Cutting Balloon Device Research Articles

Acucise® Endoureterotomy: A Forgotten Treatment Option in Ureteral Strictures of Benign Origin between the Ureteropelvic and Ureterovesical Junctions; Long-Term Results

Objective: To describe our results and experience with the Acucise® cutting balloon device in ureteral strictures of benign origin and to compare success rates with other available minimal invasive endourologic procedures to clarify its value. Methods: We performed a retrospective analysis of a prospectively kept database of all patients treated with Acucise® for non-malignant ureteral strictures between ureteropelvic and vesicoureteral junctions from 2004 until 2012. We retrieved data on perioperative diagnostic imaging, the Acucise® treatment performed, complications and outcome. Results: Fourteen patients underwent Acucise® ureterotomy for ureteral strictures (mean age 59 years). A total of 21 strictures were treated. In all procedures, the ureterotomy was successful. In all patients, a double-J catheter was placed for 6 weeks. One intra operative bleeding complication was observed, treated conservatively. Overall success rate was 71% (mean follow-up 44.1 months). Conclusion: Study results with Acucise® showed a comparable or even higher success rate than with other forms of endoureterotomy. Acucise®is a safe, effective and fast method with low associated morbidity and short hospital stays. In selected patients this is a suitable treatment option, which should always be considered for treating relatively short ureteral strictures of benign origin.

Successful Endourologic Management of Lower Pole Moiety Ureteropelvic Junction Obstruction in a Partially Duplicated Collecting System

We present two cases of symptomatic lower pole moiety ureteropelvic junction obstruction (UPJO) in a partially duplicated collecting system that were successfully treated with minimally invasive endourologic procedures. In the first case, we performed retrograde endopyelotomy with the Acucise® ureteral cutting balloon device, and in the latter case, we performed percutaneous nephrolithotomy and antegrade endopyelotomy because of the presence of multiple renal stones. Subsequent intravenous pyelography confirmed marked resolution of the obstruction, and both patients remained asymptomatic during 1 year of follow-up.

Ureteroplasty with a cutting balloon: A novel approach to ureteric anastomotic strictures

The Peripheral Cutting Balloon device was originally described to treat in-stent coronary artery stenosis. We aim to evaluate the use of this device in the management of ureteric anastomotic strictures. Four patients with radiologically proven ureteric anastomotic strictures were treated with the Peripheral Cutting Balloon Device using an antegrade approach. Follow up ranged between 2 and 12 months. All patients' initial procedure was successful, and all patients had improvement of symptoms. No patient showed evidence of biochemical deterioration of renal function, and no periprocedural complications occurred. One patient had restenosis as a result of invasive bladder cancer and required subsequent cystectomy. The Peripheral Cutting Balloon device is a novel instrument for the treatment of ureteric anastomotic strictures. Our experience shows promising short-term results but more follow up is required.

The use of the acucise technique for ureteropelvic junction obstruction: A trade-off between efficacy and invasiveness?

Open pyeloplasty is traditionally the recommended treatment for ureteropelvic junction obstruction. In the past decades, several less invasive procedures emerged with the advantages of lower morbidity and better patient tolerance. In 1993, an electrosurgical cutting balloon device called the Acucise (Applied Medical Resources Corp., Laguna Hills, CA) was introduced. It was presented as a straightforward, safe procedure that can be performed in a complete retrograde fashion under fluoroscopic guidance. Despite these advantages; however, it is not yet a generally excepted procedure. This is mainly due to the fact that specific patient selection is needed, and success rates are comparable with other already established endoscopic procedures. Considering the large variety of minimally invasive procedures available, treatment of choice must be based on several factors such as success rate, morbidity, cost, and surgeon's experience. Acucise is considered a good alternative for the treatment of ureteropelvic junction obstruction in selected patients. However, the efficacy is significantly lower than the reference standard.

Sterility Concern Prompts Recall of Cutting Balloon Device

Sterility Concern Prompts Recall of Cutting Balloon Device

Cutting Balloon angioplasty for the treatment of haemodyalisis vascular accesses: midterm results

The purpose of this study was to assess the effectiveness of Cutting Balloon angioplasty in the treatment of stenoses in haemodialysis arteriovenous accesses. Over the past 2 years, we have observed 80 patients with stenotic haemodialysis accesses; 24 of these (mean age 66.4 years, range 50-81) with 26 stenoses of 24 accesses (21 Cimino-Brescia fistulas and 3 dialysis loops) were selected for Cutting Balloon angioplasty. In 11 cases, the Cutting Balloon device was used after failure to dilate the access with a high-pressure balloon whereas in 15 cases (10 focal stenoses and 5 restenoses), it was used as a first choice. Two Cutting Balloon devices had a diameter of 8 mm, two of 7 mm, 11 of 6 mm, eight of 5 mm and one of 4 mm. The follow-up was performed by colour Doppler ultrasound (CDUS) and clinical assessment at 1, 3, 6, 12, 18 and 24 months. In all patients, postprocedure angiography demonstrated immediate technical success. No periprocedural complications occurred. Follow-up examinations (range 3-24 months, mean 18.2 months) demonstrated patency of the vascular access and its good functioning during dialysis in 23/24 cases (95%). Only in one case did we observe a haemodynamically significant restenosis, which was treated again with Cutting Balloon angioplasty. Cutting Balloon angioplasty is safe and effective in the treatment of haemodialysis access stenosis, especially in cases of severe stenosis, with low restenosis rate both in the short and medium term.

Endopyelotomy and Endoureterotomy with the Ureteral Cutting Balloon Device (Acucise®)

Purpose: Endourological management of ureteropelvic junction obstruction (UPJO) has gained increased acceptance with high procedural success rates and low morbidity being reported. It has been suggested that Acucise endopyelotomy should be the procedure of choice for patients with UPJO. The purpose of this study is to determine the efficacy of the Acucise balloon for the treatment of ureteral strictures and UPJO. Materials and Methods: Between March 2004 and June 2005, 13 consecutive patients (8 primary and 5 secondary cases of UPJO) underwent Acucise endopyelotomy at our institution. The preoperative evaluation included ultrasound and/or intravenous urogram with diuretic renography. The success of the procedure was based on objective radiologic improvement and the subjective resolution of symptoms. Results: The mean follow-up was 6.77±3.83 months (range: 3-14). The mean operating time was 64.23±34.87 min and the mean hospital stay was 4.15±2.44 days. The objective success rate was 61.5% and the subjective success rate was 69.2%. There were no major complications such as vascular injury requiring transfusion. Yet a small urinoma developed in one patient. Of the 5 objective failures, 3 patients have since successfully undergone open pyeloplasty. Conclusions: In this small series, Acucise endopyelotomy is a safe and minimally invasive procedure that offered effective first-line treatment for UPJO, although multicenter randomized trials are needed to make a better comparison with the other techniques. (Korean J Urol 2006;47:818-823) ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ

Noninvasive Evaluation of a Cutting Balloon Entrapped in a Left Main Coronary Artery Using Transesophageal Echocardiography

There are reports in the literature describing the utility of transesophageal echocardiography (TEE) in the evaluation of the coronary arteries. Studies have also shown the value of TEE in patients undergoing coronary intervention such as assessing coronary anatomy and flow following angioplasty. We report an interesting case where TEE helped to establish the location of a fractured cutting balloon device lodged in the left main coronary artery and obviated the need for cardiac surgery to remove the fractured balloon catheter. To our knowledge, this is the first case report of this type of complication utilizing a cutting balloon device.

Impact of hydronephrosis and renal function on treatment outcome: antegrade versus retrograde endopyelotomy

ObjectivesTo compare, in a single-surgeon, single-institution study, the efficacy of antegrade and retrograde endopyelotomy in terms of success rate and morbidity and to identify which risk factors affect treatment outcomes. MethodsThe results were retrospectively reviewed for 88 patients with ureteropelvic junction obstruction treated with endopyelotomy. Antegrade endopyelotomy was performed with a hook knife, scissors, or cutting balloon device. Retrograde endopyelotomy was performed with a cutting balloon device. Objective results were based on intravenous urogram and/or diuretic nuclear renal scan findings, and subjective results were based on direct patient query and questionnaire. ResultsNinety-three endopyelotomy procedures, 64 antegrade and 29 retrograde, were performed. The mean follow-up was 37.0 months (range 5 to 76). The overall success rates between antegrade and retrograde endopyelotomy (81.3% versus 75.9%) were not statistically different (P = 0.553). Patients with massive hydronephrosis and poor initial renal function were less likely to have successful endopyelotomy. Antegrade endopyelotomy, however, was more successful than retrograde endopyelotomy in patients with massive hydronephrosis (66.7% versus 20.0%; P = 0.046). The average operative time for antegrade and retrograde endopyelotomy was 93.9 and 32.7 minutes (P <0.001), respectively. The average length of hospital stay after antegrade and retrograde endopyelotomy was 3.20 and 0.14 nights (P <0.001), respectively. ConclusionsBoth antegrade and retrograde endopyelotomy are effective treatments for ureteropelvic junction obstruction associated with minimal morbidity. Antegrade endopyelotomy appears to be more successful in patients with high-grade hydronephrosis. Retrograde endopyelotomy results in a shorter hospital stay, a shorter operative time, and less postoperative pain.

Using 6-mm Cutting Balloon Angioplasty in Patients with Resistant Peripheral Artery Stenosis: Preliminary Results

The objective of this study was to assess the efficacy of 6-mm Cutting Balloon angioplasty in patients with resistant peripheral stenoses caused by neointimal hyperplasia or irradiation-induced arteriopathy in vascular territories that are not amenable for use of the smaller Cutting Balloons that are used in cardiology. Peripheral Cutting Balloon angioplasty with the new 6-mm Cutting Balloon device proved useful in the short term for treatment of peripheral arterial stenoses resistant to conventional angioplasty.

Endopyelotomy with ureteral cutting balloon device: long-term follow up of 13 patients

This study investigated the feasibility and long term results of retrograde endopyelotomy with the Acucise ureteral cutting balloon device in the management of ureteropelvic junction (UPJ) obstruction. Thirteen patients (primary: 12, secondary: 1, male: 7, female: 6, mean age: 36) with UPJ obstruction were treated by the Acucise under fluoroscopic guidance. After cutting the stenotic area electrically using cutting wire and dilatation by the balloon, ureteral catheter (7-14 Fr) was inserted for 6-8 weeks. The mean operative time was 43 minutes, the median postoperative hospital stay was 4 days. The subjective success rate (disappearance of the abdominal pain) was 92% (11/12) and the objective success rate evaluated by radiographic studies was 62% (8/13). One patient needed a transfusion but no other major complication occurred in the treatment. The failure 5 patients were now under conservative follow up. Our limited data suggest that endopyelotomy with the Acucise device offer lower morbidity with slightly lower success rate compared other endopyelotomies. We believe that Acucise endopyelotomy can be an appropriate one of the first-line therapy for UPJO.

ADULT ENDOPYELOTOMY: IMPACT OF ETIOLOGY AND ANTEGRADE VERSUS RETROGRADE APPROACH ON OUTCOME

Purpose We evaluate our experience with endopyelotomy for ureteropelvic junction obstruction by stratifying the results of an antegrade versus a retrograde approach for primary, secondary, calculi related, high insertion and impaired renal function related obstruction, individually. Materials and Methods We retrospectively reviewed results of 149 nonradomized patients treated for ureteropelvic junction obstruction, of whom 83 underwent antegrade percutaneous endopyelotomy using a right angle Greenwald electrode and 66 underwent retrograde endopyelotomy using a cutting balloon device. Subjective results were based on an analog pain scale, objective results on renal scan, excretory urography or Whitaker test and cost-effectiveness analysis on total treatment cost. Results In both primary and secondary ureteropelvic junction obstruction, retrograde endopyelotomy was related to a significantly shorter operating room time and hospital stay (p < 0.05). When treating noncalculous primary ureteropelvic junction obstruction (92 patients) there was a better objective, albeit not statistically significant, success rate with antegrade endopyelotomy (89 versus 71%) but retrograde endopyelotomy was 20% more cost-effective. When treating secondary ureteropelvic junction obstruction (37 patients) there was a better objective, albeit not statistically significant, success rate (83 versus 77%) with retrograde endopyelotomy, which was 37% more cost-effective. Complication rates were higher with antegrade compared to retrograde endopyelotomy for primary and secondary ureteropelvic junction obstruction (25 versus 14% and 26 versus 0%). In 20 patients with concomitant stones endopyelotomy results were better (93 to 100% success) than for any other categories of ureteropelvic junction obstruction. Of note, endopyelotomy also provided a reasonable outcome among patients with a high insertion primary ureteropelvic junction obstruction (70% success). Conclusions Antegrade endopyelotomy is the preferred approach in patients with primary ureteropelvic junction obstruction and concomitant renal calculi (13.4% of cases), and may also be preferable in patients with high insertion obstruction (6.7%). For all other primary and all secondary ureteropelvic junction obstruction, antegrade and retrograde endopyelotomy is effective therapy yet retrograde endopyelotomy results in less operating room time, shorter hospital stay, fewer complications and significantly less expense to achieve the desired outcome.

Endopyelotomy with the ureteral cutting balloon device for ureteropelvic junction obstruction

This study investigated the feasibility of retrograde endopyelotomy with the Acucise ureteral cutting balloon device in the management of ureteropelvic junction (UPJ) obstruction. Six patients (male: 3, female: 3, age: 6-18) with UPJ obstruction and abdominal pain as the chief complaint, were treated by the Acucise ureteral cutting balloon device (flexible ureteral catheter, 7 Fr) under epidural or general anesthesia (for the 6-year-old girl only). After cutting the stenotic area electrically and posteriolaterally using a 3 cm cutting wire and dilation by the balloon to a maximum of 24 Fr for 10 seconds, a 6/10 Fr (for children) or 7/14 Fr (for adults) endopyelotomy ureteral catheter was left in situ for 8 weeks after the operation. After removing the ureteral catheter transurethrally, the results, including the patency of the UPJ, of this procedure were evaluated by intravenous pyelography and the disappearance of the chief complaint, abdominal pain, 12 weeks after removing the ureteral catheter. Mean operative time was 47 (25-90) minutes and the hospital stay after the operation was 5.3 (3-14, median: 4) days. There was no transfusion or emergent open operation for uncontrolled bleeding in this series. The results 20 months after the operation: improvement of hydronephrosis was shown in 4 patients (66.7%) on intravenous pyelography and abdominal pain disappeared in all patients. UPJ obstruction may be easily and safely treated by retrograde endopyelotomy with the Acucise ureteral cutting balloon device. The principal potential advantage of this procedure is reduced morbidity compared to that with antegrade or retrograde endopyelotomy by endoscopy.

Acucise Endopyelotomy: Evolution of a Less-Invasive Technology

Since its introduction in 1993, the electrosurgical cutting balloon device (Acucise) has been utilized for endopyelotomies by a number of investigators. The fact that the procedure can be performed in a completely retrograde fashion under fluoroscopic guidance without percutaneous access has made Acucise endopyelotomy appealing to many urologists. To date, overall Acucise endopyelotomy success rates ranging from 66% to 84% have been reported. The average hospital stay has ranged from 1.7 to 3.7 days, and serious complications have been rare (transfusion 0-2%, bleeding necessitating embolization 0-3%). On the basis of its track record and its minimally invasive nature, a compelling argument can be made for use of the Acucise device whenever an endopyelotomy is indicated.

Evaluation of optimal stent size after endourologic incision of ureteral strictures.

The stent size necessary to promote optimal ureteral healing after an endoureterotomy is not known. We compared healing of an endoureterotomy over a 7F indwelling ureteral stent with healing over a 14F endopyelotomy stent. A midureteral stricture was created in each of 25 anesthetized female minipigs using an electrified stone basket passed retrograde. Six weeks later, the stricture was incised with a 24F cutting balloon device. Twenty pigs were randomized to receive a 7F or a 14F stent; four control pigs received neither incisions nor stents. At 1 week, a radiograph was performed to confirm proper stent position, and the stents were removed. At 3 months, a retrograde ureterogram was performed, and the ureters were examined grossly and harvested for histologic studies. Two of the ten pigs in each study group developed a recurrent stricture. The use of a 14F stent provided no advantage over the use of a smaller, more easily positioned 7F stent.

Endopyelotomy and endoureterotomy with the acucise ureteral cutting balloon device: preliminary experience.

Endoureterotomy and endopyelotomy usually involve an endoscopic antegrade approach. In an effort to simplify this technique, we designed an 8-mm balloon catheter with a 100-microns electrocautery cutting wire (Acucise) for retrograde incision of the ureter under fluoroscopic control. Twenty-eight patients with ureteral or ureteropelvic junction obstruction of 3.5 cm or less underwent Acucise endoureterotomy or endopyelotomy. The average operating time was 100 minutes, and the average hospital stay was 2.6 days. Follow-up was obtained with a subjective symptom score, intravenous urography, diuretic renal scan, a Whitaker test, or various combinations thereof. All patients had a minimum of 3 months of follow-up (mean 3.8 months; range 3-9 months). Overall, of the 21 patients who had symptoms of upper tract urinary obstruction, 14 (67%) had complete resolution, and another 4 (19%) had partial resolution, of their symptoms. Postoperative studies demonstrated normal upper tracts in 71% and improvement in another 14% of the patients. In our experience, the Acucise ureteral cutting balloon device provides an effective and efficient means for performing a retrograde endoureterotomy or endopyelotomy.