AN UPDATE ON BALLOONS: FROM POBA TO THE NEWEST TECHNOLOGIES
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1 AN UPDATE ON BALLOONS: FROM POBA TO THE NEWEST TECHNOLOGIES Pradeep K. Nair, MD, FACC, FSCAI Interventional Cardiologist Cardiovascular Institute of the South Houma, LA, USA
2 Disclosures Speaker s Bureau: None Honorarium: None Consultant: None Stockholder: None Grant/Research Support: No Personal Financial Support Clinical Trial Investigator for: W.L Gore & Associates, Inc C.R. Bard, Inc. Boston Scientific Juventas Therapeutics Boehringer Ingelheim Intelligent Delivery Systems, LLC Medical/Scientific Boards: None
3 Balloon Angioplasty
4 BALLOON ANGIOPLASTY Historical perspective Principles and mechanisms Current and Emerging technologies
5 HISTORICAL PERSPECTIVE
6 Thomas J. Fogarty, MD Balloon on Catheter 1960: 1 st catheter Ingredients - size 5 latex glove, 6Fr ureteral catheter Skill - luring techniques from fly fishing Testing - Jell-O in a test tube 1961: 1 st patient (63-yo iliac embolectomy) Fogarty TJ, et al. Surg Gynecol Obstet.1963;116: : Open surgical balloon thrombectomy introduced
7 Charles T. Dotter, MD Father of Intervention My favorite conceptual trademark is a sketch that I did years ago of a crossed pipe and wrench. It's a gross oversimplification, of course, but what it means to me is that if a plumber can do it to pipes, we can do it to blood vessels. January 16, 1964: 1 st percutaneous transluminal angioplasty (Dotter Technique) Courtesy of Dotter Interventional Institute, Oregon Health & Science University Anonymous. Portraits in radiology: Charles T. Dotter, MD. Appl Radiol 1981;10(Jan-Feb):28,116.
8 Andreas R. Gruentzig, MD Father of Balloon Angioplasty Courtesy of the Andreas Gruentzig Cardiovascular Center, Atlanta GA Created a semi-compliant balloon made of polyvinyl chloride in his kitchen February 12, 1974: PTA of femoral artery September 16, 1977: 1 st PTCA in Zurich, Switzerland Barton, M. Front. Cardiovasc. Med., 29 December 2014
9 Gruentzig s 1 st angioplasty balloon New Dilatation Catheter Barton, M. Front. Cardiovasc. Med., 29 December 2014
10 JOHN B. SIMPSON, MD FATHER OF ATHERECTOMY 1982: Invented over-the-wire balloons 1985: Invented directional atherectomy (Simpson AtheroCath) Nair PK, Walker CM. Atherectomy: A Historical Perspective. In: Textbook of Atherectomy. 2016
11 Principles and Mechanisms of Balloon Angioplasty
12 Angioplasty Mechanism Angioplasty Plaque Compression Plaque Fracture Controlled Injury -Andreas Gruentzig Vessel Stretching Lumen expansion Kinney TB, et al. Radiology 153, 1984 Casteneda-Zuniga WR, et al. Angiology. 35, 1984
13 Controlled Injury and Consequences Dissection Elastic recoil Neointimal hyperplasia Restenosis Thrombosis
14 Laplace s Law Physics of Balloon Angioplasty
15 Torsional Stress Wall Stress of POBA Radial Stress Longitudinal Stress
16 Complex Plaque Morphologies Lower Wall Stress Higher Wall Stress
17 Semi Compliant Non Compliant Composition: Polyolefin copolymer, Polyurethanes pressure = growth Grow in areas of least resistance ( dog bone ) Softer, thinner wall = trackability, may burst at ultra high pressures Re-wraps better Composition: Polyethylene terephthalate pressure = growth Intended for resistant lesions Thicker walled balloon (withstands higher pressure) Less flexibility and tracking Re-wraps worse
18 Strain Rate and Vessel Injury Strain rate Vessel injury is related to the RATE at which the vessel wall is stretched Slow, low pressure inflations minimize trauma Solar, R. Cardio Radiation Medicine, 2003 Schmitz, et al. Am Heart J., 1996 Ilia R, et al. Cath Cardiovasc Diag, 1993 Shawl F. Cath Cardiovasc Diag., 1993 Chenu P, et al. Cath Cardiovasc Diag., 1993 Banka V, eya l. Am Heart J., 1993
19 Non-randomized, unblinded, and totally fun Kindergartener's Silly Putty Strain Rate Experiment Fast Strain Rate Uncontrolled Injury Slow Strain Rate Controlled Injury
20 Tips and Tricks with Peripheral POBA Slow inflations Longer inflations (2-3 minutes) Understand balloon characteristics -wire compatibility -shaft lengths -crossing profiles -rapid exchange versus OTW -compliance Zorger, N, et al. J Vasc Interv Radiol 2002
21 Current and Emerging Specialty Balloon Technologies (Beyond POBA)
22 Focal Force Balloons Increased dilating force to crack the resistant lesion Wires Cutting Scoring
23 Focal Force: VascuTrak BARD Semi-Compliant Balloon with 2 external wires
24 Focal Force: Cutting Balloon Diameter 2-8mm Length: 15-20mm Boston Scientific CBA Designed by Barath atherotomes ( cutting blades ) mounted on a noncompliant balloon Controlled dissection Size 1.0:1.1 (balloon:vessel) Slow inflation/deflation Cotroneo AR, et al. J Endovasc Ther. 2008
25 Focal Force: AngioSculpt Components 1. Angioplasty Ballon Semi-compliant 2. Scoring Element laser-cut Nitinol hypotube helical configuration rectangular edges Diameter: 2-8mm Length: mm SPNC Advantages Minimal Slippage - Precision locks in without watermelon seeding More Dilating Force - Power x the dilating force of conventional balloons Low dissection and perforation rates - Safety Mooney M, et al. Am J Cardiol. 2006;98(8 suppl):121m Costa JR, et al. Am J Cardiol. 2007;100: Scheinert D, et al. Catheter Cardiovasc Interv. 2007;70: Increased luminal gain
26 Focal Force: Advance Enforcer 35 Cook Medical Diameter: 6-12mm Length: 40mm Wire: inch
27 Focal Force: Serranator CAGENT VASCULAR
28 Caged Balloon: Chocolate Balloon QT Vascular Nitinol constrained semi-compliant balloon OTW, mm balloons Pillows - reduces strain and trauma Valleys - stress relief, plaque modification
29 Chocalate BAR: Below-the-Knee Outcomes Razavi MK, et al. JVIR 2014;25: , 96 e1-3
30 Drug Coated Balloons Two Currently Available DCBs: 1. Lutonix (Bard) Platform: 0.035, 4-7mm x mm Excipient: urea Paclitaxel dose: 2.0 µg/mm 2 2. In.Pact Admiral (Medtronic) Platform: 0.035, 4-7mm x mm Excipient: polysorbate/sorbitol Paclitaxel Dose: 3.5 µg/mm 2
31 DCB s > POBA (in the SFA) N Engl J Med 2015; 373:
32 CONCLUSIONS: In comparison with uncoated balloons or drug-eluting stents, the treatment of infra-popliteal arteries with DCBs is associated with similar clinical outcomes and favorable angiographic efficacy at 1-year follow-up. Further studies in larger numbers of patients are still needed to definitely address the role of DCB technology in this setting. Cassese S, et al. JACC Intvn. May 2016; Volume 9, Issue 10
33 Calcium: The Kryptonite to DCB s? IN.PACT DCB and Calcium Propsective Study (n=60) 12 month results Calcium distribution and severity affect late lumen loss and primary patency Calcium serves as a barrier to optimal drug absorption Solution Debulking? Fanelli F, et al. Cardiovasc Intervt Radiol 2014;Aug37(4):
34 In-Stent Restenosis FDA Approved Treatments for ISR 1.Laser atherectomy 2.Viabahn 3.In.Pact Admiral DCB
35 Drug Coated Balloons Leave nothing behind except Paclitaxel cytotoxic agent prevents microtubule deploymerization arresting cells in mitosis (G2/M phase) leads to apoptosis Paclitaxel and Doses DCBs 2-3 µg/mm mg in 120mm DCB Limited data beyond 21mg Chemotherapy at mg
36 Cryoplasty NuCryo Vascular LLC Proposed Mechanism of Action Apoptosis: smooth muscle cells Altered plaque response: limit vessel trauma, flow limiting dissections Reduced Elastic Recoil: elastin fiber function Non-Compliant Balloon Diameter: 2-8mm Length: mm Compatibility: and Liquid Nitrogen: 14 o F
37 PROTEUS Angioslide Zankar A, et al. J Invasive Cardiol. 2011;23:
38 Lithoplasty Shockwave Medical, Inc
![Stay Tuned America New DCBs (Stellarex [SPNC], Ranger [BoSci]) Drug Coated Focal Force Balloons (e.g. AngioSculpt X, SPNC) Drug Coated Caged Balloons (e.](/docs-images/71/66134969/images/39-1.jpg "g. Chocolate Touch, QT Vascular) Occlusion perfusion balloons (Advanced Catheter Therapies) Sizing balloons (IDS, LLC) and so much more")
39 Stay Tuned America New DCBs (Stellarex [SPNC], Ranger [BoSci]) Drug Coated Focal Force Balloons (e.g. AngioSculpt X, SPNC) Drug Coated Caged Balloons (e.g. Chocolate Touch, QT Vascular) Occlusion perfusion balloons (Advanced Catheter Therapies) Sizing balloons (IDS, LLC) and so much more
40 Conclusion POBA is cheap and works best if you understand the: 1. Physics 2. Plaque morphology 3. Proper technique When POBA fails or clinical judgement dictates consider specialty balloons. DCBs may be the future for PAD intervention, but we still have much to learn.
41 Thank You
42 AN UPDATE ON BALLOONS: FROM POBA TO THE NEWEST TECHNOLOGIES Pradeep K. Nair, MD, FACC, FSCAI Interventional Cardiologist Cardiovascular Institute of the South Houma, LA, USA
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