Thrombotic vs. Bleeding Events of Interruption of Dual Antiplatelet Therapy within 12 Months among Patients with Stent-Driven High Ischemic Risk Definition following PCI

Background. There is a paucity of real-world data regarding the clinical impact of dual antiplatelet therapy (DAPT) interruption (temporary or permanent) among patients at high ischemic risk. The aim of this study was to assess the risk of cardiovascular events after interruption of DAPT in high-risk PCI population. Methods. This study used data from the Fuwai PCI registry, a large, prospective cohort of consecutive patients who underwent PCI. We assessed 3,931 patients with at least 1 high ischemic risk criteria of stent-related recurrent ischemic events proposed in the 2017 ESC guidelines for focused update on DAPT who were free of major cardiac events in the first 12 months. The primary ischemic endpoint was 30-month major adverse cardiac and cerebrovascular events, and the key safety endpoints were BARC class 2, 3, or 5 bleeding and net adverse clinical events. Results. DAPT interruption within 12 months occurred in 1,122 patients (28.5%), most of which were due to bleeding events or patients’ noncompliance to treatment. A multivariate Cox regression model, propensity score (PS) matching, and inverse probability of treatment weighting (IPTW) based on the propensity score demonstrated that DAPT interruption significantly increased the risk of primary ischemic endpoint compared with prolonged DAPT (3.9% vs. 2.2%; Cox-adjusted hazard ratio (HR): 1.840; 95% confidence interval (CI): 1.247 to 2.716; PS matching-HR: 2.049 [1.236–3.399]; IPTW-adjusted HR: 1.843 [1.250–2.717]). This difference was driven mainly by all-cause death (1.8% vs. 0.7%) and MI (1.3% vs. 0.5%). Furthermore, the rate of net adverse clinical events (4.9% vs. 3.2%; Cox-adjusted HR: 1.581 [1.128–2.216]; PS matching-HR: 1.639 [1.075–2.499]; IPTW-adjusted HR: 1.554 [1.110–2.177]) was also higher in patients with DAPT interruption (≤12 months), whereas no significant differences between groups were observed in terms of BARC 2, 3, or 5 bleeding. These findings were consistent across various stent-driven high-ischemic risk subsets with respect to the primary ischemic endpoints, with a greater magnitude of harm among patients with diffuse multivessel diabetic coronary artery disease. Conclusions. In patients undergoing high-risk PCI, interruption of DAPT in the first 12 months occurred infrequently and was associated with a significantly higher adjusted risk of major adverse cardiovascular events and net adverse clinical events. 2017 ESC stent-driven high ischemic risk criteria may help clinicians to discriminate patient selection in the use of long-term DAPT when the ischemic risk certainly overcomes the bleeding one.

Rapid Classification and Treatment Algorithm of Cardiogenic Shock Complicating Acute Coronary Syndromes: The SAVE ACS Classification

Introduction. We aimed to identify the independent “frontline” predictors of 30-day mortality in patients with acute coronary syndromes (ACS) and propose a rapid cardiogenic shock (CS) classification and management pathway. Materials and Methods. From 2011 to 2019, a total of 11439 incident ACS patients were treated in our institution. Forward conditional logistic regression analysis was performed to determine the “frontline” predictors of 30 day mortality. The C-statistic assessed the discriminatory power of the model. As a validation cohort, we used 431 incident ACS patients admitted from January 1, 2020, to July 20, 2020. Results. Independent predictors of 30-day mortality included age (OR 1.05; 95% CI 1.04 to 1.07, p < 0.001 ), intubation (OR 7.4; 95% CI 4.3 to 12.74, p < 0.001 ), LV systolic impairment (OR severe_vs_normal 1.98; 95% CI 1.14 to 3.42, p = 0.015 , OR moderate_vs_normal 1.84; 95% CI 1.09 to 3.1, p = 0.022 ), serum lactate (OR 1.25; 95% CI 1.12 to 1.41, p < 0.001 ), base excess (OR 1.1; 95% CI 1.04 to 1.07, p < 0.001 ), and systolic blood pressure (OR 0.99; 95% CI 0.982 to 0.999, p = 0.024 ). The model discrimination was excellent with an area under the curve (AUC) of 0.879 (0.851 to 0.908) ( p < 0.001 ). Based on these predictors, we created the SAVE (SBP, Arterial blood gas, and left Ventricular Ejection fraction) ACS classification, which showed good discrimination for 30-day AUC 0.814 (0.782 to 0.845) and long-term mortality p log − rank < 0.001 . A similar AUC was demonstrated in the validation cohort (AUC 0.815). Conclusions. In the current study, we introduce a rapid way of classifying CS using frontline parameters. The SAVE ACS classification could allow for future randomized studies to explore the benefit of mechanical circulatory support in different CS stages in ACS patients.

Improved Outcomes of Combined Main Branch Stenting and Side Branch Drug-Coated Balloon versus Two-Stent Strategy in Patients with Left Main Bifurcation Lesions

Background. Drug-eluting stent (DES) plus drug-coated balloon (DCB) is a safe and effective treatment strategy for coronary artery bifurcation lesions, but there is no report about this strategy being used for left main (LM) bifurcation lesions. We aim to explore the efficacy and safety of DES plus DCB in the treatment of LM bifurcation lesions. Methods. A total of 100 patients diagnosed with LM bifurcation lesions by coronary angiography were retrospectively enrolled at our center from January 2018 to December 2019. They received either a two-stent strategy or a main branch (MB) stenting plus side branch (SB) DCB strategy and were accordingly divided into the 2-DES group and the DES + DCB group. Patients treated with DES + DCB were compared with a cohort of matched patients treated with a 2-DES strategy. Clinical data was collected and quantitative coronary analysis was performed. Results. For immediate postoperative angiography, though the two groups had no differences in the minimal luminal diameter (MLD) and luminal stenosis of MB, the DES + DCB group had significantly lower SB ostial MLD and a higher degree of residual lumen stenosis than the 2-DES group ( P < 0.05 ). At the time of follow-up, the SB ostial MLD of the DES + DCB group was higher than that of the 2-DES group, but lumen stenosis, late lumen loss (LLL), and LLL at the distal end of the left MB were all smaller than those of the 2-DES group ( P s < 0.05 ). Furthermore, the incidence of lumen restenosis and MACE between the two groups had no significance. Conclusion. The combination of DES and DCB is relatively safe and effective for the treatment of LM bifurcation lesions, and this strategy seems to have advantages in reducing LLL at the SB ostium.

Safety of Occlutech Septal Occluder ACCELL Flex II for Transcatheter Closure of Secundum Atrial Septal Defects in Children: A Long-Term Follow-Up

Objectives. To assess the long-term safety and efficacy of the Occlutech® ACCELL® Flex II device used for atrial septal defect (ASD) closure. This device differs from the regular device by having two very thin patches that are made of polyethylene terephthalate (PET). These patches enhance faster sealing of the defect. Background. Transcatheter closure has become the method of choice to manage most patients with secundum ASDs. There are different types of devices. The regular Occlutech device used to close an ASD is called the Occlutech Figulla Flex II. A newer modification of this device (Occlutech® ACCELL® Flex II) has been designed to eliminate/reduce thrombus formation and to enhance faster sealing. Methods. Thirty patients were followed up after occlusion of secundum ASD using the Occlutech® ACCELL® Flex II Device. The follow-up period ranged from 5.2–5.5 years with median of 5.3 years. Detailed history and full clinical examination, twelve-lead electrocardiogram (ECG), plain chest radiograph, and full 2D transthoracic echocardiography (TTE) were performed at discharge, at one month, six months, and yearly thereafter. Results. The mean age of the study group at the last follow-up was 10.4 ± 4.6 years, with 63.3% (nineteen patients) females. There were no residual shunts or complications encountered immediately after the procedure and at the latest follow-up. Conclusion. This study confirmed the transcatheter closure (TCC) of secundum ASDs using the Occlutech® ACCELL® Flex II device to be safe and effective with no complications detected in children and adolescents.

Surgical Challenges in Multi-Vessel Minimally Invasive Coronary Artery Bypass Grafting

Objectives. Minimally invasive coronary artery bypass grafting (MICS CABG) has emerged as an alternative treatment for patients with multi-vessel coronary artery disease, but there are certain surgical challenges inherent in the adoption of this approach. The present study was conducted to provide insight regarding the outcomes associated with our first 118 cases, to discuss the surgical difficulties encountered in these patients, and to outline the potential countermeasures. Methods. Between January 2017 and January 2020, 118 patients underwent multi-vessel MICS CABG. These patients were stratified into two groups based upon whether they did or did not experience surgical challenges, and early clinical outcomes were compared between these groups to assess the incidence of technical difficulties and associated factors. Results. Surgical challenges arose in 38 of the 118 cases in this study, including 13 cases of exposure-related difficulties, 11 cases of proximal anastomosis-related difficulties, 15 cases of distal anastomosis-related difficulties, 4 cases of LITA-related difficulties, and 3 cases of lung-related difficulties. Relative to the other 80 patients, those patients for whom intraoperative technical challenges arose experience significant increases in operative duration (4.94 ± 0.89 vs. 5.59 ± 1.11 h, P = 0.001 ), intraoperative blood loss (667 ± 313 vs. 892 ± 532 mL, P = 0.005 ), length of the ICU admission (17.59 ± 3.51 vs. 22.59 ± 17.31 h, P = 0.015 ), and the duration of postoperative hospitalization (5.96 ± 1.23 vs. 6.71 ± 1.92 days, P = 0.012 ). There were no significant differences between these groups with respect to the mean graft number, major complications such as stroke or organ dysfunction, or one-year graft patency. Conclusions. There is a substantial learning curve associated with performing off-pump MICS CABG to treat multi-vessel disease. Surgical challenges encountered during this procedure may increase the operative duration, intraoperative blood loss, ICU admission, and the duration of postoperative hospitalization. However, these issues do not appear to compromise the efficacy of complete revascularization, and early clinical outcomes associated with this procedure remain acceptable.

Procedure and Clinical Success of Drug-Coated Balloon Fistuloplasty of the Drainage Vein in Dysfunctional Native Arteriovenous Fistulas

Purpose. Native arteriovenous fistulas (AVFs) are the most effective vascular access (VA) for haemodialysis. We aimed to evaluate the results of balloon angioplasty (fistuloplasty) from drainage vein performed for the treatment of AVF dysfunction in haemodialysis patients and examine potential patient and AVF-associated factors that might affect such results. Methods. This is a nonrandomized, retrospective, and single-centred study. A total of 105 balloon fistuloplasties were performed for dysfunctional AVFs of 82 haemodialysis patients. Patients were treated with a drug-coated balloon according to standard procedures. Evaluations were performed by physical examinations and if needed by color Doppler imaging in every 6 months. The primary endpoint was patency by balloon fistuloplasty. Patency was evaluated clinically by detecting the thrill in AVF and by the adequacy of the dialysis. Multidimensional scaling (MDS) technique was used as a method for the statistical analysis. Results. The success of the procedure after the first attempt was 85.3% with 70 patients. Patency in the 6th, 12th, 18th, and 24th months were 63 (76.8%), 60 (73.1%), 53 (64.6%), and 44 (54%), respectively. The procedure was considered successful when the thrill was detected in AVF and when dialysis was adequate. The statistical analysis by MDS revealed that patients’ age was the most effective factor acting on the procedure success followed by the age of AVF. Other patient-associated and AVF-associated factors were not found as effective statistical evaluation. Conclusions. Haemodialysis through native AVFs with restored functionality contributes positively to the life span and the quality of life of the patient. Probably, advanced age and high fistula age are unfavourable factors leading to the development of neointimal hyperplasia and venous stenosis. Balloon fistuloplasty of the draining vein is an effective and safe method regardless of patient age and the age of AVF.

Efficacy and Safety of Emergent Transcatheter Aortic Valve Implantation in Patients with Acute Decompensated Aortic Stenosis: Systematic Review and Meta-Analysis

Introduction. The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of emergent transcatheter aortic valve implantation (TAVI) in patients with decompensated aortic stenosis (AS) by comparing the clinical outcomes with the patients who had received the elective TAVI. Methods. By searching PubMed, EMBASE, and Cochrane databases, we obtained the studies comparing the clinical outcomes of emergent TAVI and elective TAVI. Finally, 14 studies were included. Results. A total of 14 eligible articles with 73,484 patients were included in this meta-analysis. Emergent TAVI was associated with a higher mortality during hospitalization (HR 2.09, 95% CI [1.39 to 3.14]), 30 days (HR 2.29, 95% CI [1.69 to 3.10]), and 1 year (HR 1.96, 95% CI [1.55 to 2.49]). Consistently, the incidence of acute kidney injury (AKI) (RR 2.48, 95% CI [1.85 to 3.32]), dialysis (RR 2.37, 95% CI [1.95 to 2.88]), bleeding (RR 1.62, 95% CI [1.27 to 2.08]), major bleeding (RR 1.05, 95% CI [1.00 to 1.10]), and 30-day rehospitalization (RR 1.30, 95% CI [1.07, 1.58]) were more common in patients receiving emergent TAVI. No statistical differences were found in the occurrence rate of vascular complications (RR 1.11, 95% CI [0.90, 1.36]), major vascular complications (RR 1.14, 95% CI [0.52, 2.52]), permanent pacemaker (PPM) placement (RR 1.05, 95% CI [0.99, 1.11]), cerebrovascular events (RR 1.11, 95% CI [0.98, 1.25]), moderate to severe paravalvular leakage (PVL) (RR 1.23, 95% [CI 0.94 to 1.61]), and device success (RR 0.99, 95% CI [0.97, 1.01]). Conclusion. Emergent TAVI is associated with some postoperative complications and increased mortality compared with elective TAVI. Emergent TAVI should be implemented cautiously and individually.

New Discovery of Left Atrial Macroreentry Tachycardia: Originating from the Spontaneous Scarring of Left Atrial Anterior Wall

Aims. This study sought to describe left atrial macroreentry tachycardia (LAMRT) originating from the spontaneous scarring of left atrial anterior wall (LAAW) and its clinical and electrophysiological characteristics, mechanisms, and the formation of substrates. Methods and Results. 9 of 123 patients (89% female, age 79.78 ± 5.59 years) had LAMRT originating from the LAAW with no cardiac surgery or prior left atrial (LA) ablation. The mean tachycardia cycle length (TCL) was 241.67 ± 38.00 milliseconds. Spontaneous scars areas and low voltage areas (LVAs) in the LAAW were found in all patients. Successful ablation of the critical isthmus caused termination of the LAMRT and was not inducible in all patients. Arrhythmogenic substrates of LAMRT were the spontaneous scars of LAAW, which matched with the aorta or/and pulmonary artery contact area. The area under the curve (AUC) of age and combination of gender and age for predicting the LAMRT originating from the LAAW were 0.918 and 0.951, respectively, with a cutoff value of ≥73.5 years of age and gender (female) predicting LAMRT with 88.9% sensitivity and 89% specificity. Conclusion. Combination of gender and age provides a simple and useful criterion to distinguish LAMRT from cavotricuspid isthmus- (CTI-) dependent atrial tachycardia in macroreentry atrial tachycardia (MRAT) in patients without a history of surgery or ablation. Aorta or/and pulmonary artery contacting LA may be related to spontaneous scars. Ablation the isthmus eliminated LAMRT in all patients.

The Clinical Outcomes of Ventricular Septal Rupture Secondary to Acute Myocardial Infarction: A Retrospective, Observational Trial

Background. Ventricular septal rupture (VSR) is a severe mechanical complication secondary to acute myocardial infarction (AMI) with a dreadful prognosis. The goal of our study was to evaluate the mortality and to identify the predictors of mortality for this population. Methods. From June 2012 to July 2021, patients with VSR secondary to AMI were initially screened for eligibility in this study. The potential risk predictors were determined using appropriate logistic regression models. Results. In this retrospective study, a total of 50 cases were included, and 14 patients survived and got discharged successfully. Univariable analyses indicated that the heart rate (HR), white blood cell (WBC) count, neutrophils count, serum glucose, serum creatinine, serum lactic acid, and the closure of rupture were significantly associated with mortality among these special populations. Conclusion. This study found that such high mortality in patients with VSR after AMI was significantly correlated with these risk factors representing sympathetic excitation and large infarct size. Coronary revascularization combined with the closure of rupture might be helpful in improving their prognosis.

Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion

Aims. To evaluate the vascular response after directional coronary atherectomy (DCA) for left main (LM) bifurcation lesion. Methods. This study was a retrospective, single-center study enrolling 31 patients who underwent stentless therapy using DCA followed by drug-coated balloon (DCB) angioplasty for LM bifurcation lesion. We compared intravascular ultrasound (IVUS) findings before and after DCA. Results. After DCA, the lumen and vessel areas significantly increased, whereas the plaque area (PA) and %PA were significantly reduced. When the lesions were divided into small vessel and large vessel groups using the median value of the vessel area, the maximum balloon pressure of the DCA catheter was greater in the large vessel group. Changes in the lumen and vessel areas were also significantly greater in the large vessel group. On the other hand, the changes in PA and %PA were similar between groups. Conclusions. The main vascular responses associated with lumen enlargement after DCA were plaque reduction and vessel expansion. Contribution of vessel expansion to lumen enlargement was larger than the effect of plaque reduction in large vessel lesions.