Modes of failure with fractional flow reserve guidewires:Insights from the manufacturer and user facility device experience database

BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Removal of a guide-wire sliding into abdominal cavity via transgastric natural orifice transluminal endoscopic surgery: A case report

BACKGROUND Guidewire slippage into the peritoneal cavity during clinical operations is extremely rare.Therefore,this paper aims to report a successful case of guidewire removal using transgastric natural orifice transluminal endoscopic surgery(NOTES).The goal is to enhance physicians'understanding of the management plan for this unique scenario and provide a valuable reference for clinical practice.CASE SUMMARY A 64-year-old man presented with abdominal distension and was diagnosed with cirrhosis combined with massive ascites.To proceed with treatment,the patient underwent ultrasound-guided peritoneal puncture and underwent catheterization and drainage.Unfortunately,a 0.035-inch guidewire slipped into the abdominal cavity during the procedure.Following a comprehensive evaluation and consultation by a multidisciplinary team,the guidewire was successfully removed using NOTES.CONCLUSION This case highlights the potential consideration of transgastric NOTES removal when encountering a foreign body,such as a guidewire,within the abdominal cavity.

ERCP wire systems: The long and the short of it

Guidewires are routinely used at the time of endoscopic retrograde cholangiopancreatography (ERCP) to gain and maintain access to the desired duct and aid in the advancement of various devices. Limitations of the traditional long-wire systems have led to the introduction of three proprietary short-wire systems. These systems differ in many respects but share two main principles: They lock a shorter wire in position to allow advancement or removal of various devices without displacement of the wire and they all allow for physician control of the wire. In this comprehensive review, we describe the key features of the three currently available short-wire systems: RX, Fusion and V systems. We also focus on the potential benef its and drawbacks that accompany the short-wire concept as a whole and each specif ic system in particular. Although the available data are limited, it appears that the use of the short-wire systems lead to reduced procedure, fluoroscopy and device exchange times, decreased sedation requirements, improved wire stability and increased endoscopist control of the wire. Furthermore, the physician-controlled wire-guided cannulation has the potential to decrease ampullary trauma and the rate of post-ERCP pancreatitis. The short guidewire systems appear to be an improvement over the traditional long-wire systems but further studies directly comparing the two approaches are needed.

Chronic total occlusions for intermediate volume operators: An antegrade step-up algorithm allows high success in easy and intermediate difficult CTO lesions

To improve the success rates of chronic total occlusion (CTO) intervention, a large range of CTO-dedicated guidewires (GWs), devices and techniques have been developed. However, such an abundant choice of materials confuses inexperienced operators. Therefore, the usefulness of a simple antegrade treatment algorithm with a limited set of GWs, for easy to intermediate lesions, was investigated. Between November 2011 and March 2013, 105 patients were included, who underwent CTO PCI following the algorithm. Lesions were classified according to the Multicenter CTO Registry of Japan score. Overall technical success was achieved in 77%. Study endpoint was successful GW crossing within 30 min and was reached in 57%. High success rates were achieved in easy (81%) and intermediate (64%) lesion types. In both types, a soft wire could successfully cross in 57% and 51% respectively, with the Fielder XT®?(Asahi Intecc Co.) capable of crossing most commonly (90%). The proposed treatment algorithm simplifies the percutaneous treatment of easy to intermediate CTO lesions. However, it merits further evaluation, especially for operators/centers who perform a low to intermediate amount of CTO PCI.

Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation

AIM:To compare the outcomes between doubleguidewire technique(DGT) and transpancreatic precut sphincterotomy(TPS) in patients with difficult biliary cannulation.METHODS:This was a prospective,randomized study conducted in single tertiary referral hospital in Korea.Between January 2005 and September 2010.A total of 71 patients,who bile duct cannulation was not possible and selective pancreatic duct cannulation was achieved,were randomized into DGT(n = 34) and TPS(n = 37) groups.DGT or TPS was done for selective biliary cannulation.We measured the technical success rates of biliary cannulation,median cannulation time,and procedure related complications.RESULTS:The distribution of patients after randomization was balanced,and both groups were comparable in baseline characteristics,except the higher percentage of endoscopic nasobiliary drainage in the DGT group(55.9% vs 13.5%,P < 0.001).Successful cannulation rate and mean cannulation times in DGT and TPS groups were 91.2% vs 91.9% and 14.1 ± 13.2 min vs 15.4 ± 17.9 min,P = 0.732,respectively.There was no significant difference between the two groups.The overall incidence of post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis was 38.2% vs 10.8%,P < 0.011 in the DGT group and the TPS group;post-procedure pancreatitis was significantly higher in the DGT group.But the overall incidence of post-ERCP hyperamylasemia was no significant difference between the two groups;DGT group vs TPS group:14.7% vs 16.2%,P < 1.0.CONCLUSION:When free bile duct cannulation was difficult and selective pancreatic duct cannulation was achieved,DGT and TPS facilitated biliary cannulation and showed similar success rates.However,post-procedure pancreatitis was significantly higher in the DGT group.

Impact of changing our cannulation method on the incidenceof post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement

AIM： To clarify whether the incidence of post-endoscopic retrograde cholangiopancreatography （ERCP） pancreatitis （PEP） after pancreatic guidewire placement （PGW） can be reduced by using a different cannulation method. METHODS： BebNeen April 2001 and October 2009, PGW was performed in 142 patients with native papilla to overcome difficult biliary cannulation. Our cannulation method for ERCP was changed from contrast injection （CI） using a single-lumen catheter （April 2001-May 2008） to wire-guided cannulation （WGC） using a double-lumen catheter （June 2008-October 2009）. The CI protocol was also changed during the study period： in the first period it was used for routine pancreatography for detecting small pancreatic cancer （April 2001-November 2002）, whereas in the second period it was not （December 2002-May 2008）. In PGW with CI using a single- lumen catheter, the contrast medium in the catheter lumen was injected into the pancreatic duct. The success rate of biliary cannulation, the incidence of PEP according to the cannulation method, and the impact of CI using a single-lumen catheter on PEP in comparison with WGC using a double-lumen catheter were investigated.RESULTS： CI with routine pancreatography, CI without routine pancreatography, and WGC were performed in 27 patients, 77 patients and 38 patients, respectively. Routine pancreatography did not contribute to the early diagnosis of pancreatic cancer in our study period. In CI without routine pancreatography and WGC, diagnostic pancreatography was performed in 17 patients and no patients, respectively. The success rate of biliary cannulation by PGW alone was 69%, and the final success rate was increased to 80.3% by the addition of consecutive maneuvers or a second ERCP. PEP occurred in 22 patients （15.5%）, and the severity was mild in all cases. When analyzed according to cannulation method, the incidence of PEP was 37.0% （10/27） in the patients who underwent CI with routine pancreatography, 14.3% （11/77） in those who underwent CI without routine pancreatography, and 2.6% （1/38） in those who underwent WGC. In all patients who underwent CI using a singlelumen catheter, the incidence of PEP was 20% （21/104）, which was significantly higher than that in WGC using a double-lumen catheter. In univariate and multivariate analysis, CI using a single-lumen catheter showed a high, statistically significant, odds ratio for PEP after PGW. CONCLUSION： The practice of a cannulation method involving the use of a double-lumen catheter minimizes the CI dose administered to the pancreatic duct and reduces the incidence of PEP after PGW.

Subcapsular hepatic haematoma of the right lobe following endoscopic retrograde cholangiopancreatography: Case report and literature review

Sub capsular hepatic haematoma is a rare complication after endoscopic retrograde cholangiopancreatography (ERCP). Exact pathological mechanism is still unclear and few reports are nowadays available in literature. We report the case of a 58-year-old woman with recurrent episodes of upper abdominal pain, nausea and vomiting. On the basis of laboratory exams, abdomen ultrasound and magnetic resonance imaging she was diagnosed with a common bile duct stone. Endoscopic biliary sphincterotomy was performed. On the following day the patient complaint severe abdominal pain with rebound and hemodynamic instability. A computed tomography scan reveal a 14 cm &#x000d7; 6 cm &#x000d7; 19 cm sub-capsular hepatic haematoma on the right lobe that was successfully managed via percutaneous embolization. Sub capsular liver haematoma is a rare life threatening complication after ERCP that should be managed according to patients&#x02019; haemodynamic and clinic.

Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by pancreatic duct stenting using a loop-tipped guidewire

AIM: To examine whether it is possible to prevent the occurrence of post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis in patients experiencing difficulties with selective biliary duct cannulation by pancreatic duct stenting using a looptipped guidewire.METHODS: Procedure success rate, frequency of unintended insertion of the guidewire into side branches of the pancreatic duct, and incidence of procedural accidents were examined using a loop-tipped guidewire(Group A, 20 patients), and a conventional straighttype guidewire(Group B, 20 patients).RESULTS: The success rate of the procedure was 100% in both groups. Unintended insertion of the guidewire into a side branch of the pancreatic duct occurred 0.056 ± 0.23(0-1) times in Group A and 2.3 ±1.84(0-5) times in Group B; thus, unintended insertion of the guidewire into a side branch of the pancreatic duct was seen significantly less frequently in Group A. There were no procedural accidents in Group A, whereas pancreatitis occurred in one Group B patient; however, the difference between the two groups was not statistically significant. The serum amylase level after ERCP was 257.15 ± 136.4(88-628) IU/L in Group A, and 552.05 ± 534.57(101-2389) IU/L in Group B, showing a significantly lower value in Group A. Hyperamylasemia was found in two patients(10%) in Group A, and nine(45%) in Group B, showing a significantly lower value in Group A.CONCLUSION: The results suggest that in patients who experience difficulties with biliary cannulation, the use of a loop-tipped guidewire for pancreatic duct stenting may assist with the prevention of post-ERCP pancreatitis, and thereby to a reduction of the risk of post-ERCP pancreatitis or hyperamylasemia.

Needle-knife fistulotomy vs double-guidewire technique in patients with repetitive unintentional pancreatic cannulations

AIM: To compare the success rates and adverse events of early needle-knife fistulotomy(NKF) and double-guidewire technique(DGT) in patients with repetitive unintentional pancreatic cannulations.METHODS: From a total of 1650 patients admitted for diagnostic or therapeutic endoscopic retrograde cholangiopancreatography(ERCP) at a single tertiary care hospital(Pusan National University Yangsan Hospital, Yangsan, South Korea) between January2009 and December 2012, 134(8.1%) patients with unsuccessful biliary cannulation after 5 min trial of conventional methods, together with 5 or more repetitive unintentional pancreatic cannulations, were enrolled in the study. Early NKF and DGT groups were assigned 67 patients each. In the DGT group, NKF was performed for an additional 7 min if successful cannulation was not achieved.RESULTS: The success rates with early NKF andthe DGT were 79.1%(53/67) and 44.8%(30/67)(P< 0.001), respectively. The incidence of post-ERCP pancreatitis(PEP) was lower in the early NKF group than in the DGT group [4.5%(3/67) vs 14.9%(10/67),P = 0.041]. The mean cannulation times in the early NKF and DGT groups after assignment were 257 s and312 s(P = 0.013), respectively.CONCLUSION: Our data suggest that early NKF should be considered as the first approach to selective biliary cannulation in patients with repetitive unintentional pancreatic cannulations.

Need for pancreatic stenting after sphincterotomy in patients with difficult cannulation

AIM: To investigate the need for pancreatic stenting after endoscopic sphincterotomy (EST) in patients with difficult biliary cannulation.

A prospective cross-over study using a sphincterotome and a guidewire to increase the success rate of common bile duct cannulation

AIM: During endoscopic retrograde cholangiopancreatography (ERCP), selective cannulation of the common bile duct (CBD) is required in most of the cases.METHODS: From June 2001 till December 2002, all patients referred to our unit for ERCP were considered for entry into the study. Selective CBD cannulation was first attempted with a standard catheter with or without the use of a guidewire. In cases, where CBD cannulation was considered unsuccessful, patients were crossed over to a double-lumen sphincterotome and a guidewire. All patients were hospitalized for 24 h after the procedure in order to assess the incidence of post-ERCP complications.RESULTS: The study sample consisted of 158 patients.Selective CBD cannulation using a standard ERCP catheter with or without the assistance of a guidewire, was accomplished in 129 patients (success rate: 81.65%).From the 29 patients who were crossed over to a sphincterotome and a guidewire, selective CBD cannulation was achieved in 24; the overall success rate rising to 96.8%. Meanwhile, the use of this technique did not increase the incidence of post-ERCP complications.CONCLUSION: The use of a sphincterotome and a guidewire increases the success rate of selective bile duct cannulation in cases that this has not been accomplished with a standard catheter.

Peroral cholangioscopy-assisted guidewire placement for removal of impacted stones in the cystic duct remnant

It is well known that impacted biliary stones are difficult to remove endoscopically.Among the many factors associated with failure of endoscopic therapy for removal of bile duct stones,impaction ranks high.One of the reasons behind failure of endoscopic therapy in such cases is that the impacted stone often does not allow passage of a guidewire.Recent introduction of a novel single-operator cholangioscopy system has made it possible for a single endoscopist to use cholangioscopy for evaluation and treatment of a wide variety of biliary disorders.This cholangioscopy system was used for placement of a guidewire in the cystic duct remnant with subsequent removal of an impacted stone which had prevented passage of a guidewire by conventional means.

Newly designed J-shaped tip guidewire: A preliminary feasibility study in wire-guided cannulation

AIM: To perform wire-guided cannulation using a newly designed J-shaped tip guidewire, and to verify feasibility and safety for use. METHODS: The study was conducted on endoscopic retrograde cholangiopancreatography (ERCP) patients with na ve papilla undergoing diagnosis and treatment of biliary diseases between September 2011 and July 2012. We performed ERCP in a succession of 50 cases with a J-shaped tip guidewire. The first insertion attempt began with a trainee who had 5 min to complete cannulation, followed if necessary by the trainer for another 5 min. We assessed the primary success rate of selective biliary cannulation within 10 min and adverse events such as post-ERCP pancreatitis (PEP), bleeding or perforation.RESULTS: The primary success rate was 90% (45/50) within 10 min, the initial success rate within 5 min by trainee staff was 76% (38/50). The rate of PEP was 6% (3/50), but all 3 cases were mild pancreatitis. All patients were managed successfully with conservative treatment. There was no bleeding or perforation. CONCLUSION: A newly designed J-shaped tip guidewire has the possibility to facilitate selective biliary cannulation for ERCP and appears to be safe.

Conventional endoscopic retrograde cholangiopancreaticography vs the Olympus V-scope system

AIM: To compare the new Olympus V-scope (VS) to conventional endoscopic retrograde cholangiopancreati-cography (ERCP). METHODS: Forty-nine patients with previous endoscopic papillotomy who were admitted for interventional ERCP for one of several reasons were included in this single-centre, prospective randomized study. Consecutive patients were randomized to either the VS group or to the conventional ERCP group. ERCP-nave patients who had not undergone papillotomy were excluded. The main study parameters were interventional examination time, X-ray time and dose, and premedication dose (all given below as the median, range) and were investigated in addition to each patient's clinical outcome and complications. Subjective scores to assess each procedure were also provided by the physicians and endoscopy assistants who carried out the procedures. A statistical analysis was carried out using the Wilcoxon rank-sum test.RESULTS: Twenty-five patients with 50 interventions were examined with the VS ERCP technique, and 24 patients with 47 interventions were examined using the conventional ERCP technique. There were no significant differences between the two groups regarding the age, sex, indications, degree of ERCP difficulty, or interventions performed. The main study parameters in the VS group showed a nonsignificant trend towards a shorter interventional examination time (29 min, 5-50 min vs 31 min, 7-90 min, P = 0.28), shorter X-ray time (5.8 min, 0.6-14.1 min vs 6.1 min, 1.6-18.8 min, P = 0.48), and lower X-ray dose (1351 cGy/m2 , 159-5039 cGy/m2 vs 1296 cGy/m2 , 202.2-6421 cGy/m 2 , P = 0.34). A nonsignificant trend towards fewer adverse events occurred in the VS group as compared with the conventional ERCP group (cholangitis: 12% vs 16%, P = 0.12; pain: 4% vs 12.5%, P = 0.33; post-ERCP pancreatitis: 4% vs 12.5%, P = 0.14). In addition, there were no statistically significant differences in assessment by the physicians and endoscopy assistants using subjective questionnaires.CONCLUSION: ERCP using the short-guidewire V-system did not significantly improve ERCP performance or patient outcomes, but it may reduce and simplify the ERCP procedure in difficult settings.

Endoscopic occlusion with silicone spigots for the closure of refractory esophago-bronchiole fistula after esophagectomy

A 65-year-old man with cT1bN0M0 stage I middle thoracic esophageal cancer underwent subtotal esophagectomy and gastric tube reconstruction through the posterior mediastinal route after preoperative carbon-ion radiotherapy and chemotherapy in a clinical trial. Anastomotic leakage occurred, but it spontaneously improved. At six months after the operation, he was rehospitalized with a cough and dysphagia. An esophago-bronchiole fistula and stenosis of the gastric tube were observed. He first underwent stent placement in the gastric tube. Two weeks later, the syringeal epithelium was burned by argon plasma coagulation after stent removal. Endoscopic occlusion was then performed for the fistula with two guidewire-assisted silicone spigots. Two weeks later, he was discharged on an oral diet, and he has not developed recurrence of the fistula or cancer for three years. This is the first report of endoscopic occlusion with a guidewire-assisted silicone spigot through the esophagus.

Fluoroscopic removal of fractured,retained,embedded Z self-expanding metal stent using a guidewire lasso technique:A case report

BACKGROUND There are few reports of a fractured esophageal self-expanding metallic stent(SEMS)and the lasso retrieval technique,forming a guidewire loop by directing the guidewire back up the external stent for retrieval.CASE SUMMARY A 74-year-old man complained of dysphagia approximately 6 mo after radical resection of esophageal cancer.Benign anastomotic stenosis was diagnosed,and a 20 mm in diameter and 60 mm in length esophageal covered SEMS was inserted after repeated balloon dilatation.About 13.5 mo after stenting,dysphagia recurred and esophagography showed severe stenosis above the proximal stent and stent removal was performed.One-third of the stent was removed and the fractured stent remained in the proximal esophagus.A suction tube was introduced through the guidewire and then the guidewire was grabbed,acting like a“lasso”on tightening.The remaining fractured stent was successfully removed by slowly pulling back the guidewire,with no fragments of stent wires retained.CONCLUSION The guidewire lasso technique is a simple,effective method of removing esophageal SEMS in rare cases of stent fracture.

Clinical utility of 0.025-inch guidewire VisiGlide2TM in the endoscopic retrograde cholangiopancreatography-related procedures

AIM To examine the result of the use of 0.025-inch guidewire(GW) Visi Glide2 TM as the first choice in the endoscopic retrograde cholangiopancreatography(ERCP)-related procedures without selecting the patient in a multicenter prospective study. METHODS ERCP using 0.025-inch GW VisiGlide2^(TM) as the first choice was conducted in patients who have needed ERCP, and its accomplishment rate of procedure, procedural time, incidence of accidental symptoms were compared with those of ERCP using 0.025-inch GW VisiG lideTM.RESULTS The accomplishment rate of procedure was 97.5%(197/202), and procedural time was 23.930 ± 16.207 min. The accomplishment rate of procedure using 0.025-inch GW Visi GlideTM was 92.3%(183/195), and procedural time was 31.285 ± 19.122 min, thus the accomplishment rate of procedure was significantly improved and procedural time was significantly shortened(P < 0.05). Accidental symptoms by ERCPrelated procedures were observed in 3.0%(6/202), and all were conservatively alleviated. CONCLUSION When 0.025-inch GW VisiG lide2 TM was used for ERCPrelated procedure as the first choice, it showed high accomplishment rate of procedure and low incidence of accidental symptoms, suggesting it can be used as the universal GW. Clinical Trial Registry(UMIN0000016042).

Resection of recurrent third branchial cleft fistulas assisted by flexible pharyngotomy

BACKGROUND Treatment of fistulas arising from the third branchial cleft includes endoscopic cauterization or open cervical fistulectomy.Both approaches are associated with recurrence rates of 14%-18%,and possibly greater rates when the fistula has been treated operatively beforehand.Treatment of fistulas arising from the third branchial cleft is associated with an inordinate recurrence rate.Recurrence may be multifactorial and related to incomplete resection of all of the anatomical elements of the fistula.AIM To present a new approach that involves complete resection of the recurrent fistula by a combined therapeutic approach.METHODS Here,12 adult patients diagnosed with recurrent third branchial cleft fistulas underwent a combined therapy assisted by flexible fiber-optic pharyngoscopy to identify and resect the entry site of the fistula into the pyriform sinus.The fistulous opening into the pyriform sinus was identified by flexible fiber-optic pharyngoscopy.The application of intubation with a guidewire by pharyngoscopy,in addition to the removal of the partial excision of the thyroid cartilage,allowed complete resection of the opening and all parts of the fistula tract.RESULTS All of the internal openings of the fistulas in the pharynx were found and easily identified by flexible fiber-optic pharyngoscopy.All of the 12 patients underwent complete resection of the recurrent fistula by the combined therapeutic approach.There were no postoperative complications such as parapharyngeal abscess or wound infection,injury or dysfunction of the recurrent laryngeal or superior laryngeal nerves.The pharyngeal edema had degraded,and the pharyngeal wound healed postoperatively within 1 wk.Laryngeal endoscopy and voice analysis were performed on the 14th d post-operatively.Vocal cord movements did not change.The characters of voice for jitter,shimmer,and normalized noise energy were all within normal limits.In addition,no recurrences were observed during the 13-60 mo follow-up period.CONCLUSION It can be concluded that the proposed combined therapy is associated with excellent results,minimal morbidity,and no recurrence.

Optimal use of fielder XT guidewire enhances the success rate of chronic total occlusion percutaneous coronary intervention

BACKGROUND Chronic total occlusion(CTO) is found in 18-31% of patients who undergo coronary angiography. Successful recanalization of CTOs is associated with reduced recurrent angina pectoris rates and increased long-term survival.Although the success rate of CTO percutaneous coronary intervention(CTO-PCI)has improved, CTO-PCI remains technically challenging. The Fielder XT guidewire was designed for CTO lesions. To validate whether the use of the guidewire increases the success rate, we compared the results of CTO-PCI with or without the guidewire. We hypothesized that the use of Fielder XT guidewire can increase the success rate of CTO-PCI.AIM To investigate whether the use of Fielder XT guidewire increases the final procedural success of CTO-PCI via the anterograde approach.METHODS Between January 2013 and December 2015, a retrospective study was conducted on 1230 consecutive patients with CTO who received PCI via the anterograde approach at the General Hospital of Northern Theater Command. The patients were divided into an XT Group(n = 686) and a no-XT Group(n = 544) depending on whether Fielder XT guidewire was used. Both groups were compared for clinical parameters, lesion-related characteristics, procedural outcomes and inhospital complications. The data were statistically analyzed using Pearson's χ~2 test for categorical variables, and Students' t test was used to compare the quantitative data. Significant independent factors and a risk ratio with 95%confidence interval(CI) were assessed by multivariate logistic regression analysis.RESULTS In total, 1230 patients were recruited; 75.4% of the patients were male, and 55.8%of the patients were in the XT group. The overall success rate was 83.9%, with87.8% in the XT group. Based on multivariate logistic regression analysis, factors positively associated with procedural success were the use of Fielder XT guidewire(P = 0.005, 95%CI: 1.172-2.380) and systolic blood pressure(P = 0.011,95%CI: 1.003-1.022), while factors negatively associated with procedural success were blunt stump(P = 0.013, 95%CI: 1.341-11.862), male sex(P = 0.016, 95%CI:0.363-0.902), New York Heart Association(NYHA) class(P = 0.035, 95%CI: 0.553-0.979), contrast amount(P = 0.018, 95%CI: 0.983-0.998) and occlusion time(P =0.009, 95%CI: 0.994-0.999). No significant differences were found between the XT group and the no-XT group with respect to clinical parameters, lesion-related characteristics, coronary artery rupture [3(0.4%) vs 8(1.5%), P = 0.056], inhospital death [2(0.3%) vs 6(1.1%), P = 0.079] or in-hospital target lesion revascularization [3(0.4%) vs 7(1.3%), P < 0.099]. However, there were significant differences between the groups with respect to success rate [602(87.8%) vs 430(79.0%), P < 0.001], procedure time [(74 ± 23) vs(83 ± 21), P < 0.001], stent length[(32.0 ± 15.8) vs(37.3 ± 17.6), P < 0.001], contrast amount [(148 ± 46) vs(166 ± 43),P < 0.001], post-PCI myocardial infarction [43(6.3%) vs 59(10.8%), P = 0.004],major adverse cardiovascular event [44(6.4%) vs 57(10.7%), P = 0.007], side branch loss [31(4.5%) vs 44(8.1%), P = 0.009], contrast-induced nephropathy [29(4.2%) vs 40(7.4%), P = 0.018] and no reflow [8(1.2%) vs 14(2.9%), P = 0.034].CONCLUSION The use of Fielder XT guidewire shortens the Procedure and increases the success rate of CTO-PCI, and is also associated with reduced complication rates.

Jailing polymer jacketed guide-wires during bifurcation coronary interventions is associated with procedural myocardial infarction

AIM To study the relationship of jailed polymer jacketed guide wires(PGW) with procedural myocardial infarction(PMI) after bifurcation coronary interventions.METHODS Consecutive bifurcation interventions performed from January 2010 to October 2014 were included in the study. Chart review was performed to obtain demographic, clinical and procedural data. PMI was defined as Creatine Kinase MB > 3 × upper reference limit of normal. Multivariate logistic regression was used to ascertain relationship of PGW use with PMI.RESULTS Two hundred and ninety-three patients(age 63.5 ± 12.3 years; 33.8% diabetic) were included in the study. Eighty point two percent(n = 235) were true bifurcation lesions use of PGW was associated with PMI on univariate analysis(OR = 4.1; P = 0.002). This association remained significant after adjusting for other possible risk factors(OR = 3.5; P = 0.02).CONCLUSION Our results suggest that PGW use for side branch protection may be associated with PMI. Randomized studies are needed to validate these findings.