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Aims The aim of this study was to assess the clinical course and outcomes of all heart transplant recipients affected by COVID-19 who were followed at the leading heart transplant centers of Northern Italy. Method and Results Since February 2020, we enrolled all 47 cases (79% male) in a first cohort of patients, with a mean age of 61.8 ± 14.5 years, who tested positive for SARS-CoV-2, out of 2676 heart transplant recipients alive before the onset of the COVID-19 pandemic at 7 heart transplant centers in Northern Italy. To date, 38 patients required hospitalization while 9 remained self-home quarantined and 14 died. Compared to the general population, prevalence (18 vs 7 cases per 1000) and related case fatality rate (29.7 vs 15.4%) in heart transplant recipients were doubled. Univariable analysis showed older age (p=0.002), diabetes mellitus (p=0.040), extracardiac arteriopathy (p=0.040), previous PCI (p=0.040), CAV score (p=0.039), lower GFR (p=0.004), and higher NYHA classes (p=0.023) were all significantly associated with in-hospital mortality. During the follow-up two patients died and a third patient has prolonged viral-shedding alternating positive and negative swabs. Since 1st July 2020, we had 6 new patients who tested positive for SARS-CoV-2, 5 patients asymptomatic were self-quarantined, while 1 is still hospitalized for pneumonia. A standard therapy was maintained for all, except for the hospitalized patient. Conclusion The prevalence and mortality of SARS-CoV-2 should spur clinicians to immediately refer heart transplant recipients suspected as having SARS-CoV2 infection to centers specializing in the care of this vulnerable population., Graphical abstract

Objective To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Design Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR–taVi procedures for severe Aortic steNosis Treatment) study. Setting Multicenter study, including Italian hospitals performing TAVR interventions. Participants One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. Interventions Transfemoral TAVR under general or local anesthesia. Measurements and Main Results A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). Conclusions Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

Background— The proven efficacy of transcatheter aortic valve implantation (TAVI) in high-risk patients is leading to the expansion of its indications toward lower-risk patients. However, this shift is not supported by meaningful evidence of its benefit over surgical aortic valve replacement (SAVR). This analysis aims to describe outcomes of TAVI versus SAVR in low-risk patients. Methods and Results— We compared the outcome after TAVI and SAVR of low-risk patients (European System for Cardiac Operative Risk Evaluation II [EuroSCORE II] P =0.82). Cardiac tamponade, permanent pacemaker implantation, major vascular damage, and moderate-to-severe paravalvular regurgitation were significantly more frequent after TAVI compared with SAVR. Stroke rates were equal in the study groups. SAVR was associated with higher risk of cardiogenic shock, severe bleeding, and acute kidney injury. At 3 years, survival was 83.4% after SAVR and 72.0% after TAVI ( P =0.0015), whereas freedom from major adverse cardiac and cerebrovascular events was 80.9% after SAVR and 67.3% after TAVI ( P Conclusions— In patients with low operative risk, significantly better 3-year survival and freedom from major adverse cardiac and cerebrovascular events were observed after SAVR compared with TAVI. Further studies on new-generation valve prostheses are necessary before expanding indications of TAVI toward lower-risk patients.

Background There are scarce data on outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with renal failure. Methods We evaluated the impact of renal failure on outcomes after TAVI and SAVR and compared the results of these procedures in patients with chronic kidney disease stages 3b to 5 from the Observational Study of Effectiveness of AVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. Results Chronic kidney disease (CKD) stages 3b to 5 was associated with an increased risk of mortality after either TAVI or SAVR compared with CKD stages 1 to 3a. Among 170 propensity score–matched pairs with CKD stages 3b to 5, patients who underwent TAVI had a significantly higher rate of permanent pacemaker implantation, vascular damage, and mild to moderate paravalvular regurgitation, and tended to have a higher 30-day mortality (7.1% versus 2.9%; p = 0.09). Thirty-day mortality after transapical TAVI was 7.1%. SAVR had a significantly higher rate of blood transfusions, stroke, and acute kidney injury. At 2 years, patients undergoing TAVI had somewhat higher all-cause mortality (31.2% versus 23.4%; p = 0.118), major cardiac and cerebrovascular events (37.2% versus 31.0%; p = 0.270), and a lower risk of dialysis (12.4% versus 21.2%; p = 0.052) compared with SAVR. Conclusions CKD stages 3b to 5 increases the risk of mortality after TAVI and SAVR. In this subset of patients, SAVR was associated with somewhat better early and late survival. The risk of acute kidney injury was higher after SAVR. These findings suggest that CKD stages 3b to 5 does not contraindicate SAVR. Strategies to prevent severe acute kidney injury should be implemented with either SAVR or TAVI.

The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p0.0001), and paravalvular leak (8.9% vs 2.4%; p0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality.

A few studies recently reported controversial results with transfemoral transcatheter aortic valve replacement (TF-TAVR) versus transapical transcatheter aortic valve replacement (TA-TAVR), often without adequate adjusted analysis for baseline differences. Data on patients who underwent TF-TAVR and TA-TAVR from the Observational Study of Effectiveness of avR-tavI procedures for severe Aortic stenosis Treatment study were analyzed with propensity score 1-to-1 matching. From a cohort of 1,654 patients (1,419 patients underwent TF-TAVR and 235 patients underwent TA-TAVR), propensity score matching resulted in 199 pairs of patients with similar operative risk (EuroSCORE II: TF-TAVR 8.1 ± 7.1% vs TA-TAVR, 8.4 ± 7.3%, p = 0.713). Thirty-day mortality was 8.0% after TA-TAVR and 4.0% after TF-TAVR (p = 0.102). Postoperative rates of stroke (TA-TAVR, 2.0% vs TF-TAVR 1.0%, p = 0.414), cardiac tamponade (TA-TAVR, 4.1% vs TF-TAVR 1.5%, p = 0.131), permanent pacemaker implantation (TA-TAVR, 8.7% vs TF-TAVR 13.3%, p = 0.414), and infection (TA-TAVR, 6.7% vs TF-TAVR 3.6%, p = 0.180) were similar in the study groups but with an overall trend in favor of TF-TAVR. Higher rates of major vascular damage (7.2% vs 1.0%, p = 0.003) and moderate-to-severe paravalvular regurgitation (7.8% vs 5.2%, p = 0.008) were observed after TF-TAVR. On the contrary, TA-TAVR was associated with higher rates of red blood cell transfusion (50.0% vs 30.4%, p = 0.0002) and acute kidney injury (stages 1 to 3: 44.4% vs 21.9%, p

Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.

ObjectiveDespite demonstration of the superior outcomes of transcatheter aortic valve implantation (TAVI) versus optimal medical therapy for severe left ventricular systolic dysfunction, studies comparing TAVI and surgical aortic valve replacement (AVR) in this high-risk group have been lacking.MethodsWe performed propensity matching for age, gender, baseline comorbidities, previous interventions, priority at hospital admission, frailty score, New York Heart Association class, EuroSCORE, and associated cardiac diseases. Next, the 30-day mortality and procedure-related morbidity of 162 patients (81 TAVI vs 81 AVR) with severe left ventricular systolic dysfunction (ejection fraction ≤ 35%) were analyzed at the Italian National Institute of Health.ResultsThe 30-day mortality was comparable (P = .37) between the 2 groups. The incidence of periprocedural acute myocardial infarction (P = .55), low output state (P = .27), stroke (P = .36), and renal dysfunction (peak creatinine level, P = .57) was also similar between the 2 groups. TAVI resulted in significantly greater postprocedural permanent pacemaker implantation (P = .01) and AVR in more periprocedural transfusions (P

Diabetes mellitus is a well known risk factor for extensive coronary disease. The optimal route for cardioplegia administration in patients with severe ischaemic heart disease undergone surgery, especially with left main stem disease (LMSD) is still under debate. Aim of the study is to compare 2 different strategies of myocardial protection in diabetics with LMSD.Between January 2000 and June 2003 90 consecutive patients with type II diabetes mellitus and LMSD undergoing isolated myocardial revascularization were divided into 2 groups according to the route of cardioplegia delivery: antegrade in 45 patients (group A), antegrade followed by intermittent retrograde in 45 (group B). ECG, Troponin I, MB-CPK, MB-CPK mass were performed at 12, 24, 48, and 72 hours postoperatively. Echocardiography was performed preoperatively and before hospital discharge.Groups were homogeneous in preoperative and intraoperative variables, apart from higher incidence of unstable angina and longer cardiopulmonary bypass time in Group B and hypertension in Group A. Hospital deaths, in intensive care units (ITU) stay, perioperative acute myocardial infarction, intra-aortic balloon pump support, postoperative recovery of left ventricle ejection fraction and wall motion score index were similar in both groups. In hospital stay proved shorter in group B (p=0.002), whereas postoperative atrial fibrillation was higher in group A (p0.001), as postoperative inotropic support (p=0.006). Troponin I proved significantly higher in group A from the 12 degrees to the 72 degrees postoperative hour (p0.0001).Despite major in hospital end-points did not differ with strategy of cardioplegia administration, combined route of intermittent blood cardioplegia allows better biochemical and perioperative results in diabetics with LMSD.

Background Few studies have yielded information on comparative effectiveness of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) procedures in a real-world setting. The aim of this analysis is to describe procedural and post-procedural outcomes in a TAVI/SAVR intermediate risk propensity-matched population. Methods OBSERVANT is an observational prospective multicenter cohort study, enrolling AS patients undergoing SAVR or TAVI. Propensity score method was applied to analyze procedural and post-procedural outcomes. Pairs of patients with the same probability score were matched (caliper matching). Results The unadjusted enrolled population (N=2108) comprises 1383 SAVR patients, 602 transarterial-TAVI patients and 123 transapical-TAVI patients. Matched population comprised a total of 266 patients (133 patients for each group). A relatively low risk population was selected (mean logistic EuroSCORE 9.4±10.4% vs 8.9±9.5%, SAVR vs TAVI; p=0.650). Thirty-day mortality was 3.8% for both SAVR and TAVI (p=1.000). The incidence of stroke (1.5% SAVR and 0.0% TAVI; p=0.156) and myocardial infarction (0.8% SAVR and 0.8% TAVI; p=1.000) was not statistically different between groups, whereas a higher requirement for blood transfusion was reported across the surgical cohort (49.6% vs 36.1%; p=0.026). A higher incidence of major vascular damage (5.3% vs. 0.0%; p=0.007) and pacemaker implantation(0.8% vs 12.0%; p=0.001) were reported in the TAVI group. Conclusions Patients undergoing transcatheter and surgical treatment of severe aortic stenosis are still extremely distinct populations. In the relatively low-risk propensity-matched population analyzed, despite similar procedural and 30-day mortality, SAVR was associated with a higher risk for blood transfusion, whereas TAVI showed a significantly increased rate of vascular damage, permanent AV block and residual aortic valve regurgitation.

BACKGROUND AND AIM OF THE STUDY: Enlarged (> 50 mm) atria, longstanding (> 5 years) persistent atrial fibrillation (AF) and age > 70 years are considered predictive of recurrent AF following surgical ablation. The electrophysiological and clinical outcome after AF-ablation was evaluated in high-risk patients undergoing concomitant procedures. METHODS: Between January 2005 and January 2009, a total of 45 patients who complied with the three major predictors of failure, but who had undergone AF ablation ('left + right bipolar radiofrequency Maze') during concomitant mitral surgery were followed up. Freedom from AF, atrial flutter (AFL) and atrial tachycardia (AT), without anti-arrhythmic therapy (discontinued at the sixth month) was the primary endpoint. Survival, freedom from AF/AFL/AT with anti-arrhythmic therapy, early events during post-ablation blanking period, freedom from congestive heart failure (CHF) and from re-hospitalization, and changes in NYHA functional class were registered. RESULTS: Postoperatively, 18 patients (40%) showed sinus rhythm (SR) at admission to the intensive care unit, while 16 (26%) showed junctional rhythm and five (11%) required definitive pacemaker. Eleven of the 40 patients (28%) were discharged without a pacemaker, and experienced early events during the post-ablation blanking period. After a mean of 21 +/- 14 months' follow up, the actuarial survival was 88 +/- 7%. The prevalence of SR at six, 12, and 18 months was 74%, 64%, and 64% respectively. Freedom from AF/AFL/AT was 54 +/- 10% without anti-arrhythmic medications, and 51 +/- 9% with such drugs. Freedom from CHF was 85 +/- 6%, and significantly better in SR patients (94 +/- 6%) than in AF patients (69 +/- 13%; p = 0.018). Freedom from rehospitalization was 75 +/- 8%, and better in SR patients (94 +/- 6%) than in AF patients (37 +/- 14%; p = 0.0001). Accordingly, when compared to AF patients, the NYHA class was significantly ameliorated in SR patients at both six months (1.4 +/- 0.6 versus 2.7 +/- 0.9) and at the final follow up control (1.2 +/- 0.5 versus 1.9 +/- 0.7; p < 0.0001). The E/A wave recovered in 22 (85%) of the SR patients. CONCLUSION: AF ablation during mitral valve surgery achieves good electrophysiological results, even in patients traditionally considered as poor candidates. SR recovery allows a higher freedom from CHF and rehospitalization, with a better functional recovery when compared to AF.

AIM: Recent reports have shown anti-inflammatory effects with conventional hemofiltration (CUF) in patients undergoing cardiopulmonary bypass (CPB). The aim of this study was to evaluate the immunological and the hemodynamic response to CUF or metilprednisolone in patients undergoing coronary artery bypass grafting. METHODS: Twenty-four consecutive patients were prospectively randomized to receive CUF (12 patients, Group A) or metilprednisolone (12 patients, Group B). Hemodynamic response was evaluated by Swan-Ganz catheter, immunological response was analyzed by IL-2, IL-4, IL-6, TNF-alpha, IFN-gamma, IL-10 before anesthetic induction (T0), at aortic-declamping (T1), at the end of surgery (T2), ITU admission (T3) and 24 hours (T4). Troponin I was measured at the same time-points. Hematological and coagulative controls were performed. RESULTS: Morbidity and mortality were comparable between the two groups. Group A demonstrated lower cardiac index at T1 (2.1 +/- 0.69 L/min m2 vs. 3.917 +/- 1.28, P = 0.034) without significantly higher indexed-systemic-vascular-resistances at the end of surgery (1 101 +/- 434.3 dyne s cm(-5) m(-2) vs. 797.7 +/- 316.67, P = 0.233). When proinflammatory and anti-inflammatory cytokines were considered, all improved during the postoperative time course, without differences between the 2 Groups (P = NS). Hematological and coagulative data were similar in the two groups, in terms of white blood cells, platelets, prothrombin time, and activated partial thromboplastin time (P = NS). CONCLUSIONS: Anti-inflammatory action of CUF was comparable to steroids, thus determining a similar proinflammatory response to CPB. However, hemodynamics was slightly impaired by CUF. Therefore, there is no reason to prefer CUF to steroids in patients undergoing elective CABG.

AIM: Atrio-ventricular anatomo-functional response to successful surgical atrial fibrillation (AF) ablation has been poorly investigated. Determinants of AF recurrence following surgical ablation are still debated. METHODS: Sixty-nine patients underwent AF ablation during major cardiac surgery. Main outcomes were clinical and echocardiographic results after monopolar and/or bipolar ablation were recorded. Secondary outcomes were freedom from AF, rehospitalization and congestive heart failure (CHF) at follow-up. Predictors of AF-recurrence were evaluated. RESULTS: Fifty-three patients (76.8%) were in sinus rhythm (SR) at 31.4±10.6 months of mean follow-up. Overall freedom from AF-recurrence was 61.4±6.6%, from hospital readmission 89.9±3.6%, from CHF 91.9±5.05%. Compared to AF-patients, SR-patients demonstrated better freedom from re-hospitalization (98.1±1.9% vs. 62.5±12.1%; P=0.0001) and CHF (94.7±5.1% vs. 77.8±13.9%; P=0.006). At follow-up SR-patients demonstrated atrial (preoperative 5.9±1.2 cm vs. follow-up 5.2±1.0; P=0.01) and ventricular reverse remodelling (preoperative LVDd 5.8±1.6cm vs. follow-up 5.0±1.3 cm; P=0.002 - preoperative LVDs 4.2±1.8 cm vs. follow-up 3.8±1.2 cm; P=0.045). E/A ratio was normal in 90.6% of SR-patients (69.6% of the total population of the study). TDI at the level of the left lateral annulus showed an improved left ventricular systole (Sm), and diastole (Em, E/Em) for SR-patients compared to AF-patients (Sm 9.30±1.66 vs. 7.81±1.41, P=0.001; Em: 10.55±1.87 vs. 7.44±0.40, P=0.001; E/Em: 0.06±0.02 vs. 0.11±0.05, P=0.0001). Preoperative atrial diameter (OR=23.9; P=0.002) and tricuspid insufficiency at follow-up (OR=3.5; P=0.008) were independent predictors of AF-recurrence. Neither etiology, nor duration of AF, nor even ablation technique influenced SR recovery (P=NS for all measurement). CONCLUSION: Radiofrequency AF ablation achieves 76.8% of SR recovery at follow-up. Maintenance of SR improves clinical, haemodynamic and echocardiographic results.

Transthoracic Doppler echocardiography of internal mammary artery grafts (MAGs) has been tested by the supraclavicular approach, but little information is available about the parasternal approach.

Pericardial effusions often complicate the postoperative course of ascending aortic surgery. We evaluated whether an unconventional use of hemostatic fleeces (TachoSil, Nycomed; Austria), wrapped around aortic tube grafts, may reduce such complication. Twenty-nine consecutive patients undergoing button-Bentall were submitted - according to surgeon's choice - to 360 degrees wrapping of the aortic grafts with hemostatic fleeces immediately before sternal wiring (11 patients - group A) or sternal wiring without any wrapping of the prosthesis (18 patients - group B). Hospital outcome was recorded. No differences were recorded in hospital mortality and major organ morbidity. When pericardial complications were considered, group A showed lower chest drains (P=0.0001), time of chest drainage (P=0.002), pretamponade/tamponade with need for pericardiocentesis (P=0.039), predischarge echocardiographic amount of pericardial effusion (P=0.026), fever (P=0.029), need for anti-inflammatory (P=0.05) or antibiotic drugs (P=0.007), hospital stay (P=0.010) and white blood cell count (P=0.016 on postoperative day 3; P=0.014 on day 6). Wrapping of aortic tube grafts with hemostatic fleeces is effective in reducing pericardial effusion and its deleterious effects following aortic surgery.

Aortic dissection is frequently complicated by regurgitation of the aortic valve resulting from leaflet prolapse or tearing of the annulus or leaflet. The authors have evaluated the results using the technique of aortic valve preservation in patients with acute type A aortic dissection (AAD).In a consecutive series of 79 AAD observed from January 1994 to September 2007, 51 (64.6%) presented aortic valve insufficiency (AI). All patients were emergency operated on via median sternotomy and femoral (46/79, 58.2%) or axillary artery-right atrium (33/79, 41.8%) cardiopulmonary bypass with 60 cases (75.9%) of antegrade selective cerebral perfusion. The dissected aorta was resected and the aortic valve was replaced in 2 patients/51 (3.9%) and was preserved in the remaining 49 cases as follows: 42 (85.7%) commissural resuspensions due to commissural prolapse, 3 (6.1%) resuspensions due to cusp prolapse, 3 (6.1%) commissural plication and 1 (2.1%) circumclusion due to annular dilatation.The overall hospital mortality was 20.3% (16/79) with a percentage of 19.6% (10/51) in the AI group. 1 patient presented a type B dissection at 1 months and died after reoperation. The remaining 40 patients with a preserved native valve were followed by echocardiography and computed tomography (CT) (follow-up ranged from 3 to 165 months) with 4 late deaths. Twenty-six patients had absent or grade I AI (72.2%), 8 had grade II AI (22.2%) and 2 presented grade III or IV AI (5.6%). Actuarial freedom from significant AI was 96.2+/-2.4% and 94.2+/-2.3% at 5 and 10 years respectively.The experience with this technique demonstrates the effectiveness of valve conservative treatment within a vascular graft. The reconstruction of the sinotubular junction reducing annular dilatation with appropriated sized graft is obviously mandatory. Although this procedure is not applicable to every patient, we firmly believe that is a valid option when a morphologically intact valve is present.

In this paper we report our clinical experience with extended utilization of axillary artery cannulation for cardiopulmonary bypass (CPB) and discuss the indications and the results of the procedure in terms of complications and usefulness.Between January 1999 and May 2004, 26 patients underwent right axillary artery cannulation for CPB. Fifteen patients presented acute type A aortic dissection and were operated urgently. Axillary cannulation was also used in 11 elective cases: 3 reoperative coronary surgery, 3 valve redo-operations and 5 cases of aortic valve regurgitation+aneurysm of the ascending aorta.All axillary artery cannulations were successful (21 direct and 5 with a side graft) without neurologic or vascular injuries to the right upper extremities. Hospital mortality was 7.7% and included 2 patients operated in an emergency procedure because of acute type A aortic dissection. In all cases, this cannulation site provided adequate perfusion, with a range of peak flows from 4.1 to 5.7 L/min.Our preliminary results demonstrate that the right axillary artery may be considered an alternative cannulation site for achieving full CPB and providing antegrade flow, thus avoiding complications related to retrograde flow when femoral artery perfusion is performed. This safe and useful method may be used not only in aortic surgery but in other such complex cardiac procedures as redo-operations.

Background: To assess early and late mortality in patients with isolated acute tricuspid valve infective endocarditis (TVIE) using data from a multicenter registry.Methods: From 1983 to 2018, isolated acute TVIE was surgically treated in 157 (3.8%) patients [mean age 47 +/- 16 years (range 15-86 years), 25% females]. Of these, 142 (90%) had native tricuspid regurgitation, 7 (5%) native tricuspid valve (TV) steno-regurgitation, and 8 (5%) prosthetic TVIE. Intravenous drug use (IVDU) was recorded in 38% of patients, infection involved cardiac implantable electronic device leads in 21%, and vascular catheters for dialysis in 1%; in the remaining cases, the cause was unknown. The primary endpoint was in-hospital outcome, long-term freedom from recurrence and overall survival.Results: Overall, 77 (49%) patients underwent TV repair, 72 (46%) TV replacement, and 8 (5%) prosthetic TV replacement. Early mortality was 11% (n = 17). Expected early mortality according to EndoSCORE was 12%, with age (odds ratio 1.06) and redo (odds ratio 6.64) as risk factors. Late deaths occurred in 31 patients and TVIE recurrences in 4. Survival rates at 10, 20, and 25 years were 66%, 60%, and 44%, respectively. Risk factors were age [hazard ratio (HR) 1.06], mycotic TVIE (HR 4.2), IVDU (HR 4.90), infected prosthesis replacement (HR 4.4), and presence of cardiac implantable electronic device leads (HR 3.0). No significant difference was found in valve repair vs. replacement and in IVDUs vs. non-IVDUs.Conclusions: Patients with isolated acute TVIE undergoing surgical treatment show acceptable early and late outcomes. TVIE recurrence was low, and repair of the affected valve does not seem to confer any advantage either at early or long term up to 25 years. (C) 2019 Elsevier B.V. All rights reserved.

Background: Bilateral internal mammary artery (BIMA) grafting largely is underutilized in patients undergoing coronary artery bypass grafting (CABG), partly because of the perceived increased complexity of the procedure. Aims: In this study, we evaluated whether BIMA grafting can safely be performed also in centers, where this revascularization strategy infrequently is adopted. Methods: Out of 6,783 patients from the prospective multicenter E-CABG study, who underwent isolated non-emergent CABG from January 2015 to December 2016, 2,457 underwent BIMA grafting and their outcome was evaluated in this analysis. Results: The mean number of BIMA grafting per center was 82 cases/year and hospitals were defined as high or low volume, according to this cutoff value. Six hospitals were considered as centers with a high volume of BIMA grafting (no. of procedures ranging from 120 to 267/year; overall: 2,156; prevalence: 62.2%) and nine hospitals as centers with a low volume of BIMA grafting (no. of procedures ranging from 2 to 39/year; overall: 301; prevalence: 9.1%). Multilevel mixed-effects regression analysis showed that the low- and high-volume cohorts had similar outcomes. Propensity score one-to-one matching analysis of 292 pairs showed that the low-volume cohort had a significantly shorter intensive care unit stay (2.2 ± 2.3 versus 2.9 ± 4.8 days, P = .020). The rates of in-hospital death (1.0% versus 0.3%, P = .625), deep sternal wound infection/mediastinitis (3.8% versus 3.1%, P = .824), and 1-year survival (98.1% versus 99.7%, P = .180) as well as other outcomes were similar between the high- and low-volume cohorts. Conclusions: BIMA grafting can be safely performed also in centers in which this revascularization strategy is infrequently performed.

Summary The antiplatelet agent ticagrelor has recently been found to have bactericidal activity, demonstrated in vitro and in an in vivo mouse model, which warrants further clinical investigations. The aim of this study was to evaluate infectious complications after coronary artery bypass grafting in patients pre-operatively treated with ticagrelor or clopidogrel. In a multi-centre trial, all adult patients who were pre-operatively treated with ticagrelor or clopidogrel prior to isolated primary coronary artery bypass grafting were eligible. Propensity score matching was used. Outcome measures were any sternal wound infection, deep sternal wound infection, and any in-hospital use of postoperative antibiotics. Of 2311 patients who were included, 1293 (55.9%) received clopidogrel and 1018 (44.1%) ticagrelor pre-operatively. In both overall and propensity score matched analyses, ticagrelor was associated with a similar incidence of infectious complications compared to clopidogrel. Our findings do not support a clinically relevant bactericidal effect of ticagrelor in patients undergoing coronary artery bypass grafting.

Background: Patients with increased glycated hemoglobin (HbA1c) seem to be at increased risk of sternal wound infection (SWI) after coronary artery bypass grafting (CABG). However, it is unclear whether increased baseline HbA1c levels may affect other postoperative outcomes. Material and methods: Data on preoperative levels of HbA1c were collected from 2606 patients undergoing elective isolated CABG from 2015 to 2016 and included in the prospective, multicenter E-CABG registry. Results: The prevalence of HbA1c ≥ 53 mmol/mol (7.0%) among non-diabetics was 5.3%, among non-insulin dependent diabetics was 53.5% and among insulin dependent diabetics was 67.1% (p < 0.001). The prevalence of HbA1c > 75 mmol/mol (9.0%) among non-diabetics was 0.5%, among non-insulin dependent diabetics was 5.8% and among insulin dependent diabetics was 10.6% (p < 0.001). Baseline levels of HbA1c ≥ 53 mmol/mol (7.0%) was a significant predictor of any SWI (10.7% vs. 3.3%, adjusted p-value

Aims No data exists on inter-institutional differences in terms of adherence to international guidelines regarding the discontinuation of antithrombotics and rates of severe bleeding in coronary artery bypass grafting (CABG). Methods and results This is an analysis of 7118 patients from the prospective multicentre European CABG (E-CABG) registry who underwent isolated CABG in 15 European centres. Preoperative pause of P2Y12 receptor antagonists shorter than that suggested by the 2017 ESC guidelines (overall 11.6%) ranged from 0.7% to 24.8% between centres (adjusted P < 0.0001) and increased the rate of severe-massive bleeding [E-CABG bleeding grades 2-3, OR 1.66, 95% confidence interval (CI) 1.27-2.17; Universal Definition of Perioperative Bleeding (UDPB) bleeding grades 3-4, OR 1.50, 95% CI 1.16-1.93]. The incidence of resternotomy for bleeding (overall 2.6%) ranged from 0% to 6.9% (adjusted P < 0.0001), and surgical site bleeding (overall 59.6%) ranged from 0% to 84.6% (adjusted P = 0.003). The rate of the UDPB bleeding grades 3-4 (overall 8.4%) ranged from 3.7% to 22.3% (P < 0.0001), and of the E-CABG bleeding grades 2-3 (overall 6.5%) ranged from 0.4% to 16.4% between centres (P < 0.0001). Resternotomy for bleeding (adjusted OR 5.04, 95% CI 2.85-8.92), UDPB bleeding grades 3-4 (adjusted OR 6.61, 95% CI 4.42-9.88), and E-CABG bleeding grades 2-3 (adjusted OR 8.71, 95% CI 5.76-13.15) were associated with an increased risk of hospital/30-day mortality. Conclusions Adherence to the current guidelines on the early discontinuation of P2Y12 receptor antagonists is of utmost importance to reduce excessive bleeding and early mortality after CABG. Inter-institutional variation should be considered for a correct interpretation of the results in multicentre studies evaluating perioperative bleeding and use of blood products.

The impact of thrombocytopenia on postoperative bleeding and other major adverse events after cardiac surgery is unclear. This issue was investigated in a series of patients who underwent isolated coronary artery bypass grafting (CABG) from the prospective, multicenter E-CABG registry. Preoperative thrombocytopenia was defined as preoperative platelet count

OBJECTIVES The aim of this study was to assess the impact of frailty on the outcome after coronary artery bypass grafting (CABG) and whether it may improve the predictive ability of European System for Cardiac Operative Risk Evaluation (EuroSCORE II). METHODS The Clinical Frailty Scale (CFS) was assessed preoperatively in patients undergoing isolated CABG from the multicentre E-CABG registry, and patients were stratified into 3 classes: scores 1-2, scores 3-4 and scores 5-7. RESULTS Of the 6156 patients enrolled, 39.2% had CFS scores 1-2, 57.6% scores 3-4, and 3.2% scores 5-7. Logistic regression adjusted for multiple covariates showed that the CFS was an independent predictor of hospital/30-day mortality [CFS scores 3-4, odds ratio (OR) 3.95, 95% confidence interval (CI) 2.19-7.14; CFS scores 5-7, OR 5.90, 95% CI 2.67-13.05] and resulted in an Integrated Improvement Index of 1.3 (P

BACKGROUND Excessive bleeding and blood transfusion are associated with adverse outcome after cardiac surgery, but their mechanistic effects are difficult to disentangle in patients with increased operative risk. This study aimed to evaluate the incidence and prognostic impact of bleeding and transfusion of blood products in low-risk patients undergoing coronary artery bypass grafting (CABG). STUDY DESIGN AND METHODS Sixteen tertiary European centers of cardiac surgery contributed to the prospective European registry of CABG (E-CABG). The severity of bleeding was defined by the E-CABG bleeding severity classification and universal definition of perioperative bleeding (UDPB) classification. RESULTS Of 1213 patients with EuroSCORE II of less than 2% (mean, 1.1 ± 0.4%), 18.5% suffered from mild bleeding (E-CABG bleeding Grade 1) and 3.4% experienced severe bleeding (E-CABG bleeding Grade 2-3). Similarly, 19.7% had UDPB Class 2 and 5.9% had UDPB Classes 3 and 4. Mild and severe bleeding defined by the E-CABG and UDPB classifications were associated with an increased risk of several adverse events as adjusted by multiple covariates. The risk of death, stroke, and acute kidney injury was particularly increased in patients with severe bleeding. CONCLUSION Severe bleeding is rather uncommon in low-risk patients undergoing CABG, but it is associated with an increased risk of major adverse events. Prevention of excessive perioperative bleeding and patient blood management may improve the outcome of cardiac surgery also in low-risk patients.

Glycated hemoglobin (HbA1c) is a suspected risk factor for sternal wound infection (SWI) after CABG.Methods and Results:Data on preoperative HbA1c and SWI were available in 2,130 patients undergoing isolated CABG from the prospective E-CABG registry. SWI occurred in 114 (5.4%). Baseline HbA1c was significantly higher in patients with SWI (mean, 54±17 vs. 45±13 mmol/mol, P0.0001). This difference was also observed in patients without a diagnosis of diabetes (P=0.027), in insulin-dependent diabetic (P=0.023) and non-insulin-dependent diabetic patients (P=0.034). In the overall series, HbA1c70 mmol/mol (NGSP units, 8.6%) was associated with the highest risk of SWI (20.6% vs. 4.6%; adjusted OR, 5.01; 95% CI: 2.47-10.15). When dichotomized according to the cut-off 53 mmol/mol (NGSP units, 7.0%) as suggested both for diagnosis and optimal glycemic control of diabetes, HbA1c was associated with increased risk of SWI in the overall series (10.6% vs. 3.9%; adjusted OR, 2.09; 95% CI: 1.24-3.52), in diabetic patients (11.7% vs. 5.1%; adjusted OR, 2.69; 95% CI: 1.38-5.25), in patients undergoing elective surgery (9.9% vs. 2.7%; adjusted OR, 2.09; 95% CI: 1.24-3.52) and in patients with bilateral mammary artery grafts (13.7% vs. 4.8%; adjusted OR, 2.35; 95% CI: 1.17-4.69).Screening for HbA1c before CABG may identify untreated diabetic patients, as well as diabetic patients with suboptimal glycemic control, at high risk of SWI.

OBJECTIVES To evaluate the results of aortic valve replacement through sternotomic approach in redo scenarios (RAVR) vs transapical transcatheter aortic valve replacement (TAVR), in patients in the eighth decade of life or older already undergone previous coronary artery bypass grafting (CABG). METHODS One hundred and twenty-six patients undergoing RAVR were compared with 113 patients undergoing TaTAVR in terms of 30-day mortality and Valve Academic Research Consortium-2 outcomes. The two groups were also analysed after propensity-matching. RESULTS TaTAVR patients demonstrated a higher incidence of 30-day mortality (P = 0.03), stroke (P = 0.04), major bleeding (P = 0.03), worse 'early safety' (P = 0.04) and lower permanent pacemaker implantation (P = 0.03). TaTAVR had higher follow-up hazard in all-cause mortality [hazard ratio (HR) 3.15, 95% confidence interval (CI) 1.28-6.62; P < 0.01] and cardiovascular mortality (HR 1.66, 95% CI 1.02-4.88; P = 0.04). Propensity-matched patients showed comparable 30-day outcome in terms of survival, major morbidity and early safety, with only a lower incidence of transfusions after TaTAVR (10.7% vs RAVR: 57.1%; P < 0.01). A trend towards lower Acute Kidney Injury Network Classification 2/3 (3.6% vs RAVR 21.4%; P = 0.05) and towards a lower freedom from all-cause mortality at follow-up (TaTAVR: 44.3 ± 21.3% vs RAVR: 86.6 ± 9.3%; P =. 08) was demonstrated after TaTAVR, although cardiovascular mortality was comparable (TaTAVR: 86.5 ± 9.7% vs RAVR: 95.2 ± 4.6%; P = 0.52). Follow-up freedom from stroke, acute heart failure, reintervention on AVR and thrombo-embolisms were comparable (P = NS). EuroSCORE II (P = 0.02), perioperative stroke (P = 0.01) and length of hospitalization (P = 0.02) were the determinants of all-cause mortality at follow-up, whereas perioperative stroke (P = 0.03) and length of hospitalization (P = 0.04) impacted cardiovascular mortality at follow-up. CONCLUSIONS Reported differences in mortality and morbidity after TaTAVR and RAVR reflect differences in baseline risk profiles. Given the lower trend for renal complications, patients at higher perioperative renal risk might be better served by TaTAVR.

Objective: Unstable angina/non-ST elevation myocardial infarction (UA/NSTEMI) still causes significant hospital morbidity and mortality. We evaluated whether surgical outcome can be modified by different myocardial protection strategies. Methods: This was a prospective clinical study conducted in the cardiac surgery units of two university hospitals. Two hundred and sixty-two consecutive patients undergoing CABG for UA/NSTEMI between January 2002 and June 2004 were prospectively divided in three groups: 126 patients underwent on-pump CABG with antegrade blood cardioplegia (Group A); 67 underwent antegrade and retrograde blood cardioplegia (Group B); 69 off-pump CABG (Group C). Hospital outcome was analysed. Differences in outcome variables were detected with ANOVA; Tukey’s multiple comparison test and Tamhane’s T2 test were used when appropriate. Results: Group A showed higher mortality (PZ.001; PZ.014 vs. Group B; PZ.003 vs. Group C) and perioperative myocardial infarction (PZ.001; PZ.016 vs. Group B; PZ.05 vs. Group C). Hospital stay was shorter in Group B and Group C, compared to Group A (PZ.005; PZ.043 and PZ.05, respectively). Group A required higher doses of inotropes compared to Group B and Group C (PZ.0001; PZ.0001 and PZ.03, respectively), whereas Group B and Group C did not require any inotropic support at all (PZ.0001; PZ.002 and PZ.001 vs. Group A, respectively). Total morbidity was higher in Group A (PZ.006; PZ.007 vs. Group B; PZ.005 vs. Group C). Wall motion score index recovered only in Group B (PZ.0001) and Group C (PZ.001). Troponin I was higher in Group A at 12 h (PZ.0001; P!.001 vs. Group B and Group C), 24 (PZ.0001; PZ.001 vs. Group B and Group C), 48 (PZ.0001; PZ.001 vs. Group B, PZ.002 vs. Group C) and 72 h (PZ.0001; PZ.004 vs. Group B; PZ.05 vs. Group C). Conclusions: Isolated antegrade cardioplegia should be questioned in UA/NSTEMI. Outcome using off-pump revascularization was as good as that of combined antegrade and retrograde warm blood cardioplegia.

Background. Myocardial infarction remains a devastating complication after coronary revascularization. Although electrocardiography (ECG) and echocardiography suggest transmural infarction, myocardial damage and the quality of myocardial protection are not recognized unless troponin I (TnI) is assessed. Determinants and prognosis of TnI elevation after coronary artery bypass grafting (CABG) were evaluated. Methods. Data of 776 consecutive patients undergoing CABG between January 2002 and January 2004 were prospectively exposed to univariate and multivariate analysis. We evaluated the prognosis of patients with all the ECG, echocardiographic, and biochemical criteria for acute myocardial infarction and that of patients with only TnI elevation. Twelve-month follow-up survival and freedom from cardiac events (FCE) were accomplished. Results. Troponin I greater than 3.1 g/L at 12 hours was detected in 6.9% of the population, and correlated with lower in-hospital (p < 0.001) and follow-up survival (p 0.00001), and lower FCE (p 0.0009). Twenty-one (38.8%) of these fulfilled ECG-echocardiographic criteria (p 0.05), demonstrating higher TnI values at 12 (p 0.001), 24 (p 0.01), 48 (p 0.01), and 72 (p 0.04) hours, prolonged ventilation time (p 0.001), higher in hospital mortality (p 0.003), lower follow-up survival (p 0.023), and lower FCE (p 0.0084). A EuroSCORE greater than 6, ongoing unstable angina, aortic cross-clamp time greater than 90 minutes, cardiopulmonary bypass time greater than 180 minutes, incomplete revascularization, and intraoperative intraaortic balloon pump were independent predictors of myocardial damage (MD) at multivariate analysis. Combined antegrade and retrograde cardioplegia and postoperative enoximone infusion were associated with a lower TnI elevation. Conclusions. Troponin I greater than 3.1 g/L at 12 hours defines perioperative MD. Associated ECG-echocardiographic criteria indicate acute myocardial infarction and anticipate a worse outcome. Identification of predictors for MD is important to develop preventative strategies, as antegrade plus retrograde cardioplegia and enoximone infusion.

Objective : To assess whether routine postoperative enoximone infusion compared with dobutamine improved clinical and biochemical results after coronary artery bypass grafting with cardiopulmonary bypass. Design : Prospective nonrandomized study. Data collection was blinded to the choice of inotrope. Setting : Double-institutional clinical investigation. Participants : Two hundred sixteen consecutive patients undergoing myocardial revascularization between May 2000 and December 2002. Interventions : Seventy-two patients underwent myocardial revascularization and were treated with enoximone, 5 μg/kg/min (group A). They were compared in a ratio of 1:2 to 144 patients treated with dobutamine at the same dose (group B) after aortic cross-clamp removal. The groups proved to be homogenous in preoperative and intraoperative characteristics. Measurements and Main Results : Hospital outcome, electrocardiogram, echocardiography, further inotropic support, and biochemical markers of ischemia were compared. Subsets of patients with comorbidities and total arterial revascularization were analyzed. Perioperative myocardial infarction, postoperative low-output syndrome, intra-aortic balloon pump, atrial fibrillation, ST-segment changes, postoperative echocardiographic findings, and intensive care and hospital durations were similar between groups. In the postoperative course, more patients belonging to group A maintained low-dose inotropic support, whereas more patients belonging to group B required higher doses. Troponin I and creatine kinase—MB values were higher in patients of group B, especially when subgroups with diabetes, left ventricular hypertrophy, or total arterial revascularization were included. Conclusion : Postoperative enoximone reduced troponin I release and need for inotropic support in patients undergoing on-pump myocardial revascularization. Subgroup data were confirmed in diabetes, left ventricular hypertrophy, and total arterial revascularization.

In this prospective trial the results of preoperative and intraoperative IABP in coronary artery bypass graft (CABG) patients with low left ventricular ejection fraction (LVEF) were compared. Sixty CABG patients with preoperative LVEF ≤0.30 were enrolled: in group A patients (n=30) IABP was started within 2 hours preoperatively; in group B (n=30) it was instituted intraoperatively before weaning from cardiopulmonary bypass. Cardiac performance was assessed through Swan-Ganz catheter monitoring and daily echocardiography. Hospital survival, length of IABP support, intubation, ICU and hospital stay, need for postoperative inotropic drugs and incidence of myocardial infarction were compared between the two groups. Survival in group A patients proved significantly higher (P=0.047). Cardiac performance after myocardial revascularization improved in both groups with significantly better outcomes in group A patients (p

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.

Although commonly reported as single-centre experiences, redo aortic valve replacement (RAVR) has overall acceptable results. Nevertheless, trans-catheter aortic valve replacement has recently questioned the efficacy of RAVR.Early-to-mid-term results and determinants of mortality in 711 cases of RAVR from seven European institutions were assessed in the entire population and in selected high-risk subgroups [elderly75 years, urgent/emergent procedures, preoperative New York Heart Association (NYHA) functional Class IV and endocarditis].Hospital mortality was 5.1%, major re-entry cardiovascular complications (MRCVCs) 4.9%, low cardiac output syndrome (LCOS) 15.3%, stroke 6.6%, acute respiratory failure (ARF) 10.6%, acute renal insufficiency (ARI) 19.3% and need for continuous renal replacement therapy (CRRT) 7.2%, transfusions 66.9% and for permanent pacemaker (PMK) 12.7%. Mid-term survival, freedom from acute heart failure (AHF), reinterventions, stroke and thrombo-embolisms were 77.2 ± 2.7, 84.4 ± 2.6, 97.2 ± 0.8, 97.2 ± 0.9 and 96.3 ± 1.2%, respectively; 87.5% of patients were in NYHA functional Class I-II. Preoperative left ventricular ejection fraction of30% [odds ratio (OR) 8.7, 95% confidence interval (CI) 2.1-35.6], MRCVCs (OR 20.9, 95% CI 5.6-78.3), cardiopulmonary bypass time (OR 1.1, 95% CI 1.0-1.1), perioperative LCOS (OR 17.2, 95% CI 5.1-57.4) and ARI (OR 5.1, 95% CI 1.5-18.1) predicted hospital death. Endocarditis (OR 7.5, 95% CI 2.9-19.1), preoperative NYHA functional Class IV (OR 4.7, 95% CI 1.0-24.0), combined RAVR + mitral surgery (OR 5.1, 95% CI 1.5-17.3) and AHF at follow-up (OR 2.8, 95% CI 1.3-6.0) predicted late death at the Cox proportional hazard regression model. Elderly75 years had similar hospital mortality (P = 0.06) and major morbidity, except for a higher need for PMK (P = 0.03), as well as comparable mid-term survival (P = 0.89), freedom from AHF (P = 0.81), reinterventions (P = 0.63), stroke (P = 0.21) and thrombo-embolisms (P = 0.09). Urgent/emergent indication resulted in higher hospital death, LCOS, transfusions, MRCVCs, intra-aortic balloon pumping (IABP), stroke, prolonged (48 h) ventilation, pneumonia, ARI, CRRT, lower mid-term survival and freedom from AHF (P ≤ 0.03). Preoperative NYHA functional Class IV correlated with higher LCOS, IABP, prolonged ventilation, pneumonia, ARF, ARI, CRRT and MRCVCs and lower mid-term survival, freedom from AHF, reinterventions and stroke (P ≤ 0.02). Endocarditis demonstrated higher hospital mortality, MRCVCs, LCOS, IABP, stroke, ARF, prolonged intubation, pneumonia, ARI, CRRT, transfusions and PMK and lower mid-term survival and freedom from AHF and reinterventions (P ≤ 0.04).RAVR achieves overall satisfactory results. Baseline risk factors and perioperative complications strongly affect outcomes and mandate improvements in perioperative management. New emerging strategies might be considered in selected high-risk cases.

This study was planned to identify the determinants of outcome after coronary artery bypass (CABG) in young patients. Data on 592 patients aged ≤50 years who underwent CABG from 9 European institutions were collected retrospectively. Twenty-eight percent of patients received at least 2 arterial grafts. Clopidogrel was used at discharge in 16.2% and statins in 67.2% of patients. Freedom from major adverse cardiac and cerebrovascular events at 1, 3, and 5 years was 93.8%, 90.1%, and 85.0%; survival rate was 98.3%, 96.3%, and 94.9%; freedom from myocardial infarction was 96.3%, 95.1%, and 92.5%; and freedom from repeat revascularization was 96.3%, 95.1%, and 92.5%, respectively. Neither types of grafts nor medication at discharge had any impact on the late outcome. Age40 years (relative risk [RR] 2.19, 95% confidence interval [CI] 1.17 to 4.11), diabetes (RR 1.71, 95% CI 1.02 to 2.88), estimated glomerular filtration rate60 ml/min/1.73 m(2) (RR 2.44, 95% CI 1.26 to 4.72), non-ST-elevation myocardial infarction/ST-elevation myocardial infarction (RR 2.12, 95% CI 1.27 to 3.55), emergency procedure (RR 2.34, 95% CI 1.13 to 4.88), and left ventricular ejection fraction30% (RR 3.18, 95% CI 1.41 to 7.16) were independent predictors of major adverse cardiac and cerebrovascular events. Patients with left ventricular ejection fraction30% had a particularly poor survival rate (at 5 years 67.7% vs 96.1%; adjusted analysis RR 14.01, 95% CI 5.16 to 38.03). Poor left ventricular function, myocardial infarction, diabetes, renal failure, and age40 years are major determinants of late outcome after CABG in young patients. In conclusion, data from this real-world registry indicate that multiple arterial grafts and statin treatment are largely underutilized in these patients.

Results after isolated aortic valve replacement with bileaflet prostheses in patients over 70 years old were reviewed. One-hundred-twenty-eight elderly patients were operated on between January 1988 and January 2000. Patients with associated heart disease were excluded from the study. Preoperative data, early and late postoperative mortality, all valve related complications and data concerning anticoagulation status were recorded. Hospital mortality was 9.3%. Mean follow-up time was 60.98±2.23 months. Twelve-year actuarial survival was 69.6±0.08%. Valve related and anticoagulation related complication rates (0.8% and 1.6% respectively) and actuarial freedom (99±0.009 both) were low, as well as the mean interval between consecutive INR checks (18.39±1.90 days) and the mean INR value (2.17±0.135). Late echocardiographic results showed low postoperative mean transprosthetic gradients (15.48±0.94). Bileaftlet prostheses in the elderly can achieve excellent results with a low incidence of anticoagulation related complications and low risk of reoperation. Older age can no longer be considered a contraindication to bileaftlet prosthesis implant.

Surgical aortic valve replacement (S-AVR) after previous cardiac surgery is expected to be associated with a high rate of adverse events. The aim of this study was to estimate the rate and identify the determinants of postoperative stroke in these patients. This is a multicenter study including 741 patients who underwent S-AVR after previous cardiac surgery. Forty-eight patients (6.5%; after isolated AVR, 6.0%) suffered stroke and 10 of them died during the in-hospital stay (20.8%). At multivariate analysis, women (10.2% vs 4.4%, odds ratio [OR] 2.57, 95% confidence interval [CI] 1.36 to 4.86), emergency procedure (15.1% vs 4.8%, OR 2.63, 95% CI 1.12 to 5.78), perioperative use of intra-aortic balloon pump (22.9% vs 5.3%, OR 2.67, 95% CI 1.15 to 6.19), cardiopulmonary bypass time of >210 minutes (15.7% vs 5.0%, OR 2.31, 95% CI 1.13 to 4.71), blood products transfusion (9.3% vs 0.8%, OR 7.75, 95% CI 1.83 to 32.93), and reexploration for bleeding (24.0% vs 5.2%, OR 4.84, 95% CI 2.18 to 10.77) were independent predictors of postoperative stroke. These findings were confirmed by a regression model including CHA 2 DS 2 -VASc score of ≥2, which itself was predictive of stroke (8.2% vs 1.6%, OR 4.52, 95% CI 1.34 to 15.28). Survival at 3 years in patients with postoperative stroke was 51.9%, whereas it was 85.0% in control patients (adjusted analysis: relative risk 2.97 and 1.86 to 4.72, respectively). In conclusion, the risk of postoperative stroke after S-AVR in patients with previous cardiac surgery is high and has an impact on the immediate and late mortality. Excessive bleeding requiring blood transfusion and/or reexploration, prolonged cardiopulmonary bypass time, and use of intra-aortic balloon pump were associated with an extremely high rate of stroke.

Purpose To evaluate if the use of an intra-aortic balloon pump (IABP) during cardioplegic arrest improves body perfusion. Methods 158 coronary artery bypass graft (CABG) patients were randomized to linear cardiopulmonary bypass (CPB) (n=71, Group A) or automatic 80 bpm intra-aortic ballon pump (IABP) induced pulsatile CPB (n=87, Group B). We evaluated hemodynamic response by Swan-Ganz catheter, inflammation by cytokines, coagulation and fibrinolysis, transaminase, bilirubin, amylase, lactate and renal function (estimated glomerular filtration rate (eGFR), creatinine, and incidence of renal insufficiency and failure). Results IABP induced Surplus Hemodynamic Energy was 15.8±4.9 mmHg, with higher mean arterial pressure during cross-clamping (p=0.001), and lower indexed systemic vascular resistances during cross-clamping (p=0.001) and CPB discontinuation (p=0.034). IL-2 and IL-6 were lower, while IL-10 proved higher in Group B (pConclusion Pulsatile flow by IABP improves whole-body perfusion during CPB.

Objective: Stroke remains a devastating complication of coronary artery bypass grafting (CABG): we evaluated whether a more aggressive diagnostic and therapeutic approach can reduce its incidence. Methods: Between January 1998 and January 2002, 1388 consecutive patients underwent isolated on pump CABG with blood cardioplegia. Among the first 627 patients (Group A), Echo-Doppler study (DS) was performed only in selected patients (58) with history of cerebrovascular disease (CVD) and/or carotid bruit; in 761 patients (Group B), DS was performed routinely. Carotid endarterectomy (CEA) was performed in 45 patients in Group A associated to CABG during cardiopulmonary bypass (CPB) and in 90 patients in Group B under local anaesthesia before CABG. Brain CT scan was performed in all cases with postoperative neurological symptoms. Results: The two groups were homogeneous for age, sex, associated diseases, history of CVD, number of graft and CPB time. There were no differences in terms of hospital mortality between Group A (22/627: 3.5%) and Group B (21/761: 2.75%); p = 0.5. Postoperative stroke was observed in 24/627 (3.82%) patients of Group A and in 2/761 (0.26%) of Group B ( p < 0.001). Hospital mortality for stroke was higher in Group A (12/627: 1.91%) than in Group B (0/761; p < 0.001) as well as the incidence of non-fatal stroke (Group A 12/627: 1.91% versus Group B 2/761: 0.26% p = 0.006). Conclusions: Preoperative DS, performed in all cases of CABG, followed by CEA under local anaesthesia in patients with critical carotid stenosis reduces the incidence of postoperative stroke.

This prospective randomized study compared the effects in heart transplant recipients of thymoglobulin and ATG, two rabbit polyclonal antithymocyte antibodies available for induction therapy. Among 40 patients (29 men and 11 women, mean age: 40.7 +/- 14 years) undergoing orthotopic heart transplantation, 20 were randomly allocated to receive induction with thymoglobulin (group A) and 20 to ATG-fresenius (group B). Comparisons between the two groups included early posttransplant (6 months) incidence of acute rejection episodes (grade/= 1B), bouts of steroid-resistant rejection, time to first rejection, survival, graft atherosclerosis, infections, and malignancies. The study groups displayed similar preoperative and demographic variables. No significant difference was found with regard to actuarial survival (P =.98), freedom from rejection (P =.68), number of early rejections1B (P =.67), mean time to first early cardiac rejection (P =.13), number of steroid-resistant rejections (P =.69). Cytomegalovirus reactivations were more frequent among group A (65%) than group B (30%; P =.028). New infections due to cytomegalovirus occurred only in group A (four patients; 20%; P =.05). No cases of malignancies were observed at a mean follow-up of 32.8 +/- 8.9 months. Although thymoglobulin and ATG showed equivalent efficacy for rejection prevention, they have different immunological properties. In particular, thymoglobulin seems to be associated with a significantly higher incidence of cytomegalovirus disease/reactivation.

Objective: Postoperative respiratory failure is a frequent and serious complication in patients with type A acute aortic dissection. Experimental evidence suggests that pulmonary artery perfusion using hypothermic protective solutions helps prevent lung injury. The aim of this pilot prospective study was to evaluate the effect of pulmonary artery flushing during selective cerebral perfusion (SCP) on lung function. Methods: Twenty patients referred for acute type A aortic dissection, who were free from preoperative respiratory dysfunction, were assigned prospectively and alternately to two treatment groups. Pulmonary flushing was performed during SCP in group P (10 patients), while conventional Kazui technique was applied in group N (10 patients). Lung perfusion consisted of single-shot hypothermic pulmonary artery flush with Celsior. Lung function was evaluated by intubation time, scoring of chest radiograms at 12 hours after CPB, and PaO 2 /FiO 2 assessed from immediately before surgery to 72 hours after termination of cardiopulmonary bypass. Results: Incidence of pre, intra and post operative determinants of lung dysfunction proved homogeneous in both groups. Lung oxygenation function showed a marked post operative decline followed by a slow improvement in both groups. Analysis of respiratory ratios did not disclose significant differences even though the flushed group had a better performance in all study patients. The incidence of prolonged ventilator support (longer than 72 hours) (30% vs 20%, p=NS) and severity of x-ray pulmonary infiltrate score were comparable (mean score 1.7±0.71 vs 1.6±0.68, p=NS). Conclusions: Pulmonary artery flushing with Celsior solution does not seem to provide an effective preservation of lung function. (Int J Artif Organs 2003; 26: 1032-8)

Sorin Bicarbon (SB) and Baxter Mira (BM) are almost identical bileaflet prostheses that share the same mechanical design, the only difference being in the sewing cuff. Hence, the long-term clinical performance of the two prostheses, when implanted in the aortic position, was evaluated in a combined population of patients.Between January 1992 and December 2002, 714 patients (454 males, 260 females; mean age 60 +/- 13 years) underwent single aortic valve replacement with SB (n = 392) or BM (n = 322) valves. Concomitant non-valve procedures were performed in 64 patients (9.5%). Follow up was 95.7% complete, with a mean of 3.1 +/- 2.4 years.Operative mortality was 5.4% (39/714). Overall patient survival at five and 10 years was 89.3 +/- 1.4% and 77.7 +/- 4.3%, respectively; the linearized rate was 3.37% per pt-yr. Overall freedoms from complications at 10 years and valve group freedoms at four years were: thromboembolism 92.9 +/- 3.6% (SB 96.8 +/- 1.2% versus BM 98.4 +/- 0.8%); bleeding 94.5 +/- 3.5% (SB 97.5 +/- 1.1% versus BM 98.5 +/- 0.5%); nonstructural dysfunction 85.8 +/- 7.5% (SB 97.1 +/- 1.2% versus BM 99.3 +/- 0.07%); endocarditis 98.0 +/- 1.2% (SB 98.6 +/- 0.9% versus BM 100%); reoperation 95.1 +/- 3% (SB 98.6 +/- 0.9% versus BM 100%). Neither structural dysfunction nor valve thrombosis were observed. At the end of follow up, 78.3% of survivors were in NYHA class I, 17.3% in class II, 3.6% in class III, and 0.8% in class IV.Experience with Sorin Bicarbon and Baxter Mira valve prostheses shows that these valves, when implanted in the aortic position, provide a satisfactory clinical performance, with low complication rates.

Thromboembolism and hemorrhage related to anticoagulation remain a major concern in elderly patients with mechanical valves. Clinical results following isolated aortic valve replacement (AVR) with tilting disk and bileaflet prostheses in patients aged over 70 years were analyzed and compared with results in patients aged45 years.Between January 1980 and August 2002, 319 consecutive older patients (group A) and 497 young patients AVR. Preoperative clinical data, early and late mortality, valve-related complications and data related to anticoagulation status (including mean INR and mean interval between INR assays) were compared between groups.Hospital mortality was lower in group B (3.4%) than in group A (10.7%; p0.0001). Twelve-year actuarial survival was lower in older patients (54% in group A versus 78% in group B; p0.001). The two groups showed similar 12-year actuarial freedom from hemorrhage (99.6% versus 99.5%; p = 0.69), endocarditis (99.6% versus 98.43%; p = 0.25) and perivalvular leak (99.6% versus 97.9%; p = 0.21). However, actuarial freedom from thromboembolism was lower in older patients (98.8% versus 99.7%; p = 0.041).Despite lower rates of long-term mortality and thromboembolism (the latter because of advanced atherosclerosis) in group A, there were no differences in rates of other valve-related complications. Hence, older age cannot be considered a contraindication to implantation of mechanical valves in the aortic position.

Background:The optimum route for cardioplegia administration in patients with severe coronary disease is still under debate. This study compared clinical, echocardiographic, and biochemical results in patients with left main stem disease treated with 2 different strategies of myocardial protection.MethodsBetween March 2000 and November 2002, 148 consecutive patients with left main stem disease undergoing coronary artery bypass grafting were divided into 2 groups according to the route of cardioplegia delivery: antegrade in 87 patients (group A) or antegrade followed by retrograde in 61 patients (group B). Electrocardiography, troponin I, MB-creatine kinase, and MB-creatine kinase mass were performed at 12, 24, 48, and 72 hours postoperatively. Echocardiography was performed preoperatively and before hospital discharge. Data were stratified in subgroups of patients with the following associated risk factors: left ventricular hypertrophy, diabetes, and right coronary stenosis.ResultsGroups were homogeneous in preoperative and intraoperative variables, apart from the higher incidence of unstable angina and severity of left main stem disease in group B. Hospital deaths, intensive therapy unit and hospital stay, perioperative acute myocardial infarction, and intraaortic balloon pump support were similar in both groups. Postoperative recovery of left ventricle ejection fraction and wall motion score index did not differ between the 2 groups. However, postoperative atrial fibrillation was higher in group A (P = .015), especially in patients with diabetes (P < .0001). Troponin I was significantly higher in group A from postoperative hours 12 to 72 (P < .01), and the same pattern was observed in patients with diabetes (P < .001), critical right coronary stenosis (P < .001), and left ventricle hypertrophy (P < .001).ConclusionThe combined route of intermittent blood cardioplegia allows better results in left main stem disease. Such data are confirmed even in risk subgroups.

Objective Postoperative respiratory failure is a frequent and serious complication in patients with type A acute aortic dissection operated on with deep systemic hypothermia. Interaction between neutrophils and pulmonary endothelium along with ischemic insult and reperfusion are the major determinants of lung injury. The aim of this prospective study was to evaluate the effect of continuous pulmonary perfusion during retrograde cerebral perfusion on lung function. Methods Twenty-two patients referred for acute type A aortic dissection, who were free from preoperative respiratory dysfunction, were assigned prospectively and alternately to one of 2 treatment groups. Pulmonary perfusion was performed during retrograde cerebral perfusion in group B (11 patients), whereas the conventional Ueda technique was applied in group A (11 patients). Lung function was evaluated on the basis of intubation time, scoring of chest radiographs at 12 hours after cardiopulmonary bypass, and Pao 2 /fraction of inspired oxygen ratio assessed from immediately before the operation to 72 hours after termination of cardiopulmonary bypass. Results Study groups were homogeneous for age, sex, interval between symptom onset and surgical operation, previous aortic surgery, preoperative ejection fraction and pulmonary gas exchange function, extent of aortic repair, and concomitant procedures. Cardiopulmonary bypass time, length of retrograde cerebral perfusion, operation time, need for blood substitutes, and surgical revision for bleeding did not differ between treatment groups. Postoperative Pao 2 /fraction of inspired oxygen ratios were higher in group B than in group A, and the difference remained statistically significant throughout the study period. The incidence of prolonged ventilator support (>72 hours) and the severity of the radiographic pulmonary infiltrate score were lower in the perfused group (18.2% vs 72.7% [ P = .015] and 0.81 ± 0.75 vs 1.8 ± 0.78 [ P = .028], respectively). Conclusions Continuous pulmonary perfusion provided a better preservation of lung function in patients operated on with deep systemic hypothermia.

Background: Prolonged survival in the Western world has increased the number of elderly patients referred for open-heart surgery during the last decade. Aortic valve disease is the most common heart valve disease in aged patients. Which aortic valve substitute is best employed in the elderly is still a debated matter. The main concern is about the thromboembolic and hemorrhagic risks related to mechanical valves and anticoagulation. Objective: The study aimed at reviewing clinical results after isolated aortic valve replacement with bileaflet prostheses in patients over 70 years and at retrospectively comparing them with those of a group of otherwise comparable patients under 50 years of age who underwent isolated aortic valve replacement with a mechanical device. Methods: The study population included 118 consecutive elderly patients (group A) operated on between January 1988 and January 1999 and 122 young patients (group B) who underwent aortic valve replacement during the same time period. Patients with associated coronary artery disease, mitral stenosis or regurgitation, type A aortic dissection, and infective endocarditis were excluded from the study. Preoperative clinical data, early and late postoperative mortality, all valve-related complications, and all data concerning the anticoagulation status – including the mean international normalized ratio (INR) and the mean time interval between each INR assay – were compared between the two groups. Results: The hospital mortality was significantly lower in group B (2.45%) than in group A (9.3%; p = 0.022). The mean follow-up period was 50.98 ± 2.23 months. The 12-year actuarial survival was significantly lower (69.6 ± 0.08%) in group A than in group B (94.4 ± 0.02%; p < 0.001). No significant difference was found in terms of valve-related and anticoagulation-related complication rates and actuarial freedom as well as mean interval between consecutive INR checks (p = 0.219) and mean INR value (p = 0.914). Conclusions: Bileaflet prostheses in elderly patients can achieve excellent early and late clinical results, with a low incidence of anticoagulation-related complications and an extremely low risk of a reoperation. Older age can no longer be considered a contraindication to bileaflet prosthesis implantation in the aortic position.

Background: Despite the widespread use of transcatheter aortic valve implantation (TAVI), the role of sex on outcome after TAVI or surgical aortic valve replacement (AVR) has been poorly investigated. We investigated the impact of sex on outcome after TAVI or AVR. Methods: There were 2108 patients undergoing TAVI or AVR who were enrolled in the Italian Observational Multicenter Registry (OBSERVANT). Thirty-day mortality, major periprocedural morbidity, and transprosthetic gradients were stratified by sex according to interventions. Results: Female AVR patients showed a worse risk profile compared with male AVR patients, given the higher mean age, prevalence of frailty score of 2 or higher, New York Heart Association class of 3 or higher, lower body weight, and preoperative hemoglobin level (P ≤.02). Similarly, female TAVI patients had a different risk profile than male TAVI patients, given a higher age and a lower body weight and preoperative hemoglobin level (P ≤.005), but with a similar New York Heart Association class, frailty score, EuroSCORE (P = NS), a better left ventricular ejection fraction and a lower prevalence of left ventricular ejection fraction less than 30%, porcelain aorta, renal dysfunction, chronic obstructive pulmonary disease, arteriopathy, and previous cardiovascular surgery or percutaneous coronary intervention (P ≤.01). Women showed a smaller aortic annulus than men in both populations (P

Objective We sought to compare the long-term clinical outcomes of patients who underwent isolated aortic valve replacement with single-disc and bileaflet mechanical heart valves. Methods From May 1975 through October 2001, 590 single-disc valves (7 models) were used for isolated valve replacement, and from November 1980 through July 2002, 1283 bileaflet valves (10 models) were used for isolated valve replacement. Detailed follow-up was performed to a maximum of 27.4 and 21.9 years with a total of 6872 and 5811 patient-years for single-disc valves and bileaflet valves, respectively. Survival and valve-related events were analyzed. Results Single-disc valves were mainly implanted from 1975 through 1995, whereas bileaflet valves were mainly implanted from 1987 through 2002; thus the years of concurrent use were 1987 through 1995. The bileaflet valve had a significantly lower explantation rate, whereas the single-disc valve had a significantly lower thromboembolism rate. No significant differences were detected in early mortality, long-term survival, and other valve-related complications. When limiting the comparison to the concurrent period of 1987 through 1995, no significant difference was detected in survival or in any valve-related complication. Conclusion Single-disc and bileaflet valves provide similar clinical performance. The predominant use of bileaflet valves is not based on clinical outcomes.

An enhanced bileaflet valve, the Edwards MIRA feminine Mechanical Valve became available in 1998. Favorable hydrodynamic features and a redesigned sewing ring encouraged us to implant this device in indicated patients. Hemodynamics and clinical performance parameters were evaluated.Between February 1998 and October 1999, 338 patients (171 males, 167 females) underwent native valve replacement with a MIRA prosthesis. Mean age 56.6+/-13.6 years, 320 patients were in NYHA class III/IV. Sixty-seven patients had echocardiographic examinations. Standard cardiopulmonary bypass was employed utilizing institutionally accepted implantation techniques. Aortic valve replacement was performed in 163 patients, mitral valve replacement in 134 patients, 35* double valve replacements and 1 triple valve replacement.Follow-up is 98% complete. Mean follow-up is 6.9+/-3.3 months (178.2 patient years). There were no operative deaths. Four early deaths were seen (1.18%). Late deaths reported in 12 patients. Linearized rate of late mortality was 6.7% per patient year (ppy). Overall actuarial survival at 13 months is 92.2%. Mean gradients and Effective Orifice Areas (EOA's) are comparable to other bileaflet valves. Linearized rates for valve-related complications was 4.49% ppy. Only 5 transient thromboembolic events (TE = 2.81% ppy) and 3 non-structural valve dysfunction events (NSVD = 1.68%) were seen. No reports of bleeding events, prosthetic endocarditis, valve thrombosis or structural valve deterioration. One patient required mitral valve reoperation for perivalvular leak.Short-term hemodynamic and clinical results are comparable to other bileaflet valves. The sewing ring is non-obstructive, compliant with smoother needle penetration. Early clinical results are encouraging, follow-up should be continued.