OBJECTIVES: In this study, we sought to evaluate the association between smoking status and subclinical coronary atherosclerosis, as detected by coronary computed tomography angiography (CCTA), in asymptomatic individuals. METHODS: We retrospectively analyzed 9,285 asymptomatic participants (mean age, 53.7±8.0 years; n=6,017, 64.8% male) with no history of coronary artery disease (CAD) who had undergone self-referred CCTA. Of these participants, 4,333 (46.7%) were considered never smokers, 2,885 (31.1%) former smokers, and 2,067 (22.3%) current smokers. We assessed the degree and characteristics of subclinical coronary atherosclerosis using CCTA, with obstructive CAD defined as a diameter stenosis of at least 50%. RESULTS: Compared with never-smokers, former smokers exhibited no significant differences in the probabilities of obstructive CAD, any coronary plaque, calcified plaque, or mixed plaque, as determined using adjusted odds ratios (aORs; p>0.05 for all). However, the risk of non-calcified plaque was significantly higher in former smokers (aOR, 1.34; 95% confidence interval [CI], 1.00 to 1.78; p=0.048). Current smokers had significantly higher rates of obstructive CAD (aOR, 1.46; 95% CI, 1.10 to 1.96; p=0.010), any coronary plaque (aOR, 1.41; 95% CI, 1.20 to 1.65; p<0.001), calcified plaque (aOR, 1.32; 95% CI, 1.13 to 1.55; p=0.001), non-calcified plaque (aOR, 1.72; 95% CI, 1.28 to 2.32; p<0.001), and mixed plaque (aOR, 2.00; 95% CI, 1.39 to 2.86; p<0.001) compared to never smokers. CONCLUSIONS This cross-sectional study revealed a significant association between current smoking and subclinical coronary atherosclerosis, as detected on CCTA. Additionally, former smoking demonstrated an association with non-calcified plaque, indicating elevated cardiovascular risk.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

OBJECTIVES: In this study, we sought to evaluate the association between smoking status and subclinical coronary atherosclerosis, as detected by coronary computed tomography angiography (CCTA), in asymptomatic individuals. METHODS: We retrospectively analyzed 9,285 asymptomatic participants (mean age, 53.7±8.0 years; n=6,017, 64.8% male) with no history of coronary artery disease (CAD) who had undergone self-referred CCTA. Of these participants, 4,333 (46.7%) were considered never smokers, 2,885 (31.1%) former smokers, and 2,067 (22.3%) current smokers. We assessed the degree and characteristics of subclinical coronary atherosclerosis using CCTA, with obstructive CAD defined as a diameter stenosis of at least 50%. RESULTS: Compared with never-smokers, former smokers exhibited no significant differences in the probabilities of obstructive CAD, any coronary plaque, calcified plaque, or mixed plaque, as determined using adjusted odds ratios (aORs; p>0.05 for all). However, the risk of non-calcified plaque was significantly higher in former smokers (aOR, 1.34; 95% confidence interval [CI], 1.00 to 1.78; p=0.048). Current smokers had significantly higher rates of obstructive CAD (aOR, 1.46; 95% CI, 1.10 to 1.96; p=0.010), any coronary plaque (aOR, 1.41; 95% CI, 1.20 to 1.65; p<0.001), calcified plaque (aOR, 1.32; 95% CI, 1.13 to 1.55; p=0.001), non-calcified plaque (aOR, 1.72; 95% CI, 1.28 to 2.32; p<0.001), and mixed plaque (aOR, 2.00; 95% CI, 1.39 to 2.86; p<0.001) compared to never smokers. CONCLUSIONS This cross-sectional study revealed a significant association between current smoking and subclinical coronary atherosclerosis, as detected on CCTA. Additionally, former smoking demonstrated an association with non-calcified plaque, indicating elevated cardiovascular risk.

OBJECTIVES: In this study, we sought to evaluate the association between smoking status and subclinical coronary atherosclerosis, as detected by coronary computed tomography angiography (CCTA), in asymptomatic individuals. METHODS: We retrospectively analyzed 9,285 asymptomatic participants (mean age, 53.7±8.0 years; n=6,017, 64.8% male) with no history of coronary artery disease (CAD) who had undergone self-referred CCTA. Of these participants, 4,333 (46.7%) were considered never smokers, 2,885 (31.1%) former smokers, and 2,067 (22.3%) current smokers. We assessed the degree and characteristics of subclinical coronary atherosclerosis using CCTA, with obstructive CAD defined as a diameter stenosis of at least 50%. RESULTS: Compared with never-smokers, former smokers exhibited no significant differences in the probabilities of obstructive CAD, any coronary plaque, calcified plaque, or mixed plaque, as determined using adjusted odds ratios (aORs; p>0.05 for all). However, the risk of non-calcified plaque was significantly higher in former smokers (aOR, 1.34; 95% confidence interval [CI], 1.00 to 1.78; p=0.048). Current smokers had significantly higher rates of obstructive CAD (aOR, 1.46; 95% CI, 1.10 to 1.96; p=0.010), any coronary plaque (aOR, 1.41; 95% CI, 1.20 to 1.65; p<0.001), calcified plaque (aOR, 1.32; 95% CI, 1.13 to 1.55; p=0.001), non-calcified plaque (aOR, 1.72; 95% CI, 1.28 to 2.32; p<0.001), and mixed plaque (aOR, 2.00; 95% CI, 1.39 to 2.86; p<0.001) compared to never smokers. CONCLUSIONS This cross-sectional study revealed a significant association between current smoking and subclinical coronary atherosclerosis, as detected on CCTA. Additionally, former smoking demonstrated an association with non-calcified plaque, indicating elevated cardiovascular risk.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

OBJECTIVES: In this study, we sought to evaluate the association between smoking status and subclinical coronary atherosclerosis, as detected by coronary computed tomography angiography (CCTA), in asymptomatic individuals. METHODS: We retrospectively analyzed 9,285 asymptomatic participants (mean age, 53.7±8.0 years; n=6,017, 64.8% male) with no history of coronary artery disease (CAD) who had undergone self-referred CCTA. Of these participants, 4,333 (46.7%) were considered never smokers, 2,885 (31.1%) former smokers, and 2,067 (22.3%) current smokers. We assessed the degree and characteristics of subclinical coronary atherosclerosis using CCTA, with obstructive CAD defined as a diameter stenosis of at least 50%. RESULTS: Compared with never-smokers, former smokers exhibited no significant differences in the probabilities of obstructive CAD, any coronary plaque, calcified plaque, or mixed plaque, as determined using adjusted odds ratios (aORs; p>0.05 for all). However, the risk of non-calcified plaque was significantly higher in former smokers (aOR, 1.34; 95% confidence interval [CI], 1.00 to 1.78; p=0.048). Current smokers had significantly higher rates of obstructive CAD (aOR, 1.46; 95% CI, 1.10 to 1.96; p=0.010), any coronary plaque (aOR, 1.41; 95% CI, 1.20 to 1.65; p<0.001), calcified plaque (aOR, 1.32; 95% CI, 1.13 to 1.55; p=0.001), non-calcified plaque (aOR, 1.72; 95% CI, 1.28 to 2.32; p<0.001), and mixed plaque (aOR, 2.00; 95% CI, 1.39 to 2.86; p<0.001) compared to never smokers. CONCLUSIONS This cross-sectional study revealed a significant association between current smoking and subclinical coronary atherosclerosis, as detected on CCTA. Additionally, former smoking demonstrated an association with non-calcified plaque, indicating elevated cardiovascular risk.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

Background: and Purpose In young patients (aged 18–60 years) with patent foramen ovale (PFO)- associated stroke, percutaneous closure has been found to be useful for preventing recurrent ischemic stroke or transient ischemic attack (TIA). However, it remains unknown whether PFO closure is also beneficial in older patients. Methods: Patients aged ≥60 years who had a cryptogenic stroke and PFO from ten hospitals in South Korea were included. The effect of PFO closure plus medical therapy over medical therapy alone was assessed by a propensity-score matching method in the overall cohort and in those with a high-risk PFO, characterized by the presence of an atrial septal aneurysm or a large shunt. Results: Out of the 437 patients (mean age, 68.1), 303 (69%) had a high-risk PFO and 161 (37%) patients underwent PFO closure. Over a median follow-up of 3.9 years, recurrent ischemic stroke or TIA developed in 64 (14.6%) patients. In the propensity score-matched cohort of the overall patients (130 pairs), PFO closure was associated with a significantly lower risk of a composite of ischemic stroke or TIA (hazard ratio [HR]: 0.45; 95% confidence interval [CI]: 0.24–0.84; P=0.012), but not for ischemic stroke. In a subgroup analysis of confined to the high-risk PFO patients (116 pairs), PFO closure was associated with significantly lower risks of both the composite of ischemic stroke or TIA (HR: 0.40; 95% CI: 0.21–0.77; P=0.006) and ischemic stroke (HR: 0.47; 95% CI: 0.23–0.95; P=0.035). Conclusion Elderly patients with cryptogenic stroke and PFO have a high recurrence rate of ischemic stroke or TIA, which may be significantly reduced by device closure.

There are limited data on the impact of diabetes control on the risk of subclinical coronary atherosclerosis.