Mechanical Dilatation Research Articles

Endoscopic electroincision of challenging benign biliopancreatic strictures

Background and study aims Endoscopic drainage of benign biliary and pancreatic strictures can be challenging, especially when tightness of the stenosis does not allow passage of mechanical and pneumatic dilation catheters. Electroincision of benign biliopancreatic can be considered in selected cases. Patients and methods Three male patients (mean age 33 years, range 9–60) underwent endoscopic retrograde cholangiopancreatography to drain anastomotic biliary stricture (ABS) following orthotopic liver transplantation (n = 2) and pancreatic duct stenosis due to abdominal trauma (n = 1). The biliopancreatic strictures could be passed only with a thin 0.020-inch hydrophilic guidewire. Conventional mechanical and pneumatic dilators failed to pass the strictures due to weakness of the guidewire. Therefore, electrosurgical incision by over-the-wire 6Fr cystotome or needle-knife was attempted using pure cut current. Results The two cases of ABS were approached also by cholangioscopy and the 6Fr cystotome easily passed the strictures, allowing subsequent pneumatic dilatation and insertion of multiple plastic stents. The patient with a pancreatic duct stricture underwent electrosurgical incision using a thin needle knife over-the-wire, resulting in insertion of a 7Fr pancreatic stent. No adverse events occurred; all the patients were discharged within 24 to 48 hours. Conclusions Electrosurgical incision of benign biliopancreatic strictures could be considered in selected patients whom conventional dilation techniques fail.

COManeci MechANical Dilation for vasospasm (COMMAND): multicenter experience

BackgroundWe report the largest multicenter experience to date of utilizing the Comaneci device for endovascular treatment of refractory intracranial vasospasm.MethodsConsecutive patients undergoing Comaneci mechanical dilatation for vasospasm were extracted from...

Effect of primary balloon angioplasty on draining vein diameter and volume flow in patients with arteriovenous fistula: A cohort study

BackgroundChronic kidney disease (CKD) and end-stage kidney disease (ESKD) cause major morbidity and mortality in 10% of the global population with CKD. The most common renal replacement therapy is hemodialysis with arteriovenous fistula (AVF) access. AVF often undergoes maturation failure due to feeding artery and draining vein inadequacy. Mechanical dilatation, such as primary balloon angioplasty (PBA), can overcome AVF maturation failure. The volume flow (VF) and diameter of the draining veins in AVF patients must be known to evaluate the effect of PBA on AVF maturation. This study aims to analyze the impact of PBA on VF and draining vein diameter in ESKD patients undergoing AVF surgery. MethodsA retrospective cohort clinical trial was conducted at our institution. A total of 75 participants had AVF with an arterial diameter >1.5 mm or vein diameter at the AVF creation site of 2–4 mm. The subjects were divided into 2 groups: the intervention group undergoing PBA (n = 36) and the control group, without PBA (n = 39). PBA was performed using a Mustang ballon (3–6 mm, Medtronic). Follow-ups were conducted at 1 week, 2 weeks, and 6 weeks after AVF creation. ResultsBased on the data, the diameter and VF of the draining veins were significantly larger in the intervention group than in the control group (p < 0.001). Furthermore, we found significant differences in the mean diameter and VF of the draining veins between the control and intervention groups at all stages of examination, from preoperatively to 6 weeks postoperatively (p < 0.001). The strength of the analysis was more than 80%. ConclusionPBA can increase the diameter and VF of the draining veins in patients with AVF.

The effect of consuming evening primrose oil on cervical preparation before hysteroscopy: An RCT.

BackgroundHerbal medicine could be effective at treating various illnesses. Hysteroscopy can be an effective method for assessing the uterus in terms of anatomical, physiological and pathological anomalies.Objective This study aims to evaluate the effect of evening primrose oil (EPO) on cervical preparation in women candidates for hysteroscopy.Materials and MethodsThis study was a double-blind, randomized controlled clinical trial including 160 women candidates for diagnostic hysteroscopy who were referred to Alzahra hospital from August 2019-March 2020. They were divided into 2 groups. Group A received 100 mg EPO as a soft gel capsule 6 hr before the hysterectomy in the posterior vaginal fornix. Group B received a placebo. After receiving the treatment, primary and secondary outcomes were evaluated in the groups.ResultsThe average Hegar size in the EPO group was larger than in the control group (p 0.001 for both). Also, the need for mechanical dilation, the time taken until the first resistance and the time of dilatation completion in the EPO group were significantly less than in the placebo group (p 0.008 for all). There was also greater ease of dilatation in the EPO group. Side effects such as uterine rupture, false passage, cervical rupture, allergic reaction, abdominal pain, nausea, diarrhea, headache and increase of bowel movements were not reported in any cases.ConclusionBased on the findings of the present study, EPO is effective for cervical preparation in women undergoing hysteroscopy.

First use of a rotating mechanical dilator sheath to extract an epicardial defibrillator lead from the pericardial space.

First use of a rotating mechanical dilator sheath to extract an epicardial defibrillator lead from the pericardial space.

Simple modifications of conventional esophagogastrostomy after proximal gastrectomy adequately reduces the postoperative reflux esophagitis: a retrospective analysis of posterolateral fundoplication.

While proximal gastrectomy is being performed increasingly frequently for the treatment of gastric cancer, a standard reconstruction method to obtain optimal postoperative quality of life (QOL) still remains to be established. We modified the original esophagogastrostomy technique by introducing an additional posterolateral fundoplication (PLF) technique to minimize the risk of reflux esophagitis in patients undergoing proximal gastrectomy. The aim of this study was to clarify the clinical benefit of PLF. A retrospective analysis of the database was conducted to evaluate the effects of PLF. The data were compared between 44 patients in whom PLF was performed (PLF group) and 17 patients in whom conventional esophagogastrostomy without PLF was performed (C group). A number of incidence of postoperative reflux esophagitis and symptoms were assessed by findings of endoscopic examination and the PGSAS-45 questionnaire, respectively. The incidence of grade B or worse esophagitis after surgery was significantly lower in the PLF group than in the C group (0% vs. 58.8%, P < 0.01). The score for the esophageal reflux subscale, as the main outcome measure of PGSAS-45, was significantly better in the PLF group (PLF: 1.5 vs C: 2.4, P < 0.01). Cohen's d value was 1.75, which suggested a rather large effect size. Postoperative benign anastomotic stricture was encountered in 10 cases (22.7%) of the PLF group and 4 cases (23.5%) of the C group, all of whom were successfully treated by brief endoscopic mechanical dilatation. PLF is an expedient procedure for reconstruction after proximal gastrectomy.

The Surgical Management of Ileal Pouch Strictures.

Total proctocolectomy with IPAA reconstruction is the surgical approach of choice in ulcerative colitis, indeterminate colitis, familial adenomatous polyposis, and selected patients with Crohn's disease. Pouch stricture is a common complication after IPAA. This study aims to identify surgical management options for pouch stricture and offer a treatment algorithm. A computer-assisted search of the online bibliographic databases MEDLINE and Embase from 1990 to 2021 was performed. Randomized controlled trials, cohort studies, observational studies, and case reports were considered. Mechanical dilation, strictureplasty, stapler resection, pouch advancement, bypass, and repeat IPAA were included. Twenty-three articles were considered eligible. Overall incidence of strictures varied from 5% to 38%. Strictures were categorized into 3 areas: pouch inlet (with a reported incidence of 9% to 56%), mid-pouch (with a reported incidence of 2%), and pouch-anal anastomosis (with a reported incidence of 43% to 87%). Pouch-anal strictures were initially managed using bougie or Hegar dilation, with various surgical procedures advocated when initial dilation failed. Mid-pouch strictures are relatively unstudied with scant data. Pouch inlet strictures can be surgically managed by various transabdominal techniques' including resection and reconnection, strictureplasty, or bypass. Pouch-anal strictures should be managed in a step-up strategy as conservative procedures are associated with acceptable success rates. Initial mechanical dilation using bougie or Hegar dilation has a success rate of >80%, although it is likely to require repeat dilations. When these measures fail, transanal surgical approaches using strictureplasty, stapler resection' or pouch advancement should be offered. Transabdominal pouch revision should be offered to patients refractory to a transanal approach. In mid-pouch strictures, the treatment of choice is pouch revision and reanastomosis. Pouch inlet strictures can be managed by resection, strictureplasty, or bypass depending on the location and length of the stricture and surgeon experience. Studies were often small and retrospectively analyzed. There were no randomized controlled trials or comparison between different treatment options.

BOUGIE DILATATION IN BENIGN ESOPHAGEAL STRICTURES: EVALUATION OF ADJUVANT METHYLPREDNISOLONE INJECTION

Objective: Mechanical dilatation and adjuvant injection of triamcinolone acetate (TA) effectively preserve the opening provided and reduce the number of bougie dilation (BD) in benign esophageal strictures. In this study, we aimed to evaluate the role of Methylprednisolone (MP) injection after BD in providing permanent/long-term lumen opening. Materials and Methods: Among 22 patients diagnosed with benign esophageal strictures (BES) between January 2017 and October 2020, we evaluated the results of 8 patients who continued the endoscopic follow-up program and underwent BD and MP injection, then compared with the literature. Results: We treated 8 patients [6 (75%) women, mean age 61±16.9 years (range 22-77)] with strictures of different etiologies (3 anastomotic, 2 iatrogenic esophageal rupture repairs, 2 recurrent webs, and 1 scleroderma) with BD followed by intralesional MP injection. We performed median BD sessions 3.5 times (range 1-8). We gave a median 3 intralesional MP injection (range 1-7). The median time to resolve stricture was 2.5 months (range 1-4). The median endoscopic follow-up time was 4.5 months (range 1-17). Conclusions: Adjuvant MP injection is successful in preserving the lumen patency provided after mechanical dilatation. Randomized controlled studies are needed to determine the steroid type and dose to provide the most optimal permanent lumen opening with lesser dilatation sessions in BES.

ELECTRa Registry Outcome Score (EROS): validation in a single center population

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The ELECTRa Registry Outcome Score (EROS) was developed to identify patients at increased transvenous lead extraction (TLE) risk Purpose Aim of the study is to explore the efficiency of EROS for stratifying patients undergoing TLE. Methods We performed a retrospective analysis of 1293 patients who underwent to TLE in our center. We performed extraction procedures with manual traction or mechanical dilatation. We calculated EROS, and we divided patients into 3 groups depending on the EROS class. For this purpose, we made statistical analysis and comparison between EROS 1+2 vs. EROS 3 groups. We used an X2 for among-group comparisons or Fisher’s exact test if the expected cell count was less than five. Results Our analysis included 1293 patients. EROS-1 counted 726 patients (56,1%), EROS-2 367 (28,4%) patients and EROS-3 200 (15,5%) patients. There was no statistical difference in peri-procedural death between EROS-1+2 and EROS-3 (0.18% vs 1.50%, p=0.134). Major complications (0.82% vs. 3.00%, p=0.014), minor complications (3.11% vs. 6.50%, p=0.019) and use of internal jugular approach (6.13% vs. 14.50%, p&amp;lt;0.001) was significantly higher in EROS 3 patients. Conclusion EROS effectively separates patients at higher risk of complications. Use of internal jugular approach was significantly higher in EROS 3 patients.

Transvenous lead extraction: safety and efficacy of local anesthesia

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Patients undergoing transvenous lead extraction (TLE) usually receive general anesthesia, although in our experience local anesthesia is a frequent alternative. Purpose We sought to verify safety and effectiveness of local anesthesia in patients undergoing tranvenous lead extraction (TLE). Methods A retrospective analysis of patients who underwent to TLE in our center was performed. 1293 patients were divided in three groups depending on EROS class and comparisons were made in each group depending on type of anesthesia. Lead extraction was performed by manual traction or mechanical dilatation and use of transjugular approach was evaluated on case-by-case. Results In the EROS 1 group (726 pts.) 559 (77%) receive local anesthesia, in the EROS 2 (367 pts.) 252 (69%) and in the EROS 3 (200 pts.) 73 (36%). There was no differences in total complications (EROS 1 3.76% vs 2.99%, p=0.814, EROS 2 4.76% vs 5.21%, p=0.851, EROS 3 5.48% vs 11.81%, p=0.210) and clinical success (EROS 1 98.75% vs 99.40%, p=0.689, EROS 2 98.41% vs 94.78%, p=0.077, EROS 3 80.82% vs 85.04%, p=0.439) between local and general anesthesia throughout the groups; use of internal jugular approach was significantly higher in EROS 2 patients undergoing general anesthesia (4.76% vs 11.30%, p=0.021), while in EROS 1 and 3 patients this difference was not statistically significant (EROS 1 5.01% vs 8.38%, p= 0.101, EROS 3 8,22% vs 18,11%, p=0.056). Conclusion These results suggest that local anesthesia in patients undergoing transvenous lead extraction does not affect procedural outcomes and safety. Complex procedures with the need for internal jugular approach may drive this choice with preference for general anesthesia.

The Impact of Endovascular Rescue Therapy on the Clinical and Radiological Outcome After Aneurysmal Subarachnoid Hemorrhage: A Safe and Effective Treatment Option for Hemodynamically Relevant Vasospasm?

ObjectiveCerebral vasospasm (CVS) represents one of the multiple contributors to delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH). Especially the management of CVS, refractory to medical treatment, is a challenging task during the acute phase after aSAH. Endovascular rescue therapies (ERT), such as medical and mechanical dilation, are possible treatment options on an individual basis. However, data about the influence on the patients' functional outcomes are limited. This study aims to assess the impact of ERT on the long-term functional outcome in aSAH-patients with refractory CVS.MethodsWe performed a retrospective analysis of aSAH patients treated between 2012 and 2018. CVS was considered refractory, if it persisted despite oral/intravenous nimodipine application and induced hypertension. The decision to perform ETR was made on an individual basis, according to the detection of “tissue at risk” on computed tomography perfusion (CTP) scans and CVS on computed tomography angiography (CTA) or digital subtraction angiography (DSA). The functional outcome was assessed according to the modified Rankin scale (mRS) 3 months after the ictus, whereas an mRS ≤ 2 was considered as a good outcome.ResultsA total of 268 patients were included. Out of these, 205 patients (76.5%) were treated without ERT (group 1) and 63 patients (23.5%) with ERT (group 2). In 20 patients (31.8%) balloon dilatation was performed, in 23 patients (36.5%) intra-arterial nimodipine injection alone, and in 20 patients (31.8%) both procedures were combined. Considering only the patient group with DCI, the patients who were treated with ERT had a significantly better outcome compared to the patients without ERT (Mann–Whitney test, p = 0.02).ConclusionEndovascular rescue therapies resulted in a significantly better functional outcome in patients with DCI compared to the patient group treated without ETR. CTP and CTA-based identification of “tissue at risk” might be a reliable tool for patient selection for performing ERT.

Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term: A Randomized Controlled Trial.

To evaluate whether a synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. In an open-label, noninferiority randomized trial, pregnant women undergoing induction of labor at 37 weeks of gestation or more with Bishop scores less than 6 were randomized to either mechanical cervical dilation or oral misoprostol. Participants in the mechanical dilation group underwent insertion of synthetic osmotic cervical dilator rods, and those in the misoprostol group received up to six doses of 25 micrograms orally every 2 hours. After 12 hours of ripening, oxytocin was initiated, with artificial rupture of membranes. Management of labor was at the physician's discretion. The primary outcome was the proportion of women achieving vaginal delivery within 36 hours of initiation of study intervention. Secondary outcomes included increase in Bishop score, mode of delivery, induction-to-delivery interval, total length of hospital stay, and patient satisfaction. On the basis of a noninferiority margin of 10%, an expected primary outcome frequency of 65% for misoprostol and 71% for mechanical methods, and 85% power, a sample size of 306 participants was needed. From November 2018 through January 2021, 307 women were randomized, with 151 evaluable participants in the synthetic osmotic cervical dilator group and 152 in the misoprostol group (there were four early withdrawals). The proportion of women achieving vaginal delivery within 36 hours was higher with mechanical cervical dilation compared with misoprostol (61.6% vs 59.2%), with an absolute difference of 2.4% (95% CI -9% to 13%), indicating noninferiority for the prespecified margin. No differences were noted in the mode of delivery. Tachysystole was more frequent in the misoprostol group (70 [46.4%] vs 35 [23.3%]; P=.01). Participants in the synthetic osmotic cervical dilator group reported better sleep, less unpleasant abdominal sensations, and lower pain scores (P<.05). Synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. Advantages of synthetic osmotic cervical dilator include a better safety profile and patient satisfaction, less tachysystole, lower pain scores, and U.S. Food and Drug Administration approval. ClinicalTrials.gov, NCT03670836. Medicem Technology s.r.o., Czech Republic.

A randomised comparative study of sublingual and vaginal misoprostol for cervical priming before minor gynaecological procedures

This study aimed to compare the effect of misoprostol using vaginal or sublingual routes on the non-pregnant uterine cervix prior to minor gynaecological procedures. One hundred and forty women were randomised 1:1 into two groups: A and B. Group A received misoprostol 400 mcg vaginally and pyridoxine 40 mg sublingually and Group B received misoprostol 400 mcg sublingually and pyridoxine 40 mg vaginally 4 h prior to procedure. The outcomes studied were maximum size of Hegar’s dilator that could be inserted into the cervix without any resistance, ease of dilatation, need and time required for further dilatation, side effects and complications. Baseline cervical dilatation was significantly more in Group A than Group B. Need for further dilatation and time required for further dilatation were also significantly less in Group A than Group B. Thus, we conclude that vaginal misoprostol is more effective than sublingual misoprostol in cervical priming before minor gynaecological procedures. Clinical Trial Registration Number: www.ctri.nic.in; CTRI/2018/07/015080 IMPACT STATEMENT What is already known on this subject? Cervical priming has been shown to result in shorter operative time, easier mechanical dilatation, reduced incidence of complications and blood loss when used prior to surgical abortion and has been recommended as a standard practice in various national and international guidelines for safe abortion practices. Misoprostol has many advantages over other ripening agents like osmotic dilators, other prostaglandins and mifepristone. Misoprostol can be given through oral, sublingual, vaginal, buccal and rectal routes. Use of misoprostol has been found to improve cervical dilatation, reduce need of further dilatation and ease of dilatation without many complications when compared to placebo for cervical priming of non-pregnant cervix. Studies comparing vaginal and sublingual routes have shown no significant difference for cervical ripening in pregnant women. What the results of this study add? We found that vaginal misoprostol for cervical priming was more effective than sublingual misoprostol in reaching a higher baseline cervical dilatation, with reduced need and time required for further dilatation before minor gynaecological procedures, although the ease of dilatation was similar in both groups. This effect of vaginal misoprostol was more marked in premenopausal women. What the implications are of these findings for clinical practice and/or further research? The results of our study are at variance with other studies done on use of misoprostol via the vaginal or sublingual routes, and hence it is imperative that large multi-center studies be performed to bring about consensus on the topic.

Comparison of different pupil dilatation methods for phacoemulsification in eyes with a small pupil

PurposeTo compare 6 methods for intraoperative pupil dilatation in eyes with insufficient pupil size during phacoemulsification.MethodsThis was a prospective case–control study. 99 microcoria cataract patients (120 eyes) were collected and were divided into 6 groups(20 eyes each group), and their pupils were dilated by bimanual stretching pupil (group I), pupil radial cut open(group II), mechanical pupil dilatation with iris-retractor hooks (group III), OASIS iris expander (group IV), and Malyguin-ring (Microsurgical company, America) (group V), B-HEX Pupil Expander (Med Invent Devics, India)(group VI),respectively. 3.0 mm clear corneal incision were used in phacoemulsification. All cases were followed up at 1 week and 1, 3, 6 months after the surgery. The best corrected visual acuity (BCVA), intraocular pressure(IOP), corneal endothelium cell density(ECD), pupil diameter(PD) of before and after surgery were compared.ResultsOne same doctor finished all cataract surgeries successfully. The eyes’ condition before surgery and at 6 months after surgery were compared. There were no significant statistical differences for the conditions of the eyes before surgery among six groups. The ECDs were better at 6 months postoperatively in group III and V, median values: 2114/mm2, 1961/mm2. PD was largest in group II (median value: 5.5 mm), which was significantly larger than other groups (Padjusted < 0.05).ConclusionsAll 6 methods used in this study were effective for the mechanical dilatation of small pupils and didn’t affect the postoperative visual acuity and intraocular pressure in microcoria cataract phacoemulsification. Iris-retractor hooks and the Malyugin Ring can reduce intraoperative corneal endothelium cell loss. Postoperative PD is larger when the iris was cut open radially.

Mechanical dilatation of the stenosed cervix under local anesthesia: A prospective case series

AimCervical stenosis is traditionally managed by mechanical dilatation under general anesthesia (GA). We aimed to assess the safety, effectiveness, and patient acceptability of dilatation in the outpatient setting under local anesthesia (LA).MethodsData were collected prospectively from all patients attending the outpatient department with cervical stenosis from March 20, 2015 to September 23, 2020. Mechanical dilatation of the cervix was performed using Hegar dilators under LA. Subsequent colposcopic assessment, cytology, histology, and management were recorded.ResultsOne hundred forty‐nine cases were referred for cervical dilatation, 63 (43%) of which had complete stenosis. One hundred eighteen (79%) patients had previously undergone cervical procedures. Successful dilatation under LA was achieved in 119 (83%) patients; 5 (3%) declined (requesting GA), 6 (4%) did not tolerate speculum examination, and 19 (13%) had unsuccessful procedures. The median Hegar size used was 8 mm. Dilatation under LA was acceptable in 93% attempted procedures. Thirteen episodes of restenosis were recorded with no major adverse events. Younger age (p = 0.045) and severe (compared to complete) stenosis (p < 0.0001) were associated with procedure success, with improved results over time (p = 0.003). Successful dilatation permitted cervical assessment; eight patients required cervical excisions, two underwent hysterectomies, with one confirmed case of adenocarcinoma.ConclusionRigid cervical dilatation in the outpatient setting provides effective, instantaneous treatment for women who have failed cytological or colposcopic assessment. For the vast majority of women, the procedure was well tolerated and preferred to using GA. However, given that 1 in 10 women experienced restenosis, patients should be counseled about the possibility of requiring further management.

Lower and extended dosage of misoprostol for cervical ripening in 1st trimester miscarriage (MISO200): A randomized clinical trial

ObjectiveTo compare the efficacy of priming the uterine cervix before Manual Vaccum Aspiration (MVA) using 200 µg or 400 µg of vaginal misoprostol, inserted a mean time of 6 h before MVA in first trimester miscarriage. Study designRandomized, triple-blind, non-inferiority clinical trial. Patients between 18 and 50 years old, with a diagnosis of miscarriage, were eligible for the study. Patients were allocated to receive either 200 μg or 400 µg of misoprostol before the MVA. The primary outcome was the need to dilate the uterine cervix with mechanical dilators (Hegar dilators). As a secondary outcome, cervical dilatation ≥8 mm before the procedure was considered successful. A difference of <25% was considered as non-inferior. ResultsBetween December 21, 2016 and October 6, 2019, 269 women were screened. After screening, 105 and 106 women received 200 µg and 400 µg of misoprostol, respectively. Mechanical cervical dilatation was not necessary in 84.8% (95%CI 77% to 90%) and 96.2% (95%CI 91% to 99%), in the 200 µg and 400 µg groups, respectively [difference = 11.5% (95%CI 3.7% to 19.2%). Cervical dilatation of ≥8 mm was 52.4% (95%CI 42.9% to 61.7%) in the 200 µg misoprostol group, while in the 400 µg group was 71.7% (95%CI 62.5% to 79.4%) [difference = 19.3% (95%CI 6.5 to 32.2). ConclusionAfter a mean time of 6 h, 200 µg of vaginal misoprostol is not inferior to 400 µg of misoprostol for cervical priming before MVA, in first trimester miscarriage. This non-inferiority was not observed when the ≥8 mm criterion was considered.

689 Hybrid transvenous and surgical approach for the extraction of coronary sinus leads: a case series

Abstract Aims The rates of cardiac device-related infection have increased substantially over the past years. Transvenous lead extraction is the standard therapy for such cases. In some patients, however, the procedure cannot be completed through the transvenous route alone. A hybrid surgical and transvenous approach may provide the solution in such cases. Methods and results We present three cases who underwent hybird transvenous and surgical extraction for coronary sinus leads due to infection of CRT-D systems. One patient had an Attain Starfix lead implanted in the coronary sinus. The procedures were performed under local anaesthesia with continuous haemodynamic and transthoracic echocardiographic monitoring. We highlight the characteristics of the patients, the features of the devices, the technical difficulties, and the outcomes of the procedures. In all cases, the right atrial and right ventricular leads were extracted through the transvenous route. In one patient, they were extracted using regular stylets and manual traction, while in the other two patients, telescoping dilator sheaths (Cook), Tightrail hand-powered mechanical sheaths (Spectranetics), and/or Glidelight Excimer Laser sheaths (Spectranetics) were used. The coronary sinus lead could not be retrieved due to extensive fibrosis after utilizing locking stylets and mechanical dilator sheaths in all three cases, in addition to rotational mechanical sheaths and laser sheaths in one case, so the patients were referred to surgery. Two patients underwent left mini-thoracotomy and one patient underwent midline sternotomy to extract the remaining CS lead. The target vein was identified and ligated, then the fibrosis around the lead was dissected, this was followed by lead retrieval through the surgical incision. The patient who underwent sternotomy suffered from mediastinitis, which required reoperation and mediastinal lavage. There were no complications in the other two patients. All three patients were reimplanted with a new CRT-D device on the contralateral side after the resolution of infection. Conclusions A hybrid surgical and transvenous approach can be complementary in case the transvenous route alone fails to completely extract the coronary sinus lead. The transvenous approach can be used to free the proximal part of the lead, while the distal adhesions can be removed surgically, preferably though a limited thoracic incision.

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures.

The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications. Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria. The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

Transvenous lead extraction using the TightRail mechanical rotating dilator sheath for Asian patients

The need for transvenous lead extraction (TLE) is increasing worldwide including in Asia–Pacific regions. However, supporting evidence for TightRail, a relatively new rotating mechanical dilator sheath, is still lacking in Asian patients. The efficacy and safety of TLE using TightRail performed between March 2018 and June 2021 were evaluated in 86 consecutive patients with 131 leads. The mean lead age was 11.7 ± 7.3 (range, 1.0–41.4) years. Clinical and complete procedural success using TightRail were achieved in 93.0% and 89.5% of 86 patients, respectively, with 6 min of median fluoroscopic time and 9.3% of major complication rate: death (1.2%), cardiac tamponade (3.5%), severe tricuspid regurgitation (3.5%), and stroke (1.2%). However, in 46 patients with longest lead age ≤ 10 years, clinical/complete success and major cardiac complication rates turned out better as 97.8%, 95.7%, and 2.2%, respectively. Additionally, when patients were divided into 3 groups: the first 28, second 29, and the last 29 patients, there was a clear trend toward better efficacy and safety outcomes with more experience with TightRail (Ptrend < 0.05). Longest lead age > 10 years was closely associated with TLE-related major cardiac complication (P = 0.046) with 85.7% sensitivity, 57.0% specificity, 15.0% positive predictive value, and 97.8% negative predictive values. In conclusion, TLE using TightRail may be effectively and safely performed by experienced operators for Asian patients with the longest lead age ≤ 10 years. However, as TightRail is a potentially aggressive tool, special attention should be paid to patients with longer lead dwelling times (e.g., > 10 years).

Prostaglandins for induction in pregnancies with fetal growth restriction

The data on safety of prostaglandin agents for induction of pregnancies with fetal growth restriction is limited. To compare the rates of adverse outcomes among pregnancies with fetal growth restriction undergoing induction of labor with and without prostaglandins STUDY DESIGN: We performed a propensity-score-based secondary analysis of the Consortium on Safe Labor database. We included term, singleton, and nonanomalous pregnancies with fetal growth restriction (estimated fetal weight <10th percentile for gestational age). We excluded previous cesarean deliveries. The primary exposure was induction using prostaglandins (prostaglandin E1 or prostaglandin E2) compared with other methods. The primary outcome was a composite of adverse neonatal outcomes. The secondary outcomes included all cesarean deliveries and cesarean deliveries for nonreassuring fetal heart tracings. A subgroup analysis comparing the type of prostaglandin was planned a priori. The results are expressed as adjusted odds ratios with 95% confidence intervals. Of 756 (0.3%) inductions, 212 (28%) used prostaglandins (108 prostaglandin E1, 94 prostaglandin E2), and 553 (72%) used nonprostaglandin methods, including oxytocin (348, 63%), amniotomy (211, 38%), and/or mechanical dilation (9, 1%). There were no differences in the composite of adverse neonatal outcomes between the prostaglandin (10.4%) and the nonprostaglandin group (6.7%), adjusted odds ratio, 1.39 (0.64-3.03). The rate of cesarean delivery was higher in the inductions that received prostaglandins than those that did not (25.5% vs 14.8%, adjusted odds ratio, 1.80; 1.07-3.02). The rate of cesarean delivery for nonreassuring fetal heart tracings was higher for those that received prostaglandins than those that did not (16.0% vs 8.7%, adjusted odds ratio, 2.37; 1.28-4.41). When prostaglandin E1 and prostaglandin E2 were examined independently, there were similar increases in the composite of adverse neonatal outcomes and cesarean delivery rates for both prostaglandin E1 and prostaglandin E2 compared with nonprostaglandin controls. There were no differences in the composite of adverse neonatal outcomes when prostaglandins were used for induction in pregnancies with fetal growth restriction compared with other methods. However, there was a higher rate of cesarean delivery and cesarean delivery indicated for nonreassuring fetal heart tracings when prostaglandins (both prostaglandin E1 and prostaglandin E2) were used, compared with nonprostaglandin methods.