Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.

BACKGROUND: Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. AIMS: The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. METHODS: This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. RESULTS: A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. CONCLUSION: This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.

The influence of metabolic syndrome in heart valve intervention. A multi-centric study.

BACKGROUND: The effect of metabolic syndrome (MetS), defined as insulin resistance along with two or more of: obesity, atherogenic dyslipidaemia and elevated blood pressure, on postoperative complications after isolated heart valve intervention remains controversial. We hypothesized that MetS may negatively influence the postoperative course in these patients. METHODS: Patients from 10 cardiac units who underwent isolated valve intervention (mitral ± $\pm $ tricuspid repair/replacement (mitral valve surgery [MVS]) or surgical aortic valve replacement (SAVR), or transcatheter aortic valve replacement (TAVR) were included. MetS was defined according to the World Health Organization criteria. Primary outcome was in-hospital mortality and overall postoperative length of stay (LOS). Relevant postoperative complications were also recorded. RESULTS: From 2010 to 2019, 17,283 patients underwent valve intervention. The MVS, SVAR, and TAVR accounted for the 39.4%, 48.2%, and 12.3% respectively of the whole. MetS compared to no-MetS was associated to higher mortality in the MVS group (6.5% vs. 2%, p < .001), but not in the SAVR and TAVR group. In both surgical cohorts, MetS was associated with increased complications including red blood cells transfusion, renal failure, mechanical ventilation time, intensive care and overall postoperative LOS (11 (9) vs. 10 (6), p < .001 and 10 (6) versus 10 (5) days, p = .002, MVS and [SAVR]). No differences were found in the TAVR cohort, with similar mortality and complications. CONCLUSION: MetS was associated to more postoperative complications, with higher mortality in the MVS group. In the TAVR cohort, postoperative complications and mortality rate did not differ between patients with and without MetS, however LOS was longer in the MetS group.

Time-dependent benefits of pre-treatment with new oral P2Y12 -inhibitors in patients addressed to primary PCI for acute ST-elevation myocardial infarction.

OBJECTIVES: The aim of this observational study was to determine the benefits of the novel, orally delivered P2Y12 -inhibitors (Is) in terms of angiographic endpoints and in relation to the time of the loading dose (LD) administration. BACKGROUND: The goal of ST-elevation myocardial infarction (STEMI) treatment is timely reperfusion. The P2Y12 -Is prasugrel and ticagrelor have improved the angiographic outcome of primary percutaneous coronary intervention (pPCI) and patients' prognosis. However, their onset of action is impaired in STEMI and delayed by their oral administration. METHODS: The 328 eligible patients with STEMI consecutively referred for pPCI were divided into three groups depending on the interval of "P2Y12 -I LD administration-to-balloon time": Group 2 included patients that received P2Y12 -I LD at least 60 min prior to pPCI, Group 1 within 60 min prior to pPCI, and Group 0 at the moment of pPCI. Angiographic, clinical, and biochemical parameters were evaluated. Pre- and post-pPCI TIMI flow grade (TFG) and ST resolution (STR) were used as outcome measures to determine efficacy and optimal timing of pretreatment. RESULTS: Pre-pPCI TFG improved with increasing P2Y12 -I LD administration-to-balloon time; pre-PCI TFG 0/1 was 74.5% in Group 0, 65.5% in Group 1 and 54.9% in Group 2 (P < 0.002). Post-pPCI TFG 3 results also differed significantly between the three groups: 85.2% in Group 0, 88.1% in Group 1, 97.6% in Group 2 (P < 0.013). ST resolution rates were also positively associated with longer pretreatment intervals. CONCLUSIONS: This observational study suggests that the angiographic benefit of P2Y12 -I administration is time-dependent: longer pretreatment improves coronary reperfusion in terms of pre- and post-pPCI TFG and STR.

Prosthesis depth and conduction disturbances after last generation balloon-expandable transcatheter aortic valve implantation.

Aims: Preliminary data on Sapien 3 valve (S3-THV) use for transcatheter aortic valve implantation have shown an increased permanent pacemaker implantation (PPMI) rate with respect to Sapien XT valve. Aim of this study was to investigate the role of S3-THV position in the left ventricular outflow tract (LVOT) on electrocardiographic changes suggestive of atrioventricular (ΔPR) and/or intraventricular (ΔQRS) conduction abnormalities and 30 days PPMI rate. Methods and results: Eighty-six consecutive patients treated with S3-THV were included in the study. All patients underwent clinical and electrocardiogram evaluation. Left ventricular outflow tract prosthesis depth was assessed by fluoroscopy and expressed quantitatively (mm) and as aorto-ventricular ratio (AVR). Eight patients (9.3%) needed PPMI at 30 days. A low AVR (≤60/40) predicted PPMI (OR = 6.09, 95% CI 1.19-31.01, P = 0.030) and resulted into higher PPMI rate, compared with higher AVR (30.0 vs. 6.6%, P = 0.017). For each millimetre increase in the LVOT prosthesis depth PPMI risk increased by 1.41 times (95% CI 1.06-1.87, P = 0.017). In patients with low AVR, ΔPR was higher than in those with higher AVR (33.4 ± 56.7 vs. 12.1 ± 19.4 ms, P = 0.021) and ΔPR was associated to LVOT prosthesis depth (ß = 0.286, P = 0.009). Furthermore, ΔPR was associated with risk of PPMI (OR = 1.03, 95% CI 1.01-1.06, P = 0.024). Conclusions: A low AVR is associated to higher ΔPR and PPMI rates. The correlation between LVOT prosthesis depth with ΔPR and higher PPMI rate suggests the need of a careful S3-THV implantation.

Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions.

BACKGROUND: Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. OBJECTIVES: The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. METHODS: The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical follow-up was performed. RESULTS: A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity score-matching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. CONCLUSIONS: Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.

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.

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.

ECMOLIFE intra-hospital transport in life-saving for pulmonary vein obstruction.

BACKGROUND: Transport with extracorporeal membrane oxygenation (ECMO) in the hospital setting can become a challenge as well as in the out-of-hospital setting. In particular, the management of intra-hospital transport with ECMO support of the critically ill patient foresees his shift from the intensive care to the diagnostic areas, from the diagnostic areas to the interventional and surgical areas. CASE PRESENTATION: In this context, we present a life-saving transport case with the veno-venous (VV) configuration of the ECMOLIFE Eurosets system, for right heart and respiratory failure in a 54-year-old woman, due to thrombosed obstruction of the right superior pulmonary vein, following mitral valve repair surgery in minimally invasive approach in a patient already operated on for complex congenital heart disease. After stabilizing the vital parameters with Veno-venous ECMO for 19 h, the patient was transported to hemodynamics for angiography of the pulmonary vessels, where the diagnosis of obstruction of the pulmonary venous return was made. Subsequently, the patient was brought back to the operating room for a procedure of unblocking the right superior pulmonary vein using a minimally invasive approach, passing from the ECMO to the support in extracorporeal circulation. CONCLUSIONS: The transportable ECMOLIFE Eurosets System was safe and effective during transport in maintaining the vital parameters of oxygenation and CO2 reuptake and systemic flow, allowing the patient to be mobilized for diagnostic tests instrumental to diagnosis. The patient was extubated 36 h after the surgical procedures and was discharged 10 days later from the hospital.

Early acute kidney injury after transcatheter aortic valve implantation: predictive value of currently available risk scores.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a frequent complication associated with adverse outcomes and mortality. Various scores have been developed to predict this complication in the coronary setting. However, none have ever been tested in a large TAVI population. This study aimed to evaluate the power of four different scores in predicting AKI after TAVI. METHODS: Overall, 1535 consecutive TAVI patients from the observational multicentric "Magna Graecia" TAVI registry were included in the analysis. Of the study population, 235 (15.31%) developed AKI early. The Mehran, William Beaumont Hospital, CR4EATME3AD3, and ACEF scores were calculated retrospectively. RESULTS: The patients who developed TAVI-related AKI had significantly higher absolute values of all risk scores than those who did not. The receiver-operating characteristic analysis also showed a significant correlation between these four scores and AKI, but without a significant difference among all of them (p value = 0.176). Nevertheless, based on their area under the curve values (≤0.604 for all), none had adequate diagnostic accuracy in predicting TAVI-related AKI. Importantly, multivariate analysis identified myocardial revascularization close to the TAVI procedure and implantation of self-expanding prostheses, as well as atrial fibrillation, low-osmolar contrast media administration, corrected contrast medium volume, and any transfusion (p value < 0.05 for all) as independent risk factors for AKI. CONCLUSIONS: Although high values of current AKI risk scores are significantly associated with the development of this complication, these are not sufficiently accurate. Further studies are needed so that a TAVI-dedicated AKI risk score may be created.

Fluoroscopy Time as a New Predictor of Short-Term Outcomes after Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an almost totally cine-fluoroscopic guided procedure. The amount of radiation used during the procedure is strictly related to the fluoroscopy time (FT), that has already been demonstrated to be associated with outcomes and complexity of coronary procedures. The aim of our study is to demonstrate the relationship between FT and the short-term outcomes after TAVR defined by to the Valve Academic Research Consortium (VARC)-2 and -3 consensus documents. METHODS: After splitting 1797 consecutive patients into tertiles of FT, the composite endpoint early safety (ES) was adjudicated according to VARC-2 and VARC-3 definitions, whereas the composite endpoints device success (DS) and technical success (TS) according to VARC-3 criteria. RESULTS: The absence of all these outcomes (VARC-2 ES amd VARC-3 TS, DS, and ES) was significantly associated with longer FT: this association was independent from both intraprocedural complications and other intraprocedural factors linked to longer FT, and still persisted after propensity score matching analysis. Notwithstanding, after receiver operating characteristic analysis, FT had adequate diagnostic accuracy in identifying the absence of only VARC-3 TS and VARC-2 ES. CONCLUSION: Longer FT is related with periprocedural and short-term outcomes after the procedure, especially in those that are more challenging. A FT duration of more than 30 min has an adequate accuracy in identifying VARC-3 technical failure (TS and DS) and absence of VARC-2 ES, selecting patients who are likely to take advantage from more careful in-hospital follow-up.

Surgical Mortality Risk Scores in Transcatheter Aortic Valve Implantation: Is Their Early Predictive Value Still Strong?

BACKGROUND: Surgical mortality risk scores, even if not properly designed and rarely tested in the transcatheter aortic valve implantation (TAVI) setting, still guide the heart team in managing significant aortic stenosis. METHODS: After splitting 1763 consecutive patients retrospectively based on their mortality risk thresholds, the composite endpoint early safety (ES) was adjudicated according to Valve Academic Research Consortium (VARC)-2 and -3 consensus documents. RESULTS: ES incidence was higher if VARC-2 rather than VARC-3 defined. Despite only patients showing VARC-2 ES had significantly lower absolute values of all three main risk scores, these last still failed to foresee both VARC-2 and -3 ES in intermediate-risk patients. The receiver operating characteristic analysis also showed a significant correlation, but with poor diagnostic accuracy, among the three scores and only VARC-2 ES; moreover, the absence of VARC-2 ES and low-osmolar contrast media administration were identified as independent predictors of 1-year mortality and absence of VARC-3 ES, respectively. Finally, even a single complication included in the ES definition could significantly affect 1-year mortality. CONCLUSION: Currently, the most used mortality risk scores do not have adequate diagnostic accuracy in predicting ES after TAVI. The absence of VARC-2, instead of VARC-3, ES is an independent predictor of 1-year mortality.

Comparison between Track Technique and Conventional Approach for Measuring Artificial Chordae in the Treatment of Anterior Leaflet Prolapse and Flail during Mitral Valve Repair.

Background: Measuring the chordae tendineae for mitral valve reconstruction is feasible with various techniques. However, the effect of different strategies on the durability of plastics at follow-up is unknown. The study aims to compare a conventional surgical technique for measuring artificial chordae length with our new approach, defined "track technique". Methods: We compared the results of patients with anterior leaflet prolapse/flail who underwent mitral valve reconstruction by implanting artificial chordae from January 2020 to January 2022; 22 patients were operated on with a conventional technique, and 25 with our new alternative, "track technique". Clinical and transesophageal echocardiography data were collected postoperatively and at 2 years of follow-up. The primary outcome was freedom from mitral regurgitation. Secondary outcomes were presentation with New York Heart Association (NYHA) class < 2 and leaflet coaptation length ≥ 10 mm. Results: The patients of the 2 groups had comparable preoperative risk factors regarding the LogEuroSCORE (p = 0.33). Moreover, no difference was observed in terms of the mechanism of mitral valve insufficiency. No hospital or follow-up deaths were recorded for either group. At discharge, no echocardiographic differences were observed in the regarding degree of residual mitral regurgitation, but the measurement of coaptation length was in favor of the alternative group (8.6 ± 1.8 vs. 11 ± 1.4; p = 0.04). At 2 years of follow-up (25 ± 9; range 13-37), the NYHA class was not different; however, the number of patients with 1-2+ recurrent mitral regurgitation was significantly higher in the conventional group (8 vs. 4 patients; p = 0.02), and the coaptation length was in favor of the alternative group (8.8 ± 1.7 vs. 11 ± 1.7; p = 0.04). Conclusions: We devised both techniques to prove effective in achieving good valvular continence, but a significantly greater coaptation length was obtained with our track technique at the 2 years follow-up.

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.

Perioperative left ventricular perforation in incomplete TAVI and completion of the procedure after surgical repair.

BACKGROUND: The use of transcatheter aortic valve implantation (TAVI) continues to grow worldwide. Despite increased operator experience, evolution of the technique, and deflectable catheters, major complications still occur in ≤ 6% up to 8% of cases. Such major complications have been associated with a 2- to threefold increase in 30-day mortality. Complications specifically involving the aorta, aortic valve annulus, or left ventricle are rare, occurring in only 0.2-1.1% of cases. CASE PRESENTATION: We report the case of a 65-year-old female patient with left ventricular lateral wall perforation during incomplete implantation of a TAVI device, and successive percutaneous completion after surgical repair of the lesion under cardiopulmonary bypass. The surgical strategy and the type of surgical treatment depend on the type of perforation. In general, repair of the lesion and aortic valve replacement are performed. Removal of the TAVI prosthesis and excision of the native aortic valve are standard parts of this repair. CONCLUSION: Here we propose a safe alternative for the completion of the TAVI approach after surgical repair, which requires close coordination between the members of the heart team (anesthesiologist, perfusionist, cardiologist, nurse and cardiac surgeon).

The hemodynamic performance of balloon-expandable aortic bioprostheses in the elderly: a comparison between rapid deployment and transcatheter implantation.

BACKGROUND: Surgical aortic valve replacement with a rapid deployment valve (RDV) is a relatively recent treatment option. The aim of this study was to compare the hemodynamic performance of balloon-expandable (BE)-RDVs and BE-transcatheter heart valves (THVs) in a high surgical risk and frail-elderly population. METHODS: BE-THVs and BE-RDVs were implanted in 138 and 47 patients, respectively, all older than 75 years and with a Canadian Study of Health and Aging category of 5 or above. Echocardiographic assessment was performed at discharge and six months later. RESULTS: At discharge, transprosthetic pressure gradients and indexed effective orifice area (iEOA) were similar in both cohorts. At six-month follow-up, BE-RDVs showed lower peak (14.69 vs. 20.86 mmHg; p < 0.001) and mean (7.82 vs. 11.83 mmHg; p < 0.001) gradients, and larger iEOA (1.05 vs. 0.84 cm2/m2; p < 0.001). Similar findings were also shown considering only small-sized valves. Moderate-to-severe paravalvular leakage was more prevalent in BE-THVs at discharge (14.49 vs. 0.00%; p = 0.032) and, considering exclusively small prostheses, at six months too (57.69 vs. 15.00%; p = 0.014). Nevertheless, BE-THVs determined amelioration in left ventricular ejection fraction (53.79 vs. 60.14%; p < 0.001), pulmonary artery systolic pressure (35.81 vs. 33.15 mmHg; p = 0.042), and tricuspid regurgitation severity (40.58 vs. 19.57%; p = 0.031), from discharge to mid-term follow-up. CONCLUSIONS: BE-RDVs showed better hemodynamic performance, especially when implanted in small annuli. Despite their worse baseline conditions, transcatheter patients still exhibited a greater improvement of their echocardiographic profile at mid-term follow-up.

Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.

Background: The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. Methods: This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Results: Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

Remote ischemic preconditioning in isolated valve intervention. A pooled meta-analysis.

OBJECTIVE: Recent studies have shown no benefits from remote ischemic preconditioning (RIPC) in patients undergoing coronary artery bypass surgery. One possible explanation is that given previous exposure to angina and ischemia/reperfusion injury these patients, may be already 'naturally preconditioned'. The role of RIPC in a context of isolated valve intervention, both surgical and particularly transcatheter is less clear and remains under investigated, with few high-quality studies. METHODS: A systematic literature review identified 8 candidate studies that met the meta-analysis criteria. We analyzed outcomes of 610 subjects (312 RIPC and 298 SHAM) with random effects modeling. Each study was assessed for heterogeneity. The primary outcome was the extent of periprocedural myocardial injury, as reflected by the area under the curve for serum troponin concentration. Secondary endpoints included relevant intra- and post-operative outcomes; sensitivity and high-quality subgroup analysis was also carried out. RESULTS: Six and two studies reported the effect of RIPC in surgical and transcatheter valve intervention. There was a significant difference between-group in terms of periprocedural Troponin release (standardized mean difference (SMD: 0.74 [95% CI: 0.52; 0.95], p = 0.02) with no heterogeneity (χ2 2.40, I2 0%, p = 0.88). RIPC was not associated with any improvement in post-operative outcomes. No serious adverse RIPC related events were reported. CONCLUSIONS: RIPC seems to elicit overall periprocedural cardioprotection in patients undergoing valvular intervention, yet with no benefit on early clinical outcomes.

Magna Graecia transcatheter aortic valve implantation registry: data on contrast medium osmolality and postprocedural acute kidney injury.

A comprehensive description of baseline characteristics, procedural features and outcomes related to the development of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is reported in our research paper (Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry. Int J Cardiol. DOI: 10.1016/j.ijcard.2020.12.049). Three Italian heart centers were involved in this multicentric observational study. Between March 2011 and February 2019, a total of 888 patients underwent TAVI; according to the inclusion and exclusion criteria, 697 patients were included in the post-hoc analysis. This Data in Brief paper aims to report demographic, clinical, laboratory, echocardiographic, intraprocedural, periprocedural, postprocedural and follow-up data; all of them were prospectively collected from each patient's health record, whereas the analysis was performed retrospectively. Targets of this data analysis were: 1) to evaluate the impact of contrast medium (CM) osmolality on TAVI-related AKI; 2) to identify the most of risk factors involved in the development of such complication, and consequently in the occurrence of 1-year mortality; 3) to estimate the impact of CM osmolality on AKI in specific patient subgroups.

Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes and mortality; to date, in such setting of patients there is no consistent evidence that either low-osmolar contrast media (LOCM) or iso-osmolar contrast medium (IOCM) are superior to the other in terms of renal safety. METHODS: 697 consecutive patients not in hemodialysis treatment who underwent TAVI (327 males, mean age 81.01 ± 5.75 years, mean european system for cardiac operative risk evaluation II 6.17 ± 0.23%) were enrolled. According to osmolality of the different iodinated CM, the population was divided in 2 groups: IOCM (n = 370) and LOCM group (n = 327). Preoperatively, 40.54% of patients in IOCM vs 39.14% in LOCM group (p = 0.765) suffered from chronic kidney disease (CKD). RESULTS: The incidence of AKI was significantly lower with IOCM (9.73%) than with LOCM (15.90%; p = 0.02), and such significant difference (p < 0.001) in postprocedural change of renal function parameters persisted at discharge too. The incidence of AKI was also significantly lower with IOCM in younger patients, without diabetes, anemia, coronary artery disease history, CKD, chronic or persistent atrial fibrillation, left ventricular ejection fraction ≤35%, and in patients with low operative mortality risk scores, receiving lower amounts of dye (p < 0.05 for all). Importantly, multivariate analysis identified LOCM administration as an independent risk factor for both AKI (p = 0.006) and 1-year mortality (p = 0.001). CONCLUSIONS: The use of IOCM have a favorable impact on renal function with respect to LOCM, but it should be considered especially for TAVI patients at lower AKI risk.