慕朝伟
中国医学科学院阜外医院 冠心病中心
BACKGROUND:The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes.AIMS:We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions.METHODS:The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months.RESULTS:A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%.CONCLUSIONS:In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 2023
To assess the diagnostic performance of fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) (CT-FFR) obtained by a new computational fluid dynamics (CFD) algorithm to detect ischemia, using FFR as a reference, and analyze the characteristics of "gray zone" and misdiagnosed lesions. This prospective multicenter clinical trial (NCT03692936, https://clinicaltrials.gov/) analyzed 317 patients with coronary stenosis between 30 and 90% in 366 vessels from five centers undergoing CTA and FFR between November 2018 and March 2020. CT-FFR were obtained from a CFD algorithm (Heartcentury Co., Ltd., Beijing, China). Diagnostic performance of CT-FFR and CTA in detecting ischemia was assessed. Coronary atherosclerosis characteristics of gray zone and misdiagnosed lesions were analyzed. Per-vessel sensitivity, specificity and accuracy for CT-FFR and CTA were 89.9, 87.8, 88.8% and 89.3, 35.5, 60.4%, respectively. Accuracy of CT-FFR was 80.0% in gray zone lesions. In gray zone lesions, lumen area and diameter were significantly larger than lesions with FFR < 0.76 (both p < 0.001), lesion length, non-calcified and calcified plaque volume were all significantly higher than non-ischemic lesions (all p < 0.05). In gray zone lesions, Agatston score (OR = 1.009, p = 0.044) was the risk factor of false negative results of CT-FFR. In non-ischemia lesions, coronary stenosis >50% (OR = 2.684, p = 0.03) was the risk factor of false positive results. Lumen area (OR = 0.567, p = 0.02) and diameter (OR = 0.296, p = 0.03) had a significant negative effect on the risk of false positive results of CT-FFR. In conclusion, CT-FFR based on the new parameter-optimized CFD model provides better diagnostic performance for lesion-specific ischemia than CTA. For gray zone lesions, stenosis degree was less than those with FFR < 0.76, and plaque load was heavier than non-ischemic lesions.
Frontiers in cardiovascular medicine 2022
OBJECTIVES:To investigate the measurement discrepancy of coronary computed tomography angiography (CTA)-derived fractional flow reserve (FFR) between diastolic (CT-FFR-D) and systolic (CT-FFR-S) phases using FFR as the reference standard.METHODS:Participants, suspected of coronary artery disease and indicated for invasive coronary angiography (ICA) and FFR and coronary CTA and CT-FFR, were enrolled in this study (Clinicaltrials.gov:NCT03692936) from September 2018 to October 2019. For every participant, coronary CTA of both systolic and diastolic phases was postprocessed to calculate CT-FFR-S and CT-FFR-D, respectively. Diagnostic sensitivity, specificity, accuracy, and the area under the receiver operating characteristic (ROC) curve were compared.RESULTS:A total of 181 lesions from 151 participants (mean age 54.5 ± 7.8 years, 113 males) were analyzed. Of these, 129 lesions from 110 participants were successfully measured both in diastolic and systolic phases. Sensitivity, specificity, and accuracy of CT-FFR-D and CT-FFR-S on per-patient level were 88.9%, 91.3%, 90.1% and 66.7%, 87.7%, 76.7%, on per-vessel level were 89.5%, 91.5%, 90.6% and 66.7%, 87.0%, 77.9%, respectively. The ROC curve of CT-FFR-D was significantly higher than that of CT-FFR-S on both per-patient and per-vessel levels (0.938 vs. 0.771, 0.935 vs. 0.772, both p < 0.0001). In severe hemodynamic lesions (FFR ≤ 0.7), the absolute difference between CT-FFR-S and FFR was significantly higher than that between CT-FFR-D and FFR [0.1636, inter-quartile range (IQR): 0.0662-0.2586 vs. 0.0953, IQR: 0.0496-0.1702, p = 0.035].CONCLUSION:CT-FFR derived in diastole was superior to that derived in systole in detecting coronary ischemic lesions. For lesions with FFR < 0.7, CT-FFR measured in the diastolic phase was noted to be more closely approximated to FFR.
European journal of radiology 2022
AIMS:This study sought to report the 10-year clinical outcomes of patients who underwent unprotected left main (LM) percutaneous coronary intervention (PCI) in a large centre.METHODS AND RESULTS:A total of 913 consecutive patients who underwent unprotected LM PCI from January 2004 to December 2008 at Fu Wai Hospital were retrospectively analysed; the mean age was 60.0 ± 10.9 years, females accounted for 22% of patients, diabetes was present in 27.7% of patients, and an LM bifurcation lesion occurred in 82.9% of patients. During the median follow-up of 9.7 years, major adverse cardiac or cerebrovascular events (MACCEs) occurred in 25.6% (234) of patients, and the rates of all-cause death, myocardial infarction, and stroke were 14.9%, 11.0%, and 7.1%, respectively. Cardiac death occurred in only 7.9% of patients. The estimated event rate was 41.9% for death/myocardial infarction/any revascularization and 45.9% for death/MI/stroke/any revascularization. Definite/probable stent thrombosis occurred in 4.3% (39) of patients. According to the subgroup analysis, IVUS-guided PCI was associated with less long-term MACCEs. Further multivariate analysis identified that age and LVEF<40% were the only independent predictors for 10-year death. Age, LVEF<40%, creatinine clearance, and incomplete revascularization were independent predictors for death/MI, while a two-stent strategy, diabetes, a transradial approach, and the use of bare metal stents (BMSs) or first-generation drug-eluting stents (DESs) were not.CONCLUSIONS:Unprotected LM PCI in a large cohort of consecutive patients in a single large centre demonstrated favourable long-term outcomes up to 10 years even with the use of BMSs and first-generation of DESs.
Journal of interventional cardiology 2021
OBJECTIVE:The present study compared 10-year clinical outcomes between transradial access (TRA) and transfemoral access (TFA) for left main (LM) percutaneous coronary intervention (PCI).BACKGROUND:There are limited data regarding the long-term safety and efficacy of TRA for LM PCI.METHODS:This retrospective study evaluated consecutive patients who underwent unprotected LM PCI between January 2004 and December 2008 at Fu Wai Hospital. The exclusion criteria were age of less than 18 years and presentation with acute myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), which was defined as a composite of all-cause death, myocardial infarction, stroke, and any revascularization at the 10-year follow-up.RESULTS:Among 913 eligible patients, TRA was used for 417 patients (45.7%) and TFA was used for 496 patients (54.3%). The 30-day clinical outcomes were similar between the two groups. Results from the 10-year follow-up revealed that MACCE occurred in 180 patients (46.7%) from the TRA group and in 239 patients (51.2%) from the TFA group (log-rank p = .3). The TRA and TFA groups also had low and comparable cumulative rates of all-cause death (14.6% vs. 17.3%, log-rank p = .56) and cardiac death (7.9% vs. 9.1%, log-rank p = .7).CONCLUSION:The present study revealed no significant differences in long-term clinical outcomes when TRA or TFA were used for LM PCI.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 2021
OBJECTIVES:The FUTURE-I study aimed to assess preliminary safety and effectiveness with the long-term clinical and imaging follow-up for the Firesorb (MicroPort, Shanghai, China), a thinner-strut sirolimus-eluting bioresorbable scaffold (BRS).BACKGROUND:First-generation BRS has been associated with unexpected device-related adverse outcomes at long-term follow-up.METHODS:In this prospective, open-label, first-in-man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 (n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 (n = 15) at 12 and 36 months. All patients underwent clinical follow-up at 1, 6, and 12 months and annually up to 5 years.RESULTS:Between January and March 2016, 45 patients were enrolled. At 3-year follow-up, one patient had experienced target lesion failure and none scaffold thrombosis. In-scaffold minimal lumen diameter decreased significantly from 6-month to 2-year (2.53 ± 0.24 mm vs. 2.27 ± 0.37 mm, p = .0003), and only numerically from 1-year to 3-year follow-up (2.48 ± 0.28 mm vs. 2.22 ± 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3-year follow-up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts.CONCLUSIONS:At 3-year follow-up of the FUTURE-I study, implantation of the thinner-strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 2020
OBJECTIVES:To evaluate the feasibility and safety of a second generation robotic percutaneous coronary intervention (R-PCI) system in China.BACKGROUND:Robotic PCI has been shown to be an effective method for conducting coronary interventions. It has further benefits of more accurate lesion measurement, improved stent deployment, reduced incidence of geographic miss and reduction of operator radiation exposure.METHODS:This single center evaluation enrolled 10 consecutive patients who had been selected for PCI. Clinical success was defined as residual stenosis < 30% and no in-hospital major adverse cardiovascular events. Learning curve effect was assessed by comparing efficiency metrics of early vs. later cases.RESULTS:Eleven lesions were treated all successfully without manual interruption or MACE events. Most lesions (63%) were ACC/AHA class B2 and C. Mean procedure time was 57.7 ± 26.4 min, however two procedures were part of live demonstrations. Excluding the two live cases, the mean procedure time was 51.8 ± 23.7 min. Procedural efficiency tended to improve from early cases to later cases based on PCI time (48.3 ± 32.9 vs. 25.5 ± 13.0 min, P = 0.27), fluoroscopy time (20.3 ± 8.2 vs. 12.5 ± 4.6 min, P = 0.16), contrast volume (145.0 ± 28.9 vs. 102.5 ± 17.1 mL, P = 0.05) and Air Kerma dose (1932 ± 978 vs. 1007 ± 70 mGy, P = 0.31).CONCLUSIONS:Second generation robotic PCI was safe, effective and there were trends toward improvements in procedural efficiency during this early experience in China.
Journal of geriatric cardiology : JGC 2019
With the development of coronary angiography for the diagnosis of coronary artery disease, its clinical significance in detecting coronary artery anomalies and evaluating the seriousness is attracting more attention. In the study we aimed to assess the prevalence of anomalous origin of coronary arteries in a Chinese population who underwent coronary angiography for coronary artery disease, and explore any patterns in the common variants and typical anomalies, especially the potentially serious ones. Patients who underwent coronary angiography from January 2013 to December 2016 in Fuwai Hospital were included. Baseline characteristics and angiographic data were collected, the incidence of anomalous origin of coronary arteries was calculated, and the typical patterns were analyzed. Comparisons between the present results and those of existing reports were also conducted. A total of 110,158 patients were included in the study, among which 0.76% (835 cases) had anomalous origin of coronary arteries. Among the anomalies, the incidences of anomalous origin of the right coronary artery (RCA), the left coronary artery (LCA), both the RCA and LCA, single coronary artery (SCA) and dextrocardia were 76.76% (641 cases), 14.61% (122 cases), 1.80% (15 cases), 4.67% (39 cases) and 2.16% (18 cases), respectively. Moreover, 47.54% (397 cases) of the anomalies were shown to be potentially serious, and an RCA arising from the left sinus of Valsalva (LSV) was the most common subtype (39.28%, 328 cases). Although anomalous origin of coronary arteries is not quite common, more clinical attention should be paid to this condition due to the potential risk of serious sequelae.
The international journal of cardiovascular imaging 2018
BACKGROUND:Coronary artery involvement is not a rare presentation of Takayasu arteritis (TA) and the treatment is challenging. The optimal methods of revascularization, and prognosis of treatment have not been established.OBJECTIVES:To assess the long-term outcomes of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in TA patients.METHODS:Patients with coronary artery involved in TA who underwent either PCI or CABG were identified between February 2003 and December 2015. The primary outcome was long-term all-cause mortality. Secondary outcomes were myocardial infarction (MI), stroke, and repeat revascularization.RESULTS:Thirty-one patients were enrolled (PCI=19 vs. CABG=12). Most of them were female (25, 80.6%) and the mean age was 42.6±13.8years (16-64years). Angina pectoris was the most common initial symptom (26 cases, 83.9%) and concomitant aortic regurgitation was present in 8 (25.8%) patients. Both groups had a low rate of corticosteroids use [4/19 (21.1%) vs. 2/12 (16.7%)]. During the median follow-up of 101months (10-384months), PCI group had a significantly higher incidence of restenosis [12/19(63.2%) vs. 3/12(25%)]. Two patients with severe aortic regurgitation in PCI group suffered from cardiac death during follow-up.CONCLUSIONS:Coronary artery involvement should be suspected in TA patients with angina pectoris, especially young women. PCI had a very high rate of in-stent restenosis in patients without corticosteroids and CABG may be a preferred treatment option.
International journal of cardiology 2017
OBJECTIVE:To investigate the effect of a novel motion-correction algorithm (Snap-short Freeze, SSF) on image quality and diagnostic accuracy in patients undergoing prospectively ECG-triggered CCTA without administering rate-lowering medications.MATERIALS AND METHODS:Forty-six consecutive patients suspected of CAD prospectively underwent CCTA using prospective ECG-triggering without rate control and invasive coronary angiography (ICA). Image quality, interpretability, and diagnostic performance of SSF were compared with conventional multisegment reconstruction without SSF, using ICA as the reference standard.RESULTS:All subjects (35 men, 57.6 ± 8.9 years) successfully underwent ICA and CCTA. Mean heart rate was 68.8±8.4 (range: 50-88 beats/min) beats/min without rate controlling medications during CT scanning. Overall median image quality score (graded 1-4) was significantly increased from 3.0 to 4.0 by the new algorithm in comparison to conventional reconstruction. Overall interpretability was significantly improved, with a significant reduction in the number of non-diagnostic segments (690 of 694, 99.4% vs 659 of 694, 94.9%; P<0.001). However, only the right coronary artery (RCA) showed a statistically significant difference (45 of 46, 97.8% vs 35 of 46, 76.1%; P = 0.004) on a per-vessel basis in this regard. Diagnostic accuracy for detecting ≥50% stenosis was improved using the motion-correction algorithm on per-vessel [96.2% (177/184) vs 87.0% (160/184); P = 0.002] and per-segment [96.1% (667/694) vs 86.6% (601/694); P <0.001] levels, but there was not a statistically significant improvement on a per-patient level [97.8 (45/46) vs 89.1 (41/46); P = 0.203]. By artery analysis, diagnostic accuracy was improved only for the RCA [97.8% (45/46) vs 78.3% (36/46); P = 0.007].CONCLUSION:The intracycle motion correction algorithm significantly improved image quality and diagnostic interpretability in patients undergoing CCTA with prospective ECG triggering and no rate control.
PloS one 2015
