True Minimally Invasive Strategies for complex Interventions

Prof. Yann GouëfficUniversity Hospital of Nantes

Nantes, France

Disclosures

Y. Gouëffic reports:

- Research funding from Bard, Biotronik, Medtronic, Terumo, WL Gore

- Personal fees and grants from Abbott, Bard, Biotronik, Boston Scientic, Medtronic, Terumo, Vygon, WL Gore

(medical advisory board, educational course, speaking)

Does size matter?

Yes the size matters !Less invasive and lower delivery systems

profile

▪ Alternative access sites

▪ Lower manual compression times

▪ Decrease of contrast load

▪ Cost saving (to save arterial closure devices)

▪ Safe and effective as 6F devices

Puncture hole sizes

Slide courtesy of Dr. K. Deloose

4F vs. 6F published studies demonstrate clinical benefits 4F over 6F

Source: Deloose K, Peeters P. 4F in practice: Lessons from 4 Ever. Presented at LINC 2012

Ballout et al., Arch Mal Coeur Vaiss. 2000

4F vs 6F catheters for coronary angiography

200 patients: 100 in 4F arm, 100 in 6F arm

Benefits of 4F

Less contrast (p < 0.001)

Reduced duration of compression (p < 0.001)

Reduced complications (p < 0.001)

Durst et al., Isr Med Assoc J. 2007

4F vs 6F catheters for coronary angiography

177 patients: 91 in 4F arm, 86 in 6F arm

Benefits of 4F

Reduced complication rate (p < 0.05)

Gouvernement urges to develop ambulatoryIn France, for surgery, the outpatient rate was 36.2% in 2009 and 54% in 2016

Issues for the development of outpatients ER for PAD ?

Source: Deloose K, Peeters P. 4F in practice: Lessons from 4 Ever. Presented at LINC 2012

Economic issues

Legal issuesin case of complications ?

Clinical issuesSafety

Lower profile devices 4-5 F

ACD / Manual compression

Arterial closure device vs manual compression

Decrease of hemostasis and procedural time

More rapid resumption of walking

+ -No difference in terms of

complications.

More complications (Hematoma, false aneurysm)

Redo surgery at the femoral puncture point which presents

a greater risk after the ACD

CostUpponi SS, Eur J Radiol., 2007Koreny JAMA 2004Boston, Ann Vasc Surg, 2003

The use of smaller diameter instruments would

tend to render manual compression sufficient

Manual compression is safe for same day dischargewith 4F devices

Puncture-related bleeding complications leading to overnight admission. No difference between arterial closure device and manual compression Spiliopoulos, Cardiovasc intervent radiol, 2016

FREEDOM trial: Manual compression after endovascular repairwith 5F compatible devices allows early walking and technicalsuccess and could be an alternative to the use of arterial closuredevices for same day discharge procedures for PAD patients Bague, Ann Vasc Surg, 2018

4F solutions for the SFA therapy

Cruiser-180.018”

Guidewire

Passeo-180.018”

PTA Balloon

Fortress4F

Introducer

ACCESS CROSSPREPARE/

POST DILATETREAT SUPPORT

Pulsar-18 T30.018”

SE Stent

Passeo-18 Lux0.018” DCB*

*Passeo-18 Lux not commercially available in China

Pulsar-18 T3 is a unique innovation

Tri-axial system with braided shaft

Low profile delivery system

Thin struts, low COF

Pulsar-18 T3 - What is new?

Unique combination of 3 technologies

Source: Biotronik data on file

Pulsar-18 T3 - What is new?

Unique combination of 3 technologies

Source: Biotronik data on file

Pulsar-18 T3 self-expanding nitinol

stent: a low COF stent

▪Ø: 4.0-6.0-7.0 mm

▪L: 20-30-40-60-80-100-120-150-170-200 mm

▪Peak-to-valley stent design

▪Strut thickness 140µm

▪Low COF with sufficient crush resistance

Strut thickness in perspective (µm)

COF1 Curves

Key Messages

1 mm oversize

Stent oversizing (high COF) increase ISR

Pulsar Clinical Study data:efficacy proven in a wide range of lesions

• Source: BIOFLEX PEACE (interim). Lichtenberg M. Presented at LINC 2017. 4EVER Bosiers M. JEVT 2013;20:746–756; PEACE Lichtenberg M. JEVT, 2014, 21:373-380; BERN registry Baumann F. JCS 2012:52;475-80; TASC D registryLichtenberg M. JCS 2013: 54; 433-9; "TASC D II" registry Lichtenberg M. Clin Med Insights 2014: 8; 37-42; 4F intervention" Sarkadi H, Eur J Vasc Endovasc Surg(2015) 49, 199-204.

Short med lesions Long lesions Popliteal Dissection Occlusion

Low/Mod.Calcification High Calcification Adjunct to DCB

Pulsar-18

Key message

▪ Pulsar has demonstrated clinical performance in many clinical situations.

▪ Results are consistent across a range of lesion lengths.

0

5

10

15

20

25

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

BIOFLEX PEACE (interim) 4EVER (Pulsar-18) TASC D "TASC D II" PEACE BERN "4F INTERVENTION"

Primary Patency TLR Av. Lesion lengthPrimary Patency/TLRin Percent

AV. Lesion Lengthin cm

Pulsar shows consistently good patency rate- at least as good as modern

generation 6F stents

0%

20%

40%

60%

80%

100%

Study

A.L.L.

79.4%81.4%

4EVER (all)

71 mm

PEACE

112 mm

Pulsar-18

83.1%

ZILVER PTX

66 mm

Zilver PTX

81%79%

AURORA

143 mm

SUPERB

78 mm

Supera

77%

ZILVER PTXLong

226 mm

77%77%

BIOFLEX PEACE

116 mm

84%

SUPERA500

126 mm

86.2%

77.2%72.2%

DURABILITYII

89 mm

DURABILITY

96 mm

Everflex

65%

DURABILITY 200

242 mm

My first Pulsar-18 T3 experience

Patient history

Male, 63 y

Symptomatology: claudication of the right foot (Rutherford 3)

Medical history

- Dislipidemia, HTA, active smoking

- Peripheral arterial disease

- Coronaropathy

Duplex scan and CT scan: femoropopliteal occlusion of the rigth limb

Treatment options

Medical treatment alone

Major amputation

Open Surgery

Endovascular therapy

Ambulatory managmentDuplex guided puncture

Limbscarotid

Aorta, Iliacrenal

Radial, brachialpedal

Intra operative angiogram

Over the bifurcation approach

(Fortress 4F-45cm)

Long femoropopliteal thrombosis

Renanalization with the loop technique

(0.035 stiff guidewire with a 4F support

cathether)

Pulsar-18 T3 treatment

Switch for 0.018 stiff guidewire

Vessel preparation by a Passeoballoon catheter 5-200mm.

Stenting by 2 pulsar-18 T3 with a 1 –cm overlap (6-200 and 6-150mm)

Manual compression

BIO4AMB Study: BIOTRONIK 4French for AMBulatory peripheral intervention

AimSafety of 4F in ambulatory setting

Hypothesis

ASC in 4F ≤ 6F +/- VCD (non-inferiority)

Sample size

792 (depending on design as finalized today)

Number of sites

50 (global)

Enrolling BIOTRONIK study – First outcomes @ CIRSE 2019

Primary endpoint

Access Site Complications (ASC)

Secondary endpoints

▪ Procedural success (no crossover to larger sheath size required)

▪ Sub evaluation of ASC(major vs minor)▪ Ambulatory failure

(at least 1 unplanned overnight stay)▪ Resource utilization▪ Time to hemostasis▪ Time to discharge (at least 6h)▪ Quality of life (EQ5D)▪ VCD failure and related complications ▪ Re-intervention at 30d▪ SAE at 30 days

A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an

ambulatory setting: BIO4AMB

Conclusions

▪ True minimally 4F procedures are feasible and safe with Pulsar-18 T3 including for complex femoropopliteal lesions

▪ Pulsar-18 T3 is the world-first unique combination of tri-axial shaft design, 4F compatibility and thin-strut, low COF stent platform up to 200mm

▪ BIO4AMB Study is expected to confirm that 4F devices are as safe as 6F devices

True Minimally Invasive Strategies for complex Interventions

Prof. Yann GouefficUniversity Hospital of Nantes

Nantes, France