Hemadsorption to Contain Postoperative Cell-Free Hemoglobin and Haptoglobin Preservation for Extended Cardiopulmonary Bypass Time in Cardiac Surgery for Acute Kidney Injuries Prevention.

INTRODUCTION: Prevention of acute kidney injury during cardiopulmonary bypass (CPB) is still a challenge and has been the object of numerous studies. The incidence of acute kidney injury in the context of CPB is related to a multifactorial etiology. The role of hemadsorption in relation to cell-free hemoglobin and haptoglobin preservation is not well defined in the literature on CPB during cardiac surgery procedures. METHODS: This is a single-center pilot randomized report including 20 patients undergoing elective CPB procedures with an expected time > 120 minutes for each extracorporeal procedure. Patients were randomly allocated to either standard of care (n=10) or Jafron HA380 (n=10) during CPB. The primary outcome measured was the incidence of postoperative acute kidney injuries. RESULTS: The Jafron study group vs. control group reported postoperative values for cell-free hemoglobin at 10 minutes after CPB (mg/L) (11.6 ± 0.6 vs. 29.9 ± 0.3) (P-value 0.021), haptoglobin 10 minutes after CPB (mg/dl) (129.16 ± 1.22 vs. 59.17 ± 1.49) (P-value 0.017), creatinine peak after CPB (mg/dL) (0.92 ± 0.17 vs. 1.32 ± 0.9) (P-value 0.030), and acute kidney injury after 48 hours (number of patients) (one vs. four) (P-value 0.027). CONCLUSION: This pilot study suggested that the use of Hemoperfusion Cartridge HA380 Jafron for extended CPB time for complex cardiac surgery procedures was safe and effective and is associated with a better postoperative preservation of haptoglobin with a reduction of cell-free hemoglobin values and less incidence of acute kidney injury, though larger studies are warranted to confirm our result.

Evolocumab Treatment in Dyslipidemic Patients Undergoing Coronary Artery Bypass Grafting: One-Year Safety and Efficacy Results.

Background: The inhibition of PCSK9 lowered LDL cholesterol levels, reducing the risk of cardiovascular events. However, the effect on patients who have undergone surgical myocardial revascularization has not yet been evaluated. Methods: From January 2017 to December 2022, 180 dyslipidemic patients who underwent coronary artery bypass were included in the study. Until December 2019, 100 patients optimized therapy with statin ± ezetimibe (SG). Since January 2020, 80 matched patients added treatment with Evolocumab every 2 weeks (EG). All 180 patients were followed-up at 3 and 12 months, comparing outcomes. Results: The two groups are homogenous. At 3 months and 1 year, a significant decrease in the parameter mean levels of LDL cholesterol and total cholesterol is detected in the Evolocumab group compared to the standard group. No mortality was detected in either group. No complications or drug discontinuation were recorded. In the SG group, five patients (5%) suffered a myocardial infarction during the 1-year follow-up. In the EG group, two patients (2.5%) underwent PTCA due to myocardial infarction. There is no significant difference in overall survival according to the new treatment (p-value = 0.9), and the hazard ratio is equal to 0.94 (95% C.I.: [0.16-5.43]; p-value = 0.9397). Conclusions: The use of Evolocumab, which was started immediately after coronary artery bypass graft surgery, significantly reduced LDL cholesterol and total cholesterol levels compared to statin treatment alone and is completely safe. However, at one year of follow-up, this result did not have impact on the reduction in major clinical events.

Clinical and echocardiographic results of the MEMO 4D semi-rigid annuloplasty ring.

BACKGROUND: Mitral regurgitation is a frequent valvular disease, with an increasing prevalence. We analyzed the short-term outcomes of mitral valve repair procedures conducted in our clinic using a new semirigid annuloplasty ring featuring a gradual saddle shape design. METHODS: We retrospectively analyzed mitral valve repair surgeries performed at our Institution between December 2019 and November 2021 with the MEMO 4D semirigid annuloplasty ring. RESULTS: In total, 53 patients were included in the study. Mean patient age was 63.6 ± 11.7 years. Most patients presented with degenerative mitral valve regurgitation (N = 44; 83%). The grade of mitral regurgitation was equal or more than 3 + in 98.1% of the patients (N = 52). The most used ring size was size 34 mm (N = 30, 56.6%). There was no intraoperative or hospital mortality. No cases of stroke, bleeding, endocarditis or other major complications occurred. At discharge, most patients were in NYHA class I. Postoperative echocardiographic results showed no (90.6%) or 1+ (5.7%) mitral valve regurgitation. Only 1 patient (1.9%) presented with mitral valve regurgitation grade 2+. Mean postoperative transvalvular gradient was low (mean = 3.3 ± 1.2 mmHg). No cases of LVOT obstruction or systolic anterior motion occurred. CONCLUSIONS: Our series showed excellent mitral valve competency and very satisfactory early clinical outcomes. The transesophageal echocardiographic follow-up, despite obtained in a limited number of patients, further confirmed the effectiveness of findings of this preliminary experience.

Develop of endocavitary suction device for MiECC on minimally invasive mitral valve surgery.

The minimally invasive extracorporeal circulation (MiECC) system was developed to minimize the contact of blood with air and foreign surfaces during conventional cardiopulmonary bypass (CPB). It is also aimed to reduce the inflammatory response by further increasing the biocompatibility of the components that make up the MiECC circuits. The Minithoracotomy (MTH) approach for mitral valve disease remains associated with prolonged operative times, but it is beneficial in terms of reduced postoperative complications (renal failure, atrial fibrillation, blood transfusion, wound infection), length of stay in intensive care unit (ICU) and in hospitalization, with finally a reduction in global cost. Combining the use of the MiECC technique with minimally invasive mitral valve surgery (MIMVS) could open up new research scenarios. Although considerable progress has been made in the standardization of the surgical technique, limitations remain to be filled in the setting of Endo-cavitary aspiration for the association of MiECC with MIMVS. In this paper we introduce invention refers to a device and an air-closed endocavitary aspiration system for cardiac chamber surgery, as well as a method aimed at eliminating gaseous micro-embolic activity, hemolysis and CO2 aspiration and alteration of carbon dioxide production (VCO2) the parameters for goal directed perfusion. The system allows the surgery of the cardiac chambers to be associated with a minimally invasive extra-corporeal circulation circuit.

Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis.

Background. The in-hospital reduction in low-density lipoprotein cholesterol (LDL-C) levels following acute coronary syndrome (ACS) is recommended in the current clinical guidelines. However, the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors in those patients undergoing coronary artery bypass graft (CABG) has never been demonstrated. Methods. From January 2022 to July 2023, we retrospectively analyzed 74 ACS patients characterized by higher LDL-C levels than guideline targets and who underwent coronary bypass surgery. In the first period (January 2022-January 2023), the patients increased their statin dosage and/or added Ezetimibe (Group STEZE, 43 patients). At a later time (February 2023-July 2023), the patients received not only statins and Ezetimibe but also Evolocumab 140 mg every 2 weeks starting as early as possible (Group STEVO, 31 patients). After one and three months post-discharge, the patients underwent clinical and laboratory controls with an evaluation of the efficacy lipid measurements and every adverse event. Results. The two groups did not differ in terms of preoperative risk factors and Euroscore II (STEVO: 2.14 ± 0.75 vs. STEZE: 2.05 ± 0.6, p = 0.29). Also, there was no difference between the groups in terms of ACS (ST-, Instable angina, or NSTE) and time of symptoms onset regarding total cholesterol, LDL-C, and HDL-C trends from the preprocedural period to 3-month follow-up, but there was a more significant reduction in LDL-C and total cholesterol in the STEVO group (p = 0.01 and p = 0.04, respectively) and no difference in HDL-C rise (p = 0.12). No deaths were reported. In three STEZE group patients, angina recurrence posed the need for percutaneous re-revascularization. No STEVO patients developed significant adverse events. The statistical difference in these serious events, 7% in STEZE vs. 0% in STEVO, was not significant (p = 0.26). Conclusions. Evolocumab initiated "as soon as possible" in ACS patients submitted to CABG with high-intensity statin therapy and Ezetimibe was well tolerated and resulted in a substantial and significant reduction in LDL-C levels at discharge, 1 month, and 3 months. This result is associated with a reduction but without a statistical difference between groups.

Evaluation of the anatomic sinus after transcatheter aortic valve replacement.

BACKGROUND: Following transcatheter aortic valve replacement (TAVI), the newly formed 'anatomic sinus'. may contribute to the formation of subclinical leaflet thrombosis (SLT).The evaluation of root geometry after TAVI is generally performed using multi-detector computed tomography (MDCT), and the role of transthoracic echocardiography (2D TTE) requires further validation. Thus, we aimed to test the reproducibility of 2D TTE assessment of the anatomic sinus with MDCT as a reference and its association with SLT. METHODS: 2D TTE was performed in 90 patients, and the echocardiograms were analyzed offline. Both sinus of Valsalva (SOV) and prosthesis diameters were assessed in the long- and short-axis parasternal views (PLAX/PSAX), and the anatomic sinus area was calculated. Inter- and intra-observer reproducibility were assessed using the interclass correlation coefficient (ICC). MDCT was performed in 50 individuals to evaluate concordance with 2D TTE and to detect SLT. RESULTS: There was excellent correlation regarding the diameter of the SOV and the prosthesis in PLAX (ICC: 0.93 (95% CI: 0.76,0.97); ICC: 0.80 (95% CI: 0.63,0.96)) and PSAX view (ICC: 0.90 (95% CI: 0.68,0.97); ICC: 0.88 (95% CI: 0.63,0.96)). Bland-Altman analysis of 2D TTE and MDCT anatomic sinus areas indicated a high level of agreement. SLT was detected in 8 individuals (16%); 3 patients had severe SLT at the level of 1 cusp. CONCLUSIONS: 2D TTE might play a role in the evaluation of the anatomic sinus after TAVI. The importance of this space and its effects on the SLT remain uncertain.

About different localization of hypoattenuated lesions following transcatheter aortic valve replacement.

BACKGROUND: Subclinical leaflet thrombosis is diagnosed using multidetector computed tomography (MDCT) and is characterised by a meniscal-shaped hypoattenuated lesion of one or more leaflets. Transcatheter aortic self-expandable valves are commonly manufactured with pliable pericardium over a nitinol frame that forms leaflet and extra-leaflet components such as the valve skirt. Little is known about extra-leaflet hypoattenuated lesion localisation, including that at the anatomical sinus level. Thus, the main aim of this study was to describe leaflet and extra-leaflet (anatomic sinus and subvalvular level) hypoattenuated lesions following transcatheter aortic valve replacement with a self-expandable prosthesis. As a secondary aim, we sought to investigate predictors of hypoattenuated lesions. METHODS: Fifty patients underwent MDCT at the follow-up. RESULTS: At a follow-up of 12 months, hypoattenuated leaflet lesions with mild to severe restricted movement were detected in eight individuals (16%), anatomic sinus lesions were identified in nine patients (18%), with higher prevalence in the non-coronary sinus (16%), and subvalvular lesions with variable extension toward the valve inflow were diagnosed in eight patients (16%). In 4 patients (8%) the anatomic sinus thrombus was 'in overlap' with leaflet thrombus; in 3 patients (6%) was in continuity with subvalvular frame thrombus. Bicuspid valve was the only independent predictor associated with hypoattenuated lesions (adj OR 8.25 (95% CI: 1.38, 49.21), p = 0.02)). CONCLUSIONS: This study demonstrated that hypoattenuated lesions could be identified not only at the leaflet but also at the subvalvular and anatomic sinus levels. The clinical relevance of such lesions remains unclear.

[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.

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.

Emergent Conversion to Open Heart Surgery during Transcatheter Aortic Valve Implantation: The Presence of a Rescue Team Improves Outcomes.

OBJECTIVE: Transcatheter aortic valve implant (TAVI) is the gold standard for the high-surgical-risk group of patients with aortic valve disease and it is an alternative to surgery in patients at intermediate risk. Lethal complications can occur, and many of these are manageable only with emergent conversion to open heart surgery. We retrospectively evaluate the outcome of all patients undergoing TAVI in our departments and the impact of a complete cardiac rescue team to reduce 30-day mortality. METHODS: Data from all patients undergoing TAVI between January 2020 and August 2023 in our center were analyzed. An expert complete rescue was present in catheter laboratory. Primary outcomes were in-hospital and at 30-day mortality and evaluation of all cases needed for emergent conversion to open heart surgery. RESULTS: 825 patients were enrolled. The total mortality was 19/825 (2.3%). Eleven of the total patients (1.3%) required emergent conversion to open heart surgery. Among them, eight were alive (73%), with a theoretical decrease of 0.98% in overall mortality. CONCLUSIONS: surgical treatment is rare during TAVI. The presence of an expert complete rescue team as support means an increase in survival. Surgery must be used only to restore circulatory and to treat complication while percutaneous approaches should complete the procedure.

Infective Endocarditis After Percutaneous Device Closure of Atrial Septal Defects: Incidence, Diagnosis, and Treatment. Case Report and Literature Review.

Infective endocarditis (IE) on atrial septal defect (ASD) closure devices, while extremely rare, has been reported to be more frequent early after the procedure. We describe a case of late IE after percutaneous closure of patent foramen ovale (PFO). We also performed a literature review on this subject. We reviewed a total of 42,365 patients who were treated with percutaneous devices: 13,916 for ostium secundum (OS) (32%), 24,726 for PFO (58%) and 3,723 for OS+PFO (8%). Among these patients, we identified 50 cases of IE after atrial septal defect device closure (0.001%). In contrast to previous reports, nearly 66% of IE in this setting occurred late, after at least 6 months from the procedure (33/50 patients). A statistical analysis clearly showed that the mean time from the procedure to IE increased in the last five years, probably associated with a change in antiplatelet therapy after ASD closure. Management of IE on an ASD occluder should always be discussed in the setting of a multidisciplinary heart team that includes a cardiologist, cardiac surgeon, and anesthetist. While surgical strategies gave excellent results, conservative management might be considered in cases of small IE vegetations and for patients in good general condition. However, in these cases, the patient must be closely observed with repeated blood and instrumental tests.

Gaseous Micro-Embolic Activity and Goal-Directed Perfusion Management in a Closed System for Cardiopulmonary Bypass and Minimally Invasive Extracorporeal Circulation during Coronary Artery Bypass Grafting.

BACKGROUND: Cardiopulmonary bypass (CPB) techniques are becoming minimally invasive in clinical practice. The literature describes various extracorporeal techniques which seek to eliminate air-blood contact and reduce both hemodilution and the contact surface such as in Minimally invasive Extracorporeal Circulation (MiECC) and closed systems for CPB. However, the delivery of micro-embolic activity in the circuit and metabolic activity in terms of oxygen delivery for Goal-Directed Perfusion (GDP) management, in relation to the patient's blood volume and central venous pressure, have never been related and correlated. In this report, we present a cohort study that investigated these aspects between the closed SVR2000 System and modular MiECC (both from Eurosets SRL, Medolla, Italy). MATERIALS AND METHODS: Data were collected retrospectively and used to compare 60 consecutive patients who underwent isolated coronary artery bypass grafting (CABG) surgery by two surgeons using an SVR2000 oxygenator in 30 procedures, with a matched cohort of patients from the same period who underwent isolated CABG surgery by two other surgeons using a modular MiECC in 30 procedures. The primary endpoints collected were data on micro-embolic activity, including the number of gaseous micro-emboli in the circuit during the procedure, the mean maintenance value of oxygen delivery (DO2) and data relating to venous return volume and central venous pressure (CVP). RESULTS: During the CPB procedures, the following values were recorded for the closed SVR2000 and MiECC groups, respectively: the average number of gaseous micro-emboli (GME) in the venous line, 833 ± 23 vs 1221 ± 45 (p = 0.028); GME in the outlet of the pump, 375 ± 45 vs 429 ± 76 (p = 0.89; GME in the arterial line, 189 ± 36 vs 205 ± 27 (p = 0.92), and the volume of GME in the arterial line (mL), 0.32± 12 vs 0.49± 17 (p = 0.93). The mean Indexed Oxygen Delivery (DO2i) during cross-clamp (ml/min/m2) was 319 ±12 vs 278 ±9 (p = 0.0019), respectively. The maximum mean volume of venous return in the soft-shell venous reservoir (ml) was 1801 ±128 vs 824 ±192 (p = 0.038). The mean central venous pressure (CVP) during cross-clamp (mmHg) was 0 ± 2 vs 6 ± 2 (p = 0.019). CONCLUSIONS: In this study, the results in the closed SVR2000 group were not statistically inferior to those in the modular MiECC group in terms of gaseous micro-embolic activity during CPB. Our analysis showed an important reduction of GME delivery in both systems. The closed SVR2000 group showed better management for GDP in terms of DO2i, associated with the flexibility of dynamic volume management and the absence of cavitation and regulation of the rate per minute and pump flow, which were reported in the MiECC group. The SVR2000 and modular MiECC systems were both safe and effective in perioperative practice without iatrogenic problems.

Cardiopulmonary Bypass Settings for the Prevention of Early Hypotension During CABG.

BACKGROUND: Vasoplegic syndrome is a form of vasodilatory shock that can occur before, during or after cardiopulmonary bypass (CPB). We introduce a strategy to reduce the incidence of early hypotension phenomena during Coronary Artery Bypass Graft (CABG) procedures. MATERIALS AND METHODS: In this prospective cohort study, 100 patients underwent elective CABG with two perioperative CPB settings. The study group (50 patients) was managed with retrograde autologous priming (RAP), 3-minute stepwise for the institution of CPB, and pulsatile flow (PP). The control group (50 patients) was managed without RAP, with the rapid initiation of CPB, and non-pulsatile (NP) flow. The primary endpoints were MAP (mmHg), number of hypotensive phenomena (MAP < 50 mmHg for > 30 sec), the venous return volume on CPB (ml), the cardiac index (L/min/m2), hemoglobin (g/dL), indexed oxygen delivery (DO2i, ml/min/m2), the systemic vascular resistance index (SVRI, dynes s m2/cm5), number of 1-ml boluses of a vasoactive substance (norepinephrine), the positive fluid balance (ml), and the number of red blood cell units for transfusion. RESULTS: During CPB, the mean values in the study and control groups were as follows: MAP, 68± 7 vs 56 ± 7 (p-value, 0.0019); hypotensive phenomena, 3 ± 1 vs 8 ±2 (p-value, 0.019); venous return volume, 840±79 vs 1129 ±123 (p-value, 0.0017); cardiac index, 2.4 ± 0.4 vs 2.7 ±0.2 (p-value, 0.0023); hemoglobin, 9.13 ± 0.29 vs 7.8± 0.23 (p-value, 0.0001); DO2i, 301± 12 vs 276±23 (p-value, 0.0011); SVRI, 1879 ±280 vs 2210 ±140 (p-value, 0.0017); norepinephrine, 1±2 vs 8 ±3 (p-value, 0.0023); positive fluid balance, 750 ±212 vs 1450 ±220 (p-value, 0.005); and total number of red blood cell units for transfusion, 16 ±4.2 vs 27 ± 5.3 (p-value, 0.008). CONCLUSIONS: In this prospective cohort study, during CPB, the study group showed a better preservation of MAP, SVRI, and DO2i, and a reduction of vasoconstrictor use in a CPB setting with the RAP technique, 3-minute stepwise for the initiation of CPB and pulsatile pump flow, compared to the control group. Further studies are needed to validate this perioperative approach to CPB.

An annotation-independent algorithm based on electrogram characteristics to guide the identification of ventricular tachycardia isthmuses in patients with structural heart disease.

BACKGROUND: Criteria such as electrograms voltage or late potentials have been largely utilized in the past to help identify areas of substrate maps that are within the ventricular tachycardia (VT) isthmus; yet their specificity and positive predictive value are quite low. The Lumipoint fractionation tool of the Rhythmia system illuminates regions with fractionated electrograms irrespective of their timing and annotation. We aimed to ascertain whether the use of this tool can rapidly identify areas within VT isthmuses from substrate maps. METHODS: Thirty patients with structural cardiomyopathy in whom a complete right ventricular-paced substrate map and a full reconstruction of the diastolic isthmus during VT could be obtained were enrolled. The VT isthmus border was projected on each substrate map to verify whether the areas illuminated by Lumipoint fell within those borders. The behavior of the electrograms detected at the illuminated areas of the substrate maps was studied during a right ventricular drive train and extra stimulus protocol: if the near field potentials showed a delayed conduction after a single extra stimulus, defined as a minimum of 10 ms increase of the time interval between the far field and the near field activation measured during the drive train, the electrogram was said to have a "decremental" behavior. RESULTS: The logistic analysis showed that areas with fractionated electrograms illuminated by the Lumipoint software and showing the greatest decremental behavior fell within the VT isthmus borders (OR = 1.66, CI: 1.41-1.75, p<0.001; OR=1.57 CI: 1.32-1.72, p<0.001, respectively) with a sensitivity, specificity, and positive predictive value of 87%, 96%, and 97%, respectively. CONCLUSIONS: Fractionated electrograms illuminated by the automated Lumipoint software on right ventricular-paced substrate maps showing the greatest decremental behavior fall within the VT isthmus borders with a probability of 0.97, irrespective of their timing, annotation, or voltage, without any need for subjective assessment of their involvement in slow conduction areas.

Self-Expandable Prosthesis Valve Adaptation: Non-Uniform Expansion and Stent Frame Decoupling.

The incidence of non-uniform expansion in the context of the self-expandable transcatheter heart valve (THV) is little investigated, along with stent-frame decoupling, which is a form of stent adaptation, in which the lower part of the THV stent conforms to both the ellipticity of the left ventricle outflow tract and the native annulus while maintaining the higher part of the valve more circular. We analyzed post-implant multi-detector computed tomography scans in 50 patients. Prosthesis non-uniform expansion was assessed by computing the prosthesis eccentricity on 6 prespecified levels: (1) frame inflow, (2) native annulus, (3) leaflet inflow, (4) prosthesis waist, (5) leaflet outflow, and (6) frame outflow. Stent-frame decoupling was assessed by comparing the mean eccentricity on 6 different prosthesis levels. Implantation depth, leaflet expansion and alignment, and residual anatomic sinus area ratios were also calculated. Subclinical leaflet thrombosis was defined as hypoattenuated lesion of a meniscal shape. At a 12-month follow-up, non-uniform expansion was consistently detected at each valvular level. Highest eccentricity was measured at the native annulus level (eccentricity: 0.54 ±  0.12), while the lowest index at the frame outflow level (0.23 ± 0.11). Similar results were observed in the subgroup analyses of sizes 23, 26, 29, and 34. Eccentricity significantly decreased from the annulus level to the prosthesis frame outflow (p <0.001). Notably, the incidence of mild-to-severe subclinical leaflet thrombosis was relevant (16%). In conclusion, prosthesis non-uniform expansion and stent frame decoupling frequently occur after self-expandable THV replacement. The clinical and hemodynamic implications remain uncertain.

Subclinical Leaflet Thrombosis Following Surgical and Transcatheter Aortic Valve Replacement: A Meta-Analysis.

Subclinical leaflets valve thrombosis (SLT) is a recently identified phenomenon with multidetector computer tomography after tissue aortic valve replacement. Whether SLT is more frequent after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) is currently not known. Thus, the aim of this pairwise meta-analysis was to investigate the incidence of SLT after both TAVR and SAVR, the association with anticoagulation therapy, and the risk for neurological events. We searched PubMed, Google Scholar, and Ovid MEDLINE/Embase (January 02, 2023, last update) (PROSPERO registration: CRD42022383295). Statistical analysis was performed according to a prespecified statistical analysis plan. Time-to-event outcomes were summarized as incidence rate ratios (IRR). Pooled estimates were calculated using inverse variance method and random effect model. Overall, 2 registries, 2 randomized trials, and 1 observational study (1,593 patients) were included in this meta-analysis. There was a statistically significant difference in the incidence rate at follow-up of SLT between patients who underwent TAVR and SAVR (IRR 2.07, 95% confidence interval [CI]: [1.06; 4.03], I2 79%, 95% CI: [44; 92], p = 0.03). Oral anticoagulation therapy was associated with a reduced incidence of SLT (IRR 7.51, 95% CI: [3.24; 17.37], I2 62%, 95% CI: [0; 87], p <0.001). However, the incidence of later neurological events did not differ between patients with or without SLT (IRR 1.05, 95% CI: [0.32; 3.47], p = 0.93). In conclusion, SLT was more frequently detected after TAVR than SAVR. However, it was not associated with an increased risk for neurological events. Oral anticoagulation therapy seemed to reduce the incidence of SLT.