Incidence and feasibility of coronary access after transcatheter aortic valve replacement.

BACKGROUND: Incidence of coronary access (CA) after transcatheter aortic valve replacement (TAVR) at long-term follow-up remains unknown. CA and percutaneous coronary intervention (PCI) after TAVR might present technical challenges, particularly with supra-annular devices. METHODS: Patients undergoing CA after being treated with TAVR at our institution were included in the study. Coronary interventions for coronary obstruction during TAVR procedure were excluded. Incidence, feasibility and outcomes of CA after TAVR were analyzed. RESULTS: Out of 912 patients aged 80 ± 7 years treated with TAVR at our institution between 2007 and 2018, 48 (5.3%) underwent CA at a median follow up of 769 [363-1,471] days. Twenty-one had received a SAPIEN XT, 15 a SAPIEN 3, 6 Corevalve, 2 Evolut Pro, 2 JenaValve, and 2 Lotus valve. PCI was indicated in 26 (54%) cases. Seventeen (35%) procedures were performed for acute coronary syndromes (ACS). Independent predictors of CA after TAVR were younger age, previous PCI, and CABG. CA of both vessels was feasible in all patients with an intra-annular device, while the right coronary artery was not engaged in two patients with a supra-annular valve. PCI was successful in all but one case. All-cause mortality was similar between patients needing CA for ACS and those who had other clinical indications. CONCLUSIONS: In this high-risk AS population, incidence of CA after TAVR at long-term follow-up was rather low. CA and PCI were safe and successful in most cases, with a lower rate of selective CA for supra-annular devices.

Updated definition of pulmonary hypertension and outcome after transcatheter aortic valve implantation.

OBJECTIVE: The European Society of Cardiology guidelines have recently defined new cut-offs for pulmonary hypertension (PH) and pulmonary vasculature resistance (PVR; median pulmonary artery pressure (mPAP) >20 instead of 25 mm Hg and PVR >2 instead of 3 Wood unit). The prognostic value of this updated classification after transcatheter aortic valve implantation (TAVI) is unknown. METHODS: 579 consecutive patients treated by TAVI with preprocedural right heart catheterisation evaluation were included. Patients were grouped as: (1) no PH, (2) isolated precapillary/combined (I-PreC/Co) PH and (3) isolated postcapillary PH (I-PoC). All-cause death, cardiovascular death and hospitalisations for heart failure (HF) were evaluated at follow-up. We also analysed the prognostic role of residual postprocedural PH. RESULTS: Out of 579 patients, 299 (52%) had PH according to the new criteria compared with 185 (32%) according to the previous ones. Overall median age was 82 years, while 55.3% patients were male. Patients with PH were more frequently diagnosed with chronic obstructive pulmonary disease and atrial fibrillation and were characterised by higher surgical risk as compared with patients without PH.At a median follow-up of 2.9 years, the presence of PH according to previous definition was associated with worse survival (p<0.001) and HF hospitalisation (p=0.002) rates, irrespective of PVR values. With newer cut-offs, PH was associated with worse outcomes only in patients with increased PVR, while no differences were found between patients with PH and normal PVR values and those without PH. Postprocedural mPAP normalisation was observed in 45% of the cases, but it was associated with improved long-term survival only in the I-PoC PH group. CONCLUSIONS: New ESC PH cut-offs increased the number of PH diagnoses. The presence of PH, particularly in the setting of increased PVR, identify patients at higher risk for postprocedural mortality and rehospitalisation. Normalisation of PH was associated with better survival only in I-PoC group.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

Introduction: The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. Methods: The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. Results: A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. Conclusion: In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study.

BACKGROUND: Data on left main (LM) percutaneous coronary interventions (PCI) have mostly been obtained in studies using drug-eluting stent (DES) platforms without dedicated large-vessel devices and with limited expansion capability. AIMS: Our study aimed to investigate the safety and efficacy of LM PCI with the latest-generation Resolute Onyx DES. METHODS: ROLEX (Revascularization Of LEft main with resolute onyX) is a prospective, multicentre study (ClinicalTrials.gov: NCT03316833) enrolling patients with unprotected LM coronary artery disease and a SYNTAX score <33 undergoing PCI with the Resolute Onyx zotarolimus-eluting coronary stent, that includes dedicated extra-large vessel platforms. The primary endpoint (EP) was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR), at 1 year. All events were adjudicated by an independent clinical event committee. An independent core lab analysed all procedural angiograms. RESULTS: A total of 450 patients (mean age 71.8 years, SYNTAX score 24.5±7.2, acute coronary syndrome in 53%) were enrolled in 26 centres. Of these, 77% of subjects underwent PCI with a single-stent and 23% with a 2-stent technique (8% double kissing [DK] crush, 6% culotte, 9% T/T and small protrusion [TAP] stenting). Intravascular imaging guidance was used in 45% (42% intravascular ultrasound [IVUS], 3% optical coherence tomography [OCT]). At 1 year, the primary EP incidence was 5.1% (cardiac death 2.7%, TVMI 2.7%, ID-TLR 2.0%). The definite/probable stent thrombosis rate was 1.1%. In a prespecified adjusted subanalysis, the primary EP incidence was significantly lower in patients undergoing IVUS/OCT-guided versus angio-guided PCI (2.0 vs 7.6%; hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.13-0.58; p<0.001). CONCLUSIONS: In this large, multicentre, prospective registry, LM PCI with the Resolute Onyx DES showed good safety and efficacy at 1 year, particularly when guided by intracoronary imaging.

Mechanical circulatory support in cardiogenic shock: a critical appraisal.

INTRODUCTION: Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is a life-threatening condition frequently encounter in patients with multivessel coronary artery disease (MVD). AREAS COVERED: Despite prompt revascularization, in particular percutaneous coronary intervention (PCI), and therapeutic and technological advances, the mortality rate for CS related to AMI remains high. Differently from hemodynamically stable setting, a culprit lesion-only (CLO) revascularization strategy is currently suggested in AMI-CS patients, based on the results of a recent randomized evidence burdened by several limitations and conflicting results from non-randomized studies. Furthermore, mechanical circulatory support (MCS) devices have raised as a key therapeutic option in CS, especially in case of an early implantation without delaying revascularization and before irreversible organ damage has occurred. We provide an in-depth review of current evidences on optimal revascularization strategies of multivessel CAD in infarct-related CS, assessing the role of MCS devices, and highlighting the importance of shock teams and medical care system networks to effectively impact on clinical outcomes. EXPERT OPINION: Emerging observational experience suggested that an early implantation of MCS (prior to PCI), the performance of an extensive revascularization and the implementation of shock teams and networks are key factors for improving clinical outcomes.

When to Achieve Complete Revascularization in Infarct-Related Cardiogenic Shock.

Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is a life-threatening condition frequently encountered in patients with multivessel coronary artery disease (CAD). Despite prompt revascularization, in particular, percutaneous coronary intervention (PCI), and therapeutic and technological advances, the mortality rate for patients with CS related to AMI remains unacceptably high. Differently form a hemodynamically stable setting, a culprit lesion-only (CLO) revascularization strategy is currently suggested for AMI-CS patients, based on the results of recent randomized evidence burdened by several limitations and conflicting results from non-randomized studies. Furthermore, mechanical circulatory support (MCS) devices have emerged as a key therapeutic option in CS, especially in the case of their early implantation without delaying revascularization and before irreversible organ damage has occurred. We provide an in-depth review of the current evidence on optimal revascularization strategies of multivessel CAD in infarct-related CS, assessing the role of different types of MCS devices and highlighting the importance of shock teams and medical care system networks to effectively impact on clinical outcomes.

[Italian Society of Interventional Cardiology (SICI-GISE) Position paper: Transcatheter left atrial appendage occlusion in patients with non-valvular atrial fibrillation]. / Documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE): Chiusura percutanea dell'auricola sinistra in pazienti affetti da fibrillazione atriale non valvolare.

Atrial fibrillation (AF) is the most common arrhythmia worldwide. Thromboembolism from the left atrial appendage (LAA) is the most feared complication in patients with AF. The cornerstone for the management of AF is oral anticoagulation to reduce the incidence of cardioembolic stroke. There is, however, a significant proportion of patients who cannot undergo long-term oral anticoagulation. Transcatheter LAA occlusion is an evolving technology with proven benefits in terms of AF-related stroke prevention, representing a valid alternative to anticoagulation for high-risk patients with contraindications for long-term oral anticoagulation. This has resulted in the development of a plethora of transcatheter devices to achieve endocardial occlusion or epicardial exclusion of the LAA.A panel of expert Italian cardiologists gathered under the aegis of the Italian Society of Interventional Cardiology (SICI-GISE) with the aim of reviewing the most relevant aspects of LAA occlusion, underlying anatomy and pathophysiology, summarizing current clinical knowledge, and discussing the practicalities of available devices and imaging techniques. Finally, the position paper highlights the importance of an adequate environment and of an appropriate organization in order to optimize all steps of the procedure.