Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock.

BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear. METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation. RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09). CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

Baseline NT-proBNP predicts acute kidney injury following transcatheter aortic valve implantation.

BACKGROUND/PURPOSE: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI. METHODS: All consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed. RESULTS: We included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03-1.91]). CONCLUSIONS: Routine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI.

[Angina and no obstruction on coronary angiography : New approaches to the diagnosis and treatment of vasomotor disorders]. / Angina pectoris ohne Stenosen in der Koronarangiographie : Neue Wege zur Diagnose und Therapie von Vasomotionsstörungen.

BACKGROUND: Clinical management of patients with angina and no obstructive coronary artery disease (ANOCA) is still challenging. This scenario affects up to 50% of patients undergoing diagnostic coronary angiography due to suspected coronary artery disease. Many patients report a long and debilitating history before adequate diagnostics and management are initiated. OBJECTIVES: This article describes the current recommendations for diagnostic assessments and treatment in patients with ANOCA. Focus is placed on invasive diagnostics in the catheter laboratory, pharmacological/interventional treatment as well as the patient journey. RESULTS: In patients with ANOCA, the current European Society of Cardiology (ESC) guidelines suggest that invasive assessments using acetylcholine and adenosine for the diagnosis of an underlying coronary vasomotor disorder should be considered. Acetylcholine is used to diagnose coronary spasm, whereas adenosine is used in conjunction with a wire-based assessment for the measurement of coronary flow reserve and microvascular resistance. The invasive assessments allow the determination of what are referred to as endotypes (coronary spasm, impaired coronary flow reserve, enhanced microvascular resistance or a combination thereof). Establishing a diagnosis is helpful to: (a) initiate targeted treatment to improve quality of life, (b) reassure the patient that a cardiac cause is found and (c) to assess individual prognosis. CONCLUSIONS: Currently, patients with ANOCA are often not adequately managed. Referral to specialised centres is recommended to prevent long and debilitating patient histories until expertise in diagnosis and treatment becomes more widespread.

VARC-3 defined outcome of valve-in-valve transcatheter aortic valve implantation in stentless compared with stented aortic bioprostheses.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable alternative to redo surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in stented bioprosthetic valves (ST); stentless bioprostheses (SL) lack fluoroscopic markers and could be more challenging for ViV-TAVI. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce. We compared patient characteristics, procedural outcomes, and 5-year mortality of patients with SL versus ST aortic bioprosthetic valve failure undergoing ViV-TAVI. METHODS: Patients undergoing ViV-TAVI between 2007 and 2022 (52.5% of cases after 2015) at 3 German centers were included in this analysis. The co-primary outcome measures were technical success, device success, and early safety defined by VARC-3. Mortality was assessed up to 5 years. RESULTS: Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age, sex, clinically relevant baseline comorbidities, and surgical risk. Technical success (SL: 83.7% versus ST: 79.9%, p = 0.552), device success (SL: 67.4% versus ST: 54.3%, p = 0.105), and early safety (SL: 74.4% versus ST: 66.5%, p = 0.296) were comparable between groups. The 30-day mortality (SL: 7.0% versus ST: 2.6%, p = 0.136) and 5-year mortality rates (SL: 23.3% versus ST: 24.6%, p = 0.874) were not significantly different between groups. CONCLUSION: SL and ST ViV-TAVI led to comparable short-term outcomes according to VARC-3- defined endpoints and similar mortality rates up to 5 years of follow-up. VARC-3 defined technical success, device success, and early safety as well as 5-year all-cause mortality in patients undergoing valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) into stentless (SL) compared with stented (ST) failed aortic bioprostheses.

Timing and treatment strategies according to SCAI classification in cardiogenic shock.

In patients with cardiogenic shock (CS), particularly those with acute myocardial infarction (AMI), evidence suggests that timely diagnosis and treatment interventions are critical in the prevention of haemo-metabolic compromise. Temporary mechanical circulatory support (tMCS) has shown potential in facilitating revascularization and recovery of patients with acute myocardial infarction cardiogenic shock (AMI-CS). Timing of treatment strategies for CS patients needs to be optimized for use of tMCS devices that are applicable to this heterogeneous patient population. Here, the latest evidence as well as the gaps in knowledge surrounding the role of time in the management of patients with CS is summarized.

In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.

BACKGROUND: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI). METHODS: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed. RESULTS: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001). CONCLUSIONS: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality.

Assessment and Therapeutic Modulation of Heart Rate Variability: Potential Implications in Patients with COVID-19.

Cardiac damage has been attributed to SARS-CoV-2-related pathology contributing to increased risk of vascular events. Heart rate variability (HRV) is a parameter of functional neurocardiac integrity with low HRV constituting an independent predictor of cardiovascular mortality. Whether structural cardiac damage translates into neurocardiac dysfunction in patients infected with SARS-CoV-2 remains poorly understood. Hypothesized mechanisms of possible neurocardiac dysfunction in COVID-19 comprise direct systemic neuroinvasion of autonomic control centers, ascending virus propagation along cranial nerves and cardiac autonomic neuropathy. While the relationship between the autonomic nervous system and the cytokine cascade in general has been studied extensively, the interplay between the inflammatory response caused by SARS-CoV-2 and autonomic cardiovascular regulation remains largely unclear. We reviewed the current literature on the potential diagnostic and prognostic value of autonomic neurocardiac function assessment via analysis of HRV including time domain and spectral analysis techniques in patients with COVID-19. Furthermore, we discuss potential therapeutic targets of modulating neurocardiac function in this high-risk population including HRV biofeedback and the impact of long COVID on HRV as well as the approaches of clinical management. These topics might be of particular interest with respect to multimodal pandemic preparedness concepts.

Impact of Enterococci vs. Staphylococci Induced Infective Endocarditis after Transcatheter Aortic Valve Implantation.

BACKGROUND: The two most common organisms found in infective endocarditis following transcatheter aortic valve implantation (TAVI-IE) are enterococci (EC-IE) and staphylococci (SC-IE). We aimed to compare clinical characteristics and outcomes of patients with EC-IE and SC-IE. METHODS: TAVI-IE patients from 2007 to 2021 were included in this analysis. The 1-year mortality was the primary outcome measure of this retrospective multi-center analysis. RESULTS: Out of 163 patients, 53 (32.5%) EC-IE and 69 (42.3%) SC-IE patients were included. Subjects were comparable with regard to age, sex, and clinically relevant baseline comorbidities. Symptoms at admission were not significantly different between groups, except for a lower risk for presenting with septic shock in EC-IE than SC-IE. Treatment was performed in 78% by antibiotics alone and in 22% of patients by surgery and antibiotics, with no significant differences between groups. The rate of any complication, in particular heart failure, renal failure, and septic shock during treatment for IE, was lower in EC-IE compared with SC-IE (p < 0.05). In-hospital (EC-IE: 36% vs. SC-IE: 56%, p = 0.035) and 1-year mortality (EC-IE: 51% vs. SC-IE: 70%, p = 0.009) were significantly lower in EC-IE compared with SC-IE. CONCLUSIONS: EC-IE, compared with SC-IE, was associated with a lower morbidity and mortality. However, absolute numbers are high, a finding that should trigger further research in appropriate perioperative antibiotic management and improvement of early IE diagnosis in the case of clinical suspicion.

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

BACKGROUND: Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. METHODS: One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 µg/mm²) with the clinically proven PCB (SeQuent Please, 3 µg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. CONCLUSIONS: This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996318, NCT03242096.

Data for validation and adjustment of APACHE II score in cardiogenic shock patients treated with a percutaneous left ventricular assist device.

A precise prognosis is of imminent importance in intensive care medicine. This article provides data showing the overestimation of intrahospital mortality by APACHE II score in various subgroups of cardiogenic shock patients treated with a percutaneous left ventricular assist device. The data set includes additional baseline characteristics regarding age, pre-existing diseases, characteristics of coronary artery disease, characteristics of cardiopulmonary resuscitation, and hemodynamic parameter not included in the APACHE II score. Further data were provided which characterize derivation and validation group. Both groups were used for adjustment of the APACHE II approach. The data are supplemental to our original research article titled "Predictive value of the APACHE II score in cardiogenic shock patients treated with a percutaneous left ventricular assist device" (Mierke et al., IJC Heart & Vasculature. 40 (2022) 101013. https://doi.org/10.1016/j.ijcha.2022.101013).

Predictive value of the APACHE II score in cardiogenic shock patients treated with a percutaneous left ventricular assist device.

Background: The APACHE II score assesses patient prognosis in intensive care units. Different disease entities are predictable by using a specific factor called Diagnostic Category Weight (DCW). We aimed to validate the prognostic value of the APACHE II score in patients treated with a percutaneous left ventricular assist device because of refractory cardiogenic shock (CS). Methods: From the Dresden Impella Registry, we analyzed 180 patients receiving an Impella CP®. The main outcome was the observed intrahospital mortality ( S ^ ( t h o s p ) ), which was compared to the predicted mortality estimated by the APACHE II score. Results: The APACHE II score, which was 33.5 ± 0.6, significantly overestimated intrahospital mortality ( S ^ ( t h o s p ) 54.4 ± 3.7% vs. APACHE II 74.6 ± 1.6%; p < 0.001). Nevertheless, the APACHE II score showed an acceptable accuracy to predict intrahospital mortality (ROC AUC 0.70; 95% CI 0.62-0.78). Thus, we adapted the formula for calculation of predicted mortality by adjusting DCW. The total registry cohort was randomly divided into derivation group for calculation of adjusted DCW and validation group for testing. Intrahospital mortality was much more precisely predicted using the adjusted DCW compared to the conventional DCW (difference of predicted and observed mortality: -4.7 ± 2.4% vs. -23.2 ± 2.3%; p < 0.001). The new calculated DCW was -1.183 for the total cohort. Conclusion: The APACHE II score has an acceptable accuracy for the prediction of intrahospital mortality but overestimates its total amount in CS patients. Adjustment of the DCW can lead to a much more precise prediction of prognosis.

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues. AIMS: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80). METHODS: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR. RESULTS: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (area under the curve [AUC] 0.93; 95% confidence interval [CI]: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively. CONCLUSIONS: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.

Proteome Dynamics and Bioinformatics Reveal Major Alterations in the Turnover Rate of Functionally Related Cardiac and Plasma Proteins in a Dog Model of Congestive Heart Failure.

Protein pool turnover is a critically important cellular homeostatic component, yet it has been little explored in the context of heart failure (HF) pathophysiology. We used in vivo 2H labeling/proteome dynamics for the nonbiased discovery of turnover alterations involving functionally linked cardiac and plasma proteins in canine tachypacing-induced HF, an established preclinical model of dilated cardiomyopathy. Compared with controls, dogs with congestive HF displayed bidirectional turnover changes of 28 cardiac proteins, that is, a reduced half-life of several key enzymes involved in glycolysis, homocysteine metabolism and glycogenesis, and increased half-life of proteins involved in proteolysis. Changes in plasma proteins were more modest: only 5 proteins, involved in various functions including proteolysis inhibition, hemoglobin, calcium and ferric iron binding, displayed increased or decreased turnover rates. In other dogs undergoing cardiac tachypacing, we infused for 2 weeks the myokine Follistatin-like protein 1, known for its ameliorative effects on HF-induced alterations. Proteome dynamics proved very sensitive in detecting the partial or complete prevention, by Follistatin-like protein 1, of cardiac and plasma protein turnover alterations. In conclusion, our study unveiled, for the first time in a large mammal, numerous HF-related alterations that may serve as the basis for future mechanistic research and/or as conceptually new molecular markers.

Long-term Follow-up After Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become the standard of care in the majority of patients with symptomatic severe aortic stenosis. Data on long-term mortality and durability of transcatheter heart valves (THVs) beyond 5 years are limited. Our study aimed to assess elderly and high-risk patients' long-term outcomes treated with TAVR in a prospective single-centre registry focusing on the durability of THVs. METHODS: We included 795 patients with severe calcific aortic stenosis treated by transfemoral TAVR between 2006 and 2011. Echocardiography was performed at baseline; discharge; 1 year; and afterward, annually, until the longest available follow-up. Mortality rates were estimated for 1, 5, 6, 7, and 8 years. The rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) were assessed in accordance with consensus definitions. Outcome measures were adjudicated according to Valve Academic Research Consortium-2 (VARC-2). RESULTS: Median (interquartile range) follow-up time was 1345 (316; 2015) days. One-year, 5-year, 6-year, 7-year, and 8-year overall mortality was 25.4%, 59.0%, 64.6%, 67.9%, and 69.2%, respectively. At 8 years, no significant differences in mortality were found comparing self-expanding vs balloon-expandable valves (69.5% vs 68.0%, P = 0.709) and postdilatation (PD) vs no-PD (69.4% vs 69.2%, P = 0.363). SVD was detected in 26 patients (3.3%), and 19 (2.4%) of the 795 patients had evidence of BVF during follow-up. CONCLUSIONS: Our study demonstrates good long-term results for high-risk patients who were alive up to 8 years after TAVR.

CONTEXTE: Le remplacement valvulaire aortique par cathéter (RVAC) est maintenant la norme de soins dans la majorité des cas de sténose de l'aorte grave symptomatique. On dispose de peu de données sur la mortalité à long terme et sur la durabilité des valves cardiaques transcathéter (VCT) au-delà de 5 ans. Nous avons donc évalué les résultats à long terme, notamment la durabilité des VCT, chez les patients âgés et les patients exposés à un risque élevé traités par RVAC figurant dans un registre prospectif unicentrique. MÉTHODOLOGIE: Notre étude comprenait 795 patients présentant une sténose calcifiée de l'aorte grave traitée par RVAC transfémoral entre 2006 et 2011. Une échocardiographie a été réalisée au départ, à la sortie de l'hôpital, 1 an plus tard et tous les ans par la suite, jusqu'au suivi le plus long disponible. Les taux de mortalité à 1, 5, 6, 7 et 8 ans ont été estimés. Les taux de détérioration structurelle des valves (DSV) et de défaillance de la bioprothèse valvulaire (DBV) ont été évalués selon des définitions établies par consensus. Les mesures des résultats ont été confirmées selon les critères du VARC-2 (Valve Academic Research Consortium-2). RÉSULTATS: La durée médiane (intervalle interquartile) du suivi était de 1 345 (316 à 2 015) jours. Les taux de mortalité globaux s'établissaient comme suit : taux à 1 an : 25,4 %; à 5 ans : 59,0 %; à 6 ans : 64,6 %; à 7 ans : 67,9 % et à 8 ans : 69,2 %. À 8 ans, on n'a noté aucune différence significative en ce qui concerne la mortalité chez les patients ayant reçu une valve auto-expansible comparativement à ceux ayant reçu une valve expansible par ballonnet (69,5 % vs 68,0 %; p = 0,709) et chez ceux ayant subi une post-dilatation ou non (69,4 % vs 69,2 %; p = 0,363). Une DSV a été détectée chez 26 patients (3,3 %), et 19 (2,4 %) des 795 patients ont présenté des signes de DBV pendant la période de suivi. CONCLUSIONS: Notre étude a révélé de bons résultats à long terme chez les patients présentant un risque élevé qui étaient toujours en vie 8 ans après le RVAC.

Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.

OBJECTIVES: To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). METHODS: Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. RESULTS: Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. CONCLUSION: A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.

Remote proctoring for high-risk coronary interventions with mechanical circulatory support during COVID-19 pandemic and beyond.

Remote proctoring by advanced digital technologies may help to overcome pandemic, geographic, and resource-related constraints for mentoring and educating interventional cardiology skills. We present a case series of patients undergoing high-risk percutaneous coronary intervention (HR-PCI) with mechanical circulatory support (MCS) guided by remote proctoring to gain insights into a streaming technology platform with regard to video/audio quality, visibility of all structural and imaging details, and delay in transmission. According to our experience, remote proctoring appears to be a reliable, quick, and resource-conserving way to disseminate, educate and improve MCS-supported HR-PCI with implications far beyond the COVID-19 pandemic.

Left-Atrial Appendage Thrombosis in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Data about the impact of left-atrial appendage thrombosis (LAAT) on early safety and mortality in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) are scarce. We aimed to investigate the prevalence and predictors of LAAT and the outcome associated with this condition in patients treated by TF-TAVI. METHODS: Retrospective data analysis was derived from a prospective single-centre registry comparing patients with and without LAAT regarding early safety at 30 days, according to Valve Academic Research Consortium-2 (VARC-2) and 2-year mortality. RESULTS: LAAT was found in 7.6% of the whole cohort (n = 2527) and in 16.6% in those patients with known pre-existing atrial fibrillation (AF cohort, n = 1099). Compared with controls, patients with LAAT were sicker, indicated by a higher Society of Thoracic Surgeons (STS) score and burden of comorbidities. Neither VARC-2-defined early safety at 30 days nor the rate of stroke was different between LAAT and controls in both the whole (early safety: 29.2% vs 24.2%, P = 0.123; stroke: 5.9% vs 4.7%, P = 0.495) and AF cohort (early safety: 29.1% vs 22.9%, P = 0.072; stroke: 5.6% vs 3.3%, P = 0.142). Evaluating the whole cohort in a univariate analysis, the 2-year mortality was significantly higher in LAAT compared with controls (hazard ratio, 1.41; 95% confidence interval, 1.07-1.86; P = 0.014). However, multivariate analysis of the whole cohort and the AF cohort revealed no association between LAAT and 2-year mortality. CONCLUSIONS: LAAT was frequent in patients undergoing TF-TAVI- in particular, in patients with histories of AF-but it was not associated with an increase in periprocedural complications and did not predict 2-year mortality.

Valve-in-Valve for Degenerated Transcatheter Aortic Valve Replacement Versus Valve-in-Valve for Degenerated Surgical Aortic Bioprostheses: A 3-Center Comparison of Hemodynamic and 1-Year Outcome.

Background As transcatheter aortic valve replacement (TAVR) is expected to progress into younger patient populations, valve-in-TAVR (ViTAVR) may become a frequent consideration. Data on ViTAVR, however, are limited. This study investigated the outcome of ViTAVR in comparison to valve in surgical aortic valve replacement (ViSAVR), because ViSAVR is an established procedure for higher-risk patients requiring repeated aortic valve intervention. Methods and Results Clinical and procedural data of patients who underwent ViTAVR at 3 sites in the United States and Germany were retrospectively compared with data of patients who underwent ViSAVR at Cedars-Sinai Medical Center, according to Valve Academic Research Consortium-2 criteria. A total of 99 consecutive patients, 52.5% women, with a median Society of Thoracic Surgeons score of 7.2 were identified. Seventy-four patients (74.7%) underwent ViSAVR, and 25 patients (25.3%) underwent ViTAVR. Balloon-expandable devices were used in 72.7%. ViSAVR patients presented with smaller index devices (21.0 versus 26.0 mm median true internal diameter; P<0.001). Significantly better postprocedural hemodynamics (median prosthesis mean gradient, 12.5 [interquartile range, 8.8-16.2] versus 16.0 [interquartile range, 13.0-20.5] mm Hg; P=0.045) were observed for ViTAVR compared with the ViSAVR. Device success, however, was not different (79.2% and 66.2% for ViTAVR and ViSAVR, respectively; P=0.35), as were rates of permanent pacemaker implantation (16.7% versus 5.4%; P=0.1). One-year-mortality was 9.4% and 13.4% for ViTAVR and ViSAVR, respectively (log-rank P=0.38). Conclusions Compared with ViSAVR, ViTAVR provides acceptable outcomes, with slightly better hemodynamics, similar device success rates, and similar 1-year mortality.