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Social and Ethical Principles of Device Therapy: The Ethics of Cardiac Implantable Electronic Device Reuse and Deactivation

The Ethics of Cardiac Implantable Electronic Device Reuse Cardiovascular disease is the leading cause of death in high-income countries. The notion that it is also responsible for the majority of deaths in low- and middle-income countries (LMIC) is less intuitive. In the last several decades, the developing world has witnessed a rapid rise in the cardiovascular disease epidemic, fueled by a combination of rising risk factors,…

Establishing and Managing a Device Clinic and Database

Clinics for the Follow-Up of Cardiovascular Implantable Electronic Devices The story of cardiovascular implantable electronic devices (CIEDs) started in 1958 with the first pacemaker (PM) implant performed at Karolinska Hospital in Stockolm and evolved with the first implant of an implantable cardioverter-defibrillator (ICD) performed in Baltimore in 1980. Over time the possibilities to benefit patients with arrhythmia disturbances has evolved, and therapy with an electrical device…

Managing Advisories of Cardiac Implantable Electronic Devices

Introduction Cardiac implantable electrical devices (CIEDs) have undergone revolutionary changes in the last decade. These changes have permitted an increase in the use of both pacemakers and implantable cardioverter defibrillators (ICDs), collectively known as CIEDs. Pacemakers were the first generation of CIEDs available for implantation in humans, as early as 1957. Implantable defibrillators in the current form, that is transvenous, have been available since 1997. CIEDs…

Perioperative and Periprocedural Management, Electromagnetic Interference, and Cardiac Implantable Electronic Devices

Patients with cardiac implantable electronic devices (CIEDs) frequently undergo other surgical procedures in which there may be interference with operating room (OR) equipment. When the number of patients with CIEDs was small and CIEDs had few features, perioperative and periprocedural management usually involved only placing a magnet on the device. CIEDs had less shielding, and sometimes unpredictable behavior could occur. For instance, phantom device reprogramming was…

Follow-Up of Cardiac Implantable Electronic Devices—Remote Monitoring and in Person: Implementation and Guidelines

Aside from direct therapeutic ability, cardiovascular implantable electronic devices (CIEDs) have a sophisticated capacity to identify, quantify, and present diagnostic data regarding their own performance and also patient condition (e.g., arrhythmias, hemodynamic parameters). Attention to these may facilitate device and/or disease management. This requires mechanisms for CIED monitoring that permit timely retrieval of important diagnostic data. Hence postimplant follow-up is important. However, clinical practice is inconsistent.…

Cardiac Resynchronization Therapy Programming and Troubleshooting

Introduction In two decades the invention of transvenous left ventricular (LV) pacing integrated to a conventional pacemaker (cardiac resynchronization pacemaker, CRT-P) or an implantable cardioverter-defibrillator (CRT-D) has offered an effective therapy for patients with mild to severe heart failure (HF). Cardiac resynchronization therapy (CRT) typically involves simultaneous or sequential stimulation of both the ventricles to improve electrical and mechanical dyssynchrony, enhance pump performance, reduce functional mitral…

Implantable Cardioverter-Defibrillator Programming and Troubleshooting

Since its introduction into clinical practice in the early 1980s, the implantable cardioverter-defibrillator (ICD) has evolved from a treatment of last resort for aborted cardiac arrest to the treatment of choice for the management of resuscitated cardiac arrest and, more recently, for the primary prevention of sudden cardiac death. The latter is now the most common indication for ICD implantation. The original device (AID, Intec Systems,…

Pacemaker Programming and Troubleshooting

Acknowledgment: The author would like to acknowledge the excellent chapter on pacemaker troubleshooting and follow-up from the previous edition of this book, which was authored by Dr. Charles J. Love, with contributions by Dr. Paul A. Levine, and which formed the foundation of the present work. Some sections of the text and several figures have been reproduced in this chapter. Pacemaker Programming In order that pacemaker…

Timing Cycles of Implantable Devices

Acknowledgment: The author would like to express his sincere gratitude to Wyatt Stahl (Boston Scientific), Benjamin Coppola (St. Jude Medical), Pam Elrod (Medtronic), and David Thomas (Biotronik) for their review and comments on sections pertinent to their devices in the tables and figures in this chapter. Timing cycles refer to the beat-by-beat behavior of cardiac implantable electronic devices (CIEDs) in response to intrinsic and paced activity.…

Lead Removal and Extraction

Introduction Lead extraction or removal is increasingly required given the increased numbers of cardiovascular implantable electronic devices (CIED). The number of extractions or lead removals has increased due to increasing infection rates, expanded indications such as the need to upgrade to newer technology in the setting of occluded veins or lead/device safety alerts, and improved access to extraction providers. Leads implanted for a short duration are…

Device Removal, Replacement, and Upgrades

The need to replace the pulse generator of a pacemaker or a defibrillator may occur at any time in the life of a patient implanted with one of these devices. Although this need is most often the result of normal battery depletion, the need for replacement of the device may also be precipitated by other diverse causes such as infection, erosion, trauma, electrical or electronic component…

Prevention and Management of Procedural Complications

Introduction Cardiac implantable electronic devices (CIEDs) have proven to be an invaluable tool in the practice of cardiology, and implantation rates continue to rise. For this reason, the number of CIEDs in use and the inevitable complications associated with these devices have also increased. The knowledge and techniques associated with both CIED implantation and the management of associated complications, including transvenous lead extraction, have advanced significantly.…

Interventional Techniques for Device Implantation

The first generation of cardiac implantable electronic devices (CIEDs) were implanted by surgeons, initially with epicardial and later transvenous pacing systems. Because of this, when problems were encountered the solution was a surgical technique. As devices became smaller and almost exclusively implanted using transvenous techniques, implantation moved largely out of the hands of the surgeon and to the invasive cardiologists and electrophysiologists (EP). The mechanics of…

Left Ventricular Lead Placement Outside the Cardiac Veins

Background Cardiac resynchronization therapy (CRT) has proved a highly effective treatment for many patients suffering from heart failure. The nonresponder rate in many series is, however, still in the 30% range. There are many facets to the issue of “nonresponse.” Clinical conditions vary widely and impact on the clinical utility and outcomes of CRT: QRS width, ejection fraction, cause of ischemic or nonischemic disease, and location…

Coronary Sinus Lead Implantation

Introduction Cardiac resynchronization therapy (CRT) reduces hospitalization, improves quality of life, and lowers mortality in selected patients with congestive heart failure (CHF). CRT requires left ventricular (LV) pacing, usually via a lead placed transvenously through a coronary vein on the epicardium. Transvenous pacing of the LV epicardium via the coronary venous system can be technically difficult but is safe, and stimulation thresholds remain stable. Transvenous LV…

Intraprocedural Assessment of Stimulation, Sensing, Detection, and Defibrillation

The learning curve for implantation of cardiac implantable electronic devices (CIEDs) can be challenging due to the need to acquire surgical, lead, and catheter handling skills, as well as the ability to identify normal and abnormal CIED component function in order to troubleshoot problems. An in-depth understanding of the principles related to assessing CIED system function and the capacity to resolve problems during an implant procedure…

Implantation of the Subcutaneous Implantable Cardioverter-Defibrillator

The approach to implantable cardioverter-defibrillator (ICD) implantation has evolved ever since the first implant in the 1980s. The latest technical advancement is the development of the subcutaneous ICD (S-ICD) with an entirely subcutaneous lead. Although transvenous ICDs are highly effective and clinical experience is widespread, the intracardiac sensing and defibrillation leads remain an important limitation in transvenous ICD therapy. The S-ICD relies on a subcutaneous can…

Pacemaker and Implantable Cardioverter-Defibrillator Management in Children and Congenital Heart Disease

Cardiac rhythm device therapy is valuable for treatment of bradyarrhythmias and tachyarrhythmias in patients of all ages. Pediatric and young adult patients may present additional challenges during evaluation of implant indications such as selection of an approach to lead placement, selection of an appropriate pulse generator, and choice of device programming. In part, the problems are age- and size-related; pacemakers and implantable cardioverter-defibrillators (ICDs) can be…

Permanent Pacemaker and Implantable Cardioverter-Defibrillator Implantation in Adults

The implantation of cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices (CRT-D, CRT-P), and implantable monitors, has evolved substantially during the past six decades. The initial epicardial, and even transvenous, pacemaker and ICD implants were done predominantly by surgeons and involved large devices. Venous “cutdowns” were used exclusively for transvenous lead implantation in the early days. During the past…

Implantable Cardiac Rhythm and Hemodynamic Monitors

Ambulatory electrocardiography is used to continuously monitor a patient's heart rhythm over an extended period, encompassing normal activity and exercise and usual physiologic changes. It has demonstrated increased sensitivity compared with the standard electrocardiogram (ECG) for detecting spontaneous cardiac arrhythmia. The initial enthusiasm for ambulatory monitoring came from the observation that ventricular premature beats appeared to provoke sustained malignant dysrhythmia, which in turn was the cause…