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Background A wide variability in the perioperative management of oral anticoagulation (OAC) has been documented in patients receiving cardiac rhythm management devices (CRMDs). We sought to evaluate the safety and feasibility of a new perioperative strategy consisting in systematically continuing OAC in all patients irrespective of their individual thromboembolic (TE) risk. Methods A total of 278 consecutive patients on chronic OAC receiving CRMDs were prospectively included. Patients were classified in high and low TE risk according to current guidelines for the perioperative management of antithrombotic therapy, but underwent implantation under active OAC (international normalized ratio 2–4) irrespective of their preoperative TE risk. Bleeding and TE complications were evaluated as well as other procedure-related complications, hospital stays, and the feasibility of outpatient implantations. Results A total of 117 patients were considered at high TE risk and 161 at low TE risk. Overall, the incidence of pocket hematoma was 2.9% with only three patients requiring pocket revision. Low TE risk patients had a very low incidence of pocket hematoma (1.9%) without needing pocket revision. The mean hospital stay was 1.17 ± 1.8 days and 169 patients (61%) received their CRMD in an outpatient basis, including 77 patients who were implanted with an implantable cardioverter defibrillator. No TE events were detected during the 30-day postimplant observation period in any patient. No other significant complications related with the implant (pneumothorax, hemothorax, cardiac tamponade) were registered. Conclusions Systematic continuation of OAC in all patients undergoing implantation of CRMDs is safe and feasible, thus simplifying and standardizing the perioperative management in this setting.

Perioperative management of oral anticoagulation (OAC) in patients receiving pacemakers or implantable cardioverter-defibrillators remains an issue of concern.We sought to evaluate the safety and the effect on the hospital length of stay of a new standardized protocol for perioperative management of OAC in this setting.The new standardized protocol classified patients according to a renewed evaluation of their thromboembolic (TE) risk. Briefly, patients were considered at moderate-to-high TE risk if they had a mechanical valvular prostheses irrespective of type and location or atrial fibrillation associated with a CHADS(2)score of ≥2, mitral stenosis or previous stroke, and underwent device implantation without stopping OAC (OAC continued, n = 129). Complete interruption of OAC before surgery was performed in low-TE-risk patients (OAC interrupted, n = 82). A retrospective cohort of patients managed with a classic heparin-bridging strategy served as a control group, with 62 patients considered at moderate-to-high TE risk according to previous guidelines (receiving pre- and postoperative low-molecular-weight heparin) and 146 considered at low TE risk (receiving only low doses of postoperative low-molecular-weight heparin).TE events were comparable between the 2 strategies. Patients entering the new standardized protocol had significantly lower rates of pocket hematoma (2.3% for OAC continued vs 17.7% for moderate-to-high TE risk bridging controls, P = .0001, and 0% for OAC interrupted vs 13% for low-TE-risk bridging controls, P.0001) and shorter hospital stays. A mean of 3.34 hospitalization days per patient were saved with the new standardized protocol, with an estimated cost savings of €850.83 per patient.Implantation of the new standardized protocol resulted in a significant reduction in bleeding complications and hospital stays, with adequate protection against TE events and significant cost savings.

Background: Active-fixation pacing leads are being widely employed due to their theoretical advantages when compared with traditional passive-fixation leads: easy fixation and reposition, possible deployment in alternative pacing sites, lower rates of dislodgment, and chronic removability. However, the behavior of the active-fixation mechanism during lead removal has not been yet systematically studied and may have important clinical implications. Objective: To evaluate if the active-fixation mechanism was still working properly in pacing leads that were removed due to different causes. Methods: Thirty-one consecutive patients undergoing active-fixation lead removal (40 leads) were studied. Before lead removal, the helix was retracted using the appropriate tool, and fluoroscopy signs were evaluated. After removal, the helix status was examined, and the active-fixation mechanism was once again retested when possible. Results: In nine of 40 leads (22.5%), the helix remained extended after lead removal in spite of having applied the number of rotations recommended by the manufacturer with the clip-on tool. There was no linear relationship between lead longevity and the presence of an extended helix after lead removal. However, failure of the active-fixation mechanism was more frequent among leads implanted 1 year before (OR 6.8, 95% CI 1.1–42.7, P = 0.043). In 38% of patients with failure of the active-fixation mechanism, a previous lead reposition had been attempted before lead removal due to significant pacing threshold rise. Conclusions: In our series, the active-fixation mechanism failed in up to 22.5% of explanted leads. This may have important clinical implications during active-fixation lead removal and reposition. 2011; 34:1217–1224)

Chronic right ventricular apical pacing (RVAP) has been associated with negative hemodynamic and clinical effects. The aim of the present study was to compare RVAP with right ventricular septal pacing (RVSP) in terms of echocardiographic features and clinical outcomes. A total of 93 patients without structural heart disease and with an indication for a permanent pacemaker were randomly assigned to receive a screw-in lead either in the RV apex (n = 46) or in the RV mid-septum (n = 47). The patients were divided into 3 subgroups according to the percentage of ventricular pacing: control group (n = 21, percentage of ventricular pacingor =10%), RVAP group (n = 28), or RVSP group (n = 32; both latter groups had a percentage of ventricular pacing10%). The RVAP group had more intraventricular dyssynchrony and a trend toward a worse left ventricular ejection fraction compared to the RVSP and control groups at 12 months of follow-up (maximal delay to peak systolic velocity between any of the 6 left ventricular basal segments was 57.8 +/- 38.2, 35.5 +/- 20.6, and 36.5 +/- 17.8 ms for RVAP, RVSP, and control group, respectively; p = 0.006; mean left ventricular ejection fraction 62.9 +/- 7.9%, 66.5 +/- 7.2%, and 66.6 +/- 7.2%, respectively, p = 0.14). Up to 48.1% of the RVAP patients showed significant intraventricular dyssynchrony compared to 19.4% of the RVSP patients and 23.8% of the controls (p = 0.04). However, no overt clinical benefits from RVSP were found. In conclusion, RVAP was associated with increased dyssynchrony compared to the RVSP and control patients. RVSP could represent an alternative pacing site in selected patients to reduce the harmful effects of traditional RVAP.

Introduccion y objetivos En los ultimos anos se ha producido una sobrecarga de trabajo en las consultas de dispositivos cardiacos. La monitorizacion remota permite su evaluacion a distancia y podria reducir el numero de visitas hospitalarias. Los objetivos del estudio han sido evaluar la fiabilidad tecnica y la seguridad clinica del sistema Home Monitoring™ (HM, Biotronik GmbH, Alemania). Metodos Hemos evaluado a 162 pacientes portadores de marcapasos (115), DAI (44) y DAI-TRC (3), durante un seguimiento medio de 303 ± 244 dias. Se comparo la supervivencia libre de sucesos de alarma entre los pacientes portadores de marcapasos y DAI. La fiabilidad del HM fue analizada comprobando los datos transmitidos con la evaluacion clinica presencial inmediatamente posterior. Resultados El porcentaje medio de dias monitorizados fue el 88,2%. La incidencia de sucesos de alerta fue mayor en el grupo de marcapasos que en el de DAI (el 45 frente al 34%; p = 0,01). Los sucesos de alerta precedieron a la siguiente visita programada en 76 ± 47 dias. En el grupo de DAI los datos transmitidos por el HM fueron juzgados como verdaderos positivos en el 42%, como verdaderos negativos en el 57% y como falso positivo en un 1% de los casos. No observamos ningun falso negativo. El HM mostro en el grupo de DAI sensibilidad y especificidad del 100 y el 97% (VPP, 96%; VPN, 100%). Conclusiones El HM es una herramienta fiable y segura para el seguimiento de los pacientes con un dispositivo cardiaco. Su utilizacion rutinaria permitiria detectar precozmente anomalias del funcionamiento del dispositivo o sucesos arritmicos.

A wide variability in the perioperative management of oral anticoagulation (OAC) has been documented in patients receiving cardiac rhythm management devices (CRMDs). We sought to evaluate the safety and feasibility of a new perioperative strategy consisting in systematically continuing OAC in all patients irrespective of their individual thromboembolic (TE) risk.A total of 278 consecutive patients on chronic OAC receiving CRMDs were prospectively included. Patients were classified in high and low TE risk according to current guidelines for the perioperative management of antithrombotic therapy, but underwent implantation under active OAC (international normalized ratio 2-4) irrespective of their preoperative TE risk. Bleeding and TE complications were evaluated as well as other procedure-related complications, hospital stays, and the feasibility of outpatient implantations.A total of 117 patients were considered at high TE risk and 161 at low TE risk. Overall, the incidence of pocket hematoma was 2.9% with only three patients requiring pocket revision. Low TE risk patients had a very low incidence of pocket hematoma (1.9%) without needing pocket revision. The mean hospital stay was 1.17 ± 1.8 days and 169 patients (61%) received their CRMD in an outpatient basis, including 77 patients who were implanted with an implantable cardioverter defibrillator. No TE events were detected during the 30-day postimplant observation period in any patient. No other significant complications related with the implant (pneumothorax, hemothorax, cardiac tamponade) were registered.Systematic continuation of OAC in all patients undergoing implantation of CRMDs is safe and feasible, thus simplifying and standardizing the perioperative management in this setting.

Active-fixation pacing leads are being widely employed due to their theoretical advantages when compared with traditional passive-fixation leads: easy fixation and reposition, possible deployment in alternative pacing sites, lower rates of dislodgment, and chronic removability. However, the behavior of the active-fixation mechanism during lead removal has not been yet systematically studied and may have important clinical implications. To evaluate if the active-fixation mechanism was still working properly in pacing leads that were removed due to different causes. Thirty-one consecutive patients undergoing active-fixation lead removal (40 leads) were studied. Before lead removal, the helix was retracted using the appropriate tool, and fluoroscopy signs were evaluated. After removal, the helix status was examined, and the active-fixation mechanism was once again retested when possible. In nine of 40 leads (22.5%), the helix remained extended after lead removal in spite of having applied the number of rotations recommended by the manufacturer with the clip-on tool. There was no linear relationship between lead longevity and the presence of an extended helix after lead removal. However, failure of the active-fixation mechanism was more frequent among leads implanted1 year before versus1 year before (OR 6.8, 95% CI 1.1-42.7, P = 0.043). In 38% of patients with failure of the active-fixation mechanism, a previous lead reposition had been attempted before lead removal due to significant pacing threshold rise. In our series, the active-fixation mechanism failed in up to 22.5% of explanted leads. This may have important clinical implications during active-fixation lead removal and reposition.

Aims Perioperative management of antiplatelet (AP) therapy in patients undergoing implantation of cardiac rhythm management devices (CRMD) remains an issue of concern that has not been prospectively evaluated in a large series. We sought to describe the morbidity associated with three different AP regimens in this setting. Methods and results We conducted a prospective observational study including 849 consecutive patients who were classified in three groups according to the presence of any AP treatment: Group 1 ( n = 220): single AP therapy; Group 2 ( n = 60): dual AP therapy; and Group 3 ( n = 40): oral anticoagulant (OAC) + enoxaparin ‘bridging' + AP therapy. Two other groups served as controls: Group 4 ( n = 375): no AP or OAC therapy; and Group 5 ( n = 154): OAC + enoxaparin ‘bridging'. The incidence of pocket haematoma, pocket revisions, hospital stays duration, and unscheduled follow-up visits due to pocket-related complications were compared. Patients on Groups 2, 3 and 5 had significantly higher incidences of pocket haematoma (13.3, 15, and 14.9%, respectively) when compared with Groups 1 and 4 (3.2 and 2.4%, respectively), as well as longer hospital stays and more unscheduled follow-up visits. Of note, only patients on enoxaparin ‘bridging' required surgical revision of the pocket. Dual AP therapy ( P < 0.001), enoxaparin ‘bridging' ( P < 0.001) and renal insufficiency ( P = 0.02) were independent predictors of pocket haematoma in multivariate analysis. Conclusion Dual AP therapy and OAC + AP therapy is strongly associated with a significant risk of pocket haematoma, longer hospital stays, and unscheduled follow-up visits. Importantly, surgical revision of the pocket was associated with enoxaparin ‘bridging' strategy but was never necessary in patients taking exclusively antiaggregant agents.

Introduction and objectives In recent years, physicians have experienced a huge increase in workload associated with cardiac devices. Remote monitoring enables these devices to be monitored at a distance and could reduce the number of hospital visits. The aim of this study was to assess the technical reliability and clinical safety of the Home Monitoring™ remote monitoring system (Biotronik GmbH, Germany). Methods The study included 162 patients: 115 with pacemakers, 44 with implantable cardioverterdefibrillators (ICDs) and 3 with ICDs incorporating cardiac resynchronization therapy (CRT). Patients were followed up for a mean of 303 (244) days. We compared the survival time free of event alerts in patients with pacemakers and in those with ICDs. The remote monitoring system's reliability was evaluated by comparing the data it transmitted with clinical observations made immediately afterwards. Results The mean percentage of days monitored was 88.2%. The incidence of event alerts was higher in pacemaker than ICD patients (45% vs 34%; P =.01). Event alerts preceded the following hospital visit by 76 (47) days. In the ICD group, the data sent by the monitoring system were judged as true-positives in 42% of cases, as true-negatives in 57% and as false-positives in 1%. No false-negative was observed. In the ICD group, the remote monitoring system had a sensitivity of 100% and a specificity of 97% (positive predictive value 96%, negative predictive value 100%). Conclusions Remote monitoring was a reliable and safe method for following up patients with cardiac devices. Its routine use could enable the early detection of device malfunctions or arrhythmic events.