Cardiopulmonary Exercise Testing Distinguishes between Post-COVID-19 as a Dysfunctional Syndrome and Organ Pathologies.

(1) Background: Dyspnea is one of the most frequent symptoms among post-COVID-19 patients. Cardiopulmonary exercise testing (CPET) is key to a differential diagnosis of dyspnea. This study aimed to describe and classify patterns of cardiopulmonary dysfunction in post-COVID-19 patients, using CPET. (2) Methods: A total of 143 symptomatic post-COVID-19 patients were included in the study. All patients underwent CPET, including oxygen consumption, slope of minute ventilation to CO2 production, and capillary blood gas testing, and were evaluated for signs of limitation by two experienced examiners. In total, 120 patients reached a satisfactory level of exertion and were included in further analyses. (3) Results: Using CPET, cardiovascular diseases such as venous thromboembolism or ischemic and nonischemic heart disease were identified as either cardiac (4.2%) or pulmonary vascular (5.8%) limitations. Some patients also exhibited dysfunctional states, such as deconditioning (15.8%) or pulmonary mechanical limitation (9.2%), mostly resulting from dysfunctional breathing patterns. Most (65%) patients showed no signs of limitation. (4) Conclusions: CPET can identify patients with distinct limitation patterns, and potentially guide further therapy and rehabilitation. Dysfunctional breathing and deconditioning are crucial factors for the evaluation of post-COVID-19 patients, as they can differentiate these dysfunctional syndromes from organic diseases. This highlights the importance of dynamic (as opposed to static) investigations in the post-COVID-19 context.

Symptom burden correlates to impairment of diffusion capacity and exercise intolerance in long COVID patients.

After acute infection with the SARS-CoV-2 virus, a considerable number of patients remains symptomatic with pathological changes in various organ systems. This study aimed to relate the physical and mental burden of symptoms of long COVID patients to the findings of a somatic evaluation. In patients with persistent long COVID symptoms three months after acute infection we assessed physical and mental health status using the SF-36 questionnaire. The cohort was dichotomised by the results (upper two quartiles vs. lower to quartiles) and compared with regard to transthoracic echocardiography, body plethysmography (including diffusion capacity), capillary blood gas analysis and 6-min walk test (6-MWT). From February 22 to September 13, 2021, 463 patients were prospectively examined, of which 367 completed the SF-36 questionnaire. A positive correlation between initial disease severity (need for hospitalization, intensive care medicine) and resulting symptom burden at follow-up could be demonstrated. Patients with impaired subjective physical and mental status were significantly more likely to be women. There was a significant correlation between symptom severity and reduced exercise tolerance in the 6-MWT (495.6 ± 83.7 m vs 549.7 ± 71.6 m, p < 0.001) and diffusion capacity for carbon monoxide (85.6 ± 14.3% of target vs 94.5 ± 14.4, p < 0.001). In long COVID patients, initial disease severity is correlated with symptom burden after at least 3 months of follow-up. Highly symptomatic long COVID patients show impaired diffusion capacity and 6-MWT despite average or mildly affected mechanical lung parameters. It must be further differentiated whether this corresponds to a transient functional impairment or whether it is a matter of defined organ damage.

Imaging Challenges in Patients with Severe Aortic Stenosis and Heart Failure: Did We Find a Way Out of the Labyrinth?

Aortic stenosis (AS) is the most frequent degenerative valvular disease in developed countries. Its incidence has been constantly rising due to population aging. The diagnosis of AS was considered straightforward for a very long time. High gradients and reduced aortic valve area were considered as "sine qua non" in diagnosis of AS until a growing body of evidence showed that patients with low gradients could also have severe AS with the same or even worse outcome. This completely changed the paradigm of AS diagnosis and involved large numbers of parameters that had never been used in the evaluation of AS severity. Low gradient AS patients may present with heart failure (HF) with preserved or reduced left ventricular ejection fraction (LVEF), associated with changes in cardiac output and flow across the aortic valve. These patients with low-flow low-gradient or paradoxical low-flow low-gradient AS are particularly challenging to diagnose, and cardiac output and flow across the aortic valve have become the most relevant parameters in evaluation of AS, besides gradients and aortic valve area. The introduction of other imaging modalities in the diagnosis of AS significantly improved our knowledge about cardiac mechanics, tissue characterization of myocardium, calcium and inflammation burden of the aortic valve, and their impact on severity, progression and prognosis of AS, not only in symptomatic but also in asymptomatic patients. However, a variety of novel parameters also brought uncertainty regarding the clinical relevance of these indices, as well as the necessity for their validation in everyday practice. The aim of this review is to summarize the prevalence of HF in patients with severe AS and elaborate on the diagnostic challenges and advantages of comprehensive multimodality cardiac imaging to identify the patients that may benefit from surgical or transcatheter aortic valve replacement, as well as parameters that may help during follow-up.

Long COVID: Distinction between Organ Damage and Deconditioning.

(1) Background: Long COVID syndrome refers to long-term sequelae of the novel viral disease, which occur even in patients with initially mild disease courses. However, there is still little evidence of the actual organic consequences and their frequency, and there is no standardized workup to diagnose long COVID syndrome yet. In this study, we aim to determine the efficiency of a stepwise diagnostic approach for reconvalescent COVID-19 patients with cardiopulmonary symptoms. (2) Methods: The diagnostic workup for long COVID syndrome included three steps. In the first step, the focus was on broad applicability (e.g., blood tests and body plethysmography). In the second step, cardiopulmonary exercise testing (CPET) and cardiac MRI (CMR) were used. The third step was tailored to the individual needs of each patient. The observation period lasted from 22 February to 14 May 2021. (3) Results: We examined 231 patients in our long COVID unit (mean [SD] age, 47.8 [14.9], 132 [57.1%] women). Acute illness occurred a mean (SD) of 121 (77) days previously. Suspicious findings in the first visit were seen in 80 (34.6%) patients, prompting further diagnostics. Thirty-six patients were further examined with CPET and CMR. Of those, 16 (44.4%) had pathological findings. The rest had functional complaints without organ damage ("functional long COVID"). Cardiopulmonary sequelae were found in asymptomatic as well as severe courses of the initial COVID-19 disease. (4) Conclusions: A structured diagnostic pathway for the diagnosis of long COVID syndrome is practicable and rational in terms of resource allocation. With this approach, manifest organ damage can be accurately and comprehensively diagnosed and distinguished from functional complaints.

Catheter ablation for atrial fibrillation in HFpEF patients-A propensity-score-matched analysis.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF) are both common conditions associated with high morbidity and mortality, especially if they coexist. Catheter ablation (CA) for AF has been shown recently to induce reverse remodeling and improve symptoms in HFpEF patients. The aim of this study was to compare outcomes of AF patients with HFpEF, who either underwent CA for AF or received medical therapy only. METHODS AND RESULTS: We included all AF patients with HFpEF according to current guidelines treated at our hospital between 2013 and 2018. Out of 6614 AF patients, we identified 127 with confirmed HFpEF. After applying propensity score matching to balance patient groups, 43 patients treated by CA and 43 patients receiving medical treatment were compared. Patients in the CA group underwent a mean of 1.5 ± 0.8 ablation procedures. Arrhythmia recurrence occurred significantly less frequently in the CA group (hazard ratio [HR]: 0.47; 95% CI: 0.25-0.87; p = .016). The primary endpoint, a composite of heart failure hospitalization and death, was reduced significantly by CA compared to medical therapy (HR: 0.30; 95% CI: 0.13-0.67; p = .003). This was driven by a decrease in heart failure hospitalization. Clinical and echocardiographic parameters of HFpEF improved significantly only after CA. Remarkably, reassessment of diagnostic HFpEF criteria at the end of follow-up demonstrated HFpEF resolution in 15 out of 43 patients (35%) treated by CA and only 4 out of 43 patients (9%) treated medically (p = .008). CONCLUSION: Catheter ablation for AF in HFpEF patients in comparison to medical therapy decreases heart failure hospitalization, heart failure symptoms, and improves diastolic function. AF ablation should be considered in patients with HFpEF and concomitant AF.

The Predictive Value of Right Ventricular Longitudinal Strain in Pulmonary Hypertension, Heart Failure, and Valvular Diseases.

Right ventricular (RV) systolic function has an important role in the prediction of adverse outcomes, including mortality, in a wide range of cardiovascular (CV) conditions. Because of complex RV geometry and load dependency of the RV functional parameters, conventional echocardiographic parameters such as RV fractional area change (FAC) and tricuspid annular plane systolic excursion (TAPSE), have limited prognostic power in a large number of patients. RV longitudinal strain overcame the majority of these limitations, as it is angle-independent, less load-dependent, highly reproducible, and measure regional myocardial deformation. It has a high predictive value in patients with pulmonary hypertension, heart failure, congenital heart disease, ischemic heart disease, pulmonary embolism, cardiomyopathies, and valvular disease. It enables detection of subclinical RV damage even when conventional parameters of RV systolic function are in the normal range. Even though cardiac magnetic resonance-derived RV longitudinal strain showed excellent predictive value, echocardiography-derived RV strain remains the method of choice for evaluation of RV mechanics primarily due to high availability. Despite a constantly growing body of evidence that support RV longitudinal strain evaluation in the majority of CV patients, its assessment has not become the part of the routine echocardiographic examination in the majority of echocardiographic laboratories. The aim of this clinical review was to summarize the current data about the predictive value of RV longitudinal strain in patients with pulmonary hypertension, heart failure and valvular heart diseases.

The Prognostic Importance of Right Ventricular Longitudinal Strain in Patients with Cardiomyopathies, Connective Tissue Diseases, Coronary Artery Disease, and Congenital Heart Diseases.

Right ventricular (RV) systolic function represents an important independent predictor of adverse outcomes in many cardiovascular (CV) diseases. However, conventional parameters of RV systolic function (tricuspid annular plane excursion (TAPSE), RV myocardial performance index (MPI), and fractional area change (FAC)) are not always able to detect subtle changes in RV function. New evidence indicates a significantly higher predictive value of RV longitudinal strain (LS) over conventional parameters. RVLS showed higher sensitivity and specificity in the detection of RV dysfunction in the absence of RV dilatation, apparent wall motion abnormalities, and reduced global RV systolic function. Additionally, RVLS represents a significant and independent predictor of adverse outcomes in patients with dilated cardiomyopathy (CMP), hypertrophic CMP, arrhythmogenic RV CMP, and amyloidosis, but also in patients with connective tissue diseases and patients with coronary artery disease. Due to its availability, echocardiography remains the main imaging tool for RVLS assessment, but cardiac magnetic resonance (CMR) also represents an important additional imaging tool in RVLG assessment. The findings from the large studies support the routine evaluation of RVLS in the majority of CV patients, but this has still not been adopted in daily clinical practice. This clinical review aims to summarize the significance and predictive value of RVLS in patients with different types of cardiomyopathies, tissue connective diseases, and coronary artery disease.

Atrial fibrillation ablation in heart failure patients: improved systolic function after cryoballoon pulmonary vein isolation.

AIMS: Atrial fibrillation (AF) and heart failure (HF) are the most common cardiac diseases and often coexist leading to increased mortality and morbidity compared with AF patients without HF. As shown previously, AF ablation using radio frequency (RF) in HF patients leads to a reduction of AF burden, an increase of left ventricular ejection fraction (LVEF) and consequently to reduced hospitalization and mortality. Previous AF ablation studies on HF patients have been liberal about additional targets beyond pulmonary vein isolation (PVI). Thus, the aim of this study was to assess systematically the impact of a straightforward PVI-only strategy on LVEF, NYHA functional class, and cardiovascular hospitalization rate in HF patients. METHODS AND RESULTS: Out of 414 consecutive patients undergoing PVI, only with the cryoballoon 113 patients with reduced LVEF [mean: 38.4 ± 10.8%, reduced ejection fraction (rEF) group] and 301 patients with normal LVEF (>55%) at baseline were identified [normal ejection fraction (nEF) group]. Remarkably, even though freedom from arrhythmia recurrence after 1 year was significantly lower in the rEF group (64.9%) compared with the nEF group (71.2%, P = 0.036), mean LVEF improved from 38.4 ± 10.8% to 52.5 ± 17.2% (P < 0.001) after cryoballoon ablation in the rEF group. Accordingly, HF-related symptoms as well as hospitalization rate declined significantly in the rEF group during follow-up compared with baseline. CONCLUSIONS: The results of the present study suggest that catheter ablation restricted to a straightforward PVI-only strategy using the cryoballoon leads to improved left ventricular ejection fraction as well as improvement of NYHA functional class and increased freedom from cardiovascular rehospitalization.

Restoration of sinus rhythm by pulmonary vein isolation improves heart failure with preserved ejection fraction in atrial fibrillation patients.

AIMS: Atrial fibrillation (AF) in patients suffering from heart failure with preserved ejection fraction (HFpEF) is associated with increased symptoms and higher morbidity and mortality. Effective treatment strategies for this patient population have not yet been established. METHODS AND RESULTS: We analysed clinical outcomes and echocardiographic parameters of patients with AF and HFpEF who underwent pulmonary vein isolation (PVI). Out of 374 PVI patients, we identified 35 patients suffering from concomitant HFpEF. Freedom from atrial tachyarrhythmia (AT) after 1 year was 80%. Heart failure symptoms assessed by New York Heart Association class significantly improved from 2.7 ± 0.7 to 1.7 ± 0.9 (P < 0.001). We observed regression of diastolic dysfunction by echocardiography 12 months after the index procedure. Moreover, 15 patients (42.9%) experienced complete resolution of HFpEF after a single ablation procedure. Multivariate logistic regression revealed absence of AT recurrence as an independent predictor of recovery from HFpEF (hazard ratio 11.37, 95% confidence interval 1.70-75.84, P = 0.009). Furthermore, resolution of HFpEF by achieving freedom from AT recurrence by PVI, including multiple procedures, led to a significant reduction of hospitalizations. CONCLUSION: Our results suggest that restoration of sinus rhythm by PVI in HFpEF patients with concomitant AF induces reverse remodelling, improvement of symptoms, resolution of HFpEF and subsequently decrease of hospitalizations. Randomized controlled trials are warranted to confirm our results.

Predictors of left ventricular reverse remodeling after percutaneous therapy for mitral regurgitation with the MitraClip system.

OBJECTIVES: To investigate the predictors and clinical impact of left ventricular reverse remodeling (LVRR) after MitraClip (MC) therapy for degenerative (DMR) and functional mitral regurgitation (FMR). BACKGROUND: MC therapy induces LVRR in patients with mitral regurgitation (MR) at high-risk for surgery. However, specific data on predictors of LVRR therapy are limited. METHODS: This study included 164 patients treated by MC implantation with complete clinical and echocardiographic evaluation at baseline, 6 months, and 12 months. LVRR was defined as a decrease of ≥10% of the left ventricular end-diastolic diameter after 12 months and was found in 49% of the patients. RESULTS: LVRR was associated with significantly reduced event rate 2 years after MC procedure. In the total cohort, multivariate regression analysis determined severe recurrent/residual MR after 12 months (p = .010, odds ratio [OR] = 0.26), male gender (p = .050, OR = 0.49) and left ventricular ejection fraction (LVEF) <20% (p = .046, OR = 0.24) as predictors of absence of LVRR. In the subgroup analysis according to etiology of MR, multivariate regression analysis revealed severe recurrent/residual MR after 12 months (p = .04, OR = 0.184) to inversely predict LVRR only in the DMR subgroup. In FMR, residual severe tricuspid regurgitation (TR) inversely predicts LVRR (p = .032, OR = 0.361). CONCLUSIONS: LVRR occurs in half of the patients after MC and is associated with reduced MACCE rates at follow-up. Combined information on residual/recurrent MR, baseline LVEF and gender predict LVRR after MC procedure. While residual/recurrent MR is the independent predictor for the absence of LVRR in DMR, in FMR only severe residual TR independently predict LVRR.

Automated sleep stage classification based on tracheal body sound and actigraphy.

The current gold standard for assessment of most sleep disorders is the in-laboratory polysomnography (PSG). This approach produces high costs and inconveniences for the patients. An accessible and simple preliminary screening method to diagnose the most common sleep disorders and to decide whether a PSG is necessary or not is therefore desirable. A minimalistic type-4 monitoring system which utilized tracheal body sound and actigraphy to accurately diagnose the obstructive sleep apnea syndrome was previously developed. To further improve the diagnostic ability of said system, this study aims to examine if it is possible to perform automated sleep staging utilizing body sound to extract cardiorespiratory features and actigraphy to extract movement features. A linear discriminant classifier based on those features was used for automated sleep staging using the type-4 sleep monitor. For validation 53 subjects underwent a full-night screening at Ulm University Hospital using the developed sleep monitor in addition to polysomnography. To assess sleep stages from PSG, a trained technician manually evaluated EEG, EOG, and EMG recordings. The classifier reached 86.9% accuracy and a Kappa of 0.69 for sleep/wake classification, 76.3% accuracy and a Kappa of 0.42 for Wake/REM/NREM classification, and 56.5% accuracy and a Kappa of 0.36 for Wake/REM/light sleep/deep sleep classification. For the calculation of sleep efficiency (SE), a coefficient of determination r2 of 0.78 is reached. Additionally, subjects were classified into groups of SEs (SE≥40%, SE≥60% and SE≥80%). A Cohen's Kappa >0.61 was reached for all groups, which is considered as substantial agreement. The presented method provides satisfactory performance in sleep/wake and wake/REM/NREM sleep staging while maintaining a simple setup and offering high comfort. This minimalistic approach may address the need for a simple yet reliable preliminary sleep screening in an ambulatory setting.

Transfemoral aortic valve implantation is more successful with the Edwards Sapien 3 compared with the Edwards XT for the treatment of symptomatic severe aortic stenosis.

BACKGROUND: Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular AR. AIM: To compare a new-generation and a late-generation balloon-expandable transcatheter heart valve. METHODS: In this study, 100 consecutive patients treated with the ES3 for symptomatic native severe aortic stenosis were compared with 100 consecutive patients treated with the Edwards Sapien XT valve (EXT); all valves were implanted via transfemoral access. We compared residual AR, rate of permanent pacemaker implantation, device success according to the second Valve Academic Research Consortium (VARC-2) criteria and 30-day follow-up. RESULTS: With the ES3, the risk of moderate/severe AR was lower (0% vs 3%), the risk of mild AR was lower (31% vs 40%) and the final result with no AR was higher (P=0.07). The mean aortic gradient was significantly higher with the ES3 (12.2±4.6 vs 9.4±3.9mmHg; P<0.01). Device success according to the VARC-2 criteria was high with the ES3 and the EXT (97% vs 95%; P=0.48). Pacemaker implantation because of higher-grade atrioventricular block was similar: 9.3% after ES3 implantation and 6.9% after EXT implantation (P=0.56). There was significantly less major or life-threatening bleeding with the ES3: 5% vs 14% (P=0.03) and 0% vs 8% (P<0.01), respectively. After 30 days, the VARC-2 early-safety endpoint was significantly lower with the ES3 (P<0.01). CONCLUSIONS: In conclusion, TAVI with the ES3 in patients with symptomatic severe aortic stenosis was associated with no moderate/severe AR, a trend towards a lower rate of mild AR, a significantly lower rate of major or life-threatening bleeding and early safety according to VARC-2 criteria within 30 days compared with the EXT.

Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria.

AIMS: To compare early device success, procedural success, and 30-day safety endpoint according to the new Mitral Valve Academic Research Consortium criteria (MVARC) in severe primary and secondary mitral regurgitation (MR) patients. METHODS AND RESULTS: A total of 210 patients were enrolled; 105 patients with primary MR were compared with 105 patients with secondary MR. All patients were highly symptomatic (New York Heart Association III/IV 79.0% vs 87.6%). Decision for MitraClip therapy was done by the heart team. Patients were on optimal medical heart failure therapy. Preprocedural MR grade was 3.4 ± 0.5 in secondary MR vs 3.7 ± 0.4 in primary MR (P<.001). Device success according to MVARC was high in both groups (93.3% in secondary MR vs 94.3% in primary MR), treated with 1.4 ± 0.6 vs 1.3 ± 0.5 MitraClips (P=.14). Reduction of New York Heart Association class from baseline to 30-day follow-up was 1.7 ± 1.1 in secondary MR vs 2.2 ± 1.2 in primary MR (P<.01). Rate of MVARC minor vascular complications was low. Thirty-day safety endpoint according to MVARC criteria was low in both groups (4.8% in secondary MR vs 5.7% in primary MR (P=non-significant). CONCLUSION: Percutaneous mitral valve repair using the MitraClip device is safe and effective in patients with primary and secondary MR, with a high early device success rate and low 30-day safety endpoint according to the MVARC criteria.

The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation.

BACKGROUND: Residual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR. METHODS AND RESULTS: We compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069). We evaluated post-procedural AR, rate of permanent pacemaker implantation, device success, and 30-day clinical outcome according to the criteria of the Second Valve Academic Research Consortium (VARC-2). Frequency of post-procedural moderate or severe AR was significantly lower with ES3 compared to CV (0% vs. 20%, p<0.01), none or trace AR significantly higher with ES3 (69% vs. 38%, p<0.01) as well as device success (97% vs. 73%, p<0.01). There was a significantly lower need for permanent pacemaker implantation with ES3 compared with CV (14% vs. 31%, p<0.01). Cardiovascular mortality at 30 days was significantly lower with ES3 (0% vs. 6%, p=0.01), and the combined endpoint "early safety" was met significantly less with ES3 (10% vs. 21% with CV, p=0.03). CONCLUSIONS: Transfemoral TAVI with the ES3 compared with the CV was associated with a significantly lower rate of moderate or severe AR, significantly lower need for pacemaker implantation, and a significantly higher rate of device success according to VARC-2.

Transfemoral aortic valve implantation with the repositionable Lotus valve for treatment of patients with symptomatic severe aortic stenosis: results from a single-centre experience.

AIMS: The aim of the study was to evaluate the procedural and 30-day results for the repositionable Lotus valve in patients undergoing transfemoral aortic valve implantation in a single-centre experience. METHODS AND RESULTS: We prospectively enrolled 110 patients with severe symptomatic aortic stenosis (NCT02162069). All procedures were performed without general anaesthesia by the transfemoral approach. Patients were followed for 30 days. Patients received the 23 mm (n=20), 25 mm (n=43) or 27 mm (n=47) Lotus device. Mean oversizing in relation to annulus or left ventricular outflow tract (LVOT) did not differ among groups. There was no residual moderate or severe aortic regurgitation. The rate of mild aortic regurgitation was low at 9.1%. There was no valve embolisation, no need for a second valve and no conversion to surgery. The need for a new pacemaker implantation due to complete (third degree) or type II (Mobitz) second degree atrioventricular block was 24.1%, excluding patients with previously implanted devices. Within 30 days the rates of all-cause mortality and stroke were low. CONCLUSIONS: In patients with severe aortic stenosis, transfemoral TAVI with the repositionable Lotus valve was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complications and mortality within 30 days.

Transfemoral valve-in-valve implantation for degenerated bioprosthetic aortic valves using the new balloon-expandable Edwards Sapien 3 valve.

BACKGROUND: Surgical aortic bioprosthetic valves deteriorate 10 to 20 years after operation. Valve-in-valve implantation with first generation transcatheter aortic valve implantation (TAVI) devices has shown to be feasible. We report a first case series with the new Edwards Sapien 3 valve for transfemoral aortic valve-in-valve implantation. METHODS AND RESULTS: Nine patients underwent valve-in-valve-TAVI with the Edward Sapien 3 valve. Seven patients presented with severe aortic stenosis and two patients with severe aortic insufficiency of surgical aortic bioprosthesis. Procedures were performed in local anaesthesia under fluoroscopic guidance with pre-procedural 256 multislice computed tomography for procedural planning. In all patients the Edwards Sapien 3 was successfully implanted decreasing the mean echocardiographic gradient from 42 ± 22mmHg to 18 ± 7mmHg (p < 0.01). Device success according to VARC 2 criteria was achieved in 8 out of 9 patients. There was no death, coronary obstruction, use of second valve or need for post-dilation. Furthermore there were no access-site complications, no minor or major bleedings or vascular injury. Two patients required pacemaker implantation within the first 7 days after valve-in-valve TAVI. Post-procedural echocardiography demonstrated no or trace aortic regurgitation. Early safety events within 30 days according to VARC-2 definition occurred in 1 patient. CONCLUSIONS: The Edwards Sapien 3 valve for treatment of failed surgical bioprostheses is feasible and is associated with no relevant post-procedural aortic regurgitation and a low risk of access site complications. © 2016 Wiley Periodicals, Inc.

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.

AIMS: The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. METHODS AND RESULTS: 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. CONCLUSIONS: In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02162069.

Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk.

AIMS: The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk. METHODS AND RESULTS: 101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3-6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p < 0.05) while ischemic or thrombotic events were similar. CONCLUSION: Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score. Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events.

Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve.

BACKGROUND: The rate of paravalvular aortic insufficiency (AI) with transcatheter aortic valve implantation (TAVI) with first generation devices was higher compared with surgical replacement. Residual AI after TAVI has been linked to an increased mortality rate. We compared two second generation TAVI devices - the repositionable Lotus valve with the balloon-expandable Edwards Sapien 3 valve - regarding procedural and 30 day outcome. METHODS AND RESULTS: In 78 patients with severe aortic stenosis undergoing transfemoral TAVI we evaluated post-procedural paravalvular AI, device success and early safety according to VARC criteria. Valve size was based on a 256-multislice computed tomography. Patients were followed for 30 days. The Lotus valve (N = 26) and the Edwards Sapien 3 valve (N = 52) were implanted under fluoroscopic guidance. Baseline characteristics were similar between groups. Perimeter derived annulus diameter did not differ with 25.7 ± 1.6mm for Lotus and 25.2 ± 2.1mm for Edwards Sapien 3 patients. After TAVI aortography and transthoracic echocardiography revealed no moderate or severe AI. The rate of mild AI was 12% for Lotus and 15% for Edwards Sapien 3 (p = 0.62). There were no deaths, stroke, annulus rupture or coronary obstruction. Device success was 96% and 98% (p = 0.61), early safety according to VARC 11.5% in both groups (p = 1.0) and the need for pacemaker implantation 27% and 4% (p < 0.003), respectively. CONCLUSIONS: TAVI with second-generation devices was associated with no moderate or severe AI and a low rate of mild AI. Device success was high for Lotus and Edwards Sapien 3 while the need for permanent pacemaker was significantly higher with the Lotus valve.