High-pressure Balloon Research Articles

In vivo study of a reserved atrial septal puncture area patent foramen ovale occluder.

After patent foramen ovale interventional closure, puncture of the interatrial septum through the occluder is difficult but sometimes needed for further interventional treatment. This paper presents findings from an in vivo experimental study of a reserved atrial septal puncture area patent foramen ovale occluder. A patent foramen ovale model was established in canines using trans-septal puncture of the fossa ovale and high-pressure balloon dilation. Then, patent foramen ovale closure was performed with a reserved atrial septal puncture area and all canines were raised for 3 months. Then, the occluder was crossed and left atrial angiography was performed on the septal area with the occluder. Finally, DSA angiography, echocardiography, and histology were used to evaluate the performance and feasibility of the reserved atrial septal puncture area. A patent foramen ovale model was successfully established in 10 canines using the atrial septal puncture method. The average diameter of the patent foramen ovale was 3.77 ±0.19 mm, and the patent foramen ovale was successfully closed in all canines using a reserved atrial septal puncture area. As assessed using transoesophageal echocardiography, the new occluder exhibited an ideal position and was occluded entirely without a residual shunt intraoperatively and postoperatively. A 100% success rate of atrial septum puncture was achieved across the new occluder. The occluders were completely endothelialised 3 months post-implantation. The reserved atrial septal puncture area was effective in patent foramen ovale closure and exhibited positive sealing performance and biological compatibility. Trans-septal puncture was feasible and effective after reserved atrial septal puncture area patent foramen ovale closure.

Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.

The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied. This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT). Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization. Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n=63), a modified balloon (MB, n=103), or a super high-pressure balloon (n=34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups. In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.

TCT-142 Treatment of In-Stent Restenosis With the Use of a Dedicated Super High-Pressure Balloon

TCT-142 Treatment of In-Stent Restenosis With the Use of a Dedicated Super High-Pressure Balloon

Impact of high-pressure balloon aortic valvuloplasty on the hydrodynamic result after a transcatheter valve-in-valve procedure.

The aim of this study was to investigate the degree of functional improvement of a transcatheter heart valve (THV) for valve-in-valve after bioprosthetic valve fracture (BVF) of three small surgical aortic valve bioprostheses (SAVBP) using high-pressure balloon aortic valvuloplasty (HP-BAV) under standardized ex-vivo-conditions. A THV 26 mm (Evolut R) and SAVBP 21 mm (Perimount Magna Ease, Trifecta, and Epic supra [n = 4] were used. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOA), minimal internal diameter (MID), and pinwheeling index (PWI) were analyzed before and after HP-BAV of the SAVBP using a noncompliant balloon. Fracturing of the SAVBP was done before implantation of the THV and the balloon pressures at the point of fracture were recorded. The Magna Ease and Epic fractured at balloon pressures of 18 and 8 atm, respectively. The Trifecta did not fracture up to a balloon pressure of 30 atm but was dilated. HP-BAV led to increased THV expansion as evident by straightened coaptation lines of the Evolut R 26 mm with reduced PWI, increased MID, and increased GOA in all 21 mm SAVBP. Evolut R showed significantly lower MPG and higher EOA as ViV in all prostheses after HP-BAV (p < 0.001). MPG and EOA of Evolut R differed regarding the SAVBP. Evolut R presented the lowest MPG and highest EOA in Magna Ease and the highest MPG and lowest EOA in Epic supra. The degree of function improvement of the same THV as ViV after HP-BAV depends on the surgical valve model. Functional improvement can also be achieved without valve fracture.

In Situ Laser Fenestration Technique: Bench-Testing of Aortic Endograft to Guide Clinical Practice

Purpose: In situ laser fenestration (ISLF) is a recently introduced technology that offers the potential to perform total endovascular treatment of aortic arch and thoracoabdominal aortic pathologies in the acute setting. This experiment’s aim was to assess ISLF in some currently common aortic endografts and bridging stent-grafts. Materials and Methods: Three different aortic endografts were evaluated: (1) Zenith Alpha, (2) Zenith TX2, and (3) Conformable GORE TAG. Each endograft was submerged in 37°C saline to create fenestrations using the 308 nm CVX-300 Excimer Laser System fitted with a 2.3 mm diameter Turbo-Elite laser atherectomy catheter compatible with a 0.018″ guidewire. Three different 8 mm bridging stent-grafts were evaluated: (1) BeGraft peripheral, (2) BeGraft peripheral plus, and (3) GORE VIABAHN VBX Balloon Expandable. All bridging stent-grafts were deployed and exposed to different balloon sizes and pressures. The ISLFs and bridging stent-grafts were then evaluated for any tears, stenoses, and seal. Results: A laser fenestration was consistently rapidly obtained in the Zenith Alpha and the Zenith TX2 endografts while it proved difficult to achieve a timely fenestration in the C-TAG. No fabric tears were noted in the Zenith Alpha and Zenith TX2 when inflating Armada (Abbott) 8 mm balloon in the fenestrations with pressures up to 15 atmospheres (rated burst pressure) nor when flaring bridging stent-grafts with balloons up to 12 mm in diameter at 10 atmospheres, while major tears were frequently noted in the C-TAG when the Armada 8 mm balloons were inflated. BeGraft Peripheral and BeGraft Peripheral Plus were all firmly attached to the fenestrations showing good seal on manual testing, while every sixth VBX bridging stent-graft displayed poorer attachment to the fenestration before dilatation at high pressure. Commonly, significant stenoses remained in the bridging stent-grafts after dilatation at nominal pressure, which could only be eradicated with high-pressure balloons. Conclusion: In this limited bench-test, Dacron endografts responded well to the ISLF technology. Satisfactory deployment of the bridging stent was noted only after inflation and/or flaring with high-pressure balloons. Further work with different types of commercially-available bridging stent-grafts and endografts to assess the durability of in situ fenestration (ISF) and bridging stents in ISF is recommended. Clinical Impact This report on experimental in situ laser fenestration provide important insights for clinicians considering using in situ laser fenestration of aortic stentgrafts in vivo. In particular, different laser settings were tested together with a selection of aortic stentgrafts. Also, the target pressure needed in PTA balloons to dilate the fenestrations and any subsequent tears in the fabric were noted. This was followed by deployment of assorted balloon-expandable stentgrafts with estimation of residual stenosis and seal.

Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon

BackgroundTreatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population. MethodsFrom an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE). ResultsTotally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died. ConclusionsFor ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.

Comparative efficacy of five balloons for treating autogenous arteriovenous fistula stenosis: a Bayesian network meta-analysis.

Arteriovenous fistula (AVF) was the lifeline of patients with maintenance hemodialysis (MHD). However, stenosis of AVF may limit its use. Currently, AVF stenosis is commonly treated with balloon angioplasty. Meanwhile, several balloons were available. Therefore, this study aimed to explore the effectiveness of angioplasty with five different balloons in patients with AVF stenosis. A network meta-analysis (NMA) was performed to synthesize direct and indirect evidence. We carried out a comprehensive literature search in PubMed, Embase, the Cochrane Central Register of Controlled Trials, Scopus, and ClinicalTrials.gov databases from database inception to January 31, 2021. The main outcomes were primary patency rates of AVF after 3, 6, 9, and 12 months. The NMA was performed using Stata 15 (network and mvmeta commands) and GeMTC software. Twenty randomized controlled trials (RCTs) involving 2,607 participants were included. Direct meta-analyses revealed no significant difference in primary patency rates between different balloons after 3, 6 and 9 months. However, NMA demonstrated that the effectiveness of plain balloon angioplasty (PBA) was inferior to that of the drug-coated balloon (DCB) after 3 and 9 months. Moreover, the results suggested that the high-pressure balloon (HPB) was inferior to DCB after 9 months. Thereafter, the analysis of the surface under the cumulative ranking curve (SUCRA) revealed that DCB was ranked as the first effective treatment after 3 months. The drug-eluting balloon (DEB) was the most effective treatment after 6, 9, and 12 months. The analyses revealed no significant publication bias. DEB may be the most effective treatment of AVF stenosis, followed by DCB. However, prospective studies involving large sample sizes of clinical trials and a direct comparison between DEB and DCB are required to clarify the individual value of different treatment options.

Double guidewire technique (DGT): Optimising endovascular revision of juxta-anastomotic stenosis in AV-fistulae: A retrospective analysis.

Arteriovenous fistula (AVF) is the preferred angioaccess for haemodialysis but suffers from a high stenosis rate, juxta-anastomotic stenosis (JAS) being the most frequent. Percutaneous transluminal angioplasty (PTA) of JAS would have some advantage (such as mini-invasive and vein sparing treatment), but higher recurrence rate is observed as compared to surgery. We report results of juxta anastomotic stenosis PTA using the 'double guide technique' (DGT) as described by Turmel-Rodrigues, in a selected cohort from our Vascular Access Centre. From January to June 2018, 25 consecutive patients were treated by DGT. By means of retrograde access through the outflow vein by a 6 F introducer, two guide wires were navigated: one into proximal radial artery (GW1), the other into distal artery (GW2). GW2 was used to dilate juxta-anastomotic vein and anastomotic area with 6 mm high-pressure balloon, while by GW1 juxta-anastomotic artery was dilated with 4 mm semi-compliant balloon. Mean diameter of balloons were 6.7 and 4.1 mm for venous and arterial tract dilatation. Follow up was carried out up to 12 months. Prospectively collected data were analysed retrospectively. One-year primary and secondary patency was 52% and 95% respectively. Recurrence rate was 0.56 procedure/pt/year. Mean access blood flow at 12 months was 830 ml/min. Double Guidewire Technique is an effective and minimally invasive procedure. By avoiding under dilation of JAS the recurrence rate resulted quite satisfactorily in our population.

Clinical Case of Unprotected Left Main Percutaneous Coronary Intervention in Elderly Patient With Porcelain Aorta

Coronary artery bypass grafting (CABG) has long been considered the gold standard in the treatment of patients with lesions of the left main (LM) coronary artery. Elderly patients are one of the most difficult categories of patients with LM lesions due to severe coronary artery calcification. Thanks to constant progress in the field of engineering and technology, it has become possible to perform percutaneous coronary interventions (PCI) for patients with unprotected stenosis of the LM. Drug-eluting stents and the development of pharmacotherapy have improved the results of PCI in these lesions. Comparative studies of the efficacy and safety of PCI and CABG have shown similar results in terms of the need for revascularization. Patients with severe calcification of the coronary arteries mostly belong to the older age group and hold large part in this cohort. Technological advances enabled to treat patients with complex coronary anatomy and LM lesions not only through CABG, but also through PCI. Comparative studies show that the efficacy and safety of PCI and CABG have similar results in terms of the need in revascularization.
 The aim. To highlight the importance of discussion of each clinical case by the heart team and comprehensive approach with the use of modern equipment.
 Stage 1. A 80-year-old woman with type 2 diabetes mellitus was delivered by an ambulance team to the National Amosov Institute of Cardiovascular Surgery with severe pain; the patient was diagnosed with non-ST-elevation myocardial infarction (NSTEMI). Electrocardiography revealed ST-segment depression in leads V1-V5. After performing echocardiographic examination, valvular pathology and segmental contraction defects were not detected, EF 52%.
 Urgent coronary angiography revealed significant calcification of the ascending aorta (porcelain aorta) and coronary arteries. Coronary artery lesions: 90% unstable LM stenosis, significant calcified stenosis of the circumflex artery (CA), middle left anterior descending artery (mid-LAD), and chronic coronary occlusion of the right coronary artery, besides, 5 episodes of ventricular tachycardia were recorded. Despite the high SYNTAX Score I and SYNTAX Score II, due to the clinical picture and heart rhythm disorders, the heart team decided to perform emergency PCI. Bare-metal stent for LM – mid-LAD was implanted and angioplasty of mid-LAD was performed. Rough calcification of LM caused stent recoil; postdilatation of LM stent by high pressure balloon (p = 25 atm) was performed. The operation ended with a good angiographic result. The woman was discharged in a stable condition to plan further intervention in 1 month.
 Stage 2. A 81-year-old woman with complaints of severe chest pain was re-hospitalized with NSTEMI to the National Amosov Institute of Cardiovascular Surgery 3 months after the primary PCI. Echocardiography revealed EF 53%; valvular pathology and segmental contraction defects were not detected. Urgent coronary angiography revealed 90% of LM stenosis (stent recoil – loss of radial rigidity). Gradual angioplasty of LM stenosis and CA stenosis were performed.
 Stage 3. For reinforcing the radial rigidity in LM, LM – CA drug-eluting stent was implanted. Angioplasty of LM and CA using kissing balloon technique was performed. Final proximal optimization of LM showed good angiographic result.

Height restoration and sustainability using bilateral vertebral augmentation systems for vertebral compression fractures: a cadaveric study

BACKGROUND CONTEXTThe treatment of vertebral compression fractures using percutaneous augmentation is an effective method to reduce pain and decrease mortality rates. Surgical methods include vertebroplasty, kyphoplasty, and vertebral augmentation with implants. A previous study suggested that a titanium implantable vertebral augmentation device (TIVAD) produced superior height restoration compared to balloon kyphoplasty (BKP) but was based on a less clinically relevant biomechanical model. Moreover, the introduction of high pressure balloons and directional instruments may further aid in restoring height. PURPOSEThe objective was to evaluate three procedures (BKP, BKP w/ Kyphon Assist (KA; directional instruments), and TIVAD) used for percutaneous augmentation of vertebral fractures with respect to height restoration and sustainability post-operatively. STUDY DESIGN/SETTINGThis is an in vitro cadaver study performed in a laboratory setting. METHODSFive osteoporotic female human cadaver thoracolumbar spines (age: 63–77 years, T-score: -2.5 to -3.5, levels: T7–S1) were scanned using computed tomography and dissected into 30 two-functional spine units (2FSUs). Vertebral wedge compression fractures were created by reducing the anterior height of the vertebrae by 25% and holding the maximum displacement for 15 minutes. Post-fracture, surgery was performed on each 2FSU with a constant 100 N load. Surgeries included BKP, BKP w/ KA, or TIVAD (n=10 per treatment group). Post-surgery, cyclic loading was performed on each 2FSU for 10,000 cycles at 600 N (walking), followed by 5,000 cycles at 850 N (standing up/sitting down), and 5,000 cycles at 1250 N (lifting a 5-10kg weight from the floor). Fluoroscopic images were taken and analyzed at the initial, post-fracture, post-surgery, and post-loading timepoints. Anterior, central, and posterior heights, Beck Index, and angle between endplates were assessed. RESULTSNo difference in height restoration was observed among treatment groups (p=.72). Compared to the initial height, post-surgery anterior height was 96.3±8.7% for BKP, 94.0±10.0% for BKP w/ KA, and 95.3±5.8% for TIVAD. No difference in height sustainability in response to 600 N (p=.76) and 850 N (p=.20) load levels was observed among treatment groups. However, after 1250 N loading, anterior height decreased to 93.8±6.8% of the post-surgery height for BKP, 95.9±6.4% for BKP w/ KA, and 86.0±6.6% for TIVAD (p=.02). Specifically, the mean anterior height reduction between post-surgery and post-1250 N loading timepoints was lower for BKP w/ KA compared to TIVAD (p=.02), but not when comparing BKP to TIVAD (p=.07). No difference in Beck Index or angle between endplates was observed at any timepoint among the treatment groups. CONCLUSIONSThe present study, utilizing a clinically relevant biomechanical model, demonstrated equivalent height restoration post-surgery and at relatively lower-level cyclic loading using BKP, BKP w/ KA, and TIVAD, contrary to results from a previous study. Less anterior height reduction in response to high-level cyclic loading was observed in the BKP w/ KA group compared to TIVAD. CLINICAL SIGNIFICANCEAll three treatments can restore height similarly after a vertebral compression fracture, which may lead to pain reduction and decreased mortality. BKP w/ KA may exhibit less height loss in higher-demand patients who engage in physical activities that involve increased weight resistance.

Bioprosthetic Valve Fracturing: In vitro Testing of Edwards PERIMOUNT Model P 2900.

BackgroundBioprosthetic valve fracturing (BVF) results in low gradients following valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). For the commonly used Edwards PERIMOUNT valve data from bench-testing are lacking to provide technical specifications for successful BVF during ViV-TAVR.MethodsUsing four Perimount 19- and 21-mm valves, in-vitro high-pressure balloon valvuloplasty with the True Dilatation Balloon Valvuloplasty Catheter and Atlas Gold PTA Dilatation Catheter was performed to analyze balloon-oversizing and pressure-thresholds to successfully achieve BVF.ResultsHigh-pressure balloons one millimeter larger than the labeled valve size and pressure rates of 20 atm (for Perimount 19-mm) and > 22 atm (for Perimount 21-mm) were required to achieve BVF. Caliper measurements demonstrated 2.5 mm (Perimount 19-mm) and 1.5 mm (Perimount 21-mm) enlarged inner prosthetic diameters after BVF. The Atlas TM Gold PTA Dilatation Catheter achieved BVF with the Perimount 21-mm, whereas the True TM Dilatation Balloon Valvuloplasty Catheter failed in the Perimount 21-mm either for balloon-rupture or pinhole-defect.ConclusionBoth 19-mm and 21-mm Perimount P 2900 are amendable to BVF, thereby increasing the inner prosthetic diameter. High-pressure balloons 1 mm larger than the labeled valves are essential for this purpose, and the Atlas Gold PTA Dilatation Catheter alone should ensure success in the 21-mm prosthetics.

Abstract No. 44 ▪ FEATURED ABSTRACT Height restoration and sustainability with bilateral vertebral augmentation for vertebral compression fractures

Surgical methods for treatment of vertebral compression fractures include vertebroplasty, kyphoplasty, and vertebral augmentation with implants. A previous study suggested that a titanium implantable vertebral augmentation device (TIVAD) produced superior height restoration compared with balloon kyphoplasty (BKP) but was based on a less clinically relevant biomechanical model. Moreover, the introduction of high-pressure balloons and directional instruments for BKP may further aid in restoring height.

B-35 | Comparison of Premounted Drug Eluting Stents vs. Non-Eluting Stents for the Treatment of Pulmonary Artery Stenosis In Smaller Patients

Small patients with congenital or post-operative pulmonary artery stenosis (PAS) often require multiple catheterizations. Frequently, balloon angioplasty results in only temporary improvement and occasionally, stenting is necessary. Pre-mounted stents have a low profile and are easier to advance in this population, and recent evidence has shown some of these stents can be fractured longitudinally with high pressure balloons allowing for further growth potential. However, restenosis is common in bare metal stents.

Treatment of a severe distal thoracic and abdominal coarctation with cutting balloon and stent implantation in an infant: From fetal diagnosis to adolescence.

Background and AimsAbdominal coarctations are rare. Surgical treatment is difficult and requires re‐interventions to adjust the graft material to patient growth. We report effective treatment by interventional catheterization in an infant with the concern to allow adjustment for growth and prevention of vessel damage.Methods and ResultsAfter the diagnosis of abdominal coarctation at 27 weeks of gestation, an infant developed hypertension (170/70 mmHg) at 3 months of age despite medical therapy. Angio CT confirmed a 2 mm diameter, 2.3‐cm‐long coarctation of the descending aorta. At 4 months, a dilatation was performed using a 3 mm cutting balloon and a 5 mm Opta® balloon, Cordis®. Two noncovered Palmaz® Genesis™ XD PG1910P stents were required to keep the aortic lumen open. At 15 months, an Adventa™ V12 vascular 12 × 61 mm long covered stent was implanted to exclude an aneurysm which developed between the two stents. At 3 and 9.5 years, the stents were further dilated with a high‐pressure balloon to reach 11 mm aortic diameter with no residual pressure gradient, and normal blood pressure.ConclusionsThe use of cutting balloons and stent implantation is an effective way to relieve severe obstruction in middle aortic syndrome in neonates. The technical issues encountered were the need for a low profile sheath and material to avoid femoral artery damage, and the need to use stents that can be further expanded to adult size.

Long Term Outcome of 112 Pediatric Patients With Ureteroplevic Junction Obstruction Treated by Endourologic Retrograde Balloon Dilatation.

PurposeTo analyze the effectiveness, complications and long-term outcome of the patients with ureteropelvic junction obstruction (UPJO) treated by endoscopic retrograde balloon dilatation (ERBD) in the largest series reported.Materials and MethodsBetween years 2004 and 2018, 112 patients with primary unilateral UPJO were treated by ERBD. Endoscopic treatment consisted on a retrograde balloon dilatation of the ureteropelvic junction (UPJ), through cystoscopy and under fluoroscopic guidance, using high-pressure balloon catheters. In case of persistence in the balloon notch, a Cutting Balloon™ catheter was used. Double-J stent was placed after dilatation.ResultsMean age at surgery was 13.1 ± 21.3 months, 92 cases being younger than 18 months. Mean operative time was 24.4 ± 10.3 min; hospital stay was 1 day in 82% of patients. No intraoperative complications occurred. UPJ was calibrated at time of stent removal with cystoscopy 39.1 ± 13.7 days after dilatation. ERBD was not possible in 11 cases. An additional procedure was needed in 24 cases: second ERBD (n = 11, seven during the stent withdrawal), a third dilatation (n = 3) due to persistent hydronephrosis, and percutaneous endopyelotomy (n = 3) or open pyeloplasty (n = 7) in cases of technical failure. Significant improvement in postoperative ultrasound measures were observed (p < 0.05, T-test). Long-term success rate was 76.8% after one dilatation, and 86.6% in those who required up to 2 dilatations. Mean follow-up was 66.7 ± 37.5 months.ConclusionsERBD is a feasible and safe option for the minimally invasive treatment of UPJ obstruction in infants. Long-term outcome is acceptable with a very low complication rate.

Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures.

To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints. Mean lesion length was 40 ± 28.5mm. Mean time follow up was 36months ± 10.46months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation. Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.

Midterm safety and outcome of balloon angioplasty of native aortic coarctation in neonates and young infants and initial experience of prepartial dilatation using high-pressure noncompliant balloon.

Background:Balloon angioplasty (BA) for aortic coarctation in neonates and infants remains controversial due to high recurrence rate and vascular complications.Aim:This study aimed to determine the safety and outcome of percutaneous treatment of coarctation in neonates and infants and to share the initial experience of strategy of prepartial dilatation with high-pressure noncomplaint balloon before final targeted dilatation using low-pressure compliant balloon.Materials and Methods:Retrospective analysis of records of all neonates and infants aged <6 months who underwent BA either using only low-pressure balloon (Group A) or those with prepartial dilatation using high-pressure noncomplaint balloon followed by low-pressure compliant balloon (Group B) between July 2017 and February 2020 was performed. Demographic, clinical, echocardiographic, interventional, and follow-up data were collected for all.Results:A total of 51 patients (41.2% neonates) were included in the study. Median age was 1 month 14 days (60.8% girls) and mean weight was 3.6 ± 1.5 kg. The mean peak trans-coarctation gradient was 53 ± 12 (34–80) mmHg. The final pressure gradient dropped to <10 mmHg in all cases of Group B and only in 26.3% (5) patients of Group A (P < 0.001). Recoarctation rate was 25.5% (13) overall and was significantly higher in Group A patients (P < 0.001), in those with borderline/mildly hypoplastic arch (P = 0.04) and in those with postprocedure gradient between 10 and 20 mmHg (P = 0.02). Median time to re-coarctation was significantly delayed in Group B (P < 0.001). There were no major complications or mortality in either group.Conclusions:BA in neonates and young infants has an excellent short and mid-term safety and efficacy. The recoarctation rate is significantly reduced as well as delayed with prepartial dilatation using high-pressure noncompliant balloon.

Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: cuttIng ballooN angioplaSTy combined wITh paclitaxel drUg-coaTed balloon angioplasty, an observatIONal study (INSTITUTION Study).

To study the safety and efficacy of cutting balloon angioplasty (CBA) followed by paclitaxel drug-coated balloon (PCB) angioplasty for recurrent venous lesions in arteriovenous fistulas (AVFs). We conducted a prospective single-arm cohort study of CBA followed by PCB angioplasty for recurrent AVF stenoses between September 2017 and April 2019. In total, 44 participants were recruited. Target lesions were included if they had recurred within 12months post-angioplasty, were > = 0.5cm upstream from the arteriovenous anastomosis, and did not involve the central veins. Up to two non-target lesions per circuit/participant with the same definition were allowed. Lesions were considered separate when there was an intervening 2-cm segment of normal vessel. Technical success was defined as complete lesion effacement on angioplasty. End-points of target and circuit patency were evaluated clinically at 3, 6, and 12months post-procedure. Technical success was 96% (42/44): Two participants were excluded from analysis due to the need for high-pressure balloon angioplasty as the target lesions did not efface with CBA. The median follow-up duration was 337.5days. Mean stenosis pre- and post-angioplasty was 69.0% (51.6-84.8) and 20.8% (0-44.8), respectively. The target lesion primary, primary assisted and circuit patency for the entire study population (n = 42) were 61.6 ± 7.8%, 92.7 ± 4.0%, and 54.7 ± 7.9%, respectively, at 12months. For participants without non-target lesions (n = 22), the rates were 77.3 ± 8.9%, 90.9 ± 6.1%, and 60.7 ± 11.0%, respectively, at 12months. CBA followed by PCB angioplasty appears safe and feasible for treatment of recurrent venous lesions in dysfunctional AVFs.

Incidence and Characteristics of Incomplete Stent Apposition in Calcified Lesions: An Optical Coherence Tomography Study

BackgroundPersistent or late acquired incomplete stent apposition (ISA) may be associated with late or very late stent thrombosis following drug-eluting stent implantation. Presence of calcium at the target lesion may increase the risk of ISA even after rotational atherectomy (RA) followed by stenting with high pressure balloon inflation. The aim of this study is to examine the incidence and characteristics of ISA in heavily calcified lesions. MethodsA total of 52 heavily calcified coronary artery lesions requiring RA plus stenting were selected and studied. After successful ablation followed by stent implantation, optical coherence tomography (OCT) was performed to assess stent expansion and apposition. Presence or absence of ISA was examined and maximal stent strut to vessel wall distance (max SV distance) was measured. In lesions with repeated OCT at follow-up, serial changes in ISA were investigated. ResultsISA was documented in 51 of 52 (98%) lesions. Mean max SV distance was 713 ± 371 μm. In lesions with serial OCT images (n = 11), max SV distance decreased significantly (692.1 ± 420.2 to 462.5 ± 387.0 μm, P < 0.01) but persisted in all but 2 lesions (82%). ConclusionsISA is frequently documented in heavily calcified lesions requiring RA. Significant ISA still persisted with minimal improvement in SV distance at follow-up. Prognostic impact of the persistent ISA in such calcified lesions needs further investigations.

Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test.

IntroductionAortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated.MethodsOne unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded.ResultsAll prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root.ConclusionAll the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.