Optimal Medical Therapy Research Articles

Impact of transcatheter edge to edge repair in functional mitral regurgitation and cardiac resynchronization-therapy nonresponders.

Despite optimal medical therapy and cardiac resynchronization therapy (CRT), significant functional mitral regurgitation (MR) persisted in 30% of the patients and labeled as CRT nonresponders. We sought to study the impact of transcatheter edge-to-edge repair (TEER) in patients with symptomatic grade III and IV functional MR despite CRT. A retrospective analysis was conducted of all patients who had prior CRT for at least 6 months and underwent TEER for significant residual functional MR (grade ≥3) and symptomatic heart failure (HF) at our institution. The primary outcomes were the change in New York Heart Association classification (NYHA), MR grade, echo parameters, and NT-ProBNP from baseline to 1-year post-procedure. A total of 28 patients were identified, mean age of 73 ± 6.7 years and 89% males. Procedure success was achieved in all patients. At 1-year follow-up, patients had lower MR grade (median 2, IQR 1 [1,2] vs. 4, IQR 1 [3,4]; p < 0.001), NYHA class (median 2, IQR 1 [2,3] vs. 3, IQR 1 [3,4]; p < 0.001), and NT-ProBNP (7658 ± 11322 vs. 3760 ± 4431; p = 0.035) compared to before the TEER procedure. The left ventricular end-diastolic volume (255 ± 59vs. 244 ± 66 mm; p = 0.016) and the right ventricular systolic pressure (52 ± 14 mmHg vs. 37 ± 13 mmHg, <0.001) decreased. Patients who remain symptomatic after CRT with severe functional MR had improved functional status and MR grade at 1-year following TEER. There was a signal toward reverse remodeling.

Randomized Trials of Renal Denervation for Uncontrolled Hypertension: An Updated Meta-Analysis.

Despite optimal medical therapy, a significant proportion of patients' blood pressure remains uncontrolled. Catheter-based renal denervation (RDN) has been proposed as a potential intervention for uncontrolled hypertension. We conducted an updated meta-analysis to assess the efficacy and safety of RDN in patients with uncontrolled hypertension, with emphasis on the differential effect of RDN in patients on and off antihypertensive medications. Online databases were searched to identify randomized clinical trials comparing efficacy and safety of RDN versus control in patients with uncontrolled hypertension. Subgroup analyses were conducted for sham-controlled trials and studies that used RDN devices that have gained or are currently seeking US Food and Drug Administration approval. Fifteen trials with 2581 patients (RDN, 1723; sham, 858) were included. In patients off antihypertensive medications undergoing RDN, a significant reduction in 24-hour ambulatory (-3.70 [95% CI, -5.41 to -2.00] mm Hg), office (-4.76 [95% CI, -7.57 to -1.94] mm Hg), and home (-3.28 [95% CI, -5.96 to -0.61] mm Hg) systolic blood pressures was noted. In patients on antihypertensive medications, a significant reduction was observed in 24-hour ambulatory (-2.23 [95% CI, -3.56 to -0.90] mm Hg), office (-6.39 [95% CI, -11.49 to -1.30]), home (-6.08 [95% CI, -11.54 to -0.61] mm Hg), daytime (-2.62 [95% CI, -4.14 to -1.11]), and nighttime (-2.70 [95% CI, -5.13 to -0.27]) systolic blood pressures, as well as 24-hour ambulatory (-1.16 [95% CI, -1.96 to -0.35]), office (-3.17 [95% CI, -5.54 to -0.80]), and daytime (-1.47 [95% CI, -2.50 to -0.27]) diastolic blood pressures. RDN significantly lowers blood pressure in patients with uncontrolled hypertension, in patients off and on antihypertensive medications, with a favorable safety profile. The efficacy of RDN was consistent in sham-controlled trials and contemporary trials using US Food and Drug Administration-approved devices.

REVIVED BCIS-2: update and key learnings.

This review summarises the shifting paradigms in the treatment of ischemic left ventricular dysfunction, spotlighting the revascularization for ischemic ventricular dysfunction-British cardiovascular intervention society-2 (REVIVED-BCIS2) trial results and its impact on key therapeutic goals: survival, left ventricular function, arrhythmia prevention, quality of life and viability testing. The REVIVED-BCIS2 trial, and its subsequent sub studies highlighted that (PCI) does not provide additional benefits to optimal medical therapy in terms of improving survival, left ventricular (LV) function, arrhythmic risk or quality of life. Additionally, viability testing did not differentiate patients who could benefit from PCI, although scar burden was found to be a significant predictor of outcome in these patients. The outcomes of REVIVED have challenged multiple existing beliefs in the field of ischaemic left ventricular dysfunction management, emphasising the importance of investigating evidence free areas in our practice. Future work, including the STICH3 international consortium of trials, aims to answer some of the remaining unanswered questions.

Protocol-driven approach to guideline-directed medical therapy optimization for heart failure: A real-world application to recovery

The objective of our study was to evaluate the real-world effects of an aggressive, personalized protocol for guideline-directed medical therapy (GDMT) titration in patients with heart failure (HF) with reduced ejection fraction (HFrEF). We conducted a two-center retrospective cohort study. Patients with HFrEF who presented to a HF clinic from January 2020 to December 2022 were placed on a GDMT protocol. 180 patients were included in the study. Mean GDMT score significantly increased from 4.7 to 5.9 (p < 0.001) between initial and final visits. Mean left ventricular ejection fraction (LVEF) significantly increased from 28 % to 33 % (+5 %, p < 0.001). 27 (15.7 %) of the 172 patients with complete New York Heart Association (NYHA) classification data had improvement by at least 1 class, while 2 (1.2 %) patients had worsening NYHA classification. 140 (77.8 %) patients had no unplanned hospitalizations between visits. 21 (11.7 %) patients had an unplanned hospitalization for acute HF during the study period with a mean time from first clinic visit to hospitalization of 183 days (range: 13–821 days). 2 (1.1 %) patients were hospitalized due to GDMT-associated adverse drug events (i.e. hypotension, hyperkalemia). 7 (3.9 %) patients died during the study period, which was lower than the predicted 1-year death rate for our cohort (12.3 %) using the MAGGIC score. In conclusion, an aggressive, personalized protocol for GDMT titration in patients with HFrEF led to significant improvements in LVEF, NYHA classification, hospitalization, and mortality in a real-world setting. This protocol may help serve as a road map to lessen the gap between clinical knowledge and practice surrounding optimization of GDMT and move HFrEF patients toward a path to recovery.

Effect of enhanced external counterpulsation on coronary microcirculation dysfunction (CMD) in patients with coronary artery disease (EECP-CMD II): study protocol of a single-centre, open-label, parallel group, randomised controlled trial

IntroductionCoronary microcirculation dysfunction (CMD) is prevalent in patients with coronary artery disease (CAD). Current therapies for CMD are focused on pharmacotherapy, non-pharmacological treatments such as enhanced external counterpulsation (EECP) have...

Optimal Medical Therapy and Outcomes Among Patients With Chronic Heart Failure With Reduced Ejection Fraction

BackgroundOptimal medical therapy (OMT) scoring may stratify clinical risk in real-world chronic heart failure with reduced ejection fraction (HFrEF) by integrating use and dosing of guideline-directed medical therapy (GDMT) for HFrEF. ObjectivesThe purpose of this study was to characterize patients and associated long-term clinical outcomes by OMT score-derived treatment groups. MethodsCHAMP-HF (Change the Management of Patients with Heart Failure) included U.S. outpatients with chronic HFrEF receiving ≥1 GDMT. OMT subgroups were defined as suboptimal (score <3), acceptable (score = 3), and optimal (score ≥4) by baseline use and dose of GDMT, as proposed by the HF Collaboratory consortium. Cox proportional hazard analyses were used to assess for all-cause and cardiovascular death across subgroups, after adjusting for demographic and clinical covariates. ResultsThe authors studied 4,582 participants enrolled in CHAMP-HF with available 2-year follow-up. Median age was 68 years, 1,327 (29%) were women, and 2,842 (62%) were White, non-Hispanic. Median OMT score across the population was 4 (Q1-Q3: 2-5), and 1,628 (35%) had suboptimal, 665 (14%) had acceptable, and 2,289 (50%) had optimal therapy. Participants with optimal treatment were younger, had higher annual household income, and were enrolled from practices with dedicated HF clinics (all P < 0.001) than participants with acceptable or suboptimal treatment. Participants with optimal treatment had lower all-cause death (adjusted HR: 0.77; 95% CI: 0.64-0.92) and cardiovascular death (adjusted HR: 0.79; 95% CI: 0.65-0.96) than those with suboptimal treatment. ConclusionsAcross a large cohort of chronic ambulatory HFrEF, OMT scores stratified risk of all-cause and cardiovascular death.

Hospitalization of Symptomatic Patients With HeartFailure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.

For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in HeartFailure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25cm2; 14% >0.40cm2, 23%<0.20cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n=333) with a HF hospitalization in the 12months before randomization. At 24months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95%CI: 0.49-0.85; P=0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95%CI: 0.57-0.99; P=0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95%CI: 0.57-0.95; P=0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95%CI: 0.58-0.99; P=0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95%CI: 0.63-1.07; P=0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95%CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P< 0.0001, and 1,067 vs 1,776 total days lost; P< 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30days and at 6, 12, and 24months of follow-up (P< 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction=0.03) and of recurrent HF hospitalizations within 24months (Pinteraction=0.06). These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.

Markers of optimal medical therapy are associated with improved limb outcomes after elective revascularization for intermittent claudication

BackgroundOptimal medical therapy (OMT) is a modifiable factor that decreases mortality and cardiovascular events in patients with severe peripheral arterial disease. We hypothesized that preintervention OMT would be associated with improved 1-year reintervention and major adverse limb event (MALE) rates after elective endovascular revascularization for intermittent claudication (IC). MethodsUsing the Vascular Quality Initiative (2010-2020), we identified patients with IC undergoing elective endovascular, hybrid, and open surgical interventions. Preoperative antiplatelet, statin, and nonsmoking status defined OMT components and created three groups: complete (all components), partial (1-2 components), and no OMT. The primary outcome was 1-year reintervention. Secondary outcomes included MALE and factors associated with OMT usage. Multivariable logistic regression generated adjusted odds ratios (aOR). ResultsThere were 39,088 patients (14,907 [38.1%] complete, 22,054 [56.4%)] partial, 2127 [5.4%] no OMT) who met our criteria. Patients with any OMT were more frequently older with more cardiovascular diseases and diabetes (P < .0001). Patients without OMT were more likely to be Black or with Medicare or Medicaid (P < .05). Observed 1-year reintervention (5.3% complete OMT, 6.1% partial OMT, 8.3% no OMT; P < .001) and MALE (5.6% complete OMT, 6.3% partial OMT, 8.8% no OMT; P < .001) were decreased by partial or complete OMT compared with no OMT. Complete OMT significantly decreased the adjusted odds of reintervention and MALE by 28% (aOR, 0.72, 95% confidence interval [95% CI], 0.59-0.88) and 30% (aOR, 0.70; 95% CI, 0.58-0.85), respectively, compared with no OMT. Partial OMT decrease the adjusted odds of reintervention and MALE by 24% (aOR, 0.76; 95% CI, 0.63-0.92) and 26% (aOR, 0.74; 95% CI, 0.62-0.89), respectively. ConclusionsPreintervention OMT is an underused, modifiable risk factor associated with improved 1-year reintervention and MALE. Vascular surgeons are uniquely positioned to initiate and maintain OMT in patients with IC before revascularization to optimize patient outcomes.

Changes in 6-min walk test is an independent predictor of death in chronic heart failure with reduced ejection fraction.

Functional capacity provides important clinical information in patients with heart failure (HF) and reduced ejection fraction (HFrEF). The 6-min walk test (6MWT) is a simple and inexpensive tool for assessing functional capacity and risk. Although change in 6MWT is frequently used as a surrogate outcome in HF trials, the association with mortality is unclear. We aimed to assess the prognostic importance of changes in 6MWT. Patients with chronic HFrEF referred to HF outpatient clinics in Norway completed a 6MWT at the first visit (baseline) and at a stable follow-up visit after treatment optimization (follow-up). Absolute and relative changes in 6MWT were analysed in association with mortality risk using Cox regression models and flexible cubic splines. The study included 3636 HFrEF patients aged 67.3 ± 11.6 years, 23% women, with left ventricular ejection fraction 30 ± 7%. At baseline, mean 6MWT was 438 ± 125 m, median N-terminal pro-B-type natriuretic peptide (NT-proBNP) 1574 (732-3093) ng/L, and 27% had New York Heart Association (NYHA) class III/IV. After optimization of guideline-directed medical therapy (median 147 [86-240] days), 6MWT increased by mean 40 ± 74 m, NT-proBNP decreased by median 425 (14-1322) ng/L, and NYHA class improved in 38% of patients. Patients with greater improvements in 6MWT were younger, with greater improvements in NYHA class (r = 0.27, p < 0.001) and larger reductions in NT-proBNP concentrations (r = 0.19, p < 0.001). After mean 845 ± 595 days, 419 (11.5%) patients were dead. Both absolute and relative changes in 6MWT were non-linearly associated with survival, attenuating as 6MWT increased. A 50 m increase in 6MWT was associated with a 17% lower mortality risk (hazard ratio 0.84, 95% confidence interval 0.77-0.90, p < 0.001) in the fully adjusted model, including changes in NYHA class, NT-proBNP concentrations, and other established risk factors. The associations were more pronounced in patients with lower baseline 6MWT and higher age. Improvement in 6MWT in patients with HFrEF is associated with increased survival, independent of changes in NT-proBNP and NYHA class. These findings support 6MWT change as a surrogate outcome in HF trials.

Modelled impact of virtual fractional flow reserve in patients undergoing coronary angiography (VIRTU-4)

BackgroundThe practical application of ‘virtual’ (computed) fractional flow reserve (vFFR) based on invasive coronary angiogram (ICA) images is unknown. The objective of this cohort study was to investigate the potential...

Impact of sodium-glucose cotransporter-2 inhibitor use on peak VO2 in advanced heart failure patients.

Advanced heart failure (HF) is an epidemic that affects multiple organ systems with high morbidity and mortality rates despite optimal medical therapy (OMT) and remains the leading cause of hospitalizations in type 2 diabetes-related cardiovascular disease. The addition of sodium-glucose co-transporter inhibitors (SGLT2i) in treating these patients has seen improved mortality and hospital admission rates. As such, we felt it was important to investigate whether the use of SGLT2i improved functional capacity in patients with HF when compared to OMT by evaluating maximum oxygen consumption (peak VO2) using cardiopulmonary exercise testing (CPET). We found 94 heart failure patients between August 2020 and August 2021 who underwent CPET before and after treatment at Mayo Clinic in Florida. 50 patients received OMT and 44 received OMT and SGLT2i therapy. CPET results before and after were compared for each group. The baseline ejection fraction was not significantly different between groups, with the OMT group at 38% and the SGLT2i group at 33%, p = 0.10. OMT patients were found to have a significantly lower hemoglobin A1c of 5.7 (5.4-6.1) compared to those with SGLT2i therapy of 6.4 (5.8-7.1), p = 0.01. The baseline peak VO2 was 17.3 ml/kg/min (13.3-21.6) in the OMT group and 17.3 ml/kg/min (14.4-18.9) in the SGLT2i group, p = 0.18, not significantly different. The interesting finding is that the follow-up peak VO2 at one year for the OMT group was 17 ml/kg/min (13.3-21.6), which was not significantly different from the SGLT2i group peak VO2 of 17 ml/kg/min (14.6-19.6), p = 0.19. Our study is the first to compare before and after peak VO2 values of the OMT+SGLT2i group to the patient's own baseline and we found no significant improvement. Our single-center data shows no improvement in functional capacity after the addition of SGLT2i therapy to OMT in patients with advanced heart failure. Improved hospitalization and symptoms may be attributed to other numerous effects of SGLT2i such as volume management.

Adherence to optimal medical therapy and control of cardiovascular risk factors in patients after ST elevation myocardial infarction in Mexico.

In developing countries, there is a notable scarcity of real-world data on adherence to optimal medical therapy (OMT) and its correlation with major cardiovascular adverse events (MACEs) after ST-elevation myocardial infarction (STEMI). Our study focuses on addressing this gap by evaluating adherence to OMT, examining its influence on the risk of MACEs after STEMI, and assessing subsequent cardiovascular risk factor control in Mexico. We conducted a prospective observational study of post-STEMI patients after hospital discharge. Adherence to treatment was assessed over a median of 683 days (interquartile range: 478-833) using the Simplified Medication Adherence Questionnaire (SMAQ). Patients were followed up for 4.5 years to monitor MACEs (cardiovascular death, cardiogenic shock, recurrent myocardial infarction, and heart failure). We included 349 patients with a mean age of 58.08 years (±10.9), predominantly male (89.9%). Hypertension (42.4%), smoking (34.3%), type 2 diabetes mellitus (31.2%), obesity (22.92%), and dyslipidemia (21.4%) were highly prevalent. Adherence to OMT per SMAQ was 44.7%. The baseline clinical characteristics of adherent and non-adherent patients did not significantly differ. OMT prescription rates were as follows: acetylsalicylic acid, 91.1%; P2Y12 inhibitors, 76.5%; and high-intensity statins, 86.6%. While non-adherent patients had a numerically higher rate of MACEs (73 vs. 49 first events), there was no statistically significant difference (hazard ratio 1.30, 95% confidence interval 0.90-1.88). In this real-world study of patients after STEMI, we observed low adherence to OMT, a low proportion of global cardiovascular risk factor control, and a numerically higher incidence of recurrent major adverse cardiovascular events in non-adherent patients. Strategies to improve adherence to OMT and risk factor control are needed.

Effect of inferior caval valve implantation on circulating immune cells and inflammatory mediators in severe tricuspid regurgitation

BackgroundInterventional valve implantation into the inferior vena cava (CAVI) lowers venous congestion in patients with tricuspid regurgitation (TR). We evaluated the impact of a reduction of abdominal venous congestion following CAVI on circulating immune cells and inflammatory mediators.MethodsPatients with severe TR were randomized to optimal medical therapy (OMT) + CAVI (n = 8) or OMT (n = 10). In the OMT + CAVI group, an Edwards Sapien XT valve was implanted into the inferior vena cava. Immune cells and inflammatory mediators were measured in the peripheral blood at baseline and three-month follow-up.ResultsLeukocytes, monocytes, basophils, eosinophils, neutrophils, lymphocytes, B, T and natural killer cells and inflammatory markers (C-reactive protein, interferon-gamma, interleukin-2, -4, -5, -10, and tumor necrosis factor-alpha) did not change substantially between baseline and three-month follow-up within the OMT + CAVI and OMT group.ConclusionThe present data suggest that reduction of venous congestion following OMT + CAVI may not lead to substantial changes in systemic inflammation within a short-term follow-up.Clinical trial registrationNCT02387697Graphical

Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.

INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.

Predictive value of baseline alpha defensin level in patients with stable coronary artery disease: A retrospective single center study

BackgroundInflammation plays a central role in atherogenesis. The major neutrophilic peptide alpha-defensin is a promising evolving risk factor for atherosclerosis. The aim of the present study was to examine the role of alpha-defensin in predicting future major adverse cardiovascular events (MACE) occurrence in fully revascularized patients with stable CAD under optimal medical therapy. Methods and resultsWe retrospectively examined the prognostic value of baseline plasma alpha-defensin levels in predicting MACE occurrence in 174 fully revascularized patients for stable CAD between March 2016 and January 2017. Alpha-defensin levels were found 20 % higher among demised patients (10,859 pg/ml, IQR [6,920 to 23,320] vs. 9,020 pg/ml, IQR [5,540 to 16,180] pg/ml, P = 0.15). The absolute increase in mortality risk in patients with alpha-defensin levels greater than the median values was 72.5 % (P = 0.33). Log-rank analysis proved both recurrent PCI for de novo lesions (14.9 % and 2.3 %) and the composite of mortality and recurrent PCI for de novo lesions (27.6 % vs. 9.2 %) were significantly related to alpha-defensin values greater than the median (>9200 pg/ml). ConclusionBaseline plasma alpha-defensin is an independent predictor of mortality and recurrent PCI among patients with stable CAD. Alpha-defensin may evolve as a promising factor in cardiovascular risk assessment beyond traditional risk factors. Targeting alpha-defensin to ameliorate MACE occurrence should be addressed in future studies.

Treatment Strategies for Asymptomatic Carotid Stenosis: A Systematic Review and Bayesian Network Meta-Analysis.

To compare the safety and efficacy of carotid endarterectomy (CEA), carotid stenting (CAS), and optimal medical therapy (OMT) in patients with asymptomatic carotid stenosis. Relevant randomized controlled trials were researched with PubMed, Web of Science, and the Cochrane Library databases. Fixed-effects model and random-effects model were used to estimate the relative risks and the hazard ratios (HRs). The results of the probabilistic analysis were reported as surfaces under the cumulative ranking curve. Eight randomized controlled trials were included. Data from 10 348 patients (CEA: n = 4758; CAS: n = 3919; OMT: n = 1673) were evaluated. Compared with the previous OMT, CEA, CAS, and the current OMT (c-OMT) were all effective in reducing the risk of stroke (CEA: HR, 0.52; CI, 0.40-0.66; CAS: HR, 0.58; CI, 0.42-0.81; c-OMT: HR, 0.40; CI, 0.15-0.94); CEA and CAS reduced the risk of ipsilateral stroke (CEA: HR, 0.41; CI, 0.28-0.59; CAS: HR, 0.51; CI, 0.31-0.84), and the risk of fatal or disabling stroke (CEA: HR, 0.59; CI, 0.43-0.81; CAS: HR, 0.57; CI, 0.34-0.95). Regarding reducing the risk of stroke, only CEA was statistically significant in patients with any degree of stenosis compared with the previous medical treatment (<80%: HR, 0.48; CI, 0.33%-0.70%; 80%-99%: HR, 0.53; CI, 0.38-0.73). In the treatment of asymptomatic carotid stenosis, the perioperative outcomes of CAS were similar to that of CEA; CEA, CAS, and c-OMT shared similar long-term outcomes; and CEA and CAS may be more effective in patients with high levels of asymptomatic stenosis.

Intensive therapeutic education strategy for patients with acute heart failure (EduStra-HF): Design of a randomized controlled trial

BackgroundHeart failure is associated with reduced quality of life, hospitalizations, death and high healthcare costs. Despite care improvements, the rehospitalization rate after an acute heart failure episode, especially for acute heart failure, remains high. MethodsThe Education Strategy for patients with acute Heart Failure (EduStra-HF; ClinicalTrials.gov Identifier NCT03035123) study will randomize patients admitted for acute heart failure in six French hospitals to usual care (control) or therapeutic education (intervention). All patients will be evaluated at baseline and will meet with a therapeutic education nurse before discharge. Those in the usual care arm will have standard appointments with their cardiologist and general practitioner. Those in the intervention arm will have an intensive follow-up schedule of phone calls, home visits and text messages from the therapeutic education nurses, plus cardiologist visits. Patients will be stratified by discharge location (home or cardiac rehabilitation centre) before randomization, and will be followed up for 1 year. The primary outcome will be the readmission rates for acute heart failure during 1 year in the two groups. Secondary outcomes will include: quality of life; time from inclusion to first readmission for acute heart failure; non-heart failure cardiovascular rehospitalization rates; length of stay for heart failure; cardiovascular and all-cause death; rates of patients receiving optimal medical therapies; evolution of knowledge about heart failure; and cost-effectiveness. ConclusionsThis study will assess the efficacy and feasibility of a standardized management strategy for the care and follow-up of patients discharged after hospitalization for acute heart failure. The EduStra-HF strategy will combine various nurse care methods to help prevent rehospitalization.

Dapagliflozin Effects on Cardiac Deformation in HeartFailure and Secondary Clinical Outcome.

Sodium-glucose cotransporter 2 inhibitors were shown to reduce morbidity and mortality in patients with heart failure. This study aims to assess potential effects of dapagliflozin in nondiabetic patients with heart failure with reduced ejection fraction (HFrEF) and heart failure with mildly reduced ejection fraction (HFmrEF) on cardiac function assessed by speckle tracking echocardiography (STE). This randomized, prospective, single-center, open-label trial compared consecutive nondiabetic outpatients with HFrEF or HFmrEF receiving dapagliflozin with patients treated with optimal medical therapy (OMT) except sodium-glucose cotransporter type 2 inhibitors. Primary endpoint was the presence of a significant modification of left ventricular global longitudinal strain, diastolic function (as peak atrial longitudinal strain) and right ventricular function by STE from baseline to 6months. Cardiovascular events and parameters of congestion were assessed as safety-exploratory endpoints. Overall, 88 patients (38% HFmrEF) were enrolled and randomized to start dapagliflozin on top of OMT (n=44) or to continue with OMT (n=44). All STE values improved in the dapagliflozin group after 6months, whereas there was a nonsignificant improvement in OMT group. Moreover, when comparing the modification of STE parameters at follow-up in patients with HFrEF and HFmrEF, only the main treatment effect resulted statistically significant in both groups (P< 0.0001), indicating a significant difference between dapagliflozin and OMT. This study provided randomized data on the beneficial effect of dapagliflozin in nondiabetic patients with HFrEF and HFmrEF in terms of myocardial performance measured by the most sensitive echocardiographic technique, ie, STE. This suggests its usefulness for left ventricular reverse remodeling and better quality of life in patients with HFrEF and HFmrEF. (Effects of Dapagliflozin on cardiac deformation and clinical outcomes in heart failure with reduced and mildly reduced ejection fraction [DAPA ECHO trial]; EudraCT number: 2021-005394-66).

Heat transfer analysis of mixed convection boundary layer blood base nanofluids with the influence of viscous dissipation

In this research study, we delve into the analysis of two-dimensional boundary layer incompressible viscous flow of blood based nanofluids, incorporating a couple stress model. This investigation encompasses considerations of heat transmission and viscous dissipation effects. Specifically, focus on a particular type of nanoparticle, Magnesium oxide (MgO), dispersed in blood, the base fluid. By employing suitable similarity transformations, transform a set of partial differential equations (PDEs) into nonlinear ordinary differential equations (ODEs). To leverage the Homotopy Analysis Approach (HAM) to solve this system of equations. This study discerns the impacts of various factors on temperature and velocity distributions. Visualization through graphs depicting nanoparticle volume concentration, magnetic field strength, couple stress parameter, Eckert number, and Prandtl number aids in presenting our findings. These insights illuminate the intricate interplay among different parameters and offer insights for enhancing heat transfer in blood-based nanofluids. Additionally, scrutinize the thermal performance of the blood-based nanofluid, assessing the Nusselt number and local skin friction coefficient. Such analysis holds significance for ensuring patient safety and treatment efficacy, particularly in medical procedures involving blood circulation, where mixed convection plays a pivotal role. Understanding these dynamics is crucial for the design and optimization of various medical devices and therapies, ensuring optimal temperature maintenance during blood circulation-related operations.

Optimizing Triage of Ambulatory Patients With Advanced Heart Failure: 2-Year Outcomes From REVIVAL

BackgroundLeft ventricular assist device (LVAD) use remains uncommon in advanced heart failure (HF) patients not dependent on inotropes. ObjectivesBefore considering a randomized trial comparing a strategy of earlier use of LVAD to continued medical therapy, a better understanding is needed of the clinical trajectory of ambulatory patients with advanced systolic HF on optimal guideline-directed medical therapy (GDMT). MethodsREVIVAL enrolled 400 patients with advanced ambulatory systolic HF, ≥1 HF mortality risk marker (≥2 HF hospitalizations past year; or HF hospitalization and high natriuretic peptide; or no HF hospitalizations but low peak oxygen consumption, 6-minute walk, serum sodium, HF survival score or Seattle HF model predicted survival), and no LVAD contraindication at 21 LVAD centers from July 2015 to June 2016. Patients were followed for 2 years or until a primary outcome (death, durable ventricular assist device, or urgent transplant). Clinical outcomes and health-related quality of life were evaluated. ResultsMean baseline left ventricular ejection fraction was 21%, median 6-minute walk was 341 m, and 92% were Interagency Registry for Mechanically Assisted Circulatory Support profiles 5 to 7. Adherence to GDMT and electrical device therapies was robust. Composite primary outcome occurred in 22% and 37% at 1 and 2 years, with death alone in 8% and 16%, respectively. Patients surviving for 2 years maintained GDMT intensity and had no decline in health-related quality of life. ConclusionsStructured, serial follow-up at programs with expertise in caring for advanced ambulatory systolic HF patients facilitates triage for advanced therapies. Better strategies are still needed to avoid deaths in a small but significant group of patients who die without advanced therapies. REVIVAL patients not selected for VAD or transplant have robust survival and patient-reported outcomes, which challenges advocacy for earlier VAD implantation. (Registry Evaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407)