The endovascular option for AV-fistula creation · Procedure success: Successful endoAVF creation...

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


The Whright brother`s first flight was shorter than the Boeing 747´s wing span…. (12sec.-37m)


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


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


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


Venous 6 Fr catheter

Arterial 6 Fr catheter





1st Generation

2nd Generation

Constant Improvement endoAVF Catheter SYSTEM (BD / TVA medical)

4F

?


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


WavelinQ endoAVF 4F Procedureradial - radial


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





-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


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


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



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



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



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


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



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



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



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



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


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


Closer look to the forearm vascular system


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.


16.Oct.2018 follow upEndo AVF 03.September 2018








1st Generation

2nd Generation

Constant Improvement endoAVF Catheter SYSTEM (BD / TVA medical)

4F

?


4+ 4F

WavelinQ™ ulnar/ulnar


4+ 4F

WavelinQ™ radial/radial


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!!


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…….


The endovascular optionfor AV-fistula creationTobias Steinke, Schön Klinik Düsseldorf

The endovascular option for AV-fistula creation · Procedure success: Successful endoAVF creation...

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