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Hand Motion Analysis of Different Segments of a Procedure: Is One Segment Enough?
No full textPURPOSE: This study aims to examine if the hand motions of operators associated with certain parts of central venous access are more important than others in distinguishing between experts and non-experts.
MATERIALS AND METHODS: Experts (n = 10) and Trainees (PGY2; n = 18) performed central venous access on a phantom 4 times each as their needle hand and ultrasound probe motions were tracked. Path length-time graphs were used to divide the procedure into three phases: (1) the access phase: visualizing the internal jugular vein on ultrasound and needle placement; (2) the wire phase: passing a wire through the needle; and (3) the confirmation phase: confirming the intravascular wire position and threading a dilator on the wire. Comparisons between trainees and experts were made for the complete trial, and each phase using Mann-Whitney U tests with Benjamini-Hochberg correction. Receiver Operating Characteristic analysis was performed to compare the performance of each phase in differentiating between experts and trainees.
RESULTS: Motion data from 10 experts and 18 trainees was analyzed. Experts and trainees differed significantly for all the motion metrics (p \u3c 0.001). A comparison of the phases showed that the access phase (AUC = 0.96; R2 = 0.79) and the wire phase (AUC = 0.95; R2 = 0.59) were able to distinguish between experts and trainees with an accuracy comparable to the complete trial (AUC = 0.94; R2 = 0.69).
CONCLUSIONS: The access phase of simulated central venous access can best differentiate between experts and trainees. This sample of hand motion performance may be able to simplify motion analysis of technical performance and obviate the need for recording hand motion for the entire procedure
Impact of Mean Blood Pressure Profiles in Percutaneous Left Ventricular Assist Device-Supported High-Risk Percutaneous Coronary Intervention: The PROTECT III Study
No full textBACKGROUND: Percutaneous left ventricular assist devices are used prophylactically to prevent hypotension during high-risk percutaneous coronary intervention. However, the impact of preprocedural hemodynamic profiles on procedural and clinical outcomes in these patients is unknown.
METHODS AND RESULTS: Patients from the central venous access device PROTECT III registry (NCT04136392) were categorized according to preprocedural mean blood pressure (MBP). Procedural and in-hospital outcomes, including hypotensive episodes, need for prolonged percutaneous left ventricular assist device support, and in-hospital death, were compared between groups. We also assessed the relationship between preprocedural MBP and 90-day major adverse cardiovascular and cerebrovascular events, which included all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization, as well as with 1-year mortality. A total of 1159 patients underwent percutaneous left ventricular assist device-supported high-risk percutaneous coronary intervention and were stratified into 4 hemodynamic profiles of preprocedural MBP level: MBP\u3e100 mm Hg (n=242), \u3e90 to ≤ 100 mm Hg (n=264), \u3e80 to ≤ 90 mm Hg (n=306), and ≤ 80 mm Hg (n=347). Lower preprocedural MBP was associated with baseline anemia, history of heart failure, left main disease, and transfer from another hospital. In-hospital and procedural adverse outcomes did not differ between the BP categories. However, 90-day major adverse cardiovascular and cerebrovascular events rates and 1-year mortality increased with decreasing baseline BP levels. The association between BP category and 1-year mortality remained significant after adjustment for other factors (hazard ratio [HR], 0.79 [95% CI, 0.71-0.88],
CONCLUSIONS: In a real-world cohort undergoing high-risk percutaneous coronary intervention with percutaneous left ventricular assist device support, there was no association between hemodynamic status and in-hospital outcomes. Lower preprocedural BP was associated with higher rates of 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392
Transcatheter edge-to-edge repair in severe mitral regurgitation following acute myocardial infarction - aetiology-based analysis
No full textAIMS: To evaluate the association between transcatheter edge-to-edge repair (TEER) and outcomes in patients with significant mitral regurgitation (MR) following acute myocardial infarction (MI), focusing on the aetiology of acute post-MI MR in high-risk surgical patients.
METHODS AND RESULTS: The International Registry of MitraClip in Acute Mitral Regurgitation following Acute Myocardial Infarction (IREMMI) includes 187 patients with severe MR post-MI managed with TEER. Of these, 176 were included in the analysis, 23 (13%) patients had acute papillary muscle rupture (PMR) and 153 (87%) acute secondary MR. The mean age was 70 ± 10 years and 41% were female. PMR patients had fewer cardiovascular risk factors: hypertension (52% vs. 73%, p = 0.04), diabetes (26% vs. 48%, p \u3c 0.01) but a higher left ventricular ejection fraction (45± 15% vs.35± 10%, p \u3c 0.01) compared secondary MR patients. PMR patients were more likely to present in cardiogenic shock (91% vs. 51%, p = 0.001), require mechanical circulatory support (74% vs. 34%, p = 0.01), and had a higher EuroSCORE II (23± 13% vs. 13± 11%, p = 0.011). The median time from MI to TEER was shorter in PMR (6 days) versus secondary MR (20 days) (p \u3c 0.01). Procedural success was similar (87% vs. 92%, p = 0.49) with comparable MR grade reduction. However, PMR patients had significantly higher in-hospital mortality rates (adjusted odds ratio [OR] 3.05, 95% confidence interval [CI] 1.15-8.12, p = 0.02), 30-day mortality rates (unadjusted OR 3.99, 95% CI 1.42-11.26, p = 0.01) and a higher rate of conversion to surgical mitral valve replacement (22% vs. 3%, p \u3c 0.01) (unadjusted OR 8.17, 95% CI 2.15-30.96, p \u3c 0.001). Aetiology of MR, cardiogenic shock, and procedure timing significantly impacted in-hospital mortality. After adjusting for EuroSCORE II and cardiogenic shock, MR aetiology remained the strongest predictor (adjusted OR 6.71; 95% CI 2.06-21.86, p \u3c 0.01).
CONCLUSION: Transcatheter edge-to-edge repair may be considered a salvage or bridge procedure in decompensated post-MI MR patients of both aetiologies; however, patients with PMR have a higher risk of mortality and conversion to surgery
Diabetic Cardiomyopathy: What Clinicians Should Know
No full textDiabetes has classically been associated with atherosclerotic cardiovascular disease. However, heart failure is now increasingly recognized as a prevalent and often first cardiovascular complication among patients with diabetes. Investigation of this epidemiological relationship has led to recognition of diabetic cardiomyopathy, or structural heart disease that develops in patients with diabetes and may lead to progressive heart failure independently of coronary artery disease or conventional cardiovascular risk factors such as hypertension. Despite increased awareness, clinical management of this common cardiovascular complication remains challenging, with no consensus on its diagnosis or treatment. The lack of specific therapy has been recognized as an unmet clinical need. In this review, we summarize current understanding of the hallmark metabolic and structural changes of diabetic cardiomyopathy, appraise current tools for diagnosis and staging among patients, and describe the emerging but still preclinical data on therapeutic options
Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study
No full textINTRODUCTION: The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).
METHODS: This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum\u27s de-identified Clinformatics
RESULTS: The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.
CONCLUSIONS: At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources
Assessing Program Culture in Virtual Fellowship Interviews: Insights From Pulmonary and Critical Care Fellows
No full textBACKGROUND: Virtual interviewing for fellowship training programs has been widely adopted since the COVID-19 pandemic. However, whether fellowship candidates can adequately evaluate training program culture through virtual interviews is unclear.
OBJECTIVE: Our aim was to explore how pulmonary and critical care fellows ascertained program culture during virtual and in-person fellowship program recruitment interviews, with the overall goal of improving our virtual recruiting interview processes.
METHODS: Exploratory semi-structured one-on-one interviews (study-interviews) following a constructivist approach were done during the fall of 2022 with a convenience sample of current fellows within the pulmonary critical care medicine fellowship program in an urban tertiary care hospital. Questions probed fellows\u27 perspectives on program culture, what features of program culture they valued, and how they evaluated program culture during their initial fellowship interviews (recruitment-interviews). Study-interviews were framed to explore four deductive themes, and transcripts were analyzed with inductive thematic analysis.
RESULTS: Of the 11 fellows interviewed, two had completed in-person and nine had completed virtual recruitment-interviews. There was an overall favorable perception of program culture during all recruitment-interviews, regardless of format. Elements of program culture that fellows valued included training program quality, an academic focus, complexity in cases, workplace diversity, a positive socioemotional environment, and a collaborative/supportive working/learning environment.
CONCLUSIONS: This study suggests that important elements of program culture can be evaluated by fellowship candidates through virtual interviews when applicants are allowed ample opportunity for high-quality interactions with faculty and current trainees
The Effect of Socioeconomic Status on Clinical Outcomes and Implant Survivorship after Primary Anatomic and Reverse Total Shoulder Arthroplasty
No full textBACKGROUND: Low socioeconomic status has been shown to contribute to poor outcomes in patients undergoing joint replacement surgery. However, there is a paucity of studies investigating shoulder arthroplasty. The purpose of this study was to evaluate the effect of socioeconomic status on baseline and postoperative outcome scores and implant survivorship after anatomic and reverse primary total shoulder arthroplasty (TSA).
METHODS: A retrospective review of a prospectively collected single-institution database was performed to identify patients who underwent primary TSA. Zip codes were collected and converted to Area Deprivation Index (ADI) scores. We performed a correlation analysis between national ADI scores and preoperative, postoperative, and preoperative to postoperative improvement in range of motion (ROM), shoulder strength, and functional outcome scores in patients with minimum 2-year follow-up. Patients were additionally grouped into groups according to their national ADI. Achievement of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) and revision-free survivorship were compared between groups.
RESULTS: A total of 1148 procedures including 415 anatomic and 733 reverse total shoulder arthroplasties with a mean age of 64 ± 8.2 and 69.9 ± 8.0 years, respectively, were included. The mean follow-up was 6.3 ± 3.6 years for anatomic and 4.9 ± 2.7 years for reverse total shoulder arthroplasty. We identified a weak negative correlation between national ADI and most functional outcome scores and ROM preoperatively (R range 0.07-0.16), postoperatively (R range 0.09-0.14), and preoperative to postoperative improvement (R range 0.01-0.17). Thus, greater area deprivation was weakly associated with poorer function preoperatively, poorer final outcomes, and poorer improvement in outcomes. There was no difference in the proportion of each ADI group achieving MCID, SCB, and PASS in the anatomic total shoulder arthroplasty cohort. However, in the reverse total shoulder arthroplasty cohort, the proportion of patients achieving MCID, SCB, and PASS decreased with greater deprivation. There was no difference in survivorship between ADI groups.
CONCLUSIONS: We found a negative effect of low socioeconomic status on baseline and postoperative patient outcomes and ROM; however, the correlations were relatively weak. Patients that reside in socioeconomically deprived areas have poorer functional outcomes before and after TSA and achieve less improvement from surgery. We should strive to identify modifiable factors to improve the success of TSA in socioeconomically deprived areas
Trastuzumab Plus Pertuzumab Versus Cetuximab Plus Irinotecan in Patients With RAS/BRAF Wild-Type, HER2-Positive, Metastatic Colorectal Cancer (S1613): A Randomized Phase II Trial
No full textPURPOSE: ERBB2 overexpression/amplification in RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC; human epidermal growth factor receptor 2 [HER2]-positive mCRC) appears to be associated with limited benefit from anti-EGFR antibodies and promising responses to dual-HER2 inhibition; however, comparative efficacy has not been investigated. We conducted a randomized phase II trial to evaluate efficacy and safety of dual-HER2 inhibition against standard-of-care anti-EGFR antibody-based therapy as second/third-line treatment in HER2-positive mCRC.
METHODS: Patients with RAS/BRAF-WT mCRC after central confirmation of HER2 positivity (immunohistochemistry 3+ or 2+ and in situ hybridization amplified [HER2/CEP17 ratio \u3e2.0]) were assigned (1:1) to either trastuzumab plus pertuzumab (TP; trastuzumab 6 mg/kg and pertuzumab 420 mg once every 3 weeks) or cetuximab plus irinotecan (CETIRI; cetuximab 500 mg/m(2) and irinotecan 180 mg/m(2) once every 2 weeks) until progression or unacceptable toxicity. Crossover to TP was allowed after progression on CETIRI. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate (ORR), overall survival, safety, and HER2 gene copy number (GCN ≥20/\u3c20) as a predictive factor.
RESULTS: Between October 2017 and March 2022, 54 participants were assigned to TP (n = 26) and CETIRI (n = 28). Median PFS did not vary significantly by treatment: 4.7 (95% CI, 1.9 to 7.6) and 3.7 (95% CI, 1.6 to 6.7) months in the TP and CETIRI groups, respectively. Efficacy of TP versus CETIRI differed significantly by HER2 GCN (median PFS, GCN ≥20 [9.9 v 2.9 months] and GCN \u3c20 [3.0 v 4.2 months], respectively; P interaction = .003). On TP, ORR was 34.6% (57.1% with GCN ≥20 v 9.1% with GCN \u3c20) with median GCN of 29.7 versus 13.2 for responders and nonresponders, respectively (P = .004). Grade ≥3 adverse events occurred in 23.1% and 46.1% of participants with TP and CETIRI, respectively.
CONCLUSION: TP appears to be a safe and effective cytotoxic chemotherapy-free option for patients with RAS/BRAF-WT, HER2-positive mCRC. Higher levels of HER2 amplification were associated with greater degree of clinical benefit from TP vis-à-vis CETIRI
Multi-dimensional analyses identify genes of high priority for pancreatic cancer research
No full textPancreatic ductal adenocarcinoma (PDAC) is a drug resistant and lethal cancer. Identification of the genes that consistently show altered expression across patients\u27 cohorts can expose effective therapeutic targets and strategies. To identify such genes, we separately analyzed five human PDAC microarray datasets. We defined genes as \u27consistent\u27 if upregulated or downregulated in ≥ 4 datasets (adjusted P50%, to our knowledge, were uncharacterized in PDAC. These genes spanned multiple processes, including cell cycle, immunity, transport, metabolism, signaling and transcriptional/epigenetic regulation - cell cycle and glycolysis being the most altered. Several upregulated genes correlated with cancer features, and their suppression impaired PDAC cell viability in prior CRISPR/Cas9 and RNA interference screens. Further, the upregulated genes predicted sensitivity to bromodomain and extraterminal (epigenetic) protein inhibition, which, in combination with gemcitabine, disrupted amino acid metabolism and in vivo tumor growth. Our results highlight genes for further studies in the quest for PDAC mechanisms, therapeutic targets and biomarkers