Abstract
Background
Benchmark best practices have been shown to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI), but the impact in diverse health systems is unknown.
Aims
We evaluated the impact of Benchmark best practices implementation in Germany, Austria, France, Spain, and Italy.
Methods
International, multicentre registry of severe symptomatic aortic stenosis (AS) patients undergoing TAVI with a balloon-expandable valve, before and after Benchmark best practices implementation. Objectives were to reduce overall and intensive care unit (ICU) length of stay (LoS), and to document 30-day safety.
Results
A total of 890 patients were analysed in France, 454 in Spain, 362 in Germany, 300 in Italy, and 176 in Austria. Patients had the highest surgical risk in Germany (EuroSCORE II 6.8 ± 7.3%) and lowest in Spain (3.8 ± 2.6%). Austrian patients reported higher rates of prior myocardial infarction, severe pulmonary hypertension, and aortic valve-related symptoms at baseline. After the implementation of Benchmark best practices, the median hospital LoS was significantly reduced in France (5 vs. 3 days, p < 0.001), Spain (6 vs. 4, p < 0.001), Germany (9 vs. 6, p < 0.001), and Italy (7 vs. 5, p < 0.001); reductions in median ICU LoS were reported in France (1.1 vs. 0 days, p < 0.001), Spain (1.9 vs. 1, p < 0.001), and Germany (1 vs. 0.9, p = 0.004). Across all countries, 30-day safety outcomes were uncompromised and reduced rates of major vascular complications rates were observed in Germany (5.9 vs. 0.0%, p < 0.001).
Conclusion
The implementation of Benchmark best practices in diverse European healthcare systems resulted in reduced hospital and ICU LoS without compromising patient safety.
Trial registration
ClinicalTrials.gov NCT04579445, September 28th, 2020
Supplementary Information
The online version contains supplementary material available at 10.1007/s00392-025-02638-z.
Keywords: Aortic stenosis, Quality of care, Prospective registry, Transcatheter aortic valve implantation, TAVI, Clinical care
Introduction
Since the first-in-human transcatheter aortic valve implantation (TAVI) in 2002 in Europe, the procedure has been rapidly adopted outnumbering surgical aortic valve replacement (SAVR), with a predicted further sharp increase due to expanding indications and an ageing population [1, 2]. Currently, an estimated 115,000 candidates are eligible for TAVI per year in Europe alone, with the highest rates predicted in Germany (20,466 candidates), followed by Italy (15,784 candidates), France (14,632 candidates), and Spain (10,274 candidates) [3]. The European Society of Cardiology (ESC) and the European Association for Cardio‐Thoracic Surgery (EACTS) guidelines for the management of valvular heart disease provide detailed guidance on decision-making, including accurate diagnosis, risk assessment, as well as timing and indication for the most suitable type of intervention(s) [4]. However, there are currently no consensus recommendations on how to streamline the patient pathway to optimize timely access to care and mitigate the risks of in-hospital complications [5]. Given the steep increase in aortic stenosis (AS) prevalence and existing variation in regional strategies related to healthcare resources, pre-procedural planning, and patient management, there is a need for a comprehensive approach to standardize quality of care delivered to patients undergoing TAVI.
The European FAST-TAVI (Feasibility And Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation) project has previously shown that the use of pre-specified risk criteria effectively guided the timing of discharge and is associated with 1-year safety [6, 7]. In addition, the implementation of a clinical valve coordinator or TAVI nurse led to improved discharge management and increased patient satisfaction without compromising safety [8]. This initiative built on the minimalist Vancouver 3M (multidisciplinary, multimodality but minimalist) Clinical Pathway approach was introduced to standardize care and reduce hospital length of stay (LoS) [9]. The process includes risk-stratified pre- and peri-procedural practices, post-procedure care with early mobilization and reconditioning, and a criteria-driven discharge algorithm.
In this context, the objective of the BENCHMARK registry was to measure the impact of eight best practices on LoS (admission to discharge), duration of critical care, and patient satisfaction with uncompromised patient safety in diverse European countries. At 30 days, the standardized implementation of Benchmark was safe and reduced total hospital and critical care LoS [10].
Methods/design
BENCHMARK (ClinicalTrials Identifier: NCT04579445) is a multicentre, international study of patients with severe symptomatic AS undergoing TAVI at 28 centres across Europe including Austria, France, Germany, Italy, Czech Republic, Romania, and Spain [11]. For the current analysis, the Czech Republic and Romania were excluded due to low enrolment in single centres. Benchmark was conducted according to the European Medical Device Regulations, the International Organization for Standardization (ISO 14155:2020), and the Declaration of Helsinki. The registry was approved by the independent ethics review boards of participating sites and patients provided written informed consent.
Patient selection
Between January 2020 and March 2023, the BENCHMARK registry documented a total of 2388 patients. Patients were enrolled retrospectively prior to, and prospectively after the introduction of the Benchmark best practices. Key inclusion criteria were transfemoral TAVI with a balloon-expandable valve, 18 years and older, and scheduled for 30-day and 1-year follow-up visits. Patients were excluded if they were undergoing valve-in-valve procedures, were pregnant, or for whom key variables for the assessment were missing in the retrospective cohort.
Benchmark best practices
The development of eight best practices was informed by contemporary evidence and expert clinical opinions[12] and included (1) education of patient and family; (2) determination of anticipated discharge date at admission based on pre‐procedural risk stratification and scheduling of post‐procedural diagnostics; (3) echocardiographic‐ or angiographic check at the end of the procedure immediately performed to confirm vascular access closure and absence of peri-procedural complications; (4) nurse-led early mobilization protocol; (5) use of decision tree to determine the need for new pacemaker if required without increasing hospital stay; (6) criteria-based safe discharge home; (7) daily visit by implanting physician and interaction with the rest of the team; and (8) education and alignment of the internal team (medical, nursing, and paramedical). The detailed implementation process, including the education of centres and local planning, has been previously described elsewhere [11].
Study end points
The reduction in the total hospital LoS (from admission to discharge) and the duration of critical care admission (defined as ICU, cardiac/coronary care unit [CCU] or intermediate care [IMC]) were the primary end points. Secondary objectives included the assessment of procedural success and complications and patient safety at 30 days. While the overall Benchmark programme was powered to ascertain the safety of patients, the comparison of outcomes prior to and following Benchmark implementation across five countries is exploratory.
Statistical analysis
All available patient data were analysed and missing data were not imputed. Continuous variables were presented as mean ± standard deviation (SD) or median and interquartile ranges (IQR). The Kolmogorov–Smirnov test was used to test for normal distribution. Categorical variables were reported as frequencies and percentages. All analyses were performed using IBM SPSS Statistics version 29 (IBM, Armonk, New York) or R Core Team (https://www.R-project.org/).
Results
A total of 890 patients in France, 454 in Spain, 362 in Germany, 300 in Italy, and 176 in Austria were included. The implementation rates of Benchmark best practices by country are provided in Supplementary Fig. 1. Baseline patient characteristics by country prior and after the implementation of Benchmark are provided in Supplementary Table 1. The detailed results for each country are presented below.
France
Patients in France reported the lowest rates of aortic valve-related symptoms at baseline, including dizziness (6.4%), (pre-) syncope (6.0%), and Canadian Cardiovascular Society (CCS) angina class 3/4 (2.1%) (Table 1). Patients treated in France tended to have less comorbid conditions, including prior myocardial infarction (10.5%) and severe pulmonary hypertension (3.5%). Nevertheless, the aorto-ventricular mean pressure gradient (PG) was highest in the French cohort (47.2 ± 12.8 mmHg) (Table 2).
Table 1.
Patient characteristics in the total patient population by country
| Characteristic, n (%) or mean ± SD or median (IQR) | France (890 pts, 9 sites) |
Spain (454 pts, 5 sites) |
Germany (362 pts, 6 sites) |
Italy (300 pts, 4 sites) |
Austria (176 pts, 2 sites) |
p value |
|---|---|---|---|---|---|---|
| Age (years) |
80.1 ± 7.0 81.0 (76.0, 85.0) |
80.7 ± 6.4 81.0 (77.0, 85.0) |
79.6 ± 6.6 81.0 (76.0, 84.0) |
81.6 ± 4.9 82.0 (79.0, 85.0) |
80.1 ± 6.4 81.0 (77.8, 84.0) |
< 0.001 |
| Female gender | 344 (38.9) | 189 (41.6) | 133 (36.7) | 132 (45.8) | 61 (34.7) | 0.070 |
| Body mass index (kg/m2) |
27.6 ± 5.1 27.0 (24.2, 30.5) |
28.0 ± 5.3 27.4 (24.7, 30.4) |
27.1 ± 4.5 26.6 (24.1, 29.7) |
26.8 ± 4.5 26.5 (23.5, 29.1) |
27.9 ± 4.8 27.0 (24.7, 30.5) |
0.008 |
| Aortic valve-related symptoms | ||||||
| Dizziness with exertion | 56 (6.4) | 228 (50.2) | 62 (17.1) | 60 (21.5) | 112 (63.6) | < 0.001 |
| (Pre-)syncope | 52 (6.0) | 53 (11.7) | 40 (11.0) | 31 (11.1) | 28 (15.9) | < 0.001 |
| NYHA class III or IV | 443 (50.8) | 262 (57.7) | 233 (64.9) | 171 (61.3) | 107 (60.8) | < 0.001 |
| Angina CCS 3 or 4 | 19 (2.2) | 17 (3.7) | 15 (4.2) | 24 (8.6) | 21 (11.9) | < 0.001 |
| Risk scores and frailty | ||||||
| EuroSCORE II |
4.6 ± 6.5 2.4 (1.6, 5.0) |
3.8 ± 2.6 3.4 (2.0, 4.3) |
6.8 ± 7.3 4.3 (2.1, 8.1) |
6.0 ± 6.5 3.5 (2.2, 6.8) |
4.0 ± 3.8 2.8 (1.8, 4.7) |
< 0.001 |
| Frailty, severe | 11 (1.3) | 29 (6.4) | 19 (5.2) | 5 (1.8) | 4 (2.3) | < 0.001 |
| Impaired mobility | 52 (5.9) | 76 (16.7) | 100 (27.6) | 14 (5.0) | 30 (17.0) | < 0.001 |
| Cognitive deficit | 20 (2.3) | 23 (5.1) | 17 (4.7) | 10 (3.6) | 6 (3.4) | 0.070 |
| Comorbidities | ||||||
| Prior MI | 92 (10.5) | 79 (17.4) | 42 (11.6) | 37 (13.2) | 51 (29.0) | < 0.001 |
| Peripheral artery disease | 165 (18.8) | 43 (9.5) | 31 (8.6) | 57 (20.3) | 31 (17.6) | < 0.001 |
| Diabetes mellitus | 229 (26.1) | 194 (42.7) | 111 (30.7) | 75 (26.7) | 65 (36.9) | < 0.001 |
| PH, severea | 26 (3.5) | 30 (7.2) | 31 (8.8) | 17 (7.2) | 21 (15.4) | < 0.001 |
| Renal insufficiency | 225 (25.5) | 107 (23.6) | 95 (26.2) | 87 (31.0) | 51 (29.0) | 0.213 |
| Prior pacemaker | 53 (6.3) | 31 (6.8) | 27 (7.7) | 12 (4.4) | 14 (8.1) | 0.445 |
CCS Canadian Cardiovascular Society, IQR interquartile range, MI myocardial infarction, NYHA New York Heart Association, SD standard deviation, pts patients, PH pulmonary hypertension
aMean pulmonary arterial pressure > 55 mmHg
Table 2.
Electrocardiogram and echocardiography in the total patient population by country
| Characteristic, n (%) or mean ± SD or median (IQR) | France (883 pts, 9 sites) |
Spain (454 pts, 5 sites) |
Germany (362 pts, 6 sites) |
Italy (287 pts, 4 sites) |
Austria (176 pts, 2 sites) |
p value |
|---|---|---|---|---|---|---|
| Electrocardiogram | ||||||
| Rhythm | < 0.001 | |||||
| Sinus rhythm | 657 (77.8) | 325 (71.7) | 248 (70.5) | 216 (78.5) | 101 (58.4) | |
| Atrial fibrillation | 125 (14.8) | 97 (21.4) | 74 (21.0) | 44 (16.0) | 50 (28.9) | |
| Pacemaker rhythm | 53 (6.3) | 31 (6.8) | 27 (7.7) | 12 (4.4) | 14 (8.1) | |
| Other | 10 (1.2) | 0 (0.0) | 3 (0.9) | 3 (1.1) | 8 (4.6) | |
| AV block second or third degree | 4 (0.5) | 6 (1.3) | 3 (0.9) | 2 (0.7) | 1 (0.6) | 0.544 |
| Left bundle branch block | 85 (10.0) | 53 (11.7) | 42 (11.9) | 27 (9.8) | 31 (17.9) | 0.046 |
| Right bundle branch block | 116 (13.7) | 48 (10.6) | 37 (10.5) | 34 (12.4) | 14 (8.1) | 0.168 |
| Echocardiography | ||||||
| LVEF < 50% | 106 (12.5) | 53 (11.7) | 84 (24.6) | 42 (14.8) | 51 (29.0) | < 0.001 |
| AR, mod/severe | 122 (14.9) | 54 (11.9) | 56 (16.4) | 43 (15.2) | 12 (6.8) | 0.020 |
| AV mean PG (mmHg) |
47.2 ± 12.8 45.0 (41.0, 53.0) |
45.3 ± 11.8 44.5 (40.0, 51.0) |
43.1 ± 16.4 41.0 (32.3, 53.0) |
46.0 ± 13.6 44.0 (39.0, 53.0) |
42.6 ± 14.0 41.5 (34.0, 48.8) |
< 0.001 |
| AV peak PG (mmHg) |
71.6 ± 18.3 70.0 (61.0, 81.0) |
74.6 ± 18.3 73.5 (65.0, 83.0) |
69.5 ± 24.1 66.5 (54.0, 85.0) |
72.8 ± 19.2 71.0 (62.5, 82.0) |
71.3 ± 20.5 70.0 (60.0, 80.0) |
< 0.001 |
| Vmax (m/s) |
4.1 ± 0.9 4.2 (3.9, 4.5) |
4.3 ± 0.6 4.4 (4.1, 4.7) |
4.0 ± 0.8 4.0 (3.6, 4.4) |
4.2 ± 0.8 4.2 (4.0, 4.5) |
4.2 ± 0.6 4.2 (3.9, 4.4) |
< 0.001 |
| AVA (cm2) |
0.8 ± 0.4 0.8 (0.6, 0.9) |
0.8 ± 0.2 0.7 (0.6, 0.9) |
0.7 ± 0.2 0.7 (0.6, 0.9) |
0.7 ± 0.2 0.8 (0.6, 0.9) |
0.8 ± 0.2 0.7 (0.6, 0.9) |
0.002 |
| Indexed AVA (cm2/m2) |
0.4 ± 0.2 0.4 (0.4, 0.5) |
0.4 ± 0.1 0.4 (0.4, 0.5) |
0.4 ± 0.1 0.4 (0.3, 0.5) |
0.4 ± 0.1 0.4 (0.3, 0.5) |
0.4 ± 0.1 0.4 (0.3, 0.5) |
< 0.001 |
AR aortic regurgitation, AV aortic valve, AVA aortic valve area, IQR interquartile range, LVEF left ventricular ejection fraction, PG pressure gradient, SD standard deviation, pts patients
After the implementation of Benchmark, French patients received local anaesthesia (LA) with minimal sedation or anxiolytic more often and had the shortest intervention time (median [interquartile range (IQR)] 55.0 [45.0, 70.5]), but had the highest rates of perioperative permanent pacemaker implantations (8.4%) compared to other countries (Table 3). There was a significant reduction in the hospital LoS in France after the implementation of Benchmark (from median 5.0 to 3.0 days, 40.0% decrease; p < 0.001) (Fig. 1A). At baseline, LoS in critical care was one of the highest in France (median 1.1 days) compared to other countries. After Benchmark implementation, France reported the highest reduction in the ICU/CCU/IMC LoS (from median 1.2 to 0 days (mean 2.1 to 1.1 days); p < 0.001) (Fig. 1B). Overall, the rates of complications at 30 days were low in France and remained unchanged before or after implementation of Benchmark (Table 4).
Table 3.
Procedural details and outcomes post-Benchmark implementation by country
| Characteristic, n (%) or mean ± SD or median (IQR) | France (568 pts, 9 sites) |
Spain (248 pts, 5 sites) |
Germany (235 pts, 6 sites) |
Italy (202 pts, 4 sites) |
Austria (109 pts, 2 sites) |
p value |
|---|---|---|---|---|---|---|
| Local anaesthesia (LA) ± conscious sedation | 544 (96.8) | 224 (90.3) | 231 (98.3) | 177 (96.7) | 104 (95.4) | < 0.001 |
| LA w/o sedation/anxiolytic | 76 (13.6) | 2 (0.8) | 41 (17.4) | 18 (9.9) | 0 (0.0) | |
| LA + minimal sedation/anxiolytic | 292 (52.1) | 98 (39.7) | 94 (40.0) | 87 (47.8) | 1 (0.9) | |
| LA + moderate sedation | 173 (30.9) | 25 (10.1) | 84 (35.7) | 67 (36.8) | 103 (94.5) | |
| Deep sedation | 1 (0.2) | 98 (39.7) | 12 (5.1) | 4 (2.2) | 0 (0.0) | |
| Procedural information | ||||||
| Total procedure time |
46.2 ± 23.2 40.0 (30.0, 55.0) |
73.0 ± 31.1 70.0 (50.0, 85.0) |
46.4 ± 22.1 40.0 (32.0, 55.0) |
87.4 ± 38.1 77.5 (60.0, 100.0) |
41.5 ± 23.7 37.0 (24.0, 48.8) |
< 0.001 |
| Intervention time |
63.9 ± 31.5 55.0 (45.0, 70.5) |
106.3 ± 40.6 100.0 (80.0, 125.0) |
88.7 ± 30.0 90.0 (65.0, 106.0) |
111.6 ± 36.3 105.0 (90.0, 130.0) |
80.4 ± 35.7 80.0 (46.0, 110.0) |
< 0.001 |
| Procedural success | 546 (98.6) | 247 (100.0) | 229 (97.4) | 180 (100.0) | 109 (100.0) | 0.017 |
| Complications | ||||||
| Second valve needed | 4 (0.7) | 0 (0.0) | 2 (0.9) | 0 (0.0) | 0 (0.0) | 0.528 |
| Permanent pacemaker implantation | 47 (8.4) | 14 (5.6) | 7 (3.0) | 7 (3.8) | 1 (0.9) | 0.002 |
| Conversion to conventional surgery | 3 (0.5) | 0 (0.0) | 2 (0.9) | 0 (0.0) | 0 (0.0) | 0.657 |
| Bleedinga | 9 (1.6) | 15 (6.1) | 1 (0.4) | 3 (1.8) | 1 (0.9) | 0.002 |
IQR interquartile range, LA local anaesthesia, SD standard deviation, pts patients
aMajor bleeding (BARC type 3a) defined as overt bleeding either associated with a drop in the haemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding
Fig. 1.
Hospital LoS (A) and intensive care LoS (B) prior to and post-Benchmark best practices implementation. Legend: CCU critical care unit, ICU intensive care unit, IMC intermediate care, LoS length of stay
Table 4.
30-day outcomes prior and post-Benchmark implementation by country
| Outcome, n (%) | France (prior n = 322, post n = 568) |
p value | Spain (prior n = 206, post n = 248) |
p value | Germany (prior n = 127, post n = 235) |
p value | Italy (prior n = 98, post n = 202) |
p value | Austria (prior n = 67, post n = 109) |
p value | p valuea | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Combined end pointb | Prior | 3 (1.1) | 0.560 | 5 (2.4) | 0.326 | 2 (1.7) | 1.000 | 2 (2.2) | 0.683 | 2 (3.4) | 0.126 | |
| Post | 10 (1.9) | 10 (4.1) | 5 (2.4) | 4 (4.3) | 0 (0.0) | 0.094 | ||||||
| All-cause mortality | Prior | 0 (0.0) | 0.305 | 1 (0.5) | 1.000 | 0 (0.0) | 0.531 | 1 (1.1) | 0.492 | 0 (0.0) | – | |
| Post | 4 (0.8) | 1 (0.4) | 2 (1.0) | 0 (0.0) | 0 (0.0) | 0.913 | ||||||
| Stroke/TIA | Prior | 2 (0.8) | 1.000 | 3 (1.5) | 0.518 | 2 (1.7) | 1.000 | 2 (2.2) | 0.683 | 1 (1.7) | 0.358 | |
| Post | 5 (1.0) | 6 (2.5) | 3 (1.4) | 4 (4.2) | 0 (0.0) | 0.074 | ||||||
| Life-threatening bleeding | Prior | 2 (0.8) | 0.606 | 5 (2.4) | 0.439 | 1 (0.9) | 1.000 | 2 (2.2) | 1.000 | 1 (1.7) | 1.000 | |
| Post | 2 (0.4) | 9 (3.7) | 1 (0.5) | 3 (3.2) | 1 (0.9) | 0.002 | ||||||
| AKI (stage 2/3, incl. dialysis) | Prior | 0 (0.0) | – | 4 (2.0) | 1.000 | 0 (0.0) | – | 0 (0.0) | 0.497 | 0 (0.0) | 0.538 | |
| Post | 0 (0.0) | 4 (1.7) | 0 (0.0) | 2 (2.2) | 2 (1.9) | 0.002 | ||||||
| Coronary obstruction requiring intervention | Prior | 1 (0.4) | 0.337 | 1 (0.5) | 1.000 | 3 (2.6) | 0.671 | 0 (0.0) | 1.000 | 0 (0.0) | – | |
| Post | 0 (0.0) | 1 (0.4) | 3 (1.5) | 1 (1.1) | 0 (0.0) | 0.033 | ||||||
| Major vascular complications | Prior | 6 (2.3) | 0.603 | 9 (4.4) | 0.937 | 7 (5.9) | < 0.001 | 6 (6.7) | 0.528 | 4 (6.8) | 0.056 | |
| Post | 9 (1.7) | 11 (4.5) | 0 (0.0) | 4 (4.3) | 1 (0.9) | 0.004 | ||||||
| Re-hospitalization (all-cause) | Prior | 8 (3.0) | 0.746 | 9 (3.7) | 0.650 | 2 (1.7) | 0.716 | 0 (0.0) | 1.000 | 2 (3.4) | 0.618 | |
| Post | 18 (3.5) | 6 (2.9) | 6 (2.9) | 0 (0.0) | 2 (1.9) | 0.393 |
Bold formatting indicates statistical significance
AKI acute kidney injury, TIA transitory ischaemic attack, pts patients
aCross-country comparison post-Benchmark implementation (Chi-squared or Fisher’s exact test)
bIncludes all-cause mortality, stroke/TIA, and valve-related re-hospitalization[27]
Spain
The highest body mass index (BMI, 28.0 ± 5.3 kg/m2) and rate of diabetes mellitus (42.7%) were reported in Spain (Table 1). Nevertheless, the Spanish cohort had the lowest reported surgical risk (EuroSCORE II 3.8 ± 2.6%). Echocardiographic data reported that patients treated in Spain had the highest mean aorto-ventricular peak PG (74.6 ± 18.3 mmHg) and AV maximal velocity (Vmax, 4.3 ± 0.6 m/s) (Table 2).
Peri-procedural deep sedation was routinely used for many patients in Spain (39.7%), in contrast to other countries, where more than 90% of patients received local anaesthesia with or without conscious sedation; vascular injury rates were also comparatively higher in Spain (6.1%) (Table 3). Spain also documented one of the longest procedure (median [IQR] 70.0 [50.0, 85.0 min]) and intervention (median [IQR] 100.0 [80.0, 125.0] min) times. The hospital LoS was significantly reduced in Spain following Benchmark (from median 6 to 4 days, 33.0% decrease; p < 0.001) (Fig. 1A). Similar to France, Spain initially reported the longest stay in critical care, which significantly decreased after the introduction of Benchmark (from median 1.9 to 1 day, 47.4% decrease; p < 0.001) (Fig. 1B). At 30 days, the rates of clinical events did not significantly change after the implementation of Benchmark (Table 4).
Germany
Patients in Germany were characterized by a highly symptomatic presentation (NYHA class III/IV 64.9%), impaired mobility (27.6%), and the highest surgical risk (EuroSCORE II 6.8 ± 7.3%) at baseline (Table 1). The incidence of reduced left ventricular ejection fraction (LVEF < 50%) was high in the German cohort (24.6%) compared to France (12.5%), Spain (11.7%), and Italy (14.8%) (Table 2). Patients received LA without sedation or anxiolytic more often (17.7%) and had the lowest rate of intraprocedural bleeding complications (0.4%) (Table 3). Germany reported the longest hospital LoS prior to Benchmark and achieved the largest decrease after the implementation of Benchmark (from median 9.0 to 6.0 days, 33.0% decrease; p < 0.001), while critical care LoS was also significantly reduced (from median 1 to 0.9 days, 10.0% decrease; p = 0.004) (Fig. 1A and B). Furthermore, the implementation of Benchmark resulted in lower rates of major vascular complications at 30 days (5.9 vs 0.0%, p < 0.001) (Table 4).
Italy
Italian patients had a high surgical risk (EuroSCORE II 6.0 ± 6.5%) and presented with higher rates of cardiac symptoms (NYHA class III/IV: 21.5%) and peripheral arterial disease (20.3%) compared to other cohorts. In contrast, their rate of impaired mobility was lowest (5.0%) (Table 1). Italian patients had the longest procedure (median [IQR] 77.5 [60.0, 100.0] min) and intervention times (median [IQR] 105 [90.0, 130.0] min) (Table 3). In Italy, there was a significant reduction in the median hospital LoS after the implementation of Benchmark (7 to 5 days, 29.0% decrease; p < 0.001), although the LoS in ICU/CCU/IMC did not change significantly (median 1.1 vs. 1 day, 9.0% decrease; p = 0.128) (Fig. 1A and B). The rates of 30-day events were unchanged following the implementation of Benchmark (Table 4).
Austria
Patients in Austria reported the highest rates of dizziness with exertion (65.6%), (pre-)syncope (15.9%), and CCS angina class 3/4 (11.9%), and had the highest burden of prior myocardial infarction (29.0%, p < 0.001) and pulmonary hypertension (15.4%) (Table 1). Furthermore, patients in Austria had the highest rates of atrial fibrillation (28.9%), left bundle branch block (LBBB 17.9%) and LVEF < 50% (29.0%); overall, patients treated in Austria had lower surgical risk profiles than their European counterparts (EuroSCORE II 4.0 ± 3.8) (Table 2). Almost all patients (99.0%) received LA with moderate sedation; total procedure time was comparatively short (median [IQR] 37.0 [24.0, 48.8] minutes) (Table 3). Unlike in other countries, the implementation of Benchmark did not result in the reduction of either hospital LoS (median 7 vs 7 days, p = 0.809) or critical care LoS (0.2–0.7 days, p = 0.603) (Fig. 1A and B). The rate of major vascular complications was lower after the implementation of Benchmark (0.9% vs. 6.8%), although the difference did not reach statistical significance (p = 0.056) (Table 4).
Discussion
The current analysis demonstrates that the implementation of Benchmark best practices resulted in reduced LoS while maintaining patient safety in different European countries despite differences in healthcare systems and patients’ baseline characteristics. The adoption of an evidence-based and expert-informed streamlined hospital pathway for TAVI patients supported with a peer mentorship programme can increase access to care, hospital capacity and efficiency in treating patients with severe AS in most European countries while optimizing outcomes.
Prior to the implementation of Benchmark, Germany reported the longest hospital LoS compared to other countries. The close scrutiny of processes of care and the implementation of bundle of best practices was instrumental in achieving a 33% decrease, the highest improvement among all reported countries. The mean hospital LoS in Germany prior to Benchmark was 11.7 days, which is comparable to the average TAVI hospital LoS reported in Germany between 2020 (11.5 days) and 2022 (11.1 days) [13]. Similarly, in Italy, the median hospital LoS prior to Benchmark in our report was 7 days, which corresponds to the results of the multicentre Italian OBSERVANT TAVI registry (median 7 days) [14]. After the implementation of Benchmark in the participating Italian centres, the median hospital LoS was significantly reduced by 2 days, resulting in a median of 5 days. As for the intensive care LoS, there was no reduction documented in Italy, which may be explained by the fact that the intensive care stay prior to Benchmark was already low compared to the intensive care duration reported in the OBSERVANT registry (median 1 vs. 2 days). In France, on the other hand, the highest reduction in the intensive care LoS was observed – from median 1.1 days prior to Benchmark to close to 0 days after Benchmark, meaning that the majority of patients did not stay on an intensified care unit at all after TAVI. The total hospital LoS was also reduced from median 5 to 3 days. The recent analysis of the FRANCE 2 and FRANCE-TAVI registries as well as the single-payer national health data system (SNDS) reported a median LoS of 5 days in the period between 2010 and 2021, which corresponds to the number observed in our registry prior to the implementation of Benchmark best practices [15]. In Spain, a significant decrease in the total hospital LoS (median 6 to 4 days) and intensive care LoS (median 1.7 to 1 day) was observed as well. The median hospital LoS reported in the Spanish TAVI registry was 6 days, which, once again, corresponds with the duration of hospital admission recorded in our registry prior to the introduction of Benchmark best practices [16]. Thus, patients in this registry documented prior to the implementation of Benchmark had a hospital LoS similar to multiple other registries, which accurately reflects real world practice and indicates the effectiveness of Benchmark best practices in reducing hospital LoS in these patient populations.
The reduction in the total hospital LoS was observed in all considered countries, except for Austria, where neither the length of hospital stay nor intensive care stay were reduced. Notably, Austrian patients tended to have a sicker profile at baseline compared to other countries. These patients tended to be more symptomatic and having prior myocardial infarction, pulmonary hypertension, atrial fibrillation, LBBB, and LVEF < 50% more often. Interestingly, this finding is not reflected in the EuroSCORE II, which appeared to be on lower side of the spectrum (4.0 ± 3.8). However, the characteristics of the current Austrian population are different when comparing these patients to those included in the nationwide Austrian TAVI registry as well as the recent AUTHEARTVISIT study [17, 18]. The reason for this inconsistency may be the fact that the Austrian TAVI registry included patient data from 11 centres for interventional cardiology representing 100% of Austrian institutions offering TAVI by vascular access sites, whereas the AUTHEARTVISIT study included patient data from the Austrian Insurance funds from 2010 through 2020, making the profile of the Austrian patient population reported in the current analysis less representative.
Besides the decrease in hospital LoS, one major goal of the Benchmark implementation was to preserve safety after TAVI. In our report, the 30-day safety was uncompromised in all countries included, which reinforces the results published for the total BENCHMARK population [10]. Moreover, there was no increase in the rate of hospital readmission documented after the implementation of Benchmark best practices, despite earlier discharge. There was also a significant reduction in the rates of major vascular complications in Germany after the implementation of Benchmark best practices (5.9% vs. 0.0%). The rates of all-cause mortality were quite low across all countries (< 1.0%) before and also with the implementation of Benchmark best practices compared to the previously reported rates in other registries. For instance, the 30-day mortality in the combined analysis of French TAVI registries was 4.0% compared to 0.0% and 0.8% prior to and after Benchmark implementation, respectively [15]. Similarly, the Italian OBSERVANT registry reported the rates of 30-day mortality to be 6.7% in males and 5.1% in females as opposed to 1.1% prior to and 0.0% after Benchmark in our registry [14]. Same differences are observed when comparing the 30-day mortality rates from the Spanish, German, and Austrian TAVI registries with the rates presented here [16, 18, 19]. Lower mortality rates in our patient population may be partially attributed to the lower risk profile of TAVI patients, better device technology with the use of new generation valves as well as increased operator experience.
Streamlining care by shortening hospital LoS offers a number of benefits, including minimizing hospital costs and resources related to unnecessary hospitalization time and the positive outcomes of early mobilization. Furthermore, the risk of in hospital-acquired infections and hospital readmission at 30 days is also reduced when patients are discharged earlier after TAVI [20, 21]. Based on our findings and other reports, the main drivers of accelerated recovery and shortened hospital LoS include various preventive measures, such as determination of an anticipated discharge based on pre-procedural risk stratification, the use of cardiac catheterization laboratory and local anaesthesia with or without light procedural sedation, removal of the temporary pacemaker at the end of the procedure, post-procedure echo- or angiographic check to confirm proper closing of access site, and the reduced use of critical care facilities [9, 22, 23]. In addition, patient and family engagement to facilitate shared decision-making plays a crucial role in early discharge. It is important to note, however, that several factors, such as cultural norms and the challenges of change management, should be considered for the wider adoption of Benchmark best practices across various countries. For example, local reimbursement issues related to the fixed minimum hospital stay duration, lack of resources, or certain attitudes and ideologies may result in stronger resistance to change. However, the use of contemporary evidence, peer-to-peer coaching and strong focus on quality improvement and access to care demonstrated in the BENCHMARK registry may serve as facilitators to the broader implementation of a streamlined patient pathway.
From the economical perspective, TAVI itself has become a superior approach in terms of lower costs and better outcomes compared with surgery and the shorted hospital LoS adds an additional economic benefit to that. In the propensity-matched economic analysis of the 3M-TAVR registry, the minimalist clinical pathway led to ≈$11,000 lower cumulative costs at 30 days, of which > $8000 were saved in non-procedure related costs during the index hospitalization, driven primarily by shorter LoS [24]. A shorter hospital stay also allows additional hospital revenue by freeing up hospital beds for other patients [24]. While LoS is the major contributor to TAVI costs, the avoidance of general anaesthesia, resulting in shorter procedure times, and minimal use of critical care services result in further savings [25, 26]. The planned economic analysis of the BENCHMARK registry will further assess potential costs savings associated with the implementation of best practices across different healthcare systems.
Limitations
Although the present analysis successfully demonstrated the effectiveness of implementing Benchmark best practices across different European countries, it comes with limitations: This international, multicentre registry is purely observational, with the inherent limitations and potential bias on data collection, such as a higher potential for missing data. However, the observational design carries several advantages, including the assessment of TAVI patients in a real-world setting (high external validity), avoiding the existing issue of the strict inclusion and exclusion criteria used for randomized research (high internal, but less external validity). In addition, while the international nature of this study is highly advantageous and increases the applicability of our findings to other European countries, differences in the healthcare systems in each country (e.g., financial aspects, standard procedural and post-TAVI protocols, etc.) need to be considered when interpreting the findings. This was the reason for the present analysis. Lastly, the clinical outcomes were not independently adjudicated, which may have introduced a certain level of bias.
Conclusion
The findings from the present analysis highlight that the implementation of Benchmark best practices in different European healthcare systems is equally effective in streamlining TAVI patient pathways by reducing hospital LoS without compromising on patient safety. Thus, the benefits of Benchmark best practices seem to extend beyond national borders, country peculiarities and patient profiles, primarily improving patients’ TAVI pathway. However, the breakdown of TAVI-specific parameters by country before and after implementation of Benchmark best practices enables to broaden its scope to more countries and centres. As a results, country specific measures are currently being developed to enable a further optimization and refinement of the TAVI pathway.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgements
We thank Marie Zielinski, Daniel Greinert, Cornelia Deutsch, and Nataliya Trushina from IPPMed, Cloppenburg, for sponsor representation, excellent project management, and support with statistics. Lastly, we thank all the nursing and study coordinators from each participating centre for their immense support and active contribution to facilitating this study: Carlos Lara García, Beatriz Chamorro (Malaga, Spain); Jean-Philippe Claudel, Hervé Perrier, Viktoria Frebault (Lyon, France); Catalina Andreea Parasca (Bucharest, Romania); Katia Lassouani (Tours, France); Wassim Zitouni, Sonia Soltani (Montpellier, France); Rosalie Le Gal (Rennes, France); Elena Jimenez Xarrie (Barcelona, Spain); Niccolo Ciardetti, Francesco Meucci (Florence, Italy); Imane Bagdadi (Paris, France); Petr Raška (Prague, Czech Republic); Georg Delle-Karth, Claudia Schuster, Marie-Christine Leitgeb (Vienna, Austria); Esther Bernardo García, María Aránzazu Ortega Pozzi (Madrid, Spain); Jürgen Leick, Michael Lauterbach, Hannah Waschbüsch (Trier, Germany); Guillem Muntané (Barcelona, Spain); Olga Daxböck, Mirela Butkovic, Simona Popescu (St. Pölten, Austria); Martina Perrero (Turin, Italy); Stephanie Watbled (Besancon, France); Maxence Delomez (Lille, France); Bruno Scheller, Sebastian Ewen, Ann-Kathrin Berger, Christina Koch, Alexandra Engel (Homburg, Germany); Paolo Olivares (Milan, Italy); Frieder Wolf, Carolin Müller, Maren Hünermund (Göttingen, Germany); Mathias Konstandin, Lisa Linz, Hannah Ulbricht (Heidelberg, Germany); Sabrina Siame (Marseille, France); Nassima Ait Amrane (Pitie Salpetriere, Paris, France); Dow Rosenzweig (Munich, Germany); Barbara Cefalo (Avellino, Italy); Vera Wolf (Cologne, Germany); Jaume Maristany Daunert, Maria Carmen de la Bandera Sanchez (Mallorca, Spain).
Author contributions
Conception and design: Francesco Saia, Sandra Lauck, Eric Durand, Douglas Muir, Mark Spence, Mariuca Vasa-Nicotera, David Wood, Gemma McCalmont, Radka Rakova, Wilbert Wesselink, Jana Kurucova, Claudia M. Lüske, Peter Bramlage, Derk Frank. Acquisition, analysis, or interpretation of data for the work: Cristóbal A. Urbano-Carrillo, Damien Bouchayer, Vlad Anton Iliescu, Christophe Saint Etienne, Florence Leclercq, Vincent Auffret, Lluis Asmarats, Carlo Di Mario, Aurelie Veugeois, Jiri Maly, Andreas Schober, Luis Nombela-Franco, Nikos Werner, Joan Antoni Gómez-Hospital, Julia Mascherbauer, Guiseppe Musumeci, Nicolas Meneveau, Thibaud Meurice, Felix Mahfoud, Federico De Marco, Tim Seidler, Florian Leuschner, Patrick Joly, Jean Philippe Collet, Ferdinand Vogt, Emilio Di Lorenzo, Elmar Kuhn, Vincent Peral Disdier, Violetta Hachaturyan. Writing the first draft: Francesco Saia, Sandra Lauck, Eric Durand, Douglas Muir, Mark Spence, Mariuca Vasa-Nicotera, David Wood, Gemma McCalmont, Violetta Hachaturyan, Peter Bramlage, Derk Frank. Revising the article for important intellectual content: Cristóbal A. Urbano-Carrillo, Damien Bouchayer, Vlad Anton Iliescu, Christophe Saint Etienne, Florence Leclercq, Vincent Auffret, Lluis Asmarats, Carlo Di Mario, Aurelie Veugeois, Jiri Maly, Andreas Schober, Luis Nombela-Franco, Nikos Werner, Joan Antoni Gómez-Hospital, Julia Mascherbauer, Giuseppe Musumeci, Nicolas Meneveau, Thibaud Meurice, Felix Mahfoud, Federico De Marco, Tim Seidler, Florian Leuschner, Patrick Joly, Jean Philippe Collet, Ferdinand Vogt, Emilio Di Lorenzo, Elmar Kuhn, Vicente Peral Disdier, Radka Rakova, Wilbert Wesselink, Jana Kurucova, Violetta Hachaturyan, Claudia M. Lüske. Approving the article for submission: Francesco Saia, Sandra Lauck, Eric Durand, Douglas Muir, Mark Spence, Mariuca Vasa-Nicotera, David Wood, Cristóbal A. Urbano-Carrillo, Damien Bouchayer, Vlad Anton Iliescu, Christophe Saint Etienne, Florence Leclercq, Vincent Auffret, Lluis Asmarats, Carlo Di Mario, Aurelie Veugeois, Jiri Maly, Andreas Schober, Luis Nombela-Franco, Nikos Werner, Joan Antoni Gómez-Hospital, Julia Mascherbauer, Giuseppe Musumeci, Nicolas Meneveau, Thibaud Meurice, Felix Mahfoud, Federico De Marco, Tim Seidler, Florian Leuschner, Patrick Joly, Jean Philippe Collet, Ferdinand Vogt, Emilio Di Lorenzo, Elmar Kuhn, Vicente Peral Disdier, Gemma McCalmont, Radka Rakova, Wilbert Wesselink, Jana Kurucova, Violetta Hachaturyan, Claudia M. Lüske, Peter Bramlage, Derk Frank.
Funding
Open Access funding enabled and organized by Projekt DEAL. The study was funded by Edwards Lifesciences and performed under the sponsorship of IPPMed—Institute for Pharmacology and Preventive Medicine GmbH, Cloppenburg, Germany.
Data availability
Available from the corresponding author upon reasonable request.
Declarations
Conflict of interest
FS received payment for lectures/presentations from Edwards Lifesciences, Medtronic, and Abbott and is on the Data Safety Monitoring Board/Advisory Board of Edwards Lifesciences. SL received consulting fees and support for attending meetings from Edwards Lifesciences and Medtronic. ED received consulting fees from Edwards Lifesciences. DFM received support for the present manuscript, consulting fees, payment for lectures/presentations, and support for attending meetings from Edwards Lifesciences. DF received consulting fees from Edwards Lifesciences. CAUC received consulting fees from Edwards Lifesciences, payment for lectures/presentations from Medtronic and Biotronik, and is on the Data Safety Monitoring Board/Advisory Board of Medtronik. CSE received consulting fees from Medtronic, Edwards Lifesciences, and Abbott. VA received consulting fees from Boston Scientific and payment for lectures/presentations from Edwards Lifesciences, Medtronic, and Abbott. LA received speaker feeds from Edwards Lifesciences. JM received grants, consulting fees, and payment/honoraria for lectures/presentations from Edwards Lifesciences, payment for lectures/presentations from St. Jude Medical Coordination Center BVBA (Abbott), and stock on Leviticus Cardio Ltd. AS received grant from Edwards Lifesciences. LNF received consulting fees from Edwards Lifesciences and Abbott Vascular. NW received grant from Shockwave Medical and Abiomed, support for attending meetings from Edwards Lifesciences, Medtronic, and Boston, and is on the Data Safety Monitoring Board/Advisory Board of the Cingular Study. JM (Julia Mascherbauer) received grants and support for attending meetings from Boston Scientific, Medtronic, Edwards Lifesciences, grant from Abbott, payment for lectures/presentations from Edwards Lifesciences and AOP, is on Data Safety Monitoring Board/Advisory Board of Amgen, and is ESC Nominating Committee Member 2022–2024. GMC received honoraria for consultancy for the present manuscript, educational grant, consulting fees, and payment for lectures/presentations from Edwards Lifesciences and is now an employee of Edwards Lifesciences. JK, WW, and RR are employees of Edwards Lifesciences. PB is representing the sponsor IPPMed who received funding from Edwards Lifesciences for performing the study. VH and CL are employees of IPPMed. DF received support for the present manuscript, payment for lectures/presentations, and support for attending meetings from Edwards Lifesciences. All other authors represent centres who received compensation from Edwards Lifesciences for the documentation of patients.
Ethical approval and informed consent
The registry was approved by the independent ethics review boards at each participating site and all patients provided written informed consent.
Footnotes
Jean Philippe Collet deceased on December 15th, 2023.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Available from the corresponding author upon reasonable request.