Balloon Implantation Research Articles

Is Gastric Balloon Implantation Still an Effective Procedure for the Management of Obesity and Associated Conditions? Findings from a Multi-Center Study.

Both surgical and endoscopic procedures represent a mainstay of obesity treatment. Several procedures have been developed in recent years, although their impact on obesity is variable. This study examines and presents the results of a 6-month gastric balloon implantation (GBI). The data from the German Bariatric Surgery Registry (GBSR) for the period from 2005 to 2021 were subjected to a multi-center analysis. Six months following GBI, demographic data, the peri-interventional course, weight, BMI reduction, as well as the development of comorbidities (arterial hypertension (aHTN), diabetes mellitus (T2D), reflux (GERD), and sleep apnea syndrome (OSAS)), were evaluated in male and female patients. Of 3754 patients, 788 (45.3% male, 54.7% female) met the inclusion criteria for the study. Following 6 months of therapy, an average weight loss of 19.3 ± 15.2 kg was observed in male patients, while female patients exhibited an average weight loss of 16.3 ± 13.1 kg (p = 0.013). The EWL was found to be significantly higher in female patients than in male patients (24.8 vs. 18; p < 0.001). BMI reduction, %TWL, and mortality rate showed no significant disadvantage in either group (p > 5%). After 6 months of therapy, there was a significant advantage for women in the remission of aHTN. The remaining comorbidities did not differ significantly between the two groups (p > 5%). GBI is an efficacious procedure for the treatment of obese patients with mild obesity and comorbidities or as a bridging procedure prior to planned bariatric surgery.

Shoulder balloon spacer for massive irreparable rotator cuff tears results in significant improvements.

The aim of the present study was to assess the effectiveness of balloon implantation in patients with irreparable supraspinatus tears alone or in combination withother rotator cuff (RC) tendon tearsand the effect of several covariables, such as age, gender, status of the long head biceps, with or without tendon repair and regardless the number of tendon involved. Patients enrolled from 'San Carlo' Hospital of Potenza (Italy, IT), from January 2012 to September 2014, underwent arthroscopic implantation of shoulder balloon by a single surgeon, and followed for 3 years. The American Shoulder and Elbow Surgeons (ASES) and Constant score (CS) were administered pre-, post-operatively at 12 months, and then annually. Patients were classified on the basis of the number of tendons involved in the tears and treatment performed, considering the reparability of the tendons themselves. Gleno-humeral joint osteoarthrosis (OA) was evaluated through shoulder radiographs and classified according to the Samilson-Prieto classification, at the first examination and at the final follow-up. Statistical improvements were evaluated using a variance model (least-squares means)and a T distribution test for the evaluation between different treatment groups. A total of 61 procedures were performed, and eight patients were lost during follow-up. The mean baseline CS was 30.2 ± 15.4 with statistically significant improvement, respectively, at 1-, 2- and 3-year follow-up to 69.3 ± 4.2, 74.6 ± 3.6 and 69.7 ± 5.1 respectively. ASES score at baseline was 22.5 ± 10.9, with a statistically significant improvement to 69.7 ± 9.2, 68 ± 17.8 and 71.2 ± 16.6 at 1-, 2- and 3-year follow-up, respectively. Tenotomy or absence of long head biceps at presentation did not influence results (n.s.), with no difference according to gender and age. At final follow-up, 24 patients (43.9%) showed progression of glenohumeral OA. One patient required secondary surgery for shoulder replacement after 18 months for persistent pain and one patient required implant removal following post-operative laser treatment. Arthroscopic rotator cuff tears repair with subacromial spacer balloon implantation showed statistically significant clinical and functional improvement at 3-year follow-up. Patients treated with combined partial repair and subacromial spacer balloon implantation experienced good results independent of gender, age, type of tear and long-head biceps tendon status. The risks related to this procedure appear to be minimal. Level IV.

Long-term evaluation of the safety of a rectal-prostate spacer, the ProSpace® balloon, in patients treated with radiotherapy for prostate cancer

BackgroundDue to the close proximity of the prostate and rectum, rectal toxicity remains a major problem in patient treated by radiotherapy for prostate adenocarcinoma. One method of increasing the distance between the prostate and the rectum is to use a spacer implanted into the rectoprostatic space. This report describes the long-term outcomes obtained with a new ballon spacer.MethodsPatients treated with curative radiotherapy for low- or intermediate-risk prostate adenocarcinoma, who underwent insertion of the ProSpace® (BioProtect Ltd, Tzur Yigal, Israel) rectal-prostate balloon spacer, were included. The main objective was to evaluate the dosimetric benefit of the spacer for OARs. The secondary objectives were to evaluate the feasibility and tolerability of ProSpace® balloon placement and to evaluate its long-term therapeutic efficacy and tolerance.ResultsBetween October 2013 and March 2015, 16 patients were enrolled in the Pasteur Clinic, Toulouse, France. The median follow-up was 85.5 months. From top to bottom, the space created was a mean of 16.3 mm (range: 11–20.5 mm) at the base of the prostate, 12.1 mm (range: 4–16 mm) at the middle and 8.9 mm at the apex (range: 5–15 mm). On average, rectal volumes receiving a dose of 70 Gy, 60 Gy and 50 Gy were significantly lower after balloon implantation: -4.81 cc (1.5 vs. 6.3; p < 0.0005), -8.08 cc (6.4 vs. 14.5; p = 0.002) and -9.06 cc (16.7 vs. 25.7; p = 0.003), respectively. There were significant differences in coverage after balloon implantation: Median V95% (p < 0.0005), median Dmin (p = 0.01) and median V98% (p < 0.001) were higher after balloon implantation. At 5 years, cumulative gastrointestinal toxicity was grade 1 in 6% (1/16 patients). No toxicity of grade 2 or higher was found. At 5 years, no urinary toxicity grade 3 or 4 toxicity was found. The QoL was not deteriorated.ConclusionsThe use of the ProSpace® balloon seems to be well accepted by patients, allowing a double dosimetric gain: a decrease in doses received by the rectum and an improvement in the coverage of the high-risk PTV. The long-term gastrointestinal toxicity remains low and QoL is preserved in all treated patients.

Remote Ischemic Preconditioning Before Drug-Coated Balloon Implantation can Improve the Long-Term Prognosis of Patients with CAD.

Drug-coated balloons (DCBs) have become increasingly vital to percutaneous coronary intervention, offering many advantages. However, a significant challenge is that many patients are intolerant to the myocardial ischemia caused by DCB dilation. Remote ischemic preconditioning (RIPC) is known to enhance heart's tolerance to ischemia and hypoxia. This study investigated whether preoperative RIPC could extend the tolerated DCB inflation time and improve the long-term prognosis of patients with coronary artery disease (CAD). A total of 653 patients with CAD were recruited and randomized into a RIPC group (n = 323) and a control (n = 330) group. The RIPC group underwent RIPC on the left upper limb twice daily, starting three days before the DCB implantation. The patients were followed up for one year after the operation, and 197 patients returned for coronary angiography (CAG) examination where the quantitative flow ratio (QFR) of the target vessels was measured. The primary endpoint of the study was the incidence of target lesion failure (TLF), which included target lesion revascularization (TLR), target vessel myocardial infarction, and cardiac death. The secondary endpoint was the rate of QFR loss in the target vessels. The findings revealed a significantly lower incidence of TLR in the RIPC group compared to the control group. Additionally, at the one-year follow-up, the rate of QFR loss in target vessels was lower in the RIPC group than in the control group. The preoperative application of RIPC effectively extended the duration patients could tolerate DCB inflation. Furthermore, this approach positively impacted the long-term prognosis of CAD patients undergoing DCB treatment. NCT04766749.

Evaluation of a Balloon Implant for Simultaneous Magnetic Nanoparticle Hyperthermia and High-Dose-Rate Brachytherapy of Brain Tumor Resection Cavities

Previous work has reported the design of a novel thermobrachytherapy (TBT) balloon implant to deliver magnetic nanoparticle (MNP) hyperthermia and high-dose-rate (HDR) brachytherapy simultaneously after brain tumor resection, thereby maximizing their synergistic effect. This paper presents an evaluation of the robustness of the balloon device, compatibility of its heat and radiation delivery components, as well as thermal and radiation dosimetry of the TBT balloon. TBT balloon devices with 1 and 3 cm diameter were evaluated when placed in an external magnetic field with a maximal strength of 8.1 kA/m at 133 kHz. The MNP solution (nanofluid) in the balloon absorbs energy, thereby generating heat, while an HDR source travels to the center of the balloon via a catheter to deliver the radiation dose. A 3D-printed human skull model was filled with brain-tissue-equivalent gel for in-phantom heating and radiation measurements around four 3 cm balloons. For the in vivo experiments, a 1 cm diameter balloon was surgically implanted in the brains of three living pigs (40–50 kg). The durability and robustness of TBT balloon implants, as well as the compatibility of their heat and radiation delivery components, were demonstrated in laboratory studies. The presence of the nanofluid, magnetic field, and heating up to 77 °C did not affect the radiation dose significantly. Thermal mapping and 2D infrared images demonstrated spherically symmetric heating in phantom as well as in brain tissue. In vivo pig experiments showed the ability to heat well-perfused brain tissue to hyperthermic levels (≥40 °C) at a 5 mm distance from the 60 °C balloon surface.

Clinical study of renal artery cold perfusion combined with laparoscopic nephron retention in the treatment of complex renal angiomyolipoma.

The aim of this study is to summarize the surgical experience of renal artery cold perfusion combined with laparoscopic nephron preserving surgery for the treatment of complex renal angiomyolipoma and to evaluate the safety and feasibility of this surgical protocol. Clinical data of nine patients who received renal artery cold perfusion combined with laparoscopic nephron preserving surgery for complex renal angiomyolipoma in our hospital from February 2017 to August 2020 were retrospectively analyzed. The study parameters included imaging findings, total renal function before and after surgery, glomerular filtration rate (GFR) of affected kidney before and after surgery, and related complications. Eight of the nine patients successfully completed the operation, one patient was intolerant to renal artery balloon implantation, and the success rate of the operation was 88.89%. The mean maximum tumor diameter was 6.8 cm, and RENAL score was 7 points. Postoperative total renal function and GFR of the affected kidney had no significant changes compared with that before surgery, and imaging examination showed no tumor residue or recurrence. This surgical procedure is safe and feasible for complex renal angiomyolipoma and can be used as a surgical option for renal hamartoma. The long-term effect needs to be confirmed by further studies.

Experience in the development of a system for repeated prosthetic heart valves

The failure of heart valve bioprostheses, requiring repeated intervention to replace them, is a serious drawback that narrows the scope of such devices. The present study demonstrates the experimental investigation of a medical device designed to partially solve the problem of repeated interventions on heart valves, primarily with an emphasis on reducing the duration and trauma of such procedures due to the sutureless balloon implantation method of the «valvein- valve» method.Material and methods. The paper presents a series of in silico, in vitro and in vivo experiments to evaluate various aspects of the device under development. Numerical modeling of the final shape setting to the supporting frame of the heart valve prosthesis to select the most promising concept for prototyping was carried out in the Abaqus/CAE (Dassault Systèmes, France) based on the finite element method. The selected optimal support frame model was prototyped in the form of a series of prosthesis samples of four standard sizes for hydrodynamic studies of quantitative characteristics in vitro. The study was carried out in the Vivitro Labs unit (Vivitro Labs, Canada), imitating the physiological mode of the heart, the prostheses were examined for the mitral position. The developed prototypes of the device were supplemented with related products, an implant holder and a balloon catheter, after which the proposed method of sutureless fixation was validated in an in vitro implantation procedure on a bovine heart model and a series of in vivo (n = 3) chronic experiments on animals.Results. In the course of numerical simulation, it was shown that in Model No. 3 of the supporting frame of the prosthesis, the smallest stresses occur – with an amplitude of up to 490 MPa. For other concepts (Models No. 1 and No. 2), this indicator was significantly higher, 543 and 514 MPa, respectively. Prototypes obtained on the basis of the selected shape of the support frame demonstrated satisfactory hydrodynamic characteristics: effective hole area 190-261 mm2, regurgitation volume 6–9 ml/cycle, average transprosthetic gradient 4.4–6.4 mmHg, depending on size. The study of the technology of sutureless balloon implantation in an in vitro model of the heart and the subsequent chronic experiment on sheep confirmed the main idea of the system – the possibility of a significant reduction in the duration of repeated prosthetics. It has been shown that the time of suture implantation of the “classic” frame prosthesis of the mitral valve is 23–29 minutes, with a total access time of 41–52 minutes. When implanting the experimental device, the sutureless prosthesis itself took 4–6 minutes, access time 24–29 minutes. At the same time, one-month results of an echocardiographic study of the operation of the prosthesis demonstrated satisfactory hemodynamics.Conclusions. This work demonstrates a consistent series of tests of the system being developed for repeated heart valve replacement, which substantiates some design solutions, confirms the effectiveness and viability of the chosen approach to sutureless minimally invasive implantation.

Outcomes of reverse total shoulder arthroplasty following subacromial balloon spacer implantation

BackgroundSubacromial balloon spacer implantation can be used in the treatment of irreparable rotator cuff tears; but in cases of treatment failure reverse total shoulder arthroplasty (RTSA) may be indicated. The effect of a previously performed subacromial balloon implantation on the outcomes of a subsequent RTSA is unknown. MethodsA single-center retrospective matched cohort study was performed on patients with a history of subacromial balloon spacer implantation who subsequently underwent RTSA in the same shoulder between 2010 and 2021 (Balloon group). A control group of patients who underwent RTSA for irreparable cuff tear/cuff tear arthropathy during the same time period without prior subacromial balloon implantation history was identified and matched by the number of previous rotator cuff repair surgeries and age (No Balloon group). The minimum follow-up was 1 year. Data collected included range of motion, subjective shoulder value, visual analog scale for pain, Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score, and the proportion of patients achieving patient acceptable symptomatic state (PASS). ResultsThirty cases were included, equally distributed between the two groups. The mean follow-up was 46 ± 23 months without significant differences between groups. The Balloon group included only male patients, whereas the No Balloon group comprised of 47% female patients. The Balloon group had a less advanced arthritic disease as evidenced by a lower Hamada grade compared to the No Balloon group (P = .03). There were no significant differences in preoperative or postoperative range of motion between groups, with an average forward flexion increase of 39° and no gain in rotations. Patient-reported outcomes were comparable between groups: visual analog scale, 4.7 vs. 3.3; subjective shoulder value, 50 vs. 64; and QDASH, 65 vs. 49 (all P > .05). There were four (27%) postoperative complications leading to reintervention in the Balloon group and one (7%) in the No Balloon group (P = .15). ConclusionIn this preliminary study, patients undergoing RTSA for irreparable cuff tear/cuff tear arthropathy had comparable outcomes irrespective of a history of previous subacromial balloon spacer implantation. Further studies in a larger population are indicated to examine the trend toward inferior patient-reported outcomes observed in this small series.

Subacromial Balloon Implantation for the Treatment of Irreparable Posterosuperior Rotator Cuff Tears

Despite the development of various therapeutic options, surgical management of irreparable rotator cuff tears (IRCTs) remains controversial. Recently, implantation of a biodegradable subacromial balloon spacer (InSpace, Stryker Corporation; Kalamazoo, MI) has gained considerable interest for the treatment of certain IRCTs. The reported outcome of balloon implantation has not been consistent, likely due to differing indications and technical approaches. The purpose of this article is to present a reproducible arthroscopic technique for implantation of a subacromial balloon and to review the literature published to date, regarding the efficacy and outcomes of this procedure.

Adjustable continence therapy (proACT) for the treatment of male stress urinary incontinence post-prostatectomy: a systematic review and meta-analysis (2023 update).

Stress urinary incontinence (SUI) is a key factor for post-prostatectomy (RP) quality of life. Current international guidelines struggle to find the adequate place for each kind of surgeries. The aim of this systematic review and meta-analysis considering updated evidence is to assess the efficacy and safety of proACT in treating male patients with post-RP SUI. A review of the literature was performed by searching the PubMed database. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. 18 studies involving 1570 patients mean age of 68.8 (EC 2.1) were included. The mean follow-up reported was 34.7months (EC 17.7; median 38.5; range 1-128months). An average of 60.7% (EC 27) and 40.4% of patients suffered from mild-to-moderate and severe incontinence, respectively. The overall dryness rate was 55.1% (EC 19.3) while respecting the definition of 0-1 pads per day, and the mean dryness rate was 53% (EC 0.2). The mean overall complication rate was 31.2% (EC 18.3%), including an explantation rate of 26.5% (EC 15.3) and a reoperation rate of 22.7% (EC 8.7). The methodological quality of the 18 studies was very heterogeneous. Implantation of proACT adjustable balloons is a minimally invasive technique that provides medium outcomes (53%) with a strict definition of dryness (0-1 PPD) and important complication rate (31.2%). Past of irradiation is a negative predictive factor for incontinence.

ST-elevation acute coronary syndrome with thrombotic occlusion of the proximal segment of the circumflex artery in a patient with antiphospholipid syndrome: successful drug-coated balloon implantation

ST-elevation acute coronary syndrome with thrombotic occlusion of the proximal segment of the circumflex artery in a patient with antiphospholipid syndrome: successful drug-coated balloon implantation

InSpace Balloon for the Management of Massive Irreparable Rotator Cuff Tears: A Systematic Review and Meta-Analysis.

The best course of action for massive irreparable rotator cuff tears (MIRCTs) is not universally agreed upon. Numerous surgical techniques have been discussed. The implantation of a biodegradable spacer into the subacromial area has been documented since 2012 by several authors. The implantation method is touted as being simpler, repeatable, and less invasive than other solutions that are now available. The purpose of this systematic review and meta-analysis, being the first of its kind, was to evaluate the literature to see the efficacy of InSpace balloon (ISB) implantation in the management of MIRCTs. Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, and with 2 researchers assessing and analyzing each study separately, an extensive electronic search of the literature was conducted in the PubMed database from 1961 until July 27, 2022. Fourteen studies were included in this systematic review and three in the meta-analysis. Eleven out of fourteen studies favored ISB use for MIRCTs, while only three were against its use. All spacers were arthroscopically implanted in the subacromial space. Three studies were included in the meta-analysis. The differences in the compared outcomes were statistically insignificant. A controversy about the use of ISB remains in patients with MIRCTs. Both good and bad outcomes were reported. However, the majority of patients had good clinical outcomes across several grading scales, radiographic evidence of improved impingement, and self-report that they would redo the procedure in hindsight. To draw more solid conclusions and have statistically significant results in the meta-analysis, more randomized controlled trials and comparative studies comparing this device to other treatments are needed.

S-57-6: OBSTRUCTIVE SLEEP APNEA INDUCED GUT DYSBIOSIS STIMULATES A PROINFLAMMATORY RESPONSE THAT PROMOTES NEUROINFLAMMATION AND HYPERTENSION

Objective: Obstructive sleep apnea (OSA) is an independent risk factor for hypertension (HT). We have demonstrated that OSA induces gut dysbiosis, and a dysbiotic microbiota is causal in the development of HT. The mechanisms linking gut dysbiosis to blood pressure (BP) regulation are unclear. Recent studies demonstrate gut dysbiosis induces a pro-inflammatory host response resulting in peripheral- and neuro-inflammation, key factors in the development of HT. We hypothesized that OSA induced gut dysbiosis elicits a pro-inflammatory response that promotes neuroinflammation and HT. Methods: OSA was induced in 8-week-old male rats by repeatedly inflating a surgically implanted tracheal balloon. Sham rats underwent balloon implantation without inflations. After two weeks of apneas, lymphocytes were isolated from aorta, brain, cecum, ileum, mesenteric lymph node, and spleen for assessment by flow cytometry. In studies examining IL-17, a monoclonal antibody to neutralize IL-17 was injected every 48 hours during the 2 weeks of OSA. To track lymphocytes originating from the gut, cells in the Peyers patches of the small intestine were labelled by injection of carboxyfluorescein succinimidyl ester (CFSE) dye. Results: Two weeks of OSA significantly decreased anti-inflammatory regulatory T (Treg) cells and increased TH17 (IL-17+) in the brain, cecum, and ileum (n = 7, p &lt; 0.05). A significant increase in the Th17/Treg ratio was observed in brain, cecum and ileum of OSA, versus sham, rats (n = 7, p &lt; 0.05). To examine the role of TH17 cells, we injected an IL-17 neutralizing antibody or control IgG antibody during the 2 weeks of OSA. Compared to OSA rats receiving IgG control, neutralization of IL-17 significantly reduced BP of OSA rats (n = 6, p &lt; 0.05). Additionally, neutralization of IL-17 resulted in a significant increase of Tregs and decreased Th1 cells in brain, cecum and ileum of OSA rats (n = 6, p &lt; 0.01). To examine the distribution of lymphocytes originating from the gut, cells in the Peyers patches of sham and OSA rats were labelled with CFSE. We observed significant increases in CFSE+ Th1, Th2, and Th17 cells in the brain, MLN and spleen of OSA as compared to sham rats (n = 6, p &lt; 0.05). Conclusion: Overall, we found that OSA induced gut dysbiosis is associated with a pro-inflammatory response in the gut and brain that involves IL-17 signaling. Our findings suggest that gut dysbiosis may serve as the trigger for widespread inflammation, and treatment strategies to prevent or reverse gut dysbiosis may prove useful in reducing neuroinflammation and HT.

PHSOR03 Presentation Time: 12:40 PM: Radiation Dosimetry of a Dual-Modality Balloon Implant for Simultaneous HDR Brachytherapy and Magnetic Nanoparticle Hyperthermia to Treat Brain Tumor Resection Cavities

<h3>Purpose</h3> Glioblastoma multiforme (GBM) is an aggressive brain tumor that generally recurs locally and has a dismal median survival of less than 18 months<i>. In vivo</i> studies have shown that simultaneous hyperthermia and radiation can enhance the radiation response by a factor of up to 5. Our group developed a novel dual-modality thermobrachytherapy (TBT) balloon device to accomplish this goal. The balloon will combine magnetic fluid hyperthermia and HDR brachytherapy, which will be delivered right after brain tumor resection, so that the at-risk tissue adjacent to the tumor resection cavity will conform to the balloon shape and receive uniform radiation and thermal dose. This abstract focuses on the possible effects of hyperthermia on radiation dosimetry as well as the effects of balloon shape. <h3>Methods</h3> The current version of our TBT balloon device consists of a balloon filled with magnetic nanoparticle solution (nanofluid) and a flexible sheath with three ports to insert the HDR catheter and fiber-optic thermal probe and inject the nanofluid. We tested the balloon in air and activated the nanofluid using an external magnetic field induced by a 133 kHz induction coil. Two balloon designs were tested: a spherical one with 4 cm diameter, and a teardrop-shaped balloon with an axial diameter of 3 cm and measuring 3.7 cm along the shaft. We used Gafchromic film and RIT imaging software to analyze the in-air dose distribution of an HDR source dwell in both types of balloons, filled with distilled water and then nanofluid, as well as without and with simultaneous hyperthermia, where the coil power was escalated until reaching intra-balloon temperatures greater than 55°C. Experimental setup and radiation dose profiles can be found in Figure 1. <h3>Results</h3> The presence of the nanofluid, magnetic field and heat up to 66°C did not affect radiation dose distribution significantly in the spherical balloon (less than 10% difference). However, the teardrop-shaped balloon dose profiles showed a notable difference (about 20%) in dose magnitude with the presence of nanofluid and/or heat. Nonetheless dose distributions looked symmetrical in all cases. <h3>Conclusions</h3> The current device design is still in progress, but this study illustrated that a spherical balloon shape may be preferential for simultaneous hyperthermia and HDR brachytherapy. Furthermore, this radiation dosimetry study demonstrated compatibility and robustness of the prototype balloon components and desirable symmetrical dose distribution.

Abstract 095: Obstructive Sleep Apnea Induced Gut Dysbiosis Stimulates A Proinflammatory Response In Gut And Brain That Contribute To Hypertension

Objective: Obstructive sleep apnea (OSA) is an independent risk factor for the development of hypertension (HT). OSA induces gut dysbiosis, and a dysbiotic microbiota is causal in the development of HT. The mechanisms linking gut dysbiosis to blood pressure (BP) regulation remain unclear. Gut dysbiosis can induce a pro-inflammatory response of the host resulting in peripheral- and neuro-inflammation, key factors in the development of HT. We hypothesized that OSA induced gut dysbiosis elicits a pro-inflammatory response that promotes neuroinflammation and HT. Methods: OSA was induced in 8-week-old male rats (60 apneas/hr for 8 hrs during sleep) by inflating a tracheal balloon. Sham rats underwent balloon implantation without inflations. After 2 weeks of apneas, lymphocytes were isolated from brain, cecum, ileum, mesenteric lymph node (MLN), and spleen for flow cytometry. The role of IL-17 was tested by treating rats with a monoclonal antibody to IL-17 to neutralize circulating IL-17. To track the distribution of lymphocytes originating from the gut, cells in the Peyer’s patches of the small intestine were labelled by injection of carboxyfluorescein succinimidyl ester (CFSE) dye. Results: Following 2 weeks of OSA we found a significant decrease in anti-inflammatory regulatory T (Treg) cells along with an increase in T H 17 (IL-17+) in the brain, cecum, and ileum (n=7, p&lt;0.05 for each). To examine the role of T H 17, we injected an IL-17 neutralizing antibody or control IgG during the 2 weeks of OSA. Compared to OSA rats receiving IgG control, neutralization of IL-17 significantly reduced BP of OSA rats (n=6, p&lt;0.05). IL-17 neutralization also resulted in a significantly increased Tregs and decreased Th1 cells in brain, cecum and ileum of OSA rats (n=6, p&lt;0.01 for each). To examine the distribution of lymphocytes originating from the gut, cells in the Peyer’s patches were labelled with CFSE. We observed significant increases in CFSE+ Th1, Th2, and Th17 cells in the brain, MLN and spleen of OSA as compared to sham rats (n=6, p&lt;0.05). Conclusion: OSA induced gut dysbiosis is associated with a pro-inflammatory response in the gut and brain that involves IL-17 signaling. Treatment strategies to prevent gut dysbiosis may prove useful in reducing neuroinflammation and HT.

New adjustable modular hemipelvic prosthesis replacement with 3D-print osteotomy guide plate used in periacetabular malignant tumors: a retrospective case series

BackgroundPeriacetabular malignant tumor seriously endangers the life and health of patients. Hemipelvic replacement provides a good method for patients who want complete resection of the tumor while retaining or restoring the function of the affected limb.ObjectiveTo investigate the performance and clinical application of the new adjustable modular hemipelvic prosthesis and to compare the effects of three kinds of hemipelvic prosthesis.MethodsIn this study, 23 patients, with an average age of 44.6 years (21–75 years), were collected, who received hemipelvic replacement with new adjustable, modular, and screw-rod system hemipelvic prosthesis. Preoperative preparation was conducted on them, and operative complications were recorded. Postoperative functional follow-up was performed regularly.ResultsThe average operation time was 319 min (170–480 min), and the average blood loss was 2813 ml (1000 mL-8000 ml). The incidence of complications was 47.8%, and type A (wound-related complications) had the highest incidence (34.8%). Postoperative dislocation occurred in 3 cases (13.0%), and no dislocation occurred in the new adjustable modular hemipelvic prosthesis group. The average MSTS score of the patients was 18.6 (10–23), and the average Harris score was 73.7 (53–87).ConclusionsThe new adjustable modular hemipelvic prosthesis has the feasibility of reconstruction and good functional outcome, making it ideal for periacetabular tumors. Furthermore, preoperative tumor-feeding artery embolization and abdominal aortic balloon implantation may be an effective choice to reduce intraoperative blood loss and facilitate the operation of tumor resection.

Obstructive Sleep Apnea Induced Gut Dysbiosis Stimulates a Proinflammatory Response that Promotes Neuroinflammation and Hypertension Sriram Ayyaswamy, Bojun Zhang, Huanan Shi, Sharon Phillips, Robert Bryan and David Durgan Baylor College of Medicine, Department of Anesthesiology, Houston, Texas, United States

Background and HypothesisObstructive sleep apnea (OSA) is an independent risk factor for the development of hypertension (HT). We have previously demonstrated that OSA induces gut dysbiosis, and a dysbiotic microbiota is causal in the development of HT. However, the mechanisms linking gut dysbiosis to blood pressure (BP) regulation are unclear. Recent studies have demonstrated that gut dysbiosis can induce a pro‐inflammatory response of the host resulting in peripheral‐ and neuro‐inflammation, key factors in the development of HT. We therefore hypothesized that OSA induced gut dysbiosis elicits a pro‐inflammatory response that promotes neuroinflammation and hypertension.MethodsOSA was induced in 8‐week‐old male rats (60 apneas/hour for 8 hours during the sleep phase) by repeatedly inflating a surgically implanted tracheal balloon. Sham rats underwent balloon implantation without inflations. After two weeks of apneas, lymphocytes were isolated from aorta, brain, cecum, ileum, mesenteric lymph node, and spleen for assessment by flow cytometry. In studies examining the role of IL‐17, a monoclonal antibody to IL‐17 was injected every 48 hours during the 2 weeks of apneas to neutralize circulating IL‐17. To track the distribution of lymphocytes originating from the gut, cells in the Peyer’s patches of the small intestine were labelled by microinjection of carboxyfluorescein succinimidyl ester (CFSE) dye.Summary of resultsFollowing 2 weeks of OSA we found a significant decrease in anti‐inflammatory regulatory T (Treg) cells along with an increase in TH17 (IL‐17+) in the brain, cecum, and ileum and TH1 (IFN‐γ+) in cecum and ileum (n=7, p&lt;0.05 for each). A significant increase in the Th17/Treg ratio, a sign of inflammation associated with hypertension, was observed in brain, cecum and ileum of OSA, versus sham, rats (n=7, p&lt;0.05 for each). To examine the role of TH17 cells, we injected an IL‐17 neutralizing antibody or control IgG antibody during the 2 weeks of OSA. Compared to OSA rats receiving IgG control, neutralization of IL‐17 significantly reduced BP of OSA rats after 1 and 2 weeks (n=6, p&lt;0.05 for each). Additionally, neutralization of IL‐17 resulted in a significant increase of Tregs and decreased Th1 cells and TNFα expressing cells in brain, cecum and ileum of OSA rats (n=6, p&lt;0.01 for each). To examine the distribution of lymphocytes originating from the gut, cells in the Peyer’s patches of sham and OSA rats were labelled with CFSE. We observed significant increases in CFSE+ Th1, Th2, and Th17 cells in the brain, MLN and spleen of OSA as compared to sham rats (n=6, p&lt;0.05).ConclusionOverall, we found that OSA induced gut dysbiosis is associated with a pro‐inflammatory response in the gut and brain that involves IL‐17 signaling. Our findings suggest that gut dysbiosis may serve as the trigger for widespread inflammation, and treatment strategies to prevent or reverse gut dysbiosis may prove useful in reducing neuroinflammation and HT.

Maternal and perinatal outcomes in placenta accreta spectrum disorders with prophylactic internal iliac artery balloon catheterization and embolization.

To summarize our five-year experience with managing patients diagnosed with wide range of PAS disorder and treated with prophylactic internal iliac balloon implantation prior to cesarean section and to assess maternal and fetal outcomes. Retrospective cohort study. A total of 30 patients were included in the study. Hysterectomy was performed in 10 cases - partial hysterectomy in six and total hysterectomy in four. Median estimated blood loss was 1.18 L. In two cases technical complications were noted. In one case bilateral internal iliac artery thrombosis requiring urgent surgical intervention occurred. A total of 30 live infants were delivered. Mean birth weight was 2435 g and mean Apgar score at 1', 5' and 10' minutes was 6.8, 8 and 8.7 respectively. After average 30 days of hospitalization all infants and their mothers were discharged in good clinical condition. Placenta accreta spectrum remains a challenge for obstetricians and gynecologists and despite interdisciplinary approach is associated with numerous complications with life-threatening postpartum hemorrhage being the most serious one. Prophylactic placement of iliac balloons is a minimally invasive and safe endovascular technique which allows rapid and effective control of postpartum bleeding in patients with PAS, with low complication rate for both mother and the child.

Biodegradable balloon spacer for massive irreparable rotator cuff tears is associated with improved functional outcomes, low revisions, and complications rate at minimum oneyear follow-up.

This study was designed to investigate the efficacy of the InSpace balloon spacer with a specific focus on clinical and patient-related parameters, functional scores InSpace durability, and satisfaction in patients with massive irreparable rotator cuff tears (IRCT) at minimum oneyear follow-up. Between 2010 and 2018, patients with symptomatic IRCTs were treated with InSpace balloon implantation. Demographic characteristics, concomitant procedures, and patient's reported outcomes (PROMs) were obtained as well as satisfaction rate and willingness to undergo the procedure again. Need for subsequent surgery and conversion to reverse total shoulder arthroplasty (RTSA) and time to conversion were also evaluated. Seventy-eight patients (mean age of 70years, range 46-86) who underwent an InSpace (OrthoSpace, Inc., Caesarea, Israel) balloon implantation were included. Mean follow-up was 56months (median = 49.6, range 16-129months). Sixteen out of our 29 pseudoparalytic patients (55.2%) exceed 90° of forward flexion post-surgery with mean improvement of 73° (20-150). Patients older than 65years of age displayed a statistically significant improved ASES score (60.6 to 46.4, P < 0.05). Patients who underwent a subscapularis (SSC) repair demonstrated a superior ASES score (63.4 compared to 50.4, P = 0.06). Based on the current study, spacer implantation is a low-risk, clinically effective treatment for the patients with IRCTs. Patient-specific parameters such as age, BMI, and gender should be considered during patient selection process. SSC tendon tears should be repaired if needed. Improvement in function and symptoms from this procedure may negate or delay the need for RTSA even for some of the pseudoparalytic patients.

Assessment of the role of IL6 and IL10 gene polymorphisms as a risk factor for the development of restenosis in patients after implantation of drug-eluting stents

Relevance. Currently, the number of percutaneous coronary interventions continues to increase, which leads to an increase in the absolute number of restenosis cases, which is the main complication of the long-term postoperative period. The search for risk factors responsible for restenosis and artery re-narrowing mechanisms in order to prevent this complication is an important goal in interventional cardiology. Risk factors for the restenosis development include clinical, angiographic and genetic factors. An active search for biomolecular markers associated with the coronary artery restenosis is currently underway. Objective: to study the role of polymorphic variants C-174G of the IL6 gene and C-819T of the IL10 gene as a risk factor for the development of restenosis in patients after stent implantation. Materials and Methods : The study included 113 patients with stable coronary artery disease, who had previously undergone balloon angioplasty and implantation of drug-eluting stents, and 62 patients with intact arteries that were included to the control group. Statistical data processing was carried out using the R-language program and the SPSS Statistics 20 software package. Results: GG genotype for IL6 gene was associated with the development of coronary artery disease. In the subgroup of patients over 65 years of age and instent restenosis, the GG genotype was significantly less frequent. The homozygous CC genotype for IL10 gene was associated with rapid angiographic in-stent restenosis progression.