ABSTRACT
AIMS: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population. METHODS AND RESULTS: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU. CONCLUSIONS: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02076789.
Subject(s)
Cardiac Resynchronization Therapy/methods , Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Heart Failure/therapy , Registries , Aged , Death, Sudden, Cardiac/epidemiology , Device Removal , Female , Follow-Up Studies , Humans , Incidence , Italy/epidemiology , Male , Middle Aged , Prospective Studies , Risk Factors , Survival Rate/trends , Treatment OutcomeABSTRACT
Tetralogy of Fallot (ToF) occurs in about 4 births/1000/year and represents about one tenth of all congenital heart diseases. Nowadays 86% of patients reach adulthood with corrective surgery. Before the 1980s, these patients were treated only with "surgical palliation", which consisted in the creation of a systemic to pulmonary artery shunt or a pulmonary valvulotomy, whereas after the introduction of extracorporeal circulation, corrective surgery is performed electively between 3 and 6 months of life. After repair patients during their life may develop hemodynamic lesions, including right ventricular outflow tract dysfunction, and arrhythmias which can occur in over 30% of cases. It is estimated that these patients present a risk of sudden death of 0.2%/year. Therefore, for the prevention and treatment of arrhythmic events, a periodic follow-up in specialized centres for adult congenital heart disease is mandatory, because most often arrhythmias are triggered by the presence of hemodynamic lesions, first of all pulmonary regurgitation.
Subject(s)
Heart Defects, Congenital , Tetralogy of Fallot , Ventricular Dysfunction, Right , Humans , Adult , Tetralogy of Fallot/surgery , Tetralogy of Fallot/pathology , Heart Defects, Congenital/complications , Heart Defects, Congenital/surgery , Arrhythmias, Cardiac/therapy , Arrhythmias, Cardiac/complications , Heart Ventricles/pathology , Ventricular Dysfunction, Right/etiology , Treatment OutcomeABSTRACT
BACKGROUND: This report describes the findings of the 2019 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 15 201 ablation procedures were performed by 91 institutions. Most (78%) of the centers has one electrophysiology laboratory, and 17% of them has a hybrid cardiac surgery laboratory. Almost all (98%) centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3 and an electrophysiology technician was involved in 30% of all centers. In 88.4% of cases, ablations were performed for supraventricular arrhythmias, and among these the most frequently treated arrhythmia was atrial fibrillation (32.9%), followed by atrioventricular nodal reentrant tachycardia (23.9%), and common atrial flutter (11.7%). In 10 256 (67.4%) patients catheter ablation was performed by means of a 3D mapping system, with a "near-zero" fluoroscopic approach in 4626 (30.4%) of all patients. CONCLUSIONS: The 2019 Italian Catheter Ablation Registry confirmed that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Tachycardia, Atrioventricular Nodal Reentry , Atrial Fibrillation/surgery , Humans , Registries , Retrospective StudiesABSTRACT
BACKGROUND: Temporary transvenous cardiac pacing (TTCP) is a standard procedure in current practice, despite limited coverage in consensus guidelines. However, many authors reported several complications associated with TTCP, especially development of infections of cardiac implantable electronic devices (CIED). The aim of this survey was to provide a country-wide picture of current practice regarding TTCP. METHODS: Data were collected using an online survey that was administered to members of the Italian Association of Arrhythmology and Cardiac Pacing. RESULTS: We collected data from 102 physicians, working in 81 Italian hospitals from 17/21 regions. Our data evidenced that different strategies are adopted in case of acute bradycardia with a tendency to limit TTCP mainly to advanced atrioventricular block. However, some centers reported a greater use in elective procedures. TTCP is usually performed by electrophysiologists or interventional cardiologists and, differently from previous reports, mainly by a femoral approach and with nonfloating catheters. We found high inhomogeneity regarding prevention of infections and thromboembolic complications and in post-TTCP management, associated with different TTCP volumes and a strategy for management of acute bradyarrhythmias. CONCLUSION: This survey evidenced a high inhomogeneity in the approaches adopted by Italian cardiologists for TTCP. Further studies are needed to explore if these divergences are associated with different long-term outcomes, especially incidence of CIED-related infections.
Subject(s)
Bradycardia/therapy , Cardiac Electrophysiology/trends , Cardiac Pacing, Artificial/trends , Cardiologists/trends , Electrophysiologic Techniques, Cardiac/trends , Pacemaker, Artificial/trends , Practice Patterns, Physicians'/trends , Bradycardia/diagnosis , Bradycardia/physiopathology , Health Care Surveys , Healthcare Disparities/trends , Humans , ItalyABSTRACT
Sudden cardiac death is defined as a natural death due to termination of cardiac activity associated with loss of consciousness, spontaneous breathing and circulation. Nowadays, the prevention of sudden cardiac death represents a major issue and many areas of uncertainty are not met by current evidences. Among those, reliable tools for risk stratification are still lacking, as well as solution for patients in which the risk of sudden cardiac death is due to a transient or correctable condition.The concept of the wearable cardioverter defibrillator is based on a potential solution for such grey areas. It merges long-term monitoring capabilities, shockable rhythm discrimination and shock delivery without the need for bystander assistance or invasive procedures. The present review aims to summarize current problems in dealing with this insidious condition, and to discuss potential options for patients in whom sudden cardiac death could be prevented more safely and cost-effectively.
Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Electric Countershock/methods , Electric Countershock/instrumentation , Health Services Needs and Demand , Humans , Uncertainty , Wearable Electronic DevicesABSTRACT
In patients with cardiac implantable electronic devices (CIEDs) (implantable cardioverter-defibrillators [ICDs] and pacemakers [PMs]), the potential risk of suddenly being unable to drive, and hence of causing road accidents, is higher than in the general population. In ICD patients, this risk stems from the possibility that an arrhythmic event leading to loss of consciousness may occur while driving. In PM patients, it may be the result of a device malfunction in a PM-dependent patient. To determine a CIED patient's ability to drive, two variables must be taken into account: (i) the risk of events, which depends on the type of underlying heart disease (ICD patients have a higher risk than PM patients); (ii) the time spent driving and the type of vehicle driven (professional drivers are at higher risk than private drivers). This position paper reports the recommendations of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) regarding driving by patients with CIEDs, on the basis of the available literature and the European reference recommendations.
Subject(s)
Automobile Driving , Defibrillators, Implantable/adverse effects , Pacemaker, Artificial/adverse effects , Accidents, Traffic/prevention & control , Arrhythmias, Cardiac/complications , Arrhythmias, Cardiac/therapy , Humans , Italy , RiskABSTRACT
: In recent years, the increasing number of patients with a cardiac implantable electronic device (CIED) has required different approaches in terms of the device's control and surveillance. It is increasingly difficult to keep the traditional in-office protocol device's control: we must think of a different organization dedicated to the activity of remote control and monitoring (RC/RM) of devices and patients.A CIED team structured with nurses, technicians and physicians should be organized inside the hospital, with the aim of CIED patients' managing and of creating a network between the various departments.Small hospitals may not be able to manage independently the CIEDs RC/RM and it is possible to hypothesize the creation of a collaborative network between neighbouring structures.This activity must combine the use of technology with the ability to take care of patients and to maintain adequate and meaningful relationships.
Subject(s)
Cardiac Pacing, Artificial , Cardiology Service, Hospital/organization & administration , Defibrillators, Implantable , Delivery of Health Care, Integrated/organization & administration , Electric Countershock/instrumentation , Heart Diseases/therapy , Models, Organizational , Pacemaker, Artificial , Remote Sensing Technology , Consensus , Cooperative Behavior , Heart Diseases/diagnosis , Heart Diseases/physiopathology , Humans , Interdisciplinary Communication , Patient Care Team/organization & administration , Patient Participation , Predictive Value of Tests , Treatment OutcomeABSTRACT
In the last decade the field of cardiac pacing and electrophysiology underwent major advancements thanks to both new ways of arrhythmia management and technological innovations. At the same time, the clinical competence and the procedural qualitative level of Cardiac Rhythm Centers have increased significantly. In 2010 an ad hoc Committee of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) and the Italian Federation of Cardiology (FIC) published a consensus document on the organization of Cardiac Rhythm Centers and on the standards of professional practice in pacing and electrophysiology in Italy. In particular, this document focused on the minimal requirements of a Center to be qualified as suitable to perform first, second and third-level cardiac pacing and electrophysiology activities. However, most of these indicators have been overcome over time. Thus, an update of the previously published organizational model appeared necessary. In this document several new requirements and indicators about the organization and performance of both operators and Cardiac Arrhythmia Centers have been introduced. These include: (i) "structural and procedural requirements" (types of diagnostic and therapeutic procedures performed, logistic structures, healthcare staff and technologies), (ii) "activity indicators" (number of procedures performed); (iii) "appropriateness indicators" (adherence to guideline recommendations); (iv) "outcome indicators" (procedural success and complications); and (v) "quality of care indicators" (management and continuity of care levels). By applying these requirements and indicators, each center can optimize its procedures, increasing its performance and effectiveness. Finally, a new model for the organization of the Italian network of Cardiac Arrhythmia Centers is also suggested.
Subject(s)
Arrhythmias, Cardiac/therapy , Cardiac Care Facilities/standards , Cardiac Pacing, Artificial/standards , Consensus , Electrophysiology/standards , Arrhythmias, Cardiac/diagnosis , Cardiac Care Facilities/organization & administration , Cardiac Care Facilities/statistics & numerical data , Cardiology/organization & administration , Cardiology/standards , Clinical Competence , Electrocardiography/instrumentation , Electrocardiography/standards , Electrophysiology/organization & administration , Guideline Adherence , Humans , Italy , Quality Indicators, Health Care , Societies, MedicalABSTRACT
The complexity of cardiovascular diseases has led to an extensive use of technological instruments and the development of multimodality imaging. This extensive use of different cardiovascular imaging tests in the same patient has increased costs and waiting times.The concept of appropriateness has changed over time. Appropriateness criteria address the need for specific cardiovascular imaging tests in well-defined clinical scenarios, and define the kind of cardiovascular imaging that is appropriated for each clinical scenario in different stages of the disease. The concept of appropriateness criteria has replaced the old idea of appropriate use criteria and reflects the increasing effort of the international Scientific Societies to create and review in a critical way the management of diagnostic tests used by clinicians.The aim of this Italian consensus document is to address the use of multimodality imaging in the diagnosis and management of the major cardiovascular clinical scenarios, taking into consideration not only the international guidelines and scientific documents already published, but also the reality of Italian laws as well as the various professional profiles involved in patient management and availability of technological diagnostic instruments.
Subject(s)
Cardiovascular Diseases/diagnostic imaging , Consensus , Diagnostic Techniques, Cardiovascular/standards , Multimodal Imaging/standards , Emergency Service, Hospital , Female , Humans , Italy , PregnancyABSTRACT
BACKGROUND: This report describes the findings of the 2017 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 15 601 ablation procedures were performed by 91 institutions, with a mean of 184 ± 213 procedures per center. The most frequently treated arrhythmia was atrial fibrillation (34%), followed by atrioventricular nodal reentrant tachycardia (25%) and common atrial flutter (14%). About 10% of overall ablation procedures were performed in patients with ventricular arrhythmias. On-site cardiothoracic surgery was available in 42% of the centers performing ablation and in 49% of the centers performing atrial fibrillation ablation. In most patients, the ablation procedure was guided by a three-dimensional mapping system, and in 15% of patients a near-zero X-ray strategy was used. CONCLUSIONS: The Italian Catheter Ablation Registry systematically collected 1-year data on ablation procedures performed in Italy, revealing that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of patients treated for ventricular tachycardia.
Subject(s)
Arrhythmias, Cardiac/surgery , Catheter Ablation/statistics & numerical data , Registries , Arrhythmias, Cardiac/diagnosis , Cardiology , Electrophysiologic Techniques, Cardiac , Humans , Italy , Retrospective Studies , Societies, MedicalABSTRACT
Heart failure is one of the most important public health problems in western countries because of its frequent association with cardiac death and with rehospitalization. Patients with heart failure generally die of sudden arrhythmic death (SD) and progressive pump failure with a SD incidence inversely related to the severity of the underlying heart disease. SD occurs approximately in one half of the patients in New York Heart Association (NYHA) functional classes II-II/III and in one third of those in NYHA classes III/IV-IV, respectively. In the last decade, numerous studies have shown that the automatic implantable cardioverter-defibrillator (ICD) significantly reduces the incidence of SD in those patients who are identified as being at risk. Unfortunately, little is known on whether the ICD actually prolongs the survival of the subgroup of patients with most severe heart failure. The main reasons for such a paucity of information are the small number of available studies, the unavailability of randomized and controlled investigations and the difficulty in comparing the results of such studies owing to the lack of homogeneity. In patients with severe heart failure, both the perioperative mortality and morbidity related to transvenous ICD implantation are similar to those of patient subgroups with moderate or slight heart failure. The defibrillation threshold at implantation and the frequency of intractable ventricular arrhythmias during follow-up (2% of all ICD implantations) are slightly higher than in the patient subgroup with moderate or no heart failure. In the patient subgroup with severe heart failure or with a very poor left ventricular function, ICD implantation is unable to prolong the 1- and 2-year survival despite a clear reduction in the incidence of SD. On the other hand, in the patient subgroup with moderate left ventricular dysfunction, ICD implantation prolongs survival and reduces the incidence of SD. No information is available regarding the primary prevention of SD in patients with heart failure.
Subject(s)
Defibrillators, Implantable , Heart Failure/mortality , Heart Failure/therapy , Death, Sudden , Defibrillators, Implantable/trends , Forecasting , Heart Failure/complications , Humans , Severity of Illness Index , Survival Rate , Time FactorsABSTRACT
BACKGROUND: Pre-mRNA splicing defects may have an important impact on clinical phenotype in several diseases, but often their pathogenic role is difficult to demonstrate. The aim of this study was to validate an in vitro method to assess the effects of putative splicing variants. MATERIALS AND METHODS: We studied three novel variants in vitro using a novel minigene approach and compared results with in silico and ex vivo strategies from patient samples. RESULTS: For the c.1146C>T variant in the LMNA gene, in vitro and ex vivo studies were concordant with the prediction obtained by in silico tools, confirming the loss of 13 bp at the end of exon 6. In the second case (c.1140+1G>A, SCN5A gene), in vitro experiments identified the insertion of 94 intronic bp in exon 9 as well as exon 9 skipping, but these results were not correctly predicted by ex vivo data and in silico tools. In the third case (c.1608+1C>T, LMNA gene) in vitro and ex vivo studies suggested the recognition of an exonic cryptic site leading to the loss of 29 bp in exon 9, not predicted by in silico analysis. CONCLUSION: Our results revealed how in silico tools are often unreliable requiring "wet" RNA analysis. Since ex vivo studies are not always feasible, the use of an in vitro construct represents an efficient and useful method for the evaluation of damaging effects of unknown splicing variants, especially in diagnostic laboratories.
Subject(s)
Clinical Laboratory Techniques/methods , Mutation , RNA Splicing/genetics , Base Sequence , Computer Simulation , Exons/genetics , Humans , Lamin Type A/genetics , Male , Middle Aged , Young AdultABSTRACT
AIMS: To provide insights on the antiarrhythmic management of atrial fibrillation among patients enrolled in the Antithrombotic Agents in Atrial Fibrillation (ATA-AF) study, and to assess the adherence of the Italian cardiologists and internists to guidelines recommendations. METHODS AND RESULTS: The ATA-AF study is a multicenter, observational study with prospective data collection on the management and treatment of patients with atrial fibrillation. From March to July 2010, 6910 patients with atrial fibrillation were recruited in 164 Italian Cardiology (Card) and 196 Internal Medicine (IMed) centers. Permanent atrial fibrillation was diagnosed in 50.8%, persistent atrial fibrillation in 24.4%, paroxysmal in 15.5%, and first-detected atrial fibrillation in 9.3% of the patients. Rhythm control (rhyC) strategy was pursued in 27.5% (39.6% Card vs. 12.9% IMed; P < 0.0001) and rate control (raC) in 51.4% (43.7% Card vs. 60.7% IMed; P < 0.0001); in 21.1% the antiarrhythmic strategy was not defined. Patients assigned to rhyC were younger and with less comorbidities than those assigned to raC. Adjusted multivariable analysis showed that atrial fibrillation type, setting of management, age and site of patient discharge were the most important independent predictors of rhyC assignment. The severity of atrial fibrillation-related symptoms was not associated with rhyC assignment. At discharge, beta-blockers, amiodarone and class 1c antiarrhythmic drugs were the drugs mainly used in the Card centers; and beta-blockers, digitalis, amiodarone and diltiazem/verapamil were used in the IMed centers. Amiodarone was overused in both Card and IMed centers. CONCLUSION: In the present study, rhyC was the strategy mainly pursued by cardiologists and raC by internists; treatment strategy assignment and antiarrhythmic therapy often do not agree with the guideline recommendations.
Subject(s)
Atrial Fibrillation/drug therapy , Fibrinolytic Agents/therapeutic use , Aged , Aged, 80 and over , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Cardiology Service, Hospital/standards , Drug Therapy, Combination , Female , Guideline Adherence/statistics & numerical data , Hospitalization , Humans , Internal Medicine/methods , Internal Medicine/standards , Male , Middle Aged , Practice Guidelines as Topic , Practice Patterns, Physicians'/statistics & numerical data , Prospective Studies , Thromboembolism/etiology , Thromboembolism/prevention & controlABSTRACT
BACKGROUND: Atrial fibrillation (AF) is associated with a high risk of stroke and mortality. AIMS: To describe the difference in AF management of patients (pts) referred to Cardiology (CARD) or Internal Medicine (MED) units in Italy. METHODS AND RESULTS: From May to July 2010, 360 centers enrolled 7148 pts (54% in CARD and 46% in MED). Median age was 77 years (IQR 70-83). Hypertension was the most prevalent associated condition, followed by hypercholesterolemia (28.9%), heart failure (27.7%) and diabetes (24.3%). MED pts were older, more frequently females and more often with comorbidities than CARD pts. In the 4845 pts with nonvalvular AF, a CHADS2 score ≥ 2 was present in 53.0% of CARD vs 75.3% of MED pts (p<.0001). Oral anticoagulants (OAC) were prescribed in 64.2% of CARD vs 46.3% of MED pts (p<.0001); OAC prescription rate was 49.6% in CHADS2 0 and 56.2% in CHADS2 score ≥ 2 pts. At the adjusted analysis patients managed in MED had a significantly lower probability to be treated with OAC. Rate control strategy was pursued in 51.4% of the pts (60.5% in MED and 43.6% in CARD) while rhythm control was the choice in 39.8% of CARD vs 12.9% of MED pts (p<.0001). CONCLUSIONS: Cardiologists and internists seem to manage pts with large epidemiological differences. Both CARD and MED specialists currently fail to prescribe OAC in accordance with stroke risk. Patients managed by MED specialists have a lower probability to receive an OAC treatment, irrespective of the severity of clinical conditions.
Subject(s)
Atrial Fibrillation/epidemiology , Atrial Fibrillation/therapy , Cardiology Service, Hospital , Fibrinolytic Agents/therapeutic use , Hospitalization/trends , Internal Medicine/methods , Aged , Aged, 80 and over , Atrial Fibrillation/diagnosis , Disease Management , Female , Humans , Italy/epidemiology , MaleABSTRACT
The indications for implantable cardioverter-defibrillator (ICD) therapy for the prevention of sudden cardiac death in patients with severe left ventricular dysfunction have rapidly expanded over the last 10 years on the basis of the very satisfying results of the numerous randomized clinical trials that have provided the framework for guidelines. However, the analysis of clinical practice in the real world has highlighted some important criticisms in the complex process of selection-management of those patients candidates for ICD therapy: 1) approximately one fourth of all ICD implantations is not justified by clinical evidence, 2) approximately one half of patients with an indication for ICD therapy do not undergo implantation, 3) the benefits from ICD therapy do not apply uniformly to all patients, 4) the relationship between the lifesaving benefit and the potential for harm of ICD therapy is still scarcely known. The main reason for this clinical scenario can be ascribed to the guideline recommendations that are based only on few standard cut-off criteria and therefore too generic and insufficiently detailed. This does not help cardiologists in their decision-making process, and results in fear, uncertainty, and sometimes emotional choices. The aim of this consensus document is to discuss current guideline recommendations and to provide the Italian cardiologists with the most updated information to optimize the selection of patients with severe left ventricular dysfunction who should receive ICD therapy.
Subject(s)
Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Practice Guidelines as Topic , Primary Prevention , Ventricular Dysfunction/complications , Defibrillators, Implantable/adverse effects , Defibrillators, Implantable/economics , Defibrillators, Implantable/ethics , Humans , Prognosis , Risk Assessment , Severity of Illness IndexABSTRACT
In the last two decades atrial fibrillation (AF) has become one of the most important public health problems and a significant cause of increasing healthcare costs in developed countries. The prevalence of AF is ever increasing, and at present, in Italy, it is twice higher (1.85%) than that reported in the past decade. In addition, the ratio of AF frequency among males and females in each age subgroup is always >1.2. In the real world, the commonest AF treatment strategy is "rate control" accounting for 51-56% of all AF patients. Anticoagulant therapy is still underused, in particular among several selected AF patient subgroups. The present findings suggest the need for improving AF patient management through ad hoc educational programs.
Subject(s)
Atrial Fibrillation , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , HumansABSTRACT
OBJECTIVES: To evaluate the criteria for the use of implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT) and other strategies in order to reduce the incidence of sudden death among adults at high risk and to identify the major barriers for the implementation of quality of care involving Italian cardiology departments in the context of 'Progetto Aritmie Area Scompenso Cardiaco ANMCO'. An additional aim was to evaluate how European Guidelines are applied in 'real-life' scenarios. METHODS: The clinical survey involved 220 centres. An 11-item questionnaire with prespecified multiple choice answers was used. In the specific clinical section, three clinical scenarios were described: the first concerning a patient with non-ischaemic dilated cardiomyopathy and left ventricular ejection fraction (LVEF) 35%; the second, a patient with ischaemic dilated cardiomyopathy and LVEF 30%; and the third, a patient with ischaemic dilated cardiomyopathy and LVEF between 30 and 40%. For each clinical scenario, the centres were asked to indicate whether ICD implantation should be indicated and which diagnostic tests or clinical predictors should be used to stratify the risk. RESULTS: The mean number of procedures (ICD and CRT, ICD alone, CRT alone) performed in each centre was 59 per year with a total number of 11 â229 procedures per year. ICD, alone or with CRT, was the most common procedure performed with a mean number of 52 implants per centre per year. Concomitant diseases represented the most frequent (>94% of the cases) contraindication. Arrhythmic risk stratification was tested in 76.4% of the centres. Most of the centres (76.4%) stated that they routinely performed adjunctive tests, in addition to LVEF, to identify individuals at higher risk prior to ICD implantation, whereas 23.6% reported that they did not perform any risk stratification. The tools most frequently used for risk stratification (alone or in combination) were as follows: QRS duration on 12-lead ECG (71% of centres), presence of non-sustained ventricular tachycardia on 24-h recording (90%) and programmed ventricular stimulation (65%). CONCLUSION: This survey reveals a fairly good correspondence between the therapeutic choices made by the Italian centres involved in the study and the recommendations set out in the guidelines of the Italian, European and American scientific societies.
Subject(s)
Cardiac Resynchronization Therapy/statistics & numerical data , Cardiology Service, Hospital/statistics & numerical data , Cardiomyopathy, Dilated/therapy , Death, Sudden, Cardiac/prevention & control , Electric Countershock/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Cardiac Resynchronization Therapy Devices/statistics & numerical data , Cardiomyopathy, Dilated/diagnosis , Cardiomyopathy, Dilated/mortality , Cardiomyopathy, Dilated/physiopathology , Contraindications , Death, Sudden, Cardiac/epidemiology , Defibrillators, Implantable/statistics & numerical data , Electric Countershock/instrumentation , Guideline Adherence , Health Care Surveys , Humans , Incidence , Italy , Practice Guidelines as Topic , Risk Assessment , Risk Factors , Stroke Volume , Surveys and Questionnaires , Treatment Outcome , Ventricular Function, LeftABSTRACT
Cardiac resynchronization therapy (CRT) has proven a very useful tool to treat heart failure (HF). In HF patients with severely depressed left ventricular dysfunction and ventricular dyssynchrony who remain symptomatic despite optimal medical therapy, the "reverse remodeling" induced by CRT leads to a significant improvement of survival and quality of life. The addition of the cardioversion-defibrillation function to CRT (CRT-D) is considered a further beneficial effect to reduce overall mortality secondary to a decrease in sudden death rate. Unfortunately, the amount of this additional benefit is still uncertain; in particular, how much the cardioversion-defibrillation function contributes to prolong patient survival remains to be elucidated. Such uncertainty leads to a different therapeutic approach to HF patients, i.e., an extended or restricted use of CRT-D devices. Even the most recent guidelines do not provide a clear answer to this question. The present review summarizes the current evidence regarding efficacy, effectiveness, safety, and cost-effectiveness of CRT and CRT-D, and suggests some practical solutions to the appropriate use of CRT-D on the basis of clinical, ethical and socio-economic considerations.
Subject(s)
Cardiac Pacing, Artificial/methods , Electric Countershock/methods , Heart Failure/therapy , Ventricular Dysfunction, Left/therapy , Age Factors , Aged , Aged, 80 and over , Arrhythmias, Cardiac/therapy , Cardiac Pacing, Artificial/economics , Cardiac Pacing, Artificial/ethics , Clinical Trials as Topic , Comorbidity , Electric Countershock/economics , Electric Countershock/ethics , Heart Failure/mortality , Heart Failure/physiopathology , Heart Function Tests , Humans , Meta-Analysis as Topic , Multicenter Studies as Topic , Practice Guidelines as Topic , Risk Factors , Ventricular Dysfunction, Left/mortalityABSTRACT
The recent withdrawal from the market of nadolol (Corgard; Bristol-Myers Squibb, Sermoneta, Italy) and quinidine polygalacturonate (Ritmocor; Malesci, Bagno A Ripoli, Italy) has been causing clinical problems to many cardiologists and patients, frequently leading to discontinuance of an effective and well-tolerated pharmacological treatment. Nadolol is useful in the treatment of severe and refractory arrhythmias, particularly in some genetically determined ion-channel diseases, such as long-QT syndrome and catecholaminergic polymorphic ventricular tachycardia.Quinidine is still used in refractory atrial fibrillation recurrences. Recent studies have demonstrated the clinical efficacy of quinidine in the treatment of rare genetically determined ion-channel diseases at high risk of sudden death, such as Brugada syndrome and short-QT syndrome.We hope that scientific societies can influence healthcare and pharmaceutical institutions, in order to restore the availability of two cardiovascular drugs that are extremely important in the care of arrhythmic patients.
Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Arrhythmias, Cardiac/drug therapy , Drug Recalls , Nadolol/therapeutic use , Pectins/therapeutic use , Quinidine/therapeutic use , Cardiology , Drug Combinations , HumansABSTRACT
Sudden cardiac death (SCD) is usually due to ventricular tachycardia/fibrillation and represents one of the most important medical and socio-economical problems in western countries. It accounts for approximately 1 life/1000 subjects/year. New and effective treatments are necessary to reduce such dramatic event. During the last decade implantable cardioverter-defibrillators (ICDs) showed to be an effective tool to reduce both total and SCD mortality either when used for secondary or primary SCD prevention. At present, ICD implantation guidelines suggest to implant an ICD in all the patients on the basis of a left ventricular ejection fraction < or =30-35% only. This scarcely sensitive and specific criterion implies the necessity to implant very costly devices in a wide number of patients to save only few lives. A more accurate patient selection is desirable either from a clinical or ethical or economic point of view. Fortunately, this appears to be possible using well known and proven epidemiological, clinical and risk stratification data. On the basis of such data, more selective ICD implantation criteria might be used in older patients or in patients with significant comorbidity or in those patients identified at very low risk of SCD.