To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was ‘atrial arrhythmia recurrence’, secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm² (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70–1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64–0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26–1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34–0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48–0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

Noise and artifacts are inherent contaminating components and are particularly present in Holter electrocardiogram (ECG) monitoring. The presence of noise is even more significant in long-term monitoring (LTM) recordings, as these are collected for several days in patients following their daily activities; hence, strong artifact components can temporarily impair the clinical measurements from the LTM recordings. Traditionally, the noise presence has been dealt with as a problem of non-desirable component removal by means of several quantitative signal metrics such as the signal-to-noise ratio (SNR), but current systems do not provide any information about the true impact of noise on the ECG clinical evaluation. As a first step towards an alternative to classical approaches, this work assesses the ECG quality under the assumption that an ECG has good quality when it is clinically interpretable. Therefore, our hypotheses are that it is possible (a) to create a clinical severity score for the effect of the noise on the ECG, (b) to characterize its consistency in terms of its temporal and statistical distribution, and (c) to use it for signal quality evaluation in LTM scenarios. For this purpose, a database of external event recorder (EER) signals is assembled and labeled from a clinical point of view for its use as the gold standard of noise severity categorization. These devices are assumed to capture those signal segments more prone to be corrupted with noise during long-term periods. Then, the ECG noise is characterized through the comparison of these clinical severity criteria with conventional quantitative metrics taken from traditional noise-removal approaches, and noise maps are proposed as a novel representation tool to achieve this comparison. Our results showed that neither of the benchmarked quantitative noise measurement criteria represent an accurate enough estimation of the clinical severity of the noise. A case study of long-term ECG is reported, showing the statistical and temporal correspondences and properties with respect to EER signals used to create the gold standard for clinical noise. The proposed noise maps, together with the statistical consistency of the characterization of the noise clinical severity, paves the way towards forthcoming systems providing us with noise maps of the noise clinical severity, allowing the user to process different ECG segments with different techniques and in terms of different measured clinical parameters.

In recent years, a number of proposals for electrocardiogram (ECG) monitoring based on mobile systems have been delivered. We propose here an STM32F-microcontroller-based ECG mobile system providing both long-term (several weeks) Holter monitoring and 12-lead ECG recording, according to the clinical standard requirements for these kinds of recordings, which in addition can yield further digital compression at stages close to the acquisition. The system can be especially useful in rural areas of developing countries, where the lack of specialized medical personnel justifies the introduction of telecardiology services, and the limitations of coverage and bandwidth of cellular networks require the use of efficient signal compression systems. The prototype was implemented using a small architecture, with a 16-bits-per-sample resolution. We also used a low-noise instrumentation amplifier TI ADS1198, which has a multiplexer and an analog-to-digital converter (16 bits and 8 channels) connected to the STM32F processor, the architecture of which incorporates a digital signal processing unit and a floating-point unit. On the one hand, the system portability allows the user to take the prototype in her/his pocket and to perform an ECG examination, either in 12-lead controlled conditions or in Holter monitoring, according to the required clinical scenario. An app in the smartphone is responsible for giving the users a friendly interface to set up the system. On the other hand, electronic health recording of the patients are registered in a web application, which in turn allows them to connect to the Internet from their cellphones, and the ECG signals are then sent though a web server for subsequent and ubiquitous analysis by doctors at any convenient terminal device. In order to determine the quality of the received signals, system testing was performed in the three following scenarios: (1) The prototype was connected to the patient and the signals were subsequently stored; (2) the prototype was connected to the patient and the data were subsequently transferred to the cellphone; (3) the prototype was connected to the patient, and the data were transferred to the cellphone and to the web via the Internet. An additional benchmarking test with expert clinicians showed the clinical quality provided by the system. The proposed ECG system is the first step and paves the way toward mobile cardiac monitors in terms of compatibility with the electrocardiographic practice, including the long-term monitoring, the usability with 12 leads, and the possibility of incorporating signal compression at the early stages of the ECG acquisition.

It has been previously documented that the main features and sensing performance of electrograms (EGMs) recorded in implantable cardioverter defibrillators (ICDs) depend on lead configuration. Although this dependence has been ascribed to differences in lead sensitivity and spatial resolution, the quantification of these two properties on ICD has not yet been attempted. In this paper, an operative framework to study the spatial resolution of ICD transvenous leads is presented. We propose to quantify the spatial resolution of ICD transvenous leads based on a new characterization called lead resolution volume (ResV). We analyzed the sensitivity distribution and the ResV of two unipolar ( tip-can and coil-can ) and two bipolar (true or tip-ring and integrated or tip-coil ) ICD transvenous lead configurations. A detailed 3-D model of the human thorax based on the visible human man dataset was used to compute the lead sensitivity and computer simulations of simple cardiac dynamics were used to quantify the ResV. Differences in the sensitivity distribution throughout the ventricular myocardium (VM) were observed for each lead configuration. In our computer model of the human thorax, the ResV was found to comprise 7%, 35%, 45%, and 70% of the VM for true bipolar, integrated bipolar, tip-can unipolar, and coil-can unipolar ICD leads, respectively. Furthermore, our analysis shows that the spatial resolution depends on both lead sensitivity and cardiac dynamics, and therefore, it can vary for different heart rhythms.