Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe
Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe
Non-interventional, multi-center, international registry in patients with severe aortic
 stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK
 Registry aims to implement standardized, reproducible and scalable quality improvement
 measures, which will help to reduce resource requirements, intensive care unit bed occupancy
 and overall length of hospitalization with uncompromised patient safety.

 The registry will consist of the following phases:

 -  Retrospective phase (purpose: capture the status quo of each site prior to any Quality
 of Care improvement measures): The TAVI of patients being eligible for retrospective
 documentation must have been performed prior to the site's enrollment into the BENCHMARK
 prospective phase (follow-up: 30 days, 12 months).

 -  Education phase: Each center will undergo an online BENCHMARK education. The contents of
 the education will be: Reflection on treatment pathways with the TAVI team, education on
 8 defined Quality of Care improvement measures, followed by a center self-assessment (to
 self-assess the current alignment of hospital performance with the BENCHMARK Quality od
 Care measures).

 -  Implementation phase: After having self-assessed the current alignment of hospital
 performance with the following BENCHMARK Quality of care measures, each center will
 start to introduce the tailored Quality of Care improvement measures to their hospital
 routine within a time frame of 2 months.

 -  Prospective phase (purpose: to document the effects of defined quality of care
 improvement measure and to make sure patient safety is as least as good as in the
 retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)
Transcatheter aortic valve implantation (TAVI) has become standard of care in patients
 suffering from severe, symptomatic aortic stenosis, irrespective of risk. However, despite
 the advances in valve technology and implantation techniques, there is still no consensus on
 how to effectively screen, manage and discharge patients undergoing such an intervention.

 In an effort not to lose grounds because of an increasing inner-hospital competition for
 resources including intensive care unit (ICU) and general hospital beds, there is a need for
 a streamlined Quality of Care (QoC) pathway that delivers the procedure more efficient, but
 with at least the same patient safety. In this context, the recent FAST-TAVI and North
 American Multidisciplinary, Multimodality, But Minimalist (3M) studies have shown that
 optimized risk assessment and patient management results in a more effective, as least as
 safe treatment pathway and a reduced length of stay (LoS).

 The results gain importance especially in a situation where patients suffering from the
 coronavirus disease compete for hospital resources throughout Europe. Using a clear set of
 Quality of Care criteria, the BENCHMARK registry aims to document the progress that can be
 made if tailored Quality of Care improvement measures are initiated.

 The hypothesis is that the implementation of standardized, reproducible and scalable Quality
 of Care improvement measures will help reducing resource requirements, intensive care unit
 bed occupancy and overall length of hospitalization with uncompromised patient safety.

 There will be up to 30 centers participating across Europe (Germany, Austria, Italy, France,
 Spain, Czech Republic, Romania). Each center will enroll 80 patients (retrospective
 documentation of 30 patients, prospective enrollment of 50 patients), resulting in 2400
 patients in total.
Inclusion Criteria:

 Retrospective phase:

 -  Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter
 aortic valve implantation with a balloon-expandable transcatheter aortic valve prior
 to the center education on BENCHMARK QoC (Quality of Care) improvement measure (prior
 to the first education call)).

 -  Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12
 Months follow-up: hospital visit or phone call)

 -  All patients irrespective of valve type or access route will be documented in an
 electronic Case Report Form (eCRF) based patient logbook.

 Prospective phase:

 -  Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted
 for TAVI with a balloon-expandable transcatheter heart valve after center education on
 BENCHMARK Quality of Care measures and after the center has passed the implementation
 phase.

 -  All patients irrespective of valve type or access route will be documented in an eCRF
 based patient logbook.

 Exclusion Criteria:

 Retrospective phase:

 -  Patients with largely incomplete data with respect to the aims of the project.

 -  Patients without signed informed consent / data protection statement (according to
 requirements of local ethical committee).

 -  Pregnant women at the time of the TAVI.

 Prospective phase:

 -  Patients without signed informed consent prior to the TAVI procedure (data protection
 statement included; ideally covered by hospital routine to enable consecutiveness).

 -  Pregnant women at the time of the TAVI.