Recanalization of Failed Autogenous Conduit Utilizing Laser Revascularization

Vasc Endovascular Surg. 2011 Oct;45(7):636-40

Recanalization of failed autogenous conduit utilizing laser revascularization

Chander RK, Oza P, Patel M, Balar N

1Department of Surgery, New York Medical College at Montefiore North Division,

Bronx, NY, USA

The traditional approach for the treatment of restenosis of autogenous vein bypass has been revision of bypass with vein patch angioplasty, interposition jump graft, or thrombectomy procedures for those patients with extensive occlusive disease and limb-threatening ischemia. Endovascular intervention traditionally involves angioplasty of the graft; however, vessels with diffuse disease or extensive longitudinal lesions are generally difficult to revascularize utilizing this technique. Surgical revision of a threatened autogenous vein graft may carry a morbidity rate as high as 13.6%. We present a series of cases in which excimer laser atherectomy (LA) was used to recanalize an occluded autogenous saphenous vein bypass. Of the occluded vein bypasses failed angioplasty and were successfully atherectomized with LA measuring lengths of 35 and 30 cm, respectively. The infrainguinal has a 6-month follow-up, while the infragencular has a follow-up of 1 year, with resolution of presenting symptoms.

J Cardiovasc Med (Hagerstown). 2011 Jul 6. [Epub ahead of print]

Excimer laser coronary angioplasty with manual thrombus aspiration for a case of

very late stent thrombosis of sirolimus-eluting stent

Niccoli G, Minelli S, Cosentino N, Crea F

Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy

Very late stent thrombosis occurring after drug-eluting stent implantation is a rare complication. However, it is often associated with poor outcome. Manual thrombectomy has been shown to lower the rate of distal embolization in the case of ST-elevation myocardial infarction of native coronary arteries. However, the presence of abundant thrombus material may lead to manual thrombus aspiration failure. Here, we describe the case of a patient with acute myocardial infarction due to stent thrombosis of a sirolimus-eluting stent occurring 50 months after stent deployment showing abundant thrombus material, which led to manual thrombus aspiration failure and was then successfully treated by excimer laser coronary angioplasty. In these cases, excimer laser coronary angioplasty may be useful due to its ability to dissolve thrombus.

J Interv Cardiol. 2011 Jun 28. Epub ahead of print

A Complex Case of Angulated and Bifurcated Lesion Facilitated by Excimer Laser

Coronary Angioplasty

Niccoli G, Minelli S, Cosentino N, Crea F

Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy.

Angulated lesions have been shown to be associated with abrupt closure orperiprocedural myocardial injury. In particular, when disease is present at thelevel of the angulated or bifurcated lesion, balloon dilatation may help in wire crossing but it may also cause branch occlusion. Several methods and devices havebeen described to manipulate coronary guidewires across angulated and bifurcated lesions. This case report describes a highly angulated coronary bifurcated lesionwhere, after the failure of multiple wires to cross the lesion toward the mainbranch, it was successfully crossed after excimer laser debulking, which

facilitated the wire crossing into the main branch, without causing branchocclusion.

Conf Proc IEEE Eng Med Biol Soc. 2010;2010:1618-21

The laser driven short-term heating balloon catheter: Relation between the chronic neointimal hyperplasia formation and thermal damage to arterial smooth muscle cells

Shimazaki N, Hayashi T, Kunio M, Igami Y, Arai T, Sakurada M

Graduate School of Fundamental Science and Technology, Keio University (Japan).

We proposed a novel laser-driven short-term heating angioplasty to realizrestenosis-suppressive angioplasty for peripheral artery disease. In this study, we investigated the chronic intimal hyperplasia formation after the short-termheating dilatation in vivo, as well as the thermal damage calculation on arterialsmooth muscle cells (SMCs). The prototype short-term heating balloon catheterwith 5.0, 5.5, 6.0 mm φ in balloon diameter and 25 mm in balloon length wereemployed. The short-term heating dilatation was performed in porcine iliacarteries with dilatation conditions of 75°C (N=4) and 65°C (N=5) as peak balloon temperature, 18 ± 4s as heating duration, 3.5 atm as balloon dilatation pressure.Four weeks after the balloon dilatation, the balloon-dilated artery segments wereextracted and were stained with HE and picrosirius red for histologicalobservation. In the case of 75°C as the peak balloon temperature, neointimalhyperplasia formation was significantly reduced. In this case, the SMCs densityin the artery media measured from the HE-stained specimen was 20% lower than thatin the reference artery. According to the thermal damage calculation, it wasestimated that the SMCs lethality in artery media after the short-term heatingangioplasty was 20% in the case of 75°C as the peak balloon temperature. Wedemonstrated that the short-term heating dilatation reduced the number of SMCs inartery media. We think this SMCs reduction might contribute to the suppression ofchronic neointimal hyperplasia.

Conf Proc IEEE Eng Med Biol Soc. 2010;2010:1614-7

Development of selective laser treatment techniques using mid-infrared tunable

nanosecond pulsed laser

Ishii K, Saiki M, Hazama H, Awazu K

Medical Beam Phisics Laboratory, Division of Sustainable Energy and Environmental

Engineering, Graduate School of Engineering, Osaka University, 565-0871, Japan

Mid-infrared (MIR) laser with a specific wavelength can excite the corresponding biomolecular site to regulate chemical, thermal and mechanical interactions tobiological molecules and tissues. In laser surgery and medicine, tunable MIRlaser irradiation can realize the selective and less-invasive treatments and the special diagnosis by vibrational spectroscopic information. This paper showed anovel selective therapeutic technique for a laser angioplasty of atherosclerotic plaques and a laser dental surgery of a carious dentin using a MIR tunable

nanosecond pulsed laser.

Int J Cardiol. 2010 Nov 19;145(2):251-4. Epub 2009 Sep 13

Crossing of a calcified "balloon uncrossable" coronary chronic total occlusion facilitated by a laser catheter: a case report and review recent four years' experience at the Thoraxcenter

Shen ZJ, García-García HM, Schultz C, van der Ent M, Serruys PW

Failure to cross with a balloon is a well recognised cause of failure torecanalise a chronic total occlusion (CTO) despite successfully positioning aguidewire into the distal true lumen. One technique that is infrequently usedcurrently is excimer laser assisted coronary intervention. We report a patientwith CTO in whom in the fourth attempt, the operators succeeded by using a laser catheter. Also, we review the cases treated with laser catheter in ourinstitution during these recent 4 years. The laser catheter can be useful inselected patients including those with CTO where a balloon would not pass despitea guidewire in the distal true lumen.

Int J Cardiol. 2010 Nov 19;145(2):e60-3. Epub 2009 Jan 30

A case of very late thrombosis of bare metal stent successfully treated with excimer laser coronary angioplasty

Larosa C, Ricco A, Cosentino N, Marino M, Mongiardo R, Niccoli G

Late thrombosis occurring after bare metal stent (BMS) implantation is a rarecomplication. However, it is often associated with poor outcome. Mechanismsunderlying BMS thrombosis may differ from those underlying drug eluting stentthrombosis. In particular, severe instent restenosis may trigger thrombusformation. This case report describes a very late thrombosis of BMS occurring on an in-stent restenosis. After failure of manual thrombectomy, the case wassuccessfully faced by Excimer Laser Coronary Angioplasty (ELCA). Cases like this may be successfully treated by devices like ELCA combining debulking and thrombus removal capabilities.

Am J Cardiol. 2010 Oct 15;106(8):1113-7

Usefulness of intravascular low-power laser illumination in preventing restenosis after percutaneous coronary intervention

Derkacz A, Protasiewicz M, Poreba R, Szuba A, Andrzejak R

Department of Internal Medicine, Wroclaw Medical University, Wroclaw, Poland.

Despite the several years of studies, no factor that could reduce the restenosisrate without significant limitations has been introduced. The aim of the present study was to evaluate the influence of low-power 808-nm laser illumination ofcoronary vessels after percutaneous angioplasty in preventing restenosis. Theprocedure of laser intravascular illumination was performed on 52 patients (lasergroup), and another 49 patients formed the control group. All patients weremonitored for major adverse cardiac events (MACE) at the 6- and 12-monthfollow-up points. The MACE rate after 6 and 12 months was 7.7% in the laser groupat both points. The MACE rate was 14.3% and 18.5% at 6 and 12 months of follow-upin the control group, respectively (p = NS). Follow-up coronary angiography wasperformed after 6 months. The difference in the restenosis rate was insignificant(15.0% vs 32.4%); however, significant differences were observed in the minimallumen diameter (2.18 ± 0.70 vs 1.76 ± 0.74 mm; p < 0.05), late lumen loss (0.53 ±0.68 vs 0.76 ± 0.76 mm; p < 0.01), and the late lumen loss index (0.28 ± 0.39 vs 0.46 ± 0.43; p < 0.005) in favor of the laser group. In conclusion, the newtherapy seemed effective and safe. Marked differences between late loss, lateloss index, and minimal lumen diameter were observed. The late lumen loss in the laser group was only slightly greater than that in studies of drug-elutingstents, and MACE rate remained within very comparable ranges. This suggests that intravascular laser illumination could bring advantages comparable to those ofdrug-eluting stents without the risk of late thrombosis.

Eur J Radiol. 2010 Jul;75(1):48-56. Epub 2010 May 7

Angioplasty of the pelvic and femoral arteries in PAOD: results and review of the literature

Balzer JO, Thalhammer A, Khan V, Zangos S, Vogl TJ, Lehnert T

Dept. for Radiology and Nuclear medicine, Catholic Clinic Mainz, An der Goldgrube 11, 55131 Mainz, Germany.

Purpose: Evaluation of percutaneous recanalization of obstructed iliac as well as superficial femoral arteries (SFAs) in patients with peripheral arterial obstructive disease (PAOD)

Material and methods :The data of 195 consecutive patients with 285 obstructions of the common and or external iliac artery as well as the data of 452 consecutive patients with 602 long occlusions (length>5 cm) of the SFA were retrospectively analyzed. The lesions were either treated with percutaneous transluminal angioplasty (PTA) or Excimer laser assisted percutaneous transluminal angioplasty (LPTA). Overall 316 stents were implanted (Nitinol stents: 136; stainless steel stents: 180) in the iliac artery and 669 stents were implanted (Nitinol stents: 311; Easy Wallstents: 358) in the SFA. The follow-up period was 36-65 months (mean 46.98+/-7.11 months) postinterventionally using clinical examination, ABI calculation, and color-coded duplex sonography. Patency rates were calculated on the basis of the Kaplan-Meier analysis.

Results :The overall primary technical success rate was 97.89% for the iliac arteries and 92.35% for the SFA. Minor complications (hematoma, distal emboli and vessel dissection) were documented in 11.79% for the iliac arteries and 7.97% for the SFA. The primary patency rate was 90.3% for the iliac and 52.8% for the SFA after 4 years. The secondary patency rate was 96.84% for the iliac and 77.8% for the SFA after 4 years.

Conclusions : Percutaneous recanalization of iliac and superficial femoral artery obstructions is a safe and effective technique for the treatment of patients with PAOD. By consequent clinical monitoring high secondary patency rates can be achieved. The use of a stents seems to result in higher patency rate especially in the SFA when compared to the literature in long-term follow-up.

J Cardiovasc Surg (Torino). 2010 Apr;51(2):233-43

Update on the TURBO BOOSTER spectranetics laser for lower extremity occlusive

disease

Micari A, Vadalà G, Biamino G

GVM Care and Research, Palermo, Italy.

In the last two decades the endovascular treatment of peripheral arterialocclusive disease (PAOD) has gained a widespread and predominant role. Newtechnologies have developed in the last years as atherectomy devices, selfexpandible nitinol stents, drug eluting devices (stent and balloons), absorbable stents. In recent years, growing interest has been dedicated to laser technology due to device improvements and literature data reporting safety and efficacy ofexcimer laser. The role of this new endovascular technique for the treatment of

atherosclerotic arterial diseases should be considered with regard to two fields of interest: the claudicatio intermittens (CI) and the critical limb ischemia(CLI). A 20-year history with medical lasers has proven that not all lasers areequal. Lasers used and studied in the late 1980s and 1990s had poor outcomes due to inappropriate laser selection and undefined laser techniques. Over the last 10years, multicenter studies with the excimer laser confirm that case selection,appropriate utilization of equipment, application of safe lasing techniques, and

knowledge of indications and contraindications, all contribute to the successful application of laser-assisted angioplasty in complex coronary and peripheralartery disease. If applied properly, the Excimer Laser is a useful technique totransform complex obstructive arterial disease into more treatable lesions,improving the results of endovascular treatment and lowering the threshold ofintervention for ''untreatable'' patients. New larger studies are requested toassess the definitive role of this technique in PAD treatment and limb salvage.

This review will discuss the Laser Phisics and application in PAD along with the clinical data available to support the Excimer Laser as a reliable technology for

endovascular intervention.

Eur J Vasc Endovasc Surg. 2010 Feb;39(2):234-8. Epub 2009 Nov 25

Excimer laser ablation in the treatment of total chronic obstructions in critical

limb ischaemia in diabetic patients. Sustained efficacy of plaque recanalisation

in mid-term results

Serino F, Cao Y, Renzi C, Mascellari L, Toscanella F, Raskovic D, Tempesta P,

Bandiera G, Santini A

Department of Vascular Surgery, Istituto Dermopatico dell'Immacolata, IRCCS,

Rome, Italy.

This prospective study aims to evaluate the impact of the excimer lasertechnology as the first-line endovascular treatment of critical limb ischaemia(CLI) in diabetic patients. The protocol allowed the use of laser ablation ofobstructive lesions when conventional endoluminal guidewire crossing of theplaque was unsuccessful. We extrapolate the data of consecutive patients treated,who completed at least 12 months of follow-up, extending the observation to a26-month time frame. During this period, 67 diabetic patients with CLI werebrought to the Cath Lab for 'operative angioplasty' and to be treated withendovascular techniques. Of the 67 cases, laser was used on 35 patients to treat 51 lesions. All patients had type C or D occlusive lesions, according to the TACSII classification, showing a single type D plaque or multiple tandem C/Docclusive plaques ranging from 4 to 23 cm in length. The immediate clinical

success, defined as restored direct arterial flow to the foot, was 88.2%. Thelesions were successfully crossed by laser in 45 out of 51 attempts. Stents were required in 25% of the patients with 21% lesions. Patency rates were assessedusing the Kaplan-Meier survival curves. The patency rates of the successfullytreated lesions (freedom from target lesion revascularisation) were 96.6% at 12months and 82.7% at 24 months. Limb-salvage rate at 12 and 24 months were 100%and 94%, respectively. Our study showed that the excimer laser-assistedangioplasty, when feasible, is effective in granting event-free survival in CLI

patients with diabetes, and that endoluminal-driven atherectomy allows long-term success in reducing the need of stents in the lower limb arteries.

Acta Bioeng Biomech. 2009;11(3):11-8

Flexibility and trackability of laser cut coronary stent systems

Szabadíts P, Puskás Z, Dobránszky J

Budapest University of Technology and Economics, Department of Materials Science

and Engineering, Budapest, Hungary.

Coronary stents are the most important supports in present day cardiology.Flexibility and trackability are two basic features of stents. In this paper,four different balloon-expandable coronary stent systems were investigatedmechanically in order to compare their suitability. The coronary stent systemswere assessed by measurements of stent flexibility as well as by comparison offorces during simulated stenting in a self-investigated coronary vessel model.The stents were cut by laser from a single tube of 316L stainless steel or L-605 (CoCr) cobalt chromium alloy. The one-and four-point bending tests were carriedout to evaluate the stent flexibility E x I (Nmm(2)), under displacement control in crimped and expanded configurations. The flexibility of stents would be ratherdependent on the design than on raw material. In general a more flexible stentneeds lower tracking force during the implantation. The L-605 raw material stentsneed lower track force to pass through in the vessel model than the 316L rawmaterial stents. The sort and long stents passed through the curved vessel model in different ways. The long stents nestled to the vessel wall at the outer arcand bent, while the short stents did not bend in the curve, only the deliverysystems bent.

J Endovasc Ther. 2009 Dec;16(6):665-75

Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry

Dave RM, Patlola R, Kollmeyer K, Bunch F, Weinstock BS, Dippel E, Jaff MR, Popma J, Weissman N; CELLO Investigators

Harrisburg Hospital, Harrisburg, Pennsylvania 17101, USA.

Purpose: To evaluate the safety and efficacy of a modified laser catheter designed for the endovascular treatment of peripheral artery disease (PAD) affecting the superficial femoral artery (SFA) and proximal popliteal artery.

Methods: The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) study was a single-arm, prospective registry conducted at 17 investigational sites in the United States. The primary endpoint was the reduction in index lesion percent diameter stenosis (% DS) measured by Doppler ultrasound following laser ablation prior to any adjunctive therapy. The primary safety endpoint was major adverse events at 6 months. Sixty-five patients (39 men; mean age 68.3+/-10.1 years) with intermittent claudication, stenotic lesions >70% by visual assessment, a reference vessel diameter >or=4.0 and <or=7.0 mm, and a total lesion length >or=1.0 and <or=15.0 cm underwent laser-assisted recanalization with optional balloon angioplasty (BA) or BA + stenting. Sixty-five de novo lesions (5.6+/-4.7 cm) in 13 occluded and 52 stenotic arteries were treated.

Results:Laser ablation reduced the % DS from 77%+/-15% at baseline to 34.7%+/-17.8%, which was reduced to 21%+/-14.5% after adjunctive therapy with BA (n = 42, 64.6%) or BA + stenting (n = 15, 23.3%). Eight (12.3%) patients did not receive post laser adjunctive therapy. Patency rates (% DS <50%) were 59% and 54% at 6 and 12 months, respectively. Target lesion revascularization was not required in 76.9% of CELLO participants within the 1-year follow-up. There were no major adverse events. The study cohort demonstrated a statistically significant improvement in the walking impairment and functional status assessments during follow-up.