Uncovered Stents Research Articles

Endoluminal radiofrequency ablation with stenting versus stenting alone in patients with malignant biliary obstruction: a meta-analysis of randomized trials.

Endoluminal radiofrequency ablation (RFA) is a palliative treatment for patients suffering from malignant biliary obstruction (MBO). We aimed to conduct a meta-analysis to evaluate the impact of RFA on stent patency, patient survival, and adverse events. Major databases were searched through December 2023 for patients who had undergone stenting with or without RFA for extrahepatic MBO. A random-effects model was used for analysis, with results expressed as relative risk ratios (RRs) with 95%CIs. Nine RCTs involving 750 subjects with MBO (374 RFA plus stent vs. 376 stent only) were included. Meta-analysis revealed similar risks of stent patency at 3 months (RR 1.01, 95%CI 0.92-1.11; I 2 = 4%) for RFA plus stenting vs. stent only. Meta-analysis showed improved survival at 6 months (RR 0.84, 95%CI 0.73-0.96; I 2 = 21%; P = 0.01) for RFA plus stenting vs. stent only. Subgroup analysis comparing plastic vs. uncovered metal stents showed that stent patency was unaffected at 3 months (RR 1.06, 95%CI 0.91-1.23; I 2 = 17%). Subgroup analysis showed that patients with cholangiocarcinoma experienced an overall survival benefit with RFA plus stenting vs. stenting alone (P < 0.001); however, stent patency remained unaffected (P = 0.08). An increased incidence of cholecystitis was noted with RFA plus stenting vs. stenting alone (5.1% [95%CI 3.1%-7.8%] vs. 0.3% [95%CI 0.01%-1.5%], respectively). Combining endoluminal RFA and stenting may improve overall survival in patients with MBO. RFA did not significantly impact stent patency.

Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction

IntroductionSelf-expandable metallic stents (SEMS) have been widely placed for unresectable distal malignant biliary obstruction (UDMBO). However, the dysfunction rate is 19–40% and its treatment is controversial. We aimed asses the efficacy and safety of a secondary biliary stents (uncovered (UC) versus fully-covered (FC) stent) for the management of occluded SEMS. Patients and methodsBetween 2015 and June 2023, 41 patients with UDMBO underwent secondary biliary stent placement as “stent-in-stent” (20 FCSEMS and 21 UCSEMS). The primary outcomes were technical and clinical success of SEMS placement. Secondary outcomes included adverse events (AEs), patency and survival. Patients were prospectively followed until death or loss of follow-up. ResultsTechnical (100% vs 85.5%) and clinical (100% vs 95.2%) success rates were similar in FCSEMS and UCSEMS groups. The median follow-up period was 510 days (range 290–630). The median duration of stent patency of FCSEMS (220 days, IQR 137.5–442.5) was longer than UCSEMS (150 days, IQR 110–362.5) (P=0.395), although stent dysfunction within 6 months was not different between groups. Multivariate analysis indicated that sex (HR=0.909, 0.852–0.970), antitumor treatment (HR=0.248, 0.032–0.441), stent patency (HR=0.992, 0.986–0.998) and clinical success (HR=0.133, 0.026–0.690) were significant factors for overall survival. There were no remarkable differences in AEs. ConclusionsThe placement of additional biliary stent using the stent-in-stent method is an effective and safe rescue treatment for patients with UDMBO and occluded stent. In addition, the use of FCSEMS compared UCSEMS has unclear benefits regarding stent patency and overall survival.

Endoscopic Removal of Uncovered Metallic Airway Stents.

Self-expandable uncovered metallic stents (SEUMS) have been used in benign tracheobronchial stenosis. Stent complications may require risky removal due to SEUMS integration in the tracheobronchial wall. Our study aims to report techniques, including a novel one, and outcomes of SEUMS removal by rigid bronchoscopy. We studied a case series of 7 patients from a tertiary medical center, who underwent SEUMS removal from 2017 to 2022. SEUMS removals were performed through rigid bronchoscopy. We used a new technique with bronchoscopic hook scissors to gradually dissect the stent from the airway wall. Nine SEUMS were removed from 7 patients. The mean duration of stenting was 7 years (5 to 12y). Indications for stent removal included mostly recurrent pulmonary infections, obstructive granulation tissue, and stents' fractures. We used the usually described technique in the literature known as the "piecemeal fashion" without dissection in 4 SEUMS removals and a new dissection technique in 5 procedures. We reported one major intraoperative complication using the former technique in the form of tracheal tear with mediastinal breach, while we did not experience any major complications with the later one. One patient died 8 days after surgery from respiratory failure. Dissection and "piecemeal fashion techniques" can be used to remove SEUMS by rigid bronchoscopy even after long-term stenting. SEUMS removal is a very risky procedure and must be performed by a trained operator. Patients should be aware of possible severe complications.

COMPARISON OF DRUG-ELUTING STENTS VERSUS BARE-METAL STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE

Coronary artery disease is a condition that affects millions of people worldwide and can lead to serious complications such as heart attack or stroke. Objectives: The study compares drug-eluting stents to bare-metal stents for treating coronary artery disease. Methods: The present study aimed to compare the efficacy and safety of drug-eluting stents (1) versus bare metal stents (BMS) for the treatment of coronary artery disease (CAD). The study was conducted at Cardiology Department Hayat Abad Medical Complex Peshawar Pakistan, from 01 January 2022 till 30 June 2022. The study included a total of 384 patients with CAD who underwent percutaneous coronary intervention (PCI) with either DES or BMS. Results: The study included a total of 384 patients with CAD who underwent PCI with either DES or BMS. The mean age of the study participants was 58.2 ± 9.4 years, and 75.8% were male. The baseline characteristics, including demographic data, clinical presentation, cardiovascular risk factors, and angiographic findings, were comparable between the two groups. Conclusion: In conclusion, our study contrasting medication-eluting stents versus exposed metal stents for the treatment of coronary supply route sickness found that drug-eluting stents were related to a lower chance of unfriendly heart occasions, including objective vessel revascularization, myocardial dead tissue, and cardiovascular demise, contrasted with uncovered metal stents.

Shunt dysfunction and mortality after transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension

ObjectivesTransjugular intrahepatic portosystemic shunt (TIPS) is a catheter-based, minimally invasive procedure to reduce portal hypertension. The aim of the study was to investigate dysfunction and mortality after TIPS and to identify factors associated with these events.MethodsA retrospective analysis of 834 patients undergoing TIPS implantation in a single center from 1993–2018 was performed. Cumulative incidence curves were estimated, and frailty models were used to assess associations between potentially influential variables and time to dysfunction or death.Results1-, 2-, and 5-year mortality rates were 20.9% (confidence interval (CI) 17.7–24.1), 22.5% (CI 19.1–25.8), and 25.0% (CI: 21.1–28.8), 1-year, 2-year, and 5-year dysfunction rates were 28.4% (CI 24.6–32.3), 38.9% (CI 34.5–43.3), and 52.4% (CI 47.2–57.6). The use of covered stents is a protective factor regarding TIPS dysfunction (hazard ratio (HR) 0.47, CI 0.33–0.68) but does not play a major role in survival (HR 0.95, CI 0.58–1.56). Risk factors for mortality are rather TIPS in an emergency setting (HR 2.78, CI 1.19–6.50), a previous TIPS dysfunction (HR 2.43, CI 1.28–4.62), and an increased Freiburg score (HR 1.45, CI 0.93–2.28).ConclusionThe use of covered stents is an important protective factor regarding TIPS dysfunction. Whereas previous TIPS dysfunction, emergency TIPS implantation, and an elevated Freiburg score are associated with increased mortality. Awareness of risk factors could contribute to a better selection of patients who may benefit from a TIPS procedure and improve clinical follow-up with regard to early detection of thrombosis/stenosis.Critical relevance statementThe use of covered stents reduces the risk of dysfunction after transjugular intrahepatic portosystemic shunt (TIPS). TIPS dysfunction, emergency TIPS placement, and a high Freiburg score are linked to higher mortality rates in TIPS patients.Key PointsThe risk of dysfunction is higher for uncovered stents compared to covered stents.Transjugular intrahepatic portosystemic shunt dysfunction increases the risk of instantaneous death after the intervention.A higher Freiburg score increases the rate of death after the intervention.Transjugular intrahepatic portosystemic shunt implantations in emergency settings reduce survival rates.Graphical

Covered Endovascular Reconstruction of the Iliac Artery Bifurcation (CERIB).

The aim of this study was to present the covered endovascular reconstruction of the iliac artery bifurcation (CERIB) technique as a revascularization option for aorto-iliac occlusive disease (AIOD) involving the iliac artery bifurcation. This was a retrospective single-center study including all patients undergoing a CERIB procedure from January 2021 until December 2022. Covered endovascular reconstruction of the iliac artery bifurcation procedures were performed percutaneously with bilateral femoral access, excepting cases where simultaneous open femoral artery reconstruction was required due to the extension of peripheral arterial occlusive disease. Standard patient, procedural, and follow-up (FU) data including survival and arterial reinterventions were gathered and analyzed. A total of 13 patients were included (11/13 male, median age=70 [60-76] years). Additional open and/or endovascular procedures included endarterectomy of the femoral bifurcation (n=6), rotational atherectomy (n=2), and 1 axillary artery cutdown for upper limb access (n=1). Median operating time was 2.9 hours (1.5-4.9 hours); median radiation duration and dose were 28.4 (14.3-63.3 minutes) and 4090.6 (384.4-9430.1 cGray/cm2), respectively. The stent grafts used for CERIB were BeGraft peripheral n=31, BeGraft Aortic n=4 and BeGraft peripheral plus n=1 (Bentley InnoMed GmbH, Hechingen, Germany). In 2 patients with prior stenting of the common iliac artery (CIA), only the internal and external iliac arteries (IIA and EIA) were treated in this study, and in 2 cases, additional uncovered stents were required for relining. Technical success was 100%. During a midterm FU (median 18 [4-31] months), 2 patients died from cardiovascular reasons and 1 patient with prior iliac stenting required reinterventions for recurring occlusion. Covered endovascular reconstruction of the iliac artery bifurcation is a straightforward option for treating AIOD involving the iliac artery bifurcation that allows preservation of internal iliac artery perfusion and shows good early and midterm results. Prior iliac artery stenting may be a risk factor for early occlusion after CERIB. Aorto-iliac occlusive disease with involvement of the internal iliac artery is encountered regularly in vascular surgical practice, but the internal iliac artery is often not included in the revascularization strategy. The present article will increase the awareness for the relevance of including the internal iliac artery in revascularization strategies and presents CERIB as another method to be added to the armamentarium of (endo-)vascular surgeons and interventionalists.

Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction

IntroductionSelf-expandable metallic stents (SEMS) have been widely placed for unresectable distal malignant biliary obstruction (UDMBO). However, the dysfunction rate is 19–40% and its treatment is controversial. We aimed asses the efficacy and safety of a secondary biliary stents (uncovered (UC) versus fully-covered (FC) stent) for the management of occluded SEMS. Patients and methodsBetween 2015 and June 2023, 41 patients with UDMBO underwent secondary biliary stent placement as “stent-in-stent” (20 FCSEMS and 21 UCSEMS). The primary outcomes were technical and clinical success of SEMS placement. Secondary outcomes included adverse events (AEs), patency and survival. Patients were prospectively followed until death or loss of follow-up. ResultsTechnical (100% vs 85.5%) and clinical (100% vs 95.2%) success rates were similar in FCSEMS and UCSEMS groups. The median follow-up period was 510 days (range 290–630). The median duration of stent patency of FCSEMS (220 days, IQR 137.5–442.5) was longer than UCSEMS (150 days, IQR 110–362.5) (P=0.395), although stent dysfunction within 6 months was not different between groups. Multivariate analysis indicated that sex (HR=0.909, 0.852–0.970), antitumor treatment (HR=0.248, 0.032–0.441), stent patency (HR=0.992, 0.986–0.998) and clinical success (HR=0.133, 0.026–0.690) were significant factors for overall survival. There were no remarkable differences in AEs. ConclusionsThe placement of additional biliary stent using the stent-in-stent method is an effective and safe rescue treatment for patients with UDMBO and occluded stent. In addition, the use of FCSEMS compared UCSEMS has unclear benefits regarding stent patency and overall survival.

Endoscopic ultrasound-guided antegrade treatment with uncovered self-expanding metal stent for malignant afferent loop syndrome-complicated cholangitis after biliary reconstruction.

Endoscopic ultrasound-guided antegrade treatment with uncovered self-expanding metal stent for malignant afferent loop syndrome-complicated cholangitis after biliary reconstruction.

Efficacy and safety of uncovered self-expandable metal stents for distal malignant biliary obstruction in unresectable non-pancreatic cancer.

The efficacy of uncovered self-expandable metal stents (UCSEMS) versus fully covered self-expandable metal stents for distal malignant biliary obstruction remains controversial. Additionally, the heterogeneity of the disease conditions has been indicated in previous studies because pancreatic and non-pancreatic cancers have different characteristics in clinical course. Therefore, the etiology of biliary obstruction necessitates investigations stratified by primary disease. This study aimed to evaluate the outcomes of UCSEMS, specifically for non-pancreatic cancer-induced distal malignant biliary obstruction. We conducted a single-center retrospective review to evaluate the time to recurrent biliary obstruction and frequency of adverse events (AEs) in patients receiving UCSEMS for unresectable non-pancreatic cancer-induced malignant biliary obstruction. Overall, 32 patients were enrolled in the study between January 2016 and December 2023. The median time to recurrent biliary obstructionwas 140 days. AE rates were low at 3.1% for both pancreatitis and cholecystitis, suggesting a potential benefit of UCSEMS in reducing post-procedural AEs. UCSEMS may reduce the risk of post-procedural AEs and should be considered in patients at high risk of post-endoscopic retrograde cholangiopancreatography pancreatitis. However, the patency period may be shorter, necessitating future comparative research with fully covered self-expandable metal stentsto determine the optimal stent choice.

Evaluation of short and mid-term clinical outcomes in patients with aortic coarctation treated with self-expandable stents

The present study aimed to evaluate the outcomes of percutaneous treatment of aortic coarctation using self-expandable uncovered Nitinol stents. We conducted a retrospective clinical data review of all patients with aortic coarctation and treated with self-expandable uncovered Nitinol stents at our institution between 2009 and 2019. The gradient pressure across the coarctation site was measured using aortography. Follow-up echocardiography and computed tomography angiography were performed to assess possible stent complications. A total of 127 stents were successfully implanted in 125 patients (64.8% males) with a mean age of 35.36 ± 11.9 years. The gradient across the coarctation site decreased significantly from 67.48 ± 14.79 to 5.04 ± 3.01 mmHg (P < 0.001) after self-expandable stent implantation. Systolic blood pressure (SBP) decreased significantly from 175.53 ± 15.99 to 147.22 ± 12.83 mmHg (P < 0.001) after self-expandable stenting. There were no major technical or clinical complications, including balloon rupture, aneurysmal formation, infection, secondary stent migration, thrombosis, death during the procedure, and in-hospital mortality. On a mean follow-up of 48 ± 23.6 months (12–120 months), the gradient [from 59.43 ± 15.42 to 3.72 ± 1.38 mmHg (P < 0.001)] and SBP [from 175.53 ± 15.99 to 127.99 ± 7.82 mmHg (P < 0.001)] decreased significantly. There was no mortality, aneurysmal formation in the stent site, dislocation, or aortic re-stenosis requiring intervention during mid-term follow-up. Treatment of aortic coarctation using a self-expandable uncovered nitinol stent is safe and effective with promising mid-term outcomes.

Ultrathin-strut versus thin-strut stent healing and outcomes in preclinical and clinical subjects.

Compared with thin-strut durable-polymer drug-eluting stents (DP-DES), ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) improve stent-related clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Reduced stent strut thickness is hypothesised to underlie these benefits, but this conjecture remains unproven. We aimed to assess the impact of strut thickness on stent healing and clinical outcomes between ultrathin-strut and thin-strut BP-SES. First, we performed a preclinical study of 8 rabbits implanted with non-overlapping thin-strut (diameter/thickness 3.5 mm/80 μm) and ultrathin-strut (diameter/thickness 3.0 mm/60 μm) BP-SES in the infrarenal aorta. On day 7, the rabbits underwent intravascular near-infrared fluorescence optical coherence tomography (NIRF-OCT) molecular-structural imaging of fibrin deposition and stent tissue coverage, followed by histopathological analysis. Second, we conducted an individual data pooled analysis of patients enrolled in the BIOSCIENCE and BIOSTEMI randomised PCI trials treated with ultrathin-strut (n=282) or thin-strut (n=222) BP-SES. The primary endpoint was target lesion failure (TLF) at 1-year follow-up, with a landmark analysis at 30 days. NIRF-OCT image analyses revealed that ultrathin-strut and thin-strut BP-SES exhibited similar stent fibrin deposition (p=0.49) and percentage of uncovered stent struts (p=0.63). Histopathological assessments corroÂborated these findings. In 504 pooled randomised trial patients, TLF rates were similar for those treated with ultrathin-strut or thin-strut BP-SES at 30-day (2.5% vs 1.8%; p=0.62) and 1-year follow-up (4.3% vs 4.7%; p=0.88). Ultrathin-strut and thin-strut BP-SES demonstrate similar early arterial healing profiles and 30-day and 1-year clinical outcomes.

Safety and efficacy of large-bore uncovered stents for treating malignant superior vena cava syndrome

PurposeTo investigate the safety and efficacy of large-bore uncovered stents for treating malignant superior vena cava syndrome. MethodsThis retrospective study included 115 patients (89 men, 26 women; mean age 63.2 years; range 21–83 years) who underwent endovascular large-bore (≥18 mm in diameter) uncovered stent placement between August 2015 and July 2022. One patient was lost to follow-up. Therefore, 114 patients were available for follow-up. ResultsStent placement was technically successful in all 115 patients. Minor procedure-related complications occurred in nine (7.8 %) patients. One hundred eight (93.9 %) patients experienced complete or marked symptomatic relief (Kishi score ≤ 2) at a mean of 3 days after procedure. The cumulative stent patency rates were 98.2 %, 95 %, 93.7 %, 91.5 %, 83.5 %, and 83.5 % at 1, 3, 6, 12, 18, and 24 months, respectively. Stent occlusion occurred in ten (8.8 %) of 114 patients at a mean of 215 days (range 1–732 days) due to thrombosis (n = 7) and tumor ingrowth (n = 3). Stent occlusion did not occur in 21 patients who underwent subsequent central venous catheter insertion. The median patient survival time was 159 days (95 % confidence interval 102–216 days). Univariate and multivariate Cox regression analysis revealed adjuvant anticancer treatment (p = 0.001) and tumor response (p < 0.001) as independent predictors of patient survival. ConclusionsEndovascular placement of large-bore uncovered stents was a safe and effective treatment for malignant superior vena cava syndrome. Large-bore stent placement can effectively prevent stent occlusion by tumor ingrowth in most cases, and it can provide a sufficient diameter for subsequent insertion of central venous catheters.

Role of advanced endoscopy in the management of inflammatory digestive diseases (pancreas and biliary tract).

The progress of endoscopic diagnosis and treatment for inflammatory diseases of the biliary tract and pancreas have been remarkable. Endoscopic ultrasonography (EUS) and EUS-elastography are used for the diagnosis of early chronic pancreatitis and evaluation of endocrine and exocrine function in chronic pancreatitis. Notably, extracorporeal shock wave lithotripsy and electrohydraulic shock wave lithotripsy have improved the endoscopic stone removal rate in patients for whom pancreatic stone removal is difficult. Studies have reported the use of self-expanding metal stents for stent placement for pancreatic duct stenosis and EUS-guided pancreatic drainage for refractory pancreatic duct strictures. Furthermore, EUS-guided drainage using a double-pigtailed plastic stent has been performed for the management of symptomatic pancreatic fluid collection after acute pancreatitis. Recently, lumen-apposing metal stents have led to advances in the treatment of walled-off necrosis after acute pancreatitis. EUS-guided biliary drainage is an alternative to refractory endoscopic biliary drainage and percutaneous transhepatic biliary drainage for the treatment of acute cholangitis. The placement of an inside stent followed by switching to uncovered self-expanding metal stents in difficult-to-treat cases has been proposed for acute cholangitis by malignant biliary obstruction. Endoscopic transpapillary gallbladder drainage is an alternative to percutaneous transhepatic gallbladder drainage for severe and some cases of moderate acute cholecystitis. EUS-guided gallbladder drainage has been reported as an alternative to percutaneous transhepatic gallbladder drainage and endoscopic transpapillary gallbladder drainage. However, it is important to understand the advantages and disadvantages of each drainage method and select the optimal drainage method for each case.

A novel method of bilateral biliary decompression by EUS-guided hepaticogastrostomy with bridging stenting using the partial stent-in-stent method for reintervention of multiple metal stent failure

Video 1A novel method of bilateral biliary decompression by EUS-guided hepaticogastrostomy with bridging stenting using the partial stent-in-stent method for reintervention of multiple metal stent failure.We report a case in which anterior and posterior drainage was performed using the partial stent-in-stent method via the transpapillary approach. The patient had a bismuth type IV biliary obstruction, but only the right hepatic lobe was drained due to obstruction of the left portal vein. For the recurrent stent dysfunction, the patient underwent placement of a plastic stent within an uncovered self-expanding metal stent to correct stent dysfunction. A 7F plastic stent inside a metal stent is shown.The patient later experienced stent failure and jaundice due to tumor progression and was admitted for plastic stent replacement. Neither imaging results nor symptoms suggested duodenal stenosis. The transpapillary approach was attempted first but was unsuccessful. Duodenoscopy was challenging to perform because of duodenal stenosis. Fluoroscopy confirmed the duodenal stenosis. The plastic stent was extracted using an upper endoscope. Multiple uncovered metal stents are shown (1 stent in the anterior bile duct and 2 stents in the posterior bile duct). Jaundice did not resolve despite plastic stent removal.The patient refused to undergo percutaneous biliary drainage, so a decision was made to perform an EUS-guided hepaticogastrostomy (HGS) instead. The left bile duct was observed in the stomach. The left bile duct was punctured with a 19-gauge FNA needle. A 0.025-inch hydrophilic guidewire was directed into the left bile duct. Enhancement of the bile duct showing malignant hilar biliary obstruction (bismuth IV) is seen. Insertion of the guide wire into the posterior bile duct is shown.The stent mesh was then dilated using a balloon dilator. However, there was difficulty inserting the catheter. Additional dilation was performed using a spiral dilator. This instrument is a tapered tip dilator that fits into 0.025-inch guidewires and is expandable to 7F. Insertion of a second guidewire with a larger caliber was done to straighten the bile duct and help stabilize stent insertion. A 0.035-inch hydrophilic guidewire into the posterior bile duct using a double-lumen cannula and insertion of a 0.025-inch hydrophilic guidewire into the anterior bile duct are shown.The stent mesh was then dilated using a spiral dilator. A metal stent was placed through the anterior bile duct at a steep angle. Insertion and deployment of the first uncovered self-expanding metal stent (8× 60mm) from the anterior bile duct into the left bile duct is shown. Multiple metal stents were implanted into the hilar area, and the new stent was placed using the partial stent-in-stent method to prevent overexpansion. Guidewire seeking the posterior bile duct from inside the deployed stent through the stent mesh is shown.The stent mesh was then dilated using a balloon dilator. Insertion and deployment of an uncovered self-expanding metal stent (8× 60mm) from the posterior bile duct to the left bile duct using the partial stent-in-stent method is shown. Enhancement of the bile duct shows drainage from the right bile duct. The fistula of the HGS was only dilated with the spiral dilator. The risk of bile leakage was low, so we decided to implant a plastic stent. A 7F× 15-cm plastic stent was placed from the posterior bile duct into the stomach. Anterior and posterior segment drainage by EUS-HGS with bridging stenting using the partial stent-in-stent method is shown, with left segment drainage by EUS-HGS with the plastic stent.We performed EUS-HGS on a patient with multiple metal stents in place. There were no adverse events, and total bilirubin levels were reduced by more than half within 2 weeks. Six months have passed without stent dysfunction.

The influence of thyroid status on long-term complications after stenting in patients with acute coronary syndrome without ST-segment elevation.

Backround. It is known that both subclinical hypothyroidism (SHT) and subclinical thyrotoxicosis (STT) can influence the outcome of coronary heart disease. The feasibility of routinely determining thyroid status in patients without obvious signs of thyroid dysfunction with acute coronary syndrome without ST-segment elevation (NSTEACS) to assess the effect on the status of implanted stents has not been determined.Objective. To evaluate the effect of subclinical hypothyroidism and subclinical thyrotoxicosis on lumen loss and the degree of endothelialization of drug-eluting stents after stenting for NSTE-ACS. Design and methods. The study included 173 patients who were urgently stented for NSTE-ACS, and who subsequently underwent repeat coronary angiography within a year on a planned or emergency basis with a targeted assessment of the condition of the installed stents. In 40 patients with everolimus-eluting stents, the condition of the coronary arteries was assessed 6.3 + 0.3 months after stenting using optical coherence tomography (OCT). All patients included in the study had their thyroid status assessed.Results. SHT was detected in 8 (21.6 %) patients with loss of lumen in the stent area and in 26 (19.1 %) patients without loss of lumen, p = 0.73. STT was detected in 2 (5.4 %) and 3 (2.2 %) patients, respectively, p = 0.30. A prognostic analysis performed by logistic regression with forced inclusion as predictors of lumen loss identified the parameters Syntax Score I, stent diameter, and the number of affected coronary arteries. No effect of thyroid status on lumen loss was found. In patients with subclinical hypothyroidism, OCT data revealed insufficient endothelialization of everolimus-eluting stents 6 months after stenting for NSTE-ACS. The percentage of uncovered stent struts depended on TSH levels (r = 0.42, p = 0.007). The higher the TSH level, the higher the healing index and the worse the stent endothelialization (r = 0.37, p = 0.016). Conclusion. Thus, routine determination of thyroid status indicators in patients with NSTE-ACS in order to identify subclinical thyroid dysfunction does not provide significant prognostic information regarding the risk of lumen loss of implanted stents. Considering the potential risk of thrombotic complications associated with insufficient endothelialization of everolimus-eluting stents in the presence of subclinical hypothyroidism, it seems advisable to identify it when deciding on de-escalation of antithrombotic therapy. The question remains open about the need to correct the parameters of subclinical thyroid dysfunction in order to modify the prognosis.

Clinical outcomes of different types of metallic stents in malignant distal duodenum stenosis: A retrospective study

Background/purposeEndoscopic stenting at malignant distal duodenum stenosis (MDDS) is challenging because of the duodenal C-loop configuration, the acute angle of the duodenojejunal junction, and the limited length of the endoscope. Few studies have investigated the clinical outcomes of stenting at the distal duodenum. Therefore, this study aimed to investigate the clinical outcomes of treating MDDS with different types of metallic stents. MethodsFrom January 2012 to December 2020, fifty-six patients with MDDS who underwent duodenal stenting were enrolled for analysis. Thirty-five patients received uncovered self-expandable metallic stents (UC-SEMS), and twenty-one patients received partially covered self-expandable metallic stents (PC-SEMS). All patients were followed up till death or for 18 months. The clinical success rate, stent dysfunction rate, and stent patency were compared between the groups. Multivariate analysis was conducted to identify factors related to stent dysfunction. ResultsThe clinical success rates were 85.7 % in both the UC-SEMS and PC-SEMS groups. Stent dysfunction rates (UC-SEMS: 34.3 %, PC-SEMS: 38.1 %, p = 0.773) and the average stent patency (UC-SEMS: 117.2 days, PC-SEMS: 100.0 days, p = 0.576) were not statistically different between the groups. Multivariate analysis disclosed the age ≥65 years was significantly related to stent dysfunction (odds ratio: 4.78, p = 0.031). ConclusionBoth UC-SEMS and PC-SEMS are safe and effective treatment options for MDDS. However, stent dysfunction remains a significant issue to overcome, particularly in the elderly. Further research is needed to explore novel strategies that can improve the effectiveness of stent placement and reduce the risk of stent dysfunction.

Comparison of covered self-expandable metallic stents with 12-mm and 10-mm diameters for unresectable malignant distal biliary obstructions: a prospective randomized trial

Covered self-expandable metallic stents have longer patency than uncovered self-expandable metallic stents for unresectable malignant distal biliary obstruction because of the prevention of tumor ingrowth, and they are removable during reintervention. One main cause of recurrent biliary obstruction in covered self-expandable metallic stents is sludge formation, which can be prevented by using large-bore stents. We evaluated the treatment results of 12-mm and 10-mm covered self-expandable metallic stents for unresectable malignant distal biliary obstructions using a randomized controlled trial. This study was conducted between May 2016 and January 2019 and included 81 consecutive patients with unresectable malignant distal biliary obstruction. The primary endpoint was the rate of nonrecurrent biliary obstruction at 6 months after stent placement. The primary endpoint in the 12-mm group was significantly higher than that in the 10-mm group (P= .0369). Therefore, the median time to recurrent biliary obstruction was 172 days in the 12-mm group and 120 days in the 10-mm group. The median time to recurrent biliary obstruction in the 12-mm group was significantly longer than that in the 10-mm group (P= .0168). Using the 12-mm covered self-expandable metallic stents and receiving chemotherapy were factors affecting the rate of recurrent biliary obstruction in the multivariate analysis. The 12-mm covered self-expandable metallic stents provide a longer time to recurrent biliary obstruction than do 10-mm covered self-expandable metallic stents for managing unresectable malignant distal biliary obstruction. (Clinical trial registration number: UMIN000016911.).

Implantation of ascyrus medical dissection stent, our first-hand experience

BackgroundAcute type A aortic dissection is associated with high perioperative morbidity and mortality. Ascyrus Medical Dissection Stent (Cryolife, Kennesaw, USA) is a novel uncovered hybrid stent graft developed to be used as an adjunct to standard surgical approach to promote true lumen expansion and enhance aortic remodeling.MethodsFrom March 2021 to March 2022, four consecutive patients presented with acute Debakey type I aortic dissection and underwent emergent surgical repair with Tirone David procedure and implantation of Ascyrus Medical Dissection Stent. We reviewed patient’s files retrospectively and described the perioperative outcomes.ResultsAll four device implantations were successful. Overall 30-day mortality was 0%. Malperfusion that was present in two patients pre-operatively improved after Ascyrus Medical Dissection Stent implantation. No aortic reinterventions were needed. No aortic injury related to the device was noted. Favourable changes in aortic true lumen and false lumen dimensions were found in most of our patients but the stent was compressed at the isthmus in one patient.ConclusionAscyrus Medical Dissection Stent is a reliable and secure device. However, its benefits remain unclear when it comes to a positive remodeling and seems less likelihood comparable to a frozen elephant trunk. The main reason seems to be an insufficient radial force of the stent.

Factors associated with patency of self-expandable metal stents in malignant biliary obstruction

IntroductionEndoscopic self-expandable metal stent (SEMS) placement is the key endoscopic treatment for unresectable malignant biliary obstruction. The benefit of covered SEMS over uncovered SEMS remains unknown as are risk factors for SEMS dysfunction. This study aimed to determine the factors associated with patency of SEMS.MethodsPatients with unresectable malignant biliary obstruction who underwent endoscopic SEMS placement at Ramathibodi Hospital, during January 2012 to March 2021 were included. Patient characteristics, clinical outcomes and patency of SEMS were collected. The primary outcome were stent patency and factors associated with patency of SEMS. The factors were analyzed by univariate and multivariate analyses. Median days of stent patency, median time of patient survival, rate of reintervention and complications after SEMS placement were collected.ResultsOne hundred and fourteen patients were included. SEMS dysfunction was found in 37 patients (32.5%). Size of cancer (Hazard ratio (HR), 1.20, (95% CI 1.02, 1.40), p 0.025), presence of stones or sludge during SEMS placement (Hazard ratio (HR), 3.91, (95% CI 1.74, 8.75), p 0.001), length of SEMS, 8 cm (HR 2.96, (95% CI 1.06, 8.3), p 0.039), and total bilirubin level above 2 mg/dL at one month after SEMS placement (HR 1.14, (95% CI 1.06, 1.22), p < 0.001) were associated with SEMS dysfunction. The median stent patency was 97 days. The median patient survival was 133 days, (95% CI 75–165). The rate of reintervention was 86% in patients with SEMS dysfunction.ConclusionThe size of cancer, presence of stones or sludge during SEMS placement, the length of SEMS, and total bilirubin level above 2 mg/dL at 1 month after SEMS placement were associated with SEMS dysfunction. The median time of stent patency were not statistically different in each type of stent, covered stent, partially covered stent and uncovered stent. Median survival time of patients did not associate with SEMS patency or dysfunction.

Rationale and design of a randomized controlled trial: The effect of intensive lipid-lowering therapy with PCSK9 inhibitor on endothelial-coverage of stent strut after percutaneous coronary intervention (PCI) for patients with acute coronary syndrome (ACS): Optical coherence tomography (OCT) study (PIECES-OCT study)

BackgroundFor the patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) for at least 1 year is recommended in the guidelines to minimize the risk of stent thrombosis. Persistently uncovered stent strut means delayed neointima formation and extend the window of time in which the stent is prone to thrombosis. Previous studies showed that statins could improve post-stenting strut endothelial coverage for patients undergoing PCI. However, there are lack of evidences on whether early initiation of proprotein convertase subtilisin/Kexin type 9 monoclonal antibody (PCSK9mAb) after PCI in ACS patients can further improve the rate of stent strut coverage on the background of oral lipid-lowering therapy (LLT). MethodsThis is a single-center, randomized trial to enroll 36 patients undergoing PCI with a clinical diagnosis of non-ST-segment elevation ACS. The baseline level of low-density lipoprotein cholesterol (LDL-C) of these patients are between 1.4 mmol/L and 3.4 mmol/L. Patients will be assigned to intensive lipid-lowering therapy (LLT) with PCSK9mAb group and conventional LLT without PCSK9mAb group for 12 weeks in a clinical follow-up setting according to 1: 1 randomization. the rate of stent strut endothelial coverage by optical coherence tomography (OCT) examination at 12 weeks after enrollment between the groups will be compared. ConclusionThis will be the first study to investigate changes in the rate of stent strut endothelial coverage under intensive LLT with PCSK9mAb by OCT examination in ACS patients undergoing PCI. The finding of this study will provide clinical evidence for future research about the hypothesis of a novel strategy of “intensive LLT (PCSK9mAb + statin ± ezetimibe) combined with shortened DAPT duration” for ACS patients undergoing PCI.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: ChiCTR2200063395.