Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

Acute and Long-term Outcomes of Cryoballoon Ablation in Patients with Atrial Fibrillation. Primary Results of the Spanish Cryoballoon Ablation Registry (RECABA)

Background Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. Objectives The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Methods Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. Theprimary endpoint was ≥ 30 sec freedom from AF at 12-mo after a 3-mo blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. Results In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryoapplications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 seconds. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryoapplication. Mean procedural time was 113 ± 41 minutes. Acute complications occurred in 4.4% of the cases21. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). Conclusions RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.

Advocacia na Era Digital: Uma análise sobre possíveis impactos práticos e jurídicos das novas tecnologias na dinâmica da advocacia privada

This work aims to analyze the possible practical and legal repercussions of the implementation of technologies characteristic of the digital age in the dynamics of advocacy. Considering the increasing influence that scientific advances have exercised not only in human life, but especially in the ways of working and in the models of the professions, the objective was to prospectively investigate the transformations of this context in advocacy. In order to improve the understanding of the research, three common sectors-activities were separated between the more traditional advocacy: manual labor; systems and departments, highlighting the most recurring bottlenecks. Ahead, there were also three technologies highlighted in the technological revolution, which were: artificial intelligence; automation of legal documents and big data. In the meantime, possible resistance factors between law and technology were also discussed. Finally, through a bibliographic and exploratory methodological process, the research explored possible consequences of the direct insertion of these new technologies in each specific sector of traditional law, considering the functionalities and the problems that would be solved. Thus, there were several repercussions, both practical and legal, including the financial, methodological, strategic and organizational logistics of the offices, among which were mentioned: gain of time; fees. internal costs; data-based procedural strategy, and more. Still, in addition to the realization of the high probability of changes in the lawyer's practice, there was a need to seek solutions that really connect the law to innovations in this new scenario, with emphasis on the contracting of services offered by lawtechs.

A framework of digitalization: Insights based on resource orchestration theory for digital transformation of traditional retailers

The purpose of this article is to explore how traditional retailers implement overall organization digitalization. A cross-case study based on grounded theory was conducted across four traditional retail enterprise cases, respectively from comprehensive supermarket, department store, brand exclusive chain and home appliance chain. Four digitalization tactics dimensions were obtained: physical resource orchestration, human resource orchestration, organizational structure orchestration and ecological relationship orchestration; two digital competition strategies were distinguished: conservative and offensive strategy. Thereby, based on the resource orchestration theory, a procedural strategy framework was developed, which can be used to guide the implementation of digitalization.

Catheter ablation of atrial fibrillation: cardiac imaging guidance as an adjunct to the electrophysiological guided approach

Catheter ablation is increasingly utilized to treat patients with atrial fibrillation (AF). Despite progress in technology and procedural strategy, there remain significant limitations with suboptimal outcomes. The role of imaging has continued to evolve, and multimodality imaging now presents an important opportunity to make substantial progress in the safety and efficacy of ablation. In this review, we discuss the history of imaging in the ablation of AF with a specific focus on the ability of cardiac computed tomography and magnetic resonance imaging to characterize anatomy, arrhythmogenic substrate, and guide ablation strategy. We will review the progress that has been made and highlight many of the limitations as well as future directions for the field.

Antegrade Chronic Total Occlusion Strategies: A Technical Focus for 2020

Chronic total occlusions (CTOs) are common in patients with ischaemic heart disease. In many countries, patients with CTOs are underserved by percutaneous coronary intervention (PCI). One of the barriers to CTO PCI is the technical challenges of these procedures. Improvements in technique and dedicated devices for CTO PCI, combined with advances in procedural strategy, have resulted in a dramatic increase in procedural success and outcomes. Antegrade wiring (AW) is the preferred initial strategy in short CTOs, where the proximal cap and course of the vessel is understood. For many longer, more complex occlusions, AW has a low probability of success. Dissection and re-entry techniques allow longer CTOs and those with ambiguous anatomy to be crossed safely and efficiently, and CTO operators must also be familiar with these strategies. The CrossBoss and Stingray system is currently the primary targeted re-entry device used during antegrade dissection and re-entry (ADR), and there continues to be an evolution in its use to increase procedural efficiency. In contrast to older ADR techniques, targeted re-entry allows preservation of important side-branches, and there is no difference in outcomes compared to intraplaque stenting.

P3583Optimal procedural strategy to improve clinical outcome in primary percutaneous coronary intervention

Background Current guideline recommends potent antiplatelet agents and transradial intervention. However, it is uncertain whether routine use of IVUS, thrombus aspiration and glycoprotein IIB-IIIA inhibitor is beneficial for improving clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI). Purpose The aim of this study was to investigate optimal procedural strategy to improve clinical outcome. Methods A total of 6,046 patients who underwent primary percutaneous coronary intervention (PCI) for STEMI were analyzed from the Korean Acute Myocardial Infarction Registry (KAMIR) – National Institute of Health (NIH) database. MACCEs were defined as a composition of all cause death, non-fatal MI, repeat revascularizations including repeated percutaneous coronary intervention and coronary bypass grafting, cerebrovascular accident and rehospitalizations. This research was supported by a fund by Research of Korea Centers for Disease Control and Prevention. Results During the primary PCI, potent antiplatelet agents such as prasugrel and ticagrelor were used in 2342 (38.4%). PCI was performed through transradial approach in 1490 (25.2%). Thrombus aspiration and intravascular ultrasound (IVUS) examination was done in 2204 (36.1%) and 1079 (18.1%), respectively. Glycoprotein IIB-IIIA inhibitor was administered in 1295 (21.7%). Among them, potent antiplatelet agents, transradial intervention, IVUS, and thrombus aspiration significantly reduced MACCEs at 1 year. Glycoprotein IIB-IIIA inhibitor was not effective to improved clinical outcome. In Cox-proportional hazards model, potent antiplatelet agents (hazard ratio 0.82, 95% confidence interval 0.67–0.99; p=0.045) and transradial intervention (hazard ratio 0.61, 95% confidence interval 0.47–0.78; p<0.001) was an independent predictor of MACCEs after adjusting for confounding variables. Combined use of potent antiplatelet agents and transradial intervention (hazard ratio 0.54; 95% confidence interval 0.37–0.80; p=0.002) substantially reduced MACCEs at 1 year. Conclusion Among evidence based procedures during the primary PCI, combined use of potent antiplatelet agents and transradial intervention was optimal procedural strategy to improve clinical outcome.

5032Evaluation of the EAPCI OCT criteria for optimization of angioplasty in the DOCTORS study population

Background The recent expert consensus of the EAPCI suggested OCT criteria for the optimization of PCT after stent implantation. Using the data from the randomized, controlled DOCTORS study, we aimed to analyze the proportion of OCT criteria that were met immediately after stent implantation, and to evaluate the changes made to the revascularization strategy in order to optimize the procedure. Methods The DOCTORS study population consisted of patients admitted for non ST elevation myocardial infarction (NSTEMI) and presenting an indication for PCI with stent implantation of the target lesion. In the 120 patients randomized to the OCT-guided group, OCT was performed after initial coronary angiography and repeated immediately after stent implantation. The operator was required to evaluate quantitative measures of the reference diameter and reference area of the vessel and the length of the lesion based on the OCT images acquired before PCI. All OCT images were analyzed in a centralized core laboratory by 2 independent operators blinded to the angiographic findings. Post-PCI optimization targets to be achieved following stent implantation included optimal stent expansion (minimal stent area (MSA)/average reference lumen >80%), avoidance of landing zone in plaque burden >50% or lipid rich tissue; avoidance of large malapposition regions (axial distance <0.4 mm and <1 mm length), no extensive irregular tissue protrusion, and limited dissections (<60°, flap limited to intima, <2 mm length). Results Among the 120 patients who had an OCT run performed immediately after stent implantation, 50 patients (42%) had stent under-expansion, 59 (49%) had landing zone in plaque burden >50% or lipid rich tissue, 27 (22.5%) had stent malapposition, 25 (20.8%) had extensive irregular tissue protrusion and 45 (37.5%) had extensive edge dissection. Only 2 patients (1.7%) fullfiled all criteria of post-PCI optimization immediately after stent implantation, while no criterion was reached in 15 patients (12.5%). Post-stent overdilation was performed in all patients with stent underexpansion, and in 22/27 patients (81.5%) with stent malapposition. Additional stent implantation was performed in 32 patients (24 for landing zone in plaque burden >50% and 8 for extensive adventitial edge dissection). Overall, the use of OCT led the operator to optimize the procedural strategy in 60 patients (50%). Conclusion The proportion of suboptimal results as evaluated by OCT and based on the EAPCI criteria immediately after stent implantation was very high in the DOCTORS study, even though the choice of stent in these patients was based on pre-PCI OCT data. The post-PCI OCT findings led to a change of strategy to optimize the procedure in 50% of patients. It remains to be determined through a larger prospective study whether this optimization of PCI strategy is associated with a clinical benefit in the long term.

Los retos de la litigación transnacional en la Unión Europea: ¿se ha extendido demasiado la “noción de materia contractual” en el Reglamento Bruselas I? = The challenges of the transnational litigation in the European Union: has the notion of matters relating to a contract been extended too much in Brussels i Regultation?

Resumen: El presente trabajo tiene como objetivo el comentario a la sentencia del TJUE de 14 de julio de 2016 en el asunto Granarolo. Este asunto vuelve a poner en relieve aspectos interpretativos en relación al Reglamento Bruselas I que van a afectar al Reglamento Bruselas I bis como son lo que debe entenderse por materia contractual, por un contrato de compraventa o por un contrato de prestación de servicios. Pero la realidad es que esta interpretación va más allá de los aspectos puramente técnico jurídicos. Estas cuestiones que se plantean en la sentencia implican retos que las partes en un litigio transnacional en la Unión Europea deben tener en cuenta a la hora de organizar la estrategia procesal a seguir.Palabras clave: materia contractual, responsabilidad extracontractual, contrato de compraventa, contrato de prestación de servicios.Abstract: The goal of this paper is to analyze the ECJ judgment of 14 July 2016 in the Granarolo case. This issue highlights again interpretative aspects in relation to the Brussels I Regulation that will affect the Brussels I bis Regulation. These are what to must be understood by contractual matter or by a contract of sale or of provision of services. But the reality is that this interpretation goes beyond the purely technical and legal aspects. These issues that arise in the ruling imply challenges that the parties in a transnational litigation in the European Union must take into account when organizing the procedural strategy to be followed.Keywords: matters relating to a contract, non-contractual liability, contract of sale of goods, contract of provision of services.