Transfemoral transcatheter aortic valve replacement (TF-TAVR) has evolved to the standard of care for patients with severe symptomatic aortic valve stenosis at prohibitive, high, and even intermediate risk for surgical aortic valve replacement [
However, in many cases, alternative approaches for TAVR are necessary due to complicated peripheral vasculature [
Data from 81 high-risk patients with symptomatic aortic valve stenosis who consecutively underwent transfemoral (group A,
Incidence, cause, and amplitude of pRIP (leukocytes, C-reactive protein, procalcitonin) in association with definite outcomes were assessed. Peak pRIP up to 72 hours after implantation was evaluated. Decisions for TAVR were met by an interdisciplinary heart team [
This study received ethical approval from the “Ethical Commission of the Ruhr University, Bochum.” Informed consent had been obtained from all individual participants included in the study.
The primary endpoint was all-cause mortality mortality at 30-days and 1-year according to the Valve Academic Research Consortium (VARC II) definitions [
After TAVR, patients were admitted for 24 hours to an intensive care unit for postinterventional surveillance. Clinical examination, electrocardiogram, body temperature, and chest X-ray were assessed. All blood parameters, which had been determined by the initial examination, were rechecked. Follow-up visits took place 3 and 12 months after discharge.
Categorical data are shown as frequencies and percentages; continuous variables are presented as means and standard deviation. The normal distribution of the variables was verified by the Shapiro–Wilk test (p-Wert ≥ 0.1). Comparisons were performed with 2-sided
Our study cohort represents a typical TAVI patient population at high risk for open-heart surgery with symptomatic aortic stenosis. The transapical patients (group B) had a significantly higher European System for Cardiac Operative Risk Evaluation Score (logistic EuroSCORE I, 21.9 vs. 15.3%,
Baseline and postprocedural characteristics.
A | Overall ( | TF-TAVR ( | TA-TAVR ( | |
---|---|---|---|---|
Age, years | 82.1 ± 6.0 | 82.9 ± 4.9 | 81.2 ± 6.9 | 0.5 |
Male gender | 40 (49.4) | 19 (47.5) | 21 (51.2) | 0.8 |
Weight, kg | 77.3 ± 16.5 | 74.6 ± 14.7 | 80.0 ± 17.9 | 0.1 |
Height, cm | 167.8 ± 9.1 | 168.3 ± 9.1 | 167.2 ± 9.2 | 0.5 |
Logistic Euroscore I (%) | 18.6 ± 12.7 | 15.3 ± 9.5 | 21.9 ± 14.6 | 0.02 |
Aortic valve area, cm2 | 0.8 ± 0.3 | 0.8 ± 0.3 | 0.8 ± 0.3 | 0.7 |
Mean transvalvular PG before TAVR, mmHg | 38.5 ± 14.7 | 38.8 ± 12.7 | 38.0 ± 17.4 | 0.8 |
LVEF (%) | 52.9 ± 13.7 | 56.8 ± 9.9 | 49.0 ± 15.8 | 0.05 |
CAD | 41(50.6) | 22 (55) | 19 (46.3) | 0.5 |
Prior MI | 12 (14.8) | 5 (12.5) | 7 (17.1) | 0.7 |
Prior PCI | 28 (34.6) | 15 (37.5) | 13 (31.7) | 0.6 |
Prior heart surgery | 12 (14.8) | 3 (7.5) | 9 (22) | 0.1 |
B | ||||
Mean transvalvular PG after TAVR, mmHg | 9.3 ± 4.0 | 9.2 ± 4.2 | 9.5 ± 3.7 | 0.5 |
Vascular complications (major) | 1 (1.2) | 1 (2.5) | 0 (0) | 0.4 |
Vascular complications (minor) | 2 (2.5) | 2 (5) | 0 (0) | 0.2 |
Stroke (disabling) | 0 (0) | 0 (0) | 0 (0) | — |
Stroke (nondisabling) | 2 (2.5) | 2 (5) | 0 (0) | 0.2 |
Values are mean ± SD,
Postprocedural C-reactive protein (pCRP) and postprocedural leucocytes (pL) were significantly higher in the transfemoral group A vs. transapical group B (22.1 ± 7.9 vs. 12.1 ± 9.7 mg/dl,
Further analysis suggested pCRP >30 mg/dl (hazard ratio (HR) 3.15, confidence interval (CI) 1.22–8.14,
Survival at 30 days and 360 days was worse in patients with logistic EuroSCORE I > 20% (
Cumulative survival of patients with Logistic EuroSCORE I (ES) > 20 vs. ≤ 20% patients with ES > 20% had a worse outcome. ES > 20% was a significant predictor of mortality (
Cumulative survival of patients with postprocedural leucocytes (pL) > 14 vs. ≤ 14/nl. Further analysis showed a statistically nonsignificant trend towards a better outcome for patients with pL ≤ 14/nl (
Cumulative survival of patients with postprocedural c-reactive protein (pCRP) > 30 vs. ≤ 30 mg/dl. Patients with pCRP >30 mg/dl had a worse outcome. PCRP >30 mg/dl was a significant predictor of mortality (
The present study demonstrates that SI, as reflected by pRIP, is associated with worse clinical outcomes after TAVR. This analysis is the first to propose a feasible postprocedural inflammatory algorithm to predict mortality after TA- and TF-TAVR in association with the EuroSCORE. These data also indicate that the transfemoral approach for TAVR and associated procedural simplification can lead to lower prevalence of pRIP and, thus, favorably influence attenuation/prevention of systemic inflammatory response syndrome (SIRS). Procedural simplification could also explain lower fever duration after TF-TAVR compared to TA-TAVR, which has been previously associated with increased mortality [
In this study, pRIP after TAVR was not attributed to an infectious origin. Recent studies have shown that fever after TAVR is common and most likely represents a noninfectious postprocedural SIRS [
Peri- and postprocedural cytokine release could be a possible reason for development of a nonspecific inflammation after TAVR. The cytokine-related pathway of SIRS leading to hypotension and not adequate organ perfusion could be also found during many steps of the TAVR procedure [
The results of this analysis present a simple, easily available algorithm in order to recognize clinically relevant postprocedural inflammation, which may influence the clinical outcome. Incidence of the suggested postinterventional PCRP and PL cut-off values in patients with increased logistic EuroSCORE I> 20% appears to carry adverse prognosis, and patients with such combination should better remain under more intensive postinterventional surveillance. In addition, it is of great importance to break this suspected vicious cytokine-circle before critical inflammation occurs. Therefore, prospective studies investigating broader inflammation parameters are necessary in order to evaluate if procedure simplification (e.g., modern direct TAVR without preparatory BAV and use of a selfexpandable bioprosthesis for avoiding rapid pacing) can play a role, especially for the very elderly and markedly vulnerable high-risk population.
Current data show that direct TAVR, performed without the use of preparatory BAV, can simplify the procedure and consequently lead to lower complication rates [
Our data are derived from a retrospective analysis of consecutive patients and not from a prospective, randomized trial. Patients undergoing TA-TAVR were not suitable for the transfemoral access route and, therefore, due to complicated peripheral vasculature possibly at higher operative risk. Further prospective investigation is necessary to evaluate if direct implantation and associated procedure simplification, in general, could have a positive impact in reducing the extent of postinterventional inflammation.
Of note, the significant association between pRIP and EuroSCORE raises the question, whether patients at higher operative risk are more likely to develop SIRS due to increased fragility or incidence of SIRS remains random but has a higher impact on outcome if very vulnerable patients are affected. This correlation needs further investigation. In addition, possible negative impact of the use of general anesthesia and associated prolonged recovery in the ICU requires further research.
Inflammation after TAVR is common and most likely in terms of a SIRS. PRIP are significantly higher in patients undergoing TA-TAVR. PCRP >30 mg/dl, logistic EuroSCORE I >20%, and pL > 14/nl carry adverse prognosis and require further investigation.
Postprocedural leucocytes
Postprocedural C-reactive protein
Postprocedural routine inflammatory parameters
Paravalvular leakage
Transapical
Transcatheter aortic valve replacement
Transfemoral.
The survey data used to support the findings of this study are available from the corresponding author upon reasonable request.
P. C. Patsalis is a proctor for Edwards Lifesciences. The other authors report no conflicts of interest..
The authors thank Hiltrud Niggemann for the statistical support.