Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008–2015

Abstract

Background Transcatheter aortic valve replacement (TAVR) is routinely used in patients with severe aortic stenosis at increased operative risk. Due to potential technical difficulties, TAVR is not recommended for pure aortic regurgitation (AR). Smaller studies reported its use in AR, but data from big registries are lacking. The present study analyzes the nationwide use of surgical aortic valve replacement (SAVR) and TAVR in patients with AR from 2008 until 2015. Methods We identified 138,237 cases of aortic valve replacement in Germany based on ICD and OPS codes. Results Of 13.2% SAVR‐cases and 1.3% of TAVR cases were performed in AR. AR patients undergoing SAVR were younger with lower logistic EuroSCORE (stenosis: 6.1 ± 5.6; AR: 4.5 ± 4.9). Nevertheless, stroke rates, bleedings, prolonged mechanical ventilation, and in‐hospital mortality were higher (mortality: stenosis 2.6%, AR: 4.7%). In the TAVR group, patients with AR were at higher operative risk (logistic EuroSCORE: transfemoral (TF)‐TAVR: stenosis: 14.3 ± 10.4; AR: 17.3 ± 13.3. Transapical (TA)‐TAVR: stenosis: 16.1 ± 11.4; AR: 15.7 ± 12.2). Stroke rates were lower, but bleedings and prolonged ventilation occurred more frequently after TF‐TAVR in AR compared to stenosis. The mortality varied markedly (TF‐TAVR: 15.2% in 2011; 2.8% in 2015; TA‐TAVR: 17.7% in 2012 and 0% in 2014). Conclusion TAVR is off‐label used in AR in clinical practice. TAVR seems to be a safe option for AR with regard to in‐hospital outcomes. However, further research evaluating long‐term outcomes is required to establish the feasibility of TAVR in pure AR.

Short‐term outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation in the United States

“…Although these previous studies provided us important clinical and procedural information on TAVR for AR, scarce data are available highlighting the direct comparison of outcomes between TAVR for pure AR and AS. A recent German nationwide administrative database study compared outcomes between transfemoral TAVR for pure AR and AS, and reported that in‐hospital mortality was similar (2.82% vs. 3.10% in 2015), while the pure AR group had a higher incidence of clinically relevant bleeding requiring blood transfusion (requiring >5 units of red blood cells transfusion, 6.93% vs. 4.98%) with a lower incidence of stroke (1.47% vs. 2.53%) in the unadjusted analyses 18 . The result of clinically relevant bleeding is consistent with the result of blood transfusion in the present study.…”

“…It may be reasonable that as in a previous study, 18 TAVR for pure AS and TAVR for mixed aortic disease (AS + AR) are combined into one group (combined AS group) from the viewpoints of procedural techniques and complication risk because unlike pure AR, both pure AS and AS + AR generally have annular calcification, which provides a landmark and an anchor for valve deployment. Thus, as a sensitivity analysis, we compared the outcomes between the pure AR group and the combined AS group.…”

“…The following exclusion criteria were applied; (a) patients with no ICD‐10 code for AS or AR, (b) patients with infective endocarditis, (c) patients with a prior history of valve surgery, (d) TAVR done in hospitals where the annual number of endovascular TAVR was <20 cases (to avoid confounding data from less experienced hospitals in a manner similar to that of a previous study 17 ), and (e) patients with missing data on discharge status (alive or dead). The following ICD‐10 codes were used to identify aortic valve diseases in a manner similar to that of a previous study 18 : AS (I06.0, I35.0, Q23.0), AR (I06.1, I35.1, Q23.1), and “AS with AR (I06.2, I35.2)”. In this study, we defined TAVR for pure native AR as TAVR that was performed in patients without prior valve surgery who had AR without either AS or mixed aortic valve disease.…”

Pure aortic valve regurgitation: SAVR is the gold standard, but TAVR is another gun

“…Notwithstanding, this explorative analysis is meaningful because, going over to outcome, permits a better understanding of the feasibility and early safety of TAVR in patients with pure AR, refused from surgery. Currently, we should acknowledge that the proportion of patients with pure AR undergoing TAVR is rather low (1–2% TAVR vs. 13% SAVR in the present analysis) because the available transcatheter heart valves are not designed to address pure AR. This is because the annular or aortic dimensions are bigger compared to those of severe AS, and aortic valve calcification is poor, thus making the anchoring challenging.…”

“…In this issue, Stachon et al reported the nationwide clinical practice of SAVR and TAVR used for pure AR in Germany between 2008 and 2015, based on administrative diagnosis codes. To note, aortic valve repair procedures and patients with concomitant cardiac surgery or percutaneous coronary intervention were not included in the study.…”