Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis.

PURPOSE: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). METHODS: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. RESULTS: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). CONCLUSION: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study.

AIM: Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). METHODS AND RESULTS: This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. CONCLUSIONS: This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR).

Laser in infrapopliteal and popliteal stenosis 2 study (LIPS2): Long-term outcomes of laser-assisted balloon angioplasty versus balloon angioplasty for below knee peripheral arterial disease.

BACKGROUND: Laser-assisted balloon angioplasty (LABA) has been shown to be more effective in achieving angiographic success for treatment for below knee peripheral artery disease (PAD) compared with balloon angioplasty alone(BA). However, long-term outcomes of LABA compared with BA for popliteal and infrapopliteal PAD are unknown. METHODS: We evaluated data on 726 patients undergoing LABA (n = 395) and BA (n = 331) for popliteal and infrapopliteal PAD retrospectively at a single center (2007-2012). Outcomes included long-term ipsilateral major limb amputation, revascularization and mortality (median follow-up = 36 months). RESULTS: Baseline features were similar in two groups with the exception of more TASC-D lesions (92.4 vs. 66.5%; P < 0.0001) and chronic total occlusions (86.4 vs. 49.5%; P < 0.0001) in LABA group. Angiographic success was higher in LABA compared with BA (97.7 vs. 89.2%; P < 0.0001). Ipsilateral major limb amputation (4.1 vs. 5.1%, P = 0.48) and repeat revascularization (25.1 vs. 23.3%, P = 0.47) were similar in LABA and BA patients despite unfavorable baseline angiographic characteristics in the former. Compared with BA, death was more frequently in LABA group (35.2 and 26.3%, P = 0.01), a reflection of higher comorbid conditions in this group (adjusted HR 1.05, 95% CI 0.79-1.39). CONCLUSION: Despite worse baseline angiographic characteristics compared with BA, LABA was associated with higher angiographic success and similar ipsilateral major amputation, repeat revascularization, and long-term mortality. Future randomized clinical trial should evaluate the efficacy of LABA compared with BA (particularly drug-eluting) in improving limb salvage and reducing repeat revascularization in these high-risk PAD patients.

Contemporary management of critical lower limb ischemia in TASC D lesions with subintimal angioplasty in femoro-popliteal lesions, tibial angioplasty and sequential compression biomechanical device for infra-inguinal arterial occlusion. Experience and quality of life outcome learned over 25 years.

AIM: Patients with end-stage critical limb ischemia (CLI) survive on borrowed time and amputation is inevitable if an aggressive management stratagem is not instigated. Our primary aim was to equate effectiveness of subintimal angioplasty (SIA) and tibial balloon angioplasty (TBA) in sustaining clinical improvement and amputation free survival (AFS) in patients with CLI TASD II D. Moreover, patients with severe CLI, who were not suitable for revascularization and who were offered therapy with a sequential compression biomechanical device (SCBD) were scrutinised as part of a comprehensive lower limb salvage program. METHODS: From 2002-2012, 5876 patients were referred with peripheral vascular disease (PVD); 987 presented with CLI and 798 had intervention; 189 patients presenting with CLI were not candidates for revascularisation, out of which 171 were offered SCBD. We formed a prospective observational group study of 441 patient who had TASC D disease. All of these patients presented as emergencies and were allocated to the next available treatment list. Duplex ultrasound arterial mapping (DUAM) was the sole preoperative investigation tool in 92% of all cases. Of the 441 patients studied, 190 patients (206 procedures) has SIA for TASC D femero-popliteal occlusions, 80 patients (89 procedures) had TBA and cool eximer laser angioplasty (CELA) for tibial artery occlusions and 171 patients with severe CLI were not suitable for revascularization and joined the SCBD program. Mean age (SIA 73±13 years vs. TBA/CELA 74±8 years vs. SCBD 75±13 years), and comorbidity severity scores (P>0.05) were similar between groups. RESULTS: Perioperative mortality within the SIA group was 1.6% vs. 0% within the TBA group and 0.6% in SCBD. Length of hospital stay within the TBA group was 3.8±2 days vs. SIA 14±16 days, P<0.0001. The 5-year freedom from major adverse events (MAE) for the SIA group was 68% that was comparable to the results obtained for both the TBA group; 59%, and SCBD group: 62.5% (P=0.1935). Five-year freedom from target lesion revascularization was 85.9% within the SIA group and 79% within the TBA group. A sustained clinical improvement was seen in 82.8% of primary SIA and 68% of TBA, which mimics the outcome of SCBD at 68% at one year. A total of 83% SCBD patients had no rest pain within one week of starting the program and gangrene remained dry and non-progressive. Ulceration healed in all but 12 patients. There were no device-related complications. Limb salvage was 94% at 5 years. All-cause survival was 69%. Quality time spent without symptoms of disease or toxicity of treatment (Q-TWiST) was 24.7 months for SIA and 8.5 months for TBA and was 38.13 for SCBD for a total of 708 months of usage. Cost per quality adjusted-life years (QALY) for SIA was € 5662.79, € 12,935.18 for TBA and € 2943.56 for SCBD. CONCLUSION: All treatment pathways augmented patient-specific Q-TWiST with substantial cost reduction. SIA, TBA and SCBD expand AFS and symptom-free survival. All treatment modalities are minimally invasive and allow for a high patient turnover without compromising limb salvage, once they are performed by experienced vascular surgeons in high deliberate practice volume centers.

Role of laser atherectomy for the management of in-stent restenosis in the peripheral arteries.

The prevalence of PAD is expected to increase as the population ages and the treatment for chronic disease becomes more sophisticated. The safety, efficacy, and lower cost of endovascular treatment for peripheral vascular disease of the lower extremities when compared with surgical revascularization are well known. Despite the clinical improvements and advances in endovascular techniques over the past decade, in-stent restenosis of peripheral arteries remains a challenge for the endovascular specialist. The use of excimer laser atherectomy has been shown to be safe and effective for the revascularization of complex, critical de novo peripheral lesions and offers promise in the treatment and prevention of in-stent restenosis.

Laser debulking and DEB for in-stent restenosis: technique and review of the literature.

This paper will describe the technique of the treatment of in-stent restenosis of the infrainguinal arteries, using a combined technique of laser debulking followed by drug-eluting balloon angioplasty. The results of this technique from the literature will be discussed, and a comparison with other techniques that are currently used will be made.

Excimer Laser LEsion modification to expand non-dilatable stents: the ELLEMENT registry.

BACKGROUND/OBJECTIVES: Stent underexpansion is a risk factor for in-stent restenosis and stent thrombosis. Existing techniques to optimize stent expansion are sometimes ineffective. The aim of this study was to evaluate the effectiveness and feasibility of Excimer Laser Coronary Angioplasty (ELCA) in improving stent expansion when high-pressure non-compliant balloon inflation was ineffective. METHODS AND RESULTS: ECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1mm(2) in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2±0.4 (range 0.9-2.0mm) and a mean of 62±12mJ/mm(2) at 62±21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6±0.6mm at baseline to 2.6±0.6mm post-procedure) and MSA by IVUS (3.5±1.1mm(2) to 7.1±1.9mm(2)). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%. CONCLUSIONS: The ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions.

Cool excimer laser-assisted angioplasty (CELA) and tibial balloon angioplasty (TBA) in management of infragenicular arterial occlusion in critical lower limb ischemia (CLI).

We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P = .013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P = .0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P = .026). Three-year freedom from MACE was comparable in both the groups (P = .455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P = .048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness.

Pulmonary vein isolation with a novel endoscopic ablation system using laser energy.

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.

Combined influence of proton-pump inhibitors, calcium-channel blockers and CYP2C19*2 on on-treatment platelet reactivity and on the occurrence of atherothrombotic events after percutaneous coronary intervention.

BACKGROUND: The carriage of CYP2C19*2 and the use of proton-pump inhibitors (PPIs) and calcium-channel blockers (CCBs) has been associated with the diminished efficacy of clopidogrel. However, previous studies have only assessed the isolated impact of these risk factors for clopidogrel poor response. OBJECTIVES: The aim of the present study was to investigate the impact of the combined presence of three risk factors for clopidogrel poor response, that is, the use of CCBs, PPIs and the carriage of CYP2C19*2, on on-treatment platelet reactivity and the occurrence of atherothrombotic events in 725 patients on dual antiplatelet therapy undergoing elective coronary stenting. METHODS: In a prospective, follow-up study, on-treatment platelet reactivity was quantified using ADP-induced light transmittance aggregometry (LTA) and the VerifyNow P2Y12 assay. The clinical study endpoint was the composite of all-cause mortality, myocardial infarction, stent thrombosis and stroke at 1 year after stenting. RESULTS: Patients with either one or more than one risk factor exhibited increased platelet reactivity (mean relative increase one risk factor: 11% and > 1 risk factor: 22%, respectively). Sixty-four events occurred during follow-up (8.8% of the study population). Patients with one risk factor for clopidogrel poor response did not have an increased risk of the composite endpoint. However, patients using both CCBs and PPIs and carriers of CYP2C19*2 who used CCBs had a statistically significant increased risk of the composite endpoint [hazard ratio(HR)(adj) 2.2 95% CI, 1.0-5.3, P = 0.044 and HR(adj) 3.3 95% CI, 1.1-9.8, P = 0.032, respectively]. CONCLUSIONS: The presence of more than one of the three investigated risk factors for clopidogrel poor response is associated with an increased risk of adverse cardiovascular events within 1 year after elective coronary stenting.

Rotablation in the drug eluting era: immediate and long-term results from a single center experience.

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.

Initial experience with directed laser atherectomy using the CLiRpath photoablation atherectomy system and bias sheath in superficial femoral artery lesions.

PURPOSE: To report a safety and efficacy study of directed excimer laser atherectomy with the Bias Sheath guiding catheter to create larger lumens in the superficial femoral artery (SFA). METHODS: Fourteen patients (9 men; mean age 66+/-9 years, range 46-76) with chronic lower limb ischemia (Rutherford class 2 to 5) referable to SFA stenoses were treated with the 8-F-compatible Bias Sheath and a 1.7- or 2.0-mm laser catheter. Eight (57%) lesions were de novo and 6 (43%) were in-stent restenoses (ISR). Mean diameter stenosis was 96%+/-8% (range 80%-100%; 10 total occlusions), and mean lesion length was 126+/-78 mm (range 30-290). The primary study endpoint was laser success, defined as <50% angiographic residual stenosis post-laser, without major perforations. RESULTS: The primary endpoint was achieved in 8 (57%) lesions; all patients underwent additional balloon angioplasty, which achieved an angiographic residual stenosis <30% in all. Three lesions could not be completely traversed with the study device. Two dissections were detected after Bias Sheath application; 1 required stenting. There were 2 embolic events (specific to the antegrade device design); both were treated with aspiration therapy. Intravascular ultrasound (IVUS)-based minimal lumen diameters were 0.23+/-0.2 mm (range 0-1.0) at baseline and 3.2+/-0.8 mm after Bias Sheath application. Rutherford category improved at 1 month in 10 (71%) patients. One patient remained unchanged, another worsened (category 2 to 3), 1 died, and the fourth was not examined. The ankle-brachial index improved from 0.41+/-0.18 at baseline to 0.79+/-0.19 at discharge and to 0.80+/-0.19 at 1 month. Primary 1-month patency (<50% restenosis by duplex) was 85% (11/13 lesions). CONCLUSION: SFA lesions, including ISR, can be treated in the majority of cases with directed laser atherectomy, significantly reducing plaque burden as measured by IVUS. Embolization was attributed to device-specific features of the prototype antegrade sheath design, which was discontinued. Larger studies are mandatory to document the long-term technical and clinical impact of this new device.

Mid-term results with laser atherectomy in the treatment of infrainguinal occlusive disease.

BACKGROUND: Laser atherectomy offers a potential intervention for multivessel infrainguinal disease in patients with poor revascularization options. Despite promising early results reported in the literature, the proper patient population who might benefit from laser atherectomy has yet to be determined. METHODS: From July 2004 to June 2006, patients undergoing laser atherectomy were retrospectively reviewed and assessed for comorbidities, operative and follow-up variables potentially associated with the end points of nondefinitive therapy, and limb salvage. RESULTS: During the study period, 40 patients (21 women, 19 men) underwent laser atherectomy, and the average follow-up was 461 +/- 49 days (range, 17 to 1050 days). Their average age was 68 +/- 2 years (range, 43 to 93 years). The indication for laser atherectomy was critical limb ischemia in 26 (65%) and lower limb claudication in 11 (35%). A total of 47 lesions were treated in the following arterial segments: 34 femoropopliteal and 13 infrapopliteal. Femoropopliteal distribution by the Trans-Atlantic Society Classification (TASC) was A in 3, B in 17, C in 10, D in 4, and infrapopliteal lesions distribution was A in 1, B in 3, C in 4, and D in 5. Adjunctive angioplasty was used in 75% of cases. The overall technical success rate (<50% residual stenosis) was 88%. Laser atherectomy-based treatment was the definitive therapy for 23 patients (58%), and the overall 12-month primary patency was 44%. The limb salvage rate at 12 months in 26 patients with critical limb ischemia was 55%. Renal failure was a risk factor for amputation (P < .001) and failed primary patency (P < .05), type 2 diabetes mellitus was a risk factor for amputation (P < .05), and poor tibial runoff was associated with failed primary patency and amputation (P < .05). Outcome was associated with the number of patent infrapopliteal runoff vessels. CONCLUSION: These data demonstrate that laser atherectomy can be used with high initial technical success rate. Chronic renal failure and diabetes are risk factors for a negative outcome. Poor results in patients with diabetes and renal failure necessitate careful case selection in this subgroup, in which laser atherectomy is less likely to provide a definitive revascularization result or limb salvage.

Percutaneous laser-facilitated thrombectomy: an innovative, easily applied, and effective therapeutic option for recanalization of acute and subacute thrombotic hemodialysis shunt occlusions.

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.

[Causes and outcomes of coronary arteries perforations].

Coronary artery perforation is a rare but serious complication of percutaneous coronary interventions. Aim of this study--to assess inhospital and long term outcomes in patients in whom perforation occurred during coronary intervention and elucidation of predictors of coronary artery perforation. Between May 1997 and October 2002 perforations were formed in the course of percutaneous interventions in 127 patients what amounted 1.08% of 11,793 patients, subjected to coronary interventions, and 0.77% of 16,494 treated coronary segments. Causes of perforations were complex stenoses, chronic occlusions, calcified lesions, small predicted and minimal vessel lumen, high percent stenosis, use of excimer laser or thromboextrator. Rates of arterial perforations and subsequent adverse events including cardiac tamponade and urgent coronary artery bypass surgery as well as mortality had been declining throughout observation period.

Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter trial.

PURPOSE: To evaluate the effectiveness of laser-assisted angioplasty for patients with critical limb ischemia (CLI) who were poor candidates for surgical revascularization. METHODS: A prospective registry at 14 sites in the US and Germany enrolled 145 patients with 155 critically ischemic limbs; the patients were poor candidates for bypass surgery owing to inadequate target vessel or saphenous vein, prohibitive cardiac disease, or significant comorbidities (ASA class 4). Additional comorbid risk factors included diabetes in 66%, hypertension in 83%, previous stroke in 21%, and myocardial infarction in 23%. Endovascular treatment included guidewire traversal and excimer laser angioplasty followed by balloon angioplasty with optional stenting. RESULTS: Occlusions were present in 92% of limbs. A mean of 2.7+/-1.4 lesions were treated per limb; the total median treatment length was 11 cm (mean 16.2, range 0.2-123). Stents were implanted in 45% of limbs. Procedural success, defined as <50% residual stenosis in all treated lesions, was seen in 86% of limbs. At 6-month follow-up, limb salvage was achieved in 110 (92%) of 119 surviving patients or 118 (93%) 127 limbs. CONCLUSION: Excimer laser-assisted angioplasty for CLI offers high technical success and limb salvage rates in patients unfit for traditional surgical revascularization.

Prevention of distal embolization and no-reflow in patients with acute myocardial infarction and total occlusion in the infarct-related vessel: a subgroup analysis of the cohort of acute revascularization in myocardial infarction with excimer laser-CARMEL multicenter study.

To overcome the adverse complications of percutaneous coronary interventions in thrombus laden lesions (i.e., distal embolization, platelet activation, no-reflow phenomenon), mechanical removal of the thrombus or distal embolization protection devices are frequently required. Pulsed-wave ultraviolet excimer laser light at 308 nm can vaporize thrombus, suppress platelet aggregation, and, unlike other thrombectomy devices, ablate the underlying plaque. The following multicenter registry was instituted to evaluate the safety and efficacy of laser ablation in patients presenting with acute myocardial infarction (AMI) complicated by persistent thrombotic occlusions. Patients with AMI and complete thrombotic occlusion of the infarct-related vessel were included in eight participating centers. Patients with further compromising conditions (i.e., cardiogenic shock, thrombolysis failures) were also included. Primary endpoint was procedural respective laser success; secondary combined endpoints were TIMI flow and % stenosis by quantitative coronary analysis and visual assessment at 1-month follow-up. Eighty-four percent of all patients enrolled (n = 56) had a very large thrombus burden (TIMI thrombus scale > or = 3), and 49% were compromised by complex clinical presentation, i.e., cardiogenic shock (21%), degenerated saphenous vein grafts (26%), or thrombolysis failures (5%). Laser success was achieved in 89%, angiographic success in 93%, and the overall procedural success rate was 86%. The angiographic prelaser total occlusion was reduced angiographically to 58% +/- 25% after laser treatment and to 4% +/- 13% final residual stenosis after adjunctive balloon angioplasty and/or stent placement. TIMI flow increased significantly from grade 0 to 2.7 +/- 0.5 following laser ablation (P < 0.001) and 3.0 +/- 0.2 upon completion of the angioplasty procedure (P > 0.001 vs. baseline). Distal embolizations occurred in 4%, no-reflow was observed in 2%, and perforations in 0.6% of cases. Laser-associated major dissections occurred in 4% of cases, and total MACE was 13%. The safety and efficacy of excimer laser for thrombus dissolution in a cohort of high-risk patients presenting with AMI and total thrombotic occlusion in the infarct-related vessel are encouraging and should lead to further investigation.

Laser,"closure", stents and other new technology in the treatment of venous disease.

New technology is transforming our approach to venous disease. Once considered taboo for fear of causing deep venous thrombosis, surgical or endovenous intervention in the deep venous system is now known to be safe. Newer techniques allow minimally invasive procedures, many carried out on an outpatient basis. Traditional conservative regimens to treat acute ilio-femoral DVT are yielding to more aggressive interventional approaches to minimize the high incidence of postthrombotic syndrome with the former. Stent technology can safely and effectively relieve many of the disabling symptoms of chronic venous obstruction. Stent patency is high and morbidity low. Knowledge of venous pathophysiology has also advanced, though much remains to be learned. The beneficiaries are the large patient population with DVT and chronic venous insufficiency, which is estimated to be at least three times as large as patients with arterial disease. Unlike arterial disease, venous pathology afflicts the younger working age population in large numbers at enormous direct and social costs. In the older patient, deep venous disease is common, but seldom suspected. The symptoms are often ascribed to systemic causes. A thorough venous investigation is the key to proper diagnosis and treatment. Often, a minimally invasive procedure such as EVLT or stent insertion can offer surprising symptom relief with significant improvement in the quality of life during the twilight years.

Wireless laser-assisted angioplasty of the superficial femoral artery in patients with critical limb ischemia who have failed conventional percutaneous revascularization.

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.