Control and Precision: Self-positioning Transseptal Steerable Solution

Andreas Metzner

Asklepios Klinik St. Georg

Hamburg, Germany

• Disclosures:– Consultant: Medtronic, Cardiofocus

– Travel grants and lecture honoraria from Medtronic, Cardiofocus, Biosense-Webster, Astra-Zeneca, Boehringer-Ingelheim, Bayer

• Ablation procedures

– Atrial fibrillation

– Left atrial tachycardia / SVT

– Ventricular tachycardia via antegrade approach

• Interventional procedures

– LAA occlusion (endocardial/epicardial)

– Mitralclip

– Direct mitral annuloplasty (Cardioband)

– …

More and more interventions demand left atrial access

Life-threatening complications associated with TSP

Pericardial effusion or tamponade

Aortic root needle puncture

TIA or stroke

Coronary air embolism –Infarction

Persistence of iatrogenic ASD

Risk of life-threatening

complications

Update ww survey, > 16.000 pts

Cappato et al. Circulation AEP 2010

Causes of fatal outcome in catheter ablation of atrial fibrillation

Cappato, JACC 2009

• Due to its small size the fossa ovalis is difficult to locate

• Superior-inferior extension 10 – 30 mm

• Anterior-posterior extension 5 – 14 mm

The challenge

The fossa ovalis varies from patient to patient

* Transseptal Catheterization and Interventions

50TSP is a 50-year-old needle-based procedure

9

St. Jude Medical: BRK™ Transseptal Needles

Despite huge advancements in cardiology, this procedure has not changed much in more than 5 decades

Transseptal Puncture

• Brockenbrough Technique:

– Transseptal Sheath

– Double needle:

–Outer needle: lumen can be passed with 0.35 wire

– Inner needle (stylet): for puncture and pressure curveregistration

Transseptal puncture equipment

His

Pigtail

His

RAO LAO

Landmarks for transseptal puncture

His-catheter and pigtail in Aorta

His

Pigtail

His

RAO LAO

Landmarks for transseptal puncture

TSP under ICE / TEE

All-in-one system for transseptal puncture and left atrial catheter navigation

15

The Transseptal Crosser

TSP Crosser system

16

Needle and Stylet Assembly

Dilator

Introducer Sheath

DilatorNeedle Introducer Sheath

with wire loop Dilator

Needle Stylet

Transseptal Puncturing System:Stabilizing loop wire and

flexible needle

Steerable Introducer: Controlled catheter

navigation into the left atrium

TSP Crosser an integrated system

TSP CROSSER

Electrophysiology ablation procedure

Step-by-Step Procedure

1

Insertion and loop expansion

2

Choose Puncture Location

3

Locate Fossa Ovalis

Step-by-Step Procedure

4

Transseptal Puncture

5

Left Atrium Catheterization

Echo or fluoro transseptal puncture guidance

F.O.

TSP Crosser Sheath

Tip

Loop Wire

Tenting

TSP Crosser Sheath

Tip

Loop Wire

F.O.

Loop and Needle Double Tenting

Fluoro Guidance Echo Guidance

Clinical data – first 16 patients

A prospective, multi-center, clinical trial to evaluate the safety and performance of the TSP Crosser system for transseptal

access and left atrial navigation.

16Number of patients

10 (63%)Men

66Mean age, years

Atrial fibrillation ablationClinical procedure

90 daysFollow-up

Clinical data – first 16 patients

• High performance capabilities results

• Quick learning curve and training with high results

• Easy adaption of transseptal puncture technique for less experienced physicians

100%Ability to achieve transseptal access using the TSP Crosser needle

100%Ability to visualize location of Crosser dilator prior to insertion of

transseptal needle

100%Ablation catheter inserted and retrieved through the TSP Crosser

4.3 (out of 5)Procedural step rate (1 [unacceptable] to 5 [excellent])

Good to excellentOverall performance and usability

Conclusions

• Transseptal puncture is challenging and potentially associated with

complications

• More and more transseptal transcatheter interventions demand

transseptal access

• The TSP Crosser provides added value and capabilities when

compared to current alternative technologies of steerable or non-

steerable sheaths.

Thank you!