Aims:The aim of this study was to investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). Methods and results:The IMP-IT study was a multicentre observational national registry which enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centres from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change 39.8%, 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and one-year all-cause death in patients with CS were 46.9% and 57.0%, respectively; 18.5% underwent left ventricular assist device implantation or heart transplant at one year. Rates of in-hospital and one-year allcause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively.Conclusions: Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.

BackgroundManagement of coronary artery disease in patients undergoing transcatheter aortic valve implantation is uncertain. Fractional flow reserve (FFR) has never been clinically validated in aortic stenosis. The study aim was to analyze the clinical outcome of FFR‐guided revascularization in patients undergoing transcatheter aortic valve implantation.Methods and ResultsPatients with severe aortic stenosis and coronary artery disease at coronary angiography were included in this retrospective analysis and divided in 2 groups: angiography guided (122/216; 56.5%) versus FFR‐guided revascularization (94/216; 43.5%). Patients were clinically followed up and evaluated for the occurrence of major adverse cardiac and cerebrovascular events at 2‐year follow‐up. Most lesions in the FFR group resulted negative according to the conventional 0.80 cutoff value (111/142; 78.2%) and were deferred. The FFR‐guided group showed a better major adverse cardiac and cerebrovascular event–free survival compared with the angio‐guided group (92.6% versus 82.0%; hazard ratio, 0.4; 95% CI, 0.2–1.0; P=0.035). Patients with deferred lesions based on FFR presented better outcome compared with patients who underwent angio‐guided percutaneous coronary intervention (91.4% versus 68.1%; hazard ratio, 0.3; 95% CI, 0.1–0.6; P=0.001).ConclusionsFFR guidance was associated with favorable outcome in this observational study in patients undergoing transcatheter aortic valve implantation. Randomized trials are needed to investigate the long‐term effects of FFR‐guided revascularization against angiographic guidance alone in patients with aortic stenosis.

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Background Redo surgical mitral valve replacement (SMVR) is the current standard of care for patients with failed bioprosthetic mitral valve (MV). Transcatheter mitral valve‐in‐valve replacement (TMViV) is arising as an alternative to SMVR in high risk patients. We sought to evaluate procedural safety, early and mid‐term outcomes of patients who underwent transseptal TMViV (TS‐TMViV), transapical TMViV (TA‐TMViV), or redo‐SMVR. Methods We identified patients with failed bioprosthetic MV who underwent TS‐TMViV, TA‐TMViV, or SMVR at four Italian Centers. Clinical and echocardiographic data were codified according to Mitral Valve Academic Research Consortium definition (MVARC), except for significant valve stenosis. Results Between December 2012 and September 27, 2019 patients underwent TS‐TMViV, 22 TA‐TMViV, and 29 redo‐SMVR. TS‐TMViV and TA‐TMViV patients presented higher mean age and surgical risk scores compared with SMVR group (77.8 ± 12 years, 77.3 ± 7.3 years, 67.8 ± 9.4 years, p < .001; STS PROM 8.5 ± 7.2; 8.9 ± 4.7; 3.6 ± 2.6, p < .001). TS‐TMViV procedure was associated with shorter intensive care unit time and total length of stay (LOS) compared with TA‐TMViV and SMVR group. There were no differences in MVARC procedural success at 30‐days (74.1, 72.7, and 51.7%, p = .15) and one‐year all‐cause mortality between groups (14.8, 18.2, and 17.2%, p = 1.0). MV mean gradient was similar between TS‐TMViV, TA‐TMViV, and SMVR groups at 30 days and 12 months. Conclusions For the selected patients, TS‐TMViV and TA‐TMViV are to be considered a valid alternative to redo‐SMVR with comparable 1‐year survival. TS‐TMViV is the less invasive strategy and has the advantage of shortening the LOS compared with TA‐TMViV.

Aims To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy. Methods and results A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis. Conclusion In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.

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ST-segment elevation myocardial infarction (STEMI) equivalent patterns make the diagnosis of STEMI very challenging. We present a case of de Winter's pattern (dWp) in a man admitted to the emergency department for chest pain who developed cardiogenic shock despite successful percutaneous coronary intervention. Electrocardiograms performed at arrival, after 10 minutes, and the day after the revascularization demonstrated a dynamic and rapid evolution of dWp. Our case underlines the importance to promptly recognize dWp as a STEMI equivalent pattern to advance the patient to a rapid reperfusion strategy and confirms the high-risk and probably evolutive feature of this sign.