Edwards sapien xt

TAVI procedures were performed in “Ospedale Maggiore” of Parma or in “Hesperia Hospital” of Modena by experienced interventional cardiologists and cardiac surgeons, either by the percutaneous transfemoral, and rarely by transapical approach or surgical subclavian access. The main implanted THVs were Edwards SAPIEN-XT or S3 (Edwards Lifesciences, Irvine, CA), Medtronic CoreValve, Evolut R or EvolutPro (Medtronic Inc., Minneapolis, MN), Portico transcatheter heart valve (Abbott Structural Heart, St Paul, MN, USA) and Myval system (Meril Life Sciences Pvt Ltd., Vapi, India). The choice of THV was based upon the anatomical features of the native valve morphology and only after a careful study of the vascular accesses, analyzed by computerized angiotomography.

The self-expanding, percutaneous CoreValve (Medtronic, Minneapolis, USA)
prosthesis, the Acurate (Symetis SA, Lausanne, Switzerland) prosthesis, or the
balloon-expandable Edwards Sapien-XT (Edwards Lifesciences, Irvine, EUA) valve
prosthesis were used, at the interventional cardiologist’s discretion.
Most procedures were performed under general anesthesia and with transesophageal
echocardiography. Transfemoral vascular access was indicated in all patients who
had a favorable vascular access. Arterial hemostasis was performed using a
specific device, mediated by the Perclose ProGlide® Suture-Mediated
Closure System (Abbott Vascular™, Santa Clara, USA) or surgical access.
When transfemoral access was not possible, the transapical, transaortic or the
subclavian accesses were used as alternatives. Both predilatation and
postdilatation were performed at the intervention team’s discretion. Whenever
possible, patients were extubated in the operating room and kept in observation
in the intensive care unit during 24-48 hours. Hospital discharge occurred
according to patient’s clinical progress after TAVI. Hemodynamic data were
obtained during the TAVI procedure and by echocardiography before hospital
discharge.

All patients received antibiotic prophylaxis with cefazolin 2 g prior to the
intervention. Acetylsalicylic acid (ASA) 200 mg and clopidogrel 300 mg were
administered on the day before the procedure, except when contraindicated in the
cases of low platelet count < 80 x 10³ /mm³ or other
comorbidities. The procedures were performed in the hemodynamics laboratory or
in the hybrid room, under sedation or general anesthesia, and transesophageal
echocardiography (TEE) monitoring. Temporary transvenous pacemakers were
implanted to help in balloon valvuloplasty and/or prosthesis implantation, by
means of induction of tachycardia, and were kept on the on-demand mode for 48
hours. The choice of of whether or not to pre-dilate the valve was left to the
surgeon's discretion. The prostheses used were the self-expanding
CoreValve^® (Medtronic, Minneapolis, MN) and the
balloon-expanding Edwards-SAPIEN XT^® (Edwards Lifesciences,
Irvine, CA). After TAVI, the patients were sent to the intensive care unit and
underwent daily laboratory assessments in the first 7 days.

We chose the transfemoral approach as the first option when patients did not have an excessively narrow access route for insertion of the sheath or aortic arch atheroma. We performed TAVI under general anaesthesia in a hybrid operating room, except for two patients who underwent conscious sedation due to pulmonary dysfunction. Transcatheter heart valves were classified as balloon-expandable (Edwards Sapien XT or Sapien 3 Transcatheter Heart Valve; Edwards Lifesciences, Irvine, California, USA) or self-expandable (Medtronic classic CoreValve or CoreValve EvolutR; Medtronic, Minneapolis, Minnesota, USA). Balloon-expandable valves were the first choice, and self-expandable valves were reserved for patients with a narrow aortic annulus. We performed simultaneous catheter measurement to evaluate the invasive mAVPG as well as a measurement of left ventricular end-diastolic pressure before and after TAVI. After successful TAVI, patients were given a saline solution by intravenous infusion (1 mL/kg/hour) until the start of ingestion. The brachial blood pressure was maintained at less than 130 mm Hg using calcium channel blocker, if necessary.

This is a prospective, multicentre, non-randomised and observational study comparing the incidence of neurological injury associated with TAVI of the Edwards SAPIEN-XT (Edwards LifeSciences Irvine, CA, USA) under general anaesthetic versus bioprosthetic SAVR. Ethics approval has been obtained from the Human Research Ethics Committee of the Prince Charles Hospital, Brisbane, Australia (HREC/12/QPCH/291) and informed consent will be obtained from all participants prior to enrolment.
Regularly held 'Heart Team’ meetings - comprising of multiple disciplines including echocardiologists, interventional cardiologists, nurses and cardiothoracic surgeons – will assess high-risk patients with severe AS. Here, patients will be allocated to the intervention clinically indicated. Pending informed consent, such patients will be consecutively recruited into the SANITY study, resulting in cohort grouping as outlined in Figure 2.