scholarly journals Comparison of hemodynamic and clinical outcomes of transcatheter and sutureless aortic bioprostheses: how to make the right choice in intermediate risk patients

2017 ◽  
Vol 6 (5) ◽  
pp. 510-515 ◽  
Author(s):  
Augusto D’Onofrio ◽  
Assunta Fabozzo ◽  
Gino Gerosa
2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Alessandro Sticchi ◽  
Francesco Gallo ◽  
Stefano Benenati ◽  
Kim Won-keun ◽  
Arif A Khokhar ◽  
...  

Abstract Aims The ESC 2021 valvular heart disease [VHD] guidelines introduced an important and debated age cut-off (75 years) to lead the choice between surgical and transcatheter aortic valve implantation (TAVI) in non-high-risk patients. The aim of this study was to evaluate what impact an age cut-off has on clinical outcomes following TAVI in low-to-Intermediate Risk patients from a real word registry. Methods We performed the investigation in a large, contemporary, real-world, multicentre, international, retrospective registry of 3862 consecutive patients, comparing the rates of patient risk factors, procedural characteristics, complications, and outcomes in the populations with < or ≥ 75 years old. Results In our real-world cohort of 2977 patients with mean STS score of 3.6% (5.0–2.5), we found 301 (10.1%) patients with age <75 years and 2676 (89.9%) with ≥75 years. In the younger group compared with the older, we have a higher prevalence of male (44% vs. 35%, P=0.003), higher BMI (mean of 28.5 kg/m² vs. 26.7 kg/m², P = <0.001), diabetes (32% vs. 26%, P=0.027), insulin-dependent diabetes (12% vs. 7%, P=0.001), smoking (18% vs. 7%, P<0.001), COPD (26% vs. 16%, P<0.001). Moreover, younger patients presented less previous PM/ICD (6% vs. 11%, P=0.023), less atrial fibrillation (24% vs. 33%, P=0.033), less renal impairment (30% vs. 66%, P<0.001) and a lower mean STS score (2.6% vs. 3.7%, P<0.001). There was no difference in annular sizing, valvular and LVOT calcifications between the two groups. Older patients had a higher prevalence of porcelain aorta (2% for age<75 vs. 9%, P=0.001). Between the two groups no significant differences in procedural characteristics were observed, including rates of pre-dilatation (P=0.369), post-dilatation (P=0.159) and contrast volume (P=0.259). Procedural complications, in-hospital outcomes and 2-year Kaplan-Meier (KM) survival was equivalent between both groups (P=0.930). Finally, we assessed the best age cut-off related to 1-year mortality in our population, resulting in 86 years. Still, also in this scenario, the KM survival analysis did not show significant differences (P=0.120). Conclusions In our large real-world contemporary low-to-intermediate risk TAVI population, an age cut-off of 75 years was not associated with any difference in clinical outcomes and survival at 2-years follow-up. This data reinforces the concept that age alone is not a sufficient variable to be considered when choosing between TAVI or SAVR. The recent ESC 2021 VHD guidelines cut-off is justified only by the lack of evidence and valve durability strategy but not of a proper advantage age-related.


2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Domenico Cante ◽  
Cristina Piva ◽  
Edoardo T. F. Petrucci ◽  
Piera Sciacero ◽  
Silvia Ferrario ◽  
...  

Background. To report 5-year clinical outcomes and toxicity in organ-confined prostate cancer (PCa) for low- and intermediate-risk patients treated with a moderately hypofractionated schedule of radiotherapy (RT) delivered with simultaneous integrated boost (SIB) compared to a conventionally fractionated RT regimen. Methods. Data of 384 patients with PCa treated between August 2006 and June 2017 were retrospectively reviewed. The treatment schedule consisted of hypofractionated RT (HYPO FR) with SIB up to 70 Gy to the prostate gland and 63 Gy to seminal vesicles delivered in 28 fractions or in conventionally fractionated RT (CONV FR) up to a total dose of 80 Gy in 40 fractions. Patient allocation to treatment was based on the time period considered. For intermediate-risk patients, androgen deprivation was given for a median duration of 6 months. The 5-year biochemical relapse-free survival (bRFS), cancer-specific survival (CSS), and overall survival (OS) were assessed. Furthermore, we evaluated gastrointestinal (GI) and genitourinary (GU) toxicities. Uni- and multivariate Cox regression analyses were used to test the impact of clinical variables on both outcome and toxicity. Results. A total of 198 patients was treated with hypofractionated RT and 186 with the conventional schedule. At a median follow-up of 5 years, no significant differences were observed in terms of GI toxicity and outcome between the two groups. Early GU toxicity was significantly increased in HYPO FR, while late GU toxicity was significantly higher in CONV FR. In HYPO FR, a biochemical relapse occurred in 12 patients (6.1%), and 9 patients (4.5%) reported a clinical relapse (4 local, 2 locoregional, and 3 systemic recurrence). In CONV FR, 15 patients (8.1%) experienced a biochemical relapse and 11 patients (5.9%) showed a clinical relapse (5 local, 4 locoregional, and 3 systemic recurrences). Early grades 1-2 GU and GI toxicities were observed in 60 (30.3%) and 37 (18.7%) patients, respectively, in the hypofractionated group and in 33 (17.7%) and 27 (14.5%) patients, respectively, in the conventionally fractionated RT group. Late GU and GI toxicities occurred in 1 (0.51%) and 8 (4.1%) patients, respectively, in HYPO FR. In CONV FR, 5 (2.7%) and 6 (3.2%) patients experienced late GU and GI toxicities, respectively. The 5-year OS, bRFS, and CSS were 98.9%, 94.1%, and 99.5%, respectively, in HYPO FR, and 94.5%, 92.1%, and 99.0%, respectively, in CONV FR. Conclusions. Results obtained in this study showed that moderately hypofractionated RT employing SIB can be an effective approach providing valuable clinical outcomes with an acceptable toxicity profile.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16555-e16555
Author(s):  
Nancy P. Mendenhall ◽  
William Wong ◽  
Curtis Bryant ◽  
Sujay A. Vora ◽  
Randal H. Henderson ◽  
...  

e16555 Background: The ProtecT trial underscores the importance of treatment in men with prostate cancer and life expectancies > 10 years and the validity of radiation therapy (RT). RT can be given with photons or protons (PT). To address the controversy of which is better, clinical outcomes of photon-based intensity modulated RT (IMRT) and PT cohorts from 2 institutions were directly compared. Methods: Under respective IRB approvals, data from 2 cohorts were analyzed. The first was 301 men treated with ultrasound image guided IMRT from 2000-05 to 75.6 Gy in 42 fractions. The second was 1214 men treated with fiducial image guided PT from 2006-10 to 78 CGE in 39 fractions. Median age and followup were 74 y and 7.2 y for IMRT and 66 y and 5.6 y for PT. Hormone therapy (ADT) was used with IMRT and PT, respectively, in 3% and 7% of low-risk patients, 25% and 9.9% of intermediate-risk, and 91% and 57.8% of high-risk. Comparative endpoints were age-stratified 5-year (5Y) survival (OS), ≥ grade 3 gastrointestinal (GI) and urologic (GU) toxicity, and 5Y freedom from biochemical progression (FFBP). Results: There was a lower prevalence of GI (1.3% vs 0.1%, p = 0.0065) and GU (4.3% vs 0.1%, p < 0.0001) toxicity at last follow-up in the PT group. In the IMRT and PT cohorts, OS rates were 90.8% and 88.7% in men ≥75 (p = 0.4083). In men < 75, OS rates were 91.6% and 97.5% in the IMRT and PT low-risk patients (p = 0.003), 92.1% and 95.5% in the IMRT and PT intermediate-risk (p = 0.0535), and 92.0% and 90.0% (p = 0.4975) in the IMRT and PT high-risk. In the IMRT and PT cohorts, respectively, FFBP rates were 92.2% and 98.9% for low-risk patients (p < 0.0001), 87.3% and 94.5% for intermediate-risk patients(p = 0.0226), and 80.3% and 74.4% for high-risk patients (p = 0.5154). Conclusions: In this retrospective comparison of outcomes in cohorts of men treated with IMRT and PT for prostate cancer, FFBP rates were better with PT for men with low- and intermediate-risk disease and similar in men with high-risk disease despite longer and more frequent use of ADT in the IMRT cohort. This study underscores the difficulty of comparing retrospective series, with differences noted in age, RT dose, and ADT use between cohorts. However, the magnitude of improvement with PT is intriguing and warrants prospective testing.


2017 ◽  
Vol 153 (3) ◽  
pp. 549-558.e3 ◽  
Author(s):  
Alberto Repossini ◽  
Lorenzo Di Bacco ◽  
Bruno Passaretti ◽  
Herko Grubitzsch ◽  
Christina Schäfer ◽  
...  

2019 ◽  
Vol 40 (27) ◽  
pp. 2218-2227 ◽  
Author(s):  
Tamim M Nazif ◽  
Shmuel Chen ◽  
Isaac George ◽  
Jose M Dizon ◽  
Rebecca T Hahn ◽  
...  

Abstract Aims Transcatheter aortic valve replacement (TAVR) is now an established therapy for intermediate-risk surgical candidates with symptomatic, severe aortic stenosis. The clinical impact of new-onset left bundle branch block (LBBB) after TAVR remains controversial and has not been studied in intermediate-risk patients. We therefore sought to analyse outcomes associated with new LBBB in a large cohort of intermediate-risk patients treated with TAVR. Methods and results A total of 2043 patients underwent TAVR in the PARTNER II trial and S3 intermediate-risk registry and survived to hospital discharge. Patients were excluded from the current analysis due to baseline conduction disturbances, pre-existing permanent pacemaker (PPM), and new PPM during the index hospitalization. Clinical outcomes at 2 years were compared between patients with and without persistent, new-onset LBBB at hospital discharge, and multivariable analysis was performed to identify predictors of mortality. Among 1179 intermediate-risk patients, new-onset LBBB at discharge occurred in 179 patients (15.2%). Patients with new LBBB were similar to those without except for more frequent diabetes and more frequent treatment with SAPIEN 3 vs. SAPIEN XT. At 2 years, new LBBB was associated with increased rates of all-cause mortality (19.3% vs. 10.8%, P = 0.002), cardiovascular mortality (16.2% vs. 6.5%, P < 0.001), rehospitalization, and new PPM implantation. By multivariable analysis, new LBBB remained an independent predictor of 2-year all-cause [hazard ratio (HR) 1.98, 95% confidence interval (95% CI) 1.33, 2.96; P < 0.001] and cardiovascular (HR 2.66 95% CI 1.67, 4.24; P < 0.001) mortality. New LBBB was also associated with worse left ventricular systolic function at 1 and 2-year follow-up. Conclusions In a large cohort of intermediate-risk patients from the PARTNER II trial and registry, persistent, new-onset LBBB occurred in 15.2% of patients without baseline conduction disturbances or pacemaker. New LBBB was associated with adverse clinical outcomes at 2 years, including all-cause and cardiovascular mortality, rehospitalization, new pacemaker implantation, and worsened left ventricular systolic function. Clinical Trial Registration ClinicalTrials.gov #NCT01314313 and NCT03222128.


2021 ◽  
Author(s):  
Felipe Giron ◽  
Lina M Rodríguez ◽  
Danny Conde ◽  
Marco Vanegas ◽  
Carlos Rey ◽  
...  

Abstract Background Choledocolithiasis is the presence of stones in the bile duct, commonly associated with cholelithiasis, with an incidence of 5-18%. Risk of choledocolithiasis should be assessed in every patient who must undergo cholecystectomy to define the next step, which can be either surgical or endoscopic. The American Gastroenterology Society (ASGE) proposed a predictor scale of choledocolithiasis based on ultrasound findings, liver function tests, and the presence of pancreatitis and/or cholangitis. Therefore we aim to describe our experience managing patients with intermediate risk of choledocolithiasis according to the ASGE guidelines and actual presence of bile duct stones in magnetic resonance cholangiopancreatography. MethodsA retrospective observational study with a prospective database was conducted. Patients over 18 years old who complied with inclusion criteria between January and December 2019, were registered. Descriptive statistics of all study parameters were provided. Analysis included socio demographic data, laboratory values ​​and imaging. Bivariate, multivariate and ROC analysis was performed. Results 327 patients with biliary disease were classified as having intermediate risk for choledocolithiasis. Half the patients were at least 65 years old (iqr 20). All patients underwent MRI cholangiography. 24.77% were diagnosed with choledocolithiasis. Bile duct dilation was documented in only 3.06% of cases. Diagnosis of choledocolithiasis is associated with age OR: 1.87 (p 0.02), alkaline phosphatase OR: 2.44 (p 0.02) and bile duct dilation < 6 mm OR: 14.65 (p 0.00). ConclusionsThere is a high proportion of patients classified as intermediate risk who did not have choledocolithiasis by colangioresonance. There is a persistently high variability in accuracy of imaging techniques in intermediate risk patients. Therefore, enhancing the criteria to define intermediate risk for patients in order to optimize resources is of paramount importance.


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