Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

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.

TAVI in Patient Suffering from Niemann-Pick Disease (Acid Sphingomyelinase Deficiency) with Concomitant Situs Inversus and Dextrocardia.

Acid sphingomyelinase deficiency (ASMD)-also known as Niemann-Pick (NP) disease-is a rare, autosomal recessive disorder which is characterized by deficiency of the lysosomal enzyme acid sphingomyelinase (ASM), resulting in excessive storage of lipids in organs (i.e., spleen, liver, lung, bone marrow, lymph nodes, and vascular system). Only a few cases of moderate-to-severe valvular heart disease due to ASMD are described in the literature, mostly in adulthood. We report here the case of a patient with NP disease subtype B that was diagnosed during adulthood. NP disease in this patient was found to be associated with situs inversus. Specifically, a severe, symptomatic aortic stenosis was identified, and the need for surgical or percutaneous intervention was discussed. The heart team chose transcatheter aortic valvular implantation (TAVI), which was successfully performed with no complications on follow-up.

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.

Percutaneous exclusion of ascending aorta pseudoaneurysms: still an interventional challenge?

Ascending aortic pseudoaneurysm is a rare pathology that could have multiple etiologies such as thoracic trauma, infection, and percutaneous or surgical procedures. In patients with aortic pseudoaneurysms, open surgical or endovascular interventions are always indicated, if feasible and independent of size. Several types of endovascular treatment have been reported in the literature, but they have been mostly restricted to those cases when traditional surgery has a prohibitive risk. We report the case of a 75-year-old man with a sinotubular junction pseudoaneurysm, likely developed after coronary artery bypass grafting, which was successfully treated by implanting a multifenestrated cribriform septal occluder, a device already used in few similar cases. .

Age-Related 2-Year Mortality After Transcatheter Aortic Valve Replacement: the YOUNG TAVR Registry.

OBJECTIVE: To comparatively assess the natural history of patients of different ages undergoing transcatheter aortic valve replacement (TAVR). PATIENTS AND METHODS: For this study, we used the YOUNG TAVR, an international, multicenter registry investigating mortality trends up to 2 years in patients with aortic valve stenosis treated by TAVR, classified according to 3 prespecified age groups: 75 years or younger (n=179), 76 to 86 years (n=602), and older than 86 years (n=221). A total of 1002 patients undergoing TAVR were included. Demographic, clinical, and outcome data in the youngest group were compared with those of patients 76 to 86 years and older than 86 years. Patients were followed up for up to 2 years. RESULTS: Compared with patients 75 years or younger (reference group), patients aged 76 to 86 years and older than 86 years had nonsignificantly different 30-day mortality (odds ratio, 0.76; 95% CI, 0.41-1.38; P=.37 and odds ratio, 1.27; 95% CI, 0.62-2.60; P=.51, respectively) and 1-year mortality (hazard ratio (HR), 0.72; 95% CI, 0.48-1.09; P=.12 and HR, 1.11; 95% CI, 0.88-1.40; P=.34, respectively). Mortality at 2 years was significantly lower among patients aged 76 to 86 years (HR, 0.62; 95% CI, 0.42-0.90; P=.01) but not among the older group (HR, 1.06; 95% CI, 0.68-1.67; P=.79). The Society of Thoracic Surgeons 30-day mortality score was lower in younger patients who, however, had a significantly higher prevalence of chronic obstructive pulmonary disease (P=.005 vs the intermediate group and P=.02 vs the older group) and bicuspid aortic valves (P=.02 vs both older groups), larger left ventricles, and lower ejection fractions. CONCLUSION: In the present registry, mortality at 2 years after TAVR among patients 75 years or younger was higher compared with that of patients aged 75 to 86 years and was not markedly different from that of patients older than 86 years. The findings are attributable at least in part to a greater burden of comorbidities in the younger age group that are not entirely captured by current risk assessment tools.

Dual vs single antiplatelet therapy in patients with lower extremity peripheral artery disease - A meta-analysis.

AIMS: Peripheral artery disease (PAD) is associated with increased risk of cardiovascular events. The benefits of dual antiplatelet therapy (DAPT) vs single antiplatelet therapy (SAPT) with aspirin in patients with PAD remain subject of ongoing debate. METHODS AND RESULTS: We performed a meta-analysis of studies comparing DAPT vs aspirin monotherapy in PAD. Incidence rate ratios (RR) and respective 95% confidence intervals (CI) were used as summary statistics. The primary outcome was mortality. Secondary endpoints were ischemic and bleeding outcomes. Ten studies including 65,675 patients have been included. Compared to SAPT, DAPT was associated with a significant reduction in mortality: RR, 0.89; 95% CI, 0.86-0.92; P < 0.001. Results were consistent across patients with symptomatic PAD and those undergoing bypass or percutaneous transluminal angioplasty (PTA). Similarly, DAPT significantly reduced the risk of repeat peripheral revascularizations (RR, 0.80; 95% CI, 0.69-0.92; P = 0.002). No significant increase of major bleeding complications was observed with DAPT as compared to SAPT (RR, 1.21; 95% CI, 0.87-1.68 P = 0.26). CONCLUSIONS: DAPT, as compared to SAPT, significantly reduces mortality in patients with PAD, with no significant increase in bleeding complications. These findings support DAPT as the mainstay antiplatelet therapeutic regimen in patients with PAD.

Role of proprotein convertase subtilisin/kexin type 9 inhibitors in patients with coronary artery disease undergoing percutaneous coronary intervention.

INTRODUCTION: Although novel therapies have improved outcomes in PCI patients, a sizeable number of patients still remain at high cardiovascular risk for recurrent event. There is therefore an unmet need for novel therapies that can improve clinical outcomes, with an associated satisfactory safety profile. Proprotein convertase subtilisin/kexin type 9 (PCSK9) enzyme is a novel lipid-lowering target with a potential to impact high-cardiovascular risk populations including patients with coronary artery disease (CAD), undergoing the percutaneous coronary intervention (PCI). A number of canonical and non-canonical pathways of PCSK9 action, including inflammation and platelet activation, as well as their inhibition, are undergoing intense investigation. Areas covered: This review will discuss the currently available evidence on PCSK9 inhibitors, pathways of PCSK9 enzyme action and results or its inhibition, the potential role of PCSK9 inhibitors in specific populations undergoing PCI, and completed and ongoing studies in patients with CAD. Expert commentary: PCSK9 inhibitors clinical outcomes in high risk cardiovascular disease patients and have the potential to function as powerful adjunctive therapy in patients undergoing PCI by a twofold mechanism on both lipid lowering and platelet/inflammation pathways.

Transfemoral transcatheter ACURATE-neo™ aortic valve replacement in a patient with a previous mechanical mitral valve.

Transcatheter aortic valve replacement (TAVR) in the presence of a mechanical mitral valve (MMV) prosthesis is challenging due to the stiff mitral cage in the boundaries of the aorto-mitral curtain. We describe the technique for TAVR using the ACURATE-neo™ aortic bioprosthesis in a patient with a MMV prosthesis.

Transcatheter Simultaneous Double-Transapical Access for Paravalvular Mitral Leak Closure Using the Occlutech PLD.

A 67-year-old patient with rheumatic heart valve disease had undergone two cardiac surgeries at the age of 30 years, then re-do with mitral valve replacement at 50 years. She presented with congestive heart failure and hemolytic anemia. Doppler echocardiography showed moderate-severe mitral regurgitation due to paravalvular mitral valve leak (PVML) and severe pulmonary hypertension. Transesophageal echocardiography demonstrated severe PVML secondary to a large 20 mm-long PVML defect. Due to comorbidities, the heart team deemed a third reoperation at very high surgical risk; therefore, the patient was considered most suitable for a transcatheter approach to PVML closure. Two Occlutech paravalvular leak devices were successfully delivered using a simultaneous double-transapical access with double-wire technique.

Mid-term results of the Lupiae technique in patients with De Bakey Type I acute aortic dissection.

OBJECTIVES: The late persistence of a patent and dilated false lumen into the thoracic aorta is associated to higher re-operation rates and to a worse prognosis after the surgical repair of De Bakey Type I acute aortic dissection (TIAAD). We present the mid-term results of a hybrid, two-stage technique for TIAAD aimed to reduce the risk of late expansion of the residual false lumen. METHODS: From May 2005 to January 2011, 49 patients with TIAAD were treated with the Lupiae technique. During the emergency operation, a Vascutek Lupiae™, a multi-branched Dacron prosthesis, was implanted to replace the ascending aorta, the aortic arch and to reroute the origin of the epiaortic vessels. The debranching of the aortic arch creates a long and stable Dacron landing zone on the ascending aorta suitable for further endovascular interventions. Postoperatively, 34 patients with a patent or partially thrombosed false lumen > 22 mm or a diameter of the descending aorta > 46 mm underwent the implant endovascular stentgrafts into the descending aorta. RESULTS: Three patients died after the first procedure. One patient died after the endovascular stage. No patient experienced paraplegia or stroke. The 6-year follow-up survival was 90 ± 4%. The obliteration of the false lumen was obtained in 94% of the patients. CONCLUSIONS: In patients with TIAAD, the debranching of the aortic arch with the Lupiae technique can be safely performed. This technique creates a long and stable landing zone that can be easily used for the deployment of endovascular stentgrafts in case of distal false lumen expansion.

Use of Proxis for percutaneous coronary intervention in patients with totally occluded saphenous vein grafts: an alternative approach.

Surgery is a common approach for diffuse coronary artery disease. Saphenous vein grafts are frequently used but are characterized by degeneration and high incidence of failure at 10 years. Percutaneous coronary intervention is preferred over re-operation because of age, comorbidity and the diffusion of coronary artery disease. With the saphenous vein graft occluded, percutaneous coronary intervention of native vessels and medical therapy alone are commonly suggested. We report three cases of patients with totally occluded saphenous vein grafts with suitable characteristics for treatment with Proxis, a device able to induce a proximal protection of the target vessel, minimizing the risk of distal embolization as well as the quantity of contrast required. In all patients there were no complications or cardiac enzyme elevations, and each case resulted in complete revascularization immediately postprocedure. Patients were asymptomatic at 6-month follow-up and procedural success was shown in two patients that consented to follow-up angiography. We conclude that Proxis could be a valuable tool for percutaneous coronary intervention of totally occluded saphenous vein grafts in patients who are poor candidates for percutaneous coronary intervention of native vessel; nevertheless these observations should be confirmed by a long-term follow-up controlled study.

A very rare congenital abnormality: double right coronary artery. A case report.

The incidence of coronary artery anomalies is about 0.6-1.3% in angiographic studies of the adult population. Double right coronary artery is one of the rarest abnormalities reported in the literature. We report a case of a double right coronary artery originating from a single orifice in a woman who underwent coronary angiography for a pathological transprosthetic aortic gradient.