Development and validation of a model integrating clinical and coronary lesion-based functional assessment for long-term risk prediction in PCI patients.

OBJECTIVES: To establish a scoring system combining the ACEF score and the quantitative blood flow ratio (QFR) to improve the long-term risk prediction of patients undergoing percutaneous coronary intervention (PCI). METHODS: In this population-based cohort study, a total of 46 features, including patient clinical and coronary lesion characteristics, were assessed for analysis through machine learning models. The ACEF-QFR scoring system was developed using 1263 consecutive cases of CAD patients after PCI in PANDA III trial database. The newly developed score was then validated on the other remaining 542 patients in the cohort. RESULTS: In both the Random Forest Model and the DeepSurv Model, age, renal function (creatinine), cardiac function (LVEF) and post-PCI coronary physiological index (QFR) were identified and confirmed to be significant predictive factors for 2-year adverse cardiac events. The ACEF-QFR score was constructed based on the developmental dataset and computed as age (years)/EF (%) + 1 (if creatinine ≥ 2.0 mg/dL) + 1 (if post-PCI QFR ≤ 0.92). The performance of the ACEF-QFR scoring system was preliminarily evaluated in the developmental dataset, and then further explored in the validation dataset. The ACEF-QFR score showed superior discrimination (C-statistic = 0.651; 95% CI: 0.611-0.691, P < 0.05 versus post-PCI physiological index and other commonly used risk scores) and excellent calibration (Hosmer-Lemeshow χ2 = 7.070; P = 0.529) for predicting 2-year patient-oriented composite endpoint (POCE). The good prognostic value of the ACEF-QFR score was further validated by multivariable Cox regression and Kaplan-Meier analysis (adjusted HR = 1.89; 95% CI: 1.18-3.04; log-rank P < 0.01) after stratified the patients into high-risk group and low-risk group. CONCLUSIONS: An improved scoring system combining clinical and coronary lesion-based functional variables (ACEF-QFR) was developed, and its ability for prognostic prediction in patients with PCI was further validated to be significantly better than the post-PCI physiological index and other commonly used risk scores.

Effects of diabetes mellitus on post-intervention coronary physiological assessment derived by quantitative flow ratio in patients with coronary artery disease underwent percutaneous coronary intervention.

AIMS: To compare the prognostic implication of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) assessment in patients with and without diabetes enrolled in the all-comers, multicenter, randomized controlled PANDA III trial. METHODS: All treated vessels in PANDA III trial were retrospectively assessed for post-PCI QFR. Vessels with available post-PCI QFR were further stratified into DM and non-DM cohorts, and prognostic performance of post-PCI QFR was compared in 2 cohorts. The primary outcome was 2-year vessel-oriented composite endpoint (VOCE), defined as composite of vessel-related cardiac death, vessel-related non-procedural myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: Of 2,989 treated vessels, 2,227 (74.5%) with available post-PCI QFR were included, while 548 were presence of DM and 1,679 were not. The performance of post-PCI QFR to predict 2-year VOCE were moderate in both DM (area under the curve [AUC] 0.77, 95% confidence interval [CI]: 0.68 to 0.87) and non-DM cohorts (AUC 0.74, 95% CI: 0.67 to 0.82), while between-cohorts AUC difference was not significant (ΔAUC 0.03, P = 0.65). After multivariate adjustment, vessels with suboptimal post-PCI QFR results (≤0.92) were associated with higher risk of 2-year VOCE in both DM (adjusted HR 6.24, 95% CI: 2.40 to 16.2) and non-DM cohorts (adjusted HR 5.92, 95% CI: 3.28 to 10.7) without significant interaction (P for interaction 0.91). CONCLUSIONS: This study, the first to directly compare clinical value of post-PCI QFR assessments in patients with and without DM, showed that a higher post-PCI QFR value was associated with improved long-term prognosis regardless of the presence of DM. Clinical Trial Registration Information URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02017275.

Long-term prognostic value of dynamic function assessment of intermediate coronary lesion with computational physiology.

This study sought to investigate the dynamic functional changes of coronary intermediate lesions using quantitative flow ratio (QFR) and its implication on long-term clinical outcomes. Physiology-guided percutaneous coronary intervention in patients with angiographic intermediate lesions has been associated with favorable outcomes. This study consecutively enrolled 1130 patients with deferred intermediate lesions at baseline angiography and subsequently received second-time angiography between 9 months and 2 years later from two centers in China. The functional changes of intermediate lesions at angiographic follow-up (ΔQFR) were defined as (baseline QFR-follow-up QFR)/years. The primary outcome was vessel-oriented composite endpoint (VOCE), defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (ID-TVR) at angiographic follow-up for up to 5 years. Retrospective QFR assessment was available in 820 patients (996 intermediate lesions). QFR ≤ 0.80 at second-time angiography was associated with significantly higher 5-year VOCE (41.9% vs. 13.4%, p < 0.0001). In 777 intermediate lesions with baseline QFR > 0.80, mean ΔQFR was 0.03 ± 0.07 (median: 0.006; Q1: 0; and Q3: 0.04). The optimal cutoff of ΔQFR for predicting the primary outcome was 0.03 (area under the curve [AUC]: 0.68). The cumulative event rate of VOCE in patients with ΔQFR ≥ 0.03 was significantly higher than in those with ΔQFR < 0.03 (33.8% vs. 12.2%, p < 0.0001), driven by higher vessel-related MI and ID-TVR. The ΔQFR was a useful tool for evaluating the dynamic functional change of deferred intermediate lesions, as it demonstrates good prognostic value for long-term target vessel-related adverse events.

Cross-sectional study of retroperitoneal hematoma after invasive intervention in a Chinese population: Prevalence, characteristics, management and outcomes.

The present study aimed to explore the clinical characteristics and management of retroperitoneal hematoma (RPH) after invasive intervention during a 12-year period in China. A retrospective review of patients with RPH after various invasive interventions was conducted at the China National Center for Cardiovascular Diseases. A total of 42 patients with a mean age of 63.1±2.5 years were continuously recruited in the study between January 2007 and September 2018. The incidence, manifestations and management of RPH were analyzed. A total of 20 patients had punctures in the femoral arterial access under the inguinal ligament and 5 patients had punctures above the inguinal ligament. The majority of RPH occurred within 24 h after intervention, while some occurred after postoperative 24 h. Pain was the most common symptom in patients with RPH. All patients who underwent intervention presented a reduction in hemoglobin (HB) concentration. The overall incidence of nosocomial infection was 38.1% and mortality was 7.1%. The findings demonstrated that RPH is a rare complication after invasive intervention of cardiovascular diseases with non-specific clinical manifestations. The reduction of HB concentration was a vital manifestation for RPH. Most RPH cases could be treated by conservative treatment and blood transfusion. A puncture in the femoral arterial access under the inguinal ligament may result in RPH.

Integrating the residual SYNTAX score to improve the predictive ability of the age, creatinine, and ejection fraction (ACEF) score for cardiac mortality in percutaneous coronary intervention patients.

OBJECTIVES: To improve the prognostic value of the age, creatinine, and ejection fraction (ACEF) score following percutaneous coronary intervention (PCI) by integrating the residual SYNTAX score (rSS). BACKGROUND: ACEF score was proposed for predicting the operative mortality risk in elective cardiac operations and has been validated in numerous studies. However, it does not incorporate coronary lesion-based variables for risk assessment of patients who undergo PCI. METHODS: Overall, 10,072 patients who underwent PCI at our hospital in 2013 were enrolled. The endpoint was 2-year cardiac death after PCI, defined as death that was not attributed to a non-cardiac cause. ACEF-rSS was constructed with incremental weights attributed to the ACEF score and rSS according to their estimated coefficients. RESULTS: 2-year cardiac death occurred in 63 patients (0.63%). In multivariable analyses, the ACEF score and rSS > 8 were independently associated with the risk of cardiac death. ACEF-rSS was computed as age (years)/ejection fraction (%) + 1 (if creatinine ≥2.0 mg/dl) + 1 (if rSS >8). The discrimination of ACEF-rSS was significantly better than that of the ACEF score based on receiver operating characteristic (ROC) curve analysis and integrated discrimination improvement (IDI) (C-statistics = 0.835 vs. 0.776 for ACEF-rSS and ACEF score, respectively, p = .029; IDI = 0.014, p < .001). Compared with all other SYNTAX-derived risk scores, ACEF-rSS had significantly better discrimination ability based on ROC curve analysis, net reclassification improvement, and IDI. CONCLUSIONS: Combining the ACEF score with rSS to produce the ACEF-rSS enhanced the predictive ability for long-term cardiac mortality.

Transradial Versus Transfemoral Approach for Percutaneous Coronary Intervention in Elderly Patients in China: A Retrospective Analysis.

Objective To compare hospital costs and clinical outcomes between transradial intervention (TRI) and transfemoral intervention (TFI) in elderly patients aged over 65 years. Methods We identified 1229 patients aged over 65 years who underwent percutaneous coronary intervention (PCI) in Fuwai Hospital, Beijing, China, between January 1 and December 31, 2010. Total hospital costs and in-hospital outcomes were compared between TRI and TFI. An inverse probability weighting (IPW) model was introduced to control potential biases. Results Patients who underwent TRI were younger, less often female, more likely to receive PCI for single-vessel lesions, and less likely to undergo the procedure for ostial lesions. TRI was associated with a cost saving of CNY7495 (95%CI: CNY4419-10 420). Such differences were mainly driven by lower PCI-related costs. TRI patients had shorter length of stay (1.9 days, 95%CI: 1.1-2.7 days), shorter post-procedural stay (0.7 days, 95%CI: 0.3-1.1 days), and fewer major adverse cardiac events (adjusted odds ratio = 0.47, 95%CI: 0.31-0.73). There was no statistical significance in the incidence of post-PCI bleeding between TRI and TFI (P>0.05). Such differences remained consistent in clinically relevant subgroups of acute myocardial infarction, acute coronary syndrome, and stable angina. Conclusion The use of TRI in patients aged over 65 years was associated with significantly reduced hospital costs and more favorable clinical outcomes.

Costs and Benefits Associated With Transradial Versus Transfemoral Percutaneous Coronary Intervention in China.

BACKGROUND: Transradial percutaneous coronary intervention (PCI) has been increasingly adopted in clinical practice, given its potential advantages over transfemoral intervention; however, the impact of different access strategies on costs and clinical outcomes remains poorly defined, especially in the developing world. METHODS AND RESULTS: Using data from a consecutive cohort of 5306 patients undergoing PCI in China in 2010, we compared total hospital costs and in-hospital outcomes for transradial intervention (TRI) and transfemoral intervention. Patients receiving TRI (n=4696, 88.5%) were slightly younger (mean age 57.4 versus 59.5 years), less often women (21.6% versus 33.1%), more likely to undergo PCI for single-vessel disease, and less likely to undergo PCI for triple-vessel or left main diseases. The unadjusted total hospital costs were 57 900 Chinese yuan (¥57 900; equivalent to 9190 US dollars [$9190]) for TRI and ¥67 418 ($10,701) for transfemoral intervention. After adjusting for all observed patient and procedural characteristics using the propensity score inverse probability weighting method, TRI was associated with a lower total cost (adjusted difference ¥8081 [$1283]). More than 80% of the cost difference was related to lower PCI-related costs (adjusted difference -¥5162 [-$819]), which were likely driven by exclusive use of vascular closure devices in transfemoral intervention, and lower hospitalization costs (-¥1399 [-$222]). Patients receiving TRI had shorter length of stay and were less likely to experience major adverse cardiac events or post-PCI bleeding. These differences were consistent among clinically relevant subgroups with acute myocardial infarction, acute coronary syndrome, and stable angina. CONCLUSIONS: Among patients undergoing PCI, TRI was associated with lower cost and favorable clinical outcomes compared with transfemoral intervention.