Observed versus predicted mortality after isolated tricuspid valve surgery.

BACKGROUND: Aim of this study is to analyse the performances of Clinical Risk Score (CRS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-II in isolated tricuspid surgery. METHODS: Three hundred and eighty-three patients (54 ± 16 year; 54% female) were enrolled. Receiver operating characteristic analysis was performed to evaluate the relationship between the true positive fraction of test results and the false-positive fraction for a procedure. RESULTS: Considering the 30-day mortality the area under the curve was 0.6 (95% confidence interval [CI] 0.50-0.72) for EuroSCORE II and 0.7 (95% CI 0.56-0.84) for CRS-score. The ratio of expected/observed mortality showed underestimation when considering EuroSCORE-II (min. 0.46-max. 0.6). At multivariate analysis, the CRS score (p = .005) was predictor of late cardiac death. CONCLUSION: We suggest using both scores to obtain a range of expected mortality. CRS to speculate on late survival.

Aortic Valve Replacement in Redo-Scenarios: A Comparison Between Traditional Aortic Valve Replacement (TAVR) and Transapical-TAVR from Two Real-World Multicenter Registries.

BACKGROUND: The study aim was to compare the outcome of transapical transcatheter aortic valve replacement (TaTAVR) and traditional aortic valve replacement (AVR) in redo from two real-world registries. METHODS: The 30-day and follow up outcome of 462 patients enrolled in two multicenter redo registries, treated with redo-AVR (RAVR; n = 292 patients) or TaTAVR (n = 170 patients), were analyzed according to VARC-2 criteria, stratified also by propensity-matching analysis. RESULTS: TaTAVR-patients were older and sicker than RAVR patients, and reported a higher all-cause 30-day mortality (p <0.01), a higher risk for all-cause mortality (p = 0.006) and cardiovascular mortality (p = 0.05) at follow up, but similar 30-day cardiovascular mortality (p = 0.12). Prolonged intubation (p <0.01) and Acute Kidney Injury Network (AKIN) 2/3 p = 0.02) prevailed in RAVR. TaTAVR patients reported a higher level of major/life-threatening/disabling bleeding (p <0.01) and 'early safety-events' (ES) (p = 0.04). Thirty-day acute myocardial infarction (AMI), stroke, and follow up freedom from acute heart failure (AHF), from stroke and from reinterventions were similar (p = NS). The NYHA class was better after RAVR (p <0.01). The intermediate-to-high risk (Logistic EuroSCORE RAVR 17.1 ± 8.5; TaTAVR 16.0 ± 17.0) propensity-matched population demonstrated comparable 30-day and follow up all-cause and cardiovascular mortality, ES, AMI, stroke, prolonged intubation, follow up freedom from AHF, from stroke and from reinterventions and NYHA class. TaTAVR still reported lower levels of AKIN 2/3 (2.2% versus 15.6%, p = 0.03) and shorter hospitalization (9.5 ± 3.4 days versus 12.0 ± 7.0 days, p = 0.03). CONCLUSIONS: Outcome differences between RAVR and TaTAVR in redo-scenarios reflect methodological differences and different baseline risk profiles. Propensity-matched patients showed a better renal outcome after TaTAVR. *Drs. Onorati and D'Onofrio contributed equally to this article and should both be considered as first authors.

First-time, isolated surgical aortic valve replacement after prior coronary artery bypass surgery: results from the RECORD multicenter registry.

BACKGROUND: 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. METHODS: 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 was <32 °C in 23.9% of patients. RESULTS: 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. CONCLUSIONS: 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.

The need for a specific risk prediction system in native valve infective endocarditis surgery.

The need for a specific risk score system for infective endocarditis (IE) surgery has been previously claimed. In a single-center pilot study, preliminary to future multicentric development and validation, bivariate and multivariate (logistic regression) analysis of early postoperative mortality predictors in 440 native valve IE patients were performed. Mathematical procedures assigned scores to the independent predictors emerged (AUC of the ROC curve: 0.88). Overall mortality was 9.1%. Six predictors were identified and assigned scores, including age (5-13 points), renal failure (5), NYHA class IV (9), critical preoperative state (11), lack of preoperative attainment of blood culture negativity (5), perivalvular involvement (5). Four risk classes were drawn ranging from "very low risk" (≤5 points, mean predicted mortality 1%), and to "very high risk" (≥20 points, 43% mortality). IE-specific risk stratification models are both needed, as disease-specific factors (e.g., cultures, abscess), beside the generic ones (e.g., age, renal impairment) affect mortality, and feasible.

Long-Term Outcome of Infective Endocarditis Involving Cardiac Implantable Electronic Devices: Impact of Comorbidities and Lead Extraction.

(1) Background: Management of cardiac implantable electronic device-related infective endocarditis (CIED-IE) hinges on complete hardware removal. We assessed whether long-term prognosis is affected by device removal, considering baseline patient comorbid conditions; (2) Methods: A total of 125 consecutive patients hospitalized for CIED-IE were included in this retrospective analysis. Outcomes were in-hospital, one-year, and long-term mortality. There were 109 patients who underwent device removal, 91 by transvenous lead extraction (TLE) and 18 by open heart surgery (OHS); (3) Results: TLE translated into lower hospital mortality (4.4% vs. 22.5% with OHS; p = 0.03). Septic pulmonary embolism was the only independent predictor of in-hospital mortality (OR:7.38 [1.49-36.6], p = 0.013). One-year mortality was in contrast independently associated to tricuspid valve involvement (p = 0.01) and Charlson comorbidity index (CCI, p = 0.039), but not the hardware removal modality. After a median follow-up of 41 months, mortality rose to 24%, and was significantly influenced only by CCI. Specifically, patients with a higher CCI who were also treated with TLE showed a survival rate not significantly different from those managed with medical therapy only; (4) Conclusions: In CIED-IE, TLE is the strategy of choice for hardware removal, improving early outcomes. Long-term benefits of TLE are lessened by comorbidities. In cases of CIED-IE with high CCI, a more conservative approach might be an option.

Beating Versus Arrested Heart Isolated Tricuspid Valve Surgery: Long-term Outcomes.

BACKGROUND: Isolated tricuspid valve (TV) surgery is a rare procedure generally considered at high risk for perioperative mortality and poor long-term outcomes. Surgical treatment can be performed with either an arrested heart (AH) or beating heart (BH) technique. The aim of this study was to compare the outcomes of isolated tricuspid surgery with 2 different approaches. METHODS: The Surgical-Tricuspid Study is a multicenter international retrospective study enrolling adult patients who underwent isolated TV procedures (n = 406; age 56 ± 16 years; 56% female) at 13 international sites. The AH and BH strategies were performed in 253 and 153 patients, respectively. Propensity score-matched analysis was used to compare groups. RESULTS: After matching, 129 pairs were obtained and analyzed. The 30-day mortality rate was 6.2% versus 5.0% in the AH and BH groups, respectively (P = .9). The rates of acute renal failure requiring replacement therapy (10% versus 3%; P = .02) and stroke (1.6% versus 0%; P = .08) were numerically higher in the AH group. The 6-year survival rate was 67% ± 6% versus 78% ± 5% in the AH and BH groups, respectively (P = .18), whereas freedom from cardiac death was 75% ± 5% versus 84% ± 4% (P = .21). The 6-year composite cardiac end point of cardiac death and reoperation rate was 60% ± 9% versus 86% ± 5% (P = .024) comparing AH-TV replacement and BH-TV repair groups. CONCLUSIONS: Isolated TV surgery performed with a BH strategy is a safe option and resulted in a trend of increased long-term survival and freedom from reoperation compared with the standard AH technique. Patients undergoing BH valve repair had the best long-term outcome.

Can prosthesis type influence the recurrence of infective endocarditis after surgery for native valve endocarditis? A propensity weighted comparison.

OBJECTIVES: Our goal was to investigate whether the incidence of valve-related adverse events might be different depending on the valve substitute after valve replacement for left-sided native valve endocarditis. METHODS: We assessed the long-term freedom from recurrence, reoperation and survival of 395 patients who had valve replacements for native valve endocarditis (314 mechanical vs 81 biological). Age <18 years, reoperation, prosthetic endocarditis, right valve involvement, valve repair and homograft implants were the main exclusion criteria. The balance between the 2 groups was addressed by weighting the results on the inverse of the propensity score. RESULTS: After inverse probability of treatment weighting (IPTW), freedom from recurrence of infective endocarditis was not significantly different (mechanical 84.1 ± 3.2% vs 50.6 ± 21.7%; P = 0.29) nor was freedom from reoperation different (mechanical 85.7 ± 3.1% vs biological 50.9 ± 21.9%; P = 0.29). Excluding competing deaths, patients receiving a bioprosthesis had a similar subdistribution hazard of the above end points compared to recipients of a mechanical valve [recurrence IPTW: hazard ratio (HR) 1.631, 95% confidence interval (CI) 0.756-3.516; P = 0.21; reoperation IPTW-HR 1.737, 95% CI 0.780-3.870; P = 0.18]. Mechanical valves were associated with improved long-term survival (34.9 ± 5.8% vs 10.5 ± 7.4% at 30 years; P = 0.0009; in particular: aortic valve subgroup 41.6 ± 9.3% vs 10.1 ± 8.2%; P < 0.0001), although the hazard of cardiovascular mortality did not favour either valve type (IPTW: HR 1.361, 95% CI 0.771-2.404; P = 0.29). CONCLUSIONS: Our analysis showed a clinical trend in favour of mechanical valves as valve substitutes for native valve endocarditis, especially in the aortic position. In view of long-term freedom from adverse events, the choice of the valve type should be tailored according to patient characteristics and specific clinical conditions.

Safety of low intensity oral anticoagulant therapy in patients with bileaflet mechanical aortic valve prosthesis: A propensity weighted study.

BACKGROUND: Scarce data are available on the long-term outcomes of different regimens of oral anticoagulation in an all comer population of patients undergoing aortic valve replacement with a bileaflet mechanical heart valve. METHODS: Outcomes of 88 patients discharged with a target INR of 2.0 (LOW-INR) were compared to 147 contemporary patients who have been recommended a target INR of 2.5 (CONV). Primary outcome was the composite of any thromboembolic or haemorrhagic events. Secondary outcomes were the individual components of the primary outcome, cardiovascular mortality and stroke. To reduce selection bias, a propensity weighted analysis was performed. RESULTS: After inverse probability of treatment weighting, the primary endpoint occurred in 0.7% of patient in the LOW-INR group and in 7.0% in the CONV group (p = .0255). Linearized event rate were significantly lower in the LOW-INR group (primary endpoint: rate difference - 12.0 per 1000 patient/years, p = .0052; haemorrhage: -5.8 per 1000 patient/years, p = .0330; neurological events: -7.6 per 1000 patient/years, p = .0140). Conventional target INR was associated with an increased hazard of the composite endpoint (HR 11.193, 95% CI 1.424-88.003, p = .0217). CONCLUSIONS: Lowering the intensity of oral anticoagulation resulted in a relevant clinical benefit of reduced rates of haemorrhagic and neurological adverse events in the mid-term follow-up. This report confirms the safety profile of the low INR regimen in an all comer population undergoing aortic valve replacement with an Abbott mechanical valve.

Low-dose anticoagulation after isolated mechanical aortic valve replacement with Liva Nova Bicarbon prosthesis: A post hoc analysis of LOWERING-IT Trial.

Thromboembolic complications after cardiac valve replacement are due to a complex interplay between patients' characteristics, device features and anticoagulation intensity. Subtle design and material differences in available prostheses may thrombosis. We conducted a post-hoc sub-analysis of the LOWERING-IT database to test the safety and feasibility of a low-level oral anticoagulant regime in low-risk patients with aortic LivaNova prosthetic valve replacement. The study population included 148 patients randomized to a low INR target (1.5-2.5; LOW-INR group), and 144 patients to the standard INR (2.0-3.0; CONVENTIONAL-INR group). The non-inferiority of thromboembolic events between LOW-INR and CONVENTIONAL-INR groups was tested. Cumulative follow-up reached 1,545 patient/years. The mean INR was 1.91 ± 0.23 in the LOW-INR group, and 2.59 ± 0.26 in the CONVENTIONAL-INR group (P < 0.001). There were 3 thromboembolic events, all in the CONVENTIONAL-INR group. Comparison of thromboembolic events was not significant. The 1-sided 97.5% exact CI for the difference in primary event proportion was 0.54%, satisfying criteria non-inferiority. Bleeding events were significantly different: 6.61 per 1,000 patient-year in LOW-INR group vs 18.65 per 1,000 patient-year in CONVENTIONAL-INR group (p < 0.045, RR 0.37). In conclusions these data suggest that low-dose anticoagulation is safe in selected patients after aortic LivaNova Bicarbon prosthesis implantation.

Risk and outcomes of aortic valve endocarditis among patients with bicuspid and tricuspid aortic valves.

OBJECTIVE: Patients with structural abnormalities of cardiac valves, including bicuspid aortic valve (BAV), are said to be at higher risk of infective endocarditis (IE). We sought to determine the risk of IE of the BAV compared with the tricuspid aortic valve (TAV) and to determine the risk of aortic valve replacement and mortality after IE. METHODS: From medical records of two US and one Italian hospitals, patients with their first episode of IE of any native valve were identified. In the US cohort 42 patients with BAV and 393 patients with TAV with IE occurring between 1 January 2000 and 30 June 2014 were identified. In the Italian cohort 48 patients with BAV and 341 patients with TAV with IE underwent valve replacement surgery between 1 January 2000 and1 November 2015. The risk of IE for BAV and TAV and subsequent outcomes were determined after matching to patients without IE. RESULTS: After adjustment for risk factors, the risk of IE in the US cohort was 23.1 (95% CI 8.1 to 100, p <0.0001) times greater for BAV than TAV. Patients with BAV with IE were more likely to have an aortic root abscess. Within the subsequent 5 years, BAV patients with IE were more likely to undergo valve replacement (85%) than TAV patients with IE (46%). Patients with IE were at increased risk of death. The findings were similar in the Italian cohort. CONCLUSIONS: Patients with BAV are at markedly increased risk of IE and aortic root abscess than patients with TAV. Increased risk of IE in patients with BAV indicates they may be a candidate group for long-term trials of antibiotic prophylaxis of IE.

Impact of failed mitral valve repair on hospital outcome of redo mitral valve procedures.

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 <30% (odds ratio (OR) 21.5, P = 0.005), major injury to cardiovascular structures at re-entry (OR 27.2, P < 0.01) or injury to patent left internal mammary artery-coronary artery bypass graft (OR 7.6, P = 0.03) predicted mortality in the whole FMR population. GOLD ≥ 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.

Surgery for prosthetic valve endocarditis: a retrospective study of a national registry.

OBJECTIVES: We described clinical-epidemiological features of prosthetic valve endocarditis (PVE) and assessed the determinants of early surgical outcomes in multicentre design. METHODS: Data regarding 2823 patients undergoing surgery for endocarditis at 19 Italian Centers between 1979 and 2015 were collected in a database. Of them, 582 had PVE: in this group, the determinants of early mortality and complications were assessed, also taking into account the different chronological eras encompassed by the study. RESULTS: Overall hospital (30-day) mortality was 19.2% (112 patients). Postoperative complications of any type occurred in 256 patients (44%). Across 3 eras (1980-2000, 2001-08 and 2009-14), early mortality did not significantly change (20.4%, 17.1%, 20.5%, respectively, P = 0.60), whereas complication rate increased (18.5%, 38.2%, 52.8%, P < 0.001), consistent with increasing mean patient age (56 ± 14, 64 ± 15, 65 ± 14 years, respectively, P < 0.001) and median logistic EuroSCORE (14%, 21%, 23%, P = 0.025). Older age, female sex, preoperative serum creatinine >-2 mg/dl, chronic pulmonary disease, low ejection fraction, non-streptococcal aetiology, active endocarditis, preoperative intubation, preoperative shock and triple valve surgery were significantly associated with mortality. In multivariable analysis, age (OR = 1.02; P = 0.03), renal insufficiency (OR = 2.1; P = 0.05), triple valve surgery (OR = 6.9; P = 0.004) and shock (OR = 4.5; P < 0.001) were independently associated with mortality, while streptococcal aetiology, healed endocarditis and ejection fraction with survival. Adjusting for study era, preoperative shock (OR = 3; P < 0.001), Enterococcus (OR = 2.3; P = 0.01) and female sex (OR = 1.5; P = 0.03) independently predicted complications, whereas ejection fraction was protective. CONCLUSIONS: PVE surgery remains a high-risk one. The strongest predictors of early outcome of PVE surgery are related to patient's haemodynamic status and microbiological factors.

Surgical factors and complications affecting hospital outcome in redo mitral surgery: insights from a multicentre experience.

OBJECTIVES: Several single-centre experiences have reported significant operative mortality and morbidity after mitral valve surgery in redo scenarios (ReMVS). Several preoperative risk factors outlining 'high-risk' categories have been reported, but scanty data on the impact of different operative techniques for these major challenging procedures have been analysed to date. The aim of the study is to investigate those intraoperative factors and postoperative events affecting early survival after redo mitral procedures. METHODS: Operative mortality and major morbidity events from a large multicentre registry enrolling 832 consecutive redo mitral procedures were analysed. Intraoperative technical issues and postoperative complications impacting operative mortality were identified. RESULTS: ReMVS was associated with significant operative mortality (12.5%), acute myocardial infarction (AMI; 5.9%), stroke (4.9%), acute respiratory insufficiency (14.8%), pneumonia (7.0%), acute renal insufficiency (16.1%) and failure (12.6%), reintervention for bleeding (7.6%), massive transfusion (28.0%), need for permanent pacemaker (10.1%). Injury of a previous patent left internal mammary artery (LIMA) graft [odds ratio (OR) 4.2, 95% confidence interval (CI): 1.6-11.5; P = 0.005], major cardiovascular iatrogenic lesions at re-entry (OR 19.2, 95% CI: 9.2-39.9; P < 0.001), extracellular crystalloid cardioplegia (OR 7.3, 95% CI: 1.4-37.8; P = 0.018), and incremental cardiopulmonary bypass time (OR 1.1, 95% CI: 1.0-1.2; P = 0.001) independently predicted operative mortality, whereas combined antegrade + retrograde cardioplegia (OR 0.2, 95% CI: 0.09-0.4; P = 0.001) was the only protective factor against mortality. Among complications, AMI (OR 4.1, 95% CI: 1.8-9.6; P = 0.001), need for intra-aortic balloon pumping (IABP; OR 3.1, 95% CI: 1.5-6.1; P = 0.001), prolonged intubation >48 h (OR 5.3, 95% CI: 2.9-9.4; P = 0.001) and massive (>6 units) transfusions (OR 4.4, 95% CI: 2.4-8.0; P = 0.001) also predicted operative mortality. CONCLUSIONS: ReMVS still carries the risk of significant early mortality and major morbidity. Major lesion to cardiovascular structures is the most dreadful iatrogenic complication, and injury of a previous LIMA graft identifies patients at higher risk of operative mortality. Prolonged cross-clamp times, extracellular crystalloid cardioplegia and massive transfusions have profound impact on early outcome, as well as the development of perioperative AMI, eventually requiring IABP and prolonged intubation. The combination of antegrade and retrograde cardioplegia seems to offer a better myocardial protection in these high-risk patients.