Worldwide CTEPH Registry: Long-Term Outcomes With Pulmonary Endarterectomy, Balloon Pulmonary Angioplasty, and Medical Therapy.

BACKGROUND: The European Chronic Thromboembolic Pulmonary Hypertension registry (CTEPH), conducted between 2007 and 2012, reported the major impact of pulmonary endarterectomy (PEA) on the long-term survival of patients with CTEPH. Since then, 2 additional treatments for inoperable CTEPH have become available: balloon pulmonary angioplasty (BPA), and an approved oral drug therapy with the guanylate cyclase stimulator riociguat. The current registry aimed to evaluate the effect of these new therapeutic approaches in a worldwide context. METHODS: Participation in this international global registry included 34 centers in 20 countries. Between February 2015 and September 2016, 1009 newly diagnosed, consecutive patients were included and followed until September 2019. RESULTS: Overall, 605 patients (60%) underwent PEA and 185 (18%) underwent BPA; 76% of the 219 remaining patients not receiving mechanical intervention (ie, neither PEA nor BPA) were treated with pulmonary hypertension drugs. Oof patients undergoing PEA and BPA, 38% and 78% also received drugs for pulmonary hypertension, respectively. Median age at diagnosis was higher in the BPA and No PEA/BPA groups than in the PEA group: 66 and 69, respectively, versus 60 years. Pulmonary vascular resistance (PVR) was similar in all groups, with an average of 643 dynes/(s·cm-5). During an observation period (>3 years; ≤5.6 years), death was reported in 7%, 11%, and 27% of patients treated by PEA and BPA, and those receiving no mechanical intervention (P<0.001). In Kaplan-Meier analysis, 3-year survival was 94%, 92%, and 71% in the 3 groups, respectively. PEA 3-year survival improved by 5% from that observed between 2007 and 2012. There was no survival difference in patients receiving vitamin K antagonists and non-vitamin K oral anticoagulants (P=0.756). In Cox regression, reduced mortality was associated with: PEA and BPA in the global cohort; history of venous thromboembolism and lower PVR in the PEA group; lower right atrial pressure in the BPA group; and use of pulmonary hypertension drugs, oxygen therapy, and lower right atrial pressure, as well as functional class in the group receiving no mechanical intervention. CONCLUSIONS: This second international CTEPH registry reveals important improvement in patient survival since the introduction of BPA and an approved drug for pulmonary hypertension. The type of anticoagulation regimen did not influence survival. REGISTRATION: URL https://clinicaltrials.gov; Unique identifier: NCT02656238.

Status and Future Directions for Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease With and Without Pulmonary Hypertension: A Scientific Statement From the American Heart Association.

Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension now give balloon pulmonary angioplasty a Class 1 recommendation for inoperable and residual chronic thromboembolic pulmonary hypertension. Not surprisingly, chronic thromboembolic pulmonary hypertension centers are rapidly initiating balloon pulmonary angioplasty programs. However, we need a comprehensive, expert consensus document outlining critical concepts, including identifying necessary personnel and expertise, criteria for patient selection, and a standardized approach to preprocedural planning and establishing criteria for evaluating procedural efficacy and safety. Given this lack of standards, the balloon pulmonary angioplasty skill set is learned through peer-to-peer contact and training. This document is a state-of-the-art, comprehensive statement from key thought leaders to address this gap in the current clinical practice of balloon pulmonary angioplasty. We summarize the current status of the procedure and provide a consensus opinion on the role of balloon pulmonary angioplasty in the overall care of patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. We also identify knowledge gaps, provide guidance for new centers interested in initiating balloon pulmonary angioplasty programs, and highlight future directions and research needs for this emerging therapy.

Status 2 upgrade indication impacts posttransplant mortality in patients bridged with intraaortic balloon pump in the new heart allocation system.

To evaluate outcomes of patients undergoing heart transplants (HTs) using an intra-aortic balloon pump (IABP) under exception status. Adult patients supported by an IABP who underwent HT between November 18, 2018, and December 31, 2020, as documented in the United Network for Organ Sharing, were included. Patients were stratified according to requests for exception status. Kaplan-Meier methodology was used to look for differences in survival between groups. A total of 1284 patients were included; 492 (38.3%) were transplanted with an IABP under exception status. Exception status patients had higher body mass index, were more likely to be Black, and had longer waitlist times. Exception status patients received organs from younger donors, had a shorter ischemic time, and had a higher frequency of sex mismatch. The 1-year posttransplant survival was 93% for the nonexception and 88% for the exception IABP patients (hazard ratio: 1.85 [95% confidence interval: 1.12-2.86, P = .006]). The most common reason for requesting an exception status was inability to meet blood pressure criteria for extension (37% of patients). The most common reason for an extension request for an exception status was right ventricular dysfunction (24%). IABP patients transplanted under exception status have an increased 1-year mortality rate posttransplant compared with those without exception status.

Endoscopic Approaches to Obesity Management.

The field of endoscopic bariatric and metabolic therapy has rapidly evolved from offering endoscopic treatment of weight regain following bariatric surgery to providing primary weight loss options as alternatives to pharmacologic and surgical interventions. Gastric devices and remodeling procedures were initially designed to work through a mechanism of volume restriction, leading to earlier satiety and reduced caloric intake. As the field continues to grow, small bowel interventions are evolving that may have some effect on weight loss but focus on the treatment of obesity-related comorbidities. Future implementation of combination therapy that utilizes both gastric and small bowel interventions offers an exciting option to further augment weight loss and alleviate metabolic disease. This review considers gastric devices and techniques including space-occupying intragastric balloons, aspiration therapy, endoscopic tissue suturing, and plication interventions, followed by a review of small bowel interventions including endoluminal bypass liners, duodenal mucosal resurfacing, and endoscopically delivered devices to create incisionless anastomoses.

Hemodynamic simulation of complete transposition of the great arteries for optimal treatment strategies based on its circulatory physiology.

Our study aimed to elucidate the role of different shunts and provide novel insights into optimal treatment approaches for complete transposition of the great arteries (TGA), which is characterized by unique and complicated circulatory dynamics. We constructed a computational cardiovascular TGA model and manipulated cardiovascular parameters, such as atrial septal defect (ASD) and patent ductus arteriosus (PDA) sizes, to quantify their effects on oxygenation and hemodynamics. In addition, ASD flow patterns were investigated as innovative indications for balloon atrial septostomy (BAS). Our model of TGA with an intact ventricular septum (TGA-IVS) showed that a large ASD can achieve sufficient mixing for survival without PDA, and the presence of PDA is detrimental to oxygen delivery. A treatment strategy for TGA-IVS that enlarges the ASD as much as possible by BAS and PDA closure would be desirable. In TGA with a ventricular septal defect (TGA-VSD), the VSD allows for higher oxygenation and reduces the detrimental effects of PDA on systemic circulation. In TGA-VSD, both strategies of enlarging the ASD by BAS with a closed PDA and adjusting the PDA in response to pulmonary vascular resistance (PVR) reduction without BAS may be effective. The simulated ASD flow patterns showed that the sharp peak left-to-right flow pattern in systole (σ-wave) reflected the hemodynamically significant ASD size, independent of PDA, VSD, and PVR. The ASD flow pattern visualized by Doppler echocardiography provides clinical insights into the significance of an ASD and indications for BAS, which are not readily apparent through morphological assessment.NEW & NOTEWORTHY Complete transposition of the great arteries (TGA) represents complex and unique circulation that is dependent on blood mixing through multiple interacting shunts. Consequently, the role of each shunt and the treatment strategy remain unclear. We developed a mathematical model of TGA circulation, revealing the significant influence of atrial septal defect (ASD) on oxygenation and hemodynamics. The blood flow pattern through the ASD reflects its hemodynamic impact and helps determine treatment strategies.

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry.

BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings. RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Comparison of endovascular therapies for chronic limb-threatening ischemia and claudication.

OBJECTIVE: Analysis of regional data from the Vascular Quality Initiative (VQI) suggested improved survival for patients undergoing stent placement compared with balloon angioplasty and atherectomy. Using national data from the VQI linked to Medicare claims data through the Vascular Implant Surveillance and Interventional Outcomes Network program, this study aimed to compare the rates of mortality, reintervention, and amputation after endovascular interventions (atherectomy, stenting, and balloon angioplasty) for two separate cohorts: patients with chronic limb-threatening ischemia (CLTI) and patients with claudication. METHODS: This was a secondary data analysis of Society for Vascular Surgery National VQI data linked to Medicare claims, between October 2016 and December 2019. Patients aged ≥65 years with symptoms of claudication or CLTI and a diagnosis of occlusive disease were included. Urgent or emergent interventions or those with concurrent procedures (endarterectomy, bypass, or bilateral intervention) were excluded. Interventions were grouped into (1) balloon angioplasty only; (2) stent (with or without balloon angioplasty); or (3) atherectomy (alone, with or without stent, with or without balloon angioplasty). Propensity score-matched cohorts were constructed to conduct pairwise intervention comparisons of mortality, reintervention, and amputation rates. Multivariable logistic regression was used to derive propensity scores for each patient. Kaplan-Meier estimates and Cox proportional hazards ratios (HRs) (95% confidence interval [CI]) analyses were performed. RESULTS: A total of 9785 (2665 claudication, 7120 CLTI) eligible patients were identified. After propensity score matching for the CLTI group, 2826, 3608, and 2796 pairs of cases were used to compare balloon angioplasty vs atherectomy, balloon angioplasty vs stent, and stent vs atherectomy, respectively. No statistically significant difference in mortality was observed among all interventions. However, atherectomy was associated with a significant increase in reintervention rate compared with balloon angioplasty (HR, 1.22; 95% CI, 1.06-1.39; P = .01) and compared with stenting (HR, 1.27; 95% CI, 1.10-1.46; P < .01) within the first year after the index procedure. Of note, both atherectomy (HR, 0.82; 95% CI, 0.68-0.98; P < .05) and stenting (HR, 0.76; 95% CI, 0.64-0.90; P < .01) showed lower rates of major amputation when compared with balloon angioplasty within 1 year after the index procedure. In the claudication group, there were no significant differences observed among interventions for peripheral arterial disease for mortality, reintervention, or amputation rates. CONCLUSIONS: Further studies are needed to identify appropriate indications for atherectomy, because there may be a subset of patients with CLTI who benefit from this therapy with respect to amputation rates. Until then, caution should be exercised when using atherectomy because it is also associated with higher reintervention rates.

Mid-term Outcomes of the Viabahn VBX® Balloon-Expandable Covered Stent for Fenestrations During Complex Endovascular Aortic Aneurysm Repair (EVAR).

OBJECTIVES: The optimal bridging stent for fenestrations during complex endovascular aortic aneurysm repair (EVAR) has not been defined. At our institution, the Viabahn VBX® is frequently used given its availability and mechanical and heparin-bonding characteristics. This study aims to assess the performance of the Viabahn VBX® versus the iCast® balloon-expandable covered stents as bridging stents for fenestrations during complex EVAR. METHODS: A retrospective study of consecutive patients undergoing complex EVAR between 2015 and 2021 was performed. Celiac arteries (CAs), superior mesenteric arteries (SMAs), left renal arteries (LRAs), and right renal arteries (RRAs) stented with fenestrations were grouped according to the type of bridging stent, VBX® versus iCast®. Target vessels (TV) stented with a branch or scallop were excluded. The primary endpoints included primary patency and freedom from target vessel instability (TVI). RESULTS: A total of 292 patients undergoing complex EVAR were treated using VBX® or iCast® with a mean follow-up of 190 days (interquartile range [IQR], 36-384) for the VBX® cohort and 804 days (IQR, 384-1507) for the iCast® cohort. A total of 677 TVs were stented, including 134 (20%) CAs, 175 (26%) SMAs, 182 (27%) LRAs, 186 (27%) RRAs, and 12 (2%) additional vessels. Proximal reinforcement was more frequent with VBX than with iCast® stent (23% vs. 2.4%, P <.0001). There was no difference in primary patency rates at 2-year between VBX® and iCast® stent for CA (100% vs. 96.4%; P=.32), SMA (97.8% vs. 100%; P=.14) and renal arteries (96.7% vs. 99.4%; P=.11). There was no difference between VBX® and iCast® in the cumulative incidence of type Ic and type IIIc endoleaks (3.2% vs. 5.6%; P=.69) or freedom from TVI at 2 years. CONCLUSION: Viabahn VBX® stents are a safe and effective option as bridging stents in fenestrations during complex EVAR with comparable mid-term outcomes to iCast® stents. However, proximal stent reinforcement may be required with VBX stent to ensure adequate sealing at the fenestrations. Longer follow-ups and larger series are required to assess long-term outcomes and durability.

Surveillance and risk factors for early restenosis following transcarotid artery revascularization.

OBJECTIVE: Restenosis after transcarotid artery revascularization (TCAR) is a known complication. When identified in the early postoperative period, it may be related to technique. We evaluated our TCAR experience to identify potentially modifiable factors impacting restenosis. METHODS: This is a single-institution, retrospective review of patients undergoing TCAR from November 2017 to July 2022. Restenosis was defined as >50% stenosis on duplex ultrasound (DUS) examination or computed tomographic angiography (CTA). Continuous variables were compared using Kruskal-Wallis's test. Categorical variables were compared using the Fisher's exact test. RESULTS: Of 61 interventions, 11 (18%) developed restenosis within the median follow-up of 345 days (interquartile range, 103-623 days). Among these patients, 82% (9/11) had >50% stenosis, and 18% (2/11) had >80% stenosis. Both patients with high-grade restenosis were symptomatic and underwent revascularization. Diagnosis of post-TCAR restenosis was via DUS examination in 45% (5/11), CTA in 18% (2/11), or both CTA/DUS examination in 36% (4/11). Restenosis occurred within 1 month in 54% (6/11) and 6 months in 72% (8/11) of patients. However, three of the six patients with restenosis within 1 month had discordant findings on CTA vs DUS imaging. Patient comorbidities, degree of preoperative stenosis, medical management, balloon size, stent size, lesion characteristics, and predilatation angioplasty did not differ. Patients with restenosis were younger (P = .02), had prior ipsilateral endarterectomy (odds ratio [OR], 6.5; P = .02), had history of neck radiation (OR, 18.3; P = .01), and lower rate of postdilatation angioplasty (OR, 0.11; P = .04), without an increased risk of neurological events. CONCLUSIONS: Although post-TCAR restenosis occurred in 18% of patients, only 3% of patients had critical restenosis and required reintervention. Patient factors associated with restenosis were younger age, prior endarterectomy, and history of neck radiation. Although early restenosis may be mitigated by improved technique, the only technical factor associated with restenosis was less use of postdilatation angioplasty. Balancing neurological risk, this factor may have increased application in appropriate patients. Diagnosis of restenosis was inconsistent between imaging modalities; current surveillance paradigms and diagnostic thresholds may warrant reconsideration.

A Review on Emerging Techniques for Diagnosis of Colorectal Cancer.

Common detection methods in practice for diagnosing colorectal cancer (CRC) are painful and invasive leading to less participation of individuals for CRC diagnosis. Whereas, improved or enhanced imaging systems and other minimally invasive techniques with shorter detection times deliver greater detail and less discomfort in individuals. Thus, this review is a summary of the diagnostic tests, ranging from the simple potential use in developing a flexible CRC treatment to the patient's potential benefits in receiving less invasive procedures and the advanced treatments that might provide a better assessment for the diagnosis of CRC and reduce the mortality related to CRC.

Current Balloon Devices for Ablation of Atrial Fibrillation.

Balloon-based catheter ablation is a valuable option for the treatment of atrial fibrillation (AF) because contiguous lesions can be created to achieve pulmonary vein isolation (PVI), and the method is less dependent than traditional ablation methods on the operator's skill and experience. Cryoballoon ablation is used universally worldwide, with its efficacy and safety being comparable to the efficacy and safety of standard radiofrequency ablation, and the procedure can be completed in a relatively short time. Hot balloon ablation was developed in Japan. The balloon maintains its compliance even during the energy delivery, and a large areal ablation lesion is created. Furthermore, the hot balloon system is the only system for which oesophageal cooling is a standard feature. Laser balloon ablation, which is performed under direct endoscopic vision, has proven to be effective and safe for achieving a PVI. The laser balloon system provides an improved field of view and automated circumferential ablation for a rapid and effective PVI. The authors have reviewed the currently available balloon systems as used for AF ablation, i.e., PVI, and have provided detailed insight and perspectives on the currently available cryoballoon and hot balloon technologies, plus laser balloon technology.

Efficacy and Safety of Laser Balloon Versus Irrigated Radiofrequency Ablation as Initial Therapies for Atrial Fibrillation: A Meta-Analysis.

Background: Catheter ablation (CA) is an effective therapy for atrial fibrillation (AF) and, although radiofrequency ablation (RFA) is the standard treatment for pulmonary vein isolation (PVI), it is complex and time-consuming. Laser balloon ablation (LBA) has been introduced to simplify the conventional RFA; however, results of studies comparing LBA and RFA remain controversial. As such, this investigation aimed to comprehensively evaluate the efficacy and safety of LBA versus RFA. Methods: The PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched for relevant studies. The primary endpoints were the freedom from atrial tachyarrhythmia (ATA) and procedure-related complications. Results: Twelve studies including 1274 subjects were included. LBA and RFA yielded similar rates of freedom from ATA (72.5% vs. 68.7%, odds ratio [OR] = 1.26, 95% confidence interval [CI] 1.0-1.7, p = 0.11) and procedure-related complications (7.7% vs. 6.5%, OR = 1.17, 95% CI 0.72-1.90, p = 0.536). LBA with the second- and third-generation laser balloons (LB2/3) yielded remarkably higher rates of freedom from ATA than RFA using contact-force technology (RFA-CF) (OR = 1.91, p = 0.013). Significantly lower pulmonary vein (PV) reconnection rates (OR = 0.51, p = 0.021), but higher phrenic nerve palsy (PNP) rates (OR = 3.42, p = 0.023) were observed in the LBA group. LBA had comparable procedure (weighted mean difference [WMD] = 8.43 min, p = 0.337) and fluoroscopy times (WMD = 3.09 min, p = 0.174), but a longer ablation time (WMD = 12.57 min, p = 0.00) than those for RFA. Conclusions: LBA and RFA treatments were comparable in terms of freedom from ATA and postprocedural complications in patients with AF. Compared with RFA, LBA was associated with significantly lower PV reconnection rates, but a higher incidence of PNP and longer ablation time.

Comparison of Jailed Wire and Jailed Balloon for Prevention of Side Branch Occlusion in Provisional Stenting: Evidence from a Systematic Review and Meta-Analysis.

Background: Side branch (SB) occlusion after main vessel stenting is the main complication in treating coronary bifurcation lesions by provisional stenting. The Jailed Wire Technique (JWT), recommended by the European Bifurcation Club, is a standard technique to deal with this issue. The Jailed Balloon Technique (JBT) has been found to be more effective than the JWT in clinical practice by some interventionists, but it has not been widely accepted. In this meta-analysis, we compared the efficacy and safety of JBT and JWT. Methods: The literature comparing JBT and JWT was systematically reviewed. Stata/MP 17.0 was used to perform a meta-analysis. The primary endpoints were major adverse cardiac events (MACE), cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). The secondary endpoints were SB occlusion and SB dissection. Aggregated odds ratios and 95% confidence intervals were calculated. A sensitivity analysis was conducted if I 2 was > 50% or p < 0.01. Results: Thirteen studies involving 1789 patients were enrolled. JBT was found to have a significantly lower incidence of MACE, SB occlusion and dissection. The incidence of cardiac death, MI and TLR were also lower in the JBT group, though the differences were not significant. Conclusions: JBT prevents SB occlusion more effectively and does not increase immediate or long-term complications. JBT, or its modified versions, can be used to treat SBs with a high risk of occlusion.

Effects of right ventricular remodeling in chronic thromboembolic pulmonary hypertension on the outcomes of balloon pulmonary angioplasty: a 2D-speckle tracking echocardiography study.

BACKGROUND: Balloon pulmonary angioplasty (BPA) improves the prognosis of chronic thromboembolic pulmonary hypertension (CTEPH). Right ventricle (RV) is an important predictor of prognosis in CTEPH patients. 2D-speckle tracking echocardiography (2D-STE) can evaluate RV function. This study aimed to evaluate the effectiveness of BPA in CTEPH patients and to assess the value of 2D-STE in predicting outcomes of BPA. METHODS: A total of 76 patients with CTEPH underwent 354 BPA sessions from January 2017 to October 2022. Responders were defined as those with mean pulmonary artery pressure (mPAP) ≤ 30 mmHg or those showing ≥ 30% decrease in pulmonary vascular resistance (PVR) after the last BPA session, compared to baseline. Logistic regression analysis was performed to identify predictors of BPA efficacy. RESULTS: BPA resulted in a significant decrease in mPAP (from 50.8 ± 10.4 mmHg to 35.5 ± 11.9 mmHg, p < 0.001), PVR (from 888.7 ± 363.5 dyn·s·cm-5 to 545.5 ± 383.8 dyn·s·cm-5, p < 0.001), and eccentricity index (from 1.3 to 1.1, p < 0.001), and a significant increase in RV free wall longitudinal strain (RVFWLS: from 15.7% to 21.0%, p < 0.001). Significant improvement was also observed in the 6-min walking distance (from 385.5 m to 454.5 m, p < 0.001). After adjusting for confounders, multivariate analysis showed that RVFWLS was the only independent predictor of BPA efficacy. The optimal RVFWLS cutoff value for predicting BPA responders was 12%. CONCLUSIONS: BPA was found to reduce pulmonary artery pressure, reverse RV remodeling, and improve exercise capacity. RVFWLS obtained by 2D-STE was an independent predictor of BPA outcomes. Our study may provide a meaningful reference for interventional therapy of CTEPH.

Comparing the efficacy and pregnancy outcome of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis in infertile women: a prospective, randomized, controlled trial study.

STUDY OBJECTIVE: To evaluate the efficacy and pregnancy outcomes of intrauterine balloon and intrauterine contraceptive devices in the prevention of adhesion reformation following hysteroscopic adhesiolysis in infertile women with moderate to severe intrauterine adhesion. DESIGN: A prospective, randomized, controlled trial study. SETTING: A tertiary university hospital. PATIENTS: A total of 130 patients with moderate (American Fertility Society [AFS] score of 5-8) and severe (AFS score of 9-12) intrauterine adhesions were recruited. INTERVENTIONS: 86 patients were evenly allocated to group treated with an IUD for 1 month and group treated with an IUD for 2 months. 44 patients were allocated to group treated with a Foley catheter balloon.(IUD: Yuangong IUD). MEASUREMENTS AND MAIN RESULTS: The primary outcome measures were the AFS score, endometrial thickness, and pregnancy outcome. After hysteroscopy, the AFS score was significantly decreased(P<0.05), whereas endometrial thickness was significantly increased across the three groups(P<0.001). Notably, the decline in the AFS score in the balloon group was greater than that in the IUD-1-month group and IUD-2-month group(P<0.01), with no significant difference between the IUD groups(P = 0.298). Lastly, In addition, the extent of the increase in endometrial thickness(P = 0.502) and the pregnancy outcomes(P = 0.803) in the three groups were not significantly different. CONCLUSION: Inserting a balloon or placing an IUD for one or two months can effectively lower the risk of adhesion recurrence and restore the shape of the uterine cavity. While the therapeutic effect of the balloon was superior to that of the IUD, no significant differences were observed in the one-month and two-month IUD groups. TRIAL REGISTRATION: This research was registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/enIndex.aspx ); Clinical trial registry identification number: ChiCTR-IOR-17,011,943 ( http://www.chictr.org.cn/showprojen.aspx?proj=17979 ). Date of trial registration: July 11, 2017.

The employment of resuscitative endovascular balloon occlusion of the aorta in deployed settings.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has been often used in place of open aortic occlusion for management of hemorrhagic shock in trauma. There is a paucity of data evaluating REBOA usage in military settings. STUDY DESIGN AND METHODS: We queried the Department of Defense Trauma Registry (DODTR) for all cases with at least one intervention or assessment available within the first 72 h after injury between 2007 and 2023. We used relevant procedural codes to identify the use of REBOA within the DODTR, and we used descriptive statistics to characterize its use. RESULTS: We identified 17 cases of REBOA placed in combat settings from 2017 to 2019. The majority of these were placed in the operating room (76%) and in civilian patients (70%). A penetrating mechanism caused the injury in 94% of cases with predominantly the abdomen and extremities having serious injuries. All patients subsequently underwent an exploratory laparotomy after REBOA placement, with moderate numbers of patients having spleen, liver, and small bowel injuries. The majority (82%) of included patients survived to hospital discharge. DISCUSSION: We describe 17 cases of REBOA within the DODTR from 2007 to 2023, adding to the limited documentation of patients undergoing REBOA in military settings. We identified patterns of injury in line with previous studies of patients undergoing REBOA in military settings. In this small sample of military casualties, we observed a high survival rate.

A novel approach to alleviate acetaminophen-induced hepatotoxicity with hybrid balloon flower root-derived exosome-like nanoparticles (BDEs) with silymarin via inhibition of hepatocyte MAPK pathway and apoptosis.

INTRODUCTION: Balloon flower root-derived exosome-like nanoparticles (BDEs) have recently been proposed as physiologically active molecules with no cytotoxicity. However, the therapeutic effects of drug-induced hepatotoxicity of BDEs have not been elucidated. BDEs contain a large amount of platycodin D, which is widely known to be effective in regulating inflammation and ameliorating systemic toxicity. Thus, the main therapeutic activity of BDEs is attributed to inhibiting the inflammatory response and alleviating toxicity. In this study, we fabricated the hybrid BDEs fused with liposomes containing silymarin (SM) to enhance the synergistic effect on inhibition of acetaminophen-induced hepatotoxicity (APAP). OBJECTIVE: Considering the potential therapeutic effects of BDEs, and the potential to achieve synergistic effects to improve therapeutic outcomes, we constructed hybrid BDEs with a soy lecithin-based liposome loaded with SM. Since liposomes can provide higher thermal stability and have greater structural integrity, these might be more resistant to clearance and enzymatic degradation of drug molecules. METHODS: Hybrid BDEs with liposome-loaded SM (BDEs@lipo-SM) were fabricated by thin-film hydration and extrusion. BDEs@lipo-SM were characterized using dynamic light scattering and high-performance liquid chromatography. After confirmation of the physical properties of BDEs@lipo-SM, various therapeutic properties were evaluated. RESULTS: BDEs@lipo-SM were internalized by hepatocytes and immune cells and significantly decreased mRNA expression of apoptosis and inflammation-relevant cytokines by inhibiting the hepatocyte MAPK pathway. BDEs@lipo-SM significantly induced an increase in glutathione levels and inhibited APAP-induced hepatotoxicity. CONCLUSION: From this study, we know that BDEs are reliable and safe nanovesicles containing natural metabolites derived from balloon flower, and they can facilitate intercellular communication. BDEs are also easily modified to enhance drug loading capacity, targeting effects, and long-term accumulation in vivo. BDEs@lipo-SM have therapeutic benefits for acute liver injury and can alleviate cell death and toxicity. They can be efficiently delivered to the liver and effectively inhibit APAP-induced hepatotoxicity by inhibiting the MAPK signaling pathway and apoptosis, which accelerates liver recovery in the APAP-induced acute liver injury model. These findings highlight that BDEs represent an attractive delivery vehicle for drug delivery.

Kidney disease, diabetes, and diameter stenosis predict Rotablation bailout in modified balloon application for severely calcified coronary lesions.

BACKGROUND: Modified balloon (MB) treatment in severely calcified coronary artery lesions is an established technique. However, some lesions require Rotablation (RA) as bailout strategy. AIMS: This study aimed to assess predictors of switch from MB to RA and its impact on procedural and midterm outcomes. METHODS: Four hundred and eighty-three consecutive patients were included undergoing MB treatment (n = 204) with a scoring or cutting balloon, or upfront RA treatment (n = 279) serving as control cohort. Strategy switch from MB to RA was performed in 19 of 204 patients. Procedural success was defined as successful stent implantation and TIMI III flow. RESULTS: In the MB cohort, median age was 72 [63-78] years, 75.5% were male and 42.1% had acute coronary syndrome. Procedure success was achieved in 89.4% of the switch group versus 98.4% of the MB only group (p < 0.001) and in 96.4% of the RA cohort. In the switch group, periprocedural complications (31.6% vs. 8.1% vs. 11.8%, p = 0.007), radiation dose (149 [126-252] vs. 59 [30-97] vs. 102 [59-156] Gcm2; p < 0.001) and contrast volume (250 [190-250] vs. 190 [150-250] vs. 195 [190--250] mL; p < 0.001) were significantly higher. Diabetes (OR 3.8, 95% CI 1.1-13.9, p = 0.042), chronic kidney disease stage 4 or 5 (OR 19.0, 95% CI 3.3-108.6, p < 0.001) and pronounced calcification resulting in higher angiographic diameter stenosis (OR 1.13, 95% CI 1.1-1.2, p = 0.001) independently predicted strategy switch. Midterm results were not affected by strategy switch regarding 1-year target lesion revascularization rates (86% vs. 89% vs. 89%; log-rank p = 0.95). CONCLUSION: Primary RA strategy might be considered in patients with severely calcified coronary artery lesions with high angiographic diameter stenosis, diabetes or impaired renal function due to increased periprocedural complication rates, radiation dose, and contrast volume following strategy switch.

Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis.

BACKGROUND: Although use of sirolimus-based analogs has shown superiority over paclitaxel in drug-eluting stents, the relative efficacy of these two agents released from drug-coated balloons (DCB) is unclear. The present meta-analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel-coated balloons (PCB) versus sirolimus-coated balloons (SCB) for either in-stent restenosis or native de novo lesions. METHODS: The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow-up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random-effects models. RESULTS: A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9-12 months of follow-up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75-1.35) between the two groups. On follow-up angiography at 6-9 months, MLD (WMD 0.10, 95% CI 0.02-0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD -0.11, 95% CI -0.23-0.02) and diameter stenosis (WMD -3.33, 95% CI -8.11-1.45). CONCLUSIONS: Among patients undergoing DCB-only PCI, the risk of TLF was similar during 9-12 months of follow-up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow-up angiography.

The impact of novel scoring balloon and cutting balloon after orbital atherectomy on severely calcified coronary lesion as assessed by optical coherence tomography.

BACKGROUND: Debulking devices are often followed by a scoring or cutting balloon in percutaneous coronary intervention (PCI) for severely calcified lesions. However, there are limited data on balloon preparation after orbital atherectomy (OA) assessed using optical coherence tomography (OCT). AIM: We aimed to compare the effects of a novel scoring and cutting balloon on calcified coronary lesions with OCT. METHODS: We retrospectively examined 38 patients (38 lesions) who underwent PCI with a scoring or a cutting balloon after OA. All patients underwent pre-PCI, preballooning, postballooning, and post-PCI OCT imaging. We divided the patients into novel scoring-balloon (group A: n = 22) and cutting-balloon (group B: n = 16) groups and compared the OCT findings, including minimum lumen area (MLA) and expansion ratio (MLA divided by mean reference lumen area). RESULTS: The mean patient age was 76.1 ± 8.7 years; 71.5% were male. There were no significant differences in patient background between both groups. Regarding procedural characteristics, the maximum balloon pressure was significantly higher in group A (median 23 atm, interquartile range [IQR] 18-24 vs. 12 atm [IQR: 10-12], p < 0.01). Although a calcium score of 4 was more frequently observed in group A (86.4% vs. 62.5%, p = 0.12), post-PCI MLA was comparable between both groups (3.95 mm2 [IQR: 3.27-4.41] vs. 3.43 mm2 [IQR: 2.90-4.82], p = 0.63). Furthermore, the expansion ratio was significantly greater in group A (0.83 ± 0.20 vs. 0.68 ± 0.14, p < 0.01). CONCLUSION: Despite a higher calcium score, a larger expansion ratio was achieved in patients with a novel scoring balloon than in those with a cutting balloon after OA.