Tag: pubmed

Transplant Proc. 2022 May 19:S0041-1345(22)00199-3. doi: 10.1016/j.transproceed.2022.02.046. Online ahead of print.

ABSTRACT

BACKGROUND: In 2006 the National Transplants Registry administered by national transplant organization was introduced in Poland to monitor the results of organ transplantations. Statistical analysis is published yearly in the Poltransplant Bulletin, publicly available on the website and reported to European institutions. The transplant registry cooperates with other registers functioning online, based on the tool https://rejestrytx.gov.pl/. We present the formal analysis of data collected for the years 1996-2019.

MATERIALS AND METHODS: Analysis covered the total number of organ transplantations in every transplant center; outcomes are related to recipients living with a functioning graft 1, 5, and 10 years after transplantation; results presented are real, not extrapolated.

RESULTS: The total number of deceased-donor kidney transplantations was 20,606, the 1-year survival rate of recipients with a functioning graft was 90% (data completeness of 97%), and the 10-year survival rate was 59% (data completeness of 99%). The total number of deceased-donor liver transplantations was 4790; the 1-year survival rate of recipients with a functioning graft was 59% (data completeness of 98%).

SUMMARY: The National Transplant Registry is an important tool for quality and safety systems in the transplantation field on the national level. The registry efficiently and effectively fulfills its tasks related to collecting records of all transplantations performed. Monitoring function for graft and recipient survival is also satisfied. The data provide an important and unique source of information to be used by transplant institutions and referred to in the literature.

PMID:35599201 | DOI:10.1016/j.transproceed.2022.02.046

Eur Urol. 2022 May 19:S0302-2838(22)02330-2. doi: 10.1016/j.eururo.2022.04.031. Online ahead of print.

ABSTRACT

BACKGROUND: In metastatic seminoma, a strategy is needed for selecting patients for less intensive chemotherapy, to limit toxicities.

OBJECTIVE: To assess whether men with good-prognosis metastatic seminoma could be treated with two cycles of etoposide-cisplatin (EP) followed by only one cycle of carboplatin (CARBO) based on negative interim fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT).

DESIGN, SETTING, AND PARTICIPANTS: A nonrandomised, multicentre, phase 2 trial was conducted (NCT01887340).

INTERVENTION: All patients with baseline-positive FDG-PET/CT received EP for two cycles. After completing the first two cycles, the patients underwent a second FDG-PET/CT to assess the response. Patients with positive FDG-PET/CT proceeded directly to two additional EP cycles; those who achieved FDG-PET/CT negativity received one cycle of CARBO.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The proportion of patients with negative interim FDG-PET/CT who received carboplatin was determined.

RESULTS AND LIMITATIONS: Between 2013 and 2017, 102 patients were enrolled. After the first two EP cycles, FDG-PET/CT was available in 98 patients. Overall, 67 patients (68.4%; 95% confidence interval [CI]: 58.2-77.4) had negative FDG-PET/CT and proceeded to a single CARBO cycle. Twenty-seven patients (27.6%; 95% CI: 19.0-37.5) had positive FDG-PET/CT after two EP cycles. The 3-yr progression-free survival rate was 90.0% (95% CI: 74.4-96.5) in the EP group and 90.8% (95% CI: 81.4-95.7) in the CARBO group. The cumulative incidences of peripheral neuropathy and ototoxicity were significantly higher in the EP group.

CONCLUSIONS: Omission of two cycles of EP based on negative FDG-PET/CT after two cycles of chemotherapy appears to be feasible. However, the absence of consensus criteria for FDG-PET/CT interpretation and the short follow-up need additional studies. This strategy does not warrant routine integration yet.

PATIENT SUMMARY: Men with good-prognosis metastatic seminoma were treated with fewer cycles of chemotherapy based on interim fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT). Omission of two cycles of chemotherapy based on negative FDG-PET/CT after two initial cycles appears to be feasible, thereby limiting the burden of treatment and toxicity.

PMID:35599187 | DOI:10.1016/j.eururo.2022.04.031

Eur Urol. 2022 May 19:S0302-2838(22)02329-6. doi: 10.1016/j.eururo.2022.04.030. Online ahead of print.

ABSTRACT

BACKGROUND: Surgical extraction of testicular spermatozoa is needed in men with nonobstructive azoospermia (NOA) who wish to become biological fathers. Based on available uncontrolled studies with unspecific patient selection, microdissection testicular sperm extraction (mTESE), having a sperm retrieval rate (SRR) of 50%, is considered the most efficient sperm retrieval procedure. However, no randomized clinical trials for comparison of different sperm retrieval procedures exist. Testicular sperm aspiration (TESA) is simple and commonly used, and we hypothesized that this technique using multiple needle passes would give similar SRRs to mTESE.

OBJECTIVE: To compare mTESE and multiple needle-pass TESA in men with NOA.

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was performed between June 2017 and April 2021, with inclusion of 100 men with NOA from four centers in Denmark and Sweden. All participants received treatment at the same institution.

INTERVENTION: Participants were randomized to mTESE (n = 49) or multiple needle-pass TESA (n = 51). Patients with failed multiple needle-pass TESA proceeded directly to salvage mTESE.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was SRR. Secondary outcomes included complications and changes in reproductive hormones after surgery.

RESULTS AND LIMITATIONS: Spermatozoa were retrieved in 21/49 (43%) men after mTESE and in 11/51 (22%) men after multiple needle-pass TESA (rate difference -0.21; 95% confidence interval -0.39 to -0.03; p = 0.02). The combined SRR for multiple needle-pass TESA + salvage mTESE was 15/51 (29%). No complications occurred after multiple needle-pass TESA only, while 5/89 (6%) men having mTESE experienced a complication requiring surgical intervention. Overall, no statistically significant differences in reproductive hormones were observed between groups after 6 mo. Limitations include the low number of patients in secondary outcome data.

CONCLUSIONS: In direct comparison, SRR was higher in mTESE than in multiple needle-pass TESA.

PATIENT SUMMARY: Men with azoospermia need surgical extraction of spermatozoa to become biological fathers. In this randomized trial, we compared two surgeries (microdissection testicular sperm extraction [mTESE] and testicular sperm aspiration [TESA]) and found that mTESE gives a higher sperm retrieval rate than multiple needle-pass TESA.

PMID:35599183 | DOI:10.1016/j.eururo.2022.04.030

Med Dosim. 2022 May 19:S0958-3947(22)00038-3. doi: 10.1016/j.meddos.2022.04.002. Online ahead of print.

ABSTRACT

Volumetric modulated arc therapy (VMAT) and 3D dynamic conformal arc therapy (DCAT) are 2 methods proven useful for the clinical implementation of stereotactic body radiation therapy (SBRT) for lung lesions however, similar comparisons of SBRT liver lesions are lacking. The purpose of this study was to determine if the conformity of dose, irradiated volume, and dose to organs at risk (OAR) are equivalent or improved with the use of DCAT as an alternative treatment method when compared to standard VMAT for SBRT delivery of palliative and early-stage liver lesions. Twenty patients with liver lesions sized 2.0 to 5.0 cm were selected for this study. Plans were created with both DCAT and VMAT techniques for each patient. Metrics evaluated included the mean heart, kidney, large bowel, small bowel, esophagus, and stomach doses, the lung volume receiving 20 Gy (V₂₀), the volume of the normal liver receiving 15 Gy (V₁₅), conformity index (CI), heterogeneity index (HI), and the irradiated volume or volume receiving 25 Gy (V₂₅). The p-values for the mean dose to kidneys, small bowel, esophagus, and the lung V₂₀ were greater than 0.05, and no statistical difference could be determined between DCAT and VMAT. The p-values for the mean heart, large bowel, stomach, and liver V₁₅ were less than 0.05, indicating statistical significance and superiority of VMAT for minimizing dose to these organs, especially V₁₅ of the liver. The DCAT technique produced CI greater than 1.0 for all patients proving superior coverage, while standard VMAT produced significantly improved V₂₅ with p-values less than 0.0001, and consequently higher HI.

PMID:35599177 | DOI:10.1016/j.meddos.2022.04.002

Neuromodulation. 2022 May 19:S1094-7159(22)00646-8. doi: 10.1016/j.neurom.2022.03.009. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to demonstrate the feasibility of using motor evoked responses to intraoperative double-train stimulation to guide lead placement and matching of intraoperative contacts with postoperative electrode programming in spinal cord stimulation for pain performed under general anesthesia.

MATERIALS AND METHODS: The study included a series of 20 consecutive patients with refractory pain operated on under general anesthesia. Either percutaneous or paddle leads were implanted and positioned according to the intraoperative mapping results. Neurophysiologic mapping was performed with a double-train stimulation paradigm (intertrain interval of 60 milliseconds, three to five cathodal pulses with 0.5-millisecond pulse duration, and within-train interstimulus intervals of 2-4 milliseconds). The sites where dorsal column responses of the targeted dermatomes were detected were considered optimal for lead placement (intraoperative best contacts). Following spinal cord stimulator (SCS) lead placement, blinded postoperative programming of electrode contacts was matched with the intraoperative best contacts and the pain-paresthesia overlap for the trial phase. A binominal test was used as a statistical method; pre- and postoperative numeric rating scale (NRS) after three months was obtained.

RESULTS: A total of 15 patients underwent spinal cord stimulation trial for intractable pain. Of these, ten patients (66%) had a successful trial and received permanent implants; one patient had a successful trial but was never intended to be implanted because of her poor health condition; four patients (26%) had an unsuccessful trial, leading to trial electrode explantation; and five patients had already had an implant with percutaneous leads and therefore underwent electrode revision, of whom four patients received paddle leads. In 18 of the 20 operated patients (90%), we found a match between the best intraoperative contacts and the postoperatively programmed contacts (significantly better than chance, p = 8.2 × 10^-15). In 90% of the patients, a pain-paresthesia overlap of 100% was found. In the remaining two patients (10%), the postoperatively best programmed contacts were one contact away from the intraoperative neurophysiologic best contact. A mean preoperative NRS score of 8.2 (variance) and a mean follow-up NRS score after three months of 3.6 (variance) were obtained for all patients with implants.

CONCLUSION: In this proof-of-concept study, we were able to demonstrate that SCS lead placement using a double-train stimulation paradigm performed under general anesthesia is a safe and feasible technique, offering reliable prediction of contacts for postoperative programming and excellent pain-paresthesia coverage.

PMID:35599160 | DOI:10.1016/j.neurom.2022.03.009

J Intern Med. 2022 May 22. doi: 10.1111/joim.13523. Online ahead of print.

ABSTRACT

BACKGROUND: The Bacillus Calmette-Guérin (BCG) vaccine may confer cross-protection against viral diseases in adults. This study evaluated BCG vaccine cross-protection in adults with convalescent coronavirus disease 2019 (COVID-19).

METHOD: This was a multicenter, prospective, randomized, placebo-controlled, double-blind phase III study (ClinicalTrials.gov: NCT04369794).

SETTING: University Community Health Center and Municipal Outpatient Center in South America.

PATIENTS: A total of 378 adult patients with convalescent COVID-19 were included.

INTERVENTION: Single intradermal BCG vaccine (n = 183) and placebo (n = 195).

MEASUREMENTS: The primary outcome was clinical evolution. Other outcomes included adverse events and humoral immune responses for up to six months.

RESULTS: A significantly higher proportion of BCG patients with anosmia and ageusia recovered at the 6-week follow-up visit than placebo (anosmia: 83.1% vs. 68.7% healed, p = 0.043, number needed to treat [NNT] = 6.9; ageusia: 81.2% vs. 63.4% healed, p = 0.032, NNT = 5.6). BCG also prevented the appearance of ageusia in the following weeks: seven in 113 (6.2%) BCG recipients versus 19 in 126 (15.1%) placebos, p = 0.036, NNT = 11.2. BCG did not induce any severe or systemic adverse effects. The most common and expected adverse effects were local vaccine lesions, erythema (n = 152; 86.4%), and papules (n = 111; 63.1%). Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) humoral response measured by N protein immunoglobulin G (IgG) titer and seroneutralization by interacting with the angiotensin-converting enzyme 2 (ACE2) receptor suggest that the serum of BCG-injected patients may neutralize the virus at lower specificity; however, the results were not statistically significant.

CONCLUSION: BCG vaccine is safe and offers cross-protection against COVID-19 with potential humoral response modulation.

LIMITATIONS: No severely ill patients were included. This article is protected by copyright. All rights reserved.

PMID:35599154 | DOI:10.1111/joim.13523

Semergen. 2022 May 19:S1138-3593(22)00077-6. doi: 10.1016/j.semerg.2022.02.006. Online ahead of print.

ABSTRACT

This fourth in a series of five articles on systematic reviews demonstrates how to compile and summarize the results of the studies included in a review. The synthesis of the extracted data consists of tabulating the characteristics, and the quality of the included studies, with the effects or the magnitude of the associations found in them. Statistical methods can be used to explore the differences between studies and the reasons for the inconsistencies. The magnitude of this heterogeneity influences whether it is feasible to perform an overall or subgroup meta-analysis. Finally, information is provided both to assessment of clinical and methodological reasons for heterogeneity.

PMID:35599147 | DOI:10.1016/j.semerg.2022.02.006

J Cardiol. 2022 May 19:S0914-5087(22)00102-2. doi: 10.1016/j.jjcc.2022.04.011. Online ahead of print.

ABSTRACT

BACKGROUND: Current guidelines provide recommendation for transcatheter aortic-valve replacement (TAVR) in severe aortic stenosis without emphasis on valve systems. The comparative performances of balloon-expandable valves (BEV) and self-expanding valves (SEV) remain unclear. We aim to compare the early (30-day) and midterm (1-year) mortality and cardiovascular outcomes of BEV with SEV.

METHODS: PubMed, CENTRAL, and EMBASE were searched from inception to February 13, 2020 for randomized controlled trials (RCTs) and propensity-score matched (PSM) studies. Odds ratios (ORs) for binary outcomes and mean differences for continuous outcomes were pooled using random-effect models (DerSimonian-Laird method) with Hartung-Knapp-Sidik-Jonkman variance correction. Primary outcomes were early and midterm all-cause mortality.

RESULTS: We included 3 RCTs (1418 patients) and 12 PSM studies (36,540 patients). Compared with SEV, BEV was associated with significantly lower mortality at 30 days (OR 0.76, 95% CI 0.67-0.85, p < 0.001, I2 = 0) and 1 year (OR 0.87, 95% CI 0.77-0.99, p = 0.04, I2 = 20.4%) in PSM studies, but not RCTs with insufficient power. Similar findings were found in subgroups analysis based on valve generations and SEV types. The 30-day and 1-year cardiovascular mortality, 30-day incidences of moderate to severe paravalvular leak, procedural contrast agent volume, and procedure time were lower, but transvalvular pressure gradient was higher in BEV than SEV in PSM studies. The 30-day incidences of permanent pacemaker implantation (PPI), acute kidney injury, stroke, major bleeding, major vascular complications, and rehospitalization were not statistically different between BEV and SEV. Early-generation SEV was associated with a higher 30-day PPI risk than corresponding BEV comparators. PPI risk was lower in ACURATE neo (Boston Scientific, Natick, MA) but higher in Evolut R SEV (Medtronic Inc., Minneapolis, MN), both compared with SAPIEN 3 BEV (Edwards Lifesciences, Irvine, CA).

CONCLUSIONS: PSM studies suggest lower early and midterm mortality in BEV than SEV, but the contribution of unmeasured confounders cannot be excluded. Results from adequately powered RCTs with long-term follow-up are critically needed to confirm these findings.

PMID:35599108 | DOI:10.1016/j.jjcc.2022.04.011

J Foot Ankle Surg. 2022 Apr 29:S1067-2516(22)00115-6. doi: 10.1053/j.jfas.2022.04.005. Online ahead of print.

ABSTRACT

Adult acquired flat foot deformity (AAFD) is a progressive, tri-planar deformity involving collapse of the medial longitudinal arch, valgus deformity of the rear foot, and abduction of the mid-foot on the rear foot. There are a wide variety of surgical treatment options for this deformity, including lateral column lengthening (LCL) which results in tri-planar correction of AAFD. We retrospectively reviewed weightbearing preoperative radiographs and weight-bearing 6-week postoperative radiographs of 34 patients with stage II AAFD who underwent LCL (with and without concurrent procedures) with a minimum of 1-year of follow up. Outcomes, including complications and postoperative differences in 6 types of angle measurements were evaluated. Radiographic evaluation showed statistically significant differences in preoperative and postoperative measures in the following angles: calcaneal inclination, Meary’s, Simmons, talocalcaneal, and metatarsus adductus (each p ≤ .05). Postoperative Engel’s angle difference did not reach statistical significance (p = .07). Paired t tests showed TN coverage angles increased greater with LCL plus a Cotton osteotomy as compared to isolated LCL. Additionally, there was no significant difference in TN coverage angle based on LCL graft size (p = .20). Furthermore, the distance of the osteotomy from the calcaneocuboid joint on anteroposterior and lateral radiographs did not significantly predict TN coverage angle change. Our study suggests that LCL corrects AAFD in three planes while decreasing the metatarsus adductus angle. LCL appears to be more effective when performed with a Cotton osteotomy. Wedge size (6 mm, 8 mm, 10 mm) and osteotomy location did not demonstrate a relationship with postoperative TN coverage angle or incidence of lateral column overload.

PMID:35599073 | DOI:10.1053/j.jfas.2022.04.005

Physiotherapy. 2022 May 19:S0031-9406(21)00389-8. doi: 10.1016/j.physio.2021.12.003. Online ahead of print.

NO ABSTRACT

PMID:35599069 | DOI:10.1016/j.physio.2021.12.003