Assessing risk of lymph node invasion in complete responders to neoadjuvant chemotherapy for muscle-invasive bladder cancer.

OBJECTIVES: To investigate the lymph node invasion (LNI) rate in patients exhibiting complete pathological response (CR) to neoadjuvant chemotherapy (NAC) and to test the association of CR status with lower LNI and better survival outcomes. MATERIALS AND METHODS: We included patients with bladder cancer (BCa; cT2-4a; cN0; cM0) treated with NAC and radical cystectomy (RC) + pelvic lymph node dissection (PLND) at our institution between 2012 and 2022 (N = 157). CR (ypT0) and LNI (ypN+) were defined at final pathology. Univariable and multivariable logistic regression analysis was performed to test the association between CR and LNI after adjusting for number of lymph nodes removed (NLR). Kaplan-Meier and Cox regression analyses were used to assess overall survival (OS), metastasis-free survival (MFS) and disease free-survival (DFS) according to CR status. RESULTS: Overall CR and LNI rates were 40.1% and 19%, respectively. The median (interquartile range [IQR]) NLR was 26 (19-36). The LNI rate was lower in patients with CR vs those without CR (2 [3.2%] vs 61 [29.8%]; P < 0.001). After adjusting for NLR, CR reduced the LNI risk by 93% (odds ratio 0.07, 95% confidence interval [CI] 0.01-0.25; P < 0.001). Kaplan-Meier plots depicted better 5-year OS (69.7 vs 52.2%), MFS (68.3 vs 45.5%) and DFS (66.6 vs 43.5%) in patients with CR vs those without CR. After multivariable adjustments, CR independently reduced the risk of death (hazard ratio [HR] 0.44, 95% CI 0.24-0.81; P = 0.008), metastatic progression (HR 0.41, 95% CI 0.23-0.71; P = 0.002) and disease progression (HR 0.41, 95% CI 0.24-0.70; P = 0.001). CONCLUSION: Based on these findings, we postulate that PLND could potentially be omitted in patients exhibiting CR after NAC, due to negligible risk of LNI. Prospective Phase II trials are needed to explore this challenging hypothesis.

Learning curve for intracorporeal robotic Padua ileal bladder: 10-year functional assessment from a high-volume single-centre series.

OBJECTIVES: To assess the impact of the learning curve (LC) on perioperative and long-term functional outcomes of a consecutive single-centre series of robot-assisted radical cystectomy with Padua intracorporeal orthotopic neobladder. PATIENTS AND METHODS: Patients treated between 2013 and 2022 were included, with ≥1 year of follow-up. The entire cohort was divided in tertiles. Categorical and continuous variables were compared. Joinpoint regression analysis was used to identify significant changes over the decade in linear slope of the 1-year day- and night-time continence. Uni- and multivariable Cox regression analyses identified predictors of day- and night-time continence recovery. Day-time continence was defined as 'totally dry' (no pads), night-time continence as pad wetness ≤50 mL (one safety pad). RESULTS: Overall, 200 patients were included. The mean hospital stay (P = 0.002) and 30-day complications (P = 0.04) significantly reduced over time; the LC significantly impacted on Trifecta achievement (P < 0.001). The 1-year day- and night-time continence probabilities displayed a significant improving trend (day-time continence annual average percentage change [AAPC] 11.45%, P < 0.001; night-time continence AAPC 10.05%, P = 0.009). The LC was an independent predictor of day- (hazard ratio [HR] 1.008; P < 0.001) and night-time continence (HR 1.004; P = 0.03) over time. CONCLUSION: Patients at the beginning of the LC had significantly longer hospitalisations, more postoperative complications, and lower Trifecta rates. At the 10-year analyses, we observed a significant improving trend for both the 1-year day- and night-time continence probabilities, highlighting the crucial role of the LC. However, we are unable to assess the case volume needed to achieve a plateau in terms of day- and night-time continence rates.

Management of patients treated with oral anticoagulant therapy undergoing percutaneous coronary intervention with stent implantation: the PERSEO Registry.

In patients on oral anticoagulant (OAC) therapy undergoing percutaneous coronary intervention with stent (PCI), international guidelines endorse the use of direct oral anticoagulants (DOAC) rather than vitamin K antagonists (VKA) and dual antithrombotic therapy (DAT) rather than triple antithrombotic therapy (TAT). Aim of this study was to evaluate contemporary real-world data on antithrombotic regimens and outcome in patients on OAC undergoing PCI with stent. Consecutive patients on OAC undergoing PCI were enrolled in the multicentre, prospective, observational PERSEO registry (NCT03392948). Primary end-point was net adverse clinical events (NACE) with VKA vs DOAC, whereas a secondary pre-specified end-point was NACE with DAT vs TAT both at 1-year follow-up. From February 2018 to February 2022, 1234 consecutive patients were included. The main indication for OAC was atrial fibrillation (86%) and the mean CHA2DS2VASc and HAS-BLED scores were 4±2 and 3.6±1, respectively. Of the 1228 patients discharged alive, 222 (18%) were on VKA and 1006 (82%) on DOAC (p<0.01). DAT was employed in 197 patients whereas TAT in 1028. At follow-up, NACE rate was significantly higher with VKA compared to DOAC (23% vs 16%, p=0.013) and confirmed after propensity score adjustment. TAT and DAT did not differ as regards NACE rate (17% vs 19%, p=0.864) even though, compared to TAT, DAT was associated with less major bleedings (2% vs 5%, p= 0.014), confirmed after propensity score adjustment. In conclusion, in patients on OAC undergoing PCI, DOAC, compared to VKA, was associated with a significantly lower occurrence of NACE and DAT reduced bleedings compared to TAT.

Comparison of Perioperative, Functional, and Oncologic Outcomes of Open vs. Robot-Assisted Off-Clamp Partial Nephrectomy: A Propensity Scored Match Analysis.

Off-clamp partial nephrectomy represents one of the latest developments in nephron-sparing surgery, with the goal of preserving renal function and reducing ischemia time. The aim of this study was to evaluate and compare the functional, oncologic, and perioperative outcomes between off-clamp robot-assisted partial nephrectomy (off-C RAPN) and off-clamp open partial nephrectomy (off-C OPN) through a propensity score-matched (PSM) analysis. A 1:1 PSM analysis was used to balance variables potentially affecting postoperative outcomes. To report surgical quality, 1 year trifecta was used. Univariable Cox regression analysis was performed to identify predictors of trifecta achievement. The Kaplan-Meier method was used to compare cancer-specific survival (CSS), overall survival (OS), disease-free survival (DFS), and metastasis-free survival (MFS) probabilities between groups. Overall, 542 patients were included. After PSM analysis, two homogeneous cohorts of 147 patients were obtained. The off-C RAPN cohort experienced shorter length of stay (LoS) (3.4 days vs. 5.4 days; p < 0.001), increased likelihoods of achieving 1 year trifecta (89.8% vs. 80.3%; p = 0.03), lower postoperative Clavien-Dindo ≤ 2 complications (1.3% vs. 18.3%, p < 0.001), and lower postoperative transfusion rates (3.4% vs. 12.2%, p = 0.008). At univariable analysis, the surgical approach (off-C RAPN vs. off-C OPN, OR 2.22, 95% CI 1.09-4.46, p = 0.02) was the only predictor of 1 year trifecta achievement. At Kaplan-Meier analysis, no differences were observed between the two groups in terms of OS (log-rank p = 0.451), CSS (log-rank p = 0.476), DFS (log-rank p = 0.678), and MFS (log-rank p = 0.226). Comparing RAPN and OPN in a purely off-clamp scenario, the minimally invasive approach proved to be a feasible and safe surgical approach, with a significantly lower LoS and minor rate of postoperative complications and transfusions as a result of improved surgical quality expressed by higher 1 year trifecta achievement.

Pulmonary embolism: incidence and outcomes in a twelve-year historical series, in Tuscany - Italy (2010-2021).

Background: Pulmonary embolism poses a global health concern. Administrative databases serve as valuable sources for broad epidemiological studies on the prevalence and incidence of major diagnoses or diseases. The primary scope is to provide up-to-date insights into Pulmonary Embolism incidence trends, examining shifts in management and outcomes. Design: This retrospective observational study examines a 12-year dataset from hospitals in the Tuscany Region, covering the first two years of the Covid-19 pandemic. Methods: Administrative data from residents aged 18 and older discharged from hospital between 2010 and 2021 were used for the analysis. Results: Hospitalized pulmonary embolism incidence slightly declined from 2010 to 2019 (64.7 to 60.9 x 100,000; p=0.152). Males under 75 showed a higher incidence rate, while females had higher incidence rates in older age groups. In-hospital and 30-day mortality decreased from 2010 to 2019 (p=0.001 and 0.020 respectively). In 2020, 30-day mortality increased (12.4% vs 10.1%, p=0.029), while in-hospital mortality remained stable. One-year mortality was stable from 2010-2019 but increased in 2020 (32.6% vs 29.4%, p=0.037). Considering the multivariable model, one-year mortality is significantly associated with sex, age, and comorbidities. Conclusions: Our study shows that Pulmonary Embolism persists as a relevant burden in Tuscany region, but with improvements in management over the past decade and a decisive change in pharmacological treatment. Gender-related differences emerge, highlighting the need for a gender-specific healthcare approach.

Open versus robot-assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial.

OBJECTIVES: To compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from a randomised controlled trial (RCT). PATIENTS AND METHODS: Patients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical T stage (cT)2-4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomisation process based on the following variables: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissue surgical margins, ≥16 lymph node (LN) yield, absence of major (Clavien-Dindo Grade ≥III) complications at 90 days, absence of UD-related long-term sequalae, and absence of clinical recurrence. Trifecta was defined as the coexistence of daytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuous and categorical variables were compared using Student's t-test and chi-square test, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality of life (HRQoL). RESULTS: There was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifecta achievement were predictors of 2-year unmodified global HRQoL. CONCLUSIONS: This study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self-reported HRQoL.

Open vs robotic intracorporeal Padua ileal bladder: functional outcomes of a single-centre RCT.

PURPOSE: Functional outcomes of robot-assisted (RA) radical cystectomy (RC) with intracorporeal orthotopic neobladder (i-ON) have been poorly investigated. The study aimed to report functional outcomes of a prospective randomized controlled trial (RCT) comparing open RC (ORC) and RARC with i-ON. METHODS: Inclusion criteria were cT2-4/N0/M0, or BCG-failure high-grade urothelial carcinoma, candidate to RC with curative intent. A covariate adaptive randomization process was used, based on the following variables: BMI, ASA score, haemoglobin levels, cT-stage, neoadjuvant chemotherapy, urinary diversion. Day-time continence was defined as "totally dryness", nigh-time continence as pad wetness ≤ 50 cc. Continence recovery probabilities were compared between arms with Kaplan-Meier method and Cox regression analysis was performed to identify predictors of continence recovery. HRQoL outcomes analysis was assessed with a generalized linear mixed effect regression (GLMER) model. RESULTS: Out of 116 patients randomized, 88 received ON. Quantitative analysis of functional outcomes reported similar results in terms of day continence, while a better night continence status in ORC cohort was observed. However, 1-yr day- and night-time continence recovery probabilities were comparable. Night-time micturition frequency < 3 h was the only predictor of nigh-time continence recovery. At GLMER, 1-yr body image and sexual functioning were significantly better in RARC cohort, while urinary symptoms were comparable between arms. CONCLUSION: Despite superiority of ORC at quantitative night-time pad use analysis, we showed comparable day- and night-time continence recovery probabilities. At 1-yr analysis of HRQoL outcomes, urinary symptoms were comparable between arms, while RARC patients reported lower body image and sexual functioning worsening.

Long-term oncologic and functional outcomes following robot-assisted radical cystectomy and intracorporeal Padua ileal bladder: results from a single high-volume center.

PURPOSE: To report long-term oncologic and functional outcomes of a large consecutive single center series of Robot-assisted radical cystectomy (RARC)- intracorporeal (IC) Urinary Diversion (UD), identifying their predicting factors. METHODS: A single center Bladder cancer (BC) database was queried for "RARC" and "ICUD", including patients treated between January 2012 and September 2020. Kaplan-Meier curves were assessed disease-free (DFS), cancer-specific (CSS) and overall survival (OS) probability. Univariable (UV) and multivariable (MV) analysis were adopted to identify predictors of DFS, CSS and OS. Kaplan-Meier method evaluated day- and night-time continence recovery probabilities; UV and MV analysis were adopted to identify predictors of Day-time continence. RESULTS: Overall, 251 patients were included. Among them, 192 patients underwent intracorporeal ileal orthotopic neobladder (ION) (76.5%). Five-year DFS, CSS and OS rates were 66.5%, 65.4% and 61.5%; pT stage ≥ 3 and pathologic nodal involvement were identified as negative independent predictors of DFS (HR 2.39, p = 0.001, HR 4.64, p ≤ 0.001), CSS (HR 2.20, p = 0.01, HR 3.97, p < 0.001) and OS (HR 2.25, p = 0.005, HR 3.95, p < 0.001). In RARC-ION patients, Trifecta rate was 64.1%. One-year day- and night-time continence rates were 78.6% and 48.3%. Age (HR 0.98, p = 0.03), female gender (HR 0.57, p = 0.008) and complications Clavien grade ≥ 3 (HR 0.55, p = 0.03) were identified as independent predictors of day-time incontinence. CONCLUSIONS: Long-term oncologic outcomes and their predicting factors seem aligned to the largest historical open series and multi-institutional robotic series data. According to the identified predicting factors undermining a proper achievement of day-time continence, this represents an objective support, in order to properly advice specific sub-group of patients.

Robotic Surgery in Urology: History from PROBOT® to HUGOTM.

The advent of robotic surgical systems had a significant impact on every surgical area, especially urology, gynecology, and general and cardiac surgery. The aim of this article is to delineate robotic surgery, particularly focusing on its historical background, its evolution, its present status, and its future perspectives. A comprehensive literature review was conducted upon PubMed/MEDLINE, using the keywords "robotic surgical system", "robotic surgical device", "robotics AND urology". Additionally, the retrieved articles' reference lists were investigated. Analysis concentrated on urological surgical systems for laparoscopic surgery that have been given regulatory approval for use on humans. From the late 1980s, before daVinci® Era in 2000s, ancestor platform as Probot® and PUMA 560 were described to outline historical perspective. Thus, new robotic competitors of Intuitive Surgical such as Senhance®, Revo-I®, Versius®, Avatera®, Hinotori®, and HugoTM RAS were illustrated. Although daVinci® had high level competitiveness, and for many years represented the most plausible option for robotic procedures, several modern platforms are emerging in the surgical market. Growing competition through unique features of the new robotic technologies might extend applications fields, improve diffusion, and increase cost-effectiveness procedures. More experiences are needed to identify the role of these new advancements in surgical branches and in healthcare systems.

Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.

PURPOSE: Radical cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available randomized controlled trials were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-month outcomes from the first RCT comparing ORC and RARC with totally intracorporeal UD. MATERIALS AND METHODS: Patients were eligible for randomization if they had a diagnostic transurethral resection of bladder tumor with cT2-4, cN0, cM0 or recurrent high-grade nonmuscle-invasive bladder cancer and no anesthesiological contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: body mass index, American Society of Anesthesiologists® score, baseline hemoglobin, planned UD, neoadjuvant chemotherapy and cT stage. The primary end point was to demonstrate the superiority of RARC with intracorporeal UD in terms of a 50% transfusion rate reduction. RESULTS: Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046). CONCLUSIONS: This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in patients treated by RARC and ORC, respectively, confirming a significant benefit in favor of RARC with intracorporeal UD. However, perioperative complications, hospital stay and 6-month health-related quality of life were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer followup to observe potential differences between arms.

Diagnostic performance of fusion (US/MRI guided) prostate biopsy: propensity score matched comparison of elastic versus rigid fusion system.

PURPOSE: Many software for US/MRI guided fusion prostate biopsy (FPB), have been developed in the last years. However, there are few data comparing diagnostic accuracy of different fusion systems. We assessed diagnostic performance of elastic (EF) versus rigid fusion (RF) PB in a propensity score matched (PSM) analysis. METHODS: A total of 314 FPB were prospectively collected from two different centers. All patients were biopsy naïve and all mpMRI reported a single suspicious area. Overall, 211 PB were performed using a RF system and 103 using an EF software. The two groups were compared for the main clinical features. A 1:1 PSM analysis was employed to reduce covariate imbalance to < 10%. Detection rate (DR) for any prostate cancer (PCa) and clinically significant (cs) PCa were compared and stratified for PI-RADS Score. A per target univariable and multivariable regression analyses were applied to identity predictors of anyPCa and csPCa. RESULTS: After applying the PSM, two cohorts of 83 cases were selected. DR of any PCa cancer and csPCa were comparable between the two cohorts (all p > 0.077) as well as DR of csPCa for every PIRADS score. At univariable regression analysis lesion size, PI-RADS Score, PSA Density and EF system were predictors of any PCa (all p < 0.001); however, at multivariable analysis only PI-RADS Score was independent predictor of any PCa (p = 0.027). At multivariable analysis only PI-RADS score was independent predictor of csPCa. CONCLUSIONS: Fusion PB guarantees high diagnostic accuracy for csPCa, regardless of the fusion technology. Prospective randomized study is needed to confirm these data.

Expanding the limits of nephron-sparing surgery: Surgical technique and mid-term outcomes of purely off-clamp robotic partial nephrectomy for totally endophytic renal tumors.

OBJECTIVES: To report surgical technique, perioperative, oncological, and mid-term functional outcomes in a single-center purely off-clamp robotic partial nephrectomy series for totally endophytic masses. METHODS: A retrospective analysis of a prospectively collected, institutional review board-approved renal cancer database was carried out to include patients with a totally endophytic renal tumor treated with off-clamp robotic partial nephrectomy between January 2013 and December 2020 at our center. Our database was queried to identify cases that had been assigned 3 points for the "E" domain of the R.E.N.A.L. nephrometry score and 3 points for the "exophytic rate" domain of the PADUA (Preoperative Aspects and Dimensions Used for an Anatomical) nephrometry score. Preoperative indocyanine green renal mass marking was performed in 33 patients, in whom the tumor was vascularized by a specific feeding artery. Surgical steps, perioperative, oncological and functional data were reported. RESULTS: Fifty-six consecutive patients with totally endophytic renal masses were treated. The median tumor diameter was 3 cm, and median PADUA and R.E.N.A.L. scores were both 10. The median operative time was 82 min. Low-grade Clavien complications occurred in two patients (3.6%) and high-grade Clavien complications were observed in four patients (7.1%). Positive surgical margins were detected in one patient; 2-year recurrence-free, cancer-specific, and overall survival rates were 100%, 100%, and 98.2%, respectively. At a median follow-up of 24 months, new onset of chronic kidney disease stage 3b occurred in one patient. At last follow-up, the median estimated glomerular filtration rate was 77 mL/min, with a median estimated glomerular filtration rate percent decrease of 5.5%. Trifecta was achieved in 91% of patients. CONCLUSIONS: Purely off-clamp robotic partial nephrectomy is a feasible and safe surgical approach, even in totally endophytic renal tumors, providing a favorable perioperative complications rate, excellent oncological outcomes, and negligible impact on renal function at mid-term follow-up. Indocyanine green preoperative marking of endophytic renal tumors represents a useful tool for rapid intraoperative identification of the mass, real-time control of resection margins, and a more precise dissection.

On-clamp versus off-clamp partial nephrectomy: Propensity score-matched comparison of long-term functional outcomes.

OBJECTIVES: To compare long-term functional outcomes of off-clamp or on-clamp partial nephrectomy patients of two high-volume centers with cT1-2/N0 M0 renal tumors and baseline estimated glomerular filtration rate >60 mL/min. METHODS: A 3:1 propensity score-matched analysis was used to select two homogeneous cohorts to compare off-clamp versus on-clamp partial nephrectomy. Joinpoint regression analysis was used to compare the 2-8-year probabilities of estimated glomerular filtration rate modifications in both selected cohorts. The Kaplan-Meier method assessed the risk of developing a stage ≥3b chronic kidney disease during follow up. Multivariable analyses aimed to identify predictors of renal function deterioration. Perioperative complications and oncological outcomes were compared. RESULTS: Overall, 1073 patients were included (588 on-clamp and 485 off-clamp). After applying the propensity score-matched analysis, the two cohorts of 157 on-clamp and 472 off-clamp patients did not differ for all covariates, except for warm ischemia time and last estimated glomerular filtration rate. At joinpoint analysis, the off-clamp group showed higher probabilities of maintaining an unmodified estimated glomerular filtration rate (P = 0.02). The probability of developing a stage ≥3b chronic kidney disease was significantly higher (P < 0.001) in the on-clamp cohort. At multivariable analysis, estimated glomerular filtration rate at discharge and off-clamp approach were independent predictors of improved functional outcomes. Perioperative complications were comparable among the two cohorts (P = 0.67). There were not any statistically significant differences in terms of cancer-specific survival (P = 0.26) and overall survival (P = 0.18). CONCLUSIONS: Off-clamp partial nephrectomy seems to offer a higher probability of maintaining 100% estimated glomerular filtration rate after surgery. In our cohort, patients undergoing on-clamp partial nephrectomy presented a 7.3-fold increased risk of developing a severe chronic kidney disease during follow up.

Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413).

OBJECTIVES: To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. BACKGROUND: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. METHODS: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. RESULTS: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. CONCLUSIONS: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.

Purely off-clamp robotic partial nephrectomy: Preliminary 3-year oncological and functional outcomes.

OBJECTIVES: To describe our surgical technique and to report perioperative, 3-year oncological and functional outcomes of a single-center series of purely off-clamp robotic partial nephrectomy. METHODS: A prospective renal cancer institutional database was queried, and data of consecutive patients treated with purely off-clamp robotic partial nephrectomy between 2010 and 2015 in a high-volume center were collected. Perioperative complications, and 3-year oncological and functional outcomes were assessed. Univariable and multivariable analyses were carried out to identify independent predictors of renal function deterioration. RESULTS: Out of 308 patients treated, 41 (13.3%) experienced perioperative complications, 2.9% of which were Clavien grade ≥3. The 3-year local recurrence-free survival and renal cell carcinoma-specific survival rates were 99.5% and 97.9%, respectively. No patient with preoperative chronic kidney disease stage ≤3B developed severe renal function deterioration (chronic kidney disease stage 4) at 1-year follow up. At multivariable analysis, preoperative estimated glomerular filtration rate (P = 0.005) was the only independent predictor of a new-onset chronic kidney disease stage ≥3 in patients with preoperative chronic kidney disease stages 1 or 2. CONCLUSIONS: Off-clamp robotic partial nephrectomy is a safe surgical approach in tertiary referral centers, with adequate oncological outcomes and negligible impact on renal function.

Oncological outcomes of minimally invasive partial versus minimally invasive radical nephrectomy for cT1-2/N0/M0 clear cell renal cell carcinoma: a propensity score-matched analysis.

PURPOSE: To compare the oncologic outcomes of partial nephrectomy (PN) and radical nephrectomy (RN) for cT1-2/N0 renal tumors and pathologically confirmed pT1-pT3a-pNx clear cell (cc)-renal cell carcinoma (RCC). Few studies compared the oncologic outcomes of PN and RN for renal tumors >7 cm. METHODS: A prospective "renal cancer" database was queried for cT<3-cN0-cM0 and pT1a-pT3a-pNx cc-RCC. Out of 1650 cases treated between 2001 and 2013, 921 were cc-RCC and 666 met inclusion criteria, 232 of which treated with minimally invasive RN and 434 with MIPN. A 1:1 propensity score-matched (PSM) analysis was employed to minimize the selection bias of non-random assignment of patients to PN as opposed to RN. Kaplan-Meier method was used to compare the oncologic outcomes of the PSM cohorts. Survival rates were computed at 2, 5, and 10 years after surgery, and the log-rank test was applied to assess statistical significance between the two PSM groups. RESULTS: RN tumors were significantly larger (p < 0.001), with higher pT stages (p < 0.001), higher Fuhrman grades (p = 0.002) and a more frequent sarcomatoid differentiation (p = 0.04). After applying the PSM analysis, the two cohorts of 155 RN and 155 PN cases did not differ for all clinical and pathologic covariates (all p ≥ 0.32). PN and RN cohorts displayed comparable 5-year metastasis-free survival (88.9 vs 89.9 %, p = 0.811), local recurrence-free survival (94.2 vs 95.9 %, p = 0.283), overall survival (94.5 vs 96.8 %, p = 0.419) and cancer-specific survival (96 vs 98.6 %, p = 0.907) rates. CONCLUSIONS: PN and RN for patients with cc-RCC larger than 7 cm provided equivalent oncologic outcomes. Safety and reproducibility of our findings should be further investigated in larger multicentric cohorts.

Impact of Mixed Aortic Valve Stenosis on VARC-2 Outcomes and Postprocedural Aortic Regurgitation in Patients Undergoing Transcatheter Aortic Valve Implantation: Results From the International Multicentric Study PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration).

OBJECTIVES: We sought to evaluate the impact of mixed aortic stenosis (MAS) on postprocedural aortic regurgitation (PPAR) and clinical outcomes after transcatheter aortic valve implantation (TAVI). BACKGROUND: The impact of MAS of TAVI outcomes is unknown. METHODS AND RESULTS: Data from a multicenter registry were retrospectively analysed. Outcomes were compared between patients with pure aortic stenosis (PAS; associated AR<1+/3+) and MAS (associated AR≥1+/3+). Study objectives were PPAR incidence and short- and long-term mortality. Overall, 1,062 patients were included: 419 (39.4%) with MAS and 643 (60.5%) with PAS. At 30 days, there were no differences in mortality, however, a higher incidence of major bleeding (22.7% vs. 16.8%; P=0.016), PPAR≥1+/3+ (42.6% vs. 26.5%; P<0.001) and lower device success (89.3% vs. 93.3%; P=0.019) was observed in patients with MAS. Of note, MAS was an independent predictor of PPAR≥1+/3+ at multivariable analysis (OR: 2.882; CI: 1.851-4.488; P<0.001). At 2 years of follow-up, no survival differences were present between MAS and PAS groups. Similarly, following stratification for PPAR≥1+/3+, MAS had no protective effect on survival as compared with PAS. CONCLUSIONS: MAS was associated with lower device success and higher PPAR incidence. However, despite these findings, it had no influence on long-term postoperative outcomes.

Long-Term Oncologic Outcomes of Off-Clamp Robotic Partial Nephrectomy for Cystic Renal Tumors: A Propensity Score Matched-Pair Comparison of Cystic versus Pure Clear Cell Carcinoma.

Few data are available on survival outcomes of partial nephrectomy performed for cystic renal tumors. We present the first long-term oncological outcomes of cystic (cystRCC) versus pure clear cell renal cell carcinoma (ccRCC) in a propensity score-matched (PSM) analysis. Our "renal cancer" prospectively maintained database was queried for "cystRCC" or "ccRCC" and "off-clamp robotic partial nephrectomy" (off-C RPN). The two groups were compared for age, gender, tumor size, pT stage, and Fuhrman grade. A 1:3 PSM analysis was applied to reduce covariate imbalance to <10% and two homogeneous populations were generated. Student t- and Chi-square tests were used for continuous and categorical variables, respectively. Ten-year oncological outcomes were compared between the two cohorts using log-rank test. Univariable Cox regression analysis was used to identify predictors of disease progression after RPN. Out of 859 off-C RPNs included, 85 cases were cystRCC and 774 were ccRCC at histologic evaluation. After applying the PSM analysis, two cohorts were selected, including 64 cystRCC and 170 ccRCC. Comparable 10-year cancer-specific survival probability (95.3% versus 100%, p = 0.146) was found between the two cohorts. Conversely, 10-year disease-free survival probability (DFS) was less favorable for pure ccRCC than cystRCC (66.69% versus 90.1%, p = 0.035). At univariable regression analysis, ccRCC histology was the only independent predictor of DFS probability (HR 2.96 95% CI 1.03-8.47, p = 0.044). At the 10-year evaluation, cystRCC showed favorable oncological outcomes after off-C RPN. Pure clear cell variant histology displayed a higher rate of disease recurrence than cystic lesions.