Impact of Catheter Ablation on Arrhythmia Burden in Patients With Shock-Resistant Persistent Atrial Fibrillation.

BACKGROUND: Persistent shock-resistant atrial fibrillation (AF) is a challenging entity, with modest results from catheter ablation according to conventional survival analysis. OBJECTIVES: The aim of this study was to determine the effect of catheter ablation on atrial tachyarrhythmia (ATA) burden in persistent AF patients undergoing first-time ablation with the use of an implantable cardiac monitor (ICM). METHODS: Patients with drug-resistant ongoing persistent AF and at least 1 previous failed cardioversion were implanted with an ICM 2 months before the procedure. All patients underwent pulmonary vein isolation with or without additional substrate ablation depending on the presence of self-terminating AF on ICM and left atrium size. Median AF burden before and after ablation, off antiarrhythmic medication, was determined from ICM recordings after review by 2 independent investigators. RESULTS: Sixty patients were recruited (mean age 66 ± 9 years, 70% male). Mean left atrial diameter was 48 ± 6 mm and median CHA2DS2VASc score was 2. Ten patients (17%) unexpectedly demonstrated self-terminating AF before ablation. The median burden of ATA before ablation was 100% (95% CI: 19.6%-100%), decreasing to 0% (95% CI: 0%-95.8%) after ablation during the post-blanking follow-up period (median reduction 100%; 95% CI: 4%-100%; P < 0.001). Twenty-seven patients (45%) experienced recurrent ATA during 12-month follow-up. In these patients, median burden before ablation was 100% (95% CI: 26.9%-100%), decreasing to 11.4% (95% CI: 0.35%-99.7%) after ablation (P < 0.001). Quality of life improved significantly from baseline, driven by lack of recurrence. CONCLUSIONS: Patient-tailored catheter ablation results in a significant reduction in ATA burden (off antiarrhythmic medication) in shock-resistant persistent AF patients using ICMs implanted 2-months pre-procedure. These data suggest that conventional arrhythmia-free survival analysis does not capture the true impact of catheter ablation in this challenging cohort.

Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial.

BACKGROUND: Very high-power, short-duration (90-W/4-second) ablation for pulmonary vein isolation (PVI) may reduce procedural times. However, shorter applications with higher power may impact lesion quality. OBJECTIVES: In this multicenter, randomized controlled trial, the authors compared procedural efficiency, efficacy, and safety of PVI using 90-W/4-second ablation to 35/50-W ablation. METHODS: Patients with paroxysmal or persistent atrial fibrillation undergoing first-time PVI were randomized to pulmonary vein encirclement with contiguous applications using very high-power, short-duration applications (90 W over 4 seconds) or 35/50-W applications (titrated up to ablation index >550 anteriorly and >400 posteriorly). Prospective endpoints were procedural efficiency (procedure time and first-pass isolation), safety (including esophageal endoscopic evaluation), and 6-month effectiveness using repetitive Holter monitoring. RESULTS: A total of 180 patients were randomized, 90 to the 90-W group (mean age: 64.2 ± 8.9 years) and 90 to the 35/50-W group (mean age: 62.3 ± 10.8 years). Procedural time was shorter in the 90-W group vs the 35/50-W group (70 [IQR: 60-80] minutes vs 75 [IQR: 65-88.3] minutes; P = 0.009). A nonsignificant trend towards lower rates of first-pass isolation was seen in the 90-W group (83.9% vs 90%; P = 0.0852). No major complications were observed in both groups with esophageal injury occurring in 1 patient per group. At 6 months, 17% of patients in the 90-W group vs 15% in the 35/50-W group experienced recurrent arrhythmia (P = 0.681). CONCLUSIONS: Contiguous ablation using very high-power, short-duration applications results in a significant but modest reduction in procedure time with similar safety and 6-month efficacy vs a conventional approach. A hybrid approach combining both ablation modalities might be the most optimal strategy. (POWER PLUS [Very High Power Ablation in Patients With Atrial Fibrillation Schedule for a First Pulmonary Vein Isolation]; NCT04784013).

Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation.

OBJECTIVES: In this study, the authors sought to investigate the added value of vein of Marshall ethanol infusion (VOMEt) as first step in facilitating radiofrequency (RF)-guided mitral isthmus (MI) block. BACKGROUND: Achieving MI block with the use of RF ablation is challenging. METHODS: Seventy patients planned for MI ablation were randomized 1:1 to VOMEt as a first step preceding RF (endocardial and epicardial, VOMFIRST group) vs RF ablation as a first step preceding VOMEt (RFFIRST group). The study end point was incidence of MI block after RF ablation and after the 2 steps. RESULTS: In VOMFIRST, VOMEt was successful in 30/35 patients (86%) resulting in a low-voltage area of 12 ± 7.4 cm2 and MI block in 2/35 patients (6%). VOMFIRST, compared with RFFIRST, was associated with higher incidence of MI block after endocardial (46% vs 11%; P < 0.001) and epicardial ablation (94% vs 43%; P < 0.001), with fewer endocardial applications (4 vs 11 vs 4; P < 0.001) and similar epicardial applications (7 vs 8; P = 0.68). Incidence of MI block after the 2 steps was 94% vs 63% (P = 0.001) in VOMFIRST vs RFFIRST, respectively. Additional touch-up RF ablation in both groups resulted in final MI block in all but 1 patient (99%). CONCLUSIONS: VOMEt as a first step in RF-guided MI line ablation significantly reduced the number of RF applications needed to achieve MI block, even if the sequence of the ablation steps did not affect the final incidence of block. (Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation [MARSHALINE]; NCT04124328).

Trends in diagnosis, referral, red flag onset, patient profiles and natural outcome of de novo cardiac amyloidosis and their multidisciplinary implications.

BACKGROUND: Cardiac amyloidosis (CA) is often overlooked or misdiagnosed. Effects of growing disease awareness, diagnostic ameliorations and novel treatment options on CA diagnosis and management are scarcely reported. OBJECTIVE: To report trends in diagnosis, referral routes, clinical presentation, early onset diagnostic red flags and outcome in de novo CA subjects. METHODS: An unselected cohort of 139 de novo CA patients over an 8-year period in a tertiary referral hospital was recruited. RESULTS: Transthyretin (ATTR, 82%, n = 114) was the most common CA form; Light-chain (AL, 15%, n = 21) and secondary (AA, 3%, n = 4) are less prevalent. Increased awareness over time led to a marked ATTR diagnostic surge, steep non-invasive diagnostic approach increment and increased nuclear medicine and external cardiologist referrals (all p < 0.001). A total of 41% (n = 57/139) of patients were referred by non-cardiology specialist disciplines. Specific referral to rule out CA (24-36%) and diagnostic time lag from symptom onset (9 ± 12 to 8 ± 14 months), however, did not improve (all p > 0.050). Multiple early red flag events preceded CA diagnose several years in ATTR: Left ventricular hypertrophy (LVH, 60%, 4.9 ± 4.3 y), heart failure (54%, 2.5 ± 3.5 y), atrial fibrillation (47%, 5.9 ± 6.7 y), bilateral carpal tunnel syndrome (43%, 9.5 ± 5.7 y) and spinal stenosis (40%, 7.4 ± 6.5 y). LVH ≥ 12 mm was absent in 11% ATTR (n = 13/114) and 5% AL (n = 1/21) patients. Hypertension was common in both ATTR (n = 70/114, 62%) and AL (n = 10/21, 48%). 56% (n = 78/139) of CA presented with heart failure. Cumulative 1 and 5-year mortality of 10%/66%, 40%/52% and 75%/75% for ATTR, AL, and AA, respectively, remains high. CONCLUSIONS: Although CA diagnostic uptake and referral improve, specialist-specific disease and diagnostic red flag ignorance result in non-timely diagnosis and unfavourable outcome.

How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol.

Catheter ablation for atrial fibrillation (AF) is a common treatment strategy in patients with drug-resistant, symptomatic AF. In patients with paroxysmal and short-standing persistent AF, pulmonary vein isolation (PVI) is often enough to prevent recurrence of atrial tachyarrhythmia (ATA). Point-by-point encircling of the PVs with radiofrequency (RF) applications, together with cryoballoon ablation, have been the mainstay strategies for the last 10 to 20 years. Each of these strategies, however, suffers from the delicate balance between preventing PV reconnection, on the one hand (toward more energy), and preventing (mainly esophageal) complications (toward less energy), on the other. The CLOSE protocol was developed as an RF ablation strategy that would result in the safe creation of durable isolation leading to improved outcomes. Basically, the aim of the protocol is to enclose the pulmonary veins with stable, contiguous (intertag distance, ITD ≤ 6 mm) and optimized lesions (35 Watts, W, RF applications up to ablation index targets of ≥400 and ≥550 at the posterior and anterior wall). In this review, we describe the background of the CLOSE protocol and the studies from the St Jan Bruges research group on procedural performance, efficacy, and safety of the CLOSE protocol in (a) single-center prospective PILOT study (CLOSE-PILOT), (b) a single-center prospective study with continuous rhythm monitoring (CLOSE to CURE), (c) a database of systematic esophageal endoscopic studies, (d) a multicenter prospective study (VISTAX), and (e) the CLOSE database (comprising > 400 patients). We also discuss the results of the randomized POWER-AF study comparing conventional CLOSE to high power CLOSE (up to 50 W). Finally, we discuss the performance, safety, and efficacy of the CLOSE protocol in light of the emerging changes in the field of catheter ablation being ultra-short high-power ablation and electroporation.

A randomised wait-list controlled trial to evaluate Emotional Freedom Techniques for self-reported cancer-related cognitive impairment in cancer survivors (EMOTICON).

BACKGROUND: Cancer-related cognitive impairment (CRCI) is a prevalent source of comprised quality of life in cancer survivors. This study evaluated the efficacy of Emotional Freedom Techniques (EFT) on self-reported CRCI (sr-CRCI). METHODS: In this prospective multicentre randomised wait-list controlled study (ClinicalTrials.gov Identifier: NCT02771028), eligible cancer survivors had completed curative treatment, were 18 years or older and screened positive for sr-CRCI with ≥ 43 on the Cognitive Failures Questionnaire (CFQ). Participants were randomised to the immediate treatment group (ITG) or wait-list control (WLC) group, based on age (< or ≥ 65 years), gender, treatment (chemotherapy or not), and centre. The ITG started to apply EFT after inclusion and performed this for 16 weeks. The WLC group could only start the application of EFT after 8 weeks of waiting. Evaluations took place at baseline (T0), 8 weeks (T1) and 16 weeks (T2). The primary outcome was the proportion of patients with sr-CRCI according to the CFQ score. FINDINGS: Between October 2016 and March 2020, 121 patients were recruited with CFQ ≥ 43 indicating sr-CRCI. At T1, the number of patients scoring positive on the CFQ was significantly reduced in the ITG compared to the WLC group (40.8% vs. 87.3% respectively; p<0.01). For the WLC group, a reduction in CFQ scores was observed at T2, comparable to the effect of the ITG at T1. Linear mixed model analyses indicated a statistically significant reduction in the CFQ score, distress, depressive symptoms, fatigue and also an improvement in quality of life. INTERPRETATION: This study provides evidence for the application of EFT for sr-CRCI in cancer survivors and suggests that EFT may be useful for other symptoms in cancer survivors.

Predictors of recurrence after durable pulmonary vein isolation for paroxysmal atrial fibrillation.

AIMS: Catheter ablation of paroxysmal atrial fibrillation (AF) reduces AF recurrence, AF burden, and improves quality of life. Data on clinical and procedural predictors of arrhythmia recurrence are scarce and are flawed by the high rate of pulmonary vein reconnection evidenced during repeat procedures after pulmonary vein isolation (PVI). In this study, we identified clinical and procedural predictors for AF recurrence 1 year after CLOSE-guided PVI, as this strategy has been associated with an increased PVI durability. METHODS AND RESULTS: Patients with paroxysmal AF, who received CLOSE-guided PVI and who participated in a prospective trial in our centre, were included in this study. Uni- and multivariate models were plotted to find clinical and procedural predictors for AF recurrence within 1 year. Three hundred twenty-five patients with a mean age of 63 years (CHA2DS2VASc 1 [1-3], left atrium diameter 41 ± 6 mm) were included. About 60.9% were male individuals. After 1 year, AF recurrence occurred in 10.5% of patients. In a binary logistic regression analysis, the diagnosis-to-ablation time (DAT) was found to be the strongest predictor of AF recurrence (P = 0.011). Diagnosis-to-ablation time ≥1 year was associated with a nearly two-fold increased risk for developing AF recurrence. CONCLUSION: The DAT is the most important predictor of arrhythmia recurrence in low-risk patients treated with durable pulmonary vein isolation for paroxysmal AF. Whether reducing the DAT could improve long-term outcomes should be investigated in another trial.

D-dimer blood concentrations to exclude left atrial thrombus in patients with atrial fibrillation.

OBJECTIVE: Left atrial (LA) thrombus is routinely excluded by transoesophageal echocardiography (TOE) before cardioversion for non-valvular atrial fibrillation (AF). In the D-dimer blood concentrations to exclude LA thrombus in patients with AF study, two D-dimer cut-offs were compared to exclude LA thrombus prior to cardioversion. One was fixed to 500 ng/mL (DD500), based on clinical practice where such values are commonly accepted to exclude a thrombus. The other cut-off was adjusted to 10 times the patient's age (DDAge), based on the cut-off used to exclude pulmonary embolism. METHODS: 142 consecutive patients with non-valvular AF aged 69.7±11.4 years (52% with paroxysmal AF) referred for precardioversion TOE to exclude LA thrombus were prospectively enrolled. D-dimers were measured at the time of TOE by an ELISA test. RESULTS: LA thrombus was excluded with TOE in 129 (91%) and confirmed in 13 (9%) patients. D-dimers were significantly lower in patients without LA thrombus (729±611 vs 2376±1081 ng/L; p<0.05). DDAge indicated absence of LA thrombus with higher specificity than DD500 (66.4% vs 50.4%; p<0.05). Both cut-offs were able to identify all 13 patients with LA thrombus (false negative 0%). Patients with D-dimers

Effectiveness of Adjunctive Analgesics in Head and Neck Cancer Patients Receiving Curative (Chemo-) Radiotherapy: A Systematic Review.

OBJECTIVE: Our aim was to give an overview of the effectiveness of adjunctive analgesics in head and neck cancer (HNC) patients receiving (chemo-) radiotherapy. DESIGN: Systematic review. INTERVENTIONS: This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov were searched for studies concerning "head neck cancer," "adjunctive analgesics," "pain," and "radiotherapy." OUTCOME MEASURES: Pain outcome, adverse events, and toxicity and other reported outcomes, for example, mucositis, quality of life, depression, etc. RESULTS: Nine studies were included in our synthesis. Most studies were of low quality and had a high risk of bias on several domains of the Cochrane Collaboration tool. Only two studies comprised high-quality randomized controlled trials in which pregabalin and a doxepin rinse showed their effectiveness for the treatment of neuropathic pain and pain from oral mucositis, respectively, in HNC patients receiving (chemo-) radiotherapy. CONCLUSIONS: More high-quality trials are necessary to provide clear evidence on the effectiveness of adjunctive analgesics in the treatment of HNC (chemo-) radiation-induced pain.

Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study.

BACKGROUND: CLOSE-guided atrial fibrillation (AF) ablation is based on contiguous (intertag distance ≤6 mm), optimized (Ablation Index >550 anteriorly and >400 posteriorly) point-by-point radiofrequency lesions. The optimal radiofrequency power remains unknown. METHODS: The POWER-AF study is a prospective, randomized controlled monocentric study including patients with paroxysmal AF, planned for first CLOSE-guided pulmonary vein isolation using a contact force radiofrequency catheter (Thermocool SmartTouch, Biosense Webster, Inc, Irvine, CA). A total of 100 patients were randomized into 2 groups (1:1). The control group received AF ablation using the standard CLOSE protocol (35 W), whereas in the experimental group, pulmonary vein isolation was performed using high power (45 W). Endoscopic evaluation was performed in patients with intraesophageal temperature rise >38.5 °C. RESULTS: The resulting sample size was 96 (48+48) patients. In the high power group, shorter procedure time (80 versus 102 minutes, P<0.001), shorter total radiofrequency application time (16 versus 26 minutes, P<0.001), and radiofrequency time per application (26 versus 37 s anteriorly, P<0.001 and 13 versus 17 s posteriorly, P<0.001) were observed. Endoscopic evaluation (performed in 19/48 versus 25/48 patients respectively, P=0.31) showed an ulcerative perforation in a high power group patient (treated by endoscopic stenting and normalization after ≈4 months) and a superficial ulcerative lesion in a control group patient (conservative treatment). Both occurred following excessive Ablation Index applications (up to 460 and 480, respectively) with excessive contact force (30 g on average, with peaks up to 50 g). Six-months AF recurrence was not significantly different (10% in high power versus 8% in control, P=0.74). CONCLUSIONS: This randomized controlled study shows that a 45 W radiofrequency power CLOSE protocol in patients with paroxysmal AF significantly increases the global procedural efficiency with similar midterm efficacy. However, our study showed a narrower safety margin and a limited increased efficiency at the posterior wall using high power. This advocates against the use of high power in the region neighboring the esophagus.

The prognostic value of patient-reported Health-Related Quality of Life and Geriatric Assessment in predicting early death in 6769 older (≥70 years) patients with different cancer tumors.

OBJECTIVES: We aimed to determine the prognostic value of baseline Health-Related Quality Of Life (HRQOL) and geriatric assessment (GA) to predict three-month mortality in older patients with cancer undergoing treatment. METHODS: Logistic regressions analysed HRQOL, as measured with the EORTC Global Health Status (GHS) scale, and geriatric information prognostic for early mortality controlling for oncology variables. The assessment was established with the odds ratio (OR), 95% confidence interval (CI) and level of significance set at p < 0.05. Discriminative power was evaluated with area under the curve (AUC). RESULTS: In total, 6769 patients were included in the study, of whom 1259 (18.60%) died at three months. Our model showed higher odds of early death for patients with lower HRQOL (GHS, OR 0.98, 95% CI 0.98-0.99; p < 0.001), a geriatric risk profile (G8 Screening Tool, 1.94, 1.14-3.29; p = 0.014), cognitive decline (Mini Mental State Examination, 1.41, 1.15-1.72; p = 0.001), being at risk for malnutrition (Mini Nutritional Assessment-Short Form, 1.54, 1.21-1.98; p = 0.001), fatigue (Visual Analogue Scale for Fatigue, 1.45, 1.16-1.82; p = 0.012) and comorbidities (Charlson Comorbidity index, 1.23, 1.02-1.49; p = 0.033). Additionally, older age, poor ECOG PS and being male increased the odds of early death, although the magnitude differed depending on tumor site and stage, and treatment (all p < 0.05). Predictive accuracy increased with 3.7% when including HRQOL and GA in the model. CONCLUSION: The results suggest that, in addition to traditional clinical measures, HRQOL and GA provide additional prognostic information for early death, but the odds differ by patient and tumor characteristics.

Quality of blood samples collected at home does not affect clinical decision making for the administration of systemic cancer treatment.

The aim of this exploratory clinical study was to evaluate whether the preanalytical quality of blood samples subjected to delayed centrifugation and transport - as a result of home-sampling - is affected in a way it alters the clinical decision-making for patients under systemic cancer therapy. This evaluation is part of a comprehensive investigation of the opportunities for oncological home-hospitalization. Forty-nine patients with cancer donated two additional blood samples during their ambulatory hospital visit. Fifteen blood analytes were compared between routine blood samples and samples that were subjected to transport and delayed centrifugation in order to mimic a locally implemented model for oncological home-hospitalisation. Deviations were analysed by means of Deming regression. For those analytes showing statistically significant intercepts and/or slopes, the mean deviations were compared to the desirable analytical bias; and the intra-individual differences were compared with the limits for clinical decision-making. Statistically significant intercepts and/or slopes were observed for haematocrit (HCT), mean cellular volume (MCV), platelets count (PLT) and C-reactive protein (CRP). Differences exceeding the allowable margins of desirable analytical bias were observed for HCT and MCV. Risk of different clinical decision-making couldn't be observed for any of the analytes showing statistically significant differences. These results demonstrate that home-collection of blood samples, transported at room temperature and centrifuged within a mean time of five hours after sampling, has no effect on clinical decision-making with regards to systemic cancer therapy. However, attention should be paid to the potential occurrence of haemolysis during the preanalytical phase, which can negatively influence haemolysis-dependent variables.

Evaluation of higher power delivery during RF pulmonary vein isolation using optimized and contiguous lesions.

AIMS: "CLOSE"-guided pulmonary vein isolation (PVI) is based on contiguous (≤6 mm) and optimized radiofrequency (RF) ablation lesions (ablation index [AI] ≥ 400 posteriorly and ≥ 550 anteriorly]. However, the optimal RF power to reach the desired AI is unknown. Therefore we evaluated the efficiency of an ablation strategy using higher power (40 W) during a first "CLOSE"-guided PVI. METHODS: Eighty consecutive patients undergoing "CLOSE"-guided PVI for symptomatic paroxysmal atrial fibrillation were ablated with 40 W (group A). Results were compared with 105 consecutive patients enrolled in the "CLOSE to CURE"-study and were ablated using the same protocol with 35 W (group B). RESULTS: In group A, ablation was associated with shorter ablation procedure time (91 vs 111 minutes; P < .001), shorter fluoroscopy time (5 vs 11 minutes; P < .001), shorter PVI time (48 vs 64 minutes; P < .001), shorter RF time (20 vs 28 minutes; P < .001), lower RF time per application (22 vs 29 seconds; P < .001), less RF applications (52 vs 58; P < .001), and less catheter dislocations (1 vs 2; P = .002). The impedance drop (12 vs 13 Ω; P = .192), first-pass isolation rate (99% vs 93%; P = .141) and acute reconnection rate (6% vs 4%; P > .733) were similar in both groups (groups A and B, respectively). No complications occurred. In group A, a gastroscopy-performed in five patients with esophageal temperature rise more than 42°C-did not reveal any esophageal lesion. Postprocedural recurrence of atrial tachyarrhythmia at 1 year was not significantly different between both groups. CONCLUSIONS: Using the "CLOSE"-protocol, increased power increases the efficiency of PVI without compromising patients' safety.

Endovascular baroreflex amplification for resistant hypertension: what you need to know.

Endovascular baroreflex amplification is an alternative treatment strategy for patients with resistant hypertension. In endovascular baroreflex, the carotid baroreflex is activated by a MobiusHD® device (MD) which has been implanted in the internal carotid artery. This review will discuss the MD technology and mechanism of action and promising results in the first-in-human prospective study involving the use of the MD in patients with resistant hypertension.

Prospective evaluation of entrainment mapping as an adjunct to new-generation high-density activation mapping systems of left atrial tachycardias.

BACKGROUND: Identification of atrial tachycardia (AT) mechanism remains challenging. OBJECTIVE: We sought to investigate the added value of entrainment maneuvers (EM) when using new high-density activation mapping (HDAM) technologies for the identification of complex left ATs. METHODS: Thirty-six consecutive complex ATs occurring after ablation of persistent atrial fibrillation were prospectively analyzed. The AT mechanism was diagnosed in 2 steps by 2 experts: (1) based on HDAM only (Coherent module, CARTO, Biosense Webster Inc., Irvine, CA) and (2) with additional analysis from EM. RESULTS: EM resulted in atrial fibrillation in 1 patient, who was excluded from the analysis. Ten of 11 single loop macroreentries identified by HDAM were confirmed by EM. Only 4 of 14 double loop macroreentries identified by HDAM wereconfirmed by EM (in 10 patients, EM unmasked passive activation of one of the visual circuits). One sole microreentry circuit identified by HDAM was confirmed by EM. A combination of macro- and microreentry circuits was visualized in 3 ATs using HDAM. However, EM revealed passive activation of the visual macroreentrant loop in 2 of these 3 cases. By using HDAM in 6 of 35 ATs (17%), no univocal mechanism could be identified, whereas EM finally enabled the diagnosis of 5 microreentry circuits and 1 macroreentrant AT. All the diagnoses made from EM in addition to HDAM were confirmed by ablation. CONCLUSION: Entrainment maneuvers are still useful during mapping of complex left ATs, mostly to differentiate active from passive macroreentrant loops and to demonstrate microreentry circuits.

Shifting specialized oncological care from hospital- to home-setting: is there support among patients, specialists and general practitioners?

OBJECTIVES: Oncological home-hospitalization (OHH) might be a patient-centred approach to deal with the increasing burden of cancer on health-care facilities and finances. Before implementation into practice, its feasibility, costs and support among stakeholders should be evaluated. The purpose of this trial was to explore patients', specialists' and general practitioners' (GPs) perspectives towards the opportunities of implementing OHH within the Belgian health-care system. METHODS: A regional cross-sectional survey study was launched in order to investigate the stakeholders' views on OHH and the current cancer care focusing on integration of primary care and continuous care. RESULTS: Of the responders, 37 out of 163 patients (23%), 45 of 62 GPs (73%) and 10 of 15 specialists (67%) feel positive about the opportunities for OHH. Nevertheless, 11/15 specialists (73%) and 51/62 GPs (82%) feel primary care might currently be (too) little involved in order to ensure continuous care for cancer patients. Opportunities for improved continuous care are seen in better communication between primary care and hospital, and more patient contacts for primary care during the cancer treatment process. CONCLUSION: The results of this local survey study demonstrated there is support among different stakeholder groups for the implementation of OHH within the Belgian health-care context. However, some barriers impeding transmural continuous care should be tackled before implementing such model into practice. Better communication between health-care professionals and more patients contacts are suggested, and an adjusted legal and financial framework is required.

Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: A case-control study.

OBJECTIVES: We aimed to determine the proportion of "fit" versus "vulnerable" older patients with cancer included in phase II and III oncology registration trials, as compared to the proportions in a real life oncology setting. METHODS: Trial and patient characteristics of older (≥70years) patients treated at the OECI-designated clinical cancer centre in Kortrijk and included in a phase II or III oncology registration trial were collected retrospectively. These patients were matched individually with randomly-selected patients from the general oncology setting, based on gender, age, tumour type, tumour stage, and treatment intent. Patients' fitness, based on routine Geriatric-8 (G8) screening, was retrieved from prospectively constructed databases. RESULTS: Between November 2012 and October 2018, 218 older patients with cancer were included in a phase II or III oncology registration trial. Of those, 41 cases with a mean age of 76.0years were included in the analyses. A Fisher's Exact Test revealed a statistical significant difference between cases and matched controls, with a higher proportion of "fit" patients included in phase II or III oncology registration trials compared to the proportion in the matched control group (respectively 70.7% and 41.5%, p<.010). DISCUSSION: We provide evidence for the hypothesis that older patients included in phase II or III oncology trials are significantly fitter than the real life oncology population. Some form of geriatric evaluation should be integrated in future cancer clinical trials to enable stratification according to this parameter and allow subgroup analysis. This will broaden the application and interpretation of trial results.

Identification of repetitive atrial activation patterns in persistent atrial fibrillation by direct contact high-density electrogram mapping.

INTRODUCTION: Recent studies have characterized drivers in persistent atrial fibrillation using automated algorithm detection with panoramic endocardial mapping by means of basket catheters. We aimed to identify repetitive atrial activation patterns (RAAPs) during ongoing atrial fibrillation (AF) based upon automated annotation of unipolar electrograms (EGMs) recorded with a high-density regional endocardial contact mapping catheter. METHODS: In 14 persistent AF patients, high-resolution EGMs were recorded for 30 seconds at sequential PentaRay (Biosense Inc) positions covering the entire biatrial surface. All recordings were reviewed off-line with dedicated software allowing automated annotation of the local activation time of the unipolar fibrillatory EGMs (CARTOFINDER; Biosense Inc). RAAPs were defined as a consistent activation pattern (for ≥3 consecutive beats) of either focal activity with centrifugal spread (RAAPfocal ) or rotational activity across the PentaRay splines spanning the AF cycle length (RAAProtational ). RESULTS: A total of 498 PentaRay recordings were analyzed (35.6 ± 7.6 per patient). The number of PentaRay recordings displaying RAAP was 9.8 ± 3.1 per patient (range = 3-15), of which 2.4 ± 2.4 RAAProtational (range = 0-7), and 7.4 ± 4.4 RAAPfocal (range = 1-13). 77% of RAAPs portrayed focal firing. The median number of repetitions per 30 second recording was 11 (range = 3-225) per recording. RAAPs were observed both in the right atrium (RA) (35%) and left atrium (LA) (65%), with the majority being near the left PVs/appendage (35% of all RAAPs) and the superior vena cava/right appendage (23% of all RAAPs). CONCLUSION: High-resolution, sequential endocardial EGM-based mapping allows identification of RAAPs in persistent AF. In our series, focal firing was the most frequently observed pattern.

An observational pilot study to evaluate the feasibility and quality of oncological home-hospitalization.

PURPOSE: The objective of this pilot study was to evaluate the feasibility of oncological home-hospitalization and to compare its quality with standard ambulatory hospital care in terms of patient-reported quality of life and related endpoints by means of a set of validated patient-reported outcome measures (PROMs). METHODS: An observational cohort study (clinicaltrials.gov identifier: NCT03073499) was conducted, allocating patients to (partial) home-hospitalization or standard ambulatory hospital care. PROMs were completed by both cohorts at start of treatment and eight weeks later. An additional study-specific questionnaire was presented to the intervention cohort at study-end assessing their satisfaction with and preferences for the provided homecare. RESULTS: Thirty patients received home-hospitalization, corresponding to 116 interventions. For twenty-eight patients, this comprised all assessments required prior to administration of treatment, which resulted in a significant reduction of waiting time for treatment administration at the hospital in comparison with the control cohort (n = 24) (average reduction of 1:12 h, p < 0.001). Two patients received actual subcutaneous therapy at home. None of the PROM's evaluated revealed significant differences between both cohorts (all p > 0.05). 29/30 patients of the intervention cohort were satisfied with the provided homecare and preferred to have it continued, 22/25 patients declared to feel at home at least as safe as in the hospital. No serious safety concerns were reported. CONCLUSION: The results of this pilot study suggest that (partial) oncological home-hospitalization is feasible, safe and statistically not affecting patient-reported quality of life. Furthermore, this care model was acceptable and preferred by a substantial number of cancer patients.

Health related quality of life in older patients with solid tumors and prognostic factors for decline.

OBJECTIVES: This study aims to investigate health-related quality of life (HRQOL) at baseline and at follow-up in older patients with cancer and to determine prognostic factors for HRQOL decline. METHODS: A prospective Belgian multicentre (n = 22) study was performed. Patients ≥70 years with a malignant tumor and abnormal G8 (≤14/17) screening tool were included. Patients underwent geriatric assessment (GA) and HRQOL evaluation with follow up at three months. Uni- and multivariate regression models were performed to determine factors associated (p < .05) with baseline HRQOL and HRQOL decline at follow-up. RESULTS: Results reflect data collected from 3673 patients. A multivariate analysis showed that younger patients, and those with poor Eastern Cooperative Oncology Group - Performance Status (ECOG-PS), specific tumor types (gastrointestinal, gynaecological and thorax) and higher stage had lower baseline HRQOL. In addition worse functional status and presence of pain, fatigue, depression and malnutrition were associated with lower baseline HRQOL. During treatment (n = 2972), improvement in HRQOL was observed in 1037 patients (35%) and a decline in 838 patients (28.2%). In multivariate analysis, stage and presence of baseline comorbidities, pain, fatigue or malnutrition were associated with HRQOL evolution. CONCLUSION: Baseline HRQOL in older patients with cancer and an abnormal G8 depends on tumor and age related parameters. During follow-up, HRQOL improved in one third of patients, indicating that they may benefit from cancer treatment while one quarter demonstrated a HRQOL decline for which prognostic factors were identified.