High-pressure Balloon Catheter Research Articles

Endoscopic balloon dilation of primary obstructive megaureter: is fluoroscopic guidance necessary?

To compare the long-term effectiveness, complications, and outcomes of primary obstructive megaureter (POM) treated by endoscopic balloon dilation under fluoroscopic guidance versus not using radioscopy during the procedure. A comparative study between POM cases treated at our institution by endoscopic balloon dilation (EBD) under fluoroscopic guidance (FG) (n = 43) vs no fluoroscopic guidance (NFG) (n = 48) between the years 2004 and 2018 was conducted. The procedure in FG consisted of performing a retrograde pyelography before dilation.Then, a guidewire is introduced to the renal pelvis, and the dilation of the vesicoureteral junction is performed using high-pressure balloon catheters under fluoroscopic vision. Finally, a double-J stent is placed between the renal pelvis and bladder. The procedure in NFG was performed exclusively under cystoscopic vision without radiological exposure. Complications, outcomes, and success rates were analyzed using Spearman's correlation test. Mean follow-up was 12.5 ± 2.2years in FG and 6.4 ± 1.3years in NFG. MAG-3 showed significant differences in renal drainage before and after endoscopic treatment in both groups (p < 0.001 T-test). Statistical analysis did not reveal differences between groups in initial technical failure (r: - 0.035,p = 0.74), early postoperative complications (r: - 0.029,p = 0.79), secondary VUR (r: 0.033, p = 0.76), re-stenosis (r: 0.022, p = 0.84), long-term ureteral reimplantation (r: 0.065, p = 0.55), and final outcome (r: - 0.054, p = 0.61). The endoscopic approach of POM had a long-term success rate of 86.5% in FG VS 89.6% in NFG. Endoscopic balloon dilation of POM can be done with no radiation exposure with similar results, effectiveness, and outcomes.

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.

Endoscopic endonasal balloon-dacryoplasty in failed dacryocystorhinostomy.

Endoscopic endonasal balloon-assisted dacryoplasty is a minimally-invasive surgical procedure that can be used in recurrent epiphora, a common pathology in both adulthood and childhood. We present a retrospective case series of eight patients who underwent trans-nasal balloon-assisted dacryoplasty after a failed external or endoscopic dacryocystorhinostomy, from March 2019 to January 2020, at the Department of Otolaryngology, San Raffaele Hospital, Milan, Italy. All patients underwent routine preoperative work-up including fluorescein test (Jones test I-II), probing and irrigation of the lacrimal pathway and nasal endoscopy. Because of the recurrent nature of the pathology, pre-operatory computed tomography scan or dacryocystography was not performed. The surgical procedure was based on enlargement of the stenotic neorhinostomy created by primary dacryocystorhinostomy through the use of a high-pressure balloon catheter. Anatomical success was defined as a patent ostium on irrigation, whereas functional success was defined as free lacrimal flow on functional test and resolution of epiphora. Anatomic and functional success was achieved in 100% of patients. Operative time ranged from 9 to 22 min (mean 16 min). No significant complications were reported. Our results indicate that trans-nasal balloon-assisted dacryoplasty can be considered as a safe and reliable surgical approach after a failed primary dacryocystorhinostomy. The shorter surgical time and reduced post-operative complication rates are the main advantages of this procedure.

Long-Term Outcomes in Primary Obstructive Megaureter Treated by Endoscopic Balloon Dilation. Experience After 100 Cases.

Aim: To assess long-term effectiveness, complications, and outcomes of primary obstructive megaureter (POM) treated by endoscopic balloon dilation (EBD) in the largest series reported.Patients and Methods: Hundred POM in 92 consecutive patients were treated by EBD between years 2004 and 2016. A total of 79 POM (73 patients) with more than 18 months of follow-up after treatment have been analyzed. EBD of the vesicoureteral junction was performed with semicompliant high-pressure balloon catheters (2.7FG) with minimum balloon diameter of 5 mm, followed by temporary Double-J stent placement. Follow-up protocol included periodical clinical reviews, US and MAG-3 renogram scans.Results: Median age at surgery was 4 months (15 days−3.6 years), with median operating time of 20 min (10–60) and hospital stay of 1 day (1–7). Initial renal function was preserved in all patients with significant improvement in renal drainage on the MAG-3 diuretic renogram after endoscopic treatment (p < 0.001 T-test). Significant post-operative differences were observed in hydronephrosis grade and ureteral diameter that were maintained in the long-term (p < 0.001 T-test). Endoscopic approach of POM had a long-term success rate of 87.3%, with a mean follow-up of 6.4 ± 3.8 years. Secondary VUR was found in 17 cases (21.5%), being successfully treated by endoscopic subureteral injection in 13 (76.4%). Nine cases developed long-term re-stenosis (12.2%) that were successfully treated with a new EBD in 8. Endoscopic management of POM failed in 10 cases (12.7%) that required ureteral reimplantation. Five were early failures (4 intraoperative technical problems and 1 double-J stent migration with severe re-stenosis), and 5 long-term (4 persistent VUR and 1 re-stenosis recurrence).Conclusion: EBD has shown to be an effective treatment of POM with few complications and good outcomes at long-term follow up. Main complication was secondary VUR that could also be treated endoscopically with a high success rate. In our opinion, EBD may be considered first-line treatment in POM.

High-Pressure Balloon-Assisted Stretching of the Coracohumeral Ligament to Determine the Optimal Stretching Positions: A Cadaveric Study

BackgroundThe coracohumeral ligament (CHL) is a thick capsular structure and markedly thickened when affected by adhesive capsulitis. Therapeutic stretching is the most commonly applied treatment for adhesive capsulitis, but optimal stretching postures for maximal therapeutic effects on the CHL have not been fully investigated. ObjectiveTo investigate the most effective stretching direction for the CHL by measuring the stretching intensity in 5 different directions and to determine whether the stretching intervention resulted in loosening of the ligament by comparing the changes of CHL tightness before and after stretching. DesignBiomechanical cadaver study. SettingAcademic institution cadaver laboratory. ParticipantsNine fresh frozen cadaveric shoulders. MethodsA high-pressure balloon catheter inserted under the CHL and intraballoon pressure was measured, to evaluate CHL tightness without ligament damage as well as to augment and monitor stretching intensity. To find the optimal stretching direction, the glenohumeral joint was stretched from the neutral position into 5 directions sequentially under pressure-monitoring: flexion, extension [EX], external rotation [ER], EX+ER, and EX+ER+adduction [AD] directions. Main Outcome MeasurementsCHL tightness was determined by a surrogate parameter, the additional pressure created by the overlying CHL. The pressure increase (ΔPstr) by a specific directional stretch was considered as the stretching intensity. ResultsΔPstr by the 5 directions were mean (standard deviation) values of 0.03 ± 0.07 atm, 0.87 ± 1.31 atm, 1.13 ± 1.36 atm, 1.49 ± 1.32 atm, and 2.10 ± 1.70 atm, respectively, revealing the highest ΔPstr by the EX+ER+AD stretch (P < .05). The balloon pressure by the overlying CHL was decreased from 0.45 ± 0.35 atm to 0.18 ± 0.14 atm (P = .012) before and after the stretching manipulation. ConclusionsEX+ER+AD of the glenohumeral joint resulted in the greatest increase in balloon pressure, implying that it could be the most effective stretching direction. A series of stretching manipulations assisted with an underlying pressure balloon were capable of decreasing CHL tightness. With further development and modification, high-pressure balloon-assisted stretching can be a potential therapeutic option to release tight CHL, including the advantage of augmenting and monitoring stretching intensity. Level of EvidenceII

Percutaneous nephrolithotripsy under assisted local anaesthesia for high risk patients: Is it effective?

ObjectivesThe aim of the present study is to evaluate the feasibility and safety of performing PNL under local anesthesia in a selected group of patients who are at high risk for general anesthesia. Patients and methodsForty seven patients underwent PNL under local anesthesia. There were 38 males and 9 females with a mean age of 62 years. All patients were at medical high-risk for general anesthesia, with an American Society of Anesthesiologists (ASA) score of 3. The indications for local anesthesia in this study were obstructed single functioning kidney with azotemia in 29 patients, hepatic insufficiency in 8 patients, cardiac problems in 7 patients and 3 patients had hepatocellular carcinoma. The mean stone size was 2.7cm (range 2–3.1cm). Local infiltration with 10–20cc of 2% lidocaine at the site of puncture was used in all cases. Narcotics were given 30min prior to the procedure and medazolam was given intraoperatively upon demand. Utrasound guided puncture was performed in all cases and tract dilatation was then done under fluoroscopy using high pressure balloon catheter in 35 and Alken's metal dilators in 12 cases. Stones were then retrieved after disintegration in the same cession in 33 patients, while the other 14 patients underwent staged PNL, where a 12 Fr. nephrostomy tube was placed in the first stage, followed by tract dilatation and stone retrieval one week later. ResultsOut of 47 patients included, 44 had successful PNL either one stage (30 patients) or two stages (14 patients). Only 3 patients could not tolerate pain and the procedure was terminated after placement of nephrostomy tube and stone retrieval was completed later under general anesthesia. ConclusionOur results demonstrated that PNL under local anesthesia with narcotics and sedatives seems to be a satisfying solution for the treatment of a selected group of patients with renal pelvic stones and who have high anesthetic risk. However, additional studies with different groups of patients are required to validate our results.

Comparison of a Novel One-Step Percutaneous Nephrolithotomy Sheath with a Standard Two-Step Device

Percutaneous nephrolithotomy (PCNL) is the treatment of choice for large renal calculi. The most widely used access sheath for PCNL involves two steps including placement of a high-pressure balloon catheter (HPBC) followed by advancement of a sheath over the balloon. A novel PCNL balloon/sheath combination (NSS) has been developed that allows for both dilation and sheath placement in a single step. The objective of this study was to compare the safety and efficacy of the NSS to the HPBC in a porcine model. Six farm pigs underwent placement of a standard HPBC in one kidney and the NSS on the contralateral side. We obtained access in the upper pole in 2 animals, middle pole in 2 animals, and lower pole in 2 animals. We obtained data on insertion time, difficulty of insertion, estimated blood loss (EBL), ability to visualize the collecting system, and gross and histopathologic analysis. There was no statistical difference in degree of difficulty in placing the NSS (3 easy, 3 moderate) versus HPBC device (1 easy, 5 moderate; P = 0.07), estimated blood loss (P = 0.10), or the ability to visualize the collecting system (P = 0.32). There was a significantly shorter insertion time in the NSS group compared with the HPBC group (1:37 versus 2:26 minutes, P = 0.04). This study demonstrates that the NSS is safe and effective in the porcine model. Trials in patients are currently under way.

Comparación entre la posición de Valdivia y la posición prona en la nefrolitectomía percutánea (NLP)

Comparison between valdivia position and prone position in percutaneous nephrolithotomy IntroductionAlthough the supine position created by Dr. Valdivia two decades ago to perform the procedure known as percutaneous nephrolitectomy (PNL) presents advantages against the prone position in some aspects concerning anesthesia and surgical ergonomy, its use has failed to spread widely among the urology community due to certain technical difficulties, a lower rate of calculi clearing and a higher rate of complications, in spite of the fact that the scarce comparative studies do not show enough data to support this opinion. The present study compares both positions considering the technical difficulties encountered, their effectiveness and their results and complications Material and methodsA series of 50 patients that underwent PCNL by prone position is compared retrospectively with another series of 54 patients that underwent consecutively PCNL by prone position. All procedures were performed under general anesthesia, the inferior calyx approach was the one used the most over the supracostal approach, and the sole tract over the multi-tract approach was predominant. Dilatation of the nephrostomy tract was done, in most of the cases, with a high-pressure balloon catheter. The stone surface treated was 399.93+58.2 mm2 for the supine group, and 416.36+46.54 mm2 for the prone one (p=0.456). The management of the stones was carried out by ultrasonic or ballistic fragmentation, and a small group of patients underwent direct stone removal ResultsAs far as demographic parameters and operative variables such as number of tracts performed, calyx election, type of tract dilatation and kind of energy used for fragmentation, both groups were homogeneous. In 3 cases of each group there was a failure to access the kidney. The rate of failure was 6%, and 5.56%, for the supine and prone groups, respectively (p=0.716). Average operating time was 74.55+25.54 and 91.82+ 24.82 minutes, respectively, p=0.123. A postoperative x-ray showed a stone-free rate of 76% for the supine group and 74% for the prone group, p=0.308. ESWL was the supplementary treatment for 12% of the patients in the supine group, and for 12.96% of the patients in the prone group p= 0.478, and a second procedure was performed on 4 (8%) patients in the supine group and on 3 (5.56%) in the prone one, p=0.697. Hospital stay was the same for both groups (5.89± 4.7 for the supine group, and 5.5 ± 4.09 for the prone one, p= 0.694). As far as analgesia required, 6.89 ± 4.87 was administered for the supine against 6.18±4.09 for the prone, p= 0.580. The complications rate was very low for both groups and also very similar; one of the patients in the supine group suffered a lesion to the colon ConclusionsValdivia position is as feasible as the prone position for PCNL. Success rates, as far as stone clearing, and complications are similar for both positions

Percutaneous Treatment of the Obstructive Uropathy

Purpose to analyse the technical aspects, the patient's selection criteria, and some useful tactics to reduce the complications of percutaneous nephrostomy and of other interventional procedures to temporarily treat obstructive uropathy (OU), such as double J stent insertion, dilatation of the stricture using high-pressure balloon catheters, removal of renal or ureteral calculi, fistulas treatment. Materials and Methods a fluoroscopy table and an ultrasonographic guidance are key elements. Two techniques are employed, either the Seldinger type (wire-guided catheters) or the trocar needle type. Sole contraindication: uncorrectable severe coagulopathy. Most important risk factors are: dendritic calculus, non corrected high blood pressure, obesity, small size kidney, severe scoliosis. Results high technical success of the procedure in case of dilated collecting systems (98%); it is minor without dilatation (85%). Conclusion percutaneous nephrostomy is indicated in 87% of obstructive uropathy cases. It represents the basic technique allowing other interventional procedures to treat obstructive uropathy; it should be performed by most radiologists following an adequate training with technique and materials.

One-step percutaneous nephrolithotomy sheath versus standard two-step technique

Objectives Advances in technique and equipment have allowed urologists to perform percutaneous stone removal with increasing efficacy and decreasing complications. The procedure of choice for large renal calculi is percutaneous nephrolithotomy. At our institution, percutaneous access is achieved by a two-step process using either Amplatz dilators or placement of a high-pressure balloon catheter for tract dilation, followed by advancement of a sheath over the balloon. A novel device, the Pathway Access Sheath (PAS) has been developed that allows for balloon tract dilation and percutaneous access sheath placement in one simple step. Methods Our study population consisted of 21 patients, who were randomized to one of two arms. Of the 21 patients, 10 underwent standard two-step access using a high-pressure balloon catheter and 11 underwent percutaneous nephrolithotomy using the novel PAS. We compared the insertion time, blood loss, and cost between the two techniques. Results The average insertion time was shorter in the PAS group (3 minutes) compared with the high-pressure balloon catheter (5 minutes, 42 seconds); a difference that was statistically significant ( P <0.01). The estimated blood loss and cost were similar between the two groups. The increased sheath flexibility of the PAS was noted to be an advantage in some patients. Conclusions The results of our study have shown that a novel single-step renal access device is safe and efficacious and results in a shorter insertion time for percutaneous nephrolithotomy. Blood loss was less in the PAS group as well, although the difference was not statistically significant. Additional studies will establish whether this device will provide a new standard of obtaining renal access.

Ureteral Metal Stents: A Tale or a Tool?

There are four types of ureteral metal stents: self expandable, balloon expandable, covered, and thermoexpandable shape-memory. Insertion of metal stents requires expertise with transurethral and percutaneous techniques. The stricture is traversed with the aid of a guidewire via a percutaneous nephrostomy, and the stenotic segment is dilated using a high-pressure balloon catheter. The stent is then inserted over the guidewire, such that the upper end bypasses the obstruction by at least 3 to 4 cm, while the lower end extends intravesically for 0.5 to 1 cm from the ureteral orifice. If necessary, two or more stents are placed in sequence, overlapping by at least 2 to 3 cm. Metal stents were initially used for the relief of end-stage malignant disease, and their role in the treatment of benign ureteral strictures is still undefined. Patients often complain of abdominal discomfort and mild pain after stent insertion, which soon resolve spontaneously. Hematuria usually stops after a few days and does not necessitate any treatment. Mild urothelial hyperplasia in the stent lumen is common but usually regresses after 4 to 6 weeks. Many authors suggest the use of a double-pigtail catheter for the first 4 to 6 weeks to avoid narrowing of the ureteral lumen. The influence of stents on ureteral peristalsis is a major but poorly documented issue. Encrustation is a significant problem that needs to be addressed. The characteristics of both the patient and the stent influence its likelihood. Migration of coated metal stents was seen in 81% of patients at our center. Virtual endoscopy has recently been introduced as a tool for the follow-up of patients with stented ureters. Further design development is necessary to obtain the ideal ureteral metal stent. In a recent study in female pigs, paclitaxel-eluting metal stents engendered less inflammation and hyperplasia of the surrounding tissues.

Stenotic lesions in vascular access: treatment with transluminal angioplasty using high-pressure balloons.

In our institute, one hundred sixty-four balloon dilatations of stenotic lesions in vascular access have been performed since November 1991. All of these procedures were done with high-pressure balloon catheters. In addition to seventy-four cases treated with only percutaneous transluminal angioplasty, there were thirty-four cases which were treated by thrombectomy and/or surgical revision with subsequent intraoperative balloon angioplasty. These angioplastic procedures were initially successful in 142 (87%) of 164 stenoses. The patency rate after 3 months was 68%; after 6 months, 42%; and after 1 year, 25%. There were no serious adverse reactions in our series. This procedure can be safely done with minimal traumatization and, although long-term patency rates are low, repeated dilatations can be performed with ease, when restenosis occurs, to keep a fistula functioning for a long time in appropriate patients.

Treatment of Tuberculous Bronchial Stenosis with Expandable Metallic Stents

Gianturco expandable metallic stents were placed in 5 patients with dyspnea on exercise due to tuberculous bronchial stenosis. The stents were placed after dilatation with a 10-mm diameter high pressure balloon catheter. In all 5 patients, obstructive changes disappeared following the procedure, and dyspnea on exercise improved markedly. No complications related to the procedure were encountered. At follow-up during a period of up to 38 months, 2 patients showed bronchial restenosis at 11 and 17 months, respectively, after stent placement. Restenosis by granulomatous tissue was successfully treated by laser ablation. One patient showed slight one-day hemoptysis 26 months after stent placement.

Transluminal angioplasty of venous stenoses in polytetrafluoroethylene vascular access grafts

Since 1984, percutaneous transluminal angioplasty (PTA) utilizing high pressure balloon catheters has been used as an initial approach to restore patency of PTFE (polytetrafluoroethylene, GORE-TEX) hemodialysis vascular access grafts. Seventeen stenotic lesions detected by fistulogram underwent elective PTA. Twelve of these lesions were detected after thrombectomy and five were detected because of increased venous pressures during dialysis. Fourteen attempts at PTA were completely successful in restoring functional patency to the vascular graft. Three attempts were unsuccessful; two of these three grafts were subsequently repaired surgically. Venous stenoses that extended far greater than 6 cm were not considered for PTA. We conclude that PTA is a technique of promise in the non-surgical salvage of failing PTFE grafts. PTA can prolong the useful life of PTFE vascular access grafts and can be performed on an outpatient basis, eliminating the hospitalization that is usually required for surgical revision.

A manual injection syringe for inflation of high pressure balloon catheters.

A commercially available manual injection syringe has been modified for use in inflating high pressure dilating balloons. Accurate long term balloon inflation is easily accomplished.