CRT implant using Mediguide: towards fluoroless implant?
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1 CRT implant using Mediguide: towards fluoroless implant? Christopher Piorkowski University Dresden Heart Center - Department of Electrophysiology
2 Presenter Disclosure Information C. Piorkowski has the following disclosures Lecture honoraria: St. Jude Medical, Biotronik, Advisory board member: St. Jude Medical, Siemens Research support: St. Jude Medical, Biotronik, Imricor, Philips
3 Event-free Survival (%) Event-free Survival (%) Avignon 2013 CRT current standard 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 CRT-ICD p=0.010 CRT-HSM p=0.014 CRT-HSM Pharmacologic therapie Pharmacologic therapie Days after Randomization COMPANION Days after Randomization CARE-HF
4 CRT Difficulties met in daily clinical practise 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
5 Challenges during CRT implantation narrow ostium valves left SVC target vein kinking
6 mean TFT 20.3 min mean DAP 111 Gy*cm 2 PACE 2010;33:
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
8 Mediguide technology: Auto-registration of device tracking and cardiac image 3D electromagnetic field emitters integrated into X-ray detector Tracking of intracardiac MPS devices sensor equipped with sensors
9 Sensor devices and their potential clinical applications 1mm EP Catheters Intracardiac Sheaths 0.27mm Guidewires
10 Mediguide enabled LV lead placement first in human 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 16 th ; training completed January 18 th First case Jan 19 th ; Last case Feb 29 th
11 Mediguide enabled LV lead placement first in human
12 Introduction of Mediguide sheath Richter et al., Circulation A+E 2013
13 CS cannulation with sheath and EP catheter Richter et al., Circulation A+E 2013
14 Placement of landmark at CS ostium Richter et al., Circulation A+E 2013
15 Acquisition of CS angiograms, biplane modus Richter et al., Circulation A+E 2013
16 Attempt to access target vein with guidewire Richter et al., Circulation A+E 2013
17 Target vein access with sub-selector and guidewire Richter et al., Circulation A+E 2013
18 Lead deployment within motion compensated 2D overlay Richter et al., Circulation A+E 2013
19 Mediguide enabled CRT implant key observations 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
20 Mediguide enabled LV lead placement next steps 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
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
22 Study on Mediguide enabled LV wall motion analysis 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
23 Study on Mediguide enabled LV wall motion analysis RAO LAO
24 Summary 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: individual LV wall motion analysis to tailor CRT delivery
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