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Supplemental material, Visual Abstract, for Leaflet Dimensions as a Guide to Remodeling Annuloplasty During Aortic Valve Repair by Marek J. Jasinski, J. Scott Rankin, Domenico Mazzitelli, Theodor Fischlein, Yeong-Hoon Choi, Lawrence M. Wei, Marek A. Deja, and Vinay Badhwar in Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

Objective: The SURE-AVR registry was established to collect real-world clinical and haemodynamic performance of LivaNova aortic valve prostheses in a prospective, International setting. We report t...

Aim: A Prospective Randomized Multicenter Trial is ongoing to evaluate Posthorax and prevention of sternal dehiscence/instability: clinical percept is optimistic for Posthorax use. The aim of this mono-center analysis is to give a preliminary result of Posthorax support vest after sternotomy. Methods: One hundred and eighty three cases elective patients were consecutive operated and included in this study conducted in our department since June 2009. Patients were randomized as following: 68 patients were treated with the Posthorax support vest and 115 received a standard bandage postoperatively. The primary endpoints were the Infective Events. Secondary endpoints included a composite of postoperative clinical variables and mortality. Results: The two groups are homogeneous for these characteristic except sex (more women in Control Group, p = 0.022). Operative data were comparable in both groups. Deep sternal infections occurred in four patients, all in Control Group (3.5% vs 0%, p = 0.153). At Follow up, we recorded 2 cases of superficial infection in the control group versus 0 (1.7%, p = 0.394) and 1 case of wound dehiscence always in Control Group versus 0 (0.9%, p = 0.628). Cumulative Infective Events are statistically more in Control Group (7 cases 6.1% versus 0 cases, p = 0.036*). According to the secondary endpoints, there were also no differences between the two compared groups except length of hospitalization (10.6 ± 4 days versus 13.4 ± 9.5, p = 0.019*). Conclusion: Preliminary results show the Posthorax sternum support vest as a valuable adjunct to prevent sternum-related complications: We record a statistical reduction of length of hospital stay and infective events using the support vest in a 3-month follow-up.

This multicenter study was undertaken to determine the immediate and long-term outcomes in patients undergoing a primary surgical aortic valve replacement (AVR) who had a previous coronary artery bypass graft surgery with patent grafts.One hundred and thirteen consecutive patients (mean EuroSCORE II, 10.3 ± 7.7%, median 8.0%) who underwent first-time isolated AVR after coronary artery bypass grafting (CABG) were the subjects of this multicenter study. The procedure was performed through a full sternotomy in 95.7% of cases, a patent internal mammary artery graft was clamped in 76.6% of patients. The temperature of cardioplegia was ≤12 °C in 62.8% of patients and systemic temperature was32 °C in 23.9% of patients.Thirty-day mortality was 4.4%. Stroke was observed in 8.0% of patients, low cardiac output syndrome in 14.1%, prolonged tracheal intubation in 20.8%, and intensive care unit stay was longer than five days in 19.5% of patients. Among patients with a patent internal mammary graft (91 patients), clamping of this graft (5.7% vs. 0%, p = 0.57) was associated with a nonsignificant trend toward increased 30-day mortality. One-, three- and five-year survival rates were 91.5%, 90.4%, and 88.4%, respectively.Patients undergoing isolated AVR after prior CABG have a good immediate and late survival. A history of prior CABG should not be considered an absolute indication for transcatheter AVR.

Left ventricular free-wall rupture (LVFWR) is an uncommon but serious mechanical complication of acute myocardial infarction (AMI). Surgical repair, though challenging, is the only definitive treatment. However, given the rarity of this condition, results following surgery are still not well established. The aim of this study was to review a multicenter experience with the surgical management of post-infarction LVFWR and analyze the associated early outcomes. Background: Left ventricular free-wall rupture (LVFWR) is an uncommon but serious mechanical complication of acute myocardial infarction. Surgical repair, though challenging, is the only definitive treatment. Given the rarity of this condition, however, results after surgery are still not well established. The aim of this study was to review a multicenter experience with the surgical management of post-infarction LVFWR and analyze the associated early outcomes. Methods: Using the CAUTION (Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study) database, we identified 140 patients who were surgically treated for post–acute myocardial infarction LVFWR in 15 different centers from 2001 to 2018. The main outcome measured was operative mortality. Multivariate analysis was carried out by constructing a logistic regression model to identify predictors of postoperative mortality. Results: The mean age of patients was 69.4 years. The oozing type of LVFWR was observed in 79 patients (56.4%), and the blowout type in 61 (43.6%). Sutured repair was used in the 61.4% of cases. The operative mortality rate was 36.4%. Low cardiac output syndrome was the main cause of perioperative death. Myocardial rerupture after surgery occurred in 10 patients (7.1%). Multivariable analysis revealed that preoperative left ventricular ejection fraction (P

OBJECTIVES This study aims to investigate the incidence and determinants of major early adverse events in low-risk patients undergoing isolated coronary artery bypass grafting (CABG). METHODS The multicentre E-CABG registry included 7352 consecutive patients who underwent isolated CABG from January 2015 to December 2016. Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of RESULTS Out of 2397 low-risk patients, 11 (0.46%) died during the index hospitalization or within 30 days from surgery. Five deaths were cardiac related, 4 of which were secondary to technical failures. We estimated that 8 out of 11 deaths were potentially preventable. Logistic regression model identified porcelain aorta [odds ratio (OR) 34.3, 95% confidence interval (CI) 1.3–346.3] and E-CABG bleeding grades 2–3 (OR 30.2, 95% CI 8.3–112.9) as independent predictors of hospital death. CONCLUSIONS Mortality and major complications, although infrequently, do occur even in low-risk patients undergoing CABG. Identification of modifiable causes of postoperative adverse events may be useful to develop preventative strategies to improve the quality of care of patients undergoing cardiac surgery. Clinical Trial Registration NCT02319083 (https://clinicaltrials.gov/ct2/show/NCT02319083).

Salvage coronary artery bypass grafting (CABG) is often performed for cardiogenic shock on compassionate basis without clinical data justifying this aggressive approach. The aim of this study was to analyze early and intermediate outcomes after salvage CABG. We retrospectively reviewed the data of 85 patients who underwent salvage CABG at 11 European cardiac surgery centers. Salvage CABG was defined according to the EuroSCORE criteria, that is, a procedure performed in patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theater or before induction of anesthesia. A percutaneous coronary intervention procedure preceded salvage CABG in 55 patients (64.7%). Thirty patients (35.3%) died during the inhospital stay. The mean EuroSCORE II was 32.0% and the observed-to-expected ratio was 1.08. Salvage CABG was associated with high rates of postoperative stroke (9.4%), resternotomy for bleeding (23.5%), resternotomy for hemodynamic instability (15.3%), dialysis (18.8%), severe gastrointestinal complications (12.9%), and deep sternal wound infection (10.6%). Survival at 1, 3, and 5 years was 58.6%, 49.8%, and 40.9%, respectively. Twenty patients (23.5%) were postoperatively treated with extracorporeal membrane oxygenation (ECMO). The rates of adverse events after ECMO were particularly high (stroke 40%, resternotomy for bleeding 60%, dialysis 35%, gastrointestinal complications 30%, and deep sternal wound infection 30%). Of patients treated with ECMO, 8 (40%) survived to discharge, and 1-year survival was 29.2%. Salvage CABG is associated with high risk of immediate mortality and severe adverse events. However, the observed immediate and intermediate outcome justify coronary surgery in these critically ill patients. A number of these patients are currently treated by ECMO, and its results are encouraging.

Background The aim of this study was to analyze early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) with the sutureless Perceval bioprosthesis (Sorin Biomedica Cardio Srl, Salluggia, Italy) performed through ministernotomy compared with full sternotomy. Methods This was a study of 267 consecutive patients who underwent isolated AVR with the sutureless Perceval bioprosthesis between 2007 and 2014 at 6 European centers. Of these, 189 (70.8%) were performed through ministernotomy and 78 through a full sternotomy. Propensity score matching was used to reduce selection bias. Results In the overall cohort of ministernotomy and full sternotomy patients, in-hospital mortality was 1.1% and 2.6% and 2-year survival was 92% and 91%, respectively. Propensity score matching resulted in 56 pairs with similar characteristics and operative risk. Aortic cross-clamp (44 minutes in both groups, p = 0.931) and cardiopulmonary bypass time (69 vs 74 minutes, p = 0.363) did not differ between the groups. Apart from higher values in the ministernotomy group for postoperative peak gradients (28.1 vs 23.3 mm Hg, p = 0.026) and mean aortic valve gradients (15.2 vs 11.7 mm Hg, p = 0.011), early postoperative outcomes did not differ in the propensity-matched cohort. There were no differences in the in-hospital mortality rate or 2-year survival between the groups. Conclusions AVR with the sutureless Perceval bioprosthesis through a ministernotomy was a safe and reproducible procedure that was not associated with prolonged aortic cross-clamp or cardiopulmonary bypass time compared with a full sternotomy. Early postoperative outcomes and 2-year survival were comparable between patients undergoing ministernotomy and full sternotomy.

Rationale: The pathogenesis of bicuspid aortic valve (BAV)–associated aortopathy is poorly understood, and no prognostic biomarker is currently available. Objective: We aimed to identify putative circulating biomarkers pathogenetically and prognostically linked to bicuspid aortopathy. Methods and Results: By reverse transcription polymerase chain reaction, we evaluated gene expression variations (versus normal aorta) of transforming growth factor-β1 (TGF-β1), connective tissue growth factor, matrix metalloproteinase-2 (MMP-2), MMP-14, endoglin (ENG), and superoxide dismutase 3 in ascending aorta samples from 50 tricuspid and 70 patients with BAV undergoing surgery for aortic stenosis (aorta diameter ≤45 mm: BAV non-dil or >45 mm: BAV dil ). Expression changes of the TGF-β1 active dimer and ENG were analyzed also by Western blot in ascending aorta samples from other 10 tricuspid aortic valve, 10 BAV non-dil , and 10 BAV dil patients. The serum concentration of study targets was assessed through ELISA and the ratio of serum TGF-β1/ENG (T/E) was evaluated. All BAV non-dil patients underwent follow-up echocardiography to assess aortic growth rate. In BAV non-dil patients, TGF-β1 and MMP-2 gene expression increased significantly, whereas MMP-14 and ENG expression decreased versus controls. Expression changes were confirmed at protein level for TGF-β1 and ENG. TGF-β1 serum concentration significantly decreased in tricuspid aortic valve and BAV non-dil patients versus healthy subjects. ENG serum concentration decreased in all patients, more markedly in BAV dil . A significant increase of the T/E ratio versus healthy subjects was unique of patients with BAV. In BAV non-dil patients, a T/E ≥9 was independently associated in multivariable analysis with higher MMP-2 and lower superoxide dismutase 3 gene expression, independent of age and aortic diameter. A significant correlation was observed between baseline T/E ratio and aortic diameter growth rate in BAV non-dil patients ( r =0.66, P Conclusions: The novel evidence of a possible value of the T/E ratio as a biomarker of BAV aortopathy was presented: further validation studies are warranted.

Objective The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy). Methods This is a retrospective analysis of 314 patients (mean age, 77.9 ± 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% ± 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers. Results The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 ± 20 minutes (isolated procedure, 39 ± 15 minutes; concomitant coronary surgery, 52 ± 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2% (1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively ( P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively. Conclusions The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis.

The prognostic impact of failed mitral valve repair (FMR) on in-hospital outcome after redo mitral valve surgery has not been thoroughly investigated. OBJECTIVES: The prognostic impact of failed mitral valve repair (FMR) on in-hospital outcome after redo mitral valve surgery has not been thoroughly investigated.METHODS: Hospital outcomes after redo mitral valve surgery because of an FMR in patients from nine European centres were reported. Logistic regressions identified predictors of mortality in combined or isolated redo mitral valve operations. Hospital outcome was compared between propensity-matched cohorts with FMR and native mitral valves in the context of redo surgery and FMR versus failed prostheses.RESULTS: A total of 246 patients with FMR yielded a 6.5% mortality rate at redo surgery. FMR per se did not impact mortality at multivariable analysis (P = 0.64). A preoperative Global Initiative for Chronic Obstructive Lung Disease (GOLD) score >= 2 chronic obstructive lung disease (COPD) (OR 15.2, P < 0.01), left ventricular ejection fraction = 2 COPD (OR 12.3, P = 0.049), age at surgery (OR 1.15 for each incremental year, P = 0.049) and cardiopulmonary bypass duration (OR 1.02, P = 0.022) predicted mortality in isolated redo mitral valve surgery for FMR. The fourth (> 68 years = 13.8% mortality) and the fifth quintiles of age (>= 73.4 years = 14.8%) reported the highest mortality (OR 3.8 and 4.2 respectively, P = 0.002) in this subgroup. Propensity-matched cohorts of FMR and native mitral valves in the context of redo surgery showed no differences in terms of mortality (P = 0.69) and major morbidity (acute myocardial infarction P = 0.31, stroke P = 0.65, acute kidney injury P = 1.0), whereas more perioperative dialysis (P = 0.04) and transfusions (P = 0.02) were noted in propensity-matched failed prostheses compared to FMR.CONCLUSIONS: A failed mitral repair does not impact hospital outcome of redo surgery. Given the role of severe left ventricular dysfunction and advanced age on hospital mortality rates, an early indication for redo surgery may improve outcome.

Objective Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. The aim of the current multi-institutional study was to compare hemodynamics of transcatheter (TAVR) and the Freedom SOLO Stentless (FS) valve in an intermediate risk population undergoing surgical aortic valve replacement. Methods From 2010 to 2014, 420 consecutive patients underwent isolated surgical aortic valve replacement with FS and 375 patients underwent TAVR. Only patients with intermediate operative risk (Society of Thoracic Surgeons score 4-10) and small aortic annulus (≤23 mm) were included. After a propensity matched analysis 142 patients in each group were selected. Thirty-day postoperative clinical and echocardiographic parameters were evaluated. Results Mean prosthesis diameter was 22.2 ± 0.9 mm for FS and 22.4 ± 1.0 mm for TAVR. In-hospital mortality was 2.1% for FS and 6.3% for TAVR (P = .02). Postoperative FS peak gradients were 19.1 ± 9.6 mm Hg (mean 10.8 ± 5.9 mm Hg); TAVR peak gradients were 20.2 ± 9.5 mm Hg (mean 10.7 ± 6.9 mm Hg) P = .57 (P = .88). Postoperative effective orifice area was 1.93 ± 0.52 cm2for FS and 1.83 ± 0.3 cm2for TAVR (P = .65). There was no prostheses-patient mismatch in either group. Postoperative grade 2-3 paravalvular leak was present in 3.5% for TAVR and 0.7% for FS. Postoperative permanent pacemaker implant rate was 12% for TAVR and only 1 case (0.7%) in the FS group (PÂ

International audience; INTRODUCTION: This study was planned to investigate the impact of severe bleeding and blood transfusion on the development of stroke after coronary surgery.METHODS: This cohort study includes 2357 patients undergoing isolated CABG from the prospective European Coronary Artery Bypass Grafting (E-CABG) registry. Severity of bleeding was categorized according to the Universal Definition of Perioperative Bleeding (UDPB), E-CABG and PLATO definitions.RESULTS: Thirty patients (1.3%) suffered postoperative stroke. The amount of transfused red blood cell (RBC) (OR 1.10, 95%CI 1.03-1.18), preoperative use of unfractioned heparin (OR 4.49, 95%CI 1.91-10.60), emergency operation (OR 3.97, 95%CI 1.47-10.74), diseased ascending aorta (OR 4.62, 95%CI 1.37-15.65) and use of cardiopulmonary bypass (p = 0.043, OR 4.85, 95%CI 1.05-22.36) were independent predictors of postoperative stroke. Adjusted analysis showed that UDPB classes 3-4 (crude rate: 3.6% vs. 1.0%; adjusted OR 2.66, 95%CI 1.05-6.73), E-CABG bleeding grades 2-3 (crudes rate: 6.3% vs. 0.9%; adjusted OR 5.91, 95%CI 2.43-14.36), and PLATO life-threatening bleeding (crude rate: 2.5% vs. 0.6%, adjusted OR 3.70, 95%CI 1.59-8.64) were associated with an increased risk of stroke compared with no or moderate bleeding.CONCLUSIONS: Bleeding and blood transfusion are associated with an increased risk of stroke after CABG, which is highest in patients with severe bleeding.

OBJECTIVES: The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy with a sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis. METHODS: Patients who underwent primary isolated non-emergent AVR at six European centres were included in the study. Of these, 182 (32%) underwent a ministernotomy with a sutureless bioprosthesis (ministernotomy sutureless group) and 383 (68%) a full sternotomy with a stented bioprosthesis (full sternotomy stented group). Propensity score matching was used to reduce selection bias. RESULTS: In the overall cohort, 30-day mortality was 1.6 and 2.1%, and 2-year survival was 92 and 92% in the ministernotomy sutureless group and in the full sternotomy stented group, respectively. Propensity score matching resulted in 171 pairs with similar characteristics and operative risk. Aortic cross-clamp (40 vs 65 min, P < 0.001) and cardiopulmonary bypass time (69 vs 87 min, P < 0.001) were shorter in the ministernotomy sutureless group. Patients undergoing ministernotomy received less packed red blood cells but the risk for postoperative permanent pacemaker implantation was higher. There were no differences regarding 30-day mortality or 2-year survival between the two groups. CONCLUSIONS: AVR through a ministernotomy with implantation of a sutureless bioprosthesis was associated with shorter aortic cross-clamp and cardiopulmonary bypass time and less transfusion of packed red blood cells, but a higher risk for postoperative permanent pacemaker implantation compared with a full sternotomy with a stented bioprosthesis.

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.

During recent years, pericardial bioprostheses have gained widespread acceptance as cardiac valve substitutes. The study aim was to evaluate the early clinical and hemodynamic performance of the Sorin SopranoTM supra-annular aortic bioprosthesis, as used for aortic valve replacement (AVR).Between January 2004 and August 2006, a total of 501 patients (55% males; mean age 75 +/- 6.4 years) was prospectively enrolled into the study, which involved 10 European institutions. The indications for AVR were aortic stenosis in 91% of patients, aortic incompetence in 8%, and redo surgery in 1%. Preoperatively, 62% of the patients were in NYHA class III, and 12% in class IV. The mean prosthesis size was 21.4 +/- 1.8 mm. A non-everting technique was used in 88% of patients. Concomitant procedures were performed in 52% of cases (mainly coronary artery bypass grafts; 41%). The mean cross-clamp and cardiopulmonary bypass times were 70 +/- 27.2 min and 99 +/- 39.7 min, respectively. Doppler echocardiography performed at one and 12 months after surgery was evaluated by an independent core laboratory.Postoperatively, there were 25 early deaths (5%) and 13 late deaths, with an overall survival at one year of 92.9% (95% CI: 90.2-94.8) and freedom from valve-related death of 98.6% (95% CI: 97.5-99.6). After 12 months, most patients (87%) were in NYHA classes I-II. Actuarial freedoms from thromboembolism, bleeding, endocarditis and paraprosthetic leak at one year were 97.1% (CI: 95.1-98.2), 98.9% (CI: 97.4-99.5), 99.1% (CI: 97.7-99.7), and 99.6% (CI: 98.3-99.9), respectively. No events of thrombosis and structural valve deterioration (SVD) were observed. Subsequent echocardiographic evaluation showed low mean (11.1 +/- 5.1 mmHg at one year) and peak (19.5 +/- 8.9 mmHg at one year) transvalvular gradients, and a significant reduction in left ventricular mass, from 211 +/- 78.5 g at one month to 185 +/- 64.7 g at 12 months (p0.0001).After 12 months, the clinical outcome with the Soprano bioprosthesis, when used for AVR, was excellent. The bioprosthesis also showed good hemodynamic performance, with a significant reduction of left ventricular hypertrophy.