Significant Differences In All-cause Death Research Articles

Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices - Insight From the OCEAN-LAAC Registry.

Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients.Methods and Results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial

Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome. In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed. Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41-0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups. In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone. The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. For the Mandarin translation of the abstract see Supplementary Materials section.

Azvudine for the Treatment of COVID-19 in Pre-Existing Cardiovascular Diseases: A Single-Center, Real-World Experience.

COVID-19 can lead to adverse outcomes in patients with pre-existing diseases. Azvudine has been approved for treating COVID-19 in China, but the real-world data is limited. It is aimed to investigate the efficacy of Azvudine in patients with COVID-19 and pre-existing cardiovascular diseases. Patients with confirmed COVID-19 and pre-existing cardiovascular diseases are retrospectively enrolled. The primary outcome is all-cause death during hospitalization. Overall, 351 patients are included, with a median age of 74 years, and 44% are female. 212 (60.6%) patients are severe cases. Azvudine is used in 106 (30.2%) patients and not in 245 (69.8%). 72 patients died during hospitalization. After multivariate adjustment, patients who received Azvudine a lower risk of all-cause death (hazard ratio: 0.431; 95% confidence interval: 0.252-0.738; p=0.002) than controls. Azvudine therapy is also associated with lower risks of shock and acute kidney injury. For sensitivity analysis in the propensity score-matched cohort (n = 90 for each group), there is also a significant difference in all-cause death between the two groups (hazard ratio: 0.189; 95% confidence interval: 0.071-0.498; p<0.001). This study indicated that Azvudine therapy is associated with better outcomes in COVID-19 patients with pre-existing cardiovascular diseases.

5 Year Survival with Percutaneous Coronary Intervention Compared to Coronary Artery Bypass Graft Surgery in Patients with Diabetes and Multivessel Disease

BackgroundCoronary artery bypass graft (CABG) surgery is preferred over percutaneous coronary intervention (PCI) in patients with diabetes (DM) and multivessel disease (MVD). However, it is unclear whether CABG confers a survival advantage. MethodsPatients with DM and MVD undergoing either PCI (with drug-eluting stents) or CABG within 90-days of cardiac catheterization between 01/05/2009-03/29/2019 in Alberta, Canada were included. The study excluded patients with previous revascularization or other cardiac interventions. We examined death and death or myocardial infarction (MI) 5-years post revascularization via linkage with vital statistics death registry and hospitalization data. Inverse probability of treatment weighting was used to balance baseline characteristics between PCI and CABG groups and then compared the survival difference with Cox proportional hazards model. ResultsAmong 4803 patients, 2941 (61.2%) had PCI and 1862 (38.8%) had CABG. PCI recipients were more likely to be female, younger, to have higher body mass index, present with ST-elevation MI or lesser extent of MVD than CABG patients. At 5-years there was no significant difference in the death rate or the death/MI rate between two groups (Death, PCI: 3.2, CABG 3.6 events per 100 person-year, p=0.16) and (Death/MI PCI: 5.1, CABG 4.7 events per 100 person-year, p=0.35). Adjusting for confounding factors did not change the associations of PCI vs CABG (Death HR: 0.96, 95% CI 0.73, 1.24) and (Death/MI HR: 1.16 95% CI 0.92, 1.45). ConclusionNo significant difference in all-cause death or death/MI was found between revascularization strategies, providing guidance on selection for patients with DM and MVD.

Pericardiocentesis versus pericardial window surgery in malignant pericardial effusion: trends and clinical outcomes

Abstract Backgrounds Pericardial effusion (PE) is often an obstacle to cancer treatment and a life-threatening factor. Although cancer survival has improved over the past two decades, an appropriate treatment method for PE in cancer patients has not yet been established. The purpose of this study was to investigate the temporal trends and clinical results in the method of drainage of PE. Methods Between 2003 and 2022, 744 consecutive patients with malignant PE who underwent pericardial drainage were retrospectively analyzed. The patients were divided according to the time of pericardial drainage (Period 1: 2003-2012, Period 2: 2013-2022) and initial drainage method (pericardiocentesis vs. window surgery). The rates of all-cause death and redo pericardial drainage for recurrent PE were compared according to the drainage methods. Results In comparison with Period 1, there was an increasing number of patients who underwent pericardial drainage in Period 2 (235 vs. 509). However, the proportion of window surgery decreased (21.7 vs. 14.9%, P=0.029). The median survival time of patients was improved (4.4 vs. 6.3 months, log-rank P&amp;lt;0.001). There was no significant difference in all-cause death and 30-day mortality (24.4 vs. 18.6%, P=0.171) after drainage between surgery and pericardiocentesis groups. The window surgery group had a significantly lower incidence of redo pericardial drainage than the pericardiocentesis group (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.26–0.91, P=0.022). In Period 1, there was no significant difference in redo pericardial drainage between window surgery and pericardiocentesis (HR: 0.78, 95% CI: 0.35–1.74, P=0.540). However, the window surgery group had significantly lower redo pericardial drainage than the pericardiocentesis group in Period 2(HR: 0.33, 95% CI: 0.12–0.91, P=0.024). Conclusions The window surgery was safe in cancer patients. As cancer survival rates improve, surgery showed benefits in reducing redo pericardial drainage. Pericardial window surgery could be preferred over pericardiocentesis in patients who expected longer life expectancy.

Abstract 16541: Early Aortic Valve Replacement in Symptomatic Normal-Flow, Low-Gradient Severe Aortic Stenosis: A Propensity Score-Matched Retrospective Cohort Study

Introduction: Aortic valve replacement (AVR) is a class I indication for symptomatic severe aortic stenosis (AS). However, there is little evidence of the benefit of early AVR in symptomatic patients with normal-flow, low-gradient (NFLG) severe AS. Hypothesis: Early AVR has benefit in patients with NFLG severe AS Methods: Two-hundred eighty-one patients diagnosed with symptomatic NFLG severe AS (stroke volume index ≥ 35 mL/m 2 , mean transaortic pressure gradient &lt; 40 mmHg, peak transaortic velocity &lt; 4 m/s, and aortic valve area &lt; 1.0 cm 2 ) between January 2010 and December 2020 were retrospectively reviewed. After 1:1 propensity score matching, 121 patients aged 75.1 ± 9.8 years (including 63 women) who underwent early AVR within three months after index echocardiography were compared with 121 patients who received conservative care. The primary outcome was a composite of all-cause death and heart failure hospitalization. Results: During a median follow-up of 21.9 months, 48 primary outcomes (18 in the early AVR group and 30 in the conservative care group) occurred. The early AVR group presented a significantly lower incidence of primary outcomes (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.29-0.93; P = 0.028); specifically, there was no significant difference in all-cause death (HR, 0.51; 95% CI, 0.23-1.16; P = 0.110), although the early AVR group showed a significantly lower incidence of hospitalization for heart failure (HR, 0.43; 95% CI, 0.19-0.95, P = 0.037). Subgroup analyses supported the main findings. Conclusions: An early AVR strategy may benefit guard against a composite outcome of death or hospitalization for heart failure in symptomatic patients with NFLG severe AS. Future randomized studies must confirm our findings.

Two-Year Outcomes of Valve-in-Valve Using New-Generation Transcatheter Devices Compared With Redo-SAVR

Few studies have compared the clinical outcomes between valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) with new-generation valves and re-operative surgical aortic valve replacement (Redo-SAVR). We compared the clinical outcomes of patients who underwent ViV-TAVR with those of patients who underwent Redo-SAVR at Cedars-Sinai Medical Center between 2015 and 2021. New-generation valves were used for ViV-TAVR. A propensity score-matched (PSM) analysis was performed to adjust for differences in baseline characteristics. The primary end point was all-cause mortality at 30days and 2years. In-hospital procedural and clinical outcomes were also compared between the groups. A total of 256 patients (140 who underwent ViV-TAVR and 116 who underwent Redo-SAVR) were eligible for PSM. In the unmatched cohort, patients in the ViV-TAVR group were older and had more co-morbidities than those in the Redo-SAVR group. After PSM, there were no significant differences in all-cause death between the ViV-TAVR and Redo-SAVR groups at 30days (3.9% vs 2.6%, p=0.65) or 2years (6.5% vs 7.8%, p=0.75). The incidences of stroke and heart failure rehospitalization were similar at 30days and 2years. The cumulative complication rates during hospitalization were significantly lower in the ViV-TAVR group than in the Redo-SAVR group (11.7% vs 28.6% p=0.015). The long-term outcomes of ViV-TAVR using new-generation valves were similar to those of Redo-SAVR, although ViV-TAVR was associated with lower rates of in-hospital complications.

Lipoprotein(a) is a new prognostic factor in patients with psoriasis and coronary artery disease: a retrospective cohort study

BackgroundThe prognostic value of lipoprotein (Lp) (a) in patients who have suffered from coronary artery disease (CAD) has not been fully studied, and the results are inconsistent. This study was conducted to evaluate whether increased Lp(a) concentrations cause differences in clinical adverse outcomes in patients with psoriasis who have already suffered from CAD.MethodsThis retrospective cohort study included consecutive patients with psoriasis and CAD between January 2017 and May 2022 in our hospital. The clinical records were collected, and comparisons were made between patients in the low Lp(a) and high Lp(a) groups. Cox proportional hazard analysis and log-rank tests were used to evaluate the association between variables.ResultsAmong 295 patients, 148 patients were in the low Lp(a) group, and 147 were in the high Lp(a) group. These two groups did not differ significantly in age, gender or body mass index. Compared with the low Lp(a) group, the levels of platelet counts (P = 0.038) and high sensitivity C reactive protein (P = 0.012) were higher in the high Lp(a) group. Patients in the high Lp(a) group had higher total cholesterol levels (P = 0.029) and lower triglyceride levels (P = 0.037). Among the whole cohort, clinical adverse events were not correlated with Lp(a) concentrations after a median follow-up of 3 years. However, in the subgroup analysis, there were significant differences in all-cause death (log rank P = 0.036) and rehospitalization (log rank P = 0.037) between the two groups in patients with diabetes; a difference in rehospitalization (log rank P = 0.042) was also found between the two groups in men.ConclusionsIn patients with psoriasis and CAD, high levels of Lp(a) were related to a poor prognosis, especially in patients with diabetes and in men. These results will provide valuable information for the risk stratification of patients with psoriasis and CAD.

Aspirin versus LMWH for VTE prophylaxis after orthopedic surgery.

Low molecular weight heparin (LMWH) is often used to prevent perioperative venous thrombosis after surgery, but aspirin is also recommended by academics. Studies were searched in electronic databases until February 24, 2023. We performed a meta-analysis to evaluate the safety and efficacy of aspirin and LMWH for venous thromboembolism (VTE) prophylaxis in patients after orthopedic surgery. The outcomes were death from any causes, deep vein thrombosis (DVT), pulmonary embolism (PE), etc. This study was registered with INPLASY, number 202320117. Six randomized controlled trials enrolled 13,851 patients with postoperative joint surgery. The risk of DVT was comparable between the two groups when aspirin was combined with mechanical devices (RR 0.61 [95% CI 0.27-1.39], I² = 62%, P = 0.24). No significant differences in all cause death, PE, wound infection, and wound complication were found between the aspirin and LMWH groups. In this meta-analysis, the mortality rate was comparable between the aspirin and LMWH groups. However, aspirin alone had a higher risk of DVT than LMWH. Based on the results of this meta-analysis, we suggest aspirin combined with mechanical devices for VTE prophylaxis in patients after orthopedic surgery.

Low-to-moderate dose statins improve the functional outcome of acute ischemic stroke with conventional medication treatment.

Low-to-moderate dose statins (LMDSs) are more commonly used among Asian acute ischemic stroke (AIS) patients in clinical practice. However, the correlation between the LMDS use and prognosis has not been evaluated in AIS patients with conventional medication treatment alone. This study aimed to investigate the influence of LMDS on the prognosis of AIS patients and how prognosis and potential prognostic factors interact with different statin doses. This retrospective cohort study included AIS patients who were admitted within 7 days after symptom onset and received conventional medication treatment alone from November 2019 to November 2020 in the Neurology, Department of West China Hospital, Sichuan University. From a total of 782 initial patients, a final cohort of 327 patients was included in the study. These patients were divided into three groups based on statin doses: non-statin (48 patients), LMDS (152 patients), and high-dose statin (HDS) (127 patients). The follow-up period was 3 months after the onset of stroke and the primary outcome was defined as a modified Rankin scale (mRS) score of 0 to 2 at 3 months, secondary outcomes were hemorrhagic transformation (HT) and death within 3 months. Stratified analysis was also conducted to test the robustness of the relationship between the use of different statin doses and functional outcomes in various subgroups. Compared with non-statin therapy, both LMDS therapy and HDS therapy were associated with good functional outcomes [odds ratio (OR) =3.68, 95% confidence interval (CI): 1.13-12.01, P=0.0309; OR =3.45, 95% CI: 1.06-11.26, P=0.0402, respectively] and a lower risk of HT (OR =0.30, 95% CI: 0.11-0.86, P=0.0253; OR =0.36, 95% CI: 0.13-0.99, P=0.0488, respectively). However, there was no significant difference in all-cause death within 3 months among the three groups (OR =0.84, 95% CI: 0.29-2.46, P=0.7468; OR =0.76, 95% CI: 0.26-2.22, P=0.6104). Additionally, no significant differences were observed between LMDS therapy and HDS therapy regarding good functional outcomes at 3 months (OR =0.94, 95% CI: 0.50-1.77, P=0.8411) and the occurrence of HT (OR =1.19, 95% CI: 0.47-3.02, P=0.7093). The results of the relationship between different statin doses and 3-month good functional outcome were consistent after interaction tests. Our findings provide evidence for the benefit and safety of LMDS therapy in AIS patients with medication treatment alone. LMDS therapy is associated with favorable impacts on 3-month functional outcomes and a reduced risk of HT compared to non-statin therapy. There were no significant differences in achieving 3-month good functional outcome, the risk of HT or death within 3 months were observed between LMDS and HDS therapy in our study. Further studies with prospective design and larger sample sizes are necessary to validate our results.

Oral Azvudine for hospitalised patients with COVID-19 and pre-existing conditions: a retrospective cohort study.

As the COVID-19 pandemic continues to spread, the number of associated deaths continues to increase, especially among those with pre-existing conditions. Azvudine is recommended as a priority treatment for patients with COVID-19, but its efficacy in patients with pre-existing conditions is unknown. This is a single-centre, retrospective cohort study between December 5, 2022 and January 31, 2023 in Xiangya Hospital of Central South University in China to evaluate the clinical efficacy of Azvudine in hospitalised patients with COVID-19 and pre-existing conditions. Patients with Azvudine and controls were propensity score-matched (1:1) for age, gender, vaccination status, time from symptom onset to treatment exposure, severity at admission, concomitant treatments initiated at admission. The primary outcome was a composite outcome of disease progression, and the secondary outcome was each of these individual disease progression outcomes. The univariate Cox regression model was used to estimate a hazard ratio (HR) with 95% confidence interval (CI) for each result between the groups. We identified 2118 hospitalised patients with COVID-19 during the study period, with a follow-up of up to 38 days. After exclusions and propensity score matching, we included 245 Azvudine recipients and 245 matched controls. Azvudine recipients had lower crude incidence rate of composite disease progression outcome compared with matched controls (7.125/1000 person-days vs. 16.004/1000 person-days, P=0.018). There was no significant difference in all-cause death between these two groups (1.934/1000 person-days vs. 4.128/1000 person-days, P=0.159). Azvudine treatment was associated with significantly lower risks of composite disease progression outcome compared with matched controls (HR: 0.49; 95% CI: 0.27-0.89, P=0.016). A significant difference in all-cause death was not found (HR: 0.45; 95% CI: 0.15-1.36, P=0.148). These findings indicate that Azvudine therapy showed substantial clinical benefits in hospitalised patients with COVID-19 and pre-existing conditions, and should be considered for this population of patients. This work was supported by the National Natural Science Foundation of China (Grant Nos. 82103183 to F. Z., 82102803, 82272849 to G. D.), National Natural Science Foundation of Hunan Province (Grant Nos. 2022JJ40767 to F. Z., 2021JJ40976 to G. D.), Huxiang Youth Talent Program (Grant Nos. 2022RC1014 to M.S.) and Ministry of Industry and Information Technology of China (Grant Nos. TC210804V to M.S.).

Clinical study on the classification of renal artery involvement and comparison of renal function and prognosis of Stanford type B aortic dissection after thoracic aortic endovascular repair

Objective: To investigate the different types of renal artery involvement in Stanford type B aortic dissection (TBAD) and the comparison of clinical effecacy after thoracic endovascular aortic repair (TEVAR). Methods: This is a retrospective cohort study included 330 patients with TBAD and renal artery involvement treated with TEVAR from June 2002 to September 2021 in General Hospital of Northern Theater Command of the PLA. According to aortic CTA image, unilateral renal artery involvement conditions were divided into 5 types: the true lumen type (renal artery opening completely from the true lumen), false lumen type (renal artery opening completely from the false lumen), double lumen type (renal artery opening from the true and false double lumen), compression type (renal artery opening connected with the true lumen, but the renal artery opening was extremely squeezed by the inner membrane), open type (renal artery opening with intimal tear). There were seven types of bilateral renal artery involvement: true-true type (true lumen-true lumen type), true and false type (true lumen-false lumen type), true-double type (true lumen-double lumen type), true-opening type (true lumen-opening type), false-false type (false lumen-false lumen type), false-compression type (false lumen-compression type), double-double type (double lumen-double lumen type). The primary observation index of this study was the comparison of postoperative renal function and the incidence of clinical adverse events of different types of renal artery involvement. One-way ANOVA test, Kruskal-Wallis H test and paired sample rank sum test were used to compare postoperative renal function between different types of bilateral renal artery involvement. The Chi-square test or Fisher's exact probability test were used to compare the near and long term adverse events between different types of bilateral renal artery involvement. Kaplan-Meier method was used to compare the all-cause mortality of patients with severe renal functional injury and non-severe renal functional injury before surgery. Results: The average age of the patients included in this study was (53±11) years, including 276 males (83.6%) and 54 females (16.4%). There were statistical difference in the level of serum creatinine (preoperative:H=18.686, P=0.005, postoperative:H=18.101, P=0.006) and cystatin C (preoperative:H=17.566, P=0.007, postoperative:H=10.433, P=0.016), pre-and post-operative, between the seven groups of TBAD patients with different renal artery involvement types (P<0.05), and the false-false type group shown the worst kidney function. However, no statistically significant differences were shown when comparing their pre- and post-operative change values (P>0.05). The 30-day follow-up result showed that there were statistically significant differences in the incidence of postoperative acute kidney injury (χ2=15.623, P=0.007), aorta-related adverse events (χ2=15.523, P=0.010), and intraoperative endoleak (χ2=17.935, P=0.004) among the seven groups, and the false-false group was the highest (2/9, 5/9 and 5/9, respectively). In terms of long-term follow-up results, there were statistically significant differences in all-cause death (χ2=14.772, P=0.011) and non-aortic death (χ2=15.589,P=0.008) among the seven groups. Kaplan-Meier survival analysis showed that patients with worse pre-operative renal function showed higher long-term all cause death (17.7% vs. 4.8%, P=0.009). Conclusions: For TBAD patients with renal artery involvement, there were differences in renal function among different types, and TEVAR showed no significant effect on renal function in TBAD patients. The long-term all cause death was higher in patients with worse renal function pre-operative.

Early Aortic Valve Replacement in Symptomatic Normal-Flow, Low-Gradient Severe Aortic Stenosis: A Propensity Score-Matched Retrospective Cohort Study.

Aortic valve replacement (AVR) is considered a class I indication for symptomatic severe aortic stenosis (AS). However, there is little evidence regarding the potential benefits of early AVR in symptomatic patients diagnosed with normal-flow, low-gradient (NFLG) severe AS. Two-hundred eighty-one patients diagnosed with symptomatic NFLG severe AS (stroke volume index ≥35 mL/m², mean transaortic pressure gradient <40 mmHg, peak transaortic velocity <4 m/s, and aortic valve area <1.0 cm²) between January 2010 and December 2020 were included in this retrospective study. After performing 1:1 propensity score matching, 121 patients aged 75.1±9.8 years (including 63 women) who underwent early AVR within 3 months after index echocardiography, were compared with 121 patients who received conservative care. The primary outcome was a composite of all-cause death and heart failure (HF) hospitalization. During a median follow-up of 21.9 months, 48 primary outcomes (18 in the early AVR group and 30 in the conservative care group) occurred. The early AVR group demonstrated a significantly lower incidence of primary outcomes (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.29-0.93; p=0.028); specifically, there was no significant difference in all-cause death (HR, 0.51; 95% CI, 0.23-1.16; p=0.110), although the early AVR group showed a significantly lower incidence of hospitalization for HF (HR, 0.43; 95% CI, 0.19-0.95, p=0.037). Subgroup analyses supported the main findings. An early AVR strategy may be beneficial in reducing the risk of a composite outcome of death or hospitalization for HF in symptomatic patients with NFLG severe AS. Future randomized studies are required to validate and confirm our findings.

Time Trends of Ventricular Reconstruction and Outcomes among Patients with Left Ventricular Thrombus and Aneurysms.

Background: Clinical guidelines recommend surgical intervention when left ventricular thrombus (LVT) is complicated with left ventricular aneurysm (LVA). Objectives: This study aimed to review the changes in the treatment of LVT combined with LVA over the past 12 years at our center and to compare the efficacy of medical therapy and surgical treatment on patient outcomes. Methods: Between January 2009 and June 2021, 723 patients with LVT combined with LVA were enrolled, of whom 205 received surgical ventricular reconstruction (SVR) therapy and 518 received medical therapy. The following clinical outcomes were gathered via observation: all-cause death, cardiovascular death, and major adverse cardiovascular and cerebrovascular events (MACCEs; defined as the composite of cardiovascular death, ischemic stroke, and acute myocardial infarction). The median follow-up time was 1403 [707, 2402] days. Results: The proportion of SVR dropped yearly in this group of patients, from a peak of 64.5% in 2010 to 7.5% in 2021 (p for trend < 0.001). Meanwhile, the proportion of anticoagulant use increased quickly, from 8.0% in 2016 to 67.9% in 2021 (p for trend < 0.001). The incidence rates of all-cause mortality, cardiovascular death, and MACCEs were 12.9% (n = 93), 10.5% (n = 76), and 14.7% (n = 106), respectively. In the multivariable analysis, there were no significant differences in all-cause death (HR of 0.60, 95% CI of 0.32−1.13, p = 0.11), cardiovascular death (HR of 0.79, 95% CI of 0.41−1.50, p = 0.5), and MACCEs (HR of 0.82, 95% CI of 0.49−1.38, p = 0.5) between the two groups. The competing risk regression performed in the propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) analyses was in line with the unmatched analysis. Conclusions: The rate of SVR dropped significantly among patients with both LVT and LVA, while there was an improvement in oral anticoagulant utilization. SVR with thrombus removal did not improve all-cause mortality and cardiovascular outcomes in patients with LVT and LVA. Ventricular aneurysm with thrombus may not be an indication for surgery.

ISCHEMIA-EXTEND studies: Rationale and design

The ISCHEMIA and the ISCHEMIA-CKD trials found no statistical difference in the primary clinical endpoint between initial invasive management and initial conservative management of patients with chronic coronary disease and moderate to severe ischemia on stress testing without or with advanced chronic kidney disease (CKD). In ISCHEMIA, there was numerically lower cardiovascular mortality but higher non-cardiovascular mortality with no significant difference in all-cause death with an initial invasive strategy when compared with a conservative strategy. However, an invasive strategy increased peri-procedural myocardial infarction (MI) but decreased spontaneous MI with continued separation of curves over time, which potentially may lead to reduced risk of cardiovascular and all-cause mortality. Thus, the long-term effect of invasive management strategy on mortality remains unclear. In ISCHEMIA-CKD, the treatment and cause-specific mortality rates were similar during follow-up. Funded by the National Heart, Lung, and Blood Institute, the ISCHEMIA-EXTEND observational study is the long-term follow-up of surviving participants (projected median of 10 years) with chronic coronary disease from the ISCHEMIA trial. In the ISCHEMIA trial, 5,179 participants with moderate or severe stress-induced ischemia were randomized to initial invasive management with angiography, revascularization when feasible, and guideline-directed medical therapy (GDMT), or initial conservative management with GDMT alone and angiography reserved for failure of medical therapy. ISCHEMIA-CKD EXTEND is the long-term follow-up of surviving participants (projected median of 9 years) from the ISCHEMIA-CKD trial, a companion trial that included 777 patients with advanced CKD. Ascertainment of death will be conducted via direct participant contact, medical record review, and/or vital status registry search. The overarching objective of long-term follow-up is to assess whether there are between-group differences in long-term all-cause, cardiovascular, and non-cardiovascular mortality, and increase precision around the treatment effect estimates for risk of all-cause, cardiovascular, and non-cardiovascular mortality. We will conduct Bayesian survival modeling to take advantage of rich inferences using the posterior distribution of the treatment effect. The long-term effect of an initial invasive versus conservative strategy on all-cause, cardiovascular, and non-cardiovascular mortality will be assessed. The findings of ISCHEMIA-EXTEND and ISCHEMIA-CKD EXTEND will inform patients, practitioners, practice guidelines, and health policy.

Anatomic and functional discordance among patients with non-obstructive coronary disease

Abstract Background Non-obstructive coronary artery disease (CAD) is associated with increased adverse cardiovascular (CV) events. However, it is unclear if functional stenosis, as assessed by FFRCT &amp;lt;0.80, further stratifies risk among patients with non-obstructive CAD and which factors contribute to this anatomic-functional discordance (stenosis &amp;lt;50% and FFRCT &amp;lt;0.80). Purpose We hypothesized that patients with anatomically non-obstructive CAD by CTA and an abnormal FFRCT value of ≤0.80 have a phenomenon termed anatomic-functional discordance, and this discordance would be associated with increased adverse outcomes. Methods Patients in the ADVANCE (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care) Registry who had exclusively non-obstructive CAD (anatomic stenosis &amp;lt;50%) were stratified by FFRCT &amp;gt;0.80 in all coronary vessels (concordant) vs. FFRCT &amp;lt;0.80 in at least one vessel (discordant). Baseline patient demographics, coronary computed tomography angiography findings, downstream testing and clinical outcomes were compared between groups. The primary composite endpoint included revascularization, CV hospitalization, heart failure, arrhythmia, non-fatal myocardial infarction, unplanned hospitalization for an acute coronary syndrome leading to urgent revascularization, and all-cause death. Results Among 1,261 patients with non-obstructive CAD, 543 (43.1%) had functional stenosis with FFRCT &amp;lt;0.80. Patients in the discordant group were older, more likely to have hypertension, hyperlipidemia, and had significantly higher indexed left ventricular (LV) mass and significantly lower coronary volume-to-mass ratios when compared with patients in the concordant group. Downstream non-invasive testing was more common among patients with discordance (35.9% vs 20.2%, p&amp;lt;0.0001) and more frequently resulted in a positive downstream test (10.3% vs. 3.3%, p&amp;lt;0.0001). Invasive angiography was also more common among patients with discordance (25.2% vs. 11.6%, p&amp;lt;0.0001). Anatomic-functional discordance was associated with higher rates of CV hospitalization and percutaneous coronary intervention (both p&amp;lt;0.0001), but no significant difference in all-cause death. After adjustment, anatomic-functional discordance was associated with a significantly higher risk of the composite endpoint (adjusted HR 2.79, 95% CI 1.67–4.65), Figure 1. As shown in Figure 2, the more vessels with anatomic-functional discordance, the higher the rate of adverse cardiac events. Conclusion Anatomic-functional discordance was present in nearly half of patients with exclusively non-obstructive CAD. The lower coronary volume: LV mass ratio may reflect abnormal coronary physiology at lower thresholds of anatomical stenosis among those with discordance. Compared to patients with concordance, patients with discordance had worse clinical outcomes suggesting that anatomic-functional discordance may stratify risk for adverse CV events among patients with non-obstructive CAD. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The analysis was an investigator-initiated analysis sponsored by Heart Flow.

Comparison on the prognosis of severe aortic stenosis patients treated with transcatheter aortic valve replacement versus surgical aortic valve replacement: a systematic review and meta-analysis

Objective: To systematically review the prognosis of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. Methods: A systematic search of PubMed, EMBASE, Scopus, Cochrane Library, China biomedical literature database, China journal full text database (CNKI), Wanfang database and VIP database from January 2012 to February 2022 was conducted for randomized controlled trial (RCT) that comparing TAVR and SAVR in the treatment of severe aortic stenosis. The primary outcomes were the incidence of all-cause mortality, stroke incidence, reoperation rate and complications (pacemaker implantation, atrial fibrillation) at 1 month and 1, 2, 5 years after operation. Jadad scale was used to evaluate the literature quality of RCTs. All statistical analyses were performed using the standard statistical procedures provided in RevMan 5.4.1. Results: A total of 17 studies including 11 712 patients were identified, including 6 007 patients treated with TAVR and 5 705 patients treated with SAVR. There were 4 high-quality studies and 13 medium-quality studies. The results of meta-analysis showed that the rate of new onset atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.28, 95%CI 0.21-0.38, P<0.001), and there was no significant difference in all-cause death, stroke, pacemaker implantation and reoperation rate (all P>0.05) at 30 days follow-up. At one year after TAVR and SAVR treatment, all-cause mortality (RR=0.85, 95%CI 0.74-0.97, P=0.01) and new onset atrial fibrillation (RR=0.28, 95%CI 0.20-0.39, P<0.001) were lower in TAVR group than SAVR group. However, the pacemaker implantation rate was higher in TAVR group than that of SAVR group (RR=1.79, 95%CI 1.11-2.89, P=0.02), while there was no significant difference in the incidence of stroke and reoperation between the two groups (P>0.05). At two years after TAVR and SAVR treatment, the pacemaker implantation rate was higher in TAVR group than that in SAVR group (RR=2.23, 95%CI 1.28-3.86, P=0.004), and the rate of new atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.46, 95%CI 0.38-0.56, P<0.001). There was no significant difference in all-cause death, stroke and reoperation rates between the two groups (P>0.05). At five years after TAVR and SAVR treatment, the pacemaker implantation rate (RR=1.89, 95%CI 1.13-3.17, P=0.02) and reoperation rate (RR=3.64, 95%CI 1.75-7.58, P=0.000 5) were higher in TAVR group than those in SAVR group, while the rate of new onset atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.45, 95%CI 0.37-0.55, P<0.001). There was no significant difference in all-cause death and stroke incidence between the two groups (all P>0.05). Conclusions: The all-cause mortality and the incidence of new onset atrial fibrillation after TAVR are lower than SAVR, and TAVR is a preferred therapy for patients with aortic stenosis.

Toripalimab (anti-PD-1) versus high-dose interferon-α2b as adjuvant therapy in resected mucosal melanoma: a phase II randomized trial

No standard of care for mucosal melanoma (MM) in the adjuvant setting has been established. Meanwhile, relapse-free survival (RFS) is only ∼5 months after surgery alone. This phase II trial aimed to compare toripalimab versus high-dose interferon-α2b (HDI) as an adjuvant therapy for resected MM. From July 2017 to May 2019, 145 patients with resected MM were randomized (1 : 1) to receive HDI (n= 72) or toripalimab (n= 73) for 1 year until disease relapse/distant metastasis, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS. The secondary endpoints included distant metastasis-free survival (DMFS), overall survival (OS), and safety. After a median follow-up of 26.3 months, the number of RFS, OS, and DMFS events was 51 versus 46, 33 versus 29, and 49 versus 44 in the toripalimab arm and the HDI arm, respectively. The median RFS was 13.6 [95% confidence interval (CI) 8.31-19.02] months and 13.9 (95% CI 8.28-19.61) months in the toripalimab arm and the HDI arm, respectively. The DMFS was not significantly different between the two arms [hazard ratio (HR) 1.00; 95% CI 0.65-1.54]. The median OS was 35.1 months (95% CI 27.93 months-not reached) in the toripalimab arm, with no significant difference in all-cause death (HR 1.11, 95% CI 0.66-1.84) for the two arms. The median sums of the patients' actual infusion doses were 3672 mg and 1054.5 MIU in the toripalimab arm and the HDI arm, respectively. The incidence of treatment-emergent adverse events with a grade ≥3 was much higher in the HDI arm than in the toripalimab arm (87.5% versus 27.4%). Toripalimab showed a similar RFS and a more favorable safety profile than HDI, both better than historical data, suggesting that toripalimab might be the better treatment option. However, additional translational studies and better treatment regimens are still warranted to improve the clinical outcome of MM.

Long-Term Beta-Blocker Therapy in Patients With Stable Coronary Artery Disease After Percutaneous Coronary Intervention.

BackgroundIt is unclear whether beta-blocker treatment is advantageous in patients with stable coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). We evaluated the clinical impact of long-term beta-blocker maintenance in patients with stable CAD after PCI with drug-eluting stent (DES).MethodsFrom a nationwide cohort database, we identified the stable CAD patients without current or prior history of myocardial infarction or heart failure who underwent DES implantation. An intention-to-treat principle was used to analyze the impact of beta-blocker treatment on long-term outcomes of major adverse cardiovascular events (MACE) composed of cardiovascular death, myocardial infarction, and hospitalization with heart failure.ResultsAfter stabilized inverse probability of treatment weighting, a total of 78,380 patients with stable CAD was enrolled; 45,746 patients with and 32,634 without beta-blocker treatment. At 5 years after PCI with a 6-month quarantine period, the adjusted incidence of MACE was significantly higher in patients treated with beta-blockers [10.0 vs. 9.1%; hazard ratio (HR) 1.11, 95% CI 1.06–1.16, p < 0.001] in an intention-to-treat analysis. There was no significant difference in all-cause death between patients treated with and without beta-blockers (8.1 vs. 8.2%; HR 0.99, 95% CI 0.94–1.04, p = 0.62). Statistical analysis with a time-varying Cox regression and rank-preserving structure failure time model revealed similar results to the intention-to-treat analysis.ConclusionsAmong patients with stable CAD undergoing DES implantation, long-term maintenance with beta-blocker treatment might not be associated with clinical outcome improvement.Trial RegistrationClinicalTrial.gov (NCT04715594).

Low Parathyroid Hormone Versus Secondary Hyperparathyroidism and Survival in Patients Undergoing Hemodialysis: A Propensity-Matched Analysis.

IntroductionLow serum parathyroid hormone (PTH) and secondary hyperparathyroidism (SHPT) are very common in patients undergoing hemodialysis. However, it remains unclear which of these has a lower mortality.ObjectiveIn this study, we compared outcomes between hemodialysis patients with low PTH and those with SHPT.MethodsThis was a multi-center, retrospective, matched cohort study. Median intact PTH (iPTH) was used as the cutoff for allocating participants to low PTH (iPTH<100 pg/mL) and SHPT groups (iPTH ≥600 pg/mL). Sex, diabetes, age, and dialysis vintage were matched between the groups. The primary outcome was all-cause death at 72 months.ResultsThe study cohort comprised 2282 patients (1166 in each study group). Prior to matching, the primary outcome occurred in 429/1166 patients (36.79%) in the low PTH group and in 284/1116 (25.45%) in the SHPT group. There were no significant differences in all-cause death between the groups according to multivariable Cox regression (P=0.423). The hazard ratio for low PTH versus SHPT was 1.08 (95% confidence interval, 0.90–1.30). Propensity matching created 619 pairs of patients. Baseline characteristics, including age, sex, diabetes, and dialysis vintage were comparable between the groups. The primary outcome occurred in 195/619 patients (31.50%) in the low PTH group and in 193/619 (31.18%) in the SHPT group. There were no significant differences in all-cause death between the groups according to multivariable Cox regression (P=0.43). The adjusted hazard ratio for low PTH versus SHPT was 1.10 (95% confidence interval, 0.87–1.39).ConclusionsHemodialysis patients with low PTH have similar all-cause death rates to the rates for those with SHPT.