Control and Precision: Self-positioning Transseptal Steerable...
Transcript of Control and Precision: Self-positioning Transseptal Steerable...
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Control and Precision: Self-positioning Transseptal Steerable Solution
Andreas Metzner
Asklepios Klinik St. Georg
Hamburg, Germany
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• Disclosures:– Consultant: Medtronic, Cardiofocus
– Travel grants and lecture honoraria from Medtronic, Cardiofocus, Biosense-Webster, Astra-Zeneca, Boehringer-Ingelheim, Bayer
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• 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
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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
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Update ww survey, > 16.000 pts
Cappato et al. Circulation AEP 2010
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Causes of fatal outcome in catheter ablation of atrial fibrillation
Cappato, JACC 2009
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• 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
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The fossa ovalis varies from patient to patient
* Transseptal Catheterization and Interventions
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50TSP is a 50-year-old needle-based procedure
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St. Jude Medical: BRK™ Transseptal Needles
Despite huge advancements in cardiology, this procedure has not changed much in more than 5 decades
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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
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Transseptal puncture equipment
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His
Pigtail
His
RAO LAO
Landmarks for transseptal puncture
His-catheter and pigtail in Aorta
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His
Pigtail
His
RAO LAO
Landmarks for transseptal puncture
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TSP under ICE / TEE
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All-in-one system for transseptal puncture and left atrial catheter navigation
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The Transseptal Crosser
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TSP Crosser system
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Needle and Stylet Assembly
Dilator
Introducer Sheath
DilatorNeedle Introducer Sheath
with wire loop Dilator
Needle Stylet
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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
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Electrophysiology ablation procedure
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Step-by-Step Procedure
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Insertion and loop expansion
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Choose Puncture Location
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Locate Fossa Ovalis
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Step-by-Step Procedure
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Transseptal Puncture
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Left Atrium Catheterization
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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
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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
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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
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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.
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Thank you!