Occurrence Of Primary Endpoint Research Articles

Effect of pre-procedural blood pressure on one-year cardiovascular events after percutaneous coronary intervention in patients with acute myocardial infarction

Abstract Background Although high systolic blood pressure (SBP) and low diastolic blood pressure (DBP) are associated with adverse cardiovascular outcomes in coronary artery disease, their impact on patients with acute myocardial infarction (AMI) remains unclear. Methods This multicenter prospective study included 874 AMI patients undergoing percutaneous coronary intervention (PCI) with pre-procedural blood pressure recorded. Patients with cardiogenic shock and missing blood pressure data were excluded. The patients were categorized based on SBP (high ≥120 mmHg, low <120 mmHg) and DBP (high ≥70, low <70 mmHg) into four groups: high SBP and high DBP (HSHD), high SBP and low DBP (HSLD), low SBP and high DBP (LSHD), and low SBP and low DBP (LSLD) group. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding. Results The average age of the patients was 68.9 years, with a mean pulse pressure of 58 ± 19 mmHg. The Kaplan-Meier curves showed significant differences in the primary endpoints among the four groups (Log-rank test, p <0.001). At 12 months, the primary endpoint occurrence was highest in the HSLD group (13.3%) and lowest in the LSHD group (2.4%). Additionally, multivariate Cox regression analysis revealed that the HSLD group, compared to the HSHD group, was independently correlated with an increased risk of cardiovascular events (hazard ratio 2.43, 95% confidence interval 1.16-5.11; p = 0.019). Conclusion Pre-procedural HSLD serves as an independent predictor and is associated with one-year adverse cardiovascular outcomes in AMI patients.Patient diagramKaplan-Meier one-year outcome

Baseline heart rate as a key prognostic indicator in AMI patients with cardiogenic shock undergoing successful primary PCI

Abstract Background Cardiogenic shock presents as a critical condition in patients experiencing acute myocardial infarction (AMI). Even that primary percutaneous coronary intervention (PCI) has become widespread, the mortality rate of AMI complicated with cardiogenic shock remains high. However, comprehensive prognostic stratification remains elusive. Objective Our study sought to elucidate the relationship between baseline parameters and prognostic outcomes in AMI patients with cardiogenic shock. Methods From the GETBACK-AMI multicenter retrospective registry encompassing 935 AMI patients who underwent primary PCI and attained TIMI 3 flow upon final angiography. There were 73 patients diagnosed with cardiogenic shock were ultimately analyzed. The primary endpoint of our study was all-cause mortality. Results Over a median follow-up duration of 425 days, 17 patients (23%) succumbed, of which 14 were in-hospital fatalities. Employing the Cox regression model, we identified that heart rate (HR) at the time of admission bore a potent and independent correlation with the primary endpoint (hazard ratio: 1.04 [95% CI: 1.01-1.06], p=0.002), even post-adjustment for various covariates. ROC analysis pinpointed an admission HR of 82 bpm as the threshold for the primary endpoint. Kaplan-Meier curves further highlighted a pronounced elevation in the primary endpoint occurrence rate for patients with HR > 82 bpm compared to those with HR < 82 bpm (53% vs. 13%, p=0.0002). Conclusions Within our multicenter study cohort, a heightened admission HR was demonstrably linked to increased mortality in AMI patients with cardiogenic shock who reached a final TIMI 3 flow. This readily accessible and impactful prognostic marker may guide clinicians in identifying high-risk patients, subsequently allowing for enhanced support and interventions to optimize patient outcomes.

Metabolic score for insulin resistance as a predictor of mortality in heart failure with preserved ejection fraction: results from a multicenter cohort study

BackgroundThe metabolic score for insulin resistance (METS-IR) has been validated as a novel, simple, and reliable surrogate marker for insulin resistance; however, its utility for evaluating the prognosis of heart failure with preserved ejection fraction (HFpEF) remains to be elucidated. Therefore, we aimed to analyze the association between METS-IR and the long-term prognosis of HFpEF.MethodsWe enrolled a total of 4,702 participants with HFpEF in this study. The participants were divided into three groups according to METS-IR tertiles: (Ln [2 × fasting plasma glucose + fasting triglycerides] × body mass index) / (Ln [high-density lipoprotein cholesterol]). The occurrence of primary endpoints, including all-cause mortality and cardiovascular (CV) death, was documented.ResultsThere were 3,248 participants with HFpEF (mean age, 65.7 ± 13.8 years; male, 59.0%) in total who were included in the final analysis. The incidence of primary outcomes from the lowest to the highest METS-IR tertiles were 46.92, 86.01, and 124.04 per 1000 person-years for all-cause death and 26.75, 49.01, and 64.62 per 1000 person-years for CV death. The multivariate Cox hazards regression analysis revealed hazard ratios for all-cause and CV deaths of 2.48 (95% CI 2.10–2.93; P < 0.001) and 2.29 (95% CI 1.83–2.87; P < 0.001) when the highest and lowest METS-IR tertiles were compared, respectively. In addition, the predictive efficacy of METS-IR remained significant across various comorbidity subgroups (all P < 0.05). Further, adding the METS-IR to the baseline risk model for all-cause death improved the C-statistic value (0.690 for the baseline model vs. 0.729 for the baseline model + METS-IR, P < 0.01), the integrated discrimination improvement value (0.061, P < 0.01), the net reclassification improvement value (0.491, P < 0.01), and the clinical net benefit.ConclusionsAn elevated METS-IR, which is associated with an increased mortality risk, is a potential valuable prognostic marker for individuals with HFpEF.

Relationship between the severity of functional mitral regurgitation at admission and one-year outcomes in patients hospitalized for acute heart failure with mildly reduced ejection fraction

BackgroundThe epidemiological distribution of functional mitral regurgitation (FMR) in heart failure (HF) and mildly reduced ejection fraction (HFmrEF) patients and its impact on outcomes remains unclear. We attempt to investigate the prognosis of FMR in patients with HFmrEF.MethodsThe HF center registry study is a prospective, single, observational study conducted at the Second Affiliated Hospital of Shenzhen University, where 2330 patients with acute HF (AHF) were enrolled and 890 HFmrEF patients were included in the analysis. The patients were stratified into three categories based on the severity of FMR: none/mild, moderate, and moderate-to-severe/severe groups. Subsequently, a comparison of the clinical characteristics among these groups was conducted, along with an assessment of the incidence of the primary endpoint (comprising all-cause mortality and readmission for HF) during a one-year follow-up period.ResultsThe one-year follow-up results indicated that the primary composite endpoint occurrence rates in the three groups were 23.5%, 32.9%, and 36.5%, respectively. The all-cause mortality rates in the three groups were 9.3%, 13.7%, and 16.4% respectively. Survival analysis demonstrated a statistically significant difference in the occurrence rates of the primary composite endpoint and all-cause mortality among the three groups (P < 0.05). Multifactor Cox regression revealed that moderate FMR and moderate-to-severe/severe FMR were independent risk factors for adverse clinical prognosis in HFmrEF patients, with hazard ratios and 95% confidence intervals of 1.382 (1.020–1.872, P = 0.037) and 1.546 (1.092–2.190, P = 0.014) respectively.ConclusionsModerate FMR and moderate-to-severe/severe FMR independently predict an unfavorable prognosis in patients with HFmrEF.

Treat-to-target or high-intensity statin treatment in older adults with coronary artery disease: a post hoc analysis of the LODESTAR trial.

The optimal statin treatment strategy that is balanced for both efficacy and safety has not been clearly determined in older adults with coronary artery disease (CAD). In the post hoc analysis of the LODESTAR (low-density lipoprotein cholesterol-targeting statin therapy versus intensity-based statin therapy in patients with coronary artery disease) trial, the impact between a treat-to-target strategy versus a high-intensity statin therapy strategy was compared in older adults (aged 75years or older). The goal of treat-to-target low-density lipoprotein cholesterol (LDL-C) level was 50-70mg/dl. The primary endpoint comprised the three-year composite of all-cause death, myocardial infarction, stroke or coronary revascularisation. Among 4,400 patients with CAD enrolled in the LODESTAR trial, 822 (18.7%) were aged 75years or older. Poor clinical outcomes and risk factors for atherosclerosis were more frequently observed in older adults than in younger population (<75years old). Among these older adults with CAD, the prescription rate of high-intensity statin was significantly lower in the treat-to-target strategy group throughout the study period (P < 0.001). The mean LDL-C level for three years was 65 ± 16mg/dl in the treat-to-target strategy group and 64 ± 18mg/dl in the high-intensity statin group (P = 0.34). The incidence of primary endpoint occurrence was 10.9% in the treat-to-target strategy group and 12.0% in the high-intensity statin group (hazard ratio 0.92, 95% confidence interval 0.61-1.38, P = 0.69). High-intensity statin therapy is theoretically more necessary in older adults because of worse clinical outcomes and greater number of risk factors for atherosclerosis. However, the primary endpoint occurrence with a treat-to-target strategy with an LDL-C goal of 50-70mg/dl was comparable to that of high-intensity statin therapy and reduced utilisation of a high-intensity statin. Taking efficacy as well as safety into account, adopting a tailored approach may be considered for this high-risk population. ClinicalTrials.gov, NCT02579499.

Impact of age on atrial arrhythmia recurrence following cryoballoon pulmonary-vein isolation

Abstract Background Age is a major risk factor for development of atrial fibrillation (AF) and associated with increased recurrence rates in the setting of rhythm control. Current data tend to support catheter ablation in elderly patients, but it remains unclear whether there is an age limit for ablation and whether the potential benefits of catheter ablation justify the potentially increased complication rate in elderly. Objective To prospectively analyze the impact of age on efficacy and safety of cryoballoon ablation (CBA). Methods ; We prospectively analyzed consecutive patients who underwent CBA in a single-center cohort between 2018 and 2023. Patients were stratified by age (&amp;lt;75yrs versus ≥75yrs) and AF type. Primary efficacy endpoint was recurrence of atrial arrhythmia after 90-day blanking period. Linear and spline regression were used to assess the association between age and primary efficacy endpoint. Safety endpoints were death, stroke or procedure-related complications. Results 873 patients underwent CBA (525 paroxysmal, 348 persistent AF). Median follow-up was 18-months. At 1-year, primary efficacy endpoint occurred in 19.6% (71/363) of young (&amp;lt;75yrs) versus 27.8% (45/162) of elderly (≥75yrs) patients with paroxysmal AF (HR 0.62; 95%CI, 0.41-0.92; P=0.019; fig. 1A) and in 25.0% (57/228) of young versus 39.2% (47/120) of elderly patients with persistent AF (HR 0.57; 95%CI, 0.37-0.85; P=0.006; fig. 1B). A significant linear relationship between age and primary efficacy endpoint occurrence was found for both paroxysmal (P=0.01) and persistent AF (P=0.002; fig.2) while spline regression was non-significant (P=0.45/ P=0.12). No difference was observed regarding the incidence of safety endpoints between young and elderly patients (P=0.76). Conclusion Atrial arrhythmia recurrence rate after CBA increases linearly with age (thus not allowing determination of a clear "cut-off-age") and is highest in elderly patients (≥75 yrs) with persistent AF. Safety of CBA in elderly is comparable to patients of younger age.

Long-term outcomes and quality of life following implementation of dedicated mitral valve Heart Team decisions for patients with severe mitral valve regurgitation in tertiary cardiovascular care center.

This study was purposed to investigate which treatment strategy was associated with the most favourable prognosis for patients with severe mitral regurgitation (MR) following Heart Team (HT)-decisions implementation. In this retrospective study, long-term outcomes of patients with severe MR qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and MitraClip (MC) procedure or OMT and mitral valve replacement (MVR) were evaluated. The primary endpoint was defined as cardiovascular (CV) death and the secondary endpoints included all-cause mortality, myocardial infarctions (MI), strokes, hospitalizations for heart failure exacerbation and CV events during a mean (standard deviation [SD]) follow-up of 29 (15) months. From 2016 to 2019, 176 HT meetings were held and a total of 157 participants (mean age [SD] = 71.0 [9.2], 63.7% male) with severe MR and completely implemented HT decisions (OMT, MC or MVR for 53, 58 and 46 patients, respectively) were included into final analysis. Comparing OMT, MC and MVR groups statistically significant differences between the implemented procedures and occurrence of primary and secondary endpoints with the most frequent in OMT-group were observed (p < 0.05). However, for interventional strategy MC was non-inferior to MVR for all endpoints (p > 0.05). General health status assessed at the end of follow-up were significantly the lowest for MVR, then for MC and the highest for OMT-group (p < 0.01). In the present study it was demonstrated that after careful HT evaluation of patients with severe MR at high risk of surgery, percutaneous strategy (MC) can be considered as equivalent to surgical treatment (MVR) with non-inferior outcomes.

Glycated haemoglobin, HOMA2-B, C-peptide to glucose ratio and type 2 diabetes clusters as predictors for therapy failure in individuals with type 2 diabetes without insulin therapy: A registry analysis.

Some people with type 2 diabetes mellitus (T2D) and declining β-cell function do require insulin over time. Various laboratory parameters, indices of glucose metabolism or phenotypes of T2D (clusters) have been suggested, which might predict future therapy failure (TF), indicating the need for insulin therapy initiation. This analysis evaluated glycated haemoglobin (HbA1c), homeostatic model assessment (HOMA)2-B, C-peptide to glucose ratio (CGR) and diabetes clusters as predictive parameters for the occurrence of glycaemic TF in individuals diagnosed with T2D without previous insulin therapy. In total, 159 individuals with T2D [41% female, median age 50 (IQR: 53-69) years, diabetes duration 9 (5-15) years], without insulin therapy were prospectively evaluated for the occurrence of a composite primary endpoint, including HbA1c increasing or remaining >8.0% (64 mmol/mol) 3 months after baseline on non-insulin glucose-lowering agents, insulin initiation or hospital admissions because of acute hyperglycaemic events. Diabetes clusters were formed according to previously described characteristics. Only severe autoimmune diabetes clusters were excluded because of a small amount of glutamate decarboxylase antibody-positive participants. The other clusters were distributed as mild age-related diabetes 33%; severe insulin-deficient diabetes 31%; mild obesity-related diabetes 20%; and severe insulin-resistant diabetes 15%. During a median observation of 57 months, higher tertiles of HbA1c at baseline, HOMA2-B, as well as a lower CGR were significantly predictive for the occurrence of the primary endpoint. The probability of meeting the primary endpoint was the highest for mild obesity-related diabetes [hazard ratio 3.28 (95% confidence interval 1.75-6.2)], followed by severe insulin-deficient diabetes [hazard ratio 2.03 (95% confidence interval 1.1-3.7)], mild age-related diabetes and the lowest for severe insulin-resistant diabetes. The best performance to predict TF with an area under the curve (AUC) of 0.77 was HbA1c at baseline, followed by HOMA2-B (AUC 0.69) and CGR (AUC 0.64). HbA1c, indices of insulin secretion capacity (HOMA2-B and CGR) and T2D clusters might be applicable tools to guide practitioners in the decision of whether insulin is required in people already diagnosed with T2D. These findings need to be validated in prospective studies.

Impact of extra-mitral valve cardiac involvement in patients with primary mitral regurgitation undergoing transcatheter edge-to-edge repair.

In the context of primary mitral regurgitation (PMR), the selection of patients for transcatheter edge-to-edge repair (TEER) does not include a systematic assessment of PMR-associated cardiac remodelling. We aimed to investigate the epidemiology and prognostic significance of different phenotypes of extra-mitral valve (MV) cardiac involvement in a large series of patients with PMR referred for TEER. The study included 654 patients from the multicentre Italian GIOTTO registry, stratified into groups according to extra-mitral valve (MV) cardiac involvement. The primary endpoint was all-cause death at 2-year follow-up. Patients with no cardiac involvement (NI; n=58), left heart involvement (LHI; n=343) and right heart involvement (RHI; n=253) were analysed. Acute technical success was achieved in 98% of patients. Kaplan-Meier curve analysis revealed significantly worse survival in patients with LHI and RHI (p=0.041). On multivariate Cox regression analysis, extra-MV cardiac involvement, haemoglobin level and technical success were independent predictors of the primary endpoint occurrence. Grading cardiac involvement may help refine risk stratification, since at least 1 group of extra-MV cardiac involvement represents in itself a negative predictor of midterm outcome.

Cryoballoon pulmonary vein isolation for atrial fibrillation in obese patients: A non-inferiority analysis

BackgroundPatients with obesity are at higher risk of developing atrial fibrillation (AF) and benefit from radiofrequency ablation. Potentially, cryoballoon ablation (CBA) may be equally effective and safe in such patients. MethodsWe conducted a prospective, single-center study to investigate whether CBA for pulmonary vein isolation is as effective and safe in obese patients as it is in non-obese controls. Primary efficacy endpoint was recurrence of AF, atrial flutter or atrial tachycardia after a 90-day blanking period. Safety endpoints were death, stroke or procedure-associated complications. Conduction of a subgroup analysis regarding the impact of additional diabetes was predefined in case the primary efficacy endpoint was met. The study was event driven and powered for noninferiority. ResultsA total of 949 patients underwent CBA (251 obese with mean body-mass-index 33.5 ± 3 kg/m2 and 698 non-obese with mean body-mass-index 25.3 ± 3 kg/m2) during a 5-year recruitment period. Median follow-up was 15 months. The primary efficacy endpoint occurred in 78/251 obese and 247/698 non-obese patients (12-months Kaplan-Meier event-rate estimates, hazard ratio 0.79; 95% confidence interval [CI], 0.58 to 1.07; log-rank P = 0.0002 for noninferiority). No differences were observed in safety end point occurrence (P = 0.78). The occurrence of primary efficacy end point was found to be unaffected by the presence of diabetes in the prespecified subgroup analysis (log-rank P = 0.57). ConclusionCBA is effective and safe in obese and DM patients. Weighing the high cardiovascular risk of obese patients against a reduction of cardiovascular events by early rhythm control, CBA should be offered to this patient population.

Self-expanding TAVI using the cusp overlap technique versus the traditional technique: electrocardiogram changes and 1-year cardiovascular outcomes

Introduction and objectivesTranscatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up. MethodsObservational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year. ResultsWe included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P=.002) and less P wave (13.1±21.0 msec vs 5.47±12.5 msec; P=.003) and QRS prolongation (29.77±27.0 msec vs 16.38±25.4 msec, P <.001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P=.005). ConclusionsAt 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint.

Left atrial appendage occlusion in the absence of intraprocedural product specialist monitoring: is it time to proceed alone? Results from a multicenter real-world experience.

Percutaneous left atrial appendage occlusion (LAAO) presents many technical complex features, and it is often performed under the intraprocedural surveillance of a product specialist (PS). Our aim is to assess whether LAAO is equally safe and effective when performed in high-volume centers without PS support. Intraprocedural results and long-term outcome were retrospectively assessed in 247 patients who underwent LAAO without intraprocedural PS monitoring between January 2013 and January 2022 at three different hospitals. This cohort was then matched to a population who underwent LAAO with PS surveillance. The primary end point was all-cause mortality at 1 year. The secondary end point was a composite of cardiovascular mortality plus nonfatal ischemic stroke occurrence at 1 year. Of the 247 study patients, procedural success was achieved in 243 patients (98.4%), with only 1 (0.4%) intraprocedural death. After matching, we did not identify any significant difference between the two groups in terms of procedural time (70 ± 19 min vs. 81 ± 30 min, p = 0.106), procedural success (98.4% vs. 96.7%, p = 0.242), and procedure-related ischemic stroke (0.8% vs. 1.2%, p = 0.653). Compared to the matched cohort, a significant higher dosage of contrast was used during procedures without specialist supervision (98 ± 19 vs. 43 ± 21, p < 0.001), but this was not associated with a higher postprocedural acute kidney injury occurrence (0.8% vs. 0.4%, p = 0.56). At 1 year, the primary and the secondary endpoints occurred in 21 (9%) and 11 (4%) of our cohort, respectively. Kaplan-Meier curves showed no significant difference in both primary (p = 0.85) and secondary (p = 0.74) endpoint occurrence according to intraprocedural PS monitoring. Our results show that LAAO, despite the absence of intraprocedural PS monitoring, remains a long-term safe and effective procedure, when performed in high-volume centers.

TAVI autoexpandible con superposición de senos coronarios frente a la técnica tradicional: alteraciones en el ECG y eventos cardiovasculares al año

Introduction and objectivesTranscatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up. MethodsObservational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year. ResultsWe included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P=.002) and less P wave (13.1±21.0 msec vs 5.47±12.5 msec; P=.003) and QRS prolongation (29.77±27.0 msec vs 16.38±25.4 msec, P <.001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P=.005). ConclusionsAt 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint.

Contribution of artificial intelligence and left atrial strain in the prediction of sudden cardiac death in hypertrophic cardiomyopathy. Results of a multicentric cohort

Sudden cardiac death (SCD) remains a serious outcome in hypertrophic cardiomyopathy (HCM), with an estimated incidence of 1%/year. Its risk prediction stays challenging for clinicians. Implantation of cardioverter-defibrillator is recommended with a strong level of evidence when the HCM risk score is over 6%. However, the ESC HCM risk score is criticized for its moderate diagnostic performance (C-index 0,70), and its low sensibility. Recent studies suggest that low PALS (peak atrial longitudinal strain) is associated with poor prognosis in HCM. Artificial intelligence, wich is experiencing an unprecedented boom, may be an interesting tool in association to left atrial strain in Prognostication. This preliminar study aimed to evaluate the value of the left atrial strain coupled with artificial inteligence algorythm in the prediction of suddent cardiac death in hypertrophic cardiomyopathy. This restrospective multi-center cohort (Marseille la Timone, Bordeaux and Rennes) included 431 patients with sarcomeric HCM from 2007 to 2018. The average follow-up time was 57 months. The primary endpoint was all cause death, ventricular arythmias, recovered SCD and internal electric shock. Analyses were entrusted to the LIS laboratory specialized in Computer Science at Aix-Marseille University. Sixty-six percent of men composed the cohort with a mean age of 52 ± 16 yo. Sarcomeric mutations were found in 52% of them, the mean left ventricular ejection fraction was 63 ± 16, 23% had significant ventricular obstruction. The mean PALS was 25 ± 12%. In the multivariate analysis, PALS 4 chamber, left ventricular global longitudinal strain and syncope were associated with the primary endpoint, (respectivly HR 2,48 IC95% [1,09–5,63]; P 0,030; HR 1,13 IC95% [1,03–1,25]; P 0,012; HR 0,95 IC95% [0,92–0,99]; P: 0.023). The random Forrest algorithm was able to successfully classify the patient (occurrence of primary endpoint or not) in 92,2% of the cases. Left atrial strain coupled with the Random Forrest algorithm could offer an interesting implementative value for the prediction of sudden cardiac death in hypertrophic cardiomyopathy. Further analysis are required to define its sensibility and specificity.

Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment

IntroductionA major knowledge gap in the treatment of complicated Staphylococcus aureus bacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce...

Abstract 13319: Cryoaballoon Ablation in Patients With Atrial Fibrillation and Heart Failure - Insights From Ongoing POLAR-HF Trial

Background Atrial Fibrillation (AF) and heart failure (HF) often co-exist and increase cardiovascular mortality. Radiofrequency ablation is safe and effective in patients with AF and HF. There is evidence for a reduction in mortality in treated patients (CASTLE, NEJM 2019), and the European Society of Cardiology recommends catheter ablation (class 1A), particularly in patients with tachycardiomyopathy. However, there is no large-scale prospective study evaluating efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) in patients with AF and HF. Objective Prospective comparison of cryoPVI in patients with and without HF (defined as LVEF ≤ 40%) regarding efficacy and safety. Methods POLAR-HF trial is an investigator-initiated, single-center, prospective, non-inferiority, interventional study. Follow-up was performed at 3, 6 and 12, 18 and 24 months after ablation. Endpoints were: symptomatic AF recurrence for efficacy and bleeding, stroke or death for safety. Periprocedural parameters were observed. Results: We analyzed 668 consecutive patients who underwent cryoPVI. Of these 581 had normal LVEF (age 69±10 years, CHA2DS2-VASc Score 2.7±1.5, 54% male) while 87 patients (13%) suffered from HF (age 70±10 years, CHA2DS2-VASc Score 3.3±1.4, 70% male). After 24 months primary efficacy endpoint occurrence was similar in normal LVEF and HF group (34.1 % vs. 35.6%, P=0.66, Figure). Safety endpoint occurred in form of pericardial effusion or transient phrenic nerve injury in six patients with normal LVEF (1.2%) and none in HF group. No deaths or strokes were observed in either group. Conclusion The interim results of the POLAR-HF study suggest that cryoPVI is a safe and effective ablation method for patients with atrial fibrillation and heart failure.

The Acute-Phase Ambulation Program Improves Clinical Outcome for Acute Heart Failure.

It remains unclear whether the acute-phase ambulation program (AAP) improves the prognosis of heart failure (HF) patients. We examined the association between the initiation of AAP and the prognosis of patients with worsening HF. We enrolled 560 consecutive patients admitted due to worsening HF from March 2019 to April 2021. Our hospital introduced AAP in May 2020, but we did not perform AAP until April 2020. We retrospectively compared cardiac events within 180 days after discharge between patients admitted before April 2020 (conventional group) and after May 2020 (AAP group). Primary endpoints were all-cause mortality and readmission for worsening HF. The Kaplan–Meier survival curves showed a significantly lower event rate in the AAP group in HF readmission or the primary endpoint (p = 0.020 and p = 0.014). The occurrence of the primary endpoint was associated with age, history of HF, systolic blood pressure, medications including renin–angiotensin system inhibitors or angiotensin receptor blocker, hemoglobin, NT-proBNP, and AAP participation. After adjusting for these parameters and sex, participation in AAP was an independent factor associated with a reduced risk of primary endpoint occurrence (hazard ratio of 0.62 (0.41–0.95), p = 0.028). The AAP for patients with acute HF might lead to improved short-term prognosis and should be considered for implementation.

Clinical Characteristics Predicting Worse Long-Term Outcomes in Patients with Myocardial Infarction and Non-Obstructive Coronary Arteries (MINOCA).

Non-obstructive coronary artery disease occurs in 3.5–15% of patients presenting with acute myocardial infarction. This group of patients has a poor prognosis. Identification of factors that predict worse outcomes in myocardial infarction with non-obstructive coronary arteries (MINOCA) is therefore important. Patients with a diagnosis of MINOCA (n = 110) were enrolled in this single-center, retrospective registry. Follow-up was performed 12, 24 and 36 months after discharge. The primary composite endpoint was defined as myocardial infarction, coronary revascularization, stroke or TIA, all-cause death, or hospital readmission due to any cardiovascular event. The mean age of the study group was 64.9 (± 13.5) years and 38.2% of patients were male. The occurrence of the primary composite endpoint was 36.4%. In a COX proportional hazards model analysis, older age (p = 0.027), type 2 diabetes (p = 0.013), history of neoplasm (p = 0.004), ST-segment depression (p = 0.018) and left bundle branch block/right bundle branch block (p = 0.004) by ECG on discharge, higher Gensini score (p = 0.022), higher intraventricular septum (p = 0.007) and posterior wall thickness increases (p = 0.001) were shown to be risk factors for primary composite endpoint occurrence. Our study revealed that several factors such as older age, type 2 diabetes, ST-segment depression and LBBB/RBBB in ECG on discharge, higher Gensini score, and myocardial hypertrophy and history of neoplasm may contribute to worse clinical outcomes in MINOCA patients.

One-year duplex ultrasound-assessed closure outcomes of percutaneous endovenous microwave ablation for the treatment of varicose veins of the lower limbs.

This study aims to investigate the safety and efficacy of a new device using microwave technology for the endovenous ablation of the great saphenous vein (GSV) causing symptomatic lower limb varicose veins (LLVV). This prospective, single-arm, single-center, cohort study investigated the safety and effectiveness of endovenous microwave ablation for the treatment of symptomatic LLVV. Enrollment period was set between January and December 2020. Primary safety endpoint was the occurrence of procedure-related complications and primary efficacy endpoint was anatomical success defined as the duplex ultrasound (DUS)-proven GSV occlusion at 1year follow-up. Secondary endpoints included 1-year clinical success (CEAP classification improvement), repeat procedures rate due to GSV recanalization, and pain assessment at 24h post treatment. In total, 50 patients (42 female; mean age: 62 ± 12years) with 64 limbs were treated. No procedure-related complications were noted. Technical success was 95.3% (61/64 GSVs), as three cases of GSV recanalization were detected. Clinical success was 100%, as in all cases symptoms improvement by at least one grade according to CEAP classification, was achieved. Mean CEAP grade significantly improved from 3.3 ± 0.72 (median: 3) at baseline to 1.8 ± 0.85 (median: 2) at 1-year (p < 0.0001). There were no repeat procedures due to GSC recanalization. The median 24-h VAS value was 2 (mean: 1.9 ± 1.4). Endovenous microwave ablation was safe and effective for the treatment of varicose veins, achieving high 1-year GSV occlusion rates.

MO579: The Long-Term Efficacy and Safety of Low-Protein Diets in Non-Diabetic Patients with Advanced CKD: Focus on Elderly

Abstract BACKGROUND AND AIMS Current data suggest the benefits of protein restriction in the management of advanced chronic kidney disease (CKD), improving metabolic abnormalities, optimizing blood pressure control and allowing to postpone kidney replacement therapy (KRT). However, feasibility, safety and even the long-term benefits of low protein diets (LPDs) are questioned, especially in elderly. This study aimed to compare the long-term efficacy and safety of two types of LPDs in elderly non-diabetic patients with advanced CKD. METHOD Long-term follow-up (FU) data from a prospective randomized controlled single-center trial (RCT) on 207 CKD stage 4 + non-diabetic patients are presented. The RCT compared the effects of vegetarian very low protein diet supplemented with keoanalogues of essential amino acids (sVLPD, vegetable proteins 0.3 g/kg-day plus, Ketosteril®, Bad Homburg, Germany, 1 tb/5 kg bw-day) with conventional LPD (mixed proteins 0.6g/kg-day) for 15 months (Garneata L et al. JASN. 2016; doi:10.1681/ASN.2 015 040 369). The composite endpoint was the need of KRT or the patients’ death. The census point was either the occurrence of primary endpoint or 31 July 2018. We are presenting a sub-analysis focusing on elderly patients (&amp;gt;65 years old). Safety was assessed throughout the study by anthropometric measures, Subjective Global Assessment (SGA), serum levels of albumin (SAlb) and C-reactive protein (CRP). Davies Comorbidity score was also registered during the follow-up. RESULTS Two hundred patients who ended the RCT were enrolled in the FU. All of them voluntarily continued the prescribed intervention. Data analysis showed sVLPD to be superior to LPD on long-term with respect to the primary endpoint, preserving the nutritional status (published data). Of the 200 subjects, 36 (18%) were elderly, 15 on LPD and 21 on sVLPD. At 31 July 2018, more than 10 years after the end of RCT, 70% of the elderly patients were alive with no statistically significant difference between groups (81 versus 43.3%, P = 0.08 in sVLPD and LPD, respectively). The median follow-up was significantly higher in the sVLPD group: 116 (106–123) versus 97 (49–115) months. The need for KRT during FU was significantly lower in patients on sVLPD: 43 versus 100%. The time until KRT was similar between groups: 32 (7–54) versus 35 (6–131) months, sVLPD and LPD, respectively. There were no significant differences between sVLPD and LPD at the end of FU (EOFU) in the nutritional status assessed by SGA and SAlb [4.41 (4.14–4.56) versus 4.31 (3.90–4.35) g/dL]. At the EOFU, CRP was significantly lower in the sVLPD group: 7 (4–9) versus 10.5 (7–16) mg/L. Davies Comorbidity Score increased during the FU in both groups, with no difference: 3 (1–3) versus 3 (3–5), sVLPD and LPD, respectively. Kaplan–Meier analysis showed better survival rates in the sVLPD group, both for the patient (10-year survival 78 versus 53% in sVLPD and LPD, respectively) and for kidney (10-year survival 82 versus 20% in sVLPD and LPD, respectively). Cox regression analysis of data showed SGA A and the sVLPD to be associated with better patients’ survival, while only sVLPD was associated with better kidneys’ survival. CONCLUSION Both types of protein-restricted diets proved feasible and safe on long-term in elderly. Vegetarian very low protein diet supplemented with ketoanalogues was associated with better patients and kidneys survival as compared with low protein diet in elderly non-diabetic patients.