Transcatheter Aortic Valve Implantation: Selection, Early Mortality, and Complications

A multicenter evaluation of more than 33 000 implantations (2013–2023)

Background: Transcatheter aortic valve implantation (TAVI) has become the standard treatment of persons aged 75 and above with severe aortic valvular stenosis. In this study, we analyzed temporal trends in risk profiles and treatment results from 2013 to 2023.

Methods: We carried out a retrospective analysis of patient characteristics, periprocedural complications, and 30-day mortality after 33 079 TAVI procedures that were carried out in seven German cardiac care centers.

Results: TAVI case numbers rose from 1605 in 2013 to 4459 in 2023. The mean age of the patients remained constant at 81 years, while the operative risk (STS score) fell from 5.9% to 4.1%. The percentage of low-risk patients (STS < 4%) rose from 47% to 66%. From 2013 to 2023, there was a steady decline in periprocedural complications including severe bleeding of VARC types 3 and 4 (8.5% to 2.9%), vascular complications (17.2% to 4.9%), stroke (4.2% to 2.1%), and pacemaker implantations (15.5% to 11.4%). Over the same period, the risk-adjusted 30-day mortality fell from 3.8% to 3.2%.

Conclusion: The improved short-term results of TAVI from 2013 to 2023 are attributable to a change in patients’ risk profiles as well as the increasing experience of the interventionists and refinements of the procedure. The mortality rate, which has remained unchanged in recent years, indicates that the care of older patients with severe aortic stenosis has been largely optimized.

Cite this as: Wrobel JM, Abdel-Wahab M, Shamekhi J, Voran JC, Frank D, Hannen L, Adam M, Kim WK, Wienemann H, Guthoff H, Finke K, Schröder J, Nickenig G, Schofer N, Baldus S, Rudolph TK, Mauri V: Transcatheter aortic valve implantation: Selection, early mortality, and complications. A multicenter evaluation of more than 33 000 implantations (2013–2023). Dtsch Arztebl Int 2026; 123: 35–9. DOI: 10.3238/arztebl.m2025.0210

Transcatheter aortic valve implantation (TAVI) has become established in recent years as the standard treatment for isolated aortic valve stenosis in patients aged 75 and above, in all surgical risk categories (1). More TAVI procedures are carried out in Germany than in any other country in Europe (2). Calcific aortic valve stenosisa typical age-related disease and the main cause of valve-specific morbidity and mortality (3, 4).

According to the German Heart Report 2024, the age-standardized mortality from cardiac valvular disease rose by 11.3% from 2013 to 2022 (from 18.3 to 20.3 deaths per 100 000 persons), possibly because of the increasing prevalence of severe valve defects, changes in care, or insufficient use of interventional treatment in certain patient groups (5). The importance of TAVI is underscored by the fact that severe aortic valve stenosis, if untreated, carries a mortality of nearly 50% within four years (6). TAVI was originally reserved for older patients with a high surgical risk. In the PARTNER-2 and SURTAVI trials, patients in the intermediate surgical risk category had comparable mortality at two years after being treated either with TAVI (16.7% and 12.6% in the two trials) or with surgical aortic valve replacement (sAVR) (18.0% and 14.0%) (7, 8). The indication for TAVI was, therefore, extended to patients in this risk category in the 2017 edition of the guidelines. It was further extended to low-risk patients in 2021 on the basis of the findings of the PARTNER-3 and Evolut Low-Risk trials: the one-year mortality in low-risk patients in the PARTNER-3 trial was 1.0% for TAVI versus 2.5% for sAVR, while the two-year mortality in the Evolut Low-Risk trial was 4.4% for TAVI versus 4.5% for sAVR (9, 10). Patient-centered decision-making about treatment with TAVI or sAVR involves the consideration of relevant factors including the patient’s age, comorbidities, and preferences by an interdisciplinary heart team (cardiology/cardiac surgery). Traditional surgical risk scores, such as the Society of Thoracic Surgeons (STS) score and the EuroSCORE, have diminished in importance. Even though the indication for TAVI was extended to younger patients, the age distribution of TAVI patients in Germany was largely stable until the end of 2021 (5). The true impact of the guideline updates, particularly in 2021, on patient selection and treatment outcomes in Germany remains unclear. In the present study, we analyze changes in clinical features, risk profiles, and treatment outcomes of TAVI patients at seven major German heart centers from 2013 to 2023.

Methods

Study cohort

This retrospective multicenter analysis includes all 33 079 consecutive patients with severe symptomatic aortic valve stenosis who were treated with TAVI at seven German heart centers over the period 2013—2023. The indication was determined by an interdisciplinary heart team in each case. Data collection was register-based, and the evaluation was centralized and pseudonymized with the approval of the responsible ethics committees. Multiple entries were excluded by data cleansing and reconciliation within the reports of each center. The patients were classified by age (<75, 75, 76, 77, 78, 79, 80, ≥ 80 years) and STS surgical risk score. Complications were recorded with the aid of the Valve Academic Research Consortium (VARC-3) criteria (11).

Statistical analysis

Patient characteristics, treatment outcomes, and 30-day mortality were described on a year-to-year basis. No primary endpoint was specified in advance for this retrospective, hypothesis-generating analysis. Secular trends from 2013–2023 were examined with simple linear regression analyses without correction for multiple testing. Results are reported as annual changes (slope) with 95% confidence intervals. All of the acquired data were communicated in full by the participating centers. Adjusted 30-day mortality was calculated with multivariable logistic regression, including relevant clinical covariates; these are listed in eMethods under “additional information on statistical analysis.” Model quality was assessed with ROC curve analysis. All analyses were performed with SPSS, Version 28. Graphs were created with GraphPad Prism, Version 10.2.3.

Results

Age and surgical risk

33 079 patients who underwent TAVI from 2013 to 2023 were included in the analysis. The annual number of procedures increased from 1605 in 2013 to 4459 in 2023 (Table). The patients’ mean age was stable over the entire period, varying from 80.6 ± 6.4 to 81.2 ± 6.0 years. The absolute patient numbers rose in all age groups (<75 years, 75–80 years, and ≥ 80 years), while the age distribution remained constant; patients aged 80 and above were always the largest group (65%) (eFigure 1a–c). The STS score (surgical risk score) decreased from 5.9 ± 6.2% (2013) to 4.1 ± 4.3% (2023). The percentage of patients at low risk (STS score < 4%) rose from 47% to 66.4% (Table); this trend was seen in age groups. Data from the years 2014–2022 are presented in the eTable.

Table

Baseline characteristics and periprocedural complications by year

eFigure 1

Secular trends in age distribution within the STS risk groups. The absolute case numbers for the age groups are shown: <75 years (red), 75–80 years (blue), and >80 years (black).

Patient characteristics

In parallel with the decline in predicted surgical risk, there was also a change in the comorbidity profile of TAVI patients over time (Table, eTable). A marked decline was seen in the prevalence of diabetes, chronic obstructive pulmonary disease (COPD), peripheral arterial occlusive disease (PAOD), and prior cardiac surgery (Table, eTable), while the prevalence of atrial fibrillation, coronary heart disease, and hypertension largely remained largely stable (eTable). The percentage of women fell steadily from 52.8% in 2013 to 45.3% in 2023.

Procedural complications and outcomes

The rate of transfemoral TAVI procedures rose over the period of observation (2013: 59.3%; 2023: 95.2%; eTable), while the unadjusted complication rates fell. The rate of vascular complications fell from 17.2% in 2013 to 4.9% in 2023, mainly because of a decline in severe vascular complications according to VARC-3 criteria. Hemorrhagic complications (VARC-3 types 1–4) fell from 24.1% to 8.1% over the same period. The percentage of patients needing to have a new permanent pacemaker implanted fell from 15.5% (2013) to 11.4% (2023). The percentage of patients whose TAVI had to be converted to open heart surgery fell as well, from 2.2% in 2013 to 0.7% in 2023. Age-, sex-, and comorbidity-adjusted complication rates declined only slightly from 2013 to 2023 (eFigures 2–5).

eFigure 2

Prediction and effect of patient-specific characteristics on 30-day mortality after TAVI

eFigure 3

Prediction and influence of patient-specific characteristics on pacemaker rate after TAVI

eFigure 4

Prediction and influence of patient-specific characteristics on the stroke rate after TAVI

eFigure 5

Prediction and effect of patient-specific characteristics on vascular complications after TAVI

Unadjusted 30-day mortality fell from 7.1% in 2013 to 2.5% in 2023 (mean annual change, –0.45 percentage points [−0.66; −0.25]) (Figure a, eTable). This decline was mainly due to a marked drop in 30-day mortality among patients in patients over age 80 (2013: 8,.7%; 2023: 2.0%), those aged 75–80 (2013: 4.6%; 2023: 2.8%), and to a lesser extent, in those under age 75 (2013: 4.7%; 2023: 4.0%) (Figure b). 30-day mortality declined in all risk groups (STS < 4%: 2013 3.7%; 2023 2.1%; STS 4–8%: 2013 10.3%; 2023 2.3%), but remained relatively high in high-risk patients (STS > 8%) (2013: 9.9%; 2023: 6.9%) (Figure c). Age-, sex-, and comorbidity-adjusted 30-day mortality fell slightly from 2013 to 2023 (2013: 3.8% versus 2023: 3.2%) (Figure a, eFigure 6). From 2018 onward, the adjusted mortality was higher than the observed mortality.

Figure

Trends in 30-day mortality

eFigure 6

Prediction and influence of patient-specific characteristics on vascular complications after TAVI

Discussion

In this study, we analyzed nationwide trends in TAVI patients in seven German heart centers over the period 2013—2023. The data represent approximately 16% of all TAVI procedures nationwide (12). Three main findings were identified: a decline in surgical risk, a marked decline in procedural complications and adjusted 30-day mortality, and a high percentage of younger patients (<75 years) with a low STS score (<4%).

Figures from the German Heart Report reveal that TAVI has become the dominant treatment option for aortic valve stenosis in Germany since 2014 (5). This was accompanied by a rise in the overall number of procedures until 2016, but the number of sAVR procedures has been falling steadily since then, especially in patients aged 75 and above. The shift from sAVR to TAVI is reflected not only in national registries, but also in the data from the present cohort (13, 14, 15). The shift has multiple causes, including the lower procedural risk and shorter recovery time after TAVI, as well as its effectiveness, which is now similar to that of sAVR. Across Europe, Germany leads with 30 TAVI procedures per 100 000 inhabitants per year (as of 2019), followed by Switzerland (22), Finland (18), and Austria (18). The rate of TAVI is much lower in France (11 cases), England (9), and Poland (4). These figures underscore the difference in healthcare structures across European countries, despite the availability of common European guidelines (16).

The average STS score in the cohort of the present study fell from 5.9% in 2013 to 4.1% in 2023, while the average age remained constant at approximately 81 years (Table). This indicates an expansion of the indication for TAVI to healthier patients with lower risk despite their advanced age. This trend has also been observed in other countries, including Sweden, the Netherlands, France, and England (17, 18, 19, 20, 21). The decline in comorbidities, particularly diabetes mellitus, COPD, PAOD, and prior heart attack and stroke, accords with this change in patient profiles. At the same time, there has been a steady fall in the rates of perioperative complications, including vascular events and hemorrhage, as well as observed 30-day mortality, particularly in patients over age 80 (15, 22, 23, 24, 25).

Over the period of observation, the observed morbidity and 30-day mortality in fact declined to a much greater extent than the predicted morbidity and 30-day mortality. The decline in predicted morbidity and 30-day mortality is explained by the expansion of TAVI to a population at lower overall risk, as evidenced by trends over time in the treated patients’ age and sex distributions and their comorbidity profiles. The more pronounced fall in observed morbidity and 30-day mortality is likely due to additional factors: these presumably include advances in prosthesis technology, increasing experience of implantation centers, improved procedure planning, and optimized implantation techniques (26, 27). Interestingly, a registry study in the USA has revealed a trend in the opposite direction since 2019, with a 10% annual increase in risk-adjusted mortality, particularly among high-risk patients (28). It should be noted that risk models for mortality after TAVI are of limited predictive power (29). This applies to our model as well: its discriminatory power is weak, with an area under the curve (AUC) of 0.651 (eFigure 6). The registry just mentioned did not include information on known predictors of individual complications; reported complication rates that have been adjusted for baseline characteristics, but not for such predictors, must be interpreted with caution.

The rise in TAVI procedures in patients under age 75 is particularly noteworthy: this figure trebled from 2013 to 2023, albeit from a low baseline (Table). Most of these patients had an STS score below 4%. Younger, low-risk patients of this type became markedly more common from 2020 onward (eFigure 1a), largely as the result of a consensus recommendation jointly issued in that year by the German Society of Cardiology and the German Society for Thoracic, Cardiac, and Vascular Surgery with a widening of the indications for TAVI to include decision-making on a patient-to-patient basis by an interdisciplinary cardiology/cardiac surgery team for patients aged 70 to 75 (30). Meanwhile, the 3– and 5-year data from the Evolut Low Risk and PARTNER-3 trials have revealed comparable mortality and rates of severe stroke in younger, low-risk patients (9, 31). The 10-year data from the NOTION trial show comparable overall mortality for TAVI (62.7%) and sAVR (64.0%) as well as at least comparable durability of TAVI prostheses, with moderate or severe valve wear rates of 15.4% (TAVI) and 20.8% (sAVR) (32).

Only 1-year data from the above trials were available when the European Society of Cardiology (ESC) guidelines were published in 2021, with the result that they recommended TAVI rather than sAVR only in patients over age 75. This lower limit for age, set by consensus, reflected the predominant age groups of patients in existing randomized trials and registries, along with concerns about valve durability in patients undergoing TAVI at younger ages. For low-risk patients under age 75, the 2021 ESC guidelines recommended TAVI only in the presence of specific anatomical or clinical contraindications for surgery, such as porcelain aorta, chest deformity, or prior cardiac surgery (1). These factors were not systematically recorded in the cohort of the present study, but the predominance of low risk profiles suggests that decisions for TAVI rather than sAVR are often based on reasons other than a high surgical risk score. Patient-related factors, e.g., a desire for a less invasive procedure, may also have contributed to rise of TAVI in younger, low-risk patients.

The ESC and North American ACC/AHA guidelines both emphasize the role of shared decision-making in the interdisciplinary heart team. The ACC/AHA guidelines go as far as to advocate TAVI for 65– to 80-year-olds with a life expectancy of less than 20 years, at any level of surgical risk (33). In the US, TAVI is now performed in more than half of patients under age 65 (34). Recent randomized trials, including DEDICATE-DZHK6 and NOTION II, have shown the non-inferiority of TAVI to sAVR after one year in low-risk, middle-aged patients (71–74 years) (35, 36). It remains unclear whether the same is true for even younger patients. Currently available evidence underscores the need for further prospective long-term trials to ensure that TAVI will not be performed for excessively broad indications, with potential overtreatment of younger patients. For younger patients in particular, special attention must be paid to specific risks such as bicuspid anatomy, the more frequent need for a permanent pacemaker because of TAVI-related compression of the conduction system near the left ventricular outflow tract, or the development of paravalvular regurgitation (37). Such complications not only impair the quality of life, but also increase the risk of later reintervention. Aspects such as prosthesis durability and anatomical suitability for follow-up procedures are therefore becoming increasingly relevant to what is now called “patient lifetime management.”

In the recently updated joint guidelines of the European Society of Cardiology and Cardiac and Thoracic Surgery, the age limit for considering TAVI instead of sAVR was lowered to 70 years (38). This adjustment was based on the findings of the DEDICATE DZHK6 and NOTION II trials. However, as only short-term results are available so far, the recommendation in favor of TAVI for patients over 70 years of age is still based largely on expert consensus. It is pointed out in the guidelines that life expectancy should be a more important criterion for treatment decisions than chronological age; it is further pointed out, however, that the utility of life expectancy as a criterion is limited in many cases, as it is strongly affected by geographical and interindividual variation.

Limitations

This is a retrospective observational analysis with the usual limitations of this study design. All data were reported by the participating centers themselves, and only German hospitals were included. Detailed information on patient selection criteria was not available. Factors that were not taken into account in this analysis may affect the validity of conclusions regarding morbidity and mortality. Another limitation is that no long-term data were recorded in this registry.

Overview

This study reveals pronounced trends in TAVI at German heart centers from 2013 to 2023. The average a priori surgical risk (STS score) of patients treated with TAVI became lower over this period, and there was a drop in complications and 30-day mortality after TAVI. The increasing expansion of TAVI to younger, low-risk patients makes 30-day mortality hard to predict reliably; further anatomical and technical considerations are needed for a reliable risk assessment. The findings confirm the central role of TAVI in the treatment of older patients with aortic valve stenosis.

Conflict of interest statement

MA received consulting fees (advisory board) and/or lecture honoraria and/or reimbursement of travel expenses and meeting participation fees from Medtronic, JenaValv, Abbott, Edwards Lifesciences, and Meril.

SB received lecture honoraria and/or fees for continuing education events and/or reimbursement of travel expenses and meeting participation fees from Abbott, Edwards, JenaValve, and Medtronic.

DF received consulting fees (advisory board) and/or lecture honoraria and/or reimbursement of travel expenses and meeting participation fees from Edwards Lifesciences, Medtronic, and Abbott.

LH received travel expense support through travel grants from the DZHK and funding from the German Heart Foundation (F/55/23).

WKK received consulting fees from Abbott, Anteris, Boston Scientific, Cardiawave, Meril Life Sciences, HID Imaging, and P&F, as well as lecture fees from Edwards Lifesciences, JenaValve, and Medtronic, and is also on the advisory boards of DSMB and P&F.

TR received consulting fees (advisory board) from Edwards Lifesciences, JenaValve, and Medtronic.

NS received lecture fees from Edwards Lifescience, Abbott, Medtronic, and Boston Scientific.

JCV is supported by the Clinician Scientist Program of the Medical Faculty of Christian-Albrechts University in Kiel and is a member of the board of the BDI.

HW received consulting fees and/or lecture honoraria and/or travel expenses and meeting participation fee reimbursement from JenaValve.

JMW, JS, M.A, GN, SB, and V are supported by the German Research Foundation as part of Collaborative Research Center 259 (397484323).

The remaining authors state that they have no conflict of interest.

Manuscript submitted on 10 April 2025, revised version accepted on 6 November 2025.

Translated from the original German by Ethan Taub, M.D.

Corresponding author
PD Dr. med. Victor Mauri

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