A worldwide survey on incidence, management and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: The POTTER-AF study.

AIMS Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management and outcome are sparse. METHODS AND RESULTS This international multicenter registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553,729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed at 214 centers in 35 countries. In 78 centers 138 patients (0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (p<0.0001)) were diagnosed with an oesophageal fistula. Periprocedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8%, and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) (odds ratio 7.463 (2.414, 23.072) p<0.001). CONCLUSIONS Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high

Seeing the Immaterial: A New Instrument for Evaluating Integrated Management Systems’ Maturity

Integrated management systems (IMSs) can already be considered a proven tool to help companies cope with the challenges associated with staying competitive in the face of dynamic stakeholder requirements. The present paper proposes a new instrument designed to evaluate and communicate the maturity achieved by an integrated management system (IMS) for responding properly to the requirements of its reference standards in a consolidated manner. The approach mainly aims to highlight the level of integration achieved on common requirements of the component standards and to determine the extent to which they work together as a whole. At the same time, it is useful to identify the needs for improvement in the system as a whole or in its sub-systems. The proposed methodology uses the transmutation in the RGB color space (red–green–blue) of the process audits’ results achieved under each standard, followed by the analysis of the IMS characteristics, with tools specific to the color space, based on the affinities between the two domains. To sustain the thoroughness of this approach, a case study of an integrated system for an industrial company is presented, analyzing the situation from two different evolution stages of the IMS. The approach is presented as a proof-of-concept, without large scale validation

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis

Aims: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. Methods and results: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. Conclusion: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577. Keywords: Atrial fibrillation; Catheter ablation; Cryoballoon; Phrenic nerve injur

Monomorphic VT Non-Inducibility after Electrical Storm Ablation Reduces Mortality and Recurrences

Background: Electrical storm (ES) is defined by clustering episodes of ventricular tachycardia (VT) and is associated with severe long-term outcomes. We sought to evaluate the prognostic impact of radiofrequency catheter ablation (RFCA) in ES as assessed by aggressive programmed ventricular stimulation (PVS). Methods: Single-center retrospective longitudinal study with 82 consecutive ES patients referred for RFCA with a median follow-up (IQR 25&ndash;75%) of 45.43 months (15&ndash;69.86). All-cause mortality and VT recurrences were assessed in relation to RFCA outcomes defined by 4-extrastimuli PVS: Class 1&mdash;no ventricular arrhythmia; Class 2&mdash;no sustained monomorphic VTs (mVT) inducible, but non-sustained mVTs, polymorphic VTs, or VF inducible; Class 3&mdash;clinical VT non-inducible, other sustained mVTs inducible; and Class 4&mdash;clinical VT inducible. Results: Class 1, Class 2, Class 3, and Class 4 were achieved in 56.1%, 13.4%, 23.2%, and 7.4% of cases, respectively. The combined outcome of Class 1 + Class 2 (no sustained monomorphic VT inducible) led to improved survival (log-rank p &lt; 0.001) and reduced VT recurrence (log-rank p &lt; 0.001). Residual monomorphic VT inducibility (HR 6.262 (95% CI: 2.165&ndash;18.108, p = 0.001), NYHA IV heart failure symptoms (HR 20.519 (95% CI: 1.623&ndash;259.345), p = 0.02)), and age (HR 1.009 (95% CI: 1.041&ndash;1.160), p = 0.001)) independently predicted death during follow-up. LVEF was not predictive of death (HR 1.003 (95% CI: 0.946&ndash;1.063) or recurrences (HR 0.988 (95% CI: 0.955&ndash;1.021)). Conclusions: Non-inducibility for sustained mVTs after aggressive PVS post-RFCA leads to improved survival in ES, independently of LVEF

The Importance of Haemogram Parameters in the Diagnosis and Prognosis of Septic Patients

Sepsis represents a severe pathology that requires both rapid and precise positive and differential diagnosis to identify patients who need immediate antimicrobial therapy. Monitoring septic patients′ outcome leads to prolonged hospitalisation and antibacterial therapy, often accompanied by substantial side effects, complications and a high mortality risk. Septic patients present with complex pathophysiological and immunological disorders and with a predominance of pro-inflammatory or anti-inflammatory mediators which are heterogeneous with respect to the infectious focus, the aetiology of sepsis or patients′ immune status or comorbidities. Previous studies performed have analysed inflammatory biomarkers, but a test or combinations of tests that can quickly and precisely establish a diagnosis or prognosis of septic patients has yet to be discovered. Recent research has focused on re-analysing older accessible parameters found in the complete blood count to determine the sensitivity, specificity, positive and negative predictive values for the diagnosis and prognosis of sepsis. The neutrophil/lymphocyte count ratio (NLCR), mean platelet volume (MPV) and red blood cells distribution width (RDW) are haemogram indicators which have been evaluated and which are of proven use in septic patients′ management

Pulmonary vein isolation durability after very high-power short-duration ablation utilizing a very-close protocol – The FAST AND FURIOUS redo study

Background: Very high-power short-duration (vHP-SD) radiofrequency (RF) ablation of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective and faster procedures. Although acute efficacy and safety for PVI was recently shown data on chronic PVI durability is limited. Here chronic PVI durability was evaluated during repeat electrophysiological procedures in patients after initial vHP-SD and conventional RF based PVI. Methods: A total of 25 consecutive patients with repeat left atrial procedures after initial vHP-SD based PVI were included in this study. Twenty-five patients with previous conventional RF based PVI and repeat left atrial procedures served as control (control group). Results: For index procedures the median RF time was 328 (277, 392) seconds (vHP-SD) and 1470 (1310, 1742) seconds (control); p < 0.001, the median procedure time was 55 (53, 68) minutes (vHP-SD) and 110 (94, 119) (control); p < 0.001). First pass isolation rate was 84 % (vHP-SD) and 88 % (control, p = 0.888). No differences for severe adverse events (vHP-SD: 1/25, 4 % vs. control: 0/25, 0 %; p = 0.676 were detected.Chronic durability of all PVs was assessed in vHP-SD: 16/25 (64 %) and control: 8/25 (32 %) patients (p = 0.023) and vHP-SD: 81 % and control: 62 % of PVs were found to be isolated (p = 0.003). For right PVs vHP-SD: 84 % vs. control: 60 % of PVs (p < 0.001) and for left PVs vHP-SD: 78 % vs. control: 64 % (p = 0.123) were found to be isolated. Conclusions: PVI solely utilizing vHP-SD via a very close-protocol provides fast, safe and effective acute PVI. High rates of chronically isolated pulmonary veins have been detected

Polymorphisms in autophagy genes and active pulmonary tuberculosis susceptibility in Romania

Autophagy, a homeostatic process involved in nutrient regeneration and immune responses, may be involved in intracellular killing of M. tuberculosis. Several studies linked variation in autophagy genes with susceptibility to pulmonary tuberculosis, but others did not confirm these findings