LEADLESS AND NON TRANS-VENOUS TECHNOLOGY:

CURRENT AND FUTURE DIRECTIONS

JONATHAN LOWY MD

• 58 year old woman with severe rheumatic mitral stenosis, Tricuspid Insufficiency, Aortic Stenosis factor 5 Leiden, and Type II DM had prior AVR replacement in Ukraine 10 years

• Complete Heart block after surgery sternal infection, and she developed bilateral venous thrombosis of her upper extremity venous return.

• Epicardial post-surgical pacing wires began to fail after 7days with intermittent capture• Temporary femoral Trans-venous pacing was required • Surgeons did not want to place an epicardial lead and EP was uncomfortable with

anything permanent in the venous system due to risk of thrombosis. • She remained in the ICU for 36 days with temporary trans-venous pacing before being

transferred to our institution

Tong, F Reddy,V Circulation. 2017;135:1458–1470. DOI: 10.1161/CIRCULATIONAHA.116.025037

Why leadless pacemakers?• 1,000,000 pacemakers implanted worldwide

• 200,000 implanted in the US every year

Leadless pacing

Requirements for a leadless pacemakerDeliverableStable and SafeBattery life 8-12 yearsRate responseMRI compatibleTelemetry Remote Monitoring

Retrievable/ExtractableModular

CURRENTLY THE MICRA SINGLE CHAMBER VVIR PACEMAKER IS

THE ONLY FDA APPROVED LEADLESS CARDIAC PACEMAKER

NANOSTIM: ST. JUDE MEDICAL(NOT FDA APPROVED)

N Engl J Med 2015; 373:1125-113

Nanostim Implants Suspended in 2016 prior to FDA approvalBattery failure in a small number of implants resulted in voluntary recall in 2016Delivery button malfunction in 2017

Per Abbott they are working on a dual chamber version of Nanostim with updated battery and design. Plans for a clinical IDE trial in the “near future” The plans for the dual chamber system have not been publically disclosed.

MICRA MEDTRONIC-FDA APPROVED

MICRA LEADLESS PACEMAKEREasy to Implant Battery life 8-12 yearsMRI compatibleRate response with 3 vector accelerometerRetrievable/Extractable +/-Reliable In animal models up to 3 devices implanted in the RV

Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control

Boston Scientific “EMPOWR”(Investigational Device)

32.1 mm x 6.0 mm0.8 cc

EMPOWER Delivery and Retrieval(Investigational Device & System)

Dedicated delivery and retrieval catheters

tether loop/ retrieval groove

20.7 Fr Preloaded delivery catheter withextendable inner catheter

Dedicated retrieval system with single & tri-loop snares

Active fixationtalons

FDA PMA FOR MICRA:

Data for 40k patients show 20% TV-lead malfunction at 10 years

1. Koneru, JN, Jones, PW, Hammill, EF, Wold, N, and Ellenbogen, KA, Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads. J Am Heart Assoc, 2018. 7(10).

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Mechanical Failure of Transvenous LeadsTrends from 10 Year Optum Data for > 40,000 Patients

WHY DO WE NEED AN ALTERNATIVE TO TRANSVENOUS ICDS?

• Patients are living longer requiring lead durability that may not last a patient’s lifespan• Sicker patients with more systemic disease increasing the risk of infection• A vast majority of patients do not need pacing or ATP• Extraction of Transvenous systems is not without significant risks

Evolution of S-ICD therapy

2å0022009

2015

2016

1st Generation

2nd Generation

3rd Generation

• EMBLEM Electrode (Model 3501)

• Electrode Delivery System (EDS)

• 2 Incision Technique Labeling

2017

• SMART Pass1

• MRI compatible1**

• AF MonitorTM 1

• Smaller, thinner,

longer-lasting device*

• LATITUDETM

compatible1

2012 Automated Screening Tool

DETECTION

CONDITIONAL ZONE DISCRIMINATORS

ONGOING TRIALS:• UNTOUCHED:• Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction

(UNTOUCHED)

• LATE BREAKING UPDATE AT HRS 2019

• PRAETORIAN TRIAL:• Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy.

• ATLAS S-ICD• AVOID TRANSVENOUS LEADS IN APPROPRIATE SUBJECTS

• RANDOMIZE S-ICD VS SINGLE CHAMBER ICD

• PRAETORIAN-DFT• RANDOMIZING DFT VS NO DFT WITH XRAY TO CONFIRM APPROPRIATE DEVICE LOCATION

MEDTRONIC EV SUB-STERNAL ICD-EXPERIMENTAL-

• PILOT TRIAL: SPACE• 9 PATIENTS IMPLANTED IN AUSTRALIA AND

NEW ZEALAND

• HAS ABILITY TO DELIVER ATP AND POST SHOCK PACING

• WORLD WIDE STUDY INCLUDING US SITES NOW UNDWERWAY

IMAGE COURTESY MEDTRONIC

Courtesy of Brandon Fellows BSCI

WISE-CRT/SELECT LVEXPERIMENTAL NOT FDA APPROVED

THE FUTURE: