Use of Laser When the Balloon Cannot Cross Cases - Excimer Laser for Complex Coronary Artery Lesions Itsik Ben-Dor, MD, Salem Bader, MD, Lowell Satler, MD, Augusto Pichard ,MD, Ron Waksman, MD Washington Hospital Center

I have no real or apparent conflicts of interest to report. Itsik Ben-Dor, MD I have no real or apparent conflicts of interest to report.

What it is Excimer Laser Coronary Atherectomy (ELCA)? Light Amplification Stimulated Emission Radiation

Catheter Overview 0.9mm RX and OTW (Concentric) 1.4mm RX (Concentric) 1.7mm RX (Eccentric & concentric) 2mm RX (Eccentric & concentric) Proximal Coupler Distal Tip

Excimer Laser Is a form of ultraviolet light. A cold laser which does not burn or cut. Vaporize tissue by breaking bonds between molecules.

Excimer Laser Coronary Atherectomy (ELCA) Ultraviolet energy photoablates arterial blockages into particles most of which are smaller than a red blood cell and are absorbed into the blood stream without embolizing distal capillaries The energy pulses create a forward acting vapor bubble that can weaken the very fibrotic proximal cap, vaporization of thrombi, ablation of underlying atherosclerotic plaque. The Size of the Vapor Bubble is dependent upon the fluency delivered  Photochemical  Photothermal  Photomechanical Dissolving molecular bonds Produces photo-thermal energy Creating kinetic energy

Excimer Laser Coronary Atherectomy (ELCA) Spectranetics CVX -300, Spectranetics, Colorado Springs, CO) Wavelength 308 nm Pulse duration 125-200 nS Fluence 30-80 mJ/mm2 Repetition Rate 25-80* Hz Catheter-diameter 0.9 - 2.5 mm 6 FR- compatible Approved by FDA for coronary 1992 for: 1. Dubulking of SVG 5. Total occlusions crossable by guide wire 2. Ostial lesion 6. Moderately calcified lesion 3. Eccentric lesions 7. Balloon refractory lesions 4. Long lesions 20mm 8. In stent restenosis * Acute myocardial infarction

Guiding support Confirm distal bed Saline flush 60/40----60/80----80/80

Washington Hospital Center(2000-2005)

Washington Hospital Center(2005-2011)

Calcified lesion and chronic total occlusion Baseline characteristics Calcified lesion N=25 Chronic total occlusion N=32 Age 71.2±13.2 62.1±11.5 Male 14(56%) 23(71.9%) Hypertension 22(88%) 29(90.6%) Diabetes 9(36%) 15(46.9%) Hyperlipidemia 23(92%) 31(96.9%) Peripheral vascular disease 2(8%) 9(28.1%) Renal failure 15(60%) 18(56.3%) Prior PCI 10(40%) 9(31.0%) Prior CABG 7(28%) 5(15.6%) Ejection fraction 54±11% 45±17%

Chronic total occlusion Procedural data Calcified lesion N=25 Chronic total occlusion N=32 Procedure length (min) 94.4±29.4 106.1±36.4 Contrast (ml) 226.9±115.4 206.9±78.5 Left main LAD CX RCA 1(4%) 5(20%) 4(16%) 15(60%) 5(15.6%) 6(18.7%) 21(65.6%) Stent DES Diameter Length 21(84%) 12(48%) 2.9±0.3 19.1±4.6 26(81.2%) 23(71.8%) 2.8±0.3 24.8±6.9 Laser 0.9mm 1.4mm 1.7mm 2.0mm 23(92%) 27(84.3%) 3(9.3) 1(3.1%) Laser success 20(80%) 30(93.7%) Angiographic success 29(90.1%) Balloon non crossable lesions 14(56%) Concomitant Rota ablation Before After 2(6.2%) IABP 4(16.6%)

Calcified lesion and chronic total occlusion In hospital complication Calcified lesion N=25 Chronic total occlusion N=32 Dissection 3(9.3%) Perforation 1(4%) 1(3.1%) No reflow 2 (8%) Thrombus formation Death Q wave MI Max CKMB (ng/ml) 12.2±22.3 9.8±18.2 Troponin (ng/ml) 11.8±41.0 4.7±11.3 TLR/TVR CABG Stent thrombosis Renal failure 1(4.2%) In hospital dialysis TIA/CVA Vascular complication Major bleeding 2(6.2%)

Novel use of a high-energy excimer laser catheter for calcified and complex coronary artery lesions. Prospective multicenter study that examined of 100 calcified and/or balloon-resistant lesions (in 95 patients) that were treated with 0.9mm X-80 excimer laser catheter Luc Bilodeau, MD, et al. Catheter Cardiovasc Interv. 2004 Jun;62(2):155-61.

Success:Laser 92%, Procedural 93%, Clinical 87% Novel use of a high-energy excimer laser catheter for calcified and complex coronary artery lesions. Lesions meeting inclusion criteria Crossing success of balloon failed lesions is 94% n=100 n=5 Abandoned lesions (31/33). n=95 Fail n=29 Standard laser parameter therapy Increased laser parameter therapy Success n=21 Fail n=8 Success n=66 Adjunctive therapy Success:Laser 92%, Procedural 93%, Clinical 87% Luc Bilodeau, MD, et al. Catheter Cardiovasc Interv. 2004 Jun;62(2):155-61.

Novel use of a high-energy excimer laser catheter for calcified and complex coronary artery lesions. Complications n (%) SLT (n = 66) ILT (n = 29) Laser complications 3 (5) 2 (7) Dissection Perforation Spasm No reflow/embolization Thrombus formation Acute closure X-80 (n=95)* n % Laser success 87 92% Procedural success 89 93% Clinical success 83 86% In-hospital MACE 8 8% * ILT, increased laser therapy; SLT, standard laser therapy. X-80 laser catheter is ideal for treating: CTOs, calcified lesions, and balloon-resistant lesions (the laser crossed 92% of the time) X-80 crossed 94% of lesions which previously failed balloon angioplasty Data suggests that laser may also change the compliance of plaque, allowing for improved lesion management (i.e. 4 lesions which were previous balloon failures were adequately treated with balloons and stents after lasing with the X-80, despite the the fact that the laser catheter had not entirely crossed the target lesion) Luc Bilodeau, MD, et al. Catheter Cardiovasc Interv. 2004 Jun;62(2):155-61.

Cases

CASE I- Balloon refractory lesion Clinical history 73 female, diabetes Insulin treatment She has developed progressive S.O.B and chest pain Nuclear stress test –Inferior ischemia

CASE I- Balloon refractory lesion

CASE I- Balloon refractory lesion

CASE I- Balloon refractory lesion Guide – 7F HS Guide wire – Fielder XT Balloon 1.5/8mm APEX did not cross FineCross did not cross (exchange for ROTA wire) ?

CASE I- Balloon refractory lesion 0.9mm OTW Repetition rate of 40Hz and a fluence of 60 mJ/mm2 and then increased to a repetition rate of 80Hz with a fluence of 80 mJ/mm2

CASE I- Balloon refractory lesion Rotablator wire was passed through the OTW laser catheter 1.5mm Rota burr

CASE I- Balloon refractory lesion Balloon 3/12mm Voyager Stent- Xience 3/15mm

CASE II- Balloon refractory lesion Clinical History 82 years female who admitted with dizziness and syncope post viral gastroenteritis. On ECG she had rapid atrial fibrillation with prolong post conversion sinus pauses. She had positive cardiac enzyme PMH: Hypertension Hyperlipidemia

CASE II- Balloon refractory lesion Guiding catheter 8F HS, SH Guide wire BMW Balloon 2.5/20 Sprinter did not cross Balloon 1.5/15 Sprinter did not cross

CASE II- Balloon refractory lesion Rotational Atherectomy 1.25mm did not cross

CASE II- Balloon refractory lesion The 0.9 Excimer Laser Start off with high energy and rates 60/40 and increase to 80/80 Than Rotational atherectomy 1.25mm and 1.5mm 2.5/20mm Sprinter 2.5/14mm Micro Driver

CASE II- Balloon refractory lesion

CASE III- Chronic total occlusion 58 years old male Known CAD, s/p PCI RCA and LAD 1999 Admitted due to chest pain and positive thallium scan- ischemia in inferior wall PMH: Hyperlpidemia HTN Tobacco abuse Clinical History

CASE III- Chronic total occlusion

CASE III- Chronic total occlusion Venture catheter was used to direct the Miracle 6 guide wire

CASE III- Chronic total occlusion 1.5 OTW balloon did not cross 0.9 Excimer Laser did not cross, until fluency 80/80 was used

CASE III- Chronic total occlusion IVUS of CX after laser+1.5 balloon

CASE III- Chronic total occlusion CX after 2 drug eluting stents deployed at 24 atm

CASE IV- Chronic total occlusion Clinical History 57 years old male Presented with chest pain He underwent a stress test that was positive –inferior wall PMH: Hyperlpidemia Hypertension

CASE IV- Chronic total occlusion Guiding catheter 7F 3DRight

CASE IV- Chronic total occlusion CTO 2.1f 135cm Tornus Guide wire.014in MiracleBros 6

CASE IV- Chronic total occlusion Guide wire.014in Confianza Balloon 1.5mm 15mm Apex did not cross An Excimer Laser .9mm Did mot cross

CASE IV- Chronic total occlusion An anchoring balloon and Excimer Laser .9mm Drug Eluting Stent 2.5mm 30mm Cypher

Summary Laser is a very useful tool in complex coronary intervention including calcified, CTO, SVG, AMI and unexpanded stent Laser is safe and effective for balloon refractory lesions Laser is safe and effective for total occlusions crossable by guide wire

Summary Laser can also be used as an adjunct to facilitate rotational atherectomy calcified lesion – rotational atherectomy better but: -Rotational atherectomy hard to manipulate the guide wire -Can not protect side branch -Can not in AMI -In stent there is risk distal embolization of microparticles

CASE V- Under expanded stents with recurrent restenosis Clinical History 64-year-old male 9 years ago PCI prox CX (3.0/24 BMS) Seven months later, recurrent anginA-Diffuse ISR rotational atherectomy, POBA, and Irdium-192 radiation to 14 pGy, and a 3.0-mm BMS. 3 years ago, symptomatic ISR: PCI 3mm TAXUS Now mild exertional angina reappeared and lateral ischemia

CASE V- Under expanded stents with recurrent restenosis 3 stents not expanded 2 mm Laser 3.69 mm2 Quantum 28 atm

CASE V- Under expanded stents with recurrent restenosis

CASE VI- Saphenous vein graft Clinical History 71-year-old female History of hypertension, hyperlipidemia, diabetes mellitus, and CABG in 2005 Admitted after developing hypotension and chest pain during nuclear stress testing. The scintigraphy revealed extensive ischemia involving the anterior, inferior and lateral walls.

CASE VI- Saphenous vein graft 0.9 mm Laser D distal protection device (Spider FX 5.0-mm)

CASE VI- Saphenous vein graft

CASE VI- Saphenous vein graft

CASE VII- Acute myocardial infarction Clinical History 80-year-old male History of diabetes, hyperlipidemia, and prior CABG, and mechanical aortic valve replacement (1998). 1 year ago PCI SVG to the LAD Cypher 3.0/28-mm. Presented 1with acute onset of chest pain and ST-segment elevation in the precordial leads

CASE VII- Acute myocardial infarction 1.4 mm Laser repetition rate of 40 Hz and a fluence of 60 mJ/mm2

CASE VII- Acute myocardial infarction