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Background: Transient increases in postvoid residual urine volume (PVR) requiring clean intermittent catheterization (CIC) have occurred with onabotulinumtoxinA treatment for overactive bladder (OAB)., Objective: To evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVR max ) on CIC initiation in adults with OAB and urinary incontinence (UI)., Design Setting and Participants: This was a pooled post hoc analysis of four placebo-controlled, multicenter randomized trials that included adults with idiopathic OAB after first onabotulinumtoxinA treatment (NCT00910845, NCT00910520, NCT01767519, NCT01945489). Patients had at least three urgency UI episodes over 3 d and at least eight micturitions per day, had inadequate management with at least one anticholinergic agent, and were willing to use CIC., Outcome Measurements and Statistical Analysis: We measured the following outcomes: PVR max within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity)., Results and Limitations: Of 1504 patients, 87.7% were women and 88.8% were White. The mean age was 60.5 yr across 10-yr age groups, baseline PVR was 13.8-35.0 ml, and estimated functional capacity was 293.5-475.7 ml. Mean baseline PVR was 21.3 ml overall versus 34.0 ml in the group that started CIC. The CIC incidence was 6.2% for women (range 1.1-8.4%) and 10.5% for men (range 0-14.6%). Higher CIC rates were observed for PVR max >350 ml (women 91.9%, men 84.6%) in comparison to PVR max of 201-350 ml (women 32.5%, men 17.4%) and PVR max <200 ml (women 1.2%, men 1.6%). Overall, 2/1504 patients (both women) were unable to void spontaneously. The mean PVR ratio was highest at week 2. Some subgroups had small sample sizes., Conclusions: CIC incidence was low overall, was less frequent for women, was rare with PVR max ≤200 ml, and did not appear to correlate with baseline PVR., Patient Summary: After onabotulinumtoxinA treatment for OAB, patients sometimes insert a catheter to help in emptying their bladder after urinating. In this study, few patients needed a catheter, especially when less urine volume remained after urination., (© 2023 The Author(s).)

Background: Minimally invasive mitral valve surgery (MIV) through a right lateral thoracotomy has become the standard of care at specialized centers and might soon will be the only acceptable surgical treatment option in the future era of interventional procedures. The aim of our study was to analyze the outcomes of our MIV-specialized, single-center, mixed valve pathology cohort with regard to morbidity, mortality and midterm outcomes comparing two different repair techniques (respect versus resect)., Methods: Baseline and operative variables, postoperative outcomes and follow-up information about survival, valve competence and freedom from reoperation were retrospectively collected and analyzed. The repair cohort was divided into three groups (resection, neo-chordae and both) and compared for outcomes., Results: Between July 22 nd 2013 and May 31 st 2022 a total of 278 consecutive patients underwent MIV. Out of those, we identified 165 eligible patients for the three repair groups: 82 patients (29.5%) had "resection", 66 "neo-chordae" (23.7%) and 17 "both" (6.1%). All preoperative variables were comparable between the groups. The predominant valve pathology of the entire cohort was degenerative disease with 20.5% Barlow's, 20.5% bi-leaflet and 32.4% double segment pathology. Bypass time was 164±47, cross-clamp time 106±36 minutes. All valves planned for repair (85.6%) were successfully repaired except for 13 resulting in a repair rate of 94.5%. Only 1 patient (0.4%) had to be converted to clamshell and 2 (0.7%) needed rethoracotomy for bleeding. Mean intensive care unit (ICU) stay was 1.8 days and hospital stay 10.6±1.3 days. In-hospital mortality was 1.1% and the incidence of stroke (1.8%). All in-hospital outcomes were comparable between the groups. Follow up was complete in 86.2% (n=237) for a mean of 3.7±0.8, up to 9 years. Five-year survival was 92.6% (P=0.5) and freedom from re-intervention 96.5% (P=0.1). All but 10 patients had mitral regurgitation less than grade 2 (95.8%, P=0.2) and all but two had less than New York Heart Association (NYHA) II (99.2%, P=0.1)., Conclusions: Despite a heterogeneous cohort with mixed valve pathologies, there is a high reconstruction rate, low short- and midterm morbidity, mortality and need for re-intervention with comparable outcomes of the resect and respect technique in a specialized MIV center., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-22-1796/coif). The authors have no conflicts of interest to declare., (2023 Journal of Thoracic Disease. All rights reserved.)

Background: There is increasing evidence that female gender is an independent risk factor for cardiac surgery. Minimally invasive mitral surgery (MIV) has proven to have excellent long-term results, but little is known about gender-dependent outcomes. The aim of our study was to analyze our heart team's decision-based MIV-specialized cohort., Methods: In-hospital and follow-up data were retrospectively collected. The cohort was divided into gender groups and propensity-matched groups., Results: Between 22 July 2013 and 31 December 2022, 302 consecutive patients underwent MIV. Before matching, the total cohort showed that women were older, had a higher EuroSCORE II, were more symptomatic, and had more complex valve pathology and tricuspid regurgitation resulting in more valve replacements and tricuspid repairs. Intensive and hospital stays were longer. In-hospital deaths (n = 3, all women) were comparable, with more atrial fibrillation in women. The median follow-up time was 3.44 (0.008-8.9) years. The ejection fraction, NYHA, and recurrent regurgitation were low and comparable and atrial fibrillation more frequent in women. The calculated 5-year survival and freedom from re-intervention were comparable ( p = 0.9 and p = 0.2). Propensity matching compared 101 well-balanced pairs; women still had fewer resections and more atrial fibrillation. During the follow-up, women had a better ejection fraction. The calculated 5-year survival and freedom from re-intervention were comparable ( p = 0.3 and p = 0.3)., Conclusions: Despite women being older and sicker, with more complex valve pathology and subsequent replacement, early and mid-term mortality and the need for reoperation were low and comparable before and after propensity matching, which might be the result of the MIV setting combined with our patient-tailored decision-making. We believe that a multidisciplinary heart team approach is crucial to optimize patient outcomes in MIV, and it might also reduce the widely reported increased surgical risk in female patients. Further studies are needed to prove our findings.

Objectives: This randomized, multicenter, placebo-controlled, phase IV study assessed the efficacy and tolerability of onabotulinumtoxinA in patients with overactive bladder., Methods: Patients were randomized 1:1 to onabotulinumtoxinA 100 U or placebo. Assessments over 12 weeks included: change from baseline in urinary incontinence (UI) episodes/day; proportions of patients who achieved 100% and 50% or greater reductions in UI episodes/day; proportion of patients using no incontinence pads in the previous 24 hours; and changes from baseline in micturition frequency, nocturia, urgency UI, Incontinence-Quality of Life, King's Health Questionnaire, International Consultation on Incontinence Questionnaire-UI Short Form scores and time to request retreatment., Results: Significant reductions in UI episodes/day were seen with onabotulinumtoxinA versus placebo within week 1 posttreatment (-2.9 vs -2.0, P = 0.005) through week 12 (coprimary endpoint: -3.5 vs -1.6, P < 0.001). Significantly more onabotulinumtoxinA-treated patients achieved 100% (coprimary endpoint) and 50% or greater reductions in UI episodes/day. Decreases in other urinary symptoms were also seen within 1 week with onabotulinumtoxinA that continued through at least week 12. More onabotulinumtoxinA-treated versus placebo-treated patients required no incontinence pads at weeks 1 to 12, and greater improvements in quality of life measurements were seen. Time to request retreatment was significantly longer with onabotulinumtoxinA versus placebo (30.0 weeks vs 13.1 weeks; P < 0.001). No unexpected safety signals were observed. Urinary tract infection was the most commonly observed adverse event., Conclusions: Urinary symptom and quality of life improvements were observed with onabotulinumtoxinA within 1 week of treatment and were sustained for at least 12 weeks., Competing Interests: Conflicts of Interest and Source of Funding: This study and its analysis were sponsored by Allergan plc, Dublin, Ireland. Medical writing and editorial assistance was provided by Jennifer L. Giel, PhD, CMPP, and Karen Pemberton, PhD, CMPP, on behalf of Evidence Scientific Solutions, Inc., Philadelphia, PA, and was funded by Allergan plc, Dublin, Ireland., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Aims: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented., Methods: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented., Results: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred., Conclusions: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population., (© 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Aims: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented., Methods: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants., Results: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events., Conclusions: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms., (© 2020 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.)

Purpose: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented., Materials and Methods: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants., Results: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events., Conclusions: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Objective: To evaluate the impact of onabotulinumtoxinA on individual domains of the quality of life questionnaires in a pooled analysis of two phase 3 trials in overactive bladder patients with urinary incontinence who were inadequately managed by ≥1 anticholinergic., Methods: Patients received intradetrusor injections of onabotulinumtoxinA 100U (n = 557) or placebo (n = 548). The proportions of patients with a positive response (condition "greatly improved" or "improved") on the Treatment Benefit Scale, and changes in Incontinence Quality of Life scores and King's Health Questionnaire domain scores were analyzed in the overall population and subgroups with clean intermittent catheterization use and urinary tract infection status during the first 12 weeks of treatment. Responses to individual King's Health Questionnaire items were also assessed., Results: Significantly greater proportions of onabotulinumtoxinA-treated patients achieved positive Treatment Benefit Scale response versus placebo (61.8% vs. 28.0%; P < 0.001). OnabotulinumtoxinA showed significantly greater improvements versus placebo in Incontinence Quality of Life total (22.5 vs. 6.6), Incontinence Quality of Life subscale scores and all domains of the King's Health Questionnaire. Notably, a similar trend was observed regardless of clean intermittent catheterization/urinary tract infection status. Additionally, onabotulinumtoxinA resulted in significantly greater improvements than the placebo in practical aspects of patients daily lives, including pad use, need to change undergarments, sleep, relationship with partner and work life/daily activities., Conclusion: In overactive bladder patients with urinary incontinence, onabotulinu-mtoxinA 100U demonstrated significant improvements across the individual domains of the quality of life questionnaires, regardless of clean intermittent catheterization or urinary tract infection status, and provided a positive impact on practical aspects of patients' daily lives., (© 2015 The Authors. International Journal of Urology published by Wiley Publishing Asia Pty Ltd on behalf of the Japanese Urological Association.)

Background: Echocardiographic quantification of mitral regurgitation (MR) can be challenging if the valve geometry is significantly altered. Our aim was to compare the quantification of MR by the recently developed real time three-dimensional (3D) volume color flow Doppler (RT-VCFD) method to the conventional two-dimensional (2D) echocardiographic methods during the MitraClip procedure., Methods: Twenty-seven patients (mean age 76 ± 8 years, 56% male) were prospectively enrolled and severity of MR was assessed before and after the MitraClip procedure in the operating room by 3 different methods: (1) by integrative visual approach by transesophageal echocardiography, (2) by transthoracic 2D pulsed-wave Doppler-based calculation of aortic stroke volumes (SV) and mitral inflow allowing calculation of regurgitant volume, and (3) by transthoracic 3D RT-VCFD-based calculation of regurgitant volume., Results: We found moderate agreement between the integrative visual approach and the 3D RT-VCFD method for assessment of MR severity before (κ = 0.4, P < 0.05) and after MitraClip (κ = 0.5, P < 0.05). Relevant MR (3+ and 4+) was detected by visual approach in 27/27 and by 3D-VCFD method in 24/27 patients before and in 1 patient by both methods after the MitraClip procedure. In contrast, MR quantification by 2D SV method did not agree with the integrative visual approach or with the 3D RT-VCFD method., Conclusions: Quantification of MR before and after percutaneous MV repair by 3D RT-VCFD is comparable to the integrative visual assessment and more reliable than the 2D SV method in this small study population. Further automation of 3D RT-VCFD is needed to improve the accuracy of peri-interventional MR quantification., (© 2014, Wiley Periodicals, Inc.)

Aims: To evaluate short-term clinical outcomes following transcatheter aortic valve implantation (TAVI) using CE-mark approved devices in Switzerland., Methods and Results: The Swiss TAVI registry is a national, prospective, multicentre, monitored cohort study evaluating clinical outcomes in consecutive patients undergoing TAVI at cardiovascular centres in Switzerland. From February 2011 to March 2013, a total of 697 patients underwent TAVI for native aortic valve stenosis (98.1%), degenerative aortic bioprosthesis (1.6%) or severe aortic regurgitation (0.3%). Patients were elderly (82.4±6 years), 52% were females, and the majority highly symptomatic (73.1% NYHA III/IV). Patients with severe aortic stenosis (mean gradient 44.8±17 mmHg, aortic valve area 0.7±0.3 cm²) were either deemed inoperable or at high risk for conventional surgery (STS 8.2%±7). The transfemoral access was the most frequently used (79.1%), followed by transapical (18.1%), direct aortic (1.7%) and subclavian access (1.1%). At 30 days, rates of all-cause mortality, cerebrovascular events and myocardial infarction were 4.8%, 3.3% and 0.4%, respectively. The most frequently observed adverse events were access-related complications (11.8%), permanent pacemaker implantation (20.5%) and bleeding complications (16.6%). The Swiss TAVI registry is registered at ClinicalTrials.gov (NCT01368250)., Conclusions: The Swiss TAVI registry is a national cohort study evaluating consecutive TAVI procedures in Switzerland. This first outcome report provides favourable short-term clinical outcomes in unselected TAVI patients.

Aims: A living heart valve with regeneration capacity based on autologous cells and minimally invasive implantation technology would represent a substantial improvement upon contemporary heart valve prostheses. This study investigates the feasibility of injectable, marrow stromal cell-based, autologous, living tissue engineered heart valves (TEHV) generated and implanted in a one-step intervention in non-human primates., Methods and Results: Trileaflet heart valves were fabricated from non-woven biodegradable synthetic composite scaffolds and integrated into self-expanding nitinol stents. During the same intervention autologous bone marrow-derived mononuclear cells were harvested, seeded onto the scaffold matrix, and implanted transapically as pulmonary valve replacements into non-human primates (n = 6). The transapical implantations were successful in all animals and the overall procedure time from cell harvest to TEHV implantation was 118 ± 17 min. In vivo functionality assessed by echocardiography revealed preserved valvular structures and adequate functionality up to 4 weeks post implantation. Substantial cellular remodelling and in-growth into the scaffold materials resulted in layered, endothelialized tissues as visualized by histology and immunohistochemistry. Biomechanical analysis showed non-linear stress-strain curves of the leaflets, indicating replacement of the initial biodegradable matrix by living tissue., Conclusion: Here, we provide a novel concept demonstrating that heart valve tissue engineering based on a minimally invasive technique for both cell harvest and valve delivery as a one-step intervention is feasible in non-human primates. This innovative approach may overcome the limitations of contemporary surgical and interventional bioprosthetic heart valve prostheses.

Purpose: To evaluate the diagnostic performance of coronary computed tomographic (CT) angiography for the diagnosis of mitral valve prolapse (MVP)., Materials and Methods: The retrospective case-controlled multicenter study protocol was approved by the institutional review boards. The U.S. part of the study was HIPAA compliant. One hundred twelve patients who underwent electrocardiographically gated 64-section coronary CT angiography (n = 60) or dual-source coronary CT angiography (n = 52) and transthoracic echocardiography (TTE) were included. Fifty-three patients with MVP were matched for age and sex with 59 patients without MVP. CT images were analyzed on three-, two-, and four-chamber (CH) views by two independent observers. MVP was defined as a greater than 2-mm displacement of leaflets below the annulus plane and was subclassified as "billowing" (bowing) or "flail leaflet" (free leaflet margin displacement). Leaflet thickness was measured and defined as thickened if it was greater than 2 mm., Results: The diagnostic performance of CT when three- and two-CH views were combined for the diagnosis of MVP was as follows: sensitivity, 96%; specificity, 93%; positive predictive value (PPV), 93%; and negative predictive value, 96%. On four-CH views, the excursion of billowing was higher than it was on three-CH views (P <.001), and the PPV of the four-CH view for diagnosis of MVP was 89%. The correlation between CT and TTE for excursion of billowing was high (r = 0.80-0.91). In a subset of 32 patients, the agreement between CT and TTE for differentiation of billowing (n = 13) and flail leaflet (n = 2) was 100%. Leaflet thickening was more prevalent in patients with MVP than it was in those without (71% vs 20%, P <.001), and correlation with TTE was good (r = 0.81 [anterior leaflet] and 0.77 [posterior leaflet])., Conclusion: The combined use of three- and two-CH views allows an accurate diagnosis of MVP at coronary CT angiography., ((c) RSNA, 2010)

Purpose: Gynecare tension-free vaginal tape (Ethicon, Inc., New Brunswick, New Jersey) is a propylene mesh tape recently introduced in the United States as minimally invasive treatment for stress urinary incontinence. We report the combined experience at 3 tertiary care institutions with graft erosion and bladder outlet obstruction after procedures performed elsewhere., Materials and Methods: We reviewed the records of 5 patients with complications who presented to 1 of 3 institutions after polypropylene mesh tape placement. All pertinent information was obtained from the medical records and the operating surgeon at the referring institution., Results: Treatment was required in 2 patients with urethral erosion, 1 with vaginal and bladder erosion, and 2 with bladder outlet obstruction. Common presenting symptoms included urge, urge incontinence and gross hematuria. Cystoscopy showed polypropylene graft erosion at the urethra or through the bladder wall. Each patient required explantation of the polypropylene mesh tape and further surgery to restore continence. The graft was divided transvaginally in the 2 patients presenting with outlet obstruction. Urge incontinence resolved and they returned to complete spontaneous voiding., Conclusions: High clinical suspicion is necessary when evaluating patients presenting with urinary symptoms after polypropylene mesh tape placement. Bladder outlet obstruction and possible graft erosion should be considered.