The Future of Cardiac Devices: New devices, indications and ways to - - PowerPoint PPT Presentation

The Future of Cardiac Devices:

New devices, indications and ways to use Jeff Healey MD, MSc, FHRS Director of Arrhythmia Service PHRI Chair in Cardiology Research McMaster University

Evolution of Cardiac Device Therapy

• Better cardiac implantable electrical devices

– Smaller devices, longer battery life – MRI-conditional devices, wireless, remote-monitoring – Leadless pacemakers and defibrillators, injectable ILR

• Better ways to minimize CIED morbidity

– Better surveillance of devices and leads – Studies to reduce infection, bleeding, lead failure

• Novel applications of CIED technology

– Detection of atrial fibrillation – Advance warning of heart failure

ICD: Mirowski M. 1978 Circulation 58(1):90-4

209 cc 120 cc 80 cc 80 cc 72 cc 54 cc 62 cc 49 cc 39.5 cc 39.5 cc 36 cc 38 cc 39.5 cc

MRI-Conditional Pacemakers/ICDs

• All ILR, Most PM,

many ICD

• Some cautions remain
• Coordination with

PM/ICD clinic

• Cost issues

MDT Sure-Scan pacemaker

Heart Rhythm 2011

Surveillance of Devices and Leads

• Most centres with electronic databases
• CHRS Device committee, volunteer group
• Provide clinical guidance to hospitals
• World leaders in publications on

– Device reliability (Marquis, Riata, Fidelis, etc.) – Implant-related device complications – Randomized trials to reduce device morbidity

• (PADIT, SIMPLE, BRUISE-CONTROL, etc.)

The Lead is the Weakest Part of the ICD System

Leadless Pacing

Medtronic Micra; NEJM 2015

Leadless Pacing

• St. Jude Nanostim

A new category of implantable defibrillators

Transvenous (TV) ICDs The S-ICD System

• Provides effective defibrillation for

ventricular tachyarrhythmias

• Provides Brady pacing
• Provides ATP for patients with incessant

monomorphic VT

• Provides atrial diagnostics
• Familiar implant technique
• Provides effective defibrillation for

ventricular tachyarrhythmias

• No risk of vascular injury
• Low risk of systemic infection
• Preserves venous access
• Avoids risks associated w/ endovascular

lead extraction

• Fluoroscopy not required

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S-ICD in clinical practice

S-ICD Pooled Results

Demographics

43% of the study population were Primary Prevention Patients with an EF 35%

Demographic N (%)

Age (years) 50.3 ± 16.9 Male (n, %) 636 (72.5)

Ischemic 330 (37.8%) Genetic 58 (6.7%) Idiopathic VF 40 (4.6%) Channelopathies 90 (10.3%) NYHA Classification II-IV 327 (37.5%) Atrial Fibrillation 143 (16.4%) Previous Defibrillator 120 (13.7%)

S-ICD Pooled Results

S-ICD and TV-ICD Spontaneous Conversion Efficacy

Spontaneous Shock Efficacy First Shock Final Shock in episode

S-ICD Pooled Data*

90.1% 98.2%

ALTITUDE First Shock Study1

90.3% 99.8%

SCD-HeFT2

83%

PainFree Rx II2

87%

MADIT-CRT3

89.8%

LESS Study4

97.3%

* Excluded VT/VF Storm events

1 Cha YM et al. Heart Rhythm 2013;10:702–708. 2 Swerdlow CD et al. PACE 2007; 30:675–700. 3 Kutyifa V, et al. J Cardiovasc Electrophysiol 2013;24:1246-52. 4 Gold MR et al. Circulation 2002;105:2043-2048.

S-ICD Pooled Data 100% Clinical conversion to normal sinus rhythm

Of two “unconverted” episodes

• One spontaneously terminated after the 5th shock
• In the other episode, the device prematurely declared the episode ended. A new episode

was immediately reinitiated and the VF was successfully terminated with one shock

When evaluating TV-ICD studies1-4, S-ICD was as effective as TV-ICD in treating spontaneous arrhythmias

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Objectives: ATLAS

Primary Objective: To compare the rate of perioperative complications, measured at 6- months following implant, between patients receiving an S-ICD compared to those receiving a TV-ICD. Secondary Objectives:

• 1. To determine if the S-ICD is associated with fewer long-term

device-related complications.

• 2. To determine if the S-ICD has a similar effectiveness for the

treatment of ventricular arrhythmias and is associated with a similar risk of failed appropriate ICD shock and/or arrhythmic death

Implantable Monitoring

Smaller devices Improved diagnostics Outpatient implant Wireless telemetry Increased cost

Sub-Clinical AF Detected by Pacemakers

1.Mostly asymptomatic 2.Relatively short episodes detected only with long-term, continuous monitoring

ASSERT-II: Incidence of SCAF

34.4% (27.7% – 42.3%) Rate per year (95% CI) 21.8% (16.7% – 27.8%) 7.1% (4.5% – 10.6%) 2.7% (1.2% – 5.0%)

Conclusions

Cardiac implantable electrical devices

– Getting smaller – Wireless telemetry, remote monitoring – MRI conditional – Leadless devices

Many advances to reduce device morbidity

– Prevent ICD shocks – Prevent unnecessary pacing – Prevent infection and hematoma