Safety and efficacy of balloon angioplasty compared to stent-basedstrategies with pulmonary vein stenosis:A systematic review and meta-analysis

BACKGROUND Pulmonary vein stenosis(PVS)is an uncommon but known cause of morbidity and mortality in adults and children and can be managed with percutaneous revascularization strategies of pulmonary vein balloon angioplasty(PBA)or pulmonary vein stent implantation(PSI).AIM To study the safety and efficacy outcomes of PBA vs PSI in all patient categories with PVS.METHODS We performed a literature search of all studies comparing outcomes of patients evaluated by PBA vs PSI for PVS.We selected all published studies comparing PBA vs PSI for PVS with reported outcomes of restenosis and procedure-related complications in all patient categories.In adults,PVS following atrial fibrillation ablation and in children PVS related to congenital etiology or post-procedural PVS following total or partial anomalous pulmonary venous return repair were included.The patient-centered outcomes were risk of restenosis requiring re-intervention and procedural-related complications.The metaanalysis was performed by computing odds ratios(ORs)using the random effects model based on underlying statistical heterogeneity.RESULTS Eight observational studies treating 768 severe PVS in 487 patients met our inclusion criteria.The age range of patients was 6 months to 70 years and 67%were males.The primary outcome of the re-stenosis requiring re-intervention occurred in 196 of 325 veins in the PBA group and 111 of 443 veins in the PSI group.Compared to PSI,PBA was associated with a significantly increased risk of re-stenosis(OR 2.91,95%CI:1.15-7.37,P=0.025,I2=79.2%).Secondary outcomes of the procedurerelated complications occurred in 7 of 122 patients in the PBA group and 6 of 69 in the PSI group.There were no statistically significant differences in the safety outcomes between the two groups(OR:0.94,95%CI:0.23-3.76,P=0.929,I^(2)=0.0%).CONCLUSION Across all patient categories with PVS,PSI is associated with reduced risk of re-intervention and is as safe as PBA and should be considered first-line therapy for PVS.

Primary balloon angioplasty for chronic occlusion of intracranial internal carotid artery: A case report

Chronic occlusion of large intracranial arteries is the main cause of ischemic stroke in China.Patients with symptomatic intracranial artery occlusion and hemodynamic impairment are at high risk of recurrent stroke.Chronic occlusion of the intracranial segment of the internal carotid artery is a common type of intracranial artery occlusion.Medical management is regarded as the standard treatment for this disease.With the development of endovascular treatment,some patients with chronic cerebral artery occlusion have achieved satisfactory results with endovascular therapy.We reported a patient with symptomatic chronic occlusion of the ophthalmic segment of the internal carotid artery.Simple balloon angioplasty was performed,and the occluded ophthalmic segment of the internal carotid artery was successfully recanalized without perioperative complications.At 4 months followup,the internal carotid artery remained patent and perfusion of the right cerebral hemisphere improved dramatically.In addition,we briefly reviewed the relevant literature.

Preliminary experience with drug-coated balloon angioplasty in primary percutaneous coronary intervention

We evaluated the clinical feasibility of using drugcoated balloon(DCB) angioplasty in patients undergoingprimary percutaneous coronary intervention(PPCI). Between January 2010 to September 2014,89 STelevation myocardial infarction patients(83% male,mean age 59 ± 14 years) with a total of 89 coronary lesions were treated with DCB during PPCI. Clinical outcomes are reported at 30 d follow-up. Left anterior descending artery was the most common target vessel for PCI(37%). Twenty-eight percent of the patients had underlying diabetes mellitus. Mean left ventricular ejection fraction was 44% ± 11%. DCB-only PCI was the predominant approach(96%) with the remaining 4% of patients receiving bail-out stenting. Thrombolysis in Myocardial Infarction(TIMI) 3 flow was successfully restored in 98% of patients. An average of 1.2 ± 0.5 DCB were used per patient,with mean DCB diameter of 2.6 ± 0.5 mm and average length of 23.2 ± 10.2 mm. At 30-d follow-up,there were 4 deaths(4.5%). No patients experienced abrupt closure of the infarctrelated artery and there was no reported target-lesion failure. Our preliminary experience showed that DCB angioplasty in PPCI was feasible and associated with a high rate of TIMI 3 flow and low 30-d ischaemic event.

Drug coated balloon angioplasty for renal artery stenosis due to Takayasu arteritis: Report of five cases

BACKGROUND Takayasu arteritis is a rare but intractable chronic disease in young female patients. Percutaneous transluminal angioplasty of the involved renal arteries has been reported;however, few studies have reported the use of drug coated balloon angioplasty in the treatment of Takayasu arteritis. We aimed to demonstrate five young female patients who presented with a history of hypertension due to Takayasu arteritis. CASE SUMMARY From April 2017 to October 2018, five female patients were diagnosed with hypertension due to Takayasu arteritis by computed tomography angiography (CTA) and laboratory tests. Four patients had a complaint of headache with or without dizziness, and one patient showed no symptom. There was no significant family or past history of hypertension or kidney disease, and the physical examinations were almost normal on admission. We performed a treatment by drug coated balloon angioplasty. Blood pressure decreased dramatically in all patients after balloon angioplasty, and the patency of treated renal artery was demonstrated with CTA over 5 months after the angioplasty procedure. CONCLUSION Drug coated balloon angioplasty is safe and effective for renal artery stenosis due to Takayasu arteritis. A prospective study with a larger sample size is necessary to further demonstrate the effectiveness of the treatment.

Percutaneous transluminal angioplasty balloons for endoscopic ultrasound-guided pancreatic duct interventions

BACKGROUND Endoscopic ultrasound(EUS)-guided main pancreatic duct(PD)access may be used when conventional endoscopic retrograde cholangiopancreatography(ERCP)techniques fail.The use of a percutaneous transluminal angioplasty balloon(PTAB),originally developed for vascular interventions,can be used to facilitate transmural(e.g.,transgastric)PD access and to dilate high-grade pancreatic strictures.AIM To describe the technique,efficacy,and safety of PTABs for EUS-guided PD interventions.METHODS Patients who underwent EUS with use of a PTAB from March 2011 to August 2021 were retrospectively identified from a tertiary care medical center supply database.PTABs included 3-4 French angioplasty catheters with 3-4 mm balloons designed to use over a 0.018-inch guidewire.The primary outcome was technical success.Secondary outcomes included incidence of adverse events(AEs)and need for early reintervention.RESULTS A total of 23 patients were identified(48%female,mean age 55.8 years).Chronic pancreatitis was the underlying etiology in 13(56.5%)patients,surgically altered anatomy(SAA)with stricture in 7(30.4%),and SAA with post-operative leak in 3(13.0%).Technical success was achieved in 20(87%)cases.Overall AE rate was 26%(n=6).All AEs were mild and included 1 pancreatic duct leak,2 cases of post-procedure pancreatitis,and 3 admissions for post-procedural pain.No patients required early re-intervention.CONCLUSION EUS-guided use of PTABs for PD access and/or stricture management is feasible with an acceptable safety profile and can be considered in patients when conventional ERCP cannulation fails.

Long-Term Results of Balloon Angioplasty for Native Coarctation of the Aorta in the Surgical Specialty Teaching Hospital/Cardiac Center/Hawler

Background: Coarctation of aorta is a common congenital cardiac malformation;controversy has surrounded the use of balloon angioplasty for native coarctation of aorta as the primary treatment for patients with various ages with coarctation. Aim: This study aimed to assess the long term outcome of balloon angioplasty especially concerning aneurysm formation. Patients and Methods: A case series (case follow-up) study was carried out on a total of 50 patients (31 male and 19 female) with native coarctation of aorta aged 1 - 21 years of age who were treated with balloon angioplasty for more than 1 year at the time of follow up evaluation in surgical specialty hospital/cardiac center in Erbil Iraq. They were recalled and subjected to detail clinical examination, body weight, height, blood pressure measurements. Radiographic, Echo Doppler data, CT angiography were obtained. CT angiography was done for 34 patients. Full echocardiographic evaluation was done in follow up visits. Results: There was a significant reduction in the peak instantaneous pressure gradient across the coarctated area by Doppler echocardiogram gradient before balloon angioplasty and at the follow up visit from 56.92 ± 14.6 mmHg to 30.68 ± 16.89, P = 0.00. Six cases of total 50 patients had evidence of diastolic runoff pattern by Doppler Echcardiogram. While the only 6 of total 34 cases had the report of CT angiography that documented aneurysm formation (12%). Conclusions: Balloon angioplasty of native aortic coarctation can be performed safely and effectively with good immediate outcome. Furthermore, it offers satisfactory long-term results with low incidence of persisting restenosis, hypertension and aneurysm formation.

Prolonged high-pressure balloon angioplasty of femoropopliteal lesions：Impact on stent implantation rate and mid-term outcome

ObjectivesTo 在 stent 培植率和回顾地注册的 femoropopliteal lesions.MethodsWe 的延长高压力 angioplasty 的中间的结果上估计影响从 2011 年 1 月的 620 个连续病人到 2011 年 12 月(75.6 &#x000b1；12.3 年， 355 男性， 76.5% 在卢班 5-6 ) ，为批评手足局部缺血参考了并且提交了到 femoropopliteal 损害的延长高压的 angioplasty。延长高压的 angioplasty 的定义为至少 120 s 包括膨胀到至少 18 atm。程序的数据，和临床、仪器的后续被分析估计比较喜欢的培植率和中间的 outcomes.ResultsThe 接近的 stent 是 ipsilateral 在 433/620 病人(69.7%) 和在 164/620 (26.4%) 的 contralateral 转线路的大腿骨的 antegrade 并且腿弯部后退 +在 23/620 (3.7%)的大腿骨的 antegrade 。技术在 193/620 病人(31.2%) 在 427/620 病人(68.8%) 和 endoluminal angioplasty 包括了 subintimal angioplasty。延长高压力汽球 angioplasty 过程在 86.2% 是成功的(次要的 intra 程序的复杂并发症率 15.7 %) ， stent 培植在 74 个病人(11.9%) 被执行，与脚关节臂的索引的重要改进(0.29 &#x000b1；0.6 对 0.88 &#x000b1；0.3， P &#x0003c；00.1 ) 并且卢班(5.3 &#x000b1；0.8 对 0.7 &#x000b1；1.9， P &#x0003c；0.01 ) ， 86.7% 的主要明显率， Doppler 超声和在 18.1 &#x000b1 的吝啬的后续的 14.8% 的目标损害 revascularization 上的 18.6 % 的狭窄；6.4 个月(范围 1-24 月) 。第二等的明显率高是 87.7%.ConclusionsProlonged femoropopliteal 损害的压力 angioplasty 看起来安全、有效允许可接受的明显和狭窄在期中考试上评价。

The Efficacy and Safety of Drug-Coated Balloons in the Treatment of Acute Myocardial Infarction

The incidence of acute myocardial infarction (AMI) is increasing year by year, which seriously endangers human health around the world. The preferred treatment strategy for AMI patients is the use of drug-eluting stents (DES), as there is ample evidence to suggest that stent implantation can reduce major adverse cardiovascular events (MACEs). With the application of drug-coated balloons (DCBs) and the enhancement of the concept of interventional without implantation, the question is whether DCBs can be safely and effectively used in patients with AMI? The purpose of this study was to investigate the safety and effectiveness of DCBs in the treatment of AMI. A retrospective review of clinical data was conducted on 55 AMI patients who underwent primary percutaneous coronary intervention (PCI) from January 2020 to December 2021. Of these patients, 25 were treated with DCBs and 30 were treated with DESs. Optical coherence tomography (OCT) was used to measure the minimum lumen diameter, lumen stenosis, and coronary artery dissection before and after surgery, and angina pectoris attacks and various MACEs were recorded at 1, 6, and 12 months after surgery. The results showed that there were no significant differences in clinical baseline data between the two groups. However, the minimum lumen diameter of the DCB group immediately after the operation was smaller than that of the DES group, and the stenosis degree of the lumen in the DCB group was higher than that in the DES group. The incidence of coronary artery dissection in the DCB group was significantly higher than that in the DES group, but the majority of them were type B. At 1, 6, and 12 months after treatment, there was no significant difference in the occurrence of MACEs between the two groups. In conclusion, DCBs is a safe and effective treatment for AMI. However, the incidence of coronary artery dissection in DCB patients is higher than that in DES patients, but the majority of them are type B. .

Effi cacy of partial and complete resuscitative endovascular balloon occlusion of the aorta in the hemorrhagic shock model of liver injury

BACKGROUND:Resuscitative endovascular balloon occlusion of the aorta(REBOA)can temporarily control traumatic bleeding.However,its prolonged use potentially leads to ischemia-reperfusion injury(IRI).Partial REBOA(pREBOA)can alleviate ischemic burden;however,its security and eff ectiveness prior to operative hemorrhage control remains unknown.Hence,we aimed to estimate the effi cacy of pREBOA in a swine model of liver injury using an experimental sliding-chamber ballistic gun.METHODS:Twenty Landrace pigs were randomized into control(no aortic occlusion)(n=5),intervention with complete REBOA(cREBOA)(n=5),continuous pREBOA(C-pREBOA)(n=5),and sequential pREBOA(S-pREBOA)(n=5)groups.In the cREBOA and C-pREBOA groups,the balloon was inflated for 60 min.The hemodynamic and laboratory values were compared at various observation time points.Tissue samples immediately after animal euthanasia from the myocardium,liver,kidneys,and duodenum were collected for histological assessment using hematoxylin and eosin staining.RESULTS:Compared with the control group,the survival rate of the REBOA groups was prominently improved(all P<0.05).The total volume of blood loss was markedly lower in the cREBOA group(493.14±127.31 mL)compared with other groups(P<0.01).The pH was significantly lower at 180 min in the cREBOA and S-pREBOA groups(P<0.05).At 120 min,the S-pREBOA group showed higher alanine aminotransferase(P<0.05)but lower blood urea nitrogen compared with the cREBOA group(P<0.05).CONCLUSION:In this trauma model with liver injury,a 60-minute pREBOA resulted in improved survival rate and was effective in maintaining reliable aortic pressure,despite persistent hemorrhage.Extended tolerance time for aortic occlusion in Zone I for non-compressible torso hemorrhage was feasible with both continuous partial and sequential partial measures,and the significant improvement in the severity of acidosis and distal organ injury was observed in the sequential pREBOA.

Pseudoaneurysm formation following transarterial embolization of traumatic carotid-cavernous fistula with detachable balloon:An institutional cohort long-term study

BACKGROUND The goal of therapy for traumatic carotid-cavernous fistula(TCCF)is the elimination of fistula while maintaining patency of the parent artery.The treatment for TCCF has evolved from surgery to endovascular management using detachable balloons,coils,liquid embolic agents,covered stents,or flow-diverter stent through arterial or venous approaches.Despite the withdrawal of detachable balloons from the market in the United States since 2004,transarterial embolization with detachable balloons has currently remained the best initial treatment for TCCF in several countries.However,the pseudoaneurysm formation following transarterial detachable balloon embolization has rarely been observed in long-term follow-up.AIM To determine the occurrence and long-term follow-up of pseudoaneurysm after transarterial detachable balloon for TCCF.METHODS Between January 2009 and December 2019,79 patients diagnosed with TCCF were treated using detachable latex balloons(GOLDBAL)of four sizes.Pseudoaneurysm sizes were stratified into five grades for analysis.Initial and follow-up assessments involved computed tomography angiography at 1 month,6 month,1 year,and longer intervals for significant cases.Clinical follow-ups occurred semi-annually for 2 years,then annually.Factors analyzed included sex,age,fistula size and location,and balloon size.RESULTS In our cohort of 79 patients treated for TCCF,pseudoaneurysms formed in 67.1%,with classifications ranging from grade 0 to grade 3;no grade 4 or giant pseudoaneurysms were observed.The majority of pseudoaneurysms did not progress in size,and some regressed spontaneously.Calcifications developed in most large pseudoaneurysms over 5-10 years.Parent artery occlusion occurred in 7.6%and recurrent fistulas in 16.5%.The primary risk factors for pseudoaneurysm formation were identified as the use of specific balloon sizes,with balloon SP and No.6 significantly associated with its occurrence(P=0.005 and P=0.002,respectively),whereas sex,age,fistula size,location,and the number of balloons used were not significant predictors.CONCLUSION Pseudoaneurysm formation following detachable balloon embolization for TCCF is common,primarily influenced by the size of the balloon used.Despite this,all patients with pseudoaneurysms remained asymptomatic during long-term follow-up.

Chinese expert consensus on the clinical application of drugcoated balloon(2^(nd) Edition)

Percutaneous coronary interventions have progressed through the era of plain balloon dilation, bare-metal stent insertion to drug-eluting stent treatment, which has significantly reduced the acute occlusion and restenosis rates of target vessels and improved patient prognosis, making drug-eluting stents the mainstream interventional treatment for coronary artery disease. In recent years, drug-coated balloons(DCBs) have become a new treatment strategy for coronary artery disease, and the drugs used in the coating and the coating technology have progressed in the past years. Without permanent implant, a DCB delivers antiproliferative drugs rapidly and uniformly into the vessel wall via the excipient during a single balloon dilation. Many evidence suggests that DCB angioplasty is an effective measure for dealing with in-stent restenosis and de novo lesions in small coronary vessels.As more clinical studies are published, new evidence is emerging for the use of DCB angioplasty in a wide range of coronary diseases, and the indications are expanding internationally. Based on the latest research from China and elsewhere, the Expert Writing Committee of the Chinese Expert Consensus on Clinical Applications of Drug-Coated Balloon has updated the previous DCB consensus after evidence-based discussions and meetings in terms of adequate preparation of in-stent restenosis lesions, expansion of the indications for coronary de novo lesions, and precise guidance of DCB treatment by intravascular imaging and functional evaluation.

Significance of balloon aortic valvuloplasty as palliative procedure for symptom benefit in patients with severe aortic stenosis

Aortic stenosis(AS)stands out as the most prevalent individual valvular defect globally.The onset and progression of AS mirror an active process akin to atherosclerosis,and the traditional triad of symptoms includes chest pain,breathlessness,and loss of consciousness.Prognosis takes a significant downturn when symptoms manifest,with mortality reaching approximately 50%-85% within the subsequent 5 years after symptom onset.

Ultrasound-guided carotid angioplasty and stenting in a patient with iodinated contrast allergy:A case report

BACKGROUND Ischemic stroke is an entity with high incidence,morbidity,and mortality rates.Carotid artery stenosis is an important and independent risk factor for ischemic stroke.The three current approaches for treating carotid artery stenosis are drug treatment,carotid endarterectomy(CEA),carotid angioplasty and stenting(CAS).The approach is chosen based on the degree of stenosis.CEA or CAS could have been chosen for the current patient,who had severe carotid stenosis and an iodinated contrast allergy.After thoroughly communicating with the patient,the patient chose CAS for treatment.Therefore,we performed ultrasound-guided CAS to avoid the use of iodinated contrast.CASE SUMMARY The main symptoms of the patient were numbness and weakness of the left limb.Computed tomography angiography of the head and neck at another hospital indicated multiple sites of stenosis in the arteries of the head and neck.The patient requested CAS for treatment but was allergic to iodinated contrast media.Thus,routine digital subtraction angiography(DSA)with iodinated contrast could not be used for the procedure.The diagnosis of this patient was as follows:(1)Right parietal lobe cerebral infarction;(2)multiple sites of stenosis in the arteries of the head and neck(severe stenosis of the right internal carotid artery,severe stenosis of the right subclavian artery);(3)right subclavian steal syndrome;and(4)hypertension(stage 3,high risk).The interventions included routine treatment for cerebral infarction,oral administration of clopidogrel(75 mg qd)and aspirin(100 mg qd),ultrasound-guided CAS,and postoperative follow-up.Postoperative color Doppler ultrasound and cerebrovascular magnetic resonance angiography of the carotid artery showed good vascular recovery,and the postoperative follow-up indicated a good prognosis.CONCLUSION This case study suggests that ultrasound-guided endovascular treatment is a potential option for patients with contraindications to the iodinated contrast agents used in DSA-guided surgery,although excellent surgical operating skills are needed.

Experimental Study on the Early Efficacy of Excimer Laser with Adjunctive Balloon Angioplasty in Dog＇s Femoral Artery

The effect of domestically-manufactured excimer laser with adjunctive balloon angioplasty in achieving revascularization and reduction of residual stenosis was assessed. 20 femoral arteries with thrombosis and occlusion from 12 dogs were subject to angiography. At first excimer laser angioplasty was done followed by balloon angioplasty. The diameter and residual stenosis of revascularized vessel were measured. The result showed that 17 out of 20 vessels (85 %) were revascularized. The diameter of revascularized vessel by excimer laser were 1. 22±0.14 mm,while residual stenoses were 54 %±5%. After adjunctive balloon angioplasty the diameter and residual stenoses were 2. 04±0. 16 mm and 20 %±7 %respectively (P<0. 05 and P<0. 01), Complication in form of vasoperforation occurred in 3/20 vessels (15%). It is concluded that China-manufactured excimerlaser angioplasty is effective when used for revascularization. While the reduction of narrowing and residual stenoses was enhanced after adjunction of balloon angioplasty. This method can be employed in treating peripheral occlusive disease effectively and safely.

Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension:State of the art

Chronic thromboembolic pulmonary hypertension(CTEPH)is a complex chronic disease in which pulmonary artery stenosis or obstruction caused by organized thrombus can lead to increased pulmonary artery pressure and pulmonary vascular resistance,ultimately triggering progressive right heart failure and death.Currently,its exact mechanism is not fully understood.Pulmonary endarterectomy(PEA)has immediate effects with low perioperative mortality and satisfactory prognosis in experienced expert centers for CTEPH patients with proximal lesions.Nevertheless,37%of patients are deemed unsuitable for PEA surgery due to comorbidities and other factors,and nearly half of the operated patients have residual or recurrent pulmonary hypertension.Riociguat is the only approved drug for CTEPH,although its effect is limited.Balloon pulmonary angioplasty(BPA)is a promising alternative treatment for patients with CTEPH.After more than 30 years of development and refinements,emerging evidence has confirmed its role in patients with inoperable CTEPH or residual/recurrent pulmonary hypertension,with acceptable complications and comparable longterm prognosis to PEA.This review summarizes the pathophysiology of CTEPH,BPA history and development,therapeutic principles,indications and contraindications,interventional procedures,imaging modalities,efficacy and prognosis,complications and management,bridging and hybrid therapies,ongoing clinical trials and future prospects.

Six intragastric balloons:Which to choose?

Endoscopically placed intragastric balloons(IGBs)have played a significant role in obesity treatment over the last 30 years,successfully bridging the gap between lifestyle modification/pharmacotherapy and bariatric surgery.Since they provide a continuous sensation of satiety that helps the ingestion of smaller portions of food,facilitating maintenance of a low-calorie diet,they have generally been considered an effective and reversible,less invasive,non-surgical procedure for weight loss.However,some studies indicate that balloons have limited sustainable effectiveness for the vast majority attempting such therapy,resulting in a return to the previous weight after balloon removal.In this review we try to summarize the pros and cons of various balloon types,to guide decision making for both the physician and the obese individual looking for effective treatment.We analyzed the six most commonly used IGBs,namely the liquid-filled balloons Orbera,Spatz3,ReShape Duo and Elipse,and the gas-filled Heliosphere and Obalon-also including comments on the adjustable Spatz3,and the swallowable Obalon and Elipse-to optimize the choice for maximum efficacy and safety.

Learning curve and analysis of curative effects after balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension

To the Editor:Chronic thromboembolic pulmonary hypertension(CTEPH)is a chronic progressive disease in which pulmonary artery pressure(PAP)increases and eventually leads to right heart failure and death.Balloon pulmonary angioplasty(BPA)is a new and effective treatment for CTEPH patients who are unsuitable for surgery or who develop recurrent or persistent pulmonary hypertension after pulmonary endarterectomy(PEA).In recent years,major medical centers at home and abroad have been gradually developing and improving BPA,but overall,a unified treatment process and complication control strategy is lacking.

“Guidezilla”extension catheter combined with balloon technique for treating pulmonary artery stenosis caused by Takayasu arteritis

Takayasu arteritis(TA)is a rare systemic vasculitis of the aorta and its primary branches,which usually occurs in young women.Due to its insidious onset and lack of specific symptoms,this disease can be easily misdiagnosed or missed.Approximately 50%of the patients having TA with pulmonary artery involvement develop pulmonary hypertension(PH).The 3-year survival rate among patients with TA-related PH is lower than that among patients with TA alone.Early balloon pulmonary angioplasty(BPA)can improve the clinical symptoms and survival of patients with stable TA.To the best of our knowledge,this is the first case reported in the English literature in which a“Guidezilla”catheter was used during BPA to treat stenosis and occlusion of the pulmonary artery caused by Takayasu arteritis(TA).

Predictive Factors of No Reflow during Primary Angioplasty

Introduction: No reflow during primary angioplasty is associated with a poor prognosis despite the reopening of the culprit coronary. The aim of our work was to determine the predictive factors of no reflow. Methodology: Single-center retrospective analytical study from June 2000 to December 2016 that included patients presenting with STEMI took care of by primary angioplasty. No reflow was defined according to angiographic criteria: a TIMI flow Results: The prevalence of no reflow was 24%. In univariate analysis mean age, diabetes,hypertension, tachycardia, hypotension, killip stage 4 left ventricular failure, hyperglycemia > 11, renal failure, left ventricular dysfunction, tritruncal status, common trunk involvement, initial TIMI flow at 0, significant thrombotic load, delay to angioplasty > 6 hours, and predilation were all correlated with no reflow with a p 75 years [OR = 6.02, 95% CI 1.4 - 27, p = 0.014], tachycardia [OR = 4.3, 95% CI 1.6 - 7.4, p = 0.037], delay to angioplasty > 6 hours [OR = 1.3, 95% CI 1.1 - 2.1, p = 0.003] and high thrombotic load [OR = 1.5, 95% CI 1.3 - 3.2, p = 0.02] were independent predictors of no reflow. Conclusion: No reflow is associated with a poor short-term prognosis. Its care requires knowledge of predictive factors, prevention and treatment.

A novel cerebrovascular drug-coated balloon catheter for treating symptomatic intracranial atherosclerotic stenosis lesions:Study protocol for a prospective,multicenter,single-arm,target-value clinical trial

Background:Previous single-center studies have demonstrated that drug-coated balloons(DCBs)may reduce restenosis rates,which is an important factor affecting the prognosis for intracranial interventional therapy.However,currently available cardiac DCBs are not always suitable for the treatment of intracranial atherosclerotic stenosis(ICAS).This study aimed to evaluate the safety and efficacy of a novel DCB catheter designed for patients with severely symptomatic ICAS.Methods:This prospective,multicenter,single-arm,target-value clinical trial was conducted in 9 Chinese stroke centers to evaluate the safety and efficacy of a novel DCB catheter for treating symptomatic severe ICAS.Primary metrics and other indicators were collected and analyzed using SAS version 9.4(SAS Institute,Cary,NC,USA).Results:A total of 155 patients were enrolled in this study.The preliminary collection of follow-up data has been completed,while data quality control is ongoing.Conclusion:Results of this study demonstrated the patency rate,safety,and effectiveness of a novel on-label paclitaxel DCB designed for the treatment of ICAS.Ethics and dissemination:This study,involving human participants,was reviewed and approved by the Ethics Committee of Drugs(Devices)Clinical Experiment at Henan Provincial People’s Hospital(reference number:2020-145-03)and other research centers participating in the clinical trial.The results of this study will be presented at international conferences and sent to peer-reviewed journals for publication.Standard protocol items:The Recommendations for Interventional Trials checklist was used when drafting the study protocol.Trial registration number:Registered with the Chinese Clinical Trial Registry on June 11,2021(Chi CTR2100047223).