Michel Mirowski and the beginning of a new era of fighting sudden arrhythmic death.

Prior to the implantable cardioverter-defibrillator (ICD), life-threatening ventricular arrhythmias were treated using anti-arrhythmic drugs. The concept of an implantable defibrillator to prevent sudden arrhythmic death was first published by Michel Mirowski in 1970. Despite critical opinions by leading physicians, Michel Mirowski continued development of his vision. Hallmarks in the development of the ICD include the following: internal-external defibrillator used during surgery on humans in 1971/1972; fully implantable defibrillator tested in canines in 1975; defibrillator successfully implanted in a 57-year-old woman in 1980; second generation devices introduced in 1982; US Food and Drug Administration device approved in 1985. Today it is hard to imagine modern medicine without ICD therapy. This article provides the reader a history of the development of the ICD.

The implantable cardioverter-defibrillator: An update.

The implantable cardioverter-defibrillator (ICD) provides life-saving therapy to prevent sudden cardiac death. ICDs have been implanted in millions of patients worldwide since the first human implant in 1980. Clinical trials have helped establish guidelines for ICD implantation in primary and secondary prevention of sudden cardiac death. Recent trials have also tested and compared various programing strategies to avoid unnecessary shocks and improve survival among ICD recipients. ICDs may also assist with monitoring for heart failure management. In this review, we discuss the clinical science to date that has helped define the role of ICDs in current practice.

The story of a lead.

The totally transvenous implantable defibrillator lead, conceived by Mirowski and Mower 45 years ago, is irrevocably related to the wide acceptance of this therapy. It paved the way for the era for non-thoracotomy implantation. This paper covers the most important details of the evolution--over this 45-year period--of the original (ENDOTAK) transvenous ICD lead and subsequent iterations. Over that time period, there have been over 800 000 patients implanted with this family of leads. The 'story' addresses the multiple problems encountered, technological improvements in materials, design, and testing to overcome them. And, the need for continued close collaboration between physicians and industry focused on reliability and longevity of this critical component of these life-saving systems.

Cardiodesfibrilador implantável subcutâneo: um novo dispositivo para o tratamento da morte súbita / Subcutaneous implantable defibrillator: a new device for sudden death treatment

A morte súbita é um importante problema de saúde pública e o cardiodesfibrilador implantável (CDI) tem se mostrado mais efetivo que as drogas antiarrítmicas em seu tratamento. A despeito do grande benefício clínico dessa terapia, existem relatos de complicações relevantes relacionadas ao cabo-eletrodo transvenoso. Com o propósito de as minimizar, recentemente foi lançado nos mercados europeu, neozelandês e norte-americano um CDI com sistema totalmente subcutâneo (CDI-S) que dispensa a fluoroscopia. Os resultados iniciais de estudos clínicos publicados são promissores e mostram que o CDI-S converte com sucesso episódios de taquicardia ventricular (TV) e fibrilação ventricular (FV) induzidas ou espontâneas, com taxas de complicações ou de choques inapropriados semelhantes às do CDI convencional. Parece ser uma opção atraente para pacientes pediátricos com doença cardíaca congênita, pacientes com acesso venoso obstruído ou com alto risco de infecção, bem como para jovens com doença cardíaca elétrica, tais como miocardiopatia hipertrófica e síndromes de Brugada e do QT longo. Devido à impossibilidade de estimulação cardíaca permanente, não está indicado para os que necessitam de estimulação anti-bradicardia, terapia de ressincronização cardíaca (TRC) ou com história de taquicardia ventricular monomórfica repetitiva que se beneficiariam de estimulação anti-taquicardia (ATP). Estudos clínicos em andamento irão definir com maior precisão a segurança e a eficácia em longo prazo, o custo-efetividade e o perfil ideal dos pacientes que obterão os maiores benefícios dessa nova tecnologia...

Sudden death is an important public health problem; the implantable cardioverter defibrillator (ICD) has proven more effective than antiarrhythmic drugs in the treatment of sudden death. Despite the great clinical benefit of this therapy, there are reports of significant complications related to transvenous lead-electrode. In order to minimize these complications, recently was launched on the market in Europe, New Zealand and the United States a subcutaneous system (S-ICD) that even eliminates the need for fluoroscopy. The initial results of published clinical studies have been promising and show that ICD-S successfully converts the ventricular tachycardia episodes (VT)/ventricular fibrillation(VF), induced or spontaneous, with rates of complications or inappropriate shocks similar to conventional ICD. It seems to be an attractive option for pediatric patients with congenital heart disease that limits the implantation of transvenous leads, in cases of obstructed venous access, in patients at high risk of infection, as well as young people with electrical heart disease, such as hypertrophic cardiomyopathy, Brugada syndrome and long QT syndrome. Due to the impossibility of permanent cardiac pacing, the S-ICD is not indicated for patients that requiring anti-bradycardia pacing, or cardiac resynchronization therapy (CRT), or with a history of repetitive monomorphic ventricular tachycardia that would benefit from anti-tachycardia pacing (ATP). Ongoing clinical studies will better define its safety and long-term efficacy, cost effectiveness and better patient profile that this new technology will benefit...

Sudden cardiac death--historical perspectives.

Sudden cardiac death (SCD) is an unexpected death due to cardiac causes that occurs in a short time period (generally within 1 h of symptom onset) in a person with known or unknown cardiac disease. It is believed to be involved in nearly a quarter of human deaths, with ventricular fibrillation being the most common mechanism. It is estimated that more than 7 million lives per year are lost to SCD worldwide. Historical perspectives of SCD are analyzed with a brief description on how the developments in the management of sudden cardiac arrest evolved over time.

Risk stratification and role of implantable defibrillators for prevention of sudden death in patients with hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden cardiac death (SCD) in young people, including trained athletes. It is now 30 years since the introduction of implantable cardioverter-defibrillators (ICDs) to clinical cardiovascular practice and coronary artery disease, and now device therapy represents the most significant therapeutic innovation and the only definitive strategy for prolonging the life of HCM patients. ICDs have proved effective in preventing SCD in young HCM patients with appropriate intervention rates of 11% for secondary and 4% for primary prevention, despite massive left ventricular (LV) hypertrophy, LV outflow obstruction, diastolic dysfunction or microvascular ischemia. Targeting candidates for prophylactic ICD therapy can be complex, compounded by the unpredictability of the arrhythmogenic substrate, the absence of a dominant risk factor, and difficulty in assembling randomized trials. However, a single major risk factor is often sufficient to justify an ICD, although additional markers and other disease features can resolve ambiguous decision-making. Nevertheless, the absence of all risk factors does not convey absolute immunity to SCD. The current risk factor algorithm, when combined with a measure of individual physician judgment (and patient autonomy considerations), is an effective guide to identifying high-risk HCM patients. ICDs have altered the natural history of HCM for many patients and provided an opportunity to achieve many decades of productive life, and the potential for normal or near-normal longevity. Indeed, prevention of SCD has now become a new paradigm in the management of HCM.

The development and application of the implantable cardioverter defibrillator.

Several years ago, implantable defibrillators were recommended only for survivors of cardiac arrest. With improvement of surgical techniques and advancement in technology, defibrillator implantation is now considered an outpatient procedure. Clinical trials have now demonstrated improvement in survival in high risk patients who receive defibrillators which has greatly increased the number of defibrillators implanted. This manuscript reviews important features of the development of implantable defibrillators and reviews current indications for use.

Implantable defibrillators: 30 years of history.

The first concept of an implantable defibrillator was published in 1970 by Dr. Michel Mirowski and his colleague and friend Dr. Morton Mower. Within 30 years implantable defibrillator therapy has gone through a breathtaking development. However, it started with a vision and a concept of one man, who went through difficult times, personally, and in his intention to make his idea of a device that prevents sudden death come true. As with other innovative approaches in medicine, in the beginning there were more opponents than supporters of the concept. Device technology has impressively improved, but the principal concept remained the same: automatic shock delivery to a fibrillating heart by an implanted defibrillator will restore normal heart rhythm and save the life of the patient.

The implantable cardioverter defibrillator: its history, current psychological impact and future.

The innovation of the implantable cardioverter defibrillator (ICD) represents a modern medical achievement with substantial life-saving benefits for patients at risk for potentially life-threatening arrhythmias. Over a decade of research resulted in the first ICD implantation in 1980, dramatically changing the face of cardiac care. The introduction of the device was met by skepticism and outright rejection by some, yet large-scale clinical trials clearly demonstrated the mortality benefit of the ICD. Today, specific challenges for this technology have emerged, including barriers to individual and social acceptance of the ICD as a viable form of technology, as well as psychosocial adjustment difficulties and fears in patients. To address these challenges, scientific research, improved communication regarding devices and psychosocial interventions have been developed and extended to this patient population. As such, it is hypothesized that the future will hold expanding indications for ICD implantation, while further meeting patients' medical and psychosocial adjustment needs. The purposes of this paper are to review the history of ICD innovation, describe past and present research on psychosocial adjustment to the ICD, and corresponding psychosocial interventions, analyze individual and social acceptance and utilization of device technology, and forecast future applications and developments of the ICD.

Implantable device therapy.

Sudden cardiac death (SCD) accounts for two-thirds of fatal events related to heart disease. Coronary heart disease and non-ischemic cardiomyopathy are the most common causes of SCD. Data from major randomized trials have consistently shown that therapy with an implantable cardioverter defibrillator (ICD) results in a significant and meaningful effect on survival through a reduction in the risk of SCD in these population. These data have resulted in a marked increase in the application of implantable device therapy in the past 2 decades from secondary prevention with an implantable cardioverter/defibrillator (ICD) in survivors of a cardiac arrest to primary prevention of SCD in asymptomatic patients with ischemic and non-ischemic left ventricular dysfunction, and prevention of symptomatic heart failure progression and death with cardiac resynchronization therapy (CRT), and devices that combine CRT and ICD therapies (CRT-D). However, there are still areas of uncertainty regarding device therapy that include inconsistent benefit in risk-subgroups of patients with low ejection fraction; increased risk of heart failure after life-prolonging ICD therapy, and a considerable rate of device malfunction despite increasing sophistication. In the present review we focus on current data regarding the clinical indications as well as the safety and efficacy of implantable device therapy, including ICD, CRT, and CRT-D.