Adequate Patient Selection Research Articles

Living Donor Kidney Transplantation in Patients With Donor-Specific HLA Antibodies After Desensitization With Immunoadsorption.

Due to the current organ shortage, living donor kidney transplantation is increasingly performed across HLA (human leukocyte antigen) or ABO antibody barriers. There is still uncertainty about the risk of antibody-mediated rejection (AMR) episodes, which may limit long-term graft survival. From March 2007 to December 2016, 58 sensitized living donor kidney transplant candidates were identified and 38 patients eventually included in the study: 36 patients (95%) had pre-transplant and pre-desensitization Luminex-detected donor-specific HLA antibodies (DSA), and 17/36 patients (47%) in addition had a positive crossmatch result. Two patients had no detectable DSA but a positive CDC B-cell crossmatch result. Patients were treated with pre- and post-transplant apheresis and powerful immunosuppression including the anti-CD20 antibody rituximab (N = 36) in combination with thymoglobulin (N = 20) or anti-IL2 receptor antibody (N = 18). The results of the 38 successfully desensitized and transplanted patients were retrospectively compared to the results of 76 matched standard-risk recipients. Desensitized patients showed patient and graft survival rates similar to that of standard-risk recipients (P = 0.55 and P = 0.16, respectively). There was a trend toward reduced death-censored graft survival in desensitized patients (P = 0.053) which, however, disappeared when the 34 patients who were transplanted after introduction of sensitive Luminex testing were analyzed (P = 0.43). The incidence of rejection episodes without borderline changes were in desensitized patients with 21% similar to the 18% in standard-risk patients (P = 0.74). Thirty-six patients had pre-transplant HLA class I and/or II DSA that were reduced by 85 and 81%, respectively, during pre-transplant desensitization (P < 0.001 for both). On day 360 after transplantation, 20 of 36 (56%) patients had lost their DSA. The overall AMR rate was 6% in these patients, but as high as 60% in 5 (14%) patients with persistent and de novo DSA during year 1; 2 (40%) of whom lost their graft due to AMR. Eleven (31%) patients with persistent DSA but without de novo DSA had an AMR rate of 18% without graft loss while one patient lost her graft without signs of AMR. Our desensitization protocol for pre-sensitized living donor kidney transplant recipients with DSA resulted in good graft outcomes with side effects and rejection rates similar to that of standard-risk recipients. Adequate patient selection prior to transplantation and frequent immunological monitoring thereafter is critical to minimize rejection episodes and subsequent graft loss.

PP209 Analysis Of The Efficacy And Safety Of Robotic Spinal Surgery

IntroductionRobotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications.MethodsA systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3.ResultsEight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p &lt; 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies.ConclusionsWe found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.

Pancreaticoduodenectomy in octogenarians: The importance of “biological age” on clinical outcomes

IntroductionWith the prolongation of life expectancy, an increasing number of elderly patients are evaluated for pancreatic surgery. However, the influence of increasing age on outcomes after pancreaticoduodenectomy (PD) is still unclear, especially in octogenarians. Aim of this study is to evaluate the perioperative characteristics and outcomes of octogenarians undergoing PD. MethodsData for 812 patients undergoing PD between 2019 and 2020 in 10 referral centers in Italy were reviewed. Patients aged 80 years or older were matched based on nearest neighbor propensity scores in a 1:1 ratio to patients younger than 80 years. Propensity scores were calculated using 7 perioperative variables including gender, ASA score, neoadjuvant treatment (NAT), biliary stent positioning, type of surgical approach (open, laparoscopic, robot-assisted), associated vascular resections, type of lesion. Perioperative characteristics and short-term postoperative outcomes were compared before and after matching. ResultsOverall, 81 (10%) patients had 80 years or more. Before matching, octogenarians had a higher rate of ASA score≥ 3 (n = 35, 43.2% vs. n = 207, 28.3%; p = 0.005) and less frequently underwent NAT (n = 11, 13.6% vs. n = 213, 29.1%; p = 0.003). Matching was successfully performed for 70 octogenarians. After matching, no differences in preoperative and intraoperative characteristics were found. Postoperatively, ICU admission was more frequent in octogenarians (50% vs 30%; p = 0.01). Although in-hospital mortality was higher in octogenarians before matching (7.4% vs 2.9% in the younger cohort; p = 0.03), no difference was noted between the matched cohorts (p = 0.36). Postoperative morbidity was comparable between groups in the whole and selected populations. At the multivariate analysis, chronological age was not recognized as a prognostic factor for cumulative major complications, while ASA ≥3 was the only confirmed influencing feature (OR 2.98; 95%CI: 1.6–6.8; p = 0.009). ConclusioIn high-volume centers, PD in octogenarians shows similar outcomes than younger patients. Age itself should not be considered an exclusion criterion for PD, but a focused preoperative assessment is essential for adequate patient selection.

Safe Labia Minoraplasty: A Systematic Review and Meta-analysis of the Surgical Management for Labia Minora Hypertrophy

PURPOSE: In line with the figures reported by the American Society of Aesthetic Plastic Surgeons, the requests for labiaplasty have increased by 217.2% from 2012 to 2017. This considerable increase in labia minoraplasty demands plastic surgeons to be up to date with the surgical techniques and their respective indications, complications, and satisfaction rates. Therefore, we systematically reviewed the available evidence on labia minoraplasty for functional, psychological, or aesthetic indications. Additionally, we performed a meta-analysis to evaluate the effectiveness of the most commonly used techniques in terms of safety and patient satisfaction. METHODS: A comprehensive search across PubMed, Web of Science, SCOPUS, and Cochrane CENTRAL was performed from January 2000 through October 2020. The pooled satisfaction rate and the pooled incidence of complications was calculated using meta-analysis with Stata/IC 16.1 (StataCorp LLC, College Station, Tex.). RESULTS: Forty-three studies, including 3804 patients, fulfilled the inclusion criteria and were included in the meta-analysis. The age of patients ranged from 10 to 72 years, and the postoperative follow-up from 0.25 to 109 months. The most common indications for labia minoraplasty were aesthetic dissatisfaction, discomfort in clothing, discomfort while practicing sports, hygiene problems, and sexual discomfort or dysfunction. Eight different techniques were reported: Deepithelialization (n = 4), Edge linear resection (n = 19), Laser-assisted edge resection (n = 3), W-shaped edge resection (n = 3), Wedge resection (n = 21), Wedge resection with preservation of the central blood vessels and nerve bundle (PCBVNB) (n = 2), and Composite reduction (n = 3). Several procedures were performed in addition to labia minoraplasty. The most common were clitoral hood resection (n = 138); vaginoplasty or/and perineoplasty (n = 107); labia majora augmentation (n = 80); and clitoropexy (n = 35). The overall pooled satisfaction rate following labiaplasty was 99% (95%CI: 97%–99%; Fig. 8). Substantial heterogeneity was present across studies (I2 = 63.09%, P < 0.001). The funnel plot graph suggested no evidence of publication bias regarding the satisfaction rate, which was further supported with an Egger’s test meta-regression model (P = 0.69). Subgroup analysis revealed a higher pooled incidence of dehiscence for laser-assisted labiaplasty (5%, 95%CI: 2%–8%), W-shape resection (3%, 95%CI: <1%–15%), wedge resection (3%, 95%CI: 1%–5%), and when the surgical technique was not specified (8%, 95%CI: <1%–27%). The pooled incidence of infection was less than 1% for all techniques. Subgroup analysis revealed a higher pooled incidence of hematoma for W-shape resection (8%, 95%CI: <1%–23%), and a higher pooled incidence for bleeding with W-shape resection (2%, 95%CI: <1%–15%) and composite reduction labiaplasty (1%, 95%CI: <1%–6%). Subgroup analysis revealed a higher pooled incidence of pain or discomfort for deepithelialization (2%, 95%CI: <1%–23%) and W-shape resection (2%, 95%CI: <1%–15%). Finally, a higher pooled incidence of labia asymmetry was reported after composite reduction labiaplasty (3%, 95%CI: 1%–7%). CONCLUSIONS: Overall, labia minoraplasty is a safe procedure. However, serious complications requiring formal surgical interventions have been reported. In this sense, adequate patient selection, proper knowledge of the female genital anatomy, a thorough technique selection, and an experienced surgeon are mandatory in order to reduce complications and improve patient satisfaction.

Characterization of superresponders to cryoballoon ablation

Abstract Background Isolation of pulmonary veins is the cornerstone in the treatment of symptomatic atrial fibrillation rather with radiofrequency or cryo balloon. Recurrence rate is quite common in the long term follow up, clearly related to previosly described factors. Nevertheless some patients maintain sinus rhythm forever after the index ablation. The aim of this study is characterize this kind of patients (so called superresponders). Methods This is a Unicentric, retrospective, consecutive study including all patients summited for cryoablation in our hospital from January 2011 to September 2020. We looked for clinical, electrical, echocardiographic variables and those linked to the ablation procedure. A transversal FU to discard recurrences was done. A univariate and multivariate logistic regression was performed. Results We included 422 patients, 193 of them were finally excluded: 21 lost in the FU, 30 got radiofrequency ablation and 142 did not reach a minimum 5 years FU. About the 229 finally included, 85 (group 1) didn't have any recurrence during the FU, in front of 144 (group2) with recurrences. The univariate analysis showed that grup 1 patients were younger, the rate of hypertension, CHA2DS2VASc score, moderate sleep apnea, body mass index (BMI), p wave duration, and the size of left atrial was lower in grup 1 in front of patients of grup 2. Left ventricular ejection fraction was higher and the number of pulmonary veins in whom the temperature was lower than −40°C in grup 1 in front to grup 2. In the multivariate analysis the p wave duration: OR 0.92; 95% CI [0.89–0.94]; p&amp;lt;0.001, BMI kg/m2: OR 0.74; 95% CI [0.65–0.85]; p&amp;lt;0.001, a temperature &amp;lt;−40°C in all the targeted veins: OR 3.52 95% CI [1.45–8.54]; p=0.005 and SR on the ablation index day OR: 7.29; 95% CI [1.53–34.71]; p=0.012, maintained statistical significance. Conclusions In our series patients with a p wave duration, BMI, SR the ablation index day and achieving a temperature &amp;lt;−40°C in all the targeted veins, resulted as protective factors to maintain SR in the long term FU. An adequate selection of patients can improve results and optimize resources. Funding Acknowledgement Type of funding sources: None.

Predicting procedural success in patients treated with Cardioband system for severe tricuspid regurgitation by employing a random forest algorithm

Abstract Background Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality despite optimal medical treatment. Transcatheter tricuspid valve intervention (TTVI) is therefore emerging as a novel treatment option, fueling the hope to prolong survival and reduce rehospitalization for heart failure. Obviously, procedural success of TTVI is an important determinant of survival, but predictors for procedural success in patients treated with Cardioband system, which mimics the surgical approach by implanting an annular reduction system and hence targets tricuspid annulus dilatation as the central pathology in most patients, are largely elusive. Purpose This study aims to refine prediction of procedural success in patients with severe TR undergoing TTVI with Cardioband system by employing a random forest algorithm. Methods Procedural success was evaluated in 72 patients enrolled at two tertiary centers in Germany between 2018 and 2020. Key inclusion criterion was TR ≥ III/V° with high symptomatic burden despite optimal medical treatment. Procedural success war defined as patient alive at the end of the procedure, successful Cardioband implantation, and TR reduction ≥ II/V° as assessed on transthoracic echocardiography before discharge. Since 66.7% of patients were classified as “success”, a synthetic minority over-sampling technique was applied in order to train the random forest algorithm on a balanced data set. Results A random forest algorithm reached 85.4% accuracy (AUC: 0.923) in predicting procedural success in a balanced data set using eight parameters from pre-procedural echocardiography as input variables. Partial dependence analysis revealed that enlargement of the tricuspid valve (TV) anteroseptal diameter was most important for model accuracy. Applied to the real-world data set (24 patients classified as “failure” and 48 patients classified as “success”), the now trained random forest algorithm predicted procedural success with high sensitivity (70.8%) and specificity (100.0%), significantly outperforming the no information rate (p-value: 0.0069). Patients with low probability for success were characterized by impaired right ventricular function (TAPSE: 15.5±3.63 mm) and enlarged right sided cardiac diameters (basal right ventricular diameter: 51.6±3.79 mm; TV anteroseptal diameter: 45.0±5.10 mm). Notably, systolic pulmonary artery pressure (sPAP) and TV effective regurgitant orifice area were negatively correlated (R: −0.3004, p-value: 0.0322), and elevation in sPAP was attenuated in patients with low probability for procedural success (sPAP: 34.0±11.7 mmHg). Conclusion A random forest algorithm enables precise prediction of procedural success in patients treated with Cardioband system. TR reduction ≥ II/V° appears less achievable in patients with advanced stages of right heart failure, emphasizing the importance of adequate patient selection and timing of intervention. Funding Acknowledgement Type of funding sources: None.

The Role of Pelvic Lymphadenectomy in Organ-sparing Treatment of Muscule-invasive Bladder Cancer

The Role of Pelvic Lymphadenectomy in Organ-sparing Treatment of Muscule-invasive Bladder Cancer

Characterization of “Super-Responders” to Cryoballoon Ablation

Background: Pulmonary Veins Isolation (PVI) is the cornerstone in the treatment of atrial fibrillation. Recurrence rate is common in the long-term followup (FU); nevertheless, some patients maintain Sinus Rhythm (SR) for more than 5 years after the index ablation. The aim of this study is characterize this kind of patients so called “super-responders”. Methods: This is a retrospective single-center study including all patients summited for cryo-balloon ablation in our hospital from January 2011 to September 2020. We investigated clinical, electrocardiographic, echocardiographic variables and those linked to the ablation procedure. A univariate and multivariate logistic regression was performed. Results: During this period, 422 patients underwent PVI; however, 193 were excluded: 21 lost in the FU, 30 got radiofrequency ablation and 142 did not reach a minimum 5 years FU. Of the 229 finally included, 85 (group 1) did not have any recurrence during the follow-up, in front of 144 (group 2) with AF recurrences. In the multivariate analysis the p wave duration: OR: 0.92; 95% CI (0.89-0.94); p &lt;0.001, BMI kg/m²: OR: 0.74; 95% CI (0.65-0.85); p &lt;0.001, a temperature &lt;-40°C in all the targeted veins: OR: 3.52; 95% CI (1.45-8.54); p=0.005 and SR on the ablation index day OR: 7.29; 95% CI (1.53-34.71); p=0.012, maintained statistical significance. Conclusions: In our series the p wave duration, BMI, the presence of SR the ablation index day and achieving a temperature &lt;-40°C in all the targeted veins, resulted as protective factors to maintain SR in the long term follow-up. An adequate selection of patients probably could improve results and optimize resources.

Combined Endoscopic Transsphenoidal and Tubular Retractor-Assisted Transventricular Approach for Giant Pituitary Adenomas

Surgical resection remains the standard treatment for most giant pituitary adenomas (GPAs). The selected surgical approach for these complex lesions depends mainly on their extension. Single approaches may be limited in some cases presenting with invasion into multiple compartments, thereby limiting extent of resection. We report a series of patients with GPA operated on through a combined approach involving an endoscopic endonasal transsphenoidal approach and a tubular retractor-assisted transventricular approach, describing the technique, its indications, limitations, and outcomes. Baseline and postoperative clinical, functional, and morphologic variables were documented up until each patient's last follow-up visit. Five patients harboring tumors extending into the third and lateral ventricles were included. Mean extent of resection was 94.6%. Mean follow-up was 39.4 months. One patient presented with a growth hormone-secreting GPA, who achieved remission after repeat resection during follow-up. There were no intraoperative complications, and 1 patient required reoperation for cerebrospinal fluid leak repair. One patient received adjuvant radiotherapy, and 3 patients remained stable requiring no additional treatment. All patients maintained an adequate postoperative functional status. The combined approach herein described may be a safe and effective option for some patients with GPAs extending into the third and lateral ventricles. An adequate patient selection is mandatory to exploit the benefits of each individual approach.

PD07-07 PREDICTING SURGICAL OUTCOME IN POSTERIOR RETROPERITONEOSCOPIC ADRENALECTOMY BASED ON PREOPERATIVE PATIENT CHARACTERISTICS

You have accessJournal of UrologyAdrenal (PD07)1 Sep 2021PD07-07 PREDICTING SURGICAL OUTCOME IN POSTERIOR RETROPERITONEOSCOPIC ADRENALECTOMY BASED ON PREOPERATIVE PATIENT CHARACTERISTICS Allon van Uitert, Elle van de Wiel, Jordache Ramjith, Jaap Deinum, Henri Timmers, Alfred Witjes, Leo Schultze Kool, and Johan Langenhuijsen Allon van UitertAllon van Uitert More articles by this author , Elle van de WielElle van de Wiel More articles by this author , Jordache RamjithJordache Ramjith More articles by this author , Jaap DeinumJaap Deinum More articles by this author , Henri TimmersHenri Timmers More articles by this author , Alfred WitjesAlfred Witjes More articles by this author , Leo Schultze KoolLeo Schultze Kool More articles by this author , and Johan LangenhuijsenJohan Langenhuijsen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001975.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Posterior retroperitoneal adrenalectomy (PRA) shows several advantages over the transabdominal approach (TLA), including shorter operating time, less postoperative pain, faster recovery, improved cost-effectiveness, and abolished risk of access site herniation. To improve adequate patient selection, a nomogram was developed to predict surgical outcome of PRA. METHODS: All consecutive patients who underwent unilateral PRA by one surgeon between February 2011 and March 2020 were included in the study. Patients were eligible for PRA with a body mass index (BMI) of <35 kg/m2, tumor diameter ≤7 cm, and with low suspicion of malignancy. Since the number of complications and conversions are generally low, the primary outcome of PRA was operating time (OT) as surrogate endpoint for surgical complexity. We hypothesize that with an OT >90 minutes, which accounts for ±18% of the procedures, PRA is less profitable and TLA may be the better choice, as it offers larger working space and more anatomical landmarks. To create an optimal prediction model, 10 patient variables were used. These included 6 radiological measurements on preoperative CT-scans to measure the amount of retroperitoneal fat and the position of the adrenal tumor. A best subsets regression analysis was performed to find the best 1-variable model up to the best 10-variables model. RESULTS: In total, 215 patients were included in this study. The mean age was 51.6±12.2 years, 49% were male, and mean tumor diameter was 2.4±1.6 cm. After best subset regression analysis, a 4-variable nomogram was selected (Figure 1a). This model included sex, pheochromocytoma, BMI and perinephric fat, which were all individually significant predictors. An example of applying the model is shown in Figure 1b, which shows a predicted OT of 87 minutes. The model showed an ideal balance between predictive power and applicability, with an R2 of 38.6, i.e. 39% of the variation in OT is reliably explained by this model. CONCLUSIONS: A new 4-variable nomogram was developed to predict outcome in PRA, which may aid the surgeon to preoperatively identify the patients in which PRA is feasible. When predicted OT exceeds 90 minutes, indicating high-complex surgery, TLA could be the preferred technique. Source of Funding: Radboudumc © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e107-e108 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Allon van Uitert More articles by this author Elle van de Wiel More articles by this author Jordache Ramjith More articles by this author Jaap Deinum More articles by this author Henri Timmers More articles by this author Alfred Witjes More articles by this author Leo Schultze Kool More articles by this author Johan Langenhuijsen More articles by this author Expand All Advertisement Loading ...

Pelvic exenteration in patients with locally advanced, symptomatic castration-resistant prostate cancer

Ziel der ArbeitDie retrospektive Evaluation der klinischen Ergebnisse nach palliativer pelviner Tumorchirurgie (ppTC) bei subvesikalen und supravesikalen Komplikationen eines lokal symptomatisch fortgeschrittenen kastrationsresistenten (CRPC) Prostatakarzinoms.Patienten und MethodenInsgesamt 84 Patienten mit lokal fortgeschrittenem und symptomatischem CRPC erhielten eine radikale Zystoprostatektomie (n = 71, 83,3 %) oder anteriore und posteriore Exenteration (n = 13, 16,7 %). Das lokale Staging erfolgte mittels MRT des Beckens, Zystoskopie und Rektoskopie. Ein systemisches Staging erfolgte mittels Computertomographie von Thorax, Abdomen, Becken sowie Skelettszintigraphie. Die perioperativen Komplikationen wurden nach Clavien-Dindo-Klassifikation evaluiert. Das primäre Studienziel war das symptomfreie Überleben (sÜL, Fehlen von Symptomen am unteren oder oberen Harntrakt, fehlende endoluminale oder perkutane Intervention).ErgebnisseNach einem medianen Follow-up von 43,5 (3–139) Monaten betrug das sÜL nach einem und drei Jahren 95,2 % bzw. 86,7 %. Insgesamt 86,7 % der Patienten blieben für ihre gesamte verbleibende Lebensdauer bezüglich lokaler Symptome beschwerdefrei. Das OS nach einem und drei Jahren betrug 92,9 % bzw. 54,7 %. Clavien-Dindo-Grad-2-, -3- und -4-Komplikationen ergaben sich in 19 (22,6 %), 7 (8,3 %) bzw. 3 (3,6 %) Patienten.SchlussfolgerungenDie ppTC ist mit einer geringen Komplikationsrate möglich und führt zu deutlicher Symptomlinderung bei ca. 90 % der Patienten, von denen > 80 % für die verbleibende Lebenszeit beschwerdefrei verbleiben. Voraussetzung sind die Patientenauswahl, ein interdisziplinäres Vorgehen und eine entsprechende chirurgische Expertise.

Transcatheter tricuspid valve repair: early experience in the Netherlands.

BackgroundSymptomatic tricuspid regurgitation (TR) is increasingly prevalent and impairs quality of life and survival, despite medical treatment. Transcatheter tricuspid valve repair (TTVR) has recently become available as a treatment option for patients not eligible for tricuspid valve surgery. In this study we describe the early experience with TTVR in the Netherlands.MethodsAll consecutive patients scheduled for TTVR in two tertiary hospitals were included in the current study. Patients were symptomatic and had severe functional TR. TTVR was performed either with the MitraClip (off-label use) or dedicated TriClip delivery system and device. Procedural success was defined as achievement of clip implantation, TR reduction ≥ 1 grade and no need for re-do surgical or transcatheter intervention. Clinical improvement was evaluated after 4 weeks.ResultsTwenty-one patients (median age 78 years, 33% male, 95% New York Heart Association class ≥ 3, 100% history of atrial fibrillation) underwent TTVR. Procedural success was achieved in 16 patients, of whom 15 reported symptomatic improvement (New York Heart Association class 1 or 2). There was no in-hospital mortality and no major complications occurred. Baseline glomerular filtration rate and TR coaptation gap size were associated with procedural success.ConclusionThe current study showed that TTVR seems a promising treatment option for patients with severe functional TR deemed high risk for surgery. Successful TR reduction is most likely in patients with limited coaptation gap size and strongly determines clinical benefit. Adequate patient selection and timing of treatment seem essential for an optimal patient outcome.Supplementary InformationThe online version of this article (10.1007/s12471-021-01613-3) contains supplementary material, which is available to authorized users.

The potential impact of acute coronary syndromes on automatic sensing system in Subcutaneous-ICDs.

The Subcutaneous-ICD (S-ICD) is emerging as a suitable option for most ICD candidates, however some open issues regarding the sensing algorithm still remain. We aimed to examine the performance of the S-ICD sensing algorithm in patients hospitalized for ST elevation myocardial infarction (STEMI), non ST elevation acute coronary syndrome (NSTE-ACS) or chronic coronary syndrome (CCS), before and after revascularization. We performed a S-ICD automated screening on 75 patients, 21 hospitalized for STEMI, 23 for NSTE-ACS and 31 for CCS, before and after percutaneous revascularization, regardless their eligibility to ICD implantation. Patients did not differ in clinical, electrocardiographic and echocardiographic parameters. Rates of screening pass were significantly lower in STEMI patients compared to NSTE-ACS and CCS (5% vs 56.7% vs 81% respectively, p<.0001). The viability of the primary vector was lower in STEMI patients compared to NSTE-ACS and CCS (33% vs 56% vs 71%, p .027 respectively). After revascularization, there were no more significant differences between groups. Pairing subjects at baseline and after revascularization, STEMI subjects percentages of screening success were respectively 5% and 81% (p<.001) and the rates of primary vector viability were 33% and 81% (p .002). STEMI was the only independent predictor of screening failure at multivariate logistic regression analysis (odds ratio 10.68 confidence interval 2.77-41.38, p=.001). The performance of the S-ICD and possible malfunction detections in the context of an acute ischemic event deserve further evaluation. Adequate patient selection and the development of dynamic device programming are warranted.

European Society of Hypertension position paper on renal denervation 2021.

This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25-30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients' perspective and preference that needs to be respected in a shared decision-making process.

Immunotherapy in rare ovarian cancer.

Ovarian cancer (OC) is a heterogeneous disease and a mounting body of evidence shows that a 'one-size-fits-all' approach is obsolete. Differences in epidemiology, tumor biology, genetic profiles and treatment responses of these different types necessitate a tumor and patient-specific approach. Ninety percentage consists of epithelial OC with 70% being high-grade serous OC. The other rarer subtypes are low-grade serous (5%), clear cell (12%), endometrioid (11%) and mucinous carcinoma (3%). The remaining 10% are nonepithelial rare OCs: germ cell (3%) and sex-cord stromal tumors (7%). Over the past few decades, the 5-year survival rates have only improved modestly, therefore novel therapies are urgently needed. Recently, immunotherapy has been introduced into clinical practice in a number of solid tumors. Although preclinical data confirm the presence of an immunogenic microenvironment in a number of ovarian tumor types, no single-agent immune checkpoint inhibitor has been approved hitherto. Identifying suitable treatment combinations, adequate patient selection and thus correct implementation of immunotherapy remain major challenges. In this review, we focus on the rationale of incorporating immune therapy in rare OC, we summarize the recent developments with preclinical data and results of clinical trials, with particular focus on rare ovarian histological subtypes.

Enzymatic liver function measured by LiMAx is superior to current standard methods in predicting transplant-free survival after TIPS implantation

Transjugular intrahepatic portosystemic shunt (TIPS) is one of the main treatment options in patients with decompensated liver cirrhosis but is still associated with partly severe complications. For adequate patient selection, prognostic parameters are of crucial importance. The liver maximum capacity (LiMAx) breath test measures enzymatic liver function and could potentially represent an efficient prognostic marker. We therefore aimed to assess the role of LiMAx in predicting survival of TIPS patients in a prospective analysis. LiMAx was performed for patients who underwent TIPS implantation between October 2016 and February 2018. Associations with transplant-free survival after 24 weeks were assessed by logistic regression. A total number of 30 patients were included, of whom seven received liver transplantation (N = 2) or died (N = 5) during follow-up. LiMAx values after (P = 0.01, OR = 1.24, 95% CI = 1.04–1.47) and before (P = 0.03, OR 1.21, 95% CI = 1.02–1.43) TIPS implantation and MELD score (P = 0.03, OR = 0.79, 95% CI = 0.63–0.98) were significantly associated with transplant-free survival according to univariate logistic regression. In AUROC analysis, LiMAx at day one after TIPS (sensitivity 85.7%, specificity 78.3%, AUROC 0.85, cut-off ≤ 165 µg/kg/h), LiMAx value at the day before TIPS (sensitivity 100%, specificity 73.9%, AUROC 0.82, cut-off ≤ 205 µg/kg/h) and MELD score (sensitivity 71.4%, specificity 73.9%, AUROC 0.82, cut-off ≥ 15) had the highest prognostic accuracy. LiMAx values prior and after TIPS procedure seem to be good prognostic parameters regarding prediction of transplant-free survival of patients undergoing TIPS implantation.

The "right" patient for implant surgery in urology : Why patient selection, informed consent, and communication are so important for patient satisfaction

In implant surgery for erectile dysfunction and urinary incontinence, adequate patient selection is essential for postoperative therapy success. Several scientific studies report patient satisfaction rates for penile implants and artificial urinary sphincter implantation of over 90%. Nevertheless, studies also report, that between 5 and 30% of the patients are not satisfied with the result of their operation. Sufficient patient information and consent prior surgical procedure in urological prosthetics are akey determinant for later patient satisfaction and therapy success. Diligent assessment of realistic expectations, possible complications, and risks must be made. Unrealistic and exaggerated expectations need to be met and discussed with the patient. Therefore adequate physician-patient communication is essential. Especially in the case of surgical revision or for patients with risk factors, the probability of complications is higher and may significantly increase later dissatisfaction. Also, the involvement of the partner plays amajor role in later patient satisfaction in urological implant surgery. Finally, there is agroup of patients for which the risk of later dissatisfaction is particularly high. These are patients with compulsive/obsessive behavior, unrealistic expectations, patients after revision surgery, self-entitled patients, as well as those patients who deny the extent of their illness, visit multiple surgeons (surgeon hopping) or have psychiatric illnesses. These patients are referred to with the acronym "CURSED" patients.

Percutaneous Left Atrial Appendage Occlusion: An Emerging Option in Patients with Atrial Fibrillation at High Risk of Bleeding.

Atrial fibrillation (AF) is a common cardiac arrhythmia with an estimated prevalence of 1% in the general population. It is associated with an increased risk of ischemic stroke, silent cerebral ischemia, and cognitive impairment. Due to the blood flow stasis and morphology, thrombus formation occurs mainly in the left atrial appendage (LAA), particularly in the setting of nonvalvular AF (NVAF). Previous studies have shown that >90% of emboli related to NVAF originate from the LAA, thus prevention of systemic cardioembolism is indicated. According to the current guidelines, anticoagulant therapy with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs), represents the standard of care in AF patients, in order to prevent ischemic stroke and peripheral embolization. Although these drugs are widely used and DOACs have shown, compared to VKAs, non-inferiority for stroke prevention with significantly fewer bleeding complications, some issues remain a matter of debate, including contraindications, side effects, and adherence. An increasing number of patients, indeed, because of high bleeding risk or after experiencing life-threatening bleedings, must take anticoagulants with extreme caution if not contraindicated. While surgical closure or exclusion of LAA has been historically used in patients with AF with contradictory results, in the recent years, a novel procedure has emerged to prevent the cardioembolic stroke in these patients: The percutaneous left atrial appendage occlusion (LAAO). Different devices have been developed in recent years, though not all of them are approved in Europe and some are still under clinical investigation. Currently available devices have shown a significant decrease in bleeding risk while maintaining efficacy in preventing thromboembolism. The procedure can be performed percutaneously through the femoral vein access, under general anesthesia. A transseptal puncture is required to access left atrium and is guided by transesophageal echocardiography (TEE). Evidence from the current literature indicates that percutaneous LAAO represents a safe alternative for those patients with contraindications for long-term oral anticoagulation. This review summarizes scientific evidences regarding LAAO for stroke prevention including clinical indications and an adequate patient selection.

Impact of COVID-19 pandemic on patients and health professionals of a radiation oncology department at a Spanish tertiary hospital.

The sanitary emergency created by the COVID-19 pandemic forced us to take exceptional measures that affect decision-making and administration of treatments with radiotherapy. The aim of the study was to analyze the impact of the COVID-19 pandemic on patients and professionals in a radiation oncology department. We implement a plan with the objectives of maintaining radiotherapy treatment in those patients who need it and, at the same time, reducing the risk of spreading the virus to staff and patients. This plan included measures aimed at limiting the patient's stay in hospital, selecting those patients in whom radiotherapy cannot be delayed and protecting against infection through the use of physical protective measures. Between March 16 and May 31, 2020, 360 patients received radiotherapy in our department. In 14 patients (4.7%) the start of treatment was delayed by an average of 28 days. Four patients had a positive COVID-19 polymerase chain reaction (PCR ) (6.6% and 1.1% of tested and all patients, respectively). Among the professionals, two PCR s were positive (16.6% and 4% of tested and all individuals, respectively). In the serology analysis 4 out of 50 department members were IgG positive (8%). Despite the fact that our department is located in a region with a high incidence of COVID-19 infection, the impact of the pandemic on our patients and staff has been moderate. The implementation of measures against infection and an adequate selection of patients for treatment allows radiation oncology departments to maintain clinical activity.

Radical Resection for Locally Advanced Pancreatic Cancers in the Era of New Neoadjuvant Therapy-Arterial Resection, Arterial Divestment and Total Pancreatectomy.

Simple SummaryAggressive arterial resection or total pancreatectomy in surgical treatment for locally advanced pancreatic cancer (LAPC) has gradually been encouraged thanks to new chemotherapy regimens such as FOLFIRINOX or Gemcitabine and nab-paclitaxel, which have provided more adequate patient selection and local tumor suppression, justifying aggressive local resection. The development of surgical techniques provides the safety of arterial resection (AR) for even major visceral arteries, such as the celiac axis or superior mesenteric artery. Total pancreatectomy has been re-evaluated as an effective option to balance both the local control and postoperative safety. In this review, we investigate the recent reports focusing on arterial resection and total pancreatectomy for locally advanced pancreatic cancer (LAPC) and discuss the rationale of such an aggressive approach in the treatment of PC.Aggressive arterial resection (AR) or total pancreatectomy (TP) in surgical treatment for locally advanced pancreatic cancer (LAPC) had long been discouraged because of their high mortality rate and unsatisfactory long-term outcomes. Recently, new chemotherapy regimens such as FOLFIRINOX or Gemcitabine and nab-paclitaxel have provided more adequate patient selection and local tumor suppression, justifying aggressive local resection. In this review, we investigate the recent reports focusing on arterial resection and total pancreatectomy for LAPC and discuss the rationale of such an aggressive approach in the treatment of PC. AR for LAPCs is divided into three, according to the target vessel. The hepatic artery resection is the simplest one, and the reconstruction methods comprise end-to-end, graft or transposition, and no reconstruction. Celiac axis resection is mainly done with distal pancreatectomy, which allows collateral arterial supply to the liver via the pancreas head. Resection of the superior mesenteric artery is increasingly reported, though its rationale is still controversial. Total pancreatectomy has been re-evaluated as an effective option to balance both the local control and postoperative safety. In conclusion, more and more aggressive pancreatectomy has become justified by the principle of total neoadjuvant therapy. Further technical standardization and optimal neoadjuvant strategy are mandatory for the global dissemination of aggressive pancreatectomies.