Vascular complications of chronic pancreatitis and its management

Chronic pancreatitis is a chronic fibro-inflammatory disorder of the pancreas,resulting in recurrent abdominal pain,diabetes mellitus,and malnutrition.It may lead to various other complications such as pseudocyst formation,benign biliary stricture,gastric outlet obstruction;and vascular complications like venous thrombosis,variceal and pseudoaneurysmal bleed.Development of varices is usually due to chronic venous thrombosis with collateral formation and variceal bleeding can easily be tackled by endoscopic therapy.Pseudoaneurysmal bleed can be catastrophic and requires radiological interventions including digital subtraction angiography followed by endovascular obliteration,or sometimes with a percutaneous or an endoscopic ultrasound-guided approach in technically difficult situations.Procedure-related bleed is usually venous and mostly managed conservatively.Procedure-related arterial bleed,however,may require radiological interventions.

Pregnancy and retinal and retinal vascular complications

Pregnancy requires several changes in the body of the mother to successfully carry and deliver a child.Multiple alterations occur,including changes in cardiovascular system to meet the increased demands of the mother and placenta,the tilting of the hypercoagulable status to a more pro-coagulable state to prevent excessive blood loss post-delivery,and immunologic manipulations to protect the mother and fetus and decreasing the risk of a fatal immunologic response to the allogeneic fetus.These alterations are physiologically normal and expected,but can become pathologic when thresholds are crossed.Pregnancy may cause or exacerbate underlying retinal vascular diseases,a class of disorders compromised predominantly of retinal vein occlusion(RVO),retinal artery occlusion(RAO),central serous retinopathy(CSR),diabetic retinopathy,and hypertensive-related retinopathy,which includes pre-eclampsia,eclampsia,and hemolysis,elevated liver enzymes,and low platelets(HELLP)syndrome.The majority of the literature on retinal changes associated with pregnancy has focused on diabetic retinopathy,while the knowledge regarding the pathogenesis and treatment options of other pregnancy-related vascular diseases remains scarce.Understanding the implications pregnancy has on these rare,but severe,retinal vascular complications can help guide clinical management and potential treatment modalities.This paper aims to serve as a review of the retinal manifestations of diseases outside of diabetic retinopathy.

Vascular complications of pancreatitis

More than 200000 hospital admissions happen per year for acute pancreatitis and more than 50000 for chronic pancreatitis in the United States of America.Necrotizing pancreatitis accounts for 20%-30%of the cases.One-quarter of the patients with pancreatitis develop vascular complications,which carries a high mortality.This mini-review will address these complications that can help primary care physicians and hospitalists in managing their patients effectively.

Effect of Intensive Therapy of Multiple Factors Intervention on Vascular Complications in Type 2 Diabetes

The effects of intensive versus regular therapy on incidence and progress of microalbuminuria in type 2 diabetes were compared. During a follow-up of 3 years, 96 cases of diabetes mellitus were randomized to intensive and regular therapy groups. HbA 1c goal was same in the two groups, but the goal of blood pressure (Bp) and lipid was more strict in the intensive therapy group than in the regular therapy group. There was statistically significant difference in the incidence and progression of vascular complications between the two groups. Logistic stepwise-regression analysis (odds ration, OR) showed that there was significant difference in the progression of nephropathy (OR 0.24, 95 % CI 0.12-0.76), retinopathy (OR 0.38, 95 % CI 0.16-0.88), peripheral neuropathy (OR 0.42, 95 % CI 0.22-0.86) and autonomic neuropathy (OR 0.29, 95 % CI 0.12-0.86) between the two groups (P<0.01). It was concluded that intensive blood glucose controlling could retard diabetic vascular complications. Intensive therapy of multiple factors interventions (controlling Bp, regulating blood lipid, improving microcirculation) could decrease various risk factors for diabetic vascular complications.

Real role of growth factor receptor-binding protein 10:Linking lipid metabolism to diabetes cardiovascular complications

Cardiovascular complications of patients with type 2 diabetes mellitus(T2DM)threaten the health and life of numerous individuals.Recently,growth factor receptor-binding protein 10(GRB10)was found to play a pivotal role in vascular complications of T2DM,which participates in the regulation of lipid metabolism of T2DM patients.The genetic variation of GRB10 rs1800504 is closely related to the risk of coronary heart disease in patients with T2DM.The development of GRB10 as a key mediator in the association of lipid metabolism with cardiovascular complications in T2DM is detailed in and may provide new potential concerns for the study of cardiovascular complications in T2DM patients.

Prognostic value of ultrasound in early arterial complications post liver transplant

Liver transplantation is the primary therapeutic intervention for end-stage liver disease.However,vascular complications,particularly those involving the hepatic artery,pose significant risks to patients.The clinical manifestations associated with early arterial complications following liver transplantation are often non-specific.Without timely intervention,these complications can result in graft fai-lure or patient mortality.Therefore,early diagnosis and the formulation of an op-timal treatment plan are imperative.Ultrasound examination remains the pre-dominant imaging modality for detecting complications post liver transplan-tation.This article comprehensively reviews common causes and clinical present-ations of early hepatic artery complications in the post-transplantation period and delineates abnormal sonographic findings for accurate diagnosis of these con-ditions.Overall,ultrasound offers the advantages of convenience,safety,effect-iveness,and non-invasiveness.It enables real-time,dynamic,and precise evalua-tion,making it the preferred diagnostic method for post-liver transplantation assessments.INTRODUCTION Liver transplantation stands as the primary therapeutic approach for end-stage liver disease.Continuous advancements in surgical techniques and the application of novel immunosuppressive agents contribute to ongoing improvements in the success rate and overall survival in patients undergoing liver transplantation procedures.Despite these advan-cements,vascular complications,particularly those involving the hepatic artery,pose significant risks to patients.During the early stages following liver transplantation(within the first 30 d),proper hepatic artery function is crucial for hepatic arterial blood flow.During later stages,collateral circulation,including arteries such as the phrenic artery,right gastric artery,and gastroduodenal artery,becomes important for maintaining hepatic blood supply.It is now understood that the establishment of effective collateral circulation is pivotal for determining the prognosis of hepatic artery complic-ations.The clinical manifestations of these complications are closely linked to factors such as timing,severity,and the specific type of onset.Insufficient hepatic arterial blood flow can lead to abnormal liver function,hepatic infarction,and the formation of hepatic abscesses.Additionally,since the hepatic artery is the sole blood supply to the biliary tract,hepatic artery-related ischemia may result in biliary stricture,obstruction,and the formation of bile ducts.Ultrasound examination remains the primary imaging modality for diagnosing complications post liver transplantation.This article comprehensively reviews common causes and clinical presentations of early hepatic artery complications in the post-transplantation period and outlines abnormal sonographic findings for accurately diagnosing these conditions.NORMAL HEPATIC ARTERY During the intraoperative phase,an ultrasound examination is typically conducted to evaluate the hepatic artery anas-tomosis.The normal internal diameter of the hepatic artery typically ranges from 2 to 5 mm.Two strong echo points are typically identified near the anastomosis.To assess blood flow dynamics,peak systolic velocity,end-diastolic velocity,and resistance index are measured at the donor and recipient sides of the anastomosis following angle correction.Anastomotic stenosis presence and severity can be evaluated by comparing the velocity at the anastomotic site with that at the recipient side.Postoperatively,direct visualization of the anastomosis site through gray ultrasound scans is often challenging.The surgical approach has a significant impact on the proper hepatic artery’s position,resulting in a lower overall success rate of continuous visualization.Color Doppler ultrasound is primarily employed to trace the artery’s path,and spectral measurements are taken at the brightest position of the Color Doppler blood flow signal,primarily used to identify the presence of high-speed turbulence.Hepatic artery spectrum examination plays a crucial role,as a favorable arterial spectral waveform and appropriate hepatic artery flow velocity typically indicate a successful anastomosis,even in cases where the hepatic artery anastomosis cannot be directly visualized by ultrasound.The hepatic artery runs alongside the portal vein,often selected as a reference due to its larger inner diameter.A normal hepatic artery spectrum displays a regular pulsation pattern with a rapid rise in systole and a slow decline in diastole.Parameters for assessing hepatic artery resistance include a resistance index between 0.5 to 0.8 and an artery systolic acceleration of less than 80 ms.Instantaneous increases in the resistance index(RI>0.8)often occur within 2 d after surgery,followed by a subsequent return to normal hepatic arterial parameters.It has been established that the maximum blood flow velocity during systole in the hepatic artery should not exceed 200 cm/s[1].

Role of BKCa channels in diabetic vascular complications

Objective This review focuses on the role of the large conductance calcium-activated potassium （BKCa） channels in diabetic vascular complications.Data sources Relevant articles published in English or Chinese from 1981 to present were selected from PubMed.The search terms were ＂BKCa channels＂ and ＂diabetes＂.Important references from selected articles were also retrieved.Study selection Articles regarding the role of BKCa channels in diabetic vascular complications and relevant mechanisms were selected.Results The BKCa channels are abundantly expressed in vascular smooth cells and play an important role in regulation of vascular tone.Multiple studies indicated that the expression and function of BKCa channels are altered by different mechanisms in diabetic vascular diseases such as coronary arterial disease,cerebral arterial disease,and diabetic retinopathy.Conclusion BKCa channels may play an important role in diabetic vascular complications and may be an effective therapeutic target for relieving and reducing the burden of diabetic vascular complications.

Serum galectin-3： a risk factor for vascular complications in type 2 diabetes mellitus

Background Plasma galectin-3, a mediator of fibrogenesis and inflammation, its potential to associate with type 2 diabetes （T2DM） is poorly investigated. Here, we explored its interaction with the serum galectin-3 and vascular complications. Methods We conducted a population-based cross-sectional survey in Zhejiang, China involving 165 men and 119 women （age range, 43-84 years）, investigating the relationship between serum galectin-3 and vascular disease in patients with T2DM. Results Serum galectin-3 was higher in subjects with T2DM than that in control participants （27.4 vs. 17.6 ng/ml, P 〈0.001）. Compared with subjects with galectin-3 values in the lowest quartile, those with values in the highest quartile had an increased likelihood of vascular complications （4th quartile odds ratio （OR） 2.52, 95% confidence interval （CI）, 1.25- 4.07）. Increased risk of micro- or macrovascular complications corrrelated with serum galectin-3 concentration （ORs 11.4 and 8.5, respectively）. An increased number of vascular complications was associated with high serum galectin-3 levels （P 〈0.05）. Patients with serum galectin-3 levels 〉25 ng/ml had an elevated risk of diabetes relative to patients with levels 〈10 ng/ml （OR for any vascular complication 2.64, for heart failure 3.97, for nephropathy 4.09, for peripheral arterial disease （PAD） 4.18; all P 〈0.05）. Complication risk was higher in patients with neurogenic, stroke, or retinopathy complications, but this difference was not significant after risk factor adjustment. Serum galectin-3 levels correlated with diabetes duration, C-reactive protein （CRP） levels, and albuminuria. Conclusion High galectin-3 values were associated with increased odds of developing heart failure, nephropathy, and peripheral arterial disease in patients with T2DM.

Food-advanced glycation end products aggravate the diabetic vascular complications via modulating the AGEs/RAGE pathway

The aim of this study was to investigate the effects of high-advanced glycation end products （AGEs） diet on diabetic vascular complications. The Streptozocin （STZ）-induced diabetic mice were fed with high-AGEs diet. Diabetic characteristics, indicators 3f renal and cardiovascular functions, and pathohistology of pancreas, heart and renal were evaluated. AGEs/RAGE/ROS pathway parameters were determined. During the experiments, the diabetic mice exhibited typical characteristics including weight loss, polydipsia, polyphagia, polyuria, high-blood glucose, and low-serum insulin levels. However, high-AGEs diet effectively aggravated these diabetic sharacteristics. It also increased the 24-h urine protein levels, serum levels of urea nitrogen, creatinine, c-reactive protein （CRP）, low density lipoprotein （LDL）, tumor necrosis factor-a （TNF-a）, and interleukin-6 （IL-6） in the diabetic mice. High-AGEs diet deteriorated the histology of pancreas, heart, and kidneys, and caused structural alterations of endothelial ceils, mesangial cells and podocytes in renal ：ortex. Eventually, high-AGEs diet contributed to the high-AGE levels in serum and kidneys, high-levels of reactive oxygen species ＇,ROS） and low-levels of superoxide dismutase （SOD） in serum, heart, and kidneys. It also upregulated RAGE mRNA and protein expression in heart and kidneys. Our results showed that high-AGEs diet deteriorated vascular complications in the diabetic mice. The activation of AGEs/RAGE/ROS pathway may be involved in the pathogenesis of vascular complications in diabetes.

Distribution of apolipoprotein E genotype in NIDDM patients with vascular complications

Objective To investigate the distribution of apolipoprotein E (ApoE) genotype among different vascular complications and the variation of allele frequency with age in non insulin dependent diabetes mellitus (NIDDM). Methods 125 NIDDM patients and 50 healthy individuals were selected randomly. Polymerase chain reaction was used to determine their ApoE genotypes. Results The prevalence of ∈3/3 in any vascular complication group was 59.3%, which was significantly lower than 76.0% in controls (P<0.05). The prevalences of ∈3/3, ∈4/3 and ∈4 in coronary heart disease (CHD) group were 51.8%, 33.9% and 20.5%, respectively, which were significantly lower (∈3/3, P<0.01 ) or higher (∈4/3, P<0.01; ∈4, P< 0.05 ) than those in the controls, respectively. The ∈4 frequency was significantly lower in the elderly than in the non elderly group of NIDDM (P<0.05). Conclusion ∈4 increases the risk for vascular complications, especially CHD, and ∈4 may affect the life expectancy of NIDDM patients.

Vascular complications following prophylactic balloon occlusion of the internal iliac arteries resolved by successful interventional thrombolysis in a patient with morbidly adherent placenta

The increasing incidence of morbidly adherent placenta （MAP） is placing women at a higher risk of life-threatening massive hemorrhage. The involvement of interventional radiology to manage this complex condition by performing prophylactic lilac artery balloon occlusion has been reported recently. However, the effectiveness and safety of this technique have not been fully determined. Here we report the case of a 25-year-old woman with placenta increta with preemptive bilateral internal lilac artery balloons who had external lilac artery thrombosis detected by computed tomography angiography （CTA） 72 h post cesarean section. A digital subtraction angiogram （DSA） and intra-arterial thrombolysis were instantly performed followed by supplementary conservative treatments, leading to a desirable resolution, of thrombus without sequela. This is the first report of vascular complications with successful interventional thrombolysis in this setting. Our experience suggests that prophylactic lilac artery balloon occlusion should be used cautiously in cases of MAP and consideration given to minimizing vascular complications given the hypercoagulable state of pregnancy.

Effects of Puerarin on Plasma Endothelin and Serum Tumor Necrosis Factor-α in Type 2 Diabetes Mellitus Patients with Vascular Complications

Objective: To study the changes of endothelin (ET), tumor necrosis factor-α (TNF-α) before and after puerarin treatment in patients with diabetes mellitus vascular complications (DMVC). Methods: Ninety-eight DMVC patients were divided into 2 groups, they were given puerarin (n=68) and normal saline (n=30) respectively, 20 diabetic patients without vascular complications (NDMVC) were taken as control, who were also given puerarin. All the patients were treated on the basis of controlling blood glucose. Plasma ET and serum TNF-α were determined by radioimmunoassay (RIA) before and after treatment. Results: Plasma ET and serum TNF-α in DMVC got higher than that of NDMVC patients (P<0.05), and ET level was correlated with TNF-α (r=0.69, r=0.73, P<0.01). After treatment, the levels of ET and TNF-α were significantly lower than those before treatment of DMVC patients with puerarin (P<0.05). Conclusion: Puerarin could regulate the levels of plasma ET and serum TNF-α of DMVC patients, suggesting that it has the function of regulating endothelial cells.

A novel role of chitosan in reducing vascular access bleeding complications after transradial angiography

To investigate the safety and efficacy of chitosan ( Anscare,Daxon) in reducing vascular ac cess complications compared to a kind of radial compression device( TR-BAND,Terumo) . Method: We studied 128 patients who had undergone transradial angiography in our center from December 2009 to April 2010. Among them,64 patients were randomly treated with radial compression device ( TR-BAND,Terumo) when the procedure was over ( CD group) . The other 64 patients were dealt with chitosan ( CS group) . The compression time,the major and minor access site bleeding complications and the errhysis were observed. Results: There were no statistical differences in the baseline clinical characteristics of the patients between two groups. The compression time in CS group was significantly shorter than that of CD group ( P < 0. 001) . There were 12 patients suffering from minor access site bleeding while only 3 patients experienced these minor complications in CS group( 19% vs 4% ,P < 0. 05) . At the same time 20 patients had er- rhysis in CD group and 4 patients in CS group ( 31% vs 6% ,P < 0. 001) . Conclusion: Chitosan,compared to radial compression device ( TR-BAND,Terumo) ,can not only shorten the compression time,but also significantly reduce the rate of minor access site bleeding and puncture-site errhyis.

Optical angiography for diabetes-induced pathological changes in microvascular structure and function:An overview

Diabetes mellitus(DM)is a kind of metabolic disorder characterized by chronic hyperglycemia and glucose intolerance due to absolute or relative lack of insulin,leading to chronic damage of vasculature within various organ systems.These detrimental e®ects on the vascular networks will result in the development of various diseases associated with microvascular injury.Modern optical imaging techniques provide essential tools for accurate evaluation of the structural and functional changes of blood vessels down to capillaries level,which can o®er valuable insight on understanding the development of DM-associated complications and design of targeted therapy.This review will brie°y introduce the DM-induced structural and functional alterations of vasculature within di®erent organs such as skin,cerebrum and kidneys,as well as how novel optical imaging techniques facilitate the studies focusing on exploration of these pathological changes of vasculature caused by DM both in-vivo and ex-vivo.

Factors affecting complications development and mortality after single lung transplant

Lung transplantation(LT)is a life-saving therapeutic procedure that prolongs survival in patients with end-stage lung disease.Furthermore,as a therapeutic option for high-risk candidates,single LT(SLT)can be feasible because the immediate morbidity and mortality after transplantation are lower compared to sequential single(double)LT(SSLTx).Still,the long-term overall survival is,in general,better for SSLTx.Despite the great success over the years,the early post-SLT period remains a perilous time for these patients.Patients who undergo SLT are predisposed to evolving early or late postoperative complications.This review emphasizes factors leading to post-SLT complications in the early and late periods including primary graft dysfunction and chronic lung allograft dysfunction,native lung complications,anastomosis complications,infections,cardiovascular,gastrointestinal,renal,and metabolite complications,and their association with morbidity and mortality in these patients.Furthermore,we discuss the incidence of malignancy after SLT and their correlation with immunosuppression therapy.

Selective embolization for bleeding visceral artery pseudoaneurysms in patients with pancreatitis

BACKGROUND:Pancreatitis is associated with arterial complications in 4%-10%of patients,with untreated mortality approaching 90%.Timely intervention at a specialist center can reduce the mortality to 15%.We present a single institution experience of selective embolization as first line management of bleeding pseudoaneurysms in pancreatitis. METHODS:Sixteen patients with pancreatitis and visceral artery pseudoaneurysms were identified from searches of the records of interventional angiography from January 2000 to June 2007.True visceral artery aneurysms and pseudoaneurysms arising as a result of post-operative pancreatic or biliary leak were excluded from the study. RESULTS:In 50%of the patients,bleeding complicated the initial presentation of pancreatitis.Alcohol was the offending agent in 10 patients,gallstones in 3,trauma,drug-induced and idiopathic pancreatitis in one each.All 16 patients had a contrast CT scan and 15 underwent coeliac axis angiography. The pseudoaneurysms ranging from 0.9 to 9.0 cm affected the splenic artery in 7 patients:hepatic in 3,gastroduodenal and right gastric in 2 each,and left gastric and pancreatico-duodenal in 1 each.One patient developed spontaneous thrombosis of the pseudoaneurysm.Fourteen patients had effective coil embolization of the pseudoaneurysm.One patient needed surgical exclusion of the pseudoaneurysm following difficulty in accessing the coeliac axis radiologically.There were no episodes of re-bleeding and no in-hospital mortality. CONCLUSIONS:Pseudoaneurysms are unrelated to the severity of pancreatitis and major hemorrhage can occur irrespective of their size.Co-existent portal hypertension and sepsis increase the risk of surgery.Angiography and selective coil embolization is a safe and effective way to arrest the hemorrhage.

Trocar-related abdominal wall bleeding in 200 patients after laparoscopic cholecistectomy: Personal experience

AIM: To determine the complications and incidence of the first and second access-related vascular injuries induced by videolaparoscopic cholecistectomy. METHODS: We retrospectively reviewed vascular injuries in 200 consecutive patients who underwent videolaparoscopic cholecistectomy from 2003 to 2005. One hundred and one patients with placement of radial expanding trocars were assigned into group A and 99 patients with placement of pyramidal tipped trocars into group B. All the patients were submitted to open access according to Hasson for the first trocar. RESULTS: Bleeding did not occur at the intraoperative cannula-site in group A. However, it occurred at the intraoperative cannula-site of 7 patients (7.1%) in group B, with a statistically significant difference (P < 0.01). No mortality was registered. More vascular lesions were found in group B. CONCLUSION: The advantage of Hasson technique is that peritoneal cavity access is gained under direct vision, preventing most severe injuries. The open technique with radial expanding trocars is recommended for secure access to the abdominal cavity in videolaparoscopy. Great care should be taken to avoid major complications and understanding the abdominal wall anatomy is important for reducing bleeding during or after s placement of trocars.

Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves:A single-center experience

AIM To investigate the clinical outcomes of transcatheter aortic valve implantation(TAVI) with the SAPIEN 3 transcatheter heart valve(S3-THV) vs the SAPIEN XT valve(XT-THV).METHODS We retrospectively analyzed 507 patients that underwent TAVI with the XT-THV and 283 patients that received the S3-THV at our institution between March 2010 and December 2015.RESULTS Thirty-day mortality(3.5% vs 8.7%:OR=0.44,P=0.21) and 1-year mortality(25.7% vs 20.1%,P=0.55) were similar in the S3-THV and the XT-THV groups.The rates of both major vascular complication and paravalvular regurgitation(PVR)>1 were almost 4 times lower in the S3-THV group than the XT-THV group(major vascular complication: 2.8% vs 9.9%,P<0.0001:PVR>1: 2.4% vs 9.7%,P<0.0001).However,the rate of new pacemaker implantation was almost twice as high in the S3-THV group(17.3% vs 9.8%,P=0.03).In the S3 group,independent predictors of new permanent pacemaker were pre-procedural RBBB(OR=4.9:P=0.001),pre-procedural PR duration(OR=1.14,P=0.05) and device lack of coaxiality(OR=1.13:P=0.05) during deployment.CONCLUSION The S3-THV is associated to lower rates of major vascular complications and PVR but higher rates of new pacemaker compared to the XT-THV.Sub-optimal visualization of the S3-THV in relation to the aortic valvular complex during deployment is a predictor of new permanent pacemaker.

Diagnosis and spontaneous healing of asymptomatic renal allograft extra-renal pseudo-aneurysm:A case report

BACKGROUND Transplant renal artery stenosis is a relatively frequent vascular complication after transplantation.However,extra-renal pseudo-aneurysms(EPSAs)are rare after transplantation;they can be life-threatening and usually need open surgical repair.We discuss the diagnosis and spontaneous healing of an asymptomatic renal allograft EPSA caused by renal artery anastomotic stenosis,which was diagnosed in a timely manner and managed by conservative treatments.CASE SUMMARY We present a 37-year-old male patient diagnosed with a renal allograft EPSA caused by renal artery anastomotic stenosis due to multiple atherosclerotic plaques with ultrasonographic examination 6 mo post transplantation.The stenosis rate of 90%and the EPSA were verified by computed tomography angiography.The diagnosis was further confirmed with digital subtraction angiography.Percutaneous transluminal angiography was conducted,and a metallic stent was successfully implanted at the stenosed site of the main renal artery trunk.No further intervention for the EPSA was undertaken due to the difficulty of stenting and the risk of bleeding;regular ultrasonographic follow-ups were recommended.The stenosis was significantly relieved immediately after stent implantation and the EPSA was healed spontaneously by completely filling with hypo-echoic thrombosis 8 mo after stenting.CONCLUSION Ultrasonography combined with a high-frequency linear probe can detect vascular complications post renal transplantation at an early stage and improve prognosis.

Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique

BACKGROUND The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valvereplacement(TF-TAVR);yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding.Thus,a bailout intervention is needed.So far,the best management of pre-closure device failure has not been recognized.AIM To report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR.METHODS We developed a“pledget-assisted hemostasis”technique to manage residual access-site bleeding.This consists of the insertion of a surgical,non-absorbable,polytetrafluoroethylene pledget over the sutures of the two ProGlide(Abbott Vascular,CA,United States).The ProGlide’s knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak.This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique.Post-procedural access-site angiography was systematically performed.In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria.RESULTS Out of 136 consecutive patients who underwent TF-TAVR,15 patients(mean age 80.0±7.2 years,66.7%female)with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis.In the majority of patients,16F sheath was used(n=12;80%).In 2 cases(13%),a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation.Angiography-confirmed hemostasis(primary efficacy endpoint)was achieved in all patients.After the procedure,1 patient required blood transfusion(2 units),and no other bleeding or major ischemic complication was noticed.CONCLUSION The“pledget assisted hemostasis”might be considered as a possible bailout technique to treat patients with residual access site bleeding.Further studies are needed to compare this approach with other bail-out techniques.