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Results of the Solriamfetol\u27s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP): A Randomized Placebo-Controlled Double-Blind Repeated-Measures Crossover Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in OSA With Excessive Daytime Sleepiness and Cognitive Impairment
No full textBACKGROUND: OSA causes episodes of fragmented sleep and intermittent hypoxia and leads to excessive daytime sleepiness (EDS). Deficits in cognitive function are a troublesome symptom in patients with OSA and EDS.
RESEARCH QUESTION: How does solriamfetol affect cognitive function in patients with cognitive impairment associated with OSA and EDS?
STUDY DESIGN AND METHODS: Solriamfetol\u27s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP) was a phase IV, randomized double-blind placebo-controlled crossover trial. Participants (N = 59) were randomized to receive placebo or solriamfetol (75 mg/d for 3 days, then 150 mg/d) for 2 weeks, with crossover separated by a 1-week washout period. Efficacy measures included the Coding subtest, comparable to the Digit Symbol Substitution Test (DSST), of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the British Columbia Cognitive Complaints Inventory (BC-CCI), the Patient Global Impression of Severity (PGI-S), and the Epworth Sleepiness Scale (ESS). The primary end point was change from baseline in average postdose DSST RBANS scores. Secondary end points were changes from baseline in BC-CCI, PGI-S, ESS, and DSST RBANS scores at 2, 4, 6, and 8 hours\u27 postdose. Safety was monitored by assessment of treatment-emergent adverse events.
RESULTS: Solriamfetol was shown to significantly improve postdose average DSST RBANS scores compared with placebo (P = .009; effect size [Cohen\u27s d], 0.37). When evaluated at each 2-hour time point, cognitive function was significantly improved at 2, 6, and 8 hours after dosing (all, P \u3c .05). During solriamfetol treatment, there were significant improvements in BC-CCI (P = .002; d = 0.45), PGI-S (P = .034; d = 0.29), and ESS (P = .004; d = 0.40) compared with placebo. The most common treatment-emergent adverse events were nausea (7%) and anxiety (3%).
INTERPRETATION: SHARP showed that solriamfetol can improve objective and subjective measures of cognitive function in patients with cognitive impairment associated with OSA and EDS.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT04789174; URL: www.
CLINICALTRIALS: gov and EudraCT; No.: 2020-004243-92; URL: https://eudract.ema.europa.eu
Obstructive sleep apnea syndrome in chronic total occlusion percutaneous coronary intervention; insights from the PROGRESS-CTO registry
No full textOBJECTIVE: To examine the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in patients with obstructive sleep apnea syndrome (OSAS).
METHODS: We compared the procedural characteristics and outcomes of CTO PCIs in patients with and without OSAS in a multicenter registry.
RESULTS: Of 7403 patients who underwent 7408 CTO PCIs between 2012 and 2024 at 47 centers, 942 (13%) had OSAS. Compared with patients without OSAS, patients with OSAS were older; more likely to be men; and had higher prevalence of diabetes, hypertension, dyslipidemia, cerebrovascular disease, previous heart failure, coronary artery bypass graft surgery, and prior PCI. They had higher J-CTO (2.73 ± 1.20 vs. 2.30 ± 1.25; p \u3c 0.001) and PROGRESS-CTO (1.35 ± 1.01 vs. 1.16 ± 0.96; p \u3c 0.001) scores, longer lesion length, and more complex angiographic characteristics. Compared with patients without OSAS, OSAS patients had similar technical success (87.6% vs. 88.3%, p = 0.552) and procedural success (85.9% vs. 87.2%, p = 0.260). There were no differences in terms of in hospital MACEs and death. After a median follow-up of 71 days, the incidence of MACEs (3.9% vs. 1.6%, p = 0.026) and death (2.6% vs. 0.6%, p = 0.003) was higher in patients with OSAS. In multivariable analysis, OSAS was independently associated with higher follow-up MACEs (hazard ratio 2.32, 95% confidence intervals 1.22-3.26, p = 0.006).
CONCLUSION: OSAS is common in patients undergoing CTO PCI. Compared with patients without OSAS, OSAS patients had more comorbidities and more complex CTOs, similar rates of periprocedural success and complications, and higher incidence of follow-up MACEs
Racial and ethnic disparities in the prevalence, outcomes, and management of infective endocarditis in the United States
No full textINTRODUCTION: Racial/ethnic differences in the prevalence, outcomes, and management of infective endocarditis (IE) remain unclear.
METHODS: We assessed racial/ethnic differences in the prevalence, baseline characteristics, surgical intervention (valve replacement/repair), and clinical outcomes of hospitalizations for IE from 2016 to 2021 using the National Inpatient Sample (NIS). A multivariable regression model was used to adjust for potential confounders.
RESULTS: A total of 78,600 hospitalizations for IE were identified, of which 76.7 % included White race, 10.7 % Black race, 7.7 % Hispanic ethnicity, and 4.9 % from other races/ethnicities. The median age was 51 (Interquartile Range [IQR] 34-67), and 41.1 % were female. Black race, Hispanic ethnicity, and other races/ethnicities were not associated with a significant difference in odds of receiving cardiac valve intervention when compared to White race. Black race (aOR 1.40; CI 1.08-1.80) was associated with higher odds of in-hospital mortality compared to White race. Black race, Hispanic ethnicity, and patients of other races/ethnicities were associated with higher odds of acute kidney injury requiring dialysis compared to White patients. Black race and patients of other races/ethnicities were associated with higher odds of cardiogenic shock when compared to White race. Black race was associated with lower odds of spleen infarction when compared to White patients.
CONCLUSION: Racial/ethnic disparities exist in the prevalence, outcomes, and management of patients hospitalized for IE in the US. Further studies are warranted to identify the reasons for such disparities and to guide policy initiatives to achieve equity
Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial
No full textBACKGROUND: Coronary artery calcification is common among patients undergoing percutaneous coronary intervention (PCI), and severe coronary artery lesion calcification is associated with increased procedural complexity, stent under-expansion, and high rates of intraprocedural complications and out-of-hospital adverse events. Whether calcium ablation before stent implantation can mitigate these adverse events is not currently established. We aimed to prospectively compare orbital atherectomy with a balloon angioplasty-based strategy before stent implantation for the treatment of severely calcified coronary lesions.
METHODS: In this multicentre, open-label, randomised controlled trial conducted at 104 medical centres in the USA, patients (aged ≥18 years) with severely calcified coronary lesions were randomly assigned (1:1) to orbital atherectomy or balloon angioplasty before PCI with drug-eluting stents using a web-based system (block sizes of four and six) and stratified by intended treatment of single versus multiple lesions and enrolling site. Randomly assigned lesions were deemed by operators to be eligible for both treatment strategies. Operators and patients were not masked to treatment. The two powered coprimary study endpoints were target vessel failure at 1 year (a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation) and post-procedural minimal stent area at the site of maximal calcification, as assessed by intravascular optical coherence tomography in an imaging patient cohort. Primary analyses were by intention-to-treat. The trial is registered at ClinicalTrials.govNCT03108456, and 2-year follow-up is ongoing.
FINDINGS: From March 27, 2017, to April 13, 2023, 2005 patients with 2492 lesions were randomly assigned to lesion preparation with orbital atherectomy (1008 patients with 1250 lesions) or balloon angioplasty (997 with 1242 lesions) before stent implantation. Median patient age was 70·0 years (IQR 64·0-76·0). 541 (27·0%) of 2005 patients were female and 1464 (73·0%) were male. Angiographically severe calcium was confirmed by the core laboratory in 1088 (97·1%) of 1120 lesions assigned to orbital atherectomy and 1068 (97·0%) of 1101 lesions assigned to balloon angioplasty. PCI was guided by intravascular imaging in 627 (62·2%) of 1008 patients in the orbital atherectomy group and 619 (62·1%) of 997 in the balloon angioplasty group. Target vessel failure events within 1 year occurred in 113 of 1008 patients in the orbital atherectomy group (1-year target vessel failure 11·5% [95% CI 9·7 to 13·7]) and in 97 of 997 patients in the balloon angioplasty group (10·0% [8·3 to 12·1]; absolute difference 1·5% [96% CI -1·4 to 4·4]; hazard ratio 1·16 [96% CI 0·87 to 1·54], p=0·28). Among those in the optical coherence tomography substudy cohort (276 patients with 286 lesions in the orbital atherectomy group and 279 patients with 292 lesions in the balloon angioplasty group), the mean minimal stent area at the site of maximal calcification was 7·67 mm(2) (SD 2·27) in the orbital atherectomy group and 7·42 mm(2) (2·54) in the balloon angioplasty group (mean difference 0·26 [99% CI -0·31 to 0·82]; p=0·078). Cardiac death events within 1 year occurred in 39 of 1008 patients in the orbital atherectomy group and in 26 of 997 in the balloon angioplasty group.
INTERPRETATION: Routine treatment with orbital atherectomy before drug-eluting stent implantation did not increase minimal stent area or reduce the rate of target vessel failure at 1 year compared with a balloon angioplasty-based approach in severely calcified lesions deemed eligible for both treatment strategies. These data support a balloon-first approach for most calcified coronary artery lesions that can be crossed and dilated before stent implantation, guided by intravascular imaging.
FUNDING: Abbott Vascular (Abbott)
The American Academy of Dermatology and International League of Dermatological Societies\u27 Drug Resistant Dermatophytes (Tinea) Registry: The latest addition to the COVID-19, mpox, and Emerging Infections Registry
No full textIn Our Simulation Era: Transitioning from Passive to Immersive Training
Get PDFBackground: Simulation-based training is an essential component of education for bedside nurses; simulation can include procedural skills and complex nursing assessments and interventions (Tsiouris et al., 2024). High fidelity simulations have been shown to improve professional nurses’ self-confidence (Guerrero, Ali, & Atallah, 2022). Based on the organization’s annual learning needs assessment, nurses identified their preferred method of education was through hands-on, simulation-based educational offerings. Purpose/Aim: The purpose of this quality improvement project was to increase nurses’ knowledge of critical care concepts, while increasing confidence implementing advanced nursing skills within their patient population through tailored simulation-based training. Methods: The Plan, Do, Check, Act Cycle was the theoretical framework for this quality improvement project. The clinical nurse specialists (CNSs) and staff development educators outlined low-volume, high-risk clinical scenarios to include the organization’s annual requirements in addition to patient population specific competencies. The intervention included two separate simulations (thirty minutes each including debrief) tailored to required competencies based on progressive or critical care population. Following the simulations, the staff completed interactive, hands-on demonstration with equipment specific to their area. In addition to simulation, hands-on demonstration, and discussion the staff were provided with reference guides for nursing therapies. The sample included nurses (bedside nurses, clinical unit leaders, unit managers, house shift managers) and technical care associates (TCAs) on progressive and critical care units. Pre-and post-surveys were completed assessing the nurses’ and TCAs level of confidence, knowledge, and effectiveness of simulation-based training compared to passive learning modalities. Results: Post-surveys (n= 158) demonstrated a 17.6% increase in staff feeling extremely confident caring for their specific patient population compared to pre-survey (n= 165). Results demonstrated a 20.7% increase in staff feeling very knowledgeable caring for their specific patient population. Post-surveys demonstrated that 97% of staff felt all or most of the topics applied to their specialty area. Finally, compared to previous years’ annual competency training 97.2% of staff preferred this immersive education and competency validation (see Figure 1, “N/A” represents staff who had not experienced the traditional competency validation of previous years).https://scholarlycommons.henryford.com/hfjhrs2025/1007/thumbnail.jp
The assessment and management of patients with type 2 myocardial infarction: an international Delphi study
No full textAIMS: Type 2 myocardial infarction due to myocardial oxygen supply-demand imbalance is associated with poor outcomes. There are no guidelines to inform care for these patients. The consensus on the assessment and management of type 2 myocardial infarction is gained.
METHODS AND RESULTS: An international e-Delphi study including experts in type 2 myocardial infarction identified through systematic review was conducted. Participants were asked to describe their approach to (i) definition and diagnosis, (ii) risk stratification, (iii) assessment of coronary artery disease and cardiac function, (iv) specialty management, (v) treatment and secondary prevention, and (vi) communication and rehabilitation. Statements generated in round one were circulated, with consensus defined a priori as ≥70% agreement on a 5-point Likert scale. Where no consensus was reached, statements were amended and recirculated for a final round. The response rate was 56% (38/68), 54% (37/68), and 72% (49/68) in the first, second, and third rounds, respectively. Following the first round, 67 unique statements were generated across six domains. Overall, consensus was achieved on 64% (43/67) of statements. Consensus was achieved for 42% (5/12) of statements on the diagnosis of type 2 myocardial infarction, 75% (3/4) on risk stratification, 50% (9/18) on the assessment of coronary artery disease and cardiac function, 60% (6/10), on specialty management, 100% (9/9) on treatment and secondary prevention, and 79% (11/15) on communication and rehabilitation.
CONCLUSION: Consensus was obtained across a number of domains for the assessment and management of patients with type 2 myocardial infarction. However, there was limited agreement amongst experts on the diagnostic criteria, which may benefit from refinement
Characteristics and Outcomes of ST-Segment Elevation Myocardial Infarction due to Left Main Coronary Artery Stenosis
No full textThere is limited data on the incidence and outcomes of ST-segment elevation myocardial infarction (STEMI) due to the left main coronary artery (LMCA) lesions. We aimed to examine the trends and outcomes of STEMI due to LMCA lesions. The Nationwide Readmissions Database was utilized to identify hospitalizations with LMCA STEMI between January 2016 and December 2022. The primary outcome was all-cause in-hospital mortality during index admission. Among 1,528,764 weighted hospitalizations with STEMI from 2016 to 2022, 4,885 (0.3%) were due to LMCA lesions, of which 2,156 (44.1%) had cardiogenic shock (CS). The number of LMCA STEMI hospitalizations and the incidence of CS increased over time. Mechanical circulatory support was used in 78.8% of the patients with LMCA STEMI and CS, with intra-aortic balloon pump being the most common modality (63%). Impella utilization increased from 4.5% in Q1 2016 to 34% in Q4 2022. Revascularization was performed in 78.2% of cases, with percutaneous coronary intervention (PCI) being the most common revascularization modality (62.1%). Among those who had PCI, intravascular imaging (IVI) was used in 18.3%, with a significant increase from 9.6% in Q1 2016 to 26.3% in Q4 2022. All-cause in-hospital mortality was 25.5% and was significantly higher among CS patients (43.4% vs. 11.4%, P\u3c 0.001). In conclusion, the incidence of LMCA STEMI increased from 2016 to 2022 with nearly half of the patients developing CS. IVI use in LMCA PCI was low (18.3%) but increased over time. More than 1 in 4 patients with LMCA STEMI died during the index hospitalization
Precision in Action: Using Intracardiac Echocardiography for Targeted Removal of a Large Lead-Related Vegetation in a Patient With Infective Endocarditis
No full textBACKGROUND: Lead-related infective endocarditis is a serious complication of implantable cardioverter-defibrillators (ICDs), especially in patients with advanced heart failure who are poor surgical candidates. Management of large lead-associated vegetations remains a clinical challenge.
METHODS: We present the case of a 54-year-old woman with ischemic cardiomyopathy and recurrent ICD complications who developed bacteremia and infective endocarditis with vegetations on the aortic valve and a 1.5 × 1.3 cm mass on the right ventricular lead. Given her poor surgical candidacy due to worsening heart failure, a percutaneous approach was pursued.
RESULTS: The patient underwent successful intracardiac echocardiography (ICE)-guided catheter-based vegetation removal using a vacuum-assisted aspiration system, followed by transvenous lead extraction. The procedure was well tolerated, and the patient demonstrated clinical improvement post intervention.
CONCLUSIONS: This case illustrates the utility of ICE-guided percutaneous aspiration and lead extraction for managing large lead-related vegetations in patients with infective endocarditis who are not candidates for surgery
The atrial mass without an auscultatory plop : renal cell carcinoma presenting with cardiac syncope-a case report
No full textBACKGROUND: Renal cell carcinoma (RCC) presenting with extension of tumor thrombus into the inferior vena cava (IVC) and right atrium is a rare, life-threatening condition that requires surgical treatment with the simultaneous involvement of multiple surgical subspecialties.
CASE DESCRIPTION: We present a case of a 65-year-old male who presented to the hospital with syncope, and was subsequently diagnosed with a level four cavoatrial sinus tumor thrombus extending from a primary renal mass. The patient had no concerning physical exam and electrocardiogram (EKG) findings, however, transthoracic and transesophageal echocardiography revealed severely reduced systolic function with a hyperechoic, vascular, and cystic mass extending from the IVC into the right atrial cavity that originated from a renal mass that involved the right renal vein and IVC.
CONCLUSIONS: The purpose of this case is to highlight the critical importance of early recognition and timely intervention in patients who present with nonspecific symptoms, such as syncope, which may signal underlying fatal conditions. This case illustrates RCC with tumor thrombus extending into the IVC and right atrium. This rare but serious manifestation highlights the need for a high index of suspicion and comprehensive evaluation when faced with vague clinical presentations. Early recognition not only facilitates appropriate management but can also alter the patient\u27s prognosis and survival outcomes