Systematic Safety Research Articles

Introducing a systematic and sustainable patient safety oversight function in a U.K. arms-length healthcare body

Background The healthcare landscape is experiencing a profound period of change with accelerating developments in medical research, new treatments, care delivery and the use of innovative technology to meet the challenges of delivering care. These changes offer opportunities but as with all innovation, require careful management to reduce the likelihood of harm and error. Objective The National Institute for Health and Care Excellence (NICE) has set out to introduce an adaptable, sustainable and systematic patient safety oversight group to ensure that patient safety is embedded at an organisation level supporting the healthcare system to overcome challenges and deliver high quality care, safely implementing the latest innovations in a timely manner. Method The patient safety oversight group was established through a scoping exercise, led by the senior responsible officer and a small project team. The article sets out the methods used, including extensive internal engagement through structured interviews with senior leadership teams, purposive sampling, data synthesis and reporting. An overview of the group is given and considerations for promoting patient safety information flows and optimising the use of safety signal intelligence are made. Conclusion Through reflection on changing needs within and surrounding the organisation, along with patient safety and complexity literature, NICE has developed an adaptable, systematic and sustainable model for managing patient safety. In addition to generating learning within NICE, the process highlights opportunities for improvement within the patient safety system. Result NICE has developed an adaptable, systematic and sustainable model for managing patient safety.

334P Cardiovascular events related to CDK4/6 inhibitors: A systematic review and safety meta-analysis of randomized controlled trials

334P Cardiovascular events related to CDK4/6 inhibitors: A systematic review and safety meta-analysis of randomized controlled trials

The integrated methodology for assessing the safety of the road network infrastructure in Romania.

Abstract Romania has the highest road fatality rate in the EU and the lowest perception of road quality. This study presents the implementation of a preliminary procedure and tools provided by the European Commission for the safety assessment of the DN2-E85 road infrastructure, which covers 472.23 km. This road was selected due to the high number of road deaths between 2017 and 2022. The research focuses on the application of both proactive and reactive methodologies as required by Directive (EU) 2019/1936, which requires full road network safety assessments by 2024, with subsequent assessments every five years. The proactive methodology assesses the built-in road safety of the road infrastructure based on design parameters, while the reactive methodology is based on historical data on accidents and traffic flows. The integration of these methodologies allows the classification of road segments into five risk levels. Preliminary results indicate that approximately 59% of the length of the DN2-E85 road is classified as “very high priority”, highlighting significant safety deficiencies, which require actions to immediately improve traffic safety. This study highlights the need for systematic road infrastructure safety assessments and prioritisation of high-risk segments to reduce road fatalities and improve overall road safety. The findings serve as crucial information for road safety auditors and the Romanian Road Authority - ARR, supporting the identification of high-risk areas and the allocation of resources to improve safety. In addition, this research provides a basic basis for future adaptations of road infrastructure safety assessment guidelines, considering the specific characteristics of national and county roads. By aligning with EU directives and national standards, the study aims to increase road safety and reduce the incidence of serious accidents in Romania. The insights gained from this research are essential for developing effective road safety strategies and implementing remedial measures that address the most dangerous segments of the road network.

Detection of hydrogen gas leak using distributed temperature sensor in green hydrogen system

This study addresses the challenges of hydrogen gas detection in pipelines, focusing on the highly flammable nature and low ignition energy of hydrogen. It highlights the limitations of traditional point-based detection methods and emphasizes the need for advanced safety technologies. An integrated approach combining onsite monitoring with Internet of Things (IoT) technology is proposed to enhance systematic safety management and quick leak detection in hydrogen infrastructures. The study reviews various hydrogen detection methods, emphasizing distributed temperature sensing (DTS) techniques to identify leaks through temperature variations. Over nine months of monitoring, the results indicate that DTS temperature variations are more influenced by sensor location than chamber configuration, suggesting that external DTS chamber installation is more effective for leak detection. Additionally, the study integrates Gaussian Process Regression with Machine Learning to predict temperature distribution in pipelines, providing valuable insights for future hydrogen leak detection research.

요양병원 입원환자 환자안전사고 위해정도에 영향을 미치는 요인

Purpose: This study aimed to identify the characteristics of patient safety incidents among patients admitted to long-term care hospitals and the factors affecting the severity of these incidents, and provide essential data for developing strategies to prevent and manage patient safety incidents in long-term care hospitals. Method: The study utilized 7,594 patient safety report data collected from 2017 to 2022, based on Patient Safety Reporting and Learning System. Descriptive statistics and cross-analysis were conducted to identify the characteristics of patient safety incidents among inpatients of long-term care hospitals. Multinomial logistic regression analysis was performed to analyze the related factors. All statistical analyses were carried out using the SPSS statistical program. Results: Factors identified as affecting the severity of patient safety incidents in long-term care hospital inpatients included gender, age, primary diagnosis, the impact of COVID-19, the number of beds, the location of the incident, and the type of incident. Conclusion: As the aging population leads to an increase in patient safety incidents in long-term care hospitals, it is crucial to prevent these incidents and ensure their severity does not escalate. This requires systematic safety education for all healthcare workers and efforts such as implementing patient safety incident prevention programs and monitoring systems within long-term care hospitals.

System theory safety analysis of network malfunction in nuclear power plant distributed control systems

Abstract A secure and highly reliable communication network is a crucial component of the distributed control system (DCS) in nuclear power plants (NPPs), particularly for the protection system. However, there have been numerous reported cases of cyber-attacks in the field of nuclear power, and the cybersecurity threats faced by a DCS are increasing. Given that the DCS is a complex integrated system combining computers, communication, and control with a large number of interactions between components and external interferences, traditional linear safety analysis methods fail to meet its requirements. To minimize cybersecurity accidents caused by potential vulnerabilities, it is necessary to conduct systematic safety analysis on DCS cybersecurity accidents in NPPs. Therefore, this paper selected a specific case of cybersecurity accidents in a NPP for abstract modeling and reproduction. The causal analysis based on system theory (CAST) method was applied to conduct an analysis of the accident causes. It can identify existing vulnerabilities and potential factors impacting the safe operation of NPPs, and countermeasures and recommendations can be proposed. The reference for assessing potential risks and devising solutions can be provided for other DCS communication networks.

A Bayesian network model integrating organizational, individual and psychological factors for strengthening construction worker safety behavior

Objectives. Construction worker safety behavior (CWSB) may be affected by a confluence of multilevel and interrelated factors. Cultivating and maintaining CWSB is vital for improving construction safety. Current studies focus on organization-level or individual-level CWSB antecedents. However, few studies have examined the influence of psychological factors on CWSB, thereby reducing the joint effects of multilevel factors on CWSB. Methods. To determine effective strategies for strengthening CWSB, this study adopted the Bayesian network technique to explore the interrelationships between CWSB and its antecedent factors. A Bayesian belief network model was developed and trained with data collected from Chinese construction workers, which connected organizational, individual and psychological factors with CWSB. Results. According to the sensitivity analysis, safety knowledge, safety climate and psychological capital are the three most significant influencing factors for CWSB. A combined strategy that enhances safety knowledge, safety climate and communication competence simultaneously is the most effective option for strengthening CWSB. The validation and robustness of the network showed good accuracy for safety behavior judgment. Conclusion. This study proposes an alternative way to improve safety behavior by identifying its interactive causes and illustrates the importance of initiating systematic safety measures, which may help to mitigate the problem of safety plateau.

Safety Evaluation Index System for Dangerous Goods Transportation by Water in Weihai City

With the development of China's shipping industry, the maritime cargo transportation industry chain is becoming more and more complete, resulting in more and more problems. Among them, the transportation of dangerous goods by waterway is also receiving more and more attention. As an important method of transporting dangerous goods, the safety of waterway transportation is particularly important. In order to ensure the safety of waterway dangerous goods transportation, it is necessary to establish a scientific and reasonable safety evaluation index system, and conduct a comprehensive and systematic safety evaluation of waterway dangerous goods transportation. Firstly, this paper takes the transportation of dangerous goods by waterway in Weihai City as an example, and selects five primary evaluation indicators, including environment, personnel, ships, goods, and management, as well as their secondary and tertiary evaluation indicators, based on the actual situation; secondly, a safety index system for the transportation of dangerous goods by water in Weihai City has been constructed, and an example analysis has been conducted on it; finally, safety management measures for the transportation of dangerous goods by waterway in Weihai City were proposed.

Abstract 3315: Preclinical studies of TSN1611, a potent, selective, and orally bioavailable KRASG12D inhibitor

Abstract Background: KRAS mutations are the most frequently encountered driver oncogene, involved in ~25% of all human cancers [1,2]. KRASG12D is the predominant KRAS mutation isoform, detected in approximately 35% of pancreatic cancer, 13% of colorectal cancer, and 5% of NSCLC [3]. Compared to KRASG12C, targeting KRASG12D has proven to be more challenging since the target protein lacks a reactive amino acid residue for irreversible inhibitory modification by a ligand. Herein, we disclose TSN1611, a potent and selective KRASG12D inhibitor, which possesses favorable oral PK profiles and demonstrates significant in vitro and in vivo anti-tumor activity in various KRASG12D-mutant models. Method: Biochemical HTRF assay was used to measure the inhibition of TSN1611 to both GDP-bound and GTP-bound state of KRASG12D. Biophysical SPR method was used to directly measure the binding of TSN1611 to GDP-bound KRASG12D and KRASWT. Cell based activities were evaluated in a series of in vitro cell proliferation assay utilizing Ba/F3 cells engineered with KRASG12D or non-KRASG12D mutations and tumor cell lines harboring KRASG12D mutation. Human cancer cell-derived xenograft models of HPAC (pancreatic) and GP2D (colorectal) were used to evaluate its in vivo antitumor effect. in vitro and in vivo PK studies were performed in mouse, rat, and dog. Systematic nonclinical safety evaluations, including safety panel screen testing, safety pharmacology studies, and repeat-dose toxicity studies were carried out to assess its preliminary toxicity profile. Results: TSN1611 inhibited both active (GTP-bound) and inactive (GDP-bound) forms of KRASG12D protein at IC50 1.23 and 1.49 nM, respectively; the KD value of its direct binding to KRASG12D protein is 1.93 pM in SPR assay. TSN1611 demonstrated potent anti-proliferation activity against several tumor cell lines harboring KRASG12D mutation, and excellent selectivity over cells of NRAS, HRAS, and other KRAS isoforms. It also showed dose-dependent anti-tumor efficacy in GP2D and HPAC models. Mechanism of action studies concluded that the antitumor effect of TSN1611 is resulted from its effective inhibition of KRAS signaling pathway. Oral bioavailability and safety profile across multiple species supported its further development. Conclusion: TSN1611 is a selective KRASG12D inhibitor. It exhibited excellent selectivity and activity both in vitro and in vivo; it demonstrated favorable physicochemical properties, oral PK profiles, and brain penetration potential; it also showed acceptable margins of safety. The preclinical data supports further development. Pending regulatory submission and review, the phase I/II study is planned to start in H1 of 2024.

An explainable unsupervised risk early warning framework based on the empirical cumulative distribution function: Application to dairy safety

Efficient food safety risk assessment significantly affects food safety supervision. However, food detection data of different types and batches show different feature distributions, resulting in unstable detection results of most risk assessment models, lack of interpretability of risk classification, and insufficient risk traceability. This study aims to explore an efficient food safety risk assessment model that takes into account robustness, interpretability and traceability. Therefore, the Explainable unsupervised risk Warning Framework based on the Empirical cumulative Distribution function (EWFED) was proposed. Firstly, the detection data’s underlying distribution is estimated as non-parametric by calculating each testing indicator’s empirical cumulative distribution. Next, the tail probabilities of each testing indicator are estimated based on these distributions and summarized to obtain the sample risk value. Finally, the “3σ Rule” is used to achieve explainable risk classification of qualified samples, and the reasons for unqualified samples are tracked according to the risk score of each testing indicator. The experiments of the EWFED model on two types of dairy product detection data in actual application scenarios have verified its effectiveness, achieving interpretable risk division and risk tracing of unqualified samples. Therefore, this study provides a more robust and systematic food safety risk assessment method to promote precise management and control of food safety risks effectively.

Research on the Application Mode of Construction Engineering Safety Management Combined with BIM Technology

Abstract The advent of Building Information Modeling (BIM) technology heralds a new era in construction safety management. This research integrates BIM to forge a safety management system that proactively identifies construction risks and counteracts worker safety hazards in real-time. It also constructs a comprehensive BIM-based safety evaluation index, applying advanced multi-level fuzzy comprehensive assessment techniques and refined hierarchical analysis to calculate index importance. The study dissects safety management on multiple fronts through a detailed analysis of the construction safety practices at the new campus of People’s Hospital in Province A. The findings denote a basic level of success in collaborative safety efforts and an overall disappointing safety management score of 2.463, spotlighting an urgent need for systematic safety improvements within the project.

Identification and characteristic analysis of semi-natural habitats in China's economically developed areas: New insights to inform cultivated land system ecological conservation

Identifying and characterizing semi-natural habitats (SNHs) are important to the ecological conservation of cultivated land systems and implementing China's ecological civilization strategy. This study revealed the concept and characteristics of SNHs in Chinese cultivated land systems regarding human activities, resource types, and spatial landscape patterns. The resource quantity, landscape quality, and spatial distribution of SNHs in Southern Jiangsu's cultivated land system were analyzed by constructing the identification model of “land use/land cover type-cultivated land use intensity-spatial landscape pattern”. The results showed that the area of SNHs in Southern Jiangsu's cultivated land system was 25.35%, significantly influenced by cultivated land intensification and expansion. The higher the cultivated land use intensity, the lower the quantity of SNHs, and the proportion of SNHs in the intensive-use pattern was only 2.97%. 68.18% of the SNHs in Southern Jiangsu were water, and habitats for important species, such as woodland, grassland, wetlands, and bare land, were scarce. A small patch area, high landscape fragmentation, poor landscape richness and diversity, and low connectivity accompanied increased cultivated land use intensity. From the extensive to intensive utilization, the spatial spread of SNHs from low-value aggregation to high-value scatter areas, with hotspot areas of cultivated land use intensity and SNHs existing only in a small part of Nanjing and Changzhou. This study provides a scientific reference for the rehabilitation and restoration of SNHs in the context of the ecological transformation of land use. It promotes the sustainable intensification of cultivated land systems. It also provides new ideas for linking ecological and urban spaces to form a stable and systematic national ecological safety network.

Hematological Toxicity of PARP Inhibitors in Metastatic Prostate Cancer Patients with Mutations of BRCA or HRR Genes: A Systematic Review and Safety Meta-analysis.

PARP inhibitors (PARPis) are effective treatment options for patients with metastatic castration-resistant prostate cancer (mCRPC) as single agents or in combination with androgen receptor-targeted agents (ARTA). However, a clinically relevant adverse effect of these agents is hematological toxicity, a typical class adverse event (AE), which can lead to treatment modifications and discontinuations. We aimed to analyze the risk of hematological AEs, including anemia, neutropenia, and thrombocytopenia secondary to PARPi treatments in mCRPC. This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. We systematically searched the PubMed, EMBASE, and Cochrane databases, the American Society of Clinical Oncology (ASCO), and the European Society of Medical Oncology (ESMO) meeting abstracts for clinical trials concerning the use of PARPis, both as single agents and in combination, in patients with mCRPC. The search deadline was 30 June, 2023. We analyzed the pooled incidence of all grades of and ≥ G3 anemia, neutropenia, and thrombocytopenia. We subsequently calculated risk ratios (RRs) for all grades of and ≥ G3 AEs of PARPis versus non-PARPis from randomized clinical trials (RCTs). Eleven phase 2/3 trials with olaparib, niraparib, rucaparib, and talazoparib administered as single agents or combined with ARTA were selected. Anemia was the most common all grades (38.6%) and ≥ G3 AE (24.9%). In the analysis of relative risk, six RCTs were included. The administration of PARPis significantly increased the risk of developing all grades of anemia (RR = 2.44), neutropenia (RR = 3.15), and thrombocytopenia (RR = 4.66) compared with non-PARPis. Similarly, a significant increase in the risk of ≥ G3 anemia (RR = 5.73) and thrombocytopenia (RR = 5.44), and a not significant increased risk of neutropenia (RR = 3.41), were detected. In mCRPC, PARPis increase the risk of hematological toxicity compared with other treatments, both as single agents or combined with ARTA (high-quality evidence). Clinicians should be aware of this risk and the correct management, especially with the expected increased PARPis use in mCRPC.

Improving the Safety Culture and Climate of Smaller Construction Firms: A Necessary Addition to the OSH Intervention Model

The unsatisfactory safety performance of smaller construction firms has been identified as a challenge that requires further investigation and intervention. There are few studies, if any, that investigate the safety culture and climate of smaller construction firms. This study represents a much needed attempt to clarify the obstacles that prevent smaller construction firms from creating a satisfactory level of safety culture and climate. The study aims to propose a framework that is better suited for smaller construction firms based on literature. To validate the proposed framework, a questionnaire was designed and administered. The findings support the proposed framework and deliver an objective defining criterion that classifies smaller construction firms into small firms and micro firms. Among other factors, the findings suggest that smaller construction firms often lack systematic safety operations due to the absence of safety personnel. Accordingly, a revised occupational safety and health (OSH) model for smaller construction firms has been developed based on the model previously developed by the National Institute of Occupational Safety and Health (NIOSH). It is expected that this study will improve safety intervention programs for smaller construction firms and the safety performance of the construction industry.

The recombinant BMP-2 loaded silk fibroin microspheres improved the bone phenotype of mild osteogenesis imperfecta mice.

Osteogenesis imperfecta (OI) is an inherited congenital disorder, characterized primarily by decreased bone mass and increased bone fragility. Bone morphogenetic protein-2 (BMP-2) is a potent cytokine capable of stimulating bone formation, however, its rapid degradation and unanticipated in vivo effects restrict its application. The sustained release characteristic of silk fibroin (SF) microspheres may potentially address the aforementioned challenges, nevertheless they have not previously been tested in OI treatment. In the current investigation, recombinant BMP-2 (rBMP-2) loaded SF (rBMP-2/SF) microspheres-based release carriers were prepared by physical adsorption. The SF microparticles were characterized by scanning electron microscopy (SEM) and were investigated for their cytotoxicity behavior as well as the release profile of rBMP-2. The rBMP-2/SF microspheres were administered via femoral intramedullary injection to two genotypes of OI-modeled mice daily for two weeks. The femoral microstructure and histological performance of OI mice were evaluated 2 weeks later. The findings suggested that rBMP-2/SF spheres with a rough surface and excellent cytocompatibility demonstrated an initial rapid release within the first three days (22.15 ± 2.88% of the loaded factor), followed by a transition to a slower and more consistent release rate, that persisted until the 15th day in an in vitro setting. The factor released from rBMP-2/SF particles exhibited favorable osteoinductive activity. Infusion of rBMP-2/SF microspheres, as opposed to blank SF spheres or rBMP-2 monotherapy, resulted in a noteworthy enhancement of femoral microstructure and promoted bone formation in OI-modeled mice. This research may offer a new therapeutic approach and insight into the management of OI. However, further investigation is required to determine the systematic safety and efficacy of rBMP-2/SF microspheres therapy for OI.

Application of Predatory Bacteria in the Prevention and Control of Aquaculture Diseases

The green and healthy development of aquaculture is an important guarantee for food security. Pathogenic bacteria are a major factor constraining the development of aquaculture. Predatory bacteria are a class of potentially beneficial bacteria that can be used as an alternative to antibiotics for the prevention and control of aquatic animal diseases. This article reviews the application of predatory bacteria in the prevention and control of aquaculture diseases, discusses their potential as probiotics, and also points out some unresolved issues, including limited bacterial resources, insufficient studies on biological and ecological properties, lack of systematic safety and

Acute and 90-day toxicological safety assessment of Shang-Ke-Huang-Shui lotion in New Zealand White rabbits

Ethnopharmacological relevanceShang-Ke-Huang-Shui lotion (SKHS), an experiential formula based on the theory of traditional Chinese medicine as a hospital preparation, combines Coptidis Rhizoma, Phellodendri Chinensis Cortex, Gardeniae Fructus, Arnebiae Radix, Menthae Haplocalycis Herba and Alumen. While it has acquired positive effects on the treatment of soft tissue injuries, there is no systematic safety assessment in recent studies. Aim of the studyThe study aimed to investigate the acute and long-term toxicity in New Zealand White rabbits using topical administration of SKHS. Materials and methodsIn the acute toxicity study, rabbits were given topical administration of SKHS extract (2.775 g crude drug/mL) 3 times daily in normal and broken skin. In the long-term toxicity study, rabbits underwent topical administration of SKHS extract (1.390, 0.694, 0.139 g crude drug/mL) 1 time per day in normal and broken skin for 90 days. Their general behavior, body weight, food intake, biochemical and hematologic parameters, organ coefficients, and pathological morphology were analyzed. ResultsMild skin irritation was observed in rabbits with normal or broken skin following acute exposure to the high dose of SKHS. Evidence of toxicity was not observed in the rabbits exposed to SKHS for an extended period. Although some parameters have been significant changes, they cannot be considered treatment-related because they have remained within normal limits. ConclusionTopical administration of SKHS could be considered relatively safe and did not reveal any severe toxicity or side effects in this study.

Safety assessment of ship-bridge system during sea transportation under complex sea states

With a constantly increasing demand for sea-crossing bridges, sea transportation of bridges has a broad application prospect. Although current studies have investigated the environmental loads in complex sea states and the effects of the loads on ships and bridges in their service states, there are few studies on the safety assessment of a ship-bridge system during sea transportation. The safety assessment standards of ships and bridges cannot meet the safety requirements of bridge sea transportation. The imperfection of the safety assessment technology hinders the development of bridge sea transportation. To bridge the gap, this study proposed a systematic safety assessment for the sea transportation of bridges. Firstly, the calculation of marine environmental loads and the determination of load combinations were presented. Then, the safety assessment technology was proposed from the aspects of the ship-bridge system strength, system stability, bridge stability, and anti-sliding ability. Next, the ship-bridge system of the Tseung Kwan O Bridge was numerically simulated. The dynamic responses of the system subjected to the load combinations of wind, current, and wave were evaluated. Finally, the safety of the bridge during transportation was quantitatively assessed. The technology can greatly enhance bridge safety during sea transportation.

A systematic safety pipeline for selection of T-cell receptors to enter clinical use

Cancer immunotherapy using T cell receptor-engineered T cells (TCR-Ts) represents a promising treatment option. However, technologies for pre-clinical safety assessment are incomplete or inaccessible to most laboratories. Here, TCR-T off-target reactivity was assessed in five steps: (1) Mapping target amino acids necessary for TCR-T recognition, followed by (2) a computational search for, and (3) reactivity screening against, candidate cross-reactive peptides in the human proteome. Natural processing and presentation of recognized peptides was evaluated using (4) short mRNAs, and (5) full-length proteins. TCR-Ts were screened for recognition of unintended HLA alleles, and as proxy for off-target reactivity in vivo, a syngeneic, HLA-A*02:01-transgenic mouse model was used. Validation demonstrated importance of studying recognition of full-length candidate off-targets, and that the clinically applied 1G4 TCR has a hitherto unknown reactivity to unintended HLA alleles, relevant for patient selection. This widely applicable strategy should facilitate evaluation of candidate therapeutic TCRs and inform clinical decision-making.

Clinical and Economic Outcomes of a Systematic Same-Day Discharge Program After Pulmonary Vein Isolation: Comparison between Cryoballoon versus Radiofrequency Ablation.

Same-day discharge (SDD) is feasible after pulmonary vein isolation (PVI). We aim to compare prospectively cryoballoon (CRYO) versus radiofrequency (RF) ablation in a systematic SDD program. We prospectively analyzed the 617 scheduled PVI performed consecutively at our institution (n = 377 CRYO, n = 240 RF) from April 1, 2019 to December 31, 2022 within a systematic program of SDD. The feasibility of SDD, the 10-day incidence of urgent/unplanned medical care after discharge (UUC-10), and the cost per procedure due to hospital resource use were studied. The 100 procedures performed during the previous year, in which patients were systematically hospitalized, were used as a control group. SDD was achieved in 585/617 (95%) procedures, with a significant trend towards a higher monthly SDD rate from 2019 to 2022 (p = 0.03). The frequency of SDD was similar in CRYO (356/377; 94%) vs. RF (229/240; 95%). After SDD, the UUC-10 was 66/585 (11.3%), being similar for CRYO (41/356; 11.5%) and RF (25/229; 10.9%); p = 0.8 (log-rank test). Of these, 10 patients were re-hospitalized, with an identical rate in CRYO- (6/356; 1.7%) and RF-treated (4/229; 1.7%) patients and owing to similar causes (4 hematomas, 4 pericarditis, and 2 symptomatic sinus node dysfunction). SDD was associated with an average savings per procedure of 63% (p < 0.001), but no differences were found between the CRYO and RF (p = 0.8). In a systematic SDD program, feasibility (95%, increasing over time), safety (11% UUC-10, 1.7% re-hospitalizations), and savings (63% per procedure) were similar for CRYO and RF ablation.