Myocarditis and pericarditis in individuals exposed to the Ad26.COV2.S, BNT162b2 mRNA, or mRNA-1273 SARS-CoV-2 vaccines.

Importance: There is a high level of public and professional interest related to potential safety issues of the COVID-19 vaccines; however, no serious adverse cardiovascular events were reported in phase 3 randomized controlled trials of their safety and efficacy. Moreover, none of the case series from the United States (US) of these potential complications have been population-based. Objectives: To estimate the reporting rates of myocarditis and pericarditis in the US using the Vaccine Adverse Event Reporting System (VAERS), and to assess if these adverse events were disproportionally reported among the different COVID-19 vaccines. Design setting and participants: All cases of myocarditis and pericarditis from VAERS reported up to July 28, 2021. Exposure: Single-dose Ad26.COV2.S, BNT162b2 mRNA, or mRNA-1273 SARS-CoV-2 vaccinations. Main outcomes and measures: Reporting rates were computed by dividing the total number of cases of myocarditis and pericarditis (combined) by the total number of vaccine doses administered. Disproportionality analyses were performed to evaluate disproportional reporting of myocarditis and pericarditis for the Ad26.COV2.S and mRNA-1273 vaccines vs. the BNT162b2 mRNA vaccine. Results: By July 28, 2021, 1392, 699, and 68 cases of myocarditis or pericarditis had been reported out of 1.91, 1.38, and 1.33 million administered doses of the BNT162b2 mRNA, mRNA-1273, and Ad26.COV2.S COVID-19 vaccines, respectively. Median times to event were 3 days, 3 days, and 9 days for the BNT162b2 mRNA, mRNA-1273, and Ad26.COV2.S COVID-19 vaccines. The reporting rates for myocarditis or pericarditis were 0.00073 (95% confidence interval, 95% CI 0.00069-0.00077), 0.00051 (95% CI 0.00047-0.00055), and 0.00005 events per dose (95% CI 0.00004-0.00006) for the BNT162b2 mRNA, mRNA-1273, and Ad26.COV2.S COVID-19 vaccines, respectively. Myocarditis and pericarditis were disproportionally reported following the BNT162b2 mRNA vaccine when compared with the other vaccines, using both disproportionality measures. Conclusions and relevance: We found reporting rates of myocarditis and pericarditis to be less than 0.1% after COVID-19 vaccination. Rates were highest for the BNT162b2 mRNA vaccine, followed by the mRNA-1273 and Ad26.COV2.S, respectively. However, the reporting rates of myocarditis and pericarditis secondary to vaccination remains less common than those seen for SARS-CoV-2 infection.

Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction.

We aimed to review the current evidence on surgical and functional outcomes of Transperineal Laser Ablation for LUTS due to BPH. A comprehensive review of the English-language literature was performed using the MEDLINE and Web of Science databases until 1 August 2022, aiming to select studies evaluating TPLA for the treatment of LUTS due to BPH. Additional records were found from Google Scholar. Data were extracted and summarized in Tables. An appropriate form was used for qualitative data synthesis. Seven studies were included in the review, with all being single arm, non-comparative studies. In all studies, functional outcomes were evaluated with uroflowmetry parameters and validated questionnaires, showing a promising effectiveness at short- and mid-term follow-up. There is a lack of standardized pathways for preoperative assessment of patients suitable for TPLA, and even the technique itself has been reported with a few nuances. A good safety profile has been reported by all the authors. Although promising results have been reported by different groups, selection criteria for TPLA and few technical nuances regarding the procedure were found to be heterogeneous across the published series that should be standardized in the future. Further research is needed to confirm these findings.

Could transperineal interstitial laser ablation of the prostate be the right option for highly-comorbid patients with lower urinary tract symptoms due to benign prostatic obstruction? A preliminary single-center experience focusing on functional and safety outcomes.

In this paper, we aimed to highlight functional and safety outcomes of highly-comorbid patients undergoing transperineal laser ablation (TPLA) of prostate at a referral academic center. Patients undergoing TPLA from April 2021 and February 2023 with moderate to severe lower urinary tract symptoms (LUTS), prostate volume ranging from 30 to 100 mL, and an American Society of Anesthesiologists (ASA) Score ≥3 were included. All patients were evaluated as unfit for standard surgery. Procedures were performed in an outpatient setting using local anesthesia. Failure after the procedure was defined as the shift to other ultra-minimally invasive surgical treatment or the need for long-term indwelling catheter replacement. Overall, 23 patients were enrolled with a median age of 76 years. Median ASA Score and Charlson Comorbidity Index were 3 and 5, respectively. Of these, 11 (48%) were under antiplatelets, 4 (17%) under new oral anticoagulants (NOACs) and 3 (13%) under warfarin. Six (26%) patients had an indwelling catheter preoperatively. Median prostate volume was 42 mL. Median follow-up was 12 months. No Clavien-Dindo Grade ≥2 complications were recorded. Four/six (66%) patients with an indwelling catheter before TPLA achieved spontaneous micturition. Treatment failure occurred in 2 (8.5%) patients. Of the remaining 21 patients, 12/21 (57%) patients reported an improvement in International Prostate Symptoms Score (IPSS) symptoms class (i.e., severe to moderate, moderate to mild, etc.); all patients whose IPSS symptoms class remained stable (N.=8 [38%]) had a significant improvement of the IPSS score as compared to the preoperative period, while 1 (4.5%) patient reported worsening of LUTS. In conclusion, TPLA appears to be a safe and feasible ultra-minimally-invasive option for LUTS due to benign prostatic obstruction (BPO) in patients with significant comorbidities at high-risk for standard surgical options.

Urinary Continence Recovery after Robotic Radical Prostatectomy without Anterior or Posterior Reconstruction: Experience from a Tertiary Referral Center.

BACKGROUND: The aim of our study is to evaluate the prevalence and predictive factors of short- (30 d) and mid-term continence in a contemporary cohort of patients treated with robotic-assisted laparoscopic prostatectomy (RALP) without any posterior or anterior reconstruction at our referral academic center. METHODS: Data from patients undergoing RALP between January 2017 and March 2021 were prospectively collected. RALP was performed by three highly experienced surgeons following the principles of the Montsouris technique, with a bladder-neck-sparing intent and maximal preservation of the membranous urethra (if oncologically safe) without any anterior/posterior reconstruction. (Self-assessed urinary incontinence (UI) was defined as the need of one or more pads per die (excluding the need for a safety pad/die. Univariable and multivariable logistic regression analysis was used to assess the independent predictors of early incontinence among routinely collected patient- and tumor-related variables). RESULTS: A total of 925 patients were included; of these, 353 underwent RALP (38.2%) without nerve-sparing intent. The median patient age and BMI were 68 years (IQR 63-72) and 26 (IQR 24.0-28.0), respectively. Overall, 159 patients (17.2%) reported early (30 d) incontinence. In multivariable analysis adjusting for patient- and tumor-related features, a non-nerve-sparing procedure (OR: 1.57 [95% CI: 1.03-2.59], p = 0.035) was independently associated with the risk of urinary incontinence in the short-term period, while the absence of cardiovascular diseases before surgery (OR: 0.46 [95% CI: 0.320.67], p ≤ 0.01) was a protective factor for this outcome. At a median follow-up of 17 months (IQR 10-24), 94.5% of patients reported to be continent. CONCLUSIONS: In experienced hands, most patients fully recover urinary continence after RALP at mid-term follow-up. On the contrary, the proportion of patients who reported early incontinence in our series was modest but not negligible. The implementation of surgical techniques advocating anterior and/or posterior fascial reconstruction might improve the early continence rate in candidates for RALP.

Morbidity of Transrectal MRI-Fusion Targeted Prostate Biopsy at a Tertiary Referral Academic Centre: An Audit to Guide the Transition to the Transperineal Approach.

Despite transrectal prostate biopsy (TRPB) being still widespread globally, the EAU Guidelines strongly recommend the transperineal approach, due to the reported lower infectious risk. Our study aims to evaluate the impact of a standardized clinical pathway for TRPB on post-operative complications. We prospectively collected data from all patients undergoing mpMRI-targeted TRPB at our Academic Centre from January 2020 to December 2022. All patients followed a standardized, structured multistep pathway. Post-procedural complications were collected and classified according to the Clavien-Dindo (CD) Classification. Among 458 patients, post-procedural adverse events were reported by 203 (44.3%), of which 161 (35.2%) experienced CD grade 1 complications (hematuria [124, 27.1%], hematochezia [22, 4.8%], hematospermia [14, 3.1%], or a combination [20, 4.4%]), and 45 (9.0%) reported CD grade 2 complications (acute urinary retention or hematuria needing catheterization, as well as urinary tract infections, of which 2 cases required hospitalization). No major complications, including sepsis, were observed. At uni- and multivariable analysis, age > 70 years and BMI > 25 kg/ m2 for patients were identified as predictors of post-operative complications. The results of our study confirm that TRPB is a safe and cost-effective procedure with a low risk of severe adverse events in experienced hands and following a standardized pathway.

Proctored Step by Step Training Program for GreenLight Laser Anatomic Photovaporization of the Prostate: A Single Surgeon's Experience.

Objectives: To evaluate the feasibility and safety of a proctored step-by-step training program for GreenLight laser anatomic photovaporization (aPVP) of the prostate. Methods: Data from patients undergoing aPVP between January 2019 and December 2020 operated by a single surgeon following a dedicated step-by-step proctored program were prospectively collected. The procedure was divided into five modular steps of increasing complexity. Preoperative patients' data as well as total operative time, energy delivered on the prostate and postoperative data, were recorded. Then, we assessed how the overall amount of energy delivered and the operative times varied during the training program. Surgical steps were analyzed by cumulative summation. Univariable and multivariable regression models were built to assess the predictors of the amount of energy delivered on the prostate. Results: Sixty consecutive patients were included in the analysis. Median prostate volume was 56.5 mL. The training program was succesfully completed with no intraoperative or meaningful post-operative complications. The energy delivered reached the plateau after the 40th case. At multivariable analysis, increasing surgeon experience was associated with lower amounts of energy delivered as well as lower operative times. Conclusions: A step-by-step aPVP training program can be safely performed by surgeons with prior endoscopic experience if mentored by a skilled proctor. Considering the energy delivered as an efficacy surrogate metrics (given its potential impact on persistent postoperative LUTS), 40 cases are needed to reach a plateau for aPVP proficiency. Further studies are needed to assess the safety of our step-by-step training modular program in other clinical contexts.

Prostate Cancer Characteristics in Renal Transplant Recipients: A 25-Year Experience From a Single Centre.

Objectives: The incidence of prostate cancer in renal transplant recipients (RTRs) is increasing, but few data are available in the literature. In this study, we reviewed the 25-year experience in the management of prostate cancer after kidney transplantation at the Florence Transplant Centre. Methods: We retrospectively reviewed the data from 617 RTR male patients who underwent renal transplantation at our institute between July 1996 and September 2016. Data regarding demographics, renal transplantation, prostate cancer and immunosuppressive treatment were analyzed. The probability of death was estimated by using the Kaplan-Meier method and differences between patients' groups were assessed by the log-rank test. Results: From July 1991 to September 2016, 617 kidney transplantations of male patients were performed at our institute. Among these, 20 patients were subsequently diagnosed with prostate cancer accounting for a cumulative incidence of 3.24%. After a median follow-up of 59 months, 10 patients underwent radical prostatectomy whereas 10 patients underwent primary radiotherapy. A biochemical recurrence was identified in five (25%) patients while a fatal event occurred in 11 (55%) patients. Univariate Cox regression showed that the basal value of PSA >10 ng/ml was the only significant factor negatively affecting the survival of patients. Conclusions: Standard treatments can be proposed to RTR with satisfactory results on both post-operative and oncological outcomes. Further studies are needed to address the issue of prostate cancer screening based on PSA levels and the optimal management of prostate cancer in RTRs.

Case Report: Optimizing Pre- and Intraoperative Planning With Hyperaccuracy Three-Dimensional Virtual Models for a Challenging Case of Robotic Partial Nephrectomy for Two Complex Renal Masses in a Horseshoe Kidney.

Objective: To report a case of robot-assisted partial nephrectomy (RAPN) for two highly complex renal tumors in a patient with a Horseshoe kidney (HSK), focusing on the utility of hyperaccuracy three-dimensional (HA3D) virtual models for accurate preoperative and intraoperative planning of the procedure. Methods: A 74-year-old Caucasian male patient was referred to our Unit for incidental detection of two complex renal masses in the left portion of a HSK. The 50 × 55 mm, larger, predominantly exophytic renal mass was located at the middle-lower pole of the left-sided kidney (PADUA score 9). The 16 × 17 mm, smaller, hilar renal mass was located at the middle-higher pole of the left-sided kidney (PADUA score 9). Contrast-enhanced CT scan images in DICOM format were processed using a dedicated software to achieve a HA3D virtual reconstructions. RAPN was performed by a highly experienced surgeon using the da Vinci Si robotic platform with a three-arm configuration. A selective delayed clamping strategy was adopted for resection of the larger renal mass while a clampless strategy was adopted for the smaller renal mass. An enucleative resection strategy was pursued for both tumors. Results: The overall operative time was 150 min, with a warm ischemia time of 21 min. No intraoperative or postoperative complications were recorded. Final resection technique according to the SIB score was pure enucleation for both masses. At histopathological analysis, both renal masses were clear cell renal cell carcinoma (ccRCC) (stage pT1bNxMx and pT3aNxMx for the larger and smaller mass, respectively). At a follow-up of 7 months, there was no evidence of local or systemic recurrence. Conclusions: Surgical management of complex renal masses in patients with HSKs is challenging and decision-making is highly nuanced. To optimize postoperative outcomes, proper surgical experience and careful preoperative planning are key. In this regard, 3D models can play a crucial role to refine patient counseling, surgical decision-making, and pre- and intraoperative planning during RAPN, tailoring surgical strategies and techniques according to the single patient's anatomy.

Deferring Elective Urologic Surgery During the COVID-19 Pandemic: The Patients' Perspective.

OBJECTIVES: To explore the perspective of urological patients on the possibility to defer elective surgery due to the fear of contracting COVID-19. METHODS: All patients scheduled for elective urological procedures for malignant or benign diseases at 2 high-volume centers were administered a questionnaire, through structured telephone interviews, between April 24 and 27, 2020. The questionnaire included 3 questions: (1) In light of the COVID-19 pandemic, would you defer the planned surgical intervention? (2) If yes, when would you be willing to undergo surgery? (3) What do you consider potentially more harmful for your health: the risk of contracting COVID-19 during hospitalization or the potential consequences of delaying surgical treatment? RESULTS: Overall, 332 patients were included (51.5% and 48.5% in the oncology and benign groups, respectively). Of these, 47.9% patients would have deferred the planned intervention (33.3% vs 63.4%; P < .001), while the proportion of patients who would have preferred to delay surgery for more than 6 months was comparable between the groups (87% vs 80%). These answers were influenced by patient age and American Society of Anesthesiologists score (in the Oncology group) and by the underlying urological condition (in the benign group). Finally, 182 (54.8%) patients considered the risk of COVID-19 potentially more harmful than the risk of delaying surgery (37% vs 73%; P < .001). This answer was driven by patient age and the underlying disease in both groups. CONCLUSIONS: Our findings reinforce the importance of shared decision-making before urological surgery, leveraging patients' values and expectations to refine the paradigm of evidence-based medicine during the COVID-19 pandemic and beyond.

Intraoperative and postoperative surgical complications after ureteroscopy, retrograde intrarenal surgery, and percutaneous nephrolithotomy: a systematic review.

INTRODUCTION: Retrograde ureteroscopy (URS), intra-renal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) represent routine interventions for the treatment of ureteral and renal stones, although at times associated with serious adverse events. Of note, the evidence on perioperative complications after these procedures remains sparse and controversial. Moreover, there is a lack of standardized reporting of adverse events using uniform systems. The aim of the present study was to systematically review of the available evidence on URS/RIRS and PCNL for the surgical treatment of urinary stone, assessing the incidence of intra- and postoperative events, classified according to the modified Clavien-Dindo scale. EVIDENCE ACQUISITION: A systematic review of the literature was performed according to PRISMA recommendations and was conducted on intra- and postoperative complications, as well as on their management, following URS, RIRS and PCNL procedures, particularly focusing on major events. EVIDENCE SYNTHESIS: Overall, 26 studies (13 on URS/RIRS and 11 on PCNL) met the inclusion criteria and were evaluated. The highest intraoperative complication rate was 11.5% and 8.5% for RIRS and PCNL, respectively. Major complication rate following URS/RIRS and PCNL ranged between 0.3-31.7% and 2-17.1%, respectively. The most frequent adverse events were obstructive pyelonephritis or urinary leakage requiring the placement of a double J stent or a drainage. Among PCNLs series, life-threatening adverse events have also been reported, including bleeding requiring renal angioembolization and urothorax. CONCLUSIONS: Despite the inclusion of series using a standardized reporting system, the complication rate after URS/RIRS/PCNL remains extensively heterogeneous in the literature; in addition, a non-negligible proportion of studies did not characterize the adverse events nor report the actual management strategy to solve them. Future research is needed to standardize the classification and reporting of surgical complications after endourological procedures (taking into consideration the surgeon's experience and skills), aiming to improve patient counseling and potentially the strategy for their prevention.