Experience from a regional percutaneous coronary intervention center: Aiming to assess and improve quality of care.

INTRODUCTION AND OBJECTIVES: Ischemic heart disease is the single most common cause of death in Europe. Mortality in patients presenting with ST-elevation myocardial infarction (STEMI) is associated with many factors, one of which is the time delay to treatment. The purpose of this work is to analyze the coronary pathway in our region in terms of timing, taking into consideration the place of first medical contact (FMC). METHODS: Consecutive patients admitted to our center with STEMI to undergo percutaneous coronary intervention (PCI) between 2013 and 2022 were analyzed. Age, gender, and time delays were collected. Analysis was performed with IBM SPSS version 28 for a significance level of 0.05. RESULTS: We found that non-PCI centers had a significantly greater FMC to diagnosis delay and diagnosis to wire delay compared to other places of origin. Only 2.2% of patients met the 10-min FMC to diagnosis target; 44.8% met the target of 90 min from diagnosis to wire in transferred patients, while 40.6% met the 60-min target for patients admitted to a PCI center. Median patient, electrocardiogram (ECG) and logistic delays are 92.0±146.0 min, 19.0±146.0 min and 15.5±46.3 min, respectively. CONCLUSION: A significant difference between state-of-the-art targets and reality was found, depending on the place of FMC, with the worst delays in non-PCI centers. Patient delay, ECG delay, FMC to diagnosis and logistic delay are identified as key areas in which to intervene.

Outcomes in Pregnant Women with Valvular Heart Disease from Portuguese-Speaking African Countries Treated in Portugal through an International Agreement of Health Cooperation.

Aims: We performed a clinical audit of maternal and fetal outcomes in pregnant women with valvular heart disease (VHD) from Portuguese-speaking African countries who were transferred for their care, during a twenty-year period, through a memorandum of agreement of international cooperation. Methods and results: A retrospective analysis of 81 pregnancies in 45 patients with VHD (median age 24, interquartile range 22-29 years) from 2000 to 2020 was performed. The main outcome measures were maternal cardiovascular and fetal outcomes. History of rheumatic heart disease was present in 60 (74.1%) pregnancies. Most were in New York Heart Association (NYHA) functional class I or II; at the first evaluation, 35 (43.2%) were on cardiac medication and 49 (60.5%) were anticoagulated. Forty-eight pregnancies had at least one valvular prosthesis, including 38 mechanical heart valves. During pregnancy, deterioration in NYHA functional class occurred in 35 (42.0%), and eight (9.9%) patients required initiation or intensified cardiac medication. Mechanical valve thrombosis complicated four (4.9%) pregnancies, all cases on heparin, and resulted in one maternal death. Haemorrhagic complications happened in 7 (8.6%) anticoagulated patients, in the immediate postpartum or puerperal period. The 81 pregnancies resulted in 56 (69.1%) live births, while miscarriage and fetal malformations occurred in 19 (23.5%) and 12 (14.8%) pregnancies, respectively. In multivariate analysis, vitamin K antagonist therapy was the only independent predictor of an unsuccessful pregnancy (p = 0.048). Conclusion: In a high-income country, successful pregnancy was possible with low rate of maternal events in women with VHD transferred from five low-middle income countries in Africa. The use of anticoagulation with a vitamin K antagonist was associated with an unsuccessful pregnancy.

Efficiency in the cath lab: Pursuing value-based improvements following a sociotechnical approach.

INTRODUCTION: Cardiac catheterization laboratories (cath labs) are commonly designed to achieve the best clinical outcomes while being efficient. This study develops methods to support healthcare managers in analyzing the added value of improvement measures, following a value-based healthcare (VBHC) framework. METHODS: Based on a sociotechnical approach, the applied methods aimed to increase efficiency, reduce duplication of tasks, cut costs, and improve patient care, while creating a more inclusive and trusting decision making process. Within the process of building a multicriteria evaluation model, meetings, interviews, and a decision conference were designed. In parallel, a workflow discrete event simulation model was built to replicate current patient flow and activities and to reproduce the impact of implementing improvement measures and variations in human resources. RESULTS: Four evaluation criteria were considered for workflow improvement: contribution to the efficiency of the admission process, compliance with schedules, agility among procedures, and human resources training. The designed improvement measures sought to 1) improve the start-up of the day, 2) improve pre-exam assessment, and 3) improve staff training. Results prioritize 'Measure 2' and demonstrate that improving human resources allocation increases efficiency and offers significant cost savings. CONCLUSIONS: The proposed solution is in line with VBHC principles, as it improves efficiency and care delivery while optimizing costs. Simulation was an effective tool to replicate and explore possible changes. Multicriteria modeling proved to be a useful approach for a transparent prioritization and redesign of improvements in the healthcare sector.

Not all pseudoaneurysms are femoral-A transcaval transcatheter aortic valve replacement rare complication.

We report a case of a 73-year-old male with multiple comorbidities, including postpoliomyelitis severe scoliosis, referred to our tertiary center due to a severe symptomatic aortic stenosis, considered high risk for surgical aortic valve replacement (AVR). Due to unsuitable femoral and subclavian accesses, the patient underwent a transcaval transcatheter AVR (TAVR) procedure, complicated by the development of an iatrogenic infrarenal aortic pseudoaneurysm with aortocaval fistula. Scoliosis can cause varying anatomic relationships between retroperitoneal vessels and intervertebral disk spaces, which increase the difficulty of the procedure and consequently lead to this vascular complication. Although most aortocaval fistulas close spontaneously after 1 year, the risk of pseudoaneurysm rupture in this critical area was crucial in the decision of a new successful percutaneous aortic stent intervention.

Prevalence and prognostic impact of apical sparing contractility pattern in patients with aortic stenosis referred for transcatheter aortic valve implantation.

INTRODUCTION: Prolonged afterload increase in aortic stenosis (AS) may alter left ventricular (LV) contractility, irrespective of LV ejection fraction (LVEF). The prevalence and morbimortality associated with the apical sparing strain pattern (ASP), a typical finding of cardiac amyloidosis (CA), are not fully understood in patients with AS. We assessed the prevalence of the ASP in patients with severe AS and its clinical impact after transcatheter aortic valve implantation (TAVI). METHODS: Eighty-nine consecutive patients with severe AS and LV hypertrophy referred for TAVI were included. Baseline clinical and echocardiographic data were assessed, including the ASP in bull's eye plots (ASPB), relative apical longitudinal strain (RALS) and EF to global longitudinal strain (EF/GLS) ratio. We analysed all-cause mortality; a composite of all-cause mortality, stroke, and heart failure hospitalizations; and the rate of pacemaker implantation, after TAVI. RESULTS: Mean age was 82 ± 6 years and mean LVEF was 57 ± 10%. ASPB and RALS >1 were present in 43.8% and 24.7% of patients, respectively. Over a median follow-up of 13 months (IQR 6-32), ASPB was associated with higher rates of all-cause mortality (log-rank P=0.001) and was an independent predictor of all-cause mortality in multivariate analysis. Combination of the ASPB and GLS or EF/GLS ratio improved the risk stratification. Patients with RALS >1 were more likely to have new BBB and an indication for pacemaker implantation (P=0.048). CONCLUSION: The ASP, as assessed by the ASPB and RALS, was frequent in patients with AS regardless of the diagnosis of CA. The ASPB may refine risk stratification in patients referred for TAVI.

Creatinine variation improves Zwolle score in selecting low-risk patients after ST-segment elevation myocardial infarction.

BACKGROUND: The Zwolle score is recommended to identify ST-segment elevation myocardial infarction (STEMI) patients with low-risk eligible for early discharge. Our aim was to ascertain if creatinine variation (Δ-sCr) would improve Zwolle score in the decision-making of early discharge after primary percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 3296 patients with STEMI that underwent primary PCI were gathered from the Portuguese Registry on Acute Coronary Syndromes. A Modified-Zwolle score, including Δ-sCr, was created and compared with the original Zwolle score. Δ-sCr was also compared between low (Zwolle score ≤3) and non-low-risk patients (Zwolle score >3). The primary endpoint is 30-day mortality and the secondary endpoints are in-hospital mortality and complications. Thirty-day mortality was 1.5% in low-risk patients (35 patients) and 9.2% in non-low-risk patients (92 patients). The Modified-Zwolle score had a better performance than the original Zwolle score in all endpoints: 30-day mortality (area under curve 0.853 versus 0.810, P < 0.001), in-hospital mortality (0.889 versus 0.845, P < 0.001) and complications (0.728 versus 0.719, P = 0.037). Reclassification of patients lead to a net reclassification improvement of 6.8%. Additionally, both original Zwolle score low-risk patients and non-low-risk patients who had a Δ-sCr ≥0.3 mg/dl had higher 30-day mortality (low-risk: 1% versus 6.6%, P < 0.001; non-low-risk 4.4% versus 20.7%, P < 0.001), in-hospital mortality and complications. CONCLUSION: Δ-sCr enhanced the performance of Zwolle score and was associated with higher 30-day mortality, in-hospital mortality and complications in low and non-low-risk patients. This data may assist the selection of low-risk patients who will safely benefit from early discharge after STEMI.

Short and long-term clinical impact of transcatheter aortic valve implantation in Portugal according to different access routes: Data from the Portuguese National Registry of TAVI.

INTRODUCTION: The Portuguese National Registry of Transcatheter Aortic Valve Implantation records prospectively the characteristics and outcomes of transcatheter aortic valve implantation (TAVI) procedures in Portugal. OBJECTIVES: To assess the 30-day and one-year outcomes of TAVI procedures in Portugal. METHODS: We compared TAVI results according to the principal access used (transfemoral (TF) vs. non-transfemoral (non-TF)). Cumulative survival curves according to access route, other procedural and clinical variables were obtained. The Valve Academic Research Consortium-2 (VARC-2) composite endpoint of early (30-days) safety was assessed. VARC-2 predictors of 30-days and 1-year all-cause mortality were identified. RESULTS: Between January 2007 and December 2018, 2346 consecutive patients underwent TAVI (2242 native, 104 valve-in-valve; mean age 81±7 years, 53.2% female, EuroSCORE-II - EuroS-II, 4.3%). Device success was 90.1% and numerically lower for non-TF (87.0%). Thirty-day all-cause mortality was 4.8%, with the TF route rendering a lower mortality rate (4.3% vs. 10.1%, p=0.001) and higher safety endpoint (86.4% vs. 72.6%, p<0.001). The one-year all-cause mortality rate was 11.4%, and was significantly lower for TF patients (10.5% vs. 19.4%, p<0.002). After multivariate analysis, peripheral artery disease, previous percutaneous coronary intervention, left ventricular dysfunction and NYHA class III-IV were independent predictors of 30-day all-cause mortality. At one-year follow-up, NYHA class III-IV, non-TF route and occurrence of life-threatening bleeding predicted mortality. Kaplan-Meier survival analysis of the first year of follow-up shows decreased survival for patients with an EuroS-II>5% (p<0.001) and who underwent non-TF TAVI (p<0.001). CONCLUSION: Data from our national real-world registry showed that TAVI was safe and effective. The use of a non-transfemoral approach demonstrated safety in the short term. Long-term prognosis was, however, adversely associated with this route, with comorbidities and the baseline clinical status.

Short- and long-term outcome after alcohol septal ablation in obstructive hypertrophic cardiomyopathy: Experience of a reference center.

INTRODUCTION: In obstructive hypertrophic cardiomyopathy (HCM), alcohol septal ablation (ASA) can lead to gradient reduction and symptom improvement. We aimed to assess the efficacy and safety of ASA in a long-term outcome study. METHODS: We analyzed patients who underwent ASA over a seven-year period in a tertiary center. The primary echocardiographic endpoint was >50% reduction in left ventricular outflow tract (LVOT) gradient within a year of the procedure. The primary clinical endpoints were improvement in functional capacity and a combined endpoint of cardiac death and rehospitalization for cardiac cause. The follow-up period was 4.17±2.13 years. RESULTS: A total of 80 patients, mean age 63.9±12.3 years, 30.0% male, were analyzed. Baseline LVOT gradient was 96.3±34.6 mmHg and interventricular septal thickness was 21.6±3.1 mm. Minor complications were observed in 6.3% and major complications in 2.5%, and 8.8% received a permanent pacemaker. The primary echocardiographic endpoint was achieved by 85.7%. At three-month follow-up, LVOT gradient was 25.8±26.0 mmHg in the successful procedure group, compared to 69.2±35.6 mmHg in the other patients (p=0.001). At six months, LVOT gradient was 27.1±27.4 vs. 58.2±16.6 mmHg (p=0.024). Among 74 patients in NYHA class III/IV before the procedure, 57 (77%) improved to NHYA class I/II. The combined primary clinical endpoint (cardiac death and rehospitalization for cardiac cause) was observed in 27.5% (n=22). In the unsuccessful group, the combined endpoint was observed in 54.5%, compared to only 22.7% in the successful group. Only two patients died of cardiac causes. CONCLUSION: ASA is a safe procedure with a high success rate. Patients who achieved significant reductions in LVOT gradient suffered less cardiac death and rehospitalization for cardiac cause.

Spontaneous coronary artery dissection: Still a lot to learn.

Non-atherosclerotic spontaneous coronary artery dissection (SCAD) is an uncommon but probably underdetected pathological substrate for acute coronary syndrome. Clinical associations have been noted, like female gender and young age, but its pathophysiology is not yet fully understood. In this report we describe the case of a 50-year-old woman, without cardiovascular risk factors presenting with non-ST segment elevation myocardial infarction, in whom SCAD was diagnosed. Treatment was initially conservative but due to aggravation of the dissection she eventually underwent a complex percutaneous coronary intervention, requiring implantation of multiple stents, but with a good clinical outcome. The procedure was guided by optical coherence tomography (OCT). Carefully analyzing the combined pictures of OCT and angiography, the dissection appeared to be filled with a clear fluid, but not contrast.

Long-Term Follow Up After Successful Percutaneous Balloon Mitral Valvuloplasty.

BACKGROUND: Percutaneous balloon mitral valvuloplasty (PMV) is the cornerstone of rheumatic mitral stenosis treatment in suitable patients. Previous studies have reported low rates of technical failure and few major complications, with good long-term results after successful PMV. The study aim was to assess the very long-term outcome in patients after PMV performed at a single tertiary center. METHODS: Between 1991 and 2010, a total of 213 consecutive patients underwent PMV at the authors' center. The criteria used to define successful procedure were post-procedural mitral valve area ≥1.5 cm2 and mitral regurgitation less than grade III, without in-hospital major cardiac or cerebrovascular events. The primary endpoint evaluated during the follow up period was the occurrence of cardiovascular death and need for mitral reintervention (percutaneous or surgical). Kaplan-Meier curves were generated to determine event rates, and predictors of major cardiac events in patients with successful PMV were determined using Cox regression analysis. RESULTS: A total of 190 patients (89%) underwent a successful PMV; 88% of these are currently being followed up at the authors' center. During a mean follow up of 11.2 ± 7.3 years, at least one major adverse cardiac event occurred in 25.1% of patients (6.6% all-cause death, 6.6% repeated PMV, 21% required mitral valve surgery). Cumulative event-free survival at 20 years was 54.7 ± 6.3%. On univariate analysis, the echocardiographic score [hazard ratio (HR) = 1.25 (1.00-1.70), p <0.05], left atrial diameter [HR = 1.06 (1.01-1.11), p <0.05] and mean mitral valve gradient soon after the procedure [HR = 1.25 (1.02-1.55), p <0.05] were predictors of events. On multivariate analysis, the echocardiographic mitral valve score before PMV was the only independent predictor of primary outcome [HR=1.75 (1.16-2.64), p<0.01]. CONCLUSIONS: Up to 20 years after successful PMV, a sizeable proportion of patients remained event-free, which confirmed the late efficacy of PMV. Among the present patient cohort, echocardiographic score before PMV was the only independent predictor of long term events.

Conventional and Novel Predictors of Permanent Pacemaker after TAVI in Atrial Fibrillation Patients.

BACKGROUND AND AIM OF THE STUDY: Atrial fibrillation (AF) is common in patients submitted for transcatheter aortic valve implantation (TAVI), and these patients are at higher risk of developing conduction system disturbances requiring pacemaker (PM) implantation. Conventional predictors for PM use in this population have limited applicability. It was hypothesized that a post-procedural heart rate reduction could gauge the degree of atrioventricular (AV) node injury, and that this would be a clinically useful predictor of a need for PM. METHODS: All consecutive patients submitted for TAVI between December 2009 and August 2015 were included prospectively in a local registry. Clinical and electrocardiographic data and procedural details were recorded, and patients in sinus rhythm or with pre-existing PM were excluded. Heart rate (HR) at the start and end of the procedure were used to assess post-procedural HR reduction by calculating the HR ratio (HRratio = HRend/HRstart). The relationship between previously described predictors of PM, HRratio and implantation of a permanent PM during the 30 days after TAVI were analyzed using the Wilcoxon ranksum test and receiver operating characteristic (ROC) curve. RESULTS: A total of 102 patients was submitted for TAVI, 24 of whom had AF and no previous PM. Of the latter 24 patients, 10 (41.6%) received a PM during the 30 days after TAVI. Conventional predictors of permanent PM such as male gender, left anterior hemiblock and right bundle branch block were not significantly associated with PM implantation. The HRratio was significantly lower in patients submitted for PM implantation (median 0.76, IQR 0.68-0.86 versus 1.18, IQR 1.10-1.26; p <0.001; Wilcoxon ranksum test). ROC curve analysis of the HRratio showed a good discrimination for the need of PPM with a c-statistic of 0.93. An optimal cut-off value of 0.9 predicted the need for PM implantation with a sensitivity of 90% and specificity of 92.8% CONCLUSIONS: Conventional predictors of PM after TAVI were not associated with PM implantation in patients with AF. The fall in post-procedural HR was significantly associated with PM implantation, with an HRratio cut-off value of 0.9 accurately predicting a need for PM within 30 days.

Spontaneous Coronary Dissection: "Live Flash" Optical Coherence Tomography Guided Angioplasty.

Optical Coherence tomography (OCT) is a light-based imaging modality which shows tremendous potential in the setting of coronary imaging. Spontaneous coronary artery dissection (SCAD) is an infrequent cause of acute coronary syndrome (ACS). The diagnosis of SCAD is made mainly with invasive coronary angiography, although adjunctive imaging modalities such as computed tomography angiography, IVUS, and OCT may increase the diagnostic yield. The authors describe a clinical case of a young woman admitted with the diagnosis of ACS. The ACS was caused by SCAD detected in the coronary angiography and the angioplasty was guided by OCT. OCT use in the setting of SCAD has been already described and the true innovation in this case was this unique use of OCT. The guidance of angioplasty with live and short images was very useful as it allowed clearly identifying the position of the guidewires at any given moment without the use of prohibitive amounts of contrast.

Coronary optical coherence tomography: A practical overview of current clinical applications.

Coronary optical coherence tomography has emerged as the most powerful in-vivo imaging modality to evaluate vessel structure in detail. It is a useful research tool that provides insights into the pathogenesis of coronary artery disease. This technology has an important clinical role that is still being developed. We review the evidence on the wide spectrum of potential clinical applications for coronary optical coherence tomography, which encompass the successive stages in coronary artery disease management: accurate lesion characterization and quantification of stenosis, guidance for the decision to perform percutaneous coronary intervention and subsequent planning, and evaluation of immediate and long-term results following intervention.

Rotational Atherectomy Combined With Bioresorbable Vascular Scaffold Implantation: A Feasible Approach for Recurrent In-stent Restenosis When Other Therapies Failed.

The optimal treatment for recurrent in-stent restenosis (ISR) is uncertain. Everolimus-eluting bioresorbable vascular scaffold (BVS) use has been reported in a few cases as an interesting alternative, as it avoids long-term metal exposure to coronary circulation. Nevertheless, the underlying neointima and the multiple layers of previously implanted stents with underexpanded struts may contribute to recurrent ISR following BVS placement. We describe a feasible combined treatment for recurrent ISR in 2 patients using neointimal debulking and ablation of underexpanded stents by rotational atherectomy followed by BVS implantation. This conceptually attractive approach has not yet been reported.

Drug-eluting stent thrombosis in the treatment of chronic total coronary occlusions: incidence, presentation and related factors. Data from the CIBELES trial.

INTRODUCTION AND OBJECTIVES: The aim of this study was to analyze the incidence of drug-eluting stent thrombosis (sirolimus or everolimus) in patients with chronic total coronary occlusions (CTO) and to determine its clinical implications and related factors. METHODS: Data from the 12-month follow-up of the 207 patients included in the CIBELES trial with CTO were analyzed. RESULTS: Stent thrombosis occurred in three patients, two definite and one probable (overall thrombosis rate: 1.4%). However, there were no cases of death or Q-wave myocardial infarction. In univariate analysis, patients with a higher incidence of stent thrombosis were those in whom the target vessel was the left anterior descending, who had single-vessel disease, were assigned to treatment with sirolimus-eluting stents, and those with smaller minimum luminal diameter immediately after the procedure. In multivariate analysis, the only independent predictor of stent thrombosis was minimal luminal diameter immediately after the procedure. CONCLUSIONS: The rate of drug-eluting stent thrombosis in patients with CTO is relatively low (1.4%). The only independent predictor of stent thrombosis in this context was minimal luminal diameter after the procedure and the clinical presentation was in all cases relatively benign.

Prosthetic mitral valve thrombosis in pregnancy: from thrombolysis to anticoagulation.

INTRODUCTION: Pregnant women with mechanical prosthetic heart valves are at increased risk for valve thrombosis. Management decisions for this life-threatening complication are complex. Open-heart surgery has a very high risk of maternal mortality and fetal loss. Bleeding and embolic risks associated with thrombolytic agents, the limited efficacy of thrombolysis in certain subgroups, and a lack of experience in the setting of pregnancy raise important concerns. CASE REPORT: We report a case of mitral prosthetic valve thrombosis in early pregnancy, which was successfully treated with streptokinase. Ten years later, the same patient had an uneventful pregnancy, throughout which acenocoumarol was maintained. CONCLUSION: With this case we review the prevention (with oral anticoagulant therapy) and treatment of prosthetic valve thrombosis during pregnancy, which is important for both obstetrician and cardiologist.

[Comment on "1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement. Results from the Italian OBSERVANT study"]. / Comentário a «Resultados a um ano após substituic¸ão valvular aórtica transfemoral percutânea ou cirúrgica. Resultados do estudo italiano OBSERVANT¼

BACKGROUND: There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. OBJECTIVES: This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. METHODS: The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. RESULTS: The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1:10.2 ±9.2%±7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0,99%; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.83). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. CONCLUSIONS: The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. The data need to be confirmed in longer term and dedicated ongoing randomized trials.

[Comment on "1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement. Results from the Italian OBSERVANT study"]. / Comentário a «Resultados a um ano após substituic¸ão valvular aórtica transfemoral percutânea ou cirúrgica. Resultados do estudo italiano OBSERVANT¼

BACKGROUND: There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. OBJECTIVES: This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. METHODS: The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. RESULTS: The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1:10.2 ±9.2%±7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0,99%; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.83). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. CONCLUSIONS: The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. The data need to be confirmed in longer term and dedicated ongoing randomized trials.