Embolization of percutaneous left atrial appendage closure devices: timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Long-term impact of intravascular ultrasound-guidance for percutaneous coronary intervention on unprotected left main. The IMPACTUS-LM, an observational, multicentric study.

INTRODUCTION: The potential benefit on long term outcomes of Percutaneous Coronary Intervention (PCI) on Unprotected Left Main (ULM) driven by IntraVascular UltraSound (IVUS) remains to be defined. METHODS: IMPACTUS LM-PCI is an observational, multicenter study that enrolled consecutive patients with ULM disease undergoing coronary angioplasty in 13 European high-volume centers from January 2002 to December 2015. Major Adverse Cardiovascular Events (MACEs) a composite of cardiovascular (CV) death, target vessel revascularization (TVR) and myocardial infarction (MI) were the primary endpoints, while its single components along with all cause death the secondary ones. RESULTS: 627 patients with ULM disease were enrolled, 213 patients (34%) underwent IVUS-guided PCI while 414 (66%) angioguided PCI. Patients in the two cohorts had similar prevalence of risk factors except for active smoking and clinical presentation. During a median follow-up of 7.5 years, 47 (22%) patients in the IVUS group and 211 (51%) in the angio-guided group underwent the primary endpoint (HR 0.42; 95% CI [0.31-0.58] p < 0.001). After multivariate adjustment, IVUS was significantly associated with a reduced incidence of the primary endpoint (adj HR 0.39; 95% CI [0.23-0.64], p < 0.001), mainly driven by a reduction of TVR (ad HR 0.30, 95% CI [0.15-0.62], p = 0.001) and of all-cause death (adj HR 0.47, 95% CI [0.28-0.82], p = 0.008). IVUS use, age, diabetes, side branch stenosis, DES and creatinine at admission were independent predictors of MACE. CONCLUSIONS: In patients undergoing ULM PCI, the use of IVUS was associated with a reduced risk at long-term follow-up of MACE, all-cause death and subsequent revascularization.

Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate/High-Risk Pulmonary Embolism: Design of the Multicenter USAT IH-PE Registry and Preliminary Results.

Catheter-based revascularization procedures were developed as an alternative to systemic thrombolysis for patients with intermediate-high- and high-risk pulmonary embolisms. USAT IH-PE is a retrospective and prospective multicenter registry of such patients treated with ultrasound-facilitated, catheter-directed thrombolysis, whose preliminary results are presented in this study. The primary endpoint was the incidence of pulmonary hypertension (PH) at follow-up. Secondary endpoints were short- and mid-term changes in the echocardiographic parameters of right ventricle (RV) function, in-hospital and all-cause mortality, and procedure-related bleeding events. Between March 2018 and July 2023, 102 patients were included. The majority were at intermediate-high-risk PE (86%), were mostly female (57%), and had a mean age of 63.7 ± 14.5 years, and 28.4% had active cancer. Echocardiographic follow-up was available for 70 patients, and in only one, the diagnosis of PH was confirmed by right heart catheterization, resulting in an incidence of 1.43% (CI 95%, 0.036-7.7). RV echocardiographic parameters improved both at 24 h and at follow-up. In-hospital mortality was 3.9% (CI 95%, 1.08-9.74), while all-cause mortality was 11% (CI 95%, 5.4-19.2). Only 12% had bleeding complications, of whom 4.9% were BARC ≥ 3. Preliminary results from the USAT IH-PE registry showed a low incidence of PH, improvement in RV function, and a safe profile.

Coronary calcification in patients presenting with acute coronary syndromes: insights from the MATRIX trial.

AIMS: The role of coronary calcification on clinical outcomes among different revascularization strategies in patients presenting with acute coronary syndromes (ACSs) has been rarely investigated. The aim of this investigation is to evaluate the role of coronary calcification, detected by coronary angiography, in the whole spectrum of patients presenting with acute ACS. METHODS AND RESULTS: The present study was a post hoc analysis of the MATRIX programme. The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction (MI), or stroke up to 365 days. Among the 8404 patients randomized in the MATRIX trial, data about coronary calcification were available in 7446 (88.6%) and therefore were included in this post hoc analysis. Overall, 875 patients (11.7%) presented with severe coronary calcification, while 6571 patients (88.3%) did not present severe coronary calcification on coronary angiography. Fewer patients with severe coronary calcification underwent percutaneous coronary intervention whereas coronary artery bypass grafting or medical therapy-only was more frequent compared with patients without severe calcification. At 1-year follow-up, MACE occurred in 237 (27.1%) patients with severe calcified coronary lesions and 985 (15%) patients without severe coronary calcified lesions [hazard ratio (HR) 1.91; 95% confidence interval (CI) 1.66-2.20, P < 0.001]. All-cause mortality was 8.6% in patients presenting with and 3.7% in those without severe coronary calcification (HR 2.38, 1.84-3.09, P < 0.001). Patients with severe coronary calcification incurred higher rate of MI (20.1% vs. 11.5%, HR 1.81; 95% CI 1.53-2.1, P < 0.001) and similar rate of stroke (0.8% vs. 0.6%, HR 1.35; 95% CI 0.61-3.02, P = 0.46). CONCLUSION: Patients with ACS and severe coronary calcification, as compared to those without, are associated with worse clinical outcomes irrespective of the management strategy.

Predictors of fractional flow reserve/instantaneous wave-free ratio discordance: impact of tailored diagnostic cut-offs on clinical outcomes of deferred lesions.

BACKGROUND: Patient-related and lesion-related factors may influence instantaneous wave-free ratio (iFR)/fractional flow reserve (FFR) concordance, potentially affecting the safety of revascularization deferral. METHODS: Consecutive patients with at least an intermediate coronary stenosis evaluated by both iFR and FFR were retrospectively enrolled. The agreement between iFR and FFR at their diagnostic cut-offs (FFR 0.80, iFR 0.89) was assessed. Predictors of discordance were assessed using multivariate analyses. Tailored iFR cut-offs according to predictors of discordance best matching an FFR of 0.80 were identified. The impact of reclassification according to tailored iFR cut-offs on major cardiovascular events (MACE: cardiovascular death, myocardial infarction or target-lesion revascularization) among deferred lesions was investigated. RESULTS: Two hundred and ninety-nine intermediate coronary stenosis [FFR 0.84 (0.78-0.89), iFR 0.91 (0.87-0.95), 202 left main/left anterior descending (LM/LAD) vessels, 67.6%] of 260 patients were studied. Discordance rate was 23.4% (n = 70, 10.7% iFR-negative discordant, 12.7% iFR-positive discordant). Predictors of discordance were LM/LAD disease, multivessel disease, non-ST-elevation myocardial infarction, smoking, reduced eGFR and hypertension. Lesion reclassification with tailored iFR cut-offs based on patient-level predictors carried no prognostic value among deferred lesions. Reclassification according to lesion location, which was entirely driven by LM/LAD lesions (iFR cut-offs: 0.93 for LM/LAD, 0.89 for non-LM/LAD), identified increased MACE among lesions deferred based on a negative FFR, between patients with a positive as compared with a negative iFR (19.4 vs. 6.1%, P = 0.044), whereas the same association was not observed with the conventional 0.89 iFR cut-off (15 vs. 8.6%, P = 0.303). CONCLUSION: Tailored vessel-based iFR cut-offs carry prognostic value among FFR-negative lesions, suggesting that a one-size-fit-all iFR cut-off might be clinically unsatisfactory.

Device entrapment during percutaneous coronary intervention of chronic total occlusions: incidence and management strategies.

BACKGROUND: Equipment delivery in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can be challenging and it is associated with a higher risk of device entrapment. Data regarding the incidence of device entrapment during CTO PCI are lacking. AIMS: The aim of this study was to describe the incidence and procedural characteristics of device entrapment in patients undergoing PCI for CTOs and discuss management strategies for dealing with it. METHODS: Device entrapment was characterised in a large consecutive series of 2,361 CTO PCI cases performed by five high-volume CTO Italian operators between January 2015 and January 2020. RESULTS: Device entrapment occurred in 36 out of 2,361 cases (1.5%) and consisted of coronary guidewires in 13 (0.5%), microcatheters in 6 (0.2%), balloons in 6 (0.2%), rotational atherectomy burrs in 10 (0.4%) and guiding catheter extension in 1 patient (0.04%). Complete device retrieval was achieved in 63.9%, with at least partial removal of material in 97.2%. Vessel recanalisation was still possible in 86.1% of cases even after device entrapment. Intraprocedural myocardial infarction occurred in 3 patients (8.3%), tamponade with urgent pericardiocentesis in 1 (2.8%) and emergency surgical removal of the entrapped device in 1 patient (2.8%). Mean radiation dose was 4.7±2.3 Gy. At 30-day follow-up, one patient died with stent thrombosis of a non-target vessel and another required repeat percutaneous revascularisation. CONCLUSIONS: Device entrapment during CTO revascularisations is a rare but potentially severe complication. We describe and discuss current techniques of percutaneous retrieval that can be employed to achieve procedural success safely.

P2Y12 inhibitors in acute coronary syndrome patients with renal dysfunction: an analysis from the RENAMI and BleeMACS projects.

AIMS: The aim of the present study was to establish the safety and efficacy profile of prasugrel and ticagrelor in real-life acute coronary syndrome (ACS) patients with renal dysfunction. METHODS AND RESULTS: All consecutive patients from RENAMI (REgistry of New Antiplatelets in patients with Myocardial Infarction) and BLEEMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registries were stratified according to estimated glomerular filtration rate (eGFR) lower or greater than 60 mL/min/1.73 m2. Death and myocardial infarction (MI) were the primary efficacy endpoints. Major bleedings (MBs), defined as Bleeding Academic Research Consortium bleeding types 3 to 5, constituted the safety endpoint. A total of 19 255 patients were enrolled. Mean age was 63 ± 12; 14 892 (77.3%) were males. A total of 2490 (12.9%) patients had chronic kidney disease (CKD), defined as eGFR <60 mL/min/1.73 m2. Mean follow-up was 13 ± 5 months. Mortality was significantly higher in CKD patients (9.4% vs. 2.6%, P < 0.0001), as well as the incidence of reinfarction (5.8% vs. 2.9%, P < 0.0001) and MB (5.7% vs. 3%, P < 0.0001). At Cox multivariable analysis, potent P2Y12 inhibitors significantly reduced the mortality rate [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.54-0.96; P = 0.006] and the risk of reinfarction (HR 0.53, 95% CI 0.30-0.95; P = 0.033) in CKD patients as compared to clopidogrel. The reduction of risk of reinfarction was confirmed in patients with preserved renal function. Potent P2Y12 inhibitors did not increase the risk of MB in CKD patients (HR 1.00, 95% CI 0.59-1.68; P = 0.985). CONCLUSION: In ACS patients with CKD, prasugrel and ticagrelor are associated with lower risk of death and recurrent MI without increasing the risk of MB.

Clinical impact of optical coherence tomography findings on culprit plaque in acute coronary syndrome: The OCT-FORMIDABLE study registry.

BACKGROUND: Aim of this study was to evaluate the clinical impact of the culprit plaque features assessed by optical coherence tomography (OCT) in patients with acute coronary syndrome (ACS). METHODS: The OCT-FORMIDABLE register enrolled retrospectively all consecutive patients who perform OCT on culprit plaque in patients with ACS in nine European centres. The primary endpoint was the prevalence of culprit plaque rupture (CPR) in patients experiencing major adverse cardiovascular events (MACEs). Secondary endpoint was the prevalence necrotic core with macrophage infiltrations (NCMI) in the patients experiencing MACEs. RESULTS: Two-hundred and nine patients were included in the study. Mean age was 60.1 ± 12.9 years old, 19.1% were females. Main clinical presentation was ST-elevation myocardial infarction (55%). At OCT analysis, CPR was observed in 71.8% patients, while 31.6% presented NCMI. During follow-up (12.6 ± 14.5 months), 11% of the patients experienced MACEs. The presence of CPR (HR 3.7,1.4-9.8, P < .01) and NCMI (HR 3.3,1.6-6.6, P < .01) were independent predictors for MACEs, while dual antiplatelet therapy with prasugrel/ticagrelor at discharge (HR 0.2,0.1-0.6, P < .01) were protective. The protective impact of new antiplatelet drugs was reported only in patients with CPR while in patients without any of the baseline clinical or procedural features impacted on MACEs. CONCLUSIONS: CPR and the presence of NCMI are independent predictors of worse outcome. Patients with CPR seem to benefit more of an intensive therapy, both from a pharmacological and interventional point of view. (NCT02486861).

[SICI-GISE Position paper: Use of Absorb BVS in clinical practice]. / Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica.

Drug-eluting stents (DES) are the current gold standard for percutaneous treatment of coronary artery disease. However, DES are associated with a non-negligible risk of long-term adverse events related to persistence of foreign material in the coronary artery wall. In addition, DES implantation causes permanent caging of the native vessel, thus impairing normal vasomotricity and the possibility of using non-invasive coronary imaging or preforming subsequent bypass surgery. On the contrary, coronary bioresorbable stents (BRS) may provide temporary mechanical support to coronary wall without compromising the subsequent recovery of normal vascular physiology, and have the potential to prevent late adverse events related to permanent elements. Several types of BRS have been introduced into clinical practice in Europe or are being tested. However, most of available clinical data relate to a single BRS, the Absorb bioresorbable Vascular Scaffold (Absorb BVS) (Abbott Vascular, Santa Clara, CA). Despite encouraging clinical results, no societal guidelines are available on the use of BRS in clinical practice.A panel of Italian expert cardiologists assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide recommendations on the use of bioresorbable stents in terms of clinical indications, procedural aspects, post-percutaneous coronary angioplasty pharmacologic treatment and follow-up. Based on current evidence and BRS availability in Italian cath-labs, the panel decided unanimously to provide specific recommendations for the Absorb BVS device. These recommendations do not necessarily extend to other BRS, unless specified, although significant overlap may exist with Absorb BVS, particularly in terms of clinical rationale.

Restenosis treatment in the drug-eluting stent era.

Despite recent advances, the in-stent restenosis (ISR) remains a challenging problem in interventional cardiology with an estimated overall restenosis rate of 20%, 25-30% in bare metal stents and 12% in drug-eluting stents (DES). In this review, we provide an overview of therapeutic options which include balloon angioplasty, cutting balloon, debulking techniques, brachytherapy and DES. Intracoronary brachytherapy using beta or gamma radiation had been considered the standard of care for some years. However, the use of DES to treat ISR has been shown to be safe, effective and ease-of-use for the prevention of recurrent restenosis. ISR after DES when focal angiographic pattern is present can be often treated with balloon angioplasty whereas if a non-focal pattern is recognized a new DES implantation is indicated. Waiting for a definitive answer regarding the optimal treatment of ISR from ongoing trials, we present our current approach to ISR.

[Left internal mammary artery graft stenosis. Atherosclerosis, spasm or kinking?]. / Stenosi del corpo del graft di arteria mammaria interna sinistra. Aterosclerosi, spasmo o "kinking"?

The internal mammary artery is the most frequently used bypass conduit for the left anterior descending coronary artery in patients treated with bypass surgery, with excellent long-term patency rates. However, the mammary artery may also be affected by functionally significant stenoses. Most stenoses of the mammary artery are secondary to the surgical procedure at the anastomosis site, but atherosclerotic lesions may also develop. The mammary artery is often tortuous and extreme kinking of the vessel may cause flow obstruction. The treatment of such kind of stenoses is not codified. The clinical course and interventional procedure of 2 patients with previous mammary artery bypass graft and severe angina due to kinking stenosis of the graft are described. The 2 cases are characterized by the short time frame during which the stenosis became apparent, suggesting a vasoactive component in the first case that was resolved with medical treatment and an aggressive atherosclerotic progression in the second that required a percutaneous intervention. Therefore, etiology of the stenosis of the body of the mammary artery graft may differ from that of the native circulation. The role of marked bends in bypass grafts could deserve selective studies to determine whether they are associated with the development of functional stenosis. This information may be useful when performing mammary artery bypass graft surgery for avoiding extremely twisted vessel courses.