LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

Risk scores for predicting incident heart failure admission in patients with chronic coronary syndromes: Validation in a prospective, monocentric, long-term, cohort study.

BACKGROUND: Heart failure (HF) admission in chronic coronary syndrome (CCS) patients has a prognostic impact. Stratification schemes have been described for predicting this endpoint, but none of them has been externally validated. OBJECTIVES: Our aim was to develop point scores for predicting incident HF admission with data from previous studies, to perform an external validation in an independent prospective cohort and to compare their discriminative ability for this event. METHODS: Independent predictive variables of HF admission in CCS patients without baseline HF were selected from four previous prospective studies (CARE, PEACE, CORONOR and CLARIFY), generating scores based on the relative magnitude of the coefficients of Cox of each variable. Finally, the scores were validated and compared in a monocentric prospective cohort. RESULTS: The validation cohort included 1212 patients followed for up to 17 years, with 171 patients suffering at least one HF admission in the follow-up. Discriminative ability for predicting HF admission was statistically significant for all, and paired comparisons among them were all nonsignificant except for CORONOR score was superior to CLARIFY score (C-statistic 0.73, 95%CI 0.69-0.76 vs. 0.69, 95% CI 0.65-0.73; p = 0.03). CONCLUSION: All tested scores showed significant discriminative ability for predicting incident HF admission in this independent validation study. Their discriminative ability was similar, with significant differences only between the two scores with higher and lower performance.

Bifurcation left main stenting with or without intracoronary imaging: Outcomes from the EBC MAIN trial.

BACKGROUND: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown. OBJECTIVES: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study). METHODS: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year. RESULTS: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220). CONCLUSIONS: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy.

Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial.

BACKGROUND: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. AIM: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. METHODS: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). RESULTS: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). CONCLUSION: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02497014.

External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries.

BACKGROUND: Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed. RESULTS: Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p < 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p < 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p < 0.001), proximal cap ambiguity (52% vs. 34%, p < 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72-0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5). CONCLUSION: Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI.

Instantaneous wave-free ratio for guiding treatment of nonculprit lesions in patients with acute coronary syndrome: A retrospective study.

BACKGROUND: The aim of this study was to analyze the feasibility of a physiological coronary evaluation with the instantaneous wave-free ratio (iFR) of nonculprit lesions in patients with acute coronary syndrome (ACS) successfully revascularized. METHODS: A multicenter registry including patients of four high-volume PCI centers with ACS and underwent successful revascularization of the culprit vessel and had other nonculprit lesions that were physiologically evaluated with the iFR between January 2017 and December 2019. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction, probable or definitive stent thrombosis and new revascularization (MACEs). RESULTS: A total of 356 patients with 472 nonculprit lesions were included. The mean age was 66 ± 11 years. The clinical presentation was ACS without persistent ST-segment elevation (NSTE-ACS) in 235 patients (66%) and ST-segment elevation myocardial infarction (STEMI) in 121 patients (34%). After a median follow-up period of 21 (14-30) months, the primary endpoint occurred in 32 patients (9%). There were no differences in outcomes regarding clinical presentation (NSTEMI vs. NSTE-ACS, 9.1 vs. 8.9%, padj  = 0.570) or iFR induced treatment strategy (patients with all lesions revascularized vs. patients with at least one lesion with an iFR > 0.89 deferred for revascularization, 10.5 vs. 8.4%, padj  = 0.476). CONCLUSIONS: The use of the iFR to guide percutaneous coronary intervention decision making in nonculprit lesions seems to be feasible, with an acceptable percentage of MACEs at the mid-term follow-up. Patients with deferred revascularization of lesions without physiological significance and patients undergoing complete revascularization had a similar risk of MACEs.

The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN).

BACKGROUND: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. METHODS AND RESULTS: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. CONCLUSIONS: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. STUDY REGISTRATION: http://clinicaltrials.gov NCT02497014.

Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes. METHODS AND RESULTS: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge. CONCLUSIONS: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality.

Excimer laser coronary atherectomy for uncrossable coronary lesions. A multicenter registry.

OBJECTIVES: To assess the efficacy and safety of excimer laser coronary atherectomy (ELCA), as well as, the long-term outcomes and the factors associated with ELCA failure in uncrossable lesions. BACKGROUND: Uncrossable lesions constitute a challenge for percutaneous coronary intervention. METHODS: This multicenter registry included 126 patients with 126 uncrossable lesions. Study endpoints were ELCA success, technical success and a composite of cardiac death, myocardial infarction (MI), and target-lesion revascularization (TLR) on follow-up. Predictors of ELCA failure were analyzed. RESULTS: Moderate or severe calcification was present in 79 (62.7%) of the lesions and 58 (46%) were a chronic total occlusion. ELCA success was obtained in 103 (81.8%) patients. Rotational atherectomy was attempted as bailout in 21 out of 23 ELCA failure (91.3%), being successful in 14 (66.7%) of them. Finally, technical and procedural success were achieved in 114 (90.5%) and 110 (87.3%) of the patients. Severe calcification was independently associated with ELCA failure (OR: 3.73, 95% CI: 1.35-10.32; p = .011). Two (1.6%) patients died (one after a stroke and another patient because of heart failure), 4 (3.2%) developed a non-Q MI without clinical consequences and 1 (0.8%) patient had a Q-MI. Other complications were ventricular tachycardia/fibrillation (n = 2; 1.6%) and flow-limiting dissection (n = 1, 0.8%). At follow-up (median 424 days), 3 (2.4%) patients died (1 (0.8%) from cardiovascular cause) and 15 (11.9%) required TLR. CONCLUSIONS: In our multicenter experience, ELCA use demonstrated to be safe and reasonably effective with a rate of events on follow-up relatively low. Severe calcification was associated with ELCA failure.

Mapping interventional cardiology in Europe: the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas Project.

AIMS: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas of Interventional Cardiology has been developed to map interventional practice across European Society of Cardiology (ESC) member countries. Here we present the main findings of a 16-country survey in which we examine the national availability of interventional infrastructure, human resource, and procedure volumes. METHODS AND RESULTS: Sixteen ESC member countries participated in the EAPCI Atlas survey. Interventional data were collected by the National Cardiac Society of each participating country. An annual median of 5131 [interquartile range (IQR) 4013-5801] diagnostic heart procedures per million people were reported, ranging from <2500 in Egypt and Romania to >7000 in Turkey and Germany. Procedure rates showed significant correlation (r = 0.67, P = 0.013) with gross national income (GNI) per capita. An annual median of 2478 (IQR 1690-2633) percutaneous coronary interventions (PCIs) per million people were reported, ranging from <1000 in Egypt and Romania to >3000 in Switzerland, Poland, and Germany. Procedure rates showed significant correlation with GNI per capita (r = 0.62, P = 0.014). An annual median of 48.2 (IQR 29.1-105.2) transcatheter aortic valve implantation procedures per million people were performed, varying from <25 per million people in Egypt, Romania, Turkey, and Poland to >100 per million people in Denmark, France, Switzerland, and Germany. Procedure rates showed significant correlation with national GNI per capita (r = 0.92, P < 0.001). CONCLUSION: The first report from the EAPCI Atlas has shown considerable international heterogeneity in interventional cardiology procedure volumes. The heterogeneity showed association with national economic resource, a reflection no doubt of the technological costs of developing an interventional cardiology service.

Impact of the repositionable Evolut R CoreValve system on the need for a permanent pacemaker after transcatheter aortic valve implantation in patients with severe aortic stenosis.

OBJECTIVES: To compare the incidence of permanent pacemaker implantation (PPI) with the CoreValve and Evolut R prostheses, to evaluate the implantation depth with both types of prostheses, and to study factors predicting the need for PPI. BACKGROUND: The Evolut R CoreValve can be recaptured and repositioned during deployment, allowing a more precise implantation. METHODS: A total of 208 patients treated with CoreValve and 137 patients treated with Evolut R were analyzed. The depth of the prosthesis in the LVOT was measured by angiography in the annular perpendicular view projection after deploymen in all patients. RESULTS: Baseline conduction abnormalities were comparable between the groups (85/208, 40.9% vs. 53/137, 38.7%; p = 0.69). The mean prosthesis depth was 10.3 ± 8.6 mm in the CoreValve group and 5.5 ± 2.7 mm in the Evolut R group; p < 0.0001. Conduction disturbances after valve implantation were more frequent with the CoreValve (new-onset left bundle branch block: 93, 44.7% vs. 16, 11.7%; p < 0.05, first-degree atrioventricular block: 23, 11.1% vs. 5, 3.6%; p < 0.05). In addition, the incidence of PPI was significantly lower with Evolut R (45, 21.6% vs. 15, 10.9%; p = 0.01). The predictors of the need for PPI were the mean depth of the prosthesis (OR: 1.13, 95% CI: 1.06-1.21; p < 0.0001) and prior right bundle branch block (OR 10.22, 95% CI: 4.62-22.63; p < 0.0001). CONCLUSIONS: The recapturable capability of the Evolut R system allowed for higher and precise valve implantation. This fact had an impact on the reduction in the need for PPI.

Conventional vascular access site approach versus fully trans-wrist approach for chronic total occlusion percutaneous coronary intervention: a multicenter registry.

OBJECTIVES: To evaluate the incidence of vascular complication and major bleeding in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with a fully trans-wrist access (TWA) approach versus a conventional approach based on trans-femoral access (TFA). BACKGROUND: TFA is the preferred vascular access in CTO PCI, but it has been associated with a non-negligible risk of complications. METHODS: This retrospective registry included all patients undergoing CTO PCI at five institutions between July 2011 and October 2018. Patients were divided into two groups: Conventional (patients treated with at least one TFA) and Fully TWA (subjects exclusively treated with one or two TWA). The primary safety endpoint was a composite of vascular complications and major bleeding. The primary efficacy endpoint was procedural success. RESULTS: We included 1,900 patients (Conventional n = 1,496 and Fully TWA n = 404). Conventional patients showed higher occlusion complexity (J-CTO score 2.1 ± 1.2 vs. 1.5 ± 1.1, p < .001). Procedural success showed no significant difference between both groups (85.7 vs. 83.0%, p = .17). The primary safety endpoint occurred more frequently in the Conventional group (10.3 vs. 4.5%, p < .001), driven by vascular complications (9.4 vs. 3.7%, p < .001). On multivariate analysis, not using a Fully TWA approach was an independent predictor of the study endpoint, after adjusting for age, sex, diabetes, body mass index, chronic kidney disease, prior coronary artery bypass graft, and J-CTO score. CONCLUSIONS: Embracing a Fully TWA approach for CTO PCI might be associated with lower incidence of a composite endpoint of vascular complications and major bleeding, compared with a Conventional approach.

European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions.

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.

Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol.

BACKGROUND: Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC. METHODS: This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size. DISCUSSION: The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comité Coordinador de Ética en Investigación Biomédica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013-002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278 ; EudraCT number: 2013-002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98 . Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.

Myocardial deformation and acute cellular rejection after heart transplantation: Impact of inter-vendor variability in diagnostic effectiveness.

PURPOSE: Our objective was to investigate the impact of inter-vendor variability in the ability of myocardial strain analysis to detect acute cellular rejection (ACR) in heart transplant recipients. METHODS: We performed serial echocardiographic examinations in 18 consecutive adult heart transplanted patients, in their first year post-transplantation, within 3 hours of the routine surveillance endomyocardial biopsies (EMB) in a single center. Myocardial strain was analyzed using two software in two different institutions, and inter-vendor variability of strain values and its association with ACR (any grade or grade ≥2R) was investigated. The parameter of comparison was the peak value of the average curve of strain during the entire cardiac cycle. RESULTS: A total of 147 pairs of EMB-echocardiogram were performed, 65 with no ACR, 63 with ACR grade 1R, and 19 with ACR grade ≥2R. Intra-class correlation coefficients for left ventricle longitudinal, radial, and circumferential strain were 0.38, 0.39, and 0.77, respectively, and 0.32 for right ventricular longitudinal strain. Neither software found significant association of left ventricular longitudinal strain with rejection. Grade ≥2R ACR was associated with left ventricular circumferential strain measured with the first software and with left ventricular radial strain with the other; and ACR of any grade was only significantly associated with right ventricle longitudinal strain measured with the first software. CONCLUSIONS: Inter-vendor reproducibility of strain values was low in this study. Some strain parameters were associated to ACR, although these results were inconsistent between two commercially available software. Specific validation of each software is warranted for this clinical indication.

Subadventitial stenting around occluded stents: A bailout technique to recanalize in-stent chronic total occlusions.

OBJECTIVES: To evaluate the outcomes of subadventitial stenting (SS) around occluded stents for recanalizing in-stent chronic total occlusions (IS-CTOs). BACKGROUND: There is little evidence on the outcomes of SS for IS-CTO. METHODS: We examined the outcomes of SS for IS-CTO PCI at 14 centers between July 2011 and June 2017, and compared them to historical controls recanalized using within-stent stenting (WSS). Target-vessel failure (TVF) on follow-up was the endpoint of this study, and was defined as a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization. RESULTS: During study period, 422 IS-CTO PCIs were performed, of which 32 (7.6%) were recanalized with SS, usually when conventional approaches failed. The most frequent CTO vessel was the right coronary artery (72%). Mean J-CTO score was 3.1 ± 0.9. SS was antegrade in 53%, and retrograde in 47%. Part of the occluded stent was crushed in 37%, while the whole stent was crushed in 63%. Intravascular imaging was used in 59%. One patient (3.1%) suffered tamponade. Angiographic follow-up was performed in 10/32 patients: stents were patent in six cases, one had mild neointimal hyperplasia, and three had severe restenosis at the SS site. Clinical follow-up was available for 29/32 patients for a mean of 388 ± 303 days. The 24-month incidence of TVF was 13.8%, which was similar to historical controls treated with WSS (19.5%, P = 0.49). CONCLUSIONS: SS is rarely performed, usually as last resort, to recanalize complex IS-CTOs. It is associated with favorable acute and mid-term outcomes, but given the small sample size of our study additional research is warranted.

Long-term outcomes of rotational atherectomy for the percutaneous treatment of chronic total occlusions.

OBJECTIVES: To study the long-term outcomes of rotational atherectomy (RA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: There is little evidence on the incidence, procedural results and long-term outcomes of RA for CTO PCI. METHODS: This registry included data from consecutive patients undergoing CTO PCI at four specialized centers. Major adverse cardiac events (MACE: cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization) on follow-up were the primary endpoint. RESULTS: A total of 1003 patients were included. Of these, 35 (3.5%) required RA. As compared with Conventional PCI, RA patients were older (68.9 ± 9.5 vs. 64.6 ± 10.7 years, P = 0.02), had higher prevalence of diabetes (58% vs. 37%, P = 0.01) and of a J-CTO score ≥2 (80% vs. 58%, P = 0.009), driven by severe calcification. Antegrade wire escalation was used more frequently in RA (74% vs. 53%, P = 0.08). RA was performed for balloon failure-to-cross in 51% and failure-to-expand in 49%. One burr was utilized in 86%. The 1.25-mm burr was the largest burr used in 43%. Slow flow/no-reflow was observed in 17%. No other serious RA-related complications were observed. Procedural success was 77% vs. 89% (P = 0.04) in RA vs. Conventional PCI. After a mean follow-up of 658 ± 412 days, MACE rates were similar between groups (15% vs. 13%, P = 0.70). CONCLUSIONS: The use of RA in CTO PCI was safe, despite a worse patient risk profile and higher procedural complexity, as compared with conventional techniques. Although procedural success was lower in the RA group, there were no differences in long-term clinical outcomes between groups. © 2016 Wiley Periodicals, Inc.

Infective endocarditis after transcatheter aortic valve implantation: results from a large multicenter registry.

BACKGROUND: We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1-14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55-9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37-7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. CONCLUSIONS: The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.

Direct bioresorbable vascular scaffold implantation: Feasibility and midterm results.

OBJECTIVES: To analyze the feasibility and safety of direct bioresorbable vascular scaffold (BVS) implantation without previous balloon dilation. BACKGROUND: Lesion preparation through predilation is recommended before BVS implantation. There is no information on the routine use of direct BVS implantation. METHODS AND RESULTS: One hundred fifty-three patients with a total of 200 coronary lesions, were treated with BVS. A baseline intravascular ultrasound study (IVUS) was performed in 171 lesions (86%), and after BVS implantation, the quality of scaffolding was assessed with an additional IVUS (83, 41%) or optical coherence tomography (77, 38%). Elective predilation was conducted in 50 lesions. In 150 lesions, direct BVS implantation was attempted. In 129 lesions (86%), the BVS was implanted successfully, and in the remaining 21 (14%), direct implantation failed. In these cases, the scaffolds were retrieved and successfully implanted after balloon angioplasty. Longer and C-type lesions, and a larger plaque burden, were associated with failure to directly cross the lesion. Balloon postdilation was needed in 34% of the lesions. Ten patients (6.6%) had a periprocedural myocardial infarction. One patient (0.6%) died 60 days after BVS implantation due to thrombosis of the scaffold. At follow-up, target lesion revascularisation was needed in eight patients (5%). After 12 ± 3 months, the remaining patients were symptom-free. CONCLUSIONS: Direct BVS implantation is safe and feasible in most soft coronary plaques.

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

AIMS: Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). METHODS AND RESULTS: From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). CONCLUSION: Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high.