A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes.

BACKGROUND: There is no established technique for managing large thrombus burden (LTB) in patients with acute coronary syndrome (ACS). AIMS: The aim of this study was to assess the safety and efficacy of the NeVa (Vesalio) mechanical thrombectomy device (MTD) in ACS patients with LTB. METHODS: Consecutive patients with ACS and LTB were treated with the NeVa MTD as the primary vessel recanalisation and thrombus removal modality, followed by conventional intervention. We further developed a bench model and applied to a subset of patients, a vacuum-assisted aspiration technique, exploiting 6 Fr-compatible conventional guiding catheter extensions, as an adjudicative manoeuvre to the use of stent-based MTD. A core laboratory reviewed the angiographic images for procedural complications, Thrombolysis In Myocardial Infarction (TIMI) flow, myocardial blush grade (MBG) and TIMI thrombus grade (TTG). RESULTS: Between November 2019 and March 2021, 61 patients underwent thrombectomy with the NeVa device. Non-flow limiting and reversible coronary spasm occurred in 14 (23%) patients. One patient (#10) suffered from side branch embolisation, which was successfully treated with the NeVa, triggering the development of a vacuum-assisted aspiration technique in a bench model, which was then applied to the subsequent 51 patients. No other device-related complications occurred. After NeVa use, TIMI flow <3 decreased from 68.3% at baseline to 10.3% (p<0.001), MBG <2 from 65% to 27.6% (p<0.001), TTG ≥3 from 96.7% to 43.2% (p<0.001), respectively. CONCLUSIONS: In patients with LTB, the NeVa MTD was safe and associated with high rates of vessel recanalisation and thrombus removal. The concomitant use of vacuum-assisted aspiration has potential to improve the effectiveness and safety of the technique.

A new iteration for the single-access large-bore technique during Impella supported complex and high-risk coronary intervention: a case report.

BACKGROUND: Complex and high-risk coronary intervention (CHIP-PCI) and PCI in cardiogenic shock complicating acute coronary syndrome (ACS) are increasingly performed under mechanical circulatory support-so-called protected PCI. Among the available options, Impella Cardiac Power (CP) heart pump (Abiomed) is percutaneously inserted over the femoral artery and typically requires a second arterial access to perform PCI, which further enhances the risk of vascular and bleeding complications. The single-access technique allows Impella CP placement and PCI performance through the same vascular access. When a 7 Fr system is desirable, only a long and entirely hydrophilic coated sheath has been previously used, which is not available in Europe. CASE SUMMARY: A 85-year-old patient admitted with non ST-elevation - acute coronary syndrome (NSTE-ACS), severely reduced left ventricular function and three-vessel coronary artery disease underwent single-access CHIP-PCI under Impella CP support. After a failed attempt to insert a standard 7 Fr long femoral sheath alongside the Impella catheter, we successfully introduced a 7.5 Fr sheathless guiding catheter and delivered the planned percutaneous treatment with the benefits conferred by a 7 Fr-rather than 6-lumen catheter, without the need for an additional arterial access. DISCUSSION: This is, to the best of our knowledge, the first case of CHIP-PCI performed under Impella support utilizing the single-access technique with a 7.5 Fr sheathless guiding catheter. Beyond advantages of the single-access technique in sparing time and avoiding vascular complications associated with gaining a second arterial access, the lower outer diameter of the sheathless catheter compared with standard 7 Fr sheaths may allow improved limb perfusion and lower chance of interference with the Impella CP catheter.

Baseline mitral regurgitation predicts outcome in patients referred for dobutamine stress echocardiography.

A number of parameters recorded during dobutamine stress echocardiography (DSE) are associated with worse outcome. However, the relative importance of baseline mitral regurgitation (MR) is unknown. The aim of this study was to assess the prevalence and associated implications of functional MR with long-term mortality in a large cohort of patients referred for DSE. 6745 patients (mean age 64.9 ± 12.2 years) were studied. Demographic, baseline and peak DSE data were collected. All-cause mortality was retrospectively analyzed. DSE was successfully completed in all patients with no adverse outcomes. MR was present in 1019 (15.1%) patients. During a mean follow up of 5.1 ± 1.8 years, 1642 (24.3%) patients died and MR was significantly associated with increased all-cause mortality (p < 0.001). With Kaplan-Meier analysis, survival was significantly worse for patients with moderate and severe MR (p < 0.001). With multivariate Cox regression analysis, moderate and severe MR (HR 2.78; 95% CI 2.17-3.57 and HR 3.62; 95% CI 2.89-4.53, respectively) were independently associated with all-cause mortality. The addition of MR to C statistic models significantly improved discrimination. MR is associated with all-cause mortality and adds incremental prognostic information among patients referred for DSE. The presence of MR should be taken into account when evaluating the prognostic significance of DSE results.

Potential Clinical Utility and Feasibility of Combined Left Atrial Appendage Closure and Positioning of Miniaturized Pacemaker Through a Single Right Femoral Vein Access.

This study assessed the clinical utility and feasibility of concomitant of combined left atrial appendage (LAA) closure and positioning of miniaturized pacemaker (Micra TPS). All consecutive patients who underwent VVI-PM implant from November 2015 to October 2016 were considered. VVI-PM implant was conducted either using transvenous approach or by positioning Micra TPS. In selected patients with concomitant contraindication to OAC, Micra TPS was combined with LAA occlusion ("combined approach"), performed in general anesthesia and guided by multimodality imaging; procedural and follow-up data of these specific patients were registered. Sixty patients were treated with VVI-PM implant. Six patients (10.0%) presented OAC contraindication, of which 4 (6.7%) were eligible for the "combined procedure"; 2 of 4 of these patients presented chronic hemodialysis-dependent renal failure. The combined approach was successful in all 4 patients without intra- or periprocedural complications. No adverse events linked to the combined approach occurred during mid-term follow-up (7.5, interquartile range 5.0 to 7.9 months). In conclusion, VVI-PM indication and concomitant contraindication to OAC is not uncommon; in selected patients, combined LAA closure and positioning of Micra TPS may be a feasible therapeutic option.

Evaluation of a protocol for same-day discharge after radial lounge monitoring in a southern Swiss referral percutaneous coronary intervention centre.

AIMS: The aim of the study was to retrospectively evaluate safety and patient satisfaction of same-day discharge after elective radial coronary angiography/percutaneous coronary intervention (PCI) after the implementation of a radial lounge facility. METHODS: All patients admitted to our radial lounge with a planned same-day discharge after an uncomplicated coronary angiography/PCI, having a co-living caregiver, were day enrolled in the study. Rates of same-day discharge, unplanned overnight stay, and in-hospital and first complications [death, myocardial infarction (MI), unplanned coronary angiography, access site hematoma, bleedings requiring hospitalization] were analysed; satisfaction was also evaluated through a questionnaire. RESULTS: From February 2015 to January 2016, 312 patients with a mean age of 66.6 ±â€Š10.8 years were admitted to the radial lounge (coronary angiography, n = 232; PCIs, n = 80). Of them, 245 (78.5%) were discharged the same day. Mean radial lounge monitoring was 6:35 h (interquartile range 5:30-7:30 h). No episodes of death/MI/unplanned coronary angiography were observed both in same-day discharged and postponed patients. Reasons to postpone discharge were: PCI deemed to need prolonged monitoring in 31, patient's preference in 14, femoral shift in 13, surgery in four, chest pain in four, and bleeding in one. At day 1, 11 access site hematoma and one hospitalization for access site bleeding were reported. Patients reported complete satisfaction in 97% of cases. Unplanned overnight stay was common among PCIs patients (RR 6.2, 95% CI 3.9-9.9, P < 0.001). CONCLUSION: A low rate of minor complications was observed in elective radial coronary angiography and PCIs showing the feasibility and safety of the development of an institutional protocol for same-day discharge after the implementation of a radial lounge facility.

Clinical outcomes of bioresorbable versus durable polymer-coated everolimus-eluting stents in real-world complex patients.

AIMS: The aim of this study was to evaluate the safety and efficacy profile of new-generation, SYNERGY everolimus-eluting stents (S-EES) as compared to XIENCE everolimus-eluting stents (X-EES) with a durable polymer coating in "complex patients". METHODS AND RESULTS: We included 2,001 consecutive patients treated with S-EES (n=400) or X-EES (n=1,601) at two Italian centres between May 2013 and May 2015. We used propensity score matching to obtain two cohorts of patients with similar baseline risk profiles. Patients were stratified according to baseline complexity based on the EVOLVE II trial exclusion criteria. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, myocardial infarction (MI), and target lesion revascularisation (TLR), at one year. Among 391 matched pairs of patients treated with S-EES or X-EES, we identified 253 (63%) as complex. At one-year follow-up, among "complex" patients, MACE rates did not differ between the S-EES and X-EES groups (9.9% vs. 9.5%, p=0.830, HR 1.04, CI: 0.72-1.48). Similarly, death, MI, and TLR, stratified for complexity, were comparable between S-EES and X-EES treated patients at one year. Of note, no definite ST was observed in either the S-EES or the X-EES cohort. CONCLUSIONS: New-generation S-EES with a bioresorbable polymer coating appear to be safe and effective irrespective of patient complexity as compared to X-EES.

Genetic bases of dilated cardiomyopathy.

Cardiomyopathies represent a wide and heterogeneous group of diseases wherein a genetic cause has been consistently identified.Dilated cardiomyopathy (DCM) is characterized by ventricular dilation and progressive systolic dysfunction, and it is the most common form of cardiomyopathy.Causative genetic mutations have been identified in more than 40 genes encoding proteins belonging to different cellular structures and pathways.A great diversity of pathways has been implied in the pathogenesis of DCM, depending on the affected genes and on the dislodged intracellular structures or mechanisms.This review describes the major genes and focus on the pathophysiologic mechanisms of DCM, with a special consideration of the most recent discoveries in the field.

The prognostic value of dobutamine stress echocardiography amongst British Indian Asian and Afro-Caribbean patients: a comparison with European white patients.

BACKGROUND: The incidence of cardiovascular disease is considerably disparate among different racial and ethnic populations. While dobutamine stress echocardiography (DSE) has been shown to be useful in Caucasian patients, its role among ethnic minority groups remains unclear. This study aimed to investigate the prognostic importance of DSE in three ethnic groups in the UK. METHODS: DSE was performed on 6231 consecutive patients. After exclusions, 5329 patients formed the study (2676 [50.2%] Indian Asian, 2219 [41.6%] European white and 434 [8.1%] Afro-Caribbean). Study outcome measures were non-fatal cardiac events (NFCE) and all-cause mortality. RESULTS: There were 849 (15.9%) NFCE and 1365 (25.6%) deaths over a median follow-up period of 4.6 years. In total 1174 (22%) patients had inducible myocardial ischaemia during DSE, 859 (16.1%) had fixed wall motion abnormalities and 3645 (68.4%) patients had a normal study. Ethnicity did not predict events. Among the three ethnic groups, ischaemia on DSE was associated with 2 to 2.5 times the risk of non-fatal cardiac events and 1.2 to 1.4 times the risk of all-cause mortality. Peak wall motion score index was the strongest independent predictor of non-fatal cardiac events and all-cause mortality in all groups. The C statistic for the prediction of NFCE and all-cause mortality were significantly higher when DSE parameters were added to the standard risk factors for all ethnic groups. CONCLUSIONS: DSE is a strong predictor of NFCE and all-cause mortality and provides predictive information beyond that provided by standard risk factors in three major racial and ethnic groups. No major differences among racial and ethnic groups in the predictive value of DSE was detected.