New echocardiographic screening tool for left ventricular tract obstruction risk assessment in TMVR.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is an alternative to conventional surgery to treat severe mitral disease but its use is limited by the risk of left ventricular outflow tract obstruction (LVOTO). Screening depends on ECG-gated computed tomography (CT) that is not widely available and requires contrast. We developed and validated a transthoracic echocardiographic (TTE) method to assess the risk of LVOTO after TMVR with the Tendyne System. METHODS: We measured the LVOT longitudinal area on preoperative TTE dataset of patients screened for TMVR. The LVOT was measured as the box-area included by the aortic valve annulus, the anterior mitral leaflet (AML), the c-septum distance line, and the respective length of the AML on the interventricular septum. We analyzed the correlation between the TTE LVOT-box and the CT-measured neoLVOT area. Prediction performance for eligible patients was tested with ROC curves. RESULTS: Thirty-nine patients were screened, out of 14 patients (36%) not eligible for TMVR, 8 had risk of LVOTO. We found a linear correlation between the TTE LVOT-box and the CT-measured Neo-LVOT (r = 0.6, p = 0.002). ROC curve showed that the method is specific and sensitive and the cut-off value of the measure LVOT-box is 350 mm2. CONCLUSIONS: The proposed method is reliable to evaluate the risk of LVOTO after TMR with the Tendyne System. It is quick and easy and can be used as a first-line assessment in the outpatient clinic. Patients with LVOT-box <350 mm2 should not be further screened with ECG-gated cardiac CT.

Minimally invasive left atrial appendage occlusion plus reduced dose direct oral anticoagulant to prevent stroke in patients with atrial fibrillation-the LAAO-PlusRE.

The onset of atrial fibrillation (AF) has a direct association with left atrial appendage (LAA) function, as demonstrated by recent studies demonstrating the link between left atrial (LA) wall fibrosis, impaired contractility, and the development of AF. Non-valvular AF (NVAF) affects almost 30 million people worldwide, with this number expected to increase in the next 20 years. It is the main cause of ischemic stroke, with significant subsequent economic and social impact. Currently, the mainstay of stroke prevention in patients with NVAF is oral anticoagulation (OAC), which reduces the incidence of ischemic events at the stake of increased hemorrhagic events. Despite the introduction and widespread use of direct oral anticoagulants (DOACs), which almost completely replaced vitamin K antagonists (VKAs), the adherence to OAC is still low, hindering the efficacy of stroke prevention. Percutaneous LAA occlusion (LAAO) is now indicated (class IIB) in patients with NVAF at increased ischemic risk who cannot undergo OAC. Recently published data demonstrated that a reduced dose of DOAC after percutaneous LAAO is superior to long-term dual antiplatelet therapy (DAPT) for stroke prevention in the mid-term. One of the possible pitfalls of percutaneous LAAO is postprocedural peri-device leaks (PDLs) that have been associated with increased thromboembolic events. According to LAAOS III results, surgical LAAO during cardiac surgery brings a 33% reduction in risk of stroke at five years, independently from the OAC regimen with a high rate of complete appendage occlusion. The combination of surgical LAAO and reduced dose DOAC might ensure adequate embolic prevention, lowering the hemorrhagic risk. The present manuscript aims to describe the rationale and design of the Minimally Invasive Left Atrial Appendage Occlusion Plus REduced Dose DOAC To Prevent Stroke In Patients With Atrial Fibrillation Randomized Clinical Trial (LAAO-PlusRE).

Native-Valve Aspergillus Endocarditis: Case Report and Literature Review.

Aspergillus endocarditis represents the second etiological cause of prosthetic endocarditis following Candida spp. On the other hand, native-valve endocarditis due to Aspergillus are anecdotally reported with increasing numbers in the last decade due to new diagnostic technologies such as polymerase chain reaction (PCR) on samples like valve tissue or entire blood. We performed a review of the literature presenting one case report observed at Pisa University Hospital. Seventy-four case reports have been included in a period between 1950-2022. Immunocompromised status (patients with solid tumor/oncohematological cancer or transplanted patients) was confirmed to be the main risk factor for this rare opportunistic infection with a high rate of metastatic infection (above all, central nervous system) and mortality. Diagnosis relies on serum galactomannan and culture with PCR on valve tissue or whole blood. Cardiac surgery was revealed to be a life-saving priority as well as appropriate antifungal therapy including b-liposomal amphotericin or new triazoles (isavuconazole). The endocarditis team, facing negative blood culture endocarditis affecting an immunocompromised patient, should investigate this difficult-to-treat pathogen.

Case report: Treatment of left-sided valve endocarditis using the Transapical AngioVac System and cerebral embolism protection device: A case series.

The AngioVac System (AngioDynamics, Latham, NY) was developed for the treatment of right-sided heart and intravenous masses. Lately, it has been employed to deal with left-sided heart masses, in particular, native valve endocarditis (NVE) and valve prostheses endocarditis (VPE) in high-risk patients. Left-sided heart endocarditis has a high morbidity, and it also has a high mortality when open heart surgery is performed. Recently, patients presenting with left NVE and VPE have been treated with the off-label use of the AngioVac System even if the solution presents a considerable cerebral embolization risk issue due to the risk of fragmentation rather than a complete en-bloc aspiration of the masses. A percutaneous cerebral embolism protection system is currently used in TAVI procedures, especially when the native valve presents extensive calcifications and consequent significant embolic risks. We hereby present a clinical case series of a combined utilization of the AngioVac System and cerebral embolism protection system Triguard (Keystone Heart Ltd., Herzliya, Israel) to treat left NVE and VPE in prohibitive-surgical-risk patients.

Cardiac Vascular Hamartoma: Adult Diagnosis and Cardiac Reconstruction.

Cardiac hamartoma is a rare benign tumor of the heart, and the vascular type is an extremely rare histologic diagnosis. A small number of cases have previously been described in childhood. We report the case of a 63-year-old woman with an incidentally detected cardiac mass that was finally diagnosed as vascular hamartoma. Approval for publication was obtained from the patient.

Outcomes of transapical mitral valve repair with neochordae implantation.

OBJECTIVE: Transapical off-pump beating-heart neochord implantation (NC) has shown encouraging early results in patients with degenerative mitral regurgitation. The aim of this study was to evaluate clinical and echocardiographic 5-year outcomes of patients who underwent NC. METHODS: All patients who underwent NC at our institution from November 2013 to March 2016 were included. Indications were severe symptomatic degenerative mitral regurgitation due to leaflet prolapse/flail. Patients were classified as having favorable anatomy (FA) and unfavorable anatomy (UA) on the basis of the extent and severity of mitral valve disease. All patients underwent clinical and echocardiographic follow-up at 1, 3, 6, and 12 months, and annually thereafter. Data were prospectively collected and retrospectively analyzed. Outcomes were on the basis of the Mitral Valve Academic Research Consortium guidelines. RESULTS: One hundred consecutive patients were included in the analysis (FA: 81%; UA: 19%). Median age was 66 years (interquartile range, 58-76) and median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 1.4% (interquartile range, 0.7-2.3). Technical and procedural success were 98% and 94%, respectively. Thirty-day mortality was 2%. Device success was 94%, 92%, and 78%, at 30 days, 1-year, and 5 years, respectively. Patient success at 1 year was 92%. Median follow-up was 5.1 years. At 5 years, overall survival was 83% with no difference between FA and UA patients. Cumulative incidence of severe mitral regurgitation recurrence at 5 years was 14% (95% CI, 6.5%-22.8%) in FA patients and 63% (95% CI, 39.7%-86.2%) in UA patients, respectively (P < .001). Patients with FA compared with UA had a lower incidence of reintervention (14.7% vs 43.4%; P < .001). CONCLUSIONS: Transapical off-pump beating heart NC might represent an acceptable option in patients with degenerative mitral valve disease and FA.

A 20-year experience in cardiac tumors: a single center surgical experience and a review of literature.

INTRODUCTION: Cardiac tumors are rare and heterogeneous entities which still remain a diagnostic and therapeutic challenge. The treatment for most cardiac tumors is prompt surgical resection. We sought to provide an overview of surgical results from a series of consecutive patients treated at our tertiary care center during almost a 20-year experience. METHODS AND RESULTS: In this single center study, 55 consecutive patients with diagnosis of cardiac tumor underwent surgical treatment from January 2002 to April 2021. Of these, 23 (42%) were male and the mean age was 62 ±â€Š12 years. Fifteen (27%) patients were symptomatic at the time of the diagnosis, mostly for dyspnea and palpitations. The most frequent benign cardiac tumor was myxoma (32; 58%), occurring mainly in the left atrium (31; 97%). Pleomorphic sarcoma was the most frequent primary malignant cardiac tumor (4; 7%), mainly located in the ventricles (1; 25% in the left ventricle; 2; 50% in the right ventricle). In all cases of benign tumors surgery was successful with no relapses. Two (50%) pleomorphic sarcomas showed subsequent relapses. After a median follow-up of 44 months, 15 (27%) patients died. Although malignant tumors presented a limited survival, benign tumors showed a very good prognosis. CONCLUSION: Cardiac tumors require a multidisciplinary approach to guarantee a prompt diagnosis and appropriate treatment. In our surgical experience, outcome after surgery of benign tumors was excellent, while malignant tumors had poor prognosis despite radical surgery.

Late Iatrogenic Coronary Sinus Hematoma During Cardiac Surgery.

Retrograde cardioplegia is commonly used in cardiac surgery to induce cardioplegic arrest. However, this method could be potentially associated with coronary sinus injuries, which can be fatal or extremely difficult to manage. This report describes the conservative management of an iatrogenic coronary sinus hematoma by daily transthoracic echocardiography and weekly computed tomography follow-up. (Level of Difficulty: Intermediate.).

Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability.

OBJECTIVES: The goal of this multicentre retrospective study was to compare long-term clinical and haemodynamic outcomes of the Carpentier-Edwards Magna Ease (CEME) bioprosthesis by patient age. METHODS: We included consecutive patients who underwent isolated and combined surgical aortic valve replacement (AVR) with CEME valve between January 2008 and March 2020 at 4 cardiac surgery centres in Italy. Survival distribution was evaluated at follow-up according to age and surgery type (combined or isolated AVR), together with freedom from structural valve deterioration (SVD), reoperation and combined events, i.e. SVD, reoperation, endocarditis and thromboembolic events. RESULTS: A total of 1027 isolated and 1121 combined AVR were included; 776 patients were younger than 65 years whereas 1372 were 65 years or older. The 30-day Valve-Academic-Research-Consortium mortality was 2% (<65 years) and 6% (≥ 65 years) (P < 0.001), whereas it was 3% for isolated AVR and 7% for combined AVR (P < 0.001). The 12-year survival was 81% for those younger than 65 years vs 45% for those equal to or older than 65 years (P < 0.001), whereas they were 61% vs 49% for isolated and combined AVR (P = 0.10). The 12-year freedom from combined events, excluding death, was 79% for those younger than 65 years vs 87% for those equal to or older than (P = 0.51), whereas they were 83% for isolated and 86% for combined AVR (P = 0.10). The 12-year freedom from SVD was 93% and 93% in patients younger than 65 and those equal to or older than 65 years (P = 0.63), and the results were comparable even in cases with isolated and combined AVR (92% vs 94%, P = 0.21). A multivariable Cox analysis including gender, presence of patient-prosthesis mismatch, isolated AVR and age showed that only the age was an independent risk factor for the incidence of SVD (P = 0.029). CONCLUSIONS: Outcomes from this large multicentre analysis demonstrated that a CEME bioprosthesis provides good clinical results and long-term durability even in patients younger than 65 years. Furthermore, the hazard for SVD has been shown to be lower for older age. CLINICAL TRIAL REGISTRATION NUMBER: 105n/AO/21.

Transapical mitral valve repair procedures: Primetime for microinvasive mitral valve surgery.

INTRODUCTION: Nowadays micro-invasive-procedures (off-pump, beating-heart) for mitral valve repair (MVRe) are abruptly expanding with the potential to be adopted as a valuable alternative to surgery. In the present manuscript, the authors review the available technologies intended to treat mitral regurgitation (MR) through transapical approach, including annuloplasty and chordal-repair options. ANNULOPLASTY: To date, Valcare Amend is the only transapical MV ring to have been implanted in patients. The device allows for stabilization of the annulus through a complete semirigid d-shaped ring. The first-in-human successful procedure was performed in 2016 by our Group and subsequent clinical experience included a total of 14 implanted patients. Currently, the technology is under clinical trial evaluation to validate the efficacy and safety profile of the device. CHORDAL REPAIR: Beating-heart chordal implantation via transapical approach is a current feasible, safe and reproducible option. Neochord DS1000 is the most widely used technology in the field, with a solid procedural experience and good results in well-selected patients. Its clinical use has been validated in Europe since 2012, while it is still under clinical investigation in the United States. Harpoon MVRe system is a novel technology, recently CE-mark approved for clinical use. DISCUSSION AND CONCLUSIONS: Transapical micro-invasive technologies are current viable therapies to treat MR in selected patients. Although there are still several limitations that preclude an extensive use of such procedures, their results are promising in well-selected patients. Embracing transcatheter MVRe therapies should guide the cardiac surgeon through the new revolution of micro-invasive MV tailored repair.

Feasibility of percutaneous coronary intervention before mitral NeoChord implantation: Single-center early results.

BACKGROUND AND AIM OF THE STUDY: Micro-invasive cardiac surgery identifies procedures performed off-pump, on beating heart. Aim of this single-center retrospective study was to assess early outcomes of a totally micro-invasive strategy (percutaneous coronary intervention-PCI-followed by transapical off-pump NeoChord mitral repair) in patients with concomitant coronary artery disease (CAD) and degenerative mitral regurgitation (MR). METHODS: We analyzed early and 1-year follow-up data of patients who underwent a NeoChord procedure between November 2013 and May 2020, and preceded by PCI. Outcomes were defined according to Mitral Valve Academic Research Consortium (MVARC) definitions. RESULTS: Among 220 patients who underwent NeoChord repair in the study period, 17 (7.7%) underwent PCI previously. CAD was an accidental finding during preoperative mitral evaluation in nine patients (52.9%; Group 1; with PCI occurring 2 months before NeoChord, interquartile range [IQR] = 1.0-2.7), while it was part of the past medical history in the remaining eight patients (47.1%; Group 2; with PCI occurring 30 months before NeoChord, IQR = 24.5-64.0). Twelve patients (70.6%) presented single-vessel disease, two patients (11.8%) triple-vessel disease. No surgical revisions for bleeding were required after NeoChord. At 1-year follow-up (n = 16), all patients were alive and did not experience major adverse events except for one reoperation due to late NeoChord failure. None required additional PCI. CONCLUSION: In our experience, PCI before NeoChord seems safe and effective, and performing PCI before NeoChord might not affect outcomes. A totally micro-invasive strategy in selected patients suffering from MR and CAD should be considered as a reasonable alternative to conventional surgery.

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes.

BACKGROUND: The NeoChord echo-guided transapical beating heart repair is a promising early-stage minimally invasive surgical procedure for degenerative mitral valve (MV) regurgitation (DMR) correction. The technique has been improved since its inception following procedure standardization, patient selection optimization, and learning curve stabilization. We hereby present the mid-term clinical results through three years of our large single center experience. METHODS: All consecutive patients with severe symptomatic DMR due to prolapse or flail of one or both mitral leaflets that underwent the NeoChord procedure between November 2013 and June 2019 were included. Patients were categorized according to MV anatomy; Type A isolated central posterior leaflet prolapse and/or flail, Type B posterior multi-segment prolapse and/or flail, Type C anterior and/or bi-leaflet prolapse or flail, Type D paracommissural prolapse and/or flail and/or significant leaflet and/or annular calcifications. Patients underwent clinical and echocardiographic follow-up at one, three, six, twelve months and yearly thereafter. Clinical outcomes and the composite primary endpoint (patient success) were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria. Mitral regurgitation (MR) severity was graded as absent, mild, moderate and severe according to American Society of Echocardiography (ASE) and European Society of Cardiology (ESC) guidelines. RESULTS: Two hundred and three patients were included; median follow-up was 24 months [interquartile range (IQR), 9-36]. Median age was 64 years (IQR, 54-74 years), median Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) was 0.60% (IQR, 0.32-1.44%). There were 106 Type A patients (52.2%), 68 Type B (33.5%), 16 Type C (7.9%), and 13 Type D (6.4%). Kaplan-Meier estimate of survival was 99.0%±0.7% at one and two years and 94.0%±2.9% at three years. At one-year follow-up patient success was 91.2%±2.0% and 111 patients (74%) presented a residual MR mild or less (1+). At three-year follow-up patient success was 81.2%±3.8% and 32 patients (64%) had a residual MR mild or less (1+). Patient success was significantly different according to anatomical type (P=0.001). Echocardiographic analysis showed a significant acute left ventricle and left atrial reverse remodeling that was maintained up to three years. CONCLUSIONS: The NeoChord echo-guided transapical beating heart repair procedure demonstrated good clinical outcomes and echocardiographic results up to three-year follow-up.

Coronavirus disease 2019 (COVID-19) in the heart transplant population: a single-centre experience.

OBJECTIVES: Few anecdotal cases have been reported in the literature regarding heart transplant recipients and infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report our experience with 6 patients hospitalized in Northern Italy during the outbreak. METHODS: Of the 396 living heart transplant recipients from 1985 to 2020 included in the study, 6 patients developed the novel 2019 coronavirus disease. Risk factors, last follow-up characteristics, onset presentation, in-hospital course of disease and blood examinations data were collected for these patients. RESULTS: All patients were symptomatic and had positive results from a nasopharyngeal swab test for SARS-CoV-2. Of the 6 patients, 5 were hospitalized and 1 remained self-quarantined at home. Two patients died and 3 were discharged home. Two patients were admittted to the intensive care unit . Immunosuppressive therapy was modified with a median reduction comprising doses that were 50% cyclosporine and 50% mycophenolate. All patients received a medium-dose of corticosteroids as a bolus medication in addition to their therapy. All hospitalized patients received hydroxychloroquine; 2 patients received ritonavir/lopinavir. Broad-spectrum antibiotics for prophylaxis were administered to all. One patient had an ischaemic stroke and died of sepsis. CONCLUSIONS: In the absence of any strong evidence regarding the treatment of heart transplant recipients infected with SARS-CoV-2, we faced a new challenge in managing viral infection in an immunosuppressed population. Because immunomodulation interaction with the infection seems to be crucial for developing severe forms of the disease, we managed to reduce immunosuppressive therapy by adding medium doses of corticosteroids. Despite the limited number of affected patients, this report suggests that special considerations should be given to treating coronavirus disease in the heart transplant recipient population.

Transcatheter Mitral Valve Chordal Repair: Current Indications and Future Perspectives.

Transcatheter Mitral Valve Repair (TMVRe) technologies constitute a rapidly expanding field, and have the potential of being adopted as a valuable alternative to surgery in selected patients. TMVRe devices can be distinguished depending on the targeted part of the Mitral Valve (MV) apparatus. Standard classification includes leaflet repair, direct/indirect annuloplasty, chordal repair, and ventricular/chamber remodeling devices. We present the current device situation on chordal repair technologies. Nowadays, transapical off-pump beating heart chordal implantation procedure has become a safe and reproducible option for Degenerative Mitral Regurgitation (DMR). Besides the truly minimally-invasiveness of the procedure, another unique advantage offered by a beating-heart chordal implantation is the real-time assessment of chordal length adjustment during heart cycle with a normally filled left ventricle. Currently, one system is commercially available in Europe, the NeoChord DS 1000 (NeoChord, Inc., St. Louis Park, MN) and the Harpoon TDS-5 (Edwards Lifesciences, Irvine, CA) should become available soon. There is also a diffuse and strong interest to move from a transapical procedure toward a fully transcatheter (transfemoral and transeptal) procedure as shown by the increased number of preclinical programs under development. Interestingly, to achieve outcomes that equate to those of open surgery in DMR, transcatheter therapies will need to follow rigid indications due to strict patient selection criteria for each device, or adopt multiple techniques in a single repair procedure for complex MV disease. Continuous analysis of current clinical results together with future dedicated trial will be of extreme importance to foster the new and upcoming field of transcatheter MV therapy technology development.

Mechanisms of recurrent regurgitation after transapical off-pump mitral valve repair with neochord implantation†.

OBJECTIVES: The aim of this study was to describe possible mechanisms of recurrent mitral regurgitation (MR) in patients who have been treated with the NeoChord procedure. METHODS: Patients presenting with recurrent severe or moderate MR were categorized as Not Expected Surgical-Like Result (NESLR)-Redo and NESLR-MR2 [NESLR reintervention or moderate MR (2+), respectively]. NESLR patients were stratified by onset (intraoperative, perioperative 24 h-30 days, or early 30 days to follow-up), by MR jet direction (central or eccentric) and by jet orientation (anterior or posterior). Specific mechanisms of NESLR were analysed. RESULTS: Fifty-two patients were identified with 13 (25%) categorized as NESLR-Redo, and 39 (75%) as NESLR-MR2. NESLR-Redo patient stratification included: intraoperative = 2 patients (1.2%), both eccentric anteriorly directed jets; perioperative = 7 patients (4.2%), all eccentric with 3 anteriorly and 4 posteriorly directed jets; and early = 4 patients (2.4%), 1 central, 3 eccentric, 2 posteriorly and 1 anteriorly directed jets. NESLR-MR2 patient stratification included: perioperative = 2 patients (5.1%), both eccentric, 1 anteriorly and 1 posteriorly directed jets; and early = 37 patients (94.9%), 4 central, 33 eccentric, 22 anteriorly and 11 posteriorly directed jets. Possible mechanisms of recurrent MR were identified as: patient selection (17.3%), technical issues (28.8%), progression of baseline disease (15.4%), left ventricle reverse remodelling (1.9%), excessive over-tensioning (35.8%) and PML curling (30.8%). CONCLUSIONS: The mechanisms of recurrent MR after the NeoChord procedure can be determined. Understanding recurrent MR mechanisms has led to improvements in procedural standardization and ad hoc prevention strategies that have been widely adopted since our initial clinical experience.

Learning curve analysis of transapical NeoChord mitral valve repair.

OBJECTIVES: Transapical off-pump mitral valve intervention with neochordae implantation is a novel, minimally invasive procedure for treatment of degenerative mitral valve regurgitation. The aim of this study was to apply control charts (CUSUM curves) to monitor the performance of NeoChord repair during the initial phase of its adoption. METHODS: The first 112 consecutive patients who underwent NeoChord repair at our institution between November 2013 and March 2016 were included in the analysis. Mitral Valve Academic Research Consortium criteria for 1-year patient success was utilized to determine failed procedures. Control charts had predetermined acceptable and unacceptable failure rates of 5% and 15%, respectively. RESULTS: The actual incidence of 1-year-patient failure was 11% (12 of 112 cases), with a cluster of failures within the first 20 cases. The CUSUM analysis demonstrated an initial learning curve; however, the upper boundary (alarm line) was never crossed. The reassurance line was first crossed after 40 procedures and performance remained stable after 49 procedures. CONCLUSIONS: NeoChord repair is a safe procedure, and the results are maintained through the 1-year follow-up. A relative high number of implants were required to overcome the learning curve at our institution due to the concurrent development of patient selection criteria and the technical refinement of the procedure. Future studies are needed to assess the evolution of the learning curve after the wide adoption of the procedure across European and North American centres.

Transapical NeoChord mitral valve repair.

Transapical off-pump mitral valve repair (MVr) with NeoChord implantation has become widely applied in Europe for patients presenting with severe mitral regurgitation due to leaflet prolapse or flail. The procedure is performed under real-time 2D- and 3D-transesophageal echocardiography (TEE) for both implantation and neochordae tension adjustment allowing real-time monitoring of hemodynamic recovery. Preoperative anatomic and echocardiographic selection criteria, procedure refinement, as well as innovative ex-vivo surgical simulator training have been developed and strategically employed in the past few years, to generate a robust precision-based procedural framework with significantly enhanced operator use, patient safety and clinical outcomes. The procedure has evolved into a reproducibly successful and safe approach, which complements existing surgical treatment strategies available to eligible patients with chronic severe degenerative mitral regurgitation.