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OBJECTIVES We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p

Objectives The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. Background The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. Methods A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported. Results Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients. Conclusions Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

Objectives This multicenter registry aimed to assess the reproducibility and safety of intentional coronary vein exit and carbon dioxide insufflation to facilitate subxiphoid epicardial ac...

AIMS: The aim of this study was to assess the one-year safety and efficacy of the transcatheter ARTO system in the treatment of functional mitral regurgitation (FMR). METHODS AND RESULTS: MAVERIC is a multicentre, prospective, non-randomised pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA Class II-IV systolic heart failure and had an FMR grade ≥2+. The ARTO system was implanted in forty-five (100%) patients. The primary safety composite endpoint (death, stroke, myocardial infarction, device-related surgery, cardiac tamponade, renal failure) at 30 days and one year was 4.4% (95% CI: 1.5-16.6) and 17.8% (95% CI: 9.3-32.4), respectively. Periprocedural complications occurred in seven patients (15.5% [95% CI: 6.5-29.5]), and five patients (11.1% [95% CI: 4.9-24.0]) died during one-year follow-up. Paired results for 36 patients demonstrated that 24 (66.7%) had grade 3+/4+ mitral regurgitation at baseline; however, only five (13.9%) and three (8.3%) patients remained at grade 3+/4+ 30 days and one year post procedure (p

OBJECTIVE Octogenarians are a high-risk group presenting for percutaneous coronary intervention (PCI). We aimed to create a 30-day mortality risk model for octogenarians presenting with both acute coronary syndrome (ACS) and chronic stable angina (CSA), using comprehensive mandatory UK data submissions to the UK National database. BACKGROUND Octogenarians are a high-risk group presenting for percutaneous coronary intervention, and decisions on whether or not to undertake intervention in this cohort can be challenging. The increasing number of octogenarians in the general population means they represent an important high-risk subgroup of patients. METHODS The data group consisted of 425,897 PCI procedures undertaken in the UK between 2008 and 2012 during which time there was comprehensive data linkage to mortality via the Office of National Statistics. Of these procedures, 44,221 (10.4%) were in patients aged ≥80. These comprised the model group. Logistic regression was used to create a predictive score which ultimately consisted of the following weightings: age 80-89 (n = 1); age > 90 (n = 2); unstable angina/non-ST-elevation myocardial infraction (NSTEMI) (n = 1); STEMI (n = 2); creatinine >200 mmol/L (n = 1); preprocedural ventilation (n = 1); left ventricular ejection fraction

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.

OBJECTIVES: To describe the occurrence of postprocedural atrial fibrillation (AF) among patients with cryptogenic stroke undergoing patent foramen ovale (PFO) closure in the REDUCE clinical study and analyze for potential risk factors for the development of postprocedural AF.BACKGROUND: AF is an adverse event that might potentially counterbalance the stroke prevention benefit from PFO closure. Data on AF after transcatheter PFO closure are sparse.METHODS: We evaluated data from patients having PFO closure (Gore HELEX or Gore Cardioform Septal Occluder) in the REDUCE clinical trial (n = 408) in at post hoc explorative analysis. Median follow-up was 5.0 years.RESULTS: AF occurred in 30 patients (7.4%) after PFO closure with a total of 34 AF events. Most were reported as non-serious (68%), detected within 45 days post-procedure (79%), and resolved within 2 weeks of onset (63%). One subject with AF had recurrent stroke. Postprocedural AF occurred more frequently among subjects with higher age and large device sizes. Male sex was the only independent predictor of postprocedural AF. We found no association between the type of occluder (HELEX or Gore Cardioform Septal Occluder) or PFO anatomical characteristics and post-procedural AF.CONCLUSION: In the REDUCE clinical study, postprocedural atrial fibrillation was mostly early onset, transient and with no later recurrence. Postprocedural AF occurred more frequently among patients with higher age and larger devices. Male sex was the only independent predictor of postprocedural AF.

Objectives Subclavian (SC) and transapical (TA) approaches are the main alternatives to the default femoral delivery for transcatheter aortic valve implantation (TAVI). The aim of this study was to compare complications and morbidity/mortality associated with SC and TA in a long-term time frame. Methods From January 2007 to July 2015, 1506 patients underwent TAVI surgery in 36 United Kingdom TAVI centers. Primary outcomes were complications according to VARC-2 criteria. The secondary outcome was long-term survival. Results The enrolled patients were distributed as follows: 1216 in the TA group and 290 in the SC group. There were no differences in the rates of acute myocardial infarction, emergency valve-in-valve, paravalvular leak, balloon post dilatation, cardiac tamponade, stroke, renal replacement therapy, vascular injuries, and 30-day mortality among the groups. Conversely, the rate of permanent pacemaker implantation (p = .02), the procedural time duration (p = .04), and the 12-month mortality (p = .03) was higher in SC than in TA, while in-hospital length of stay was reduced in SC than in TA (p = .01). Up to 8 years, the long-term mortality was not different among groups (p = .77), and no difference in long-term survival between self- versus balloon-expandable devices was found (p = .26). Conclusions According to our results, TA provided the best 12-month survival compared to SC, while the long-term survival up to 2900 days is not significantly different between groups, so SC and TA may both represent a safe non-femoral access if femoral is precluded.

Introduction This case series describes use of the Acurate Neo transcatheter aortic valve in patients with symptomatic severe native aortic regurgitation (AR). TAVI is not currently mentioned in either the European Society of Cardiology or American College of Cardiology guidance for management of severe symptomatic AR. There are no randomised trials comparing the outcomes of patients with pure severe AR treated with a TAVI valve vs surgical aortic valve replacement (sAVR). Method We present a case series of four patients with isolated AR treated using the Acurate Neo valve (Boston Scientific). Each case had been turned down for sAVR but deemed suitable for TAVI after review at the structural heart multi-disciplinary team meeting. TAVI implantation was successful in each case with reduction or resolution of their AR and improved cardiac haemodynamics. Results Three of the patients had significant symptomatic improvement, one had limited symptomatic improvement despite resolution of her AR on aortogram post TAVI. Conclusion Our case series adds to the growing literature that TAVI is a viable option for patients with pure AR but further long-term follow-up is required to assess the longevity and robustness of the valves.

Rates of permanent pacemaker (PPM) implantation following transcatheter aortic valve implantation (TAVI) are higher than following surgery and are dependent on patient factors and valve type. There is an increasing trend towards pre-emptive PPM insertion in patients with significant conduction disease prior to TAVI. We report results from the British Cardiovascular Intervention Society (BCIS) on pre- and post-procedural PPM implantation in the TAVI population. All centres in the United Kingdom performing TAVI are required to submit data on all TAVI procedures to the National database which are then reported annually. During 2015, there were 2373 TAVI procedures in the UK. 22.4% of TAVI patients had a PPM implanted either pre-procedure (including the distant past), or during the in-hospital procedural episode. Of these, 7.9% were pre-procedure and 14.5% post-procedure. Overall PPM rates were Edwards Sapien (13.5%), Medtronic CoreValve (28.2%) and Boston Lotus (42.1%; p

Acute coronary collateralisation of an infarct-related arterial (IRA) territory may be identified during angiography for ST elevation myocardial infarction (STEMI). Whether the presence or absence of these collaterals affects outcomes remains uncertain. A search of EMBASE, MEDLINE and Cochrane Library, using the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines was conducted to identify studies which reported on the association between coronary collaterals and in-hospital and longer term mortality, left ventricular ejection fraction (LVEF), risk of repeat acute myocardial infarction (AMI) and repeat revascularisation. Patients with Rentrop grade 0 or 1 were defined as poor collaterals whilst those with Rentrop grade two or three were defined as those with robust collaterals. Studies were eligible if they included patients ≥ 18 years of age who had immediate coronary angiography for STEMI. Included studies were observational which recorded the degree of collateral blood flow to the IRA. Two investigators reviewed all citations using a predefined protocol with final consensus for all studies, the data from which was then independently entered to ensure fidelity of results. Inverse variance random effects model for the meta-analysis along with risk of bias assessment was performed. 20 studies with a total of 14,608 patients were identified and included in the analysis. Patients with robust collaterals had lower mortality (OR 0.55, 95% CI 0.48–0.64), both in-hospital (OR 0.47, 95% CI 0.35–0.63) and longer term (OR 0.58, 95% CI 0.46–0.75). Patients with robust collaterals also had a higher mean LVEF (SMD 0.23, 95% CI 0.10–0.37). There was no difference in the rates of AMI or repeat revascularisation between patients with robust or poor collaterals. The presence of robust collaterals during STEMI is associated with reduced in-hospital and longer term mortality and improved left ventricular function. These findings have implications for prognostication and identifying patients who require close monitoring following STEMI.

Background: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison. Methods: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice. Results: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques (“provisional” and “inverted provisional”) and (b) 2-stent techniques (“T/TAP,” “culotte,” and “DK-crush”). Conclusions: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.

Aims: We sought to compare the efficiency of the novel EuroCTO (CASTLE) score with the commonly used Multicentre CTO registry in Japan (J-CTO) score in predicting procedural success of percutaneous recanalization (PCI) for coronary chronic total occlusions (CTOs). Methods and results: We evaluated 660 consecutive CTO PCIs (mean age: 66±11 years, 84% male). The mean J-CTO and EuroCTO (CASTLE) scores were 1.86 ± 1.2 and 1.74 ± 1.2, respectively. Antegrade wire escalation, antegrade dissection re-entry and retrograde approach were used in 82%, 14% and 37% of cases, respectively. Receiver-operator characteristic analysis demonstrated equal overall discriminatory capacity between the two scores (AUC: 0.698, 95%CI: 0.653-0.742 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.

ObjectiveThe primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide.Methodse-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions.ResultsA total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y12 inhibitors were prescribed in 48% of patients at discharge, while at 1 year 72% were on any dual antiplatelet therapy. Lipid-lowering treatment was administered in 80.9% and 75.5% of patients at discharge and 1 year, respectively. Regional differences in the profile of the treated patients as well as in PCI practice were reported.ConclusionsIn this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.

Background: 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). Methods: 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. Results: 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. Conclusions: 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.

Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome. Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV. Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]). Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm2 vs 1.3 ± 0.8 cm2; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176). Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.

Background\ud Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac surgery. Iron deficiency is a frequent cause of low preoperative haemoglobin. An effective treatment for preoperative anaemia associated with iron deficiency has not been determined.\ud \ud Methods\ud We conducted a single-centre, open-label, pragmatic randomised trial, enrolling 156 elective cardiac surgery patients who had low preoperative haemoglobin (100–130 g L−1) with iron deficiency (serum ferritin

The aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI).Retrograde CTO PCI is an established technique, but predictors of success remain poorly understood.A multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry.In calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P 0.0001), and the top tertile of operator volume (120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success.Less calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.

To assess the impact of balloon use for predilation, valve implantation, or postdilation on in-hospital mortality among patients undergoing transcatheter aortic valve replacement (TAVR).TAVR utilizes self-expanding, mechanically expanding, or balloon-expandable valves. Balloon inflation is inherent to deployment of balloon-expandable valves. Balloons may additionally be used with all valve types for pre- and postdilation. The relationships between valve mechanism, balloon use, and in-hospital mortality are not fully characterized.Prospective data were collected on 4063 patients undergoing TAVR for aortic stenosis at 4 high-volume centers in the United Kingdom. In-hospital mortality was analyzed according to valve expansion mechanism, use of balloons for pre- and postdilation, and specific cause of death.Mean patient age was 83 ± 8 years. Implanted valves were self expanding (n = 2241; 55%), mechanically expanding (n = 1092; 27%), or balloon expandable (n = 727; 18%). In-hospital death occurred in 66 cases (1.6%). Thirty-six deaths (54.5%) were classified as implantation-related mortalities, with rates of 0.8%, 0.5%, and 1.7% (P=.04) among self-expanding, mechanically expanding, and balloon-expandable technologies, respectively. Patients who underwent balloon inflation at any stage of their procedure (n = 2556; 63%) had significantly higher implantation-related mortality than those who did not (1.3% vs 0.3%, respectively; P.01). Balloon-expandable valve procedures were associated with significantly higher all-cause mortality (2.6% vs 1.4%; P=.02) and implantation-related mortality (1.7% vs 0.7%; P=.02) than non-balloon-expandable valve procedures. Balloon-related complications accounted for 18 cases (26%) of total in-hospital mortality, including all 12 cases (17.4%) of annular rupture and 5 cases (7.2%) of coronary occlusion.Balloon use for predilation, valve implantation, or postdilation was associated with an increased mortality risk. Balloon-related complications were the largest contributor to in-hospital mortality, comprising all cases of annular rupture and the majority of coronary occlusion cases.

AIMS: The aim of this study was to determine whether revascularisation of an infarct-related artery chronic total occlusion (IRA-CTO) has a modulatory effect on myocardial scar composition. METHODS AND RESULTS: This is a unique, first-time report of three consecutive patients presenting with myocardial scar-related recurrent ventricular tachycardia (rVT) on a background of ischaemic cardiomyopathy. Electro-anatomic mapping of the left ventricular endocardium was performed before and immediately after IRA-CTO percutaneous coronary intervention (PCI) to assess for changes in scar composition and size. There were substantial percentage reductions in the low voltage area of scar compared to baseline after IRA-CTO PCI (Patient 1: −12.8%, Patient 2: −27.0%, and Patient 3: −15.3%). Interval remapping ≥6 months after the index procedure demonstrated extensive net reductions in all areas of myocardial scar (Patient 1: dense scar =−7.5%, border zone scar =−54.9%, low voltage area =−32.7%, and Patient 2: dense scar =−38.6%, border zone scar =−59.6%, low voltage area =−51.7%). Patient 3 declined interval remapping but has remained free of rVT at one-year follow-up. CONCLUSIONS: IRA-CTO PCI may positively modify the size and composition of myocardial scar associated with rVT in the context of ischaemic cardiomyopathy.

AIMS We report the 2-year outcomes of the MitrAl ValvE RepaIr Clinical (MAVERIC) trial. Functional mitral regurgitation (FMR) is associated with poor outcomes for which there remains an unmet clinical need. ARTO is a transcatheter annular reduction device for the treatment of FMR and an emerging alternative for patients at high surgical risk. The MAVERIC trial was designed to evaluate the safety and performance of the ARTO system in FMR and heart failure (HF). METHODS AND RESULTS MAVERIC is an international multicentre, prospective, single arm study enrolling patients with FMR grade ≥ 2, New York Heart Association (NYHA) class ≥II symptoms despite maximal medical therapy. Patients were excluded if they had significant structural mitral valve abnormality or life expectancy

Background Coronary collaterals are often seen supplying retrograde flow to an acutely occluded arterial territory. Whether this early collateralization offers prognostic benefit is not well established. Methods We analyzed data from all patients presenting to our regional cardiac unit with acute ST-elevation myocardial infarction requiring immediate angiography (years 1999-2017). Data on all patients is entered prospectively into a bespoke tailored database prior to knowledge of patient outcome. Only patients with TIMI 0 or 1 flow in the infarct-related vessel were included in the analysis. In-hospital and long-term outcome were assessed according to the presence or absence of angiographically visible collateral flow prior to treatment of the occluded vessel. Results Two thousand five hundred and forty-two patients were included in the analysis. 76% of these (n = 1944) had TIMI 0/1 flow at angiography. Angiographically-visible collateralization was seen in 17% (n = 322) and was more commonly observed in the right coronary artery (64%) than in the left anterior descending (25%) or Cx (6%). Cardiogenic shock (10.8%) and use of an intra-aortic balloon pump (5.4%) were more frequent in patients without coronary collateralisation (p = .04 and p = .02, respectively). The presence of collaterals improved long term survival (95% CI 11.4-18.7 months; p Conclusion One-sixth of patients with STEMI have angiographically visible collaterals to the infarcted territory. Patients without collaterals are more likely to present in cardiogenic shock. The presence of angiographically visible collaterals at the time of STEMI is associated with an improved long-term survival.

The role of glycoprotein IIb/IIIa inhibitors (GPI) in primary percutaneous coronary intervention (PPCI) remains uncertain. Previous analyses compare PPCI outcomes with clopidogrel plus GPI, versus without GPI. This does not reflect modern contemporary PPCI practice with ticagrelor or prasugrel. Nor does it answer the important question faced daily by PPCI operators: should GPI be used routinely or selectively? We aim to determine whether a strategy of routine use of GPI in contemporary PPCI practice is superior to selective GPI use. A total of 110,327 consecutive PPCIs performed in England were prospectively recorded in the British Cardiovascular Intervention Society Database (2009 to 2015). The cohort was divided into routine and selective GPI usage groups based on the PPCI operator's strategy, defined as GPI used in75% and25% PPCIs, respectively. Overall, GPI use declined from 73.1% to 43.3% of PPCIs. Routine compared with selective GPI usage was associated with lower all-cause 1-year mortality: 9.7% versus 11.0%, p 0.001. There was a consistent survival benefit for routine GPI usage as compared with selective GPI usage: univariable analysis (hazard ratio = 0.88 [95% confidence interval 0.83 to 0.93], p 0.001), multivariable analysis (hazard ratio = 0.82 [0.77 to 0.88], p 0.001). For survival, there was no interaction between GPI usage and the type of P2Y12-inhibitor used. In conclusion, a strategy of routine GPI usage in patients who underwent PPCI was associated with lower all-cause mortality as compared with selective GPI usage. This benefit was maintained despite 44.3% of patients receiving prasugrel or ticagrelor.

P2Y12-inhibitor initiation with clopidogrel using a loading dose (LD) versus no LD (NLD) provides more rapid inhibition of platelet activation and reduced risk of ischemic events after coronary stenting. Whether a similar beneficial effect is achieved in the setting of transcatheter aortic valve implantation (TAVI) is unknown. We evaluate the effects of preprocedural clopidogrel LD versus no NLD on 48-hour and 30-day clinical outcomes after TAVI. In the BRAVO-3 trial, 802 patients with severe aortic stenosis who underwent transfemoral TAVI were randomized to intraprocedural anticoagulation with bivalirudin or unfractionated heparin. Administration of clopidogrel LD was left to the discretion of the treating physician. For this analysis, patients were stratified according to receiving clopidogrel LD (n = 294, 36.6%) or NLD (n = 508, 63.4%) before TAVI. LD patients more often received a self-expandable prosthesis using larger sheaths. P2Y12-inhibitor maintenance therapy pre-TAVI was similar in patients with LD versus NLD (28.2% vs 33.1%, p = 0.16). LD versus NLD was associated with similar incidences of major adverse cardiovascular events (i e., death, myocardial infarction, or stroke) (4.1% vs 4.1%, p = 0.97) and major bleeding (8.5% vs 7.7%, p = 0.68), but a higher rate of major vascular complications (11.9% vs 7.1%, p = 0.02). Multivariable adjustment showed that clopidogrel LD did not affect any of the studied clinical events, including major vascular complications (odds ratio 0.91, 95% confidence interval 0.60 to 1.39, p = 0.67). Also patients on clopidogrel maintenance therapy and thus considered in steady state were not at reduced risk of major adverse cardiovascular events compared with patients not on clopidogrel (3.7% vs 5.2%, p = 0.36). In conclusion, in patients who underwent TAVI, use of clopidogrel LD was associated with higher vascular complications and otherwise similar clinical events compared to NLD patients.

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.

Objectives The aim was to establish a contemporary scoring system to predict the outcome of chronic total occlusion coronary angioplasty. Background Interventional treatment of chronic total coronary occlusions (CTOs) is a developing subspecialty. Predictors of technical success or failure have been derived from datasets of modest size. A robust scoring tool could facilitate case selection and inform decision making. Methods The study analyzed data from the EuroCTO registry. This prospective database was set up in 2008 and includes >20,000 cases submitted by CTO expert operators (>50 cases/year). Derivation (n = 14,882) and validation (n = 5,745) datasets were created to develop a risk score for predicting technical failure. Results There were 14,882 patients in the derivation dataset (with 2,356 [15.5%] failures) and 5,745 in the validation dataset (with 703 [12.2%] failures). A total of 20.2% of cases were done retrogradely, and dissection re-entry was performed in 9.3% of cases. We identified 6 predictors of technical failure, collectively forming the CASTLE score (Coronary artery bypass graft history, Age (≥70 years), Stump anatomy [blunt or invisible], Tortuosity degree [severe or unseen], Length of occlusion [≥20 mm], and Extent of calcification [severe]). When each parameter was assigned a value of 1, technical failure was seen to increase from 8% with a CASTLE score of 0 to 1, to 35% with a score ≥4. The area under the curve (AUC) was similar in both the derivation (AUC: 0.66) and validation (AUC: 0.68) datasets. Conclusions The EuroCTO (CASTLE) score is derived from the largest database of CTO cases to date and offers a useful tool for predicting procedural outcome.

Objectives The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. Background TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. Methods The RESPOND (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. Results One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). Conclusions One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302)

Service Specification for TAVI: Recommendations of the British Cardiovascular Intervention Society – Updated July 2019 Severe AS (sAS) is the most common primary valve disease leading to surgery or catheter intervention in Europe and North America, with a growing prevalence due to the ageing population.[3] It is a degenerative condition in which the outflow of blood from the heart is restricted by progressive narrowing of the aortic valve. This leads to symptoms of breathlessness, exertional chest pain or blackouts. Untreated, the condition causes left ventricular failure and death, with up to 40% of patients dying within 1 year of symptom onset. No medical therapy can improve outcome for this condition and therefore valve intervention is the only treatment option that alters prognosis. The standard of care for this condition has historically been surgical aortic valve replacement (sAVR), but around one-third of patients are ineligible for sAVR due to a combination of age and comorbidities. TAVI is a transformational technology; it is a much less invasive approach than sAVR and involves implantation of a new valve without the need for complex surgery or the use of a heart–lung bypass machine. This is most commonly done via the femoral arteries (transfemoral or TF approach), but it may also be accomplished via the subclavian arteries or via minimally invasive access using the cardiac apex between the ribs, directly into the aorta through a small incision. Less common approaches via the carotid arteries, axillary artery and the femoral veins or abdominal aorta have also been described. Therefore, for most patients undergoing TAVI, the procedure is performed via the femoral artery, under local anaesthesia or conscious sedation in a catheter laboratory. This results in quicker patient recovery, a shorter hospital stay and reduced use of expensive and limited resources such as cardiac operating theatres and intensive care unit beds, as well as postoperative nursing care. A number of different valve designs are available, including balloon-expandable and self-expandable devices. Each has different performance characteristics, which may be tailored to specific anatomical or patient-specific features. TAVI has been proven to be superior to medical therapy for inoperable patients and superior to sAVR in patients who are high risk for sAVR (Society of Thoracic Surgeons [STS] or Euroscore II >8%).[4–6] Trials have also shown that patients with intermediate surgical risk (STS or Euroscore II >4%) who are eligible for a TF approach have superior outcomes with TAVI.[7–9] Moreover, randomised trials have shown TAVI to be superior to sAVR in patients classified as low risk (STS

Extended 5-Year Follow-up of the PFO Closure Trial In the initial report of the Gore REDUCE trial of patent foramen ovale closure, with a median follow-up of 3.2 years, 18 patients had stroke recur...

BACKGROUND Transcatheter aortic valve implantation (TAVI) is maturing as a treatment option and is now often undertaken during an unscheduled index hospital admission. The aim of this study was to look at procedural and mid-term outcomes of patients undergoing elective versus urgent in-hospital transcatheter aortic valve implantation. METHODS We identified a total of 1,157 patients who underwent TAVI between November 2007 and November 2019 at the Sussex Cardiac Centre in the UK. We compared the demographics, procedural outcomes, 30-day and 1-year mortality between elective and urgent patients. Emergency and salvage TAVI cases were excluded. RESULTS Of the 1,157 patients who underwent the procedure, 975 (84.3%) had elective while 182 (15.7%) had urgent TAVI. Predominant aortic stenosis was more frequent in elective patients (91.7% vs. 77.4%); p

Objectives To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. Background New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. Methods We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. Results Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. Conclusions A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.

© 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC By-NC-ND License (http://creativecommons.org/licenses/by-nc-nd/4), The authors developed a global chronic total occlusion crossing algorithm following 10 steps: 1) dual angiography; 2) careful angiographic review focusing on proximal cap morphology, occlusion segment, distal vessel quality, and collateral circulation; 3) approaching proximal cap ambiguity using intravascular ultrasound, retrograde, and move-the-cap techniques; 4) approaching poor distal vessel quality using the retrograde approach and bifurcation at the distal cap by use of a dual-lumen catheter and intravascular ultrasound; 5) feasibility of retrograde crossing through grafts and septal and epicardial collateral vessels; 6) antegrade wiring strategies; 7) retrograde approach; 8) changing strategy when failing to achieve progress; 9) considering performing an investment procedure if crossing attempts fail; and 10) stopping when reaching high radiation or contrast dose or in case of long procedural time, occurrence of a serious complication, operator and patient fatigue, or lack of expertise or equipment. This algorithm can improve outcomes and expand discussion, research, and collaboration.

Dual lumen microcatheters (DLMC) have become indispensable tools in the setting of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). Other than allowing preservation and treatment of bifurcated coronary branches within or in the proximity of the CTO-body, they enable the use of modified parallel wiring, antegrade dissection and re-entry, collateral selection and retrograde negotiation of the distal CTO-cap. This Euro-CTO consensus document describes current DLMCs and suggests a practical guide to anatomies and techniques in which these devices are applicable.

BACKGROUND Although the presence of a thrombus contraindicates left atrial appendage closure procedure (LAAC), a previous study reported the feasibility of the thrombus trapping procedure (TTP) technique to overcome this limitation. AIMS This study aimed to analyse the short-term outcomes in a series of patients who underwent LAAC using the TTP (TTP-LAAC). METHODS This retrospective series included patients who underwent TTP-LAAC between January 2018 and May 2020 in 13 European centres. Device choice, pre-interventional work-up and post-discharge antithrombotic therapy regimens were left to the discretion of the operators. The primary endpoint was the 30-day occurrence of stroke, systemic embolism or cardiovascular death. RESULTS During the study period, a total of 1,918 patients underwent LAAC. A thrombus was identified in 71 cases but completely disappeared in 24 patients before procedure. TTP-LAAC was finally performed in 53 cases (3%). Thrombi were identified ahead of the actual day of implantation in 47 patients (87 %) and were mostly limited in size (50 cases with extension

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.

Importance Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures Mortality at 30 days and 1 year. Results The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P���=���.02), aortic regurgitation���of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P���

Iatrogenic femoral artery pseudoaneurysm is an infrequent but troublesome complication of vascular access during transcatheter aortic valve implantation. There are non-invasive, percutaneous and surgical treatment options for management of this complication. This case series report demonstrates a novel technique using an Amplatzer Duct Occluder II closure device to successfully treat iatrogenic common femoral pseudoaneurysm following transcatheter aortic valve implantation.

Background: In the treatment of left main coronary artery (LMCA) disease, patients’ age may affect the clinical outcome after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). This study stratified the clinical outcome according to the age of patients treated for LMCA stenosis with PCI or CABG in the Nordic-Baltic-British Left Main Revascularization (NOBLE) study. Methods: Patients with LMCA disease were enrolled in 36 centers in northern Europe and randomized 1:1 to treatment by PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST elevation myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCEs), a composite of all-cause mortality, nonprocedural myocardial infarction, any repeat coronary revascularization, and stroke. Age-stratified analysis was performed for the groups younger and older than 67 years and for patients older than 80 years. Results: For patients ≥67 years, the 5-year MACCEs were 35.7 versus 22.3% (hazard ratio [HR] 1.72 [95% confidence interval [CI] 1.27–2.33], p = 0.0004) for PCI versus CABG. The difference in MACCEs was driven by more myocardial infarctions (10.8 vs. 3.8% HR 3.01 [95% CI 1.52–5.96], p = 0.0009) and more repeat revascularizations (19.5 vs. 10.0% HR 2.01 [95% CI 1.29–3.12], p = 0.002). In patients younger than 67 years, MACCE was 20.5 versus 15.3% (HR 1.38 [95% CI 0.93–2.06], p = 0.11 for PCI versus CABG. All-cause mortality was similar after PCI and CABG in both age-groups. On multivariate analysis, age was a predictor of MACCE, along with PCI, diabetes, and SYNTAX score. Conclusions: As the overall NOBLE results show revascularization of LMCA disease, age of 67 years or older was associated with lower 5-year MACCE after CABG compared to PCI. Clinical outcomes were not significantly different in the subgroup younger than 67 years, although no significant interaction was present between age and treatment. Mortality was similar for all subgroups (ClinicalTrials.gov identifier: NCT01496651).

BACKGROUND: Historically the elderly have been under-represented in non-ST-elevation myocardial infarction (NSTEMI) management trials. AIMS: The aim of this trial was to demonstrate that an intervention-guided strategy is superior to optimal medical therapy (OMT) alone for treating NSTEMI in elderly individuals. METHODS: Patients (≥80 years, chest pain, ischaemic ECG, and elevated troponin) were randomised 1:1 to an intervention-guided strategy plus OMT versus OMT alone. The primary endpoint was a composite of all-cause mortality and non-fatal myocardial reinfarction at 1 year. Ethics approval was obtained by the institutional review board of every recruiting centre. RESULTS: From May 2014 to September 2018, 251 patients (n=125 invasive vs n=126 conservative) were enrolled. Almost 50% of participants were female. The trial was terminated prematurely due to slow recruitment. A Kaplan-Meier estimate of event-free survival revealed no difference in the primary endpoint at 1 year (invasive 18.5% [23/124] vs conservative 22.2% [28/126]; p=0.39). No significant difference persisted after Cox proportional hazards regression analysis (hazard ratio 0.79, 95% confidence interval 0.45-1.35; p=0.39). There was greater freedom from angina at 3 months (p

Introduction New onset left bundle branch block (LBBB) is the most common conduction disturbance associated with transcatheter aortic valve implantation (TAVI). It has been shown to adversely affect cardiac function and increase re-hospitalisation, although its impact on mortality remains contentious. Methods We conducted an observational cohort analysis of all TAVI procedures performed by 13 heart teams in the United Kingdom from inception of their structural programmes until 31st July 2013. The primary outcome was 1-year all-cause mortality. Secondary outcomes included left ventricular ejection fraction (LVEF) at 30 days and need for a post-TAVI permanent pacemaker (PPM). Results 1785 patients were eligible for inclusion to the study. The primary analysis cohort was composed of 1409 patients with complete electrocardiographic (ECG) data pre- and post-TAVI. Pre-existing LBBB was present in 200 (14.2%) patients. New LBBB occurred in 323 (22.9%) patients post TAVI, which resolved in 99 (7%) patients prior to discharge. A balloon-expandable device was implanted in 968 (69%) patients, whilst 421 (30%) patients received a self-expandable valve. New LBBB was observed in 120 (12.4%) and 192 (45.6%) patients receiving a balloon- or self-expandable prosthesis respectively. Overall 1-year all-cause mortality post TAVI was 18.7%. New onset LBBB was not associated with an increase in 1-year all-cause mortality (p=0.416). Factors that were associated with mortality included an increasing logistic EuroScore (p=0.05), history of previous balloon aortic valvuloplasty (p=0.001), renal impairment (p=0.003), previous myocardial infarction with pre-existing LBBB (p=0.028) and atrial fibrillation (p=0.039). Lower baseline peak and mean AV gradients were also associated with greater mortality at 1 year (p=0.001), likely reflecting underlying left ventricular dysfunction. In the majority of patients, LVEF remained unchanged following TAVI. Interestingly, the presence or absence of new onset LBBB did not affect LVEF improvement at 30 days. 10% of patients required a PPM post TAVI. Predictors of PPM included new LBBB (OR 2.6, p Conclusions These findings suggest that new onset LBBB post TAVI does not increase mortality at 1 year or adversely affect LVEF at 30 days. Funding Acknowledgement Type of funding source: None