About:

This concise and clearly written handbook covers all aspects of cardiac leads for pacing, defibrillation, and cardiac resynchronization therapy. A useful and thorough guide for implanters, it is also an asset to anyone either entering in the field of devices for pacing or preparing for an examination.

A complete history of cardiac leads development from its beginning in the late 1950s to its status today. This comprehensive publication:

• Presents basic principles of cardiac pacing

• Defines essential lead structure, terminology and technology

• Clarifies complex aspects of lead engineering, design, function and reliability

• Explains how leads operate in the intensely hostile human heart environment

• Describes implant dynamics and practical aspects of in vivo conditions

• Includes important updates and incorporates today’s technical and scientific developments

• Serves as an excellent review to stay on the edge of this rapidly advancing field• Features over 1,450 drawings, pictures, diagrams, illustrations and tables, most in full color

Table of Contents

Sample Pages

Table of Contents:

Foreword
Introduction

1. Historical Milestones
Electrical stimulation
Cardiac pacing
Cardiac defibrillation
Cardiac resynchronization therapy (CRT)

2. Cardiovascular System, Cardiac Rhythm and Disorders
The heart
Cardiac function
Electrical conduction system
Heart beat anatomy
Heart rhythm disorders
Bradycardia
Tachycardia
Heart failure

3. Pacing Leads
Description of an implantable pacemaker system
Evolution of pacemaker technology
Construction and components
Polarity
Lead stiffness
Single-pass VDD lead
Biatrial pacing lead
Length and diameter

4. Tachy Leads
Description of an implantable cardioverter defibrillator system
Evolution of technology - ICDs and leads
Construction and components
Polarity
Shocking circuits
Coil electrode
Single-pass VDD ICD lead

5. CRT Leads and Delivery Systems
Description of an implantable biventricular pacing system
Construction, components and programming options
Delivery systems
Lead fixation mechanisms
Over-the-wire (OTW)
Endocardial cardiac resynchronization therapy (eCRT)

6. Epimyocardial Leads
The early days
Construction and components
Clinical applications
Special tools required for implants

7. Temporary Pacing Leads
Epicardial
Transvenous
Transthoracic
Transesophageal
Transcutaneous

8. Electrode
Fixation mechanisms - the early days
Passive fixation mechanisms
Active fixation mechanisms
Materials and designs
Electrode-myocardium interface
Anti-inflammatory drugs

9. Conductor
Materials
Design and definition
Failure mechanisms

10. Insulation
History of insulation materials
Silicone
Polyurethane
Fluoroethylene polymers
Copolymers
SI Polyimide
Degradation of insulation materials
Abrasion
Crush
Creep
Elongation

11. Connector
The early days
The need for standardization, the IS-1 connector
Connectors for high power leads and the DF-1 standard
Four-pole connector standards, the IS-4 and the DF-4
Adaptors

12. Stylet and Guide Wire
Stylet
Three-dimensional curve stylet
Stylet guide
Locking stylet
Guide wire
Hybrid guide wire

13. Suture Sleeve
Design and clinical implications

14. Accessories
Analyzer cable interface tool
Connector plug
Fixation tool
Guide wire steering handle
Lead pin cap
Medical adhesive kit
Vein lifter

15. Lumenless Lead and Delivery System
Lead and delivery system
The driving force for change
Definitions of pacing sites
Definitions of alternative pacing sites
His bundle pacing

16. Fluorovisibility
Equipment
Views and interpretations

17. Lead Performance
Classification of medical devices and regulatory pathways
Class I medical devices
Class II medical devices
Class III medical devices
Concept of reliability
Reliability and performance
Tracking and monitoring
Bench testing guidance
Complications
Recall
Manufacturer and User Facility Device Experiences (MAUDE) database

18. Lead Extraction
Indications for transvenous lead extraction
Infection
Chronic pain
Thrombosis or venous stenosis
Functional leads
Non-functional leads
Fibrous encapsulation
Elements and technical considerations prior to lead extraction
Description of tools and techniques for lead extraction
Traction
Weighted traction
Intravascular counter-traction
Locking stylet
Retriever tool
Laser-assisted extraction
Mechanical dilator sheath set
Extraction tools and techniques for lumenless lead

19. Lessons Learned
Abandoned leads
Calcification and encapsulation
Contact allergy
Dextrocardia
Electrocautery effect on lead insulation material
Endocarditis with lead infections
Erosion and infection
Incomplete contact between lead connector pin and device header
Lead dislodgement
Leads related cardiac perforation
Pacemaker-induced superior vena cava syndrome
Pericardial effusion
Persistent left superior vena cava
Phrenic nerve stimulation in CRT
Subclavian vein obstruction
Tricuspid valve regurgitation
Twiddler’s syndrome

20. Manufacturers – Background, Acquisitions and Mergers

21. Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices
Classification of recommendations
Levels of evidence

22. Magnetic Resonance Imaging (MRI)
Basic concept and description of MRI equipment
Patient safety and system classification
State of technology
Future

23. Sensors Integrated in Pacing Leads
Cardiac pressure sensor
Mixed venous oxygen saturation sensor
Central venous blood temperature sensor
Minute ventilation sensor
Cardiac muscle vibrations sensor
Left atrial pressure sensor

24. Forces, Flexing and Other Implant Dynamics Leads Experience In Vivo
Interaction of factors
Design and material considerations
Lead mechanics and patient anatomy
Classification of in vivo environments
Pocket, skeleto-muscular region and venous entry point
Vascular and intracardiac
Electrode-tissue interface
Coronary sinus
Subcutaneous/Extravascular
Epicardial/Epimyocardial

25. Leadless Pacing
Review of concept
Reasoning for leadless pacing
Current state of technology

Glossary
Suggested Readings
Index

Foreword:

The long-sought dream of leadless cardiac pacing has finally been achieved thanks to on-going technology development.

Leadless pacemakers and subcutaneous/extravascular implantable cardioverter defibrillators (S-ICDs/EV-ICDs) mark a new era in cardiac pacing, allowing for a potentially significant reduction in device and lead-related complications.

Nevertheless, traditional transvenous pacing remains the most common method used to treat our patients. If on the one hand, the era of wireless cardiac pacing has begun, on the other hand, we are witnessing a rediscovery of a more physiological cardiac stimulation with the use of transvenous lead, that is permanent His bundle pacing.

Leads continue to be the Achilles' heel of transvenous cardiac pacing, and as long as transvenous cardiac pacing exists, we will have to deal with leads at implant, follow- up and extraction.

To maximize safety and efficacy and understand why possible failures and complications occur, implanters and physicians must be familiar with both the traditional and new cardiac implantable electronic devices (CIEDs).

This book is a must-read for anyone involved in the treatment of patients with CIEDs. It offers a complete overview of the historical milestones in cardiac pacing, defibrillation and cardiac resynchronization, and the important technological developments for the best treatment of our patients.

Federico Migliore, MD, PhD, FESC, FEHRA Cardiologist and Electrophysiologist
Department of Cardiac, Thoracic, Vascular Sciences and Public Health - University of Padova
Padova Italy