A novel versatile concept of cardioplegia delivery in cardiac surgery: The ReverseTWO cardioplegia circuit system.

Nowadays, the necessity of having a cardioplegia circuit capable of being adapted in order to administer different types of cardioplegia is strategically fundamental, both for the perfusionist and for the cardiac surgeon. This allows to avoid cutting tubes, guarantees sterility and, most of all, limits the number of cardioplegia circuits for the different strategies of cardiac arrest. The novel "ReverseTWO cardioplegia circuit system" is the development of the precedent "Reverse system" where mainly the 4:1 and crystalloid cardioplegia were used, It has the advantage of allowing immediate change of cardioplegia set-up versus four types of cardioplegia technique, when the strategy is unexpectedly changed before the beginning of cardiopulmonary bypass (CPB), is safe and enables the perfusionist to use one single custom pack of cardioplegia. Two pediatric roller pumps are usually used in our centre for cardioplegia administration; they have a standardized calibration (the leading with » inch and the follower with 1/8 inch) and the circuit consequently has two different tube diameters for the two different pumps. The presence in the circuit of two different shunts coupled with two different coloured clamps allows the immediate set-up for different cardioplegia administration techniques utilizing a colour-coding mechanism The aim of this manuscript is to present the new ReverseTWO Circuit. This novel system allows to administer four different cardioplegic solutions (4:1, 1:4, crystalloid, ematic) based on multiple tubes, which can be selectively clamped, identified through a color-coding method. The specificity of this circuit is the great versatility, which leads to numerous advantages, such as reduced risk of perfusion accident and reduced costs related not only to the purchase of different cardioplegia kits but also to the storage. https://youtu.be/ovJBE4ok2Ds.

Direct oral anticoagulants in patients with nonvalvular atrial fibrillation and extreme body weight.

BACKGROUND: Limited clinical data exist describing the use of direct oral anticoagulants (DOACs) in patient with extreme body weight. Thus, the International Society of Thrombosis and Haemostasis (ISTH) recommends avoiding DOACs in patients with weight >120 Kg, and on the contrary, no restrictions exist for underweight patients. OBJECTIVE: To evaluate the effects of extreme body weight on DOAC activity and to compare the clinical outcomes of patients with an extreme body weight versus patients with a normal weight (61-119 Kg) treated with DOACs. METHODS: Single tertiary care Italian centre multidisciplinary registry including nonvalvular atrial fibrillation (NVAF) patients treated with DOACs. Based on weight, three subcohorts were defined: (i) underweight patients (≤60 Kg); (ii) patients with a normal weight (61-119 Kg, as control group); and (iii) overweight patients (≥120 Kg). Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test. RESULTS: 812 NVAF patients were included, 108 patients weighed ≤60 Kg (13%, underweight), 688 weighed between 61 and 119 Kg (85%, normal weight), and 16 weighed ≥120 Kg (2%, overweight). In particular, among underweight patients, dabigatran was prescribed in 26% patients, apixaban in 27%, rivaroxaban in 28% and edoxaban in 22% ones. Instead, among overweight patients, 44% were treated with dabigatran, 25% with apixaban, 25% with rivaroxaban and 4% with edoxaban. Underweight patients were older, more frequently women, with lower creatinine clearance and a history of previous strokes, resulting in higher CHA2DS2-VASc score than in both remaining groups. Up to 2 years, no statistically significant difference was observed between the three groups of weight for thromboembolic events (P = .765) and for overall bleeding (P = .125), but a trend towards decreased overall bleeding rates was noticed as weight increased (24.1% vs 16.7% vs 12.5%, respectively). CONCLUSION: In this tertiary care centre registry, 15% of patients treated with DOACs presented an extreme weight. Compared to patients with a normal weight, no significant rates of thromboembolic events were observed for underweight or overweight patients. A trend towards decreased overall bleeding frequency as weight increased was highlighted up to 2 years. The present results should be considered as preliminary and hypothesis generating.

Clinical characteristics and outcomes of patients with ventricular arrhythmias after continuous-flow left ventricular assist device implant.

BACKGROUND: Ventricular arrhythmias (VAs) are observed in 25%-50% of continuous-flow left ventricular assist device (CF-LVAD) recipients, but their role on mortality is debated. METHODS: Sixty-nine consecutive patients with a CF-LVAD were retrospectively analyzed. Study endpoints were death and occurrence of first episode of VAs post CF-LVAD implantation. Early VAs were defined as VAs in the first month after CF-LVAD implantation. RESULTS: During a median follow-up of 29.0 months, 19 patients (27.5%) died and 18 patients (26.1%) experienced VAs. Three patients experienced early VAs, and one of them died. Patients with cardiac resynchronization therapy (CRT-D) showed a trend toward more VAs (p = 0.076), compared to patients without CRT-D; no significant difference in mortality was found between patients with and without CRT-D (p = 0.63). Patients with biventricular (BiV) pacing ≥98% experienced more frequently VAs (p = 0.046), with no difference in mortality (p = 0.56), compared to patients experiencing BiV pacing <98%. There was no difference in mortality among patients with or without VAs after CF-LVAD [5 patients (27.8%) vs. 14 patients (27.5%), p = 0.18)], and patients with or without previous history of VAs (p = 0.95). Also, there was no difference in mortality among patients with a different timing of implant of implantable cardioverter-defibrillator (ICD), before and after CF-LVAD (p = 0.11). CONCLUSIONS: VAs in CF-LVAD are a common clinical problem, but they do not impact mortality. Timing of ICD implantation does not have a significant impact on patients' survival. Patients with BiV pacing ≥98% experienced more frequently VAs.

Fate of moderate secondary mitral regurgitation in patients undergoing aortic valve replacement for severe aortic regurgitation.

OBJECTIVES: Moderate secondary mitral regurgitation is common in patients with severe aortic regurgitation, but whether it has to be addressed at the time of aortic valve surgery remains unclear. With this study, we evaluated the long-term fate of moderate secondary mitral regurgitation in this specific scenario. METHODS: Between January 2004 and January 2018, in 154 patients admitted to our institution for treatment of severe aortic regurgitation, a moderate secondary mitral regurgitation was diagnosed. Ninety-four patients underwent isolated aortic valve replacement (group 1) and 60 patients underwent also concomitant mitral valve annuloplasty (group 2). RESULTS: One death (1.1%) occurred in group 1, whereas two deaths (3.3%) occurred in group 2 (p = .561). At 11 years, the cumulative incidence function of cardiac death, with noncardiac death as a competing risk was 11.5 ± 5.11% in group 1 and 8.3 ± 5.15% in group 2 (p = .731). The cumulative incidence function of mitral valve reintervention, with death as a competing risk, was 3.7 ± 2.61% in group 1 and 4.5 ± 4.35% in group 2 (p = .620) at 11 years. Secondary mitral regurgitation improved to ≤mild in 66% and 76% of the survivors of group 1 and group 2, respectively (p = .67). CONCLUSIONS: In our experience, in patients with moderate secondary mitral regurgitation undergoing aortic valve replacement for severe aortic regurgitation, concomitant mitral valve annuloplasty did not improve the long-term survival, the incidence of cardiac death and mitral valve reoperation or the evolution of the mitral valve disease.

Characterization of the electrophysiological substrate in patients with Barlow's disease.

BACKGROUND: Myxomatous mitral valve prolapse (MVP) and mitral-annular disjunction (Barlow disease) are at-risk for ventricular arrhythmias (VA). Fibrosis involving the papillary muscles and/or the infero-basal left ventricular (LV) wall was reported at autopsy in sudden cardiac death (SCD) patients with MVP. OBJECTIVES: We investigated the electrophysiological substrate subtending VA in MVP patients with Barlow disease phenotype. METHODS: Twenty-three patients with VA were enrolled, including five with syncope and four with a history of SCD. Unipolar (Uni < 8.3 mV) and bipolar (Bi < 1.5 mV) low-voltage areas were analyzed with electro-anatomical mapping (EAM), and VA inducibility was evaluated with programmed ventricular stimulation (PES). Electrophysiological parameters were correlated with VA patterns, electrocardiogram (ECG) inferior negative T wave (nTW), and late gadolinium enhancement (LGE) assessed by cardiac magnetic resonance. RESULTS: Premature ventricular complex (PVC) burden was 12 061.9 ± 12 994.6/24 h with a papillary-muscle type (PM-PVC) in 18 patients (68%). Twelve-lead ECG showed nTW in 12 patients (43.5%). A large Uni less than 8.3 mV area (62.4 ± 45.5 cm2 ) was detected in the basal infero-lateral LV region in 12 (73%) patients, and in the papillary muscles (2.2 ± 2.9 cm2 ) in 5 (30%) of 15 patients undergoing EAM. A concomitant Bi less than 1.5 mV area (5.0 ± 1.0 cm2 ) was identified in two patients. A history of SCD, and the presence of nTW, and LGE were associated with a greater Uni less than 8.3 mV extension: (32.8 ± 3.1 cm2 vs. 9.2 ± 8.7 cm2 ), nTW (20.1 ± 11.0 vs. 4.1 ± 3.8 cm2 ), and LGE (19.2 ± 11.7 cm2 vs. 1.0 ± 2.0 cm2 , p = .013), respectively. All patients with PM-PVC had a Uni less than 8.3 mV area. Sustained VA (ventricular tachycardia 2 and VF 2) were induced by PES only in four patients (one with resuscitated SCD). CONCLUSIONS: Low unipolar low voltage areas can be identified with EAM in the basal inferolateral LV region and in the papillary muscles as a potential electrophysiological substrate for VA and SCD in patients with MVP and Barlow disease phenotype.

Use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: A multicenter observational experience (MITRA-SHOCK study).

OBJECTIVES: The aim of this study was to evaluate the impact of edge-to-edge PMVR on short and mid-term clinical outcomes in patients with CS and severe MR. BACKGROUND: Severe mitral regurgitation (MR) in the setting of cardiogenic shock (CS) is associated with three times higher risk of 1-year mortality. In refractory CS, edge-to-edge percutaneous mitral valve repair (PMVR) can be a potential therapeutic option. METHODS: We retrospectively included consecutive patients with refractory CS and concomitant severe MR treated with MitraClip® system. CS was defined according to the criteria used in the SHOCK trial and procedural success according to Mitral Valve Academic Research Consortium (MVARC) criteria. The 30-day and 6-month mortality were the primary and secondary endpoints respectively. RESULTS: Thirty-one patients (median age 73 years [interquartile range, IQR 66-78], 25.8% female), STS mortality score 37.9 [IQR 30.4-42.4]), with CS and concomitant severe MR treated with edge-to-edge PMVR were retrospectively enrolled. Procedural success was 87.1%. Thirty-day and 6-month survival rates were 78.4 and 45.2% respectively. Univariate Cox Regression Model analysis showed that procedural success was a predictor of both 30-day (HR = 0.12, 95% CI 0.03-0.55, p < .01) and 6-month survival (HR = 0.22, 95% CI 0.06-0.84, p = .027). CONCLUSIONS: Edge-to-edge PMVR in patients with CS and concomitant severe MR was associated with good procedural safety and success with acceptable short and mid-term survival rates. It could be considered a bailout option in this setting of patients.

Impact of surgical timing on survival in patients with infective endocarditis: a time-dependent analysis.

The purpose of this study was to evaluate the impact of surgical timing on survival in patients with left-sided infective endocarditis (IE). This was a retrospective study including 313 patients with left-sided IE between 2009 and 2017. Surgery was defined as urgent (US) or early (ES) if performed within 7 or 28 days, respectively. A multivariable Cox regression analysis including US and ES as time-dependent variables was performed to assess the impact on 1-year mortality. ES was associated with a better survival (aHR 0.349, 95% CI 0.135-0.902), as US (aHR 0.262, 95% CI 0.075-0.915). ES and US were associated with a better prognosis in patients with left-sided IE.

Aortic and mitral bioprosthetic valve dysfunction: surgical or percutaneous solutions?

In the last years, there has been a trend to prefer biological prostheses, especially among young patients, with the aim to avoid anticoagulant treatment. Surgical tissue valves have so far demonstrated their solid long-term durability. However, younger age has been identified as one of the main risk factors for developing structural valve deterioration (SVD). As a consequence, the proportion of subjects at risk for valve dysfunction will constantly rise in the near future. However, while surgical reintervention has always been considered the gold standard for treatment of prosthesis deterioration, the introduction of transcatheter heart valves could offer new therapeutical options, particularly among high-risk patients, aiming a second less invasive chance. The recent standardization of valve durability definitions will soon allow a more comprehensive understanding of the mechanism underlying SVD and guide the choice of prosthesis for patients needing valve replacement.

Is mitral annuloplasty an effective treatment for severe atrial functional mitral regurgitation?

INTRODUCTION: Unlike secondary mitral regurgitation (MR) in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken. The aim of this study is to analyze short to midterm results of isolated ring annuloplasty in patients with severe atrial functional MR, in comparison with a matched cohort of patients with secondary MR. METHODS: A retrospective review of our Institutional database was carried out to find all patients fulfilling strict echocardiographic criteria to define atrial functional MR. A control group of patients with MR secondary to ventricular disease was selected. All patients underwent mitral repair by means of isolated ring annuloplasty. Mortality, reoperation for severe MR, and recurrence of MR were assessed by clinical and echocardiographic follow-up. Cumulative incidence function (CIF) of recurrence of MR using death and reoperation as the competitive risk was used. RESULTS: Twenty patients were selected for the study group and 25 for the control group. There were no differences between the two groups in terms of mortality and reoperation rate. At 2 years, the CIF of recurrence of MR ≥ 3+ and ≥ 2+ was significantly higher in patients with secondary MR compared to patients with atrial functional MR (20.8 ± 8.29% vs 5.9 ± 5.71% and 45.8 ± 10.17% vs 5.9 ± 5.71%) CONCLUSION: In patients with severe atrial functional MR, mitral valve repair by means of isolated ring annuloplasty seems a more effective and durable treatment as compared to patients with MR secondary to ventricular disease. Larger cohorts with longer follow up are needed to confirm these results.

First-in-man Valve-in-Valve with the new balloon-expandable Myval transcatheter heart valve in a failed sutureless Perceval bioprosthesis.

Sutureless aortic bioprostheses were introduced more than ten years ago, with the aim of decreasing cross-clamp time and thus becoming the first choice in older patients for many surgeons. However, published data are limited to a 5-year follow-up, and some cases of deterioration have already been described. High-risk patients who once have benefitted from a fast sutureless aortic replacement and now are experiencing a prosthesis dysfunction, could take advantage of a percutaneous Valve-in-Sutureless technique. Furthermore, thanks to technological improvement, new transcatheter prostheses have been designed, allowing a more precise positioning. In this report, we described the first Myval-in-Perceval case, which resulted in a safe and effective procedure.

Fate of mild-to-moderate bicuspid aortic valve disease untreated during ascending aorta replacement.

BACKGROUND: Bicuspid aortic valve (BAV) is the most common congenital heart defect and it is responsible for an increased risk of developing aortic valve and ascending aorta complications. In case of mild to moderate BAV disease in patients undergoing supracoronary ascending aorta replacement, it is unclear whether a concomitant aortic valve replacement should be performed. METHODS: From June 2002 to January 2020, 75 patients with mild-to-moderate BAV regurgitation (±mild-to-moderate stenosis) who underwent isolated supracoronary ascending aorta replacement were retrospectively analyzed. Clinical and echocardiographic follow-up was 100% complete (mean: 7.4 ± 3.9 years, max: 16.4). Kaplan-Meier estimates were employed to analyze long-term survival. Cumulative incidence function (CIF) for time to reoperation, recurrence of aortic regurgitation (AR) ≥3+ and aortic stenosis (AS) greater than moderate, with death as competing risk, were computed. RESULTS: There was no hospital mortality and no cardiac death occurred. Overall survival at 12 years was 97.4 ± 2.5%, 95% confidence interval (CI: 83.16-99.63). At follow-up there were no cases of aortic root surgery whereas three patients underwent AV replacement. At 12 years the CIF of reoperation was 2.6 ± 2.5%, 95% CI [0.20-11.53]. At follow-up, AR 3+/4+ was present in 1 pt and AS greater than moderate in 3. At 12 years the CIF of AR more than 2+/4+ was 5.1 ± 4.98% and of AS more than moderate 6.9 ± 3.8%. CONCLUSIONS: In our study mild to moderate regurgitation of a BAV did not do significantly worse at least up to 10 years after isolated supracoronary ascending aorta replacement.

Complicated postoperative course in isolated tricuspid valve surgery: Looking for predictors.

BACKGROUND: This study aims at better defining the profile of patients with a complicated versus noncomplicated postoperative course following isolated tricuspid valve (TV) surgery to identify predictors of a favorable/unfavorable hospital outcome. METHODS: All patients treated with isolated tricuspid surgery from March 1997 to January 2020 at our institution were retrospectively reviewed. Considering the complexity of most of these patients, a regular postoperative course was arbitrarily defined as a length-of-stay in intensive care unit less than 4 days and/or postoperative length-of-stay less than 10days. Patients were therefore divided accordingly in two groups. RESULTS: One hundred and seventy-two patients were considered, among whom 97 (56.3%) had a regular (REG) and 75 (43.6%) a non-regular (NEG) postoperative course. The latter had worse baseline clinical and echocardiographic characteristics, with higher rate of renal insufficiency, previous heart failure hospitalizations, cardiac operations, and right ventricular dysfunction. NEG patients more frequently needed tricuspid replacement and experienced a greater number of complications (p < .001) and higher in-hospital mortality (13% vs. 0%, p < .001). The majority of these complications were related to more advanced stage of the tricuspid disease. Among most important predictors of a negative outcome univariate analysis identified chronic kidney disease, ascites, previous right heart failure hospitalizations, right ventricular dysfunction, previous cardiac surgeries, TV replacement and higher MELD scores. At multivariate analysis, liver enzymes and diuretics' dose were predictors of complicated postoperative course. CONCLUSION: In isolated TV surgery a complicated postoperative course is observed in patients with more advanced right heart failure and organ damage. Earlier surgical referral is associated to excellent outcomes and should be recommended.

Severe aortic stenosis in the young, with or without bicuspid valve: is transcatheter aortic valve implantation the first choice?

During the last decade, transcatheter aortic valve implantation (TAVI) has represented a valid alternative to surgical aortic valve replacement in patients with aortic stenosis and elevated surgical risk. Recent randomized clinical trials reported excellent results also for patients at low surgical risk, but in clinical practice, the mean age of the patients treated remain over 75 years, and the presence of a bicuspid aortic valve still represents an important exclusion criteria. Today, aortic valve replacement with a mechanical prosthesis remains the treatment of choice for young adults with aortic stenosis, although the desire to avoid oral anticoagulants drives more patients younger than 65 years of age towards biological prostheses. Furthermore, despite the follow-up of patients after TAVI is still limited to a few years, the opportunity of a second percutaneous treatment (TAVI-in-TAVI), extends the scope of percutaneous strategy. In the next few years, TAVI has to face many challenges to become a valid alternative to surgery in the younger patients as well.

Emergency aortic arch replacement using the debranch-first technique with a custom-made prosthesis.

Acute aortic arch dissections represent life-threatening conditions with a high rate of mortality and neurological complications. Past longer techniques included an "en bloc" replacement of epiaortic vessels or the frozen elephant trunk (FET) procedure with conventional grafts for chronic dilatation. In this report, we described a case of an acute aortic dissection in a patient with aberrant right subclavian artery and challenging sovra-aortic vessel anatomy, treated with the new custom-made E-Vita Open Plus FET graft.

Mesothelial or monocytic incidental cardiac excrescence on anterior leaflet of mitral valve.

Mesothelial or monocytic incidental cardiac excrescence (MICE) is a rare, benign lesion composed of a mixture of mesothelial and inflammatory cells, histiocytes and fibrin without a vascular network usually accidentally found during cardiac surgery or after cardiac catherization. We report the case of a 45-year-old man admitted for suspected myxoma on the mitral valve. The lesion was removed via a minimally invasive video-assisted approach, without compromising the valve competency. The histopathological exam led to the diagnosis of MICE. The 2-year follow-up echocardiography confirmed normal mitral function without recurrence. Most of the cases were treated concomitantly to other cardiac procedure, lesions were more frequently founded in the left cardiac chambers or valves, our experience suggest that these lesions should be safely treated alone by surgical removal, to prevent embolic events.

Self-expandable valve-in-valve treatment for failing sutureless aortic bioprosthesis.

Aortic valve replacement still represents the gold standard treatment for severe symptomatic aortic stenosis. Sutureless bioprostheses have been so far developed to enhance the minimally invasive approach, resulting in a reduction of cross-clamp time. Even if the first implantation was carried out more than 10 years ago, some cases of valve degeneration treated with balloon-expandable valve-in-valve procedures have been previously described in the literature. Here, we present a case of early sutureless valve degeneration resulting in severe aortic regurgitation. After careful evaluation of the patient's comorbidities, a successful valve-in-valve was finally performed using a self-expandable transcatheter prosthesis. A wide discussion of the Heart Team decision-making process and of the technical aspects has been addressed.

Mid-term outcomes (up to 5 years) of percutaneous edge-to-edge mitral repair in the real-world according to regurgitation mechanism: A single-center experience.

OBJECTIVES: To report mid-term results after MitraClip repair, according to mitral regurgitation (MR) mechanism, in a real-world single-center experience. BACKGROUND: Mid-term outcomes of percutaneous edge-to-edge mitral repair in the real world are still limited. METHODS: We assessed the follow-up results of patients treated with MitraClip at a single high-volume mitral center from 2008 to 2016. All patients underwent Heart-Team discussion, prospective data collection and enrolment in a dedicated outpatient clinic. Functional (FMR, n = 242, 68.6%) and degenerative (DMR, n = 97, 27.5%) MR patients were separately analyzed. RESULTS: 5-Year survival was 53.5 ± 4.5% in FMR vs 57.1 ± 7.5% in DMR (P = 0.087). Reduced survival was strongly associated with worse left ventricle remodeling (ESV HR 1.01, CI 1.01-1.02, P < 0.001) in FMR, and with worse symptoms (New York Heart Association IV HR 6.72, CI 1.78-25.45, P = 0.005) in DMR. 5-Year cumulative incidence function for MR ≥ 3 was 23.7 ± 3.4% in FMR vs 27.9 ± 5.9% in DMR (P = 0.39), being associated with residual MR = 2 both in FMR (HR 4.67, CI 2.49-8.74, P < 0.001) and DMR (HR 7.15, CI 2.72-18.75, P < 0.001). At 5-year, patients in NYHA class I-II increased from 17.9% to 45.3% in FMR (P < 0.001) and from 33.3% to 51.3% in DMR (P < 0.001). CONCLUSIONS: In this single-center real-world experience, 5-year after MitraClip, half of the patients were alive and 3/4 were free from MR, both in FMR and DMR. Symptoms benefit was sustained in both groups. Advanced ventricular remodeling, advanced symptoms, and suboptimal MR reduction were associated with worse results. Refined patient selection, improved efficacy and more data will be all required to improve long-term outcomes.

Mycobacterium chimaera in heater-cooler units: new technical approach for treatment, cleaning and disinfection protocol.

Mycobacterium chimaera infections have mainly been associated with the heater-cooler unit (HCU) and, ultimately, linked to contaminated aerosols in the operation room. The contamination status of HCUs seems to be influenced by the maintenance, therefore, according to the manufacturer's recommendations, peracetic acid (Puristeril) was introduced to increase HCU cleaning and disinfection protocol maintenance. Aerosol dispersion from Puristeril during maintenance can cause adverse effects to nearby workers. We aim to describe our technique to reduce the impact of Puristeril on operating room staff and to limit dispersion of its aerosol in the environment by performing the cleaning procedure through a closed circuit.

Late Retrograde Migration of a Left Subclavian Artery Chimney Stent-Graft Into the Innominate Artery.

PURPOSE: To report an uncommon case of chimney stent-graft migration in the aortic arch. CASE REPORT: A 29-year-old man presented with chronic left arm hyposthenia after late displacement and thrombosis of a left subclavian artery (LSA) chimney graft that migrated retrogradely into the innominate artery 2 years after deployment. The self-expanding LSA chimney was placed during a redo procedure to repair a pseudoaneurysm and type I endoleak after an index emergency thoracic endovascular aortic repair for traumatic aortic rupture 1 year earlier. The patient was successfully treated in an elective procedure via a median sternotomy, with arch aortotomy under circulatory arrest to remove the proximal end of the thrombosed chimney graft from the ostium of the innominate trunk. Three months later, a left carotid-to-subclavian bypass was performed to restore flow to the left arm. CONCLUSION: Migration of the proximal end of an overly long chimney graft that moved freely in the aortic arch exposed the patient to a high risk of stroke and death. Because of the high-risk situation, open repair under circulatory arrest was elected to remove the proximal end of the chimney graft, with no major complications.

E-vita OPEN NEO in the treatment of acute or chronic aortic pathologies: first interim results of the NEOS study.

OBJECTIVES: The aim of this multicentre study was to demonstrate the safety and clinical performance of E-vita OPEN NEO Stent Graft System (Artivion, Inc.) in the treatment of aneurysm or dissection, both acute and chronic, in the ascending aorta, aortic arch and descending thoracic aorta. METHODS: In this observational study of 12 centres performed in Europe and in Asia patients were enrolled between December 2020 and March 2022. All patients underwent frozen elephant trunk using E-vita OPEN NEO Stent Graft System. Primary end point was the rate of all-cause mortality at 30 days and secondary end points included further clinical and safety data are reported up to 3-6 months postoperatively. RESULTS: A total of 100 patients (66.7% male; mean age, 57.7 years) were enrolled at 12 sites. A total of 99 patients underwent surgery using the E-vita OPEN NEO for acute or subacute type A aortic dissection (n = 37), chronic type A aortic dissection (n = 33) or thoracic aortic aneurysm (n = 29), while 1 patient did not undergo surgery. Device technical success at 24 h was achieved in 97.0%. At discharge, new disabling stroke occurred in 4.4%, while new paraplegia and new paraparesis was reported in 2.2% and 2.2%, respectively. Renal failure requiring permanent (>90 days) dialysis or hemofiltration at discharge was observed in 3.3% of patients. Between discharge and the 3-6 months visit, no patients experienced new disabling stroke, new paraplegia or new paraparesis. The 30-day mortality was 5.1% and the estimated 6-month survival rate was 91.6% (standard deviation: 2.9). CONCLUSIONS: Total arch replacement with the E-vita OPEN NEO can be performed with excellent results in both the acute and chronic setting. This indicates that E-vita OPEN NEO can be used safely, including in the setting of acute type A aortic dissection.