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.

A retrospective analysis of laser endartherectomy assisted balloon angioplasty for popliteal and infrapopliteal peripheral arterial disease.

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.

Incidence, management, and outcome of coronary artery perforation during percutaneous coronary intervention.

We have analyzed the incidence, management, and outcome of 84 cases of coronary artery perforation in patients who underwent percutaneous coronary intervention at our institution. This complication was more frequent in female patients and in patients who underwent lesion modification with atheroablative devices. A total of 8 patients (9.5%) died after the procedure. They were usually older and had a higher incidence of cardiac tamponade; a larger percentage of these patients underwent emergency surgery than those who survived.

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.

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.

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.