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.

Anesthesiological Management in Transcatheter Mitral Valve Repair With MitraClip: Beyond the EVEREST Criteria.

Percutaneous mitral valve repair with the MitraClip system recently emerged as a viable and less invasive therapeutic option in patients with severe mitral regurgitation deemed to be high-risk surgical candidates. Mitral valve morphology and geometry features are key elements for MitraClip eligibility. In the setting of functional mitral regurgitation, the presence of a leaflet coaptation gap due to advanced left ventricle remodeling can be a potential exclusion criterion for MitraClip therapy. In this article, the authors present a case of successful MitraClip implantation in a patient with severe functional mitral regurgitation and a significant coaptation gap. Periprocedural and intraoperative pharmacological and anesthesiological management were fundamental for successful grasping and procedural success.

Increased Gradients After Aortic Valve Replacement With the Perceval Valve: The Role of Oversizing.

BACKGROUND: Significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and, possibly, early structural degeneration. We investigated the relationship between a computed tomography measure of the degree of oversizing and the early hemodynamic and clinical outcomes in patients undergoing aortic valve replacement with the Perceval sutureless aortic valve (LivaNova, Saluggia, Italy). METHODS: The degree of oversizing of the implanted prosthesis was calculated as the ratio between the patients' aortic annulus cross-sectional area and the ex vivo cross-sectional area of the implanted prosthesis in 151 Perceval patients who underwent preoperative cardiac computed tomography. This value was then entered in a multivariate analysis to ascertain its role as a predictor of increased postoperative gradient. RESULTS: The operative mortality was 1.3%. Procedural success, defined as having a normally functioning valve in the proper anatomical location, was achieved in 150 patients (99.3%). The mean transprosthetic gradient was 13.4 ± 5.0 mm Hg, and 23 patients (15.2%) showed a gradient of 20 mm Hg or more at discharge or at the 1-month follow-up. The degree of oversizing of the implanted prosthesis was the most important predictor of increased postoperative gradient (odds ratio, 1.264; 95% confidence interval, 1.147 to 1.394; p < 0.0001). Interestingly, other relevant factors (patients' body surface area, prosthesis size) were not associated with increased gradients. CONCLUSIONS: Our study demonstrates that excessive oversizing should be avoided in Perceval patients and suggests that a different sizing algorithm, possibly based on cardiac computed tomography, should be developed. Further studies are needed to optimize the sizing strategy for the Perceval sutureless valve.

[Lotus Sadra valve implantation complicated by type B aortic dissection: diagnosis and treatment]. / Impianto di Lotus Sadra complicato da dissezione aortica di tipo B: diagnosi e trattamento.

Transcatheter aortic valve implantation (TAVI) is a validated technique for the treatment of aortic valve stenosis in patients with high surgical risk or inoperable. We present the case of an 80-year-old woman with severe aortic valve stenosis (mean gradient 55 mmHg), mild surgical risk, who refused traditional surgery. We implanted a Lotus Sadra 25 mm (Boston Scientific, Marlborough, MA, USA) via the transfemoral route. During pull back delivery, the patient experienced interscapular pain with angiographic evidence of type B aortic dissection effectively treated by implanting a vascular endoprosthesis Valiant 30 x 150 mm (Medtronic Vascular, Santa Rosa, CA, USA). Type B aortic dissection is a rare event during TAVI. The onset of procedural complications, often unpredictable, suggests the need for more extensive knowledge of materials and techniques, in particular with respect to endovascular treatment of the aortic and iliac-femoral district.