scholarly journals Achieving stomal continence with an ileal pouch and a percutaneous implant

2022 ◽  
Vol 33 (1) ◽  
Author(s):  
Martin L. Johansson ◽  
Leif Hultén ◽  
Olof Jonsson ◽  
Heithem Ben Amara ◽  
Peter Thomsen ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Adverse Events ◽  
Biofilm Formation ◽  
Fibrous Tissue ◽  
Histological Evaluation ◽  
Granulation Tissue Formation ◽  
Reservoir Volume ◽  
Low Degree

AbstractIn this study, a soft-tissue-anchored, percutaneous port used as a mechanical continence-preserving valve in reservoir ileo- and urostomies was functionally and morphologically evaluated in eight dogs. During follow-up, the skin failed to attach to the implant, but the intestine inside the stoma port appeared to be attached to the mesh. After reaching adequate reservoir volume, the urostomies were rendered continent by attaching a lid to the implant. The experiments were ended at different time intervals due to implant-related adverse events. In only one case did the histological evaluation reveal integration at both the implant-intestine and implant-skin interfaces, with a low degree of inflammation and the absence of bacterial colonisation. In the remaining cases, integration was not obtained and instead mucosal downgrowth and biofilm formation were observed. The skin-implant junction was characterised by the absence of direct contact between the epidermis and the implant. Varying degrees of epidermal downgrowth, granulation tissue formation, inflammatory cell infiltration and bacterial growth and biofilm formation were prominent findings. In contrast, the subcutaneously located anchor part of the titanium port was well integrated and encapsulated by fibrous tissue. These results demonstrate the opportunity to achieve integration between a soft-tissue-anchored titanium port, skin and intestine. However, predictable long-term function could not be achieved in these animal models due to implant- and non-implant-related adverse events. Unless barriers at both the implant-skin and implant-intestine junctions are created, epidermal and mucosal downward migration and biofilm formation will jeopardise implant performance.

Physiological Pacing: A New Road to Future

2021 ◽  
pp. 263246362097804
Author(s):  
Vanita Arora ◽  
Pawan Suri
Keyword(s):  
Side Effects ◽  
Fibrous Tissue ◽  
Cardiac Pacing ◽  
His Bundle ◽  
Anatomy And Physiology ◽  
Long Term Follow Up ◽  
Pacing Lead ◽  
The Right

Anatomy and physiology are the basis of human body functioning and as we have progressed in management of various diseases, we have understood that physiological intervention is always better than an anatomical one. For more than 50 years, a standard approach to permanent cardiac pacing has been an anatomical placement of transvenous pacing lead at the right ventricular apex with a proven benefit of restoring the rhythm. However, the resultant ventricular dyssynchrony on the long-term follow-up in patients requiring more than 40% ventricular pacing led to untoward side effects in the form of heart failure and arrhythmias. To counter such adverse side effects, a need for physiological cardiac pacing wherein the electrical impulse be transmitted directly through the normal conduction system was sought. His bundle pacing (HBP) with an intriguing alternative of left bundle branch pacing (LBBP) is aimed at restoring such physiological activation of ventricles. HBP is safe, efficacious, and feasible; however, localization and placement of a pacing lead at the His bundle is challenging with existing transvenous systems due to its small anatomic size, surrounding fibrous tissue, long-learning curve, and the concern remains about lead dislodgement and progressive electrical block distal to the HBP lead. In this article, we aim to take the reader through the challenging journey of HBP with focus upon the hardware and technique, selective versus nonselective HBP, indications and potential disadvantages, and finally the future prospects.

scholarly journals POS0815 CLINICAL CHARACTERISTICS, IMAGING PHENOTYPE, AND LONG-TERM OUTCOMES OF TAKAYASU ARTERITIS PATIENTS WITH HYPERTENSION

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 661.1-661
Author(s):  
Y. Sun ◽  
L. Ma ◽  
H. Chen ◽  
C. Rongyi ◽  
L. Jiang
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Clinical Features ◽  
Takayasu Arteritis ◽  
Pressure Control ◽  
Free Survival ◽  
The World ◽  
Cluster 2

Background:Hypertension occurred in 30-80% of TAK patients around the world. The occurrence of hypertension might severely worsen TAK prognosis. Nevertheless, data describing the specific imaging features in hypertensive TAK patients and the associations between hypertensive severity, blood pressure control status and long-term outcome were still lacking.Objectives:To investigate the characteristics and associations of hypertensive characteristics with adverse events-free survival in Takayasu arteritis (TAK) patients with hypertension.Methods:This research was based on a prospectively on-going observational cohort-East China Takayasu Arteritis (ECTA) cohort. In all, 618 TAK patients, who registered in the ECTA cohort up to December 2019, were enrolled. The main outcome was the adverse-events-free survival among hypertensive TAK patients during the follow-up ended on August 2020.Results:Totally, 204 (33.0%) patients suffered from hypertension, with 48 (23.5%), 62 (30.4%), and 94 (46.1%) mild, moderate, and severe hypertension, respectively. Cluster analysis indicated three imaging phenotypes for hypertensive TAK patients: Cluster 1: involvement of the abdominal aorta and/or renal artery (n=56, 27.5%); Cluster 2: involvement of the ascending aorta, thoracic aorta, and the aortic arch and its branches (n=38, 18.6%); Cluster 3: combined involvement of Cluster 1 and Cluster 2 (n=111, 54.4%). By the end of the follow-up, the blood pressure control rate was 50.8%, while the adverse-events-free survival was 67.9% in the entire hypertensive population. Multivariate Cox regression analysis indicated that well-controlled blood pressure (HR=2.13, 95%CI 1.32–3.78, p=0.047), co-existence of severe aortic valve regurgitation (HR=0.87, 95%CI 0.64–0.95, p=0.043), Cluster 1 (HR=0.69, 95%CI 0.48–0.92, p=0.017) and Cluster 3 (HR=0.72, 95%CI 0.43–0.94, p=0.048) imaging phenotype was associated with the adverse-events-free survival.Conclusion:Patients with controlled hypertension showed better adverse-events-free survival, while those with the Cluster 1 imaging phenotype were more likely to suffer from worse adverse-events-free survival. Hypertension occurred in 30-80% of TAK patients around the world. The occurrence of hypertension might severely worsen TAK prognosis.References:[1]Johnston SL, Lock RJ, Gompels MM. Takayasu arteritis: a review. J Clin Pathol 2002; 55:481–6.[2]Watanabe Y, Miyata T, Tanemoto K. Current clinical features of new patients with Takayasu arteritis observed from a cross-country research in Japan: age and sex specificity. Circulation 2015; 132:1701–9.[3]Yilmaz N, Can M, Oner FA, et al. Impaired quality of life, disability and mental health in Takayasu’s arteritis. Rheumatol. (Oxford) 2013; 52:1898–904.[4]Laurent A, Julien H, Nicolas L, et al. Takayasu arteritis in France: a single-center retrospective study of 82 cases comparing white, North African, and black patients. Medicine 2010; 89:1–17.[5]Mwipatayi BP, Jeffery PC, Beningfield SJ, et al. Takayasu arteritis: clinical features and management: report of 272 cases. ANZ J Surg 2005; 75:110–7.Disclosure of Interests:None declared

scholarly journals Long-term outcomes after endoscopic retrograde pancreatic drainage for symptomatic pancreaticojejunal anastomotic stenosis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Akihiko Kida ◽  
Yukihiro Shirota ◽  
Taro Kawane ◽  
Hitoshi Omura ◽  
Tatsuo Kumai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Anastomotic Stenosis ◽  
Technical Success ◽  
Long Term Outcomes ◽  
Endoscopic Retrograde ◽  
Technical Success Rate ◽  
Registration Number ◽  
Clinical Trial Register

AbstractThere is limited evidence supporting the usefulness of endoscopic retrograde pancreatic drainage (ERPD) for symptomatic pancreaticojejunal anastomotic stenosis (sPJS). We examined the usefulness of ERPD for sPJS. We conducted a retrospective analysis of 10 benign sPJS patients. A forward-viewing endoscope was used in all sessions. Following items were evaluated: technical success, adverse events, and clinical outcome of ERPD. The technical success rate was 100% (10/10) in initial ERPD; 9 patients had a pancreatic stent (no-internal-flap: n = 4, internal-flap: n = 5). The median follow-up was 920 days. Four patients developed recurrence. Among them, 3 had a stent with no-internal-flap in initial ERPD, the stent migrated in 3 at recurrence, and a stent was not placed in 1 patient in initial ERPD. Four follow-up interventions were performed. No recurrence was observed in 6 patients. None of the stents migrated (no-internal-flap: n = 1, internal-flap: n = 5) and no stents were replaced due to stent failure. Stenting with no-internal-flap was associated with recurrence (p = 0.042). Mild adverse events developed in 14.3% (2/14). In conclusions, ERPD was performed safely with high technical success. Recurrence was common after stenting with no-internal-flap. Long-term stenting did not result in stent failure.Clinical trial register and their clinical registration number: Nos. 58-115 and R2-9.

scholarly journals SAT0540 ONE-YEAR OUTCOMES AFTER RHEUMATIC IMMUNE-RELATED ADVERSE EVENTS FROM CHECKPOINT INHIBITORS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1227.2-1227
Author(s):  
E. Berard ◽  
T. Barnetche ◽  
L. Rouxel ◽  
C. Dutriaux ◽  
L. Dousset ◽  
...  
Keyword(s):  
Adverse Events ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Symptomatic Treatment ◽  
Musculoskeletal Symptoms ◽  
Day Range ◽  
One Year

Background:Description and initial management of rheumatic immune-related adverse-events (irAEs) from cancer immunotherapies have been reported by several groups but to date, few studies have evaluated the long-term outcomes and management of rheumatic irAEs (1).Objectives:To describe the long-term management and assess the one-year outcomes of patients who experienced rheumatic immune-related adverse events (irAEs) due to immune checkpoint inhibitors (ICI).Methods:This was a single-centre prospective observational study including patients referred for musculoskeletal symptoms while treated with ICI. After baseline rheumatological evaluation defining the clinical entity presented, follow-up visits were organised according to the type and severity of irAE. At one year, persistence of irAE, ongoing treatment, as well as cancer outcomes were assessed.Results:63 patients were included between September 2015 and June 2018. 24 patients (38%) presented with non-inflammatory musculoskeletal conditions managed with short-term symptomatic treatment and did not require specific follow-up. 39 patients (62%) experienced inflammatory manifestations, mimicking either rheumatoid arthritis (RA, n=19), polymyalgia rheumatica (PMR, n=16), psoriatic arthritis (PsA, n=3) and one flare of a preexisting axial spondyloarthritis. Overall, 32 patients (82%) received systemic glucocorticoids, with a median rheumatic dosage of 15mg/day (range: 5-60mg/day). None of the patients had to permanently discontinue ICI therapy for rheumatic irAE. 20 patients (67%) were still receiving glucocorticoids at one year, with a median dosage of 5mg/day (range: 2-20mg/day). Glucocorticoids were more frequently discontinued for patients with RA-like condition (44%) than PMR-like condition (23%), but no other predictive factor of glucocorticoids withdrawal could be identified. At one year, overall survival and progression-free survival were comparable between patients who were still receiving glucocorticoids for rheumatic irAE and patients who have discontinued. Eight patients required csDMARDs.Conclusion:At one year, a majority of patients required long-term low-dose glucocorticoids for chronic rheumatic irAE, which seems not altering oncological control.References:[1]Braaten TJ, Brahmer JR, Forde PM, et al. Immune checkpoint inhibitor-induced inflammatory arthritis persists after immunotherapy cessation. Ann Rheum Dis. 2019 Sep 20.Disclosure of Interests:None declared

scholarly journals Long-term follow-up results of medial opening wedge high tibia osteotomy with a pre-countered non-locking steel plate

2021 ◽  
Author(s):  
Simo S. A. Miettinen ◽  
Hannu J. A. Miettinen ◽  
Jussi Jalkanen ◽  
Antti Joukainen ◽  
Heikki Kröger
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Mechanical Axis ◽  
Steel Plate ◽  
Cox Regression ◽  
Opening Wedge ◽  
Cumulative Survival ◽  
Long Term Follow Up

Abstract Introduction This retrospective study investigated the long-term follow-up results of medial opening wedge high tibial osteotomy (MOWHTO) with a pre-countered non-locking steel plate implant (Puddu plate = PP) used for medial knee osteoarthrosis (OA) treatment. Materials and methods Consecutive 70 MOWHTOs (66 patients) were performed between 01.01.2004 and 31.12.2008 with the mean follow-up time of 11.4 (SD 4.5; range 1.2–16.1) years. The Kaplan–Meier survival analysis was used to evaluate the cumulative survival of the implant in terms of age (< 50 years old and ≥ 50 years old) and gender. Adverse events were studied and Cox regression analysis was used to evaluate risk factors [age, gender, body mass index (BMI), preoperative mechanical axis, severity of OA, use of bone grafting or substitution and undercorrection of mechanical axis from varus to valgus] for revisions. Results The estimates for the cumulative survival with no need for TKA after MOWHTO were 86% at 5 years, 67% at 10 years and 58% at 16.1 years (SE 0.6, CI 95% 11.1–13.5). A total of 33/70 (47%) adverse events occurred and 38/70 (54%) knees required some revision surgery during the follow-up. Cox regression did not show any statistically significant risk factors for revision. Conclusions The PP has feasible MOWHTO results with a cumulative survival of 67% at 10 years with no need for conversion to TKA. Many adverse events occurred and revision rate due to any reason was high. Age or gender did not have statistically significant differences in terms of survival.

scholarly journals Predictors of adverse prognosis in patients with infective endocarditis in a surgical referral center

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Scheggi ◽  
I Olivotto ◽  
N Ceschia ◽  
I Merilli ◽  
V Andrei ◽  
...  
Keyword(s):  
Renal Failure ◽  
Infective Endocarditis ◽  
Adverse Events ◽  
Ejection Fraction ◽  
Relapse Rate ◽  
Left Ventricular Ejection ◽  
All Cause Mortality ◽  
Fatal Adverse Events

Abstract Background Despite optimal medical and surgical treatment, mortality in infective endocarditis (IE) remains high. Aim of this study was to identify predictors of long term mortality for any cause, adverse event rate, relapse rate and valvular dysfunction at follow-up, in a high-volume surgical center. Methods We retrospectively analyzed 358 consecutive patients (127 women) admitted to our department with definite diagnosis of IE not device-related. IE occurred on native valves in 224 patients (63%); the infection involved the aortic valve in 192 (54%), mitral valve in 139 (39%) and tricuspid valve in 26 (7%). Overall 285 (80%) patients underwent surgery and 73 (20%) were treated conservatively, 38 due to absence of surgical indication and 35 due to refusal or prohibitive surgical risk. Long-term follow-up was obtained by structured telephone interviews. Primary endpoints were all-cause mortality, freedom from recurrent endocarditis, postoperative incidence of major adverse events (hospitalization for any cause, pace-maker implantation, new onset of atrial fibrillation, sternal dehiscence), worsening of left ventricular ejection fraction (LVEF) and valvular dysfunction. Results Mean age was 65 years (SD 15.2). Mean vegetation length was 8.9 mm (SD 7.6). Endocarditis was left-sided in 332 (93%). Average follow-up was 6 months. At univariable analysis, mortality was associated with female gender (p=0.031), age (p&lt;0.001), higher EuroSCORE 2 (p&lt;0.001), chronic renal failure (p&lt;0.001), diabetes (p=0.002), brain embolism on presentation (p=0.05), double valve infection (p=0.008), low ejection fraction (p&lt;0.001), paravalvular extension (p=0.031), prosthetic infection (p=0.018), exclusion from surgery if indicated (p&lt;0.001), high procalcitonin levels (p=0.035); factors associated with a significantly lower mortality were streptococcal infection (p=0.04; OR 0.34) and early surgery (p=0.009, OR 0.55). At multivariable analysis independent predictors of all-cause mortality were lower EF, EuroSCORE2, procalcitonin levels and diabetes. Non-fatal adverse events were associated with renal failure (p 0.035, OR 2.8). Relapse rate was associated with S aureus infection (p=0.005, OR 3.8), right-sided endocarditis (p&lt;0.001, OR 6.7) and drug abuse (p&lt;0.001, OR 9.4). Conclusions The present study shows that low EF, EuroSCORE2, procalcitonin levels and diabetes are independent predictors of death in patients with IE. Non-fatal adverse events are more frequent in patients with renal failure. Relapse rate is higher in drug abusers. These informations may help personalize follow-up strategies after acute admission for IE. Funding Acknowledgement Type of funding source: None

scholarly journals Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor–Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial

2019 ◽  
Vol 37 (2) ◽  
pp. 105-114 ◽  
Author(s):  
Thomas Ruhstaller ◽  
Anita Giobbie-Hurder ◽  
Marco Colleoni ◽  
Maj-Britt Jensen ◽  
Bent Ejlertsen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Contralateral Breast Cancer ◽  
Disease Free Survival ◽  
Luminal Breast Cancer ◽  
Free Survival ◽  
Long Term Follow Up ◽  
Disease Free

Purpose Luminal breast cancer has a long natural history, with recurrences continuing beyond 10 years after diagnosis. We analyzed long-term follow-up (LTFU) of efficacy outcomes and adverse events in the Breast International Group (BIG) 1-98 study reported after a median follow-up of 12.6 years. Patients and Methods BIG 1-98 is a four-arm, phase III, double-blind, randomized trial comparing adjuvant letrozole versus tamoxifen (either treatment received for 5 years) and their sequences (2 years of one treatment plus 3 years of the other) for postmenopausal women with endocrine-responsive early breast cancer. When pharmaceutical company sponsorship ended at 8.4 years of median follow-up, academic partners initiated an observational, LTFU extension collecting annual data on survival, disease status, and adverse events. Information from Denmark was from the Danish Breast Cancer Cooperative Group Registry. Intention-to-treat analyses are reported. Results Of 8,010 enrolled patients, 4,433 were alive and not withdrawn at an LTFU participating center, and 3,833 (86%) had at least one LTFU report. For the monotherapy comparison of letrozole versus tamoxifen, we found a 9% relative reduction in the hazard of a disease-free survival event with letrozole (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.01). HRs for other efficacy end points were similar to those for disease-free survival. Efficacy of letrozole versus tamoxifen for contralateral breast cancer varied significantly over time (0- to 5-, 5- to 10-, and > 10-year HRs, 0.62, 0.47, and 1.35, respectively; treatment-by-time interaction P = .005), perhaps reflecting a longer carryover effect of tamoxifen. Reporting of specific long-term adverse events seemed more effective with national registry than with case-record reporting of clinical follow-up. Conclusion Efficacy end points continued to show trends favoring letrozole. Letrozole reduced contralateral breast cancer frequency in the first 10 years, but this reversed beyond 10 years. This study illustrates the value of extended follow-up in trials of luminal breast cancer.

scholarly journals Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices

2021 ◽  
Vol 12 ◽  
Author(s):  
Ruben M. Strijbos ◽  
Louise V. Straatman ◽  
Tim G. A. Calon ◽  
Martin L. Johansson ◽  
Arthur J. G. de Bruijn ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Soft Tissue ◽  
Bone Conduction ◽  
Tissue Preservation ◽  
Implant Stability ◽  
Implant Stability Quotient ◽  
Incision Technique

Objective: Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months.Methods: In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group. The primary outcome was an (adverse) soft tissue reaction. Secondary outcomes were pain, loss of sensibility, soft tissue height/overgrowth, skin sagging, implant loss, Implant Stability Quotient measurements, cosmetic scores, and quality of life questionnaires.Results: Sixty-three subjects were analyzed in the intention-to-treat population. No differences were found in the presence of (adverse) soft tissue reactions during complete follow-up. Also, there were no differences in pain, wound dehiscence, skin level, soft tissue overgrowth, and overall quality of life. Loss of sensibility (until 3-month post-surgery), cosmetic scores, and skin sagging outcomes were better in the MIPS group. The Implant Stability Quotient was higher after the LITT-P for different abutment lengths at various points of follow-up. Implant extrusion was nonsignificantly higher after the MIPS (15.2%) compared with LITT-P (3.3%).Conclusion: The long-term results show favorable outcomes for both techniques. The MIPS is a promising technique with some benefits over the LITT-P. Concerns regarding nonsignificantly higher implant loss may be overcome with future developments and research.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02438618.

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