Spot-stenting-Multi-LOC theoretical background and first real world results
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1 2016 Spot-stenting-Multi-LOC theoretical background and first real world results Dr. K. Amendt Center of Vascular Medicine Oberrhein (Mannheim Speyer) Clinic for Internal Medicine I: Angiology, Cardiology and Subsequent Complications of Diabetes mellitus Diakonissenkrankenhaus Mannheim Germany Academic Teaching Hospital Clinical Medicine Mannheim University Heidelberg
2 Disclosure I have the following potential conflicts of interest to report: Advisory Board and Consultant: BAYER AG Boehringer Ingelheim UCB Pharma BIOTRONIK B. BRAUN
3 stent
4 SFA III and popliteal artery Free floating rubber band? Axis Elongation - shortening torsion Radial Compression Flexion distal arteries Pulsatile distension SFA +17 bis 25% 113 ( 6 /cm) 10% r: 20 mm % AP - 14% 1-6 /cm 10% r: 13 mm % Cave: data mainly from healthy volunteers (MRT) and cadavers less angiographically (angio MRA) VSM SFA Mod. Nach W. Meichelboeck, Chir. Vasculaire, Nov , 2009 Paris
5 early result Long stents late result Biomechanical stress Conformability missmatch: arterial wall- stent distention Stent- fracture Intimal hyperplasia Restenosis: LLL Occlusion Re-do Costs compression
6 Accepted problems with Stenting 1. changes in biomechanical properties and chronical inflammation of stented segement /artery stent fracture intimal hyperplasia late lumen loss problems increase with length of treated vessel segment = Stent- disease long lesion long stent problem leave nothing behind
7 Concept of focal stenting Calcified lesions demand ongoing mechanical stabilisation of initial balloon-result: mandatory scaffolding DEB, Tack-it, BVS and DBVS alone do not solve this problem There is still a need for permanent scaffolding: long lasting with a reduced mass of foreign body (as few as possible) = focal- spot / taget- stenting
8 optimal: DEB focal stenting full lesion coverage Multiple-Stent-Delivery-System MSDS Standard procedure
9 The concept of focal stenting Custom length stent 5 x 80mm Domestic pig acute result Multi-Loc Multi-Stent-Delivery-System: 5 x 15 mm x 5 angiographic control 27d after implantation
10 radial force (N) 5 radial force / stentdesigns Newton (N) 4,5 4 3,5 3 3,28 2,5 2 1,5 2,35 2,44 1,64 2,72 2,03 2,38 2,35 2,10 1 0,5 0 sinus-superflex (OptiMed) SelfEx (Jomed) Luminexx (Bard/Angiomed) ABSOLUTE (Guidant) Smart Control ( Cortis) Misago (Terumo) EverFlex (Ev3) Complete SE Iliac (Medtronic) Multi-Loc (medicut) Design - Stent-Größe Conclusion: 1. Animal experiments show technical feasibility of the multi stent delivery system (MSDS): Multi-Loc. 2. Exact anatomically controlled implantation of short stents is possible. 3. Short stents in actively bended arterial segments do not fracture (0 vs 5). 4. Patency of arterial segments after stenting with 4-5 short individual stents is superior to single long stent implantation in all animals.
11 F.E. 74J ESRD, RF 6 DEKRA: CE marking: First in man: First real world experiences ( not really results) Popliteal artery
12 G.G PTA POBA 5x80mm POBA 5x80 mm
13 G.G PTA
14 G.G PTA PTA prolonged woundhealing after minor amputation
15 G.G PTA PTA
16 G.G PTA PTA
17 First real world experiences ( not really results) Femoro-Popliteal Artery long lesion
18 E.I PAVK IV, RF 6 PTA: POBA 1 4x60mm POBA 2 5x60mm AstronP 5x30 (2013)
19 E.I PAVK IV, RF 6 PTA: multi-loc 5x AstronP 5x30 (2013) 5 6
20 E.I PAVK IV, RF 6 PTA: AstronP 5x ML 2 bis ML 5 ML 1 AP2-AP3
21 K.A (73) 1. PTA: PTA: x30 mm (AstronP) 6x60 mm (AstronP) 6x30 mm (AstronP) 6x60 mm (AstronP) 6x30 mm (AstronP)
22 K.A (73) PTA: x40 mm 6x40 mm (POBA)
23 K.A (73) PTA: x40 mm (POBA) ML-1 ML-2 ML-3 ML-4 ML-5 ML-6 ML- 6x13mm
24 K.A PTA: Re-Re-Angio: ML-4 ML-5 ML-1 ML-2 ML-3 ML-6 ML-4 ML-5
25 K.A PTA: K.A Re-Angio: K.A PTA: K.A Re-Angio: ML-4 ML-1 ML-5 ML-2 ML-3 ML-1 ML-2 ML-6 ML-4 ML-3 ML-5 ML-6 ML-4 ML-5 after 10 weeks: No fractures ML-6
26 K.A (73) PTA: K.A (73) Re-Angio: K.A (73) Re-Angio: ML-4 ML-1 ML-5 ML-2 ML-1 ML-3 ML-2 ML-4 ML-3 ML-5 ML-4 ML-6 ML-5 after 10 weeks: No restenosis (LL) No edge phenomenon ML-6
27 First real world experiencs N: 30 pat.; LL: 4-30 cm; LL av :12 cm; M-L: 141; M-L/pat.: 2-12 (4.7); M-L/cm LL: 0,41; LL /ML: 2,46 cm ML-stents are safe: technic. succ: 100% exact anatomically controlled release no stents lost no conversion to standard stenting no acute occlusion radial force in severely calcified lesions: no recoil, no fracture biomechanical properties of artery: unchanged Cave: release stents in an optimal prepared bed = predilatation: Ø-POBA/DEB Ø lumen artery = Ø-stent Ø lumen artery (no oversizing) post stent dilatation = to align longitudinal axis
28 LOCOMOTIVE: all comers registry n: 20
29 Further developments Nitinol ring outer sheath Multi-Loc stent-body Closed cell design stent-anchor = marker
30 VascuFlex_2_LOC open cell desig VascuFlex_3_LOC open cell desig
31 2016 Spot-stenting-Multi-LOC theoretical background and first real world results Dr. K. Amendt Center of Vascular Medicine Oberrhein (Mannheim Speyer) Clinic for Internal Medicine I: Angiology, Cardiology and Subsequent Complications of Diabetes mellitus Diakonissenkrankenhaus Mannheim Germany Academic Teaching Hospital Clinical Medicine Mannheim University Heidelberg
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