Standardized in vitro bleeding tests in a non-coated novel hybrid prosthesis for frozen elephant trunk demonstrates minimal oozing during full heparinization, supported by clinical data.

Introduction: Recent reports have questioned the blood impermeability of the novel frozen elephant trunk (FET) device E-vita Open NEO© (EO-NEO). Therefore, standardized in vitro bleeding tests using porcine heparinized blood were performed, as well as stress testing on the blood tightness of the collar suture line, to investigate this observation. Material and methods: EO-NEO prostheses were examined in vitro for blood permeability in three test series. Initially, antegrade perfusion with heparinized porcine blood [activated clotting time (ACT) of 500 s, with a 60 min duration] was performed, followed by ante/retrograde testing via the EO-NEO side port. Testing of the collar suture line under a tension of 10 Newton (N) within a suspension device (blood pressure 120 mmHg, ACT of 560 s, 1 min duration) was carried out with the suture material force fiber white (FFWs) yarn, using standard fixation (5 stitches/cm), FFWh yarn in hemostatic fixation (15 stitches/cm), and flow weave yarn (FWYh). Results: Blood permeability testing of EO-NEO through the prosthetic lumen or via the side port demonstrated minor leakage without statistical difference between the standard and hemostatic suture lines or suture materials used, or positioning on the crimped or tapered portion (p > 0.05). The specific collar anastomosis testing demonstrated leakage volumes of 140 ml/min for FFWs vs. 16 ml/min for FFWh (p = 0.02), vs. 9 ml/min with the FWYh (p = 0.01). Conclusion: Different blood leakage tests showed minimal oozing and no difference in blood loss through the fabric and different collar suture lines, but unphysiological pressurized retrograde perfusion of the collar region showed significantly less leakage using FWYh and FFWh, prompting production modification of EO-NEO. Clinical results confirmed low blood loss using this novel FET device.

Limited versus Radical Resection in Mitral Valve Infective Endocarditis Surgery.

Background: Mitral valve repair is preferred in patients undergoing surgical treatment for infective endocarditis (IE) of the native mitral valve, however, radical resection of infected tissue and patch-plasty might potentially lead to low or non-durable repair. We aimed to compare a limited-resection and non-patch technique with the classic radical-resection technique. Methods: Eligible candidates were patients with definitive IE of the native mitral valve undergoing surgery between January 2013 and December 2018. Patients were classified according to the surgical strategy into two groups: limited- versus radical-resection strategy. Propensity score matching was used. Endpoints were repair rate, all-cause mortality (30-day and 2-year), re-endocarditis and reoperation at q-year follow-up. Results: After propensity score matching, 90 patients were included. Follow-up was 100% complete. Mitral valve repair rate was 84% in the limited-resection versus 18% in the radical-resection strategy, p < 0.001. The 30-day and 2-year mortality were 20% versus 13% (p = 0.396) and 33% versus 27% (p = 0.490) in the limited-resection versus radical-resection strategy, respectively. The incidence of re-endocarditis during the 2-year follow-up was 4% in the limited-resection strategy versus 9% in the radical-resection strategy, p = 0.677. Three patients in the limited-resection strategy underwent reoperation of the mitral valve, while there were none in the radical-resection strategy (p = 0.242). Conclusions: Although mortality in patients with IE of the native mitral valve remains high, the limited-resection and non-patch surgical strategy is associated with a significantly higher repair rates with comparable 30-day and mid-term mortality, risk of re-endocarditis and re-operation compared to the radical-resection strategy.

Role of Antiplatelet Therapy in Patients with Severe Coronary Artery Disease Undergoing Coronary Artery Endarterectomy within Coronary Artery Bypass Surgery.

Background-Coronary endarterectomy (CEA) has been introduced to allow revascularization in end-stage coronary artery disease (CAD). After CEA, the injured remnants of the vessel's media could result in fast neo intimal tissue ingrowth, which require an anti-proliferation agent (antiplatelet therapy (APT). We aimed to review outcomes of patients undergoing CEA within bypass surgery who received either single-APT (SAPT) or dual-APT (DAPT). Methods-We retrospectively evaluated 353 consecutive patients undergoing CEA within isolated coronary artery bypass grafting (CABG) in the period 01/2000-07/2019. After surgery, patients received either SAPT (n = 153), or DAPT (n = 200) for six months then lifelong SAPT. Endpoints included early, late survival, and freedom from major-adverse-cardiac and cerebrovascular events (MACCE), which were defined as incidence of stroke, myocardial infarction, need for coronary intervention (PCI or CABG) or death for any cause. Results-Patients' mean age was 67 ± 9.3 years; they were predominantly male 88.1%. Both DAPT- and SAPT-groups had the same extent of CAD (mean SYNTAX-Score-II: 34.1 ± 11.6 vs. 34.4 ± 17.2, p = 0.91). Postoperatively, no difference between DAPT- and SAPT-groups was reported in the incidence of low-cardiac-output syndrome (5% vs. 9.8%, p = 0.16), revision for bleeding (5% vs. 6.5% p = 0.64), 30-day mortality (4.5% vs. 5.2%, p = 0.8) or MACCE (7.5% vs. 11.8%, p = 0.19). Imaging follow-up reported significantly higher CEA and total grafts patency (90% vs. 81.5% and 95% vs. 81%, p = 0.017) in DAPT patients. Late outcomes within 97.4 ± 67.4 months show lower incidence of overall mortality (19 vs. 51%, p < 0.001) and MACCE (24.5 vs. 58.2%, p < 0.001) in the DAPT patients when compared with SAPT patients. Conclusions-Coronary endarterectomy allows revascularization in end-stage CAD when the myocardium is still viable. The use of dual APT after CEA for at least six months seems to improve mid-to-long-term patency rates and survival, and reduced the incidence of major adverse cardiac and cerebrovascular events.

Outcomes of Patients Undergoing Closed Traction CoronaryEndarterectomy: A Long-Term Single Center Study.

Background-Coronary endarterectomy (CEA) is an option for treating severely diffused coronary artery diseases; however, many surgeons avoid performing it due to its complexity and reported controversial results. Therefore, we aimed to review the results of patients undergoing CEA within coronary artery bypass grafting (CABG). Methods-This is a retrospective observational study evaluating the results of patients undergoing CEA within CABG surgery between March 2003 and February 2018. Follow-up via active personal and/or telephone interviews was performed to evaluate long-term clinical outcomes. The study endpoints included early postoperative incidence of myocardial infarction or cardiac mortality, long-term survival, and freedom from major adverse cardiac and cerebrovascular events (MACCE). Results-A total of 326 patients were included in this study for evaluation. The patients' mean age was 67 years; 88% were male, and most presented with three-vessel disease, reporting a mean SYNTAX score of 33.1 ± 12. Approximately 5.5% (n = 18) of the patients had undergone previous CABG surgery. A total of 394 CEAs within a mean of 4.3 ± 1.1 grafts per patient were performed. The indication for CEA was either totally (n = 111, 28.2%) or sub-totally (n = 283, 71.8%) occluded coronary arteries. Early results included perioperative myocardial infarction in eight (2.4%), stroke in eight (2.4%), and in-hospital mortality in thirteen (4.0%) patients. Long-term clinical follow-up reported mortality in 27.6% and overall incidence of MACCE in 41.4% of the patients at the ten-year follow-up. Conclusions-Patients with severe and diffuse CAD are difficult candidates for surgical revascularization. CEA offers an option to allow complete revascularization, even in the case of chronic occlusion, when the myocardium is still viable. The closed traction CEA technique presented here is our preferred method; it achieves satisfactory short- and long-term results.

Five-Year Results of Coronary Artery Bypass Grafting With or Without Carotid Endarterectomy in Patients With Asymptomatic Carotid Artery Stenosis: CABACS RCT.

BACKGROUND: In patients with coronary artery disease and concomitant asymptomatic severe carotid stenosis, combined simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) has been widely performed despite lack of evidence from randomized trials. We recently showed that the risk of stroke or death within 30 days was higher following CABG+CEA compared with CABG alone. Here, we report long-term outcomes following CABG with versus without CEA. METHODS: The CABACS (Coronary Artery Bypass Graft Surgery in Patients With Asymptomatic Carotid Stenosis Study) is a randomized, controlled, multicenter, open trial. Patients with asymptomatic severe (≥70%) carotid stenosis undergoing CABG were allocated either CABG+CEA or CABG alone, and follow-up was 5 years. Major secondary end points included nonfatal stroke or death, any death and any nonfatal stroke. Due to low recruitment, the study was stopped prematurely after randomization of 127 patients in 17 centers. RESULTS: By 5 years, the rate of stroke or death did not significantly differ between groups (CABG+CEA 40.6% [95% CI, 0.285-0.536], CABG alone 35.0% [95% CI, 0.231-0.484]; P=0.58). Higher albeit statistically nonsignificant rates of nonfatal strokes occurred at any time following CABG+CEA versus CABG alone (1 year: 19.3% versus 7.1%, P=0.09; 5 years: 29.4% versus 18.8%, P=0.25). All-cause mortality up to 5 years was similar in both groups (CABG+CEA: 25.4% versus CABG alone: 23.3%, hazard ratio, 1.148 [95% CI, 0.560-2.353]; P=0.71). Subgroup analyses did not reveal any significant effect of age, sex, preoperative modified Rankin Scale and center on outcome events. CONCLUSIONS: During 5-years follow-up, combined simultaneous CABG+CEA was associated with a higher albeit statistically nonsignificant rate of stroke or death compared with CABG alone. This was mainly due to a nonsignificantly higher perioperative risk following CABG+CEA. Since the power of our study was not sufficient, no significant effect of either procedure could be observed at any time during follow-up. REGISTRATION: URL: http://www.controlled-trials.com; Unique identifier: ISRCTN13486906.

Early and midterm results of frozen elephant trunk operation with Evita open stent-graft in patients with Marfan syndrome: results of a multicentre study.

BACKGROUND: Endovascular treatment of patients with Marfan syndrome (MFS) is not recommended. Hybrid procedures such as frozen elephant trunk (FET), which combines stent-graft deployment with an integrated non-stented fabric graft for proximal grafting and suturing, have not been previously evaluated. The aim of this study was to assess the safety and feasibility of FET operation in patients with MFS. METHODS: Patients enrolled in the International E-vita Open Registry (IEOR) who underwent FET procedure between January 2001 and February 2020 meeting Ghent criteria for MFS were included in the study. Early and midterm results were retrospectively analyzed. Preoperative, postoperative and follow-up computed tomography angiography scans were analysed. RESULTS: We analyzed 37 patients [mean age 38 ± 11 years, 65% men]. Acute or chronic aortic dissection was present in 35 (95%) patients (14 and 21 patients respectively). Two (5%) patients had an aneurysm without dissection. Malperfusion syndrome was present in 4 patients. Twenty-nine (78%) patients had history of aortic surgical interventions. The 30-day and in-hospital mortality amounted to 8 and 14% respectively. False lumen exclusion was present in 73% in stented segment in last postoperative CT. The overall 5-year survival was 71% and freedom from reintervention downstream was 58% at 5 years. Of the nine patients who required reintervention for distal aortic disease, one patient died. CONCLUSIONS: FET operation for patients with MFS can be performed with acceptable mortality and morbidity. In long-term follow-up no reinterventions on the aortic arch were required. FET allows for easier second stage operations providing platform for surgical and endovascular reinterventions.

NEO E-vita-NEO era!

In this review article, the history of the first commercially available thoracic aortic hybrid graft, the E-vita Open, later modified to the blood-impermeable E-vita Open Plus, is reported from its beginning in 2005 until its newest variation, the E-vita Open NEO, European conformity (CE) marked in 2020. Besides the background of its design and clinical experience in Essen, concomitant evolutionary steps in surgery as well as in strategic approaches like the hybrid operating room concept are displayed, finally leading to a well-rounded surgical package with a device that can be applied in all elective as well as emergency situations with complex arch involving aortic pathologies. With the E-vita Open NEO, now, surgery has been facilitated to convenient anastomosing in any of the arch zones, with the opportunity to use the island technique with a straight graft variation as well as individual head vessel anastomosing with either a trifurcated graft for zone 0 or the branched graft for zone 2 or 3 implantation. With its proven long-term stability, the surgical armamentarium to cope with complex multisegmental thoracic aortic pathologies has been significantly improved.

New 3-zone hybrid graft: First-in-man experience in acute type I dissection.

OBJECTIVE: Acute type I aortic dissection (AAD) represents a surgical emergency with time-dependent evolving complications. Frozen elephant trunk (FET) enables false lumen exclusion downstream but is still debated in AAD due to its greater dimension of surgery. To combine the benefits of fast proximal repair with the FET benefits, a 3-zone hybrid graft was developed consisting of an ascending polyester portion, an arch noncovered stent, and a descending stent graft. Mid-term results of this new technique are presented. METHODS: A total of 6 patients (age mean 69 years) with type I AAD in critical status (Penn classification B n = 5, BC n = 1) were operated between July 2016 and April 2018 using the 3-zone hybrid graft. The device was implanted on the basis of strict compassionate use. Operations were performed under distal hypothermic circulatory arrest and selective antegrade cerebral perfusion (SACP). RESULTS: Operative mortality was 17% (n = 1). Mean crossclamp and SACP time were 92 and 34 minutes, respectively, but came down in the last 2 cases to 75/65 crossclamp and 23/24 SACP minutes each. During follow up, mean 19 ± 12 months, one endovascular extension downstream was performed. Imaging control demonstrated no anastomotic-related proximal entry and no true lumen collapse downstream. CONCLUSIONS: The goal to achieve fast and reliable repair of complicated type I AAD down to midthoracic level seems to be achievable. Noncovered stenting of the head vessel's origin does not cause stenosis or obstruction. A multicenter studying of this concept is next.

A New Era of Diagnosis and Therapy in Acute Aortic Syndromes: The Mainz-Essen Experience (Part II)-Management and Outcomes.

Over the years, the cardiovascular department of Johannes Gutenberg University in Mainz-West-German Heart Centre in Essen (Germany) designed and implemented the hybrid operating room (2003) along with advanced endovascular and surgical procedures, including the frozen elephant trunk technique. For the study purpose, the Mainz-Essen experience on acute aortic syndromes was summarized by considering original articles from single-center or multicenter studies performed at West German Heart Centre, Essen, Germany, or at the cardiovascular department of Johannes Gutenberg University, Mainz, Germany. We present the 35-year-long Mainz-Essen research, education, and patient management journey in creating an integrated multidisciplinary "Aortic Center" in the heart of Europe.

Initiating a New Era of Cardiovascular Diagnosis and Therapy in Acute Aortic Syndromes: The Mainz-Essen Experience (Part I)-Imaging and Biomarkers.

Acute aortic syndromes (AAS) encompass a group of life-threatening medical conditions (acute aortic dissection [AAD], intramural hematoma, and penetrating aortic ulcer) with a common pathophysiological pathway. Due to overlapping symptoms and signs with other cardiovascular emergencies, the diagnosis remains challenging resulting in time delays and related increased in-hospital and long-term morbidity and mortality. The Cardiovascular Department of Johannes Gutenberg University in Mainz at West-German Heart Centre in Essen (Germany) first described (in 1984) AAD by transesophageal echocardiography, AAD diagnostic features, and furtherly explored the implementation of "invasive" imaging techniques, namely, intravascular ultrasound and intraluminal phased-array imaging. Furthermore, pioneer studies were undertaken on the biomarker and imaging interplay, namely, D-dimer and F-fluorodeoxyglucose positron emission tomography/computed tomography. We discuss the unique 35-year-long Mainz-Essen experience on the diagnostic and prognostic role of serological and imaging biomarkers in AAS.

Paving the way for E-vita open NEO hybrid prosthesis implantation for complex aortic arch disease in Asia-Pacific.

We report first in man implantations of the newly designed Evita-open-NEO hybrid prosthesis for complex aortic arch disease from three different countries in Asia-Pacific including instructions on how to proceed with perioperative coagulation management.

The frozen elephant trunk technique: impact of proximalization and the four-sites perfusion technique.

OBJECTIVES: To improve organ protection with the frozen elephant trunk (FET) procedure, a so-called four-sites perfusion in combination with proximalization for the distal aortic anastomosis was performed. The impact of these techniques on patient outcome is reported. METHODS: Between February 2005 and April 2020, a total of 357 patients underwent the FET procedure for acute (54%) or chronic (22%) aortic dissection or aneurysmal disease (24%). The level of the distal FET anastomosis was defined according to aortic arch zones 0-3. Patients were divided into 3 groups according to the intraoperative perfusion strategy: (i) selective antegrade cerebral perfusion (SACP) alone (N = 96, 2 sites); (ii) SACP plus left subclavian artery or distal aorta (N = 84, 3 sites) and (iii) SACP plus left subclavian artery plus distal aorta (N = 177, 4 sites). Early outcome was addressed by a composite end point: occurrence of either a disabling stroke, a disabling spinal cord injury, extracorporeal circulatory support, kidney dialysis or death within 90 days. RESULTS: Preoperative characteristics were similar among the groups. Surgery in group C was characterized by FET proximalization in arch zone ≤2, moderate hypothermia at 28°C and shorter periods of extracorporeal circulation, SACP, hypothermic circulatory arrest and cardioplegic arrest (P < 0.001, respectively). Occurrence of the composite end point was reduced in group C (P = 0.008). The combination of FET proximalization and four-sites perfusion was a protective factor for the composite outcome in multivariable analysis (P = 0.009). The 5-year survival was improved in patients who underwent FET proximalization in zone ≤2 (hazard ratio 0.7, 95% confidence interval 0.4-1.0; P = 0.036). CONCLUSIONS: FET proximalization in combination with four-sites perfusion has the potential to improve patient outcomes in terms of survival and major events. SUBJECT COLLECTION: 120; 161.

Right size matters! The ideal size of hybrid prosthesis in frozen elephant trunk.

There is abundant of literature emerging to support the use of the frozen elephant trunk prosthesis, but there is still a lack of clear consensus on the sizing of the hybrid prosthesis. There is a general consensus that the stent should not be oversized in acute aortic dissection and chronic aortic dissection. Some surgeons consider that only the true lumen has to be measured while others argue that the entire diameter of the aorta has to be measured, and a few measure the aorta intraoperatively. In regards to thoracic aortic aneurysm, most surgeons oversize the stent-graft by 10% to 20%. A small device may not provide adequate sealing, whereas a larger device may cause new entry points distally. Hence, an appropriate device has to be selected for the optimal outcome.

From E-VITA open plus to E-VITA NEO and E-NOVIA.

The first clinical implantation of the "Essen I prosthesis" took place in 2005, which was then followed by E-Vita open plus. With further advancements E-Vita Neo and E-Novia was introduced. These devices enable the surgeons to perform frozen elephant trunk in zone 0/1 which eventually reduce the incidence of paraplegia, recurrent laryngeal nerve palsy and proximalization of supraaortic arch vessels. E-vita open plus and successors alleviate frozen elephant trunk operations rendering more stable results in promoting positive remodelling of the distal aorta.

Surgical revascularization for acute coronary syndromes: a report from the North Rhine-Westphalia surgical myocardial infarction registry.

OBJECTIVES: The aim of this was to analyse current outcomes in patients referred to coronary artery bypass grafting (CABG) for acute coronary syndromes (ACSs), including ST-elevation or non-ST-elevation ACS (non-ST-segment elevation myocardial infarction) or unstable angina. METHODS: Patients (n = 2432) undergoing CABG for ACS between January 2010 and December 2017 were prospectively entered into a surgical myocardial infarction registry in North Rhine-Westphalia, Germany. Key end points were in-hospital all-cause mortality (IHM) and major adverse cardio-cerebral events (MACCE). Predictors for IHM and MACCE were analysed by multivariable logistic regression. RESULTS: Patients (78% males) were referred for CABG for unstable angina (25%), non-ST-segment elevation myocardial infarction (50%), and ST-segment elevation myocardial infarction (25%). The mean patient age was 68 ± 11 years, logistic EuroSCORE was 19 ± 18% and three-vessel and left main stem diseases were diagnosed in 81% and 45% of patients, respectively. On-pump CABG with cardiac arrest or beating heart was performed in 92% and 2%, respectively, with only 6% off-pump surgery and 6% multiple arterial revascularization (3.1 ± 1.0 grafts, 93% left internal thoracic artery). Emergency CABG was performed in 23% of patients (42% in ST-segment elevation myocardial infarction; P < 0.001). The total IHM and MACCE rates were 8.1% and 17.5% and were highest in ST-segment elevation myocardial infarction patients with 12.6% and 28.5%, respectively (P < 0.001). Key predictors for IHM and MACCE were female gender, elevated troponin, left ventricular ejection fraction, inotropic support, logistic EuroSCORE, cardiopulmonary bypass and aortic clamp time and the need for emergency CABG. CONCLUSIONS: Surgical myocardial revascularization in patients with ACS is still linked to substantial in-hospital mortality. Emergency CABG for patients with ACS was associated with poorer outcomes.

Frozen elephant trunk with straight vascular prosthesis.

We present a recapitulation of 15 years of experience starting with conception, inception, development, and clinical implementation and application of the E-vita open hybrid graft. Concomitantly, we delve into surgical techniques that shaped our clinical results. Introduced in February 2005, the novel "Essen I Prosthesis", was first-in-human surgically implanted. Follow on to this success, and within six months, eight further applications were performed. Once, the CE mark was attained, the prosthesis was branded as E-vita Open Prosthesis. In 2008, the blood-tight modification was introduced, and with time and clinical practice and application, the device's indications were expanded. Hence, the focus remained on managing complex thoracic aneurysmal disease and in particular acute and chronic type I aortic dissections. With the surge of our surgical experience and the integration of various surgical modifications, 30-days mortality was reduced to 12%, while morbidities such as stroke and spinal cord injury were reduced to 7% and 3%, respectively. The rate of re-intervention on distal aorta was significantly reduced; an attestation to the prosthesis's effectuated performance which contrasted proximal aortic repairs. With new additional device variations on the horizon, a wider range of patient-specific treatment options can now be offered.