Impact of new X-ray technology on patient dose in pacemaker and implantable cardioverter defibrillator (ICD) implantations

PURPOSE: New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. METHODS: In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. RESULTS: The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm(2) for the non-CRT implantations (p < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm(2) for the CRT implantations (p < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology (p = 0.09 and p = 0.20, respectively). CONCLUSIONS: Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected

Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy:Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort

Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits

Five-year safety and efficacy of leadless pacemakers in a Dutch cohort

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing.OBJECTIVE: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort.METHODS: In this retrospective cohort study, all consecutive patients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure- or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2.0 V at implantation and without ≥1.5-V increase at the last follow-up visit.RESULTS: A total of 179 patients were included (mean age 79 ± 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 ± 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%).CONCLUSION: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold.</p

Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique

Aims Pulmonary vein isolation (PVI) has become a cornerstone of the invasive treatment of atrial fibrillation. Severe complications are reported in 1-3% of patients. This study aims to compare complications and follow-up outcome of PVI in patients with atrial fibrillation. Methods and results The data were extracted from the Netherlands Heart Registration. Procedural and follow-up outcomes in patients treated with conventional radiofrequency (C-RF), multielectrode phased RF (Ph-RF), or cryoballoon (CB) ablation from 2012 to 2017 were compared. Subgroup analysis was performed to identify variables associated with complications and repeat ablations. In total, 13 823 patients (69% male) were included. The reported complication incidence was 3.6%. Patients treated with C-RF developed more cardiac tamponades (C-RF 0.8% vs. Ph-RF 0.3% vs. CB 0.3%, P Conclusion The reported complication rate during PVI was low. Patients treated with C-RF ablation were more likely to develop cardiac tamponades and vascular complications. Female sex was associated with more cardiac tamponade and bleeding complications

Mapping and Surgical Ablation of Focal Epicardial Left Ventricular Tachycardia

We describe a technical challenge in a 17-year-old patient with incessant epicardial focal ventricular arrhythmia and diminished LV function. Failure of ablation at the earliest activated endocardial site during ectopy suggested an epicardial origin, which was supported by specific electrocardiographic criteria. Epicardial ablation was not possible due to the localization of the origin of the ventricular tachycardia adjacent to the phrenic nerve. Minimal invasive surgical multielectrode high-density epicardial mapping was performed to localize the arrhythmia focus. Epicardial surgical RF ablation resulted in the termination of ventricular ectopy. After 2 years, the patient is still free from arrhythmias

Dominant frequency of atrial fibrillation correlates poorly with atrial fibrillation cycle length

Localized sites of high frequency during atrial fibrillation (AF) are used as target sites to eliminate AF. Spectral analysis is used experimentally to determine these sites. The purpose of this study was to compare dominant frequencies (DF) with AF cycle length (AFCL) of unipolar and bipolar recordings. Left and right atrial endocardial electrograms were recorded during AF in 40 patients with lone AF, using two 20-polar catheters. Mean age was 53+/-9.9 years. Unipolar and bipolar electrograms were recorded simultaneously during 16 seconds at 2 right and 4 left atrial sites. AFCLs and DFs were determined. QRS subtraction was performed in unipolar signals. DFs were compared with mean, median, and mode of AFCLs; 4800 unipolar and 2400 bipolar electrograms were analyzed. Intraclass correlation was poor for all spectral analysis protocols. Best correlation was accomplished with DFs from unipolar electrograms compared with median AFCL (intraclass correlation coefficient, 0.67). A gradient in median AFCL of >25% was detected in 16 of 40 patients. In 13 of 16 patients (81%) with a frequency gradient of >25%, the site with highest frequency was located in the left atrium (posterior left atrium in 8 patients). The site with shortest median AFCL and highest DF corresponded in 25% if unipolar and in 31% if bipolar electrograms were analyzed. DFs from unipolar and bipolar electrograms recorded during AF correlated poorly with mean, median, and mode AFCL. If a frequency gradient >25% existed, the site with highest DF corresponded to the site of shortest median AFCL in only 25% of patients. Because spectral analysis is being used to identify ablation sites, these data may have important clinical implication

Dutch outcome in implantable cardioverterdefibrillator therapy: Implantable cardioverter-defibrillator–related complications in a contemporary primary prevention cohort

BACKGROUND: One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. METHODS AND RESULTS: Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverterdefibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0–2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. CONCLUSIONS: One in 13 patients experiences at least one major implantable cardioverter-defibrillator–related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits

Renal sympathetic denervation induces changes in heart rate variability and is associated with a lower sympathetic tone

BackgroundRenal nerve stimulation (RNS) is used to localize sympathetic nerve tissue for selective renal nerve sympathetic denervation (RDN). Examination of heart rate variability (HRV) provides a way to assess the state of the autonomic nervous system. The current study aimed to examine the acute changes in HRV caused by RNS before and after RDN.Methods and results30 patients with hypertension referred for RDN were included. RNS was performed under general anesthesia before and after RDN. Heart rate (HR) and blood pressure (BP) were continuously monitored. HRV characteristics were assessed 1min before and after RNS and RDN. RNS before RDN elicited a maximum increase in systolic BP of 45 (22)mmHg which was attenuated to 13 (+/- 12)mmHg (