OPTImized coronary interventions eXplaIn the bEst cliNical outcomEs (OPTI-XIENCE) study. Rationale and study design.

INTRODUCTION: Clinical events may occur after percutaneous coronary intervention (PCI), particularly in complex lesions and complex patients. The optimization of PCI result, using pressure guidewire and intracoronary imaging techniques, may reduce the risk of these events. The hypothesis of the present study is that the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with an unrestricted use of intracoronary tools that allow PCI optimization. METHODS AND ANALYSIS: Observational prospective multicenter international study, with a follow-up of 12 months, including 1064 patients treated with a cobalt­chromium everolimus-eluting stent. Inclusion criteria include any of the following: Lesion length > 28 mm; Reference vessel diameter < 2.5 mm or > 4.25 mm; Chronic total occlusion; Bifurcation with side branch ≥2.0 mm;Ostial lesion; Left main lesion; In-stent restenosis; >2 lesions stented in the same vessel; Treatment of >2 vessels; Acute myocardial infarction; Renal insufficiency; Left ventricular ejection fraction <30 %; Staged procedure. The control group will be comprised by a similar number of matched patients included in the "extended risk" cohort of the XIENCE V USA study. The primary endpoint will be the 1-year rate of target lesion failure (TLF) (composite of ischemia-driven TLR, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel). Secondary endpoints will include overall mortality, cardiovascular mortality, acute myocardial infarction, TVR, TLR, target vessel failure, and definitive or probable stent thrombosis at 1 year. IMPLICATIONS: The ongoing OPTI-XIENCE study will contribute to the growing evidence supporting the use of intra-coronary imaging techniques for stent optimization in patients with complex coronary lesions.

Spanish cardiac catheterization and coronary intervention registry. 32nd official report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2022).

INTRODUCTION AND OBJECTIVES: This article presents the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) for the year 2022. METHODS: All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company in collaboration with the members of the board of the ACI-SEC. RESULTS: A total of 111 centers participated. The number of diagnostic studies increased by 4.8% compared with 2021, while that of percutaneous coronary interventions (PCI) remained stable. PCIs on the left main coronary artery increased by 22%. The radial approach continued to be preferred for PCI (94.9%). There was an upsurge in the use of drug-eluting balloons, as well as in intracoronary imaging techniques, which were used in 14.7% of PCIs. The use of pressure wires also increased (6.3% vs 2021) as did plaque modification techniques. Primary PCI continued to grow and was the most frequent treatment (97%) in ST-segment elevation myocardial infarction. Most noncoronary procedures maintained their upward trend, particularly percutaneous aortic valve implantation, atrial appendage closure, mitral/tricuspid edge-to-edge therapy, renal denervation, and percutaneous treatment of pulmonary arterial disease. CONCLUSIONS: The Spanish cardiac catheterization and coronary intervention registry for 2022 reveals a rise in the complexity of coronary disease, along with a notable growth in procedures for valvular and nonvalvular structural heart disease.

Changes in the Treatment Strategy Following Intracoronary Pressure Wire in a Contemporaneous Real-Life Cohort of Patients With Intermediate Coronary Stenosis. Results From a Nationwide Registry.

BACKGROUND: Intracoronary pressure wire is useful to guide revascularization in patients with coronary artery disease. AIMS: To evaluate changes in diagnosis (coronary artery disease extent), treatment strategy and clinical results after intracoronary pressure wire study in real-life patients with intermediate coronary artery stenosis. METHODS: Observational, prospective and multicenter registry of patients in whom pressure wire was performed. The extent of coronary artery disease and the treatment strategy based on clinical and angiographic criteria were recorded before and after intracoronary pressure wire guidance. 12-month incidence of MACE (cardiovascular death, non-fatal myocardial infarction or new revascularization of the target lesion) was assessed. RESULTS: 1414 patients with 1781 lesions were included. Complications related to the procedure were reported in 42 patients (3.0 %). The extent of coronary artery disease changed in 771 patients (54.5 %). There was a change in treatment strategy in 779 patients (55.1 %) (18.0 % if medical treatment; 68.8 % if PCI; 58.9 % if surgery (p < 0.001 for PCI vs medical treatment; p = 0.041 for PCI vs CABG; p < 0.001 for medical treatment vs CABG)). In patients with PCI as the initial strategy, the change in strategy was associated with a lower rate of MACE (4.6 % vs 8.2 %, p = 0.034). CONCLUSIONS: The use of intracoronary pressure wire was safe and led to the reclassification of the extent of coronary disease and change in the treatment strategy in more than half of the cases, especially in patients with PCI as initial treatment.

Feasibility and safety of zero-fluoroscopy left bundle branch pacing: An initial experience.

INTRODUCTION: Left bundle branch pacing (LBBP) has emerged in recent years as a new pacing modality, providing patients with a narrower paced QRS than conventional pacing and stable pacing parameters. At the same time, there is a growing concern about the use of fluoroscopy in pacemaker implantations, given its harmful effects on both patients and operators. However, there are no prior experiences of zero-fluoroscopy in LBBP procedure. METHODS: We conducted an observational prospective study recruiting consecutive patients that underwent zero-fluoroscopy LBBP pacemaker implantation. A 6-month follow-up visit was programmed for every patient. The main goal of our study was to assess the efficacy, feasibility, and safety of the procedure. RESULTS: From January 2021 to February 2022, we included 10 patients, 8 males. The average age was 63 ± 4 years. The procedure was successful in all patients. We observed a significant reduction in paced QRS width compared with basal QRS width (149 ± 31.9 vs. 116 ± 15.6 ms, p = .02). All device parameters remained stable at 6-month follow-up: no significant differences in mean impedance (700.5 ± 136.4 vs. 494 ± 72.7 Ohm, p = .09), capture threshold (0.67 ± 0.2 vs. 0.83 ± 0.2 V @ 0.4 ms, p = .27) or endocardial V-wave amplitude (10.6 ± 5.2 vs. 13.9 ± 6.3 mV, p = .19). No complications were reported in any case. CONCLUSION: Zero-fluoroscopy LBBP is feasible and safe, and it may be considered in cases where radiation exposure is contraindicated or especially undesirable. Future randomized clinical trials are needed for the widespread use of this new technique.

Local impedance and contact force guidance to predict successful cavotricuspid isthmus ablation with a zero-fluoroscopy approach.

Introduction: A new technology capable of monitoring local impedance (LI) and contact force (CF) has recently been developed. At the same time, there is growing concern regarding catheter ablation performed under fluoroscopy guidance, due to its harmful effects for both patients and practitioners. The aim of this study was to assess the safety and effectiveness of zero-fluoroscopy cavotricuspid isthmus (CTI) ablation monitoring LI drop and CF as well as to elucidate if these parameters can predict successful radiofrequency (RF) applications in CTI ablation. Methods: We conducted a prospective observational study recruiting 50 consecutive patients who underwent CTI ablation. A zero-fluoroscopy approach guided by the combination of LI drop and CF was performed. In each RF application, CF and LI drop were monitored. A 6-month follow-up visit was scheduled to assess recurrences. Results: A total of 767 first-pass RF applications were evaluated in 50 patients. First-pass effective RF applications were associated with greater LI drops: absolute LI drops (30.05 ± 6.23 Ω vs. 25.01 ± 5.95 Ω), p = 0.004) and relative LI drops (-23.3 ± 4.9% vs. -18.3 ± 5.6%, p = 0.0005). RF applications with a CF between 5 and 15 grams achieved a higher LI drop compared to those with a CF below 5 grams (29.4 ± 8.76 Ω vs. 24.8 ± 8.18 Ω, p < 0.0003). However, there were no significant differences in LI drop between RF applications with a CF between 5 and 15 grams and those with a CF beyond 15 grams (29.4 ± 8.76 Ω vs. 31.2 ± 9.81 Ω, p = 0.19). CF by itself, without considering LI drop, did not predict effective RF applications (12.3 ± 7.54 g vs. 11.18 ± 5.18 g, p = 0.545). Successful CTI ablation guided by a zero-fluoroscopy approach was achieved in all patients. Only one patient experienced a recurrence during the 6-month follow-up. Conclusions: LI drop (absolute and relative values) appears to be a good predictor of successful RF applications to achieve CTI conduction block. The optimal CF to achieve a good LI drop is between 5 and 15 g. A zero-fluoroscopy approach guided by LI and CF was feasible, effective, and safe.

His-Bundle Pacing in a Patient With Tricuspid and Mitral Prosthetic Valves Without Suitable Coronary Veins for Lead Placement.

Atrioventricular block in patients with a prosthetic tricuspid valve and a pacemaker with a dysfunctional epicardial lead is not uncommon. In such instances, coronary sinus lead placement is the preferred option, but it has a failure rate of 10%-15%. An atrial transseptal left ventricular lead placement has been proposed as an alternative, but this approach is not feasible in patients with a prosthetic mitral valve. This analysis represents the first reported case of His-bundle pacing from the atria in a patient with prosthetic tricuspid and mitral valves, with no suitable coronary veins for lead placement.

Le bloc auriculo-ventriculaire n'est pas rare chez les patients ayant reçu une valve tricuspide prothétique et porteurs d'un stimulateur cardiaque dont la sonde épicardique est dysfonctionnelle. Dans de tels cas, le positionnement de la sonde sur le sinus coronaire est l'option à privilégier, mais son taux d'échec varie entre 10 et 15 %. L'implantation de la sonde sur le ventricule gauche par la voie transsetale a été proposée à titre de solution de rechange, mais cette approche n'est pas envisageable chez les patients ayant reçu une valve mitrale prothétique. La présente analyse constitue le premier cas de stimulation du faisceau de His à partir des oreillettes chez un patient ayant reçu des valves tricuspides et mitrales prothétiques, en l'absence de veines coronaires se prêtant à l'implantation de la sonde.

Impact of diabetes in patients waiting for invasive cardiac procedures during COVID-19 pandemic.

BACKGROUND: During COVID-19 pandemic, elective invasive cardiac procedures (ICP) have been frequently cancelled or postponed. Consequences may be more evident in patients with diabetes. OBJECTIVES: The objective was to identify the peculiarities of patients with DM among those in whom ICP were cancelled or postponed due to the COVID-19 pandemic, as well as to identify subgroups in which the influence of DM has higher impact on the clinical outcome. METHODS: We included 2,158 patients in whom an elective ICP was cancelled or postponed during COVID-19 pandemic in 37 hospitals in Spain. Among them, 700 (32.4%) were diabetics. Patients with and without diabetes were compared. RESULTS: Patients with diabetes were older and had a higher prevalence of other cardiovascular risk factors, previous cardiovascular history and co-morbidities. Diabetics had a higher mortality (3.0% vs. 1.0%; p = 0.001) and cardiovascular mortality (1.9% vs. 0.4%; p = 0.001). Differences were especially important in patients with valvular heart disease (mortality 6.9% vs 1.7% [p < 0.001] and cardiovascular mortality 4.9% vs 0.9% [p = 0.002] in patients with and without diabetes, respectively). In the multivariable analysis, diabetes remained as an independent risk factor both for overall and cardiovascular mortality. No significant interaction was found with other clinical variables. CONCLUSION: Among patients in whom an elective invasive cardiac procedure is cancelled or postponed during COVID-19 pandemic, mortality and cardiovascular mortality is higher in patients with diabetes, irrespectively on other clinical conditions. These procedures should not be cancelled in patients with diabetes.

Consequences of canceling elective invasive cardiac procedures during Covid-19 outbreak.

BACKGROUND: During COVID-19 pandemic in Spain, elective procedures were canceled or postponed, mainly due to health care systems overwhelming. OBJECTIVE: The objective of this study was to evaluate the consequences of interrupting invasive procedures in patients with chronic cardiac diseases due to the COVID-19 outbreak in Spain. METHODS: The study population is comprised of 2,158 patients that were pending on elective cardiac invasive procedures in 37 hospitals in Spain on the 14th of March 2020, when a state of alarm and subsequent lockdown was declared in Spain due to the COVID-19 pandemic. These patients were followed-up until April 31th. RESULTS: Out of the 2,158 patients, 36 (1.7%) died. Mortality was significantly higher in patients pending on structural procedures (4.5% vs. 0.8%, respectively; p < .001), in those >80 year-old (5.1% vs. 0.7%, p < .001), and in presence of diabetes (2.7% vs. 0.9%, p = .001), hypertension (2.0% vs. 0.6%, p = .014), hypercholesterolemia (2.0% vs. 0.9%, p = .026) [Correction added on December 23, 2020, after first online publication: as per Dr. Moreno's request changes in p-values were made after original publication in Abstract.], chronic renal failure (6.0% vs. 1.2%, p < .001), NYHA > II (3.8% vs. 1.2%, p = .001), and CCS > II (4.2% vs. 1.4%, p = .013), whereas was it was significantly lower in smokers (0.5% vs. 1.9%, p = .013). Multivariable analysis identified age > 80, diabetes, renal failure and CCS > II as independent predictors for mortality. CONCLUSION: Mortality at 45 days during COVID-19 outbreak in patients with chronic cardiovascular diseases included in a waiting list due to cancellation of invasive elective procedures was 1.7%. Some clinical characteristics may be of help in patient selection for being promptly treated when similar situations happen in the future.

Prediabetes y pronóstico clínico de los pacientes con cardiopatía isquémica y revascularización coronaria percutánea / Prediabetes and coronary artery disease: Outcome after revascularization procedures

Objetivo: Determinar si la prediabetes, a largo plazo, se asocia a un mayor riesgo de eventos cardiovasculares en pacientes con cardiopatía isquémica y revascularización coronaria percutánea. Método: Cohortes retrospectivo. De los procedimientos de revascularización realizados durante 2010 se seleccionaron aquellos sin diagnóstico de diabetes y con determinación de hemoglobina glucosilada. Se constituyeron 2 grupos: prediabetes (5,7-6,5%) y control (< 5,7%). Se registraron variables demográficas, clínicas e intervencionistas. Los objetivos de estudio fueron mortalidad, ingresos hospitalarios, infarto de miocardio (IM) y procedimientos de revascularización. Resultados: Los sujetos de estudio fueron 132 (hombres 82,6%; edad 65,26 ± 12,46). No se encontraron diferencias significativas en las variables demográficas, clínicas ni intervencionistas. La prevalencia de prediabetes fue 40,2%. El 64,1% de los casos de revascularización se debieron a IM con elevación de ST. Tras un seguimiento de 42,3 ± 3,6 meses no se encontraron diferencias entre prediabetes y control en mortalidad total: 5,4% vs 1,9% (riesgo relativo [RR]: 2,86, intervalo de confianza del 95% [IC 95%]): 0,27-30,44, p = 0,56), mortalidad no cardiovascular: 2,7% vs 1,9% (RR: 1,43, IC 95%: 0,93-22,18, p = 0,79), ingresos de cualquier causa: 19% vs 25% (RR: 1,13, IC 95%: 0,73-1,73, p = 0,57), IM: 3% vs 1% (RR: 4,28, IC 95%: 0,46-39,52; p = 0,30) ni revascularización de la lesión tratada: 3% vs 6% (RR: 0,70, IC 95%: 0,18-2,61, p = 0,72). Conclusiones: En pacientes sometidos a revascularización coronaria la presencia de prediabetes, definida según valores de hemoglobina glucosilada, no se asocia a un incremento de eventos cardiovasculares a largo plazo (AU)

Objective: To assess the long-term association between prediabetes and an increased risk of cardiovascular events in patients with coronary artery disease and percutaneous coronary intervention (PCI). Methods: A retrospective cohort study. We searched our database to identify all PCI procedures performed in 2010. Patients with no diabetes and HbA1c measurement in the index hospitalization were enrolled and divided into two groups based on HbA1c value: 5.7-6.5% for prediabetes and <5.7% for controls. Demographic, clinical, and procedure-related variables were recorded. Study endpoints were mortality, hospital admissions, myocardial infarction (MI), and revascularization procedures. Results: The study population consisted of 132 subjects (82.6% males, age: 65.26 ± 12.46 years). No difference was found as regards distribution of demographic, clinical, and procedure-related variables. A majority (64.1%) of PCI procedures were performed for ST-segment elevation MI. Prevalence of prediabetes was 40.2%. After a mean follow-up period of 42.3 ± 3.6 months, no differences were found in outcomes between the prediabetes and control groups in total mortality (5.4% vs 1.9%; relative risk [RR] 2.86, 95% confidence interval [95% CI] 0.27-30.44; P = .56), non-cardiovascular mortality (2.7% vs 1.9%; RR 1.43, 95% CI 0.93-22.18; P = .79), hospital admissions (19% vs 25%; RR 1.13, 95%CI 0.73-1.73; P = .57), MI (3% vs 1%; RR 4.28, 95%CI .46-39.52; P = .30), or target lesion revascularization (3% vs 6%); RR .70, 95%CI .18-2.61; P = .72). Conclusions: Prediabetes, as determined by HbA1c (5.7%-6.5%), is not associated with long-term adverse cardiovascular outcomes in patients with CAD and PCI (AU)

Prediabetes and coronary artery disease: Outcome after revascularization procedures.

OBJECTIVE: To assess the long-term association between prediabetes and an increased risk of cardiovascular events in patients with coronary artery disease and percutaneous coronary intervention (PCI). METHODS: A retrospective cohort study. We searched our database to identify all PCI procedures performed in 2010. Patients with no diabetes and HbA1c measurement in the index hospitalization were enrolled and divided into two groups based on HbA1c value: 5.7-6.5% for prediabetes and <5.7% for controls. Demographic, clinical, and procedure-related variables were recorded. Study endpoints were mortality, hospital admissions, myocardial infarction (MI), and revascularization procedures. RESULTS: The study population consisted of 132 subjects (82.6% males, age: 65.26 ± 12.46 years). No difference was found as regards distribution of demographic, clinical, and procedure-related variables. A majority (64.1%) of PCI procedures were performed for ST-segment elevation MI. Prevalence of prediabetes was 40.2%. After a mean follow-up period of 42.3 ± 3.6 months, no differences were found in outcomes between the prediabetes and control groups in total mortality (5.4% vs 1.9%; relative risk [RR] 2.86, 95% confidence interval [95% CI] 0.27-30.44; P=.56), non-cardiovascular mortality (2.7% vs 1.9%; RR 1.43, 95% CI 0.93-22.18; P=.79), hospital admissions (19% vs 25%; RR 1.13, 95%CI 0.73-1.73; P=.57), MI (3% vs 1%; RR 4.28, 95%CI .46-39.52; P=.30), or target lesion revascularization (3% vs 6%); RR .70, 95%CI .18-2.61; P=.72). CONCLUSIONS: Prediabetes, as determined by HbA1c (5.7%-6.5%), is not associated with long-term adverse cardiovascular outcomes in patients with CAD and PCI.

Sustained benefit of left ventricular remodelling after valve replacement for aortic stenosis.

BACKGROUND: Valve replacement for aortic stenosis (AS) determines negative ventricular remodelling. We used cross sectional and Doppler echocardiography to check how rapidly it occurs and to assess if these changes are sustained over time. METHODS: We evaluated in 34 patients subjected to aortic valve replacement for AS morphological and functional (ejection fraction and E:A ratio) left ventricular data by echocardiography prior to surgery and 2 postoperative studies: early after surgery (pQ1) and at mid-term evolution (pQ2). RESULTS: Left ventricular mass index was reduced at pQ1 (from 152 +/- 47 g/m2 to 113 +/- 31 g/m2; p < 0.01) as well as end-diastolic (from 51.3 mm to 48.3 mm; p < 0.03), end-systolic (from 32.2 mm to 29.4 mm; p < 0.02), interventricular septum (from 12.9 mm to 10.3 mm; p < 0.01), and posterior wall (from 12.5 mm to 11 mm; p < 0.01) dimensions. Left ventricular ejection fraction (from 61.2% to 65.2%; p < 0.04) and E:A ratio (from 0.94 to 0.98; p < 0.01) increased significantly at pQ1. There were no significant differences in measurements between pQ1 and pQ2. CONCLUSIONS: Aortic valve replacement surgery leads to a rapid negative left ventricular remodelling during the first 7 months, including a decrease in myocardial hypertrophy and an improvement in systolic and diastolic function. These beneficial hemodynamic changes are sustained for at least 3 years.