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BACKGROUND: Left ventricular (LV) lead position may be an important factor for delivering effective cardiac resynchronization therapy (CRT). We therefore aimed to evaluate the effects of LV lead position, stratified by native QRS morphology, regarding the clinical outcome. METHODS: A total of 1295 CRT-implanted patients were retrospectively evaluated. LV lead position was classified as lateral, anterior, inferior, or apical, and was determined using the left and right anterior oblique X-ray views. Kaplan Meier and Cox regression were performed to evaluate the effects on all-cause mortality and heart failure hospitalization, and the potential interaction between LV lead position and native ECG morphologies. RESULTS: A total of 1295 patients were included. Patients were aged 69 ± 7 years, 20% were female, 46% received a CRT-Pacemaker (vs. CRT-Defibrillator), mean LVEF was 25% ± 7%, and median follow-up was 3.3 years [IQR 1.6-5-7 years]. Eight hundred and eighty-two patients (68%) had a lateral LV lead location, 207 (16%) anterior, 155 (12%) apical, and 51 (4%) inferior. Patients with lateral LV lead position had larger QRS reduction (-13 ± 27 ms vs. -3 ± 24 ms, p < .001). Non-lateral lead location was associated with a higher risk for all-cause mortality (HR 1.34 [1.09-1.67], p = .007) and heart failure hospitalization (HR 1.25 [1.03-1.52], p = .03). This association was strongest for patients with native left or right bundle branch block, and not significant for patients with prior paced QRS or nonspecific intraventricular conduction delay. CONCLUSIONS: In patients treated with CRT, non-lateral LV lead positions (including apical, anterior, and inferior positions) were associated with worse clinical outcome and less reduction of QRS duration. This association was strongest for patients with native LBBB or RBBB.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Humanos , Feminino , Masculino , Terapia de Ressincronização Cardíaca/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Eletrocardiografia/efeitos adversos , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/etiologia , Bloqueio de Ramo/diagnóstico por imagem , Bloqueio de Ramo/terapiaRESUMO
Malpositioned pacemaker lead in the left ventricle (LV) is a rare procedural complication, which causes a special risk of thromboembolic events. Hence, prompt identification and early management of misplaced leads inside the LV is critical. Herein, we present a case of malpositioned pacemaker lead with transient ischemic attacks after the pacemaker implantation. The misplaced ventricular lead was discovered during regular echocardiography. Both leads were extracted percutaneously after dabigatran treatment. To our knowledge, this is the first report of uncomplicated percutaneous extraction of an inadvertently placed LV lead after dabigatran treatment. No neurologic events during a follow-up of 4 years.
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Marca-Passo Artificial , Tromboembolia , Dabigatrana/efeitos adversos , Ecocardiografia , Ventrículos do Coração/diagnóstico por imagem , Humanos , Marca-Passo Artificial/efeitos adversosRESUMO
Objectives. This study assessed the management approach and outcome of the pacemaker or implantable cardioverter-defibrillator (ICD) leads malpositioned in the left heart. Malpositioned leads (MPLs) may have deleterious consequences, and appropriate management remains uncertain. Methods. The study population included all patients referred to a single institution for MPL in the left side of the heart after pacemaker or ICD implantation during the period from 2015 to 2021. The approach and outcome of lead management were retrospectively assessed. Results. During the study period, 6887 patients underwent device implantation. MPL was diagnosed in five patients (0.07%). In four cases, the pacing lead was placed in a coronary sinus (CS) branch, while the pacing lead was inside the left ventricle (LV) in one case. Symptoms suggestive of lead malposition were reported by 2 patients (40%). One of the patients presented with recurrent TIAs. Another presented with inappropriate ICD shocks. In one asymptomatic case, an ICD lead changed position from the right ventricle to the CS, suggesting idiopathic lead migration. In 4/5 patients, the leads were removed or repositioned by percutaneous approach, with no major periprocedural complications. Conclusions. In this series of MPL in the left heart, two patients presented with thromboembolic events or inappropriate ICD shocks. These serious complications highlight the critical need for early correct diagnosis and proper management of MPL.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Estimulação Cardíaca Artificial/efeitos adversos , Desfibriladores Implantáveis/efeitos adversos , Humanos , Marca-Passo Artificial/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
We present a case of combination of a leadless pacemaker (Micra) and a subcutaneous implantable cardioverter-defibrillator (S-ICD). The patient had a total of nine adequate shock treatments of ventricular fibrillation during 18â¯months of follow-up after the implantation. The shock treatments did not lead to any alteration in the Micra. All three sensing vectors of the S-ICD worked well. After 18â¯months, the functioning of both Micra and S-ICD continues to be uneventful. This case demonstrates that S-ICD combined with Micra may be a safe and feasible approach to provide pacing and ICD treatment without intracardiac leads.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Arritmias Cardíacas/terapia , Eletrocardiografia , Seguimentos , HumanosRESUMO
Aims: Dual coil (DC) electrodes are preferred to single coil (SC) electrodes because of an assumed higher shock efficacy. However, DC-electrodes may be associated with an increased difficulty and risk of lead extraction. We aimed to compare SC- and DC-electrodes with respect to the first shock efficacy (FSE) after implantable cardioverter defibrillator (ICD) implantation. Methods and results: One thousand and seventy-seven patients of the NORDIC ICD trial were randomly assigned to first time ICD implantation with or without defibrillation (DF) testing. The electrode configuration was determined before randomization. One thousand and sixty-seven patients eventually received an ICD, 516 (48.4%) with a SC- and 551 (51.6%) with a DC-electrode. DC-electrodes were preferentially selected in older patients, renal failure, atrial fibrillation, dual chamber, Cardiac Resynchronization Therapy (CRT) devices, angiotensin-converting-enzyme (ACE) inhibitors/angiotensin (AT) receptor blockers and without Sotalol. However, the preference of the investigational site was dominant over clinical parameters. The DF energy at the final electrode position was higher in SC-electrodes (adjusted difference +1.15 J; P = 0.005; only patients tested). Less patients with DC-electrodes required intra-operative system reconfiguration (adjusted difference -3.9; P = 0.046; only patients tested). Using mixed logistic regression, the FSE was 92.6% in SC- and 97.8% in DC-electrodes (adjusted odds ratio 4.3 (95% confidence interval [1.9, 9.8]; P < 0.001)). Conclusion: Dual coil-electrode selection mainly depends on the preference of the investigational site and seems to be preferred in older patients, renal failure, atrial fibrillation, dual chamber, and CRT devices. Patients with DC-electrodes required less intraoperative system reconfigurations. Dual coil-electrodes provided a substantially higher FSE during follow-up. Mortality rates were not significantly different in patients with DC- and SC-electrodes.
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Arritmias Cardíacas/terapia , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Idoso , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/classificação , Cardioversão Elétrica/métodos , Desenho de Equipamento/métodos , Feminino , Humanos , Cuidados Intraoperatórios/métodos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. METHODS AND RESULTS: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). CONCLUSION: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.
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Desfibriladores Implantáveis/normas , Cardioversão Elétrica/normas , Cuidados Intraoperatórios/métodos , Taquicardia/terapia , Desfibriladores Implantáveis/efeitos adversos , Cardioversão Elétrica/efeitos adversos , Feminino , Humanos , Cuidados Intraoperatórios/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Taquicardia/mortalidade , Resultado do TratamentoRESUMO
AIMS: Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing. METHODS AND RESULTS: Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance. CONCLUSION: The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation. CLINICALTRIALSGOV IDENTIFIER: NCT01282918.
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Desfibriladores Implantáveis , Análise de Falha de Equipamento/métodos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/prevenção & controle , Monitorização Intraoperatória/métodos , Projetos de Pesquisa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Cardiac resynchronization therapy (CRT) with or without a defibrillator has a positive effect on mortality and morbidity for patients with heart failure. However, comparisons between CRT-defibrillators (CRT-D) and CRT-pacemakers (CRT-P) are relatively scarce outside the clinical trial setting. This study aimed to assess baseline characteristics in relation to long-term prognosis in patients treated with CRT, and to investigate the potential benefit of CRT-D versus CRT-P. METHODS: Data were retrospectively collected from the medical records of all consecutive patients treated with CRT-P or primary prophylactic CRT-D at a large tertiary care center between 1999 and 2012. Predictors of mortality were investigated, and time-dependent analysis was performed with all-cause mortality as the primary end point. RESULTS: A total of 705 patients were included (69.6 ± 10 years, 78% New York Heart Association classes III-IV, left ventricular ejection fraction median 25%, 16% female, 36% CRT-D). The patients were followed for a median of 59 months. Annual mortality differed between CRT-D primary prophylactic and CRT-P groups (5.3% and 11.8%, respectively), but when adjusted for covariates, CRT-D treatment (compared to CRT-P) was not associated with better long-term survival. Independent predictors of survival were: age, use of loop diuretics, hemoglobin levels, and use of renin angiotensin aldosterone system blockers. CONCLUSIONS: In CRT treatment outside of the clinical trial setting, CRT-D treatment was not an independent predictor of long-term survival. Future research should focus on correct selection of the patients who receive enough benefit of an added defibrillator to justify CRT-D implantation instead of CRT-P treatment only.
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Terapia de Ressincronização Cardíaca/métodos , Idoso , Causas de Morte , Desfibriladores Implantáveis , Feminino , Humanos , Masculino , Marca-Passo Artificial , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de SobrevidaRESUMO
AIMS: Cardiac resynchronization therapy (CRT) has a well-documented positive effect on mortality and heart failure morbidity. The aim of this study was to assess the long-term survival and the predictive value of self-assessed functional status on the long-term prognosis of patients treated with CRT-pacemaker (CRT-P). METHODS AND RESULTS: Data were retrospectively collected from medical records of 446 consecutive patients implanted with CRT-P at a large-volume Swedish tertiary care centre. Primary outcome was all-cause mortality, predictive variables were assessed by log-rank test and univariate cox regression. Three hundred and nine patients had reliable information available on early improvement after implantation and were included in the multivariate analyses. The cohort was followed for a median of 79 months and was similar in baseline characteristics compared with major controlled trials. During follow-up 204 patients died, yearly mortality was 11.7%. Early improvement of self-assessed functional status was a strong independent predictor of survival [hazard ratio, HR 0.59, confidence interval (CI) 0.40-0.87, P = 0.007], together with well-known predictors; NYHA III-IV vs I-II (HR 1.66, CI 1.09-2.536, P = 0.018), age (HR 1.05, CI 1.03-1.08, P < 0.001), male gender (HR 2.0, CI 1.11-3.45, P = 0.021), and loop diuretic use (HR 4.41, CI 1.08-18.02). Patients with early improvement of self-assessed functional status had better 2-year and 5-year survival (P < 0.001). CONCLUSIONS: Real-life patient characteristics and predictors of outcome compare well with those in published prospective trials. Self-assessed functional status is a strong predictor of long-term survival, which may have implications for a more active follow-up of patients without spontaneous improvement.
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Terapia de Ressincronização Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Autoavaliação (Psicologia) , Idoso , Idoso de 80 Anos ou mais , Terapia de Ressincronização Cardíaca/efeitos adversos , Distribuição de Qui-Quadrado , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Risco , Autorrelato , Índice de Gravidade de Doença , Fatores Sexuais , Inibidores de Simportadores de Cloreto de Sódio e Potássio/uso terapêutico , Suécia , Centros de Atenção Terciária , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: To determine whether a steerable catheter with electrogram guidance (CS-assist group) could facilitate access to the coronary sinus (CS) during cardiac resynchronization therapy (CRT) implantation. DESIGN: Consecutive patients who underwent CRT implantation were recruited prospectively into the CS-assist group (n = 81) and compared with those using conventional techniques without an electrogram guidance (conventional group, n = 101). RESULTS: The CS cannulation success rate was clearly greater in the CS-assist group (100%) than that in the conventional group (95%, p < 0.05), with significantly shorter mean procedure time (52.6 ± 20.6 min vs. 73.2 ± 40.9 min, p < 0.01) and fluoroscopy time (3.6 ± 3.2 min vs. 14.2 ± 20.4 min, p < 0.01). In the five CS cannulation failure cases, mean procedure time (144.0 ± 37.0 min) and fluoroscopy time (57.8 ± 24.8 min) were significantly longer than those in the other patients (61.2 ± 32.3 and 8.2 ± 13.6 min, respectively, n = 177, both p < 0.01). CONCLUSIONS: Using the steerable catheter with real-time electrogram guidance, location of and access to the CS is more rapid and successful, which may improve the success of the CRT implantation and may give significant time savings.
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Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Terapia de Ressincronização Cardíaca , Seio Coronário , Insuficiência Cardíaca/cirurgia , Idoso , Idoso de 80 Anos ou mais , Dispositivos de Terapia de Ressincronização Cardíaca , Seio Coronário/diagnóstico por imagem , Seio Coronário/fisiopatologia , Técnicas Eletrofisiológicas Cardíacas , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Fluoroscopia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Radiografia Intervencionista/métodos , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: We aimed to evaluate if optimization by maximizing QRS duration (QRSd) reduction is feasible in an all-comer cardiac resynchronization therapy (CRT) population, and if reduced, QRSd is associated with a better clinical outcome. METHODS: Patients with LBBB receiving CRT implants during the period 2015-2020 were retrospectively evaluated. Implants from 2015-2017 were designated as controls. Starting from 2018, an active 12-lead electrogram-based optimization of QRSd reduction was implemented (intervention group). QRSd reduction was evaluated in a structured way at various device AV and VV settings, aiming to maximize the reduction. The primary endpoint was a composite of heart failure hospitalization or death from any cause. RESULTS: A total of 254 patients were followed for up to 6 years (median 2.9 [1.8-4.1]), during which 82 patients (32%) reached the primary endpoint; 53 deaths (21%) and 58 (23%) heart failure hospitalizations. Median QRS duration pre-implant was 162 ms [150-174] and post-implant 146ms [132-160]. Mean reduction in QRS duration was progressively larger for each year during the intervention period, ranging from - 9.5ms in the control group to - 24 in the year 2020 (p = 0.005). QRS reduction > 14 ms (median value) was associated with a lower risk of death or heart failure hospitalization (adjusted HR 0.54 [0.29-0.98] (p = 0.04). CONCLUSIONS: Implementing a general strategy of CRT device optimization by aiming for shorter QRS duration is feasible in a structured clinical setting and results in larger reductions in QRS duration post-implant. In patients with a larger QRS reduction, compared to those with a smaller QRS reduction, there is an association with a better clinical outcome.
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Background: Observational data suggest that an anterior or apical left ventricular (LV) position in cardiac resynchronization therapy (CRT) is associated with worse outcome and higher likelihood of "nonresponse." It is not known whether the benefits of optimizing LV lead position in a second procedure outweighs the procedural risks. Objective: To evaluate the clinical effects of LV lead repositioning. Methods: During the period 2015-2020, we identified all patients in whom the indication for the procedure was LV lead repositioning owing to "nonresponse" in combination with suboptimal LV lead position. All patients were followed with a structured visit 6 months post LV lead revision. Heart failure hospitalization and mortality data were gathered from the medical records and cross-checked with the population registry. Results: A total of 25 patients were identified who fulfilled the inclusion criteria. All procedures were successful in establishing LV lead pacing in a lateral mid or basal location. Median follow-up was 2.5 years [1.1-3.7]. There were improvements in NYHA class (mean -0.5 ± 0.5 class, P < .001), LV ejection fraction (+5 [interquartile range 2-11] absolute %, P = .01), QRS duration (-36 [-44 to -8], P < .001) and N-terminal pro-brain natriuretic peptide (NT-proBNP) (-615 [-2837 to +121] ng/L, P = .03). Clinical outcome was similar to a reference population with CRT (P = ns). Conclusion: In nonresponders to CRT with either an anterior or inferior LV lead position, it was feasible to perform LV lead repositioning in all cases, with a low complication rate. Changing the LV lead position was associated with improved LV ejection fraction, larger QRS reduction, and larger NT-proBNP reduction.
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AIMS: Two independent studies have revealed a potential limitation of post-mode switch overdrive pacing (PMOP), which is its delayed start. METHODS AND RESULTS: We conducted a prospective, randomized, single blind, crossover design study (the post-long pause overdrive pacing study) to test the efficacy of an improved version of PMOP (PMOP(enhanced)). A total of 45 patients were enrolled, of whom 41 were analysed. The median number of atrial tachycardia/atrial fibrillation (AT/AF) episodes per day (1.38 vs. 1.19), the median number of early recurrences of atrial fibrillation (ERAF) per day (0.56 vs. 0.51), and the median AT/AF burden (time per day spent in AT/AF) (2.47 vs. 2.51 h) were not significantly different during the control and active study periods. Based on the median number of episodes per week recorded 90 days prior to enrollment, the patients were stratified by the median and then split into two groups, Group A (lower 2-Quartiles) and Group B (upper 2-Quartiles). The median AT/AF burden was significantly lower in Group B during the active study period (3.71 vs. 1.71 h, P = 0.02).The median number of AT/AF episodes per day and the median number of ERAF per day in Group B showed a trend towards reduction when the algorithm was turned on (3.79 vs. 2.44 and 2.77 vs. 1.86, respectively). In contrast, in Group A we did not demonstrate any difference in AT/AF frequency, ERAF frequency, or burden. CONCLUSION: The main finding of this study is that temporary overdrive pacing at 90 bpm for 10 min starting just prior to device-classified AT/AF termination does not show a positive effect on the overall study population. However, when enabled in patients who suffer from a high percentage of ERAF, a significant reduction in the AT/AF burden could be demonstrated. Based on these findings, further prospective studies on a more targeted patient population are needed to confirm our results.
Assuntos
Algoritmos , Fibrilação Atrial/prevenção & controle , Diagnóstico por Computador/métodos , Eletrocardiografia/métodos , Terapia Assistida por Computador/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Prevenção Secundária , Sensibilidade e Especificidade , Método Simples-Cego , Resultado do TratamentoRESUMO
Aromatic aldehydes have been converted into the corresponding carbamoyl azides using iodine azide. These reactions have been performed safely under continuous flow reaction conditions in microreactors.
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AIMS: Unnecessary right ventricular pacing has deleterious effects and becomes more significant when cumulative percent ventricular pacing (Cum%VP) exceeds 40% of time. The Managed Ventricular Pacing (MVP) mode has been shown to significantly reduce the percent ventricular pacing compared to the DDD/R mode. This study assessed the percent of ventricular pacing in a standard pacemaker population programmed to MVP and for which patients it is possible to achieve a Cum%VP < or = 40%. METHODS AND RESULTS: Unselected, consecutive patients were implanted with a dual chamber pacemaker with a mean follow-up period of 76 days. The Cum%VP was calculated from device diagnostics between pre-hospital discharge (PHD) and the 1-month post implant visit. The median Cum%VP of 107 patients (age 67.2 +/- 14 years; 53% male) who were programmed to MVP was 3.9%. The median Cum%VP was 1.4% in patients with sinus node disease (SND) and 28.8% in patients with AV block (AVB). Cum%VP < or = 40% was observed in 72% of all patients, in 50% of AVB patients, and in 86% of SND patients. CONCLUSION: The MVP mode is capable of achieving a low percent of ventricular pacing in a standard pacemaker population with SND and AVB. In addition, 72% of patients in MVP mode demonstrated Cum%VP < or = 40%.
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Estimulação Cardíaca Artificial/métodos , Bloqueio Cardíaco/diagnóstico , Bloqueio Cardíaco/terapia , Marca-Passo Artificial , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Estimulação Cardíaca Artificial/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Reações Falso-Positivas , Feminino , Seguimentos , Bloqueio Cardíaco/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: Managed Ventricular Pacing (MVP) and Search AV+ (SAV+) are two pacing algorithms designed to reduce ventricular pacing. MVP promotes conduction by operating in AAI/R mode with backup ventricular pacing during atrioventricular block (AVB). SAV+ operates in DDD/R mode with a nominal AV extension of 290 ms during atrial sensing and 320 ms during atrial pacing. The reduction in ventricular pacing was compared with these two algorithms in pacemaker patients. METHODS: The EnRhythm and EnPulse clinical studies assessed the percentage of ventricular pacing (%VP) after 1 month. Each patient's AVB status was assigned using the following hierarchical categories: persistent third-degree AVB (p3AVB), episodic third-degree AVB (e3AVB), second-degree AVB (2AVB), first-degree AVB (1AVB), and no AVB (nAVB). The%VP was tabulated for each AVB status category. RESULTS: Data were available from 322 patients of whom 129 received DDD(R) pacing with the MVP algorithm activated and 193 patients with DDD(R) pacing and the SAV+ function activated, each for a month period. MVP resulted in a significantly lower median%VP than SAV+ in all AVB categories except for p3AVB: nAVB (0.3 vs 2.9, P < 0.0001), 1AVB (0.9% vs 80.6%, P < 0.0001), 2AVB (37.6 vs 99.3, P< 0.002), e3AVB (1.2 vs 42.2, P = 0.02), p3AVB (98.9 vs 100, P = 1.00). CONCLUSION: MVP resulted in a greater reduction in%VP than SAV+ across all patient groups except persistent third-degree AV block. The greatest reduction in%VP was observed in patients with mildly impaired AV conduction.
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Algoritmos , Nó Atrioventricular/fisiopatologia , Estimulação Cardíaca Artificial/métodos , Bloqueio Cardíaco/terapia , Análise de Variância , Ensaios Clínicos como Assunto , Feminino , Bloqueio Cardíaco/fisiopatologia , Humanos , MasculinoRESUMO
BACKGROUND: The Medtronic EnPulse pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES: The purpose of this study was to evaluate the clinical performance of ACM. METHODS: Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS: All 200 implanted patients had a 1-month visit, and validated manual and in-office ACM threshold data were available for 123 patients. The ACM threshold was 0.595 +/- 0.252 V, and the manual threshold was 0.584 +/- 0.233 V. The mean difference was 0.010 V with a 95% confidence interval of (-0.001, 0.021). The mean difference over all visits was 0.011 V. For all patients, the individual threshold differences were within the range of clinical equivalence at all visits. No atrial arrhythmias were observed during 892 ACM tests in 193 patients. CONCLUSION: This study demonstrated that the ACM algorithm is safe, accurate, and reliable over time. ACM was demonstrated to be clinically equivalent to the manual atrial threshold test in all patients at 1 month and over the entire follow-up period of up to 6 months. ACM ensures atrial capture, may save time during follow-up, and can be used to manage atrial pacing outputs.
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Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial/métodos , Frequência Cardíaca/fisiologia , Marca-Passo Artificial , Idoso , Arritmias Cardíacas/fisiopatologia , Eletrocardiografia , Eletrodos Implantados , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: We compare two widely used risk algorithms for coronary bypass surgery: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) and The Society of Thoracic Surgeons (STS) risk stratification algorithm. METHODS: Risk factors for all adult patients undergoing heart surgery at the University Hospital of Lund between 1996 and 2001 were collected prospectively at preoperative admission. Predictive accuracy for 30-day mortality was assessed by comparing the observed and the expected mortality for equal-sized quintiles of risk by using the Hosmer-Lemeshow goodness-of-fit test. The discriminatory power was evaluated by calculating the areas under receiver operating characteristics (ROC) curves. RESULTS: The study included 4497 coronary artery bypass-only operations. The average age was 66.4 +/- 9.3 years (range 31 to 90 years). Most patients were men (77.0% versus 23.0%). The actual 30-day mortality was 1.89%. The Hosmer-Lemeshow goodness-of-fit test gave a p value of 0.81 (EuroSCORE) and 0.83 (STS), which indicates a good accuracy of both models. The area under the ROC curve was 0.84 (95% confidence interval [CI] 0.80 to 0.88) for EuroSCORE and 0.71 (95% CI 0.66 to 0.77) for STS. The discriminatory power (area under the ROC curve) was significantly larger for EuroSCORE compared with STS (p < 0.00005). CONCLUSIONS: In this large, single institution study the additive EuroSCORE algorithm had a significantly better discriminatory power to predict 30-day mortality than the STS risk algorithm for patients undergoing coronary artery bypass.
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Ponte de Artéria Coronária/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Curva ROC , Medição de Risco , Fatores de RiscoRESUMO
This review traces the development and study of the second-generation photosensitizer 5,10,15,20-tetra(m-hydroxyphenyl)chlorin through to its acceptance and clinical use in modern photodynamic (cancer) therapy. The literature has been covered up to early 2011.
Assuntos
Mesoporfirinas/uso terapêutico , Fármacos Fotossensibilizantes/uso terapêutico , Animais , Humanos , Mesoporfirinas/farmacologia , Fotoquimioterapia , Fármacos Fotossensibilizantes/farmacologiaRESUMO
Gastrointestinal (GI) complications are serious consequences of cardiac surgery. The aim of this study was to develop, evaluate and validate a new risk score model for GI complications after cardiac surgery. The risk score model, named gastrointestinal complication score (GICS), was developed using prospectively collected data from 5593 patients who underwent 5636 cardiac surgical procedures between 1996 and 2001. The model was validated on 1031 cardiac surgery patients between 2005 and 2006. The scoring system's ability to predict GI complications was estimated by receiver operating characteristic (ROC)-curves and Hosmer-Lemeshow test. Fifty GI complications were identified in 47 patients (0.8%) in the developmental data set and eight (0.8%) in the validation data set. The ROC area in the developmental data set was 0.81 with a good calibration estimated by Hosmer-Lemeshow test (P=0.89). In the validation data set, the area under the curve was 0.83. The estimated probability for the patient to develop a GI complication after cardiac surgery at a GICS >or=15 is >20% and at a GICS Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos
, Gastroenteropatias/etiologia
, Indicadores Básicos de Saúde
, Idoso
, Idoso de 80 Anos ou mais
, Procedimentos Cirúrgicos Cardíacos/mortalidade
, Feminino
, Gastroenteropatias/diagnóstico
, Gastroenteropatias/mortalidade
, Humanos
, Masculino
, Pessoa de Meia-Idade
, Razão de Chances
, Valor Preditivo dos Testes
, Estudos Prospectivos
, Curva ROC
, Reprodutibilidade dos Testes
, Medição de Risco
, Fatores de Risco