Early reduction of estimated Glomerular Filtration Rate (eGFR) predicts poor outcome in acutely ill hospitalized COVID-19 patients firstly admitted to medical regular wards (eGFR-COV19 study).

BACKGROUND: Analysis of autopsy tissues obtained from patients who died from COVID-19 showed kidney tropism for SARS-COV-2, with COVID-19-related renal dysfunction representing an overlooked problem even in patients lacking previous history of chronic kidney disease. This study aimed to corroborate in a substantial sample of consecutive acutely ill COVID-19 hospitalized patients the efficacy of estimated GFR (eGFR), assessed at hospital admission, to identify acute renal function derangement and the predictive role of its association with in-hospital death and need for mechanical ventilation and admission to intensive care unit (ICU). METHODS: We retrospectively analyzed charts of 764 patients firstly admitted to regular medical wards (Division of Internal Medicine) for symptomatic COVID-19 between March 6th and May 30th, 2020 and between October 1st, 2020 and March 15th, 2021. eGFR values were calculated with the 2021 CKD-EPI formula and assessed at hospital admission and discharge. Baseline creatinine and GFR values were assessed by chart review of patients' medical records from hospital admittance data in the previous year. The primary outcome was in-hospital mortality, while ARDS development and need for non-invasive ventilation (NIV) and invasive mechanical ventilation (IMV) were the secondary outcomes. RESULTS: SARS-COV-2 infection was diagnosed in 764 patients admitted with COVID-19 symptoms. A total of 682 patients (age range 23-100 years) were considered for statistical analysis, 310 needed mechanical ventilation and 137 died. An eGFR value <60 mL/min/1.73 m2 was found in 208 patients, 181 met KDIGO AKI criteria; eGFR values at hospital admission were significantly lower with respect to both hospital discharge and baseline values (p < 0.001). In multivariate analysis, an eGFR value <60 mL/min/1.73 m2 was significantly associated with in-hospital mortality (OR 2.6, 1.7-4.8, p = 0.003); no association was found with both ARDS and need for mechanical ventilation. eGFR was non-inferior to both IL-6 serum levels and CALL Score in predicting in-hospital death (AUC 0.71, 0.68-0.74, p = 0.55). CONCLUSIONS: eGFR calculated at hospital admission correlated well with COVID-19-related kidney injury and eGFR values < 60 mL/min/1,73 m2 were independently associated with in-hospital mortality, but not with both ARDS or need for mechanical ventilation.

Transcatheter Aortic Bioprosthesis Durability: A Single-Center Experience.

BACKGROUND: Transcatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort. METHODS: We analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference. RESULTS: At a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected. CONCLUSION: In the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up.

Impact of horizontal aorta on procedural and clinical outcomes in second-generation transcatheter aortic valve implantation.

AIMS: The aim of this study was to evaluate the impact of a horizontal aorta (HA) on device success and short-term clinical outcomes of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We retrospectively assessed 547 consecutive patients treated with transfemoral second-generation non-balloon-expandable (NBE) (n=447) and balloon-expandable (BE) (n=100) TAVI for symptomatic severe aortic stenosis. Aortic angulation (AA) was evaluated with preprocedural computed tomography. Patients were dichotomised according to a previously established AA cut-point: HA group (AA ≥48°, n=230) and normal aorta (NA) group (AA <48°, n=317). Endpoints were considered according to the Valve Academic Research Consortium-2 definitions. Fluoroscopy time (32.8±16.4 vs 30.3±13.9 minutes, p=0.060) and radiation dose (kerma area product 120.8±99.7 vs 103.7±81.1 Gy·cm2, p=0.033) were higher in the HA group as compared to the NA group. No difference in device success was observed between patients with and without an HA (88.3% vs 88.0%, p=0.929). No differences in device success and 30-day outcomes were observed when comparing HA and NA patients, according to BE and NBE prostheses. CONCLUSIONS: The presence of an HA has no impact on device success and short-term clinical outcomes of TAVI with either second-generation NBE or BE devices.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

AIMS: Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. METHODS AND RESULTS: Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). CONCLUSIONS: Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Comparison of suture-based vascular closure devices in transfemoral transcatheter aortic valve implantation.

AIMS: The aim of this study was to compare outcomes with the use of two haemostasis strategies after transfemoral transcatheter aortic valve implantation (TAVI) - one Prostar® vs. two ProGlide® devices (Abbott Vascular Inc., Santa Clara, CA, USA). METHODS AND RESULTS: This was a retrospective study enrolling consecutive patients undergoing fully percutaneous transfemoral TAVI in our centre (Ferrarotto Hospital, Catania, Italy) from January 2012 to October 2014. All patients were dichotomised according to the vascular closure device (VCD) used for common femoral artery haemostasis (Prostar vs. ProGlide). All outcomes were defined according to VARC-2 criteria. The study population encompassed a total of 278 patients. Of these, 153 (55.1%) underwent TAVI using the Prostar, and 125 (44.9%) using two ProGlide devices. Vascular complications occurred in 48 patients (17.3%), being more frequent in the ProGlide group (11.8% vs. 24.0%, p=0.007). Patients who had TAVI using the ProGlide were also more likely to have a higher rate of percutaneous closure device failure (4.6% vs. 12.8%, p=0.013). Percutaneous peripheral intervention was performed in 13.7% and 28.0% of Prostar and ProGlide cases, respectively (p=0.003). CONCLUSIONS: Patients undergoing transfemoral TAVI had significantly lower rates of vascular complications and percutaneous closure device failures when the Prostar was used compared with two ProGlide devices.

Early discharge after transfemoral transcatheter aortic valve implantation.

BACKGROUND: The aim of this study was to assess the feasibility and the safety of early discharge (within 72 h) after transfemoral transcatheter aortic valve implantation (TAVI) and to identify baseline features and/or peri-procedural variables, which may affect post-TAVI length-of-stay (LoS) duration. METHODS AND RESULTS: Patients discharged within 72 h of TAVI (early discharge group) were compared with consecutive patients discharged after 3 days (late discharge group). Propensity-matched cohorts of patients with a 2:1 ratio were created to better control confounding bias. Among 465 patients, 107 (23.0%) were discharged within 3 days of the procedure. Multivariable regression analysis of unmatched patients demonstrated that baseline New York Heart Association (NYHA) class IV (OR: 0.22, 95% CI 0.05 to 0.96; p=0.045) and any bleeding (OR: 0.31, 95% CI 0.74 to 0.92; p=0.031) were less likely to be associated with early discharge after TAVI. Conversely, the year of procedure (OR: 1.66, 95% CI 1.25 to 2.20; p<0.001) and the presence of a permanent pacemaker (PPM) before TAVI (OR: 2.80, 95% CI 1.36 to 5.75; p=0.005) were associated with a higher probability of early discharge. In matched populations, patients in the early discharge group reported lower incidence of in-hospital bleeding (7.9% vs 19.4%, p=0.014), major vascular complications (2.3% vs 9.1%, p=0.038) and PPM implantation (7.9% vs18.5%, p=0.021), whereas after discharge, at 30-day, no significant differences were reported between groups in terms of death (2.2% vs 1.7%, p=0.540), bleeding (0.0% vs 1.1%, p=0.444), PPM implantation (1.1% vs 0.0%, p=0.333) and re-hospitalisation (1.1% vs 1.1%, p=1.000). CONCLUSIONS: Early discharge (within 72 h) after transfemoral TAVI is feasible and does not seem to jeopardise the early safety of the procedure, when performed in a subset of patients selected by clinical judgement. Patients undergoing TAVI in unstable haemodynamic compensation and patients experiencing bleeding after the procedure demonstrated to be poorly suitable to this approach, whereas increasing experience in post-TAVI management was associated with a reduction of LoS.

Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke: a systematic review and comprehensive meta-analysis of 2,303 patients from three randomised trials and 2,231 patients from 11 observational studies.

AIMS: We aimed at updating the evidence coming from randomised and observational studies of patent foramen ovale (PFO) closure compared to medical therapy in patients with cryptogenic stroke (CS). METHODS AND RESULTS: Comparative studies of PFO closure versus medical therapy published or presented through March 2013 were identified. Data from 2,303 patients in three randomised clinical trials (RCTs) and from 2,231 patients in 11 observational studies were included. In RCTs, the stroke hazard ratio (HR) for PFO closure versus medical therapy was 0.62 (95% confidence interval [CI]: 0.34-1.11; p=0.10 in the random effects model) with no significant heterogeneity or systematic bias. There was no significant difference in transient ischaemic attacks (TIA) (HR 0.77, 95% CI: 0.46-1.32; p=0.34) and no study-related deaths occurred. Pooling trials of the AMPLATZER PFO occluder device resulted in a significant reduction of stroke (HR 0.44, 95% CI: 0.20-0.95; p=0.04). Procedural success, new onset atrial fibrillation and cardiac thrombus were observed more frequently with the STARFlex compared with the AMPLATZER device. In observational studies, with high potential for baseline confounders, PFO closure was found to reduce the risk of recurrent stroke significantly (HR 0.23, 95% CI: 0.11-0.49; p<0.01 in the random effects model), with no significant effect on TIAs. CONCLUSIONS: In RCTs, unlike observational studies, PFO closure compared with medical therapy failed to achieve a statistically significant reduction in recurrent stroke. However, pooling RCTs of the AMPLATZER PFO occluder device yielded a statistically significant reduction in stroke over medical treatment that may warrant further investigation.