Angioplasty Research Articles

Percutaneous transluminal angioplasty and stenting for severe stenosis of the intracranial carotid artery and its branches: Comparison of the Wingspan stent versus the Credo stent.

Despite the widespread use of the Wingspan stent system for treating severe medically refractory intracranial artery stenosis (SMR-ICAS), a new Credo stent system was approved because it could integrate stent delivery within the balloon catheter. However, the therapeutic outcomes of these two systems have not been compared. This preliminary study aimed to compare the results of percutaneous angioplasty and stenting (PTAS) in SMR-ICAS patients treated with either Wingspan or Credo stents within the anterior circulation. SMR-ICAS patients with more than 70% stenosis in the anterior circulation who underwent PTAS using either the Wingspan or Credo stent system were analyzed. We evaluated the technical success, safety, and outcomes of the two stent systems. A total of 29 patients were analyzed, including 17 patients treated with Wingspan stents and 12 with Credo stents. The outcomes of the Wingspan stent vs. Credo stent were as follows: technical success (16/17 [94%] vs. 11/12 [92%], p = 1.00); periprocedural intracranial hemorrhage (2/17 [12%] vs. 0/12 [0%], p = 0.50); silent embolic ischemic lesions on peri-procedural MRI (13/17 [76%] vs. 7/12 [58%], p = 0.42); and significant (more than 50%) in-stent restenosis in one year (4/17 [24%] vs. 2/12 [17%], p = 1.00). No recurrent stroke or mortality was noted within 30 days after the procedures or during the one-year follow-up period. The technical success, safety, and outcomes of the Credo stent system were comparable to those of the Wingspan stent system in the management of SMR-ICAS patients. Further large-scale studies are warranted to substantiate these findings.

Loop9 closure technique for mucosal defects after colorectal endoscopic submucosal dissection (with video)

Background and study aims: Mucosal defect closure after colorectal endoscopic submucosal dissection (ESD) has the potential to reduce the occurrence of delayed adverse events (AEs) such as bleeding and perforation. This study aimed to assess the feasibility and effectiveness of the Loop9 method for closing mucosal defects following colorectal ESD. Patients and methods: A retrospective single-center study was conducted using prospectively collected data from May 2020 to March 2023. Loop9 was deployed through a single instrument channel and anchored with clips at the defect site. Closure was accomplished by tightening the loop and deploying additional conventional clips as needed for complete closure. The primary outcome was complete closure rate, with secondary outcomes including the sustained closure rate at 4 to 5 days post-ESD, closed defect size, closure time, number of additional clips, and incidence of delayed AEs. Results: This study included 118 cases. Complete closure was achieved in 96.6% of cases (114/118) with a sustained closure rate of 93.9% (107/114). The median size of the closed mucosal defects was 30 mm (interquartile range [IQR]: 25-38, range: 15-74). The median closure time was 14 minutes (IQR: 11.25-17), and the median number of additional clips deployed was six (IQR: 4-7). Stenosis requiring balloon dilatation was observed in one patient; however, there were no instances of post-ESD bleeding or delayed perforation. Conclusions: The Loop9 method proved feasible and effective for closing mucosal defects following colorectal ESD, achieving high rates of complete and sustained closure.

Loop9 closure technique for mucosal defects after colorectal endoscopic submucosal dissection (with video)

Background and study aims: Mucosal defect closure after colorectal endoscopic submucosal dissection (ESD) has the potential to reduce the occurrence of delayed adverse events (AEs) such as bleeding and perforation. This study aimed to assess the feasibility and effectiveness of the Loop9 method for closing mucosal defects following colorectal ESD. Patients and methods: A retrospective single-center study was conducted using prospectively collected data from May 2020 to March 2023. Loop9 was deployed through a single instrument channel and anchored with clips at the defect site. Closure was accomplished by tightening the loop and deploying additional conventional clips as needed for complete closure. The primary outcome was complete closure rate, with secondary outcomes including the sustained closure rate at 4 to 5 days post-ESD, closed defect size, closure time, number of additional clips, and incidence of delayed AEs. Results: This study included 118 cases. Complete closure was achieved in 96.6% of cases (114/118) with a sustained closure rate of 93.9% (107/114). The median size of the closed mucosal defects was 30 mm (interquartile range [IQR]: 25-38, range: 15-74). The median closure time was 14 minutes (IQR: 11.25-17), and the median number of additional clips deployed was six (IQR: 4-7). Stenosis requiring balloon dilatation was observed in one patient; however, there were no instances of post-ESD bleeding or delayed perforation. Conclusions: The Loop9 method proved feasible and effective for closing mucosal defects following colorectal ESD, achieving high rates of complete and sustained closure.

Thirty‐two‐month‐old with multiple duodenal webs diagnosed after failed gastrojejunostomy exchange successfully treated with combination endoscopic therapy

AbstractIntestinal webs are either congenital or acquired. There are few reported cases of either chemotherapy or nonsteroidal anti‐inflammatory medications leading to acquired intestinal webs in adults. There are limited descriptions of endoscopic interventions used for therapy of numerous duodenal webs in pediatrics. Here, we describe a 32‐month‐old patient undergoing chemotherapy who had multiple duodenal webs. The patient was diagnosed after failed gastrojejunostomy tube exchange via atypical contrast filling pattern and direct visualization with endoscopy. This patient likely has acquired duodenal webs from the combination of nonsteroidal anti‐inflammatory drug containing chemotherapy treatment and repeated tube trauma. Treatment involved serial esophagogastroduodenoscopy with a combination of endoscopic therapy including balloon dilation and incisional therapy with insulated‐tip knife and cautery scissors. The patient now tolerates G‐tube feedings.

Thirty‐two‐month‐old with multiple duodenal webs diagnosed after failed gastrojejunostomy exchange successfully treated with combination endoscopic therapy

AbstractIntestinal webs are either congenital or acquired. There are few reported cases of either chemotherapy or nonsteroidal anti‐inflammatory medications leading to acquired intestinal webs in adults. There are limited descriptions of endoscopic interventions used for therapy of numerous duodenal webs in pediatrics. Here, we describe a 32‐month‐old patient undergoing chemotherapy who had multiple duodenal webs. The patient was diagnosed after failed gastrojejunostomy tube exchange via atypical contrast filling pattern and direct visualization with endoscopy. This patient likely has acquired duodenal webs from the combination of nonsteroidal anti‐inflammatory drug containing chemotherapy treatment and repeated tube trauma. Treatment involved serial esophagogastroduodenoscopy with a combination of endoscopic therapy including balloon dilation and incisional therapy with insulated‐tip knife and cautery scissors. The patient now tolerates G‐tube feedings.

Cucurbitacins mitigate vascular neointimal hyperplasia by suppressing cyclin A2 expression and inhibiting VSMC proliferation.

Restenosis frequently occurs after percutaneous angioplasty in patients with vascular occlusion and seriously threatens their health. Substantial evidence has revealed that preventing vascular smooth muscle cell proliferation using a drug-eluting stent is an effective approach to improve restenosis. Cucurbitacins have been demonstrated to exert an anti-proliferation effect in various tumors and a hypotensive effect. This study aims to investigate the role of cucurbitacins extracted from Cucumis melo L. (CuECs) and cucurbitacin B (CuB) on restenosis. C57BL/6 mice were subjected to left carotid artery ligation and subcutaneously injected with CuECs or CuB for 4 weeks. Hematoxylin-Eosin, immunofluorescence and immunohistochemistry staining were used to evaluate the effect of CuECs and CuB on neointimal hyperplasia. Western blot, real-time PCR, flow cytometry analysis, EdU staining and cellular immunofluorescence assay were employed to measure the effects of CuECs and CuB on cell proliferation and the cell cycle invitro. The potential interactions of CuECs with cyclin A2 were performed by molecular docking. The results demonstrated that both CuECs and CuB exhibited significant inhibitory effects on neointimal hyperplasia and proliferation of vascular smooth muscle cells. Furthermore, CuECs and CuB mediated cell cycle arrest at the S phase. Autodocking analysis demonstrated that CuB, CuD, CuE and CuI had high binding energy for cyclin A2. Our study also showed that CuECs and CuB dramatically inhibited FBS-induced cyclin A2 expression. Moreover, the expression of cyclin A2 in CuEC- and CuB-treated neointima was downregulated. CuECs, especially CuB, exert an anti-proliferation effect in VSMCs and may be potential drugs to prevent restenosis.

Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Case Report: Endovascular approach with kissing stent technique in aortoiliac occlusive disease (Leriche syndrome) patient

Background: Aortoiliac occlusive disease (AIOD) or Leriche syndrome, is a peripheral artery disease, specifically affecting the infrarenal aorta and iliac arteries. Presentation of AIOD patients ranged from asymptomatic to having limb-threatening emergencies. Advances and innovations in endovascular devices have replaced surgical approach for AIOD treatment. Here we reported a 52-year-old man presenting with AIOD managed by endovascular approach using kissing stent technique. Case presentation: A 52-year-old man, with history of chronic coronary artery disease, diabetes mellitus type 2, long-standing hypertension, and who was a heavy smoker, was admitted to our hospital with symptoms of long time with bilateral claudication and became leg rest pain. He had history of aorto-infrarenal occlusion known from previous percutaneous coronary intervention from right and left femoral artery access. Aortoiliac occlusive disease (TASC II Type D Class) diagnosis was made by lower extremity duplex ultrasound and CT angiography. The patient underwent urgent percutaneous transluminal angioplasty with kissing stent technique. The patient was discharged 4 days after the procedure without any significant complaints, received optimal medical treatment, and was educated about smoking cessation. Conclusion: Treatment of AIOD should include both modification of risk factors and efforts to increase perfusion to the lower extremities. An endovascular approach is an excellent alternative and may replace surgical approach in complex aortoiliac obstructive disease. In this case report, an endovascular approach with kissing stent technique showed good results for the patient.

Prospective Randomized Controlled Trial for the Efficacy and Safety of Using Different Doses of Recombinant Tissue Plasminogen Activator in Pulse-Spray Thrombolysis of Thrombosed Hemodialysis Arteriovenous Access

Abstract Background Maintaining vascular access for hemodialysis (HD) is a major source of hospitalization, and patient morbidity. In cases of recently thrombosed arteriovenous access (AVA), minimally invasive thrombolysis and adjunctive angioplasty is considered as a reasonable management to restore patency & function of AVA. Objectives The study aims to compare the efficacy and safety of using two different doses (6ml vs 10ml) of recombinant tissue plasminogen activator (rTPA) for pulse-spray thrombolysis of AVA. Methods A Prospective randomized controlled clinical study conducted at Ain -shams university hospitals during the period from July 2022 to December 2022 on 32 patients with recently thrombosed AVAs recruited for ultrasound guided Pulse-Spray Thrombolysis followed by angiography +/- balloon dilatation of the stenosed segments. Patients were included in the study if their AVAs were mature, the duration of AVA thrombosis didn’t exceed two weeks and had no contraindications for rTPA. Patients had been divided randomly into two equal groups by closed envelops method, Group I received 6ml rTPA, Group II received 10ml rTPA, and followed up for six weeks post procedure. Results The immediate post-procedure technical success was 100% in both study groups. Clinical success was 81.25% in group I, and 93.75% in group II (P-value = 0.285), With mean period from thrombolysis till resuming HD 2.769 ± 1.878 days in group I, and 4.00 ± 2.726 days in group II (P-value =0.183). No mortality cases reported, no statistically significant difference between the two groups regarding the procedure- related complications. Conclusions Both doses were effective, we didn’t find statistically significant difference between the two groups as regard clinical and technical success, but using dose of 10ml rTPA yields slightly higher clinical success and longer patency than using 6ml with no statistically significant increase in the rate of adverse effects.

Successful prevention of balloon dilatation after complete circumferential endoscopic submucosal dissection including long-segment Barrett's esophagus.

Successful prevention of balloon dilatation after complete circumferential endoscopic submucosal dissection including long-segment Barrett's esophagus.

Endoscopic ultrasound-guided drainage for infected biloma using a unique long-type balloon catheter.

Endoscopic ultrasound-guided drainage for infected biloma using a unique long-type balloon catheter.

Advancements in Surgical Management of Megaureters.

To review and describe the recent evolution of surgery for the various types of pediatric megaureter. Megaureter management first relies on determining the underlying cause, whether by obstruction, reflux, or a combination, and then setting appropriate surgical indications because many cases do not require surgery as shown by observation studies. Endoscopic balloon dilation has been on the rise as a major treatment option for obstructive megaureter, while refluxing megaureters can also be treated by laparoscopic and robotic techniques, whether extravesically or transvesicoscopically. During ureteral reimplantation, tapering is sometimes necessary to address the enlarged ureter, but there are also considerations for not tapering or for tapering alternatives. Endoscopic and minimally invasive surgeries for megaureter have been the predominant focus of recent megaureter literature. These techniques still need collaborative prospective studies to better define which surgeries are best for patients needing megaureter interventions.

Prophylactic Radiologic Interventions for Postpartum Hemorrhage Control in Women With Placenta Accreta Spectrum Disorder: A Systematic Review and Meta-analysis.

To quantify the association between prophylactic radiologic interventions and perioperative blood loss during cesarean delivery in women with placenta accreta spectrum disorder through a systematic review and network meta-analysis. On January 3, 2023, a literature search was conducted in PubMed, EMBASE, Cochrane Library, and Web of Science. We also checked ClinicalTrials.gov retrospectively. Prophylactic radiologic interventions to reduce bleeding during cesarean delivery involved preoperative placement of balloon catheters, distal (internal or common iliac arteries) or proximal (abdominal aorta), or sheaths (uterine arteries). The primary outcome was volume of blood loss; secondary outcomes were the number of red blood cell units transfused and adverse events. Studies including women who received an emergency cesarean delivery were excluded. Two authors independently screened citations for relevance, extracted data, and assessed the risk of bias of individual studies with the Cochrane Risk of Bias in Non-randomized Studies of Interventions tool. From a total of 1,332 screened studies, 50 were included in the final analysis, comprising 5,962 women. These studies consisted of two randomized controlled trials and 48 observational studies. Thirty studies compared distal balloon occlusion with a control group, with a mean difference in blood loss of -406 mL (95% CI, -645 to -167). Fourteen studies compared proximal balloon occlusion with a control group, with a mean difference of -1,041 mL (95% CI, -1,371 to -710). Sensitivity analysis excluding studies with serious or critical risk of bias provided similar results. Five studies compared uterine artery embolization with a control group, all with serious or critical risk of bias; the mean difference was -936 mL (95% CI, -1,522 to -350). Reported information on adverse events was limited. Although the predominance of observational studies in the included literature warrants caution in interpreting the findings of this meta-analysis, our findings suggest that prophylactic placement of balloon catheters or sheaths before planned cesarean delivery in women with placenta accreta spectrum disorder may, in some cases, substantially reduce perioperative blood loss. Further study is required to quantify the efficacy according to various severities of placenta accreta spectrum disorder and the associated safety of these radiologic interventions. PROSPERO, CRD42022320922.

Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial

To report the five-year outcomes from the ILLUMENATE Pivotal Randomized Controlled Trial (RCT) of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease (PAD). Long-term safety and effectiveness data for DCBs remains limited. ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford 2-4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. Three hundred patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60-months, freedom from a primary safety event was in 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log rank, P=0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (P=0.597), respectively. Freedom from clinically driven-target lesion revascularization (CD-TLR) was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (P=0.505). Time to first CD-TLR was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (P=0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log rank, P=0.980). The five-year results of the ILLUMENATE Pivotal RCT add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the five-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic PAD. ILLUMENATE Pivotal was a multi-center, single-blinded RCT which assessed the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. At five years, the Stellarex DCB showed similar freedom from clinically driven-target lesion revascularization (70.3% versus 68.2%; P=0.505) and no difference in all-cause mortality (80.1% versus 80.2%; log rank, P=0.980) compared with PTA. These results reinforce the previously established safety of the Stellarex DCB from the broader ILLUMENATE clinical program. Importantly, this the first report of five-year safety and effectiveness outcomes for a lower dose (2 µg/mm2) DCB.

Drug-coated balloons versus conventional percutaneous transluminal angioplasty for treatment-naïve dysfunctional arteriovenous fistulas.: A 10-year single center retrospective study.

To compare the primary patency and restenosis rates in treatment naieve dialysis arteriovenous fistulas (AVFs) after drug-coated balloons (DCB) versus plain balloon angioplasty (PTA). This retrospective study included 157 patients who underwent AVF angioplasty for treatment-native AVF stenosis between January 2012 to 2022. The fistulas were Brachiocephalic (75%), Brachiobasilic (17%), and radiocephalic (8%). The index intervention was with either DCB or percutaneous transluminal angioplasty (PTA) with subsequent follow up. Patients with central venous stenosis, thrombosed fistula, fistula stents, AV graft or surgical intervention after the index procedure were excluded. Arteriovenous fistula angioplasty was done in 28 patients using DCB and in 129 patients using PTA. A total of 108 patients presented with a single stenosis, 42 with 2 stenoses, and 7 with 3 stenoses. The location of these stenoses was in the venous outflow (57%), the juxta anastomotic segment (31%), and cephalic arch (12%). The median time to re-intervention for the PTA was 216 days compared to 304 days for the DCB (p=0.079). Primary patency at 6 months was 60.4% for PTA and 75% for DCB (p=0.141) CONCLUSION: Although DCB angioplasty of treatmentnaïve dysfunctional AVF tends to improve the time to intervention and 6-month primary patency compared to PTA, this difference did not reach statistical significance.

Women’s Experiences of Mechanical Balloon Catheter Induction With Self-Traction

ObjectiveTo explore women’s experiences of mechanical labor induction using a balloon catheter with self-traction. DesignDescriptive qualitative. SettingBirth unit of an urban hospital in Quebec, Canada. ParticipantsFourteen women who experienced labor induction with a balloon catheter using self-traction. MethodsWe conducted individual structured interviews between May 2022 and January 2023 to collect data that we subsequently analyzed using the manifest content analysis approach of Graneheim et al. We adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ). ResultsWe identified five categories: Expectations, Pain or Comfort Experienced, Emotions Felt, Support From Nursing Staff, and Appreciation of the Procedure. The participants anticipated rapid, effective induction, expressed concerns about potential discomfort, and appreciated control of their experiences. We found a generally positive trend in terms of appreciation for all categories. ConclusionThe positive experiences of participants underline the promising potential of the balloon catheter method of labor induction with self-traction. Given the continuing growth in labor induction rates, it becomes necessary to continue efforts to offer services specifically geared to women’s needs. Offering an additional option such as self-traction is a step in this direction.

The impact of coronavirus disease 2019 on acute coronary syndrome: Differences between epidemic waves

IntroductionSince the beginning of the COronaVIrus Disease 2019 (COVID-19) pandemic, poor attention has been paid to the indirect effects of the pandemia on cardiovascular health system, in particular in patients with Acute Coronary Syndrome (ACS). The aims of this study is to compare possible epidemiological, clinical and management differences between the four epidemic waves in groups of patients hospitalized for ACS with a view to highlighting the burden of the pandemic on the management of this syndrome. Materials and methodsIn this retrospective observational study we included 98 patients admitted to Coronary Intensive Care Unit (CICU) for ACS between March 2020 and March 2022, who underwent revascularization procedure using percutaneous coronary angioplasty (PCI). The patients examined were divided into four groups representative of the four epidemic waves that affected our country. ResultsThe rate of hospitalization for ACS increased progressively to a 178 % increase in the third wave compared to the first (p = 0.003), with an increase of 900 % if we consider only Non-ST-Elevation Myocardial Infarction (NSTEMI) (representing 54 % of the ACS diagnoses of the third group against 14.3 % in the first). Longer door-to-balloon times were recorded in the third wave for the increased presence of NSTEMI. The average hospital stay was lower in the third wave with 5 ± 2 days (p = 0.007) as well as mortality (5.1 % in the third wave; the highest in the fourth wave with 9.5 %). ConclusionsThe study show that the management of ACS suffered most from the indirect effects of the pandemic during the first wave, both because of the unpreparedness of hospital facilities and because of the fear of infection that has dissuaded people from asking for help.

Two-year outcomes of sirolimus-coated balloon angioplasty for coronary artery disease: the EASTBOURNE Registry.

Two-year outcomes of sirolimus-coated balloon angioplasty for coronary artery disease: the EASTBOURNE Registry.

The effect of different degrees of Eustachian tube dysfunction on hearing threshold in patients with acquired primary middle ear cholesteatoma after balloon eustachian tuboplasty

Objective:To investigate the changes in hearing threshold of the acquired primary cholesteatoma of the middle ear with different degrees of eustachian tube dysfunction after balloon eustachian tuboplasty. Methods:This retrospective study included forty cases with middle ear cholesteatoma and eustachian tube dysfunction who underwent open mastoidectomy + tympanoplasty + balloon eustachian tuboplasty were enrolled. All patients were admitted from November 2020 to April 2022. The preoperative eustachian tube score of 0-2 were defined as the lower group, and the scores of 3-5 were defined as the higher group. Pure tone audiometry was measured preoperatively and 1, 3, 6 and 12 months postoperatively. The average value of bone conduction threshold and air conduction threshold of 250-4 000 Hz were calculated, and the air-bone gap was calculated simultaneously. SPSS 25.0 was used for statistical analysis. P<0.05 was considered statistically significant. Results:In the lower group, the air conduction threshold and air-bone gap at 3 months postoperatively were significantly decreased in comparison with those preoperatively（P<0.05），as was the air-bone gap at 6 months postoperatively（P<0.05）. In the higher group, the air conduction threshold and air-bone gap were significantly decreased at 3, 6 and 12 months postoperatively（P<0.05）. Conclusion:The air conduction threshold and air-bone gap of patients with the acquired primary cholesteatoma of the middle ear and eustachian tube dysfunction were significantly decreased after eustachian tube balloon dilatation. Hearing improvement lasted longer in patients with slight eustachian tube dysfunction.

Outpatient balloon catheter versus expectant management for post-term labor induction in nulliparous women: A randomized trial.

Background— Increased use of labor induction has renewed interest in outpatient cervical ripening. Post-term pregnancy (i.e., ≥ 41 weeks) is a specific situation of increased neonatal risk, including greater risk of perinatal death and adverse perinatal outcomes. While a high proportion of these patients will need induction, outpatient management of this specific population has never been studied. Therefore, our objective was to compare two policies of management of post term pregnancies: the use of a transcervical Foley catheter for outpatient cervical ripening compared with expectant management. Methods— Multicenter, randomized controlled open-label study comparing home induction with a Foley catheter versus expectant management. Inclusion criteria were nulliparous, live singleton fetus in a vertex position, post-term (at 41 + 4 days), requiring cervical ripening (Bishop score < 6), intact membranes, and distance home-hospital within 40 minutes. The primary endpoint was change in Bishop score beetween randomization (41 + 4 days) and consultation (41 + 5 days). Results— Forty-five women were included: 21 in the home induction group and 24 in the control group. The study was stopped due to low recruitment. The difference in Bishop score increases one day after randomization approached significance (p = 0.055), with home induction showing a larger change compared with expectant management (Cohen's d = 0.60; 95% confidence interval [CI] −0.002 to 1.21). Regarding change in Bishop score, 81% of home induction group patients had a better score at 41 + 5 days versus 52.2% in the control group (relative risk = 1.55; 95%CI 0.99 to 2.15). Conclusion— By specifically evaluating home induction in nulliparous women with post term pregnancies, we observed a Bishop score improvement in the home induction group. These data support further evaluation of induction methods and birth experiences in a larger cohort of this population. Trial registrationThe study was registered under European policy (number EudraCT 2015-A01298-41) and on www.clinitrials.gov (number NCT02932319). Date of registration: 13/10/2016, Date of initial participant enrollment: 31/03/2017