SLIDE 1
Presenter Disclosure Information
- C. Piorkowski has the following disclosures
CRT implant using Mediguide: towards fluoroless implant ? - - PowerPoint PPT Presentation
CRT implant using Mediguide: towards fluoroless implant ? - - PowerPoint PPT Presentation
Avignon 2013 CRT implant using Mediguide: towards fluoroless implant ? Christopher Piorkowski University Dresden Heart Center - Department of Electrophysiology Avignon 2013 Presenter Disclosure Information C. Piorkowski has the following
SLIDE 2
SLIDE 3
- indications according to current guidelines:
EF < 35%, LVEDD > 55 mm NYHA III/IV despite optimal medical therapy QRS > 150 ms or QRS > 120 ms + Echo-Asynchrony
Days after Randomization Event-free Survival (%)
CRT-HSM p=0.014 CRT-ICD p=0.010 Pharmacologic therapie
COMPANION CARE-HF
CRT-HSM Pharmacologic therapie
Event-free Survival (%) Days after Randomization
CRT – current standard
Avignon 2013
SLIDE 4
- Indication in patients not covered by current guidelines
- Difficulties during the implantation procedure
- Technical challenges
- Anatomical challenges
- Leading to long procedures with extensive radiation/contrast
- CRT non-response despite
- valid indication, implantation and therapy delivery
CRT – Difficulties met in daily clinical practise
Avignon 2013
SLIDE 5
narrow ostium valves left SVC target vein kinking
Challenges during CRT implantation
Avignon 2013
SLIDE 6
PACE 2010;33:1003-1012
- mean TFT 20.3 min
- mean DAP 111 Gy*cm2
Avignon 2013
SLIDE 7
Imaging of CS anatomy
Limitations: – static 3D anatomical model – moving implantation targets (cardiac and respiratory motion) – moving delivery tools – not integrated within the 3D environment
Avignon 2013
SLIDE 8
3D electromagnetic field emitters integrated into X-ray detector
MPS sensor
Tracking of intracardiac devices equipped with sensors
Mediguide technology: Auto-registration of device tracking and cardiac image
Avignon 2013
SLIDE 9
9 Intracardiac Sheaths Guidewires EP Catheters 1mm 0.27mm
Sensor devices and their potential clinical applications
Avignon 2013
SLIDE 10
Site: University of Leipzig - Heart Center Investigators: Dr. Piorkowski, Dr. Gasper, Dr. Doering, Dr. Richter, Prof. Hindricks Purpose: Evaluate safety and performance of MediGuide system and tools for LV lead implant Sample size: Maximum of 15 cases; feasibility study Inclusion criteria: Patients indicated for CRT implant Data Collected:
- Procedural success rate of LV lead implantation
- Total fluoroscopy time & radiation exposure
- Procedure time; Amount of contrast used; Safety
Status:
- EC approval received Jan 16th ; training completed January 18th
- First case – Jan 19th ; Last case – Feb 29th
Mediguide enabled LV lead placement – first in human
Avignon 2013
SLIDE 11
Mediguide enabled LV lead placement – first in human
Avignon 2013
SLIDE 12
Introduction of Mediguide sheath
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 13
CS cannulation with sheath and EP catheter
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 14
Placement of landmark at CS ostium
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 15
Acquisition of CS angiograms, “biplane” modus
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 16
Attempt to access target vein with guidewire
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 17
Target vein access with sub-selector and guidewire
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 18
Lead deployment within motion compensated 2D overlay
Richter et al., Circulation A+E 2013
Avignon 2013
SLIDE 19
– Implant success rate: 15/15 (100%) cases – Intra procedural complications: – lead dislodgement while sub-selector slitting n=2 – target vein perforation n=1 – Fluoroscopy needed during CS cannulation: – in 12/15 cases fluoroscopy was not needed for CS cannulation – Median total fluoroscopy time: 5.2 (3.0 ; 8.4) min – Median LV lead implant fluoroscopy time: 2.6 (1.8 ; 5.8) min – Very difficult implantation: 2/15 (13%) with severe target vein kinking – one case: conversion to X-ray based delivery after lead dislodgment – one case: conversion to X-ray based delivery after vein perforation
Mediguide enabled CRT implant – key observations
Avignon 2013
SLIDE 20
- Evaluation of potential clinical benefits
– significant fluoroscopy reduction
- likely
– shortening of the procedure
- needs to be assessed
– implantation success
- needs to be assessed
- Later on use of the technology to
– perform basic science on concept and development of CRT – potentially come out with strategies for
- tailored lead placement, device optimization
Mediguide enabled LV lead placement – next steps
Avignon 2013
SLIDE 21
Study on Mediguide enabled LV wall motion analysis
- Mediguide enabled analysis of 4D LV wall motion in
– 10 patients with structural normal hearts – 10 patients with heart failure and narrow QRS – 10 patients with heart failure wide QRS
- Study procedure
– Mediguide enabled endocardial LV wall motion mapping – Mediguide enabled epicardial LV wall motion mapping
- Primary objective is to
– to collect data on 4D wall motion behavior relevant for CRT
Avignon 2013
SLIDE 22
- 72 year-old male
- Sustained monomorphic VT; Ischemic cardiomyopathy
- Non-classical LBBB with left anterior hemiblock
- Intrinsic QRS width 180ms; EF 21%; NYHA II
- Dual-chamber ICD first implanted in 2002
Study on Mediguide enabled LV wall motion analysis
Avignon 2013
SLIDE 23
RAO LAO
Study on Mediguide enabled LV wall motion analysis
Avignon 2013
SLIDE 24
- Cardiac anatomy is crucial for challenging CRT implantations
- Mediguide tracking technology allows
– integration of CRT delivery tools into the cardiac target anatomy – compensation of primary and secondary organ motion
- Mediguide has been successfully used for in-human CRT implants
- the first clinical use indicated:
– significant impact on procedural aspects (fluoroscopy)
- further scientific expectations: