Nevin Manimala

J Card Surg. 2022 Nov 15. doi: 10.1111/jocs.17208. Online ahead of print.

ABSTRACT

BACKGROUND: The effect of the surgical sealant AQUABRID on outcomes after acute aortic dissection repair has not been evaluated. The objective of this study was to examine whether the use of AQUABRID affects the volume of intraoperative blood transfusion or operative time in patients undergoing emergency surgery to repair acute aortic dissection.

METHODS: A multicenter retrospective cohort study from January 2007 to December 2021. A total of 399 patients underwent emergency acute aortic dissection repair. Propensity score matching was used to adjust for the type of surgery and other patient characteristics.

RESULTS: A total of 387 of the eligible 399 patients were included in this study and propensity score matching yielded 94 patients for whom characteristics were not significantly different between the two groups. The type of surgery was exactly matched (ascending aorta replacement: 19 [40%]; partial arch replacement: 13 [28%]; total arch replacement: 15 [32%] in each group). Within the matched cohort, there was a statistically significant difference in the volume of intraoperative blood transfusion. (AQUABRID vs. control: 34 [26-38] vs. 50 [38-60] U in Japan, p = .03). Operating time was significantly shorter in the AQUABRID group (total operation: mean ± SD, 343 ± 92 vs. 402 ± 161 min, p = .03; reconstruction for arch vessels: 29 ± 17 vs. 56 ± 22, p < .01). The rate of postoperative complications was comparable in the two groups. Failure to use AQUABRID was a significant predictor of the need for massive transfusion (>40 U) (odds ratio: 7.20; 95% confidence interval: 2.56-20.23; p < .01).

CONCLUSIONS: The use of AQUABRID during emergency acute aortic dissection repair significantly decreased the volume of intraoperative blood transfusion and the duration of surgery.

PMID:36378886 | DOI:10.1111/jocs.17208

J Card Surg. 2022 Nov 15. doi: 10.1111/jocs.17191. Online ahead of print.

ABSTRACT

OBJECTIVES: The objective of this study was to evaluate the predictive value of main pulmonary artery (MPA) Z score, pulmonary valve annulus (PVA) prop, great aortic valve annulus (GA) ratio, PVA index (PAI), and PVA area index (PAAI) indicators in patients with Tetralogy of Fallot (TOF) and whether or not to undergo transannular patch (TAP).

METHODS: A retrospective analysis was performed on the clinical data of 263 patients with TOF who underwent radical operations from 2010 to 2021 at Beijing Children’s Hospital. Sixteen cases were excluded, and 247 cases (male/female = 155/92) were included in this study. Based on whether TAP was selected intraoperatively, the patients were divided into the TAP group (82/247) and the non-TAP group (165/247). The diameter of the PVA, the aortic valve annulus, and the MPA were measured by echocardiography, and the PVA Z score, MPA Z score, PVA prop, GA ratio, PAI, and PAAI indexes were calculated, and statistical analysis was carried out.

RESULTS: The PVA Z score, MPA Z score, PVA prop, GA ratio, PAI, and PAAI of the TAP group were lower than those of the non-TAP group (p < .0001, p < .0001, p < .0001, p < .0001, p < .0001, and p < .0001). Receiver-operating curve analysis showed that the cut-off value of PVA Z score was -1.96 (area under the curve [AUC]: 0.822; 95% confidence interval [CI]: 0.769-0.874); the cut-off value of MPA Z score was -1.04 (AUC: 0.778; 95% CI: 0.711-0.845); the cut-off value of PVA prop was 0.37 (AUC: 0.812; 95% CI: 0.751-0.874); the cut-off value of GA ratio was 0.64 (AUC: 0.812; 95% CI: 0.750-0.874); the cut-off value of PAI is 0.78 (AUC: 0.812; 95% CI: 0.750-0.874); and the cut-off value of PAAI is 0.4 (AUC: 0.812; 95% CI: 0.750-0.874). Pulmonary valve bicuspid malformation is one reason why predictive models fail to predict the possible avoidance of TAP. Pearson’s correlation and linear regression analysis showed that PAI had the strongest correlation with PVA Z score, followed by that between PVA prop and PVA Z score, and the weakest correlation between PAAI and PVA Z score.

CONCLUSIONS: PVA prop, GA ratio, PAI, and PAAI can well predict TAP selection, and the measurement is simple and convenient. Compared with PVA Z score, they are not hindered by other confounding factors, and can well replace the application value of PVA Z score in TAP prediction. The predictive efficacy of PAI and PVA prop is numerically better than the GA ratio, and PAAI, PAI, and PVA prop combined with MPA Z score can improve the predictive value of PAI and PVA prop, respectively. Although various echocardiographic parameters can be used as indicators to predict surgical approach in patients with TOF, PV morphology and tissue characteristics should also be considered.

PMID:36378883 | DOI:10.1111/jocs.17191

J Card Surg. 2022 Nov 15. doi: 10.1111/jocs.17209. Online ahead of print.

ABSTRACT

BACKGROUND: Impella devices are increasingly utilized as a bridge to heart transplantation (BTT) and are now prioritized as Status 2 under the current heart allocation policy. This study evaluated waitlist and post-transplant outcomes of patients supported with Impella 5.0/5.5 devices.

METHODS: The United Network of Organ Sharing registry was used to identify adults waitlisted or transplanted with Impella 5.0 or 5.5 devices from 2010 to 2021. Separate analyses were performed for waitlist and transplantation outcomes for patients supported by Impella 5.0/5.5 devices. Competing outcomes for the waitlist analysis included rates of transplantation, recovery, and death or clinical deterioration. Among patients undergoing transplantation, the primary outcome was 1-year survival. Secondary outcomes included rates of rejection, new postoperative dialysis, stroke, and pacemaker implantation after transplantation.

RESULTS: There were 344 patients waitlisted and 394 patients transplanted with an Impella 5.0 (n = 212 and 251) or 5.5 (n = 132 and 143) device. Competing risk regression demonstrated similar likelihood of transplant (subhazard ratio [SHR], 1.33 (0.98-1.81, p = 0.067)) and similar likelihood of death or clinical deterioration (SHR, 0.67 [0.27-1.69, p = 0.400]) for Impella 5.5 patients. In the transplanted cohort, unadjusted 1-year post-transplant survival was comparable at 91.3% versus 94.6% (log-rank p = 0.661) for patients supported by Impella 5.0 or 5.5 device, respectively, a finding that persisted after risk-adjustment (HR 1.22, p = 0.699). Post-transplant complication rates were also comparable between 5.0 and 5.5 patients.

CONCLUSIONS: Impella devices can be used as a BTT with excellent survival and minimal post-transplant morbidity. Outcomes were comparable for Impella 5.0 and 5.5 devices.

PMID:36378877 | DOI:10.1111/jocs.17209

J Card Surg. 2022 Nov 15. doi: 10.1111/jocs.17186. Online ahead of print.

ABSTRACT

OBJECTIVES: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) predicts in-hospital mortality for patients undergoing cardiac surgery. Many variables associated with increased surgical mortality persist postoperatively. The aim of this study was to investigate the predictive value of the logistic EuroSCORE to long-term survival after coronary artery bypass surgery.

METHODS: Data were collected retrospectively for all patients undergoing coronary artery bypass graft (CABG) at a single center between January 1, 2009 and December 31, 2009. Data submitted to NICOR were used for EuroSCORE and in-hospital outcomes; longer-term, all-cause mortality from NHS digital Personal Demographic Service. Low (<3), intermediate (3-6), and high-risk (>6) logistic EuroSCORE groups were identified and analyzed using the appropriate statistical methodology, with p values less than .05 being taken as significant.

RESULTS: Six hundred and sixty-three patients underwent isolated CABG procedures during the study. The 1-, 3-, 5-, and 10-year survival rates were 97.6%, 94.3%, 89.3%, and 73.5%, respectively. Comparing survival outcomes between low-, intermediate-, and high-risk groups showed that the logistic EuroSCORE was able to predict long-term outcomes (p < .05). In addition, poor left ventricular ejection fraction, serum creatinine above 200 ml, chronic pulmonary disease, extracardiac arteriopathy, and pulmonary hypertension were identified as independent predictors of long-term mortality.

CONCLUSIONS: Our study demonstrates the logistic EuroSCORE predicted long-term outcomes following CABG surgery. This finding can inform patients of the long-term risks of CABG surgery and guide MDT decision-making.

PMID:36378861 | DOI:10.1111/jocs.17186

J Ocul Pharmacol Ther. 2022 Nov 15. doi: 10.1089/jop.2022.0012. Online ahead of print.

ABSTRACT

Purpose: The purposes of this study were to investigate cytokine changes in the aqueous humor after treatment of acquired immune deficiency syndrome (AIDS) complicated with cytomegalovirus retinitis (CMVR) and to determine whether these changes are useful prognostic indicators. Methods: This study included 12 patients (15 eyes) undergoing treatment for AIDS and CMVR. The patients received intravitreal injections and systemic intravenous treatment with ganciclovir and foscarnet sodium. The aqueous humor of each eye was sampled before treatment and before the third and fifth injections. The samples were tested to determine the concentrations of each of 27 cytokines using the Luminex 200™ liquid phase chip. Results: The concentrations of cytokines interleukin (IL)-1rα (P = 0.002), IL-1b (P = 0.001), IL-8 (P = 0.001), basic fibroblast growth factor (bFGF) (P < 0.001), interferon γ-induced protein 10 (IP-10) (P = 0.001), and tumor necrosis factor (TNF)-α (P = 0.004) in the aqueous humor before the third and fifth injections were significantly lower after than before treatment. The reductions in TNF-α (P = 0.028) and IL-1b (P = 0.028) concentrations after treatment were statistically significant compared with the postoperative visual acuity improvement (≥3 lines and <3 lines). The difference in TNF-α (P = 0.018) level before and after treatment (the difference between before treatment and before the fifth intravitreal injection) was also statistically significant compared with the number of injections (≥6 times and <6 times). Conclusion: The cytokines IL-1rα, IL-1b, IL-8, bFGF, IP-10, and TNF-α may offer new avenues for evaluation of therapeutic effect, and TNF-α and IL-1b may be important cytokines for prognostic evaluation (based on visual acuity and the number of injections) in patients suffering from AIDS and CMVR. Clinical Trial Registration: Number: ChiCTR2200056955.

PMID:36378859 | DOI:10.1089/jop.2022.0012

Neurourol Urodyn. 2022 Nov 15. doi: 10.1002/nau.25091. Online ahead of print.

ABSTRACT

INTRODUCTION: Gender dysphoria affects over 1 million American adults. Vaginoplasty is a critical step in gender affirmation, and many patients have insufficient genital skin for full-depth penile inversion vaginoplasty (PIV). We reviewed the literature for technical considerations addressing this and present our data supporting the use of peritoneal flaps (Davydov technique).

MATERIALS AND METHODS: A comprehensive review of modern literature was conducted. Second, we present a retrospective case review of our experience with PIV, including data from procedures utilizing peritoneal flaps.

RESULTS: We identified 20 original articles, including retrospective and prospective case and cohort studies. Approaches included the application of local soft tissue grafts and flaps, peritoneal flaps, and intestinal segments. Between June 2018 and February 2021, 47 patients at our institution, underwent PIV for the treatment of gender dysphoria. Nineteen of those patients underwent robotic-assisted peritoneal flap procedure in addition to PIV. In this cohort, the mean follow-up was 200.6 ± 124.8 days. Mean neovaginal depth was 13.1 ± 3.0 cm intra-operatively and 11.0 cm at the last follow-up. Twenty-six percent of complications were Clavien Grade 1 or 2; others included wound dehiscence (30.4%), perianal and urethral fistula (13.0%), and neovaginal stenosis (8.7%). The majority of patients reported satisfactory results in terms of sexual function with intact tactile and erogenous sensation. Almost half were able to have penetrative vaginal intercourse at the last follow-up. We did not aim to perform statistical calculations to compare the outcomes of PIV with and without robotic-assisted peritoneal flap augmentation, as the groups were not constructed in that manner. However, it is evident that anatomical and functional results as well as the distribution of postoperative complications seem similar.

CONCLUSION: Vaginoplasty is indicated in a growing population of patients with a wide range of medical histories and anatomic variations. Genitourinary reconstructive surgeons must have several methods to achieve full-depth vaginoplasty in cases of inadequate genital skin. Peritoneal flaps serve as a versatile, safe, and functionally advantageous solution.

PMID:36378843 | DOI:10.1002/nau.25091

Neurourol Urodyn. 2022 Nov 15. doi: 10.1002/nau.25096. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the efficacy of perineal electrical stimulation (ES) on anxiety, depression, incontinence-related quality of life (QoL), and clinical parameters in men with urinary incontinence (UI) after radical prostatectomy (RP).

METHODS: Fifty-eight men with UI after RP were randomized into two groups using the random numbers generator as follows: Group 1 received perineal ES (n:29), and Group 2 no treatment (n:29). Perineal ES was performed in lithotomy position via a stimulation device (Enraf Myomed 632) with surface electrodes, 3 days a week, 20 min a day, for a total of 24 sessions for 8 weeks. Men were evaluated in terms of continence rates (primary outcome), incontinence severity (24 h-pad test), incontinence episodes (3-day bladder diary), anxiety-depression (HADS), QoL (IIQ-7), and improvement rates and treatment satisfaction (Likert scale) at the baseline and the end of treatment (8th week).

RESULTS: A statistically significant improvement was found in all parameters except depression in Group 1, in the severity of incontinence and QoL parameters in Group 2 at the 8th week compared to the baseline values (p < 0.05). At the end of treatment; the severity of incontinence, incontinence episodes, QoL, and anxiety were significantly improved in Group 1 compared to Group 2 (p < 0.05). No difference was found between the two groups in terms of depression (p > 0.05). The continence and improvement rates and treatment satisfaction were significantly higher in Group 1 than in Group 2 (p < 0.05).

CONCLUSION: Perineal ES is more effective than no treatment in men with UI after RP as an alternative ES option that is well tolerated and does not produce serious adverse events. Clinical Trial Registration: This study was registered with ClinicalTrials.gov number, NCT05236140.

PMID:36378836 | DOI:10.1002/nau.25096

Am J Respir Crit Care Med. 2022 Nov 15. doi: 10.1164/rccm.202204-0629OC. Online ahead of print.

ABSTRACT

RATIONALE: The respective effects of PEEP and pressure support delivered through the helmet interface in hypoxemic patients need to be better understood.

OBJECTIVES: To assess the respective effects of helmet pressure support (NIV) and continuous positive-airway pressure (CPAP) compared to high-flow nasal oxygen (HFNO) on effort to breathe, lung inflation and gas exchange in hypoxemic patients (PaO2/FiO2≤200).

METHODS: Fifteen patients underwent 1-hour phases (constant FiO2) of HFNO (60 L/min), helmet NIV (PEEP=14 cmH2O, pressure support=12 cmH2O) and CPAP (PEEP=14 cmH2O) in randomized sequence.

MEASUREMENTS: Inspiratory esophageal (ΔPES) and transpulmonary pressure (ΔPL) swings were used as surrogates for inspiratory effort and lung distension, respectively. Tidal volume (VT) and end-expiratory lung volume were assessed with electrical impedance tomography.

MAIN RESULTS: ΔPES was lower during NIV vs. CPAP and HFNO (5[3-9] cmH2O vs. 13[10-19] vs. 10[8-13], p=0.001 and p=0.01). ΔPL was not statistically different between treatments. PaO2/FiO2 ratio was significantly higher during NIV and CPAP vs. HFNO (166[136-215] and 175[158-281] vs. 120[107-149], p=0.002 and p=0.001). NIV and CPAP similarly increased VT vs. HFNO (mean change: 70%[95%CI: 17-122], p=0.02; 93% [95%CI: 30-155], p=0.002) and end-expiratory lung volume (mean change: 198%[95%CI: 67-330], p=0.001; 263%[95%CI: 121-407], p=0.001), mostly due to increased aeration/ventilation in dorsal lung regions. During HFNO, 14/15 patients had pendelluft involving>10% of VT: pendelluft was mitigated by CPAP and further by NIV.

CONCLUSIONS: Compared to HFNO, helmet NIV, but not CPAP, reduced ΔPES. CPAP and NIV similarly increased oxygenation, end-expiratory lung volume and VT, without affecting ΔPL. NIV, and to a lesser extent, CPAP, mitigated pendelluft. Clinical trial registration available at www.

CLINICALTRIALS: gov, ID: NCT04241861.

PMID:36378814 | DOI:10.1164/rccm.202204-0629OC

J Cardiovasc Electrophysiol. 2022 Nov 15. doi: 10.1111/jce.15747. Online ahead of print.

ABSTRACT

BACKGROUND: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small diameter, lumenless, catheter delivered, defibrillator lead was developed with the aim to improve long term reliability.

METHODS AND RESULTS: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled.

CONCLUSION: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach. This article is protected by copyright. All rights reserved.

PMID:36378803 | DOI:10.1111/jce.15747

IEEE Trans Med Imaging. 2022 Nov 15;PP. doi: 10.1109/TMI.2022.3220706. Online ahead of print.

ABSTRACT

Dataset auditing for machine learning (ML) models is a method to evaluate if a given dataset is used in training a model. In a Federated Learning setting where multiple institutions collaboratively train a model with their decentralized private datasets, dataset auditing can facilitate the enforcement of regulations, which provide rules for preserving privacy, but also allow users to revoke authorizations and remove their data from collaboratively trained models. This paper first proposes a set of requirements for a practical dataset auditing method, and then present a novel dataset auditing method called Ensembled Membership Auditing (EMA). Its key idea is to leverage previously proposed Membership Inference Attack methods and to aggregate data-wise membership scores using statistic testing to audit a dataset for a ML model. We have experimentally evaluated the proposed approach with benchmark datasets, as well as 4 X-ray datasets (CBIS-DDSM, COVIDx, Child-XRay, and CXR-NIH) and 3 dermatology datasets (DERM7pt, HAM10000, and PAD-UFES-20). Our results show that EMA meet the requirements substantially better than the previous state-of-the-art method. Our code is at: https://github.com/Hazelsuko07/EMA.

PMID:36378795 | DOI:10.1109/TMI.2022.3220706