemical thrombolysis., Methods: This study was a prospective, nonrandomized study. The National Institutes of Health Stroke Scale (NIHSS) score and the modified Rankin Scale (mRS) score were recorded before treatment. The presence of recanalization was assessed by angiography. To measure outcome, follow-up examinations were performed at 24 hours, 7 days, and 30 days after stroke onset., Results: Thirty-four patients (median NIHSS 19) were enrolled. Ten patients had internal carotid artery occlusion, 12 patients had middle cerebral artery occlusion, 11 patients had vertebrobasilar occlusion, and 1 patient had posterior cerebral artery occlusion. The overall recanalization rate was 41.1% (14/34). Complete EPAR treatment was possible in 18 patients (median NIHSS 18), with vessel recanalization in 11 patients (61.1%) after EPAR. The average lasing time was 9.65 minutes. Incomplete EPAR treatment (16/34, median NIHSS 19) was defined as intention to treat with EPAR and that the EPAR microcatheter entered the patient. Additional treatment with intraarterial application of rTPA occurred in 13 patients. An adverse event associated with use of the device occurred in 1 patient. Symptomatic hemorrhages occurred in 2 patients (5.9%). The mortality rate was 38.2%., Conclusions: This study demonstrates the safety and technical feasibility of EPAR. This new technique may provide another treatment option in the therapeutic armamentarium for patients with acute ischemic stroke.

Background and Purpose: The goal of this study was to determine safety and long-term outcome of the excimer laser-assisted high-flow extracranial/intracranial (EC/IC) bypass in patients with symptomatic carotid artery occlusion (CAO) at high risk of recurrent stroke., Methods: In a prospectively collected cohort of 103 patients with symptomatic CAO, 15 patients were selected for excimer laser-assisted EC/IC bypass surgery on the basis of predefined selection criteria: (1) transient or moderately disabling symptoms of focal cerebral ischemia, not symptoms of the retina only; (2) continuing symptoms after documentation of the CAO; (3) evidence of a possible hemodynamic origin of symptoms; and (4) informed consent of the patient., Results: Eleven patients underwent the operation without complications One patient had a severely disabling stroke (Rankin grade 4) 11 days after the operation; the bypass was found occluded on reoperation. Two other patients had a moderately disabling stroke (Rankin grade 3) immediately after the operation. One patient died of myocardial infarction 1 day after surgery. Median follow-up time was 27 months. Of the 11 patients who underwent the operation without complications, 1 died 17 months after the operation of a brainstem stroke, and another patient had a new stroke ipsilateral to his CAO 10 months after the operation but without a change in Rankin grade., Conclusions: The excimer laser-assisted high-flow EC/IC bypass operation is a potentially promising procedure in patients with symptomatic CAO and a presumably high risk of recurrent stroke, but the procedure carries a definite risk. This risk is probably related not only to the procedure itself but also to the selection of patients.

Background and Objectives: Debulking is still a technique of choice for in-stent restenosis (ISR). Excimer laser debulking has enabled high procedural success with very low complication rates, but has demonstrated markedly heterogeneous results owing to differences in lasing and laser technology, and selected patient populations. Since new area-ablation technique enables ablation of larger areas than its own device size, we have evaluated their effectiveness and safety in an uncontrolled study., Study Design/materials and Methods: Fifty-three patients with diffuse ISR were treated by laser area ablation, followed by adjunctive balloon angioplasty. Primary endpoint was percent of binary stenosis at 6-month follow-up; secondary endpoints were procedural success; target lesion revascularization (TLR); major adverse cardiac events (MACE); diameter stenosis (DS); and minimal lumen diameter (MLD) before and after laser debulking, and at 6-month follow-up., Results: Laser debulking was feasible (as defined as < or =30% residual stenosis) in 98.1% of patients. At 6-month follow-up, binary stenosis was 26.4%; angiographic TLR, 20.7%; and MACE, 3.7%. DS decreased from 87+/-17% to 20 +/- 9% after laser debulking, and to 9+/-7% after PTCA; it was 29+/-14% at follow-up (P-values in comparison to baseline: 0.0047; 0.0036; 0.0064). MLD increased from 0.6+/-0.3 to 2.4+/-0.5 mm after laser debulking, to 2.8+/- 0.6 mm after adjunctive PTCA, and to 1.9 +/- 0.4 mm at follow-up (P-values in comparison to baseline: 0.0059; 0.0031; 0.0088)., Conclusions: Owing to a significantly greater MLD, area ablation facilitates significantly enhanced immediate and follow-up results for diffuse ISR, including a simpler and more effective laser-debulking procedure than former lasing techniques., (Copyright 2002 Wiley-Liss, Inc.)

Background: Prior studies have suggested that percutaneous transmyocardial laser revascularization (PTMR) may be effective as a sole treatment modality in reducing angina in patients with severe coronary artery disease and no revascularization alternatives. The safety and efficacy of the hybrid or adjunctive use of PTMR during the same procedure as percutaneous intervention (PCI) has not previously been reported., Methods: A US phase I feasibility study was therefore performed to determine whether PTMR performed in the same myocardial territory as PCI is able to ameliorate symptomatic recurrence from restenosis., Results: After successful and uncomplicated PCI in 26 patients with class III-IV angina and lesion(s) at high risk for restenosis, PTMR was performed in the same myocardial territories subtended by the treated vessel(s). Major periprocedural adverse events (death, Q-wave myocardial infarction, and bypass surgery) occurred in 3 (11.5%) patients, as the result of subacute vessel closure in 2 patients, and tamponade in the third. Cumulative 6-month mortality rate was 19.2%, including 2 late deaths between 3 and 4 months after discharge (1 death caused by late stent closure and 1 unexplained death during sleep.) Late repeat revascularization for restenosis in the PCI plus PTMR treated target vessel was required in 19.2% of patients, and an additional 11.5% of patients had class III-IV angina at 6-month follow-up., Conclusions: These data demonstrate that in a patient population at high risk for restenosis, recently created PTMR channels are not protective against severe ischemia caused by acute vessel closure and that late symptomatic restenosis after PCI may still frequently occur despite PTMR in the same region.

In recent years, laser therapy has been evaluated for the treatment of patients with angina who have coronary artery disease which is not amenable to conventional revascularization techniques. The results of transmyocardial revascularization and percutaneous myocardial revascularization are reviewed.

Percutaneous transluminal myocardial revascularisation presently appears to be a potential palliative treatment for coronary artery disease, neither controlled with drugs nor amenable to available coronary revascularisation techniques. Ongoing trials will provide answer to short and long term efficacy. Recent developments using angiogenic growth factors appear very promising, and the role of growth factors as an adjunct to percutaneous transmyocardial revascularisation with laser remains to be seen.

A high restenosis rate remains a limiting factor for coronary angioplasty and stenting. Recently, use of intravascular red light therapy (IRLT) has been shown to be effective in different animal models and in humans in reducing the restenosis rate. Sixty-eight patients were treated with IRLT in conjunction with coronary stenting procedures. Mean age was 64 +/- 9 years. Treated lesions were type A (11), type B (42), and type C (18) with a mean lesion length of 16.5 +/- 2.4 mm. Reference vessel diameter and minimal lumen diameter (MLD) before therapy were 2.90 +/- 0.15 and 1.12 +/- 0.36 mm, respectively. After stenting and laser irradiation, MLD was 2.76 +/- 0.39 mm. No procedural complications or in-hospital adverse events occurred. All patients were followed up as depicted in the protocol. Sixty-one patients underwent angiographic restudy, which revealed restenosis in 9 patients (14.7%). Observed restenosis rate by artery size was > 3 mm (n = 21, 0%), 2.5 to 3.0 mm (n = 28, 14.2%), and <2.5 mm (n = 12, 41.6%). We conclude that IRLT is safe and feasible and reduces the expected restenosis rate in patients after coronary stenting in arteries of >2.5 mm.

Objectives: Evaluation of the long-term functional outcome assessed by exercise myocardial perfusion imaging following excimer laser angioplasty compared to balloon angioplasty in coronary lesions > 10 mm in length., Background: Previous randomized studies evaluating the effect of coronary interventions mainly focused on the long-term clinical and angiographic outcome. The functional outcome, assessed by myocardial perfusion scintigraphy, has not been evaluated in a randomized setting., Methods: A total of 308 patients with stable angina and a longer coronary lesion (> 10 mm) were randomized to excimer laser angioplasty or balloon angioplasty. A 99mTechnetium-2-methoxy isobutyl isonitrile (MIBI) single-photon emission computed tomography (SPECT) study was performed in 139 patients before the initial angioplasty procedure and at 6 months follow-up (73 patients in the laser group versus 66 patients in the balloon group, respectively). Exercise tolerance at follow-up was compared to baseline values by means of exercise duration and double product at peak exercise. Myocardial perfusion of the randomized vascular bed was assessed semi-quantitatively on the MIBI SPECT images. The reversible defects were graded as mild, moderate or severe. Myocardial perfusion at follow-up was expressed as a percentage reduction in incidence and grading of the reversible defects compared to baseline values., Results: Forty-four (61%) patients assigned to laser angioplasty were asymptomatic at 6 months follow-up compared to 34 (52%) patients assigned to balloon angioplasty (p = NS). Improvement in exercise duration and double product were 0.7 +/- 2.1 min and 4.3 +/- 6.2 min/mmHg/l,000, respectively, in the laser group, versus 0.3 +/- 2.5 min and 3.1 +/- 5.5 min/mmHg/1,000, respectively, in the balloon group (both p = NS). The percentage reduction of reversible defects was 23% in patients assigned to laser angioplasty vs. 29% in patients assigned to balloon angioplasty (Relative risk [RR]: 0.79, 95% confidence interval [CI]: 0.40-1.57; p = 0.50). The mild, moderate and severe reversible defects improved in 44.4, 63.6 and 66.6%, respectively, in the laser angioplasty group vs. 66.6, 53.8 and 90%, respectively, in the balloon angioplasty group. None of the comparisons were significantly different., Conclusion: Excimer laser angioplasty compared to balloon angioplasty in coronary lesions > 10 mm in length yields a similar long-term functional outcome assessed by anginal status, exercise tolerance and myocardial perfusion.

The Prima laser guidewire system (Spectranectics Corp., Colorado Springs, CO) consists of an 0.018" hypotube containing a bundle of 45-microm optical fibers coupled to a pulsed excimer laser operating at a tip fluence of 60 ml/mm2 and a repetition rate ranging from 25-40 Hz. This laser guidewire was specifically designed to cross total occlusions refractory to passage with conventional wires. The Prima wire was evaluated in a feasibility study at 15 U.S. centers. Following failure to cross a total occlusion with approved guidewires, the Prima wire was utilized in 179 patients. Average age of subjects was 61 yr. Lesion locations included left anterior descending (36%), right (45%), and circumflex (19%) coronary arteries. Mean angiographic age of total occlusions was 70 wk (range, 2-1,020 wk, median, 14 wk). The use of the Prima wire either solely or in combination with conventional guidewires resulted in successful crossing in 61% of these previously impenetrable occlusions. Failure of the device was commonly related to length of the occlusion and tortuosity along the occluded pathway. Major complications included myocardial infarction in 7 patients (3.9%), tamponade in 3 (1.7%), and death in 2 (1.1%). This "learning phase" pilot study confirmed the feasibility of a laser guidewire in chronic total occlusions that are resistant to passage of conventional guidewires. An extended registry at these investigative sites is planned.