Prognostic value of SARS-CoV-2 on patients undergoing cardiac surgery.

OBJECTIVE: To analyze Italian Cardiac Surgery experience during the pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identifying risk factors for overall mortality according to coronavirus disease 2019 (COVID-19) status. METHODS: From February 20 to May 31, 2020, 1354 consecutive adult patients underwent cardiac surgery at 22 Italian Centers; 589 (43.5%), patients came from the red zone. Based on COVID-19 status, 1306 (96.5%) were negative to SARS-CoV-2 (COVID-N), and 48 (3.5%) were positive to SARS-CoV-2 (COVID-P); among the COVID-P 11 (22.9%) and 37 (77.1%) become positive, before and after surgery, respectively. Surgical procedures were as follows: 396 (29.2%) isolated coronary artery bypass grafting (CABG), 714 (52.7%) isolated non-CABG procedures, 207 (15.3%) two associate procedures, and three or more procedures in 37 (2.7%). Heart failure was significantly predominant in group COVID-N (10.4% vs. 2.5%, p = .01). RESULTS: Overall in-hospital mortality was 1.6% (22 cases), being significantly higher in COVID-P group (10 cases, 20.8% vs. 12, 0.9%, p < .001). Multivariable analysis identified COVID-P condition as a predictor of in-hospital mortality together with emergency status. In the COVID-P subgroup, the multivariable analysis identified increasing age and low oxygen saturation at admission as risk factors for in-hospital mortality. CONCLUSION: As expected, SARS-CoV-2 infection, either before or soon after cardiac surgery significantly increases in-hospital mortality. Moreover, among COVID-19-positive patients, older age and poor oxygenation upon admission seem to be associated with worse outcomes.

Midterm outcomes of transaortic and transapical TAVI in patients with unsuitable vascular anatomy for femoral access: A propensity score inverse probability weight study.

AIMS: Transaortic (TAo) and transapical (TA) implantation can be used in transcatheter aortic valve implantation (TAVI) when the transfemoral (TF) approach is precluded. We compare the safety and efficacy of these alternative techniques. METHODS: From October 2007 to February 2016, TAo and TA patients' data were collected. Propensity score inverse probability of treatment weight (IPTW) method was employed to minimize the impact of no-randomization bias. RESULTS: From our single-center non-TF-TAVI registry, 282 patients were included: 235 (83.3%) underwent TAo and 47 (16.7%) TA. Differences in baseline characteristics were statistically significant in age, sex, risk profile according to logistic-EuroSCORE, and previous cardiac surgery. No difference in hospital morbidity and mortality, but lower stroke-rate in TAo (1.27% vs. 8.5% p < .01) was observed. This was confirmed at logistic regression after IPTW adjustment (odds ratio [OR]: 0.16, 95% CI 0.03-0.71, p = .01), together with reduced risk of the paravalvular leak (PVL) (OR: 0.14, 95% confidence interval [CI]: 0.02-0.81, p = .02). Kaplan-Meier estimates did not demonstrate differences in long-term mortality among access routes (logrank test p = .13). At the IPTW-Cox regression model, long-term mortality was related to New York Heart Association III-IV (hazard ratio [HR]: 2.92, 95% CI: 1.15-7.40, p = .026), chronic renal failure (HR: 3.25; 95% CI: 1.02-10.32 p = .046), previous transient ischemic attack/stroke (HR: 2.29, 95% CI: 1.25-4.20 p = .007). Sapien-3 device resulted to be a protective factor, reducing long-term mortality (HR: 0.18, 95% CI 0.04- 0.90 p = .03). CONCLUSIONS: TAo is safe and feasible in case of contraindication to femoral approach demonstrating comparable midterm outcomes to TA, thus representing a central access alternative, to increase the overall safety of high-risk TAVI procedures.

Comparison between three different equations for the estimation of glomerular filtration rate in predicting mortality after coronary artery bypass.

BACKGROUND: This study was undertaken to compare the accuracy of chronic kidney disease-epidemiology collaboration (eGFRCKD-EPI) to modification of diet in renal disease (eGFRMDRD) and the Cockcroft-Gault formulas of Creatinine clearance (CCG) equations in predicting post coronary artery bypass grafting (CABG) mortality. METHODS: Data from 4408 patients who underwent isolated CABG over a 11-year period were retrieved from one institutional database. Discriminatory power was assessed using the c-index and comparison between the scores' performance was performed with DeLong, bootstrap, and Venkatraman methods. Calibration was evaluated with calibration curves and associated statistics. RESULTS: The discriminatory power was higher in eGFRCKD-EPI than eGFRMDRD and CCG (Area under Curve [AUC]:0.77, 0.55 and 0.52, respectively). Furthermore, eGFRCKD-EPI performed worse in patients with an eGFR ≤29 ml/min/1.73m2 (AUC: 0.53) while it was not influenced by higher eGFRs, age, and body size. In contrast, the MDRD equation was accurate only in women (calibration statistics p = 0.72), elderly patients (p = 0.53) and subjects with severe impairment of renal function (p = 0.06) whereas CCG was not significantly biased only in patients between 40 and 59 years (p = 0.6) and with eGFR 45-59 ml/min/1.73m2 (p = 0.32) or ≥ 60 ml/min/1.73m2 (p = 0.48). CONCLUSIONS: In general, CKD-EPI gives the best prediction of death after CABG with unsatisfactory accuracy and calibration only in patients with severe kidney disease. In contrast, the CG and MDRD equations were inaccurate in a clinically significant proportion of patients.

Neurologic Injury in Adults Supported With Veno-Venous Extracorporeal Membrane Oxygenation for Respiratory Failure: Findings From the Extracorporeal Life Support Organization Database.

OBJECTIVES: To assess in-hospital neurologic (CNS) complications in adult patients undergoing veno-venous extracorporeal membrane oxygenation for respiratory failure. DESIGN: Retrospective analysis of the Extracorporeal Life Support Organization's data registry. SETTING: Data reported to Extracorporeal Life Support Organization from 350 international extracorporeal membrane oxygenation centers during 1992-2015. PATIENTS: Adults (≥ 18 yr old) supported with veno-venous extracorporeal membrane oxygenation for respiratory failure. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We included 4,988 adults supported with veno-venous extracorporeal membrane oxygenation for respiratory failure. Neurologic injury was defined as brain death, seizures, stroke, and intracranial hemorrhage occurring during extracorporeal membrane oxygenation support. We used multivariable logistic regression to explore patient and extracorporeal membrane oxygenation factors associated with neurologic injury. Median age of the study cohort was 46 (interquartile range, 32-58). Four hundred twenty-six neurologic complications were reported in 356 patients (7.1%), and included 181 intracranial hemorrhage (42.5%), 100 brain deaths (23.5%), 85 stroke (19.9%), and 60 seizure events (14.1%). In-hospital mortality was significantly higher for those with CNS complications (75.8% vs 37.8%; p < 0.001) and varied by type of CNS injury; mortality was 79.6% in patients with intracranial hemorrhage, 68.2% in patients with stroke, and 50% in patients with seizures. Pre-extracorporeal membrane oxygenation cardiac arrest, continuous veno-venous hemofiltration, and hyperbilirubinemia during extracorporeal membrane oxygenation were associated with increased odds of neurologic injury. CONCLUSIONS: Approximately 7% of adults supported with veno-venous extracorporeal membrane oxygenation for respiratory failure had neurologic injury. Intracranial hemorrhage was the most frequent type, and survival for patients with neurologic injury was poor. Future investigations should evaluate anticoagulation management as well as brain/extracorporeal membrane oxygenation interaction to reduce these life-threatening events.

Endoscopic versus open radial artery harvesting: A meta-analysis of randomized controlled and propensity matched studies.

BACKGROUND: We sought to investigate the impact of radial artery harvesting techniques on clinical outcomes using a meta-analytic approach limited to randomized controlled trials and propensity-matched studies for clinical outcomes, in which graft patency was analyzed. METHODS: A systematic literature review was conducted using PubMed and MEDLINE to identify publications containing comparisons between endoscopic radial artery harvesting (ERAH) and open harvesting (ORAH). Only randomized controlled trials and propensity-matched series were included. Data were extracted and analyzed with RevMan. The primary endpoint was wound complication rate, while secondary endpoints were patency rate, early mortality, and long-term cardiac mortality. RESULTS: Six studies comprising 743 patients were included in the meta-analysis. Of them 324 (43.6%) underwent ERAH and 419 (56.4%) ORAH. ERAH was associated with a lower incidence of wound complications (odds ratio: 0.33, confidence interval 0.14-0.77; p = 0.01). There were no differences in graft patency, and early and long-term cardiac mortality between the two techniques. CONCLUSION: ERAH reduces wound complications and does not affect graft patency, or short- and long-term mortality compared to ORAH.

In-Hospital Neurologic Complications in Adult Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation: Results From the Extracorporeal Life Support Organization Registry.

OBJECTIVES: To elucidate the epidemiology, complication profiles, hospital outcome, and predisposing factors of CNS complications occurring during venoarterial extracorporeal membrane oxygenation in adults. DESIGN: Retrospective analysis of the Extracorporeal Life Support Organization registry. SETTING: Data reported to Extracorporeal Life Support Organization by 230 extracorporeal membrane oxygenation centers from 1992 to 2013. PATIENTS: Patients more than 16 years old supported with a single-run of venoarterial extracorporeal membrane oxygenation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We examined 4,522 adult patients supported with venoarterial extracorporeal membrane oxygenation and included in the Extracorporeal Life Support Organization registry. Venoarterial extracorporeal membrane oxygenation was used for cardiac dysfunction in 3,005 patients (66.5%), cardiopulmonary resuscitation in 877 patients (19.4%), and respiratory failure in 640 patients (14.1%), respectively. Multivariate logistic regression was performed to identify factors independently associated with CNS injury. Neurologic complications occurred in 682 patients (15.1%), and included brain death in 358 patients (7.9%), cerebral infarction in 161 patients (3.6%), seizures in 83 patients (1.8%), and cerebral hemorrhage in 80 patients (1.8%). Multiple CNS complications in the same patient occurred in 70 cases. Hospital mortality in patients with CNS complications was 89%, compared with 57% in patients without (p < 0.001). In a multivariable model, age, pre-extracorporeal membrane oxygenation cardiac arrest, the use of inotropes on extracorporeal membrane oxygenation, and post-extracorporeal membrane oxygenation hypoglycemia were shown to be associated with CNS complications. CONCLUSIONS: Neurologic complications in adult patients on venoarterial extracorporeal membrane oxygenation support are common and associated with poor survival. Further research should focus on better understanding and management of brain/extracorporeal membrane oxygenation interaction to avoid such catastrophic complications.

Long-term results (≤18 years) of the edge-to-edge mitral valve repair without annuloplasty in degenerative mitral regurgitation: implications for the percutaneous approach.

BACKGROUND: To assess the long-term results of the edge-to-edge mitral repair performed without annuloplasty in degenerative mitral regurgitation (MR). METHODS AND RESULTS: From 1993 to 2002, 61 patients with degenerative MR were treated with an isolated edge-to-edge suture without any annuloplasty. Annuloplasty was omitted in 36 patients because of heavy annular calcification and in 25 for limited annular dilatation. A double-orifice repair was performed in 53 patients and a commissural edge-to-edge in 8. Hospital mortality was 1.6%. Follow-up was 100% complete (mean length, 9.2±4.21 years; median, 9.7; longest, 18.1). Survival at 12 years was 51.3±7.75%. At the last echocardiographic examination, MR ≥3+ was demonstrated in 33 patients (55%). At 12 years, freedom from reoperation was 57.8±7.21% and freedom from recurrence of MR ≥3+ was 43±7.6%. Residual MR >1+ at hospital discharge was identified as a risk factor for recurrence of MR ≥3+ (hazard ratio, 3.8; 95% confidence interval, 1.7-8.2; P=0.001). In patients with residual MR ≤1+ immediately after surgery, freedom from MR ≥3+ at 5 and 10 years was 80±6% and 64±7.58%, respectively. CONCLUSIONS: In degenerative MR, the overall long-term results of the surgical edge-to-edge technique without annuloplasty are not satisfactory. Early optimal competence (residual MR ≤1+) was associated with higher freedom from recurrent severe regurgitation.

Does EuroSCORE II perform better than its original versions? A multicentre validation study.

AIMS: The European system for cardiac operation risk evaluation (EuroSCORE) is widely used for predicting in-hospital mortality after cardiac surgery. A new score (EuroSCORE II) has been recently developed to update the previously released versions. This study was undertaken to validate EuroSCORE II, to compare its performance with the original EuroSCOREs and to evaluate the effects of the removal of those factors that were included in the score even if they were statistically non-significant. METHODS AND RESULTS: Data on 12,325 consecutive patients who underwent major cardiac surgery in a 6-year period were retrieved from three prospective institutional databases. Discriminatory power was assessed using the c-index and comparison among the scores' performances was performed with Delong, bootstrap, and Venkatraman methods. Calibration was evaluated with calibration curves and associated statistics. The in-hospital mortality rate was 2.2%. The discriminatory power was high and similar in all algorithms (area under the curve 0.82, 95% CI: 0.79-0.84 for additive EuroSCORE; 0.82, 95% CI: 0.79-0.84 for logistic EuroSCORE; 0.82, 95% CI: 0.80-0.85 for EuroSCORE II). The EuroSCORE II had a fair calibration till 30%-predicted values and over-predicted beyond. The removal of non-significant factors from EuroSCORE II did not affect performance, being both the calibration and discrimination comparable. CONCLUSION: This validation study demonstrated that EuroSCORE II is a good predictor of perioperative mortality. It showed an optimal calibration until 30%-predicted mortality. Nonetheless, it does not seem to significantly improve the performance of older versions in the higher tertiles of risk. Moreover, it could be simplified, as the removal from the algorithm of non-significant factors does not alter its performance.

Composite end points and competing risks analysis.

Composite end points are common primary outcomes in clinical trials. Their main benefit of utilizing a composite outcome is increasing the number of primary outcome events, meaning fewer participants are required to deliver an adequately powered trial. By combining multiple important end points in the primary outcome rather than having to select only 1, composite end points potentially make clinically meaningful benefits easier to detect and avoid ranking outcomes hierarchically. However, there are a number of important considerations when designing and interpreting clinical trials that utilize composite end points. In this Statistical Primer, issues with composite end points such as competing events, halo effect, risk of bias, time-to-event limitations and the win ratio are discussed in the context of real world clinical trials.

SURgical vs. PERcutaneous ACCESS in Transfemoral Transcatheter Aortic Valve Implantation (SU-PER-ACCESS Study).

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

[Percutaneous treatment of post-acute myocardial infarction mechanical complications: state of the art]. / Trattamento percutaneo delle complicanze meccaniche dell'infarto miocardico acuto: stato dell'arte.

Left ventricular free wall rupture, ventricular pseudoaneurysm, papillary muscle rupture and ventricular septal rupture are life-threatening mechanical complications of acute myocardial infarction. Despite significant improvements over the last decades in overall mortality for patients with myocardial infarction, the outcome of subjects who develop post-infarction mechanical complications remains poor. Surgical treatment is considered the standard of care. However, percutaneous approaches (such as pericardial fibrin-glue injection for left ventricular free wall rupture, transcatheter edge-to-edge mitral repair for papillary muscle rupture and device closure for ventricular pseudoaneurysm or septal rupture) have been proposed in selected high-risk or inoperable patients, or in subjects with ideal characteristics for feasibility, as therapeutic alternatives to open surgery. The aim of the present review is to provide a comprehensive overview of the percutaneous strategies for the management of post-acute myocardial infarction mechanical complications.

[Total artificial heart: past, present, and future]. / Cuore artificiale totale: passato, presente e futuro.

Every year, approximately 5 out of 1000 patients receive a diagnosis of advanced heart failure, with a prevalence of 1-2% in the adult population. This figure is likely underestimated, considering undiagnosed cases. Despite significant progress in medical therapy for heart failure, mortality rates persist around 20% within the first year, reaching 50-60% at 5 years from the initial diagnosis. For patients with severe end-stage heart failure, the 1-year mortality rate can reach up to 70%. Heart transplantation remains the preferred treatment for terminal stages of the disease; however, the significant challenge lies in the mismatch between available donors and recipients. Given this dilemma, both short-term solutions including extracorporeal membrane oxygenation and long-term options such as left ventricular assist devices have gained prominence. These mechanical circulatory support systems become crucial for patients in critical conditions, temporarily ineligible for heart transplantation, such as those with severe irreversible pulmonary hypertension or acute organ failure. Despite these advancements, a growing number of patients on the waiting list develops severe biventricular dysfunction, precluding the use of a left ventricular assist device as a bridge to transplant. In such cases, a total artificial heart emerges as a viable therapeutic option.

Hybrid coronary revascularization: position paper of the European Society of Cardiology Working Group on Cardiovascular Surgery and European Association of Percutaneous Cardiovascular Interventions.

Myocardial revascularization in coronary artery disease via percutaneous coronary intervention or coronary artery bypass graft (CABG) surgery effectively relieves symptoms, significantly improves prognosis and quality of life when combined with guideline-directed medical therapy. Hybrid coronary revascularization is a promising alternative to percutaneous coronary intervention or CABG in selected patients and is defined as a planned and/or intended combination of consecutive CABG surgery using at least 1 internal mammary artery to the left anterior descending (LAD), and catheter-based coronary intervention to the non-LAD vessels for the treatment of multivessel disease. The main indications for hybrid coronary revascularization are (i) to achieve complete revascularization in patients who cannot undergo conventional CABG, (ii) to treat patients with acute coronary syndromes and multivessel disease with a non-LAD vessel as the culprit lesion that needs revascularization and (iii) in highly select patients with multivessel disease with complex LAD lesions and simple percutaneous coronary intervention targets for all other vessels. Hybrid coronary revascularization patients receive a left internal mammary artery graft to the LAD artery through a minimal incision along with percutaneous coronary intervention to the remaining diseased coronary vessels using latest generation drug-eluting stents. A collaborative environment with a dedicated heart team is the optimal platform to perform such interventions, which aim to improve the quality and outcome of myocardial revascularization. This position paper analyses the rationale of hybrid coronary revascularization and the currently available evidence on the various techniques and delves into the sequence of the interventions and pharmacological management during and after the procedure.

[Surgical treatment of isolated tricuspid valve disease: indications, new evidence, and risk stratification]. / Trattamento cardiochirurgico della patologia tricuspidale isolata: indicazioni, nuove evidenze e stratificazione del rischio.

The tricuspid valve, long neglected as a passive structure and often termed the "forgotten valve", has recently gained attention from the international medical and cardiological community due to the association of tricuspid regurgitation with an unfavorable prognosis. Isolated tricuspid regurgitation represents a relatively unknown and variable condition, closely linked to the shape and function of the right ventricle and the state of the pulmonary circulation. Currently, guidelines are not clear regarding the optimal treatment strategy, the process of patient selection, and the surgical or transcatheter procedural timing, nor for predicting patient outcomes. Surgical procedures specifically aimed at correcting isolated tricuspid regurgitation, without other concomitant indications for open-heart surgery, have been considered complex and risky, with a high rate of postoperative complications and a poorly understood impact on patient survival and life expectancy. In this review, we will attempt to examine tricuspid valve pathology by analyzing preoperative assessment, essential for risk stratification, various surgical techniques, and outcomes.

Mechanical heart valves and oral anticoagulation: a survey of the Italian Society of Cardiac Surgery.

In the latest European guidelines for the management of valvular heart disease, mechanical valve prostheses maintain a strategic role, particularly for certain patient subsets and age groups. Despite the high number of devices implanted in clinical practice, particularly in non-European and North American regions, current scientific literature and debate seem to suggest a limited use of mechanical heart valves. The cardiac surgery community seems to be highly interested in biological and transcatheter valve prostheses but less interested in mechanical heart valves, including possible strategies for self-management of anticoagulation therapy. In this respect, the Italian Society of Cardiac Surgery (SICCH), in particular the Italian Group of Research for Outcome in Cardiac Surgery (GIROC), has promoted a survey among its members to stimulate the interest in this topic and express their opinion on this issue that, due to the prevalence of the affected population and the new treatment options for improving patients' quality of life, should be more appraised and debated in the cardiac surgery community. The recorded results, obtained on the answers to 111 questionnaires, seem to divide the specialists into 'pros' and 'contras' on a useful tool for the entire cardiac surgery community. For this reason, SICCH proposes in conclusion to declare its unified and institutional opinion on this topic.

[Choosing a tailored prosthetic valve in cardiac surgery: what is the current role of mechanical prostheses?] / Il ruolo delle protesi valvolari meccaniche oggi. Dalla letteratura alla situazione italiana.

The choice of the mechanical/biological heart valve prosthesis is a topic currently debated in the light of the transcatheter prosthetic models and the results obtained/expected with the new biological valve models. Consequently, it seems that increasingly younger patients would be indicated for an implantation of a biological prosthesis. This is also in order to improve the quality of life of patients who want to avoid oral anticoagulant therapy. On the other hand, the guidelines for the treatment of heart valve disease assign a central role to the use of mechanical valve prostheses, particularly for certain patient subsets and age groups. This means that mechanical prostheses are still widely used worldwide, especially in non-European or North American regions. The cardiac surgery community therefore seems to be very interested in biological prostheses and transcatheter implants and scarcely interested in mechanical prostheses, including possible strategies for self-management of anticoagulant therapy. Recently, the Italian Society of Cardiac Surgery promoted a survey among its members to stimulate interest in the cardiac surgery community. This review article aims to summarize the most current results recorded with the use of mechanical prostheses and possible strategies, especially for the management of oral anticoagulant therapy, which can improve the patient's quality of life.

Comparison of 4 mortality scores for surgical repair of type A aortic dissection: a multicentre external validation.

OBJECTIVES: In the last decades, 4 different scores for the prediction of mortality following surgery for type A acute aortic dissection (TAAD) were proposed. We aimed to validate these scores in a large external multicentre cohort. METHODS: We retrospectively analysed patients who underwent surgery for TAAD between 2000 and 2020. Patients were enrolled from 10 centres from 2 European countries. Outcomes were the early (30-day and/or in-hospital) and 1-year mortality. Discrimination, calibration and observed/expected (O/E) ratio were evaluated. RESULTS: A total of 1895 patients (31.7% females, mean age 63.72 ± 12.8 years) were included in the study. Thirty-day mortality and in-hospital mortality were 21.7% (n = 412) and 22.5% (n = 427) respectively. The German Registry of Acute Aortic Dissection Type A (GERAADA) score shows to have the best discrimination [area under the curve (AUC) 0.671 and 0.672] in predicting as well the early and the 1-year mortality, followed by the International Registry of Acute Aortic Dissection (IRAD) model 1 (AUC 0.658 and 0.672), the Centofanti (AUC 0.645 and 0.66) and the UK aortic score (AUC 0.549 and 0.563). According to Hosmer-Lemeshow and Brier tests, the IRAD model I and GERAADA, respectively, were well calibrated for the early mortality, while the GERAADA and Centofanti for the 1-year mortality. The O/E analysis showed a marked underestimation for patients labelled as low-risk for UK aortic score and IRAD model I for both outcomes. CONCLUSIONS: The GERAADA score showed the best performance in comparison with other scores. However, none of them achieved together a fair discrimination and a good calibration for predicting either the early or the 1-year mortality.