Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is an interventional technology in which an artificial aortic valve is compressed and assembled outside the body, then delivered through a catheter and implanted at the site of the diseased aortic valve, thereby functionally replacing the native valve. Two versions of the Chinese expert consensus on TAVR were issued in China in 2015 and 2020, respectively. To promptly update the field's understanding of TAVR and to promote its broader, more standardized, and higher-quality application in China, an expert panel has developed this new version of the consensus. This consensus includes substantial updates compared with the previous version, covering topics such as the epidemiology of aortic valve disease, recent advances in TAVR research, indications, procedural standards, post-procedural antithrombotic therapy, prevention and management of complications, management of special cases, and future development trends. This consensus integrates international research evidence and references international guidelines to ensure rigor and evidence-based recommendations, while also incorporating domestic research findings and clinical practice in China, thereby enhancing both its forward-looking perspective and practical applicability.
Rationale: Among patients undergoing transcatheter aortic valve replacement (TAVR), serious perivalvular leakage (PVL) caused by valve dislocation is a rare but serious complication. Patient concerns: A 50-year-old male patient was admitted due to chest tightness. Diagnosis: Patient was diagnosed with rheumatic valvular heart disease, aortic stenosis, severe acute insufficiency, acute decompensated heart failure, cardiac function grade IV (New York Heart Association), and multiple organ failure. Interventions: After TAVR, delayed left ventricular dislocation of the valve prosthesis caused severe PVL and severe heart failure. A 2nd emergency TAVR operation was performed, and the TAVR artificial valve was implanted again using the transcatheter “valve-in-valve” technique. Outcomes: Postoperative evaluation showed mild PVL, and the clinical symptoms were relieved. Conclusions: Rheumatic aortic valve disease and multiple organ failure, severe PVL caused by delayed dislocation of valve prosthesis after TAVR is rare, which might necessitate prosthetic valve reimplantation using the transcatheter “valve-in-valve” technique.
Background and purpose: Matching the anti-proliferative drug effect with endothelial healing after drug-eluting stent (DES) implantation may help reduce cardiac events, especially stent thrombosis. A previous PIONEER II optical coherence tomography (OCT) sub-study demonstrated significantly better 1-month strut coverage with the novel healing-targeted BuMA Supreme DES, which was designed with a drug elution period of 4 to 6 weeks after implantation, compared with the XIENCE everolimus eluting stent (EES). This clinical trial aimed to evaluate whether the early endothelial healing observed in previous OCT sub-study would translate into improved intermediate-term angiographic and short-term clinical outcomes. Methods: PIONEER II was a multicenter, prospective, tandem clinical trial conducted in China. It was part of a series of clinical investigations of the BuMA Supreme DES, together with PIONEER I in Europe and PIONEER III in the United States, Canada, Europe, and Japan. The efficacy and safety of the BuMA Supreme DES were evaluated in patients with de novo coronary artery lesions. Results: From December 2015 to March 2018, 459 patients were randomly assigned to the randomized controlled trial (RCT) arm and received either the BuMA Supreme DES (n = 226) or the BuMA biodegradable polymer sirolimus-eluting stent (BP-SES; n = 233). In addition, 819 patients were enrolled in the objective performance criteria (OPC) arm. In the RCT arm, the BuMA Supreme DES was non-inferior to the BuMA BP-SES with respect to 9-month in-stent late lumen loss (LLL), with values of 0.23 ± 0.37 mm and 0.27 ± 0.36 mm, respectively (difference: −0.046 mm, 95% confidence interval: −0.107 to 0.015; P < 0.001 for non-inferiority). Furthermore, the BuMA Supreme DES demonstrated significantly lower values for secondary angiographic endpoints, including in-segment LLL and in-stent/in-segment diameter stenosis, compared with the BuMA BP-SES. In the OPC arm analysis, which combined patients from the BuMA Supreme group of the RCT arm with patients enrolled in the single-arm cohort, the 1-year target lesion failure rate was 4.17%. Both primary endpoints met the pre-specified non-inferiority criteria. Conclusion: The BuMA Supreme DES was non-inferior to the BuMA BP-SES with respect to 9-month in-stent LLL and was associated with the expected target lesion failure rate and a low incidence of stent thrombosis at 1-year follow-up.
BACKGROUND:Our objective was to compare the efficacy and safety of a drug-eluting stent featuring an abluminal bioabsorbable sirolimus-containing polymer coating (BP-SES) with an everolimus-eluting stent with a durable polymer (DP-EES) in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs). METHODS:TARGET CTO is a multicenter, open-label, noninferiority trial that randomized patients to either BP-SES or DP-EES in a 1:1 fashion following successful CTO re-canalization. The primary endpoint that was powered for noninferiority assessment is in-stent late lumen loss (LLL) at 12 months. RESULTS:A total of 206 subjects underwent randomization, with 103 assigned to the BP-SES group and 103 to the DP-EES group. Baseline clinical and angiographic characteristics were comparable. The primary endpoint demonstrated noninferiority for the BP-SES group compared to the DP-EES group (0.21 ± 0.43 mm vs 0.21 ± 0.33 mm; P = .934, 2-sided; difference 0.01mm [BP-SES minus DP-EES]; 95% CI: -0.13 to 0.12 mm; p noninferiority < .001,1-sided). No significant differences were observed in secondary angiographic or clinical endpoints. The rates of 12-month in-stent and in-segment binary restenosis in the BP-SES group and the DP-EES group were similar (6.8% vs 7.5%, P = .86; and 8.1% vs 8.8%; P = .89, respectively). Although there was a trend favoring the BP-SES group, the difference between the BP-SES group and DP-EES group at 12 months in target lesion failure (2.1% vs 8.0%, P = .054) and target lesion revascularization (2.1% vs 7.1%, P = .089) did not reach statistical significance. No definite or probable stent thromboses were reported in either group. CONCLUSIONS:Compared to DP-EES, PCI of CTOs with BP-SES showed similar results in terms of late loss and binary restenosis at the 12-month follow-up. CLINICAL TRIAL:ClinictalTrial.gov, number NCT03040934.
BACKGROUND:Previous trials have demonstrated increased 5-year risks for adverse clinical events after coronary artery implantation of poly-l-lactic acid-based bioresorbable scaffolds (BRS) compared with cobalt chromium (CoCr) everolimus-eluting stents (EES). OBJECTIVES:The aim of this study was to evaluate the 5-year clinical outcomes of the novel sirolimus-eluting NeoVas BRS compared with CoCr EES. METHODS:A total of 560 patients with single de novo native coronary artery lesions with reference vessel diameter 2.5 to 3.75 mm and lesion length ≤20 mm were randomized 1:1 to NeoVas BRS vs CoCr EES and followed for 5 years. Optical coherence tomography and fractional flow reserve were performed in a prespecified subgroup of 166 patients at 3-year follow-up. RESULTS:The 5-year target lesion failure rates were 9.5% in the NeoVas group and 7.2% in the CoCr EES group (HR: 1.33; 95% CI: 0.74 to 2.38; P = 0.33). The 5-year rates of device thrombosis were not different between the groups (1.5% vs 0.7%, respectively; HR: 2.05; 95% CI: 0.37 to 11.16; P = 0.45). In a subset of patients in whom optical coherence tomography was performed at 3 years, it demonstrated that NeoVas was substantially absorbed (72.3% ± 13.2%). Fractional flow reserve was not significantly different between the 2 groups either postprocedure or at 3 years (0.89 ± 0.07 vs 0.90 ± 0.05, respectively; P = 0.11). CONCLUSIONS:At 5-year follow-up, target lesion failure and stent thrombosis rates were comparable after NeoVas BRS and CoCr EES implantation in noncomplex lesions. However, comparability or the potential signs of harm of NeoVas BRS should be investigated in appropriately sized randomized trials in the future. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).
ABSTRACT Background Biodegradable polymer stents may reduce the risk of neoatherosclerosis and stent thrombosis. Limited data is available for biodegradable polymer sirolimus‐eluting stent (BP‐SES) and durable polymer drug‐eluting stents (DP‐EES) in chronic total occlusions (CTO). Aim This study was to evaluate healing patterns of BP‐SES versus DP‐EES in CTO at 3 and 13 months based on optical coherence tomography (OCT). Methods The TARGET‐CTO study is a prospective, multicenter, randomized noninferiority controlled trial for BP‐SES compared to DP‐EES in CTO. In the current predefined subanalysis, 44 consecutive patients underwent OCT follow‐up at 3 and 13 months. The primary endpoint was mean neo‐intimal thickness at 3 months. Results At 3 months, mean neo‐intimal thickness was 47.6 ± 15.7 µm in BP‐SES and 62.5 ± 37.3 µm in DP‐EES ( p = 0.384), meeting the noninferiority for BP‐SES ( p noninferiority < 0.001). Mean neo‐intimal thickness at 13 months was 76.4 ± 34.1 µm in BP‐SES and 106.6 ± 54.9 µm in DP‐EES ( p = 0.086). No significant differences in strut coverage were observed at 3 or 13 months. At 13 months significantly higher percentages of frames with layered neo‐intima and neoatherosclerosis were observed in DP‐EES compared to BP‐SES ( p = 0.015 and p = 0.021, respectively). Conclusions BP‐SES was noninferior to DP‐EES in terms of neo‐intimal thickness at 3 months and healing responses at 3‐month follow‐up were comparable. At 13 months, less advanced neoatherosclerosis patterns were observed in BP‐SES as compared to DP‐EES.
Transcatheter aortic valve replacement (TAVR) was initially used to treat aortic stenosis (AS), and gradually expanded into aortic regurgitation (AR) treatment. Scholars worldwide have explored the use of marketed transfemoral TAVR (TF-TAVR) valves for AR patients, offering another option for high-risk surgical patients. However, AR presents distinct challenges compared to AS, including anatomical differences, valve selection, procedural nuances, and complication profiles. Overall, TF-TAVR for AR is more complex with lower success rate than for AS. In order to promote the safe and standardized TF-TAVR for AR in China, the Structural Heart Disease Group of Chinese College of Cardiovascular Physician drafted this consensus. The writing expert team focused on key clinical challenges in TF-TAVR for AR patients, combining evidence from literature up to September 1, 2023, to formulate nine core viewpoints. These encompass indications, valve selection, preoperative evaluation, intraoperative techniques, complication prevention and management, postoperative care, and other aspects.
BackgroundLeft bundle branch pacing (LBBP) can physiologically correct complete left bundle branch block (CLBBB), and has become the best alternative to biventricular pacing (BiVP).ObjectiveTo compare the efficacy of LBBP and BiVP in patients with heart failure (HF) complicated with CLBBB.MethodsThis was a single-center retrospective study. Patients with HF complicated with CLBBB who underwent successful cardiac resynchronization therapy (CRT) in Wuhan Asian Heart Hospital from June 2018 to June 2023 were enrolled and divided into LBBP group and BiVP group according to the pacing method. The primary endpoints were the absolute increase of left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), and echocardiographic response rate. Secondary endpoints were all-cause mortality, heart failure hospitalization (HFH), NT-proBNP, paced QRS duration, pacing threshold, and procedural duration.ResultsA total of 120 patients were enrolled in this study, including 60 patients in LBBP group and 60 patients in BiVP group. The median follow-up time was 37 ± 19 months. Compared with BiVP group, LBBP group had a more significant increase in absolute LVEF (ΔLVEF) (14.8 ± 9.9% vs. 10.7 ± 9.0%, P = 0.02), a more significant reduction in LVEDD (56.9 ± 10.9 mm vs. 61.1 ± 10.8 mm, P = 0.03), and a higher echocardiographic super response rate (65% vs. 45%, P = 0.02). There were no significant differences in all-cause mortality (1.7% vs. 10.0%, P = 0.11) and HFH (6.7% vs. 13.3%, P = 0.22). In terms of paced QRS duration (128.7 ± 14.1 ms vs. 137.5 ± 16.5 ms, P = 0.002), pacing threshold (0.72 ± 0.21 V/0.4 ms vs. 1.39 ± 0.51 V/0.4 ms, P < 0.001), procedural duration (134.1 ± 32.2 min vs. 147.7 ± 39.4 min, P = 0.04), the LBBP group was superior to the BiVP group.ConclusionIn nonischemic cardiomyopathy (NICM) patients with HF combined with CLBBB and LVEF ≤ 35%, LBBP is better than BiVP.
Objective:Both atrial fibrillation (AF) and patent foramen ovale (PFO) has been associated with occurrences of ischemic stroke. The aim of this study was to investigate whether patients with concomitant AF and PFO were at an increased risk of stroke, and whether PFO closure was necessary for the prevention of stroke in AF patients who underwent left atrial appendage closure (LAAC). Method:We retrospectively analyzed 614 patients who underwent LAAC at Wuhan Asia Heart Hospital from May 2014 to April 2021. We compared the baseline clinical characteristics and ischemic stroke rates before LAAC, major adverse cardiovascular events (MACEs) and other long-term outcomes between AF patients with and without PFO after LAAC. The predictor for ischemic stroke or TIA after LAAC was analyzed with univariate and multivariable Cox regression, and the long-term cumulative survival rates of AF patients with PFO compared to those without PFO after LAAC were analyzed with the Kaplan-Meier graph. Results:A total of 614 patients who underwent LAAC and had completed follow-up data were included in our study. Among them, 74 patients were diagnosed with AF with PFO, and 540 with AF without PFO. There was no significant difference between their baseline clinical data, including ischemic stroke rates (p = 0.961). Patients with and without PFO had similar device implantation success rates (98.6 % vs 99.4 %, P = 0.403) and procedure-related complications. During follow-up (medium follow-up period 36.9 months), no significant difference was observed in the incidence of MACEs (8.1 % in PFO group vs 5.7 % in non-PFO group, P = 0.432) or the cumulative ischemic stroke/TIA rates (5.4 % in PFO group vs 4.3 % in non-PFO group, P = 0.554). The Cox multivariable regression analysis indicated that the presence of PFO in patients with AF had no correlation with ischemic stroke or TIA after LAAC implantation (HR 1.685, 95 % CI 0.570-4.978, P = 0.345). The only predictor for ischemic stroke/TIA events after LAAC was major leakage (>5 mm) seen on transesophageal echocardiography (TEE) or left atrial CTA at the 45-day follow-up (HR 10.352, 95 % CI 1.221-87.736, P = 0.032). Conclusion:AF patients with PFO are not at increased risk for ischemic stroke or TIA before LAAC. The presence of PFO in AF patients did not affect the success rate and safety of LAAC. The presence of mild PFO is not a viable predictor of stroke events in AF patients who underwent LAAC during long-term follow-up. Major leakage (>5 mm) is associated with a higher ischemic stroke/TIA rate in AF patients who underwent LAAC.
Background:The clinical performance of left atrial appendage occlusion (LAAO) as a procedure and the long-term impact of its varied implantation configurations and anticoagulation regimens remain unclear. Objectives:This study sought to provide data in routine practice from a prospective multicenter registry. Methods:A total of 3,096 consecutive patients from 39 Chinese centers undergoing LAAO were enrolled between April 1, 2019, and October 31, 2020. Results:The baseline CHA2DS2-VASc and HAS-BLED scores were 4.0 ± 1.8 and 2.4 ± 1.2, respectively; mean age was 69 ± 9 years. One-year follow-up was completed in 3,013 (97.8%) patients. The ischemic endpoint of death, stroke, and systemic embolism occurred in 133 (4.51%) patients, and life-threatening, disabling, or major bleeding occurred in 71 (2.36%) patients. After inverse probability of treatment weighting, no significant association was found between anesthesia type (moderate sedation vs general anesthesia) or image guidance (transesophageal/intracardiac echocardiography vs fluoroscopy) and ischemic or bleeding events. In 1,295 (42.0%) cases, LAAO combined with catheter ablation was associated with a significantly lower rate of death, stroke, or systemic embolism than LAAO only (3.5% vs 5.2%, inverse probability of treatment weighting HR: 0.68; 95% CI: 0.47-0.99). The most common post-LAAO antithrombotic regimen was warfarin/direct oral anticoagulant monotherapy for 45 days, followed by single-/dual-antiplatelet therapy (38.1%). Conclusions:In Chinese centers, patients undergoing LAAO had low rates of ischemic and bleeding events at 1 year. Combining LAAO with catheter ablation was associated with a lower rate of ischemic events than LAAO only. (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With Atrial Fibrillation Using the Watchman Left Atrial Appendage Closure Technology [RECORD]; NCT03917563).
Objectives: This study was aimed at comparing the “late catch-up” phenomenon between the BuMA Supreme bioresorbable polymer sirolimus-eluting stent and the XIENCE stent through serial optical coherence tomography (OCT) at within 2 months and 2 year follow-ups. Methods: A total of 49 of 75 patients from the PIONEER-II study were enrolled in a 2 year OCT follow-up study; 44 patients with 50 lesions were included in the statistical analysis. The primary endpoints were neointimal thickness and late luminal loss (LLL) after stent implantation. Results: The stenosis diameter, and minimum in-stent or in-segment diameter, did not significantly differ between the BuMA Supreme and XIENCE arms at within 2 months and 2 year follow-ups. The strut neointimal coverage and thickness were greater in the BuMA group than the XIENCE group at the 1 and 2 month follow-ups (P = 0.044 and P = 0.010, respectively) but not at the 2 year OCT follow-up. Neither early luminal loss at the within 2 months follow-up (P = 0.849) nor LLL at the 2 year OCT follow-up (P = 0.613) showed differences between device arms. No significant differences in imaging and clinical endpoints were observed between device arms at follow-up. Conclusions: The BuMA Supreme stent’s faster re-endothelization with no “late catch-up” phenomenon has potential advantages over the XIECE stent for patients with coronary artery disease and high bleeding risk because it decreases the duration of dual antiplatelet therapy.
BACKGROUND:The relationship between long-term outcomes and operator experience for left atrial appendage occlusion (LAAO) is still unknown. OBJECTIVES:This study sought to explore the association between operator LAAO experience and one-year clinical outcomes. METHODS:The RECORD study (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology; NCT03917563) was a multicenter, prospective registry that included patients with the WATCHMAN LAAO device (Boston Scientific) in China from April 1, 2019, to October 31, 2020. The current analyses included patients with solely LAAO from the registry; those who had concomitant LAAO and ablation/other procedures were excluded. The primary outcome was a composite endpoint of death, stroke, systemic embolism, and Bleeding Academic Research Consortium (BARC)-defined type 3 or 5 bleeding at 1 year. RESULTS:A total of 1,547 LAAO patients and 111 operators were included. The mean CHA2DS2-VASc and HAS-BLED scores of patients were 4.0 ± 1.8 and 2.5 ± 1.1, respectively. The mean age of operators was 47.0 ± 7.2 years, 15 (13.5%) were female, and 52 (46.8%) were electrophysiologists. Utilizing maximally selected log-rank statistics, the thresholds to categorize an experienced operator were performing ≥32 LAAOs annually or ≥134 LAAOs in total. Performing ≥32 LAAOs annually is the better criterion than ≥134 LAAOs in total (absolute net reclassification index: 25.79%; P < 0.001). Compared with the ≥32 LAAO annually group, the <32 group was associated with a 1.8-fold (HRadjusted: 1.79; 95% CI: 1.16-2.78; P = 0.009) increase in the risk of the primary endpoint, and such risk in the <32 group can be reduced by ∼12% after performing each additional 5 cases (HRadjusted per 5 cases: 0.88; 95% CI: 0.78-0.99; P = 0.033). CONCLUSIONS:Performing ≥32 LAAOs annually could be a threshold to categorize an experienced operator. Before reaching this threshold, the risk of death, stroke, systemic embolism, and BARC-defined type 3 or 5 bleeding decreased by 12% after every 5 cases performed.
AIMS:Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. METHODS AND RESULTS:Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. CONCLUSION:Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing.
Hypertension constitutes a critical risk factor for cardio-cerebrovascular disease. Despite the effectiveness of lifestyle adjustments and medications in blood pressure (BP) management, the hypertension control rates remain inadequate. Percutaneous renal denervation (RDN) has emerged as a forward-looking and evidence-supported interventional modality for the improvement of BP regulation and enhancement of hypertension control. Comprehensive evidence from randomized, sham-controlled clinical trials supports the sustained the efficacy and satisfactory safety profile of RDN in lowing BP. This scientific statement, endorsed by Chinese authorities, aims to provide a comprehensive overview of global and national clinical evidence on RDN. It seeks to highlight the therapeutic advancements of RDN, articulate expert consensus and recommendations for its utilization in hypertension management. Through the promotion of structured, safe, and standardized incorporation of RDN into clinical practice, this statement strives to optimize hypertension treatment within the Chinese medical community.
Objective: Patients with untreated severe aortic regurgitation (AR) have a high risk of mortality. Transfemoral transcatheter aortic valve replacement (TF-TAVR) is a treatment option for AR; however, the safety and efficacy of this technique have not been sufficiently established. This study aimed to evaluate the clinical and anatomical variables correlating with device success of TF-TAVR using a self-expanding valve system for pure AR. Methods: Patients with pure native severe AR who underwent TF-TAVR using a self-expanding valve system were registered at 5 Chinese centers. The primary endpoint was device success at 1 month after TAVR. The secondary endpoint was the composite of major adverse cardiovascular events (MACE) at 6 months, including all-cause death, ischemic stroke, emergency conversion to cardiac surgery, and permanent pacemaker implantation. Echocardiography was used to analyze the left ventricular function before the TAVR procedure and during follow-up. Multivariable logistic regression and Cox regression analyses were performed to find relevant independent risk factors. Results: Between September 2019 and February 2022, 79 patients with AR were enrolled in the study. At 1 month, device success was achieved in 60 (75.9%) patients. By 6 months, 29 (36.7%) patients had MACE. Echocardiography revealed improved left ventricular function after TAVR. Multivariate regression analysis demonstrated that the Society of Thoracic Surgeons risk score (odds ratio 0.760, 95% confidence interval (CI): 0.584-0.989; P = 0.041) and annulus perimeter (odds ratio 0.888, 95% CI: 0.796-0.992; P = 0.035) were 2 predictors of device success. Moreover, annulus perimeter (<80.2 mm), but not Society of Thoracic Surgeons risk score, was associated with a significant reduction in MACE at 6 months (hazard ratio 2.223, 95% CI: 1.060-4.659; P = 0.028). Conclusions: TF-TAVR using a self-expanding valve system appears to be a safe and feasible treatment for patients with pure native severe AR, particularly those with a less enlarged annulus.
巨细胞心肌炎(GCM)是一种快速进展且预后不良的急性心肌炎,生存期一般不到3个月.本病例报道1例突发GCM迅速进展为终末期心力衰竭的中年女性患者,成功植入左心室辅助装置.然而在术中由于右心室心力衰竭,因此在术中置入体外膜肺氧合作为临时右心室辅助,并在术中取心肌活检明确诊断.术后心功能恢复良好,随访状态良好.本病例的诊治过程可为GCM的救治提供参考.
Panvascular disease has emerged as a growing disease burden worldwide, highlighting the requirement of advanced research based on a holistic perspective. Establishing a standard set of data variables for clinical research on epidemiology, risk evaluation, diagnostic strategy, the efficacy of therapeutics, and care quality monitoring is paramount. A multidisciplinary working group consisting of 12 experts developed a standardized data variables and definitions through a systemic review and analysis of major domestic and international guidelines, clinical research articles, and standard terminologies in conjunction with data on Chinese clinical treatment and practice and research needs. A total of 555 data variables were included, among which 129 were mandatory. The key domains based on the timeline of care delivery are as follows: (1) demographics, (2) patient characteristics and comorbidities, (3) presentation details, (4) laboratory testing, (5) non-invasive tests, (6) invasive procedures/operations, (7) pre-discharge review, (8) risk assessment, and (9) follow-up. Patients with atherosclerotic cardiovascular disease, subclinical atherosclerosis, and high-risk factors are eligible for enrollment into the database. As of March 31, 2023, a total of 20 participating hospitals have started collecting patient data. A total of 2,106 patients have been enrolled.