[Management of patent foramen ovale in non-cardiac surgery]. / Gestione della pervietà del forame ovale nella chirurgia non cardiaca.

Patent foramen ovale (PFO) is a remnant of normal fetal anatomy which may persist into adulthood, mostly asymptomatic. In some adults, PFO may result in a potential for shunting venous thromboembolism to the arterial circulation; less frequently it can cause interatrial, right-to-left shunting of deoxygenated blood. The pathogenesis of several medical conditions is related to the presence of PFO. Some randomized clinical trials have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. The literature reported several cases of carbon dioxide embolism during general laparoscopic surgery and sometimes stroke after laparoscopic or neurosurgery but there are neither prospective studies addressing these issues, nor randomized clinical trials assessing the effectiveness of pharmacotherapy or interventional procedures at decreasing risk. The European position paper suggests routine monitoring in non-cardiac surgery of patients with a PFO and no actual indications for closure. This article aims to further stratify the risk of periprocedural stroke and paradoxical embolism in this category of patients.

Characterisation of coronary microvascular dysfunction in patients with severe aortic stenosis undergoing TAVI.

BACKGROUND: Microvascular resistance reserve (MRR) is a validated measure of coronary microvascular function independent of epicardial resistances. AIMS: We sought to assess whether MRR is associated with adverse cardiac remodelling, a low-flow phenotype and extravalvular cardiac damage (EVCD) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS: Invasive thermodilution-based assessment of the coronary microvascular function of the left anterior descending artery was performed in a prospective, multicentre cohort of patients undergoing TAVI. Coronary microvascular dysfunction (CMD) was defined as the lowest MRR tertile of the study cohort. Haemodynamic measurements were performed at baseline and then repeated immediately after TAVI. EVCD and markers of a low-flow phenotype were assessed with echocardiography. RESULTS: A total of 134 patients were included in this study. Patients with low MRR were more frequently females, had a lower estimated glomerular filtration rate and a higher rate of atrial fibrillation. MRR was significantly lower in patients with advanced EVCD (median 1.80 [1.26-3.30] vs 2.50 [1.87-3.41]; p=0.038) and in low-flow, low-gradient AS (LF LG-AS) (median 1.85 [1.20-3.04] vs 2.50 [1.87-3.40]; p=0.008). Overall, coronary microvascular function tended to improve after TAVI and, in particular, MRR increased significantly after TAVI in the subgroup with low MRR at baseline. However, MRR was significantly impaired in 38 (28.4%) patients immediately after TAVI. Advanced EVCD (adjusted odds ratio 3.08 [1.22-7.76]; p=0.017) and a low-flow phenotype (adjusted odds ratio 3.36 [1.08-10.47]; p=0.036) were significant predictors of CMD. CONCLUSIONS: In this observational, hypothesis-generating study, CMD was associated with extravalvular cardiac damage and a low-flow phenotype in patients with severe AS undergoing TAVI.

Valve-in-valve transcatheter aortic valve implantation: The issues behind crossing a bioprosthesis.

Valve-in-valve transcatheter aortic valve implantation (ViV TAVI) is rapidly arising as a safe and effective alternative to redo-surgery in the treatment of bioprostheses deterioration. While scientific community is currently focusing its attention on the most common limitations related to this procedure, such as the risk of coronary obstruction and patient-prosthesis mismatch, data regarding the first step of a ViV TAVI, the crossing of a degenerated bioprosthesis, are still lacking. The aim of this review is to analyze the available information about bioprosthesis crossing, to show the inherent challenges encountered by interventional cardiologists during valve crossing and to describe the current strategies to perform a correct crossing.

Microvascular lung vessels obstructive thromboinflammatory syndrome in patients with COVID-19: Insights from lung intravascular optical coherence tomography.

Background: Microvascular lung vessels obstructive thromboinflammatory syndrome has been proposed as a possible mechanism of respiratory failure in COVID-19 patients. However, it has only been observed in post-mortem studies and has never been documented in vivo, probably because of a lack of CT scan sensitivity in small pulmonary arteries. The aim of the present study was to assess the safety, tolerability, and diagnostic value of optical coherence tomography (OCT) for the assessment of patients with COVID-19 pneumonia for pulmonary microvascular thromboinflammatory syndrome. Methods: The COVID-OCT trial was a multicenter, open-label, prospective, interventional clinical study. Two cohorts of patients were included in the study and underwent pulmonary OCT evaluation. Cohort A consisted of patients with COVID-19 with a negative CT scan for pulmonary thrombosis and elevated thromboinflammatory markers (D-dimer > 10,000 ng/mL or 5,000 < D-dimer < 10,000 ng/mL and one of: C-reactive Protein > 100 mg/dL, IL-6 > 6 pg/mL, or ferritin > 900 ng/L). Cohort B consisted of patients with COVID-19 and a CT scan positive for pulmonary thrombosis. The primary endpoints of the study were: (i) to evaluate the overall safety of OCT investigation in patients with COVID-19 pneumonia, and (ii) to report on the potential value of OCT as a novel diagnostic tool for the diagnosis of microvascular pulmonary thrombosis in COVID-19 patients. Results: A total of 13 patients were enrolled. The mean number of OCT runs performed in each patient was 6.1 ± 2.0, both in ground glass and healthy lung areas, achieving a good evaluation of the distal pulmonary arteries. Overall, OCT runs identified microvascular thrombosis in 8 patients (61.5%): 5 cases of red thrombus, 1 case of white thrombus, and 2 cases of mixed thrombus. In Cohort A, the minimal lumen area was 3.5 ± 4.6 mm2, with stenosis of 60.9 ± 35.9% of the area, and the mean length of thrombus-containing lesions was 5.4 ± 3.0 mm. In Cohort B, the percentage area obstruction was 92.6 ± 2.6, and the mean thrombus-containing lesion length was 14.1 ± 13.9 mm. No peri-procedural complications occurred in any of the 13 patients. Conclusion: OCT appears to be a safe and accurate method of evaluating the distal pulmonary arteries in hospitalized COVID-19 patients. Here, it enabled the first in vivo documentation of distal pulmonary arterial thrombosis in patients with elevated thromboinflammatory markers, even when their CT angiogram was negative for pulmonary thrombosis. Clinical trial registration: ClinicalTrial.gov, identifier NCT04410549.

Coronary Obstruction From TAVR in Native Aortic Stenosis: Development and Validation of Multivariate Prediction Model.

BACKGROUND: Transcatheter aortic valve replacement (TAVR)-related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies. OBJECTIVES: This study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis. METHODS: Preprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort. RESULTS: Sixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm3) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right. CONCLUSIONS: A novel computed tomography-based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

Chronic anticoagulant treatment and risk of mortality in SARS-Cov2 patients: a large population-based study.

BACKGROUND: Hypercoagulability is often seen in COVID-19 patients and thromboembolic events appear frequent; antithrombotic treatment has been proposed therefore as part of standard treatment for COVID-19. Under these premises, prior-to-infection antithrombotic treatment may have a protective effect with respect to COVID-19 related thromboembolic events. Aim of the present work was to evaluate the impact of prior-to-infection anticoagulant or antiplatelet treatment on COVID-19 outcomes. METHODS: Beneficiaries of the Regional Health Service of the Lombardy region of Italy aged ≥40 years with a COVID-19 diagnosis made between February 21st and July 18th, 2020 were included in the present study. The impact on COVID-19 mortality of pre-existing and chronic therapy with anticoagulant drugs (vitamin-K antagonist or new oral anticoagulants) was evaluated. Analyses were repeated with antiplatelets drugs. RESULTS: Among 79,934 SARS-CoV-2 patients beneficiaries of the Regional Healthcare System of the Lombardy Region who received a diagnosis between February 21st and July 18th, 2020, chronic pre-existing anticoagulant assumption was present in 6.0% and antiplatelets in 12.7%. The overall unadjusted mortality rate was 20.6%, with male sex, age category and comorbidity burden being significantly associated to increased mortality risk. Anticoagulant chronic treatment was not associated with a reduction in mortality. Similar results were observed when repeating the analyses for pre-existing oral antiplatelet treatment. CONCLUSIONS: In a large population-based study evaluating more than 79,000 COVID-19 patients, pre-existing antithrombotic therapy was not associated to a benefit in terms of mortality. Further studies are needed to evaluate the role of antithrombotic therapy as standard treatment among COVID-19 patients.

Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy.

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.

Patients younger than 70 undergoing transcatheter aortic valve implantation: Procedural outcomes and mid-term survival.

INTRODUCTION: Based on recent data, the indication for transcatheter aortic valve implantation (TAVI) is expanding to individuals at lower surgical risk, who are generally younger than subjects historically treated for severe aortic stenosis. Indeed, younger patients have traditionally been under-represented in current TAVI literature. The aim of the present study is to report about clinical features, procedural outcomes and mid-term outcomes of patients younger than 70 who underwent TAVI in a single high-volume center. MATERIALS AND METHODS: Consecutive patients younger than 70 years of age who underwent TAVI for severe, symptomatic aortic stenosis between 2007 and 2019 at a single, tertiary referral center have been included in this retrospective study. Procedural and mid-term outcomes were analyzed, comparing 1st generation with 2nd generation devices. RESULTS: Between 2007 and 2019, 1740 TAVI procedures were performed in our center. Among these, one hundred twenty-nine (7.4%) patients were younger than 70 years at the time of the intervention and were included in the present analysis. Fifty-eight patients (45%) were implanted with a 1st generation prosthesis while seventy-one patients (55%) were implanted with a 2nd generation device. Reasons which lead to a transcatheter approach in this population were: previous CABG (27.9%); porcelain aorta (24%); severe left ventricular systolic dysfunction (21.7%); prior chest radiation (19.4%); severe lung disease (8.5%); hemodynamic instability (7.0%); advanced liver disease (4.6%) and active cancer (3.9%). Overall device success rate was 89%, with no differences among 1st and 2nd generation devices. Threeyears all-cause mortality was 34%, with no difference among the two groups. Low incidence of aortic-valve re-intervention was observed at mid-term follow-up (late valve re-intervention = 2.3%). CONCLUSIONS: TAVI in young patient with appropriate indication for intervention is a safe procedure, associated with low rate of in hospital mortality and low rate of severe complications both with 1st and with 2nd generation devices. When considering long term durability, more data are needed; in our case series long-term follow up shows a good survival and also an extremely low rate of valve re-intervention.

Timing of Impella implantation and outcomes in cardiogenic shock or high-risk percutaneous coronary revascularization.

OBJECTIVE: To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre-percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high-risk PCI populations. BACKGROUND: A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance. METHODS: A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP-IT Registry were included. Through propensity-score weighting (PSW) analysis, 1-year clinical outcomes were assessed separately in CS and HR-PCI patients, stratified by timing of Impella support. RESULTS: Pre-procedural insertion was associated with an improvement in 1-year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR-PCI (p < .01 both before and after PSW). Among patients undergoing HR-PCI, early Impella support was also associated with a lower rate of the composite of mortality, re-hospitalization for heart failure, and need for left-ventricular assist device/heart transplantation at 1-year (p = .04 before PSW, p = .01 after PSW). Furthermore, Impella use during/after PCI was associated with an increased in-hospital life-threatening and severe bleeding among patients with AMI-CS receiving PCI (7 vs. 16%, p = .1) and HR-PCI (1 vs. 9%, p = .02). CONCLUSIONS: Our findings suggested a survival benefit and reduced rates of major bleeding when a pre-PCI Impella implantation instead of during-after procedure was used in the setting of HR-PCI and AMI-CS.

[Transcatheter aortic valve implantation for aortic regurgitation in patients with left ventricular assist device]. / Impianto transcatetere di valvola aortica per insufficienza aortica nei pazienti con assistenza ventricolare sinistra.

Aortic valve regurgitation is a not negligible complication of prolonged support with continuous-flow left ventricular assist device (LVAD) and is associated with recurrence of heart failure and reduced survival. Transcatheter aortic valve implantation has been described as a feasible option in this setting, usually with self-expanding prosthesis. Giving the absence of valvular calcification, a proper prosthesis oversizing should be guaranteed in order to achieve sufficient sealing and avoid prosthesis migration or paravalvular leak. Current self-expanding prosthesis may be too small to fit aortic annulus anatomies without calcification and with the need of significant oversize. We report the first case of 32 mm balloon expandable Myval prosthesis implantation in a patient with LVAD-related aortic regurgitation. Large balloon-expandable prosthesis can be considered when a significant oversize is needed.

[Aortic annulus rupture during transcatheter aortic valve implantation: complication prevention and management]. / Rottura dell'anello aortico durante impianto transcatetere di valvola aortica: prevenzione e gestione della complicanza.

Aortic annulus rupture is a dangerous complication of transcatheter aortic valve implantation, with an overall incidence of around 1%. Ruptures can be distinguished into supra-annular, involving injuries of the sinus of Valsalva and the sinotubular junction, annular, involving the fibrous portion of the aortic annulus, and sub-annular, located in the left ventricular outflow tract below the aortic valve cusp insertion. Annular rupture can be "contained", which usually evolves in aortic hematoma or pseudoaneurysm and rarely requires emergent cardiac surgery; or "non-contained", acutely evolving in hemopericardium with cardiac tamponade, often requiring emergent cardiac surgery and with an in-hospital mortality of 75%. Balloon-expandable oversizing and severe left ventricular outflow tract calcifications, especially under the left coronary cusp, are the most important risk factors for annular rupture. A careful computed tomography scan-based procedural planning is of paramount importance to reduce the risk of this complication. The presence and extension of left ventricular outflow tract calcifications, together with precise measurement of the virtual basal ring, should drive the operator to the right choice of prosthesis type and size in order to prevent this terrible complication.