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Objectives The optimal hypothermic level during circulatory arrest in aortic arch surgery remains controversial, particularly in frozen elephant trunk (FET) procedures. We describe herein our experience for total arch replacement with FET technique under moderate systemic hypothermic circulatory arrest (≥ 28°C) during selective antegrade cerebral perfusion. Methods Between January 2009 and January 2016, 38 consecutive patients underwent elective total arch replacement for various aortic arch pathologies with FET technique using the E-vita Open hybrid prosthesis (Jotec GmbH, Hechingen, Germany). Selective unilateral or bilateral cerebral perfusion under moderate systemic hypothermic circulatory arrest (28.7°C ± 0.5°C) was used in all patients. Minimally invasive total arch replacement with FET via partial upper sternotomy was performed in 15 patients (39%) and in the remaining 23 patients (61%) via full sternotomy. Mean late follow-up was 3 ± 2 years and was 98% complete. Clinical data were prospectively entered into our institutional database. Results Cardiopulmonary bypass time accounted for 198 ± 58 minutes and the myocardial ischemic time 109 ± 29 minutes. Selective antegrade cerebral perfusion time was 55 ± 6 minutes. Lower body circulatory arrest time was 39 ± 11 minutes. Unilateral cerebral perfusion was performed in 31 patients (82%), and bilateral in 7 patients (18%). Intensive care unit stay was 4 ± 3 days. Thirty-day mortality was 5% (n = 2). Late survival at 3 years was 87 ± 3%. Two patients (5%) required reexploration for bleeding. Patients were discharged after a hospital length of stay of 7 ± 2 days. Postoperative permanent neurologic complication occurred in two patients (5%). Three patients (8%) experienced a transient neurologic disorder. New transient renal replacement therapy was necessary in three patients (8%). No spinal cord injury was noted. Conclusions Our data suggest that moderate systemic hypothermic circulatory arrest (≥ 28°C) in combination with antegrade cerebral perfusion can safely be applied for total aortic arch replacement with FET and offers sufficient neurologic and visceral organ protection. [ABSTRACT FROM AUTHOR]

Background: The aim of the current study is to report our experience with fast-track treatment of patients undergoing transapical transcatheter aortic valve implantation (TA-TAVI) and to determine perioperative predictors for fast-track protocol failure.Methods: Being one of the pioneering centers to start performing TA-TAVI back in 2005, we routinely included patients undergoing this procedure into our fast-track management program since 2008. Between January 2008 and June 2013, 207 consecutive high-risk patients (mean age 79 ± 7 years, mean Log. EuroSCORE 24 ± 10) who underwent TA-TAVI accordingly to our institutional fast-track approach were prospectively collected and analyzed. Uni- and multivariate analysis were performed to identify independent pre- and perioperative predictors of fast-track protocol failure, defined as inability to discharge the patient from the intensive care unit (ICU) on the day of surgery or as readmission to the ICU 48 h after the initial discharge.Results: Fast-track management was successful in 83 % of the patients. 30-day mortality was 8 %. Fast-track protocol failure (17 %) was associated with an outcome worsening compared to the remaining patients (mortality: 40 % vs. 2 % and mean hospital stay: 19 ± 12 vs. 10 ± 9 days; P = .002). Independent predictors of fast-track protocol failure were age ≥85 years (OR 3.1; CI 95 % 1.89-6.21), ejection fraction (EF) ≤30 % (OR 2.6; CI 95 % 1.99-7.52), moderate to severe preoperative mitral valve regurgitation (OR 2.7; CI 95 % 1.27-6.43) and fluoroscopy time ≥12 min (OR 2.9; CI 95 % 1.28-7.46).Conclusions: Fast-track patient management following TA-TAVI is safe and reproducible in the majority of patients. Besides patient-related preoperative risk factors (age ≥85 years, EF ≤30 % and moderate to severe preoperative mitral valve regurgitation) a technically challenging intraoperative course as evidenced in a prolonged fluoroscopy time are independent predictors of fast-track protocol failure which is associated with high loss of patient outcome. [ABSTRACT FROM AUTHOR]

Background: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research., Methods: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation., Discussion: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses., Trial Registration: ClinicalTrials.gov identifier: NCT04053088 .

Background: Malperfusion adversely affects outcomes in patients with acute type A aortic dissection, but reliable quantitative data are lacking., Objectives: The aim of this study was to analyze the impact of various forms of malperfusion on early outcome., Methods: A total of 2,137 consecutive patients enrolled in GERAADA (German Registry for Acute Aortic Dissection Type A) who underwent surgery between 2006 and 2010, of whom 717 (33.6%) had any kind of pre-operative malperfusion, were retrospectively analyzed., Results: All-cause 30-day mortality was 16.9% and varied substantially according to the number of organ systems affected by malperfusion (none, 12.6%; 1 system, 21.3%; 2 systems, 30.9%; 3 systems, 43.4%; p < 0.001). Pre-operative cerebral malperfusion, comatose state, peripheral malperfusion, visceral malperfusion, involvement of supra-aortic branches, coronary malperfusion, and renal malperfusion were all independent predictors of developing any post-operative malperfusion syndrome. When survival was considered, age, peripheral malperfusion, involvement of supra-aortic branches, coronary malperfusion, spinal malperfusion, a primary entry in the descending aorta, and pre-operative comatose state were independent predictors, again with increasing significance., Conclusions: Malperfusion remains a severe clinical condition with strong potential for adverse outcomes in patients undergoing surgery for acute type A aortic dissection. The GERAADA registry suggests that the impact of the number of organs involved and the type of malperfusion on outcome differs substantially. Introducing an appropriate classification system, such as "complicated" and uncomplicated" acute type A aortic dissection, might help predict individual risk as well as select a surgical strategy that may quickly resolve malperfusion., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The MitraClip percutaneous mitral valve repair system, developed as an option for percutaneous mitral repair, was clinically introduced in 2007. From 2010 through 2012, 6 of our patients underwent mitral valve surgery after MitraClip failure. Their mean age was 75 ± 7.7 years (range, 62-87 yr). Three had undergone cardiac surgery previously. In 5 of the 6 patients, mitral regurgitation recurred after initially successful MitraClip deployment and was the indication for surgery. The mean interval between MitraClip implantation and surgery was 106 ± 86 days (range, 0-238 d). Mitral valve repair was feasible in 3 patients; the others underwent valve replacement. All the patients underwent additional cardiac procedures, because the MitraClip worsened existing conditions. Echocardiograms revealed sufficient valvular repairs. Two patients died during hospitalization, one of cerebral infarction and the other of bowel ischemia. Mitral valve repair after failed MitraClip therapy can be complex and a surgical challenge. Careful consideration should be given to appropriate patient selection for MitraClip therapy, because the MitraClip can cause existing pathologic valvular conditions to deteriorate substantially. The interval between MitraClip failure and corrective surgery should be as short as possible. The primary indication is an issue of ongoing discussion.

Background: The aim of this study was to compare outcome of patients with previous cardiac surgery undergoing transapical aortic valve implantation (Redo-TAVI) to those undergoing classic aortic valve replacement (Redo-AVR) by using propensity analysis., Methods: From January 2005 through May 2012, 52 high-risk patients underwent Redo-TAVI using a pericardial xenograft fixed within a stainless steel, balloon-expandable stent (Edwards SAPIEN™). During the same period of time 167 patients underwent classic Redo-AVR. Logistic regression analysis was used to identify covariates among 11 baseline patient variables including the type of initial surgery. Using the significant regression coefficients, each patient's propensity score was calculated, allowing selectively matched subgroups of 40 patients each. Initial surgery included coronary artery bypass grafting in 30 patients, aortic valve replacement in 7 patients and mitral valve reconstruction in 3 patients in each group. Follow-up was 4 ± 2 years and was 100% complete., Results: Postoperative chest tube drainage (163 ± 214 vs. 562 ± 332 ml/24 h, p = 0.02) and incidence of early permanent neurologic deficit (0 vs. 13%, p = 0.04) was lower in patients with Redo-TAVI and there was a trend towards improved 30-day survival (p = 0.06). Also we detected a decreased ventilation time (p = 0.04) and lower transfusion rate of allogenic blood products (p ≤ 0.05) in the Redo-TAVI group. At late follow up differences regarding incidence of major adverse events, including death and permanent neurologic deficits (25% vs. 43%, p = 0.01) statistically supported early postoperative findings., Conclusion: The encouraging results regarding early and long-term outcomes following TAVI in patients with previous cardiac surgery show, that this evolving approach may be particularly beneficial in this patient cohort.

Objectives: We reviewed the initial patient series (n=116) of our institution performing minimally invasive coronary artery bypass grafting (CABG) (n=79), mitral valve surgery (n=1), or atrial septal closure (ASD) procedures (n=26) using an endoaortic occlusion system. With this technique relevant intra-aortic pressures are exerted on the aortic wall during the clamping time. This might lead to late aortic degeneration and aneurysm formation. Our study sought to evaluate postoperative aortic complications and the quality of life (modified SF-12)., Methods: One hundred sixteen patients (56% male; 54 years ± 14.5; range 19 years to 77 years) underwent a cardiac procedure using an endoaortic clamp. The endoaortic balloon clamp catheter was used to occlude the ascending aorta at pressures >300 mmHg. Patients were rescheduled for echocardiographic examination after a mean follow-up period of 8.8 years., Results: The analysis performed among 78 patients showed no incidence of any structural damage to the ascending aorta at the intraoperative position of the endoaortic balloon. The physical and mental summary scores are equal to those of comparable patient groups., Conclusions: The endoaortic occlusion system causes no damage to the aortic wall. If the system causes any problems, they occur immediately during surgery. Patients treated with this minimally invasive technique exhibited the same quality of life as those undergoing conventional surgery.

Background: The recombinant human coagulation FVIIa was approved for the treatment of bleeding in hemophilia patients. The reports of a good hemostatic effect were followed by studies and applications without a regulatory extension of the therapeutic indication (off-label use). The aim of this retrospective study is the evaluation of thromboembolic adverse events and side effects in a large cohort of patients with FVIIa therapy., Methods: In the period from January 2009 to March 2011, a total of 143/2453 (5.8%) cardiac surgical patients (69% male; age 67 ± 11 years; 39% thoracic aorta) were treated with different doses (mean, 6.1 mg; range, 1 to 27.2 mg) of factor VIIa. The administration of FVIIa was seen as a last therapeutic option and administered at the end of the treatment algorithm for severe bleeding., Results: Due to an acute bleeding situation in 143 patients, 7.9 ± 5.8 units of packed red blood cells, 9.5 ± 6.1 units of fresh frozen plasma, 1740 ± 1860 IU PPSB (Prothrombin-Proconvertin-Stuart Factor-Antihemophilic Factor B), 5.6 ± 4 g fibrinogen, and 7.9 ± 7.6 units of platelets were administered. A re-thoracotomy was necessary, despite maximal procoagulant therapy, in 55% of patients. The in-hospital mortality was 36% (51/2453 = 2%). Thrombotic complications occurred with a frequency of 16% (mesenteric infarction, n = 9; stroke/transient ischemic attack, n = 3; myocardial infarction, n = 3; other, n = 8)., Conclusion: The proof of direct causality of the events in relation to the administration of FVIIa is difficult because the temporal and therapeutic relationships with concomitant vasoconstrictive and procoagulant therapies were not obvious. However, there remains a suspicion that a higher rate of mesenteric infarctions may be provoked by the administration of FVIIa.

Background: The introduction of fast-track treatment procedures following cardiac surgery has significantly shortened hospitalisation times in intensive care units (ICU). Readmission to intensive care units is generally considered a negative quality criterion. The aim of this retrospective study is to statistically analyse risk factors and predictors for re-admission to the ICU after a fast-track patient management program., Methods: 229 operated patients (67 ± 11 years, 75% male, BMI 27 ± 3, 6/2010-5/2011) with use of extracorporeal circulation (70 ± 31 min aortic crossclamping, CABG 62%) were selected for a preoperative fast-track procedure (transfer on the day of surgery to an intermediate care (IMC) unit, stable circulatory conditions, extubated). A uni- and multivariate analysis were performed to identify independent predictors for re-admission to the ICU., Results: Over the 11-month study period, 36% of all preoperatively declared fast-track patients could not be transferred to an IMC unit on the day of surgery (n = 77) or had to be readmitted to the ICU after the first postoperative day (n = 4). Readmission or ICU stay signifies a dramatic worsening of the patient outcome (mortality 0/10%, mean hospital stay 10.3 ± 2.5/16.5 ± 16.3, mean transfusion rate 1.4 ± 1,7/5.3 ± 9.1). Predicators for failure of the fast-track procedure are a preoperative ASA class > 3, NYHA class > III and an operation time >267 min ± 74. The significant risk factors for a major postoperative event (= low cardiac output and/or mortality and/or renal failure and/or re-thoracotomy and/or septic shock and/or wound healing disturbances and/or stroke) are a poor EF (OR 2.7 CI 95% 0.98-7.6) and the described ICU readmission (OR 0.14 CI95% 0.05-0.36)., Conclusion: Re-admission to the ICU or failure to transfer patients to the IMC is associated with a high loss of patient outcome. The ASA > 3, NYHA class > 3 and operation time >267 minutes are independent predictors of fast track protocol failure.

Objectives: The use of selective antegrade cerebral perfusion (ACP) makes deep hypothermia nonessential for aortic arch replacement. Consequently, a growing tendency to increase the body temperature during circulatory arrest with ACP has recently been reported from various institutions. However, very little is known about the clinical effect of different modes of ACP (unilateral vs bilateral) on neurologic morbidity. Also, the safe limits of this approach for spinal chord and visceral organ protection are yet to be defined., Methods: Between January 2000 and January 2011, 1002 consecutive patients underwent aortic arch repair during ACP (unilateral, 673; bilateral, 329) with mild systemic hypothermia (30°C ± 2°C; range, 26°-34°C) at 2 centers in Germany. The mean patient age was 62 ± 14 years, 663 patients (66%) were men, and 347 patients (35%) had acute type A dissection. Hemiarch replacement was performed in 684 patients (68%), and 318 (32%) underwent total arch replacement., Results: The cardiopulmonary bypass time accounted for 158 ± 56 minutes and the myocardial ischemic time, 101 ± 41 minutes. Isolated ACP was performed for 36 ± 19 minutes (range, 9-135). We observed new postoperative permanent neurologic deficits in 28 patients (3%; stroke in 25 and paraplegia in 3) and transient neurologic deficits in 42 patients (4%). All 3 cases of paraplegia occurred in patients with acute type A dissection and a broad range of ACP times (24, 41, and 127 minutes). A trend was seen toward a reduced permanent neurologic deficit rate after unilateral ACP (P = .06), but no difference was seen in the occurrence of transient neurologic deficits (P = .6). Overall, the early mortality rate was 5% (n = 52). Temporary dialysis was necessary primarily after surgery in 38 patients (4%). When corrected for the unequal distribution of type A dissection, neurologic morbidity, early mortality, and the need for temporary dialysis were independent of the duration of ACP and were not affected by unilateral versus bilateral ACP., Conclusions: Current data suggest that ACP and mild systemic hypothermic circulatory arrest can be safely applied to complex aortic arch surgery even in a subgroup of patients with up to 90 minutes of ACP. Unilateral ACP offers at least equal brain and visceral organ protection as bilateral ACP and might be advantageous in that it reduces the incidence of embolism arising from surgical manipulation on the arch vessels., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)