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Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases). Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation. Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV. This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation. • Para-valvular regurgitation (PVR) after TAVI is associated with increased mortality. • Redo-TAVI reduced PVR in 90% of patients with PVR after TAVI. • AR persisted in 10% of patients with PVR vs. 2.4% with intra-valvular AR, p = 0.137. • Procedural success, safety and mortality were comparable. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Given the vicissitudes of percutaneous coronary intervention (PCI) technology, epidemiology, and mode of practice, the aim of this study was to define contemporary outcome predictors in a very large consecutive patient cohort. Data from 11,441 consecutive patients who underwent PCI at a tertiary medical center from April 2004 to September 2013 are presented. A comprehensive database was built using various data sources, with outcome end points defined as all-cause mortality and as a composite of death or nonfatal myocardial infarction during follow-up. Candidate variables to influence outcome were chosen a priori and were tested using multivariate time-dependent models to estimate each interaction. Mean follow-up was 5.5 years (range 3 months to 9.5 years). The cohort consisted of 75% men, 42% patients with diabetes, and 61% patients who underwent PCI in acute coronary syndrome settings and 7.8% for ST-elevation myocardial infarction. Drug-eluting stents were used in 43.4% of patients, bare-metal stents in 52%, and balloon angioplasty alone in 4.6%. In multivariate analysis, in addition to already well-recognized predictors of death or myocardial infarction such as advanced age (hazard ratio [HR] 1.031, p <0.001), female gender (HR 1.23, p <0.001), urgent setting (HR 1.23, p <0.001) and diabetes mellitus (HR 1.28, p <0.001), we particularly noted previous anemia (HR 1.55 p <0.001), previous chronic kidney injury (HR 1.93, p <0.001) and previous moderate to severe left ventricular dysfunction (HR 2.29, p <0.001). Drug-eluting stent placement was associated with better outcomes (HR 0.70, p <0.001). In conclusion, this analysis confirms the effect of some known predictors of PCI outcomes. However, the extent of their effect is modest, while other predictors may have a greater influence on outcomes. Risk stratification of PCI patients should take into account kidney injury, anemia, and left ventricular function. Drug-eluting stents provide sustained benefit. [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri‐procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI—transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri‐procedural and short‐term safety, efficacy and durability of repeated TAVI. Methods: The ReTAVI Prospective observational registry is an investigator‐initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon‐expandable SAPIEN prosthesis to evaluate procedural and short‐term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high‐volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30‐day and 12‐month follow‐up. The estimated study completion is 2025. Conclusions: The registry will collect pre‐, peri‐, postoperative and 12‐months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC‐3‐defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis. [ABSTRACT FROM AUTHOR]

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). 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 < 400 mm2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm2, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs. • TAVR can be successfully performed in severe bicuspid aortic stenosis. • However, interaction between annular size and THV type is still unclear. • We compared BEV and SEV hemodynamics by aortic annulus size in BAV patients. • In large annuli a higher rate of PVLs was observed SEVs compared to BEVs. • No differences in clinical outcomes were observed according to annular size nor THV. [ABSTRACT FROM AUTHOR]

Background: The extent of myocardial fibrosis in patients with severe aortic stenosis might have an important prognostic value. Non-invasive imaging to quantify myocardial fibrosis by measuring extracellular volume fraction might have an important clinical utility prior to aortic valve intervention. Methods: Seventy-five consecutive patients with severe aortic stenosis, and 19 normal subjects were prospectively recruited and underwent pre- and post-contrast computed tomography for estimating myocardial extracellular volume fraction. Serum level of galectin-3 was measured and 2-dimensional echocardiography was performed to characterize the extent of cardiac damage using a recently published aortic stenosis staging classification. Results: Extracellular volume fraction was higher in patients with aortic stenosis compared to normal subjects (40.0±11% vs. 21.6±5.6%; respectively, p<0.001). In patients with aortic stenosis, extracellular volume fraction correlated with markers of left ventricular decompensation including New York Heart Association functional class, left atrial volume, staging classification of aortic stenosis and lower left ventricular ejection fraction. Out of 75 patients in the AS group, 49 underwent TAVI, 6 surgical AVR, 2 balloon valvuloplasty, and 18 did not undergo any type of intervention. At 12-months after aortic valve intervention, extracellular volume fraction predicted the combined outcomes of stroke and hospitalization for heart failure with an area under the curve of 0.77 (95% confidence interval: 0.65–0.88). A trend for correlation between serum galectin-3 and extracellular volume was noted. Conclusion: In patients with severe aortic stenosis undergoing computed tomography before aortic valve intervention, quantification of extracellular volume fraction correlated with functional status and markers of left ventricular decompensation, and predicted the 12-months composite adverse clinical outcomes. Implementation of this novel technique might aid in the risk stratification process before aortic valve interventions. [ABSTRACT FROM AUTHOR]

Although bicuspid aortic valve (BAV) is not considered a "sweet spot" to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs). patients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium–2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year. Type 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%, p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%; p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%, p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups. Our study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV. • Despite being a relative contraindication a certain number of BAV underwent TAVR. • We assessed the impact of BAV type on procedural and clinical outcomes post TAVR. • VARC-2 success tended to be lower in type 0 vs. type 1 BAV. • higher rate of high residual gradient was observed in type 0 compared to type 1 BAV. • No differences were noted in the rate of AR and clinical outcomes between BAV types. [ABSTRACT FROM AUTHOR]

Randomized clinical trials demonstrated the benefits of percutaneous coronary interventions (PCI) in diverse clinical settings. Patients with cancer were not routinely included in these studies. Literature search of PubMed, Cochrane, Medline, SCOPUS, EMBASE, and ClinicalTrials was conducted to identify studies that assessed one-year all-cause, cardiovascular and non-cardiovascular mortality in patients with historical or active cancer. Using the random effects model, we computed risk ratios (RRs) and standardized mean differences and their 95% confidence intervals for the dichotomous and continuous measures and outcomes, respectively. Of 171 articles evaluated in total, 5 eligible studies were included in this meta-analysis. In total, 33,175 patients receiving PCI were analyzed, of whom 3323 patients had cancer and 29,852 no cancer history. Patients in the cancer group had greater all-cause mortality [RR 2.22 (1.51–3.26; p < 0.001)], including cardiovascular mortality [RR 1.34 (1.1–1.65; p = 0.005)] and non-cardiovascular mortality [RR 3.42 (1.74–6.74; p ≤ 0.001], at one-year compared to non-cancer patients. Patients in the cancer group had greater one-month all-cause mortality [RR 2.01 (1.24–3.27; p = 0.005)] and greater non-cardiovascular mortality [RR 6.87 (3.10–15.21; p ≤0.001)], but no difference in one-month cardiovascular mortality compared to non-cancer patients. Meta-regression analyses showed that the difference in one-year all-cause and cardiovascular mortality between both groups was not attributable to differences in baseline characteristics, index PCI characteristics, or medications prescribed at discharge. Patients with cancer undergoing PCI have worse mid-term outcomes compared to non-cancer patients. Cancer patients should be managed by a multi-specialist team, in an effort to close the mortality gap. • First meta-analysis of outcomes after PCI in cancer patients • In total, 33,175 patients receiving PCI were analyzed in this study. • Cancer patients were found to have increased risk of 1-year all-cause mortality. • Cancer patients have increased risk of 1-year cardiovascular mortality. • In meta-regression, 1-year outcomes differences were independent of baseline traits. [ABSTRACT FROM AUTHOR]

Background: Drug-eluting stents with biodegradable polymer might be particularly useful in diabetic patients who are at increased risk for target lesion/target vessel revascularization. We therefore aimed at assessing the safety and performance of a biodegradable polymer sirolimus-eluting stent (BP-SES) in combination with comprehensive optimal medical therapy following coronary interventions.Methods: This prospective, multicenter registry was conducted at six centers in Israel. Aside of stent treatment, we aimed for an LDL-C level<70mg/dl; at one and six months post-intervention a diabetic consultancy was required, and follow-up data were collected at six and twelve months. The primary outcome measure was target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven target vessel revascularization. Secondary outcomes were target lesion failure, its individual components, and stent thrombosis.Results: From August 2013 until May 2014, 120 diabetic patients with 158 lesions were treated with a BP-SES. Mean age was 63.9±9.2years, 27.5% were insulin dependent, 28.3% had a history of myocardial infarction, and 47.5% had prior coronary interventions. By visual estimation, lesions were 3.0±0.5mm in diameter and 15.2±7.4mm long; mean stent diameter and length were 3.0±0.5mm and 19.2±6.8mm. Target vessel failure and target lesion failure at 12months occurred in seven (6.4% [95% CI: 3.1-13.0]) and four patients (3.5% [95% CI: 1.3-9.2]), respectively, and definite stent thrombosis in one patient (1.0% [95% CI: 0.1-7.0]).Conclusion: Treatment with a BP-SES demonstrated excellent target-vessel and target-lesion revascularization rates in a high-risk diabetic patient population undergoing catheter-based revascularization followed by intensified medical care.Annotated Table Of Contents: In 120 high-risk diabetic patients with coronary artery stenosis, treatment with the Orsiro sirolimus-eluting stent with biodegradable polymer and comprehensive antidiabetic therapy resulted in excellent clinical outcomes. Target vessel revascularization occurred in 6.4% of patients and target lesion revascularization in 3.5%. [ABSTRACT FROM AUTHOR]