Conventional Balloon Catheter Research Articles

Balloon dacryoplasty: A boon for dacryologists in managing persistent congenital nasolacrimal duct obstructions.

To study the outcomes of balloon dacryoplasty (BD) or (BDCP) in children with persistent congenital nasolacrimal duct obstruction (pCNLDO) by using new and reused balloon catheters. Our retrospective analysis focused on managing pCNLDO by using the BD or BDCP technique. The study included children aged >1 year to <12 years who underwent single or multiple probings before. Our specific lacrimal workup included a detailed history and examination, as published earlier. We used conventional, straight, 2 mm × 13 mm/3 mm × 15 mm lacrimal balloons (FCI, Ophthacath). We have described a technique to use the same catheter for three BD procedures (1 new + 2 reuse). The outcomes were categorized as complete success, partial success, and failure. The minimum follow-up of each child was 6 months. We analyzed 64 children (89 eyes) with a mean age of 58 months (15-132 months). All children (100%) had epiphora with discharge and positive FDDT. All children underwent BD under general anesthesia - new balloons in 59 eyes and reused balloons in 30 eyes. The balloons were plasma sterilized akin to vitrectomy cutters and tubings of phaco machines. We noted three leaks from reused balloons (2 from the balloon tip and 1 from the plastic hub). At a mean follow-up of 14.5 months, complete success was noted in 77 eyes (86.5%) (52 new and 25 reuse), while 8 eyes had partial success (8.9%) (4 new and 4 reuse). Failure of BD was noted in four eyes (4.5%) (3 new and 1 reuse). None had significant complications with new or reused balloons. BD or BDCP is a quick, safe, easy, and effective procedure that resolves pCNLDO symptoms satisfactorily. Carefully reusing a conventional balloon catheter is possible with comparable efficacy and no additional complications in pCNLDO.

Rationale and design of the sirolimus eluting balloon utilization for treatment of vasculogenic erectile dysfunction: the SUASION Registry.

Conventional angioplasty balloon catheter, drug coated balloon (DCB), or angioplasty with drug eluting stent (DES) have been used on the percutaneous treatment of erectile dysfunction (ED). Currently available DCBs are paclitaxel eluting balloon (PEB), very recently, sirolimus eluting balloon (SEB). Although endovascular revascularization with balloon resulted in improvement of ED, there have been no prior reports on the feasibility of SEB treatment for ED. We present an observational, retrospective-prospective multicentre registry in patients evaluating the use of SEB for the treatment of de novo stenosis in native internal pudendal arteries. We will include 100 patients affected by vasculogenic ED non responder to PDE5i with up to two lesions requiring treatment. ED patients should present a IIEF-5 Score<15, positive dynamic doppler (PSV <25 cm/s) and/or evidence at basal CT angiography. At 30 days, 180, 240, and 365 days following the index procedure, IIEF-5 score will be assessed, and medication regimen and adverse event monitoring will be assessed. At 8 months a dynamic Doppler will be performed. Patients will be followed up for 2 years. The primary endpoints are the Delta IIEF-5 Score and a Delta PSV between basal and 8 months follow-up. The secondary endpoint is the incidence of major adverse event (MAE), binary restenosis and late loss in patients who will repeat control angiography if clinically indicated. Considering the limitations and safety concerns of PEB, POBA and DES used so far in ED clinical investigations, we hypothesize that sirolimus nanocarriers-coated balloon can potentially be an improved next-generation treatment for ED patients.

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.

BackgroundDrug coated balloons (DCB) with paclitaxel (Ptx) dose of 2–3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model.Methods and resultsThe current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each.Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon.ConclusionThe dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.

A Microneedles Balloon Catheter for Endovascular Drug Delivery

AbstractDisorders of the inner parts of blood vessels have been significant triggers of cardiovascular diseases (CVDs). Different interventional methods have been employed, from complex surgeries to balloon angioplasty techniques to open the narrowed blood vessels. However, CVDs continue to be the lead cause of death in the world. Delivering a therapeutic agent directly to the inner wall of affected blood vessels can be a transformative step toward a better treatment option. To open the door for such an approach, a catheter delivery system is developed based on a conventional balloon catheter where a fluidic channel and microneedles (MNs) are integrated on top of it. This enables precise and localized delivery of therapeutics directly into vessel walls. Customizable MNs are fabricated using a high‐resolution 3D printing technique where MN's height ranges from 100 to 350 µm. The MNs penetration into a synthetic vascular model is investigated with a computerized tomography scan. Ex vivo tests on rabbit aorta confirm the MN‐upgraded balloon catheter's performance on real tissue. Delivery of fluorescent dye is accomplished by injecting it through the fluidic channel and MNs into the aortic tissue. The dye is observed at up to 180 µm of depth, confirming site‐specific endovascular delivery.

Comparative performance analysis of interventional devices for the treatment of ischemic disease in below-the-knee lesions: a systematic review and meta-analysis

This meta-analysis aimed to evaluate the device performance of conventional balloon catheters (POBA), drug-coated balloons (DCB), bare-metal stents (BMS), and drug-eluting stents (DES) in below-the-knee (BTK) ischemic lesions with regard to lesion characteristics. Online searches of PubMed, Web of Science, and Cochrane databases (2010–2019) were conducted for each of the test devices. Primary patency rates (pp) and major amputation rates 1 year after the use of each device were analyzed using a random-effects meta-analysis model. Meta-regression analysis was conducted to test associations between the outcomes and lesion characteristics. The analysis included 18 studies reporting on 24 separate cohorts comprising 2,438 patients. DES demonstrated the best pp among the test devices (83.6%; 95% confidence interval = 78.4–88.8%, studies = 8; I2 = 66%, P = 0.005). A negative coefficient between lesion length and pp (P = 0.002) was obtained. The ratio of critical limb ischemia (CLI) patients impacted the amputation rates (P = 0.031), whereas no statistically significant difference was found between the devices. DES showed favorable pp in BTK lesions; however, as the lesion lengths using DES were short, pp in long lesions still needs to be evaluated. Shorter lesions gained better pp. A higher ratio of CLI patients resulted in increased amputation rates.

Use of the novel curved GOKU balloon catheter for acute-angled lesions in palliative surgery for congenital heart disease: comparison with a conventional straight balloon

Obstruction develops commonly at the acute-angled portion of the vessels following palliative surgery, such as systemic–pulmonary shunt (SP shunt), right ventricle–to–pulmonary artery shunt (RV–PA shunt) in the Norwood–Sano procedure for hypoplastic left heart syndrome, and cavopulmonary (Glenn) anastomosis. Although balloon angioplasty is a treatment option, dilation with existing straight balloons is sometimes ineffective and technically complicated because of balloon slippage and target vessel distortion. In this study, we investigated the effectiveness of a curved GOKU balloon catheter for balloon angioplasty in postoperative acute-angled lesions associated with palliative surgery for congenital heart disease. We reviewed patients who underwent balloon angioplasty for angled lesions complicated by SP shunt, RV–PA shunt, or Glenn anastomosis, using the novel curved GOKU or a conventional balloon catheter, such as a Sterling balloon catheter. We evaluated patients’ backgrounds, balloon specifications, target lesion anatomical features and angles, and short-term outcomes. We evaluated 45 procedures in 18 patients. A curved GOKU was used in 20 procedures, and a Sterling balloon in 25 procedures. The angulation of the lesions at maximum balloon inflation was significantly smaller using a curved GOKU vs a Sterling balloon [70–120 (mean ± standard deviation, 97 ± 40) degrees vs 110–180 (149 ± 46) degrees, respectively; p < 0.001], while the original angle was similar between the groups. Patients’ short-term outcomes with the curved GOKU were excellent, with a significantly better percent increase in minimum lumen diameter of 0–220% (92% ± 66%) vs 0–46% (18% ± 15%) with the Sterling balloon (p < 00.1) and with less frequent balloon slippage. The curved GOKU was more effective in balloon angioplasty for acute-angled lesions compared with a conventional straight balloon, likely because of better conformability to the lesion angle and slip resistance.

Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II–BTK)

Purpose To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods The prospective, multicenter, randomized study AcoArt II–BTK study (ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). Conclusion This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

Detailed measurements of oesophageal pressure during mechanical ventilation with an advanced high-resolution manometry catheter

BackgroundOesophageal pressure (PES) is used for calculation of lung and chest wall mechanics and transpulmonary pressure during mechanical ventilation. Measurements performed with a balloon catheter are suggested as a basis for setting the ventilator; however, measurements are affected by several factors. High-resolution manometry (HRM) simultaneously measures pressures at every centimetre in the whole oesophagus and thereby provides extended information about oesophageal pressure. The aim of the present study was to evaluate the factors affecting oesophageal pressure using HRM.MethodsOesophageal pressure was measured using a high-resolution manometry catheter in 20 mechanically ventilated patients (15 in the ICU and 5 in the OR). Different PEEP levels and different sizes of tidal volume were applied while pressures were measured continuously. In 10 patients, oesophageal pressure was also measured using a conventional balloon catheter for comparison. A retrospective analysis of oesophageal pressure measured with HRM in supine and sitting positions in 17 awake spontaneously breathing patients is also included.ResultsHRM showed large variations in end-expiratory PES (PESEE) and tidal changes in PES (ΔPES) along the oesophagus. Mean intra-individual difference between the minimum and maximum end-expiratory oesophageal pressure (PESEE at baseline PEEP) and tidal variations in oesophageal pressure (ΔPES at tidal volume 6 ml/kg) recorded by HRM in the different sections of the oesophagus was 23.7 (7.9) cmH2O and 7.6 (3.9) cmH2O respectively. Oesophageal pressures were affected by tidal volume, level of PEEP, part of the oesophagus included and patient positioning. HRM identified simultaneous increases and decreases in PES within a majority of individual patients. Compared to sitting position, supine position increased PESEE (mean difference 12.3 cmH2O), pressure variation within individual patients and cardiac artefacts. The pressure measured with a balloon catheter did not correspond to the average pressure measured with HRM within the same part of the oesophagus.ConclusionsThe intra-individual variability in PESEE and ΔPES is substantial, and as a result, the balloon on the conventional catheter is affected by many different pressures along its length. Oesophageal pressures are not only affected by lung and chest wall mechanics but are a complex product of many factors, which is not obvious during conventional measurements. For correct calculations of transpulmonary pressure, factors influencing oesophageal pressures need to be known. HRM, which is available at many hospitals, can be used to increase the knowledge concerning these factors.Trial registrationClinicalTrials.gov, NCT02901158

Magnetic Particle Imaging–Guided Stenting

Purpose:To assess the feasibility of magnetic particle imaging (MPI) to guide stenting in a phantom model. Materials and Methods: MPI is a new tomographic imaging method based on the background-free magnetic field detection of a tracer agent composed of superparamagnetic iron oxide nanoparticles (SPIOs). All experiments were conducted on a custom-built MPI scanner (field of view: 29-mm diameter, 65-mm length; isotropic spatial resolution 1–1.5-mm). Stenosis phantoms (n=3) consisted of polyvinyl chloride (PVC) tubes (8-mm inner diameter) prepared with centrally aligned cable binders to form a ~50% stenosis. A dedicated image reconstruction algorithm allowed precise tracking of endovascular instruments at 8 frames/s with a latency time of ~115 ms. A custom-made MPI-visible lacquer was used to manually label conventional guidewires, balloon catheters, and stainless steel balloon-expandable stents. Vascular stenoses were visualized by injecting a diluted SPIO tracer (ferucarbotran, 10 mmol iron/L) into the vessel phantoms. Balloon angioplasty and stent placement were performed by inflating balloon catheters and stent delivery balloons with diluted ferucarbotran. Results: After deployment of the stent, the markers on its ends were clearly visible. The applied lacquer markers were thin enough to not relevantly alter gliding properties of the devices while withstanding friction during the experiments. Placing an optimized flexible lacquer formulation on the preexisting radiopaque stent markers provided enough stability to withstand stent expansion. Final MPA confirmed successful stenosis treatment, facilitated by the disappearance of the lacquer markers on the stent due to differences in SPIO concentration. Thus, the in-stent lumen could be visualized without interference by the signal from the markers. Conclusion: Near real-time visualization of MPI-guided stenting of stenoses in a phantom model is feasible. Optimized MPI-visible markers can withstand the expansion process of stents.

Tu1405 LONG TERM OUTCOMES OF ENDOTHERAPY USING A DEDICATED PANCREATIC BASKET CATHETER FOR PANCREATIC DUCT STONES

Residual pancreatic duct (PD) stone after endoscopic retraction may cause recurrent symptom. Fragmented stones after ESWL, tortuous PD, stricture and dilated branch duct are the causes of residual stones after the endoscopic retraction with conventional basket and balloon catheter. Reforma (Piolax Medical Devices Inc., Japan), a dedicated basket for PD stone retraction with Nitinol fine mesh structure could reduce the incidence of PD stone residue in our previous report ( GIE 2013; 78: 925-929). In this study, we further investigated the long term outcomes of endotherapy using Reforma for PD stones. This is a single center, retrospective analysis of consecutive patients with symptomatic PD stones who underwent the initial endotherapy and achieved complete stone removal on pancreatogram between February 2008 and June 2017. In cases with PD stone larger than 8 mm or refractory to endotherapy underwent extracorporeal shock wave lithotripsy (ESWL). The type of basket catheter was selected at the discretion of the attending physician. Primary outcome was the incidence of pancreatic events due to recurrent PD stones such as acute exacerbation, pancreatic pain and pseudocyst. Pancreatic events were compared between those who were treated using Reforma (Reforma group) and those who were not (Non-Reforma group). Among 103 patients who underwent the initial endotherapy during the study period, complete stone removal on pancreatogram was achieved in 90 patients (87%). The median age was 58 years (range, 27 – 90), and the median size of PD stones was 10mm (range, 3 – 30). ESWL was performed in 91% (82/90). A conventional basket catheter and Refroma were used in 37% (33/90) and 30% (27/90), respectively. Reforma was used as a single device in 9, in combination with a balloon catheter in 18. During the median follow up of 27.7 (range, 0.1 – 97.1) months, the incidence of pancreatic events was 19%: Acute exacerbation in 7%, pancreatic pain in 11% and pseudocyst in 1%. When Reforma group (n = 18) and non-Reforma group (n = 55) were compared, the incidence of pancreatic events was 11% and 24% in the Reforma group and non-Reforma group (P = 0.254). In Cox proportional hazard models, Reforma group tended to be associated with reduction of pancreatic events (Hazard ratio 0.49; P = 0.301). This dedicated pancreatic basket catheter, which can potentially catch all fragmented PD stones better than a conventional one, may reduce the development of pancreatic events after complete PD stone removal. A large scale, prospective study is warranted to confirm our hypothesis.

Vascular stents with submicrometer-scale surface patterning realized via titanium deep reactive ion etching

Herein, we report progress towards realization of vascular stents that will eventually provide opportunity for evaluating cellular response to rationally-designed, submicrometer-scale surface patterning in physiologically-relevant contexts, i.e. those that provide exposure to the complex multicellular milieu, flow-induced shear, and tissue-device interactions present in vivo. Specifically, using our novel titanium deep reactive ion etching technique (Ti DRIE), we discuss recent advances that have enabled: (a) fabrication of precisely-defined, grating-based surface patterns on planar Ti foils with minimum feature sizes as small as 0.15 μm; (b) creation of cylindrical stents from micromachined planar Ti foils; and (c) integration of these processes to produce the first submicrometer-scale surface-patterned Ti stents that are compatible with conventional balloon catheter deployment techniques. We also discuss results from elastoplastic finite element simulations and preliminary mechanical testing of these devices to assess their mechanical performance. These efforts represent key steps towards our long-term goal of developing a new paradigm in stenting, where rationally-designed surface patterning provides a physical means for facilitating healing, and thus, improving outcomes in vascular intervention applications.

Liquid- and Air-Filled Catheters without Balloon as an Alternative to the Air-Filled Balloon Catheter for Measurement of Esophageal Pressure

BackgroundMeasuring esophageal pressure (Pes) using an air-filled balloon catheter (BC) is the common approach to estimate pleural pressure and related parameters. However, Pes is not routinely measured in mechanically ventilated patients, partly due to technical and practical limitations and difficulties. This study aimed at comparing the conventional BC with two alternative methods for Pes measurement, liquid-filled and air-filled catheters without balloon (LFC and AFC), during mechanical ventilation with and without spontaneous breathing activity. Seven female juvenile pigs (32–42 kg) were anesthetized, orotracheally intubated, and a bundle of an AFC, LFC, and BC was inserted in the esophagus. Controlled and assisted mechanical ventilation were applied with positive end-expiratory pressures of 5 and 15 cmH2O, and driving pressures of 10 and 20 cmH2O, in supine and lateral decubitus.Main ResultsCardiogenic noise in BC tracings was much larger (up to 25% of total power of Pes signal) than in AFC and LFC (<3%). Lung and chest wall elastance, pressure-time product, inspiratory work of breathing, inspiratory change and end-expiratory value of transpulmonary pressure were estimated. The three catheters allowed detecting similar changes in these parameters between different ventilation settings. However, a non-negligible and significant bias between estimates from BC and those from AFC and LFC was observed in several instances.ConclusionsIn anesthetized and mechanically ventilated pigs, the three catheters are equivalent when the aim is to detect changes in Pes and related parameters between different conditions, but possibly not when the absolute value of the estimated parameters is of paramount importance. Due to a better signal-to-noise ratio, and considering its practical advantages in terms of easier calibration and simpler acquisition setup, LFC may prove interesting for clinical use.

Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis

We aimed to investigate the effectiveness of a scoring balloon catheter in expanding a circumferentially calcified lesion compared to a conventional balloon catheter using an in vitro experiment setting and elucidate the underlying mechanisms of this ability using a finite element analysis. True efficacy of the scoring device and the underlying mechanisms for heavily calcified coronary lesions are unclear. We employed a Scoreflex scoring balloon catheter (OrbusNeich, Hong Kong, China). The ability of Scoreflex to dilate a calcified lesion was compared with a conventional balloon catheter using 3 different sized calcium tubes. The thickness of the calcium tubes were 2.0, 2.25, and 2.5 mm. The primary endpoints were the successful induction of cracks in the calcium tubes and the inflation pressures required for inducing cracks. The inflation pressure required for cracking the calcium tubes were consistently lower with Scoreflex (p < 0.05, Student t test). The finite element analysis revealed that the first principal stress applied to the calcified plaque was higher by at least threefold when applying the balloon catheter with scoring elements. A scoring balloon catheter can expand a calcified lesion with lower pressure than that of a conventional balloon. The finite element analysis revealed that the concentration of the stress observed in the outside of the calcified plaque just opposite to the scoring element is the underlying mechanism of the increased ability of Scoreflex to dilate the calcified lesion.

First-in-human experience using the Volcano VIBE-RX vascular imaging balloon catheter system (Volcano IVUS-guided Balloon Evaluation - New Zealand: VIBE-NZ Study)

Intravascular ultrasound (IVUS) is a proven and safe imaging modality used to guide percutaneous coronary intervention (PCI). The Volcano VIBE™ RX Vascular Imaging Balloon Catheter is a novel rapid exchange, 0.014" wire-compatible multi-lumen conventional balloon catheter modified with the addition of an IVUS transducer proximal to the balloon, delivered via a standard 6 Fr sheath. We sought to evaluate the safety, balloon performance, and image quality of the VIBE™ RX in patients scheduled for coronary intervention. Patients aged >21 and <85 years with single or multivessel coronary disease scheduled for PCI due to coronary ischaemic symptoms were included. Those with angiographic features that precluded the safe or informative use of the device were excluded. Twenty-nine patients having angiography because of ischaemic symptoms underwent 44 VIBE RX imaging runs, with balloon dilation in 20. Successful device deployment was achieved in all but one patient. All images were adequate and reproducible. One patient had a non-ST-elevation MI felt to be due to the complexity of the procedure rather than directly related to the VIBE™ RX. The study demonstrated the safety and effectiveness of the VIBE™ RX for its intended purpose with minimal failure rate and no directly related complications.

The glider balloon: A useful device for the treatment of bifurcation lesions

Final kissing balloon dilatation (FKBD) is a recommended final step in case of treatment of bifurcation lesions by two stents approaches. Furthermore, dilatation of the side branch (SB) may be necessary following main vessel (MV) stenting. Occasionally, recrossing the stent struts with a balloon is hampered because the tip hits a stent strut. The Glider (TriReme Medical, Pleasanton, CA) is a dedicated balloon designed for crossing through struts of deployed stents toward a SB. From October 2010 to January 2012, FKBD was attempted in 236 consecutive bifurcation lesions treated in our Institution. FKBD was successfully performed by conventional balloon catheters in 221 (93.5%) lesions (Conventional group). In the remaining 15 (6.5%) lesions, where a conventional balloon failed to cross the stent strut, the Glider balloon was attempted (Glider group). The angle beta (between the axis of the MV after the branch point and the SB axis at the point of divergence) was wider in the Glider group (83±17° versus 65±27°; p=0.032). A trend toward an higher rate of the true bifurcation lesions was observed in the Glider group (93% versus 70.5%; p=0.07). The Glider balloon successfully crossed through MV stent struts toward a SB in 12 patients (80%), whereas failed in the remaining 3 patients. The Glider balloon represents an unique bail-out device which offers an effective rescue strategy for recrossing stent struts during complex bifurcation stenting.

Materials for multifunctional balloon catheters with capabilities in cardiac electrophysiological mapping and ablation therapy.

Developing advanced surgical tools for minimally invasive procedures represents an activity of central importance to improving human health. A key challenge is in establishing biocompatible interfaces between the classes of semiconductor device and sensor technologies that might be most useful in this context and the soft, curvilinear surfaces of the body. This paper describes a solution based on materials that integrate directly with the thin elastic membranes of otherwise conventional balloon catheters, to provide diverse, multimodal functionality suitable for clinical use. As examples, we present sensors for measuring temperature, flow, tactile, optical and electrophysiological data, together with radiofrequency electrodes for controlled, local ablation of tissue. Use of such 'instrumented' balloon catheters in live animal models illustrates their operation, as well as their specific utility in cardiac ablation therapy. The same concepts can be applied to other substrates of interest, such as surgical gloves.

A scoring angioplasty balloon catheter for the management of complex tibial arterial lesions in critical lower limb ischaemia: A prospective study

Introduction: Complex tibial lesions represent a challenging problem in a large proportion of patients presenting with critical limb ischemia. In this particular subset of patients, heavily calcified and fibrocalcific lesions in the distal tibial tree, embodies an exigent problem for the success of the procedure. Aim: To report our initial experience with the AngioSculptTM (ASC) scoring balloon catheter, which incorporates a laser-cut highly flexible three nitinol spiral struts which encircle a semi- compliant conventional balloon catheter to create focal concentration of the dilating force leading to scoring (indenting) the surface of calcific plaques. Methods: Patients scheduled for angioplasty of the tibial vessels for critical limb ischemia, were included in our study. Primary end points were limb salvage rate, clinical improvement, and primary patency. Secondary end points were, technical success, difficulties, and complications associated with the use of the scoring balloon. Results: Forty Eight patients underwent peripheral angioplasty procedures in our institute, of which 11 patients with complex lesions fulfilled the inclusion criteria. Mean lesion length was 35±12.2 mm, ostial lesion in 36.4% of patients. The AngiosculptTM balloon was used as sole therapy in all attempted tibial lesions. Limb salvage rate was 81.8%. Primary patency rate of the treated vessels was 63.6% at 6 months. Conclusion: The AngiosculptTM scoring balloon is a highly effective solution for challenging tibial complex lesions, and is associated with a very high technical success with low complication rate.

Cutting-balloon angioplasty of resistant ureteral stenosis as bridge to stent insertion

Ureteral stenting is a routine, minimally invasive procedure performed for relief of benign or malignant obstruction. In case of ureteral stenosis, to allow a correct insertion of the stent, a predilatation of the ureter stenosis with a conventional balloon catheter can be necessary. In exceptional cases, it can be difficult to advance an 7–8 Fr JJ-catheter over a tight resistant ureter stenosis following unsuccessful high-pressure balloon dilatation. In the present report, we describe two cases of resistant ureter stenosis successfully dilated by a cutting-balloon following the failure of high-pressure balloon dilatation, allowing a correct and uncomplicated antegrade stent insertion.

Renal artery rupture following cutting balloon angioplasty for fibromuscular dysplasia: a case report.

Angioplasty with the use of cutting balloons has been suggested by some case reports and small series for the treatment of renal artery stenoses that are resistant to conventional balloon catheters. Based on this limited experience, the use of this technology has been suggested as safe. Herein, we report a renal artery rupture following angioplasty with a cutting balloon. The complication was salvaged with a stent graft. A 30-year-old white female patient with resistant hypertension caused by a severe renal artery stenosis attributed to fibromuscular dysplasia, was submitted to conventional balloon angioplasty without success. Dilatation of the lesion with a cutting balloon resulted in arterial rupture, with concomitant retroperitoneal hematoma. Cutting balloon angioplasty of renal artery lesions resistant to conventional balloon angioplasty should not be considered as safe as previously thought. When proceeding with such a procedure, a stent graft should be available for immediate use.

Renal artery rupture following cutting balloon angioplasty for fibromuscular dysplasia: a case report

IntroductionAngioplasty with the use of cutting balloons has been suggested by some case reports and small series for the treatment of renal artery stenoses that are resistant to conventional balloon catheters. Based on this limited experience, the use of this technology has been suggested as safe. Herein, we report a renal artery rupture following angioplasty with a cutting balloon. The complication was salvaged with a stent graft.Case presentationA 30-year-old white female patient with resistant hypertension caused by a severe renal artery stenosis attributed to fibromuscular dysplasia, was submitted to conventional balloon angioplasty without success. Dilatation of the lesion with a cutting balloon resulted in arterial rupture, with concomitant retroperitoneal hematoma.ConclusionCutting balloon angioplasty of renal artery lesions resistant to conventional balloon angioplasty should not be considered as safe as previously thought. When proceeding with such a procedure, a stent graft should be available for immediate use.