ABSTRACT

Conventional surgical aortic valve replacement (SAVR) is a standardized procedure with good outcomes in patients with symptomatic aortic valve stenosis (AS).1,2 Over the years, an increasing number of patients have been presenting with steadily advancing age, as well as an increasing number of comorbidities who are judged

as inoperable or at a high risk. In parallel with this demographic change, transcatheter aortic valve implantation (TAVI) techniques have been developed for minimally invasive therapy. In contrast to most new medical devices, which were initially used in low-risk patients, such as off-pump coronary revascularization, percutaneous coronary intervention, and minimally invasive mitral surgery, TAVI was rst applied in inoperable patients as

Introduction ................................................................................................................................................................. 27 Case Load Development ............................................................................................................................................. 28 TAVI Approach ........................................................................................................................................................... 30 TAVI Devices and Clinical Data ................................................................................................................................. 30

TAVI Devices with Considerable Clinical Experience ........................................................................................... 31 The CoreValve™ Revalving System .................................................................................................................. 31 Edwards SAPIEN Prosthesis .............................................................................................................................. 32 Leipzig 5-year VARC Experience of TA-TAVI with the Edwards SAPIEN Prosthesis ..................................... 33 Comparative Data ............................................................................................................................................... 34

Post-and Close-to-CE-approval TAVI Devices with Limited Clinical Experience ................................................ 37 JenaValve Aortic Valve Replacement System .................................................................................................... 37 Symetis ACURATE TA™ .................................................................................................................................. 37 Engager™ Aortic Valve Bioprosthesis ............................................................................................................... 38 SJM Portico ........................................................................................................................................................ 39

TAVI Devices with Premarket Data ........................................................................................................................ 39 The Direct Flow Medical Valve™ ...................................................................................................................... 39 Boston Scienti c Sadra Lotus™ Valve ............................................................................................................... 40 Edwards CENTERA ........................................................................................................................................... 40

Indications for TAVI.................................................................................................................................................... 40 Imaging and Navigation .............................................................................................................................................. 41

Intraoperative Imaging and Hybrid Operating Room ............................................................................................. 41 Summary ..................................................................................................................................................................... 43 References ................................................................................................................................................................... 43

an  alternative to surgical aortic valve replacement and recommended for high-risk patients only.3 Following Conformité Européenne (CE) approval in 2007, TAVI procedures have gained increasing acceptance. Subsequently, TAVI has developed in many directions, including implantation techniques, discussions about the best access for valve delivery, increasing indications, constitution of institutional and multidisciplinary Heart Valve Teams, re nement of present TAVI prostheses, and construction of new devices. As a consequence, no surgeon today can deny the value of TAVI procedures, but needs to tailor the treatment option for a particular patient presenting with symptomatic aortic valve stenosis. This, however, requires the surgeon to be familiar with all the pros and cons of each particular procedure to convince both patients and multidisciplinary team members.