Technology and technique for left ventricular assist device optimization: A Bi-Tech solution.

BACKGROUND: We investigated the synergistic effect of the new cone-bearing design of Jarvik 2000 (Jarvik Heart Inc., NY) together with a minimally-invasive approach to outcomes of LVAD patients. METHODS: We retrospectively reviewed all patients from 5 institutions involved in the Jarvik 2000 Italian Registry, from October 2008 to October 2016. Patients were divided into three groups according to pump design and implantation technique: pin-bearing design and conventional approach (Group 1); cone-bearing and conventional approach (Group 2); cone-bearing and minimally-invasive implantation (Group 3). RESULTS: A total of 150 adult patients with end-stage heart failure were enrolled: 26 subjects in Group 1, 74 in Group 2, and 50 in Group 3. Nineteen patients (73%) in Group 1, 51 (69%) in Group 2, and 36 (72%) in Group 3 were discharged. During follow-up, 22 patients underwent transplantation, while in 3 patients the LVAD was explanted. The overall 1-year survival was 58 ± 10%, 64 ± 6%, and 74% ± 7% in Groups 1, 2, and 3, respectively (p = 0.034). The competing-risks-adjusted cumulative incidence rate for adverse events was 42.1 [27-62.7] per 100 patient-years in Group 1, 35.4 [25.3-48.2] in Group 2, and 22.1 [12.4-36.4] in Group 3 (p = 0.046 for Group 1 vs. 3). CONCLUSIONS: The association of the modern cone-bearing configuration of Jarvik 2000 and minimally invasive surgery improved survival and minimized the risk for cardiovascular events, as a result of combining technology and technique.

T1 mapping and cardiac magnetic resonance feature tracking in mitral valve prolapse.

OBJECTIVES: T1 mapping (T1-map) and cardiac magnetic resonance feature tracking (CMR-FT) techniques have been introduced for the early detection of interstitial myocardial fibrosis and deformation abnormalities. We sought to demonstrate that T1-map and CMR-FT may identify the presence of subclinical myocardial structural changes in patients with mitral valve prolapse (MVP). METHODS: Consecutive MVP patients with moderate-to-severe mitral regurgitation and comparative matched healthy subjects were prospectively enrolled and underwent CMR-FT analysis to calculate 2D global and segmental circumferential (CS) and radial strain (RS) and T1-map to determine global and segmental native T1 (nT1) values. RESULTS: Seventy-three MVP patients (mean age, 57 ± 13 years old; male, 76%; regurgitant volume, 57 ± 21 mL) and 42 matched control subjects (mean age, 56 ± 18 years; male, 74%) were included. MVP patients showed a lower global CS (- 16.3 ± 3.4% vs. - 17.8 ± 1.9%, p = 0.020) and longer global nT1 (1124.9 ± 97.7 ms vs. 1007.4 ± 26.1 ms, p < 0.001) as compared to controls. Moreover, MVP patients showed lower RS and CS in basal (21.6 ± 12.3% vs. 27.6 ± 8.9%, p = 0.008, and - 13.0 ± 6.7% vs. - 14.9 ± 4.1%, p = 0.013) and mid-inferolateral (20.6 ± 10.7% vs. 28.4 ± 8.7%, p < 0.001, and - 12.8 ± 6.3% vs. - 16.5 ± 4.0%, p < 0.001) walls as compared to other myocardial segments. Similarly, MVP patients showed longer nT1 values in basal (1080 ± 68 ms vs. 1043 ± 43 ms, p < 0.001) and mid-inferolateral (1080 ± 77 ms vs. 1034 ± 37 ms, p < 0.001) walls as compared to other myocardial segments. Of note, nT1 values were significantly correlated with CS (r, 0.36; p < 0.001) and RS (r, 0.37; p < 0.001) but not with regurgitant volume. CONCLUSIONS: T1-map and CMR-FT identify subclinical left ventricle tissue changes in patients with MVP. Further studies are required to correlate these subclinical tissue changes with the outcome. KEY POINTS: • T1 mapping (T1-map) and cardiac magnetic resonance feature tracking (CMR-FT) techniques have been introduced for the early detection of interstitial myocardial fibrosis and deformation abnormalities. • In MVP patients, we demonstrated a longer global nT1 with associated reduced global circumferential (CS) and radial strain (RS) as compared to control subjects. • Among MVP patients, the mid-basal left ventricle inferolateral wall showed longer nT1 with reduced CS and RS as compared to other myocardial segments. Further studies are required to correlate these subclinical tissue changes with the outcome.

Preliminary Results of Extracorporeal Membrane Oxygenation Assisted Tracheal Sleeve Pneumonectomy for Cancer.

OBJECTIVE: Tracheal sleeve pneumonectomy is a challenge in lung cancer management and in achieving long-term oncological results. In November 2018, we started a prospective study on the role of extracorporeal membrane oxygenation (ECMO) in tracheal sleeve pneumonectomy. We aim to present our preliminary results. METHODS: From November 2018 to November 2019, six patients (three men and three women; median age: 61 years) were eligible for tracheal sleeve pneumonectomy for lung cancer employing the veno-venous ECMO during tracheobronchial anastomosis. RESULTS: Only in one patient, an intrapericardial pneumonectomy without ECMO support was performed, but cannulas were maintained during surgery. The median length of surgery was 201 minutes (range: 162-292 minutes), and the average duration of the apneic phase was 38 minutes (range: 31-45 minutes). No complications correlated to the positioning of the cannulas were recorded. There was only one major postoperative complication (hemothorax). At the time of follow-up, all patients were alive; one patient alive with bone metastasis was being treated with radiotherapy. CONCLUSION: ECMO-assisted oncological surgery was rarely described, and its advantages include hemodynamic stability with low bleeding complications and a clean operating field. As suggested by our preliminary data, ECMO-assisted could be a useful alternative strategy in select lung cancer patients.

A genetic variant c.553G > T (rs2075291) in the apolipoprotein A5 gene is associated with altered triglycerides levels in coronary artery disease (CAD) patients with lipid lowering drug.

BACKGROUND: Elevated plasma triglycerides (TGs) are widely used as a major cardiovascular risk predictor and are thought to play an important role in the progression of coronary heart disease (CHD). It has been demonstrated that lipid lowering was associated with lower mortality in patients with CHD. The present study therefore aimed to investigate the consequences of the genetic variant c.553G > T (rs2075291) in apolipoprotein A5 gene to determination of triglycerides levels in CAD patients receiving, atorvastatin, lipid lowering drug. METHODS: We here report that a recently identified genetic variant, c.553G > T in the APOA5 gene which causes a substitution of a cysteine for a glycine residue at amino acid residue 185(G185C) is also associated with increased TG levels. To investigate theses effects, a case-control study compressing 608 subjects from the same area was performed. RESULTS: TG levels in T allele patients were significantly lower than the control GT allele patient (χ2 = 2.382E2a, P-value < 0.001). Overall, patients carrying T allele showed lower levels of TG than patients carrying GG allele. The homozygous patient for the T allele presented normal cholesterol levels of 134 mg/dl, and the levels in GG patients ranged from 25 to 340 mg/dl (P-value < 0.001). In summary, we demonstrated that the presence of c.553G > T variant (rs2075291); in APOA5 gene increases human plasma TG levels. CONCLUSION: Nevertheless, T allele is found to reduce TG levels in CAD patients who are on the cholesterol medication, atorvastatin. Thus, c.553G > T variant can be considered as a significant predicator of hypertriglyceridemia. In addition, it could be used as a hallmark for the diagnosis and prognosis of CAD.

Mitral valve endothelial cells secrete osteoprotegerin during endothelial mesenchymal transition.

AIMS: Mitral valve prolapse (MVP) has a prevalence of 3% in the general population, affecting >176 million people worldwide. Despite this, little is known about the molecular and cellular mechanisms involved in the progression of MVP and surgical intervention is the only available option. In this study we investigated the role of osteoprotegerin (OPG) during endothelial to mesenchymal transition (EndMT) in MVP. METHODS AND RESULTS: VECs and VICs were isolated from posterior mitral valve leaflets of patients undergoing mitral valve repair (n=25). Plasma was collected from 57 subjects (29 controls and 28 MVP patients). Overexpression of OPG during EndMT followed by autocrine effects characterised by reactive oxygen species increment and accelerated migration was documented. In addition, OPG increased VIC proliferation. Finally, OPG plasma levels were significantly higher in MVP patients compared to control subjects and the area under the ROC curve was 0.92. CONCLUSION: EndMT has been recognised as a possible pathological mechanism for MVP. For the first time, we report the involvement of OPG in cellular and molecular changes in MVP isolated cells. In addition, we detected elevated circulating OPG levels in MVP patients when compared to controls, which supports the hypothesis that OPG is involved in MVP development and progression.

Resection of right ventricular metastasis subsequent to liver transplant for hepatocellular carcinoma.

We report a case of a 54-year-old Caucasian male with exertional dyspnea who underwent palliative resection of a solitary right ventricular metastasis one year after liver transplant for a multifocal HBV-related hepatocellular carcinoma (HCC). After nine months the patient remains asymptomatic and cardiac MRI shows no local progression of the tumor.

Diagnostic accuracy of multidetector computed tomography coronary angiography in 325 consecutive patients referred for transcatheter aortic valve replacement.

BACKGROUND: Multidetector computed tomography (MDCT) provides detailed assessment of valve annulus and iliofemoral vessels in transcatheter aortic valve replacement (TAVR) patients. However, data on diagnostic performance of MDCT coronary angiography (MDCT-CA) are scarce. The aim of the study is to assess diagnostic performance of MDCT for coronary artery evaluation before TAVR. METHODS: A total of 325 consecutive patients (234 without previous myocardial revascularization, 49 with previous coronary stenting, and 42 with previous coronary artery bypass graft [CABG]) underwent invasive coronary angiography and MDCT before TAVR. MDCT-CA was performed using the same data set dedicated to standard MDCT aortic annulus evaluation. Multidetector computed tomography-CA evaluability and diagnostic accuracy in comparison with invasive coronary angiography as criterion standard were assessed. RESULTS: The MDCT-CA evaluability of native coronaries was 95.6%. The leading cause of unevaluability was beam-hardening artifact due to coronary calcifications. In a segment-based analysis, MDCT-CA showed sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for detecting ≥50% stenosis of 91%, 99.2%, 83.4%, 99.6% and 98.8%, respectively. The MDCT-CA evaluability of coronary stents was 82.1%. In a segment-based analysis, MDCT-CA showed sensitivity, specificity, PPV, NPV, and accuracy for detecting ≥50% in-stent restenosis of 94.1%, 86.7%, 66.7%, 98.1%, and 88.3%, respectively. All CABGs were correctly assessed by MDCT-CA. In a patient-based analysis, MDCT-CA showed sensitivity, specificity, PPV, NPV, and accuracy of 89.7%, 90.8%, 80.6%, 95.4%, and 90.5%, respectively. CONCLUSIONS: Multidetector computed tomography-CA allows to correctly rule out the presence of significant native coronary artery stenosis, significant in-stent restenosis, and CABG disease in patients referred for TAVR.

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.

Case Report: Persistent residual shunt after a first percutaneous PFO closure followed by minimally invasive surgical failure: third time is a charm.

Background: Even though the optimal management of a moderate or large residual shunt following patent foramen ovale (PFO) closure is open to question, recent data confirmed that it is associated with an increased risk of stroke recurrence. Case summary: A 48-year-old woman, a migraineur with visual aura, was diagnosed with a PFO associated with a huge multifenestrated atrial septal aneurysm (mfASA) and a moderate right-to-left shunt, detectable only after a Valsalva maneuver on contrast-transthoracic echocardiography. Brain magnetic resonance imaging showed a 1-mm silent white matter lesion in the right frontal lobe. Although the indication was not supported by guidelines, a transcatheter PFO closure was performed at another center with implantation of a large, equally sized, double-disc device (Figulla UNI 33/33 mm). At 6-month follow-up, a 2D/3D transesophageal echocardiography (TEE) color Doppler showed incorrect orientation of the device, which was not parallel to the interatrial septum, with two discs failing to capture the aortic muscular rim and partially protruding in the right atrium; furthermore, a 4 mm × 7 mm ASA fenestration was documented with a residual bidirectional shunt. Thereafter, the same team performed a minimally invasive cardiac surgery under femoro-femoral cardiopulmonary bypass; however, the procedure proved ineffective and was complicated by postoperative pericarditis with pericardial effusion, requiring further rehospitalization 1 month later due to persistent pericarditis, bilateral pleuritis, phrenic nerve palsy, and atrial flutter, which was treated with amiodarone. The patient asked for a second opinion, and our multidisciplinary heart team decided to offer a percutaneous redo intervention. An uneventful implantation of a regular PFO occluder (Figulla Flex II 16/18 mm) across the septal defect was performed successfully. Twelve-month follow-up with 2D TTE color Doppler and contrast transcranial Doppler showed correct position and good interaction between the two devices, with no residual shunt. Discussion: In addition to the incorrect indication for PFO closure and the failure of minimally invasive surgery, the procedural mishap in this case could have been due to the inappropriate implantation of the first large device within the tunnel. It would have been better to deploy the same large device in the most central fenestration, covering the PFO and a greater part of the remaining mfASA at the same time.

Diagnosis and treatment of a left atrial myxoma originating from an atrial septal defect closure device: a case report.

Background: Ostium secundum atrial septal defect (osASD) is a common congenital heart disease and transcatheter closure is the preferred treatment. Late device-related complications include thrombosis and infective endocarditis (IE). Cardiac tumours are exceedingly rare. The aetiology of a mass attached to an osASD closure device can be challenging to diagnose. Case summary: A 74-year-old man with atrial fibrillation was hospitalized for evaluating a left atrial mass discovered incidentally 4 months earlier. The mass was attached to the left disc of an osASD closure device implanted 3 years before. No shrinkage of the mass was observed despite optimal intensity of anticoagulation. We describe the diagnostic workup and management of the mass that at surgery turned out to be a myxoma. Discussion: A left atrial mass attached to an osASD closure device raises the suspect of device-related complications. Poor endothelialisation may promote device thrombosis or IE. Cardiac tumours (CT) are rare, and myxoma is the most common primary CT in adults. Although no clear relationship exists between the implantation of an osASD closure device and a myxoma, the development of this tumour is a possible occurrence. Echocardiography and cardiovascular magnetic resonance play a key role in the differential diagnosis between a thrombus and a myxoma, usually identifying distinctive mass features. Nevertheless, sometimes non-invasive imaging may be inconclusive, and surgery is necessary to make a definitive diagnosis.

Aortic annulus area assessment by multidetector computed tomography for predicting paravalvular regurgitation in patients undergoing balloon-expandable transcatheter aortic valve implantation: a comparison with transthoracic and transesophageal echocardiography.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgery in high-risk patients with severe aortic stenosis. Aortic annulus (AoA) sizing is crucial for TAVI success. The aim of the study was to compare AoA dimensions measured by multidetector computed tomography (MDCT) vs those obtained with transthoracic (TTE) and transesophageal echocardiography (TEE) for predicting paravalvular aortic regurgitation (PVR) after TAVI. METHODS: Aortic annulus maximum diameter, minimum diameter, and area were assessed using MDCT and compared with TTE and TEE diameter and area for predicting PVR after TAVI in 151 patients (45 men, age 81.2 ± 6.4 years). RESULTS: Aortic annulus maximum, minimum diameter, and area detected by MDCT were 25.04 ± 2.39 mm, 21.27 ± 2.10 mm, and 420.87 ± 76.10 mm(2), respectively. Aortic annulus diameter and area measured by TTE and TEE were 21.14 ± 1.94 mm and 353.82 ± 64.57 mm(2) and 22.04 ± 1.94 mm and 384.33 ± 67.30 mm(2), respectively. A good correlation was found between AoA diameters and area evaluated by MDCT vs TTE and TEE (0.61, 0.65, and 0.69 and 0.61, 0.65, and 0.70, respectively), with a mean difference of 3.90 ± 1.98 mm, 0.13 ± 1.67 mm, and 67.05 ± 55.87 mm(2) and 3.0 ± 2.0 mm, 0.77 ± 1.70 mm, and 36.54 ± 56.43 mm(2), respectively. Grade ≥2 PVR occurred in 46 patients and was related to male gender, higher body mass index, preprocedural aortic regurgitation, and lower mismatch between the nominal area of the implanted prosthesis and AoA area detected by MDCT. CONCLUSIONS: Mismatch between prosthesis area and AoA area detected by MDCT is a better predictor of PVR as compared with echocardiography mismatch. Specific MDCT-based sizing recommendations should be developed.

Reply to Chen et al. Improvements in Outcomes and Expanding Indications for the Commando Procedure. Comment on "Giambuzzi et al. Surgical Aortic Mitral Curtain Replacement: Systematic Review and Metanalysis of Early and Long-Term Results. J. Clin. Med. 2021, 10, 3163".

We would like to thank Lin Chen et al. [...].

Bioprosthetic aortic valve replacement in patients aged 50 years old and younger: Structural valve deterioration at long-term follow-up. Retrospective study.

Background: Structural valve deterioration (SVD) remains the major determinant of bioprosthesis durability. The aim of this study was to investigate the SVD incidence, predictors and outcomes in patients aged 50 years and younger after bioprosthetic aortic valve replacement (bAVR). Methods: We retrospectively analyzed 73 consecutive patients ≤50 years old who underwent bioprosthetic AVR at our center between 2005 and 2015. Median age at surgery was 44 (interquartile range [IQR]: 39-47) years. Follow-up was 93.2% complete at a median time of 7.2 (IQR: 5.5-9.5) years. Cumulative follow-up was 545.5 valve-years. Bioprosthesis SVD was determined by strict echocardiographic assessment. Results: The overall survival-rate at 10/15 years and freedom from SVD at 10/12.5 years were 89.6 ± 5.2%/81.5 ± 9.1% and 73.5 ± 8.2%/41.9 ± 18.9%, respectively. SVD occurred at a median time of 8.2 (IQR: 6.0-9.9) years after bAVR. Age was not found as an independent predictor for SVD at the multivariable model, despite a higher rate of SVD in the age group ≤30 years. Freedom from reoperation due to SVD at 10/15 years was 71.3 ± 14.1%/13.6 ± 12.3%. Reoperation was performed at a median time of 10.0 (IQR: 8.9-11.9) years since first bAVR and was associated with a 100% 12-month survival. Conclusions: In our study, the rate and time of SVD occurrence were comparable to those of other studies' older age groups. Strict echocardiographic monitoring of valve performance is mandatory to set the appropriate timing of eventual reoperation. This attitude can improve outcomes of bAVR in younger patients.

Looking Back to Look Forward: What to Expect in a Redo Surgery for a Bioprosthesis Replacement.

Redo surgeries are becoming more common because of an increased rate of bioprosthesis implantation. We performed a retrospective study on patients who underwent redo replacement of an aortic and/or mitral bioprosthesis between 2005 and 2018 to evaluate intra-hospital mortality and morbidity. Univariate analysis was performed on the propensity score variables to determine predictors of mortality. A total of 180 patients were enrolled in the study: Group A (replacement of aortic bioprosthesis) with 136 patients (75.56%) and group B (replacement of mitral bioprosthesis ± aortic bioprosthesis) with 44 patients (24.44%). NYHA class ≥ 3 and female sex were significantly more common in group B. Cardiopulmonary-bypass time and aortic cross-clamping time in group A and group B were, respectively, 154.95 ± 74.35 and 190.25 ± 77.44 (p = 0.0005) and 115.99 ± 53.54 and 144.91 ± 52.53 (p = 0.0004). Overall mortality was 8.89%. After propensity score adjustment, Group B was confirmed to have an increased risk of death (OR 3.32 CI 95% 1.02−10.88 p < 0.0001), gastrointestinal complications (OR 7.784 CI 95% 1.005−60.282 p < 0.0002) and pulmonary complications (OR 2.381 CI 95% 1.038−5.46 p < 0.0001). At the univariate analysis, endocarditis, cardiopulmonary-bypass and aortic cross clamping time, NYHA class ≥ 3 and urgency setting were significantly associated to death. Intra-hospital outcomes were acceptable regarding mortality and complications. Patients who need redo surgery on mitral bioprosthesis have an increased risk of post-operative pulmonary and gastrointestinal complications and mortality. Therefore the choice of mitral bioprosthesis at time of first surgery should be carefully evaluated.

Cardiac tumors: imaging findings, clinical correlations and surgical treatment in a 15 years single-center experience.

BACKGROUND: The aims of this study were: to present the clinical and pathological characteristics of cardiac tumors in a single-center series of patients; to describe the association of imaging characteristics, clinical presentation and surgical treatment; to analyze if second level imaging tests, computed tomography (CT) and cardiac magnetic resonance (CMR); and to improve the diagnostic accuracy when compared to first-line imaging technique (transthoracic echocardiography [TTE]). METHODS: We reviewed the medical and surgical records, TTE, CT and CMR examinations of 86 patients with a histological diagnosis of cardiac tumors between 2004 and 2019. RESULTS: The majority were benign tumors (81%) with myxoma accounting for 66% of cases. Among malignancies, metastasis (8%) and primary tumors (10%) were equally recognized. Symptoms at presentation (45% of patients) were associated to larger diameters at TTE. Malignancies were larger (mean diameter 37±14 mm vs. 27±13 mm, P<0.01), more frequently exhibited irregular shape (67% vs. 17%, P<0.01), frayed or polylobulated surface (73% vs. 38%, P=0.035), heterogeneous aspect (67% vs. 32%, P=0.012). A maximum diameter >28 mm and a minimum diameter >19.5 mm emerged as possible cut-off values for the differentiation of benign and malignant tumors. The ability of TTE, CT and CMR features in identifying malignancies was moderate (diagnostic accuracy of 84%, 81%, 76% respectively). The mean survival time after surgery was 1.6±1.4 years in malignancies and 6.8±4.7 years in benign tumors. CONCLUSIONS: Cardiac tumors are rare and mostly benign; their nature and clinics related to TTE appearance. CT and CMR may be used synergically with TTE. Surgery is curative in benign tumors, survival remains scarce in malignancies.

Intraoperative Extra Corporeal Membrane Oxygenator for Lung Cancer Resections Does Not Impact Circulating Tumor Cells.

BACKGROUND: The diagnosis of active neoplastic disease was traditionally judged an absolute contraindication for extracorporeal membrane oxygenator (ECMO) because of the fear of tumor cells being scattered or seeded. The aim of this study is to compare the number of circulating tumor cells (CTCs) before and after surgery in patients receiving lung cancer resection with and without intraoperative ECMO support. METHODS: This is a prospective, non-randomized, two-arms observational study comparing the number of CTCs before and after surgery in patients receiving lung cancer resection with and without intraoperative ECMO support. The ECMO arm includes patients suffering from lung cancer undergoing pulmonary resection with planned intraoperative ECMO support. The non-ECMO arm includes patients suffering from non-early-stage lung cancer undergoing pulmonary resection without planned intraoperative ECMO support. RESULTS: Twenty patients entered the study, eight in the ECMO arm and twelve in the non-ECMO arm. We did not observe any significant difference between the ECMO and non-ECMO groups in terms of postoperative complications (p = 1.00), ICU stay (p = 0.30), hospital stay (p = 0.23), circulating tumor cells' increase or decrease after surgery (p = 0.24), and postoperative C-reactive protein and C-reactive protein increase (p = 0.80). The procedures in the non-ECMO arm were significantly longer than those in the ECMO arm (p = 0.043). CONCLUSIONS: Intraoperative ECMO for lung cancer resections did not impact CTC increase or decrease after the procedure.

Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation.

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

Long-term secondary cardiovascular prevention programme in patients subjected to coronary artery bypass surgery.

AIMS: Patients with coronary heart disease (CHD) are at very high risk of recurrent events. A strategy to reduce excess risk might be to deliver structured secondary prevention programmes, but their efficacy has been mostly evaluated in the short term and in experimental settings. This is a retrospective case-control study aimed at assessing, in the real world, the efficacy of a secondary prevention programme in reducing long-term coronary event recurrences after coronary artery bypass surgery (CABG). METHODS AND RESULTS: Programme participants (henceforth 'cases') were men and women aged <75 years subjected to CABG between 2002 and 2014, living within 100 km of the hospital. Key programme actions included optimization of treatments according to the most updated European preventive guidelines, surveillance of therapy adherence, and customized lifestyle counselling. Controls were analogous patients not involved in the programme because living farther than 100 km away, matched 1:1 with cases for gender, age at CABG, and year of CABG. Both groups (n = 1248) underwent usual periodic cardiology follow-up at our centre. Data on symptomatic or silent CHD recurrences were obtained from the hospital electronic health records. Cox analysis (adjusted for baseline differences between groups) shows that programme participation was associated with a significantly lower incidence throughout 5 years post-CABG of symptomatic [hazard ratio (95% confidence interval): 0.59 (0.38-0.94)] and silent [0.53 (0.31-0.89)] coronary recurrences. CONCLUSION: In a real-world setting, taking part in a structured longstanding secondary prevention programme, in addition to usual cardiology care, meaningfully lowers the risk of coronary recurrences.

Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses.

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients' survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45-70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14-23 mm Hg) and 10 mmHg (IQR: 8-13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91-1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3-96.7%); 90.7% (88.3-93.1%); 86.4% (82.6-90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04-1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002-1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.

Left atrial reverse remodeling and functional improvement after mitral valve repair in degenerative mitral regurgitation: a real-time 3-dimensional echocardiography study.

BACKGROUND: Severe mitral regurgitation is often associated with left atrium (LA) enlargement, which is a well-known predictor of adverse cardiovascular outcomes. However, only few data are available on the effect of mitral valve (MV) repair on LA size. The aim of this study was to evaluate, using real-time 3-dimensional echocardiography, the changes in LA volumes after MV repair. METHODS: A total of 65 patients with severe mitral regurgitation due to MV prolapse and scheduled for repair at an early stage were enrolled. Before the procedure, real-time 3-dimensional echocardiography was performed to assess LA volumes (maximum, before atrial active contraction [preA], and minimum). The same evaluation was repeated 6 months and 1 year after MV repair. Twenty healthy subjects matched for age and gender were enrolled as a control group. RESULTS: Before MV repair, patients showed significantly higher values of LA volumes (maximum 43 ± 14 mL/m², preA 33 ± 12 mL/m², minimum 23 ± 11 mL/m²) as compared to controls (maximum 22 ± 6 mL/m², preA 13 ± 4 mL/m², minimum 8 ± 3 mL/m²). Six months after the operation, LA volumes significantly decreased (maximum 25 ± 8 mL/m², preA 18 ± 8 mL/m², minimum 13 ± 5 mL/m²), with a further reduction at 1-year follow-up (maximum 23 ± 7 mL/m², preA 15 ± 7 mL/m², minimum 11 ± 5 mL/m²), resulting in values similar to controls. The extent of LA reverse remodeling was inversely correlated with age (r = -0.42) and postoperative transmitral mean pressure gradient (r = -0.32), whereas a positive correlation was found with the reduction in left ventricular volume after MV repair (r = 0.35). DISCUSSION: In patients with severe mitral regurgitation due to MV prolapse, MV repair, when performed at an early stage, results in a significant LA reverse remodeling.