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Nevin Manimala Statistics

Comparing the Effects of Two Culture Methods to Determine the Total Heterotrophic Bacterial Colony Count in Hospital Purified Water

J Epidemiol Glob Health. 2024 Feb 15. doi: 10.1007/s44197-023-00186-1. Online ahead of print.

ABSTRACT

BACKGROUND: Accurately detecting the quantity of microorganisms in hospital purified water is of significant importance for early identification of microbial contamination and reducing the occurrence of water-borne hospital infections. The choice of detection method is a prerequisite for ensuring accurate results. Traditional Plate Count Agar (PCA) belongs to a high-nutrient medium, and there may be limitations in terms of accuracy or sensitivity in detecting microorganisms in hospital purified water. On the other hand, Reasoner’s 2A agar (R2A) has characteristics, such as low-nutrient levels, low cultivation temperature, and extended incubation time, providing advantages in promoting the growth of aquatic microorganisms. This study, through comparing the differences in total colony counts between two detection methods, aims to select the method more suitable for the growth of aquatic microorganisms, offering new practical insights for accurately detecting the total count of heterotrophic bacteria in hospital purified water.

METHODS: The most commonly used plate count agar (PCA) method, and the R2A agar culture were adopted to detect microorganisms and determine the total number of bacterial colonies in the water for oral diagnosis and treatment water and terminal rinse water for endoscopes in medical institutions. The two water samples were inoculated by pour plate and membrane filtration methods, respectively. Using statistical methods including Spearman and Pearson correlation, Wilcoxon signed-rank sum test, paired-Chi-square test, and linear regression, we analyze the differences and associations in the bacterial counts cultivated through two different methods.

RESULTS: In 142 specimens of the water, the median and interquartile range of the heterotrophic bacterial colony number under the R2A culture method and under the PCA culture method were 200 (Q1-Q3: 25-18,000) and 6 (Q1-Q3: 0-3700). The total number of heterotrophic bacteria colonies cultured in R2A medium for 7 days was more than that cultured in PCA medium for 2 days (P < 0.05). The linear regression results showed a relatively strong linear correlation between the number of colonies cultured by the R2A method and that cultured by the PCA method (R2 = 0.7264). The number of bacterial species detected on R2A agar medium is greater than that on PCA agar medium.

CONCLUSION: The R2A culture method can better reflect the actual number of heterotrophic bacterial colonies in hospital purified water. After logarithmic transformation, the number of colonies cultured by the two methods showed a linear correlation.

PMID:38358615 | DOI:10.1007/s44197-023-00186-1

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Nevin Manimala Statistics

Endovenous laser ablation (EVLA) for vein insufficiency: two-year results of a multicenter experience with 1940-nm laser diode and a novel optical fiber

Lasers Med Sci. 2024 Feb 15;39(1):61. doi: 10.1007/s10103-024-04000-7.

ABSTRACT

Thermoablative techniques currently represent, in accordance with international guidelines, the most used methods in the treatment of varicose veins. From some years, lasers with a wavelength greater than 1900 nm have been introduced for EndoVenous Laser Ablation (EVLA) treatment. However, currently, few clinical studies regarding this new technology are reported in the medical literature. The aim of this study is to evaluate outcomes at a 2-year follow-up (mid-term) of EVLA of varicose veins of the lower limbs using a 1940-nm laser and a new cylindric monoring fiber. This clinical trial was conducted as a multicenter, retrospective, non-randomized, non-blind clinical study. Ninety-three patients were enrolled for a total of one hundred consecutive procedures performed in the period between January 2021 and May 2021 in two Italian facilities. The primary efficacy endpoint was the occlusion rate of the treated vein immediately after surgery and at the follow-up (24 months). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power and linear energy density or LEED). The primary safety endpoints were the incidence of pain (1 day and 7 days after surgery) and the rate of intraoperative and postoperative complications. The precepted pain was evaluated with the visual analog scale (VAS). The secondary safety endpoint was the evaluation of the improvement of the patient’s symptoms related to venous disease. This evaluation was conducted by recording the changes in clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification. All procedures were carried out regularly on an outpatient basis, and no intraoperative complications occurred. The occlusion rate of the target veins was 100% at 7- and 30-day controls. At follow-up controls, performed at 6 months, 1 and 2 years carried out showed an occlusion rate respectively of 99% (97 to 100), 96.9% (93.6 to 100), and 95.9% (92.1 to 99.9). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power watt and linear energy density): As regards the power parameters, we report an average of watts of 4.5 ± 0.8 [2.5 to 6] and linear energy density delivered (LEED) of 41.2 ± 8.6 [(21.1 to 66.7)]. The pain reported (with VAS scale) on 1 day of the procedure was 2 [1; 3] and 1 [0 to 4] at 7 days. All patients showed improved symptoms related to venous disease, with reduction of the individual CEAP class to which they belong. This study demonstrates that EndoVascular Laser Ablation (EVLA) treatment of varicose veins with a wavelength > 1900 nm is safe and effective. The overall occlusion rate was high. The reported results suggest that using lower parameters, such as output power (watts) and LEED (linear energy density), do not reduce the success rate of the treatment when used over 35 J/cm.

PMID:38358591 | DOI:10.1007/s10103-024-04000-7

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Nevin Manimala Statistics

Does the universal adhesive’s film thickness affect dentin-bonding effectiveness?

Clin Oral Investig. 2024 Feb 15;28(2):150. doi: 10.1007/s00784-024-05523-7.

ABSTRACT

OBJECTIVES: To investigate the influence of adhesive resin application modalities on the film thickness of the adhesive resin and the effectiveness of a two-step universal adhesive (UA) bonded in self-etch (SE) bonding mode to high C-factor class-I cavity-bottom dentin.

MATERIALS AND METHODS: After application of the primer of G2-Bond Universal (G2B, GC), the adhesive resin was applied into standard class-I cavities (human molars) following four application modalities: (1) one layer, strongly air-blown; (2) one layer, gently air-blown; (3) two layers, each gently air-blown; (4) one layer, not air-blown. After being restored with composite, each tooth was sectioned to obtain one micro-specimen (n = 10), of which the adhesive resin film thickness was measured using optical microscopy. The micro-tensile bond strength (μTBS) was tested immediately or upon 100,000 thermocycles. Statistical analyses involved Kruskal-Wallis and Mann-Whitney U testing (p < 0.05).

RESULTS: G2B’s μTBS was significantly affected by the adhesive resin application modality and aging. Gently air-blowing the adhesive resin resulted in significantly higher immediate μTBS than strong air-blowing or no air-blowing. No significant difference in μTBS was found between single or double gently air-blown adhesive resin applications. The adhesive resin film thickness significantly varied with the application modalities.

CONCLUSIONS: A too thin or too thick adhesive resin film thickness adversely affected bond strength of the two-step UA applied in SE mode and high C-factor condition.

CLINICAL RELEVANCE: The adhesive resin layer thickness can affect the bonding performance of two-step UAs in high C-factor cavities. Dental clinicians remain advised to avoid improper air-blowing of UAs and strictly follow the application instructions.

PMID:38358575 | DOI:10.1007/s00784-024-05523-7

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Effectiveness and safety of robot-assisted versus fluoroscopy-assisted cortical bone trajectory screw instrumentation in spinal surgery: a systematic review and meta-analysis

J Robot Surg. 2024 Feb 15;18(1):78. doi: 10.1007/s11701-024-01866-1.

ABSTRACT

Robot-assisted (RA) technology has been shown to be a safe aid in spine surgery, this meta-analysis aims to compare surgical parameters and clinical indexes between robot-assisted cortical bone trajectory (CBT) and fluoroscopy-assisted (FA) cortical bone trajectory in spinal surgery. We searched databases such as PubMed, Web of Science, the Cochrane Library, and the China National Knowledge Infrastructure. The study selection process was guided by the PICOS (Patient/Problem, Intervention, Comparison, Outcome, Study Design) strategy. The risk of bias in non-randomized comparative studies was assessed using the risk of bias in non-randomized studies of interventions (ROBINS-I) tool. We performed this meta-analysis using RevMan 5.3 software (Cochrane Collaboration, Copenhagen, Denmark), and the level of statistical significance was set at P < 0.05. Six articles involving 371 patients and 1535 screws were included in this meta-analysis. RA-CBT outperformed FA-CBT in terms of various parameters, such as accuracy of pedicle screw position (both Gertzbein-Robbins scale and Ding scale), avoidance of superior facet joint violation (FJV), and reduction of neurological injury. Our meta-analysis offered a thorough evaluation of the efficacy and safety of RA-CBT in spinal surgery. The findings revealed that RA-CBT produced statistically significant results in terms of pedicle screw position accuracy and superior facet joint violation prevention. In terms of surgical parameters and clinical indexes, future research and clinical practice should investigate the efficacy of RA-CBT further. The study was registered in the PROSPERO (CRD42023466280).

PMID:38358573 | DOI:10.1007/s11701-024-01866-1

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Smoking Behavior Change and the Risk of Heart Failure in Patients With Type 2 Diabetes: Nationwide Retrospective Cohort Study

JMIR Public Health Surveill. 2024 Jan 10;10:e46450. doi: 10.2196/46450.

ABSTRACT

BACKGROUND: Heart failure (HF) is one of the most common initial manifestations of cardiovascular disease in patients with type 2 diabetes. Although smoking is an independent risk factor for HF, there is a lack of data for the incidence of HF according to changes in smoking behaviors in patients with type 2 diabetes.

OBJECTIVE: We aimed to examine the association between interval changes in smoking behavior and the risk of HF among patients with type 2 diabetes.

METHODS: We conducted a retrospective cohort study using the National Health Insurance Service database. We identified 365,352 current smokers with type 2 diabetes who had 2 consecutive health screenings (2009-2012) and followed them until December 31, 2018, for the incident HF. Based on smoking behavior changes between 2 consecutive health screenings, participants were categorized into quitter, reducer I (≥50% reduction) and II (<50% reduction), sustainer (reference group), and increaser groups.

RESULTS: During a median follow-up of 5.1 (IQR 4.0-6.1) years, there were 13,879 HF cases (7.8 per 1000 person-years). Compared to sustainers, smoking cessation was associated with lower risks of HF (adjusted hazard ratio [aHR] 0.90, 95% CI0.86-0.95), whereas increasers showed higher risks of HF than sustainers; heavy smokers who increased their level of smoking had a higher risk of HF (aHR 1.13, 95% CI 1.04-1.24). In the case of reducers, the risk of HF was not reduced but rather increased slightly (reducer I: aHR 1.14, 95% CI 1.08-1.21; reducer II: aHR 1.03, 95% CI 0.98-1.09). Consistent results were noted for subgroup analyses including type 2 diabetes severity, age, and sex.

CONCLUSIONS: Smoking cessation was associated with a lower risk of HF among patients with type 2 diabetes, while increasing smoking amount was associated with a higher risk for HF than in those sustaining their smoking amount. There was no benefit from reduction in smoking amount.

PMID:38198206 | DOI:10.2196/46450

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Functionality and Quality of Asthma mHealth Apps and Their Consistency With International Guidelines: Structured Search and Evaluation

JMIR Mhealth Uhealth. 2024 Jan 10;12:e47295. doi: 10.2196/47295.

ABSTRACT

BACKGROUND: Asthma is a chronic respiratory disorder requiring long-term pharmacotherapy and judicious patient self-management. Few studies have systematically evaluated asthma mobile health (mHealth) apps for quality and functionality; however, none have systematically assessed these apps for their content alignment with international best practice guidelines.

OBJECTIVE: This review aims to conduct a systematic search and evaluation of current mHealth apps in the Australian marketplace for their functionality, quality, and consistency with best practice guidelines.

METHODS: The most recent Global Initiative for Asthma (GINA) guidelines were reviewed to identify key recommendations that could be feasibly incorporated into an mHealth app. We developed a checklist based on these recommendations and a modified version of a previously developed framework. App stores were reviewed to identify potential mHealth apps based on predefined criteria. Evaluation of suitable apps included the assessment of technical information, an app quality assessment using the validated Mobile App Rating Scale (MARS) framework, and an app functionality assessment using the Intercontinental Medical Statistics Institute for Health Informatics (IMS) Functionality Scoring System. Finally, the mHealth apps were assessed for their content alignment with the GINA guidelines using the checklist we developed.

RESULTS: Of the 422 apps initially identified, 53 were suitable for further analysis based on inclusion and exclusion criteria. The mean number of behavioral change techniques for a single app was 3.26 (SD 2.27). The mean MARS score for all the reviewed apps was 3.05 (SD 0.54). Of 53 apps, 27 (51%) achieved a total MARS score of ≥3. On average, the reviewed apps achieved 5.1 (SD 2.79) functionalities on the 11-point IMS functionality scale. The median number of functionalities identified was 5 (IQR 2-7). Overall, 10 (22%) of the 45 apps with reviewer consensus in this domain provided general knowledge regarding asthma. Of 53 apps, skill training in peak flow meters, inhaler devices, recognizing or responding to exacerbations, and nonpharmacological asthma management were identified in 8 (17%), 12 (25%), 11 (28%), and 14 (31%) apps, respectively; 19 (37%) apps could track or record “asthma symptoms,” which was the most commonly recorded metric. The most frequently identified prompt was for taking preventive medications, available in 9 (20%) apps. Five (10%) apps provided an area for patients to store or enter their asthma action plan.

CONCLUSIONS: This study used a unique checklist developed based on the GINA guidelines to evaluate the content alignment of asthma apps. Good-quality asthma apps aligned with international best practice asthma guidelines are lacking. Future app development should target the currently lacking key features identified in this study, including the use of asthma action plans and the deployment of behavioral change techniques to engage and re-engage with users. This study has implications for clinicians navigating the ever-expanding mHealth app market for chronic diseases.

TRIAL REGISTRATION: PROSPERO CRD42021269894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=269894.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33103.

PMID:38198204 | DOI:10.2196/47295

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Nevin Manimala Statistics

Population-Based Validation of the MIA and MSKCC Tools for Predicting Sentinel Lymph Node Status

JAMA Surg. 2024 Jan 10. doi: 10.1001/jamasurg.2023.6904. Online ahead of print.

ABSTRACT

IMPORTANCE: Patients with melanoma are selected for sentinel lymph node biopsy (SLNB) based on their risk of a positive SLN. To improve selection, the Memorial Sloan Kettering Cancer Center (MSKCC) and Melanoma Institute Australia (MIA) developed predictive models, but the utility of these models remains to be tested.

OBJECTIVE: To determine the clinical utility of the MIA and MSKCC models.

DESIGN, SETTING, AND PARTICIPANTS: This was a population-based comparative effectiveness research study including 10 089 consecutive patients with cutaneous melanoma undergoing SLNB from the Swedish Melanoma Registry from January 2007 to December 2021. Data were analyzed from May to August 2023.

MAIN OUTCOMES AND MEASURES,: The predicted probability of SLN positivity was calculated using the MSKCC model and a limited MIA model (using mitotic rate as absent/present instead of count/mm2 and excluding the optional variable lymphovascular invasion) for each patient. The operating characteristics of the models were assessed and compared. The clinical utility of each model was assessed using decision curve analysis and compared with a strategy of performing SLNB on all patients.

RESULTS: Among 10 089 included patients, the median (IQR) age was 64.0 (52.0-73.0) years, and 5340 (52.9%) were male. The median Breslow thickness was 1.8 mm, and 1802 patients (17.9%) had a positive SLN. Both models were well calibrated across the full range of predicted probabilities and had similar external area under the receiver operating characteristic curves (AUC; MSKCC: 70.8%; 95% CI, 69.5-72.1 and limited MIA: 69.7%; 95% CI, 68.4-71.1). At a risk threshold of 5%, decision curve analysis indicated no added net benefit for either model compared to performing SLNB for all patients. At risk thresholds of 10% or higher, both models added net benefit compared to SLNB for all patients. The greatest benefit was observed in patients with T2 melanomas using a threshold of 10%; in that setting, the use of the nomograms led to a net reduction of 8 avoidable SLNBs per 100 patients for the MSKCC nomogram and 7 per 100 patients for the limited MIA nomogram compared to a strategy of SLNB for all.

CONCLUSIONS AND RELEVANCE: This study confirmed the statistical performance of both the MSKCC and limited MIA models in a large, nationally representative data set. However, decision curve analysis demonstrated that using the models only improved selection for SLNB compared to biopsy in all patients when a risk threshold of at least 7% was used, with the greatest benefit seen for T2 melanomas at a threshold of 10%. Care should be taken when using these nomograms to guide selection for SLNB at the lowest thresholds.

PMID:38198163 | DOI:10.1001/jamasurg.2023.6904

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Genetic support of the causal association between gut microbiota and peripheral artery disease: a bidirectional Mendelian randomization study

Aging (Albany NY). 2024 Jan 9;15. doi: 10.18632/aging.205417. Online ahead of print.

ABSTRACT

BACKGROUND: The causal relationship between gut microbiota and peripheral artery disease (PAD) is still not clear. In this research, we employed the Mendelian randomization (MR) technique to explore the potential causal connection between 211 gut microbiota species and PAD. We also investigated whether the causal effects operate in both directions.

METHODS: We used Genome-wide Association Studies (GWAS) summary statistics data from the MiBioGen and FinnGen consortia to conduct a two-sample MR analysis to explore the causal link between gut microbiota and PAD. Sensitivity analysis is conducted to assess the robustness of the MR results. In addition to that, reverse MR analysis was performed to examine the inverse causal relationship.

RESULTS: The inverse variance weighted (IVW) method provided evidence supporting a causal relationship between 9 specific gut microbiota taxa and PAD. The study findings indicated that family Family XI (OR=1.11, CI 1.00-1.24, P=0.048), genus Lachnoclostridium (OR=1.24, 1.02-1.50, P=0.033), and genus Lachnospiraceae UCG001 (OR=1.17, 1.01-1.35, P=0.031) are risk factors associated with PAD. class Actinobacteria (OR=0.84, 0.72-0.99, P=0.034), family Acidaminococcaceae (OR=0.80, 0.66-0.98, P=0.029), genus Coprococcus2 (OR=0.79, 0.64-0.98, P=0.029), genus Ruminococcaceae UCG004 (OR=0.84, 0.72-0.99, P=0.032), genus Ruminococcaceae UCG010 (OR=0.74, 0.58-0.96, P=0.022), and order NB1n (OR=0.88, 0.79-0.98, P=0.02) may be associated with the risk factors of PAD. Moreover, our analysis did not uncover any evidence of a reverse causal relationship between PAD and the nine specific gut microbiota taxa investigated.

CONCLUSIONS: Our MR research has confirmed the potential causal relationship between gut microbiota and PAD while also identifying specific gut bacterial communities associated with PAD.

PMID:38198148 | DOI:10.18632/aging.205417

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Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial

JAMA Netw Open. 2024 Jan 2;7(1):e2350511. doi: 10.1001/jamanetworkopen.2023.50511.

ABSTRACT

IMPORTANCE: More than 80% of patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. With more than 1 million annual hospitalizations for AHF in the US, safe and effective alternatives are needed. Care for AHF in short-stay units (SSUs) may be safe and more efficient than hospitalization, especially for lower-risk patients, but randomized clinical trial data are lacking.

OBJECTIVE: To compare the effectiveness of SSU care vs hospitalization in lower-risk patients with AHF.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial randomly assigned low-risk patients with AHF 1:1 to SSU or hospital admission from the ED. Patients received follow-up at 30 and 90 days post discharge. The study began December 6, 2017, and was completed on July 22, 2021. The data were analyzed between March 27, 2020, and November 11, 2023.

INTERVENTION: Randomized post-ED disposition to less than 24 hours of SSU care vs hospitalization.

MAIN OUTCOMES AND MEASURES: The study was designed to detect at least 1-day superiority for a primary outcome of days alive and out of hospital (DAOOH) at 30-day follow-up for 534 participants, with an allowance of 10% participant attrition. Due to the COVID-19 pandemic, enrollment was truncated at 194 participants. Before unmasking, the primary outcome was changed from DAOOH to an outcome with adequate statistical power: quality of life as measured by the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 scores range from 0 to 100, with higher scores indicating better quality of life.

RESULTS: Of the 193 patients enrolled (1 was found ineligible after randomization), the mean (SD) age was 64.8 (14.8) years, 79 (40.9%) were women, and 114 (59.1%) were men. Baseline characteristics were balanced between arms. The mean (SD) KCCQ-12 summary score between the SSU and hospitalization arms at 30 days was 51.3 (25.7) vs 45.8 (23.8) points, respectively (P = .19). Participants in the SSU arm had 1.6 more DAOOH at 30-day follow-up than those in the hospitalization arm (median [IQR], 26.9 [24.4-28.8] vs 25.4 [22.0-27.7] days; P = .02). Adverse events were uncommon and similar in both arms.

CONCLUSIONS AND RELEVANCE: The findings show that the SSU strategy was no different than hospitalization with regard to KCCQ-12 score, superior for more DAOOH, and safe for lower-risk patients with AHF. These findings of lower health care utilization with the SSU strategy need to be definitively tested in an adequately powered study.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03302910.

PMID:38198141 | DOI:10.1001/jamanetworkopen.2023.50511

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Somatic and Germline Variants and Coronary Heart Disease in a Chinese Population

JAMA Cardiol. 2024 Jan 10. doi: 10.1001/jamacardio.2023.5095. Online ahead of print.

ABSTRACT

IMPORTANCE: The genetic basis of coronary heart disease (CHD) has expanded from a germline to somatic genome, including clonal hematopoiesis of indeterminate potential (CHIP). How CHIP confers CHD risk in East Asian individuals, especially those with small clones (variant allele fraction [VAF] 0.5%-2%) and different genetic backgrounds, was completely unknown.

OBJECTIVE: To investigate the CHIP profile in a general Chinese cohort by deep sequencing and further explore the association between CHIP and incident CHD considering germline predisposition.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from 3 prospective cohorts in the project Prediction for Atherosclerotic Cardiovascular Disease Risk in China. Participants without cardiovascular disease or cancer at baseline were enrolled in 2001 and 2008 and had a median follow-up of 12.17 years extending into 2021.

EXPOSURES: CHIP mutations were detected by targeted sequencing (mean depth, 916×). A predefined CHD polygenic risk score (PRS) comprising 531 variants was used to evaluate germline predisposition.

MAIN OUTCOMES AND MEASURES: The main outcome was first incident CHD.

RESULTS: Among 6181 participants, the median (IQR) age was 53.83 years (45.35-62.39 years); 3082 participants (49.9%) were female, and 3099 (50.1%) were male. A total of 1100 individuals (17.80%) harbored 1372 CHIP mutations at baseline. CHIP was independently associated with incident CHD (hazard ratio [HR], 1.42; 95% CI, 1.18-1.72; P = 2.82 × 10-4) and presented a risk gradient with increasing VAF (P = 3.98 × 10-3 for trend). Notably, individuals with small clones, nearly half of CHIP carriers, also demonstrated a higher CHD risk compared with non-CHIP carriers (HR, 1.33; 95% CI, 1.02-1.74; P = .03) and were 4 years younger than those with VAF of 2% or greater (median age, 58.52 vs 62.70 years). Heightened CHD risk was not observed among CHIP carriers with low PRS (HR, 1.02; 95% CI, 0.64-1.64; P = .92), while high PRS and CHIP jointly contributed a 2.23-fold increase in risk (95% CI, 1.51-3.29; P = 6.29 × 10-5) compared with non-CHIP carriers with low PRS. Interestingly, the diversity in CHIP-related CHD risk within each PRS group was substantially diminished when removing variants in the inflammatory pathway from the PRS.

CONCLUSIONS: This study revealed that elevated CHD risk attributed to CHIP was nonnegligible even for small clones. Inflammation genes involved in CHD could aggravate or abrogate CHIP-related CHD risk.

PMID:38198131 | DOI:10.1001/jamacardio.2023.5095