The VR leadless pacemaker: Results of an expert panel using the RAND/UCLA method.

BACKGROUND: Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long-term follow-up. Existing international guidelines lack detailed instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single-chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm. METHODS: A panel of experts, including interventional and non-interventional cardiologists, used the Research ANd Development/University of California at Los Angeles (RAND/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable. RESULTS: This consensus statement, based on available literature and the experts' opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm. CONCLUSIONS: Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.

ImmunoCAP ISAC in food allergy diagnosis: a systematic review of diagnostic test accuracy.

OBJECTIVE: To assess the diagnostic test accuracy of the component-resolved diagnosis device ImmunoCAP ISAC, compared with oral food challenge. DESIGN: Systematic review reported according to the PRISMA-DTA recommendations. DATA SOURCES: Medline, Embase and Cochrane Library databases were searched from inception to May 2019 and updated in March 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included diagnostic test accuracy studies comparing ISAC component results as the index test with oral food challenge as the reference test, in people of any age suspected of IgE mediated food allergy to milk, egg, peanut, shrimp, hake, apple, peach, kiwi, melon, walnut, hazelnut, wheat or pineapple. Risk of bias was evaluated using the QUADAS-2 tool. RESULTS: We screened 799 titles and included 11 studies - seven prospective and two retrospective cohort studies, two case-control studies. Included studies evaluated IgE to Gald1 (three studies, 300 participants, 140 with egg allergy), Bosd5 (three studies, 242 participants, 146 with milk allergy) and Arah1 or 2 (seven studies, 546 participants, 346 with peanut allergy). No studies were identified for other ISAC components. Risk of bias was high or unclear mainly due to inadequate blinding. Applicability was of high or unclear concern due to unclear thresholds, inappropriate exclusions and variable populations. Gald1 sensitivity ranged from 58 to 84%, specificity 87%-97%. Bosd5 sensitivity 24%-40%, specificity 94%-95%. Arah1 sensitivity 45%-91%, specificity 41%-93%. Arah2 sensitivity 70%-94%, specificity 75%-95%. CONCLUSIONS: Diagnostic test accuracy information for ISAC components was only available for milk, egg and peanut. Specificity is generally higher than sensitivity, which contrasts with the performance of skin prick and standard specific IgE tests for diagnosing food allergy. Higher quality information is needed to determine the clinical utility of ISAC for food allergy diagnosis. SYSTEMATIC REVIEW REGISTRATION: Not registered.

Evaluation of the safety, efficacy, effectiveness and cost-effectiveness of implantable Holter for prolonged monitoring in patients with previous stroke: a systematic review.

Background: Atrial fibrillation (AF), which is associated with cryptogenic stroke, is the most common sustained arrhythmia in the general population. Because AF is asymptomatic and intermittent, its detection rate increases with the duration of monitoring. The objective of this study is to review the available evidence on the safety, efficacy, effectiveness and cost-effectiveness of AF diagnosis by prolonged monitoring with an implantable Holter monitor in adult patients with idiopathic or cryptogenic stroke of suspected cardioembolic origin, compared to conventional monitoring. Methods: Two independent reviewers performed a systematic review of the literature, identifying relevant studies through a structured search of Medline (Ovid), EMBASE, Web of Science and Cochrane Library and the databases of national and international health technology assessment agencies. The quality of the included studies was assessed with AGREE-II, AMSTAR-2 and CHEC. GRADE criteria were used to summarise the evidence. Results: Four of the 211 papers identified were included: 1 clinical practice guideline, 2 systematic reviews, and 1 economic evaluation. The quality of the evidence reviewed was low. An implantable Holter monitor might be more effective in detecting AF than conventional monitoring. Serious adverse events were similar in both groups. The economic evaluation suggests that the technology is cost-effective. Conclusions: The available evidence suggests the diagnostic superiority of the implantable Holter monitor over the traditional Holter monitor. Due to the low quality of the evidence, further and higher quality studies on these technologies are needed before solid conclusions can be drawn.

Efficacy and safety of baroreflex activation therapy for heart failure with reduced ejection fraction: systematic review.

Baroreflex activation therapy (BAT) is a possible adjuvant treatment for patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal medical therapy and may be an alternative therapy in patients with contraindications or drug intolerance. Our aim was to evaluate the efficacy and safety of BAT in patients with HFrEF. The protocol for this study was registered with PROSPERO (CRD42022349175). Searches were conducted using MEDLINE, preMedLine (via PubMed), EMBASE, Cochrane Library, Web of Science, Trip Medical Database, WHO International Clinical Trials Registry, and ClinicalTrials.gov. We included randomized controlled trials that compared the effects of BAT with pharmacological treatment. We assessed the risk of bias of each study using the Cochrane RoB2 tool and the certainty of the results using the GRADE approach. We performed a meta-analysis of treatment effects using a fixed-effects or random-effects model, depending on the heterogeneity observed. Two studies were included in the meta-analysis (HOPE4HF and BeAT-HF). The results showed that BAT led to statistically significant improvements in New York Heart Association functional class (relative risk 2.13; 95% confidence interval [CI, 1.65 to 2.76]), quality of life (difference in means -16.97; 95% CI [-21.87 to -12.07]), 6 min walk test (difference in means 56.54; 95% CI [55.67 to 57.41]) and N-terminal probrain natriuretic peptide (difference in means -120.02; 95% CI [-193.58 to -46.45]). The system- and procedure-related complication event-free rate varied from 85.9% to 97%. The results show that BAT is safe and improves functional class, quality of life and congestion in selected patients with HFrEF. Further studies and long-term follow-up are needed to assess efficacy in reducing cardiovascular events and mortality.

Diagnostic accuracy of optical coherence tomography angiography in the detection of neovasculature in age-related macular degeneration: a meta-analysis.

This work is a systematic review and meta-analysis to evaluate the diagnostic accuracy of optical coherence tomography angiography (OCTA) in the identification of choroidal neovascularization due to age-related macular degeneration (AMD) in comparison with fluorescein angiography (FA). A systematic search of the literature was carried out on Medline, EMBASE, Web of Science, Cochrane Library and Center for Reviews and Dissemination. Studies comparing OCTA with FA for the diagnosis of choroidal neovascularization due to AMD that included data on the diagnostic validity of the test or the data necessary for its calculation were selected. The QUADAS-2 tool was used to assess the risk of bias in selected studies. The quantitative analysis of the results was performed by meta-analysis. Seven primary studies were included. The quality of the evidence was good. The total population included in the meta-analysis comprised 553 eyes, with a cumulative sensitivity and specificity of 85.9% (95% CI 81.9-89.3%) and 89% (95% CI 83.5-93.2%), respectively, cumulative positive and negative likelihood ratios of 8.36 and 0.15, respectively (95% CI of 3.05-22.890 and 0.09-0.24, respectively), and a cumulative diagnostic odds ratio of 67.21 (95% CI 22.58-200.05). The evidence obtained does not demonstrate the superiority of OCTA over FA. Its use as a support technique could improve patient flow and reduce the number of FA.

Factores determinantes en la indicación de la prótesis invertida de hombro / Facteurs déterminant l'indication de prothèse d'épaule inversée / Determining Factors in Inverted Shoulder Prosthesis Indication

Objetivo: Desarrollar criterios para determinar las indicaciones apropiadas de la prótesis invertida de hombro en artropatías por lesión del manguito rotador y las variables determinantes de este proceso. Método: Se utilizó un panel de expertos mediante metodología RAND/UCLA con 9 expertos en Traumatología, 2 en Rehabilitación y 1 en Reumatología, que evaluaron 192 casos hipotéticos. Cada experto puntuó mediante una escala del 1 (extremadamente inadecuado) al 9 (extremadamente apropiado). Resultados: 22 casos hipotéticos fueron considerados adecuados. El dolor, limitación funcional, necesidad funcional, defecto glenoideo, edad, artrosis y posibilidad de reparación del manguito rotador son variables determinantes para indicar la implantación de una prótesis invertida de hombro. Conclusiones: El método RAND/UCLA es útil para el estudio de las indicaciones de procedimientos como la prótesis invertida de hombro, y proporciona una lista de las indicaciones adecuadas. Las variables requieren ser validadas mediante estudios prospectivos o revisión de historias clínicas(AU)

Objective: Develop criteria to determine the appropriate indications of inverted shoulder prosthesis in arthropathies due to rotator cuff injury and the variables that determine this process. Method: A panel of experts assessed 192 hypothetical cases using RAND/UCLA methodology. Nine Traumatology experts, two Rehabilitation experts and one Rheumatology expert comprised this panel. Each expert scored on a scale from 1 (extremely unsuitable) to 9 (extremely appropriate). Results: 22 hypothetical cases were considered adequate. Pain, functional limitation, functional need, glenoid defect, age, osteoarthritis and possibility of rotator cuff repair are determining as variables to indicate the implantation of an inverted shoulder prosthesis. Conclusions: The RAND/UCLA method is useful for the study of procedure indications such as the inverted shoulder prosthesis, and it provides a list of suitable indications. Prospective studies or medical record reviews should validate these variables(AU)

Objectif: Proposer les critères définissant l'indication appropriée de prothèse d'épaule inversée dans les arthropathies pour lésion de la coiffe des rotateurs, et les variables déterminant ce processus. Méthodes: Un panel d'experts, compris par 9 traumatologues, 2 kinésithérapeutes et 1 rhumatologue, a été utilisé pour évaluer 192 cas hypothétiques par la méthode RAND/UCLA. Chaque expert a fait son évaluation sur une échelle de 1 (extrêmement inapproprié) à 9 (extrêmement approprié). Résultats: Vingt-deux cas hypothétiques ont été considérés comme appropriés. Des variables telles que la douleur, la limitation fonctionnelle, la nécessité fonctionnelle, le défaut glénoïdien, l'âge, l'arthrose et la possibilité de correction de la coiffe des rotateurs, ont déterminé l'indication de prothèse d'épaule inversée. Conclusions: La méthode RAND-UCLA est utile pour l'étude des indications de procédés, tels que la prothèse d'épaule inversée, et procure une liste des indications appropriées. Il faut valider les variables avec des études prospectives ou une révision des dossiers médicaux(AU)