Displaying publications 1 - 20 of 393 in total

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  1. Wan Ahmad WA, Abdul Ghapar AK, Zainal Abidin HA, Karthikesan D, Ross NT, S K Abdul Kader MA, et al.
    ESC Heart Fail, 2024 Apr;11(2):727-736.
    PMID: 38131217 DOI: 10.1002/ehf2.14608
    AIMS: Heart failure (HF) is a growing health problem, yet there are limited data on patients with HF in Malaysia. The Malaysian Heart Failure (MY-HF) Registry aims to gain insights into the epidemiology, aetiology, management, and outcome of Malaysian patients with HF and identify areas for improvement within the national HF services.

    METHODS AND RESULTS: The MY-HF Registry is a 3-year prospective, observational study comprising 2717 Malaysian patients admitted for acute HF. We report the description of baseline data at admission and outcomes of index hospitalization of these patients. The mean age was 60.2 ± 13.6 years, 66.8% were male, and 34.3% had de novo HF. Collectively, 55.7% of patients presented with New York Heart Association (NYHA) Class III or IV; ischaemic heart disease was the most frequent aetiology (63.2%). Most admissions (87.3%) occurred via the emergency department, with 13.7% of patients requiring intensive care, and of these, 21.8% needed intubation. The proportion of patients receiving guideline-directed medical therapy increased at discharge (84.2% vs. 93.6%). The median length of stay (LOS) was 5 days, and in-hospital mortality was 2.9%. Predictors of LOS and/or in-hospital mortality were age, NYHA class, estimated glomerular filtration rate, and comorbid anaemia. LOS and in-hospital mortality were similar regardless of ejection fraction.

    CONCLUSIONS: The MY-HF Registry showed that the HF population in Malaysia is younger, predominantly male, and ischaemic-driven and has good prospects with hospitalization for optimization of treatment. These findings suggest a need to reassess current clinical practice and guide resource allocation to improve patient outcomes.

    Matched MeSH terms: Registries
  2. Ho KY, Gyanwali B, Dimayuga C, Eufemio EM, Bernardo E, Raju G, et al.
    BMJ Open, 2024 Mar 19;14(3):e080620.
    PMID: 38508619 DOI: 10.1136/bmjopen-2023-080620
    INTRODUCTION: Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

    METHODS AND ANALYSIS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

    ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

    Matched MeSH terms: Registries
  3. Caiazzo G, Oliva A, Testa L, Heang TM, Lee CY, Milazzo D, et al.
    Cardiovasc Diabetol, 2024 Feb 03;23(1):52.
    PMID: 38310281 DOI: 10.1186/s12933-024-02139-9
    BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.

    AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).

    METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings.

    RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.

    CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

    Matched MeSH terms: Registries
  4. Joannides AJ, Korhonen TK, Clark D, Gnanakumar S, Venturini S, Mohan M, et al.
    Neurosurgery, 2024 Feb 01;94(2):278-288.
    PMID: 37747225 DOI: 10.1227/neu.0000000000002661
    BACKGROUND AND OBJECTIVES: Global disparity exists in the demographics, pathology, management, and outcomes of surgically treated traumatic brain injury (TBI). However, the factors underlying these differences, including intervention effectiveness, remain unclear. Establishing a more accurate global picture of the burden of TBI represents a challenging task requiring systematic and ongoing data collection of patients with TBI across all management modalities. The objective of this study was to establish a global registry that would enable local service benchmarking against a global standard, identification of unmet need in TBI management, and its evidence-based prioritization in policymaking.

    METHODS: The registry was developed in an iterative consensus-based manner by a panel of neurotrauma professionals. Proposed registry objectives, structure, and data points were established in 2 international multidisciplinary neurotrauma meetings, after which a survey consisting of the same data points was circulated within the global neurotrauma community. The survey results were disseminated in a final meeting to reach a consensus on the most pertinent registry variables.

    RESULTS: A total of 156 professionals from 53 countries, including both high-income countries and low- and middle-income countries, responded to the survey. The final consensus-based registry includes patients with TBI who required neurosurgical admission, a neurosurgical procedure, or a critical care admission. The data set comprised clinically pertinent information on demographics, injury characteristics, imaging, treatments, and short-term outcomes. Based on the consensus, the Global Epidemiology and Outcomes following Traumatic Brain Injury (GEO-TBI) registry was established.

    CONCLUSION: The GEO-TBI registry will enable high-quality data collection, clinical auditing, and research activity, and it is supported by the World Federation of Neurosurgical Societies and the National Institute of Health Research Global Health Program. The GEO-TBI registry ( https://geotbi.org ) is now open for participant site recruitment. Any center involved in TBI management is welcome to join the collaboration to access the registry.

    Matched MeSH terms: Registries
  5. McLarty J, Litton E, Beane A, Aryal D, Bailey M, Bendel S, et al.
    Thorax, 2024 Jan 18;79(2):120-127.
    PMID: 37225417 DOI: 10.1136/thorax-2022-219592
    BACKGROUND: The COVID-19 pandemic resulted in a large number of critical care admissions. While national reports have described the outcomes of patients with COVID-19, there is limited international data of the pandemic impact on non-COVID-19 patients requiring intensive care treatment.

    METHODS: We conducted an international, retrospective cohort study using 2019 and 2020 data from 11 national clinical quality registries covering 15 countries. Non-COVID-19 admissions in 2020 were compared with all admissions in 2019, prepandemic. The primary outcome was intensive care unit (ICU) mortality. Secondary outcomes included in-hospital mortality and standardised mortality ratio (SMR). Analyses were stratified by the country income level(s) of each registry.

    FINDINGS: Among 1 642 632 non-COVID-19 admissions, there was an increase in ICU mortality between 2019 (9.3%) and 2020 (10.4%), OR=1.15 (95% CI 1.14 to 1.17, p<0.001). Increased mortality was observed in middle-income countries (OR 1.25 95% CI 1.23 to 1.26), while mortality decreased in high-income countries (OR=0.96 95% CI 0.94 to 0.98). Hospital mortality and SMR trends for each registry were consistent with the observed ICU mortality findings. The burden of COVID-19 was highly variable, with COVID-19 ICU patient-days per bed ranging from 0.4 to 81.6 between registries. This alone did not explain the observed non-COVID-19 mortality changes.

    INTERPRETATION: Increased ICU mortality occurred among non-COVID-19 patients during the pandemic, driven by increased mortality in middle-income countries, while mortality decreased in high-income countries. The causes for this inequity are likely multi-factorial, but healthcare spending, policy pandemic responses, and ICU strain may play significant roles.

    Matched MeSH terms: Registries
  6. Benitez Fuentes JD, Morgan E, de Luna Aguilar A, Mafra A, Shah R, Giusti F, et al.
    JAMA Oncol, 2024 Jan 01;10(1):71-78.
    PMID: 37943547 DOI: 10.1001/jamaoncol.2023.4837
    IMPORTANCE: Stage at diagnosis is a key prognostic factor for cancer survival.

    OBJECTIVE: To assess the global distribution of breast cancer stage by country, age group, calendar period, and socioeconomic status using population-based data.

    DATA SOURCES: A systematic search of MEDLINE and Web of Science databases and registry websites and gray literature was conducted for articles or reports published between January 1, 2000, and June 20, 2022.

    STUDY SELECTION: Reports on stage at diagnosis for individuals with primary breast cancer (C50) from a population-based cancer registry were included.

    DATA EXTRACTION AND SYNTHESIS: Study characteristics and results of eligible studies were independently extracted by 2 pairs of reviewers (J.D.B.F., A.D.A., A.M., R.S., and F.G.). Stage-specific proportions were extracted and cancer registry data quality and risk of bias were assessed. National pooled estimates were calculated for subnational or annual data sets using a hierarchical rule of the most relevant and high-quality data to avoid duplicates.

    MAIN OUTCOMES AND MEASURES: The proportion of women with breast cancer by (TNM Classification of Malignant Tumors or the Surveillance, Epidemiology, and End Results Program [SEER]) stage group.

    RESULTS: Data were available for 2.4 million women with breast cancer from 81 countries. Globally, the proportion of cases with distant metastatic breast cancer at diagnosis was high in sub-Saharan Africa, ranging from 5.6% to 30.6% and low in North America ranging from 0.0% to 6.0%. The proportion of patients diagnosed with distant metastatic disease decreased over the past 2 decades from around 3.8% to 35.8% (early 2000s) to 3.2% to 11.6% (2015 onwards), yet stabilization or slight increases were also observed. Older age and lower socioeconomic status had the largest proportion of cases diagnosed with distant metastatic stage ranging from 2.0% to 15.7% among the younger to 4.1% to 33.9% among the oldest age group, and from 1.7% to 8.3% in the least disadvantaged groups to 2.8% to 11.4% in the most disadvantaged groups.

    CONCLUSIONS AND RELEVANCE: Effective policy and interventions have resulted in decreased proportions of women diagnosed with metastatic breast cancer at diagnosis in high-income countries, yet inequality persists, which needs to be addressed through increased awareness of breast cancer symptoms and early detection. Improving global coverage and quality of population-based cancer registries, including the collection of standardized stage data, is key to monitoring progress.

    Matched MeSH terms: Registries
  7. Al Saleh A, Jamee A, Sulaiman K, Sobhy M, Gamra H, Alkindi F, et al.
    PLoS One, 2024;19(1):e0296056.
    PMID: 38206951 DOI: 10.1371/journal.pone.0296056
    BACKGROUND: The Program for the Evaluation and Management of Cardiac Events in the Middle East and North Africa (PEACE MENA) is a prospective registry program in Arabian countries that involves in patients with acute myocardial infarction (AMI) or acute heart failure (AHF).

    METHODS: This prospective, multi-center, multi-country study is the first report of the baseline characteristics and outcomes of inpatients with AMI who were enrolled during the first 14-month recruitment phase. We report the clinical characteristics, socioeconomic, educational levels, and management, in-hospital, one month and one-year outcomes.

    RESULTS: Between April 2019 and June 2020, 1377 patients with AMI were enrolled (79.1% males) from 16 Arabian countries. The mean age (± SD) was 58 ± 12 years. Almost half of the population had a net income < $500/month, and 40% had limited education. Nearly half of the cohort had a history of diabetes mellitus, hypertension, or hypercholesterolemia; 53% had STEMI, and almost half (49.7%) underwent a primary percutaneous intervention (PCI) (lowest 4.5% and highest 100%). Thrombolytics were used by 36.2%. (Lowest 6.45% and highest (90.9%). No reperfusion occurred in 13.8% of patients (lowest was 0% and highest 72.7%).Primary PCI was performed less frequently in the lower income group vs. high income group (26.3% vs. 54.7%; P<0.001). Recurrent ischemia occurred more frequently in the low-income group (10.9% vs. 7%; P = 0.018). Re-admission occurred in 9% at 1 month and 30% at 1 year, whereas 1-month mortality was 0.7% and 1-year mortality 4.7%.

    CONCLUSION: In the MENA region, patients with AMI present at a young age and have a high burden of cardiac risk factors. Most of the patients in the registry have a low income and low educational status. There is heterogeneity among key performance indicators of AMI management among various Arabian countries.

    Matched MeSH terms: Registries
  8. Kamath N, Borzych-Dużałka D, Kaur A, Neto G, Arbeiter K, Yap YC, et al.
    Pediatr Nephrol, 2023 Dec;38(12):4111-4118.
    PMID: 37405492 DOI: 10.1007/s00467-023-05995-x
    BACKGROUND: The guidelines for training of patients and caregivers to perform home peritoneal dialysis (PD) uniformly include recommendations pertaining to the prevention of peritonitis. The objective of this study conducted by the International Pediatric Peritoneal Dialysis Network (IPPN) was to investigate the training practices for pediatric PD and to evaluate the impact of these practices on the peritonitis and exit-site infection (ESI) rate.

    METHODS: A questionnaire regarding details of the PD program and training practices was distributed to IPPN member centers, while peritonitis and ESI rates were either derived from the IPPN registry or obtained directly from the centers. Poisson univariate and multivariate regression was used to determine the training-related peritonitis and ESI risk factors.

    RESULTS: Sixty-two of 137 centers responded. Information on peritonitis and ESI rates were available from fifty centers. Training was conducted by a PD nurse in 93.5% of centers, most commonly (50%) as an in-hospital program. The median total training time was 24 hours, with a formal assessment conducted in 88.7% and skills demonstration in 71% of centers. Home visits were performed by 58% of centers. Shorter (

    Matched MeSH terms: Registries
  9. Jailani AS, Balqis-Ali NZ, Tang KF, Fun WH, Samad SA, Jahaya R, et al.
    BMC Public Health, 2023 Nov 14;23(1):2243.
    PMID: 37964260 DOI: 10.1186/s12889-023-17132-2
    INTRODUCTION: High-risk human papillomavirus (HPV) screening is vital for early cervical cancer detection and treatment. With the introduction of the national cervical cancer screening programme and screening registry in Malaysia, there is a need to monitor population-based HPV screening uptake and high-risk HPV prevalence as part of cervical cancer surveillance.

    OBJECTIVE: To determine the prevalence and sociodemographic factors predicting high-risk HPV infection in Malaysia based on a public, community-based cervical cancer screening registry targeting women at risk of getting HPV infection.

    METHODS: The study used data from the Malaysian cervical cancer screening registry established by the Family Health Development Division from 2019 to 2021. The registry recorded sociodemographic data, HPV test details and results of eligible women who underwent HPV screening at public primary healthcare facilities. A vaginal sample (via self-sampling or assisted by a healthcare provider) was used for DNA extraction for HPV detection and genotyping. Registry data were extracted and analysed to determine prevalence estimates of high-risk HPV infection. Multifactorial logistic regression analysis was conducted to determine predictors of high-risk HPV infection. All analyses were performed using Stata version 14.

    RESULTS: The programme screened a total of 36,738 women during the study period. Women who attended the screening programme were mainly from urban areas, aged 30-39 years, and of Malay ethnicity. The prevalence of high-risk HPV infection was 4.53% among women screened, with the yearly prevalence ranging from 4.27 to 4.80%. A higher prevalence was observed among urban settling women, those aged 30-49 years, those of Indian ethnicity, and those without children. The results from logistic regression showed that women from urban areas, lower age groups, of Indian or Chinese ethnicity, and who are self-employed were more likely to be infected with high-risk HPV.

    CONCLUSION: Targeted and robust strategies to reach identified high-risk groups are needed in Malaysia. In addition, the registry has the potential to be expanded for an improved cervical cancer elimination plan.

    TRIAL REGISTRATION: Trial registration number: NMRR ID-22-00187-DJU.

    Matched MeSH terms: Registries
  10. Juhan N, Zubairi YZ, Mahmood Zuhdi AS, Mohd Khalid Z
    BMJ Open, 2023 Nov 03;13(11):e066748.
    PMID: 37923353 DOI: 10.1136/bmjopen-2022-066748
    OBJECTIVES: Despite extensive advances in medical and surgical treatment, cardiovascular disease (CVD) remains the leading cause of mortality worldwide. Identifying the significant predictors will help clinicians with the prognosis of the disease and patient management. This study aims to identify and interpret the dependence structure between the predictors and health outcomes of ST-elevation myocardial infarction (STEMI) male patients in Malaysian setting.

    DESIGN: Retrospective study.

    SETTING: Malaysian National Cardiovascular Disease Database-Acute Coronary Syndrome (NCVD-ACS) registry years 2006-2013, which consists of 18 hospitals across the country.

    PARTICIPANTS: 7180 male patients diagnosed with STEMI from the NCVD-ACS registry.

    PRIMARY AND SECONDARY OUTCOME MEASURES: A graphical model based on the Bayesian network (BN) approach has been considered. A bootstrap resampling approach was integrated into the structural learning algorithm to estimate probabilistic relations between the studied features that have the strongest influence and support.

    RESULTS: The relationships between 16 features in the domain of CVD were visualised. From the bootstrap resampling approach, out of 250, only 25 arcs are significant (strength value ≥0.85 and the direction value ≥0.50). Age group, Killip class and renal disease were classified as the key predictors in the BN model for male patients as they were the most influential variables directly connected to the outcome, which is the patient status. Widespread probabilistic associations between the key predictors and the remaining variables were observed in the network structure. High likelihood values are observed for patient status variable stated alive (93.8%), Killip class I on presentation (66.8%), patient younger than 65 (81.1%), smoker patient (77.2%) and ethnic Malay (59.2%). The BN model has been shown to have good predictive performance.

    CONCLUSIONS: The data visualisation analysis can be a powerful tool to understand the relationships between the CVD prognostic variables and can be useful to clinicians.

    Matched MeSH terms: Registries
  11. Keat WOL, Somani BK, Pietropaolo A, Chew BH, Chai CA, Inoue T, et al.
    World J Urol, 2023 Nov;41(11):2881-2888.
    PMID: 36929407 DOI: 10.1007/s00345-023-04362-7
    PURPOSE: To evaluate outcomes of flexible ureteroscopy for renal stones by comparing hard versus soft stones based on their attenuation on computed tomography (Hounsfield Units-HU).

    METHODS: Patients were divided into two groups according to the type of laser employed [Holmium:YAG (HL) or Thulium fiber laser (TFL)]. Residual fragments (RF) were defined as > 2 mm. Multivariable logistic regression analysis was performed to evaluate factors associated with RF and RF needing further intervention.

    RESULTS: 4208 patients from 20 centers were included. In whole series, age, recurrent stones, stone size, lower pole stones (LPS), and multiple stones were predictors of RF at multivariable analysis and LPS and stone size with RF requiring further treatment. HU and TFL were associated with lesser RF and RF requiring an additional treatment. In HU 

    Matched MeSH terms: Registries
  12. Lim LL, Abdul Aziz A, Dakin H, Buckell J, Woon YL, Roope L, et al.
    Diabetes Res Clin Pract, 2023 Nov;205:110944.
    PMID: 37804999 DOI: 10.1016/j.diabres.2023.110944
    AIMS: We determined 10-year all-cause mortality trends in diagnosed type 2 diabetes (T2D) population in West Malaysia, a middle-income country in the Western-Pacific region.

    METHODS: One million T2D people aged 40-79 registered in the National Diabetes Registry (2009-2018) were linked to death records (censored on 31 December 2019). Standardized absolute mortality rates and standardized mortality ratios (SMRs) were estimated relative to the Malaysian general population, and standardized to the 2019 registry population with respect to sex, age group, and disease duration.

    RESULTS: Overall all-cause standardized mortality rates were unchanged in both sexes. Rates increased in males aged 40-49 (annual average percent change [AAPC]: 2.46 % [95 % CI 0.42 %, 4.55 %]) and 50-59 (AAPC: 1.91 % [95 % CI 0.73 %, 3.10 %]), and females aged 40-49 (AAPC: 3.39 % [95 % CI 1.32 %, 5.50 %]). In both sexes, rates increased among those with 1) > 15 years disease duration, 2) prior cardiovascular disease, and 3) Bumiputera (Malay/native) ethnicity. The overall SMR was 1.83 (95 % CI 1.80, 1.86) for males and 1.85 (95 % CI 1.82, 1.89) for females, being higher in younger age groups and showed an increasing trend in those with either > 15 years disease duration or prior cardiovascular disease.

    CONCLUSIONS: Mortality trends worsened in certain T2D population in Malaysia.

    Matched MeSH terms: Registries
  13. Castellani D, Fong KY, Lim EJ, Chew BH, Tailly T, Emiliani E, et al.
    J Urol, 2023 Aug;210(2):323-330.
    PMID: 37126223 DOI: 10.1097/JU.0000000000003504
    PURPOSE: We evaluated stone-free rate and complications after flexible ureteroscopy for renal stones, comparing thulium fiber laser and holmium:YAG laser with MOSES technology.

    MATERIALS AND METHODS: Data from adults who underwent flexible ureteroscopy in 20 centers worldwide were retrospectively reviewed (January 2018-August 2021). Patients with ureteral stones, concomitant bilateral procedures, and combined procedures were excluded. One-to-one propensity score matching for age, gender, and stone characteristics was performed. Stone-free rate was defined as absence of fragments >2 mm on imaging within 3 months after surgery. Multivariable logistic regression analysis was performed to evaluate independent predictors of being stone-free.

    RESULTS: Of 2,075 included patients, holmium:YAG laser with MOSES technology was used in 508 patients and thulium fiber laser in 1,567 patients. After matching, 284 patients from each group with comparable baseline characteristics were included. Pure dusting was applied in 6.0% of cases in holmium:YAG laser with MOSES technology compared with 26% in thulium fiber laser. There was a higher rate of basket extraction in holmium:YAG laser with MOSES technology (89% vs 43%, P < .001). Total operation time and lasing time were similar. Nine patients had sepsis in thulium fiber laser vs none in holmium:YAG laser with MOSES technology (P = .007). Higher stone-free rate was achieved in thulium fiber laser (85% vs 56%, P < .001). At multivariable analysis, the use of thulium fiber laser and ureteral access sheath ≥8F had significantly higher odds of being stone-free. Lasing time, multiple stones, stone diameter, and use of disposable scopes showed significantly lower odds of being stone-free.

    CONCLUSIONS: This real-world study favors the use of thulium fiber laser over holmium:YAG laser with MOSES technology in flexible ureteroscopy for renal stones by way of its higher single-stage stone-free rate.

    Matched MeSH terms: Registries
  14. Linn YL, Wang JC, Pua U, Yahaya SA, Choke ET, Chong TT, et al.
    Vascular, 2023 Aug;31(4):767-776.
    PMID: 35410542 DOI: 10.1177/17085381221081969
    BACKGROUND: Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians.

    METHODS: A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC).

    RESULTS: AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months.

    CONCLUSION: Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.

    Matched MeSH terms: Registries
  15. Jatuworapruk K, De Vera R, Estrella AM, Sollano MHMZ, Vaidya B, Rahman MM, et al.
    Int J Rheum Dis, 2023 Aug;26(8):1432-1434.
    PMID: 37527022 DOI: 10.1111/1756-185X.14765
    Matched MeSH terms: Registries
  16. Cortese B, Testa L, Heang TM, Ielasi A, Bossi I, Latini RA, et al.
    JACC Cardiovasc Interv, 2023 Jul 24;16(14):1794-1803.
    PMID: 37495352 DOI: 10.1016/j.jcin.2023.05.005
    BACKGROUND: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications.

    OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.

    METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.

    RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).

    CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).

    Matched MeSH terms: Registries
  17. Kuan JW, Su AT, Wahab M, Hamdan A, Hashim J, Kiyu A, et al.
    BMC Cancer, 2023 Jun 19;23(1):563.
    PMID: 37337159 DOI: 10.1186/s12885-023-10988-y
    BACKGROUND: Published epidemiological studies of haematological cancers are few. Hereby we present a 20-year epidemiological data of haematological cancers in Sarawak from a population-based cancer registry.

    METHODS: Haematological cancer cases with ICD-10 coded C81-C96 and ICD-O coded /3 diagnosed from 1996 to 2015 were retrieved from Sarawak Cancer Registry. Adult was defined as those 15 years and above. Incidence rate (IR) was calculated based on yearly Sarawak citizen population stratified to age, gender, and ethnic groups. Age-standardised IR (ASR) was calculated using Segi World Standard Population.

    RESULTS: A total of 3,947 cases were retrieved and analysed. ASR was 10 and male predominance (IR ratio 1.32, 95%CI 1.24,1.41). Haematological cancers generally had a U-shaped distribution with lowest IR at age 10-14 years and exponential increment from age 40 years onwards, except acute lymphoblastic leukaemia (ALL) with highest IR in paediatric 2.8 versus adult 0.5. There was a significant difference in ethnic and specific categories of haematological cancers, of which, in general, Bidayuh (IR ratio 1.13, 95%CI 1.00, 1.27) and Melanau (IR ratio 0.54, 95%CI 0.45, 0.65) had the highest and lowest ethnic-specific IR, respectively, in comparison to Malay. The ASR (non-Hodgkin lymphoma, acute myeloid leukaemia, ALL, chronic myeloid leukaemia, and plasma cell neoplasm) showed a decreasing trend over the 20 years, -2.09 in general, while Hodgkin lymphoma showed an increasing trend of + 2.80. There was crude rate difference between the 11 administrative divisions of Sarawak.

    CONCLUSIONS: This study provided the IR and ASR of haematological cancers in Sarawak for comparison to other regions of the world. Ethnic diversity in Sarawak resulted in significant differences in IR and ASR.

    Matched MeSH terms: Registries
  18. Schroeder M, Lim YMF, Savarese G, Suzart-Woischnik K, Baudier C, Dyszynski T, et al.
    Eur J Heart Fail, 2023 Jun;25(6):912-921.
    PMID: 37101398 DOI: 10.1002/ejhf.2868
    AIMS: In order to understand how sex differences impact the generalizability of randomized clinical trials (RCTs) in patients with heart failure (HF) and reduced ejection fraction (HFrEF), we sought to compare clinical characteristics and clinical outcomes between RCTs and HF observational registries stratified by sex.

    METHODS AND RESULTS: Data from two HF registries and five HFrEF RCTs were used to create three subpopulations: one RCT population (n = 16 917; 21.7% females), registry patients eligible for RCT inclusion (n = 26 104; 31.8% females), and registry patients ineligible for RCT inclusion (n = 20 810; 30.2% females). Clinical endpoints included all-cause mortality, cardiovascular mortality, and first HF hospitalization at 1 year. Males and females were equally eligible for trial enrolment (56.9% of females and 55.1% of males in the registries). One-year mortality rates were 5.6%, 14.0%, and 28.6% for females and 6.9%, 10.7%, and 24.6% for males in the RCT, RCT-eligible, and RCT-ineligible groups, respectively. After adjusting for 11 HF prognostic variables, RCT females showed higher survival compared to RCT-eligible females (standardized mortality ratio [SMR] 0.72; 95% confidence interval [CI] 0.62-0.83), while RCT males showed higher adjusted mortality rates compared to RCT-eligible males (SMR 1.16; 95% CI 1.09-1.24). Similar results were also found for cardiovascular mortality (SMR 0.89; 95% CI 0.76-1.03 for females, SMR 1.43; 95% CI 1.33-1.53 for males).

    CONCLUSION: Generalizability of HFrEF RCTs differed substantially between the sexes, with females having lower trial participation and female trial participants having lower mortality rates compared to similar females in the registries, while males had higher than expected cardiovascular mortality rates in RCTs compared to similar males in registries.

    Matched MeSH terms: Registries
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