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Background: Patients with progressive chronic kidney disease (CKD) are at higher risk of infections and complications from cardiac implantable electronic devices (CIED). In patients with a primary or secondary prophylactic indication, implantable cardiac defibrillators (ICD) can prevent sudden cardiac deaths (SCD). We retrospectively compared transvenous-ICD (TV-ICD) and intermuscularly implanted subcutaneous-ICD (S-ICD) associated infections and complication rates together with hospitalizations in recipients with stage 4 kidney disease. Methods: We retrospectively analyzed 70 patients from six German centers with stage 4 CKD who received either a prophylactic TV-ICD with a single right ventricular lead, 49 patients, or a S-ICD, 21 patients. Follow-Ups (FU) were performed bi-annually. Results: The TV-ICD patients were significantly older. This group had more patients with a history of atrial arrhythmias and more were prescribed anti-arrhythmic medication compared with the S-ICD group. There were no significant differences for other baseline characteristics. The median and interquartile range of FU durations were 55.2 (57.6-69.3) months. During FU, patients with a TV-ICD system experienced significantly more device associated infections (n = 8, 16.3% vs. n = 0; p < 0.05), device-associated complications (n = 13, 26.5% vs. n = 1, 4.8%; p < 0.05) and device associated hospitalizations (n = 10, 20.4% vs. n = 1, 4.8%; p < 0.05). Conclusion: In this long-term FU of patients with stage 4 CKD and an indication for a prophylactic ICD, the S-ICD was associated with significantly fewer device associated infections, complications and hospitalizations compared with TV-ICDs.
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BACKGROUND: The aim of the present study was to evaluate the long-term safety and effectiveness of the subcutaneous implantable cardioverter defibrillator (S-ICD) when implanted intermuscularly in patients with end-stage renal disease and hemodialysis. METHODS: This study is a retrospective analysis of 21 consecutive patients implanted with S-ICDs at three experienced centers in Germany with comorbid renal insufficiency requiring hemodialysis, as well as being at risk of sudden cardiac death. The S-ICD was placed intermuscularly in all patients. Follow-ups (FUs) were performed every 6 months. RESULTS: The mean ± standard deviation FU duration was 60.0 ± 11.4 months, with a range of 39 to 78 months. There were no deaths due to arrhythmia, or device-associated infections and complications. Four patients (19.1%) died during FU due to respiratory insufficiency during dialysis, systolic heart failure, septic infection of the urogenital tract, and colorectal cancer, respectively. There were six non-device-related hospitalizations with a duration of 12.7 ± 5.1 days and a hospitalization rate of 4.1 per 100 patient years. CONCLUSIONS: In the long-term FU of this small population of seriously compromised hemodialysis patients at risk of sudden cardiac death, the intermuscularly implanted S-ICD system was safe and effective. No arrhythmic complications, device-associated infections, or complications compromised survival. These data are encouraging and support testing in a larger group of similarly compromised patients.
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BACKGROUND: Cephalic vein cutdown (CVC) and subclavian vein puncture (SVP) are the most commonly used access sites for transvenous lead placement of cardiac implantable electronic devices (CIEDs). Limited knowledge exists about the long-term patency of the vascular lumen housing the leads. METHODS: Among the 2703 patients who underwent CIED procedures between 2005 and 2013, we evaluated the phlebographies of 162 patients scheduled for an elective CIED replacement (median of 6.4 years after the first operation). The phlebographies were divided into four stenosis types: Type I = 0%, Type II = 1-69%, Type III = 70-99%, and Type IV = occlusion. Due to the fact that no standardized stenosis categorization exists, experienced physicians in consensus with the involved team made the applied distribution. The primary endpoint was the occurrence of stenosis Type III or IV in the CVC group and in the SVP group. RESULTS: In total, 162 patients with venography were enrolled in this study. The prevalence of high-degree stenosis was significantly lower in the CVC group (7/89, 7.8%) than in the SVP group (15/73, 20.5%, p = 0.023). In the CVC group, venographies showed a lower median stenosis (33%) than in the SVP group (median 42%). CONCLUSIONS: The present study showed that the long-term patency of the subclavian vein is higher after CVC than after SVP for venous access in patients with CIED.
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BACKGROUND: Infection, lead dysfunction and system upgrades are all reasons that transvenous lead extraction is being performed more frequently. Many centres focus on a single method for lead extraction, which can lead to either lower success rates or higher rates of major complications. We report our experience with a systematic approach from a less invasive to a more invasive strategy without the use of laser sheaths. METHODS: Consecutive extraction procedures performed over a period of seven years in our electrophysiology laboratory were included. We performed a stepwise approach with careful traction, lead locking stylets (LLD), mechanical non-powered dilator sheaths, mechanical powered sheaths and, if needed, femoral snares. RESULTS: In 463 patients (age 69.9 ± 12.3, 31.3% female) a total of 780 leads (244 ICD leads) with a mean lead dwelling time of 5.4 ± 4.9 years were identified for extraction. Success rates for simple traction, LLD, mechanical non-powered sheaths and mechanical powered sheaths were 31.5%, 42.7%, 84.1% and 92.6%, respectively. A snare was used for 40 cases (as the primary approach for 38 as the lead structure was not intact and stepwise approach was not feasible) and was successful for 36 leads (90.0% success rate). Total success rate was 93.1%, clinical success rate was 94.1%. Rate for procedural failure was 1.1%. Success for less invasive steps and overall success for extraction was associated with shorter lead dwelling time (p < 0.001). Major procedure associated complications occurred in two patients (0.4%), including one death (0.2%). A total of 36 minor procedure-associated complications occurred in 30 patients (6.5%). Pocket hematoma correlated significantly with uninterrupted dual antiplatelet therapy (p = 0.001). Pericardial effusion without need for intervention was associated with long lead dwelling time (p = 0.01) and uninterrupted acetylsalicylic acid (p < 0.05). CONCLUSION: A stepwise approach with a progressive invasive strategy is effective and safe for transvenous lead extraction.
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There is a rising number in complications associated with more cardiac electrical devices implanted (CIED). Infection and lead dysfunction are reasons to perform transvenous lead extraction. An ideal anaesthetic approach has not been described yet. Most centres use general anaesthesia, but there is a lack in studies looking into deep sedation (DS) as an anaesthetic approach. We report our retrospective experience for a large number of procedures performed with deep sedation as a primary approach. Extraction procedures performed between 2011 and 2018 in our electrophysiology laboratory have been included retrospectively. We began by applying a bolus injection of piritramide followed by midazolam as primary medication and would add etomidate if necessary. For extraction of leads a stepwise approach with careful traction, locking stylets, dilator sheaths, mechanical rotating sheaths and if needed snares and baskets has been used. A total of 780 leads in 463 patients (age 69.9 ± 12.3, 31.3% female) were extracted. Deep sedation was successful in 97.8% of patients. Piritramide was used as the main analgesic medication (98.5%) and midazolam as the main sedative (94.2%). Additional etomidate was administered in 15.1% of cases. In 2.2% of patients a conversion to general anaesthesia was required as adequate level of DS was not achieved before starting the procedure. Sedation related complications occurred in 1.1% (n = 5) of patients without sequalae. Deep sedation with piritramide, midazolam and if needed additional etomidate is a safe and feasible strategy for transvenous lead extraction.
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Anestésicos , Sedación Profunda , Desfibriladores Implantables , Etomidato , Marcapaso Artificial , Humanos , Femenino , Masculino , Midazolam/efectos adversos , Estudios Retrospectivos , Pirinitramida , Sedación Profunda/efectos adversos , Sedación Profunda/métodos , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/métodos , Resultado del Tratamiento , Marcapaso Artificial/efectos adversosRESUMEN
In recent years, imaging techniques have improved enormously. This leads to a decrease in stress testing indication for diagnosis and management of coronary artery diseases. However, stress testing remains an indispensable diagnostic tool for assessing patients' physical activity and their circulatory behavior during exercise. Using stress testing helps to assess patients' heart rate behavior or even to detect or trigger cardiac arrhythmias, for example, assessment of chronotropic competency, tachycardia-triggering or detection of a sudden heart rate drop with relevant bradycardia. The present review focuses on the assessment of stress testing in rhythmology. Since abnormal findings, which may indicate the presence of coronary heart disease, may occur during exercise testing, relevant ischemic criteria are also briefly addressed.
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Enfermedad de la Arteria Coronaria , Electrocardiografía , Humanos , Prueba de Esfuerzo , Arritmias Cardíacas/diagnóstico , TaquicardiaRESUMEN
We present a case of posterior papillary muscle rupture associated with severe eccentric mitral regurgitation following transcatheter aortic valve implantation, that was successfully treated with transcatheter edge to edge mitral repair and review similar cases in literature.
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Rotura Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/cirugía , Músculos Papilares/diagnóstico por imagen , Resultado del Tratamiento , Rotura Cardíaca/diagnóstico por imagen , Rotura Cardíaca/etiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversosRESUMEN
Background: Bipolar active fixation (BipolarAFL) and quadripolar passive fixation left-ventricular leads (QuadPFL) have been designed to reduce the risk of phrenic nerve stimulation (PNS), enable targeted left-ventricular pacing, and overcome problems of difficult coronary venous anatomy and lead dislodgment. This study sought to report the long-term safety and performance of a BipolarAFL, Medtronic Attain Stability 20066, compared to QuadPFL. Methods: We performed a single-operator retrospective analysis of 81 patients receiving cardiac resynchronization therapy (CRT) (36 BipolarAFL, 45 QuadPFL). Immediate implant data and electrical and clinical data during follow-up (FU) were analyzed. Results: BipolarAFL has been chosen in patients with significantly larger estimated vein diameter (at the lead tip: 7.2 ± 4.1 Fr vs. 4.1 ± 2.3 Fr, p < 0.001) without significant time difference until the final lead position was achieved (BipolarAFL: 20.9 ± 10.5 min, vs. QuadPFL: 18.9 ± 8.9 min, p = 0.35). At 12 month FU no difference in response rate to CRT was recorded between BipolarAFL and QuadPFL according to left ventricular end-systolic volume (61.1 vs. 60.0%, p = 0.82) and New York Heart Association (66.7 vs. 62.2%, p = 0.32). At median FU of 48 months (IQR: 44-54), no lead dislodgment occurred in both groups but a significantly higher proportion of PNS was recorded in QuadPFL (13 vs. 0%, p < 0.05). Electrical parameters were stable during FU in both groups without significant differences. Conclusion: BipolarAFL can be implanted with ease in challenging coronary venous anatomy, shows excellent electrical performance and no difference in clinical outcome compared to QuadPFL.
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BACKGROUND: Optimization of cardiac resynchronization therapy (CRT) is often time-consuming and therefore underused in a clinical setting. Novel device-based algorithms aiming to simplify optimization include a dynamic atrioventricular delay (AVD) algorithm (SyncAV, Abbott) and multipoint pacing (MPP, Abbott). This study examines the acute effect of SyncAV and MPP on electrical synchrony in patients with newly and chronically implanted CRT devices. METHODS: Patients with SyncAV and MPP enabled devices were prospectively enrolled during implant or scheduled follow-up. Blinded 12-lead electrocardiographic acute measurements of QRS duration (QRSd) were performed for intrinsic QRSd (Intrinsic), bi-ventricular pacing (BiV), MPP, BiV with SyncAV at default offset 50 ms (BiVSyncAVdef ), BiV with SyncAV at patient-specific optimised offset (BiVSyncAVopt ), MPP with SyncAV at default offset 50 ms (MPPSyncAVdef ), and MPP with SyncAV at patient-specific optimised offset (MPPSyncAVopt ). RESULTS: Thirty-three patients were enrolled. QRSd for Intrinsic, BiV, MPP, BiVSyncAVdef , BiVSyncAVopt , MPPSyncAVdef , MPPSyncAVopt were 160.4 ± 20.6 ms, 141.0 ± 20.5 ms, 130.2 ± 17.2 ms, 121.7 ± 20.9 ms, 117.0 ± 19.0 ms, 121.2 ± 17.1 ms, 108.7 ± 16.5 ms respectively. MPPSyncAVopt led to greatest reduction of QRSd relative to Intrinsic (-31.6 ± 11.1%; p < .001), showed significantly shorter QRSd compared to all other pacing configurations (p < .001) and shortest QRSd in every patient. Shortening of QRSd was not significantly different between newly and chronically implanted devices (-51.6 ± 14.7 ms vs. -52.7 ± 21.9 ms; p = .99). CONCLUSION: SyncAV and MPP improved acute electrical synchrony in CRT. Combining both technologies with patient-specific optimization resulted in greatest improvement, regardless of time since implantation. Whats new Novel device-based algorithms like a dynamic AVD algorithm (SyncAV, Abbott) and multipoint pacing (MPP, Abbott) aim to simplify CRT optimization. Our data show that a combination of patient tailored SyncAV optimization and MPP results in greatest improvement of electrical synchrony in CRT measured by QRS duration, regardless if programmed in newly or chronically implanted devices. This is the first study to our knowledge to examine a combination of these device-based algorithms. The results help understanding the ideal ventricular excitation in heart failure.
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Algoritmos , Terapia de Resincronización Cardíaca/métodos , Cardiomiopatías/terapia , Anciano , Electrocardiografía , Femenino , Alemania , Humanos , Masculino , Estudios ProspectivosRESUMEN
BACKGROUND: The prevalence of aortic valve stenosis is increasing due to the continuously growing geriatric population. Data on procedural success and mortality of very old patients are sparse, raising the question of when this population may be deemed as "too old even for transcatheter aortic valve replacement (TAVR)." We, therefore, sought to evaluate the influence of age on outcome after TAVR and the impact of direct implantation. METHODS: The data of 394 consecutive patients undergoing TF-TAVR were analyzed. Patients were divided into four age groups: ≤75 (group 1, nâ¯= 28), 76-80 (group 2, nâ¯= 107), 81-85 (group 3, nâ¯= 148), and >85 (group 4, nâ¯= 111) years. Direct implantation was performed when possible according to current recommendations. Survival was evaluated by Kaplan-Meier analysis. RESULTS: Mortality at 30 days and 1 year was not significantly different between the four age groups (3.6 vs. 6.7 vs. 5.4 vs. 2.7% and 7.6 vs. 17 vs. 14.5 vs. 13%m respectively, log-rank pâ¯= 0.59). Direct implantation without balloon aortic valvuloplasty was more frequently performed on patients aged >85 vs. ≤85 years (33.3 vs. 14.1%, pâ¯< 0.001). the incidence of procedural complications frequently associated with advanced age (stroke, vascular complications) was not significantly increased in group 4. CONCLUSION: Outcome after TF-TAVR is comparable among different age cohorts, even in very old patients. Direct implantation simplifies the procedure and could therefore play a role in reducing the incidence of peri-interventional complications in patients of advanced age.
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Estenosis de la Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Humanos , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Current recommendations for valve size selection are based on multidimensional annular measurements, yet the overlap between two different transcatheter heart valve (THV) sizes remains. We sought to evaluate whether undersizing but overfilling eliminates the gray zones of valve sizing. METHODS: Data of 246 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable bioprosthesis with either conventional sizing and nominal filling (group 1 (NF-TAVR), n = 154) or undersizing but overfilling under a Less Is More (LIM)-Principle (group 2 (LIM-TAVR), n = 92) were compared. Paravalvular leakage (PVL) was graded angiographically and quantitatively using invasive hemodynamics. RESULTS: Annulus rupture (AR) occurred only in group 1 (n = 3). Due to AR adequate evaluation of PVL was possible in 152 patients of group 1. More than mild PVL was found in 13 (8.6%) patients of group 1 and 1 (1.1%) patient of group 2 (p = 0.019). Postdilatation was performed in 31 (20.1%) patients of group 1 and 6 patients (6.5%) of group 2 (p = 0.003). For patients with borderline annulus size in group 1 (n = 35, 22.7%) valve size selection was left to the physicians choice resulting in selection of the larger prosthesis in 10 (28.6%). In group 2 all patients with borderline annulus (n = 36, 39.1%) received the smaller prosthesis (LIM-TAVR). The postprocedural mean transvalvular pressure gradient was significantly higher in the NF-TAVR-group (11.7 ± 4 vs. 10.1 ± 3.6 mmHg, p = 0.005). CONCLUSION: LIM-TAVR eliminates the gray zones of sizing and associated PVL, can improve THV-performance, reduce incidence of annular rupture and simplify the procedure especially in borderline cases.
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INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.
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Dispositivos de Terapia de Resincronización Cardíaca , Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca/terapia , Función Ventricular Izquierda , Anciano , Anciano de 80 o más Años , Terapia de Resincronización Cardíaca/efectos adversos , Diseño de Equipo , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
Malfunctions in implanted pacemaker and defibrillator systems can affect all components of the device (battery, capacitor, central processing unit (CPU), connector, soldering points, electrodes). The resulting problems can manifest themselves as inadequate therapy, a lack of therapy despite the need for stimulation or shock release in case of ventricular tachyarrhythmia, or as an ineffective delivery of therapy. The high number of implanted pacemaker and defibrillator systems, the increased life expectancy and the technical progress of cardiac "device" therapy mean that the treating physician is confronted with increasingly complex problems in the follow-up. In addition to the knowledge of the basic function of these devices, a structured procedure to detect and treat malfunctions in a timely manner is required. In this review, frequent malfunctions of pacemaker and defibrillators are presented, individual problems are pointed out, and solutions and treatment options are shown.
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Marcapaso Artificial , Taquicardia Ventricular , Desfibriladores , Desfibriladores Implantables , HumanosRESUMEN
OBJECTIVE: In implantable cardiac defibrillators (ICDs), long-detection times safely reduce unnecessary and inappropriate therapies. We aimed to evaluate ICD treatment of ventricular arrhythmias in women, compared with men, also taking into account ICD detection. METHODS: The Advance III trial randomised patients implanted with an ICD for primary or secondary prevention in two arms-long and nominal ventricular arrhythmias detection times before therapy delivering (number of intervals needed to detect (NID) 30/40 and 18/24, respectively). The main endpoint of this post hoc analysis was the incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models. RESULTS: Overall, 1902 patients (304 women, 65±11 years) were randomised. Women showed a lower risk of ICD therapy (HR 0.63, 95% CI 0.43 to 0.93, p=0.022); this difference was observed only in the long-detection arm (HR 0.37, p=0.013) and not in the short detection arm (HR 0.82, p=0.414). No significant sex differences were observed concerning inappropriate therapies and mortality rate. Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048). CONCLUSIONS: In patients with ICDs, the strategy of setting a long-detection time to treat ventricular arrhythmias (NID 30/40) reduces overall delivered therapies, both in women and men, when compared with nominal setting (NID 18/24). The reduction was significantly higher in women. Overall, women were less likely to experience ICD therapies than men; this result was only observed in the long-detection arm. CLINICAL TRIAL REGISTRATION: NCT00617175.
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Arritmias Cardíacas/terapia , Desfibriladores Implantables , Anciano , Arritmias Cardíacas/diagnóstico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores Sexuales , Método Simple Ciego , Factores de TiempoRESUMEN
BACKGROUND: Multipoint pacing [Multipoint™ Pacing (MPP), Abbott] via a single left ventricular lead (Quartet™ LV lead, Abbott) improves acute left ventricular (LV) function and response to cardiac resynchronization therapy (CRT). Aim of this study was to examine additional benefits in terms of LV reverse remodeling and CRT response by activating MPP in responders and non-responders to conventional biventricular pacing (CONV). METHODS: 43 consecutive patients receiving CRT (Quadra Assura MP™, Abbott) received LV dP/dtmax optimized CONV programming for 6 months. MPP programming with large anatomical electrode separation (> 30 mm) and basal LV1 pacing location was activated afterwards. Echocardiographic and clinical parameters were obtained at baseline, 6- and 12-month follow-up (FU). The response was defined as an improvement of LVESV ≥ 15% and super-response as improvement ≥ 30% relative to baseline. RESULTS: 41 patients completed FU (one died of non-cardiac cause and one was lost to FU) and after 6 months CONV, 26 patients (63%) were classified as CRT responders. With MPP, the response rate increased to 90% (p < 0.001). Super-response also improved significantly with MPP compared to CONV (71% vs. 22%; p < 0.005). LV reverse remodeling in terms of LVESV improved significantly with MPP compared to CONV (79 ± 45 ml vs. 103 ± 64 ml; p < 0.001). NYHA-class only improved significantly with CONV relative to baseline (1,8 ± 0,7 vs. 2,7 ± 0,5; p < 0.001), but not further with MPP (1,7 ± 0,6 vs. 1,8 ± 0,7; p = 0.49). CONCLUSION: Multipoint pacing significantly improves response and super-response to CRT as well as LV reverse remodeling compared to conventional biventricular pacing.
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Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca/terapia , Función Ventricular Izquierda , Remodelación Ventricular , Anciano , Terapia de Resincronización Cardíaca/efectos adversos , Femenino , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Recuperación de la Función , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Presión VentricularRESUMEN
OBJECTIVES: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR. METHODS: Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed. RESULTS: Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months. CONCLUSION: TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.
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Aorta Torácica , Enfermedades de la Aorta/complicaciones , Enfermedades de la Aorta/cirugía , Estenosis de la Válvula Aórtica/cirugía , Procedimientos Endovasculares/métodos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Enfermedades de la Aorta/diagnóstico , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico , Estudios de Factibilidad , Femenino , Arteria Femoral , Estudios de Seguimiento , Alemania/epidemiología , Humanos , Incidencia , Masculino , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Tomografía Computarizada por Rayos XRESUMEN
AIMS: The objective of this paper is to assess whether cardiac contractility modulation (via the Optimizer System) plus standard of care (SoC) is a cost-effective treatment for people with heart failure [New York Heart Association (NYHA) III, left ventricular ejection fraction of 25-45%, and narrow QRS] compared against SoC alone from the perspective of the English National Health Service. METHODS AND RESULTS: We developed a regression equation-based cost-effectiveness model, using individual patient data from three randomized control trials (FIX-HF-5 Phases 1 and 2, and FIX-HF-5C) to populate the majority of parameters. A series of regression equations predicted NYHA class over time, mortality, all-cause hospitalization rates, and health-related quality of life. We conducted the analysis in line with the National Institute for Health and Care Excellence reference case, modelling costs from an English National Health Service perspective, and considering outcomes in quality-adjusted life years (QALYs) over a patient lifetime perspective. Our base case analysis produced an incremental cost per additional QALY of GBP22 988 (25 750) when comparing Optimizer + SoC to SoC alone. This result was not sensitive to parameter uncertainty but was sensitive to the time horizon over which costs and QALYs were captured and the duration over which a survival benefit with Optimizer + SoC can be assumed to apply. CONCLUSIONS: Cardiac contractility modulation is likely to be cost-effective in people with heart failure with reduced ejection fraction, NYHA III, and narrow QRS, provided that the treatment benefit can be maintained beyond the duration of the existing clinical trial follow-up. This analysis supports the current recommendations of the European Society of Cardiology that this therapy may be considered for such patients.
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Terapia por Estimulación Eléctrica , Insuficiencia Cardíaca , Marcapaso Artificial , Anciano , Análisis Costo-Beneficio , Terapia por Estimulación Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/economía , Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/mortalidad , Electrocardiografía , Femenino , Corazón/fisiopatología , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Marcapaso Artificial/efectos adversos , Marcapaso Artificial/economía , Marcapaso Artificial/estadística & datos numéricos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
AIMS: We sought to determine whether atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD) and with permanent atrial fibrillation (AF) has a positive impact on ICD shocks and hospitalizations compared with rate-slowing drugs. METHODS AND RESULTS: This is a pooled analysis of data from 179 international centres participating in two randomized trials and one prospective observational research. The co-primary endpoints were all-cause ICD shocks and all-cause hospitalizations. Out of 3358 CRT-ICD patients (2720 male, 66.6 years), 2694 (80%) were in sinus rhythm (SR) and 664 (20%) had permanent AF-262 (8%) treated with AVJA (AF + AVJA) and 402 (12%) treated with rate-slowing drugs (AF + Drugs). Median follow-up was 18 months. The mean (95% confidence intervals) annual rate of all-cause ICD shocks per 100 patient years was 8.0 (5.3-11.9) in AF + AVJA, 43.6 (37.7-50.4) in AF + Drugs, and 34.4 (32.5-36.5) in SR patients, resulting in incidence rate ratio (IRR) reductions of 0.18 (0.10-0.32) for AF + AVJA vs. AF + Drugs (P < 0.001) and 0.48 (0.35-0.66) for AF + AVJA vs. SR (P < 0.001). These reductions were driven by significant reductions in both appropriate ICD shocks [IRR 0.23 (0.13-0.40), P < 0.001, vs. AF + Drugs] and inappropriate ICD shocks [IRR 0.09 (0.04-0.21), P < 0.001, vs. AF + Drugs]. Annual rate of all-cause hospitalizations was significantly lower in AF + AVJA vs. AF + Drugs [IRR 0.57 (0.41-0.79), P < 0.001] and SR [IRR 0.85 (073-0.98), P = 0.027]. CONCLUSION: In AF patients treated with CRT, AVJA results in a lower incidence and burden of all-cause, appropriate and inappropriate ICD shocks, as well as to fewer all-cause and heart failure hospitalizations. CLINICAL TRIAL REGISTRATION: NCT00147290, NCT00617175, NCT01007474.
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Fibrilación Atrial/terapia , Nodo Atrioventricular/cirugía , Terapia de Resincronización Cardíaca/métodos , Ablación por Catéter/métodos , Desfibriladores Implantables , Hospitalización/tendencias , Taquicardia Ventricular/terapia , Anciano , Nodo Atrioventricular/fisiopatología , Femenino , Estudios de Seguimiento , Frecuencia Cardíaca/fisiología , Humanos , Masculino , Estudios Prospectivos , Resultado del TratamientoRESUMEN
This article provides a technical description of common implant practice for delivery of cardiac contractility modulation (CCM) therapy to heart failure patients. As of September 2016, the authors of this article collectively have been involved with more than 400 system implantations in five medical centers, beginning with the advent of CCM therapy approximately 12 years ago. CCM therapy has been evaluated in a variety of studies, and was shown to be safe and effective and of benefit to patient quality of life and exercise capacity. As the use of CCM therapy continuously expands among medical centers in Europe, this article describes the technical and practical aspects of the implant procedure, and additional special technical cases based on our cumulative experience.
Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Insuficiencia Cardíaca/terapia , Contracción Miocárdica , Terapia por Estimulación Eléctrica/efectos adversos , Diseño de Equipo , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Humanos , Recuperación de la Función , Resultado del TratamientoRESUMEN
AIMS: Cardiac resynchronization therapy (CRT) requires effective left ventricular (LV) pacing (i.e. sufficient energy and appropriate timing to capture). The AdaptivCRT™ (aCRT) algorithm serves to maintain ventricular fusion during LV or biventricular pacing. This function was tested by comparing the morphological consistency of ventricular depolarizations and percentage effective LV pacing in CRT patients randomized to aCRT vs. echo-optimization. METHODS AND RESULTS: Continuous recordings (≥20 h) of unipolar LV electrograms from aCRT (n = 38) and echo-optimized patients (n = 22) were analysed. Morphological consistency was determined by the correlation coefficient between each beat and a template beat. Effective LV pacing of paced beats was assessed by algorithmic analysis of negative initial EGM deflection in each evoked response. The %CRT pacing delivered, %effective LV pacing (i.e. % of paced beats with effective LV pacing), and overall %effective CRT (i.e. product of %CRT pacing and %effective LV pacing) were compared between aCRT and echo-optimized patients. Demographics were similar between groups. The mean correlation coefficient between individual beats and template was greater for aCRT (0.96 ± 0.03 vs. 0.91 ± 0.13, P = 0.07). Although %CRT pacing was similar for aCRT and echo-optimized (median 97.4 vs. 98.6%, P = 0.14), %effective LV pacing was larger for aCRT [99.6%, (99.1%, 99.9%) vs. 94.3%, (24.3%, 99.8%), P=0.03]. For aCRT vs. echo-optimized groups, the proportions of patients with ≥90% effective LV pacing was 92 vs. 55% (P = 0.002), and with ≥90% effective CRT was 79 vs. 45%, respectively (P = 0.018). CONCLUSION: AdaptivCRT™ significantly increased effective LV pacing over echo-optimized CRT.