Efficacy of a Mobile Health App (eMOTIVA) Regarding Compliance With Cardiac Rehabilitation Guidelines in Patients With Coronary Artery Disease: Randomized Controlled Clinical Trial.

BACKGROUND: Cardiac rehabilitation is fundamental among patients recovering from a coronary event, and mHealth technology may constitute a useful tool that provides guidelines based on scientific evidence in an entertaining, attractive, and user-friendly format. OBJECTIVE: This study aimed to compare the efficacy of an mHealth intervention involving the eMOTIVA app and that of usual care regarding compliance with cardiac rehabilitation guidelines in terms of lifestyle, cardiovascular risk factors, and satisfaction among patients with acute coronary syndrome. METHODS: A randomized controlled clinical trial with a parallel group design was conducted. It included 300 patients (mHealth group, 150; control group, 150) who underwent percutaneous coronary intervention for acute coronary syndrome. Both groups underwent evaluations initially (during hospitalization) and after 3 and 6 months (face-to-face consultations). The eMOTIVA app incorporates a virtual classroom providing audio and video information about a healthy lifestyle, a section for self-recording cardiovascular risk factors, and a section for feedback messages and gamification. The primary outcome variables were (1) adherence to the Mediterranean diet and the frequency of consumption of food; (2) physical activity level, sedentary time, and exercise capacity; (3) smoking cessation and nicotine dependence; (4) level of knowledge about cardiovascular risk factors; and (5) app satisfaction and usability. RESULTS: The study analyzed 287 patients (mHealth group, 145; control group, 142). Most participants were male (207/300, 69.0%), and the mean age was 62.53 (SD 8.65) years. Significant improvements were observed in the mHealth group compared with the control group at 6 months in terms of (1) adherence to the Mediterranean diet (mean 11.92, SD 1.70 vs 8.92, SD 2.66 points; P<.001) and frequency of eating foods (red meat [≤1/week]: 141/143, 97.9% vs 96/141, 68.1%; industrial pastries [<2/week]: 129/143, 89.6% vs 80/141, 56.8%; oily fish [≥2/week]: 124/143, 86.1% vs 64/141, 41.4%; vegetables [≥2/day]: 130/143, 90.3% vs 78/141, 55.3%; fruit [≥2/day]: 128/143, 88.9% vs 85/141, 60.2%; all P<.001); (2) physical activity (mean 2112.66, SD 1196.67 vs 1372.60, SD 944.62 metabolic equivalents/week; P<.001) and sedentary time (mean 8.38, SD 1.88 vs 9.59, SD 2.09 hours; P<.001); (3) exercise capacity (distance: mean 473.49, SD 102.28 vs 447.25, SD 93.68 meters; P=.04); and (4) level of knowledge (mean 117.85, SD 3.83 vs 111.00, SD 7.11 points; P<.001). App satisfaction was high (mean 42.53, SD 6.38 points), and its usability was excellent (mean 95.60, SD 4.03 points). CONCLUSIONS: With the eMOTIVA app, favorable results were obtained in the intervention group in terms of adherence to the Mediterranean diet, frequency of eating certain foods, physical activity, sedentary time, exercise capacity, knowledge level, systolic blood pressure, heart rate, and blood sugar level. Furthermore, participants reported high app satisfaction and rated its usability as excellent. Thus, this innovative tool is very promising. TRIAL REGISTRATION: ClinicalTrials.gov NCT05247606; https://clinicaltrials.gov/study/NCT05247606.

Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial.

BACKGROUND: Coronary heart disease is one of the leading causes of mortality worldwide. Secondary prevention is essential, as it reduces the risk of further coronary events. Mobile health (mHealth) technology could become a useful tool to improve lifestyles. OBJECTIVE: This study aimed to evaluate the effect of an mHealth intervention on people with coronary heart disease who received percutaneous coronary intervention. Improvements in lifestyle regarding diet, physical activity, and smoking; level of knowledge of a healthy lifestyle and the control of cardiovascular risk factors (CVRFs); and therapeutic adherence and quality of life were analyzed. METHODS: This was a randomized controlled trial with a parallel group design assigned 1:1 to either an intervention involving a smartphone app (mHealth group) or to standard health care (control group). The app was used for setting aims, the self-monitoring of lifestyle and CVRFs using measurements and records, educating people with access to information on their screens about healthy lifestyles and adhering to treatment, and giving motivation through feedback about achievements and aspects to improve. Both groups were assessed after 9 months. The primary outcome variables were adherence to the Mediterranean diet, frequency of food consumed, patient-reported physical activity, smoking, knowledge of healthy lifestyles and the control of CVRFs, adherence to treatment, quality of life, well-being, and satisfaction. RESULTS: The study analyzed 128 patients, 67 in the mHealth group and 61 in the control group; most were male (92/128, 71.9%), with a mean age of 59.49 (SD 8.97) years. Significant improvements were observed in the mHealth group compared with the control group regarding adherence to the Mediterranean diet (mean 11.83, SD 1.74 points vs mean 10.14, SD 2.02 points; P<.001), frequency of food consumption, patient-reported physical activity (mean 619.14, SD 318.21 min/week vs mean 471.70, SD 261.43 min/week; P=.007), giving up smoking (25/67, 75% vs 11/61, 42%; P=.01), level of knowledge of healthy lifestyles and the control of CVRFs (mean 118.70, SD 2.65 points vs mean 111.25, SD 9.05 points; P<.001), and the physical component of the quality of life 12-item Short Form survey (SF-12; mean 45.80, SD 10.79 points vs mean 41.40, SD 10.78 points; P=.02). Overall satisfaction was higher in the mHealth group (mean 48.22, SD 3.89 vs mean 46.00, SD 4.82 points; P=.002) and app satisfaction and usability were high (mean 44.38, SD 6.18 out of 50 points and mean 95.22, SD 7.37 out of 100). CONCLUSIONS: The EVITE app was effective in improving the lifestyle of patients in terms of adherence to the Mediterranean diet, frequency of healthy food consumption, physical activity, giving up smoking, knowledge of healthy lifestyles and controlling CVRFs, quality of life, and overall satisfaction. The app satisfaction and usability were excellent. TRIAL REGISTRATION: Clinicaltrials.gov NCT04118504; https://clinicaltrials.gov/study/NCT04118504.

Impact of mHealth application on adherence to cardiac rehabilitation guidelines after a coronary event: Randomised controlled clinical trial protocol.

Background: Coronary disease is the main cause of death around the world. mHealth technology is considered attractive and promising to promote behavioural changes aimed at healthy lifestyle habits among coronary patients. The purpose of this study is to evaluate the efficacy of an mHealth intervention regarding improved results in secondary prevention in patients after an acute myocardial infarction (AMI) or angina in terms of lifestyle, clinical variables and therapeutic compliance. Methods: Randomised clinical trial with 300 patients who underwent a percutaneous coronary intervention (PCI) with stent implant. They will be assigned to either the mHealth group, subject to a self-monitored educational intervention involving an internet application installed on their mobile phone or tablet, or to a control group receiving standard healthcare (150 patients in each arm). The primary outcome variables will be adherence to the Mediterranean diet, physical activity, smoking, therapeutic compliance, knowledge acquired, user-friendliness and satisfaction with the application. Measurements of blood pressure, heart rate, body weight, waist circumference (WC) and the 6-min walk test will be taken. Furthermore, the blood lipid profile, glucose and HbA1c will be evaluated. Clinical interview will be conducted, and validated questionnaires completed. The primary quantitative results will be compared using an analysis of covariance adjusted for age and sex. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of cardiovascular risk factors (CDRFs) and the results after the hospital discharge (major adverse events, treatment compliance and lifestyle). Conclusions: The study will provide evidence about the effectiveness of an mHealth intervention at improving the lifestyle of the participants and could be offered to patients with coronary disease to complement existing services. Trial registration: NCT05247606. [https://ClinicalTrials.gov]. 21/02/2022.

Segmental Arterial Mediolysis in a Patient With Ascending Aorta Dilatation.

A 70-year-old woman consulted us for dyspnea. Echocardiography revealed moderate aortic regurgitation secondary to ascending aorta dilatation. Study was completed with aortic angiography computed tomography, showing stenosis and dissection of several visceral arteries. There were no abnormal inflammatory or autoimmune markers, nor fluorine-18-fluorodeoxyglucose positron emission tomography uptake. Segmental arterial mediolysis was diagnosed.

Coronary Flow Reserve and Myocardial Resistance Reserve Changes After Transcatheter Aortic Valve Implantation in Aortic Stenosis.

Aortic valve stenosis (AS) induces an alteration in hemodynamic conditions that are responsible for coronary microvasculature impairment. Relief of AS by transcatheter aortic valve implantation (TAVI) is expected to improve the coronary artery hemodynamic. We aimed to assess the midterm effects of TAVI in coronary flow reserve (CFR) and myocardial resistance reserve (MRR) by a continuous intracoronary thermodilution technique. At-rest and hyperemic coronary flow was measured by a continuous thermodilution technique in 23 patients with AS and compared with that in 17 matched controls, and repeated 6 ± 3 months after TAVI in 11 of the patients with AS. In patients with AS, absolute coronary flow at rest was significantly greater, and absolute resistance at rest was significantly less, than in controls (p <0.01 for both), causing less CFR and MRR (1.73 ± 0.4 vs 2.85 ± 1.1, p <0.01 and 1.95 ± 0.4 vs 3.22 ± 1.4, p <0.01, respectively). TAVI implantation yielded a significant 35% increase in CFR (p >0.01) and a 39% increase in MRR (p <0.01) driven by absolute coronary flow at rest reduction (p = 0.03). In patients with AS, CFR and MRR determined by continuous thermodilution are significantly impaired. At 6-month follow-up, TAVI improves these indexes and partially relieves the pathophysiologic alterations, leading to a partial restoration of CFR and MRR.

Coronary Obstruction After Transcatheter Aortic Valve Replacement: Insights From the Spanish TAVI Registry.

BACKGROUND: Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied. OBJECTIVES: The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR. METHODS: Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort. RESULTS: Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001). CONCLUSIONS: In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings.

The evolving role of multi-modality imaging in transcatheter tricuspid valve interventions.

Tricuspid valve pathophysiology is not well-understood. Emergence of novel transcatheter tricuspid therapies has fueled the requirements for improved imaging visualization techniques and interventional imaging physician skillsets in guiding these complex transcatheter procedures. There is growing understanding on the clinical significance of tricuspid regurgitation which expanded the interest for percutaneous tricuspid valve interventions. The present review concentrates on three essential aspects of tricuspid valve pathophysiology: anatomical considerations for tricuspid interventions, optimal timing of tricuspid interventions by imaging guidance, and the role of interventional imaging physicians' skillset and knowledge in this field.

Design and Validation of a Scale of Knowledge of Cardiovascular Risk Factors and Lifestyle after Coronary Event.

BACKGROUND: It is important for health professionals to have tools available to assess patients' knowledge of lifestyle and cardiovascular risk factors after they have suffered a coronary event and determine whether educational interventions are effective. This study aims to design and validate a scale to evaluate this knowledge. METHODS: Four-phase instrument design: (A) Conceptual review. (B) Review by experts. (C) Pilot test-retest. (D) Psychometric validation of the final version of the questionnaire with 24 items. A panel of experts performed the content validity. The reliability of the scale was measured using Cronbach's alpha score and criterion validity was evaluated by comparing the total scores for knowledge obtained by the participants among the three education level groups. The construct and dimensional structure validity were assessed using exploratory factor analysis. RESULTS: A total of 143 people participated, 30 in the pilot study and 113 (68% male, 60.2 ± 9 years) in the psychometric validation of version 3 of the scale. A Cronbach's alpha score of 0.887 was reached for this version. The factor analysis showed that the items were distributed into five factors that explained 57% of the variance. Significant differences were observed in the level of knowledge among the patients of the three levels of education (low, moderate and high) (99.20 ± 11.93, 105.92 ± 7.85, 109.78 ± 8.76 points, p = 0.003), as there was a negative correlation between age and knowledge level (r = -0.213, p = 0.024). CONCLUSIONS: The scale presents psychometric properties that are evidence of its reliability and validity. The relationship demonstrated between the level of knowledge and age, sex and level of education shows the importance of emphasizing educational interventions for elderly people and those with a lower level of education.

State-of-the-Art Review: Technical and Imaging Considerations in Novel Transapical and Port-Access Mitral Valve Chordal Repair for Degenerative Mitral Regurgitation.

Degenerative mitral regurgitation (DMR) based on posterior leaflet prolapse is the most frequent type of organic mitral valve disease and has proven to be durably repairable in most cases by chordal repair techniques either by conventional median sternotomy or by less invasive approaches both utilizing extracorporeal circulation and cardioplegic myocardial arrest. Recently, several novel transapical chordal repair techniques specifically targeting the posterior leaflet have been developed as a far less invasive and beating heart (off-pump) alternative to port-access mitral repair. In order to perform a safe and effective minimally invasive mitral chordal repair, thorough knowledge of the anatomy of the mitral valve apparatus and adequate use of multimodality imaging both pre- and intraoperatively are fundamental. In addition, comprehensive understanding of the available novel devices, their delivery systems and the individual procedural steps are required.

Radiation protection for the interventional cardiologist: Practical approach and innovations.

Use of ionizing radiation during cardiac catheterization interventions adversely impacts both the patients and medical staff. In recent years, radiation dose in cardiac catheterization interventions has become a topic of increasing interest in interventional cardiology and there is a strong interest in reducing radiation exposure during the procedures. This review presents the current status of radiation protection in the cardiac catheterization laboratory and summarizes a practical approach for radiation dose management for minimizing radiation exposure. This review also presents recent innovations that have clinical potential for reducing radiation during cardiac interventions.

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure.

OBJECTIVE: Left atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus. METHODS: This multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively. RESULTS: IAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102). CONCLUSION: In the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up.

Early clinical outcomes after transaxillary versus transfemoral TAVI. Data from the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. METHODS: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. RESULTS: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). CONCLUSIONS: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.

Lifestyle and Treatment Adherence Intervention after a Coronary Event Based on an Interactive Web Application (EVITE): Randomized Controlled Clinical Trial Protocol.

Coronary heart disease is one of the main causes of morbimortality around the world. Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve secondary prevention strategies aimed at improving their lifestyle and adherence to treatment. Through a randomized controlled clinical trial, this study aims to evaluate the effect of an intervention involving an online health application supported by a mobile telephone or tablet (mHealth) on lifestyle (diet, physical activity, and tobacco consumption) and treatment adherence among people with coronary heart disease after percutaneous coronary intervention. The sample will comprise 240 subjects (120 in each arm: intervention and usual care). They are assessed immediately and nine months after their hospital discharge about sociodemographic, clinical, CVRF, lifestyle, and treatment adherence characteristics. The educative intervention, involving a follow-up and self-monitoring, will be performed using an online mHealth tool consisting of an application for mobile phones and tablets. The quantitative primary outcomes from the two groups will be compared using an analysis of covariance (ANCOVA) adjusted for age and gender. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of CVRFs, and outcomes after discharge in terms of the use of health services, emergency visits, cardiovascular events and readmissions.

The radioprotective effect of the Cathpax® AIR cabin during interventional cardiology procedures.

BACKGROUND: The use of ionizing radiation during cardiac catheterization interventions adversely impacts the medical staff. Traditional radiation protection equipment is only partially effective. The Cathpax® radiation protection cabin (RPC) has proven to significantly reduce radiation exposure in electrophysiological and neuroradiology interventions. Our objective was to analyze whether the Cathpax® RPC reduces radiation dose in coronary and cardiac structural interventions in unselected real-world procedures. METHODS AND RESULTS: In this nonrandomized all-comers prospective study, 119 consecutive cardiac interventional procedures were alternatively divided into two groups: the RPC group (n = 59) and the non-RPC group (n = 60). No significant changes in the characteristics of patients and procedures, average contrast volume, air kerma (AK), dose area-product (DAP) and fluoroscopy time between both groups were apparent. In the RPC group, the first-operator relative radiation exposure was reduced by 78% at the chest and by 70% at the wrist. This effect was consistent during different types of procedures including complex percutaneous interventions and structural procedures. CONCLUSIONS: Our study demonstrates, for the first time, that the Cathpax® cabin significantly and efficiently reduces relative operator radiation exposure during different types of interventional procedures, confirming its feasibility in a real-world setting.

Long-term clinical, angiographic, and optical coherence tomography findings of Mg-based bioresorbable scaffold in patients with acute coronary syndrome.

BACKGROUND: This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months. METHODS: Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%). RESULTS: At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001). At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse. CONCLUSIONS: At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.

Imaging for Native Mitral Valve Surgical and Transcatheter Interventions.

There has been rapid progress in transcatheter therapies for mitral regurgitation. These developments have elevated the need for the imager to have a core understanding of the functional mitral valve anatomy. Pre- and intraoperative echocardiography for surgical mitral valve repair for mitral regurgitation has defined contemporary interventional imaging in many ways. The central tenets of these principles apply to interventional imaging of transcatheter mitral valve interventions. However, the heightened emphasis on procedural planning and procedural imaging is one of the new challenges posed by transcatheter interventions. This need for accurate and reliable information has required the imager to be agnostic to the imaging modality. Cardiac computed tomography has become critical in procedural planning in this new paradigm. The expanded use of pre-procedural cardiac magnetic resonance to quantify mitral regurgitation and characterize the left ventricle is another illustration of this newer approach. Other illustrations of the new world of interventional imaging include the expanded use of 3-dimensional (3D) transesophageal echocardiography and real-time fusion of echocardiography and fluoroscopy images. Imaging data are also the basis for computational modeling, 3D printing, and artificial intelligence. These technologies are being increasingly explored to improve therapy selection and prediction of procedural outcomes. This review provides an update of the essentials in present interventional imaging for surgical and transcatheter interventions for mitral regurgitation.

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

OBJECTIVES: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. BACKGROUND: The MANTA is a novel plug-based device for large bore arteriotomy closure. METHODS: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. RESULTS: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. CONCLUSION: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.