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Seite 1© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
The endovascular optionfor AV-fistula creationTobias Steinke, Schön Klinik Düsseldorf
Disclosure
Speaker name: Dr. med. Tobias Steinke
I have the following potential conflicts of interest to report:
Consulting (BD/Bard/TVA medical/Meritmedical/Medtronic)
o Employment in industry
o Stockholder of a healthcare company
o Owner of a healthcare company
o Other(s)
o I do not have any potential conflict of interest
Seite 3© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
The Whright brother`s first flight was shorter than the Boeing 747´s wing span…. (12sec.-37m)
Seite 4© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
https://www.houstonchronicle.com/news/health/article/Doctor-invents-a-device-that-could-make-life-6152909.php#photo-7702160
Doctor invents a device that could make life easier for dialysis patients, March 23, 2015 Updated: March 23, 2015 2:35 p.m.
1. WavelinQ endoAVF-System2. Clinical data3. Personal Experience/Opinion
1. WavelinQ endoAVF-System2. Clinical data3. Personal Experience/Opinion
Seite 7© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
everlinQTM endoAVF SYSTEM / TVA medical
Magnets align catheters Flexible spacers6 Fr over-the-wire
Radiofrequency electrode cuts channel to create fistula
Creates an AVF without open surgery to minimize vessel trauma for high
fistula usability with low interventions1-4
1. TVA Medical data on file. GLP Animal Studies.2. J Vasc Interv Radiol 2015; 26:484–490.3. Vasc Access 2017;28;18 (Suppl. 2):8-14.4. Am J Kidney Dis. 2017 Jun 9. pii: S0272-
6386(17)30692-3.
RF Generator
6 Fr rapid exchange
Seite 8© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
4F Rapid Exchange Tips
Square Magnets
Convex Electrode
Rotational Indicators
OTW Arterial Catheter
Rapid Exchange Venous Catheter
Round Magnets
L-Shaped Electrode6F
Concave Saddle
New development: WavelinQ™ 4F EndoAVF System
Seite 9© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Venous 6 Fr catheter
Arterial 6 Fr catheter
Venous 6 Fr catheter
Arterial 6 Fr catheter
Venous 4 Fr catheter
Arterial 4 Fr catheter
1st Generation
2nd Generation
Constant Improvement endoAVF Catheter SYSTEM (BD / TVA medical)
4F
?
Seite 10© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
WavelinQ 4F provides additional procedural vessel access options
New development: WavelinQ™ 4F EndoAVF System
Parallel: From Upper Arm Parallel: From WristAnti-Parallel:
From Wrist andUpper Arm
Seite 11© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
WavelinQ endoAVF 4F Procedureradial - radial
1. WavelinQ endoAVF-System2. Clinical data3. Personal Experience/Opinion
Seite 13© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
FLEX NEAT EASE EU Post-Market
EASE-2 CONNECT-AV
WavelinQ™ Global Study
Device 6F 6F 6F and 4F 6F and 4F 4F 4F 4F
Study Type
-Single center-Multiple operators-Prospective-Single-arm
-Multi-center-Prospective-Single-arm
-Single center-Multiple operators-Prospective-Single-arm
-Multi-center-Prospective-Single-arm
-Single center-Multiple operators-Prospective-Single-arm
-Multi-center-Prospective-Single-arm
-Multi-center-Prospective
Number of Patients
33 Patients 60 Patients (+20 Roll-in) 32 Patients 100 Patients 24 Patients 254 Patients ~100 Patients
Follow-Up
0-10 Days, 1, 3, 6 Months
0-10 Days, 1, 3, 6, 12 Months
0-10 Days, 1, 3, 6 Months
0-10 Days, 1, 3, 6, 12 Months
0-10 Days, 1, 3, 6 Months TBD TBD
Location ParaguayCanada, Australia, New Zealand
Paraguay Germany, UK, Canada Paraguay United States Europe,
Canada, Asia
Status Completed in 2014
Completed in 2016
Completed in 2017
Completed in 2019
Completed in 2018
In protocol finalization
In protocol development
WavelinQ™ Clinical Studies
Seite 14© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Global Meta-Analysis -WAVELINQ™ 6F EndoAVF
See the WAVELINQ™ 6F EndoAVF Instructions for Use for more details on design of the global analysis as well as each study included herein.* EASE data was only included in the analysis of EndoAVF efficacy, but not safety as the WAVELINQ™ 4F EndoAVF was being studied. Reported data from the EndoAVF EU Study was based on an interim analysis as the study is still ongoing. See the WAVELINQ™ EndoAVF Instructions for Use for safety and efficacy outcomes of each individual study. Data as of August 2017
28 sites in:Canada,
Australia, Germany,
UK, Netherlands,
Paraguay, Switzerland
Seite 15© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER 15
Effectiveness Endpoints - Procedure
97%
0%
25%
50%
75%
100%
125%
N=157
Procedural Success
Procedure success: Successful endoAVF creation confirmed via intraprocedural fistulography or by duplex ultrasound performed post-procedure
WAVELINQ™ 6F Global Pooled Analysis
Seite 16© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Effectiveness Endpoints - Patency• Primary Patency at 6 months: 82.7%
• The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency
• Secondary Patency at 6 months: 86.5%• The interval from the time of access placement until access abandonment, lost to
thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access
WAVELINQ™ 6F Global Pooled Analysis
Seite 17© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
CVC Exposure
In pre-dialysis patients, only 14.6% (8/55) initiated dialysis with a CVC
In dialysis patients, CVC exposure dropped from 81.7% (85/102) at 1 month to 15.9% (19/102) at 6 months
14.6%
85.4%
Pre-Dialysis Patients at InitiationCVC Exposure No CVC Exposure 83.4%
18.6%
0,0%
10,0%
20,0%
30,0%
40,0%
50,0%
60,0%
70,0%
80,0%
90,0%
CVC Exposure at 1 month CVC Exposure at 6 Months
Dialysis Patients
WAVELINQ™ 6F Global Pooled Analysis
Seite 18© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
ReinterventionsIntervention Pooled Effectiveness
(N=157)Subsequent vein embolization 19Balloon angioplasty 7Stent 0Thrombectomy and thrombolytic therapy 1Transposition 6Surgical AVF/AVG 4Other 18Total Interventions 55
% of patients with 0 interventions 76%
76%of patients were intervention-free at 6 months post-procedure
WAVELINQ™ 6F Global Pooled Analysis
Seite 19© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Note: The endoAVF EU Study enrolled an additional 32 patients using the 6F device. Only 4Fr data is included in this analysis. Data current as of November 2018 and pooled from 7 sites in Germany, England and Paraguay
WAVELINQ™ 4F Global Pooled Analysis
Demographics StatisticPooled(N=91)
GenderMale n/N (%) 76/91 (83.5%)
Female n/N (%) 15/91 (16.5%)
AgeMin, Max 21.0-85.0Median 55.0
RaceCaucasian n/N (%) 24/91 (26.4%)
Asian n/N (%) 4/91 (4.4%)
Indian n/N (%) 4/91 (4.4%)
Other n/N (%) 1/91 (1.1%)
Not Reported n/N (%) 58/91 (63.7%)
EASEN=32
EASE 2N=24
Pooled Safety and Efficacy 4F Analysis Population
N=91
EndoAVF EU Study
N=35
Seite 20© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER 20
Effectiveness Endpoints - Procedure
97%
0%
25%
50%
75%
100%
125%
N=91
Procedural Success
Procedure success: Successful endoAVF creation confirmed via intraprocedural fistulography or by duplex ultrasound performed post-procedure
WAVELINQ™ 4F Global Pooled Analysis
Seite 21© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Effectiveness Endpoints - Patency• Primary Patency at 6 months: 72.4% (±5.2%)
• The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency
• Secondary Patency at 6 months: 77.3% (±5%)• The interval from the time of access placement until access abandonment, lost to
thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access
WAVELINQ™ 4F Global Pooled Analysis
Seite 22© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
CVC Exposure
In pre-dialysis patients, only 16% (4/25) initiated dialysis with a CVC
In dialysis patients, CVC exposure dropped from 81.7% (49/60) at 1 month to 15.9% (7/44) at 6 months
16%
84%
Pre-Dialysis Patients at 6 MonthsCVC Exposure No CVC Exposure 81,7%
16%
0,0%
10,0%
20,0%
30,0%
40,0%
50,0%
60,0%
70,0%
80,0%
90,0%
CVC Exposure at 1 month CVC Exposure at 6 Months
Dialysis Patients
WAVELINQ™ 4F Global Pooled Analysis
Seite 23© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Reinterventions
Intervention Pooled Effectiveness (N=91)
Subsequent vein embolization 6Balloon angioplasty 10Stent 2Thrombectomy and thrombolytic therapy 4Transposition 5Surgical AVF/AVG 6Other 1Total Interventions 30
% of patients with 0 interventions 78%
78%of patients were intervention-free at 6 months post-procedure
WAVELINQ™ 4F Global Pooled Analysis
Seite 24© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
6F and 4F Results Compared6F Global Data (N=157) 4F Global Data (N=91)
Technical Procedure Success1 97% 97%
Two-needle Cannulation at 6 Months2
75% 85%
Primary Patency3 82.7% 72.4%
Secondary/Cumulative Patency4 86.5% 77.3%
Device-related SAE 3% 3.3%
Procedure-related SAE 12% 5.5%
Intervention Free at 6 Months 76% 78% 1 Procedure success: Successful endoAVF creation confirmed via intraprocedural fistulography or by duplex ultrasound performed post-procedure2 Two-needle Cannulation at 6 Months: 2-needle access and hemodialysis through the endoAVF. Cannulation Success was calculated for all subjects and for the subset of those who were on dialysis at the time of enrollment.3 Primary Patency: The interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis, access abandonment, or the time of measurement of patency4 Secondary/Cumulative Patency: The interval from the time of access placement until access abandonment, lost to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to reestablish functionality in thrombosed access
1. WavelinQ endoAVF-System2. Clinical data3. Personal Experience/Opinion
Seite 26© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
The measurements were performed in supine (10–20 degrees reverse Trendelenburg) patient position at room temperature without use of tourniquets.
Ultrasound in Medicine & Biology, Volume 38, Issue 2, February 2012, Pages 190-194, Mapping of Superficial Extremity Veins: Normal Diameters and Trends in a Vascular Patient-Population, Dan E. Spivack, Patrick Kelly, John P. Gaughan, Paul S. van Bemmelen, https://doi.org/10.1016/j.ultrasmedbio.2011.11.008
Mapping of Superficial Extremity Veins: Normal Diameters and Trends in a Vascular Patient-Population
Seite 27© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Closer look to the forearm vascular system
Seite 28© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Henry Gray (1825–1861). Anatomy of the Human Body. 1918.
The deep veins of the forearm are the venæcomitantes of the radial and ulnar veins and constitute respectively the upward continuations of the deep and
superficial volar venous arches; they unite in front of the elbow to form the brachial veins. The radial veins are
smaller than the ulnar and receive the dorsal metacarpal veins. The ulnar veins receive tributaries from the deep
volar venous arches and communicate with the superficial veins at the wrist; near the elbow they receive the volar
and dorsal interosseous veins and send a large communicating branch (profunda vein) to the vena
mediana cubiti.
Seite 29© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Seite 30© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Seite 31© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Seite 32© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
16.Oct.2018 follow upEndo AVF 03.September 2018
Seite 33© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Seite 34© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Venous 6 Fr catheter
Arterial 6 Fr catheter
Venous 6 Fr catheter
Arterial 6 Fr catheter
Venous 4 Fr catheter
Arterial 4 Fr catheter
1st Generation
2nd Generation
Constant Improvement endoAVF Catheter SYSTEM (BD / TVA medical)
4F
?
Seite 35© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
4+ 4F
WavelinQ™ ulnar/ulnar
Seite 36© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
4+ 4F
WavelinQ™ radial/radial
Seite 37© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
WAVELINQ™ 4F EndoAVF System proximal forearm locationenables a variety of strategies to provide patients with afunctional AV-fistula.
Using wrist access:
CONCLUSION
• more options to get vessel access • shorter operating time• less exposure to radiation• better hemostasis• But: maybe less success ?
More Real World Data Analysis!! Go for bigger vessels!!
Seite 38© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
Thank you
https://ww
w.houstonchronicle.com
/news/health/article/D
octor-invents-a-device-that-could-m
ake-life-6152909.php#photo-7702160
The Wright brothers did not create the 747 because they had to start from scratch. They first had to figure out the basic principles. Today’s critics of new technology for EndoAVFprojects are basically blaming companies and physician in the developing world for not creating 747s…….
Seite 39© 2019 Schön Klinik TOBIAS STEINKE, SCHOEN KLINIK DUESSELDORF, VASCULAR CENTER
The endovascular optionfor AV-fistula creationTobias Steinke, Schön Klinik Düsseldorf