Balloon Diameter Research Articles

Relationship Between Intimal Thickness on Ultrasonography and Long-Term Patency of Arteriovenous Fistula Restenosis After Cutting Balloon Versus High Pressure Balloon Angioplasty

To investigate the relationship between intimal thickness on ultrasonography and long-term patency of arteriovenous fistula restenosis after cutting balloon and high pressure balloon angioplasty. We retrospectively compared the outcomes between cutting balloon angioplasty and high pressure balloon angioplasty in 149 patients with hemodialysis access restenosis. The relationship of intimal thickness and primary assisted patency of hemodialysis access on ultrasonography was investigated as the primary outcome, using Kaplan-Meier survival analysis and Cox proportional hazards model. The second outcomes included residual diameter, blood flow, and venous pressure of hemodialysis access before and after angiography and balloon diameter and inflation pressure. Primary assisted patency in cutting balloon angioplasty was 90.6%, which was significantly (P=0.001) more than that of 37.9% in high pressure balloon angioplasty during the 20-month follow-up period. Cox proportional hazards model screened significant factors including procedure type (high pressure or cutting, P=0.004), inflation pressure (P=0.013), preoperative intimal thickness (P=0.009), and difference of intimal thickness (P=0.029). Finally, procedure type (P=0.012) and preoperative intimal thickness (P=0.033) were identified for predicting primary assisted patency by multivariate Cox proportional hazards model. Compared to high pressure balloon angioplasty for treating patients with hemodialysis access restenosis, cutting balloon angioplasty had a better primary assisted patency. The increase of intimal thickness on ultrasonography after angiography was inversely correlated with primary assisted patency.

PO-01-169 CLINICAL APPLICATION OF A NOVEL 31MM CRYOBALLOON FOR PULMONARY VEIN ISOLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: PROCEDURAL DATA FROM THE FIT ARM OF FROZEN AF

Cryoablation of pulmonary veins (PV)s to treat paroxysmal atrial fibrillation (PAF) is well established, however there are limited choices in balloon sizes for cryoablation. Data have recently been collected on a new cryoballoon system with novel capability to deliver cryoablation in a standard 28mm diameter balloon or an expanded 31mm diameter, using the same catheter. Demonstrate the clinical utility of an expandable diameter cryoballoon, and discuss the potential advantages for occlusion, antral positioning, and lesion size. As part of the FROZEN AF Trial (NCT04133168) 50 patients received PVI ablation to treat PAF with a cryoballon capable of ablation at 28mm or 31mm. Follow-up is continuing, but we present procedural data and clinical application of this balloon. The extension arm of the FROZEN AF trial (NCT04133168) included 50 pts, 46% female and aged 64±13 years, indicated for PV isolation for treatment of PAF. Acute isolation was successful in all pts. Average procedure time was 101±59 min, with LA dwell of 51 min, and fluoroscopy of 7 min. General anesthesia was used in all patients, and the majority (49/50) underwent a single transeptal puncture. The novel 31mm configuration was used in 65% of ablations. In the 198 ablations performed at 31mm, 97.5% achieved a Grade 3 or 4 occlusion. Average nadir temperature was -54.89°C, and average TTI was 44s. In PVs where the first ablation was performed at 31mm the single shot isolation rate was significantly higher than in PVs where the first ablation was performed at 28mm. Data by PV are listed in Table 1. Notably, there was a low rate of phrenic nerve impairment, with only 1 instance of transient paralysis which resolved prior to discharge. Additionally, in a subset of pts at a single center, occlusion was assessed at both 28mm and 31mm, Figure 1. Preliminary landmark-based analysis of a subset of veins suggests that inflation to 31mm results in a marked antral shift of balloon position. The combination of maneuverability and variable size may make this balloon particularly useful in addressing challenges resulting from patient-to-patient variability in PV size and geometry. In particular, the choice between 28 and 31mm diameter in a single device may facilitate obtaining good occlusion, and the more antral positioning of a large balloon may give physicians more discretion as to the size and location of PVI lesions. As, the FROZEN AF trial is ongoing, long-term results in these patients are awaited.Tabled 1Usage, Occlusion and Single Shot Isolation rate of 28 and 31mm Balloon Sizesn Grade 4 Occlusion / N Total Ablation (%)n Single Shot Isolation / N PV (%)Pulmonary Vein28mm31mm28mm31mmLeft superior (LSPV)18 / 23 (78.3)41 / 45 (91.1)2/8 (25%)19/34 (55.9%)Left inferior (LIPV)17 / 19 (89.5)29 / 38 (76.3)4/12 (33.3%)23/30 (76.7%)Left common (LCPV)5 / 7 (71.4)6 / 19 (31.6)0/0 (%)1/8 (12.5%)Left middle (LMPV)1 / 1 (100)-1/1 (100%)0/0 (%)Right superior (RSPV)9 / 18 (50)49 / 56 (87.5)1/5 (20%)27/43 (62.8%)Right inferior (RIPV)21 / 38 (58.3)33 / 37 (89.2)10/24 (41.7%)17/24 (70.8%)Right common (RCPV)1 / 3 (33.3)2 / 3 (66.7)0/1 (0%)0/1 (0%)Total72 / 109 (67.3)160 / 198 (80.8)18/51 (35.3%)87/140 (62.1%)Single shot success in veins where first ablation was performed with specified balloon size. Only ablations with duration > 60s included in ablation counts Open table in a new tab

Failure to post-dilate BeSmooth peripheral stents to adult vessel size diameters during benchside tests

Low-profile stent implantation remains a rescue treatment for aortic coarctation and branch pulmonary arteries stenosis in small children. Stent re-expansion to cope with vascular growth remains problematic. To evaluate ex vivo feasibility and mechanical behaviour of over-dilating BeSmooth peripheral stents (Bentley InnoMed, Germany). Three BeSmooth peripheral stents in diameters of 7, 8, and 10 mm were dilated to nominal pressure and then 13 atm. BeSmooth Ø7 × 23 mm was sequentially post-dilated using 12, 14, and 16 mm high-pressure balloons. BeSmooth Ø10 × 57 mm was post-dilated with a 14 mm balloon and then with a 48 mm bare-metal Optimus XXL stent hand-mounted on a 14 mm balloon (stent-in-stent). BeSmooth Ø8 × 57 mm was directly post-dilated with a 48 mm bare-metal Optimus XXL stent hand-mounted on a 16 mm balloon (stent-in-stent). The stents' diameter and length were measured. Digital inflation pressure was noted. Balloon rupture and stent fracture patterns were closely evaluated. At 20atm pressure, BeSmooth Ø7 × 23 mm shortened to 2 mm forming a 12 mm diameter solid ring circle and the woven balloon ruptured radially. At 10 atm pressure, BeSmooth Ø10 × 57 mm fractured longitudinally in various dispatched breaking points at a diameter of 13 mm without shortening and ruptured the balloon with multiple pinholes. At 10 atm pressure, BeSmooth Ø8 × 57 mm fractured centrally at three different points at a diameter of 11.5 mm without shortening and the balloon broke radially in half. In our benchmark tests, extreme shortening, severe balloon rupture, or unpredictable stent fracture patterns at small balloon diameters limits safe post-dilation of BeSmooth stents beyond 13 mm. BeSmooth stents are not ideal candidates for off-label stent interventions in smaller patients.

Efficacy and Safety of Percutaneous Venoarterial Extracorporeal Membrane Oxygenation Decannulation Using Endovascular Balloon Dilation and Perclose ProGlide Closure Device: Results from the Multicenter SKYLINE Study

The venoarterial extracorporeal membrane oxygenation (VA-ECMO) cannula can be surgically removed, but postoperative complications and surgical staffing issues can be problematic. We previously reported a method of percutaneously removing the arterial cannula of VA-ECMO by combining intravascular balloon dilation and the Perclose ProGlide™ (PP) closure device. In this study, we investigated the efficacy and safety of this percutaneous decannulation of the VA-ECMO. This multicenter, retrospective study involved consecutive patients who underwent percutaneous VA-ECMO decannulation at two cardiovascular centers from September 2019 to December 2021. We analyzed 37 patients in whom the VA-ECMO cannula was removed by the percutaneous procedure with balloon dilation and the PP. The primary endpoint was procedural success of hemostasis. The secondary endpoints were the procedural time, procedure-related complications, and rate of surgical conversion. The patients' mean age was 65.4 years. The approach site of the endovascular therapy (EVT) procedures were the transradial approach (56.8%), transfemoral approach (27.8%), and transbrachial approach (18.9%). The mean balloon diameter was 7.3 ± 0.68 mm, and the mean balloon inflation time was 14.8 ± 7.3 min. The mean procedure time was 58.5 ± 27.0 min. The procedure success rate was 94.6%, procedure-related complication rate was 10.8%, procedure-related death and postprocedural infection rate was 0.0%, surgical conversion rate was 0.0%, and EVT access site complication rate was 2.7%. We concluded that percutaneous VA-ECMO decannulation using a combination of intravascular balloon dilation in EVT and the PP appears to be a safe, minimally invasive, and effective procedure.

Impact of calcified plaque volume on technical and 3-year outcomes after transcarotid artery revascularization

ObjectiveWe sought to quantify the percent calcification within carotid artery plaques and assess its impact on percent residual stenosis and rate of restenosis in patients undergoing transcarotid artery revascularization for symptomatic and asymptomatic carotid artery stenosis. MethodsA retrospective review of prospectively collected institutional Vascular Quality Initiative data was performed to identify all patients undergoing transcarotid artery revascularization from December 2015 to June 2021 (n = 210). Patient and lesion characteristics were extracted. Using a semiautomated workflow, preoperative computed tomography head and neck angiograms were analyzed to determine the calcified plaque volume in distal common carotid artery and internal carotid artery plaques. Intraoperative digital subtraction angiograms were reviewed to calculate the percent residual stenosis post-intervention according to North American Symptomatic Carotid Endarterectomy Trial criteria. Peak systolic velocity and end-diastolic velocity were extracted from outpatient carotid duplex ultrasound examinations. Univariate logistic regression was performed to analyze the relationship of calcium volume percent and Vascular Quality Initiative lesion calcification to percent residual stenosis in completion angiograms. Kaplan-Meier analysis examined the relationship between calcium volume percent and in-stent stenosis over 36 months. ResultsOne hundred ninety-seven carotid arteries were preliminarily examined. Predilation was performed in 87.4% of cases with a mean balloon diameter of 5.1 ± 0.7 mm and a mean stent diameter was 8.8 ± 1.1 mm. The mean calcium volume percent was 11.9 ± 12.4% and the mean percent residual stenosis was 16.1 ± 15.6%. Univariate logistic regression demonstrated a statistically significant difference between calcium volume percent and percent residual stenosis (odds ratio [OR], 1.324; 95% confidence interval [CI], 1.005-1.746; P = .046). Stratified by quartile, only the top 25% of calcified plaques (>18.7% calcification) demonstrated a statistically significant association with higher percent residual stenosis (OR, 2.532; 95% CI, 1.049-6.115; P =.039). There was no statistical significance with lesion calcification (OR, 1.298; 95% C,: 0.980-1.718; P = .069). A Kaplan-Meier analysis demonstrated a statistically significant increase in the rate of in-stent stenosis during a 36-month follow-up for lesions containing >8.2% calcium volume (P = .0069). ConclusionsA calcium volume percent of >18.7% was associated with a higher percent residual stenosis, and a calcium volume percent of >8.2% was associated with higher in-stent stenosis at 36 months. There was one clinically diagnosed stroke during the follow-up period, demonstrating the overall safety of the procedure.

A novel non-slip banded balloon catheter for endoscopic sphincteroplasty: an ex vivo and in vivo pilot study

Endoscopic balloon sphincteroplasty is an established procedure for the extraction of bile duct stones. However, the balloon often slips during the inflation process, and its length is an impediment if the distance between the papilla and scope is limited and/or the stone is located close to the papilla. This animal experimental study aimed to evaluate the feasibility of a novel short non-slip banded balloon measuring 15–20 mm in length for sphincteroplasty. The ex vivo component of this study was conducted using porcine duodenal papilla. Miniature pigs were subjected to endoscopic retrograde cholangiography in the in vivo component. The technical success of sphincteroplasty without any slippage was the primary outcome of the study and was compared between cases managed with the non-slip banded balloon (non-slip balloon group) and conventional balloon (conventional balloon group). The technical success rate of the ex vivo component, i.e., absence of any slippage, was significantly higher in the non-slip balloon group than in the conventional balloon group with the 8-mm (96.0% vs. 16.0%, P < 0.001) and 12-mm diameter balloons (96.0% vs. 0%, P < 0.001). The technical success rate of endoscopic sphincteroplasty without slippage in the in vivo component was significantly higher in the non-slip balloon group than in the conventional balloon group (100% vs. 40%, P = 0.011). No immediate adverse events were observed in either group. The slippage rate was significantly lower with sphincteroplasty using a non-slip balloon, despite the balloon length being considerably shorter than that of conventional balloons, demonstrating its potential utility in difficult cases.

Protection of side-branch ostium by the jailed balloon technique validated by three-dimensional optical coherence tomography

Objective: To evaluate the protective effect of jailed balloon technique on side branch (SB) ostium using three-dimensional optical coherence tomography(OCT). Methods: This is a retrospective study. Consecutive coronary disease patients with coronary artery bifurcation lesions who underwent percutaneous coronary intervention (PCI) and completed pre-and post-procedural OCT examinations at the Chinese People's Liberation Army General Hospital from September 2019 to March 2022 were enrolled. Patients were divided into the jailed balloon technique group and the unprotected group according to the options applied for the SB. The SB ostium area difference was calculated from OCT images (SB ostium area difference=post-PCI SB ostium area-pre-PCI SB ostium area). The SB ostium area differences were compared between the two groups and compared further in the subgroup of true bifurcation lesions and non-true bifurcation lesions. In the jailed balloon group, the SB ostium area difference was compared between the active jailed balloon technique and the conventional jailed balloon technique, between the jailed balloon>2.0 mm diameter and the jailed balloon≤2.0 mm diameter, and between the higher balloon pressure (>4 atm, 1 atm=101.325 kPa) and the lower balloon pressure (≤4 atm). Multivariate linear regression analysis was used to explore the correlation between the technical parameters of the jailed balloon technique and the SB protection effect. Results: A total of 176 patients with 236 bifurcation lesions were enrolled, aged (60.7±9.3) years, and there were 128 male patients (72.7%). There were 67 patients in the jailed balloon technique group with 71 bifurcation lesions and 123 patients in the unprotected group with 165 bifurcation lesions. Fourteen patients had 2 to 3 lesions, which were treated in different ways, so they appeared in the unprotected group and the jailed balloon technique group at the same time. The area difference in SB ostium was greater in the jailed balloon group than in the unprotected group (0.07 (-0.43, 1.05)mm2 vs.-0.33 (-0.83, 0.26)mm2, P<0.001), and the results were consistent in the true bifurcation lesion subgroup (0.29 (-0.35, 0.96)mm2 vs.-0.26 (-0.64, 0.29)mm2, P=0.004), while the difference between the two groups in the non-true bifurcation lesion subgroup was not statistically significant (P=0.136). In the jailed balloon technique group, the SB ostium area difference was greater in patients treated with the active jailed balloon technique than in those treated with the conventional jailed balloon technique ((0.43±1.36)mm2 vs. (-0.22±0.52)mm2, P=0.013). The difference in SB ostium area was greater in those using>2.0 mm diameter jailed balloons than in those using≤2.0 mm diameter jailed balloons (0.25 (-0.51, 1.31) mm2 vs.-0.01 (-0.45, 0.63) mm2, P=0.020), while SB ostium area difference was similar between those endowed with higher balloon pressure (>4 atm) compared to those with lower balloon pressure (≤4 atm) (P=0.731). Multivariate linear regression analysis showed that there was a positive correlation between jailed balloon diameter and SB ostium area difference (r=0.344, P=0.019). Conclusions: The jailed balloon technique significantly protects SB ostium, especially in patients with true bifurcation lesions. The active jailed balloon technique and larger diameter balloons may provide more protection to the SB.

Safety and Efficacy of OPN Balloon in Patients With Calcified Coronary Artery Disease

BackgroundPatients with symptomatic calcified coronary lesions have poor outcomes. Such lesions require additional atherectomy devices for bed preparation. AimTo assess the safety and efficacy of OPN balloon in patients with calcified coronary lesions. MethodsThis is an investigator-initiated, prospective, observational study. The primary outcome of the study was a procedural success. ResultsWe studied 71 patients (133 lesions). Maximum lesions were located in LAD [46.6 %]. The OPN balloon was used for pre-dilatation alone in 28.6 % (Pre-stent OPN group), post-dilatation alone in 63.2 % of lesions (Post-stent OPN group), and in both situations in 8.3 % of lesions with procedural success in 98.5 % of patients. Further dilatation with different NC balloons was required in both groups (30 %). The median (IQR) OPN balloon diameter in the pre- and post-stent OPN group were 2.5 (2.5, 3.0) and 3.0 (3.0,3.0) mm (p = 0.001), respectively. The difference between the diameter of the stent and OPN balloon used in pre-stent OPN group was 0.5 (0.2, 0.5) mm while it was 0.0 (0.0,0.2) mm in the post-stent OPN group (p < 0.001). Eight complications and two deaths occured. Distal shaft rupture was also noticed. ConclusionOPN balloon is safe, and effective in treating calcified coronary lesions. We propose to undersize the balloon by 0.5 mm for pre-dilatation followed by 0.25 mm larger NC balloon if needed. In the post-dilatation group, use a 1:1 size balloon in a non-tortuous straight segment. Use imaging especially when (1) the pressure taken more than the rated burst pressure, (2) an OPN balloon size is ≥3 mm (3) using 1:1 size OPN balloon in a tortuous segment.

Incidence, Predictors, and Clinical Impact of the Impeded-By-Stent Phenomenon After Placing Two-Linked Design New Generation Drug-Eluting Stents

BackgroundWhen a catheter device is delivered during percutaneous coronary intervention, its passage can be disrupted by a deployed in a coronary artery. However, the condition and details of this phenomenon, that is impeded-by-stent phenomenon (ISP), remain unclear. MethodsWe designed a prospective, open-label, single-center, observational study to clarify the incidence, predictors, and clinical impact of ISP in drug-eluting stents (DESs). Two independent operators observed and judged the occurrence of ISP, which was defined as all disturbances to a device delivery by deployed DESs. We consecutively used the Ultimaster™ (Terumo, Tokyo, Japan) DES for one month (109 patients, October 2018), followed by the Synergy™ (Boston Scientific Corporation, Marlborough, MA, USA) DES the next month (119 patients, November 2018). ResultsDESs (2.5–4.0 mm in diameter) were implanted in 230 de novo coronary vessels. ISPs were observed in 17 of 239 stented segments (7.1 %). Multivariate analysis showed that bifurcation lesions (adjusted odds ratio [OR], 4.2; 95 % confidence interval [CI], 1.5–12.6; p = 0.008), predilatation balloon diameter (mm) (OR, 0.2; 95 % CI, 0.1–0.9; p = 0.03), and Ultimaster™ use (OR, 6.0; 95 % CI, 1.9–27.2; p = 0.002) were independent predictors of ISPs. During the 1.5-year follow-up period, no repeat revascularization or stent thrombosis occurred in patients with ISP. ConclusionsISP itself does not trigger notable clinical outcomes, including repeat revascularization and stent thrombosis. However, caution should be considered regarding the latent risk of procedural complications.

Safety and efficacy of the expressman extension system for complex coronary lesions during percutaneous coronary intervention.

Safety and efficacy of the expressman extension system for complex coronary lesions during percutaneous coronary intervention.

Outcome and Risk Factors of Restenosis Post Percutaneous Transluminal Angioplasty at Juxta-Anastomotic of Wrist Autogenous Radial-Cephalic Arteriovenous Fistulas: A Retrospective Cohort Study

This retrospective cohort study was to determine the factors related to restenosis post percutaneous transluminal angioplasty (PTA) at juxta-anastomotic of wrist radial-cephalic arteriovenous fistulas (RC-AVFs). We conducted a retrospective study of patients who underwent their first PTA for juxta-anastomotic stenosis at RC-AVF from January 1, 2016, to December 31, 2020. Patient and stenotic lesion characteristics and PTA procedure factors were included in the analysis. The primary and assisted primary patency post PTA of RC-AVFs were evaluated using the Kaplan-Meier analysis and log-rank test. A Cox proportional hazard model was used to identify factors associated with restenosis post PTA. The receiver operating characteristic (ROC) curve was employed to evaluate the predictive value of the risk factors for restenosis post PTA. A total of 65 patients with a mean age of 59.09±14.94years were enrolled in the study. The mean RC-AVF age was 9.2 (4.9, 35.05) months, and the median time of intervention for stenosis was 10.8 (4.05, 41.35) months after AVF creation. The primary patency rates following the first PTA at 3, 6, 12, and 24months were 93.9, 84.6, 63.1, and 55.4%, respectively. The assisted primary patency rates at 3, 6, 12, and 24months were 95.4, 90.8, 87.7, and 84.6%, respectively. Cox proportional hazard regression analysis revealed the maximum balloon diameter >5mm had a lower postoperative restenosis rate compared with the maximum balloon diameter ≤5mm (hazard ratio=0.422; 95% confidence interval [CI]: 0.201-0.884; P=0.022). ROC curve analysis showed that the area under the curve of the maximum balloon diameter during PTA was 0.624 (95% CI, 0.486-0.762). The best critical value for the maximum balloon diameter was 6mm, the sensitivity was 64.5%, and the specificity was 61.8%. For the first PTA at juxta-anastomotic of wrist RC-AVFs without thrombosis and complete occlusion, the use of a balloon with a maximum diameter of ≤5mm is a risk factor to the occurrence of restenosis within 12months post PTA. The result may help in tailoring surveillance programs in patients with RC-AVF stenosis.

A coupled thermal-electrical-structural model for balloon-based thermoplasty treatment of atherosclerosis

Objectives The outcome of balloon-based atherosclerosis thermoplasty is closely related to the temperature/stress distribution during the treatment. For precise prediction of a required thermal lesion in the heterogeneous and thin atherosclerotic vessel, a numerical model incorporating heat-induced tissue expansion or shrinkage and the strain caused by balloon dilation is necessary. Methods A fully coupled thermal-electrical-structural new model was established. The model features a heterogeneous structure including eccentric plaque, healthy artery and surrounding tissue. Tissue expansion/shrinkage and hyperelasticity material model were taken into consideration. Different heating strategies and plaque mechanical properties were investigated. The temperature distribution was compared with the traditional thermal-electrical coupled model. The possibility of thermoplasty treatment using balloons with different sizes was also explored. Results The temperature, the electrical intensity and the stress during the thermoplasty were obtained. Lower stress was found in the heating region where tissue shrinkage occurred. The ablation depth was predicted to be ∼0.42 mm larger without coupling the biomechanical influence. The mechanical properties and input condition significantly affect the temperature and stress distribution considering the small dimensions of the tissue. Besides, with a 12.5% reduction of balloon diameter, the largest Von Mises stress decreases by 25.4%. Conclusions It is confirmed that a coupled thermal-electrical-structural model is needed for precise temperature prediction in the balloon-based thermoplasty of the heterogeneous and thin tissue. The model presented may help with future development of optimized treatment planning considering both ablation depth and minimum stress.

Factors associated with the efficacy and safety of endoscopic dilatation of symptomatic strictures in Crohn’s disease: a retrospective cohort study

Objective Endoscopic balloon dilatation (EBD) is a standard treatment for intestinal strictures in Crohn’s disease (CD). No evidence-based guidelines exist regarding the balloon diameter or the balloon pressure to be used, with recent studies suggesting the use of a smaller diameter than classically used. We sought to analyze the factors associated with safety and efficacy of EBD in CD strictures, particularly looking at balloon diameter and dilatation pressure. Methods We conducted a monocentric retrospective study of patients who underwent EBD between 2005 and 2020. Results Our endoscopy department performed EBD in 94 CD patients during the considered period. The mean size of balloon dilatation was 16 mm (±2.5; including 21 patients with balloon <14 mm) and the mean dilatation pressure was 5.3 atm (±1.5). No perforation was observed. Over a median follow-up of 5.6 years, the probability of being operated was 5.4% at 1 year and 10.4% at 3 years. Smaller height (HR = 0.90, p = 0.022) and a higher BMI (HR = 1.23, p = 0.014) were associated with the risk of operation. The probability of being operated or redilated was 30.1% at 1 year and 52.5% at 3 years. No factor was significantly associated with this risk. The size of the balloon had no impact on outcomes. Conclusion In this retrospective cohort, including a significant proportion of CD patients dilated with balloon <14 mm, no perforation was observed and the size of the balloon or the dilatation pressure had no impact on the risk of surgery or redilatation.

Efficacy and Safety of Endoscopic Balloon Dilatation for Treatment of Primary Obstruction Megaurater Up to 2 Years of Age

Endoscopic balloon dilatation (EBD) can be performed with different catheters and its durability is still controversial. The study aimed to compare long-term results of EBD performed &lt;20 months of age using balloons of 4 mm vs. 6 mm in diameter. Retrospective study conducted of consecutive patients with unilateral primary obstructive megaureter (POM) undergoing EBD &lt;24 months of age by two surgeons from January 2020 to January 2022. The technique was consistent, but for balloon diameter was 5 mm in group A vs. 6 mm in group B. End-points included peri-operative complications, success rate (improving dilatation and non-obstructive drainage on 9-month scintigraphy), and long-term outcome (need for reimplantation and diameter of retrovesical ureter at last ultrasound). The procedure was completed in all planned patient. Group A included 30 patients and Group B 60 patients. Groups were not significantly different for age (p &lt; 0.09), gender (p &lt; 0.1), laterality (p &lt; 0.7), and preoperative median ureteral diameter (p Z 0.08). No perioperative complications occurred. Four group A patients required a cutting balloon to achieve a satisfactory dilatation of the vesicoureteral junction (p Z 0.009). After a median (range) follow-up of 70 (19e155) months, success rate was 73.3% vs. 83.3% (p Z 0.45), 4/15 group A and 5/30 group B patients required reimplantation within 2 years of EBD. In successful cases, median (range) ureteral diameter at last follow-up was 6 (0-17) mm vs. 5 (0-16) mm, which was significantly better than preoperative value (p Z 0.003 and p &lt; 0.001, respectively), but not significantly different (p Z 0.8) between groups. EBD is an umbrella term that encompasses many technical variations, which can be key for success. Although limited by the small numbers and the comparison of patients treated over two subsequent periods, this is the first study focusing on the role of balloon size. The diameter of the balloon did not influence significantly long-term results, but the 6 mm balloon slightly increased the success rate of EBD to 83.3% and eliminated the need for cutting balloons to achieve a satisfactory dilatation.

Endoscopic balloon dilatation for the treatment of primary obstructive megaureter

Endoscopic balloon dilatation (EBD) can be performed with different catheters and its durability is still controversial. This study aimed to compare long-term results of EBD performed <24 months of age using balloons of 4mm vs. 6mm in diameter. Retrospective study of consecutive patients with unilateral primary obstructive megaureter (POM) undergoing EBD <24 months of age by two surgeons from 01/2009 to 12/2020. The technique was consistent, but for balloon diameter, which was 4mm in group A vs. 6mm in group B. End-points included peri-operative complications, success rate (improving dilatation and non-obstructive drainage on 9-month scintigraphy), and long-term outcome (need for reimplantation and diameter of retrovesical ureter at last ultrasound). The procedure was completed in all planned patient. Group A included 15 patients and Group B 30 patients. Groups were not significantly different for age (p<0.09), gender (p <0.1), laterality (p <0.7), and preoperative median ureteral diameter (p =0.08). No perioperative complications occurred. Four group A patients required a cutting balloon to achieve a satisfactory dilatation of the vesicoureteral junction (p =0.009). After a median (range) follow-up of 70 (19-155) months, success rate was 73.3% vs. 83.3% (p =0.45), 4/15 group A and 5/30 group B patients required reimplantation within 2 years of EBD. In successful cases, median (range) ureteral diameter at last follow-up was 6 (0-17) mm vs. 5 (0-14) mm, which was significantly better than preoperative value (p =0.003 and p<0.001, respectively), but not significantly different (p =0.8) between groups. EBD is an umbrella term that encompasses many technical variations, which can be key for success. Although limited by the small numbers and the comparison of patients treated over two subsequent periods, this is the first study focusing on the role of balloon size. The diameter of the balloon did not influence significantly long-term results, but the 6mm balloon slightly increased the success rate of EBD to 83.3% and eliminated the need for cutting balloons to achieve a satisfactory dilatation.

Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.

Spinal arteriovenous fistulas (AVFs) account for approximately 70% of all vascular spinal malformations and commonly develop in the lateral epidural space at the epidural /radicular venous junction. The fistula is located close to the spinal nerve root where a radiculomeningeal artery shunts to a radicular vein. Increased venous pressure leads to decreased spinal venous drainage and venous congestion causing progressive myelopathy, bowel/bladder incontinence and erectile dysfunction. Treatment consists of surgical occlusion of the intradural vein, or endovascular embolization, which has a reported success rate of 25%-75%.1 Endovascular failure can occur with inadequate embolic penetration of the nidus and the proximal segment of the draining vein, or premature reflux of the liquid embolic agent.The use of a dual-lumen balloon microcatheter offers advantage in these cases given the ability to push liquid embolysate more distally during balloon inflation. The Scepter Mini is a new dimethyl-sulfoxide (DMSO)-compatible dual-lumen balloon microcatheter with a distal-tip outer diameter of 1.6 Fr and a nominal balloon diameter of 2.2 mm, facilitating atraumatic navigation and safer balloon inflation. Limited neurointerventional experience using the Scepter Mini in predominantly cerebrovascular cases has reported favorable navigability and flow arrest2, 3 Although Onyx is rarely used for spinal AVF embolization, success has been reported considering the well-known favorable experience in cerebral cases.1, 4, 5We present one of the first cases of Onyx embolization of a spinal dural AVF through a Scepter Mini in a patient with progressively worsening lower extremity sensorimotor dysfunction. Operators should be aware of radiculomedullary arteries arising at the same level or at adjacent levels to avoid unintentional Onyx migration during balloon inflation.

Intravascular lithotripsy to facilitate transfemoral TAVI: a single-center experience

Abstract Introduction Transfemoral is considered the approach of choice for transcatheter aortic valve implantation (TAVI) and improves clinical outcomes such as death or stroke compared to transaortic or transapical access. Intravascular lithotripsy (IVL) has enabled modification of calcified intimal and medial lesions to increase vascular wall compliance which might facilitate the transfemoral TAVI approach. Purpose To present a single-center experience with intravascular lithotripsy facilitating transfemoral TAVI approach. Methods A peripheral IVL catheter was used to perform lithotripsy of calcified iliofemoral stenosis. A 0.014" guidewire was used to guide the lithotripsy catheter with a balloon diameter of 5.0 or 6.0 mm. Inflating the balloon with 4–6 atm of pressure enabled apposition with the arterial wall and several cycles of 30 pulses have been performed at various locations of the iliofemoral arteries. IVL was planned in advance as primary strategy in case of ring or as baillout strategy in case of ring or excentric calcified periferial artery stenosis, respectively. The IVL was immediately followed by transfemoral TAVI. Retrograde data were collected for the purpose of this abstract. Results From December 2019 to December 2021 433 TAVI procedures were performed in the University Medical Centre Ljubljana. In 13 of the procedures (3%) IVL was used to facilitate the transfemoral approach. The mean minimal diameter of iliofemoral arteries was 5,2 mm with calcifications affecting at least three-quarters of arterial circumference in 92% and circular calcifications in 62% of cases. In all cases, IVL was performed in a common iliac artery or aortic bifurcation, while external iliac (15%) or femoral (8%) arteries were treated less often. A 5 mm IVL balloon was used in 2 (15%), and a 6 mm balloon in 9 (69%) cases, while a combination of 5 and 6 mm balloons was used in 2 (15%) cases. IVL and subsequent TAVI were successful in all the cases. No hospital mortality or major bleeding was observed. One patient needed one unit of blood transfusion due to loss during planned surgical preparation and closure of the puncture site. The puncture site was closed using a 2 Proglide technique and no conversion from percutaneous to surgical puncture site closure was needed. A self-expanding aortic prosthesis (Evolut R, Medtronic) was used in 11 (85%) and a balloon-expandable (Sapien 3, Edwards Lifesciences) in 2 (15%) cases. Conclusion In our experience IVL of iliofemoral arteries is a safe and effective method to facilitate transfemoral approach in TAVI, especially in cases of circular calcifications affecting the majority of arterial wall circumference. Funding Acknowledgement Type of funding sources: None.

Transthoracic Echocardiography and Fluoroscopy Guided Transcatheter Atrial Septal Defect Closure with Device in Children, Adolescents, and Young Adults

Objective: The aim of this study was to evaluate the safety and efficacy of transcatheter atrial septal defect (ASD) closure guided by fluoroscopy and transthoracic echocardiography (TTE) and to present our experiences. Material and Methods: In this study, we evaluated 108 patients’ files taken to the catheter laboratory for transcatheter ASD closure retrospectively. The procedure was abandoned in ten patients because of septum device disproportion (6) and deficient rims (4), mainly inferior vena cava rim. Results: Transcatheter ASD closure guided by TTE was performed in 98 patients (59 female). The mean age of patients was 9.5±6 years (2.6-46), and the mean weight was 30.3±15.3kg (12-80). TTE-guided ASD closure was successfully performed in 92 of 98 (94%) patients. The median largest ASD diameter measured by TTE was 10.75 mm (interquartile range (IQR) 9.12-14. The median stretched balloon diameter measured by fluoroscopy was 14 mm (IQR 12.4-18). The median device waist diameter was 14 mm (IQR 13-18), the median device left atrial (LA) disk diameter was 28 mm (IQR 26-31), and the median ratio of LA disc diameter to total septal diameter was 75% (IQR 68-81). The median fluoroscopy and procedural times were 8 minutes (IQR 5.6-13.75) and 36.5 minutes (IQR 30-49) respectively. Conclusion: Transcatheter ASD closure guided by TTE and fluoroscopy is safe and effective in children, adolescents, and young adults.

Impact of Chocolate percutaneous transluminal angioplasty balloon on vessel preparation in drug-coated balloon angioplasty for femoropopliteal lesion

PurposeTo compare the impact of Chocolate and conventional balloons on vessel preparation in percutaneous transluminal angioplasty.Materials and methodsThis single-center retrospective study included 111 endovascular therapy consecutive cases of femoropopliteal lesions using drug-coated balloon strategy with a 1:1 pre-dilation balloon diameter between February 2020 and August 2021, divided into the Chocolate percutaneous transluminal angioplasty (n = 48) and conventional (n = 63) groups. Before the availability of Chocolate balloons in Japan (December 2020), a standard semi-compliant or non-compliant balloon was used for vessel preparation. The primary endpoint was rate of severe dissection after pre-dilatation. Secondary endpoints were angiographic percent diameter stenosis, bailout stent rate, primary patency rate, and freedom from target-lesion-revascularization rate at six months.ResultsThere was no significant difference in patient and lesion characteristics. The procedural characteristics comprised balloon length 90 ± 37 and 149 ± 95 mm (P = 0.004) and inflation pressure 11 ± 3 and 16 ± 7 atm (P < 0.001) in the Chocolate and conventional groups, respectively. Regarding primary endpoint, rates of severe dissection were 4.2% and 25% (P = 0.003); regarding secondary endpoints, percent diameter stenosis was 18 ± 15% and 20 ± 17% (P = 0.409), and the rate of bailout stenting was 2.1% and 15.9% (P = 0.016) in the Chocolate and conventional groups, respectively. The primary patency rates at six months were 89.1% and 85.2% (P = 0.670), and freedom from target-lesion-revascularization rate at six months was 100% and 92.8% (P = 0.691) in the Chocolate and conventional groups, respectively.ConclusionChocolate percutaneous transluminal angioplasty balloons reduce the rate of severe dissection while maintaining a sufficient dilatation effect during drug-coated balloon vessel preparation.

Relationship between annular calcification of plaques in the carotid sinus and perioperative hemodynamic disorder in carotid angioplasty and stenting

Objective: To investigate the correlation between annular plaque calcification in the carotid sinus and perioperative hemodynamic disorder (HD) in carotid angioplasty and stenting (CAS). MethodsThe clinical data of 49 patients undergoing CAS due to narrowing of the carotid sinus were retrospectively analyzed. All patients had preoperative carotid computed tomography angiography (CTA) and were divided into HD and non-HD groups based on the occurrence of HD in the perioperative period of CAS. HD was defined as persistent bradycardia (heart rate < 60 beats per min) or persistent hypotension (systolic blood pressure < 90 mmHg) in the perioperative period and lasting for at least 1 h. The baseline data, including the degree of carotid artery stenosis, plaque length, plaque thickness, calcified plaque morphologies (i.e., plaque circumferential angle: < 90° defined as dotted calcification; 90°–180° defined as arcuate calcification; > 180° defined as annular calcification), contralateral carotid artery conditions, balloon diameter, and stent types, were compared between the two groups. Binary logistic regression was used to analyze the risk factors for the occurrence of HD. ResultsAmong the 49 patients undergoing CAS, 14 (28.57%) developed perioperative HD, and 35 did not. Annular calcification was more common in the patients in the HD group than in the non-HD group. No significant differences in the probabilities of dotted and arcuate calcifications were found between the two groups (p > 0.05). The duration of continuous dopamine consumption in the HD group was 9–71 h. The average hospital stay of the HD group (10.14 ± 4.17 days) was significantly longer than that of the non-HD group (6.57 ± 1.9 days; p < 0.001). Patients in the HD group had significantly more pronounced lumen stenosis (p = 0.033) and longer plaque length (p = 0.034) than those in the non-HD group. After adjusting for age and sex, multivariate regression analysis showed that the presence of annular plaque calcification was an independent predictor of HD (odds ratio: 7.68, 95% confidence interval: 1.46–40.37, p = 0.016). ConclusionsThe occurrence of annular plaque calcification in the carotid sinus was an independent risk factor for perioperative HD in CAS. Preoperative carotid CTA assists with the early identification of high-risk patients who may develop HD.