A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial.

The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.

Pulsed field ablation technology for pulmonary vein and left atrial posterior wall isolation in patients with persistent atrial fibrillation.

INTRODUCTION: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). METHODS: The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSETM-PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared. RESULTS: Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies. CONCLUSION: LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times.

Preoperative Transcatheter Diagnosis of Right Atrial Hemangioma.

A 34-year-old man with unremarkable past medical history presents with night sweats and a recent diagnosis of intracardiac mass. The initial diagnostic workup did not provide a definitive diagnosis, so a cardiac biopsy under intracardiac echocardiography guidance was performed, revealing a hemangioma, which was then successfully resected. (Level of Difficulty: Advanced.).

Focal atrial tachycardia arising from left superior pulmonary vein in a pediatric patient, safely treated by pulsed-field ablation.

INTRODUCTION: We describe the first case of the use of pulsed-field ablation (PFA) to treat focal atrial tachycardia (FAT) in a pediatric patient. METHODS: An 11-year-old girl with obesity was referred to our center for ablation of incessant atrial tachycardia. The earliest atrial activation was shown to be present in the left superior pulmonary vein. Radiofrequency ablation of FAT seems to be associated with a lower success rate and, especially, with a higher complication rate than in adult patients. RESULTS: We performed ablation by means of a novel nonthermal energy source (PFA) that is able to reduce the risk of complications due to injury to anatomic structures surrounding the heart. After the first application, stable sinus rhythm was restored. CONCLUSIONS: PFA can be used to treat FAT arising from pulmonary veins in young children as a good alternative to RFA ablation, thereby reducing the risk of potential procedure-related complications.

Rate-Responsive Cardiac Pacing: Technological Solutions and Their Applications.

Modern cardiac pacemakers are equipped with a function that allows the heart rate to adapt to the current needs of the patient in situations of increased demand related to exercise and stress ("rate-response" function). This function may be based on a variety of mechanisms, such as a built-in accelerometer responding to increased chest movement or algorithms sensing metabolic demand for oxygen, analysis of intrathoracic impedance, and analysis of the heart rhythm (Q-T interval). The latest technologies in the field of rate-response functionality relate to the use of an accelerometer in leadless endocavitary pacemakers; in these devices, the accelerometer enables mapping of the mechanical wave of the heart's work cycle, enabling the pacemaker to correctly sense native impulses and stimulate the ventricles in synchrony with the cycles of atria and heart valves. Another modern system for synchronizing pacing rate with the patient's real-time needs requires a closed-loop system that continuously monitors changes in the dynamics of heart contractions. This article discusses the technical details of various solutions for detecting and responding to situations related to increased oxygen demand (e.g., exercise or stress) in implantable pacemakers, and reviews the results of clinical trials regarding the use of these algorithms.

Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study.

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage closure (LAAC). OBJECTIVES: The aim of this study was to investigate the efficacy and safety of ICE-guided LAAC with the Watchman FLX device. METHODS: The ICE LAA (I Can See Left Atrial Appendage) study was a prospective, multicenter study with independent adjudication of echocardiographic data by a core laboratory and clinical events by a clinical events committee. Patients with atrial fibrillation with CHA2DS2-VASc scores ≥2 and clinical indications for LAAC were eligible. Preplanning with either cardiac computed tomography or transesophageal echocardiography (TEE) within 7 days prior to LAAC was mandatory. Intraprocedural ICE was carried out from the left atrium. The primary outcome was the rate of significant peridevice leaks (>5 mm) at 45-day TEE. RESULTS: A total of 100 patients were enrolled. The mean age was 76 ± 8 years, the mean CHA2DS2-VASc score was 4.0 ± 1.5, and the mean HAS-BLED score was 2.5 ± 0.9. The incidence of the primary outcome of significant peridevice leak (>5 mm) was 0%; all patients evaluated by TEE at 45 days had effective LAAC. All patients received Watchman FLX devices, and technical success was 100%. The number of devices per case was 1.0 ± 0.1. ICE successfully guided the assessment of device release criteria, including device compression (19.2% ± 7.1%; recommended range: 10%-30%). No subject required conversion to TEE. Procedural complications were 4 access-site bleeds. There was no stroke, transient ischemic attack, systemic embolization, pericardial effusion, device embolization, or device-related thrombus during the procedure or 45-day follow-up. CONCLUSIONS: ICE can be used to successfully guide LAAC with the Watchman FLX, with excellent procedural success, a high rate of effective LAAC, and minimal periprocedural complications. (I Can See Left Atrial Appendage [ICELAA] Clinical Study; NCT04196335).

Case Report: Severe Aortic Valve Regurgitation and Pseudoaneurysm in Aortic Valve-Sparing Operation: The Usefulness of Multimodality Imaging in a Complex Clinical Scenario.

Background: Failure of the native aortic valve and degenerative anatomy of ascending aorta in patients with previous Tirone-David operation may represent a clinical challenge, because sometimes the risk of reoperation is prohibitive. Case: We described the case of a patient suffering from severe aortic valve regurgitation and pseudoaneurysm of the aortic arch, 6 years after cardiac surgery operation. The aim of this clinical case was to assess if the complex anatomy of aortic pseudoaneurysm and aortic root geometry can be accurately reproduced from contrast-enhanced computed tomography scan into a three-dimensional (3D) printed model. Based on this procedural method, with the aid of transesophageal 3D ultrasound, we efficaciously treated the patient percutaneously with a combination of transcatheter occluder device plus microcoil embolization and transfemoral aortic valve implantation. The patient was free from complications and the need to redo cardiac surgery. Conclusion: To the best of our knowledge, this is the first description of two simultaneous complications and their staged treatment in a patient with previous aortic valve-sparing operation. This is a useful report in a single 3D model applying such specific technology to these two simultaneous clinical settings.

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.

Surgical redo versus transseptal or transapical transcatheter mitral valve-in-valve implantation for failed mitral valve bioprosthesis.

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.

de Winter's Pattern: An Unusual but Very Important Electrocardiographic Sign to Recognize.

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.

Les équivalents STEMI, ces événements qui se présentent comme un infarctus du myocarde avec élévation du segment ST (STEMI), compliquent beaucoup le diagnostic de ce dernier. Nous présentons le cas d'un complexe de « de Winter ¼ chez un homme admis à l'urgence pour une douleur thoracique et ayant présenté un choc cardiogénique malgré une intervention coronarienne percutanée réussie. Les électrocardiogrammes réalisés à l'arrivée, 10 minutes plus tard et le lendemain de la revascularisation montraient une évolution dynamique et rapide d'un complexe de « de Winter ¼. Le cas présenté fait ressortir l'importance de savoir reconnaître promptement le complexe de « de Winter ¼ comme étant un équivalent STEMI afin d'appliquer sans délai une stratégie de reperfusion appropriée, et confirme le risque élevé et le caractère vraisemblablement évolutif de ce signe.

Physiological Versus Angiographic Guidance for Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background Management 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 Results Patients 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). Conclusions FFR 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.

[Updated SICI-GISE position paper on institutional and operator requirements for transcatheter aortic valve implantation]. / Update del documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Usefulness of the Finet law to guide stent size selection in ostial left main stenting: Comparison with standard angiographic estimation.

BACKGROUNDS: Intravascular ultrasound has been suggested to optimize stent diameter and length in Left Main (LM) procedures, but in the real-world ostial LM stenting is often accomplished with angiography only guidance. The Finet law which regulates the fractal geometry of human bifurcation has the potential to increase the accuracy of stent-sizing. To retrospectively evaluating the impact on outcomes of the addition of Finet Law to standard quantitative coronary angiography (QCA) in guiding stent selection of ostial LM stenting compared to standard angiography estimation. METHODS: We retrospectively evaluated the clinical and instrumental records of patients with isolated ostial LM disease and bypass surgery contraindications or refusal as determined by the local Heart Team who received stenting from 1 January 2012 to 1 January 2017 at Rovigo General Hospital. Patients were discrimined on the basis of the addition to QCA angiographic evaluation of the Finet-law. RESULTS: Seventy-three patients (45 males, mean age 69.9 ±â€¯10.9 years old) ostial LM stenting, 36 patients using QCA and Finet law (QCA-Finet) and 37 using standard QCA angiographic (QCA-angio) evaluation of the vessel diameter. By QCA, vessel size, mean stent diameter at implantation and after post-dilatation were clearly bigger in the QCA+ Finet than QCA-angio (4.4 ±â€¯0.8 and 3.8 ±â€¯0.7, p < 0.001). At a mean follow-up of 5.0 ±â€¯0.4 years, cardiovascular mortality and cardiovascular events incidence were higher in QCA-angio compared to QCA+Finet group of patients. CONCLUSIONS: Our study suggested that adding the Finet law to standard angiography estimation of the LM stent size may improve long-term outcomes.

Primary percutaneous coronary intervention during ST elevation myocardial infarction in prosthetic valve endocarditis: a case report.

BACKGROUND: Infective endocarditis (IE) is still a condition with high mortality and morbidity, especially in the elderly, and in patients with prosthetic valves. The concept of "time-to-therapy" plays a key role for the prompt management of IE and related complications, and the currently available multimodality imaging may play a key role in this setting. Myocardial ischemia due to extrinsic coronary compression from an aortic abscess is an extremely rare condition where the optimal therapeutic strategy has not been defined yet. We present herein the first case of a patient with ST elevation myocardial infarction caused by an aortic root abscess treated with percutaneous stent implantation. CASE PRESENTATION: An 82-year-old woman with a history of atrial fibrillation, chronic renal failure, anemia and a bioprosthetic aortic valve replacement performed in 2014, was admitted to hospital with profound asthenia and a pyrexia of unknown origin. Because of high clinical suspicion of endocarditis, a trans-esophageal echocardiogram was performed. Empirical broad-spectrum antimicrobial therapy was initiated, followed by targeted treatment based on the results of blood cultures (Staphylococcus aureus). The echocardiogram did not show vegetations and the patient was managed conservatively. She suddenly deteriorated, due to an acute coronary syndrome (ACS) with anterior ST segment elevation. An urgent angiogram was performed, and extrinsic compression of the left coronary system, due to an aortic root abscess, was suspected. After discussion with the surgical team, percutaneous revascularization was attempted, aiming to restore satisfactory hemodynamics, in order to plan surgery. Unfortunately, the patient rapidly developed cardiogenic shock, with multi organ failure, and died in less than 24 h. CONCLUSIONS: Patients with fever, and significant risk factors for endocarditis, who develop ACS, need a prompt diagnostic work up, including trans-esophageal echocardiography. At present, the specific timing of echocardiographic follow-up and surgical intervention is still a matter of debate, and our case aims to highlight the importance of this aspect in the management of endocarditis, in order to avoid severe complications that adversely affect patient prognosis.

Coronary physiology in patients with severe aortic stenosis: Comparison between fractional flow reserve and instantaneous wave-free ratio.

BACKGROUND: The functional assessment of coronary artery disease (CAD) in patients with aortic stenosis (AS) has not been validated so far, and the best strategy to physiologically investigate the relevance of coronary stenosis in this specific setting of patients remains undetermined. The aim of the study is to compare the diagnostic performance of instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with severe AS. METHODS: The functional significance of 179 coronary lesions was investigated with on-line iFR and FFR measurements in 85 AS patients and compared with a control group formed by 167 patients (290 lesions) with stable CAD and without AS. The iFR-FFR diagnostic agreement has been tested using the conventional 0.80 FFR cut-off. RESULTS: The correlation between iFR and FFR was similar between AS and CAD patients, as well as the area under the curve at ROC curve analysis (0.97 vs 0.96, p=0.88). However, using the standard iFR 0.89 threshold, the diagnostic accuracy of iFR was significantly lower in AS compared with CAD (76.3% vs 86.1%, p=0.009). According to ROC analysis, the best iFR cut-off in predicting FFR≤0.8 was lower in AS (0.83, J=0.82) compared with CAD (0.89, J=0.81). Using the ROC derived cut-off of 0.83, the iFR accuracy increased significantly (91.3%, p=0.003) while maintaining an elevated negative predictive value (95.5%). CONCLUSIONS: In the presence of severe AS, conventional iFR cut-off had lower diagnostic agreement with FFR classification of coronary lesions compared to stable CAD patients. AS seems to influence iFR cut-off ischemic thresholds and deserves further comparative studies.

Edge-to-Edge Technique to Minimize Ovelapping of Multiple Bioresorbable Scaffolds Plus Drug Eluting Stents in Revascularization of Long Diffuse Left Anterior Descending Coronary Artery Disease.

BACKGROUND: Implantation of Drug Eluting Stents (DES) plus bioresorbable scaffolds (BVS) in very long diffuse left anterior descending coronary artery (LAD) disease may be problematic because of multiple devices overlapping. We sought to assess the short and mid-tern outcomes of combined implantation of DES and BVS using a novel "edge-to-edge" technique in patients with diffuse LAD disease. METHODS: Patients with long diffuse LAD disease were enrolled in a prospective registry from 1st August 2014 to 1st August 2015 and treated with IVUS-aided percutaneous coronary intervention using a DES plus a single or multiple BVS using a novel "edge-to-edge" technique. Clinical follow up and invasive follow up driven by clinical justification was performed. RESULTS: Twenty-three patients (5 females, mean age 59.1± 9.1 years) were enrolled. Mean length of LAD disease was 73.1 ± 20.6 mm. Mean number of DES and BVS implanted was 1.2 ± 0.4 and 1.7 ± 1.3, respectively. At a mean follow-up of 11.3 ± 3.8 months, no stent thrombosis or MACE were observed. Angiographic and IVUS follow-up at a mean of 6.6 ± 0.7 months showed no significant angiographic restenosis and no appreciable stent gaps. CONCLUSIONS: In revascularization of long diffuse disease of the LAD, the edge-to-edge implantation technique appears to be feasible resulting in no restenosis or thrombosis on the short-term follow-up. (J Interven Cardiol 2016;29:275-284).