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The intra-aortic balloon pump (IABP) is the most widely available mechanical support device, but its use has been disputed in recent decades. Although several efforts have been made to reduce the associated complication rate, contemporary data on this matter is lacking. The present study aims to evaluate the differences in vascular complications between the sheathless and the sheathed IABP implantation technique in cardiac surgery patients. A retrospective multi-center cohort, consisting of patients treated in 8 cardiac surgical centers, was evaluated. Patients who underwent cardiac surgery with peri-operative IABP support were included. Primary outcome was a composite end point of vascular complications. Propensity score matching (PSM) was performed, and a multivariable regression model was applied to evaluate predictors of vascular complications. The unmatched cohort consisted of 2,615 patients (sheathless n = 1,414, 54%, sheathed n = 1,201, 46%). A total of 878 patients were matched (n = 439 for both groups). The composite vascular complication end point occurred in 3% of patients in the sheathless group, compared with 8% in the sheathed group (p

Left ventricular pseudoaneurysm (LVP) is a very rare, but potentially lethal mechanical complication of acute myocardial infarction (AMI). Despite representing a unique subset of cardiac rupture, it presents peculiar features that distinguish it from both ventricular free-wall rupture (FWR) and ventricular true aneurysm. LVP occurs in less than 0.5% of patients affected by AMI. However, LVP is generally burdened by high mortality, often related to false cavity rupture, leading to catastrophic and often irreversible consequences. The risk of rupture is inversely proportional to the timing from AMI onset, which also determines both the classification of LVP and drives the indication for treatment. Despite the lack of a current consensus on LVP management, urgent surgery is the treatment of choice for LVPs occurring within 3 months from AMI, especially if larger than 3 cm in diameter. A matter of debate, however, is represented by chronic LVPs, especially because the risk of rupture decreases progressively as time passes and left ventricular (LV) false cavity stabilizes. Surgical mortality rate remains not negligible (more than 20%), but these suboptimal results may be considered acceptable, especially considering the lethality associated with the occurrence of pseudoaneurysm rupture. Diagnostic workup is essential for anatomical characterization of LV rupture, which is mandatory to guide the decision on surgical approach and technique for pseudoaneurysm repair. Finally, for a subset of patients with anterior LVP and a well-defined fibrotic neck, and deemed at excessively high surgical risk, percutaneous closure of the cavity has been described with encouraging results.

To compare in-hospital outcome of Evolut-R 34 mm vs. smaller Evolut-R devices and to identify predictors of paravalvular leak (PVL) and deep implantation specific for Evolut-R 34 mm.This single-center retrospective study included 359 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with Evolut-R 34 mm (N = 84,23.4%) and Evolut-R 23/26/29 mm (N = 275,76.6%) between 2016 and 2019.Patients in Evolut-R 34 mm group were more frequently males, had lower STS score, ejection fraction, and mean aortic gradient compared to the Evolut-R 23/26/29 mm group. Horizontal aorta and large LVOT were more frequent findings in the Evolut-R 34 mm group, whereas calcium volume was comparable among the groups. During TAVR, mean implantation depth and contrast volume were greater in the Evolut-R 34 mm group, compared to the Evolut 23/26/29 mm group. Post-procedurally, 30-day mortality, ≥moderate PVL, device success and pacemaker implantation (PM) rates were comparable between groups. Among independent predictors of ≥moderate PVL, calcium volume (OR:1.04; p0.001) was predictive with different thresholds in both groups, whereas aortic angulation (OR:1.40; p = 0.005) was predictive only in Evolut-R 34 mm group at a cutoff of 60° (AUC:0.73; p = 0.043). Body weight (OR:1.03; p = 0.027), left ventricular outflow tract (LVOT) diameter (OR:1.34; p = 0.001), and mean aortic gradient (OR:0.96; p = 0.006) were independent predictors of deep implantation (mean depth ≥ 6 mm), with LVOT27 mm being predictive specifically for Evolut-R 34 mm (AUC:0.66; p = 0.024).TAVR with Evolut-R 34 mm and Evolut-R 23/26/29 mm showed comparable in-hospital outcome. Aortic angulation60° and LVOT27 mm were predictive respectively of ≥moderate PVL and deep implantation specifically in Evolut-R 34 mm patients.

Objectives The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation. Background Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking. Methods Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year. Results From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively. Conclusions The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Objectives The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). Background Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. Methods Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. Results From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. Conclusions In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only

Aims Female sex and heart failure (HF) are considered poor prognostic factors for surgery. We aimed to investigate the association between sex and surgical outcomes in patients with ischaemic HF undergoing surgical ventricular reconstruction and coronary artery bypass grafting. Methods and results From July 2001 to June 2017, 648 patients [111 women (17%) and 537 men (83%)] were referred to our centre. Follow‐up continued through June 2018. All patients underwent surgical ventricular reconstruction; coronary artery bypass grafting was performed in 582 patients (90%). Primary outcome was defined as all‐cause mortality. Secondary outcome included all‐cause mortality or all‐cause hospitalization. Women were older (70 vs. 65 years, P

We sought to determine outcomes of aortic valve replacement (AVR) versus root replacement after transcatheter AVR (TAVR) explantation because they remain unknown.From November 2009 to September 2020, data from the EXPLANT-TAVR International Registry of patients who underwent TAVR explant were retrospectively reviewed, divided by AVR versus root replacement. After excluding explants performed during the same admission as the initial TAVR and concomitant procedures involving the other valves, 168 AVR cases were compared with 28 root replacements, and outcomes were reported at 30 days and 1 year.Among 196 patients (mean age, 73.5 ± 9.9 years) who had primary aortic valve intervention at TAVR explant, the median time from TAVR to surgical explant was 11.2 months (interquartile range, 4.4-32.9 months). Indications for explant were similar between the 2 groups. Compared with AVR, patients requiring root replacement had fewer comorbidities but more unfavorable anatomy for redo TAVR (52.6% vs 26.4%; P = .032), fewer urgent/emergency cases (32.1% vs 58.3%; P = .013), longer median interval from index TAVR to TAVR explant (17.6 vs 9.9 months; P = .047), and more concomitant ascending aortic replacement (58.8% vs 14.0%; P .001). Median follow-up was 6.9 months (interquartile range, 1.4-21.6 months) after TAVR explant and 97.4% complete. Overall survival at follow-up was 81.2% with no differences between groups (log rank P = .54). In-hospital, 30-day, and 1-year mortality rates and stroke rates were not different between the 2 groups.In the EXPLANT-TAVR Registry, AVR and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities. Further investigations are necessary to identify patients at risk of root replacement in TAVR explant.

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

OBJECTIVES Although the intra-aortic balloon pump (IABP) has been the most widely adopted temporary mechanical support device in cardiac surgical patients, its use has declined. The current study aimed to evaluate the occurrence and predictors of early mortality and complication rates in contemporary cardiac surgery patients supported by an IABP. METHODS A multicentre, retrospective analysis was performed of all consecutive cardiac surgical patients receiving perioperative balloon pump support in 8 centres between January 2010 to December 2019. The primary outcome was early mortality, and secondary outcomes were balloon-associated complications. A multivariable binary logistic regression model was applied to evaluate predictors of the primary outcome. RESULTS The study cohort consisted of 2615 consecutive patients. The median age was 68 years [25th percentile 61, 75th percentile 75 years], with the majority being male (76.9%), and a mean calculated 30-day mortality risk of 10.0%. Early mortality was 12.7% (n = 333), due to cardiac causes (n = 266), neurological causes (=22), balloon-related causes (n = 5) and other causes (n = 40). A composite end point of all vascular complications occurred in 7.2% of patients, and leg ischaemia was observed in 1.3% of patients. The most important predictors of early mortality were peripheral vascular disease [odds ratio (OR) 1.63], postoperative dialysis requirement (OR 10.40) and vascular complications (OR 2.57). CONCLUSIONS The use of the perioperative IABP proved to be safe and demonstrated relatively low complication rates, particularly for leg ischaemia. As such, we believe that specialists should not be held back to use this widely available treatment in high-risk cardiac surgical patients when indicated.

The impact of the coronavirus disease-2019 (COVID-19) pandemic forced the governments worldwide to deal with an unprecedented health crisis. The aim of this review is to summarize what happened to cardiac surgery worldwide during the first wave of this pandemic. A literature search was performed to extrapolate key concepts regarding guidelines and reorganization of cardiac surgery wards during COVID-19. Supporting literature was also included to discuss the hot topics related to COVID-19 and cardiac surgery. Hence, both official documents from national scientific societies and single- or multiple-center experiences during the pandemics are reviewed and discussed. In Italy, the first western country hit by the pandemic, two different models were proposed to cope with the need for ICU/ward beds and to reallocate cardiac surgical services: Hub-and-Spoke system ('Hubs', dedicated to perform urgent and nondeferrable surgery, and 'Spokes', turned into COVID centers) and/or a progressive reduction in surgical activity. Worldwide, several guidelines/consensus statements were published, suggesting how to deal with the outbreak. Two different approaches for stratifying surgical indications were proposed: dynamic, based on the number of hospitalized COVID-19 patients; static, based only on the severity of the cardiovascular disease. Moreover, the importance of personal protective equipment was stressed. Several measures should have been adopted to deal with an unprecedented need for healthcare resources allocation to care for COVID-19 patients, putting the healthcare systems under serious stress. Cardiac surgery has, as have most surgical activities, been asked to reduce its own activity, giving priority to emergency and nondeferrable cases.

Structural valve degeneration, valve thrombosis, or acute infective endocarditis may affect the postprocedural outcome of transcatheter aortic valve implanted (TAVI) prostheses. Data of patients who required late surgical explant of TAVI prostheses were obtained from 8 European centers. There were 13 patients who underwent surgical treatment for TAVI prosthesis failure after original admission due to prosthetic infective endocarditis in 6 patients, structural valve degeneration in 4, and valve thrombosis in 3. Hospital mortality was 15%, and survival at the 2-year follow-up was 71%. Abstract word count: 80 (C) 2021 by The Society of Thoracic Surgeons

The role of surgical ventricular reconstruction (SVR) in patients with ischemic cardiomyopathy is controversial. Observational series and the Surgical Treatment of IsChemic Heart failure (STICH) trial reported contradictory results. SVR is highly dependent on operator experience. The aim of this study is to compare the long-term results of SVR between a high-volume SVR institution and the STICH trial using individual patient data.Patients undergoing SVR at San Donato Hospital (Milan) were compared with patients undergoing SVR in STICH (as-treated principle) by inverse probability treatment-weighted Cox regression. The primary outcome was all-cause mortality.The San Donato cohort included 725 patients, whereas the STICH cohort included 501. Compared with the STICH-SVR cohort, San Donato patients were older (66.0, lower quartile, upper quartile [Q1, Q3: 58.0, 72.0] vs 61.9 [Q1, Q3: 55.1, 68.8], P .001) and with lower left ventricular end-systolic volume index at baseline (LVESVI: 77.0 [Q1, Q3: 59.0, 97.0] vs 80.8 [Q1, Q3: 58.5, 106.8], P = .02). Propensity score weighting yielded 2 similar cohorts. At 4-year follow-up, mortality was significantly lower in the San Donato cohort compared with the STICH-SVR cohort (adjusted hazard ratio, 0.71; 95% confidence interval, 0.53-0.95; P = .001). Greater postoperative LVESVI was independently associated with mortality (hazard ratio, 1.02; 95% confidence interval, 1.01-1.03). At 4 to 6 months of follow-up, the mean reduction of LVESVI in the San Donato cohort was 39.6%, versus 10.7% in the STICH-SVR cohort (P .001).Patients with postinfarction LV remodeling undergoing SVR at a high-volume SVR institution had better long-term results than those reported in the STICH trial, suggesting that a new trial testing the SVR hypothesis may be warranted.

The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER).Although100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking.Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year.From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery.In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only 10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Congenital left ventricular aneurysm or diverticulum is very rare. Most congenital left ventricular aneurysms are asymptomatic but some cause systemic embolization, left ventricular free wall rupture, or ventricular arrhythmias causing sudden cardiac death. A 29-year-old woman with congenital left ventricular aneurysm and nonsustained ventricular tachycardia underwent surgical plication of the aneurysm with left ventricular reshaping to improve heart failure symptoms, prevent rupture of the aneurysm wall and the possibility of thrombus formation, and excise the fibrotic tissue of the left ventricular aneurysm, which could be a trigger for left ventricular aneurysm arrhythmias. The postoperative course was unremarkable.

A 49-year-old man was admitted to our department 6 months after emergent surgery for type-A acute aortic dissection. A chest computed tomography-scan revealed a huge aneurysm originating from the proximal aortic arch, strongly adherent to the upper part of the sternum. Extracorporeal circulation was instituted first, and chest was reopened in circulatory arrest. The mass was a giant pseudoaneurysm originating from a laceration at the base of the innominate artery. Due to tissue fragility and complete distortion of the origin of right carotid and subclavian arteries, we performed an extra-anatomic ascending aorta-to-right carotid artery bypass, followed by Teflon-reinforced suture of the proximal artery stumps. The postoperative course was uneventful.

OBJECTIVES Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices. METHODS Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class CONCLUSION The TAo-TAVI approach confirms its safety and effectiveness with satisfactory procedural and midterm outcomes with both currently available devices.

Ischaemic chronic heart failure represents one of the cardiovascular diseases with the worst degree of morbidity and mortality in the Western world, along with the highest healthcare costs. Despite several retrospective studies demonstrating that surgical revascularization (coronary artery bypass grafting), especially in the presence of viable myocardium, improves heart function and therefore survival in this subgroup of patients, the matter remains unclear and controversial. This chapter discusses the available evidence in the literature, from observational studies to randomized trials, including operative techniques and controversial issues, in order to clarify the role of coronary artery bypass grafting in the current management of patients with ischaemic left ventricular dysfunction.

The increase in left ventricular volume after a myocardial infarction is a component of the remodelling process leading to heart failure and it is associated with poor clinical outcomes. Hence, the current management strategy for ischaemic left ventricular dysfunction has been aimed to reverse the remodelling process by medical therapy, devices and/or surgical strategies. Surgical ventricular reconstruction, usually combined with myocardial revascularization, has been introduced as an optional therapeutic strategy aimed to reduce the left ventricle through the exclusion of the scar tissue. Surgical ventricular reconstruction is recommended in selected heart failure patients, especially if a postoperative left ventricular end-systolic volume index less than 70 mL/m2 can be predictably achieved, because a smaller residual volume is associated with improved survival. This chapter briefly discusses the rationale to surgically reverse left ventricular remodelling, the technique, and the indications to the best of the authors’ knowledge, coming from one of the centres with the most experience in SVR worldwide.

Objectives To investigate paravalvular leak (PVL) and devices success rates according to aortic angle (AA) in patients undergoing transcatheter aortic valve implantation (TAVI) with three new-generation self-expanding devices. Background The impact of aortic angle (AA) on TAVI device success and PVL rates is controversial. Methods This retrospective study included 392 patients submitted to TAVI for severe aortic stenosis with Portico, Evolut-R and Acurate-NEO, and available AA measurements at computed tomography (CT) angiography. AA was calculated from the implantation projection and was defined as the angle between the plane of aortic annulus and an ideal horizontal plane. Aorta was defined horizontal if AA>57° (75th percentile). Results In the horizontal group, the rates of moderate/severe PVL was higher in the Evolut-R group (20.8%), which was also characterized by a lower implant compared to that of Acurate-NEO, whereas device success was comparable among the three devices. AA was a significant predictor of moderate/severe PVLs (AUC 0.72, p = .002) only in the Evolut-R population. On multivariate analysis, calcium volume 850HU, bicuspid aortic valve, and implantation depth at the level of left coronary cusp were independent predictors of moderate/severe PVL. On univariate analysis in the horizontal aorta population, implantation depth was confirmed among the most significant predictors of moderate/severe PVL. Conclusions Despite comparable device success rates, horizontal aorta represented a technical challenge only in the Evolut-R subgroup, which showed higher rates of moderate/severe PVL than Portico and Acurate-NEO, and was associated with a low implant.

Introduction Post-infarction left ventricular remodeling is associated with increased mortality in patients with ischemic heart disease. Surgical ventricular reconstruction (SVR) in addition to coronary artery bypass grafting (CABG) has been proposed to reduce left ventricular volume and improve clinical outcomes. The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that the addition of SVR to CABG did not reduce the rates of death or rehospitalization in the 5 years after surgery compared to CABG alone. Like all randomized trials, STICH has limitations and it has been hypothesized that it may have underestimated the treatment effect of SVR. The aim of this study is to evaluate the results of SVR in one of the largest contemporary single-center series and to compare the results with those of the STICH trial using individual patient's data. Methods and analysis Individual data of patients who underwent SVR with or without CABG will be obtained from San Donato University Hospital in Milan. Using multivariable Cox regression analysis, significant prognostic indicators in this cohort will be identified. We will then compare the San Donato cohort to individual patient's data from the SVR arm of Hypothesis 2 of the STICH trial and from both arms of the STICH Extended Study (STICHES). To reduce confounders, propensity score adjustment will be used for this comparison. The primary endpoint will be all-cause mortality. Data will be merged and analyzed independently at Weill Cornell Medicine in New York.

Objective The aim of this study was to describe the clinical course of a consecutive series of patients operated of urgent cardiac surgery during COVID-19 outbreak. Background In Italy, COVID outbreak has mostly occurred in the metropolitan area of Milan, and in the surrounding region of Lombardy, and previously "conventional" hospitals were converted into COVID spokes to increase ICU beds availability, and to allow only urgent CS procedures. Methods Among urgent CS patients (left main stenosis with unstable angina, acute endocarditis, valvular regurgitation with impending heart failure), 10 patients (mean age = 57 ± 9 years), despite a negative admission triage, developed COVID-pneumonia postoperatively, at a median of 7 days after CS. Results Patients showed typical lymphopenia, higher prothrombotic profile, and higher markers of inflammation (ferritin and interleukin-6 values). At the zenith of pulmonary distress, patients presented with severe hypoxia (median PaO2/FIO2 ratio = 116), requiring advanced noninvasive ventilation (Venturi mask and continuous positive airway pressure) in the majority of cases. All patients were treated with hydroxychloroquine, azithromycin, and low-molecular-weight heparin at anticoagulant dose. Overall in-hospital mortality was 10% (1/10), peaking 25% in patients who developed COVID pneumonia immediately after CS. The remaining patients, with late infection, were all discharged home without oxygen support, at a median of 25 days after symptom onset. Conclusions As postoperative mortality in case of COVID pneumonia is not negligible, meticulous rules (precise triage, safe hospital path, high level of protection for health-care teams, prompt diagnosis of suspicious symptoms) should be strictly followed in patients undergoing CS during COVID pandemic. The role of therapies alternative to CS should be further assessed.

Cardiac fibrosis is a key physiological response to cardiac tissue injury to protect the heart from wall rupture. However, its progression increases heart stiffness, eventually causing a decrease in heart contractility. Unfortunately, to date, no efficient antifibrotic therapies are available to the clinic. This is primarily due to the complexity of the process, which involves several cell types and signaling pathways. For instance, the transforming growth factor beta (TGF-β) signaling pathway has been recognized to be vital for myofibroblasts activation and fibrosis progression. In this context, complex sphingolipids, such as ganglioside GM3, have been shown to be directly involved in TGF-β receptor 1 (TGF-R1) activation. In this work, we report that an induced up-regulation of sialidase Neu3, a glycohydrolytic enzyme involved in ganglioside cell homeostasis, can significantly reduce cardiac fibrosis in primary cultures of human cardiac fibroblasts by inhibiting the TGF-β signaling pathway, ultimately decreasing collagen I deposition. These results support the notion that modulating ganglioside GM3 cell content could represent a novel therapeutic approach for cardiac fibrosis, warranting for further investigations.

BACKGROUND: Patients with liver cirrhosis (LC) undergoing cardiac surgery (CS) face perioperative high mortality and morbidity, but extensive studies on this topic are lacking.METHODS: All adult patients with LC undergoing a CS procedure between 2000 and 2017 at 10 Italian Institutions were included in this retrospective cohort study. LC was classified according to preoperative Child-Turcotte-Pugh (CTP) score and Model for End-Stage Liver Disease (MELD) score. Early-term and medium-term outcomes analysis was performed in the overall population and according to CTP classes.RESULTS: The study population included 144 patients (mean age 66 ± 9 years, 69% male). Ninety-eight, 20, and 26 patients were in CTP class A, in early CTP class B (MELD score 12), respectively. The main LC etiologies were viral (43%) and alcoholic (36%). Liver-related clinical presentation (ascites, esophageal varices, and encephalopathy) and laboratory values (estimated glomerular filtration rate, serum albumin, and bilirubin, platelet count) significantly worsened across the CTP classes (P= .001). Coronary artery bypass grafting or valve surgery (87% bioprosthesis) were performed in 36% and 50%, respectively. Postoperative complications (especially acute kidney injury, liver complication, and length of stay) significantly worsened in advanced CTP class B (P= .001). Notably, observed mortality was 3-fold or 4-fold higher than the EuroSCORE (European System for Cardiac Operative Risk Evaluation) II-predicted mortality, in the overall population, and in the subgroups. At Kaplan-Meier analysis, 1-year and 5-year cumulative survival in the overall population was 82% ± 3% and 77% ± 4%, respectively. The 5-year survival in CTP class A, early CTP class B, and advanced CTP class B was 72% ± 5%, 68% ± 11%, and 61% ± 10%, respectively (P= .238).CONCLUSIONS: CS outcomes in patients with LC are significantly affected in relation to the extent of preoperative liver dysfunction, but in early CTP classes, medium-term survival is acceptable. Further analysis are needed to better estimate the preoperative risk stratification of these patients.

Coronary artery aneurysms (CAAs) are rare lesions in which the optimal management is poorly defined. We present a series of three patients with diffuse symptomatic coronary artery disease and giant CAAs, on the circumflex branch (6 × 5 cm - Patient 1), on the proximal right coronary artery (5 × 6 cm - Patient 2) and on the proximal left anterior descending (LAD) (4 × 5 cm - Patient 3). Standard coronary artery bypass grafting (LIMA-on-LAD plus sequential saphenous vein) and associated CAA exclusion by proximal and distal ligation was performed according to the coronary anatomy. Six month follow-up computed tomography scan control showed complete exclusion of the CAA in all three patients.

Objectives We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. Background Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. Methods Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)−2 criteria. Results Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. Conclusions RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.

OBJECTIVES Our goal was to analyse a consecutive series of patients with solid organ tumours undergoing coronary artery bypass grafting (CABG) by defining the risk factors for early and long-term outcomes. METHODS Between 2005 and 2016, a consecutive series of 4079 patients underwent isolated CABG at our institution. Of 103 patients (2.5%) with active malignancy, we enrolled 82 patients (mean age 71 ± 7 years) with solid organ tumours, divided into 4 subgroups: lung (9 patients—11%), gastroenteric (16 patients—20%), urinary (48 patients—58%) and other solid tumours (9 patients—11%). A deterministic record linkage between the clinical database and the National Hospital Information System allowed identification of long-term survival rates and freedom from major adverse cardiovascular events (acute myocardial infarction, repeated admissions for percutaneous coronary intervention and heart failure). RESULTS The most common forms of cancer were prostate, colon and carcinoma of the lung. Compared to patients without cancer, patients with neoplasms were significantly older and had a higher rate of comorbidities, without significant differences among the cancer subgroups. The 30-day mortality rate was significantly higher in patients with cancer compared to those without cancer (4.9% vs 1.8%). However, on logistic regression analysis, cancer was an independent risk factor for postoperative pulmonary dysfunction but not for in-hospital death. The median follow-up time was 58 ± 12 months. The overall 5-year survival rate was 60% [95% confidence interval (CI) 47–71%], with a dismal 32% (95% CI 5–65%) survival rate among patients who had lung tumours only. The 5-year freedom from major adverse cardiovascular events was 64% (95% CI 52–74%), without significant differences among subgroups, and was comparable to that of the non-cancer population. Resolution of coronary heart disease allowed safe cancer surgical resection in 80% of the population. CONCLUSIONS Based on the results from the present study, CABG should not be denied to patients with solid organ tumours by claiming a worse prognosis or less graft durability. Further studies with larger numbers are warranted.

Aims Longitudinal outcomes of transcatheter therapies for secondary mitral regurgitation (MR) have been variable. This study examined predictors of one-year outcome following transcatheter mitral valve implantation (TMVI) with the Tendyne device. Methods and results The first 100 consecutive patients with moderate-severe or severe MR enrolled in the Tendyne CE Mark trial were examined. Multivariable analyses assessed the impact of preoperative clinical and echocardiographic characteristics on one-year freedom from death or heart failure hospitalisation (HFH). All 100 patients underwent Tendyne TMVI without operative mortality. Univariate analysis was performed on implanted subjects, followed by multivariate analysis in those with complete predictive variable data. Patient characteristics: 76.5% male, 60.8% NYHA Class III/IV, age 75.6±7.5 years and Society of Thoracic Surgeons predicted risk of mortality of 8.5±6.1%. Increased left ventricular end-diastolic dimension was associated with one-year Tendyne benefit following univariate analysis (OR 0.35, p=0.010). Following multivariable adjustment, only severe MR, defined as a composite of effective regurgitant orifice area ≥0.3 cm2 or regurgitant volume ≥45 ml, was associated with freedom from death or HFH at one year (OR 0.16, p=0.032). Conclusions Preoperative severe MR was predictive of improved one-year outcome following Tendyne TMVI. These results may inform therapy selection for the management of secondary MR and left ventricular dilatation.

Despite the safety and efficacy of transmitral valve repair techniques, transcatheter mitral valve replacement (TMVR) has emerged as a potential treatment option for patients with severe mitral regurgitation at high or prohibitive surgical risk. To date, over 250 high-risk patients with severe mitral regurgitation have been treated with 10 different TMVR devices, demonstrating the feasibility of this technique. Parallel to the potential advantages of this procedure (reproducible mitral regurgitation reduction, possibility of targeting all potential anatomic variations), many challenges has emerged during the design and implantation phases. Further larger studies with longer follow-up are needed to evaluate safety and efficacy of TMVR.

Continuous improvement of technologies, devices and drugs needs a renewal and update of current recommendations and guidelines on antithrombotic strategies, especially in those fields where literature lacks of established scientific evidences. Accordingly, the aim of this consensus statement is to provide support for antithrombotic therapy based on current guidelines and the most recent scientific evidences.After an overview on the currently available devices, the appropriate therapy according to type of procedure and implanted device is discussed. The occurrence of postoperative thromboembolic and/or hemorrhagic complications is analyzed, along with the appropriate diagnostic tools and therapeutic approach. A section is dedicated to counseling to pregnancy in women with heart valve prosthesis. Finally, the role of novel oral anticoagulants is discussed, and indications are provided for the management of patients undergoing surgery or interventional procedures on oral anticoagulation therapy.

Patients affected by diabetes usually have extensive coronary artery disease. Coronary revascularization has a prominent role in the treatment of coronary artery disease in the expanding diabetic population. However, diabetic patients undergoing coronary artery bypass grafting or percutaneous coronary intervention experience worse outcomes than nondiabetic patients. Several studies comparing coronary artery bypass grafting vs percutaneous coronary intervention in subgroups of diabetic patients demonstrated a survival advantage and fewer repeat revascularization procedures with an initial surgical strategy. This review summarizes the current state of evidence comparing the effectiveness and safety of coronary artery bypass grafting and percutaneous coronary intervention in diabetic patients.

Extracorporeal Membrane Oxygenation (ECMO) represents a useful tool to support the lungs and the heart when all conventional therapies failed and the patients are at risk of death. While the Extracorporeal Life Support Organization (ELSO) collects data from different institutions that joined the Registry and reports overall outcome, individual centres often collide with results below expectations, either in adults and in paediatric population. Some authors suggest that poor outcomes could be overcome with a programme dedicated to ECMO, with specialized professionals adequately trained on ECMO and with a consistent number of procedures. In 2012, The IRCCS PSD ECMO Programme was instituted with the specific aim of achieving better results than hitherto obtained. After only 1 year of activity, the results justified the programme, with a better survival rate for each group investigated, particularly in adults, but surprisingly in paediatrics too, where the results were better than what reported by ELSO. Although the number of patients treated with ECMO is still growing up, the effects of the ECMO programme continue to exert a positive action on outcome even now. The present article reports data on survival, blood loss, and blood consumption during ECMO in the last few years at our institution.

Aims To present the results of a novel technique of aortic valve decalcification (AVD) in a consecutive population of elderly patients with severe aortic valve stenosis (AVS) and small aortic annulus. Methods Between January 2008 and December 2012, a consecutive series of 34 patients (mean age 80 ± 13 years) with severe AVS were operated on using AVD. They were compared with a matched population of 68 patients (mean age 82 ± 7 years) submitted to aortic valve replacement (AVR) with bioprosthesis. The two groups were comparable for cardiac risk factors and admission symptoms. Preoperatively, all patients presented with severe AVS, small aortic annulus (19 mm) and preserved left ventricular function. Results Thirty-day mortality was 8.8 vs. 7.5% in the AVD and AVR groups, respectively (P = 0.88). Actuarial 2 and 5-year survival rates were 80 vs. 82% and 64 vs. 78% in the AVD and AVR groups, respectively (P = 0.27). Long-term valve-related events incidence was significantly higher in the AVD group (12%) compared with that in the AVR group (4%; P = 0.01). However, in the AVD group, patients with no or mild residual AR experienced 2 and 5 years of freedom from valve-related events, which is not significantly different from the patients submitted to the AVR group (P = 0.76). After AVD, a significant increase in the aortic valve area (from 0.8 to 1.9 cm) and a parallel reduction in the mean gradient (from 40 to 12 mmHg) was observed in all patients (P = 0.01). Postoperative aortic valve area (1.9 vs. 1.26 cm), as well as mean gradient (12 vs. 21 mmHg), were significantly better in the AVD group compared with that in the AVR group (P = 0.01). Conclusion In this preliminary experience, AVD seems a good therapeutic option for elderly patients with severe AVS. Further studies with longer follow-up are needed in order to confirm these preliminary results and to ascertain the valve durability over time.

Ischemic chronic heart failure (CHF) represents one of the cardiovascular diseases with the worst degree of morbidity and mortality in the western world, and with the highest health care costs. Despite several studies demonstrated that surgical revascularization (CABG), especially in the presence of viable myocardium, improve heart function, and therefore, survival, the matter remains unclear and controversial. In the late 1970s, the Coronary Artery Surgery Study showed that a subgroup of patients with coronary artery disease, angina, and reduce LV function had a significant survival benefit after CABG compared to those treated medically. The key concept behind this observation was the presence of viable myocardium, which can resume function following revascularization. In contrary, the surgical treatment for ischemic heart failure (STICH) trial, which randomized patients with CAD and LV dysfunction to evidence-based medical therapy or CABG plus medical therapy, failed to demonstrate at a median follow-up of 56 months a significant difference between the CABG group and the medical therapy group in the rate of death from any cause. However, the results of the STICH extension study (STICHES) at 10 years follow-up demonstrated that CABG is associated with a significant reduction in all-cause mortality, cardiovascular mortality, and readmission for heart compared to optimal medical therapy (OMT) in patients with severe ischemic LV dysfunction. Therefore, this review discusses the available evidences in literature, from observational studies to randomized trials, including operative techniques and controversial issues, in order to better clarify the role of CABG in the current management of ischemic patients with LVD.

AIMS Despite several studies reporting a higher mortality rate for women undergoing isolated coronary artery bypass graft (CABG) surgery, this issue has not been completely clarified. The aim of the current study was to determine if sex differences in CABG surgery affect adjusted operative results and operative mortality. METHODS Between January 2005 and December 2012, 3756 consecutive patients (3009 men and 747 women) underwent isolated CABG at our institution. Women presented with older age, smaller BSA and higher rate of preoperative comorbidities. The propensity score methodology was used to obtain risk-adjusted outcome comparisons between the two groups. RESULTS The distribution of preoperative variables among matched pairs (553 patients in both groups) was, on average, equal. Propensity-matched women received a similar number of distal anastomoses (P = 0.56), had similar rate of left internal thoracic artery (LITA) graft (P = 0.73) and comparable extracorporeal circulation (P = 0.61) and aortic cross-clamp (P = 0.39) time as men. Postoperative complications were comparable in the two study groups with the exception of postoperative transfusion rate which was significantly higher in women (P = 0.01). However, operative mortality (3.8 vs. 2.7%; P = 0.20), perioperative acute myocardial infarction (P = 0.50) and stroke (P = 0.75) were not significantly different between the two groups. Interestingly, after adjustment for the other baseline characteristics, female patients with diabetes (P = 0.03), preoperative renal dysfunction (P = 0.07) and obesity (P = 0.07) exhibited a greater operative mortality rate compared with men with the same comorbidities. CONCLUSION After adjustment for preoperative variables, female sex seems not to be an independent risk factor for early mortality in isolated CABG surgery. However, renal impairment, diabetes and obesity seem to play an important role in the operative risk profile of women undergoing isolated CABG.

Patients with ischaemic cardiomyopathy and left ventricular (LV) systolic dysfunction represent the highest-risk population with heart failure (HF). The cornerstone of treatment remains guideline-driven medical therapy, which is associated with significant improvement in survival and quality of life. The most commonly considered surgical interventions are coronary artery bypass graft surgery, at times combined with surgical ventricular reconstruction (SVR) and surgery for mitral valve regurgitation. Surgical ventricular reconstruction has been introduced as an optional therapeutic strategy aimed to reduce LV volumes through the exclusion of the scar tissue, thereby restoring the physiological volume and shape and improving cardiac function and clinical status. This review will briefly discuss the rationale to surgically reverse LV remodelling, the technique, and the indications, to the best of our knowledge, coming from the Center with the largest worldwide experience. The evolving data on the role of SVR for the treatment of ischaemic HF will be addressed as well.

In a recent paper, Burri and colleagues (1) addressed the complex theme of bioprosthesis durability in patients with congenital heart disease (CHD) operated of tricuspid valve replacement (TVR). The authors reviewed a consecutive series of 51 patients (mean age 32 years) affected by CHD (mainly Ebstein disease) operated over a 25 years period of TVR with a bioprosthesis.

We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population.Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry.Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria.Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR.RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.