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Objective To compare vascular complications in patients undergoing percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) using ultrasound guidance (USG) versus fluoroscopy guidance (FSG) for femoral access. Background In patients undergoing PCI, using the arterial femoral access increases the risk of vascular complications compared using the radial access. USG reduces time to access, number of attempts, and vascular complications compared with FSG, but the efficacy of USG has never been tested in the setting of CTO-PCI. Methods A total of 197 patients undergoing CTO-PCI using at least a femoral vascular access from November 2015 to September 2020 were screened. The primary outcome was a composite of local hematoma, pseudoaneurysm , retroperitoneal hemorrhage , arteriovenous fistula or hemoglobin drop ≥3 g/dL during hospitalization. The independent association between USG and the primary outcome of interest was explored. Results The primary outcome occurred in 17.3% of patients. Patients in the USG group had a significantly lower incidence of vascular complications compared with patients in the FSG group (8.5% vs. 21.0%, p = 0.039), driven by a reduction of localized hematomas (3.4% vs 13.0%, p = 0.042). After adjustment for type of CTO approach and heparin dose, USG was significantly associated with a reduced relative risk of the composite primary outcome (adjusted odds ratio 0.16, 95% confidence interval 0.05 to 0.51; p = 0.002). Conclusion USG in CTO-PCI is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas, especially in complex CTO-PCI where the larger use of heparin increases the risk of vascular complications.

Transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of severe, symptomatic aortic stenosis and it is now a proven and effective alternative to surgery for patients regardless of preoperative risk stratification. Nevertheless, the consequent expansion towards younger patients with longer life expectancy focuses attention on long-term considerations. In particular, although the prevalence of coronary artery disease has been shown to decrease with the lowering of estimated risk stratification, the chance of requirement of future coronary interventions after TAVI increases dramatically as a function of patients' life expectancy. To date, however, only a few studies have investigated the feasibility and reproducibility of coronary artery cannulation after TAVI. Different conditions related mainly to aortic root anatomy and specific transcatheter aortic valve (TAV) designs and deployment have been associated with impaired coronary access after TAVI. In the present review, we will examine the conditions that may make coronary access after TAVI more challenging or even impossible.

BACKGROUND Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI). AIMS The aim of this study was to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular haemostasis after transfemoral (TF) TAVI. METHODS From January 2019 to April 2020, 332 consecutive patients with preprocedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS, were matched using the propensity-score method. RESULTS At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p

Background Women present specific risks for transcatheter aortic valve replacement (TAVI) but there are scarce sex-based analysis. The aim of this study was to explore the risk of vascular/bleeding complications in females vs. males that underwent TAVI and the impact of red blood cell (RBC) transfusion. Methods TRITAVI-Women is a retrospective analysis in 13 European institutions. Propensity score based on pairs of different sex was performed and global outcomes, vascular/bleeding risk factors were determined. Afterwards, the female population of the study was divided into two groups according to the need of RBC transfusion and the risk for mortality, AKI, MI, stroke at 30-days and at 1-year were compared as a combined endpoint (primary endpoint) and separately (secondary endpoints). Results The global study population included 5837 patients. Females presented more advanced NYHA class, chronic kidney disease, and baseline anemia. Vascular/bleeding complications and RBC transfusion were more common in women. However, 1-year mortality was lower for women in the matched cohort (8.1% vs.10.3%, p = 0.028). The need for RBC transfusion was an independent predictor of higher incidence of the primary endpoint at 30-day and 1-year. The main predictor of RBC transfusion in women was the presence of baseline anemia. Conclusions Women present lower risk of mortality than men at 1-year follow up, but not at 30-day due to higher rates of vascular/bleeding complications. RBC transfusion was also more often required in women and was an independent predictor or poorer outcomes. The treatment of pre-existing anemia before TAVI might improve the short-term results in women.

OBJECTIVES To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years. BACKGROUND To date, no robust, comparative data of BE and SE TAVs at long-term are available. METHODS We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching. RESULTS Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p

AIMS The Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) was conceived in order to assess the safety and efficacy of MitraClip therapy in Italy. The aim of this study was to assess procedural and mid-term outcomes, and clinical and echocardiographic predictors of mid-term mortality after MitraClip therapy, stratifying the results according to the diagnosis of functional and degenerative mitral regurgitation (FMR vs. DMR). METHODS AND RESULTS Between January 2016 and March 2020, 1659 patients were prospectively included in the GIOTTO registry (FMR 59.4% vs. DMR 40.6%). Acute Mitral Valve Academic Research Consortium (MVARC) technical success was achieved in 97.2% of patients, without differences between FMR and DMR and with sustained results at 30 days. In the study population, all-cause mortality was 4.0%, 17.5% and 34.6% at 30 days, 1 year and 2 years, respectively. Cardiovascular death was the most frequent cause of mortality. Overall hospitalization rates were 6.3%, 23.4% and 31.7% at 30 days, 1 year and 2 years, respectively. The most frequent cause of hospitalization was heart failure, particularly in the first 30 days. FMR and MVARC structural and functional failure were strongly associated with 1-year mortality. Residual mitral regurgitation 1+ (rMR) was independently related to a reduced risk of 1-year mortality (hazard ratio 0.62; P = 0.005). Coherently, at 2-year follow up, FMR was associated with worse outcomes than DMR, and Kaplan-Meier all-cause mortality was related to rMR. CONCLUSIONS Functional mitral regurgitation aetiology affects 1-year mortality after MitraClip implantation, and differences in mortality and hospitalization rates between FMR and DMR can be observed within 2 years. Optimal rMR 1+ was correlated to a more favourable mid-term outcome, particularly in FMR.

OBJECTIVES We sought to develop and validate a novel risk assessment tool for the prediction of 30-day mortality after surgical aortic valve replacement incorporating a patient’s frailty. METHODS Overall, 4718 patients from the multicentre study OBSERVANT was divided into derivation (n = 3539) and validation (n = 1179) cohorts. A stepwise logistic regression procedure and a criterion based on Akaike information criteria index were used to select variables associated with 30-day mortality. The performance of the regression model was compared with that of European System for Cardiac Operative Risk Evaluation (EuroSCORE) II. RESULTS At 30 days, 90 (2.54%) and 35 (2.97%) patients died in the development and validation data sets, respectively. Age, chronic obstructive pulmonary disease, concomitant coronary revascularization, frailty stratified according to the Geriatric Status Scale, urgent procedure and estimated glomerular filtration rate were independent predictors of 30-day mortality. The estimated OBS AVR score showed higher discrimination (area under curve 0.76 vs 0.70, P CONCLUSIONS The OBS AVR risk score showed high discrimination and calibration abilities in predicting 30-day mortality after surgical aortic valve replacement. The addition of a simplified frailty assessment into the model seems to contribute to an improved predictive ability over the EuroSCORE II. The OBS AVR risk score showed a significant association with long-term mortality.

Background The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. Methods/Design The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020–000,137–40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. Summary The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.

Objectives The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors o...

Aortic stenosis (AS) is one of the most common valvular diseases in developed countries. Transcatheter aortic valve implantation (TAVI) has emerged as alternative to medical treatment or surgical aortic valve replacement (SAVR) in all symptomatic patients with severe AS. In 2002, Cribier performed the first human TAVI through a trans-septal approach in a 57-year-old man with severe AS. Since then, several trials have compared TAVI vs. SAVR over the years. Today, it is superior in terms of mortality to medical therapy in extreme-risk patients, non-inferior or superior to surgery in high-risk patients, and non-inferior to surgery and even superior when transfemoral access is possible in intermediate-risk patients. Interesting results emerged from the latest multicentre trials involving patients with severe AS who were at low risk for death from surgery, demonstrating that this therapy will be offered to younger people in the next future.

Aims The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice. Methods and results FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge. Conclusions The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap. ClinicalTrials.gov Identifier: NCT03417011

AIM To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR). METHODS We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs.

AIMS The aim of this study was to evaluate predictors and safety of next-day discharge (NDD) after transfemoral transcatheter aortic valve implantation (TF-TAVI) in unselected patients receiving either balloon-expandable or self-expanding devices. METHODS AND RESULTS From June 2007 to August 2018, 1,232 consecutive patients undergoing TF-TAVI were discharged alive from our institution. They had a mean age of 80.9±5.4 years and an intermediate estimated surgical mortality risk; they received either balloon-expandable (26.1%) or self-expanding prostheses (73.9%). We compared patients discharged within 24 hours from the procedure (n=160, 13.0%) with those discharged later, and accounted for confounding variables through a propensity matching adjustment. After adjustment, no differences in all-cause mortality (1.2% vs 0.0%, for NDD and no-NDD matched groups, respectively, p=0.16) or permanent pacemaker implantation (PPI) after TAVI (0.6% vs 0.6%, respectively) were encountered at 30 days. At one year, no difference in the composite endpoint of all-cause death and heart failure (HF) rehospitalisation was encountered (Kaplan-Meier [KM] estimates 91.9% vs 90.6% for NDD and no-NDD matched groups, respectively, p=0.69). After excluding patients with post-procedural major complications from the unmatched population, prior PPI (OR 2.06, 95% CI: 1.21-3.51; p

Background Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. Objectives The authors sought to examine outcomes following redo-TAVR. Methods The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. Results Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. Conclusions Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

Objectives The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR). Background Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality. Methods Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019. Results Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in “valve-in-valve” procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia Conclusions In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.

Aims In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). Methods and results Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4–6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan–Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1–4.3%] and 1.6% (95% CI 0.6–3.9%), respectively, while late BVF was 2.5% (95% CI 1.2–5%). Conclusion While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.

Objectives The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli. Background Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli. Methods TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter Results Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p Conclusions Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.

BACKGROUND: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. METHODS: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). RESULTS: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. CONCLUSIONS: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF. (C) 2020 International Society for Heart and Lung Transplantation. All rights reserved.

BACKGROUND The ability of optical coherence tomography (OCT) to recognize intraplaque macrophage infiltration is now well acknowledged. This post-hoc analysis of the CLIMA study aimed to address the clinical impact of the circumferential extension of OCT-defined macrophages and their location at one year follow-up. METHODS The multicentre CLIMA study enrolled 1003 patients undergoing OCT evaluation of the untreated proximal left anterior descending (LAD) coronary artery. Measurements of circumferential extension of macrophages and measurements of the distance from intima-lumen contour to macrophages string were performed at the plaque cross-section judged as containing the greatest amount of macrophages. The main study endpoint was a composite of cardiac death, myocardial infarction (MI) and/or target vessel revascularization (TVR). RESULTS Patients with large macrophage arc (p = 0.001) and superficial macrophage arc (p

Background A-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR). Methods The study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes. Results After reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371–21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057–16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up. Conclusions MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients.

AIMS Patients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease and have a worse prognosis after percutaneous coronary interventions (PCI). The BioFreedom polymer-free biolimus-A9-eluting stent (PF-BES) has shown promising results in patients at high bleeding risk; however, its performance in CKD patients has yet to be analyzed. METHODS The all-comers RUDI-FREE registry documented patients undergoing PCI with PF-BES in routine clinical practice. Patients were stratified into three groups according to their estimated glomerular filtration rate (eGFR): preserved renal function, mild renal insufficiency (RI), and with moderate to severe RI (eGFR ≥ 90, between 90 and 45, and

Background Patients undergoing percutaneous coronary intervention (PCI) are at risk of developing bleeding and/or thrombotic complications. Bleeding and thrombotic risk characteristics may overlap in some patients, which makes decision-making for dual antiplatelet therapy duration a clinical challenge. The actual proportion of PCI patients who have an increased bleeding risk and/or an increased thrombotic risk is unclear. Purpose Aim of this study is to identify sizeable and actionable proportions of patients at high bleeding risk (HBR) and/or at high thrombotic risk (HTR) in a contemporary cohort of PCI patients. Methods We retrospectively included all patients undergoing PCI at our Institution from November 2019 to April 2020 and identified those at HBR or HTR based on criteria from the Academic Research Consortium for High Bleeding Risk (ARC-HBR) or criteria from Giustino and colleagues, respectively. Since belonging to the HBR and HTR groups was non-mutually exclusive, patients were further stratified into 4 mutually exclusive subgroups: 1) HBR/HTR; 2) HBR, non-HTR; 3) non-HBR, HTR; and 4) non-HBR, non-HTR. In addition, the new ARC-HBR trade-off model (integrating patients' characteristics to define the individual risks of bleeding and thrombotic events) was applied to rank patients based on their computed risk scores for bleeding and thrombosis. Patients were categorized based on the ratio between the ARC-HBR thrombotic and the bleeding risk scores (i.e., high [1.5], intermediate [0.75–1.5], low [ Results A total of 312 patients were included, of which 93 (30%) presented with HBR and 116 (37%) with HTR. Among patients with HBR, 41% presented with HTR. Among patients with HTR, 33% presented with HBR. Overall, 12.2% of patients had HBR/HTR, 17.6% had HBR, non-HTR, 25.0% had non-HBR, HTR, and 45.2% had non-HBR, non-HTR. Based on the ARC-HBR trade off score, 16.3% of patients had a higher risk of thrombosis than the risk of bleeding, 45.9% had similar risks, and 37.8% had a higher risk of bleeding than the risk of thrombosis. Among patients who had HBR/HTR, the trade-off model identified 8% as having a higher risk of thrombosis than the risk of bleeding and 18.4% as having a higher risk of bleeding than the risk of thrombosis. Conclusions Characterizing the risk of bleeding and thrombotic complications is an important prerequisite for tailoring strategies to individual patients, hence minimizing the risks and improving the outcome of PCI. More than half of patients undergoing PCI presented with HBR, HTR, or both. About 40% of patients presented with characteristics of high risk, which make them actionable (e.g., by using shorter durations of dual antiplatelet therapy in patients at HBR and non-HTR or using longer durations in patients at non-HBR and HTR). The ARC-HBR trade off model score is an additional useful tool that may be used to identify an additional quarter of actionable patients in the HBR/HTR category. Funding Acknowledgement Type of funding sources: None.

Publisher Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. Objectives: To investigate how the changes of left ventricle ejection fraction (LVEF) between admission and discharge affected the long-term outcome in patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Background: An acute impairment of LVEF after surgical repair of mitral regurgitation, known as afterload mismatch, has been associated with increased all-cause mortality. Afterload mismatch after percutaneous edge-to-edge mitral valve repair has been postulated to be a transient phenomenon. Methods: This study is based on a single-center, retrospective, observational registry of patients who underwent percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbot Vascular) system for the treatment of symptomatic, moderate-to-severe mitral regurgitation. We included data on 399 patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Expert echocardiographers assessed LVEF before the procedure and at discharge. The patients were divided into three groups according to the difference of periprocedural LVEF measurements: unchanged (n = 318), improved (n = 40), and decreased (n = 41) LVEF. Results: The median follow-up time was 2.0 years. When adjusted for gender, NYHA class and estimated glomerular filtration rate, decreased postprocedural LVEF was associated with an increased risk of death (adjusted HR 2.05, 95% CI 1.26–3.34) and increased postprocedural LVEF with a reduced risk of death (adjusted HR 0.47, 95% CI 0.24–0.91) compared to unchanged LVEF. Conclusion: Among patients who underwent percutaneous edge-to-edge mitral valve repair, decreased postprocedural LVEF was associated with increased mortality, while improved LVEF was associated with lower mortality compared to unchanged LVEF.

AIMS To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) using three different new-generation devices. BACKGROUND Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head-to-head comparisons are available among these devices. METHODS This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF-TAVI for native, severe aortic stenosis using a new-generation transcatheter aortic valve (TAV) with a preprocedural multi-detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30-day all-cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p

AIMS The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p

Objectives The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR). Background Non–vitamin K oral anticoagulants (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated. Methods The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. Results Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR: 0.97; 95% CI: 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR: 1.36; 95% CI: 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively. Conclusions Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.

The Absorb bioresorbable vascular scaffold (BVS) promised to avoid some of the disadvantages of its metal predecessors. Even though it has been taken off the market, limited data is available about its use in coronary chronic total occlusion (CTO) and its performance in overlap segments, which would be of special research interest due to its large thickness. This data is still pertinent since the platform of bioresorbable devices has not been abandoned, with several companies working on it. We aimed to compare healing and performance between overlap (OL) and non-overlap regions (NOL) of CTO lesions treated with BVS, using optical coherence tomography (OCT). Fourteen patients with overlapping BVS were included from the GHOST-CTO registry, resulting in 25 OL and 38 NOL regions. OCT based parameters were compared between OL and NOL groups at baseline (post-implantation) and 12-month follow-up. The mean age was 61.7 ± 7.2 years and 12 (86%) were males. Twelve (86%) patients underwent PCI for stable coronary artery disease and 2 (14%) had unstable angina. At 12-month follow-up, mean lumen area decreased in both NOL and OL regions, but the decrease was significantly larger in the OL region (NOL − 0.7 ± 1.33 vs. OL − 2.4 ± 1.54 mm2; p = 0.002). Mean scaffold area increased in both regions, but increased significantly more in NOL ( + 1.1 ± 1.54 vs. + 0.4 ± 1.16 mm2; p = 0.016). The percent of uncovered struts was lower in the OL group (5.0 ± 6.6% vs. 3.75 ± 8.7%, p = 0.043), whereas the percentage of malapposed struts was similar (0.3 ± 0.5% vs. 0.7 ± 2.3%, p = 0.441). Neointimal hyperplasia (NIH) was more pronounced in the OL region (0.13 ± 0.04 vs. 0.24 ± 0.10 mm2, p = 0.001). The OL and NOL segments showed comparable healing in terms of coverage and malapposition. However, NIH was more prominent in OL region. The long-term clinical implications of these findings needs further evaluation. The present study provides important insights for future development of BVS technology.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative to surgery for low- and intermediate-risk patients with severe, symptomatic aortic stenosis. It is increasingly being used for younger, lower-risk patients, so it is important to ensure the durability for long-term transcatheter aortic valves. The lack of standard definitions of structural valve degeneration (SVD) had made comparison among studies on prosthetic valve durability problematic. The 2017 standardised definitions of SVD by the European Association of Percutaneous Cardiovascular Intervention), the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, and the 2018 definitions by the Valve In Valve International Data group, has generated an increased uniformity in evaluations. This article examines the potential mechanisms and rates of SVD of transcatheter bioprostheses and the role of redo TAVI as a treatment option.

Objectives The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. Background The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. Methods The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)–2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. Results A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. Conclusions In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.

Transcatheter aortic valve replacement (TAVR) is the gold standard for severe valvular aortic stenosis in patients at high/prohibitive surgical risk. This procedure has also been used in patients with previous mitral valve (MV) prostheses, with contrasting outcomes reported. The aim of this study is to describe procedural and early outcomes of patients with previous MV prostheses undergoing TAVR.This is a retrospective registry of 154 patients with previous MV prostheses who underwent TAVR across high-volume medical centres at a mean of 11.7 ± 8.4 years after mitral surgery.Mean mitroaortic distance at computed tomography was 9.7 ± 4.8 mm. Procedural success was achieved in 150 (97.4%) patients, with reduction of aortic gradients (42.6 ± 14.2 to 10.0 ± 7.0 mm Hg; P0.001). Device success was achieved in 133 (86.3%) patients. MV prosthesis interference by the TAVR device was observed in 2 patients; in both, the mitroaortic distance was5 mm, with 1 complicated by TAVR prosthesis embolization. Periprocedural complications included 4 (2.6%) cerebrovascular accidents, 10 (6.6%) major vascular complications, 22 (14.4%) severe bleedings, 1 (0.7%) myocardial infarction, and 5 (3.2%) in-hospital deaths (all cases cardiovascular or procedure related). At a median follow-up of 13.5 (interquartile range 1.0 to 36.0) months, 26 (16.9%) deaths occurred; 15 (9.7%) were cardiac related. Late fatal mitral prosthesis thromboses occurred in 2 patients. We recorded a case of fatal hemorrhagic stroke; hospital readmission was observed in 25 (16.2%) patients due to worsening heart failure.TAVR in patients with previous mitral prostheses appears to be safe and feasible, with good hemodynamic results at 30-day and at longer-term follow-up.

Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high‐volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre‐SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9–9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In‐hospital all‐cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

Although optical coherence tomography (OCT) proved to be able to identify macrophage clusters, there are no available data on the possibility to obtain reproducible measurements of their circumferential extension and location. The purpose of the present post-hoc analysis of the CLIMA study was to revise the clinical and demographic variables of patients having coronary plaques with macrophages and to investigate the reproducibility of their quantitative assessment. A total of 577 patients out of 1003 undergoing OCT showed macrophage accumulation. Three groups were identified; group 1 (426 patients) without macrophages, group 2 (296) patients with low macrophage content (less than median value [67°] of circumferential arc) and group 3 (281) with high macrophage content arc [> 67°]. Patients with macrophages (groups 2 and 3) showed a higher prevalence of family history for coronary artery disease and hypercholesterolemia and had a significantly larger body mass index. Furthermore, group 3 had more commonly triple vessel disease and higher value of LDL cholesterol levels compared to the two other groups. The inter-observer agreement for macrophage interpretation was good: R values were 0.97 for the circumferential arc extension, 0.95 for the minimum distance and 0.98 for the mean distance. A non-significant correlation between circumferential extension of macrophages and hsCRP values was found (R = 0.013). Quantitative assessment of macrophage accumulations can be obtained with high reproducibility by OCT. The presence and amount of macrophages are poorly correlated with hsCRP and identify patients with more advanced atherosclerosis and higher LDL cholesterol levels.

We aimed at appraising features and outcomes of patients undergoing MitraClip treatment according to their age.We queried the prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) multicenter registry dataset including 19 Italian centers performing MitraClip implantation, distinguishing patients80 vs ≥80 years of age.In total, 1853 patients were included, 751 (40.5%) octogenarians and 1102 (59.5%) non-octogenarians. Several baseline and procedural features were significantly different, including gender, regurgitation etiology, and functional class (all p 0.05). In-hospital outcomes were similarly satisfactory, with death occurring in 18 (2.4%) and 32 (2.9%, p = 0.561), respectively, and improvement in mitral regurgitation in 732 (97.4%) and 1078 (97.8%, p = 0.746), respectively. After a mean follow-up of 15 months, death occurred in 152 (20.2%) and 264 (24.0%), and cardiac death in 85 (11.3%) and 138 (12.5%), respectively (both p 0.05). Rehospitalization for heart failure and the composite of cardiac death or rehospitalization for heart failure were significantly less common in octogenarians: 63 (8.4%) vs 156 (14.2%, p 0.001), and 125 (16.6%) vs 242 (22.0%, p = 0.005), respectively. Multivariable analysis showed that these differences were largely due to confounding features, as after adjustment for baseline, clinical and imaging characteristics no significant difference was found for the above clinical endpoints.Transcatheter mitral valve repair with the MitraClip in carefully selected octogenarians appears feasible and safe, and is associated with favorable clinical outcomes at mid-term follow-up.

BACKGROUND Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR. METHODS Exploiting the ongoing prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClips. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes. RESULTS As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip, and 940 (51.5%) receiving two MitraClips, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all p

BACKGROUND Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions. OBJECTIVES The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). METHODS Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30��days and 1 year. RESULTS For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p��=��0.045), driven by a numerically lower frequency of residual high valve gradient (p��=��0.095), ectopic valve deployment (p��=��0.081), coronary obstruction (p��=��0.091), and conversion to open heart surgery (p��=��0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p��=��0.715). Mortality at 30��days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p��=��0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p��=��0.633). Aortic valve area was larger (1.55 �� 0.5��cm2 vs. 1.37 �� 0.5��cm2; p��=��0.040), and the mean residual gradient was lower (12.6 �� 5.2��mm��Hg vs. 14.9 �� 5.2��mm��Hg; p��=��0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p��=��0.003). CONCLUSIONS In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.

Background: Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). Methods: BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area&nbsp

Background: There is no consensus on the benefit of red blood cell (RBC) transfusion after transcatheter aortic valve replacement. Methods: The multicenter Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry retrospectively included patients after transfemoral transcatheter aortic valve replacement; propensity score-matching identified pairs of patients with and without RBC transfusion. The primary end point was 30-day mortality; nonfatal myocardial infarction, cerebrovascular accident, and stage 2 to 3 acute kidney injury at 30 days were secondary end points. We repeated propensity score-matching according to the hemoglobin nadir, hemoglobin drop, and in the subgroup of uncomplicated patients, without major vascular complications or major bleeding. Results: Among 2587 patients, RBC transfusion was administered in 421 cases (16%). The primary end point occurred in 104 (4.0%) patients, myocardial infarction in 9 (0.4%), cerebrovascular accident in 38 (1.5%), and acute kidney injury in 125 (4.8%) cases. In the 842 propensity-matched patients, RBC transfusion was associated with increased mortality (hazard ratio, 2.07 [95% CI, 1.06–4.05]; P =0.034) and acute kidney injury (hazard ratio, 4.35 [95% CI, 2.21–8.55]; P P =0.044), major bleeding ( P =0.041), and RBC transfusion ( P =0.048) were independent correlates of 30-day mortality. Conclusions: RBC transfusion correlates with increased mortality and acute kidney injury early after transcatheter aortic valve replacement and is an independent predictor of 30-day mortality, irrespective of periprocedural major bleeding and vascular complications. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03740425.

To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality. Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking. The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure. Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p

Background Current medication adherence telemonitoring systems have several limitations prompting the need for simpler, low-cost and widely applicable tools. To meet these needs, we propose a novel method consisting in sending a digital feedback of medication intake by just reading a pre-defined Quick Response (QR) code attached on the pills box. Methods To assess the potential clinical applicability of the proposed QR code-based task, its feasibility was tested among elderly with heart diseases. The primary endpoint was the learning success defined as a correct execution of all QR code-based digital task steps within 10 min. Study outcomes were compared between patients 65–75 years old (younger cohort) and those aged >75 years (older cohort) admitted to the Cardiology ward of a tertiary center. Results A total of 262 patients were included: 128 (48.9%) were younger and 134 (51.1%) older. Despite a baseline low smartphone use in the overall population (41.2%), patients learning success of the digital task was as high as 75.6%, with lower rates among older vs. younger (67.9% vs. 83.6%, p = 0.005). After adjustment no significant independent association between age and success in learning the QR code-based task was found. Differently, increasing age was a negative independent predictor of smartphone use. The learning time was overall small, but longer in the older group (126 ± 100 vs. 100 ± 60 s, p = 0.03). Conclusions The QR code-based digital task was highly feasible for elderly with heart diseases suggesting its potential large-scale clinical application and encouraging the investigation of QR code-based systems for medication adherence telemonitoring.

BackgroundDespite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization.Methods and ResultsThis was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST‐TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1‐year after discharge. The end point—a composite of all‐cause mortality, vascular access–related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding—was reached in 27.0% of patients (95% CI, 23.3–31.2) within 1 year after intervention; 7.5% (95% CI, 5.5–10.2) had in‐hospital complications before discharge and 19.6% (95% CI, 16.3–23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular‐access–related complications 0.7%, life‐threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days.ConclusionsThe FAST‐TAVI risk assessment provides a tool for appropriate, risk‐based discharge that was validated with the 1‐year event rate after transfemoral TAVI.RegistrationURL:https://www.ClinicalTrials.gov; Unique identifier: NCT02404467.

Transcatheter aortic valve implantation (TAVI) is a therapeutic option widely used for the treatment of severe aortic stenosis in the elderly. Careful pre-procedural screening, operator experience, and technological innovations, accounted for a safe, reliable, and standardized procedure. To further decrease post-operative complications, few steps are important: careful planning of the procedure by the Heart Team, clinical and diagnostic evaluation including electrocardiogram, echography, and computed tomography of the heart and great vessels. This approach will allow a selection of ideal candidates for the procedure, the best vascular approach, the selection of patients candidates for early discharge, and last but not least, simplification of the TAVI procedure. Although the procedure is reaching the ‘simplicity’ of coronary interventions, it should always be kept in mind the possibility, albeit remote, that life-threatening complication could ensue, requiring the prompt intervention of the cardiovascular surgeon.

AIMS The goal of the present post hoc analysis of the CLIMA registry was to establish the relationship between calcified nodules (CNs) with (CND) or without (CNWD) disruption of the superficial intimal fibrous layer and one-year occurrence of target lesion myocardial infarction (MI) and/or cardiac death. METHODS AND RESULTS CND and CNWD were identified based on the presence or absence of superficial irregularities indicative of disruption of the intimal fibrous layer, with possible overlying local thrombus. In total, 222 CNs were found in the 1,776 non-culprit LAD plaques. CND had larger maximum calcific arc and smaller lumen area. Cardiac death and MI occurred in 20% of patients in the CND group versus 2.7% in the CNWD group and 3.3% in the group without CN (p