Reweighting and validation of the hospital frailty risk score using electronic health records in Germany: a retrospective observational study.

BACKGROUND: In the hospital setting, frailty is a significant risk factor, but difficult to measure in clinical practice. We propose a reweighting of an existing diagnoses-based frailty score using routine data from a tertiary care teaching hospital in southern Germany. METHODS: The dataset includes patient characteristics such as sex, age, primary and secondary diagnoses and in-hospital mortality. Based on this information, we recalculate the existing Hospital Frailty Risk Score. The cohort includes patients aged ≥ 75 and was divided into a development cohort (admission year 2011 to 2013, N = 30,525) and a validation cohort (2014, N = 11,202). A limited external validation is also conducted in a second validation cohort containing inpatient cases aged ≥ 75 in 2022 throughout Germany (N = 491,251). In the development cohort, LASSO regression analysis was used to select the most relevant variables and to generate a reweighted Frailty Score for the German setting. Discrimination is assessed using the area under the receiver operating characteristic curve (AUC). Visualization of calibration curves and decision curve analysis were carried out. Applicability of the reweighted Frailty Score in a non-elderly population was assessed using logistic regression models. RESULTS: Reweighting of the Frailty Score included only 53 out of the 109 frailty-related diagnoses and resulted in substantially better discrimination than the initial weighting of the score (AUC = 0.89 vs. AUC = 0.80, p < 0.001 in the validation cohort). Calibration curves show a good agreement between score-based predictions and actual observed mortality. Additional external validation using inpatient cases aged ≥ 75 in 2022 throughout Germany (N = 491,251) confirms the results regarding discrimination and calibration and underlines the geographic and temporal validity of the reweighted Frailty Score. Decision curve analysis indicates that the clinical usefulness of the reweighted score as a general decision support tool is superior to the initial version of the score. Assessment of the applicability of the reweighted Frailty Score in a non-elderly population (N = 198,819) shows that discrimination is superior to the initial version of the score (AUC = 0.92 vs. AUC = 0.87, p < 0.001). In addition, we observe a fairly age-stable influence of the reweighted Frailty Score on in-hospital mortality, which does not differ substantially for women and men. CONCLUSIONS: Our data indicate that the reweighted Frailty Score is superior to the original Frailty Score for identification of older, frail patients at risk for in-hospital mortality. Hence, we recommend using the reweighted Frailty Score in the German in-hospital setting.

Incidence and Prevalence of Borrelia burgdorferi Antibodies in Male Professional Football Players.

OBJECTIVE: Infections with Borrelia burgdorferi can cause Lyme disease with multiorganic involvement such as (myo)carditis or joint manifestations. Musculoskeletal complaints possibly mimicking some of these symptoms are common among elite athletes. This study aimed to determine seroprevalence and incidence of B. burgdorferi antibodies in professional football players. DESIGN: Prospective observational study. SETTING: Healthy professional football players. PARTICIPANTS: Five hundred thirty-five men in the first and second German league. INTERVENTIONS: Two screening assays were used to examine immunoglobulin M (IgM) and immunoglobulin G (IgG) against B. burgdorferi: an enzyme immunoassay (EIA) and a chemiluminescence assay (CLIA). In case of a positive or equivocal result, an immunoblot including in vivo antigens was performed. MAIN OUTCOME MEASURES: Course of IgM and IgG against B. burgdorferi in overall 1529 blood samples. RESULTS: A total of 96.4% of all results were concordant between EIA and CLIA. Considering only samples with identical results in both assays, prevalence was 1.6%. A positive IgM was detected in 2.3%. No player showed any symptoms of Lyme disease. A seroconversion to IgG was not found. Three players developed a positive IgM corresponding to an incidence of 1032/100 000 person-years. Depending on the assay, 49% to 75% of positive or equivocal screening results could not be confirmed by immunoblot. CONCLUSIONS: Seroprevalence and incidence of B. burgdorferi among healthy male professional football players are low. Therefore, infections with B. burgdorferi have to be regarded a rare differential diagnosis in professional football in Central Europe. The low confirmation rate of positive screening assays points to an unspecific immune activation.

Syncope due to recurrent ventricular tachycardias after transcatheter aortic valve implantation with unexpected diagnosis in cardiac computed tomography: a case report.

Background: Delayed coronary obstruction (DCO) is a rare but potentially life-threatening complication after transcatheter aortic valve implantation (TAVI) mostly affecting the left main coronary artery (LMCA) and often caused by prosthesis endothelialization or thrombus formations. Herein, we report an unusual case of a delayed LMCA-obstruction caused by a calcium nodule, which was diagnosed 4 months after TAVI due to recurrent ventricular tachycardia (VT) episodes. Case summary: A 73-year-old patient was readmitted to an external hospital with syncope three months after TAVI. Fast VT could be induced in electrophysiological examination, why the patient received a two-chamber implantable cardioverter defibrillator (ICD). However, after 1 month the patient was readmitted to our department with another syncope. Implantable cardioverter defibrillator records revealed multiple fast VT episodes (200-220 b.p.m.). In addition, the patient reported new-onset exertional dyspnoea (New York Class Association Stage III) and elevated high-sensitive cardiac troponin of 115 ng/L. Due to the symptoms and laboratory markers indicating potential myocardial ischaemia, a cardiac computed tomography angiography (CCTA) was performed. Cardiac computed tomography angiography revealed obstruction of the LMCA likely caused by calcium shift during TAVI. After CCTA-guided percutaneous coronary intervention, patient's course remained uneventful. Discussion: The present case report highlights the role of CCTA as a powerful non-invasive diagnostic tool in complex settings after TAVI. Delayed coronary obstruction as a procedural complication can occur after TAVI and manifest with various symptoms, including new-onset or recurrent VTs, like in the present case. Cardiac computed tomography angiography provided accurate assessment of the implanted prosthesis and detection of DCO, thus guiding the subsequent PCI.

Quantification of Aortic Valve Calcification in Contrast-Enhanced Computed Tomography.

Background: The goal of our study is to evaluate a method to quantify aortic valve calcification (AVC) in contrast-enhanced computed tomography for patients with suspected severe aortic stenosis pre-interventionally. Methods: A total of sixty-five patients with aortic stenosis underwent both a native and a contrast-enhanced computed tomography (CECT) scan of the aortic valve (45 in the training cohort and 20 in the validation cohort) using a standardized protocol. Aortic valve calcification was semi-automatically quantified via the Agatston score method for the native scans and was used as a reference. For contrast-enhanced computed tomography, a calcium threshold of the Hounsfield units of the aorta plus four times the standard deviation was used. Results: For the quantification of aortic valve calcification in contrast-enhanced computed tomography, a conversion formula (691 + 1.83 x AVCCECT) was derived via a linear regression model in the training cohort. The validation in the second cohort showed high agreement for this conversion formula with no significant proportional bias (Bland-Altman, p = 0.055) and with an intraclass correlation coefficient in the validation cohort of 0.915 (confidence interval 95% 0.786-0.966) p < 0.001. Conclusions: Calcium scoring in patients with aortic valve stenosis can be performed using contrast-enhanced computed tomography with high validity. Using a conversion factor led to an excellent agreement, thereby obviating an additional native computed tomography scan. This might contribute to a decrease in radiation exposure.

Comparison of Two Contemporary Quantitative Atherosclerotic Plaque Assessment Tools for Coronary Computed Tomography Angiography: Single-Center Analysis and Multi-Center Patient Cohort Validation.

BACKGROUND: Coronary computed tomography angiography (CCTA) provides non-invasive quantitative assessments of plaque burden and composition. The quantitative assessment of plaque components requires the use of analysis software that provides reproducible semi-automated plaque detection and analysis. However, commercially available plaque analysis software can vary widely in the degree of automation, resulting in differences in terms of reproducibility and time spent. AIM: To compare the reproducibility and time spent of two CCTA analysis software tools using different algorithms for the quantitative assessment of coronary plaque volumes and composition in two independent patient cohorts. METHODS: The study population included 100 patients from two different cohorts: 50 patients from a single-center (Siemens Healthineers, SOMATOM Force (DSCT)) and another 50 patients from a multi-center study (5 different > 64 slice CT scanner types). Quantitative measurements of total calcified and non-calcified plaque volume of the right coronary artery (RCA), left anterior descending (LAD), and left circumflex coronary artery (LCX) were performed on a total of 300 coronaries by two independent readers, using two different CCTA analysis software tools (Tool #1: Siemens Healthineers, syngo.via Frontier CT Coronary Plaque Analysis and Tool #2: Siemens Healthineers, successor CT Coronary Plaque Analysis prototype). In addition, the total time spent for the analysis was recorded with both programs. RESULTS: The patients in cohorts 1 and 2 were 62.8 ± 10.2 and 70.9 ± 11.7 years old, respectively, 10 (20.0%) and 35 (70.0%) were female and 34 (68.0%) and 20 (40.0%), respectively, had hyperlipidemia. In Cohort #1, the inter- and intra-observer variabilities for the assessment of plaque volumes per patient for Tool #1 versus Tool #2 were 22.8%, 22.0%, and 26.0% versus 2.3%, 3.9%, and 2.5% and 19.7%, 21.4%, and 22.1% versus 0.2%, 0.1%, and 0.3%, respectively, for total, noncalcified, and calcified lesions (p < 0.001 for all between Tools #1 and 2 both for inter- and intra-observer). The inter- and intra-observer variabilities using Tool #2 remained low at 2.9%, 2.7%, and 3.0% and 3.8%, 3.7%, and 4.0%, respectively, for total, non-calcified, and calcified lesions in Cohort #2. For each dataset, the median processing time was higher for Tool #1 versus Tool #2 (459.5 s IQR = 348.0-627.0 versus 208.5 s; IQR = 198.0-216.0) (p < 0.001). CONCLUSION: The plaque analysis Tool #2 (CT-guided PCI) encompassing a higher degree of automated support required less manual editing, was more time-efficient, and showed a higher intra- and inter-observer reproducibility for the quantitative assessment of plaque volumes both in a representative single-center and in a multi-center validation cohort.

Planned versus unplanned rotational atherectomy for plaque modification in severely calcified coronary lesions.

BACKGROUND: Evidence on the optimal timing of RA is scarce, although increased periprocedural complications for unplanned procedures have been reported. AIMS: To compare planned versus unplanned use of rotational atherectomy (RA) for plaque modification in patients with severely calcified coronary lesions. METHODS: Procedural and 1-year follow-up data of planned (n = 562 lesions in 448 vessels of 416 patients) and unplanned (n = 490 lesions in 435 vessels of 403 patients) RA between 2008 and 2020 were analyzed using the propensity score methods. The primary composite endpoint was target lesion failure (TLF), defined as cardiovascular death (CVD), target vessel myocardial infarction (TVMI), or target lesion revascularization (TLR). RESULTS: Angiographic success was > 99% in both groups. Fluoroscopy time and contrast volume were significantly lower in planned RA (p < 0.001). Periprocedural complications including slow-flow, coronary dissection, and MI occurred in 4.8% after planned, and in 5.7% after unplanned RA. TLF occurred in 18.5% after planned, and in 14.7% after unplanned RA. Weighted subdistribution hazard ratios for TLFs revealed an unfavorable 1-year outcome for planned RA (sHR 1.62 [1.07-2.45], p = 0.023), which was driven by TLR (sHR 2.01 [1.18-3.46], p = 0.011), but not by CVD, or TVMI. No differences were observed in all-cause mortality. CONCLUSIONS: Unplanned RA was associated with favorable outcome when compared to planned RA. Thus, RA can safely be reserved for lesions that prove untreatable by conventional means. Randomized and prospective trials are needed to evaluate a predominant use of rotational atherectomy as a bailout strategy in the future.

Investigation of factors determining haemodynamic relevance of leaflet thrombosis after transcatheter aortic valve implantation.

AIMS: To determine the conditions under which early hypoattenuated leaflet thickening (HALT) after transcatheter aortic valve implantation (TAVI) becomes haemodynamically relevant. METHODS AND RESULTS: The study included 100 patients (age: 81.5 ± 5.5 years; female 63%), thereof 50 patients with HALT. After anonymization and randomization, blinded readers measured maximum thrombus thickness per prosthesis (MT_pr) and movement restriction (MR_pr) on electrocardiogram (ECG)-gated whole heart cycle computed tomography angiography. These measurements were compared with echocardiographic mean pressure gradient (mPG), its increase from baseline (ΔmPG), and Doppler velocity index (DVI). Haemodynamic valve deterioration (HVD) was defined as mPG > 20 mmHg. Age, body mass index, valve type, valve size, left ventricular ejection fraction, and atrial fibrillation were considered as influencing factors. Multiple regression analysis revealed that only valve size (P = 0.001) and MT_pr (P = 0.02) had a significant influence on mPG. In an interaction model, valve size moderated the effect of MT_pr on mPG significantly (P = 0.004). Sub-group analysis stratified by valve sizes showed a strong correlation between MT_pr and echocardiographic parameters for 23 mm valves (mPG: r = 0.57, ΔmPG: r = 0.68, DVI: r = 0.55, each with P < 0.001), but neither for 26 nor 29 mm valves (r < 0.2, P > 0.2 for all correlations). Six of seven prostheses with HVD had a 23 mm valve diameter, while one had 29 mm (P = 0.02). CONCLUSION: Early HALT rarely causes significant mPG increase. Our study shows that valve size is a key factor influencing the haemodynamic impact of HALT. In small valve sizes, mPG is more likely to increase. Our study is the first to offer in vivo evidence supporting previous in vitro findings on this topic.

Pre-Procedural Assessment of the Femoral Access Route for Transcatheter Aortic Valve Implantation: Comparison of a Non-Contrast Time-of-Flight Magnetic Resonance Angiography Protocol with Contrast-Enhanced Dual-Source Computed Tomography Angiography.

Background: We aimed to evaluate the feasibility of a non-contrast time-of-flight magnetic resonance angiography (TOF-MRA) protocol for the pre-procedural access route assessment of transcatheter aortic valve implantation (TAVI) in comparison with contrast-enhanced cardiac dual-source computed tomography angiography (CTA). Methods and Results: In total, 51 consecutive patients (mean age: 82.69 ± 5.69 years) who had undergone a pre-TAVI cardiac CTA received TOF-MRA for a pre-procedural access route assessment. The MRA image quality was rated as very good (median of 5 [IQR 4-5] on a five-point Likert scale), with only four examinations rated as non-diagnostic. The TOF-MRA systematically underestimated the minimal effective vessel diameter in comparison with CTA (for the effective vessel diameter in mm, the right common iliac artery (CIA)/external iliac artery (EIA)/common femoral artery (CFA) MRA vs. CTA was 8.04 ± 1.46 vs. 8.37 ± 1.54 (p < 0.0001) and the left CIA/EIA/CFA MRA vs. CTA was 8.07 ± 1.32 vs. 8.28 ± 1.34 (p < 0.0001)). The absolute difference between the MRA and CTA was small (for the Bland-Altman analyses in mm, the right CIA/EIA/CFA was -0.36 ± 0.77 and the left CIA/EIA/CFA was -0.25 ± 0.61). The overall correlation between the MRA and CTA measurements was very good (with a Pearson correlation coefficient of 0.87 (p < 0.0001) for the right CIA/EIA/CFA and a Pearson correlation coefficient of 0.9 (p < 0.0001) for the left CIA/EIA/CFA). The feasibility agreement between the MRA and CTA for transfemoral access was good (the right CIA/EIA/CFA agreement was 97.9% and the left CIA/EIA/CFA agreement was 95.7%, Kohen's kappa: 0.477 (p = 0.001)). Conclusions: The TOF-MRA protocol was feasible for the assessment of the access route in an all-comer pre-TAVI population. This protocol might be a reliable technique for patients at an increased risk of contrast-induced nephropathy.

Impact of the Aortic Geometry on TAVI Prosthesis Positioning Using Self-Expanding Valves.

BACKGROUND: The impact of transcatheter heart valve (THV) position on the occurrence of paravalvular leakage and permanent pacemaker implantation caused by new-onset conduction disturbances is well described. The purpose of this study was to investigate the influence of the geometry of the thoracic aorta on the implantation depth after TAVI (transcatheter heart valve implantation) using self-expanding valve (SEV) types. METHODS: We evaluated three-dimensional geometry of the thoracic aorta based on computed tomography angiography (CTA) in 104 subsequently patients receiving TAVI with SEV devices (Evolut R). Prosthesis position was determined using the fusion imaging method of pre- and post-procedural CTA. An implantation depth of ≥4 mm was defined as the cut-off value for low prosthesis position. RESULTS: The mean implantation depth of the THV in the whole cohort was 4.3 ± 3.0 mm below annulus plane. THV position was low in 66 (63.5%) patients and high in 38 (36.5%) patients. After multivariate adjustment none of the aortic geometry characteristics showed an independent influence on the prosthesis position-neither the Sinus of Valsalva area (p = 0.335) nor the proximal aortic arch diameter (p = 0.754) or the distance from annulus to descending aorta (p = 0.309). CONCLUSION: The geometry of the thoracic aorta showed no influence on the positioning of self-expanding TAVI valve types.

Long-Term Follow-Up of Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement.

BACKGROUND: Early hypoattenuated leaflet thickening (HALT) occurs in at least 10% of all transcatheter aortic valve replacement (TAVR) patients. The long-term prognostic impact of HALT is uncertain. OBJECTIVES: The aim of this study was to assess the long-term risk of early HALT post-TAVR. METHODS: We report outcome data from our prospective observational registry with post-TAVR computed tomography angiography performed between May 2012 and December 2017. The outcomes were survival, cardiovascular mortality, ischemic cerebrovascular events, and symptomatic hemodynamic valve deterioration. RESULTS: Early HALT was diagnosed in 115 (16.0%) of 804 patients. During a median follow-up of 3.25 years, survival rates did not differ significantly between patients with and without HALT (Kaplan-Meier 3-year estimates for survival 70.1% vs 74.0%, P = 0.597). The 3-year cardiovascular mortality rate was 13.2% versus 11.3% (with vs without HALT, P = 0.733). The 3-year event rate for cerebrovascular events was 2.0% versus 4.4% (with vs without HALT, P = 0.246), and the 3-year event rate of symptomatic hemodynamic valve deterioration was 9.4% versus 1.5% (with vs without HALT, P < 0.001). Multivariable analysis revealed the following predictors of symptomatic hemodynamic valve deterioration: HALT (HR: 6.10; 95% CI: 2.59-14.29; P < 0.001), the mixed valve-type group (HR: 6.51; 95% CI: 2.38-17.81; P < 0.001), and prosthesis diameter (HR valve size per 3 mm [HR: 0.37; 95% CI: 0.17-0.79]; P = 0.011). CONCLUSIONS: During a median follow-up of more than 3 years, HALT was not associated with mortality or cerebrovascular events. However, we observed an association of HALT with symptomatic hemodynamic valve deterioration.

Performance of Computed Tomography Angiography (CTA) for the Diagnosis of Hypo-Attenuated Leaflet Thickening (HALT).

(1) Background: Early hypo-attenuated leaflet thickening (HALT) is diagnosed by computed tomography angiography (CTA) in approximately 15% of patients undergoing transcatheter aortic valve replacement (TAVR). We sought to investigate the diagnostic performance of CTA for the diagnosis of HALT, focusing on timing data assessment within the cardiac cycle. (2) Methods: The study enrolled 50 patients with and 50 without HALT with available post-TAVR-CTA. The primary objective was to compare the diagnostic performance of CTA readings at specific intervals and time points during the cardiac cycle (entire systole, entire diastole, end-systole, and mid-diastole) versus gold standard (consensus reading by two observers based on multiphase full cardiac cycle data sets). (3) Results: 100 CTAs were independently analysed by two observers blinded to clinical characteristics of the study population and the results from the gold standard reading. Sensitivity and specificity for the diagnosis of HALT were 84%/94% in systole, 87%/92% in diastole, 78%/95% at end-systole, and 80%/94% at mid-diastole. End-systole had the highest positive predictive value (0.88) and positive likelihood ratio (36). Cohen's kappa for interobserver reliability was 0.715 in systole, 0.578 in diastole, 0.650 at end-systole, and 0.517 at mid-diastole. (4) Conclusion: Limiting CTA reading to distinct intervals or time points during the cardiac cycle has good specificity but lowers sensitivity. For a reliable diagnosis of HALT, data sets from a multiphase CTA covering the entire cardiac cycle should be analysed. A double reader approach would be desirable in further studies investigating HALT.

Predictors for low TAVI-prosthesis position assessed by fusion imaging of pre- and post-procedural CT angiography.

BACKGROUND: Low prosthesis position after transcatheter aortic valve implantation (TAVI) is associated with higher rates of new onset conduction disturbances and permanent pacemaker implantations. Purpose of this study was to investigate possible predictors of a low prosthesis position of the SAPIEN 3 (Edwards Lifesciences, Irvine, California, USA) valve type using fusion imaging of pre- and post-procedural computed tomography angiography (CTA). METHODS: CTA fusion imaging was performed in 120 TAVI-patients with 3D-reconstruction of the transcatheter heart valve (THV) position within the device landing zone. A low implantation position was defined according to the manufacturer's recommendations as > 30% of the prosthesis below the native annulus plane. RESULTS: A low THV position was found in 17 patients (14%). Patients with low THV position had less calcification of the annulus region and a smaller annulus size compared to patients with a normal or high THV position (P = 0.003 and 0.041, respectively). The only independent predictor of a low THV position in multivariate logistic regression analysis was the extent of calcification of the cusp region (odds ratio [CI] 0.842 [0.727-0.976], P = 0.022). CONCLUSIONS: Fusion imaging of pre-and post-procedural CTA identified reduced calcification of the cusp region as an independent predictor of a low THV position of the SAPIEN 3. This should be considered when planning the TAVI procedure. Correlation of cusp region calcification and prosthesis position after TAVI.

Prosthesis Position after TAVI with Balloon-Expandable SAPIEN 3 in Bicuspid Aortic Valves.

BACKGROUND: Prior data suggest a correlation between the position of transcatheter heart valves (THV) and the occurrence of complications after transcatheter aortic valve implantation (TAVI) in patients with tricuspid aortic valves (TAV). However, data including a detailed analysis of prosthesis positioning in bicuspid aortic valves (BAV) are limited. Therefore, the purpose of this study was to investigate THV position after TAVI in BAV. METHODS: We evaluated the THV position in 50 BAV and 50 TAV patients (all received the balloon-expandable Sapien 3 prosthesis) using fusion imaging of pre- and post-procedural computed tomography angiography. According to the manufacturers' recommendations, a low implantation position was defined as >30% of the prosthesis below the annulus. RESULTS: THV position was appropriate in the majority of the patients within both groups (90.0% for BAV vs. 96.0% for TAV, p = 0.240). In BAV, we observed a more pronounced THV waist (7.4 ± 4.5% vs. 5.8 ± 3.0%, p = 0.043) and a lower average THV expansion (91.9 ± 12.2% vs. 95.5 ± 2.7% of nominal expansion, p = 0.044). CONCLUSIONS: Accurate positioning in relation to the aortic annulus of the TAVI Sapien 3 prosthesis is possible in patients with BAV with results comparable to TAV. However, there is a more pronounced prosthesis waist and a lower average THV expansion in BAV.

Implantation depth and its influence on complications after TAVI with self-expanding valves.

Prior studies in patients with transcatheter aortic valve implantation (TAVI) demonstrated an influence of transcatheter heart valve (THV) position on the occurrence of new conductions disturbances (CD) and paravalvular leakage (PVL) post TAVI in balloon-expandable valves (BEV). Purpose of this study was to investigate the THV implantation depth and its influence on the occurrence of CD and PVL in self-expanding valves (SEV). We performed fusion imaging of pre- and post-procedural computed tomography angiography in 104 TAVI-patients (all with Evolut R) to receive a 3-D reconstruction of the THV within the native annulus region. The THV length below the native annulus was measured for assessment of implantation depth. Electrocardiograms pre-discharge were assessed for conduction disturbances (CD), PVL was determined in transthoracic echocardiography. The mean implantation depth of the THV in the whole cohort was 4.3 ± 3.0 mm. Using the best cut-off of ≥ 4 mm in receiver operating characteristic curve analysis (sensitivity 83.3%, specificity 60.0%) patients with lower THV position developed more new CD after TAVI (68.2 vs. 23.7%, P < 0.001). A deep THV position was identified as the only predictor for new CD after TAVI (odds ratio [CI] 1.312[1.119-1.539], P = 0.001). The implantation depth showed no influence on the grade of PVL (r = 0.052, P = 0.598). In patients with TAVI using the Evolut R SEV, a lower THV positioning (≥ 4 mm length below annulus) was a predictor for new conduction disturbances. In contrast, implantation depth was not associated with the extent of PVL. Prostheses positions of self-expanding valves and their influence on the occurrence of new conduction disturbances and the grade of paravalvular leakage after TAVI.

Clinical and cardiac magnetic resonance findings in post-COVID patients referred for suspected myocarditis.

OBJECTIVES: We assessed possible myocardial involvement in previously cardiac healthy post-COVID patients referred for persisting symptoms with suspected myocarditis. BACKGROUND: Prior studies suggested myocardial inflammation in patients with coronavirus-induced disease 2019 (COVID-19). However, the prevalence of cardiac involvement among COVID patients varied between 1.4 and 78%. METHODS: A total of 56 post-COVID patients without previous heart diseases were included consecutively into this study. All patients had positive antibody titers against SARS-CoV-2. Patients were referred for persistent symptoms such as chest pain/discomfort, shortness of breath, or intolerance to activity. All patients underwent standardized cardiac assessment including electrocardiogram (ECG), cardiac biomarkers, echocardiography, and cardiac magnetic resonance (CMR). RESULTS: 56 Patients (46 ± 12 years, 54% females) presented 71 ± 66 days after their COVID-19 disease. In most patients, the course of COVID-19 was mild, with hospital treatment being necessary in five (9%). At presentation, patients most often reported persistent fatigue (75%), chest pain (71%), and shortness of breath (66%). Acute myocarditis was confirmed by T1/T2-weighed CMR and elevated NTpro-BNP levels in a single patient (2%). Left ventricular ejection fraction was 56% in this patient. Additional eight patients (14%) showed suspicious CMR findings, including myocardial edema without fibrosis (n = 3), or non-ischemic myocardial injury suggesting previous inflammation (n = 5). However, myocarditis could ultimately not be confirmed according to 2018 Lake Louise criteria; ECG, echo and lab findings were inconspicuous in all eight patients. CONCLUSIONS: Among 56 post-COVID patients with persistent thoracic complaints final diagnosis of myocarditis could be confirmed in a single patient using CMR.

Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR.

OBJECTIVES: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR). BACKGROUND: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences. METHODS: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included. RESULTS: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement. CONCLUSIONS: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.

Influence of prosthesis-related factors on the occurrence of early leaflet thrombosis after transcatheter aortic valve implantation.

AIMS: Early leaflet thrombosis (LT) is a well-described phenomenon after transcatheter aortic valve implantation (TAVI) with an incidence around 15%. Data about predictors of LT are scarce. The purpose of the study was to investigate the influence of prosthesis-related factors on the occurrence of LT. MATERIALS AND RESULTS: Fusion imaging of pre- and post-procedural computed tomography angiography was performed in 55 TAVI patients with LT and 140 selected patients as control groups (85 patients in an unmatched and 55 in a matched control) to obtain a 3D reconstruction of the transcatheter heart valve (THV) within the native annulus region. All patients received a balloon-expandable Sapien 3 THV. The THV length above and below the native annulus was measured within the fused images to assess the implantation depth. The deployed THV area was quantified on three heights (left ventricular outflow tract end, stent centre, and aortic end) to determine the average expansion of the prosthesis as percent of the nominal area. We also calculated the extent of prosthesis waist in percent of maximum area. After multivariate adjustment, the extent of THV waist [odds ratio (OR) per 10% (confidence interval, CI) 0.636 (0.526-0.769), P < 0.001] as prosthesis-related factor and previous oral anticoagulation [OR (CI) 0.070 (0.020-0.251), P < 0.001] had significant, independent influence on the occurrence of LT. The implantation depth showed no influence on LT manifestation (P = 0.704). CONCLUSION: Besides the absence of previous oral anticoagulation, a less pronounced waist of the implanted THV was a prosthesis-position-related independent predictor of LT after TAVI using the Sapien 3.

Long-term follow-up of patients with contained annulus ruptures after TAVI: the EuropeaN COntained RupturE (ENCORE) registry.

AIMS: The purpose of this registry was to determine the long-term outcomes in patients with asymptomatic contained annulus rupture (CR) as a rare complication of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: The ENCORE registry is a multicentre registry (six centres across Europe) of patients with CR diagnosed on post-TAVI computed tomography angiography (CTA) or transoesophageal echocardiography (TEE). A total of 21 patients (mean age 81.9±4.1 years, 81% balloon-expandable TAVI prostheses) were diagnosed with CR (mean size of lesions was 15.3±6.9 × 8.5±3.3 × 8.5±2.3 mm). Seventeen were diagnosed among a total of 1,602 consecutive routine post-TAVI CTA (incidence 1.1%), two in TEE and two in post-TAVI CTA (each conducted due to suspicion of peri-interventional complications). During a mean follow-up of 2.3±1.7 years (cumulative 48.6 patient-years), nine patients (43%) died from non-cardiac causes. None of the patients exhibited symptoms or underwent interventional treatment related to the CR; no sudden cardiac death occurred. A follow-up CTA, performed in eleven patients 240±176 days post TAVI, revealed stable CR findings in seven, regression in one, and remission in three patients. CONCLUSIONS: The results of our international multicentre registry demonstrate favourable long-term outcomes of CR after TAVI supporting a watch-and-wait strategy in these patients.

Fusion imaging of pre- and post-procedural computed tomography angiography in transcatheter aortic valve implantation patients: evaluation of prosthesis position and its influence on new conduction disturbances.

AIMS: The purpose of this study was to evaluate prosthesis position by fusion of pre- and post-transcatheter aortic valve implantation (TAVI) computed tomography angiography (CTA) images and to investigate its influence on the occurrence of new conduction disturbances (CD). METHODS AND RESULTS: We performed CTA fusion imaging in 120 TAVI patients (Edwards Sapien 3) on a standard image post-processing workstation to obtain a 3D reconstruction of the transcatheter heart valve (THV) position within the native annulus region. Optimal implantation depth of the THV was defined according to the manufacturers recommendations as 70-80% of the prosthesis above (aortic) and 20-30% below (ventricular) the native annulus plane. Pre- and post-interventional electrocardiograms (ECGs) were assessed for the development of new CD. THV position was found to be within, above, or below the prespecified margins in 32 patients (27%), 71 patients (59%), and 17 patients (14%), respectively. Interobserver reliability was high for fusion measurements [e.g. median THV position 0.983, 95% confidence interval (CI): 0.935-0.996]. Patients with low stent position were significantly more likely to develop new CD compared with patients with optimal or high stent position (P = 0.039). Independent predictors of CD in multivariate analysis were low THV position [odds ratio (CI): 1.362 (1.093-1.698), P = 0.006] and calcification of the device landing zone [odds ratio (CI): 1.149 (1.024-1.289), P = 0.018]. CONCLUSION: Fusion imaging of pre- and post-TAVI-CTA allows for the exact evaluation of THV position in relation to the native annulus plane. A low THV position as assessed by fusion imaging is associated with the development of new CD post-TAVI.

Haemodynamic prosthetic valve performance in patients with early leaflet thrombosis after transcatheter aortic valve implantation.

AIMS: We sought to evaluate haemodynamic prosthetic valve performance in patients with early leaflet thrombosis (LT) after transcatheter aortic valve implantation (TAVI). METHOD AND RESULTS: In this retrospective observational study, 59 patients with LT underwent clinical and echocardiographic follow-up. During a median follow-up of 383 days 41 patients received antiplatelet therapy (APT-group) and 18 patients oral anticoagulation due to atrial fibrillation (AC-group). The mean pressure gradient (MPG) at baseline did not differ between groups (P = 0.875). During follow-up, MPG increased from 11.0 (9.0; 14.5) to 13.0 mmHg (10.0; 18.0)_ in the APT-group (P = 0.010) but remained unchanged in the AC-group (P = 0.297) resulting in a significantly higher MPG in patients on antiplatelet therapy (P = 0.024). Similarly, change of MPG per year was significantly higher in the APT-group [1.4 (- 0.9; 7.0) vs. - 0.6 (- 2.5; 1.1), P = 0.014]. Seven (17.1%) patients in the APT-group and two(11.1%) patients in the AC-group developed MPGs of at least 20 mmHg (P = 0.558). Three patients (7.3%) in the APT- and none in the AC-group developed symptoms of obstructive thrombosis (P = 0.239). In our adjusted analysis, only lack of anticoagulation was significantly associated with change in gradients during follow-up (P = 0.012). CONCLUSIONS: In patients with LT, antiplatelet-, but not anticoagulant therapy, was associated with significant increases in MPG, which may lead to symptomatic obstructive valve thrombosis.