罗彤
中国医学科学院阜外医院
Objective: To summarize the single center experience of transcatheter aortic valve replacement (TAVR) with a simplified operative protocol. Methods: Consecutive patients who underwent transfemoral TAVR (TF-TAVR) from July 2020 to December 2020 in Fuwai Hospital were retrospectively analyzed. We compared the baseline characteristic, procedure information, 30-day follow-up outcomes of the patients who underwent TF-TAVR without the simplified operative protocol (routine group) or with the simplified operative protocol (simplified protocol group). Results: 93 patients were collected, 42 patients belonging to routine group, 51 patients belonging to simplified protocol group. In simplified protocol group, there were 51 patients planned to use ultrasound-guided femoral access puncture, procedure was successful in all 51 patients (100%). There were 49 patients planned to use the radial artery as the secondary access, procedure was successful in 45 patients (92%). There were 48 patients planned to use the strategy of avoidance of urinary catheter, this strategy was achieved in 35 patients (73%). There were 12 patients planned to use the left ventricular guidewire to pace, procedure was successful in 11 patients (92%). There were no differences in baseline characteristics, major clinical endpoints and 30-day follow-up outcomes between the two groups. Meanwhile, the procedure time ((62.5±17.9)min vs. (78.3±16.7)min, P<0.001), operation room time ((133.7±25.1)min vs. (159.2±42.6)min, P<0.001), X-ray exposure time ((17.2±6.5)min vs. (20.2±7.7)min, P=0.027) were significantly shorten in simplified protocol group compared with the routine group. Conclusion: Our study results indicate that the simplified operative protocol of TF-TAVR is as effective and safe as the routine operative protocol, meanwhile using the simplified operative protocol can significantly increase the operative efficiency of TF-TAVR.
Zhonghua xin xue guan bing za zhi 2022
INTRODUCTION:Newer generation bioresorbable scaffolds (BRSs) with thinner struts and improved deliverability are expected to enhance safety and efficacy profiles. Bioheart (Bio-Heart, Shanghai, China) BRS is constructed from a PLLA (poly-l-lactic acid) backbone coated with a PDLLA (poly D-l-lactic acid) layer eluting sirolimus. We report 2-year serial intracoronary imaging findings.METHODS:In this first-in-human study, 46 patients with single de novo lesions in native coronary vessels (vessel size 3.0-3.75 mm, lesion length ≤ 25 mm) were enrolled at a single institution. Baseline intravascular ultrasound (IVUS) and post-implantation IVUS and optical coherence tomography (OCT) examinations were mandatory. After successful implantations of BRS, the 46 patients were randomized to two different follow-up cohorts in a 2:1 ratio. Thirty patients in cohort 1 had to undergo angiography, IVUS, and OCT follow-ups at 6 and 24 months, respectively. The 16 patients in cohort 2 underwent the same types of imaging follow-ups at 12 and 36 months, respectively. Clinical follow-ups were scheduled uniformly in both cohorts at 1, 6, and 12 months and annually up to 5 years for all patients.RESULTS:Between August and November 2016, a total of 54 patients were assessed. However, 8 patients could not meet all the inclusion criteria; thus, the remaining 46 patients (age 57.5 ± 8.7 years, 34.8% female, 50.0% with unstable angina, 26.1% diabetics) with 46 target lesions were enrolled in this study. All patients in both cohorts were required to complete clinical follow-up uniformly and regularly. In cohort 1, one patient had definite scaffold thrombosis within 6 months of follow-up; thus, after 6 months, cohort 1 had 96.7% patients . Imaging follow-up was available in 24 patients, and in-scaffold late loss was 0.44 ± 0.47 mm; intracoronary imaging confirmed the late loss was mainly due to to neointimal hyperplasia, but not scaffold recoil.CONCLUSIONS:Serial 2-year clinical and imaging follow-up results confirmed the preliminary safety and efficacy of Bioheart BRS for treatment of simple coronary lesions.
Advances in therapy 2022
This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine coronary arteries. Fifty-two nitrided iron scaffolds (strut thickness of 70 μm) and 28 Vision Co-Cr stents were randomly implanted into coronary arteries of healthy mini-swine. The efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stentwithin 52 weeks after implantation. In addition, the long-term biocompatibility, safety, and bioresorption of the nitrided iron scaffold were evaluated by coronary angiography, optical coherence tomography, micro-computed tomography, scanning electron microscopy, energy dispersive spectrometry and histopathological evaluations at 4, 12, 26, 52 weeks and even at 7 years after implantation. In particular, a large number of struts were almost completely absorbed in situ at 7 years follow-up, which were first illustrated in this study. The lymphatic drainage pathway might serve as the potential clearance way of iron and its corrosion products.
Bioactive materials 2022
Objective: To explore the feasibility of the single-stage stent implantation following rotational atherectomy combined with transcatheter aortic valve replacement (TAVR) in treating patients with severe aortic stenosis(AS) and severe calcified coronary artery stenosis. Methods: Three patients who received single-stage stent implantation following rotational atherectomy combined with TAVR in Fuwai hospital from April to October 2019 were included in this retrospective analysis. Clinical and anatomical features (including echocardiography and aortic CT) of the patients were collected, efficacy and safety of this operation strategy were observed and 6 months follow up results were summarized. Results: Three patients (2 females, 66-80 years old) were included. The mean Society of Thoracic Surgeons (STS) risk score was 7.8%. The mean maximum velocity of aortic valve was 4.4 m/s, the mean transvalvular pressure gradient was 53.2 mmHg (1 mmHg=0.133 kPa), mean left ventricular ejection fraction (LVEF) was 48.6%. All three patients had severe calcified coronary artery stenosis: left anterior descending artery (LAD, n=2) and left main coronary artery (LM, n=1), requiring rotary grinding. The mean SYNTAX score was 20. All the procedures were performed through transfemoral access. After aortic valve crossing, all coronary lesions were successfully treated with stent implantation following rotational atherectomy, transfemoral TAVR was then immediately performed with a self-expandable Venus-A valve. One patient underwent"valve-in-valve"implantation due to the high-implantation position of the first valve. The procedures were completed without complications in all the three patients. The immediate effect was satisfactory. Echocardiography results showed that the mean maximum velocity of aortic valve was 2.1 m/s, mean gradient was 9.3 mmHg, and mean LVEF was 59% after the procedure. There was no death and revascularization during the 6 months follow-up. Conclusion: In patients with severe calcified coronary artery and severe AS with high risk of cardiac surgery, the single-stage stent implantation following rotational atherectomy combined with TAVR is feasible and results are satisfactory in this patient cohort.
Zhonghua xin xue guan bing za zhi 2021
Objective: To investigate the safety and efficacy of left ventricular guidewire pacing during transcatheter aortic valve replacement (TAVR). Methods: This is a retrospective study. Thirteen patients, who underwent TAVR with left ventricular guidewire pacing from October 2019 to December 2019 in Fuwai Hospital, were included. Clinical data and operational procedure data of the patients were collected. Changes in blood pressure and electrocardiogram were observed during operations. Ascending aorta angiography was performed to evaluate the regurgitation of aortic valve after valve implantion. The incidence of major adverse cardiac events during hospitalization and at 3-months after discharge was recorded. Results: There were 7 male and 6 female patients in this cohort,and age was (73.8±8.3) years old. Among the 13 patients, 9 were tricuspid aortic valves, 3 were bicuspid aortic valves, and 1 was degenerated bioprosthetic surgical aortic valve. TAVR were successfully performed in all of the 13 cases using pacing through the left ventricular guidewire. During balloon dilation, the blood pressure decreased to below 60 mmHg (1 mmHg=0.133 kPa) after 180 beats/min pacing, and the valve release process was smooth and the position was stable. The results of aortography showed that there was no regurgitation in 7 cases, mild regurgitation in 5 cases and moderate regurgitation in 1 case. Three patients required temporary pacing during the procedure due to complete heart block, among whom 1 patient was implanted with permanent pacemaker during hospitalization, and the other 2 patients recovered within 24 hours after operation. In another case, there was no significant change of electrocardiogram during the operation, and complete heart block occurred 10 days after the operation, and treated with permanent pacemaker. The other 10 patients began to carry out bedside activities and rehabilitation training 24 hours after operation. There was no death, myocardial infarction, stroke and other major adverse cardiac events during hospitalization and at 3-month follow-up after discharge. Conclusion: Left ventricular guidewire pacing is a safe and effective strategy for TAVR.
Zhonghua xin xue guan bing za zhi 2021
OBJECTIVES:The aim of this study was to investigate the operability, 6-month efficacy, and safety of the novel sirolimus-eluting iron bioresorbable coronary scaffold (IBS) system compared with a cobalt-chromium everolimus-eluting stent (EES) (XIENCE Prime stent) in porcine coronary arteries.BACKGROUND:Bioresorbable scaffolds have been considered the fourth revolution in percutaneous coronary intervention. However, the first-generation bioresorbable scaffold showed suboptimal results.METHODS:Forty-eight IBS and 48 EES were randomly implanted into nonatherosclerotic swine. The operability, efficacy, and safety of the IBS and EES were evaluated using coronary angiography, optical coherence tomography, micro-computed tomography, scanning electron microscopy, and histopathologic evaluation at 7, 14, 28, 90, and 180 days after implantation.RESULTS:The operability of the ultrathin IBS (∼70 μm) was comparable with that of the EES, except for its visibility. There was no statistically significant difference in area stenosis between the IBS and EES from 28 to 180 days. The IBS maintained its integrity up to 90 days without corrosion, while corrosion was observed in a few struts in 2 of 10 IBS at 180 days. The percentage of endothelialization of IBS was higher than that of XIENCE Prime stents within 14 days after implantation. The fibrin score was higher in the IBS group at 28 days but comparable with the EES group at 90 and 180 days. No scaffold or stent thrombosis was seen in either group. No abnormal histopathologic changes in scaffolded or stented vessel segments and 5 main remote organs were observed in either group.CONCLUSIONS:Preclinical results suggest that the novel IBS has comparable operability, mid-term efficacy, and safety with the EES, and its corrosion profile in porcine coronary arteries is reasonable, which could support initial clinical study of the IBS.
JACC. Cardiovascular interventions 2019
BACKGROUND:Mounts of studies have shown that low estimated glomerular filtration rate (eGFR) is associated with increased risk of adverse outcomes in patients with coronary artery disease. However, high level of eGFR was less reported. In the study, we aimed to explore the relationship between the baseline eGFR, especially the high level, and contrast-induced acute kidney injury (CI-AKI) in a Chinese population who underwent an emergency percutaneous coronary intervention (PCI).METHODS:Patients who underwent an emergency PCI from 2013 to 2015 were enrolled and divided into five groups as eGFR decreasing. Baseline characteristics were collected and analyzed. The rates of CI-AKI and the composite endpoint (including nonfatal myocardial infarction, revascularization, stroke, and all-cause death) at 6- and 12-month follow-up were compared. Logistic analysis for CI-AKI was performed.RESULTS:A total of 1061 patients were included and the overall CI-AKI rate was 22.7% (241/1061). The separate rates were 77.8% (7/9) in Group 1 (eGFR ≥120 ml·min-1·1.73 m-2), 26.0% (118/454) in Group 2 (120 ml·min-1·1.73 m-2> eGFR ≥90 ml·min-1·1.73m-2), 18.3% (86/469) in Group 3 (90 ml·min-1·1.73 m-2> eGFR ≥60 ml·min-1·1.73 m-2), 21.8% (26/119) in Group 4 (60 ml·min-1·1.73 m-2> eGFR ≥30 ml·min-1·1.73 m-2), and 40.0% (4/10) in Group 5 (eGFR <30 ml·min-1·1.73 m-2), with statistical significance (χ2 = 25.19, P < 0.001). The rates of CI-AKI in five groups were 77.8%, 26.0%, 18.3%, 21.8%, and 40.0%, respectively, showing a U-typed curve as eGFR decreasing (the higher the level of eGFR, the higher the CI-AKI occurrence in case of eGFR ≥60 ml·min-1·1.73 m-2). The composite endpoint rates in five groups were 0, 0.9%, 2.1%, 6.7%, and 0 at 6-month follow-up, respectively, and 0, 3.3%, 3.4%, 16.0%, and 30.0% at 12-month follow-up, respectively, both with significant differences (χ2 = 16.26, P = 0.009 at 6-month follow-up, and χ2 = 49.05, P < 0.001 at 12-month follow-up). The logistic analysis confirmed that eGFR was one of independent risk factors of CI-AKI in emergency PCI patients.CONCLUSIONS:High level of eGFR might be associated with increased risk of CI-AKI in patients with emergency PCI, implying for future studies and risk stratification in clinical practice.
Chinese medical journal 2018
We developed a new risk factor profile for contrast-induced acute kidney injury (CI-AKI) under a new definition in patients who underwent an emergency percutaneous coronary intervention (PCI). Consecutive patients (n = 1061) who underwent an emergency PCI were divided into a derivation group (n = 761) and a validation group (n = 300). The rates of CI-AKI were 23.5% (definition 1: serum creatinine [SCr] increase ≥25% in 72 hours), 4.3% (definition 2: SCr increase ≥44.2 μmol/L in 72 hours), and 7.0% (definition 3: SCr increase ≥44.2 μmol/L in 7 days). Due to the high sensitivity of definition 1 and the high rate of missed cases for late diagnosis of CI-AKI under definition 2, definition 3 was used in the study. The risk factor profile included body surface area <1.6 m2 ( P = .030), transient ischemic attack/stroke history ( P = .001), white blood cell count >15.00 × 109/L ( P = .047), estimated glomerular filtration rate <60 mL/min/1.73 m2 ( P = .002) or baseline SCr >133 μmol/L ( P = .007), intra-aortic balloon pump application ( P = .006), and diuretics administration ( P < .001), showing a significant predictive power in the derivation group and validation group. The new risk factor profile of CI-AKI under a new CI-AKI definition in emergency PCI patients is easily applicable with a useful predictive value.
Angiology 2018
BACKGROUND:Previous studies of contrast-induced acute kidney injury (CI-AKI) were mostly based on selective percutaneous coronary intervention (PCI) cases, and risk factors of CI-AKI after emergency PCI are unclear. The aim of this study was to explore the risk factors of CI-AKI in a Chinese population undergoing emergency PCI.METHODS:A total of 1061 consecutive patients undergoing emergency PCI during January 2013 and June 2015 were enrolled and divided into CI-AKI and non-CI-AKI group. Univariable and multivariable analyses were used to identify the risk factors of CI-AKI in emergency PCI patients. CI-AKI was defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl (44.2 μmol/L) above baseline within 3 days after exposure to contrast medium.RESULTS:The incidence of CI-AKI in patients undergoing emergency PCI was 22.7% (241/1061). Logistic multivariable analysis showed that body surface area (BSA) (odds ratio [OR] 0.213, 95% confidence interval [CI]: 0.075-0.607, P= 0.004), history of myocardial infarction (MI) (OR 1.642, 95% CI: 1.079-2.499, P= 0.021), left ventricular ejection fraction (LVEF) (OR 0.969, 95% CI: 0.944-0.994, P= 0.015), hemoglobin (Hb) (OR 0.988, 95% CI: 0.976-1.000, P= 0.045), estimated glomerular filtration rate (OR 1.027, 95% CI: 1.018-1.037, P < 0.001), left anterior descending (LAD) stented (OR 1.464, 95% CI: 1.000-2.145, P= 0.050), aspirin (OR 0.097, 95%CI: 0.009-0.987, P= 0.049), and diuretics use (OR 1.850, 95% CI: 1.233-2.777, P= 0.003) were independent predictors of CI-AKI in patients undergoing emergency PCI.CONCLUSION:History of MI, low BSA, LVEF and Hb level, LAD stented, and diuretics use are associated with increased risk of CI-AKI in patients undergoing emergency PCI.
Chinese medical journal 2017
BACKGROUND:Contrast-induced acute kidney injury (CI-AKI) is one of the most serious complications in patients who undergo percutaneous coronary intervention (PCI), especially in those with acute coronary syndrome. It has been shown that inflammation may play an important role in the pathophysiology of CI-AKI.HYPOTHESIS:Inflammatory factors may play a predominant role in the prediction of CI-AKI in patients who undergo emergency PCI.METHODS:Patients who underwent emergency PCI from 2013 to 2015 were consecutively enrolled and were divided into CI-AKI and non-CI-AKI groups. Logistic analysis was used to identify the risk factors of CI-AKI. Receiver operator characteristic curve analysis was performed to evaluate the area under the curve (AUC) and to establish the optimal cutoff.RESULTS:A total of 1061 patients were included, and the CI-AKI rate was 5.47% (58/1061). Logistic analysis showed that the white blood cell (WBC) count (odds ratio [OR]: 1.103, 95% confidence interval [CI]: 1.018-1.195, P = 0.016), neutrophil (N) count (OR: 1.134, 95% CI: 1.045-1.232, P = 0.003), neutrophil to lymphocyte ratio (NLR) (OR: 1.105, 95% CI: 1.044-1.169, P = 0.001), C-reactive protein (CRP) level (OR: 1.006, 95% CI: 1.001-1.011, P = 0.020), high-sensitivity C-reactive protein (hs-CRP) level (OR: 1.099, 95% CI: 1.020-1.184, P = 0.013), and big endothelin-1 (ET-1) level (OR: 4.030, 95% CI: 1.989-8.165, P < 0.001) were all significant predictors for CI-AKI, as was the left ventricular ejection fraction and diuretic administration. The AUC of the big ET-1 level was the highest (0.793, 95% CI: 0.733-0.853), followed by the NLR (0.708, 95% CI: 0.641-0.774), hs-CRP level (0.705, 95% CI: 0.627-0.782), CRP level (0.684, 95% CI: 0.607-0.761), N count (0.655, 95% CI: 0.584-0.726), WBC count (0.620, 95% CI: 0.544-0.695), and erythrocyte sedimentation rate (0.611, 95% CI: 0.527-0.695).CONCLUSIONS:The WBC count, N count, NLR, CRP level, hs-CRP level, and big ET-1 level are all associated with an increased risk of CI-AKI, and among which, the big ET-1 level, NLR, and the hs-CRP level might have high predictive value for CI-AKI after an emergency PCI.
Clinical cardiology 2017
