Use Of Cardiac Devices Research Articles

Pacemaker Reuse in Portuguese Speaking Countries: A Clinical Reflection.

There is a gap between high-income countries and others in terms of access to medical cardiac devices, such as pacemakers and implantable cardioverter defibrillators. Costs are one of the main barriers to the use of cardiac devices in these countries. There are international initiatives that aim to reduce the gap. The reuse of pacemakers has been discussed as a possible alternative to this problem. The concept of reusing pacemakers is not new; however, recent studies have proven to be safe, ethical, and effective for those who need cardiac implantable electronic devices and cannot afford them. Part of the Portuguese-speaking countries, especially in Africa, need an immediate response that benefits their countless patients who suffer from treatable arrhythmias.

Long-term results of conservative treatment of pacemaker pocket site infections.

The increasing frequency of cardiac device use has led to an increase in complication rates. The standard treatment for cardiac device-related infections is removal of the entire pacemaker system and reimplantation from the contralateral side after systemic antibiotherapy. The efficacy of various conservative treatments has been established for many years, but there is conflicting information in the literature regarding long-term efficacy. Our study investigated the long-term efficacy of conservative treatment in patients with pacemaker pocket site infection. In this retrospective study, according to the exclusion criteria, 132 patients were included. Patients were divided into conservative and standard treatment groups. Conservative treatment was considered to be opening the pacemaker pocket capsule, removing all infected and necrotic tissue, cleaning the capsule, and embedding the battery in the prepectoral region in the subpectoral muscle region. The follow-up time was 36 ±12.96 months in the conservative treatment group and 39.6 ±10.8 months in the standard treatment group. During this period, no re-infection at the pacemaker pocket site was observed in either group. Examination of the swab cultures of the patients' pacemaker wounds revealed negative culture results in 15 patients (15 out of 60) in the conservative treatment group. In the standard treatment group, 60 patients (60 out of 72) were culture-negative. This difference was statistically significant (p = 0.04). After a rigorous evaluation, conservative treatment is considered effective and safe in the long term in patients with device pocket site infection.

Abstract 14189: Isolated Tricuspid Valve Surgery Repair versus Replacement for Infective Endocarditis: A Nationwide Analysis

Introduction: Incidence of right-sided infective endocarditis (IE) is on rise secondary to opioid epidemic, and increasing use of cardiac devices, central catheters, or AV fistulas. We aimed to compare outcomes of isolated tricuspid valve (TV) repair versus replacement and determine the predictors of mortality after isolated TV surgery for hospitalizations with IE. Methods: We utilized nationwide readmission database (NRD) to identify hospitalizations for IE that underwent isolated TV repair or replacement in 2018. Hospitalizations with concomitant or previous cardiac surgery were excluded. Multivariate logistic regression analysis was performed to determine predictors of mortality after isolated TV surgery for IE. Results: 1463 hospitalizations were identified for IE undergoing either isolated TV repair (n=531, 36.3%) or replacement (n=932, 63.7%). 106 (11.3%) underwent mechanical TV replacement. Patients undergoing TV replacement had increased risk of acute kidney injury (aOR: 1.45 (1.03-2.03), p=0.03) and pacemaker implantation (aOR: 7.03 (3.95-13.45), p<0.001), however there were no significant differences in in-hospital mortality (aOR: 0.80 (0.35-1.83), p=0.59) (Table). Independent predictors of mortality for TV replacement were advanced liver disease (ALD) (5.31 (1.62-17.67), p=0.005), and acute heart failure (3.48 (1.02-18.14), p=0.044) and for TV repair were ALD (5.72 (1.31-24.90), p=0.017), and age (1.07 (1.02-1.14), p=0.026). However, predisposing conditions (drug use, infection of cardiac prosthesis, or vascular device), micro-organisms, and mechanical TV replacement were not associated with mortality in patients undergoing surgery. Conclusions: Our study reinforces that TV repair should be preferred over replacement for right sided IE when feasible, and adds to existing literature that it is the patient’s co-morbidities rather than the predisposing factors or microbiology that is associated with increased mortality.

Effect of empagliflozin on major heart failure outcomes and renal function in patients with heart failure with a reduced ejection fraction, with and without sacubitril/valsartan

In the EMPEROR-Reduced Trial, empagliflozin reduced cardiovascular death or HF hospitalization and slowed the progressive decline in kidney function in patients with HFrEF. We evaluated the influence of neprilysin inhibition with sacubitril/valsartan (ARNi) on the effects of SGLT2i with empagliflozin. The EMPEROR-Reduced trial randomized 3730patients with HF and an ejection fraction ≤ 40% to placebo or empagliflozin(10 mg/day), in addition to recommended treatment for HF, for a median of 16months. A total of 727patients (19.5%) received ARNi at baseline. Analysis of the effect of ARNi was 1 of 12 pre-specified subgroups. Patients receiving ARNi were particularly well-treated, as evidenced by lower systolic pressures, heart rates, NT-Pro-BNP, and greater use of cardiac devices (all P < 0.001) when compared with those not receiving ARNi. Nevertheless, when compared with placebo, empagliflozin reduced the risk of cardiovascular death or hospitalization for HF in patients receiving or not receiving ARNi [HR = 0.64 (95% CI 0.45–0.89), P = 0.009 and HR = 0.77(95% CI 0.66–0.90), P = 0.0008, respectively, interaction P = 0.31; Fig. 1 ]. Empagliflozin slowed the rate of decline in estimated glomerular filtration rate by 1.92 ± 0.80mL/min/1.73m 2 /year in patients taking ARNi ( P = 0.016) and by 1.71 ± 0.35mL/min/1.73m 2 /year in patients not taking ARNi ( P < 0.0001), interaction P = 0.81. Combined inhibition of SGLT2 and ARNi was well-tolerated. The effects on empagliflozin to reduce the risk of heart failure and renal events are not diminished in intensively treated patients who are receiving sacubitril/valsartan. Combined treatment with both SGLT2 and neprilysin inhibitors can be expected to yield substantial additional benefits.

Influence of neprilysin inhibition on the efficacy and safety of empagliflozin in patients with chronic heart failure and a reduced ejection fraction: the EMPEROR-Reduced trial.

AimsWe evaluated the influence of sacubitril/valsartan on the effects of sodium-glucose cotransporter 2 (SGLT2) inhibition with empagliflozin in patients with heart failure and a reduced ejection fraction.Methods and resultsThe EMPEROR-Reduced trial randomized 3730 patients with heart failure and an ejection fraction ≤40% to placebo or empagliflozin (10 mg/day), in addition to recommended treatment for heart failure, for a median of 16 months. A total of 727 patients (19.5%) received sacubitril/valsartan at baseline. Analysis of the effect of neprilysin inhibition was 1 of 12 pre-specified subgroups. Patients receiving a neprilysin inhibitor were particularly well-treated, as evidenced by lower systolic pressures, heart rates, N-terminal prohormone B-type natriuretic peptide, and greater use of cardiac devices (all P < 0.001) when compared with those not receiving sacubitril/valsartan. Nevertheless, when compared with placebo, empagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure in patients receiving or not receiving sacubitril/valsartan [hazard ratio 0.64 (95% CI 0.45–0.89), P = 0.009 and hazard ratio 0.77 (95% CI 0.66–0.90), P = 0.0008, respectively, interaction P = 0.31]. Empagliflozin slowed the rate of decline in estimated glomerular filtration rate by 1.92 ± 0.80 mL/min/1.73 m2/year in patients taking a neprilysin inhibitor (P = 0.016) and by 1.71 ± 0.35 mL/min/1.73 m2/year in patients not taking a neprilysin inhibitor (P < 0.0001), interaction P = 0.81. Combined inhibition of SGLT2 and neprilysin was well-tolerated.ConclusionThe effects on empagliflozin to reduce the risk of heart failure and renal events are not diminished in intensively treated patients who are receiving sacubitril/valsartan. Combined treatment with both SGLT2 and neprilysin inhibitors can be expected to yield substantial additional benefits.

Heart failure management in dialysis patients: Many treatment options with no clear evidence.

Heart failure with reduced ejection fraction (HFrEF) impacts approximately 20% of dialysis patients and is associated with high mortality rates. Key issues discussed in this review of HFrEF management in dialysis include dialysis modality choice, vascular access, dialysate composition, pharmacological therapies, and strategies to reduce sudden cardiac death, including the use of cardiac devices. Peritoneal dialysis and more frequent or longer duration of hemodialysis may be better tolerated due to slower ultrafiltration rates, leading to less intradialytic hypotension and better volume control; dialysate cooling and higher dialysate calcium may also have benefits. While high-quality evidence exists for many drug classes in the non-dialysis population, dialysis patients were excluded from major trials, and only limited data exist for many medications in kidney failure patients. Despite limited evidence, beta blocker and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker use is common in dialysis. Similarly, devices such as implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy that have proven benefits in non-dialysis HFrEF patients have not consistently been beneficial in the limited dialysis studies. The use of leadless pacemakers and subcutaneous ICDs can mitigate future hemodialysis access limitations. Additional research is critical to address knowledge gaps in treating maintenance dialysis patients with HFrEF.

Cardiac devices in the pediatric population: an overview of the indications and complications

Pacemakers, implantable cardioverter-defibrillators, and biventricular pacemakers have similar uses in the pediatric population as they do in the adult population. Pacemaker indications are similar in adults and children: sinus node dysfunction and second or third degree atrioventricular blocks. Pacemaker candidacy in pediatrics, however, must take into account the patient’s symptom burden rather than absolute heart rate cutoffs. Normal ranges for heart rates in children are also different than adults and vary depending on a child’s age. The guidelines for implantable cardioverter-defibrillators likewise are similar to those for adults, being indicated as secondary prevention for sudden cardiac death survivors and as primary prevention in select patients who experience ventricular tachycardia. However, there are currently no specific recommendations for these devices in children with congenital heart defects. Likewise, though there is new promising research, there are currently no specific indications for biventricular pacing in children. The potential complications of pediatric cardiac devices relate to the different heart rate requirements children have compared to adults and the general procedural risks associated with cardiac implants (infection, bleeding, device failure). Despite the recent growth in the use of cardiac devices in children, there is still much room for continued research into the potential indications for and complications from these tools in the pediatric population. Unfortunately, the lack of evidence holds true not only for South America but worldwide. Research studies conducted in South America would give a better understanding about the demographic differences in terms of outcomes.

Comportamiento de los niveles de troponina I de alta sensibilidad en pacientes con enfermedad renal crónica estadio 5 en hemodiálisis

*Trabajo ganador del Premio “Trabajo de Investigación Clínica – Internistas”, otorgado por el X Congreso SOLAMI – XXVI Congreso ACMI-ACP, Cartagena 17 – 20 de agosto de 2017&#x0D; Introducción. Los pacientes con enfermedad renal crónica (ERC) tienen mayor prevalencia de elevación de troponina, incluso en ausencia de síndrome coronario agudo. El objetivo de este estudio fue evaluar el comportamiento de la troponina I ultrasensible en pacientes con ERC antes y después de una sesión de hemodiálisis.&#x0D; Diseño. Pseudoexperimento&#x0D; Metodología. Se incluyeron pacientes mayores de 18 años con ERC estadio 5 en hemodiálisis. Pacientes con condición cardiaca activa, uso de dispositivo cardiaco, intervención coronaria percutánea ó historia de cirugía cardiaca se excluyeron del estudio. Los valores de troponinas superiores al percentil 99º fueron considerados positivos antes de la hemodiálisis y una elevación de más del 20% fue considerada positiva de acuerdo con la definición universal de infarto de miocardio. Todos los pacientes firmaron un consentimiento informado.&#x0D; Resultados. Se incluyeron 33 pacientes con edad promedio de 56 años. Un paciente presentó troponina elevada antes (3%) y dos pacientes la elevaron después de la diálisis (6%). No hubo diferencias estadísticas entre ambos grupos (p-valor 0,8506). El mismo paciente que aumentó la troponina antes la elevó postdiálisis, lo que significa que sólo un paciente elevó troponina durante la sesión de hemodiálisis.&#x0D; Conclusión. Se encontró una baja incidencia de troponina I anormal en pacientes con ERC en hemodiálisis con una diferencia no significativa de elevación asociada a la diálisis. No hubo relación con comorbilidades. Estos resultados demuestran la importancia de interpretar las elevaciones de troponina como una condición de riesgo sin considerar su elevación como consecuencia de su enfermedad renal.

Sex differences in diameter of the coronary sinus ostium: Correlation with weight of the heart

Diameter of the coronary sinus ostium is important in the designing of cannulation devices used in cardiac resynchronization therapy and percutaneous mitral valve annuloplasty. Population variation of the diameter may account for the failure rate of these procedures. Studies of the coronary sinus ostium from African populations are scarce and altogether absent for Kenya. Therefore, this study aimed at determining sex differences in the diameter of coronary sinus ostium and its correlation with the weight of the heart. Seventy-four hearts of adult black Kenyans [43 male, 31 females; age range 20 – 70 years] obtained during autopsy at the Department of Human Anatomy, University of Nairobi, Kenya were weighed. The coronary sinus ostium was identified and its transverse and supero-inferior diameters measured in millimeters. The measurements were analyzed using SPSS version 17. Sex comparison was established using student’s t test. Association between diameter and heart weight was established using Pearson’s correlation test and considered significant at a p-value of ≤0.05. Data were presented using scatter plots. Transverse and supero-inferior diameters of the ostium were 11.04±1.88mm and 9.50±1.80mm respectively. The mean diameter was 10.27 mm. These correlated positively with weight of the heart. When corrected for weight of the hearts, the transverse and supero-inferior diameters were larger in females (0.042 and 0.036 respectively) than in males (0.034 and 0.03 respectively). The diameter of coronary sinus ostium is larger in females and shows positive correlation with weight of the heart. These data should be considered during design and use of cardiac devices introduced through the coronary sinus.Key words: Coronary sinus, ostium, diameter, sex difference.

Ordinary medicine

Medicine in the twenty-first century is constituted and propelled by the production of evidence. Once produced, the use of that evidence is complicated by features inherent in the American and global biomedical economy itself. With the exponential rise in the use of cardiac devices as my case study, this think piece traces the links among evidence-based medicine, insurance reimbursement policies, and clinical trial outcomes to reveal how evidence produced by trial findings creates treatment standards. Those standards, in turn, expand what is thought to be ‘treatable’ by reconceptualizing risk as a condition that deserves intervention. Such standards affect what physicians recommend and what patients decide to do. The essay emphasizes that evidence-based medicine can be a source of anxiety that patients and families feel when considering how to proceed. It highlights the debates, increasingly common both within and beyond the health professions, about what is actually best as we grow older. It provides an example of how, today, most deaths, even among the very old, are considered premature. In an aging society, the treatment protocols that fall under the evidence-based medicine umbrella constitute an enormous truth-making regime that determines the goals of medicine and shapes health care consumers’ quandaries about medical intervention, and especially the quandary, for those in later life, about crossing the line of too much treatment.

Device therapy in cardiac disease: a success story.

Download the Issue @ a Glance podcast Subscribe to the EHJ Podcast ![Graphic][1] Ever since the development of the external defibrillator by Paul Zoll in the USA1 and the implantation of the first pacemaker by Ake Senning in Europe in the 1950s,2 cardiac devices have become a very important part of the therapeutic armamentarium for cardiac patients. The early pioneers were followed by people such as Michel Mirowski, who—25 years later—invented the implantable defibrillator for the prevention of sudden cardiac death.3 More recently, the biventricular pacemaker was introduced for patients with heart failure.4,5 All these devices have markedly improved quality of life and survival of cardiac patients, with an excellent cost-effectiveness, if appropriately used according to current guidelines.6–8 With the increasing use of cardiac devices, infection appears to be a problem according to current trends. Although a severe complication, it can at times be symptomatically mild, making the diagnosis challenging. Of note, device infections are potentially lethal, and timely diagnosis and early initiation of correct treatment are of the utmost importance for patient outcome. In order to reduce device infections, careful patient selection, preventative measures, and appropriate choice of device types are key. This issue begins with a timely Clinical Review entitled ‘ Infected cardiac implanted electronic devices: prevention, diagnosis, and treatment ’ by Jens Cosedis Nielsen from the Aarhus University Hospital, Skejby in Aarhus, Denmark.9 The article presents currently available data and a consensus opinion on device infection, and identifies important current practice aspects for future development. Due to their clinical importance, strategies for reducing device infection should be tested in sufficiently powered and well-designed multicentre randomized controlled trials in the future. Congenital heart defects are the most common birth defects. Such patients are often also in need of cardiac … [1]: /embed/inline-graphic-1.gif

0121: Increased rate of admissions for non pharmacological iatrogenic cause in coronary care unit over the last 5 years: a prospective study

Iatrogenic complications are defined as adverse reactions that can be induced by non pharmacological cause, including cardiac devices or stimulation techniques. The use of cardiac devices has considerably increased over the last decade. However, only few data are available on non pharmacological iatrogeny (NPI) as cause of admission in coronary care unit (CCU). In patients admitted in CCU for iatrogenic, we aimed to determine the prevalence, characteristics and outcomes of NPI. From 1st April 2008 to 31st December 2013, all the consecutive admissions at the coronary care unit caused by NPI defined as pacemaker (PM), Implantable Cardioverter Defibrillator (ICD), radiofrequency ablation (RFA), coronary angiography, valve surgery or transcatheter aortic valve implantation (TAVI) and any other cardiac procedure were prospectively included. Patients with NPI were compared with the other patients. Among the 11503 patients admitted in CCU over the inclusion period, 225(2%) had NPI. The major cause of admission was conduction disturbance, and acute coronary syndrome or dissection (figure).The most frequent origin was coronary angiography (25%), valve intervention (22%), PM (19%), ICD (18%). The number and rate of admission for NPI markedly increased from 2008(n= 15(1,1%)) to 2013(n=52(2,6%)). This trend was mostly linked to the increase between 2008 and 2013 in new devices such as ICD (n=4 vs n=10), TAVI (n=0 vs n=4) and RFA (n=0 vs n=2). The intra-hospital mortality was stable during this period for the overall patients and patients with NPI (8% and 7%). Non pharmacological iatrogeny represents a non-negligible cause of admission in CCU, characterized by a increased rate of complications due to new techniques over the last 5 years. Multicentric studies are needed to investigate this public health issue. Abstract 0121 – Figure

Endovascular Treatment of Intracranial Atherosclerotic Disease

Stroke is the third leading cause of death in the United States. Intracranial atherosclerotic disease plays a role in cerebrovascular accidents, with well-characterized modifiable and nonmodifiable risk factors. Surgical bypass has so far not proved to be superior to medical therapy. Both medical and endovascular therapies for intracranial atherosclerosis have evolved since the initial off-label use of cardiac devices for its treatment. Initial reports on the results of stent placement for symptomatic high-grade intracranial atherosclerotic disease were initially encouraging. However, debate remains as to the optimal treatment of symptomatic intracranial atherosclerotic disease.

Cardiac resynchronization therapy in CKD: a systematic review.

Cardiac resynchronization therapy (CRT) confers morbidity and mortality benefits to selected patients with heart failure. This systematic review examined effects of CRT in CKD patients (estimated GFR [eGFR] <60 ml/min per 1.73 m(2)). MEDLINE and Scopus (from 1990 to December 2012) and conference proceedings abstracts were searched for relevant observational studies and randomized controlled trials (RCTs). Studies comparing the following outcomes were included: (1) CKD patients with and without CRT and (2) CKD patients with CRT to non-CKD patients with CRT. Mortality, eGFR, and left ventricular ejection fraction data were extracted and pooled when appropriate using a random-effects model. Eighteen studies (14 observational studies and 4 RCTs) were included. There was a modest improvement in eGFR with CRT among CKD patients (mean difference 2.30 ml/min per 1.73m(2); 95% confidence interval, 0.33 to 4.27). Similarly, there was a significant improvement in left ventricular ejection with CRT in CKD patients (mean difference 6.24%; 95% confidence interval, 3.46 to 9.07). Subgroup analysis of three RCTs reported lower rates of death or hospitalization for heart failure with CRT (versus other therapy) in the CKD population. Survival outcomes of CKD patients (compared with the non-CKD population) with CRT differed among observational studies and RCTs. CRT improves left ventricular and renal function in the CKD population with heart failure. Given the increasing use of cardiac devices, further studies examining the effects of CRT on mortality in CKD patients, particularly those with advanced kidney disease, are warranted.

Cardiovascular Devices and Platelet Interactions

The objectives of the 2011 Platelet Colloquium were to gain a better understanding of the role of platelets and inflammatory cells in the response to cardiovascular device–associated injury; to describe the relationship between cardiac devices, shear stress, and alterations in platelet biology and function; and to review evidence derived from in vitro, in vivo, and clinical investigations supporting therapies to modify platelet and inflammatory cell–associated responses to device-related injury. Accordingly, this review summarizes the evidence for translating basic scientific concepts underlying circulatory and device-associated vascular injury to the clinical development and use of cardiac devices, supplemented by findings from the literature. Insights for platelet receptor activation, inflammatory cell biology, endothelial dysregulation, and the effects of biomechanical stress on coagulation and hemostatic proteins were examined to better determine the pathobiology, incidence, and possible prevention of adverse events in patients receiving cardiac devices. ### Shear Stress and Platelet Activation Hemodynamics play a key role in thrombus formation. Pathophysiological shear stress induces activation of platelets and the endothelium, increases platelet–leukocyte interactions, and promotes thrombin generation. The initial tethering of rolling activated platelets, subsequent stable adhesion, and aggregation each are influenced by shear stress on the vessel wall, which can range from 11.4 to 30.4 dyne/cm2 in large arteries and up to 380 dyne/cm2 at critical areas of arterial stenosis.1 Along a diseased vessel, shear forces will vary dramatically within short distances, increasing as the lumen narrows and then decreasing in the poststenotic vascular segment.2 Several platelet membrane proteins serve as mechanosensors, most notably glycoprotein (GP) Ib and its ligand, von Willebrand factor (vWF).3 vWF circulates as highly adhesive multimers (ultralarge vWF) that are cleaved by a disintegrin and metalloproteinase with thrombospondin type 1 motif member 13 (ADAMTS-13). Depletion or accumulation of ultralarge vWF, as a consequence of inappropriate ADAMTS-13 proteolysis, results in pathological bleeding …

Device therapy for arrhythmia management in adults with congenital heart disease

The number of children with congenital heart disease surviving into adulthood has increased dramatically. Refinement in surgical techniques and effective subsequent care has mainly been responsible for this change. However, many of these survivors have significant lifestyle altering symptoms associated with rhythm disorders. These may result from the primary congenital anomaly or from surgical correction. Tachyarrhythmias often result from re-entrant circuits around surgical scars in the setting of a markedly enlarged cardiac chamber. Symptomatic bradyarrhythmias may result from surgical interruption of the conduction system or from the use of antiarrhythmic medication. The management of these lifestyle altering rhythm disorders frequently involves cardiac devices, including pacemakers, antitachycardia devices, defibrillators and resynchronization devices. We review the underlying causes for common rhythm disorders and discuss the specific challenges with cardiac device use in the adult congenital heart disease population. In addition, we address pacing for improvement of ventricular function and innovations likely to impact the field.

Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical Devices

A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications.

Quality of Death: Implantable Cardioverter Defibrillators and Proactive Care

The purpose of this paper is to discuss quality of death (QOD) among patients with congestive heart failure (CHF) and implantable cardioverter defibrillators. We outline recommendations that enhance QOD from the device patient and specialty cardiology perspectives. Contemporary treatment of CHF patients routinely includes both pharmacologic therapy and the use of cardiac devices. The implantable cardioverter defibrillator prevents premature death in heart failure patients, though not death itself. Active discussion and consideration of patient's QOD is indicated in implantable cardioverter defibrillator patients to prevent unnecessary treatment and to increase control over perceived quality of life by patients and family.

Novel approaches to clinical trials: device-related infections

The explosive growth in the use of cardiac devices and the continued large number of thoracic operations produce a significant number of costly infectious complications. These infections represent a leading cause of death and disability after device implantation or surgery. Unfortunately, few objective data are available to validate the clinical epidemiology of surgical and device-related infections, and although the number of randomized trials is increasing, too few have tested strategies for prophylaxis or treatment, particularly in the cardiac arena. Because of the expected increase in invasive vascular procedures and device implantations, it is timely to consider innovative approaches to clinical research that will hasten the translation of effective therapeutic strategies and technologies into clinical practice. Because of the multidisciplinary nature of the care of patients undergoing thoracic surgery or device implantation, bringing together existing networks and several arms of the Federal government could rapidly advance this field to provide a definitive base of evidence to guide clinical practice and improve clinical outcomes. The remainder of the articles in this supplement discuss specific issues on the diagnosis and treatment of device-related or surgical infection. The purpose of this manuscript is to discuss issues about the design of studies and their organization.