Dealing with Calcification in BTK Arteries: Is Lithoplasty the Answer?

Dealing with Calcification in BTK Arteries: Is Lithoplasty the Answer? Andrew Holden, MBChB, FRANZCR, EBIR Director of Interventional Radiology Auckland, New Zealand LINC 2017 January 25 th 2017

Disclosure Speaker name: Andrew Holden I have the following potential conflicts of interest to report: X Consulting Clinical Investigator for Shockwave Medical Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

Calcification in BTK Arteries Seen in many CLI patients but especially in diabetics, elderly and dialysis-dependent patients Occurs in both intimal and medial layers (often mixed) Higher prevalence of medial calcification in tibial arteries than other locations Medial Calcification Intimal Calcification Images Courtesy J Mustapha

Calcification in BTK Arteries Risks of angioplasty with calcified stenotic disease residual stenosis, dissection, perforation, restenosis and reduced drug absorption Calcified lesions in CLI patients 1.5 X increased mortality, 5 X amputation rate! 1,2 100% 100% 100% 100% 90% 90% 87.5% 1.0 0.9 0.8 75% 50% 0.59 0.7 0.72 0.75 0.68 0.6 0.66 0.5 0.52 50% 50% 0.4 0.45 0.46 0.3 25% Primary Patency LLL 0.2 0.1 0% 0.0 1a 1b 2a 2b 3a 3b 4a 4b Calcium distribution evaluation by CTA (circumferentially) and DSA (longitudinally) 1. Fanelli et al. Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease. Cardiovasc Intervent Radiol (2014) 37: 898-907. Perforation after angioplasty 1. J Am Cardiol 2008;51(20):1967-74 2. Huang CL et al, PLoS ONE 9(2): e9020

Lithoplasty Lesion modification using localized lithotripsy in a balloon Tissue-selective: Hard on hard tissue, Soft on soft tissue Lithotripsy waves travel outside balloon Designed to disrupt both superficial, deep calcium Designed to normalize vessel wall compliance prior to controlled, low pressure dilatation Effective lesion expansion with minimized impact to healthy tissue Familiar Balloon-based endovascular technique Front-line balloon strategy (.014 compatible)

Lithoplasty

Lithoplasty in Femoropopliteal Arteries DISRUPT PAD I 35 subjects, 3 sites Jan 2014 Sep 2014 DISRUPT PAD II 60 subjects, 8 sites Jun 2015 Dec 2015 High procedural success Stand alone treatment in the vast majority of cases Excellent safety profile Sustained patency and clinical benefit, at least to 6 months

Lithoplasty in BTK Arteries: Study Design Safety and Feasibility of Lithoplasty in calcified, stenotic Infrapopliteal Arteries Device: 2.5 to 3.5 X 60 mm Lithoplasty 20 patients treated at 5 sites Population: RC 1 5 infrapopliteal disease. Target lesion: 2.5 3.5 mm, >50% stenosis, < 150 mm length, single/multiple targets allowed Safety Major Adverse Events at 30 day including death, MI, revascularization and amputation Effectiveness - % reduction in diameter stenosis

Baseline and Procedural Characteristics Baseline N= 8 Age 79 Male gender 87.5% (7) Diabetes 25.0% (2) Hypertension 100% (8) Hyperlipidemia 100% (8) Renal disease 25.0% (2) Current Smoker 0.0% (0) Rutherford Class -- RC 3 37.5% (3) RC 4 0.0% (0) RC 5 62.5% (5) Procedure N= 8 Procedure time (min) 64 Fluoroscopy time (min) 12.7 Contrast (cc) 97.4 Target lesion -- TP Trunk 12.5% (1) Anterior tibial 62.5% (5) Posterior tibial 12.5% (1) Peroneal 12.5% (1) Pre-dilatation 12.5% (1) Lithoplasty balloons (N) 1.4 Number pulses 40 Mean Pressure (mmhg) 6 Stents 0.0% (0)

Interim Angiographic and Safety Results Angiographic core lab adjudicated Pre N= 8 lesions Post N= 8 lesions MLD (mm) 1.2 2.5 % diameter stenosis (DS) 61.7% 21.2% % DS reduction -- 65.0% Pre-Procedure N=8 lesions RVD (mm) 3.1 Lesion length (mm) 38.0 Calcified length (mm) 52.2 Calcification -- Moderate 87.5% (7) Severe 12.5% (1) Post-Procedure N=8 lesions Acute gain (mm) 1.3 Thrombus 0% (0) Abrupt closure 0% (0) No reflow 0% (0) Distal embolization 0% (0) Dissections 0% (0) Perforations 0% (0)

Recorded Case 8 th November 2016 76 year old male Rest pain left foot Pre-tibial non-healing ulcer

Recorded Case 8 th November 2016

Recorded Case 8 th November 2016 Inflation to 4 ATM

Recorded Case 8 th November 2016 Lithoplasty @ 4 ATM

Recorded Case 8 th November 2016

Recorded Case 8 th November 2016 Inflation to 4 ATM Lithoplasty @ 4 ATM

Recorded Case 8 th November 2016

Conclusions Endovascular outcomes in BTK treatment are poor despite the multiple therapies currently available Calcium is a challenge in endovascular treatment and found in both intimal and medial layers Lithoplasty is designed to treat both superficial and deep calcium allowing vessel expansion without angiographic complications Early results of Lithoplasty in BTK lesions show consistent reduction in stenosis and no procedural complications, including distal embolization

Dealing with Calcification in BTK Arteries: Is Lithoplasty the Answer? Andrew Holden, MBChB, FRANZCR, EBIR Director of Interventional Radiology Auckland, New Zealand LINC 2017 January 25 th 2017