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Scott Brancato, MD, FHRSMedical Director, Cardiac Device ClinicProvidence Heart and Vascular Institute

Bradyarrhythmias – Permanent pacemakers

Tachyarrhythmias/Sudden death prevention –

Implantable Cardioverter Defibrillators (ICDs)

Cardiac rhythm monitoring – Implantable Loop Recorders (ILRs)

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Sinus node dysfunction

Symptomatic bradycardia (including pauses)

Symptomatic chronotropic incompetence

Heart Block

Asymptomatic advanced or complete AV block

Asymptomatic Mobitz Type II 2nd degree AV block

Symptomatic Mobitz Type I 2nd degree AV block

Cardiac resynchronization

CHF, LVEF 35% or less, with QRS>120ms or anticipated RV pacing >40%

Sinus bradycardia

Sinus pause

Conversion pause

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Mobitz 2 2nd degree

Mobitz 1 (Wenkebach)

Complete AV block

RBBB

Normal QRS

RV pacing QRS

LBBB

Conscious sedation

IV antibiotics

2” incision in deltopectoral groove

Access in axillary, cephalic or subclavian vein

Pacing leads are 6-7F (2-2.5mm diameter)

Leads advanced to RA/RV under fluoroscopy

Active fixation mechanisms (screws) extended

Leads connected to device

Incision closed

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RV and/or RA leads placed

Coronary sinus cannulated with introducer sheath

Venogram performed to identify CS branch

Lead advanced over wire into CS branch

Introducer sheath split

Infection

Hematoma

Pneumothorax

Hemothorax

Cardiac perforation

Contrast reaction

Lead dislodgement

Lead malfunction/failure

Overall

complication

rate 3-4%

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Complication

Lead dislodgement

Pneumothorax

Lead perforation

Venous thrombosis

Chronic lead failure

Hematoma requiring surgery

Erosion

Infection

Occurrence

2-4%

1%

<1%

1-3%

2-4% at 5 years

<0.5%

1%

1-2%

Extraction mortality 1%

In-hospital mortality for PPM infections 8.4%

The 15 month mortality rate is 36%

Hospital stay for PPM infection is 14.4 days

The incremental cost of PPM infection is estimated at $17-$25K

Unmet Clinical Needs

Access complications (pneumothorax, occlusion)

Pocket complications (Hematoma, Erosion, infections)

Lead complications (dislodgement, fracture, infections,

connection errors, interaction with vasculature & heart

structures, extraction complications)

Patient Preference

Cosmetic appeal (lack of pocket)

Minimally invasive approach

Pain and discomfort associated with pocket

Efficiency

Faster procedure?

Possibility for lower complications?

Increase Access to Brady Therapy

Availability of specialists in emerging markets

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Intended for patients that have a Class I or II indication for a single-chamber ventricular pacemaker

Contraindicated in patients with current implanted cardiac devices which:

would interfere with the placement of the Micra device

are providing active cardiac therapy

• Pacing Mode: VVIR

• Volume: 0.75cc

• Mass: 2g

• Length: 24mm

• Width: 20Fr

• Bipolar sensing (17mm spacing)

• Programmable

• Capture Management

• Diagnostics: battery status,

pacing threshold, pacing

impedance, % paced

• 7.4/10.1 year longevity (2.0/1.5V

output, 60 bpm, 100% paced)

• MRI conditional

• RF communication with

programmer & Carelink

• Device can be deactivated

Proximal Retrieval

Feature

Anode (27mm2 )

Cathode (2.5mm2)

CapSure Sense

steroid eluting

Active Fixation “Tines”

Electrically Inactive

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The Leadless Cardiac Pacemaker.

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Device-Related Serious Adverse Events.

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Single Chamber ICD Dual Chamber ICD

Biventricular ICD

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Subcutaneous ICD

LVEF<35% due to prior MI who are at least 40 days post MI (NYHA II-III)

LV dysfunction due to prior MI, LVEF < 30%, NYHA I

Survivors of Cardiac arrest due to VF or hemodynamically unstable sustained VT after evaluation to define the cause of event and excluding any reversible causes

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Primary prevention of sudden cardiac death

Cardiomyopathy (Ischemic, nonischemic)

Primary electrical disorders (Brugada, LQTS)

Secondary prevention of sudden cardiac death

Ventricular tachycardia

Ventricular fibrillation

Non-ischemic DCM LVEF < 35%, NYHA II-III

Non sustained VT due to prior MI, LVEF < 35% or inducible VF/FT on EPS

Structural heart disease and spontaneous sustained VT

Syncope of undetermined origin with clinically relevant sustained VT or VF induced at EPS

LQTS patients who experience syncope and/or VT while on b-Blockers

Reversible triggering factor for VT/VF

CAD patients without inducible or spontaneous VT undergoing bypass surgery

NYHA class IV drug refractory congestive heart failure, not candidates for transplant

Life expectancy less than 1 year

Significant behavioral disorders or psychiatric disorders

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Conscious sedation

IV antibiotics

2” incision in deltopectoral groove

Access in axillary, cephalic or subclavian vein

ICD leads are 7-8F (2.3-2.7mm diameter)

Leads advanced to RA/RV under fluoroscopy

Active fixation mechanisms (screws) extended

Leads connected to device

Incision closed

Defibrillaton threshold testing (rarely)

RV and/or RA leads placed

Coronary sinus cannulated with introducer sheath

Venogram performed to identify CS branch

Lead advanced over wire into CS branch

Introducer sheath split

Infection

Hematoma

Pneumothorax

Hemothorax

Cardiac perforation

Contrast reaction

Lead dislodgement

Lead malfunction/failure

Inappropriate shocks

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� The Danish Registry demonstrated that up to 15%

of ICD patients are at risk of a complication within

the first 6 months of implant.

� The majority of complications requiring invasive

intervention included:

� Lead related issues

� Infection

�Cardiac Perforation

�PneumothoraxKirkfeldt, R., et al. Complications after cardiac implantable electronic

device implantations: an analysis of a complete, nationwide cohort in

Denmark . European Heart Journal. Dec 2013

1. Maisel WH, Kramer DB. Implantable cardioverter defibrillator lead performance.

Circulation 2008;117:2721-2723. doi: 10.1161/CIRCULATION AHA. 108.776807.

Defibrillates without transvenous leads

Avoids lead related complications associated with traditional ICDs

Unlike traditional ICDs, it does not have the ability to function as a pacemaker

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No venous access (occluded or congenital)

High risk of complications for TV-ICD (dialysis, pediatric, immunocomprised)

Channelopathies (LQT, Brugada, HCM)

Previous device infections or lead failures

H/O endocarditis

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• Systolic heart failure and LBBB who are indicated for CRT

• Symptomatic bradycardia requiring pacemaker

• Recurrent sustained MVT for whom ATP is deemed appropriate

Cardiac implantable electronic devices have made possible incredible advances in patient care over the past several decades

Advances in technology continue to improve the size and functionality of these devices

Indications continue to evolve as the technology improves

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