Outcomes of cardiac implantable electronic device transvenous lead extractions performed in centers without onsite cardiac surgery.

BACKGROUND: While major complications associated with CIED lead extractions are uncommon, they carry a significant risk of morbidity and mortality in the absence of surgical intervention. However, there is limited data on the differences in outcomes of these procedures between centers with and without on-site CS support. The present study examined outcomes of transvenous cardiac implantable electronic device (CIED) lead extractions according to admitting hospitals' cardiac surgery (CS) facilities. METHODS: We analyzed the National Inpatient Sample for CIED lead extraction procedures, stratified by hospitals' CS facilities into two groups; on-site and off-site CS. Logistic regression analyses were performed to estimate the adjusted odds (aOR) of procedure-related complications in off-site CS centers. RESULTS: In 221,606 procedures over an 11-year-period, CIED lead extractions were increasingly undertaken in on-site as opposed to off-site CS centers (Onsite CS 2004 vs. 2014: 78.2% vs. 90.4%, p < 0.001) during the study period. In comparison to on-site CS group, patients admitted to off-site CS group were older, less comorbid, and experienced lower adjusted odds of major adverse cardiovascular events (0.72 [0.67, 0.77]), mortality (0.60 [0.52, 0.69]), procedure-related bleeding (0.48 [0.44, 0.54]) and complications (thoracic: 0.81 [0.75, 0.88]; cardiac: 0.45 [0.38, 0.54]) (p < 0.001 for all). CONCLUSIONS: Our national analysis demonstrates that transvenous CIED lead extractions are being increasingly undertaken in centers with on-site CS surgery, in compliance with international guideline recommendations. Patients managed with lead extractions in on-site CS centers are more comorbid and critically ill compared to those admitted to off-site CS centers, and remain at a higher risk of procedure-related complications.

The subcutaneous implantable cardioverter-defibrillator in review.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a completely extrathoracic device that has recently been FDA approved for the prevention of sudden cardiac death in select populations. Although the transvenous implantable cardioverter defibrillator (TV-ICD) has a proven mortality benefit in multiple patient populations, there are significant risks both with implantation and years after its placement. The S-ICD may help prevent some of these complications. Currently, the S-ICD is typically implanted in patients with prior device infection or at an increased risk for an infection, younger patients with difficult venous access related to either hemodialysis or difficult cardiac anatomy, patients who live active lifestyles, and those who may outlive the TV-ICD leads. There is an absolute contraindication for S-ICD implantations for patients who need pacing either for ventricular tachycardia or bradycardia because this device cannot perform these functions. To date, there are no randomized controlled trial (RCT) data evaluating the safety and efficacy of this relatively new device. Observational studies of both the S-ICD alone and in comparison with the TV-ICD have showed promising results, including a decrease in lead-related and periprocedural complications as well as a high level of effectiveness at terminating ventricular arrhythmias. These analyses over time may have contributed to the evolution and comfortability with the S-ICD system, as physicians are more often referring for and/or implanting this device for patients with appropriate indications. Furthermore, inappropriate shock rates with the S-ICD have decreased over time especially with dual zone programming. This review summarizes the results of a multitude of observational studies with respect to patient selection for the S-ICD, complication rates, appropriate and inappropriate shock rates, and programming. This review also tackles current ongoing randomized trials. Although the results of ongoing trials will be helpful, there is still a continued need to evaluate the efficacy of the S-ICD in broader patient populations including patients with several comorbidities and older patients so that more patients can be considered for this potentially lifesaving device.

Clinical and organizational management of cardiac implantable electronic device replacements: an Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

Subcutaneous implantable cardioverter defibrillator in patients with arrhythmogenic right ventricular cardiomyopathy: Results from an Italian multicenter registry.

BACKGROUND: Despite expanding indication of the subcutaneous implantable cardioverter defibrillator (S-ICD) in clinical practice, limited data exists on safety and efficacy of S-ICD in arrhythmogenic right ventricular cardiomyopathy (ARVC) patients. The aim of this multicenter study was to evaluate the safety and efficacy of S-ICD in ARVC patients. METHODS: The study population included 44 consecutive patients with definite ARVC diagnosis according to the 2010 ITF criteria (57% male, mean age 37 ±â€¯17 years [range 10-75 years]) who received an S-ICD. Eighteen (41%) patients were implanted for secondary prevention. RESULTS: At implant, all inducible patients (34/44) had conversion of ventricular fibrillation at 65 J. No early complications occurred. During a median follow-up of 12 months (7-19), 3 (6.8%) patients experienced complications requiring surgical revision. No local or systemic device-related infections were observed. Six patients (14%) received a total of 61 appropriate and successful shocks on ventricular arrhythmias. Six (14%) patients experienced 8 inappropriate shocks for oversensing of cardiac signal (4 cases) and non-cardiac signal (4 cases) with one patient requiring device explantation. No patients had the device explanted due to the need for antitachycardia pacing. CONCLUSIONS: The study shows that S-ICD provides safe and effective therapy for termination of both induced and spontaneous malignant ventricular tachyarrhythmias with high energy shocks in ARVC patients, but the risk of inappropriate shocks and complications needing surgical revision should be considered.

Patient-reported causes of heart failure in a large European sample.

BACKGROUND: Patients diagnosed with chronic diseases develop perceptions about their disease and its causes, which may influence health behavior and emotional well-being. This is the first study to examine patient-reported causes and their correlates in patients with heart failure. METHODS: European heart failure patients (N = 595) completed questionnaires, including the Brief Illness Perceptions Questionnaire. Using deductive thematic analysis, patient-reported causes were categorized into physical, natural, behavioral, psychosocial, supernatural and other. Clinical data were collected from medical records. RESULTS: Patients who did not report any cause (11%) were on average lower educated and participated less often in cardiac rehabilitation. The majority of the remaining patients reported physical causes (46%, mainly comorbidities), followed by behavioral (38%, mainly smoking), psychosocial (35%, mainly (work-related) stress), and natural causes (32%, mainly heredity). There were socio-demographic, clinical and psychological group differences between the various categories, and large discrepancies between prevalence of physical risk factors according to medical records and patient-reported causes; e.g. 58% had hypertension, while only 5% reported this as a cause. Multivariable analyses indicated trends towards associations between physical causes and poor health status (Odds ratio (OR) = 1.41, 95% confidence interval (95% CI) = 0.95-2.09, p = 0.09), psychosocial causes and psychological distress (OR = 1.54, 95% CI = 0.94-2.51, p = 0.09), and behavioral causes and a less threatening view of heart failure (OR = 0.64, 95% CI = 0.40-1.01, p = 0.06). CONCLUSION: European patients most frequently reported comorbidities, smoking, stress, and heredity as heart failure causes, but their causal understanding may be limited. There were trends towards associations between patient-reported causes and health status, psychological distress, and illness perceptions.

New generation cardioverter-defibrillator lead with a floating atrial sensing dipole: Long-term performance.

OBJECTIVES: The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany). BACKGROUND: The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock. METHODS: After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik). RESULTS: A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated. CONCLUSIONS: Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks.

Implantable cardioverter defibrillator therapy in repaired tetralogy of Fallot after pulmonary valve replacement: Implications for the mechanism of ventricular arrhythmia.

BACKGROUND: Ventricular tachycardia (VT), which is related to haemodynamic and electrophysiological alterations, is an important complication in repaired tetralogy of Fallot (rTOF) patients. We defined the role of implantable cardioverter defibrillator (ICD) therapy after pulmonary valve replacement (PVR) and the implications of coexisting long QT gene mutations/polymorphisms. METHODS: From 2003 to 2016, rTOF patients with VT who received ICD implantation were enrolled. rTOF patients without VT served as a control group. We performed long QT gene mutation analysis through the direct sequencing method. RESULTS: In total, 12 (male/female, 8/4) patients with VT received ICD implantation. The mean age at TOF repair and ICD implantation was 4.4±4.5years and 27.1±11.5years, respectively. All but one patient received PVR for severe pulmonary regurgitation or repair for a residual ventricular septal defect. After 5.4±4.0years of follow-up, six patients (50%) had at least one episode of appropriate shock: two had received PVR with intraoperative arrhythmia ablation and two had received PVR only. Compared with 121 patients without VT, the ICD patients had a higher frequency of long QT gene mutation/polymorphisms (10/12 vs. 54/121, p=0.014), especially in the hERG and SCN5A genes. The mechanism of VT in rTOF was discussed thoroughly. CONCLUSION: In rTOF patients who received ICD as secondary prevention, the appropriate shock rate remained high despite PVR and intraoperative arrhythmia ablation. Coexisting long QT gene mutations/polymorphisms may be associated with ventricular arrhythmia.

Interferência eletromagnética documentada em monitor de eventos implantável / Documented magnetic resonance imaging interference in implantable loop monitor

Monitores de eventos implantáveis estão cada vez mais presentes em nossa realidade. Este relato tem como foco o registro eletrocardiográ- fico obtido por monitor de eventos implantável durante ressonância magnética de paciente com síncope de repetição. O registro demonstra traçado interpretado erroneamente como taquicardia ventricular. O reconhecimento de interferências deve ser parte do treinamento do médico que atende e avalia dispositivos implantáveis

Implantable loop recorders are increasingly more present in our reality. This report is focused on the electrocardiographic recording obtained by implantable loop monitor during magnetic resonance imaging in patients with repeated syncope. The recording shows a tracing misinterpreted as ventricular tachycardia. Identifying interferences must be part of the training of attending physicians who sees patients and evaluates implantable devices

Fatores preditores para boa resposta à terapia de ressincronização cardíaca: critérios práticos para o clínico / Predicting factors of good response to cardiac resynchronization therapy: practical criteria for the clinician

A terapia de ressincronização cardíaca é uma alternativa eficaz em pacientes com insuficiência cardíaca e dessincronia, podendo reduzir significativamente a morbimortalidade. Apesar de haver indicações bem estabelecidas, cerca de um terço dos pacientes não responde à terapia; assim, a busca por critérios que possam avaliar de forma acurada a real chance de resposta à terapia de ressincronização cardíaca faz-se imprescindível. A seleção correta dos pacientes, a utilização de técnicas para otimizar o posicionamento do cabo-eletrodo de ventrículo esquerdo, a programação cuidadosa, o acompanhamento após o implante e a procura rotineira de fatores associados à ausência de resposta podem reduzir o número de não respondedores

Cardiac resynchronization therapy is an effective alternative for patients with heart failure and dyssynchrony that may significantly reduce morbidity and mortality. Although indications are well established, about 1/3 of the patients do not respond to therapy. Thus, it is critical to search for criteria that may accurately assess the actual probability of response to cardiac resynchronization therapy. Proper patient selection, the use of techniques to optimize left ventricular lead positioning, careful setting, post-implantation follow-up and routine search for factors associated with the lack of response, may reduce the number of non-responders

Identificação radiológica de dispositivos cardíacos eletrônicos implantáveis / X-ray identification of implantable electronic cardiac rhythm management devices

Introdução: Este trabalho teve por objetivos identificar as características comuns aos geradores e classificá-los no menor número possível de grupos para facilitar a identificação radiológica, e, também, identificar características que permitam diferenciar geradores DF1 de DF4. Método: A amostragem foi composta por 62 imagens de geradores de dispositivos implantáveis bem como de cabos-eletrodos comercialmente disponíveis no Brasil de 2008 até o presente momento das empresas Biotronik, Medtronic, St. Jude Medical e Boston Scientific. As imagens consideradas com qualidade adequada de cada modelo de dispositivo implantável foram selecionadas em busca de características comuns a cada fabricante. Resultados: A revisão criteriosa das características de cada fabricante e modelo possibilitou divisar claramente oito categorias, com características únicas de cada fabricante para estimuladores (grupo 1) e cardiodesfibriladores (grupo 2). Um algoritmo de identificação foi desenvolvido, a partir das características mais facilmente identificáveis de cada grupo. Conclusão: A identificação radiológica dos dispositivos implantáveis é possível e confiável. Os cabos-eletrodos de mesma função (choque ou estimulação) não puderam ser diferenciados em relação ao fabricante, mas algumas características das conexões de cabos-eletrodos de choque podem diferenciar a conexão DF1 de DF4, bem como mono coil de duplo coil

Background: This study is aimed at identifying common characteristics of generators and classify them into the lowest possible number of groups to facilitate X-ray identification as well as to identify characteristics to differentiate DF1 and DF4 generators. Method: The sample included 62 images of implantable device generators and leads available in the Brazilian market from 2008 to the present moment manufactured by Biotronik, Medtronic, St. Jude Medical and Boston Scientific. Good quality images from each implantable device model were chosen to help identify common characteristics of each manufacturer. Results: A careful review of manufacturer's characteristics and model enabled a clear division into eight categories with each manufacturer's unique characteristics for pacers (group 1) and cardiac defibrillators (group 2). An identification algorhythm was developed based on the most easily identifiable characteristics of each group. Conclusion: X-ray identification of implantable devices is possible and reliable. Leads with the same function (shock or pacing) were not differentiated by manufacturer, but some shock lead connection characteristics may differentiate DF1 from DF4 connections, as well monocoil from double coil

Implante de cardioversor-desfibrilador subcutâneo: relato de caso de paciente com taquicardia ventricular induzida por esforço / Subcutaneous cardioverter defibrillator implantation: case report of a patient with stress-induced ventricular tachycardia

As complicações relacionadas ao cardioversor-desfibrilador implantável em geral estão relacionadas a implante de cabo-eletrodo transvenoso, fratura do condutor ou ruptura do isolamento de silicone, além de infecções. Essas complicações podem ser evitadas com o implante do sistema de cardioversor-desfibrilador implantável totalmente subcutâneo. Relatamos o caso de um paciente de 60 anos de idade, assintomático, com antecedentes de morte súbita cardíaca na família, submetido ao primeiro implante de cardioversor-desfibrilador implantável subcutâneo no Brasil

Complications related to the use of implantable cardioverter-defibrillator are often related to transvenous lead implant, conductor fracture or insulation disruption in addition to infections. These complications may be avoided by implanting a totally subcutaneous implantable cardioverter-defibrillator system. We report the case of a 60-year old, asymptomatic patient with a family history of cardiac sudden death, undergoing the first subcutaneous implantable cardioverter-defibrillator implant in Brazil

Tachycardia detection in modern implantable cardioverter-defibrillators.

Implantable cardioverter-defibrillators (ICD) have to reliably sense, detect, and treat malignant ventricular tachyarrhythmias. Inappropriate treatment of non life-threatening tachyarrhythmias should be avoided. This article outlines the functionality of ICDs developed and manufactured by BIOTRONIK. Proper sensing is achieved by an automatic sensitivity control which can be individually tailored to solve special under- and oversensing situations. The programming of detection zones for ventricular fibrillation (VF), ventricular tachycardia (VT), and zones to monitor other tachyarrhythmias is outlined. Dedicated single-chamber detection algorithms based on average heart rate, cycle length variability, sudden rate onset, and changes in QRS morphology as used in ICDs by BIOTRONIK are described in detail. Preconditions and confirmation algorithms for therapy deliveries as antitachycardia pacing (ATP) and high energy shocks are explained. Finally, a detailed description of the dual-chamber detection algorithm SMART is given. It comprises additional detection criteria as stability of atrial intervals, 1:1 conduction, atrial-ventricular (AV) multiplicity, AV trend, and AV regularity to differentiate between ventricular and supraventricular tachyarrhythmias.

Outcome and incidence of appropriate implantable cardioverter-defibrillator therapy in patients with cardiac amyloidosis.

BACKGROUND: Cardiac amyloidosis (CA) is associated with a poor prognosis with the proposed mechanism of sudden cardiac death in the majority of patients being pulseless electrical activity. However, the incidence of ventricular arrhythmias (VA) and implantable cardioverter-defibrillator (ICD) indications in CA patients are unclear. We performed a detailed evaluation of our CA population undergoing ICD implantation and assessed appropriate ICD therapy and survival predictors. METHODS: We included consecutive patients from June 2008 to November 2014 in five centers. ICDs were systematically interrogated and clinical data recorded during follow-up. RESULTS: Forty-five patients (35 males, mean age 66±12years) with CA who underwent ICD implantation (84.4% primary prevention) were included. CA types were hereditary transthyretin in 27 patients (60%), light chain (AL) in 12 (27%) and senile in 6 (13%). After a mean follow-up of 17±14months, 12 patients (27%) had at least 1 appropriate ICD therapy occurring after 4.7±6.6months. Patients with or without ICD therapy had no significant differences in baseline characteristics, amyloidosis type, LVEF, and type of prevention although there was a trend towards a better 2D global longitudinal strain in patients with ICD therapy (P=0.08). Over the follow-up, 12 patients died (27%) and 6 underwent cardiac transplantation (13%). From multivariate analysis a worse prognosis was associated with higher NT-proBNP level (>6800pg/mL, HR=5.5[1.7-17.8]) and AL type (HR=4.9[1.5-16.3]). CONCLUSIONS: Appropriate ICD therapies are common (27%) in CA patients. No specific strong VA predictor could be identified. However, patients with advanced heart disease, especially with AL-CA, display a poorer outcome.

Cardiomiopatia hipertrófica dilatada com síndrome de Wolff- Parkinson-White / Dilated hypertrophic cardiomyopathy with Wolff-Parkinson-White syndrome

A cardiomiopatia hipertrófica é uma doença genética com apresentação, prognóstico e estratégias de tratamento variáveis. A visibilidade ligada à cardiomiopatia hipertrófica refere-se em grande parte a seu reconhecimento como causa comum de taquiarritmias e morte súbita cardíaca. O cardiodesfibrilador implantável é aceito como tratamento definitivo para prevenção de morte súbita, especialmente em pacientes de alto risco. Apesar da baixa prevalência, a via acessória é encontrada em 5% dos pacientes com cardiomiopatia hipertrófica e a ablação é o método de escolha, em decorrência do risco de taquiarritmias atriais. Relatamos o caso de um paciente com cardiomiopatia hipertrófica, em fase dilatada, com via acessória.

Hypertrophic cardiomyopathy is a genetic disease with variable presentation, prognosis and treatment strategies. The visibility linked to hypertrophic cardiomyopathy to a large extent refers to its recognition as a common cause of tachyarrhythmias and sudden cardiac death. Implantable cardiac defibrillator is accepted as definitive treatment for the prevention of sudden death, especially in high-risk patients. Despite the low prevalence, the accessory pathway is found in 5% of patients with hypertrophic cardiomyopathy and ablation is the method of choice due to risk of atrial tachyarrhythmias. We report the case of a patient with dilated hypertrophic cardiomyopathy and an accessory pathway.

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States.

BACKGROUND: Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. CONCLUSIONS: The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.

Risk of pocket hematoma in patients on chronic anticoagulation with warfarin undergoing electrophysiological device implantation: a comparison of different peri-operative management strategies.

OBJECTIVE: Periprocedural management of warfarin remains challenging in patients requiring electrophysiological device surgery. For patients at high risk of thromboembolic events, guidelines recommend bridging therapy with heparin; however, this strategy is associated with a high risk of pocket hematoma. This paper systematically reviews studies appraising the risk of pocket hematoma with different perioperative anticoagulation strategies. METHODS: All relevant studies identified in MEDLINE/PubMed, The Cochrane Collaboration CENTRAL, clinicaltrials.org and in bibliographies of key articles. Estimates were combined using a fixed effects model. Heterogeneity was assessed by p values of χ2 statistics and I2. Publication bias was assessed by visual examination of funnel plots and by Egger test. Fifteen studies enrolling 5911 patients met all inclusion criteria and were included in this review. RESULTS: Heparin bridging compared with no heparin was associated with increased risk of pocket hematoma (OR = 4.47, 95% CI 3.21-6.23, p < 0.00001), and prolonged hospital stay (9.13 ± 1.9 days vs. 5.11 ± 1 .39 days, p < 0.00001). Warfarin continuation was not associated with increased pocket hematoma compared to warfarin discontinuation (p = 0.38), but was associated with reduced risk of pocket hematoma compared with heparin bridging (OR = 0.37, 95% CI 0.2-0.69, p = 0.002). Thromboembolic complications were reduced with heparin bridging vs. no heparin (0.50% vs.1.07%, p = 0.02), and no significant differences were reported between heparin bridging vs. warfarin continuation (p = 0.83). CONCLUSIONS: Heparin bridging is associated with a higher risk of pocket hematoma and a prolonged hospital stay. Perioperative continuation of warfarin reduces the occurrence of pocket hematoma compared with heparin bridging without any significant differences in thromboembolic complications.