Concomitant percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) frequently have coronary artery disease requiring percutaneous coronary intervention (PCI). Usually, PCI and TAVI are performed in two separate procedures and current studies are investigating potential benefits regarding the order. However, the two interventions may also be performed simultaneously, thereby limiting the risk associated with repeated vascular access. Data evaluating benefit and harm of concomitant procedures are scarce. AIMS: Therefore, this study aimed to evaluate concomitant PCI (coPCI) in TAVI patients regarding Valve Academic Research Consortium 3 (VARC-3) endpoints and long-term mortality. METHODS: A total of 2233 consecutive TAVI patients from the EVERY-VALVE registry were analyzed according to the VARC-3 endpoint definitions. A total of 274 patients had undergone TAVI and concomitant PCI (coPCI group). They were compared to 226 TAVI patients who had received PCI within 60 days before TAVI in a stepwise approach (swPCI group) and to the remaining 1733 TAVI patients who had not undergone PCI recently (noPCI group). RESULTS: Overall median age was 81.4 years, median Society of Thoracic Surgeons score was 4.0%. Patients in the coPCI and in the swPCI group were predominantly male with reduced left-ventricular ejection fraction. Rates of VARC-3 composite endpoints technical success and 30-day device success were comparable between all three groups. Mortality rates at 3 years after TAVI were similar (coPCI, 34.2% vs. swPCI, 31.9% vs. noPCI, 34.0% p = 0.84). CONCLUSIONS: coPCI during TAVI seems comparable in a retrospective analysis. Compared to a stepwise approach, it has similar rates of composite endpoints technical success and device success as well as long-term mortality.

ADP-induced platelet reactivity and bleeding events in patients with acute myocardial infarction complicated by cardiogenic shock.

While previous reports showed ADP-induced platelet reactivity to be an independent predictor of bleeding after PCI in stable patients, this has never been investigated in patients with cardiogenic shock. The association of bleeding events with respect to ADP-induced platelet aggregation was investigated in patients undergoing primary PCI for acute myocardial infarction complicated by cardiogenic shock and with available on-treatment ADP-induced platelet aggregation measurements. Out of 233 patients, 74 suffered from a severe BARC3 or higher bleed. ADP-induced platelet aggregation was significantly lower in patients with BARC≥3 bleedings (p < .001). Multivariate analysis identified on-treatment ADP-induced platelet aggregation as an independent risk factor for bleeding (HR = 0.968 per AU). An optimal cutoff value of <12 AU for ADP-induced platelet aggregation to predict BARC≥3 bleedings was identified via ROC analysis. Moreover, the use of VA-ECMO (HR 1.972) or coaxial left ventricular pump (HR 2.593), first lactate (HR 1.093 per mmol/l) and thrombocyte count (HR 0.994 per G/l) were independent predictors of BARC≥3 bleedings. In conclusion, lower on-treatment ADP-induced platelet aggregation was independently associated with severe bleeding events in patients with AMI-CS. The value of platelet function testing for bleeding risk prediction and guidance of anti-thrombotic treatment in cardiogenic shock warrants further investigation.

Impact of Dose Reduction Strategies on Image Quality of Coronary CTA in Real-World Clinical Practice: A Subanalysis of PROTECTION VI Registry Data.

BACKGROUND. Dose reduction strategies for coronary CTA (CCTA) have been underused in clinical practice given concern that the strategies may lower image quality. OBJECTIVE. The purpose of this study was to explore associations between dose reduction strategies and CCTA image quality in real-world clinical practice. METHODS. This subanalysis of the international Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI) study included 3725 patients (2109 men, 1616 women; median age, 59 years) who underwent CCTA for coronary artery evaluation performed at 55 sites in 32 countries. CCTA image sets were reviewed at a core laboratory. A range of patient and scan characteristics, including use of three dose reduction strategies (prospective ECG triggering, low tube potential, and iterative image reconstruction) and image dose, were recorded. A single core laboratory member reviewed all examinations for quantitative image quality measures, including signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and reviewed 50% of examinations to assign a qualitative CCTA image quality score and a semiquantitative coronary calcification measure. Multivariable logistic regression models were used to identify predictors of image quality. A second core laboratory member repeated quantitative measures for 100 examinations and the qualitative measure for 383 (approximately 20%) examinations to assess interreader agreement. RESULTS. Independent predictors (p < .05) of SNR were female sex (effect size, 2.70), lower body mass index (0.38 per 1-unit decrease), stable sinus rhythm (1.71), and scanner manufacturer (variable effect across manufacturers). These factors were also the only independent predictors of CNR. Independent predictors (p < .05) of CCTA image quality were heart rate (0.17 per 10 beats/min reduction) and coronary calcification (0.15 per coronary calcification grade). None of the three dose-saving strategies or dose-length product was an independent predictor of any image quality measure. Interreader agreement analysis showed intraclass correlation coefficients of 0.874 for SNR and 0.891 for CNR and a kappa value of 0.812 for the qualitative score. CONCLUSION. This large international multicenter study shows that three dose reduction strategies were not associated with decreased CCTA image quality. CLINICAL IMPACT. The dose reduction strategies should be routinely implemented in clinical CCTA.

Reduction in radiation exposure in cardiovascular computed tomography imaging: results from the PROspective multicenter registry on radiaTion dose Estimates of cardiac CT angIOgraphy iN daily practice in 2017 (PROTECTION VI).

Aims: Advances of cardiac computed tomography angiography (CTA) have been developed for dose reduction, but their efficacy in clinical practice is largely unknown. This study was designed to evaluate radiation dose exposure and utilization of dose-saving strategies for contrast-enhanced cardiac CTA in daily practice. Methods and results: Sixty one hospitals from 32 countries prospectively enrolled 4502 patients undergoing cardiac CTA during one calendar month in 2017. Computed tomography angiography scan data and images were analysed in a central core lab and compared with a similar dose survey performed in 2007. Linear regression analysis was performed to identify independent predictors associated with dose. The most frequent indication for cardiac CTA was the evaluation of coronary artery disease in 89% of patients. The median dose-length product (DLP) of coronary CTA was 195 mGy*cm (interquartile range 110-338 mGy*cm). When compared with 2007, the DLP was reduced by 78% (P < 0.001) without an increase in non-diagnostic coronary CTAs (1.7% in 2007 vs. 1.9% in 2017 surveys, P = 0.55). A 37-fold variability in median DLP was observed between the hospitals with lowest and highest DLP (range of median DLP 57-2090 mGy*cm). Independent predictors for radiation dose of coronary CTA were: body weight, heart rate, sinus rhythm, tube voltage, iterative image reconstruction, and the selection of scan protocols. Conclusion: This large international radiation dose survey demonstrates considerable reduction of radiation exposure in coronary CTA during the last decade. However, the large inter-site variability in radiation exposure underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols.

Predictors for long-term survival after transcatheter edge-to-edge mitral valve repair.

OBJECTIVES: To determine predictors for long-term outcome in high-risk patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for severe mitral regurgitation (MR). BACKGROUND: There is no data on predictors of long-term outcome in high-risk real-world patients. METHODS: From August 2009 to April 2011, 126 high-risk patients deemed inoperable were treated with TMVR in two high-volume university centers. RESULTS: MR could be successfully reduced to grade ≤2 in 92.1% of patients (116/126 patients). Long-term clinical follow-up up to 5 years (95.2% follow-up rate) revealed a mortality rate of 35.7% (45/126 patients). Repeat mitral valve treatment (surgery or intervention) was needed in 19 patients (15.1%). Long-term clinical improvement was demonstrated with 69% of patients being in NYHA class ≤II. In a multivariable Cox regression analysis, the post-procedural grade of MR (hazard ratio [HR] 1.55 per grade, P = 0.035), the left ventricular ejection fraction (HR 0.58 for difference between 75th and 25th percentile, P = 0.031) and the glomerular filtration rate (HR 0.33 for 75th vs 25th percentile, P < 0.001) were independent predictors for long-term mortality. Patients with primary MR and a post-procedural MR grade ≤1 had the most favorable long-term outcome. CONCLUSIONS: This study determines predictors of long-term clinical outcome after TMVR and demonstrates that the grade of residual MR determines long-term survival. Our data suggest that it might be of benefit reducing residual MR to the lowest possible MR grade using TMVR-especially in selected high-risk patients with primary MR who are not considered as candidates for surgical MVR.

Prognostic value of coronary computed tomography angiography during 5 years of follow-up in patients with suspected coronary artery disease.

AIMS: Coronary computed tomography angiography (CCTA) has a high accuracy for detection of obstructive coronary artery disease (CAD). Several studies also showed a good predictive value for subsequent cardiac events. However, the follow-up period of these studies was limited to ~2 years and long-term follow-up data on prognosis out to 5 years are very limited. METHODS AND RESULTS: This study is based on 1584 patients with suspected CAD undergoing CCTA between December 2003 and November 2006. Among other CCTA parameters, the total plaque score defined as number of abnormal segments (having either a non-obstructive plaque or a stenosis) and the most severe stenosis were recorded. The primary endpoint was a composite of death and non-fatal myocardial infarction. Revascularization procedures later than 90 days after the CT study were assessed as secondary endpoints. During a median follow-up of 5.6 years (IQR: 5.1-6.3 years) 61 patients suffered death or myocardial infarction and 52 underwent late revascularization. The severity of CAD and the total plaque score were the best predictors of death and non-fatal myocardial infarction, both significantly improving prediction over standard clinical risk scores (multivariate c-index 0.60 and 0.66, respectively, P = 0.002 and <0.0001, respectively). The annual event rate ranged from 0.24% for patients with no CAD to 1.1% for patients with obstructive CAD and 1.5% for patients with CAD and extensive plaque load (>5 segments). Both parameters also improved prediction of need for subsequent revascularization (c-index 0.72 and 0.63, respectively, P < 0.0001 and P = 0.0013, respectively). CONCLUSION: Data from CCTA predict both death and myocardial infarction as well as need for subsequent revascularizations out to 5 years. CCTA imaging may be a valuable tool in the assessment of long-term prognosis in patients with suspected CAD.

Pacing Using Cardiac Implantable Electric Device During TAVR: 10-Year Experience of a High-Volume Center.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an effective and safe therapy for severe aortic stenosis. Rapid or fast pacing is required for implantation, which can be performed via a pre-existing cardiac implantable electric device (CIED). However, safety data on CIEDs for pacing in TAVR are missing. OBJECTIVES: The aim of this study was to elucidate procedural safety and feasibility of internal pacing with a CIED in TAVR. METHODS: Patients undergoing TAVR with a CIED were included in this analysis. Baseline characteristics, procedural details, and complications according to Valve Academic Research Consortium 3 (VARC-3) criteria after TAVR were compared between both groups. RESULTS: A total of 486 patients were included. Pacing was performed using a CIED in 150 patients and a transient pacemaker in 336 patients. No differences in technical success according to VARC-3 criteria or procedure duration occurred between the groups. The usage of transient pacers for pacing was associated with a significantly higher bleeding rate (bleeding type ≥2 according to VARC-3-criteria; 2.0% vs 13.1%; P < 0.01). Furthermore, impairment of the CIED appeared in 2.3% of patients after TAVR only in the group in which pacing was performed by a transient pacer, leading to surgical revision of the CIED in 1.3% of all patients when transient pacemakers were used. CONCLUSIONS: Internal pacing using a CIED is safe and feasible without differences of procedural time and technical success and might reduce bleeding rates. Furthermore, pacing using a CIED circumvents the risk of lead dislocation. Our data provide an urgent call for the use of a CIED for pacing during a TAVR procedure in general.

Atrial Functional Tricuspid Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Knowledge about atrial functional tricuspid regurgitation (afTR) in transcatheter aortic valve replacement (TAVR) patients is scarce. OBJECTIVES: The aim of the study was to analyze the association between the entity and the development of tricuspid regurgitation (TR) in patients undergoing TAVR for aortic stenosis and concomitant TR. METHODS: We analyzed patients undergoing TAVR for severe aortic stenosis from January 2013 to December 2020 and concomitant at least moderate TR at baseline. afTR was defined as enlargement of the right atrium in relation to the right ventricle. TR development after TAVR and 3-year all-cause mortality were evaluated. RESULTS: Out of 3,474 TAVR patients, we identified 420 patients with concomitant at least moderate TR. A total of 363 patients were included in the study, with 178 patients stratified in the afTR and 185 in the non-afTR group based on a receiver-operating characteristic curve cutoff of 1.132 of the right atrial/right ventricular area ratio. TR improvement after TAVR was observed in significantly less patients with afTR compared with non-afTR (31.1% vs 60.6%; P < 0.001). Multivariate regression analysis confirmed afTR as independent predictor for TR persistence (adjusted OR: 2.80; 95% CI: 1.66-4.76; P < 0.001). Moreover, afTR was associated with aggravation of TR after TAVR (17.0% vs 6.8%; P = 0.013). Three-year all-cause mortality was significantly higher in patients with persistence compared with patients with improvement of TR (P < 0.001). CONCLUSIONS: In TAVR patients, afTR is an independent predictor for TR persistence. Moreover, TR persistence is associated with increased 3-year all-cause mortality.

Right ventricular to pulmonary artery coupling in patients with different types of aortic stenosis undergoing TAVI.

BACKGROUND: Right ventricular (RV) dysfunction in patients undergoing transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) has long been disregarded. We aimed to assess the predictive value of RV to pulmonary artery coupling (RV/PAc), defined as tricuspid annular plane systolic excursion to systolic pulmonary artery pressure, on mortality in different flow types of AS after TAVI. METHODS: All patients undergoing TAVI for AS at our centre between 2018 and 2020 were assessed; 862 patients were analysed. The cohort was dichotomized using a ROC analysis (cut-off 0.512 mm/mmHg), into 429 patients with preserved and 433 patients with reduced RV/PAc. RESULTS: Reduced RV/PAc was associated with male sex and a higher rate of comorbidities. Short-term VARC-3 endpoints and NYHA classes at follow-up were comparable. Reduced RV/PAc was associated with higher 2-year all-cause mortality (35.0% [30.3-39.3%] vs. 15.4% [11.9-18.7%], hazard ratio 2.5 [1.9-3.4], p < 0.001). Cardiovascular mortality was almost tripled. Results were consistent after statistical adjustment and in a multivariate model. Sub-analyses of AS flow types revealed lower RV/PAc in classical and paradoxical low-flow low-gradient AS, with the majority having reduced RV/PAc (74% and 59%). RV/PAc retained its predictive value in these subgroups. CONCLUSIONS: RV dysfunction defined by low RV/PAc is a strong mortality predictor after TAVI independent of flow group. It should be incorporated in future TAVI risk assessment.

Short-Term Changes in Arterial Stiffness Measured by 2D Speckle Tracking in Patients Undergoing Transcatheter Aortic Valve Implantation.

Arterial stiffness has received increasing interest as a cardiovascular marker in patients with aortic valve stenosis (AS). So far, studies on the impact of aortic valve replacement (AVR) on arterial stiffness have been equivocal. Two-dimensional speckle tracking (2DST) is a novel, non-invasive method to measure the motion of the vessel wall. In this prospective observational study, we aimed to assess the change in arterial stiffness of the common carotid artery (CCA) measured by 2DST in patients undergoing transcatheter aortic valve implantation (TAVI). A total of 47 patients were included in the study (age 80.04 ± 6.065 years). Peak circumferential strain (CS) was significantly improved after TAVI (4.50 ± 2.292 vs. 5.12 ± 2.958, p = 0.012), as was the peak strain rate (CSR) (0.85 ± 0.567 vs. 1.35 ± 0.710, p = 0.002). Body mass index (BMI), mean arterial pressure (MAP) and hemodynamic parameters were associated with this change. 2DST results did not correlate with aortic pulse wave velocity (aPWV) or augmentation index normalized to heart rate (AIx@75), suggesting a distinct difference between arterial stiffness of the CCA and other stiffness parameters. 2DST seems to be a promising new tool to assess arterial stiffness in TAVI patients.

Quantification of physical activity with prospective activity tracking after transfemoral aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a well-established, safe and effective therapy for severe symptomatic aortic stenosis (AS). The aim of this study was to objectively quantify improvement of physical activity after TAVR, with consideration of different low-gradient AS subtypes. METHODS AND RESULTS: All patients undergoing TAVR for severe AS were screened. Participants received a wearable activity tracker (Fitbit®) at hospital discharge following TAVR and 6 months thereafter. The difference of median daily steps was defined as surrogate outcome for physical activity. For analysis, patients were grouped into high-gradient (HG) AS (dPmean ≥40 mmHg), classical low-flow low-gradient (LFLG) AS (dPmean <40 mmHg, EF <50%), paradoxical LFLG-AS (dPmean <40 mmHg, EF ≥50%, SVi ≤35 ml/m2) and normal-flow low-gradient (NFLG) AS (dPmean <40 mmHg, EF ≥50%, SVi >35 ml/m2) according to mean transvalvular pressure gradient (dPmean), stroke volume index (SVi) and left-ventricular ejection fraction (LVEF). RESULTS AND CONCLUSIONS: The analysis is based on 230 patients. The median daily step count was 4409 [IQR 2581-7487] after hospital discharge and 5326 [IQR 3045-8668] 6 months thereafter. Median difference of daily steps was ∆529 [IQR -702-2152]). Patients with HG-AS and paradoxical LFLG-AS showed a significant improvement of daily steps (∆951 [IQR -378-2323], p <0.001 and (∆1392 [IQR -609-4444], p = 0.02, respectively). Patients with classical LFLG-AS showed no statistically relevant improvement of daily steps (∆192 [IQR -687-770], p = 0.79). Patients with NFLG-AS showed a numerical decline in daily steps without statistical significance (∆-300 [IQR -1334-1406], p = 0.67). This first prospective study of this sample size shows significant improvement of physical activity after TAVR with an objective and reproducible method. This was mainly driven by an improvement in patients with HG-AS and paradoxical LFLG-AS.

CTA-determined tricuspid annular dilatation is associated with persistence of tricuspid regurgitation after transcatheter aortic valve replacement.

AIM: The aim of this study was to analyse the predictive value of CTA-determined tricuspid annular dilatation (TAD) on the persistence of tricuspid regurgitation (TR) in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) and concomitant at least moderate TR. METHODS AND RESULTS: 288 consecutive patients treated with TAVR due to severe AS and concomitant at least moderate TR at baseline were included in the analysis. As cutoff for TAD, the median value of the CTA-determined, to the body surface area-normalized tricuspid annulus diameter (25.2 mm/m2) was used. TAD had no impact on procedural characteristics or outcomes, including procedural death and technical or device failure according to the Valve Academic Research Consortium 3 criteria. However, the primary outcome of the study-TR persistence after TAVR was significantly more frequent in patients with compared to patients without TAD (odds ratio 2.60, 95% confidence interval 1.33-5.16, p < 0.01). Multivariable logistic regression analysis, adjusting for clinical and echocardiographic baseline characteristics, which are known to influence aetiology or severity of TR, confirmed TAD as an independent predictor of TR persistence after TAVR (adjusted odds ratio 2.30, 95% confidence interval 1.20-4.46, p = 0.01). Moreover, 2 year all-cause mortality was significantly higher in patients with persistence or without change of TR compared to patients with TR improvement (log-rank p < 0.01). CONCLUSION: In patients undergoing TAVR for severe AS and concomitant at least moderate TR at baseline, TAD is a predictor of TR persistence, which is associated with increased 2-year all-cause mortality.

TAVI for patients with normal-flow low-gradient compared to high-gradient aortic stenosis.

BACKGROUND: Normal-flow (stroke volume index, SVi >35 ml/m2) low-gradient (dPmean <40 mmHg) aortic stenosis (NFLG-AS) is subject of scientific debate. Guidelines fail to give conclusive treatment recommendations. We hypothesized that NFLG patients are heterogenous, containing a subgroup similar to high-gradient aortic stenosis patients (dPmean ≥40 mmHg, HG-AS) concerning characteristics and outcomes. METHODS: 2326 patients undergoing transcatheter aortic valve replacement (TAVI) at our centre between 2013 and 2019 were analysed. 386 patients fulfilled criteria of NFLG-AS. Their median dPmean was 33 mmHg, which was used for grouping (204 patients with higher gradient NFLG-AS, 186 patients with lower gradient NFLG-AS). They were compared to 956 HG-AS patients. RESULTS: Characteristics of lower gradient NFLG-AS patients differed from HG-AS patients in many aspects while higher gradient NFLG-AS and HG-AS patients were mostly similar, underscored by higher Society of Thoracic Surgeons scores in lower gradient NFLG-AS (lower gradient NFLG-AS, 3.9, HG-AS, 3.0, p = 0.03, higher gradient NFLG-AS, 3.0, p = 0.04). Procedural complications were comparable. Estimated 3-year all-cause mortality was higher in lower gradient NFLG-AS compared to HG-AS patients (hazard ratio 1.7, p < 0.01), whereas mortality of higher gradient NFLG-AS was similar to HG-AS patients (hazard ratio 1.2, p = 0.31). Cardiovascular mortality was highest among lower gradient NFLG-AS patients (21.6% vs. higher gradient NFLG-AS, 15.4%, vs. HG-AS, 11.1%, p < 0.01). CONCLUSIONS: NFLG-AS patients are indeed heterogenous. NFLG-AS patients with higher gradients resemble HG-AS patients in clinical characteristics and outcomes and should not be treated differently. Lower gradient NFLG-AS patients have increased long-term mortality and the use of TAVI requires careful consideration.

Impact of mitral regurgitation aetiology on the outcomes of transcatheter aortic valve implantation.

BACKGROUND: Concomitant moderate/severe mitral regurgitation (MR) is observed in 17-35% of patients undergoing transcatheter aortic valve implantation (TAVI) and contributes to a worse prognosis. Studies analysing outcomes in patients undergoing TAVI with different MR aetiologies, including atrial functional MR (aFMR), are lacking. AIMS: We aimed to analyse outcomes and changes in MR severity in patients with aFMR, ventricular functional (vFMR) and primary mitral regurgitation (PMR) following TAVI. METHODS: We analysed all consecutive patients with at least moderate MR undergoing TAVI between January 2013 and December 2020 at the Munich University Hospital. Characterisation of MR aetiology was performed by detailed individual echocardiographic assessment. Three-year mortality, changes in MR severity and New York Heart Association (NYHA) Functional Class at follow-up were assessed. RESULTS: Out of 3,474 patients undergoing TAVI, 631 patients showed MR ≥2+ (172 with aFMR, 296 with vFMR, 163 with PMR). Procedural characteristics and endpoints were comparable between groups. The rate of MR improvement was 80.2% in aFMR patients, which was significantly higher compared to both other groups (vFMR: 69.4%; p=0.03; PMR: 40.8%; p<0.001). The estimated 3-year survival rates did not differ between aetiologies (p=0.57). However, MR persistence at follow-up was associated with increased mortality (hazard ratio 1.49, 95% confidence interval: 1.04-2.11; p=0.027), mainly driven by the PMR subgroup of patients. NYHA Class improved significantly in all groups. In patients with baseline MR ≥3+, the PMR aetiology was associated with the lowest MR improvement, the lowest survival rates and least symptomatic improvement. CONCLUSIONS: TAVI reduces MR severity and symptoms in patients with aFMR, vFMR and less-pronounced PMR. The presence of aFMR was associated with the greatest MR severity improvement.

Suture-based vs. pure plug-based vascular closure devices for VA-ECMO decannulation-A retrospective observational study.

Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a valuable treatment option for patients in cardiogenic shock, but complications during decannulation may worsen the overall outcome. Therefore, the aim of this study was to compare the efficacy and safety of suture-based to pure plug-based vascular closure devices for VA-ECMO decannulation. Methods: In this retrospective study, the procedural outcome of 33 patients with suture-based Perclose ProGlide closure devices was compared to 38 patients with MANTA plug-based closure devices. Results: Rate of technically correct placement of closure devices was 88% in the suture-based group and 97% in the plug-based group (p = 0.27). There was a significant reduction of severe bleeding events during VA-ECMO decannulation in plug-based versus suture-based systems (3% vs. 21%, p = 0.04). Ischemic complications occurred in 6% with suture-based and 5% with plug-based device (p = 1.00). Pseudoaneurysm formation was detected in 3% in both groups (p = 1.00). No switch to vascular surgery due to bleeding after decannulation was necessary in both groups. Conclusion: Based on our retrospective analysis, we propose that plug-based vascular closure should be the preferred option for VA-ECMO decannulation. This hypothesis should be further tested in a randomized trial.

Heparin-Induced Thrombocytopenia in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation.

Background: Heparin-induced thrombocytopenia (HIT) is a serious, immune-mediated adverse drug reaction to unfractionated heparin (UFH) affecting also patients undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). Although the association between VA-ECMO support and the development of thrombocytopenia has long been known and discussed, HIT as one underlying cause is still insufficiently understood. Therefore, the purpose of this study was to further investigate the epidemiology, mortality, diagnosis, and clinical management of HIT occurring in VA-ECMO patients treated with UFH. Methods: We conducted a retrospective single-center study including adult patients (≥18 years) with VA-ECMO support in the cardiac intensive care unit (ICU) of the University Hospital of Munich (LMU) between January 2013 and May 2022, excluding patients with a known history of HIT upon admission. Differences in baseline characteristics and clinical outcome between excluded HIT (positive anti-platelet factor 4 (PF4)/heparin antibody test but negative functional assay) and confirmed HIT (positive anti-PF4/heparin antibody test and positive functional assay) VA-ECMO patients as well as diagnosis and clinical management of HIT were analysed. Results: Among the 373 patients included, anti-PF4/heparin antibodies were detected in 53/373 (14.2%) patients. Functional HIT testing confirmed HIT in 13 cases (3.5%) and excluded HIT in 40 cases (10.7%), corresponding to a prevalence of confirmed HIT of 13/373 (3.5%) [1.6, 5.3] and a positive predictive value (PPV) of 24.5% for the antibody screening test. The platelet course including platelet recovery following argatroban initiation was similar between all groups. One-month mortality in patients with excluded HIT was 14/40 (35%) and 3-month mortality 17/40 (43%), compared to 5/13 (38%) (p > 0.999), and 6/13 (46%) (p > 0.999) in patients with confirmed HIT. Neurological outcome in both groups measured by the cerebral performance category of survivors on hospital discharge was similar, as well as adverse events during VA-ECMO therapy. Conclusions: With a prevalence of 3.5%, HIT is a non-frequent complication in patients on VA-ECMO and was not associated with a higher mortality rate. HIT was ultimately excluded by functional essay in 75% of VA-ECMO patients with clinical suspicion of HIT and positive anti-PF4/heparin antibody test. Argatroban seems to be an appropriate and safe therapeutic option for confirmed HIT-positive patients on VA-ECMO support.

Cardio-hepatic syndrome in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Cardiohepatic syndrome (CHS) has been identified as an important but underrecognized survival predictor in multiple cardiovascular disease entities. The objectives of this study were to evaluate the prevalence and prognostic value of CHS in patients undergoing TAVR for severe aortic stenosis (AS). METHODS: The study included patients with available laboratory parameters of hepatic function who underwent TAVR from July 2013 until December 2019 at our center. CHS was defined as an elevation of at least two of three laboratory cholestasis parameters above the upper limit of normal (bilirubin, alkaline phosphatase, and gamma glutamyl transferase). Study endpoints were three-year survival, technical and device failure (VARC 3), as well as New York Heart Association (NYHA) functional class at follow-up. RESULTS: Among a total of 953 analyzed patients (47.6% females, median age 80.0 [76.0-85.0] years) CHS was present in 212 patients (22.4%). In patients with vs. without CHS, rates of technical (6.1% vs. 8.4%, p = 0.29) and device failure (18.9% vs. 17.3%, p = 0.59) were comparable. NYHA functional class at baseline and follow-up was more severe in patients with CHS. Nevertheless, heart failure symptoms improved from baseline to follow-up irrespective of hepatic function. Three-year survival rates were significantly lower in patients with CHS (49.4 vs. 65.4%, p < 0.001). The predictive value of CHS persisted after adjustment in a multivariable analysis (hazard ratio 1.58, p < 0.01). CONCLUSION: In patients undergoing TAVR, CHS is prevalent in 22% of patients and is associated with increased postinterventional mortality. Thus, CHS should be included in the decision-making process within the TAVR heart team. Cardiohepatic syndrome (CHS) as defined by an elevation of at least two of three laboratory cholestasis parameters above the upper limit of normal was prevalent in 22% of patients undergoing TAVR for severe AS. The presence of CHS was associated with more severe heart failure symptoms and worse three-year survival.

Trends and predictors of radiation exposure in percutaneous coronary intervention: the PROTECTION VIII study.

BACKGROUND: Percutaneous coronary intervention (PCI) is indispensable in cardiology; however, exposure to potentially harmful ionising radiation remains a concern. AIMS: This study was designed to assess the PCI-related radiation dose over the last decade and to identify predictors of increased dose exposure. METHODS: The PROcedural radiaTion dose Exposure in percutaneous Coronary intervenTION (PROTECTION VIII) study included all PCIs reported to a German quality assurance programme between 2008 and 2018. Dose area product (DAP) and radiation time were analysed. Effective dose (ED) was estimated (ED=DAP*k; conversion coefficient k=0.0022 mSv/cGy*cm2). Multivariate linear regression analysis was used to identify predictors associated with a clinically relevant increase of radiation dose (ED ≥1 mSv). RESULTS: We enrolled 3,704,986 patients undergoing PCI (median age 70 years, 30% female). Indications were chronic coronary syndrome (37.5%), unstable angina pectoris and non-ST-segment elevation myocardial infarction (non-STEMI; 33.2%) and STEMI (18.5%). Median DAP was 4,203 (interquartile range [IQR] 2,313-7,300) cGy*cm, ED was 9.2 mSv and median radiation time was 9.2 (IQR 5.8-15.0) min. Within the 10-year period, radiation exposure was reduced by 36% (p<0.001) and resulted in a median DAP of 3,070 cGy*cm (ED 6.8 mSv) in 2018. A significant 5.3-fold variability of median DAP was observed between catheterisation laboratories (p<0.001). We identified patient-related (gender, coronary artery bypass graft surgery, heart failure) and procedure-related (coronary occlusion PCI, ostial lesion PCI, left main PCI, multivessel PCI) predictors of increased radiation dose (all p<0.001). CONCLUSIONS: This radiation dose survey demonstrates a considerable reduction of PCI radiation exposure during the last decade. However, large variability between catheterisation laboratories underlines the need for further radiation dose reduction.

Incidence and Outcome of Patients with Cardiogenic Shock and Detection of Herpes Simplex Virus in the Lower Respiratory Tract.

(1) Herpes simplex virus (HSV) reactivation in critically ill patients can cause infection in the lower respiratory tract, prolonging mechanical ventilation. However, the association of HSV reactivation with cardiogenic shock (CS) is unclear. As CS is often accompanied by pulmonary congestion and reduced immune system activity, the aim of our study was to determine the incidence and outcome of HSV reactivation in these patients. (2) In this retrospective, single-center study, bronchial lavage (BL) was performed on 181 out of 837 CS patients with mechanical ventilation. (3) In 44 of those patients, HSV was detected with a median time interval of 11 days since intubation. The occurrence of HSV was associated with an increase in C-reactive protein and the fraction of inspired oxygen at the time of HSV detection. Arterial hypertension, bilirubin on ICU admission, the duration of mechanical ventilation and out-of-hospital cardiac arrest were associated with HSV reactivation. (4) HSV reactivation could be detected in 24.3% of patients with CS on whom BL was performed, and its occurrence should be considered in patients with prolonged mechanical ventilation. Due to the limited current evidence, the initiation of treatment for these patients remains an individual choice. Dedicated randomized studies are necessary to investigate the efficacy of antiviral therapy.

Systolic or diastolic CT image acquisition for transcatheter aortic valve replacement - An outcome analysis.

BACKGROUND: Computed tomography (CT) imaging is the standard of care before transcatheter aortic valve replacement (TAVR). The aortic annulus undergoes conformational changes during the heart cycle. Therefore, the image acquisition time point can impact prosthesis sizing and fit. Clinical outcome data are lacking. The aim of this study was to compare systolic and diastolic cardiac CT data acquisition with regard to procedural and clinical outcomes in patients undergoing TAVR for severe aortic stenosis (AS). METHODS: Preprocedural high-pitch helical CT datasets were analyzed in 1954 patients undergoing TAVR between 2013 and 2018 â€‹at our center. Patients were stratified into two groups according to the acquisition heart phase (979 systolic and 975 diastolic). The study was approved by the local ethics committee. RESULTS: Median age was 81.6 [interquartile range 77.5-85.8] years and 964 (49.3%) patients were male. No significant difference was found for the Valve Academic Research Consortium-3 (VARC-3) endpoints of technical failure (systolic, 5.1% vs. diastolic, 5.2%, p â€‹= â€‹0.94) or device failure (systolic, 13.7% vs. diastolic, 13.5%, p â€‹= â€‹0.92). There was no difference in paravalvular regurgitation. All-cause 30-day mortality was comparable (systolic, 3.6% [95% confidence interval, 2.4-4.7%] vs. diastolic, 3.6% [2.4-4.8%], p â€‹= â€‹1.00), while 3-year mortality rates were higher in the diastolic group (Society of Thoracic Surgeons score adjusted hazard ratio, 1.25 [1.07-1.46], p â€‹< â€‹0.01). CONCLUSIONS: While the 30-day technical and clinical outcomes after TAVR are comparable between systolic and diastolic CT imaging, diastolic imaging was associated with higher long-term mortality. Therefore, the data support the guideline recommendation of systolic imaging.