Βηματοδότηση χωρίς ηλεκτροκαθετήρες. Τα πρώτα αποτελέσματα από τις κλινικές μελέτες.

Ευαγγελία Χριστοφοράτου, * Επιστημονικά Υπεύθυνη Τμήματος Βηματοδότησης Βιοκλινικής Αθηνών

* Επιστημονικός Συνεργάτης Α΄ Πανεπιστημιακής Καρδιολογικής Κλινικής ΓΝΑ

Ιπποκράτειο

Σεμινάρια Ομάδων Εργασίας

Ιωάννινα, 13-2-2016

• Technology:

– Highly mature and reliable

– Still includes generator, connectors,

and leads

• Procedure:

– Requires creation of a surgical pocket

– Relies on epicardial or transvenous

leads

• Device/Pocket related challenges

– Discomfort

– Hematomas

– Infection

– Cosmetic concerns

• Leads

– Mechanical failures

– Dislodgement

– Infections

– Extractions

Pacemaker Technology: History and Challenges

Pocket infection Hematoma

Lead dislodgement

Lead fracture

Images: Kabayadondo Maidei Gugu and de Meester Antoine (2011). Early Complications After Pacemaker

Implantations, Cardiac Pacemakers - Biological Aspects, Clinical Applications and Possible Complications, Prof.

Mart Min (Ed.), ISBN: 978-953-307-639-3, InTech, DOI: 10.5772/20091.

First implantable

pacemaker

First microprocessor

based pacemaker

First AutoCapture

pacemaker

First fully wireless

pacemaker

First leadless

pacemaker

Pacemaker Technology: History and Challenges

History of Leadless Pacing: Idea Proposed in 1970

Spickler et al. J Electrocardiol 1970;3:325-331

History of Leadless Pacing: Miniature Pacemaker Tested in 1991

a: Guiding catheter

b: Pusher catheter

c: Miniature pacemaker

d: Steering arm

Vardas et al Eur J Card Pacing Electrophysiol. 1991;1:1-47

Leadless Pacemakers

NanostimTM / SJM MicraTM / MedtronicWiCSTM / EBR

May 2011 December 2012 December 2013

Heart Vessels & Stroke Σάββατο

07/03/2015 Workshop I

What’s Needed for a Leadless Pacemaker?

• Catheter-based delivery system

• High density energy source

• Low power electronics

• Novel communication scheme

• Biocompatible materials

• Dependable fixation design

• Retrievability capability

Nanostim™ Leadless Pacemaker Makes Possible

Leadless Cardiac Pacing

• Energy efficient

– High-capacity CFx battery

– Lower resistance due to lack of lead

– Low-power conductive communication

• Compatible with Merlin™ Patient Care System

• Electrode design is identical to a St. Jude

Medical electrode with same steroid elution

• Designed to prevent dislodgement

– Double fixation: single turn helix (x 2 pull-

strength) plus angled nylon sutures

– Radiographic indicator to ensure proper number

of turns

• Tethered test mode for perioperative

evaluation

• Designed for retrievability

– Catheter-based retrieval system

The Nanostim™ VVIR pacemaker is introduced through the femoral vein

into the right ventricle.

Nanostim: The Device

• Docking feature (A) for delivery, repositioning, and retrieval

• Chemical cell (B)

– Standard cell has 3/4 the capacity of improved CFx

– LCP ASIC uses ¼ the current of standard ASICS

– Result: Same longevity with 3/16 the battery volume

• Compact header (C) with no connector

– Single chip/ASIC senses, paces, and communicates

• Helix (D) provides primary fixation

– Tines add secondary fixation

• Electrode w/ steroid(E) paces, senses & communicates

ED

The Nanostim™ Leadless Pacemaker Delivery System

• Delivery catheter– Soft, flexible, deflectable catheter tip

designed to minimize complications

– Tethered feature

– Integrated protective sleeve

– 18 F

• Handle with four functions:– Steering the deflectable tip

– Docking/undocking

– Rotating the device

– Releasing tether

• 18 F introducer

The Nanostim™ Leadless Pacemaker Retrieval System

• Similar to delivery system– Flexible with deflectable tip

– Integrated protective sleeve

– 18 F

• Either single loop or triple loop

snare

• Handle with three functions:1. Steering the deflectable tip for accurate passage

2. Grabbing and docking the LP

3. Rotating the LP

Nanostim™ Programmer Link

Conductive communication via

surface ECG electrodes

– No bulky antenna

– No added circuit module

– 50x less battery current

than RF systems

– Patented technology

First-in-man LEADLESS study

• Objective: Evaluate the safety and performance of the leadless

pacemaker

• Prospective, non-randomized, multicenter study conducted at 3

European centers

• A total of 33 patients were enrolled– Mean age of 77 years (53-91 years); 67% male

– 67% chronic AF and high degree AV block

– 18% sinus rhythm 2nd /3rd degree AV block with low activity or short lifespan

– 15% infrequent pauses or unexplained syncope

Procedure

• Femoral venousaccess

• LP assessment & programming

Post-Procedure

• 2 View X-ray of pacemaker

• LP assessment & programming

2-week follow-up

• Six-minute walk test

• LP assessment & programming

6-week follow-up

• Six-minute walk test

• LP assessment & programming

3-, 6-, and 12-month follow-ups

• LP assessment & programming

Reddy et al Circulation. 2014;129:1466-1471

LEADLESS Study: Delivery procedure1

• Successful delivery in 32/33 patients (97%)*

• Procedure Times

– Introducer in/out: 28 minute (range 11 – 74 min)

– Catheter in/out: 16 minute (range 3 – 57 min)

• Time from procedure to hospital discharge: Mean 31 hrs (Range 17 – 113)

• Number of times LP was repositioned: Mean 0.5 (Range 0 – 3)

Times LP repositioned Number of patients Percent of patients

0 23 70%

1 4 12%

2 4 12%

3 2 6%

*In one patient, there was cardiac perforation and tamponade which required surgical repair. On

post-operative day 5 after an uncomplicated surgical repair, the patient (who had atrial fibrillation

and was not adequately anticoagulated) had a large right-sided stroke and ultimately expired.

This event was medically adjudicated.

Reddy et al Circulation. 2014;129:1466-1471

LEADLESS Study: LP performance is reliable and

predictable at 12-months post-implant16

Reddy et al Circulation. 2014;129:1466-1471

Heart Vessels & Stroke Σάββατο

07/03/2015 Workshop I

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07/03/2015 Workshop I

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up to 720 patients at 70 centres worldwide

140 patients at 23 centres

Micra Transcatheter Pacing Study:

Patient Characteristics

Ritter et al. European Heart Journal (2015) 36, 2510–2519

Micra Transcatheter Pacing Study:

Patient Characteristics

Ritter et al. European Heart Journal (2015) 36, 2510–2519

Implant success rate was 100% (140/140)

• 107 (76.4%) devices were placed at the RV apex

• 33 (24%) were implanted at the anterior septum, midseptum,or

outflow tract

Micra Transcatheter Pacing Study:

X-rays of various device positions in RAO view

Ritter et al. European Heart Journal (2015) 36, 2510–2519

Micra Transcatheter Pacing Study:

Procedure or system-related adverse events from 140 implanted patients

Ritter et al. European Heart Journal (2015) 36, 2510–2519

Heart Vessels & Stroke Σάββατο

07/03/2015 Workshop I

Micra Transcatheter Pacing Study:

Patient Characteristics

Ritter et al. European Heart Journal (2015) 36, 2510–2519

Heart Vessels & Stroke Σάββατο

07/03/2015 Workshop I

Heart Vessels & Stroke Σάββατο

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Nanostim: Implantation Procedure

Courtesy of St Jude Medical Inc.

Nanostim (St Jude Medical): The retrieval system

A deflectable catheter with snare (single or triple)

to retrieve the device

Courtesy of St Jude Medical Inc.

Nanostim: Retrieval Procedure

Courtesy of St Jude Medical Inc.

P. Neuzil ESC Congress Barcelona 2014

Implantation Case:

The delivery system places the device to RV apex

P. Neuzil ESC Congress Barcelona 2014

Implantation Case:

Device fixation procedure

P. Neuzil ESC Congress Barcelona 2014

Implantation Case:

Tug test

P. Neuzil ESC Congress Barcelona 2014

Implantation Case:

Contrast Injection

P. Neuzil ESC Congress Barcelona 2014

Implantation in an apically position of IVS

P. Neuzil ESC Congress Barcelona 2014

Inadvertent implantation to LV apex through a PFO

Heart Vessels & Stroke Σάββατο

07/03/2015 Workshop I

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07/03/2015 Workshop I

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