A novel esophageal retractor with eccentric balloon during atrial fibrillation ablation.

BACKGROUND: Due to the anatomically adjacent relationship between the left atrium (LA) and esophagus, energy delivery on the posterior wall of LA is limited. The aim of this study was to evaluate the feasibility of a novel esophageal retractor (SAFER) with an inflatable C-curve balloon during atrial fibrillation (AF) ablation. METHOD: Nine patients underwent AF ablation assisted with the SAFER. After inflation, the esophagus was deviated laterally away from the intended ablation site of the posterior wall under local anesthesia. The extent of mechanical esophageal deviation (MED) was evaluated under fluoroscopy, defined as the shortest distance from the trailing esophageal edge to the closest point of the ablation line. Gastroscopy was performed before and after ablation. The target ablation index used in all LA sites including the posterior wall was 400-450 after effective MED. All adverse events during the periprocedural period were recorded. RESULTS: The mean deviation distance achieved 16.2 ± 9.6 mm away from the closest ablation point of the pulmonary vein lesion set. With respect to the individual left and right pulmonary vein lesion sets, the deviation distance was 19.7 ± 11.5 and 12.7 ± 6.8 mm, respectively. The extent of deviation was 0 to 5 mm, 5.1 to 10 mm, or >10 mm in 0(0%), 7(38.9%), and 11(61.1%), respectively. Procedural success was achieved in all patients without acute reconnection. There was only one esophageal complication which manifested as esophageal erosion and this patient experienced throat pain possibly related to the SAFER retractor with no clinical sequelae. CONCLUSION: Esophageal deviation with the novel eccentric balloon is a novel feasible choice during AF ablation, enabling adequate energy delivery to the posterior wall of LA. Additional prospective randomized controlled studies are required for further validation.

Risk Factors for Left Ventricular Thrombus Formation in Patients with Dilated Cardiomyopathy.

BACKGROUND: Left ventricular thrombus (LVT) is a common complication of dilated cardiomyopathy (DCM), causing morbidity and mortality. METHODS: This study retrospectively analyzed patients with DCM from January 2002 to August 2020 in Beijing Anzhen Hospital. Clinical characteristics were compared between the LVT group and the age and sex 1:4 matched with the LVT absent group. The receiver operator characteristic (ROC) curve was plotted to evaluate the diagnostic value of D-dimer predicting LVT occurrence in DCM. RESULTS: A total of 3,134 patients were screened, and LVT was detected in 72 (2.3%) patients on echocardiography. The patients with LVT had higher D-dimer, fibrinogen, and lower systolic blood pressure than those without LVT. The ejection fraction (EF) was lower and left ventricular end-systolic diameter was larger in the LVT group. Severe mitral regurgitation (MR) was more common in the LVT absent groups. The prevalence of atrial fibrillation was lower in the LVT group. The ROC curve analysis yielded an optimal cut-off value of 444 ng/mL DDU (D-dimer units) for D-dimer to predict the presence of LVT. Multivariable binary logistic regression analysis revealed that EF (OR = 0.90, 95% CI = 0.86-0.95), severe MR (OR = 0.19, 95% CI = 0.08-0.48), and D-dimer level (OR = 15.4, 95% CI = 7.58-31.4) were independently associated with LVT formation. CONCLUSION: This study suggested that elevated D-dimer levels (>444 ng/mL DDU) and reduced EF were independently associated with increased risk of LVT formation. Severe MR could decrease the incidence of LVT.

Antithrombotic strategy and its relationship with outcomes in patients with atrial fibrillation and chronic coronary syndrome.

This study aimed to explore antithrombotic strategy and its relationship with outcomes in patients with atrial fibrillation (AF) at high risk for stroke and chronic coronary syndrome (CCS) in real-world clinical practice. Patients with AF at high risk for stroke complicated with CCS from China Atrial Fibrillation Registry (CAFR) were enrolled. The patients were divided into non-antithrombotic (Non-AT) group, oral anticoagulants (OAC) group, antiplatelet therapy (APT) group (aspirin or clopidogrel), and dual antiplatelet therapy (DAPT) group (aspirin + clopidogrel) according to their antithrombotic strategies at baseline. The patients with OAC + single antiplatelet drug (14 cases) and OAC + dual antiplatelet therapy (7 cases) were excluded for the small sample size. The primary effectiveness outcome was the composite outcome of coronary events, thromboembolism, and all-cause mortality. The primary safety outcome was major bleeding events. From 2011 to 2018, 25,512 patients were included in the CARF study, 769 patients with AF at high risk for stroke and CCS were enrolled in this study. After a follow-up of 47.4 ± 25.3 months, the incidences of primary effectiveness outcome were 44.6%, 25.7%, 43.6%, and 29.1% in the four groups, respectively (P < 0.001). The incidences of primary effectiveness and all-cause mortality were both significantly lower in the OAC group than in the Non-AT group, (25.7% vs. 44.6%, HR 0.53, 95% CI 0.39-0.73, P < 0.001) and (14.6% vs. 38.5%, HR 0.36, 95%CI 0.25-0.52, P < 0.001). In multivariate analysis, age (HR 1.03, 95%CI 1.01-1.05, P = 0.015), heart failure (HR 1.67, 95%CI 1.20-2.33, P = 0.002) and OAC (HR 0.66, 95%CI 0.47-0.91, P = 0.012) were independent factors for the composite outcome. There was no significant difference in major bleeding events between the four groups. OAC monotherapy significantly reduced the primary effectiveness composite outcome and all-cause mortality in the patients with AF at high risk for stroke complicated with CCS. However, there was no significant difference in major bleeding among the different antithrombotic strategies.Trial Registration www.chictr.org.cn (No. ChiCTR-OCH-13003729).

Chronic kidney disease and risks of adverse clinical events in patients with atrial fibrillation.

BACKGROUND: Chronic kidney disease (CKD) is highly prevalent in patients with atrial fibrillation (AF). However, the association between CKD and clinical consequences in AF patients is still under debate. METHODS: We included 19,079 nonvalvular AF patients with available estimated glomerular filtration rate (eGFR) values in the Chinese Atrial Fibrillation Registry from 2011 to 2018. Patients were classified into no CKD (eGFR ≥ 90 mL/min per 1.73 m2), mild CKD (60 ≤ eGFR < 90 mL/min per 1.73 m 2), moderate CKD (30 ≤ eGFR < 60 mL/min per 1.73 m 2), and severe CKD (eGFR < 30 mL/min per 1.73 m 2) groups. The risks of thromboembolism, major bleeding, and cardiovascular mortality were estimated with Fine-Gray regression analysis according to CKD status. Cox regression was performed to assess the risk of all-cause mortality associated with CKD. RESULTS: Over a mean follow-up of 4.1 ± 1.9 years, there were 985 thromboembolic events, 414 major bleeding events, 956 cardiovascular deaths, and 1,786 all-cause deaths. After multivariate adjustment, CKD was not an independent risk factor of thromboembolic events. As compared to patients with no CKD, those with mild CKD, moderate CKD, and severe CKD had a 45%, 47%, and 133% higher risk of major bleeding, respectively. There was a graded increased risk of cardiovascular mortality associated with CKD status compared with no CKD group: adjusted hazard ratio [HR] was 1.34 (95% CI: 1.07-1.68,P = 0.011) for mild CKD group, 2.17 (95% CI: 1.67-2.81,P < 0.0001) for moderate CKD group, and 2.95 (95% CI: 1.97-4.41, P < 0.0001) for severe CKD group, respectively. Risk of all-cause mortality also increased among patients with moderate or severe CKD. CONCLUSIONS: CKD status was independently associated with progressively higher risks of major bleeding and mortality, but didn't seem to be an independent predictor of thromboembolism in AF patients.

Comparison of prognosis and outcomes of catheter ablation versus drug therapy in patients with atrial fibrillation and stable coronary artery disease: A prospective propensity-score matched cohort study.

BACKGROUND: Atrial fibrillation (AF) and stable coronary artery disease (SCAD) frequently coexist. HYPOTHESIS: To investigate the prognosis of catheter ablation versus drug therapy in patients with AF and SCAD. METHODS: In total, 25 512 patients with AF in the Chinese AF Registry between 2011 and 2019 were screened for SCAD. 815 patients with AF and SCAD underwent catheter ablation therapy were matched with patients by drug therapy in a 1:1 ratio. Primary end point was composite of thromboembolism, coronary events, major bleeding, and all-cause death. The secondary endpoints were each component of the primary endpoint and AF recurrence. RESULTS: Over a median follow-up of 45 ± 23 months, the patients in the catheter ablation group had a higher AF recurrence-free rate (53.50% vs. 18.41%, p < .01). In multivariate analysis, there was no significant difference between the strategy of catheter ablation and drug therapy in primary composite end point (adjusted HR 074, 95%CI 0.54-1.002, p = .0519). However, catheter ablation was associated with fewer all-cause death independently (adjusted HR 0.36, 95%CI 0.22-0.59, p < .01). In subgroup analysis, catheter ablation was an independent risk factor for all-cause death in the high-stroke risk group (adjusted HR 0.39, 95%CI 0.23-0.64, p < .01), not in the low-medium risk group (adjusted HR 0.17, 95%CI 0.01-2.04, p = .17). CONCLUSIONS: In the patients with AF and SCAD, catheter ablation was not independently associated with the primary composite endpoint compared with drug therapy. However, catheter ablation was an independent protective factor of all-cause death.

[Impact of diabetes on clinical outcomes following multivessel percutaneous interventions].

OBJECTIVE: To compare the rates of mortality, myocardial infarction (MI), repeat revascularization and stent thrombosis after percutaneous coronary intervention (PCI) with implantation of stents for diabetics versus nondiabetics with multivessel disease to evaluate the impact of diabetes on long-term clinical outcomes. METHODS: We consecutively recruited a total of 1985 patients with multivessel disease at our institution from July 2003 to December 2005. And they were divided into two groups of diabetes (n = 587) or non-diabetes (n = 1398). The primary endpoint was all-cause mortality at 24 months. RESULTS: After adjusting with Logistic regression, the risk of mortality in the diabetics was significantly higher than that in the nondiabetics (4.4% vs 2.0%, hazard ratio [HR] 1.83, 95% confidence interval [CI] 1.02 to 3.67, P = 0.021). Similar outcome was also found in the adjusted risk of cardiac mortality (2.7% vs 1.1%, HR = 2.04, 95%CI 1.12 to 3.89, P = 0.032) at 24 months, although the adjusted risk of nonfatal MI and repeat revascularization was similar. However, diabetes significantly increased the risk of stent thrombosis. The major adverse cardiac event (MACE) rate was also lower in the nondiabetics (15.8% vs 11.9%, HR = 1.52, 95%CI 1.12 to 1.89, P = 0.043). CONCLUSION: In patients with multivessel disease, diabetes is correlated with increase risks of mortality, stent thrombosis and MACE at long-term follow-up compared with non-diabetes.

[Effects of chronic renal insufficiency and anemia upon long-term outcomes in patients undergoing percutaneous coronary intervention].

OBJECTIVE: To assess whether chronic renal insufficiency and anemia are significant independent and combined predictors of poor long-term outcomes after percutaneous coronary intervention (PCI). METHODS: We examined the clinical and outcome data of 3770 PCI patients based on the pre-PCI values of glomerular filtration rate (GFR) and hemoglobin (Hb). Depending on their baseline GFR and Hb, the patients were classified into six groups: normal renal function with anemia or not; mild renal impairment with combined anemia or not; severe renal insufficiency with anemia or not. The clinical features and prognosis of patients were compared. RESULTS: Significant differences were found between the groups regarding female gender, age, body mass index, prior history of hypertension, diabetes mellitus, prior stroke, acute coronary syndrome, systolic blood pressure, left ventricular ejection fraction, total serum cholesterol, LDL-C and angiographic features (P < 0. 01). When evaluated as continuous variables, GFR and Hb were independent predictors of long-term mortality after adjusting for effects of each other (GFR: HR 0.979, 95% CI 0.960-0.999, P = 0.035; Hemoglobin: HR 0.952, 95% CI 0.921-0.984, P = 0.004). Mild renal insufficiency with anemia (HR 4.123, 95% CI 1.637-10.386, P = 0.003), severe renal insufficiency without anemia (HR 5.287, 95% CI 1.627-17.183, P = 0. 006) and severe renal insufficiency with anemia (HR 7.134, 95% CI 2.180-23.342, P = 0.001) having a statistically significant decrease in survival in patients undergoing PCI . CONCLUSION: Renal insufficiency and anemia are significant independent and combined predictors of long-term mortality in patients undergoing PCI.

[Impact of drug-eluting stents on transferring treatment with coronary surgical revascularization among patients initially admitted to department of internal medicine].

OBJECTIVE: To evaluate the impact of drug-eluting stent (DES) on transferring treatment with coronary surgical revascularization among the patients initially admitted to department of internal medicine. METHODS: 2598 patients initially admitted in department of internal medicine underwent revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) before the introduction of DES from 1 July 2001 to 30 June 2002 [bare metal stent (BMS) era group, n = 923) or after the introduction of DES from 1 July 2003 to 30 June 2004 (DES era group). The clinical manifestations and coronary angiography characteristics were analyzed retrospectively. RESULTS: In the DES era group 1333 patients (80.1%) were revascularized with PCI, and 331 patients (19.9%) were transferred to treatment with CABG; and in the BMS era group, 721 patients (77.2%) underwent PCI, and 213 patients (22.8%) were transferred to treatment with CABG. The rate of transference to CABG of the DES era group was lower by 12.7% compared with the BMS era group. The rates of left main coronary disease, proximal left anterior descending coronary stenosis and diffuse long lesions among the patients revascularized with PCI in the DES era group were 3.2%, 44.2%, and 19.7% respectively, all significantly higher than those in the BMS era group (1.4%, 39.8%, and 11.2%, P = 0.025, P = 0.047, and = 0.021 respectively). But no matter if DES was implanted or not, left main coronary disease, proximal left anterior descending coronary stenosis, diffuse long lesions and ostial lesions were the most common coronary lesions in the patients revascularized with CABG. Logistic regression showed that number of diseased vessels, left main coronary disease, chronic total occlusion lesions, and proximal left anterior descending coronary stenosis were independent predictor for transferring treatment with CABG (all P < 0.0001). CONCLUSION: DES has a certain impact on the coronary revascularization strategies, because the rate of in-stent restenosis and repeat revascularization are lower significantly after implantation of DES than after implantation of BMS. Many coronary lesions that should undergo CABG in non-DES era may be revascularized with PCI and implantation of DES.

[Safety and efficacy comparison of myocardial contrast enhancement-guided and angio-pressure-guided transcoronary ablation of septal hypertrophy for patients with hypertrophic obstructive cardiomyopathy].

OBJECTIVE: To compare the safety and efficacy of myocardial contrast enhancement (MCE)-guided and angio-pressure (AP)-guided transcoronary ablation of septal hypertrophy (TASH) for patients with hypertrophic obstructive cardiomyopathy (HOCM). METHODS: TASH was performed under MCE-guide (n = 47, group I) or AP-guide (n = 25, group II) for drug-refractory patients with HOCM. Myocardial perfusion imaging (MPI) data as well as other clinical data were compared. RESULTS: TASH both under MCE-guide or AP-guide resulted in similar and significant reduction of left ventricular outflow tract gradient (PG) and associated with significant symptom improvement (all P < 0.001). Dosage of ethanol use, peak-level of CK-MB and ablated myocardial area and incidence of arrhythmia were also similar between the two groups.Similar left ventricular/atrial dimension changes post TASH were observed in the 2 groups during follow-up. However, the first selected septal vessels were changed under MCE in 6 patients. CONCLUSIONS: Our data demonstrated that the MCE-guided TASH was not superior to AP-guided TASH in safety and efficacy. However, MCE-guided TASH can avoid the misplace of ethanol to avoid innocent myocardial ablation.

Prevalence and impact of renal insufficiency on clinical outcomes of patients undergoing coronary revascularization.

BACKGROUND: Patients with renal insufficiency are more likely to die after coronary revascularization, but mild renal insufficiency is neglected and little is known about its clinical effects. METHODS AND RESULTS: In the present study 3,025 patients grouped by estimated creatinine clearance (CrCl) were analyzed to evaluate the association between CrCl and clinical outcome. The mean serum creatinine was 1.0+/-0.4 mg/dl, with 4.3% above normal; in 65.8% CrCl was <90 ml/min. During hospitalization, there were significant differences in mortality among the groups stratified by CrCl (p<0.0001). During follow-up after hospital discharge, there were significant differences in mortality (p<0.0001), new-onset myocardial infarction (p=0.007), and stroke (p=0.032). In patients with severe renal insufficiency, the in-hospital and follow-up mortality reached 15.4% and 31.3%, respectively. The independent risk factors for all-cause death after revascularization were the mode of revascularization, age and the CrCl level. In patients with mild renal insufficiency or normal renal function, the all-cause mortality after percutaneous coronary intervention was significantly lower than that after CABG. CONCLUSIONS: Renal insufficiency is not rare in patients undergoing coronary revascularization and in the present study even mild renal insufficiency correlated with adverse clinical outcomes after revascularization. In patients with normal renal function or mild renal insufficiency, the mode of revascularization might lead to a prognostic difference.

[Prognosis of metabolic syndrome in coronary artery disease patients of different genders].

OBJECTIVE: To analyze the prevalence and characteristics of metabolic syndrome (MS) in the patients with coronary artery disease (CAD) of different genders who underwent revascularization. METHODS: The clinical data of 2596 patients in the DESIRE (Drug-eluting Stent Impact on Revascularization) study who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were analyzed and the patients were followed up till death. MS was diagnosed based on the Chinese standard (modified ATP III). RESULTS: The mean follow-up time was 828.8 +/- 373.2 days. 1139 of the 2596 patients were diagnosed as with MS. The prevalence of MS in the female patients was 50.9%, significantly higher than that in the male patients (41.8%, P < 0.0001). Complication of MS was the only predictive factor of poor prognosis in female CAD patients (OR = 2.019, 95% CI = 1.751 - 2.506, P = 0.023). Fasting blood glucose >or= 110 mg/dl was responsible for most of the increased risk associated with MS (adjusted OR 2.511, 95% CI 1.396 approximately 4.511, P = 0.002). CONCLUSION: In comparison with the male patients the female patients undergoing revascularization have a higher he prevalence of MS and worse prognosis. In the 4 elements of MS hyperglycemia is directly associated with prognosis.

Effect of metabolic syndrome on prognosis and clinical characteristics of revascularization in patients with coronary artery disease.

BACKGROUND: People with metabolic syndrome are at higher risk for developing coronary artery disease (CAD). The effect of the metabolic syndrome on outcomes in patients with preexisting CAD has not been well studied. This study was conducted to assess the prevalence, characteristics, in hospital and long term prognosis of CAD with metabolic syndrome and to determine the factors influencing the prognosis of the disease. METHODS: The DESIRE registry contains data of 3696 patients with CAD between 2001 and 2004. Mean long term followup was (829 +/- 373) days. Diagnosis of metabolic syndrome was based on modified International Diabetes Federation (IDF) Worldwide Definition of the Metabolic Syndrome, using body mass index (BMI) instead of waist circumference. RESULTS: Of 2596 patients with complete records of height, weight, and so on, 1280 (49.3%) were identified with metabolic syndrome. The patients with metabolic syndrome had higher level of body mass index, systolic blood pressure, diastolic blood pressure, fasting glucose and disordered blood lipid (all P < 0.0001), with higher creatinine [(10.5 +/- 4.3) mg/L vs (9.9 +/- 2.9) mg/L, P < 0.0001] and the number of white blood cells [(7.49 +/- 2.86) x 10(9)/L vs (7.19 +/- 2.62) x 10(9)/L, P = 0.008) compared with those without metabolic syndrome. The patients with metabolic syndrome showed severer coronary angiographic alterations (left main artery and/or > or = 2-vessel) (73.6% vs 69.6%, P = 0.031). There were no significant differences of major adverse cardiac and cerebral events (MACCE) or mortality in hospital between the two groups. During followup, the ratio of MACCE in CAD with metabolic syndrome patients increased significantly (11.8% vs 10.0%, P = 0.044). Fasting blood glucose (> or = 1000 mg/L) and triglyceride (TG, > or = 1500 mg/L) were responsible for most of the increased risk associated with the metabolic syndrome (adjusted OR 1.465, 95% CI 1.037 - 1.874, P = 0.032; OR 1.378, 95% CI 1.014 - 1.768, P = 0.044). CONCLUSIONS: The prevalence of metabolic syndrome was very high in CAD patients. The metabolic syndrome confers a higher risk of long term MACCE in patients with CAD, and dysglycaemia and hypertriglycaemia appear to be responsible for most of the associated risk.

[Influence of initial admission department for coronary arteriography on choice of mode of coronary revascularization].

OBJECTIVE: To investigate the influence of initial admission department for coronary arteriography on the choice of mode of coronary revascularization. METHODS: From October 2003 to June 2004 2156 patients with coronary heart disease were admitted into the department of internal medicine (1667 cases) or department of surgery (489 cases) to undergo coronary arteriography (CAG) and coronary revascularization. The influence of the initial admission departments on the choice of mode of coronary revascularization for the patients with different clinical manifestations and angiographic characteristics, including one-vessel disease, two-vessel disease, three-vessel disease, and multi-vessel disease of different types was analyzed. RESULTS: 1336 (80.1), 326 (19.6%), and 5 (0.3%) of the 1667 patients initially admitted to the department of internal medicine, received percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), and CABG + PCI respectively with a complete revascularization rate of 63.3%. 52 (10.6%) and 437 (89.4%) of the 489 patients initially admitted to the department of surgery received PCI and CABG respectively with a complete revascularization rate of 75.5%. The CABG rates for the patients different types of lesion were all significantly higher in the patients initially admitted to the department of surgery than in the patients initially admitted in the department of internal medicine (all P < 0.05). The in-hospital death rate, new-onset myocardial infarction rate, and main adverse cardio-cerebral event rate of the patients admitted into the department of surgery were 3.9%, 1.8%, and 5.7% respectively, all significantly higher than those of the patients initially admitted in the department of internal medicine (1.2%, 0.5%, and 1.5% respectively, all P < 0.01). Logistic regression showed that initial admission into department of surgery, number of diseased vessels, left main trunk disease, proximal descending anterior branch disease, and chronic total occlusion rate were independent predictor for choice of CABG (all P < 0.01). CONCLUSION: Cardiologists are more likely to choose PCI and cardiac surgeons are more likely to choose CABG. It is imperative to collect more evidence-based data so as to develop guidelines for the choice of reasonable mode of revascularization.