Average Stent Diameter Research Articles

Inter-atrial Septum Stenting in Congenital Heart Disease Patient: A Case Series in Indonesia.

Inter-atrial septum (IAS) stenting in duct-dependent congenital heart disease patient has shown to be an effective way to maintain inter-atrial blood flow, however it is still considered a high risk procedure and inter-atrial septum stenting remains a low-frequency procedure. A single-center observational cohort study was carried out at the National Cardiovascular Center Harapan Kita (NCCHK) between April 2019 and April 2023. This study included duct-dependent congenital heart disease patients. The extracted data were baseline characteristics, clinical findings, complications, and outcomes of the patients. Eleven patients with duct-dependent physiology were intervened with inter-atrial septum stenting. The patients were 4 females and 7 males with the median age of implantation being 150 days (range 11-703 days) and the median weight being 3.9 (range 2.8-9) kg, with 2 patients weighing less than 3 kg. The average stent diameter was 8.50 (2.03) mm with an average length of 24.45 (7.94) mm. Non-restrictive atrial flow was successfully achieved in 90.90% of the procedures, corresponding to 10 patients. Inter-atrial septum stenting in duct-dependent congenital heart disease patients produces reliable patency with a very good intra-procedural success rate.

Clinical safety and performance of the world's thinnest-strut Evermine50 everolimus-eluting stent: a 24-month follow-up of the Evermine 50 EES - 1 study.

Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients. This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions. This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon. A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes. The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Expansion of WallStents® after Initial Deployment in Nonthrombotic Iliac Vein Lesions

To determine the structural changes of Wallstents (Boston Scientific, Natick, MA) invivo following deployment in iliac veins. This retrospective single-center study was performed from September 2012 to April 2013 and included 100 office-based patients who underwent initial stent placement for nonthrombotic iliac vein lesions with Wallstent as well as a second procedure for stenting of the contralateral iliac vein. Measurements were obtained with marker balloons and the diameters of the stents were compared at the time of the index procedure to the secondary procedure. The average time between the 2 procedures was 28days (range 3-237, SD±39.89). The overall average stent diameter after the index procedure was 16.38mm (range 10.95-21.45, SD±2.24). The overall average stent diameter of the index stent when remeasured during the second intervention was 17.58mm (range 12.84-24.11, SD±2.38, P=0.0003), which was significantly different from the initial measurements. There was no difference when comparing changes in stent diameter by gender or laterality of procedure. However, there was a significant difference in expansion of stents when placed in the common iliac vein versus the external iliac or common femoral veins. This study shows that self-expanding Wallstents can continue to expand days to weeks invivo following initial deployment. Additionally, we found that the change in diameter from initial placement to follow-up was more significant in stents placed in the proximal and middle segments of the common iliac vein. Wallstents are durable implants designed to last within a patient for the rest of their life, it is important to understand the structural changes occurring after their placement. This study allows for a better understanding of Wallstent dynamics invivo.

Right ventricular outflow tract stenting for late presenter unrepaired Fallot physiology: a single-center experience.

The purpose of this study was to assess the clinical outcome after right ventricular outflow tract (RVOT) stenting in late presenter patient with unrepaired Fallot physiology. In younger patients, RVOT stenting is an alternative to mBTT shunt; however, there have been few reports of this palliative technique in late presenter population, including adults. This was a single-center, retrospective study of nonrandomized, palliated Fallot patients. Clinical outcomes such as left ventricular ejection fraction and saturation were measured in 32 individuals following RVOT stenting in adults (n = 10) and children (n = 22). The Statistical Package for Social Science (SPSS) 26.0 software was used to analyze the statistical data. During the procedure, the average stent diameter and length were 8.84 ± 1.64 mm and 35.46 ± 11.23 mm, respectively. Adult patients received slightly longer stents than pediatric patients (43.60 ± 11.64 mm vs. 31.77 ± 9.07 mm). Overall, patients' saturation increased from 58.56 ± 19.03% to 91.03 ± 8.98% (p < 0.001), as did their left ventricular ejection fraction (LVEF) from 64.00 ± 18.21% to 75.09 ± 12.98% (p = 0.001). Three patients improved their LVEF from 31 to 55%, 31 to 67%, and 26 to 50%. The median length of stay was 8 (2-35) days, with an ICU stay of 2 (0-30) days. The median time from RVOT stent palliation to total repair was 3 months (range: 1 month-12 months). RVOT stenting is a safe and effective method for increasing saturation and ejection fraction not only in newborn infants but also in late presenters, including adults with unrepaired Fallot physiology.

An Evaluation of the Duration of Oral Anticoagulant Use Among Patients Undergoing Endovascular Treatment of Nonthrombotic Iliac Vein Lesions

This study aimed to compare clinical outcomes associated with the duration of postoperative direct oral anticoagulant (DOACs) therapy in patients with nonthrombotic iliac vein lesions. We retrospectively analyzed 176 consecutive patients who underwent stenting for nonthrombotic iliac vein lesions between March 2018 and December 2021. In total, 99 and 77 patients were discharged on a 3-month and >3-month regimen of DOAC therapy, respectively. The primary cumulative endpoint was a composite of thrombotic complications, bleeding complications, primary patency, primary-assisted patency, and secondary patency within 1year. Patients undergoing 3-month and >3-month DOAC therapy were similar in age, sex, lesion site, symptoms, and average stent diameter and length. Upon multivariate analysis, the primary cumulative endpoint did not differ between the 2 groups (hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 0.42-3.30; P=0.76). Moreover, the primary patency at 1year did not differ between the groups (HR: 1.50; 95% CI: 0.14-16.54; P=0.74). Furthermore, there were no discernible differences in the secondary endpoints of bleeding complications (HR: 0.66; 95% CI: 0.22-1.96; P=0.45) or thrombotic complications (HR: 1.79; 95% CI: 0.55-5.80; P=0.34) between the groups. The 3-month regimen of DOAC therapy showed a similar risk of postoperative thrombosis and bleeding when compared to longer DOAC therapy durations over the course of 1year following endovascular intervention. This could be a preferred option for patients with a higher estimated bleeding risk after venous stenting.

Optical coherence tomography-derived predictors of stent expansion in calcified lesions.

Severe coronary artery calcification is associated with stent underexpansion and subsequent stent failure. We aimed to identify optical coherence tomography (OCT)-derived predictors of absolute (minimal stent area [MSA]) and relative stent expansion in calcified lesions. This retrospective cohort study included patients who underwent percutaneous coronary intervention (PCI) with OCT assessment before and after stent implantation between May 2008 and April 2022. Pre-PCI OCT was used to assess calcium burden and post-PCI OCT was used to assess absolute and relative stent expansion. A total of 361 lesions in 336 patients were analyzed. Target lesion calcification (defined as OCT-detected maximum calcium angle ≥ 30°) was present in 242 (67.0%) lesions. Following PCI, median MSA was 5.37 mm2 in calcified lesions and 6.24 mm2 in noncalcified lesions (p < 0.001). Median stent expansion was 78% in calcified lesions and 83% in noncalcified lesions (p = 0.325). In the subset of calcified lesions, average stent diameter, preprocedural minimal lumen area, and total calcium length were independent predictors of MSA in multivariable analysis (mean difference 2.69 mm2 /mm2 , 0.52 mm2 /mm, and -0.28 mm2 /5 mm, respectively, all p < 0.001). Total stent length was the only independent predictor of relative stent expansion (mean difference -0.465% per mm, p < 0.001). Calcium angle, thickness, and the presence of nodular calcification were not significantly associated with MSA or stent expansion in multivariable analyses. Calcium length appeared to be the most important OCT-derived predictor of MSA, whereas stent expansion was mainly determined by total stent length.

B-26 | Orbital Atherectomy Clinical and Procedural Outcomes

Orbital atherectomy prior to stenting (OAptS) of severely calcified coronary artery stenosis (CCAS) may improve procedural and clinical outcomes. However, there is little data comparing in-hospital outcomes between genders. Patients who underwent OAptS between 2016-2021 at 7 participating IU Health hospitals were identified in the Indiana University Health Multicenter Cath Registry. Clinical data and procedural characteristics were collected as defined by the National Cardiovascular Data Registry criteria then analyzed according to gender. In-hospital data from 608 patients (426 male and 182 female) were analyzed. Overall, group characteristics were similar. Females had a higher proportion of diabetes (62% vs 51%, p=0.012), smaller average stent diameter (2.8 +/- 0.8mm vs. 2.9 +/- 0.7mm, p=0.008), and shorter average lesion length (41 +/- 22mm vs 46 +/- 24mm, p=0.01). In general, clinical and procedural outcomes were not significantly different between males and females (Table 1). However, females did have a significantly higher incidence of coronary artery perforation (2.2% vs. 0.5%, p=0.048). In conclusion, our study shows both men and women have low overall adverse event rates and comparable clinical outcomes. While women had a higher risk of coronary perforation, it was not associated with worse clinical outcomes or increased mortality.

Angiographic derived physiological assessment after intervention for predicting 2-year vessel-oriented composite endpoints in Multivessel TALENT trial

Abstract Aims The purpose of the study is to assess the treatment results in the first 200 patients in the ongoing Multivessel TALENT trial and to predict the vessel-oriented endpoint by assessing the quantitative flow ratio (QFR) post PCI in a central independent core laboratory. Methods In this prospective, randomized, 1:1 balanced, multi-centre, open-label trial, de novo multivessel coronary artery disease patients without left main disease are assigned to the sirolimus-eluting stent or everolimus-eluting stent arm. The percutaneous coronary intervention (PCI) is planned based on functional lesion evaluation by QFR provided by the Core laboratory and the PCI has to be optimized by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. Results Mean age of the population was 66.6±14.7 years, and 78.1% of them were male. This population consists of 17.4% unstable angina and of 31.8% diabetic patients. Anatomical SYNTAX score was 18.8±9.1. Total 458 lesions were treated from September 2020 to December 2021. Left anterior descending artery accounts for 40.3%, bifurcation lesion was present in 40.8%, total occlusion in 4.2%. The average stent diameter and total stent length were 3.0±0.4mm and 38.7±22.4mm, respectively. Intravascular imaging was used in 92.8% of treated vessels (intravascular ultrasound 56.5%, optical coherent tomography 36.3%). Pre-PCI QFR was analysable in 435 vessels (0.59±0.21), and 5.5% of them were treated even though the pre-PCI QFR values were more than 0.8. Post-PCI QFR has been so far analysed in 303 vessels (0.93±0.11) and 79.5% of them achieved a post-PCI QFR equal or superior to 0.91. Based on the previous study [1], Two-year vessel-oriented composite endpoint (VOCE) was estimated to become 5.4% in the present study population (3.7% in the patient group that achieved post PCI QFR equal or superior to 0.91, while 12% in the patients who could not reach the threshold), which was almost equal to what is expected in the power calculation. Conclusions In the Multivessel TALENT trial, the large majority of the vessels treated (94.5%) complied with the hemodynamic criteria of recommended PCI as provided by the QFRs of the Core laboratory. Favourable post-PCI QFR (≥0.91) obtained in 80% of the patients let expected a favourable VOCE outcome of 5.4%. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): The National University of Ireland Galway

Immediate postprocedure anticoagulation with factor Xa inhibitors of venous stents for nonthrombotic venous lesions does not increase stent patency

BackgroundMany clinicians will prescribe anticoagulation therapy for patients after iliac vein stenting to prevent early or late stent thrombosis. At present, it is unknown whether therapeutic anticoagulation has any effect on stent patency. Thus, we assessed the role of short-term anticoagulation on iliac vein stent patency in patients with nonthrombotic iliac vein lesions (NIVLs). MethodsWe performed a retrospective medical record review of all iliac vein stents placed for NIVLs at the Center for Vascular Medicine from January 2018 to December 2019. We compared the stent patency in the two groups. The anticoagulation (AC) group had received rivaroxaban or apixaban postoperatively for a minimum of 90 days and were compared with a group that had received no postoperative anticoagulation (NAC). Stent patency was assessed using transabdominal ultrasound at 3, 6, 12, 18, 24, and 30 months. At the discretion of the treating physician, the patients who demonstrated thrombus layering on surveillance ultrasound scanning continued rivaroxaban or apixaban until thrombus resolution was observed. The demographics and stent location, diameter, and length were assessed. Stent patency was analyzed using life table analyses. Differences in stent patency were analyzed using GraphPad Prism, version 8, statistical software (GraphPad Software Inc, La Jolla, Calif) and the log-rank (Mantel-Cox) test. ResultsThe number of patients and stents in each group were as follows: AC group, 299 patients and 308 stents; and NAC group, 77 patients and 90 stents. The average age was 52.24 ± 13.44 years and 55.63 ± 14.49 years in the AC and NAC groups, respectively (P ≤ .065). Women constituted 76% of the patients in the AC group and 72% in the NAC group. The average stent diameter and length for the AC group was 20 ± 2 mm and 77 ± 13 mm and for the NAC group was 19 ± 2 mm and 82 ± 9 mm, respectively. The stents had been placed in the right common iliac vein, bilaterally, or left common iliac vein territory in 15%, 3%, and 82% in the AC group and 18%, 2%, and 80% in the NAC group, respectively. The cumulative stent patency at 30 months was 98.7% and 94.6% for the NAC and AC groups, respectively (P ≤ .83). All the stents placed were Wallstents (Boston Scientific, Marlborough, Mass). A total of eight insertion site thromboses occurred that did not affect stent patency: five in the AC group (1.6%) and three in the NAC group (4.5%; P = .15). In addition, 19 patients demonstrated evidence of thrombus layering, with 6 receiving extended anticoagulation. ConclusionsOur data indicate that perioperative stent thrombosis in patients with NIVLs is uncommon. Thus, anticoagulation for perioperative stent thrombosis prophylaxis is not necessary. Anticoagulation should only be used for patients with insertion site thromboses and should be considered if thrombus layering is observed on surveillance scanning.

Pregnancy after iliac vein stenting for pelvic venous insufficiency

BackgroundThe use of iliac vein stenting for the treatment of pelvic pain secondary to pelvic venous insufficiency has significantly increased. In women of childbearing age, the effect of the gravid uterus on stent function and patency is unclear. The purpose of this investigation was to determine the effect of pregnancy on stent patency and reintervention rate in women with iliac vein stents. MethodsA retrospective chart review and email survey was performed to identify women treated at the Center for Vascular Medicine who were treated with iliac vein stenting and who had subsequent pregnancies. Medical and surgical comorbidities, stent type, location, length, number of stents, reintervention rates, number of pregnancies after stenting, anticoagulation usage during pregnancy, and type of delivery were assessed. ResultsFrom January 2014 to December 2020, 15 women with 16 iliac vein stents and who had 17 subsequent pregnancies were identified. The average age at stenting was 35.3 ± 4.13 years. The average interval between stenting and conception was 350 ± 287 days. Before pregnancy, stent location was in the right common/right external iliac veins in 1 patient and left common/external iliac veins in 14 patients. The average stent diameter and length were 19.6 ± 3 and 79.5 ± 20.3 mm, respectively. Thirteen Boston Scientific Wallstents and three Bard Venovo stents were used before pregnancy. One patient with a Wallstent required a stent extension before pregnancy and one patient had two stents placed at the initial procedure. Two women were pregnant twice after stenting for a total of 17 pregnancies. There were 16 term and 1 premature delivery of single infants. Patients were treated with enoxaparin (Lovenox) for stent-related thrombosis prophylaxis in 11 of 17 pregnancies, 5 had no prophylaxis, and the status of 1 pregnancy is unknown. One asymptomatic patient underwent a stent venoplasty after delivery. ConclusionsIliac vein stents tolerate a gravid uterus well. No stents thrombosed during or after pregnancy and none required reintervention secondary to pregnancy-related compression. Anticoagulation with low-molecular-weight heparin should be considered for stent thrombosis prophylaxis. Potential pregnancy should not be considered a contraindication to iliac vein stenting for the treatment of symptomatic pelvic venous insufficiency.

Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

This study was designed to evaluate the safety and performance of Metafor™ SES in real-world patients with coronary artery disease. This was retrospective, single-centre, post-marketing, observational study. The primary endpoint was the occurrence of major adverse cardiac event (MACE). A total of 141 patients (187 lesions) were treated with the study device. The average stent length and diameter was 24.75 ± 9.50 mm and 2.93 ± 0.38 mm, respectively. The cumulative incidence of MACE was 1.42%. No incidence of stent thrombosis was observed at 12-months follow-up. This retrospective study demonstrated favourable safety and performance of Metafor™ SES.

Trans-radial Angioplasty of Anomalous Origin of Right Coronary Artery from Left Sinus of Valsalva - A Single-centre Experience

Background: Percutaneous coronary intervention (PCI) to anomalous coronary arteries remain a challenge in current practice, but can be overcome with appropriate techniques and devices. The objective of this study is to explore the challenges and techniques for success in PCI of anomalous origin of right coronary artery from left sinus of Valsalva (RCA-LSV) through the trans-radial route.&#x0D; Methods: This study consisted of 13 patients who underwent PCI for an angiographically significant stenosis in RCA-LSV between November 2017 to March 2020. The procedural details including numbers of catheters used, access, hardware, techniques, duration of procedure, volume of contrast and complications were recorded and statistically analysed.&#x0D; Results: The most frequent site for RCA-LSV is at the level of left main stem (LMS) (53.8%), with 30.8% being just above the LMS level and 5.4% being just below the LMS level. Male to female ratio was 5.5:1. Mean age was 53.7±6.7 (range;42-64) years. 76.9% of our patients were diabetic, 92.3% hypertensive, 84.6% dyslipidaemic, smoker &amp; CKD were 23.1% each. PCI was done successfully in 100% cases. Our default route was transradial for coronary angiography. Angioplasty was performed through trans-radial route in 92.3% and transfemoral in 7.7%, with a single case requiring switch over from radial to femoral route. The average number of guide catheters used was (2±1.0), (range:1-4). We used 4 guide catheters in 2 cases, while the rest of the cases were done by single guide catheter. The guide catheter hooked the coronary ostium selectively and off ostium in 46.2% cases each, while in 7.6% cases it was deeply engaged. Anchoring wire to enhance the guide support was used in 7.7% of cases. The mean duration of the procedure was 33.8 minutes (range: 15-65 minutes), the mean volume of contrast used was 61.5 (range:30-150) ml. We used single stent in 61 % cases and two stents in 39 % cases. Average stent diameter was 2.9 (range;2.5-3.50) mm, length was 28.6 (range;12-43) mm. From among a range of guides used for angioplasty, Judkin’s left (JL) and Judkin’s Right (JR) successfully cannulated the RCALSV in 76.9% &amp; 23.1% respectively. We used Ikari Left (IL) guide catheter in RCA-LSV associated with subclavian tortuosity to enhance guide support. Majority of the lesions stented were of ACC/AHA classification of Type A &amp; B lesions (38.5% each), followed by Type C (23%) lesion.&#x0D; Conclusion: To the best of our knowledge, this is the first report of transradial PCI to RCA-LSV in Bangladesh, describing our experiences and techniques, with locally available hardware. PCI of RCA-LSV through radial route is technically challenging but feasible with reasonable amount of contrast and radiation. Proper localization of ostium and selection of suitable guide catheter like JL or IL is the key to success.&#x0D; Bangladesh Heart Journal 2020; 35(1) : 28-38

Treatment of iliac atherosclerotic lesions using the balloon-expandable dynamic bare metal stent: One-year outcomes of the BIODYNAMIC single-center retrospective analysis.

Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by -1.75 ± 1.53. There were four non-device-related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.

P4709Subclavian CTO stenting using bilateral retrograde wrist approach

Abstract Aims To assess the procedural safety and results of subclavian artery stenting using bilateral retrograde radial (TRA) and/or ulnar approach (TUA). Methods We report 40 consecutive patients that underwent retrograde opening and stenting of the subclavian artery using wrist approach with contralateral control from the opposite TRA or TUA. Primary outcome was procedural success rate. Secondary outcomes were: presence of procedural complications, restenosis, MI, stroke or death and presence of any type of access site bleeding hemathoma. One year clinical follow up and duplex ultrasonography was done in all patients. Results The same technique was used in all patients: 6F guiding catheter Judkins right 4.0 was most frequently used (n=37) for coronary hydrophilic wire retrograde crossing of the occlusion and ballon predilatation. Exchange of wire was made with 0,035 guide wire. Balloon expandable stents were implanted solely through the short hydrophilic sheath, with contralateral contrast check. Contralateral injection strategy was used to confirm proper wire advancement within the lesion and optimal stent positioning. Most frequently used guide wire for CTO opening was CROSS IT 400. The average stent diameter was 7 mm (range 5.0–9.0 mm), and the average stent length was 29, 1 mm (range 15–80 mm). 38 procedures were successfully done using bilateral retrograde radial approach. Only two patients required transfer to transfemoral approach to open the subclavian chronic total occlusion. Minor access site bleeding complications were recorded in 4 patients. There were no other complications. Seven patients were discharged the same day, the others one day after admission. At follow up only one patient had symptomatic in stent restenosis and a balloon angioplasty was done inside the stent 3 years after the primary intervention, the patient was a smoker. One other patient had asymptomatic in stent restenosis documented 6 months after the intervention with duplex follow up. Conclusions Bilateral wrist access can be a successful and safe strategy in opening subclavian artery occlusions with a low rate of complications.

Three-Year Outcomes of Biodegradable Polymer-Coated Ultra-Thin (60 µm) Sirolimus-Eluting Stents in Real-World Clinical Practice

Although drug-eluting stents (DES) have outclassed the use of bare metal stents, the safety and efficacy of DES at long-term follow-up has still been conflicting because of increased occurrence of late or very late restenosis and stent thrombosis after DES implantation. Hence, the present study was aimed to evaluate the 3-year safety and clinical performance of biodegradable polymer-coated ultra-thin (60 µm) sirolimus-eluting stent (SES) in real-world patients with coronary artery disease (CAD). This was a physician-initiated, retrospective, single-centre, observational study that included 237 consecutive patients who had previously undergone implantation of only Supraflex SES (Sahajanand Medical Technologies Pvt Ltd, Surat, India) for the treatment of CAD. Follow-up was received after 1 year and 3 years of stent implantation. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR). Stent thrombosis was considered as a safety endpoint. The mean age of patients was 64.1 ± 10.2 years, and 192 (81.0%) patients were male. The average stent length and diameter were 24.4 ± 9.0 mm and 3.1 ± 0.4 mm, respectively. The cumulative MACE rate at 3 years follow-up was 6.5% which included 4 (1.8%) cardiac deaths, 6 (2.8%) MI, and 4 (1.8%) TLR. There were 2 (0.9%) cases of stent thrombosis. Treatment of patients with CAD in real-world clinical practice was associated with sustained clinical safety and low rates of restenosis, stent thrombosis and MACE up to 3 years after Supraflex SES implantation.

The Ultimaster Bioresobable Polymer Sirolimus-eluting Coronary Stent. Real World Data from the Largest Australian Single-site Database

The Ultimaster stent is bioresorbable polymer sirolimus-eluting stent currently being investigated for abbreviated duration dual antiplatelet therapy in high risk bleeding patients [[1]Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen (MASTER DAPT), Cardialysis et.al. European Cardiovascular Research Center. ClinicalTrials.gov Identifier: NCT03023020.Google Scholar]. We aim to review the real-world safety and performance data from Wollongong Hospital, the highest utiliser of Ultimaster stents in Australia. A retrospective analysis of 317 patients receiving a total of 536 stents from August 2017 to January 2019 was performed. Target lesion failure (TLF), a outcome of unsuccessful intervention, target vessel related myocardial infarction and cardiac death), was measured and patient specific endpoints of MACE (composite of all-cause death, myocardial infarction and stroke) and major bleeding were also measured. Outcomes were recorded until the time of writing. Of the 317 patients (mean age 67.6 ± 11.4 years and 70% male) 65.9%, 56.8% and 30.0% had hypertension, hyperlipidaemia and diabetes respectively and 59.9% were smokers. 89.3% of patients were initiated on aspirin/clopidogrel post-PCI with ticagrelor and prasugrel replacing clopidogrel in 4.7% and 5.4% respectively. 76% of stents were inserted via radial access. Average stent diameter and length was 2.95 ± 0.48mm and 21.89 ± 8.55 mm, respectively. Analysis revealed an incidence of 4.4% TLF and 8.2% MACE while the incidence of major bleeding was 3.4%. This is the first real-world study in Australia on the Ultimaster stent and results are comparable with pre-marketing randomised controlled trials [[2]Wohrle J. Markovic S. Rottbauer W. Muramatsu T. Kadota K. Vazquez-Gonzalez N. Odenstedt J. Serra A. Antoniucci D. Varenne O. Saito S. Wijns W. Bioresorbable polymer sirolimus-eluting coronary stent compared with permanent polymer everolimus-eluting coronary stent implantation for treatment of small vessel coronary artery disease: CENTURY II trial.EuroIntervention [Internet]. 2016; 12 (In: Ovid MEDLINE(R) [Internet].): e167-e174Google Scholar] proving translation of safety and efficacy into clinical application.

Abstract 241: Incidence of Definite Stent Thrombosis in Comatose Survivors of Out-of-Hospital Cardiac Arrest Undergoing Percutaneous Coronary Intervention and Therapeutic Hypothermia - Preliminary Results

Background: Immediate percutaneous coronary intervention (PCI) is increasingly performed in comatose survivors of out-of-hospital cardiac arrest (OHCA) undergoing therapeutic hypothermia (TH). Since reported incidence of stent thrombosis (ST) varies significantly from 2.5% to 31%, we investigated definite ST using systematic coronary angiography (CAG) and autopsy. Methods: Consecutive comatose survivors of OHCA undergoing immediate PCI and TH admitted between August 2016 and May 2018 were investigated. CAG was performed if ST was suspected and systematically between day 10-14. Patients who died underwent autopsy with analysis of stented segments. Results: Among 147 consecutive patients, immediate CAG was performed 103 (70%) and 52 (50%) underwent PCI. Since 5 patients refused to participate or had no follow-up, 47 patients were included. Definite ST, which was confirmed 8 patients (17%), was diagnosed either by clinically-driven CAG (n = 6), routine CAG (n = 1) or autopsy (n = 1). Patients with ST had more often diabetes (38% vs. 5%; p = 0.008), longer interval of prehospital resuscitation (12.6 ± 10.7 minutes vs. 25.0 ± 10.6 minutes; p = 0.005), higher admission lactate (6.8 ± 6.3 mmol/L vs. 3.2 ± 2.9 mmol/L; p = 0.013), lower arterial pH (7.13 + 0.19 vs. 7.27 ± 0.11; p = 0.005) and less favorable survival with good neurological outcome - Cerebral Performance Category score 1 - 2 (13% vs. 62%; p = 0.03). There was no difference in left ventricular ejection fraction (40 ± 12% vs. 39 ± 13%; p = 0.85), periprocedural dose of unfractioned heparin (8944 ± 2504 IU/kg vs. 8188 ± 2764 IU/kg; p = 0.45), use of GP llb/llla (16 % vs. 25 %; p = 0.59) and of novel P2Y12 inhibitor ticagrelor (79% vs. 63%; p = 0.33). There was no significant difference in total length of stented segment (32.7 ± 24.4 mm vs. 36.6 ± 20.7 mm; p = 0.68) nor in average stent diameter (3.1 ± 0.5 mm vs. 3.2 ± 0.4 mm; p = 0.62). Conclusions: Incidence of definite ST in comatose survivors of OHCA undergoing immediate PCI and TH is significant (17%) and is associated with worse outcome. Prolonged prehospital resuscitation and diabetes rather than PCI characteristics represent the risk factors for development of ST.

Clinical Outcomes of World's Thinnest (50 μmr) Strut Biodegradable Polymer Coated Everolimus-Eluting Coronary Stent System in Real-World Patients.

BackgroundThe thinnest strut platform is revolutionary improvement into the field of percutaneous coronary intervention. The aim of this study was to assess the safety and performance of world’s thinnest (50 µm) strut biodegradable polymer coated Evermine 50™ everolimus-eluting coronary stent system (EES) in real-world patients with coronary artery disease.MethodsThis was a prospective, single-arm, single-center, post-marketing study in real-world patients. A total of 251 patients with de novo coronary artery lesion (lengths < 44 mm) and/or in-stent restenosis were enrolled and implanted with at least one Evermine 50 EES. The safety endpoint was major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction (MI) attributed to the target vessel and clinically-driven target lesion revascularization (CD-TLR), at 6-month follow-up.ResultsOut of 251 patients enrolled (mean age: 58.20 ± 9.92 years and 193 males), 48.6% and 45.4% patients were diabetic and hypertensive, respectively. A total of 343 lesions were intervened successfully with Evermine 50 out of 474 identified lesions (1.89 lesions per patients). Average stent length and diameter were 23.50 ± 12.21 mm and 2.83 ± 0.23 mm, respectively. At 6-month follow-up, the incidence of MACE was two (0.8%) in the form of one (0.4%) cardiac death and one (0.4%) CD-TLR. In addition, there was no definite or probable stent thrombosis reported up to 6-month follow-up.ConclusionsIn the present study, lower rate of MACE was demonstrated, which reaffirms favourable clinical safety and performance of world’s thinnest (50 µm) strut Evermine 50 EES in real-world patients with coronary artery disease.

Evaluation and efficacy of long length Pronova XR Bioabsorbable Polymer stent in the treatment of long coronary lesions

AimThe study aims an observational registry of the long and extra-long length (>33mm) Pronova XR stents in patients with long coronary lesions (>30mm) in a prospective real world study. Methods and resultsCurrent study was conducted at Ruby Hall Clinic Pune, between July 2012 and July 2013 including 30 patients who underwent PTCA using long and extra-long Pronova XR stents. Among the stents used, one stent - 33mm, 2 stents - 38mm, 5 stents - 43mm and 25 stents were of 48mm in length. In particular average stent length for the study was 46.03mm and the average stent diameter was 3.09±0.41mm.For this study coronary angioplasty was performed using femoral approach and standard practice. Lesions were predilated using undersized balloons and study stent was deployed at pressure 7–26atm. (12.8±3.2atm.) The successful delivery of stent at the intended lesion with visual residual stenosis less than 50% was defined as Procedural success. Follow up studies were conducted for all the patients at 30days, 3 months and 6 months intervals. The predefined QCA parameters were calculated using Sanders Data System QCA plus software (Palo Alto, CA, USA).No procedural complication was observed during the whole study. 100% successful stent placement was achieved in all patients. Six months clinical follow-up was available for all patients. No adverse events (Acute closure, angina, REPCI, MI, death, sub acute stent thrombosis) or hospitalization was reported for any of the patients except one. The Quantative Coronary Core Lab analysis post 6 months showed well-flowing stent with average late lumen loss 0.10mm ±0.26. ConclusionIn patients with long coronary lesions and very long length stent implantation series, Pronova XR showed excellent in 6 months results. This is for the first time reported that use of long length Pronova XR stents has shown so low restenosis rate and absent of mortality in six month period. These results offer a new opportunity to single long length stenting.

Iliac Vein Stenosis: An Underdiagnosed Cause of Pelvic Venous Insufficiency

Pelvic venous insufficiency (PVI) is a common cause of chronic pelvic pain in women. Reflux in the ovarian veins, with or without an obstructive venous outflow component, is reported to be the primary cause of PVI. The degree to which venous outflow obstruction plays a role in PVI is currently ill-defined. We retrospectively reviewed the charts of 220 women who underwent 227 procedures for PVI at the Center for Vascular Medicine from January 2012 to September 2015. Assessments and treatments consisted of an evaluation for other causes of chronic pelvic pain by a gynecologist; visual analog scale (VAS) for pain score before and after intervention; complete venous duplex ultrasound examination; and clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification. All patients underwent diagnostic venography of their pelvic and left ovarian veins as well as intravascular ultrasound (IVUS) examination of their iliac veins. Patients were treated in one of six ways: ovarian vein embolization (OVE) alone (chemical ± coils), OVE with staged iliac vein stenting, OVE with simultaneous iliac vein stenting, iliac vein stenting alone, OVE with venoplasty, and venoplasty alone. In patients with ovarian vein reflux and iliac vein stenosis, it was our policy to treat the ovarian veins first and to stage the iliac vein stenting. In patients with travel restrictions, OVE and stenting were performed simultaneously. In addition to VAS scores before and after intervention, symptoms were also assessed in terms of complete, partial, or no symptom resolution. Of the 220 women treated, the average age and number of pregnancies were 44.8 ± 10.4 years and 3.08 ± 2.21, respectively. CEAP class for 181 patients was documented as follows: C0, 16; C1, 62; C2, 45; C3, 42; C4, 13; C5, 2; and C6, 1. Treatment distribution was the following: OVE, n = 39; OVE with staged stenting, n = 88; OVE with simultaneous stenting, n = 32; stenting alone, n = 50; OVE with venoplasty, n = 8; and venoplasty alone, n = 3. Seven patients in the OVE and stenting groups (staged) and one patient in the OVE with venoplasty group required a second embolization of the left ovarian vein. Eighty-two percent of patients (181/220) demonstrated an iliac stenosis >50% by IVUS. Average stent diameter was between 20 and 22 mm. Of the six therapies employed, complete, partial, and no symptom resolution was observed as follows: stenting alone, 70%, 20%, 10%; OVE with stenting, 58%, 36%, 5%; OVE alone, 35%, 54%, 5%; OVE with venoplasty, 50%, 50%, 0%; and venoplasty alone, 33%, 63%, 0%. Dyspareunia and fullness responded best to OVE with stenting and worst to OVE alone. Average VAS scores before and after intervention for the entire cohort were 8.45 ± 1.11 and 1.86 ± 1.61 (P ≤ .001). Scores before and after intervention between groups did not differ except for venoplasty alone (P ≤ .01). To assess the role of stenting for alleviation of pain in patients with ovarian vein reflux and iliac vein occlusive disease, we analyzed the OVE staged and simultaneous groups separately. In the staged group, only 9 of 88 patients reported a decrease in the VAS score with OVE alone. The remaining 79 reported no improvement. After stenting, a significant decrease in VAS score was reported. The VAS score decreased from 8.6 ± 0.89 before OVE to 7.97 ± 2.10 after OVE (P ≤ .01). After the planned staged stenting, VAS score decreased to 1.33 ± 2.33 (P ≤ .001). Similarly, in the simultaneous group, preintervention scores were 8.63 ± 1.07 and decreased to 2.36 ± 2.67 after OVE with stenting (P ≤ .001). The postintervention scores between the staged and simultaneous groups were significantly different (P ≤ .04). The majority of patients in our series (82%) demonstrated a significant iliac vein stenosis. These observations indicate that the incidence of iliac vein outflow obstruction in PVI is greater than previously reported. In patients with combined ovarian vein reflux and iliac vein outflow obstruction, our data suggest that pelvic venous outflow lesions should be treated first and that ovarian vein reflux should be treated only if symptoms persist. We recommend that during pelvic venography, IVUS should be performed routinely as part of the diagnostic evaluation.