Rationale and algorithm for below-the-knee acute gain optimization
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1 Leipzig, 01 Feb Rationale and algorithm for below-the-knee acute gain optimization Flavio Airoldi, MD Flavio Airoldi Multimedica IRCCS Milan ITALY
2 Rationale Restenosis following PTA of BTK arteries is a multifattorial process which includes: Acute recoil Neointimal proliferation Late recoil flavio.airoldi@multimedica.it
3 Rationale Restenosis following PTA of BTK arteries is a multifattorial process which includes: Paclitaxel Acute recoil Neointimal proliferation Late recoil flavio.airoldi@multimedica.it
4 Rationale Restenosis following PTA of BTK arteries is a multifattorial process which includes: Paclitaxel Neointimal proliferation Acute recoil Late recoil Less relevant Stents??? flavio.airoldi@multimedica.it
5 Rationale: early recoil Early failures may be the leading cause of late failures 97% of tibial dilatation show early recoil: 29% lumen 15 minutes post intervention 2,5 2 1,5 1 0,5 MLD (mm) 0, minutes 1,47 0 baseline immediate post-poba 15 min post-poba Baumann F, et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia. J Endovasc Ther. 2014;21:44-51
6 Rationale: early recoil Early failures may be the leading cause of late failures -inflation time 1 minute -angiografic vessel size estimation: average 2.6 mm Baseline PTA Post-PTA 15 min Post-PTA Baumann F, et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia.; J Endovasc Ther. 2014;21:44-51
7 Algorithm for BTK acute gain optimization - Correct vessel sizing: IVUS 1:1 ratio according to IVUS media to media distance -Scoring balloon AngioSculpt, Philips -Multiple prolonged inflations Four 90 sec. inflations with 90 rotation of the scoring balloon (total 6 min)
8 AngioSculpt Device Overview 3 Scoring elements Nitinol helical configuration rectangular edges semi-compliant balloon Lengths: 10 to 200 mm Diameters: 2.0 to 8.0 mm Nominal / RBP: 6-8/ Intr. Sheath compatibility: 5 / 6 F Guidewire compatibility: / 0.018
9 Plaque Scoring Rationale Controlled dissections by focal plaque incision, focal stress concentration Increase and stabilize luminal gain ( recoil) Reduce likelihood of flow-limiting dissections Confer precision and stability to balloon dilatation Potentially increase DCB drug uptake 1. Fonseca A, et al. Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008;20: de Ribamar Costa Jr., et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100: Scheinert D, et al. Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease. Catheter Cardiovasc Interv. 2007;70:1034-9
10 Algorithm for BTK acute gain optimization Angiogram Standard PTA (angio based balloon choice ) Angio & IVUS (I) AngioSculpt PTA (4 inflations, total 6 min.) Angio & IVUS (II) 15 minutes STUDY END-POINT Angio & IVUS (III)
11 First end point: minimal lumen diameter MLD (mm) by automatic quantitative analysis (QCA) Baseline Angio- Post-PTA Post-PTA Sculpt 15 min
12 Algorithm for BTK acute gain optimization IVUS Post AngioSculpt IVUS 15 min. post AngioSculpt Second endpoint: vessel volume (mm 3 ) by intravascular ultrasound analysis (IVUS)
13 BTK acute gain optimization: angio measurements Post AngioSculpt 15 min post AngioSculpt Balloon size (mm) RVD MLD RVD MLD 3.0 (40%) 3.5 (60%) 2.9 ± ± ± ±0.3 mm N=5 lesions, 4 patients
14 BTK acute gain optimization: IVUS measurements Post AngioSculpt Vessel lumen volume 15 min post AngioSculpt Vessel lumen volume 623 ± ±42 mm 3 N=5 lesions, 4 patients Average length 88±24 mm I-Lab Boston Sc. IVUS System
15 Pre-dilatation 3.0 mm Standard balloon Lumen volume 516 mm 3 Final dilatation 3.0 mm AngioSculpt balloon Lumen volume 631 mm 3
16 Pre-dilatation 3.0 mm Standard balloon Plaque rupture
17 Plaque Scoring Rationale You can break a glass in different ways
18 Conclusions - The results of standard balloon angioplasties of BTK vessels may be jeopardized by acute vessel recoil -The combination of correct vessel sizing, scoring balloon angioplasty and multiple prolonged inflations may increase the acute gain and minimize acute vessel recoil. -The role of these strategy in association with DEB technologies should be explored in future studies.
19 Leipzig, 01 Feb Rationale and algorithm for below-the-knee acute gain optimization Flavio Airoldi, MD Flavio Airoldi Multimedica IRCCS Milan ITALY
20
21 Dissections and DCB Severe, non-flow limiting dissections do not negatively impact DCB outcomes THUNDER post-hoc analysis N=86 (43 DCB + 43 PTA) 6-month LLL (mm) by Angio Core laboratory 24-month TLR (%) p=0.02 p=0.05 p=0.001 p=0.1 p=0.02 p=0.002 Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther Dec;20(6):
22 Balloon Angioplasty Mode of Action Uncontrolled dissections, uncontrolled injury to break circumferential tensions (hoop stress) The traumatic effect of balloon dilatation: what we did not see before optical coherence tomography LAD showing the distal (A), mid (B) and proximal (C) segment of the stent after paclitaxel-coated balloon dilatation Picchi A, Micheli A, Limbruno U. Images in cardiology. The traumatic effect of balloon dilatation on neointimal hyperplasia: what we did not see before optical coherence tomography. Heart Feb;97(3):265-6
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