Balloon Diameter Research Articles

Risk Factors of New Cerebral Infarctions After Endovascular Treatment for Basilar Artery Stenosis Based on High-Resolution Magnetic Resonance Imaging.

Objective: The current study aims to analyze the risk factors of new cerebral infarctions in the distribution of basilar artery (BA) detected by diffusion-weighted imaging (DWI) after endovascular treatment in patients with severe BA stenosis.Methods: Data was collected from the electronic medical records of patients with severely atherosclerotic basilar artery stenosis (≥70%) who underwent endovascular treatment. The plaque characteristics, including the plaque distribution, plaque burden, plaque enhancement index, remodeling ratio, and stenosis degree, were evaluated qualitatively and quantitatively using high-resolution magnetic resonance imaging (HR-MRI) and digital subtraction angiography (DSA). The characteristics of the procedure, such as the type of treatment, balloon diameter, balloon length, stent diameter, and stent length, were analyzed.Results: A total of 107 patients with severe basilar artery stenosis (≥70%) who underwent endovascular treatment were enrolled. The study participants included 77 men and 30 women, with an average age of 61.6 ± 8.1 years. The rate of postoperative new cerebral infarctions was 55.1% (59/107), of which 74.6% (44/59) were caused by artery-to-artery embolism, 6.8% (4/59) due to perforator occlusion, and 18.6% (11/59) were caused by a mixed mechanism. Twelve of 59 patients had ischemic events, with nine cases of stroke and three cases of transient ischemic attacks (TIA). The plaque burden in the DWI-positive group was significantly larger than that in the DWI-negative group (3.7% vs. −8.5%, p = 0.016). Positive remodeling was more common in the DWI-positive group than in the DWI-negative group (35.6% vs. 16.7%, p = 0.028). Smoking was inversely correlated with the rate of new cerebral infarctions (odds ratio, 0.394; 95% confidence interval, 0.167–0.926; p = 0.033).Conclusion: The plaque characteristics are not associated with new cerebral infarctions in the distribution of BA, although a large plaque burden and positive remodeling are more likely to appear in patients with new cerebral infarctions after BA stenting, which warrants further studies with a larger sample size. As for smoking, the inverse correlation with new cerebral infarctions in the BA territory needs large-scale prospective randomized controlled trials to verify.

Percutaneous pulmonary artery debanding

BackgroundThere is a paucity of data on palliative or total percutaneous pulmonary artery debanding (p-debanding), particularly with use of a stent. MethodsTwelve p-debandings in eight patients were included in this study. Age at pulmonary artery banding (PAB) ranged from 3 days to 1 year (median, 13 days), while p-debanding was performed at 2–157 (7) months. The body weight at the p-debanding ranged from 3.2 to 22.2 (7.3) kg. We chose the balloon diameter of 30–50% to the circumference of the band for palliative, and larger than 50% for total p-debanding, respectively. In either way, the balloon diameter did not exceed 1.5 times the reference vessel diameter. Stent was implanted for palliative p-debanding in 2 patients. Results1. The circumference of the band ranged from 16 to 23 (20) mm, while the balloon diameter ranged from 20–60 (40)% to that, where larger than 50% was used for 2 procedures intended total p-debanding. 2. PAB diameter increased from 2.5–4.7 (3.0) mm to 2.8–9.5 (4.5) mm (p<0.01), however, there was no significant change in the diameter in 2 procedures. In one patient, p-debanding was the definitive treatment associated with spontaneous near closure of muscular ventricular septal defect, in another patient of congenitally corrected transposition of the great arteries, severely depressed left ventricular ejection fraction was recovered following p-debanding. 3. Arterial oxygen saturation (SaO2) increased from 64–97 (80)% to 66–95 (90)% (p<0.01), while in 10 procedures of 6 patients where the indication of p-debanding was hypoxia, SaO2 increased in 8 procedures. There was no significant pulmonary hypertension following p-debanding. ConclusionPalliative or total p-debanding using balloon and/or stenting is generally feasible and effective. A balloon diameter 35–50% to the band circumference in palliative, and more than 50% in total p-debanding, while in either way less than 1.5 times the reference vessel diameter, is safe.

Comparing Occlusive Balloon Performance Using 3-Dimensional Printed Models of Intracranial Aneurysmal Defects

Balloon remodeling microcatheters are essential in assisting endovascular coiling of brain aneurysms, but the performance and pressure requirements of different balloon types when used in aneurysmal defects are currently unknown. We used Tinkercad (Autodesk, Montreal, Quebec) to create model vessels with aneurysmal defects and 3-dimensionally printed these designs with polylactic acid using the Ultimaker2 (Ultimaker, Geldermalsen, Netherlands). We constructed a pressurized box capable of reaching physiologic pressures that housed our vessels and then tested compliant remodeling balloons under fluoroscopy from 3 manufacturers: Hyperglide (Medtronic, Minneapolis, Minnesota, USA), Transform (Stryker Neurovascular, Fremont, California, USA), and Scepter C (Microvention, Tustin, California, USA). Each balloon was inflated to a nominal and supranominal point at each defect, and at each inflation the maximum diameter of the balloon and internal balloon pressure were recorded. The Phillips Intellivue (Phillips, Amsterdam, The Netherlands) monitor was adapted for internal balloon pressure monitoring. A multivariate linear regression analysis was performed to model balloon compliance (balloon diameter divided by pressure). Multivariate regression modeling demonstrated the Scepter balloon had significantly greater compliance compared with both the Hyperglide and Transform balloons (P < 0.001). In addition, we found that Scepter balloons had higher compliance in larger defects compared with the other types of balloons and performance differences based on vessel size. Scepter balloons require less pressure compared with their counterparts to adequately deform through model defects, specifically in larger aneurysm necks in smaller vessel diameters. This result could inform operators of optimal balloon type and size when trying to minimize balloon pressure in fragile brain aneurysms.

Balloon deflection technique to facilitate stent delivery in impassable situations

Background: Long and multiple lesions especially in the background of tortuous coronary artery often require multiple stents. The entry and passage of another stent through an already deployed stent becomes challenging because of poorly expanded stent struts, calcified tissue, underlying tortuosity, highly angulated takeoff of the vessel, and lack of co-axiality. It can be facilitated by balloon deflection technique where balloon at proximal edge of main vessel stent over a buddy wire helps to deflect second stent either distally or into side branch by blocking potential dead. Method: The present retrospective, single-center study included 16,189 consecutive patients who underwent percutaneous coronary intervention (PCI) either through transfemoral or transradial route from January 2014 to August December 2019 at LPS Institute of Cardiology, GSVM Medical College, Kanpur, UP, India where balloon deflection technique was used in situation of impassable stent among 37 patients. Result: The mean age of patients was 75.4 ± 6.5 years. The commonest clinical presentation was chronic coronary syndrome (n=19; 51.3%) followed by NSTEMI (n=9; 24.4%), STEMI (n=5; 13.5%), and UA (n=10; 10.8%). Type-B2 lesion was commonest (45.9%) followed by type C (35.2%) and B1 (18.9%). The commonest indication for balloon deflection technique was angulation (n=10; 27.1%) followed by tortuosity (n=9; 24.3%), chronic total occlusion (n=8; 17.9%), calcification (n=7; 18.9%), and distally located lesion (n=3; 8.1%). The left circumflex artery (LCx) was the most commonly intervened artery (n=16; 43.2%) followed by left anterior descending (n=11; 29.7%) and right coronary artery (n=10; 27.1%). Mean diameter and mean length of stents were 3.3 ± 0.9 mm and 18 ± 6 mm respectively. The mean diameter and mean length of deflection balloon were 3 ± 0.5 mm and 20 ± 05 mm respectively. Lesions were modified using aggressive pre-dilatation in all cases while 19.4% of lesion required cutting balloon for additional modification. Additional wire as buddy wire was used in 54% of cases while wire in main vessel acted as buddy wire in dedicated bifurcation stenting. Stent implantation was successful in 36 cases with success rate of 97.3% while in one case, stent could not be delivered using BDT. Stent was finally delivered using GuideZilla mother-in-child catheter. Overall failure rate was 2.7% which were contributed by extreme tortuosity, angulation, and severe calcification. Conclusion: In selected cases of impassable lesions; the deflection balloon technique may provide a simple, convenient, and inexpensive solution without further need of additional hardwares except a buddy wire and a balloon.

Clinical outcomes following percutaneous coronary intervention for bifurcation lesions: kissing balloon inflation vs. sequential dilation.

Percutaneous coronary intervention for bifurcation lesions remains challenging, with there being several debatable issues, including the requirement for kissing balloon inflation (KBI). The objective of this study was to assess the clinical outcomes following single crossover stent implantation with KBI or sequential dilation alone. Data were examined for 255 non-left main bifurcation lesions (246 patients) treated with single crossover stent implantation, followed by side branch (SB) strut dilation with KBI (n = 74 lesions) or sequential dilation (n = 181 lesions) in three hospitals. Target lesion revascularization (TLR) was the primary endpoint. There was no significant difference in the pre-procedural reference diameter of both the main vessel (MV) and SB between the KBI and sequential dilation groups. However, MV post-dilation balloon size was smaller with lower pressure and post-procedural minimal lumen diameter was significantly smaller in the KBI group. During the median follow-up period of approximately 3years, TLR incidence was significantly higher in the KBI group than in the sequential dilation group; in particular, the TLR rate at the distal MV was higher in the former. For bifurcation lesions treated with single crossover stent implantation, the TLR rate was higher after KBI than after sequential dilation; this was mainly due to higher revascularization in the distal MV. For bifurcation lesions treated with KBI, MV post-dilation balloon diameter tended to be smaller with lower pressure, which might lead to poorer stent expansion and a higher TLR rate.

SAFETY OF ADEQUATE PREDILATATION IN CAROTID ANGIOPLASTY

Objective: In carotid angioplasty a lot of interventionists avoid predilatation or perform predilatation using smaller diameter balloons to avoid distal embolization. The objective of our study was to determine the procedural safety and complications of predilatation of carotid artery using adequate diameter balloon in patients undergoing angioplasty. Methodology: Symptomatic patients with greater than 50% common carotid artery (CCA) or internal carotid artery (ICA) stenosis, asymptomatic patients with 80% or more carotid stenosis, asymptomatic patients planned for Coronary Artery Bypass Graft Surgery (CABG) with bilateral severe carotid stenosis (70-99%) or a unilateral severe carotid stenosis with a contralateral occlusion undergoing CABG, were selected for carotid artery angioplasty. Cerebral angiogram was performed before and after carotid intervention. Results: A total of 25 patients were included in this study. Adequate diameter balloon used for predilatation before stenting in all cases. Post dilatation was required in 6 (24%) patients. Distal embolic protection device was used in all patients. No complication was seen after predilatation in any case. No mortality or neurological deficit was seen in the study. Conclusion: This study shows that proper predilatation with adequate diameter balloon, sized according to diameter of internal carotid artery, before carotid stent implantation is an effective and safe procedure. We believe that this leads to good stent expansion and full apposition with better long term outcomes. Moreover it is now important to adequately predilate carotid arteries, for proper sizing of carotid stents with close cell design, to avoid unnecessary longitudinal stent lengthening due to inadequately prepared carotid bed.

Dimensional compatibility of balloon-tipped bronchial blockers with the pediatric airway anatomy using different recommendations for age-related size selection.

Age-related recommendations for size selection of bronchial blocker devices are based on a few dated anatomical autopsy and radiological studies determining lower airway dimensions in children. These recommendations are based on anterior-posterior internal bronchial diameters, which are smaller than the more relevant lateral internal bronchial diameters. Outer diameters of bronchial blocker balloons inflated with the maximum recommended volume of air were compared to age-related lateral internal bronchial diameters of left and right proximal mainstem bronchi using five different recommendations for age-related size selection of bronchial blocker equipment in children published in the literature. The ratio of outer bronchial blocker diameters inflated with the maximal recommended volume of air to the median lateral internal diameters of the proximal mainstem bronchus ranged from 71.4% to 181.8% for the left side and from 61.7% to 162.6% for the right side. There were many settings where the blocker diameters did not reach the median lateral internal diameters of the proximal mainstem bronchus. This was more often observed for the right than for the left side (37 vs 22 settings). This analysis demonstrates that irrespective of the recommendation for size selection used, neither the two balloon-tipped vascular catheters included nor the Arndt endobronchial blockers are ideal for lung isolation in children are compared with the age-related relevant dimensions of pediatric airway anatomy. A redesign of bronchial blocker equipment with age-related anatomically based high-volume, low-pressure blocker balloons made from ultrathin membranes and with smaller catheters would be desirable.

Intravascular Lithotripsy for Treatment of Calcified Lesions During Carotid Artery Stenting

Purpose: To report the use of intravascular lithotripsy (IVL) in the treatment of calcified carotid artery lesions. Materials and Methods: The records of 21 high-surgical-risk patients (mean age 75.1±8.1 years; 17 men) who were treated at 8 centers for carotid artery stenosis ≥70% were retrospectively reviewed. Twelve patients had a history of cerebrovascular disease. All patients had heavily calcified carotid artery lesions: 19 de novo and 2 in-stent restenoses (ISR). The mean baseline stenosis was 82.3%±9.7%. IVL was utilized at the discretion of the operator, followed by balloon angioplasty. Embolic protection devices were used in all cases. Results: In 19 patients, IVL was followed by stent implantation; the 2 ISR lesions were dilated only. The mean IVL balloon diameter was 4.64±1.13 mm, and the mean number of IVL pulses applied was 67.2±61.4 (range 10–180). All procedures were technically successful (<30% residual stenosis). No patients developed symptomatic bradycardia or hypotension due to IVL, and there were no adverse events associated with IVL delivery. All patients were discharged on dual antiplatelet therapy. Seventeen days after the procedure, 1 patient experienced an ischemic stroke that was deemed due to aortic arch manipulation during transfemoral access. Carotid duplex ultrasound examination identified significant restenosis (>70%) in 1 asymptomatic patient at 12 months after the index procedure. No patients required reintervention during a median follow-up of 6 months (range 1–12). Conclusion: This preliminary experience demonstrates that IVL can be a safe and effective approach for the management of severely calcified carotid lesions. Further research is warranted to determine the longer-term safety and efficacy of IVL for dilation of calcified carotid artery lesions as an adjunct to carotid artery stenting.

Development of an in vitro measurement method for improved assessment of the side branch expansion capacity

Abstract The expansion capacity and accessibility of the side branch is essential for the stenting of complex bifurcations. Since previous measurement methods only provide limited information based on geometrical data of stent cells, a new measurement approach was developed which considers the mechanical deformation capacity of the stent design. This approach provides essential information on the stent with regard to the application of bifurcation stenting. Four different commercially available coronary stents (nominal diameter 3.0 mm) were dilated and a central strut cell was over-expanded by means balloon catheters of increasing nominal diameter (2.0 to 5.0 mm). After balloon inflation, the remaining cell size was investigated for maximum cell diameter and strut fractures. Large expansion capacity without cell damage is taken as a measure of the accessibility of the side branch. In none of the expansion experiments the desired target size could be achieved, which is due to the elastic recoil of the stent cells. Deviations from the target diameter between 14-38% were determined. However, larger diameters also showed a constriction of the balloon, so that in some cases the target diameter could not be achieved at all. No strut fractures occurred even at maximum balloon diameter and pressure (5.0 mm noncompliant balloons). As a result the side branch accessibility differs depending on the individual stent designs. No particular risk for the stent was found by extensive overdilatation.

Resolution of high-output cardiac failure secondary to high flow radiocephalic fistula by precision banding under ultrasound guidance: A case report

The creation of dialysis shunt affects hemodynamic and cardiac function. High-output cardiac failure may occur if dialysis access volume flow is greater than 1500 to 2000 mls/min. To resolve symptoms of cardiac failure due to high flow dialysis shunt requires flow reduction procedure. We describe successful resolution of symptoms of heart failure due to excessive flow dialysis access by adopting precision banding, totally under vascular ultrasound guidance without angiography. Hemodialysis adult patient uses the right arm radiocephalic fistula for 4 years. Recently, the patient presented with symptoms of high-output cardiac failure, including dyspnea, palpitations, fatigue, and orthopnea. The cardiac unit excluded all other causes of cardiac failure and referred the patient to our center for further evaluation. Ultrasonography revealed high blood volume flow measuring 3100 mls/min at brachial artery, marking high flow fistula and the underlying cause of cardiac failure. Juxta-anastomotic segment of fistula vein was identified; 3 mm diameter balloon was advanced to the juxta-anastomotic segment and maximally inflated. Two precision bandings were made on this segment, 1 to 2 cm apart with flow reduction to 691 mls/min. All steps of the procedure were done under ultrasound guidance without angiography. All symptoms were significantly alleviated immediately following the procedure. The patient was discharged after 48 h of monitoring. At 6 months, the patient was stable, no recurrence of high flow access, no signs or symptoms of cardiac failure, and the flow was 1119 mls/min. This case demonstrates that the precision banding procedure is feasible under ultrasound guidance, and the procedure is safe and effective in resolution of cardiac failure due to high flow radiocephalic fistula.

Experimental Analysis of the Quality of Needle-Assisted Fenestration in Aortic Stent-Grafts and the Differences Between Gradual and Rapid Balloon Dilation

Purpose: To report the findings of an in vitro experiment to evaluate the quality of needle fenestrations dilated by different size balloons in various stent-grafts and to investigate the differences between gradual and rapid dilation. Materials and Methods: Fenestrations were made using an 18-G needle in 5 different polyester or expanded polytetrafluoroethylene (ePTFE) stent-grafts: Relay, Valiant, Hercules, TAG, and Ankura. Each stent-graft received 2 groups of fenestrations: one was followed by gradual sequential dilation (4-, 6-, 8-, and 10-mm balloons) and the other by rapid dilation (4- and 10-mm balloons). The pressure was increased to 10 atmospheres or until the balloon was fully inflated with no waist. Quantitative and qualitative evaluations, including fenestration diameter, area, shape, and margins were conducted using light microscopy and scanning electron microscopy. Results: Relay had the strongest resistance to dilation and Ankura the slightest. The maximum length and area of holes expanded as the balloon diameter increased. The fenestrations in polyester devices were mostly elliptical or slit-like, with limited tears but extensive fibers visible in the margin, while ePTFE stent-grafts showed larger fenestration areas with clearer margins. Ankura showed the best quality of fenestrations, which were always circular or square without fabric tears, while the holes in the TAG were square or elliptical but sometimes had a slit after large balloon dilation (≥6 mm). The Relay, Valiant, Hercules, and Ankura devices showed no difference in maximum diameter, fenestration area, or scores of shape and margin (p>0.05). Rapid dilation in the TAG increased the rate of uncontrolled fabric tear, resulting in a larger final diameter (12.90 vs 10.82 mm, p=0.047), smaller area (30.46 vs 41.09 mm2, p=0.028), worse shape (0.75 vs 1.20, p=0.268), and worse margin (0.40 vs 1.00, p=0.174). Though the decreased fenestration shape and margin scores did not reach statistical significance, the trend for decline was more obvious than with the other devices. Conclusion: Materials and structures of the stent-grafts determine the quality of fenestrations dilated by different size balloons. The use of sequential vs rapid balloon dilation is also crucial for fashioning high-quality fenestrations and should be selected judiciously.

Acute and intermediate-term outcome of endovascular stenting of native aortic coarctation in adolescents and adult patients

Introduction Coarctation of aorta (CoA) is a common form of cardiac lesions requiring intervention. Recently, endovascular management with stent implantation has emerged as the preferred strategy. We aim to report our single-center experience of stenting in a wide range of patients using different types of stents and later on its complications. Patients and methods Between January 2012 and December 2017, 56 patients who underwent treatment with stents for CoA were retrospectively studied. All the patients underwent echocardiography and computed tomography scans at 6–12 months follow-up. Results There were 18 women and 38 men with a mean age of 23.24±15.75 years (range, 9–55 years). The median sheath size and balloon diameter were 12 mm (10–14 mm) and 14 mm (12–25 mm), respectively. We achieved an immediate success rate of 94.6% with only three cases recording major complications in the form of migration of stent, infective endarteritis, and stent fracture. At 1-year follow-up, no complications were noted in the computed tomography scans. Conclusion Stent implantation is a good choice for the treatment of CoA in adolescents and adults. It is associated with a low-residual gradient and a low rate of restenosis, both immediately and at mid-term follow-up. It has a relatively low incidence of complications.

Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.

This study aimed to evaluate the safety and efficacy of paclitaxel-coated balloon compared with conventional plain balloon for the treatment of failing native dialysis access. This prospective study included 60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access. Dilatation with a plain balloon was done in 30 patients (group I) and with a paclitaxel-coated balloon in 30 patients (group II) with either stenosis or occlusion. The majority were outflow lesions, with 20 (66.7 %) patients in group I and 21 (70%) patients in group II. Mean balloon diameter was 7.1mm (± 1.5mm) compared with 6.5mm (± 1.2mm) and length 66mm (± 19.1mm) compared with 54.6mm (± 15.7mm), respectively. Safety endpoint was reported as 30 day's freedom from procedure-related major complications and mortality. Procedural technical success was defined as a residual diameter 30% or less for treated lesions. Target lesion primary patency, circuit primary patency and secondary patency were reported at 3, 6 and 12 months. There were no 30-day procedure-related major complications or mortality in either group. Procedural technical success of 100% was achieved in both groups. Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group I, especially at 12 months (90% vs 66.7%, 83.3% vs 60% and 96.7% vs 93.3%, respectively). There was a statistically significant difference in target lesion primary patency (p = 0.029) in patients who were treated with paclitaxel-coated balloon angioplasties. The paclitaxel-coated balloon proved to be safe and effective, and improved the patency of failing vascular access. Results are comparable with previous studies.

Sa1259 SAFETY AND EFFICACY OF ESOLFIP HYDRAULIC DILATION FOR ACHALASIA

A hydraulic balloon dilation catheter, EsoFLIP (Crospon, Galway, Ireland), has recently been introduced as a new therapeutic option for patients undergoing dilation for achalasia. Current literature on EsoFLIP has been limited to small case series and abstracts, with no significant adverse events reported. In this retrospective, single center analysis, we describe our experience using the novel hydraulic dilation catheter. A retrospective chart review of consecutive patients was performed to identify individuals with achalasia who underwent hydraulic dilation using the EsoFLIP system between January 2018 and September 2019 at a tertiary care center. The primary outcome was procedure related complications and secondary outcome was clinical efficacy, defined as an Eckardt score ≤ 3. Patients were contacted at minimum one-month post procedure to determine their post-procedure Eckardt score. All patients were sedated with propofol. EsoFLIP balloon dilation was performed, as previously described. Under wire and direct endoscopic visualization, the balloon was inflated pre- and post-procedure to 30mL to measure the esophageal diameter. After measurements were obtained, the balloon was inflated up to a maximum of 30mm for dilation. Seventeen patients underwent EsoFLIP dilation for achalasia. This included 7/17 patients with type 1 achalasia, 8/17 patients with type 2, and 1/17 patients with type 3. Median patient age was 66 (range 44-87). The median pre-procedure EGJ diameter was 9.6mm (IQR 9 – 11.1) and median post-procedure EGJ diameter 16mm (IQR 13.9 – 16.4). During dilation, the balloon was inflated to a maximum of 30mm. The median maximum inflation diameter was 25mm (IQR 23 – 27.2). Nine patients achieved clinical success (52.9%), defined as an Eckardt score ≤ 3. Two complications (11.7%) occurred during the study period; one perforation requiring surgical intervention, and a 4cm mucosal tear requiring clip closure. Both complications occurred in patients with type 2 achalasia, and both patients had prior treatment attempts (Botox injection and standard endoscopic dilation), prior to referral to our center. The novel hydraulic balloon dilator, EsoFLIP, appears to be a viable treatment option for achalasia. In real world use, the typical complications associated with large diameter esophageal dilation may still occur, even with integrated balloon imaging technology. We propose that the maximum balloon diameter (30mm) achieved by EsoFLIP may be adequate for some patients, but not for others. With increased procedural experience and patient selection, safety and efficacy are likely to continue to improve.

IntravaScular Lithotripsy for the Management of UndILatable Coronary StEnt: The SMILE Registry

BackgroundIntravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. MethodsA multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). ResultsThirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5–3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30–80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3–3.5 mm] vs. pre: 0.81 mm [IQR: 0.35–1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43–7.79mm2] vs. pre: 3.35 [IQR: 2.8–4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. ConclusionsBailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only

BackgroundPercutaneous balloon pulmonary valvuloplasty (PBPV) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. Echocardiography (echo)-guided PBPV can completely avoid the use of radiation and contrast agents compared to fluoroscopy-guided PBPV. Although we have confirmed that echo-guided PBPV is feasible in humans, the poor visibility of the traditional catheter under echo greatly limits the promotion of this new technology. MethodsWe produced a novel double-balloon catheter to make the catheter easy to be detected by echo through adding a guiding balloon at the distal end of the catheter. Echo-guided PBPV was performed on thirty healthy swine using either a novel catheter or a traditional catheter to evaluate the feasibility and safety of the novel double-balloon catheter. The feasibility was evaluated by the success rate of balloon inflation at the pulmonary valve annulus and the operating time. The safety was evaluated by the frequency of balloon slippage and the incidence of complications. ResultsThere were no significant between-group differences in terms of weight and the ratio of balloon diameter to pulmonary annulus diameter. The success rate was 93.3% and 60% in the novel and traditional groups, respectively. The novel group had significantly (p<0.05) lower mean procedure time (6.33±6.86min vs 24.8±9.79min) and lower frequency of balloon slippage (0.07±0.26 vs 0.53±0.52), arrhythmia (0.07±0.26 vs 0.47±0.52), and tricuspid regurgitation (6.7% vs 40%) than the traditional group. No myocardial hematoma or pericardial tamponade occurred in the novel catheter group. ConclusionAlthough further studies and improvements are required, the study results indicate that the novel double-balloon catheter for echo-guided PBPV is feasible and safe.

Initial experience with the Scepter Mini dual-lumen balloon for transophthalmic artery embolization of anterior cranial fossa dural arteriovenous fistulae

BackgroundPrecise delivery of liquid embolic agents (LEAs) remains a challenge in the endovascular treatment of dural arteriovenous fistulae (dAVFs) and cerebral arteriovenous malformations (cAVMs). Despite significant advances in the past...

Reinforcement of the anchor balloon system in percutaneous coronary intervention: an in vitro assessment

We evaluated the factors that increase the maximum static friction force between the anchoring balloon and the vessel wall. The anchor technique in percutaneous coronary intervention (PCI) may be better supported by a guiding catheter. However, in some cases, the anchor balloon does not perform optimally due to slippage within the anchoring vessel. Furthermore, the optimal procedure for balloon anchoring remains unknown. We evaluated the maximum static friction force of the anchor balloon via in vitro assessments using a simulated vessel model and coronary balloons. The simulated vessel model was composed of polytetrafluoroethylene, and its inner diameter was 1.5mm. The various-sized balloons (diameter: 1.5mm, 1.75mm, and 2.0mm; length: 10mm and 15mm) were inflated within the simulated vessel at various atmospheres. The maximum static friction force was measured by pulling on the balloon catheter shaft using 10-g weights. We performed the same experiment with a jailing 0.014″ wire under the anchoring balloon. Evaluated wires included a silicon coating coil wire, hydrophilic coating coil wire, polymer-coated non-tapering wire, and polymer-coated tapered wire. The maximum static friction force between the anchoring balloon and the simulated vessel increased with an increase in inflation pressure and balloon length. However, increasing the balloon diameter was not effective. The jailing 0.014″ wire, particularly coil wire, was effective in increasing the maximum static friction force of the anchor balloon. A longer balloon, higher inflation pressure, and jailing coil wire could reinforce the anchor balloon system.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study.

IntroductionScoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty.MethodsWe studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).ResultsA total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).ConclusionsThe routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Cryoablation for atrial fibrillation.

Cryoballoon ablation for the treatment of atrial fibrillation has established itself as an effective and efficient modality for achieving pulmonary vein isolation. Over the past 13 years more than 100,000 Cryoballoon ablation procedures have been performed with the first to fourth generation cryoballoons. Over that time there have been significant advances in our understanding regarding the optimal procedural techniques. The purpose of this "topic in review" is to focus on the practical aspects of performing a Cryoballoon ablation procedure, within the context of the contemporary literature. Specifically there is a focus on how contemporary studies can inform clinical decision making and ensure operators are able to perform a safe and effective procedure.