Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta.

BACKGROUND: Challenging anatomies and comorbidities have impact on success in transcatheter aortic valve replacement (TAVR). There is controversy whether the extent of the aortic angle (AA) has an impact on procedural outcomes. Matched comparative outcome data of new generation transcatheter heart valves (THVs) in horizontal aorta (HA) are scarce. METHODS: A total of 1582 patients with severe native aortic stenosis (AS) treated with the SAPIEN3 Ultra (Ultra; n = 526) or ACURATE Neo2 (Neo2; n = 1056) THVs from January 2017 to January 2023 were analyzed. Patients with non-horizontal aortas (AA < 51.7°, n = 841) were excluded. The population was matched by 1-to-1 nearest-neighbor matching (Ultra, n = 246; Neo2, n = 246). Clinical and procedural outcome were evaluated according to VARC-3 recommendations. RESULTS: Technical success (93.1% vs. 94.7%, p = 0.572) was high after Ultra and Neo2. Device success (80.5% vs. 89.8%, p = 0.05) was inferior with Ultra. Neo2 reveals superior hemodynamic properties with lower rate of severe prosthesis patient mismatch (12.0% vs. 3.7%, p = 0.001) and elevated gradients ( ≥ $\ge $ 20 mmHg: 11.9% vs. 1.7%, p < 0.001). Ultra showed a lower rate of relevant paravalvular regurgitation ( > $\gt $ mild paravalvular regurgitation or Valve-in-Valve due to paravalvular regurgitation: 0.0% vs. 3.7%, p = 0.004). The rate of procedural bailout maneuvers (0.8% vs. 0.4%, p = 1.000) and thirty-day all-cause mortality (1.3% vs. 2.2%, p = 0.496) was similar. CONCLUSION: Transfemoral TAVR in patients with severe aortic stenosis and HA, using the balloon expandable Sapien3 Ultra and self-expanding ACURATE Neo2 prosthesis, is feasible and safe. Therefore, valve selection between these platforms should be made irrespective of the aortic angle by a team experienced with both valves based on their specific advantages. Large, randomized trials in this sub-group of patients would be necessary to compare long term outcomes.

[Myocardial revascularization : Controversy over noninvasive and invasive detection of ischemia]. / Myokardiale Revaskularisation : Kontroverse um den nicht-invasiven und den invasiven Ischämienachweis.

With some exceptions, myocardial revascularization in patients with chronic coronary syndrome (CCS) is generally decided on the basis of the extent of myocardial ischemia. Current data indicate that a patient will benefit from revascularization if ischemia is present in more than 10% of the myocardium. Accordingly, all patients presenting with CCS should undergo a noninvasive ischemia test that can answer this question before diagnostic coronary angiography. In order to be able to make a recommendation for revascularization based on scientific data even in those patients who previously had no clear evidence of ischemia, e.g., because of discrepant findings, measurement of the hemodynamic significance of coronary stenoses with a lumen diameter reduction ≥ 50% should be performed during coronary angiography. A decision to revascularize based on hemodynamic significance was shown to be beneficial to patients in several studies.

Latest Advances in Transcatheter Aortic Valve Implantation (2022).

Since the last decade, transcatheter aortic valve implantation (TAVI) has become the treatment of choice in patients with symptomatic severe aortic stenosis (AS) who are ineligible or at higher risk for surgery. Due to the high safety profile of current device generation, TAVI has emerged as a qualified alternative to surgical aortic valve replacement (SAVR) in patients with classic aortic stenosis and intermediate surgical risk, severe bicuspid aortic valve stenosis, and isolated pure aortic regurgitation. Moderate aortic stenosis, with and without concomitant heart failure with reduced ejection fraction, are under investigation in randomized controlled clinical trials from which we will gain exciting insights on the best timing of TAVI to protect the left ventricle from further functional deterioration due to increasing AS. In these cases, a meticulous diagnostic approach including advanced imaging is becoming more and more important. Current evidence on antithrombotic strategies after TAVI is weak, contributing to poor levels of standardization and high variability in daily clinical practice. This review will provide a short overview of recent clinical trials including best timing for TAVI with moderate AS and antithrombotic strategies after TAVI with current and future TAVI generations.

Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration).

AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.

Randomized (CO)mparison of (TRI)fecta and (P)erimount Magna Ease Supraannular Aortic Xenografts-CO.TRI.P Study.

BACKGROUND: Modern supraannular aortic xenografts offer a special design, thus providing maximized opening area for improved hemodynamics. The aim of this study was a prospectively randomized comparison of the Trifecta and the Perimount Magna Ease valves based on metric annulus sizing. METHODS: A total of 100 patients with aortic stenosis undergoing aortic valve replacement (AVR) with or without concomitant procedures were prospectively included. After decalcification of the annulus, stratified intraoperative randomization was performed. The diameter of the aortic annulus was measured using metric Hegar dilators and randomization was based on this metric annulus diameter. Exercise echocardiography was performed at 10-month follow-up. RESULTS: Mean age was 69 years, with 36% female. Predominant implanted valve sizes were 23 mm (39%) and 25 mm (32%). Unadjusted mean pressure gradient was significantly lower and effective orifice area larger for the Trifecta group (10.8 ± 5 vs. 13.2 ± 4 mm Hg, p = 0.02 and 1.93 ± 0.39 vs. 1.70 ± 0.30 cm2, p = 0.002) at discharge. In patients with small annuli, based on the metric annulus size there were no significant differences in gradients or the orifice area. At exercise echocardiography follow-up, there were no significant hemodynamic differences between both prostheses. CONCLUSIONS: The Trifecta and the Perimount Magna Ease prostheses both show excellent hemodynamic performance after AVR. In patients with larger annuli, the Trifecta valve seems to be even superior to the Magna Ease, which may be advantageous in obese patients.

Outcome after transvascular transcatheter aortic valve implantation in 2016.

Aims: We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany. Methods and results: All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P = 0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P < 0.001). Thus, in 2016 the overall in-hospital mortality rate after TV-TAVI was 2.6%, which is for the first time numerically below that of iSAVR, which was 2.9% (P = 0.19). A stratified analysis according to the German aortic valve score shows a lower observed than expected in-hospital mortality rate for TV-TAVI (O/E 0.68). Additionally, the in-hospital mortality was significantly lower after TV-TAVI than after iSAVR in the very high- (11.3% vs. 23.6%; P < 0.001), in the high- (4.1% vs. 9.2%; P < 0.001), and in the intermediate-risk group (3.0% vs. 4.6%; P = 0.016) and was similar to that of iSAVR in low-risk patients (1.6% vs. 1.4%; P = 0.4). Conclusion: The overall in-hospital mortality after TV-TAVI was numerically lower than after iSAVR in 2016 for the first time. In the low risk group in-hospital mortality was similar, whereas in all other risk groups in-hospital mortality after TV-TAVI was significantly lower than after SAVR. This is likely to contribute to a redefinition of the standard of care in the future.

Outcome of thrombus aspiration in STEMI patients: a propensity score-adjusted study.

The use of thrombus aspiration (TA) prior to primary percutaneous coronary intervention (PPCI) has undergone a radical change in intervention guidelines. The clinical implications, however, are still under scrutiny. This study investigated the clinical effects and outcome of TA before PPCI in patients with ST-segment elevation myocardial infarction (STEMI). Overall 1027 patients with STEMI were analyzed in this retrospective, propensity score-adjusted, multicenter study. The primary endpoints were in-hospital and long-term mortality. There were 418 patients in the TA group and 609 in the conventional PPCI group. The in-hospital mortality rate was significantly higher in the TA group (8.7 vs. 5.0%; P = 0.03). During long-term follow-up [median follow-up duration 689 days (IQR 405-959)] the mortality rates were similar (TA 14.3%, conventional PPCI 15.0%; P = 0.85). Survival analysis for the complete observation period revealed no significant benefit of TA [hazard ratio (HR) 1.12; 97.5% CI 0.90-0.71; P = 0.63]. There were also no significant differences between the groups in the following secondary endpoints: composite of cardiovascular death and non-fatal reinfarction at discharge (P = 0.39), post-PPCI thrombolysis in myocardial infarction flow-grade-3 (P = 0.14), left ventricular ejection fraction (P = 0.47), and non-fatal reinfarction during follow-up (P = 0.17). Rehospitalization rate (1.82 vs. 10.3%; P < 0.0001) and Canadian Cardiovascular Society (CCS) grading (P = 0.02) during follow-up were significantly lower in the TA group. In our cohort the in-hospital mortality rate was significantly higher for TA patients, but during long-term follow-up the mortality rates did not differ. The incidence of rehospitalization and CCS grading were lower in the TA-treated patients.

Transfemoral aortic valve implantation of Edwards SAPIEN 3 without predilatation.

OBJECTIVES: The purpose of the present study was to investigate whether transfemoral implantation of the balloon-expandable Edwards SAPIEN 3 device without prior balloon valvuloplasty is feasible. BACKGROUND: Transcatheter aortic valve implantation (TAVI) without predilatation may be advantageous and is feasible with various transcatheter heart valves. METHODS: A total of 163 consecutive patients with severe aortic stenosis undergoing transfemoral TAVI were enrolled at two sites. We assessed whether the crossing of the native aortic valve with the prosthesis without prior pre-dilation was feasible and evaluated for procedural success according to VARC-2 criteria. RESULTS: Direct implantation without pre-dilatation was feasible in 154 patients (94.5%), whereas in nine patients predilatation was required due to difficulties while crossing the native aortic valve. Procedural success was achieved in 85.6%. A large proportion of the procedural failures was mainly driven by increased post-procedural gradients ≥20 mm Hg, which almost exclusively concerned the smaller prostheses sizes (23-mm 10/39 (25.6%) vs. 26-mm 5/72 (6.9%) vs. 29-mm 1/52 (1.9%); P < 0.001). Patients in the pre-ballooning group had higher calcium scores of the aortic valve (5,335 [4,421-7,807] vs. 2,893 [1,879-3,993]), more advanced age, higher transvalvular gradients, and smaller aortic valve area. CONCLUSIONS: The transfemoral implantation of the balloon-expandable SAPIEN 3 prosthesis without pre-dilatation is feasible in the majority of cases. In the presence of severe aortic valve calcification and critical aortic stenosis, however, predilatation may still be necessary. Furthermore, the significance of increased post-procedural gradients requires further verification. © 2016 Wiley Periodicals, Inc.

Release kinetics of inflammatory biomarkers in a clinical model of acute myocardial infarction.

RATIONALE: Inflammation in the setting of acute myocardial infarction (MI) has been linked to risk stratification; however, the release kinetics of inflammatory biomarkers in patients with acute MI has been difficult to establish. OBJECTIVE: The aim of this study was to determine the kinetics of changes in the levels of several biomarkers specifically linked to inflammation after transcoronary ablation of septal hypertrophy, a procedure that mimics acute MI. METHODS AND RESULTS: We analyzed release kinetics of C-reactive protein, high-sensitivity C-reactive protein, interleukin-6, soluble CD40 ligand, and peripheral blood leukocyte subsets in patients (n=21) undergoing transcoronary ablation of septal hypertrophy. Blood samples were collected before transcoronary ablation of septal hypertrophy and at various times after transcoronary ablation of septal hypertrophy. Serum levels of C-reactive protein were increased at 24 hours (1.0 mg/dL [interquartile range [IQR], 0.7-1.75] versus 0.2 mg/dL [IQR, 0.1-1.05] at baseline [BL]; P<0.001), whereas high-sensitivity C-reactive protein increased as early as 8 hours (2.68 mg/L [IQR, 1.23-11.80] versus 2.17 mg/L [IQR, 1.15-5.06] at BL; P=0.002). Interleukin-6 was significantly increased at 45 minutes (2.59 pg/mL [IQR, 1.69-5.0] versus 1.5 pg/mL [IQR, 1.5-2.21] at BL; P=0.002), and soluble CD40 ligand was significantly decreased at 60 minutes (801.6 pg/mL [IQR, 675.0-1653.5] versus 1750.0 pg/mL [IQR, 1151.0-2783.0] at BL; P=0.016). Elevated counts of polymorphonuclear neutrophils were detectable at 15 minutes, with a significant increase at 2 hours (6415 cells/µL [IQR, 5288-7827] versus 4697 cells/µL [IQR, 2892-5620] at BL; P=0.004). Significant monocytosis was observed at 24 hours (729 cells/µL [IQR, 584-1344] versus 523 cells/µL [IQR, 369-701] at BL; P=0.015). CONCLUSIONS: Interleukin-6 and neutrophil granulocytes showed a continuous rise at all prespecified time points after induction of MI. Our results provide valuable additional evidence of the diagnostic value of inflammatory biomarkers in the setting of early acute MI.

Plasma microRNA-21 for the early prediction of acute kidney injury in patients undergoing major cardiac surgery.

BACKGROUND: Acute kidney injury (AKI) is a complication after major cardiac surgery that is associated with higher rates of morbidity and mortality. MicroRNA-21 (miR-21) has been described as an early biomarker for AKI. We investigated whether miR-21 is predictive of AKI and long-term mortality after cardiac surgery. METHODS: Consecutive patients (n = 115) undergoing major cardiac surgery were included. Serum creatinine was measured prior to, 4 h after, and 1, 4 and 7 days after extracorporeal circulation. Diagnosis of post-operative AKI was made in accordance with the international Kidney Disease: Improving Global Outcomes definition of AKI. Serum cystatin C and miR-21 were measured prior to and 4 h after surgery. miR-21 was determined by quantitative RT-PCR and was normalized to miRNA-39 from Caenorhabditis elegans. The median follow-up time was 2.9 years. RESULTS: AKI occurred in 36.5% (n = 42) of all patients. Baseline miR-21 was significantly lower in patients developing cardiac surgery-associated AKI (CSA-AKI) than in patients without CSA-AKI [0.27 (interquartile range, IQR, 0.14-0.30) versus 0.44 (IQR 0.25-0.75); P < 0.01]. Baseline miR-21 predicted CSA-AKI Stage 2/3 with an area under the curve of 0.701 [95% confidence interval (CI) 0.59-0.82; P = 0.007]. Baseline miR-21 <0.31 showed a hazard ratio of 3.11 (95% CI: 1.33-11.26) for CSA-AKI Stage 2/3. Patients with AKI Stage 2/3 had a significantly higher mortality (50 versus 10%; P = 0.0001) and dialysis rate (27 versus 11%; P = 0.038) within the 2.9-year follow-up. CONCLUSIONS: Our results indicate that miR-21 has the potential to identify patients at higher risk for CSA-AKI. This predictive value might be helpful in pre-procedural risk assessment and peri-procedural diagnosis and treatment.

Reference Values and Release Kinetics of B-Type Natriuretic Peptide Signal Peptide in Patients with Acute Myocardial Infarction.

BACKGROUND: The signal peptide for human B-type natriuretic peptide preprohormone (BNPsp), which is released from cardiomyocytes, is increased in plasma of patients with acute myocardial infarction (AMI); however, its exact release kinetics have not been defined. METHODS: We measured BNPsp and high-sensitivity cardiac troponin T (hs-cTnT) in a reference group of individuals without structural heart disease (n = 285) and determined the release kinetics of these biomarkers in patients (n = 29) with hypertrophic obstructive cardiomyopathy undergoing transcoronary ablation of septal hypertrophy (TASH), a procedure allowing exact timing of onset of iatrogenic AMI. Blood samples were collected before TASH and at numerous preselected time points after TASH. RESULTS: The reference median BNPsp concentration was 53.4 pmol/L [interquartile range (IQR) 47.0-61.0; 95th percentile 85.9 pmol/L; 99th percentile 116.3 pmol/L]. Baseline concentrations in patients undergoing TASH were higher than in the reference group [91.9 pmol/L (IQR 62.9-116.4); P < 0.0001]. BNPsp increased significantly, peaking at 15 min after induction of AMI [149.6 pmol/L (109.5-204.9) vs baseline; P = 0.004] and declining slowly thereafter, falling below the preprocedural value after 8 h (P = 0.014). hs-cTnT increased significantly 15 min after induction of AMI [26 ng/L (19-39) vs 18 ng/L (11-29); P = 0.001] and remained high at all later time points. CONCLUSIONS: BNPsp concentrations increased immediately after AMI induction, providing early evidence of myocardial injury. The release kinetics of BNPsp differed from those of hs-cTnT. These findings provide information that should help in establishing the diagnostic value of BNPsp in the setting of early AMI.

Neutrophil gelatinase-associated lipocalin (NGAL) for the early detection of contrast-induced nephropathy after percutaneous coronary intervention.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) occurs in up to 13% of patients undergoing percutaneous coronary intervention (PCI). Neutrophil gelatinase-associated lipocalin (NGAL) is an early biomarker for renal impairment. We investigated whether increased urinary NGAL concentrations were predictive of CI-AKI within 2 days after PCI or of a higher re-hospitalization rate within 9 months. METHODS: Consecutive patients (n = 128), with stable coronary heart disease and eGFR ≥ 30 mL/min/1.73 m(2), undergoing PCI were included. Venous serum samples for measurement of creatinine, blood urea nitrogen, and cystatin C and urine samples for NGAL measurement were collected 4 hours and 1 and 2 days after contrast medium application. Patients were followed over 9 months to determine clinical endpoints. RESULTS: CI-AKI was observed in 14 patients (10.9%) after PCI. NGAL concentrations before PCI were significantly higher in patients with subsequent CI-AKI (19.8 ng/mL [14.4-35.8] vs. 11.6 ng/mL [5.6-28.2]; p = 0.04). There was no significant difference in NGAL concentrations 4 h after PCI between patients with and without CI-AKI. One day after PCI, NGAL concentrations were significant higher in patients developing CI-AKI (100.1 ng/mL [41.5-129.2] vs. 16.6 ng/mL [9.1-28.1]; p < 0.001). Compared to common biomarkers, NGAL best predicted CI-AKI (AUC 0.939 [95% CI 0.89-0.99; p < 0.001]). The re-hospitalization rate due to progressive renal insufficiency within 9 months was higher in the group with CI-AKI than the group without (4 [28.6%] vs. 4 [3.5%], p < 0.01). CONCLUSION: Urinary NGAL is a biomarker for predicting CI-AKI when measured 1 day after PCI.

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.

BACKGROUND: Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. METHODS: A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. RESULTS: Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). CONCLUSIONS: In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry.

BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

Neutrophil gelatinase-associated lipocalin (NGAL) for the early detection of cardiac surgery associated acute kidney injury.

BACKGROUND: Acute kidney injury (AKI) is a common complication after cardiac surgery. Neutrophil gelatinase-associated lipocalin (NGAL) may be an early biomarker for cardiac surgery-associated (CSA) AKI. We investigated whether increased urinary NGAL concentrations were predictive of AKI within 4 days after surgery and of mortality within 9 months. METHODS: Consecutive patients (n = 141) undergoing major cardiac surgery were included. Creatinine, blood urea nitrogen, cystatin C and urinary NGAL were measured before, 4 hours and 4 days after extracorporeal circulation. RESULTS: AKI was observed in 47 (33.3%) patients. The 4-hour urinary NGAL measurement was an independent predictor of stage 2 and 3 AKI (AUC 0.901; 95% CI 0.81-0.99). Patients with AKI had a higher 9-month mortality rate (19.1% vs. 3.2%; logrank 10.9; P = 0.001; HR 19.8; 95% CI 3.7-107.1). Urinary NGAL was not predictive of mortality within 9 months after surgery. CONCLUSION: Urinary NGAL is a biomarker for very early risk stratification of AKI after cardiac surgery and may be useful as a basis for early interventional strategies to prevent CSA-AKI.

DynaCT-guided anatomical rotation of the SAPIEN XT valve during transapical aortic valve implantation: proof of concept.

BACKGROUND: Transcatheter aortic valve implantation (T-AVI) by using the Edwards SAPIEN (Edwards Lifesciences LLC, Irvine, California, United States) prosthesis is currently being performed by the implantation of valved stent into the aortic annulus without respecting the native commissural (rotational) orientation. Anatomical orientation may, however, be beneficial regarding optimal physiological valve performance, optimal coronary flow, and avoidance of the fully covered commissural stent part in front of the coronary ostia. With the recently introduced SAPIEN XT, transcatheter valve identification of the commissures during fluoroscopy is feasible. The aim of this study was to evaluate the concept of Dynamic-CT (DynaCT)-guided anatomical rotation of the SAPIEN XT valve during transapical-AVI (TA-AVI). METHODS: Intraoperatively, an automatically segmented DynaCT was performed using the Siemens Syngo Aortic ValveGuide (Siemens AG, Forchheim, Germany) software prototype. Commissures of SAPIEN XT could be identified with a high-quality fluoroscopic system. Before standard TA implantation, one radiopaque stent commissure of the crimped SAPIEN XT prosthesis was aligned with the native aortic valve commissure visualized by DynaCT. Resulting rotational orientation of the valve after implantation was assessed by transesophageal echocardiography. RESULTS: Feasibility of anatomical rotation was evaluated in 10 patients scheduled for TA-AVI by an interdisciplinary heart team. Mean logistic EuroSCOREs and Society of Thoracic Surgeons scores were 23.7 ± 4.9% and 8.6 ± 2.1%, mean aortic gradient improved from 46.0 ± 21.9 to 9.6 ± 3.1 mm Hg, and there was no death within 30 days. All valves were implanted successfully with none or trivial paravalvular regurgitation in seven patients, mild (1 + ) in two patients, and moderate (2 + ) in one patient. An optimal anatomical position could be achieved in six patients, minor rotational deviation (< 10 degrees) in three patients, and moderate deviation (10 to 20 degrees) in one patient only. CONCLUSIONS: DynaCT-guided anatomical rotation of the SAPIEN XT valve is feasible during TA-AVI, avoiding implantation of the fully covered commissural posts in front of the coronary ostia. This might reduce the risk of coronary obstruction. In addition, the technique provides the potential benefit of physiological valve position and performance.

Prosthesis-patient mismatch after transcatheter aortic valve implantation using the Edwards SAPIEN™ prosthesis.

OBJECTIVES: Prosthesis-patient mismatch (PPM) is defined as a too small effective orifice area (EOA) of the prosthetic valve in relation to the patient's body size and has been documented to be related to adverse outcomes after conventional aortic valve replacement (AVR). Aim of this study was to analyze the incidence of PPM after transcatheter aortic valve implantation (T-AVI) using the Edwards SAPIEN prosthesis and its relation to postoperative outcome. METHODS: 200 consecutive high-risk patients underwent transapical aortic valve implantation (TA-AVI) between February 2006 and January 2009 and fulfilled 1 year follow-up were included. Severe PPM was defined as indexed EOA (EOAi) <0.65 cm2/m2 and moderate PPM as EOAi = 0.65-0.85 cm2/m2, EOA was calculated from transthoracic echocardiographic (TTE) measurements using the continuity equation. Total 112 patients with sufficient postoperative TTE image quality formed the study group. RESULTS: EOAi increased from 0.3 ± 0.1 cm2/m2 (preoperatively) to 1.1 ± 0.4 cm2/m2 after TA-AVI (p < 0.001). According to the standard definitions, PPM was seen in 38.4% of the patients and 9.8% presented with severe PPM. The occurrence of PPM had neither an effect on clinical outcome in terms of NYHA class nor on survival. Patients with PPM had significantly higher postoperative transprosthetic gradients (mean gradient 10.4 ± 4.1 versus 7.1 ± 3.0 mm Hg, p < 0.001). Based on the in vitro EOA data obtained from pulse duplicator measurements, however, none of the patients was judged to have PPM. CONCLUSION: Transcatheter AVI provides good antegrade hemodynamic function and EOAi improves significantly. According to standardized evaluations PPM occurs after TA-AVI, but it is not associated with adverse outcomes. Thus use of the continuity equation may not adequately reflect the situation after T-AVI or the current definition of PPM is not suitable for T-AVI prostheses.

Prognostic Impact of the Get-with-the-Guidelines Heart-Failure Risk Score (GWTG-HF) after Transcatheter Aortic Valve Replacement in Patients with Low-Flow-Low-Gradient Aortic Valve Stenosis.

OBJECTIVES: This study examined the prognostic value of the get-with-the-guidelines heart-failure risk score (GWTG-HF) on mortality in patients with low-flow-low-gradient aortic valve stenosis (LFLG-AS) after transcatheter aortic valve implantation (TAVI). BACKGROUND: Data on feasibility of TAVI and mortality prediction in the LFLG-AS population are scarce. Clinical risk assessment in this particular population is difficult, and a score has not yet been established for this purpose. METHODS: A total of 212 heart failure (HF) patients with real LFLG-AS were enrolled. Patients were classified into low-risk (n = 108), intermediate-risk (n = 90) and high-risk (n = 14) groups calculated by the GWTG-HF score. Clinical outcomes of cardiovascular events according to Valve Academic Research Consortium (VARC-2) recommendations and composite endpoint of death and hospitalization for heart failure (HHF) were assessed at discharge and 1 year of follow-up. RESULTS: Baseline parameters of the groups showed a median age of 81.0 years [77.0; 84.0] (79.0 vs. 82.0 vs. 86.0, respectively p < 0.001), median EuroSCORE II of 6.6 [4.3; 10.7] (5.5 vs. 7.2 vs. 9.1, p = 0.004) and median indexed stroke volume of 26.7 mL/m2 [22.0; 31.0] (28.2 vs. 25.8 vs. 25.0, p = 0.004). The groups significantly differed at follow-up in terms of all-cause mortality (10.2 vs. 21.1 vs. 28.6%; p < 0.035). There was no difference in intrahospital event rate (VARC). Postprocedural mean gradients were lower in high-risk group (7.0 vs. 7.0 vs. 5.0 mmHg, p = 0.011). No differences in postprocedural aortic valve area (1.9 vs. 1.7 vs. 1.9 cm2, p = 0.518) or rate of device failure (5.6 vs. 6.8 vs. 7.7%, p = 0.731) could be observed. After adjustment for known predictors, the GWTG score (HR 1.07 [1.01-1.14], p = 0.030) as well as pacemaker implantation (HR 3.97 [1.34-11.75], p = 0.013) turned out to be possible predictors for mortality. An increase in stroke volume index (SVI) was, in contrast, protective (HR 0.90 [0.83-0.97]; p = 0.006). CONCLUSIONS: The GWTG score may predict mortality after TAVI in LFLG-AS HF patients. Interestingly, all groups showed similar intrahospital event and mortality rates, independent of calculated mortality risk. Low SVI and new conduction disturbances associated with PPI after THV implantation had negative impact on mid-term outcome in post-TAVI HF-patients.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Patients with Porcelain Aorta.

BACKGROUND: Severe calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear. METHODS: Data from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population. RESULTS: Technical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2. CONCLUSION: A porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.