Objective:To explore the long-term effects of intravascular ultrasound (IVUS) guidance on patients with acute coronary syndrome (ACS) undergoing drug-eluting stents (DES) implantation.Methods:Data used in this study derived from ULTIMATE trial, which was a prospective, multicenter, randomized study. A total of 1 448 all-comer patients were enrolled between 2014 August and 2017 May. Primary endpoint of this study was target vessel failure (TVF) at 3 years, including cardiac death, target-vessel-related myocardial infarction, and clinically-driven target vessel revascularization.Results:ACS was present in 1 136 (78.5%) patients, and 3-year clinical follow-up was available in 1 423 patients (98.3%). TVF in the ACS group was 9.6% (109/1 136), which was significantly higher than 4.5% (14/312) in the non-ACS group (log-rank P=0.005). There were 109 TVFs in the ACS patients, with 7.6% (43/569) TVFs in the IVUS group and 11.6% (66/567) TVFs in the angiography group (log-rank P=0.019). Moreover, patients with optimal IVUS guidance were associated with a lower risk of 3-year TVF compared to those with suboptimal IVUS results (5.4% (16/296) vs. 9.9% (27/273),log-rank P=0.041). Conclusions:This ULTIMATE-ACS subgroup analysis showed that ACS patients undergoing DES implantation were associated with a higher risk of 3-year TVF. More importantly, the risk of TVF could be significantly decreased through IVUS guidance in patients with ACS, especially in those who had an IVUS-defined optimal procedure.

Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Objective::The Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure (PADN-5) study proved that pulmonary artery denervation (PADN) is associated with significant improvements in hemodynamic and clinical outcomes in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH). This study aimed to assess the 3-year clinical results of PADN in patients who had heart failure with preserved ejection fraction (HFpEF) developing into CpcPH (HFpEF-CpcPH).Methods::In this post hoc analysis of the PADN-5 trial, 38 patients with HFpEF were included in screening out of 98 patients with CpcPH who were randomly assigned to treatment with sildenafil and sham PADN (sham PADN (plus sildenafil) group, abbreviated as sham group) or PADN (PADN group). HFpEF in the PADN-5 trial was defined as a left ventricular ejection fraction ≥50%, and CpcPH was defined as a mean pulmonary arterial pressure ≥25 mmHg, a pulmonary arterial wedge pressure >15 mmHg, and a pulmonary vascular resistance >3.0 WU. The changes in the 6-minute walk distance (6-MWD) and the plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6-month and 3-year follow-up, as well as the clinical endpoint of the occurrence of clinical worsening, defined as cardiopulmonary-related death, rehospitalization, or heart or lung transplantation at 3-year follow-up were examined. Results::Thirty-eight patients with HFpEF-CpcPH were assigned to the PADN group ( n = 19) or the sham group ( n = 19). At the 6-month follow-up, 6-MWD (433 (275, 580)m vs. 342 (161, 552)m), and reductions in NT-proBNP (-47% (-99%, 331%) vs. -12% (-82%, 54%)) were significantly improved in the PADN group (all P < 0.05). Over the 3-year follow-up period, PADN treatment resulted in marked increases in 6-MWD (450 (186, 510)m vs. 348 (135, 435)m) and reductions in NT-proBNP (-55% (-99%, 38%) vs. -10% (-80%, 95%)) (all P < 0.05). Clinical worsening was experienced by 12 patients (63%) in the sham group, but by only 5 patients (26%) in the PADN group (hazard ratio = 0.149, 95% confidence interval: 0.038–0.584, P = 0.006). The 6-MWD and PADN treatments were independent predictors of clinical deterioration in patients with HFpEF-CpcPH. Conclusions::PADN therapy is associated with improvements in exercise capacity and clinical outcomes. PADN therapy may have a potential role in patients with HFpEF-CpcPH for whom current treatment options are limited.

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.

Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Objective::The Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure (PADN-5) study proved that pulmonary artery denervation (PADN) is associated with significant improvements in hemodynamic and clinical outcomes in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH). This study aimed to assess the 3-year clinical results of PADN in patients who had heart failure with preserved ejection fraction (HFpEF) developing into CpcPH (HFpEF-CpcPH).Methods::In this post hoc analysis of the PADN-5 trial, 38 patients with HFpEF were included in screening out of 98 patients with CpcPH who were randomly assigned to treatment with sildenafil and sham PADN (sham PADN (plus sildenafil) group, abbreviated as sham group) or PADN (PADN group). HFpEF in the PADN-5 trial was defined as a left ventricular ejection fraction ≥50%, and CpcPH was defined as a mean pulmonary arterial pressure ≥25 mmHg, a pulmonary arterial wedge pressure >15 mmHg, and a pulmonary vascular resistance >3.0 WU. The changes in the 6-minute walk distance (6-MWD) and the plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6-month and 3-year follow-up, as well as the clinical endpoint of the occurrence of clinical worsening, defined as cardiopulmonary-related death, rehospitalization, or heart or lung transplantation at 3-year follow-up were examined. Results::Thirty-eight patients with HFpEF-CpcPH were assigned to the PADN group ( n = 19) or the sham group ( n = 19). At the 6-month follow-up, 6-MWD (433 (275, 580)m vs. 342 (161, 552)m), and reductions in NT-proBNP (-47% (-99%, 331%) vs. -12% (-82%, 54%)) were significantly improved in the PADN group (all P < 0.05). Over the 3-year follow-up period, PADN treatment resulted in marked increases in 6-MWD (450 (186, 510)m vs. 348 (135, 435)m) and reductions in NT-proBNP (-55% (-99%, 38%) vs. -10% (-80%, 95%)) (all P < 0.05). Clinical worsening was experienced by 12 patients (63%) in the sham group, but by only 5 patients (26%) in the PADN group (hazard ratio = 0.149, 95% confidence interval: 0.038–0.584, P = 0.006). The 6-MWD and PADN treatments were independent predictors of clinical deterioration in patients with HFpEF-CpcPH. Conclusions::PADN therapy is associated with improvements in exercise capacity and clinical outcomes. PADN therapy may have a potential role in patients with HFpEF-CpcPH for whom current treatment options are limited.

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.

Objective:In this study, the application value of a specific information platform in heart failure was explored.Methods:We constructed five modules of information platform based on clinical needs, including user interface, patient management interface, follow-up platform, data processing interface and system management. By making good use of the platform, a database of heart failure was established and quality-controlled to realize the management of chronic heart failure, and prepare database for possible clinical research.Results:More than 3 000 patients with heart failure had been registered in the heart failure special disease platform. Long-term out-of-hospital management of cerfain patients with heart failure was conducted through intelligent information means. High-quality heart failure data were obtained and translated into clinical results.Conclusions:Long-term out-of-hospital management of patients with chronic heart failure can be realized through the special disease information platform, and high-quality evidence-based medical data can be obtained. Besides, the platform provides theoretical basis and data support for evaluation system of prognosis of heart failure, provides theoretical basis and data support for improving medication and surgical treatment plans and comprehensive management system of patients with heart failure.

Objective:This article takes the practical experience of the construction of the cardiovascular disease clinical medicine research center in Nanjing First Hospital as an example to provide reference for institutions preparing to build a clinical research center.Methods:The center conducts top-level design based on clinical needs, and this study systematically elaborates the construction of the center from management mechanisms, research platforms, collaborative networks, team building and international cooperation.Results:The center has made remarkable progress in clinical research, scientific and technological innovation, transformation and promotion, standard formulation, and technology leading. On the basis of an international perspective, the level of regional diagnosis and treatment has been improved by optimizing the structure of subject talents, and focusing on the clinical needs of cardiovascular subspecialty.Conclusions:Taking the construction of the clinical medicine center as an opportunity, integrating superior resources, improving the level of disease diagnosis, treatment and service and enhancing international academic influence are effective measures to accelerate the development of health services and deepen medical reforms.

Objective::Coronavirus disease 2019 (COVID-19) exists as a pandemic. Mortality during hospitalization is multifactorial, and there is urgent need for a risk stratification model to predict in-hospital death among COVID-19 patients. Here we aimed to construct a risk score system for early identification of COVID-19 patients at high probability of dying during in-hospital treatment.Methods::In this retrospective analysis, a total of 821 confirmed COVID-19 patients from 3 centers were assigned to developmental ( n = 411, between January 14, 2020 and February 11, 2020) and validation ( n = 410, between February 14, 2020 and March 13, 2020) groups. Based on demographic, symptomatic, and laboratory variables, a new Coronavirus estimation global (CORE-G) score for prediction of in-hospital death was established from the developmental group, and its performance was then evaluated in the validation group. Results::The CORE-G score consisted of 18 variables (5 demographics, 2 symptoms, and 11 laboratory measurements) with a sum of 69.5 points. Goodness-of-fit tests indicated that the model performed well in the developmental group ( H = 3.210, P = 0.880), and it was well validated in the validation group ( H = 6.948, P= 0.542). The areas under the receiver operating characteristic curves were 0.955 in the developmental group (sensitivity, 94.1%; specificity, 83.4%) and 0.937 in the validation group (sensitivity, 87.2%; specificity, 84.2%). The mortality rate was not significantly different between the developmental ( n = 85,20.7%) and validation ( n = 94, 22.9%, P = 0.608) groups. Conclusions::The CORE-G score provides an estimate of the risk of in-hospital death. This is the first step toward the clinical use of the CORE-G score for predicting outcome in COVID-19 patients.