Lysis-Assisted Balloon (LAB) Thrombectomy
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1 Lysis-Assisted Balloon (LAB) Thrombectomy Panagiotis M. Kitrou MD, MSc, PhD, EBIR Consultant Interventional Radiologist Interventional Radiology Dpt. Patras University Hospital Greece
2 Facts & Figures Thrombosis: Most important Vascular Access- Related Complication Stenosis: Most common cause of Thrombosis But also: hypotension, dehydration, infection, compression, etc.
3 Facts & Figures Endovascular > Surgical NKF-K/DOQI 2006update vascular access. Guideline 2: selection and placement of hemodialysis access. Am J Kidney Dis 2006; 48(1 Suppl 1):s192 s200
4 Why? Facts & Figures Perform both declotting and angioplasty in the same setting. Venous preservation Rapid return to dialysis NKF-K/DOQI 2006update vascular access. Guideline 2: selection and placement of hemodialysis access. Am J Kidney Dis 2006; 48(1 Suppl 1):s192 s200
5 Options Thrombolysis Lysis: something that is solved, disintegrates (not a problem anymore) Thrombectomy Ectomy: Ablation, taking something away (not burning!)
6 Thrombectomy - Thrombolysis
7 Technique
8 AA VA
9 Technique Arterial Access: Micro-puncture Kit 5mg of rtpa for 6min Venous Access: 6Fr Sheath 7 X Long (HPB): Multiple short-term inflations Thrombus Maceration Stenosis Evaluation Access Sites: min 4cm apart
10
11
12 Venous Access: Technique IU of Heparin through the balloon catheter distal to the thrombus Slow velocity hand injection of diluted contrast (5ml, 70% saline, 30% contrast) residual thrombus estimation
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14 Technique Arterial Access: Upsize to 6Fr Sheath 4Fr catheter to inflow artery to perform DSA for thrombus estimation Fogarty like technique with a 6X40mm low pressure balloon at 3-4atm
15
16 Technique Residual Stenosis: Very High Pressure Balloon Stent Graft (Vein-Graft anastomosis or distally)
17
18 Study Single-Center, Retrospective analysis investigating the results of a hybrid thrombolysis-thrombectomy method for the treatment of thrombosed dialysis arteriovenous grafts (AVG) Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
19 Baseline Variables Period: 5 years (January 2012-Decmber 2016) De-clotting procedures: 291 for AVGs and AVFs Data available for 129 patients (75 men, 58.1%) with an AVG undergoing 241 procedures [1.87procedures/patient (1-10)]. Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
20 Baseline Variables 61 patients had 2 declotting procedures. Stent Graft Insertion: 80 cases (80/241; 33.2%) for thrombus apposition or treatment of persistent stenosis. Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
21 Outcome Measures Primary outcome measure: Circuit Survival. Secondary outcome measures included procedural complications and investigation of independent factors that could influence survival. Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
22 Results
23 Circuit Survival Median Survival: 434 days 1-year Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
24 Complications In 6 cases (6/241, 2.49%) declotting failed and a catheter was placed. There were 16 minor (16/241, 6.64%) and no major complications. Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
25 S.G. Vs. No S.G. Median Survival: No SG 406 days vs. SG 349 days; p=0.24 Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
26 1 st Vs. 2 nd Declotting Median Survival in 61 patients with 2 procedures 1 st : 162 days vs. 2 nd : 447 days; p< Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
27 Limitations Single-Center Single-Arm Retrospective Failed to report the time between the event of thrombosis and the time of the procedure Not all interim angioplasty procedures were available and therefore primary patency is not mentioned Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
28 Conclusion This hybrid de-clotting method performed in our department has high survival rates with increased technical success and minimum complications without the use of thrombectomy devices. Kitrou et al., Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures. CVIR, 2018
29 Analysis Characteristics Review Period: studies 8 prospective, 8 retrospective, 1 partly pro-retro 1,807 patients 3,000 declotting procedures AVGs: 1067 (1067/2009; 53.1%) AVFs: 942 (942/2009; 46.89%)
30 Statistical Method Study-specific outcomes (and their respective variances) were extracted from the main text and published Kaplan Meier curves at different time points. Quoted survival outcomes and numbers at risk and digitized Kaplan Meier were used to generate individual time-to-event patient data with the methods of Guyot et al. A parametric meta-analysis of the study-specific survival outcomes of the primary endpoint was performed with a multivariate random effects methodology within the R environment (MetaSurv package version 0.4). Guyot P et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC medical research methodology Feb 01;12:9. doi: / Package MetaSurv version 0.4 June 30, Meta-analysis of a single survival curve using the multivariate methodology of DerSimonian and Laird.
31 Author (Year) Study Type NoPat NoPro Access Type Procedure Type Special Device CS (%) PR (%) Complications (m/m) Kitrou (2017) Retrospective AVG (129) LAB Thrombectomy Balloon Maceration + 5mg rtpa m 16/0 Bermudez (2017) Retrospective AVG (68) M Thrombectomy Angiojet 86 12m 6/1 Regus (2017) Retrospective AVF (90) Thrombolysis rtpa 2.7 ± 1.2mg m N/A/5 Monsky (2016) Prospective AVG (15) AVF (3) M Thrombectomy XCOIL (NexGen Medical Systems) 77 N/A 0/0 Dyer (2016) Retrospective AVG (14) AVF (13) M Thrombectomy Aspirex (Straub) m N/A/0 Nassar (2014) Retrospective Partly - Pros AVF (465) Thromboaspiration Python (Applied Medical Resources) years 4/3 Simoni (2013) Prospective AVG (44) AVF (28) M Thrombectomy Angiojet (Boston Scientific) 92 3m 2/1 Yang (2012) Retrospective AVF (134) M Thrombectomy Angiojet (Boston Scientific) 76 12m 0/ AVF (106) M Thrombectomy Arrow-Trerotola (Teleflex) 91 12m 0/2 Choi (2012) Retrospective AVG (82) PM Thrombolysis Urokinase (200,000 IU) m 29/0 Vashchenko (2010) Retrospective Thrombolysis L&W Urokinase (250,000 IU) N/A 9.6m PP 18/0 AVG (157) 136 M Thrombectomy Arrow-Trerotola (Teleflex) N/A 10.7m PP 4/0 Littler (2009) Prospective AVG (20) AVF (44) M Thrombectomy Angiojet (Boston Scientific) 91 12m 6/0 Kakkos (2008) Prospective AVG (261) AVF (24) M Thrombectomy Angiojet (Boston Scientific) m 2/0 Uflacker (2004) Prospective AVG (109) M Throbectomy Amplatz MTD (Microvena) m 31/0 Cooper (2003) Prospective AVG PS Thrombolysis tpa (2mg) 94 3m PP 0/0 Sofocleous (2002) Smits (2002) Prospective Prospective PS Thrombolysis tpa (2-10mg) 95 AVG (50) Thrombolysis Lyse & Wait tpa(2-10mg) / AVG (13) Cragg Thrombolytic Brush 62 3m PP 4/ AVG (18) M Thrombectomy Hydrolyser (Cordis) 67 3m PP 10/ AVG (37) Arrow Trerotola (Arrow) 86 3m PP 16/0 Falk (2001) Prospective AVG (33) Thrombolysis tpa (2mg) 88 6m PP 6/2
32
33 Outcome Measures Primary outcome measures: Postintervention Assisted Primary Patency (PAPP): defined as the interval of patency after an endovascular intervention until dialysis circuit thrombosis or a surgical intervention of the access circuit Clinical success (CS): defined as the resumption of normal hemodialysis for a minimum of at least 1 session following percutaneous intervention Secondary outcome measures included: Subgroup analysis of independent factors that could influence PAPP Minor and major complications
34 Results
35 PAPP 6 months: 54.8% (CI: %) 12 months: 41.6% (CI: %) 24 months: 26% (CI: %) Mean PAPP: 10.9 months (CI: )
36 Clinical Success 88% (CI = 85-91%)
37 Complications Minor: 4.6% (140/3,000) Major: 0.6% (18/3,000)
38 AVFs Vs. AVGs AVFs: 18.54months (CI: ) AVGs: 8.09months (CI: ) p<0.05
39 Thrombectomy - Thrombolysis Thrombolysis-dependent 9.64months ( ) Thrombectomy- dependent 11.6months (9.2-14) p=0.128
40 Old vs. New studies Old studies 6 m (CI: ) New studies 7.82 m ( ) p=0.098
41 Conclusion Declotting procedures have significantly better results in AVFs compared to AVGs. Thrombectomy procedures using dedicated devices failed to significantly improve PAPP.
42 Lysis-Assisted Balloon (LAB) Thrombectomy Panagiotis M. Kitrou MD, MSc, PhD, EBIR Consultant Interventional Radiologist Interventional Radiology Dpt. Patras University Hospital Greece
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