刘圣文
阜外医院心内科
The Dissolve drug-coated balloons (DCBs) is a new-generation DCB coated with paclitaxel of balloon surface, with midchain triglyceride excipient. Although the use of DCBs is a promising technique, little is known about the the clinical efficacy of the novel Dissolve DCB in coronary small vessel disease. This study was a prospective, randomized, multicenter, noninferiority trial comparing the Dissolve DCB with the Resolute drug-eluting stent (DES) in patients with a reference vessel diameter ≥2.25 and ≤2.75 mm. Patients with a reference vessel diameter ≥2.00 and <2.25 mm were enrolled in the very small vessel registry. The angiographic and clinical follow-up were planned at 9 months and 1 year in all patients, respectively. The primary end point was 9-month in-segment percentage diameter stenosis. A total of 247 patients with small vessel disease from 10 Chinese sites were included (Dissolve DCB, n = 118; Resolute DES, n = 129); 30 patients were treated with the DCB in the very small vessel cohort. The 9-month in-segment percentage diameter stenosis was 31.2 ± 2.0% with Dissolve DCB versus 26.1 ± 2.1% with Resolute DES; the 1-sided 97.5% upper confidence limit of the difference was 10.3% (p for noninferiority = 0.0002). At 12 months, the DCB and DES groups were associated with similar rates of target lesion failure (8.5% vs 6.1%, p = 0.28) and major adverse cardiac and cerebrovascular events (20.9% vs 13.6%, p = 0.12). In conclusion, the Dissolve DCB was noninferior to the Resolute DES for the primary end point of 9-month in-segment percentage diameter stenosis in this multicenter, head-to-head, randomized trial (a safety and efficacy study of Dissolve In Treatment Of Coronary Small Vessel Disease; NCT03376646).
The American journal of cardiology 2024
BACKGROUND:The hybrid strategy of a combination of drug-eluting stent (DES) and drug-coated balloon (DCB) is promising for the treatment of de novo diffuse coronary artery disease (CAD).HYPOTHESIS:To investigate the efficacy and functional results of hybrid strategy.METHODS:This case series study included patients treated with a hybrid approach for de novo diffuse CAD between February 2017 and November 2021. Postprocedural quantitative flow ratio (QFR) was used to evaluate the functional results. The primary endpoint was procedural success rate. The secondary endpoints were major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) (including peri-procedural MI), and target vessel revascularization.RESULTS:A total of 109 patients with 114 lesions were treated. DES and DCB were commonly used in larger proximal segments and smaller distal segments, respectively. The mean QFR value was 0.9 ± 0.1 and 105 patients (96.3%) had values >0.8 in all the treated vessels. Procedural success was achieved in 106 (97.2%) patients. No cases of cardiac death were reported at a median follow-up of 19 months. Spontaneous MI occurred in three (2.8%) patients and target vessel revascularization in six (5.5%) patients. Estimated 2-year rate of MACE excluding peri-procedural MI was higher in the group with lower QFR value (12.1 ± 5.7% vs. 5.6 ± 4.4%, log-rank p = .035) (cut-off value 0.9).CONCLUSION:Hybrid strategy is a promising approach for the treatment of de novo diffuse CAD. Postprocedural QFR has some implications for prognosis and may be helpful in guiding this approach.
Clinical cardiology 2023
BACKGROUND:Although use of drug-coated balloons (DCB) is a promising technique, little is known about the clinical efficacy of the Dissolve DCB in drug-eluting stent (DES) in-stent restenosis (ISR).OBJECTIVES:This study sought to evaluate the efficacy and safety of the Dissolve DCB in patients with DES ISR.METHODS:This was a prospective, multicenter, randomized, noninferiority trial comparing Dissolve DCB with SeQuent Please DCB in patients with DES ISR. Angiographic and clinical follow-up was planned at 9 months in all patients. The primary endpoint was 9-month in-segment late loss.RESULTS:A total of 260 patients with ISR from 10 Chinese sites were included (Dissolve DCB, n = 128; SeQuent Please DCB, n = 132). Nine-month in-segment late loss was 0.50 ± 0.06 mm with Dissolve DCB vs 0.47 ± 0.07 mm with SeQuent Please DCB; the 1-sided 97.5% upper confidence limit of the difference was 0.18 mm (P for noninferiority = 0.03). Rates of target lesion failure and binary restenosis were numerical higher in the Dissolve DCB cohort compared with the SeQuent Please DCB cohort at 9 months (17.5% vs 10.7%; P = 0.12; 23.4% vs 16.4%; P = 0.19, respectively). At 9 months, major adverse cardiac and cerebrovascular events occurred in 36 patients (28.3%) vs 30 patients (22.9%) in the Dissolve DCB and SeQuent Please DCB groups, respectively.CONCLUSIONS:In this head-to-head randomized trial, the Dissolve DCB was noninferior to the SeQuent Please DCB for 9-month in-segment late loss. However, Dissolve DCB with its numerical increase in target lesion failure and binary restenosis warrants assessment in larger clinical trials (A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-Stent Restenosis; NCT03373695).
JACC. Cardiovascular interventions 2023
BACKGROUND:Data regarding the association between sleep apnea (SA) and atrial fibrillation (AF) in hypertrophic cardiomyopathy (HCM) are still limited. We aim to investigate the association of both types of SA, obstructive sleep apnea (OSA) and central sleep apnea (CSA), and nocturnal hypoxemia with AF in HCM.METHODS:A total of 606 patients with HCM who underwent sleep evaluations were included. Logistic regression was used to assess the association between sleep disorder and AF.RESULTS:SA was presented in 363 (59.9%) patients, of whom 337 (55.6%) had OSA and 26 (4.3%) had CSA. Patients with SA were older, more often male, had a higher body mass index, and more clinical comorbidities. Prevalence of AF was higher in patients with CSA than patients with OSA and without SA (50.0% versus 24.9% and 12.8%, p < 0.001). After adjustment for age, sex, body mass index, hypertension, diabetes mellitus, cigarette use, New York Heart Association class and severity of mitral regurgitation, SA (OR, 1.79; 95% CI, 1.09-2.94) and nocturnal hypoxemia (higher tertile of percentage of total sleep time with oxygen saturation < 90% [OR, 1.81; 95% CI, 1.05-3.12] compared with lower tertile) were significantly associated with AF. The association was much stronger in the CSA group (OR, 3.98; 95% CI, 1.56-10.13) than in OSA group (OR, 1.66; 95% CI, 1.01-2.76). Similar associations were observed when analyses were restricted to persistent/permanent AF.CONCLUSION:Both types of SA and nocturnal hypoxemia were independently associated with AF. Attention should be paid to the screening of both types of SA in the management of AF in HCM.
Journal of clinical medicine 2023
Obstructive sleep apnea (OSA) is much common and associated with worse clinical outcomes in patients with hypertrophic cardiomyopathy (HCM), however, the diagnosis of OSA in HCM is still insufficient. We aim to investigate the clinical predictors of OSA in a large series of patients with HCM. A total of 589 patients with HCM who underwent sleep evaluations were retrospectively enrolled. Data from clinical characteristics and polysomnography studies were recorded. OSA was present in 346 patients (58.7%). Patients who had OSA were older, more likely to be male and had more clinical comorbidities such as hypertension, atrial fibrillation and cardiac remodeling. Multivariate logistic analyses showed that male, age, body mass index, hypertension and left ventricular outflow tract obstruction were significant factors associated with OSA. The area under the ROC curve (AUC) was 0.78 (95% CI 0.74-0.82; P < 0.001). These factors were also able to identify moderate to severe OSA with an AUC of 0.77 (95% CI 0.73-0.81; P < 0.001). These findings suggest that identifying HCM patients with high risk for OSA is feasible using characteristics from clinical practices and clinicians should have no hesitate to conduct sleep test in these patients.
Scientific reports 2021
BACKGROUND:Percutaneous coronary intervention (PCI) in patients with unprotected left main coronary artery disease (ULMCAD) is increasing strategy in coronary artery patients. However, there is a lack of knowledge on the impact of sex on outcomes of patients undergoing ULMCAD PCI.METHODS:From January 2004 to December 2015, there were 3,960 patients undergoing ULMCAD PCI at our institution, including 3,121 (78.8%) men and 839 (21.2%) women. The clinical outcome included the incidence of major adverse cardiac events (MACE) (the composite of all-cause death, myocardial infarction (MI), and revascularization), all-cause death, MI, revascularization at three years follow-up.RESULTS:Compared with men, women had not significantly different MACE (14.7% vs. 14.6%, P = 0.89, all-cause death (3.5% vs. 3.7%, P = 0.76), MI (5.0% vs. 4.3%, P = 0.38), revascularization (9.1% vs. 8.9%, P = 0.86), respectively. After adjustment, rates of MACE (HR = 1.49; 95% CI: 1.24-1.81;P < 0.0001) and all-cause death (HR = 1.65; 95% CI: 1.09-2.48; P = 0.017) occurred more frequently in male patients, as well as revascularization (HR = 1.46; 95% CI: 1.16-1.85;P = 0.001).CONCLUSION:In this analysis, compared to men, women undergoing ULMCAD PCI have better outcomes of MACE, all-cause death, and revascularization.
Journal of geriatric cardiology : JGC 2021
BACKGROUND:Substantial studies have demonstrated that left atrial (LA) enlargement was a robust predictor of atrial fibrillation (AF) and obesity was a modifiable risk factor for cardiovascular diseases. However, the role of body mass index (BMI) on LA dimension in hypertrophic obstructive cardiomyopathy (HOCM) remains unclear.METHODS:A total of 423 HOCM patients (average BMI 25.4 ± 3.4 kg/m2) were recruited for our study. Participants were stratified into three groups based on BMI: normal weight (BMI < 23 kg/m2), overweight (BMI 23-27.5 kg/m2), and obesity (BMI ≥ 27.5 kg/m2).RESULTS:Compared with normal weight, patients with obesity had significantly lower prevalence of syncope (p = 0.007) and moderate or severe mitral regurgitation (p = 0.014), and serum NT-proBNP (p = 0.004). Multiple linear regression analysis indicated that BMI (β = 0.328, p < 0.001), log NT-proBNP (β = 0.308, p < 0.001), presence of AF (β = 0.209, p = 0.001), and left ventricular diastolic diameter index (β = 0.142, p = 0.019) were independently related with LA diameter. However, BMI was not an independent predictor of the presence of AF on multivariable binary logistical regression analysis.CONCLUSIONS:BMI was independently associated with LA diameter; however, it was not an independent predictor of prevalence of AF. These results suggest that BMI may promote incidence of AF through LA enlargement in HOCM.
Open medicine (Warsaw, Poland) 2021
OBJECTIVES:Metabolic abnormalities have been associated with long-term cardiac mortality in patients with hypertrophic cardiomyopathy (HCM). Obstructive sleep apnea (OSA) is a risk factor for metabolic abnormalities in general populations, but association between OSA and metabolic abnormalities in HCM is still undefined. This study aimed to investigate the relationship between OSA and metabolic dysfunction in a large series of patients with HCM.METHODS:A total of 587 patients with HCM who underwent sleep evaluations at Fuwai Hospital were included. Data from clinical characteristics, polysomnography studies, and metabolic measurements were collected.RESULTS:OSA was present in 344 patients (58.6%). Patients with OSA were older, more often male, and had more clinical comorbidities. Body mass index, blood pressure, fasting glucose, and triglycerides all increased (all P < 0.001) and high-density lipoprotein cholesterol decreased (P = 0.046) with the severity of OSA. In multivariate analysis, moderate to severe OSA and Log (apnea-hypopnea index + 1) were independently associated with obesity (odds ratio [OR], 2.42; 95% CI, 1.48-3.95 and OR, 1.60; 95% CI, 1.31-1.95), elevated blood pressure (OR, 1.99; 95% CI, 1.42-3.26 and OR, 1.31; 95% CI, 1.08-1.60), and elevated triglycerides (OR, 1.71; 95% CI, 1.05-2.78 and OR, 1.24; 95% CI, 1.02-1.51 but not elevated fasting glucose (OR, 0.88; 95% CI, 0.50-1.52 and OR, 1.02; 95% CI, 0.82-1.28) or reduced high-density lipoprotein cholesterol (OR, 1.30; 95% CI, 0.83-2.04 and OR, 1.06; 95% CI, 0.89-1.27).CONCLUSIONS:Severity of OSA is independently associated with some profiles of metabolic abnormalities. Clinical trials are required to determine whether OSA treatment improves metabolic abnormalities and long-term outcomes in patients with HCM.
The Journal of clinical endocrinology and metabolism 2021
Lymphatic microvessel density (LMVD) contributes to fibrosis in patients with myocardial infarction. However, the role of LMVD in the process of myocardial fibrosis in hypertrophic obstructive cardiomyopathy (HOCM) patients is unclear. We studied LMVD in ventricular septal (VS) samples from 52 individuals (42 was HOCM patients who underwent a transaortic extended septal myectomy, and 10 traffic accident victims), and examined the relationships between the LMVD stained immunohistochemically with lymphatic vessel endothelial hyaluronan receptor (LYVE-1) antibodies, collagen volume fraction (CVF), and clinical characteristics. Compared with traffic accident victims, LMVD was significantly increased in VS of HOCM patients (132.0 ± 49.0 VS 57.8 ± 48.8/mm2, p = 0.000). HOCM patients with syncope had higher level of LMVD than without syncope [166.7 (131.0-201.1) VS 116.4 (80.7-152.1)/mm2, p = 0.017], and LMVD were positively correlated with Log (CVF) (r = 0.431, p = 0.004). On multiple variables regression analysis, LMVD was independently associated with Log (CVF) (r = 0.379, p = 0.009) and syncope (r = 0.335, p = 0.020). In conclusions, the LYVE-1-positive lymphatics have close associations with VS fibrosis in HOCM patients.
Heart and vessels 2020
As highly sensitive and specific markers of myocardial damage, cardiac troponins were demonstrated to correlate with clinical parameters of patients with hypertrophic cardiomyopathy. However, the relationship between cardiac troponins and presence of non-sustained ventricular tachycardia (NSVT) in hypertrophic cardiomyopathy remains unclear. The aim of our study was to explore the association between serum cardiac troponin I (cTNI) and presence of NSVT in patients with hypertrophic obstructive cardiomyopathy (HOCM). A total of 309 HOCM patients were enrolled in our study. All participants underwent clinical evaluations, including collections of medical history, blood tests, 24-h Holter monitoring, echocardiography, and cardiac magnetic resonance imaging. There were 53 (17.2%) patients with NSVT and 256 patients without it. Compared to patients without NSVT, serum cTNI (P < 0.001) and plasma NT-proBNP (P = 0.042) were significantly higher in patients with NSVT. Moreover, cTNI and NT-proBNP were positively correlated with left atrial diameter, maximum wall thickness (MWT), left ventricular volume index and left ventricular mass index. In multivariable logistic analysis, log cTNI [odds ratio (OR) = 2.408, 95% confidence interval (CI) 1.108-5.325, P = 0.027], left ventricular end-diastole diameter (OR = 0.922, 95%CI 0.856-0.994, P = 0.034), MWT (OR = 1.131, 95%CI 1.035-1.235, P = 0.006) and left ventricular end-systole volume index (OR = 1.060, 95%CI 1.025-1.096, P = 0.001) were independent determinants of NSVT occurrence after adjustment for potential cofounders. Serum cTNI level was elevated in patients with NSVT. And it was independently associated with NSVT in patients with HOCM. Our results suggest that it may be more reasonable for HOCM patients with elevated serum cTNI to extend the time of Holter monitoring.
Heart and vessels 2020
