A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial.

The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.

Impact of pre-admission physical activity on benefits of physiology-guided complete revascularization in older patients with myocardial infarction: insights from the FIRE trial.

AIMS: The present analysis from the Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial aims to explore the significance of pre-admission physical activity and assess whether the benefits of physiology-guided complete revascularization apply consistently to sedentary and active older patients. METHODS AND RESULTS: Patients aged 75 years or more with myocardial infarction (MI) and multivessel disease were randomized to receive physiology-guided complete revascularization or culprit-only strategy. The primary outcome was a composite of death, MI, stroke, or any revascularization within a year. Secondary endpoints included the composite of cardiovascular death or MI, as well as single components of the primary endpoint. Pre-admission physical activity was categorized into three groups: (i) absent (sedentary), (ii) light, and (iii) vigorous. Among 1445 patients, 692 (48%) were sedentary, whereas 560 (39%) and 193 (13%) performed light and vigorous physical activity, respectively. Patients engaging in light or vigorous pre-admission physical activity exhibited a reduced risk of the primary outcome compared with sedentary individuals [light hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.55-0.91 and vigorous HR 0.14, 95% CI 0.07-0.91, respectively]. These trends were also observed for death, cardiovascular death, or MI. When comparing physiology-guided complete revascularization vs. culprit-only strategy, no significant interaction was observed for primary and secondary endpoints when stratified by sedentary or active status. CONCLUSION: In older patients with MI, pre-admission physical activity emerges as a robust and independent prognostic determinant. Physiology-guided complete revascularization stands out an effective strategy in reducing ischaemic adverse events, irrespective of pre-admission physical activity status. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03772743.

The Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial has shown that physiology-guided complete revascularization reduces ischaemic adverse events in older patients with myocardial infarction (MI) and multivessel disease. Older patients who engage in light or vigorous physical activity before hospitalization for MI have a reduced risk of the primary composite outcome of death, MI, stroke, or ischaemia-driven revascularization. These benefits extend to all secondary cardiovascular outcomes as well. In the present subanalysis of the FIRE trial, we find that the positive prognosis associated with physiology-guided complete revascularization holds true even for patients with a sedentary lifestyle. This means that this type of revascularization can effectively reduce ischaemic adverse events in older patients with MI and multivessel disease, regardless of their physical activity levels.

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

AIMS: To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding. METHODS: Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month. RESULTS: Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p = 0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p = 0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p = 0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p = 0.047). CONCLUSIONS: Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.

Balloon-Assisted Crossing of a Severely Calcified Aortic Valve During Transcatheter Balloon-Expandable Bioprosthesis Implantation.

A 91-year-old man presented with syncope secondary to severe aortic stenosis. A transthoracic echocardiogram revealed a calcified stenotic trileaflet aortic valve (AV) with a mean gradient of 60 mm Hg and cardiac computed tomography demonstrated a heavily calcified trileaflet AV without commissural fusion. Following heart team discussion, transfemoral transcatheter AV replacement (TAVR) was the preferred option in view of the patient's age. Due to the severe aortic leaflet calcifications, a balloon-expandable 32-mm Myval transcatheter heart valve (Meril Life Sciences) implantation preceded by balloon predilation was planned. After numerous catheter and wire exchanges, the transcatheter heart valve was finally implanted with a good final result.

Prognostic value of left ventricular blood stasis in patients with acute myocardial infarction: A cardiac magnetic resonance study.

BACKGROUND: Cerebrovascular accidents (CVAs) can complicate the follow-up of patients with acute myocardial infarction (AMI). Intracavitary blood stasis evaluation can be useful to stratify cardioembolic risk and optimize medical therapy. Cardiac magnetic resonance (CMR) imaging is increasingly used in AMI patients for prognostic purposes. Slow-flow artefact is common on T2-weighted images in presence of left ventricular (LV) blood stasis. METHODS AND RESULTS: In this observational retrospective study, all patients with AMI undergoing CMR in our hospital were included. T2-weighted images were used to assess the presence of LV blood stasis. Among the 209 patients enrolled (males 72%, mean age 61 ± 12 years), LV blood stasis was detected in 48 (23%) and was significantly more prevalent in patients with extensive anterior or antero-apical AMI, lower LV ejection fraction, greater infarct size and microvascular obstruction. During follow-up (54 months, IQR 41-70), 8 CVAs and 6 cardiovascular deaths occurred. LV blood stasis emerged as a significant risk factor for both endpoints (logRank p < 0.001 and p = 0.008, respectively) and remained independent predictor of CVAs (HR 9.819, 95% CI 1.733-55.617, p = 0.010). CONCLUSIONS: LV blood stasis identified with CMR predicts the occurrence of CVAs in patients with AMI. These results may be helpful to personalize antithrombotic therapy for prevention strategies.

SICI-GISE Position Document on the Use of the Magmaris Resorbable Magnesium Scaffold in Clinical Practice.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties make the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

Electrocardiographic Predictors of Primary Ventricular Fibrillation and 30-Day Mortality in Patients Presenting with ST-Segment Elevation Myocardial Infarction.

Primary ventricular fibrillation (PVF) may occur in the early phase of ST-elevation myocardial infarction (STEMI) prior to primary percutaneous coronary intervention (PCI). Multiple electrocardiographic STEMI patterns are associated with PVF and short-term mortality including the tombstone, Lambda, and triangular QRS-ST-T waveform (TW). We aimed to compare the predictive value of different electrocardiographic STEMI patterns for PVF and 30-day mortality. We included a consecutive cohort of 407 STEMI patients (75% males, median age 66 years) presenting within 12 h of symptoms onset. At first medical contact, 14 (3%) showed the TW or Lambda ECG patterns, which were combined in a single group (TW-Lambda pattern) characterized by giant R-wave and downsloping ST-segment. PVF prior to primary PCI occurred in 39 (10%) patients, significantly more often in patients with the TW-Lambda pattern than those without (50% vs. 8%, p < 0.001). For the multivariable analysis, Killip class ≥3 (OR 6.19, 95% CI 2.37-16.1, p < 0.001) and TW-Lambda pattern (OR 9.64, 95% CI 2.99-31.0, p < 0.001) remained as independent predictors of PVF. Thirty-day mortality was also higher in patients with the TW-Lambda pattern than in those without (43% vs. 6%, p < 0.001). However, only LVEF (OR 0.86, 95% CI 0.82-0.90, p < 0.001) and PVF (OR 4.61, 95% CI 1.49-14.3, p = 0.042) remained independent predictors of mortality. A mediation analysis showed that the effect of TW-Lambda pattern on mortality was mediated mainly via the reduced LVEF. In conclusion, among patients presenting with STEMI, the electrocardiographic TW-Lambda pattern was associated with both PVF before PCI and 30-day mortality. Therefore, this ECG pattern may be useful for early risk stratification of STEMI.

Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.

INTRODUCTION: Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy. METHODS: The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke. RESULTS: At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively. CONCLUSIONS: CSR implantation is safe and reduces angina in patients with refractory angina.

Usefulness of Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina Pectoris.

The coronary sinus (CS) Reducer is a novel device designed for the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Aim of this study was to investigate the efficacy and the safety of the CS Reducer device in a real-world, multicenter, and country-level cohort of patients presenting with refractory angina pectoris. The study included patients affected by refractory angina pectoris who underwent CS Reducer implantation in 16 centers. Clinical follow-up was carried as per each center's protocol. One hundred eighty-seven patients were included. Technical and procedural success were achieved in 98% and 95%, respectively. Minor peri-procedural complications were recorded in 8 patients. During a median follow-up of 18.4 months, 135 (82.8%) patients demonstrated at least 1 CCS class reduction after Reducer implantation, and 80 (49%) patients at least 2 CCS class reduction. Mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Treatment benefit was also reflected in a significant improvement in quality of life scores and in a reduction of the mean number of anti-ischemic drugs prescribed for patient. In conclusion, in this multicenter, country-level study, the implantation of CS Reducer in patients with refractory angina pectoris resulted to be safe and effective in reducing of angina pectoris and improving quality of life.

Short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy vs. prolonged dual antiplatelet therapy after percutaneous coronary intervention with second-generation drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials.

AIMS: After percutaneous coronary intervention (PCI) with second-generation drug-eluting stent (DES), whether short dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with a P2Y12 receptor inhibitor confers benefits compared with prolonged DAPT is unclear. METHODS AND RESULTS: Multiple electronic databases, including PubMed, Scopus, Web of Sciences, Ovid, and ScienceDirect, were searched to identify randomized clinical trials comparing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT after PCI with second-generation DES implantation. The primary and co-primary outcomes of interest were major bleeding and stent thrombosis 1 year after randomization. Summary hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by fixed-effect and random-effects models. Multiple sensitivity analyses including random-effects models 95% CI adjustment were applied. A sensitivity analysis comparing trials using P2Y12 inhibitor SAPT with those using aspirin SAPT was performed. A total of five randomized clinical trials (32 145 patients) were available. Major bleeding was significantly lower in the patients assigned to short DAPT followed by P2Y12 inhibitor SAPT compared with those assigned to 12-month DAPT (random-effects model: HR 0.63, 95% 0.45-0.86). No significant differences between groups were observed in terms of stent thrombosis (random-effects model: HR 1.19, 95% CI 0.86-1.65) and the secondary endpoints of all-cause death (random-effects model: HR 0.85, 95% CI 0.70-1.03), myocardial infarction (random-effects model: HR 1.05, 95% CI 0.89-1.23), and stroke (random-effects model: HR 1.08, 95% CI 0.68-1.74). Sensitivity analyses showed overall consistent results. By comparing trials testing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT with trials testing ≤3 months of DAPT followed by aspirin SAPT vs. 12-month of DAPT, there was no treatment-by-subgroup interaction for each endpoint. By combining all these trials, regardless of the type of SAPT, short DAPT was associated with lower major bleeding (random-effects model: HR 0.63, 95% CI 0.48-0.83) and no differences in stent thrombosis, all-cause death, myocardial infarction, and stroke were observed between regimens. CONCLUSION: After second-generation DES implantation, 1-3 months of DAPT followed by P2Y12 inhibitor SAPT is associated with lower major bleeding and similar stent thrombosis, all-cause death, myocardial infarction, and stroke compared with prolonged DAPT. Whether P2Y12 inhibitor SAPT is preferable to aspirin SAPT needs further investigation.

Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study.

BACKGROUND: In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. OBJECTIVE: This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. METHODS: This is a prospective observational study. The enrollment will be conducted 1 month before patients' SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. RESULTS: The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. CONCLUSIONS: The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. TRIAL REGISTRATION: Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20072.

The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study.

OBJECTIVES: The aim of this study was to evaluate the impact of CHA2DS2-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study. BACKGROUND: Baseline CHA2DS2-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO). METHODS: Subjects were stratified according to CHA2DS2-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee. RESULTS: Subjects were considered at low (n = 156), moderate (n = 715), and high (n = 215) risk for ischemic stroke, corresponding to CHA2DS2-VASc scores of <3, 3 to 5, and ≥6, respectively. The annual rates of ischemic stroke were 1.1%, 2.0%, and 3.5%, respectively. When compared with the predicted rate, LAAO reduced the risk of ischemic stroke by 56%, 69%, and 68%. Device-related thrombus occurred in 0.7%, 1.5%, and 3.0% of subjects at low, moderate, and high risk for ischemic stroke, respectively. The HAS-BLED score was ≤3 in 629 subjects and >3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively. CONCLUSIONS: LAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (Amplatzer™Amulet™ Post-Market Study [Amulet™PMS]; NCT02447081).

Feasibility of Left Atrial Appendage Occlusion in Left Atrial Appendage Thrombus: A Systematic Review.

OBJECTIVES: This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus. BACKGROUND: The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe. METHODS: This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus. RESULTS: There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months. CONCLUSIONS: Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach.

[Position paper of the Italian Society of Interventional Cardiology (SICI-GISE): Management of patent foramen ovale in patients with cerebral or systemic thromboembolism - 2020]. / Documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE): Gestione del forame ovale pervio in presenza di tromboembolia cerebrale o sistemica criptogenetica ­ versione 2020.

Patent foramen ovale (PFO) is implicated in the pathogenesis of different clinical syndromes in which it plays variable roles. In 2017 and 2018, four randomized clinical trials were published, allowing for the clarification of certain issues pertaining to cryptogenic stroke. Recently, eight European scientific societies collaborated to the writing of an interdisciplinary international position paper on PFO and cryptogenic stroke, based upon best available evidence, with the aim of defining the principles needed to guide decision making. Nonetheless, a tailored approach is not suitably addressed by standard position documents, considering that decisions about optimal management of PFO patients with left circulation thromboembolism are often challenging, mostly due to comorbidities and complex clinical scenarios.A panel of Italian cardiology experts gathered under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim of providing practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of PFO in patients with cerebral or systemic thromboembolism. In this position paper, various clinical scenarios in patients with and without high-risk PFO features are presented and discussed, including PFO patients with associated conditions (e.g. hypercoagulable states, deep vein thrombosis/pulmonary embolism, short runs of atrial fibrillation), and special subsets (e.g. patients with risk factors for atrial fibrillation, patients aged ≥65 years, patients who refused percutaneous PFO closure), with the Panel's recommendations being provided for each scenario.

[SICI-GISE Position paper on the use of the magnesium bioresorbable scaffold Magmaris in clinical practice]. / Documento di posizione SICI-GISE sull'uso dello scaffold riassorbibile Magmaris nella pratica clinica.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties makes the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

The impact of pre-existing peripheral artery disease on transcatheter aortic valve implantation outcomes: A systematic review and meta-analysis.

BACKGROUND: Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis. METHODS: Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed. RESULTS: A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p < .0001) follow-up, and higher risk of VC (RR 1.55, 95% CI 1.27; 1.89, p < .0001). Moreover, the adoption of smaller sheaths during TAVI procedures was associated with fewer VC both in PAD and non-PAD patients, but the latter group had a more pronounced benefit. CONCLUSIONS: Patients with pre-existent PAD are at increased risk of all-cause mortality and VC after TAVI. The adoption of smaller sheaths during the procedure seems to be associated with fewer peri-procedural VC both in PAD and non-PAD patients.

Cost-effectiveness of the coronary sinus Reducer and its impact on the healthcare burden of refractory angina patients.

AIMS: The coronary sinus Reducer is a percutaneous device proven to improve angina symptoms in refractory angina (RA). We evaluated its potential cost-effectiveness and impact on the healthcare resource use. METHODS AND RESULTS: Angina-related healthcare resource usage and quality-of-life data were collected for 215 consecutive RA patients undergoing Reducer implantation in Belgium, the Netherlands, and Italy. Costs were assessed from each country's healthcare system perspective. Data from the date of RA diagnosis to Reducer implantation [Standard-of-Care (SoC)-period] and from Reducer implantation to follow-up (Reducer-period) were compared: during Reducer-period, a significant reduction in angina-driven hospitalizations, outpatient visits, coronary angiograms, and percutaneous coronary interventions per patient-year was observed, translating into significantly reduced costs per patient-year. To assess cost-effectiveness, costs and utilities of 1-year SoC were compared with those of 1-year Reducer-period. Assumptions on Reducer efficacy duration were further explored with modelled projections. Reducer was associated with higher quality-adjusted life years (QALYs: 0.665 vs. 0.580, P < 0.001) and incremental costs, yielding incremental cost-effectiveness ratios (ICERs) of 53 197, 34 948, 63 146 €/QALY gained in Belgium, the Netherlands, and Italy, respectively. Under both the assumptions of 2 and 3 years Reducer effect duration with a 30%-year efficacy decrease, the device yielded ICERs in the range of 1977-20 796 €/QALY gained. CONCLUSION: In patients with RA, Reducer device decreases healthcare resource use and related costs. In a limited 1-year timeframe, Reducer is consistently cost-effective according to a range of cost-effectiveness thresholds. Under the explored assumptions, the device yields cost-effectiveness ratios suggesting high value from all the considered perspectives.

Coronary sinus reducer implantation in the middle cardiac vein for the treatment of refractory angina.

Coronary sinus Reducer is a current therapeutic treatment for patients with persistent refractory angina. We report a case of successful implantation of the device in the middle cardiac vein of a 65 years old female patient. The singular and unusual site for the Reducer was planned after a careful assessment of the venous drainage of the ischemic territory.