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INTRODUCTION AND OBJECTIVES: Transfemoral access is the most frequently used vascular approach in chronic total occlusion percutaneous coronary interventions (CTO-PCI). The aim of this study was to evaluate the safety and feasibility of a transradial access CTO-PCI program and its impact on angiographic and clinical results and length of hospital stay. METHODS: Retrospective multicenter cohort study including 2550 consecutive CTO-PCI procedures included in a multicenter registry with accurate information on vascular access. A total of 896 procedures were performed as radial-only access while 1654 were performed through at least 1 femoral puncture. Clinical and angiographic data were collected. RESULTS: The mean age was 66.3± 11.4 years. The mean Japan-chronic total occlusion score (2.7±0.3) was similar in the 2 groups. Successful revascularization was achieved in 2009 (79.6%) cases, 78.2% and 82.1% in the femoral and radial access cohorts, respectively (P=.002). Periprocedural in-hospital complications were observed in 5.1% and 2.3% (P=.02), with fewer access site-dependant vascular complications in the transradial cohort (2.3% vs 0.2%; P=.009). The mean length of hospital stay was significantly shorter in the transradial access group (0.89±1.4 vs 2.2±3.2 days, P<.001). CONCLUSIONS: A transradial program for CTO-PCI is safe and effective in most CTO lesions. The transradial strategy has fewer vascular complications and shorter length of hospital stay without compromising the success rate.
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Enfermedades Cardiovasculares , Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Persona de Mediana Edad , Anciano , Intervención Coronaria Percutánea/métodos , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/cirugía , Estudios de Factibilidad , Estudios de Cohortes , Arteria Radial/cirugía , Arteria Femoral/cirugía , Resultado del Tratamiento , Angiografía Coronaria , Sistema de Registros , Enfermedad CrónicaRESUMEN
BACKGROUND: It is unknown whether the availability of long drug-eluting stents modify the PCI strategy of long CTO. To describe the contemporary PCI strategy of long chronic total occlusions (CTO) using overlapping (OS) or single long stents (SS) and to analyze its results. METHODS: 2842 consecutive CTO PCIs were included. Those with an occlusion length ≥20 mm in which ≥1 drug eluting stent (DES) was implanted were analyzed. We compared procedural characteristics and clinical outcomes of CTO treated with OS or SS. RESULTS: 1088 CTO PCIs were analyzed (79.9% males; 64.7±10.6 years). Mean J-score was 2.8±0.9. A SS was used in 38.5% of cases and OS in 61.5%. Total stent length was 64.1±29.9 mm; it was higher in the OS group (OS: 79.9±25.5 mm vs. SS: 38.3±14.7 mm; P<0.0001). Mean number of stents in the OS group was 2.3±1. Very long stents (≥40 mm) were used in 27.4% of cases, more frequently in the OS group (OS:32.4% vs. SS:19.3%; P<0.0001). After a mean follow-up of 19±15.9 months, the rate of adverse events (MACE) was 2% (cardiac death: 1.6%, myocardial infarction: 1.6%, target lesion revascularization: 1.9% and stent thrombosis: 0.18%) with no significant differences between both groups. Overlapping was not an independent predictor of MACE. CONCLUSIONS: In long CTO PCIs, OS is more frequently used than single stenting, especially in more complex procedures. Clinical outcomes at a mid-term follow-up are favorable. Using newer generation DES, overlapping was not an independent predictor of MACE; however, a trend toward a higher event rate was observed in the OS group.
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Oclusión Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Masculino , Humanos , Femenino , Oclusión Coronaria/cirugía , Oclusión Coronaria/etiología , Stents Liberadores de Fármacos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Enfermedad Crónica , Stents , Sistema de RegistrosRESUMEN
INTRODUCTION AND OBJECTIVES: In patients with tricuspid regurgitation (TR), edge-to-edge transcatheter tricuspid valve repair (TTVR) is the strategy with the highest penetration worldwide. A dedicated edge-to-edge TTVR system has recently become available in Europe. The present study describes the initial experience with the system in Spain. METHODS: This multicenter study collected individual data from the centers accepted for the use of the novel system within an initial limited release. Between June 2020 and March 2021, all patients undergoing an edge-to-edge TTVR using the TriClip system in Spain were included in the study. The primary endpoint was the achievement of a TR reduction of at least 1 grade at discharge. RESULTS: We included 34 patients. Most of them reported a previous history of atrial fibrillation (91%) and only 1 had a pacemaker lead. The primary endpoint (TR reduction of at least 1 grade at discharge) was met in all patients. Most of the patients required 1 (47%) or 2 clips (44%) with a clear predominance of XT (87%) over NT (13%). The location of the first clip was anteroseptal in >90% of the patients. Only 1 patient had a partial detachment, which was stabilized with additional clips in the same procedure. At discharge, TR severity was≤2 in 91% of patients. At 3 months, mortality was nil. Overall, 88% of patients were in New York Heart Association functional class≤2 and 80% had residual TR≤2. CONCLUSIONS: Edge-to-edge TTVR seemed to be effective and safe with a sustained TR reduction at 3 months. Further studies will be needed to confirm our findings.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
BACKGROUND: The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain. AIMS: The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial. METHODS: This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee. RESULTS: Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). CONCLUSIONS: At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.
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Stents Liberadores de Fármacos , Infarto del Miocardio con Elevación del ST , Implantes Absorbibles , Humanos , Magnesio/uso terapéutico , Infarto del Miocardio con Elevación del ST/cirugía , Método Simple Ciego , Sirolimus/uso terapéutico , Stents , Resultado del TratamientoRESUMEN
AIMS: The mechanisms of coronary thrombosis can influence prognosis after ST-elevation myocardial infarction (STEMI) and allow for different treatment groups to be identified; an association between neutrophil extracellular traps (NETs) and unfavorable clinical outcomes has been suggested. Our aim was to determine the role played by NETs in coronary thrombosis and their influence on prognosis. The role of other histological features in prognosis and the association between NETs and bacteria in the coronary thrombi were also explored. METHODS AND RESULTS: We studied 406 patients with STEMI in which coronary thrombi were consecutively obtained by aspiration during angioplasty between 2012 and 2018. Analysis of NETs in paraffin-embedded thrombi was based on the colocalization of specific NET components by means of confocal microscopy. Immunohistochemistry stains were used to identify plaque fragments. Fluorescence in situ hybridization was used to detect bacteria.NETs were detected in 51% of the thrombi (NET density, median [interquartile range]: 25% [17-38%]). The median follow-up was 47 months (95% confidence interval [CI] 43-51); 105 (26%) patients experienced major adverse cardiac events (MACE). A significant association was found between the presence of NETs in coronary aspirates and the occurrence of MACE in the first 30 days after infarction (hazard ratio 2.82; 95% CI 1.26-6.35, p = 0.012), mainly due to cardiac deaths and stent thrombosis. CONCLUSION: The presence of NETs in coronary thrombi was associated with a worse prognosis soon after STEMI. In some patients, NETs could be a treatment target and a feasible way to prevent reinfarction.
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Trombosis Coronaria , Trampas Extracelulares , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Trombosis Coronaria/terapia , Humanos , Hibridación Fluorescente in Situ , Pronóstico , Resultado del TratamientoRESUMEN
AIMS: The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. METHODS AND RESULTS: SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events' outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). CONCLUSIONS: Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Puente de Arteria Coronaria/métodos , Enfermedad de la Arteria Coronaria/terapia , Humanos , Intervención Coronaria Percutánea/métodos , Resultado del TratamientoRESUMEN
INTRODUCTION AND OBJECTIVES: Severe calcification is present in> 50% of coronary chronic total occlusions (CTOs) undergoing percutaneous intervention. We aimed to describe the contemporary use and outcomes of plaque modification devices (PMDs) in this context. METHODS: Patients were included in the prospective, consecutive Iberian CTO registry (32 centers in Spain and Portugal), from 2015 to 2020. Comparison was performed according to the use of PMDs. RESULTS: Among 2235 patients, wire crossing was achieved in 1900 patients and PMDs were used in 134 patients (7%), requiring more than 1 PMD in 24 patients (1%). The selected PMDs were rotational atherectomy (35.1%), lithotripsy (5.2%), laser (11.2%), cutting/scoring balloons (27.6%), OPN balloons (2.9%), or a combination of PMDs (18%). PMDs were used in older patients, with greater cardiovascular burden, and higher Syntax and J-CTO scores. This greater complexity was associated with longer procedural time but similar total stent length (52 vs 57mm; P=.105). If the wire crossed, the procedural success rate was 87.2% but increased to 96.3% when PMDs were used (P=.001). Conversely, PMDs were not associated with a higher rate of procedural complications (3.7 vs 3.2%; P=.615). Despite the worse baseline profile, at 2 years of follow-up there were no differences in the survival rate (PMDs: 94.3% vs no-PMDs: 94.3%, respectively; P=.967). CONCLUSIONS: Following successful wire crossing in CTOs, PMDs were used in 7% of the lesions with an increased success rate. Mid-term outcomes were comparable despite their worse baseline profile, suggesting that broader use of PMDs in this setting might have potential technical and prognostic benefits.
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Oclusión Coronaria , Intervención Coronaria Percutánea , Anciano , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/cirugía , Humanos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: We aimed to compare the performance of the recent CASTLE score to J-CTO, CL and PROGRESS CTO scores in a comprehensive database of percutaneous coronary intervention of chronic total occlusion procedures. METHODS: Scores were calculated using raw data from 1,342 chronic total occlusion procedures included in REBECO Registry that includes learning and expert operators. Calibration, discrimination and reclassification were evaluated and compared. RESULTS: Mean score values were: CASTLE 1.60±1.10, J-CTO 2.15±1.24, PROGRESS 1.68±0.94 and CL 2.52±1.52 points. The overall percutaneous coronary intervention success rate was 77.8%. Calibration was good for CASTLE and CL, but not for J-CTO or PROGRESS scores. Discrimination: the area under the curve (AUC) of CASTLE (0.633) was significantly higher than PROGRESS (0.557) and similar to J-CTO (0.628) and CL (0.652). Reclassification: CASTLE, as assessed by integrated discrimination improvement, was superior to PROGRESS (integrated discrimination improvement +0.036, p<0.001), similar to J-CTO and slightly inferior to CL score (- 0.011, p = 0.004). Regarding net reclassification improvement, CASTLE reclassified better than PROGRESS (overall continuous net reclassification improvement 0.379, p<0.001) in roughly 20% of cases. CONCLUSION: Procedural percutaneous coronary intervention difficulty is not consistently depicted by available chronic total occlusion scores and is influenced by the characteristics of each chronic total occlusion cohort. In our study population, including expert and learning operators, the CASTLE score had slightly better overall performance along with CL score. However, we found only intermediate performance in the c-statistic predicting chronic total occlusion success among all scores.
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Oclusión Coronaria/cirugía , Intervención Coronaria Percutánea , Anciano , Área Bajo la Curva , Oclusión Coronaria/diagnóstico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Medición de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
OBJECTIVES: Drug-coated balloons (DCBs) have theoretical advantages over drug-eluting stents (DESs) to facilitate stent healing. We studied whether, in patients undergoing primary coronary interventions (pPCIs), a strategy of DCB after bare-metal stent improves early healing as determined by optical coherence tomography (OCT) compared with new-generation DES. METHODS: pPCI patients were randomized (1:1) to treatment with new-generation sirolimus-eluting stents (DES group) or DCB-strategy. Vessel healing was assessed by OCT at 90 days. RESULTS: Fifty-three patients were randomized (26 DES vs. 27 DCB). At 90 days, both strategies showed a low rate of uncovered struts (3.2 vs. 3.2%, P = 0.64) and a very high and similar rate of covered and apposed struts (96.6 vs. 96.1%, respectively; P = 0.58). However, DCB group had a significantly lower rate of major coronary evaginations (68 vs. 37%, P = 0.026), and more frequently developed a thin homogeneous neointimal layer (20 vs. 70.4%, P = 0.001) suggesting distinct superior healing at 3 months compared to DES. CONCLUSIONS: In pPCI both, sirolimus-DES and DCB-strategy, provide excellent strut coverage at 3 months. However, DCB ensures more advanced and optimal stent healing compared to sirolimus-DES. Further research is needed to determine whether, in patients undergoing pPCI, DCB offers superior long-term clinical and angiographic outcomes than new-generation DES (NCT03610347).
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Stents Liberadores de Fármacos/normas , Infarto del Miocardio con Elevación del ST/fisiopatología , Anciano , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/estadística & datos numéricos , Infarto del Miocardio con Elevación del ST/complicaciones , Sirolimus/farmacología , Sirolimus/uso terapéutico , Tomografía de Coherencia Óptica/métodos , Tomografía de Coherencia Óptica/estadística & datos numéricos , Resultado del TratamientoRESUMEN
BACKGROUND AND AIM: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. METHODS: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. RESULTS: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). CONCLUSIONS: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.
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INTRODUCTION AND OBJECTIVES: Mortality remains high in cardiogenic shock (CS), especially in refractory CS involving the use of mechanical circulatory support (MCS) devices. The aim of this study was to analyze the results of a care program for patients in CS after the creation of a multidisciplinary team in our center and a regional network of hospitals in our area. METHODS: Observational and retrospective study of patients attended in this program from September 2014 to January 2019. We included patients in refractory CS who required MCS and those who, because of their age and absence of comorbidities, were candidates for advanced therapies. The primary endpoint was survival to discharge. RESULTS: A total of 130 patients were included (69 local and 61 transferred patients). The mean age was 52±15 years (72% men). The most frequent causes of CS were acute decompensated heart failure (29%), acute myocardial infarction (26%), and postcardiotomy CS (25%). MCS was used in 105 patients (81%), mostly extracorporeal membrane oxygenation (58%). Survival to discharge was 57% (74 of 130 patients). The most frequent destinations were myocardial recovery and heart transplant. Independent predictors of in-hospital mortality were SAPS II score, lactate level, acute myocardial infarction etiology, and vasoactive-inotropic score. CONCLUSIONS: The creation of multidisciplinary teams for patients with mainly refractory CS and a regional network is feasible and allows survival to discharge in more than a half of attended patients with CS.
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Choque Cardiogénico , Adulto , Anciano , Femenino , Corazón Auxiliar , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Choque Cardiogénico/epidemiología , Choque Cardiogénico/terapia , Factores de Tiempo , Resultado del TratamientoRESUMEN
IMPORTANCE: Severe coronavirus disease 2019 (COVID-19) is characterized by the intense formation of neutrophil extracellular traps (NETs), leading to the occlusion of microvessels, as shown in pulmonary samples. The occurrence of ST-elevated myocardial infarction (STEMI) is a serious cardiac manifestation of COVID-19; the intrinsic mechanism of coronary thrombosis appears to still be unknown. OBJECTIVE: To determine the role of NETs in coronary thrombosis in patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This was a consecutive series of patients with COVID-19 at an academic tertiary hospital in Madrid, Spain, who underwent primary coronary interventions for STEMI in which coronary aspirates were obtained in the catheterization laboratory using a thrombus aspiration device. Patients with COVID-19 who experienced a STEMI between March 23 and April 11, 2020, from whom coronary thrombus samples were aspirated during primary coronary intervention, were included in the analysis. These patients were compared with a series conducted from July 2015 to December 2015 of patients with STEMI. MAIN OUTCOMES AND MEASURES: The presence and quantity of NETs in coronary aspirates from patients with STEMI and COVID-19. The method for the analysis of NETs in paraffin-embedded coronary thrombi was based on the use of confocal microscopy technology and image analysis for the colocalization of myeloperoxidase-DNA complexes and citrullinated histone H3. Immunohistochemical analysis of thrombi was also performed. Clinical and angiographic variables were prospectively collected. RESULTS: Five patients with COVID-19 were included (4 men [80%]; mean [SD] age, 62 [14] years); the comparison group included 50 patients (44 males [88%]; mean [SD] age, 58 [12] years). NETs were detected in the samples of all 5 patients with COVID-19, and the median density of NETs was 61% (95% CI, 43%-91%). In the historical series of patients with STEMI, NETs were found in 34 of 50 thrombi (68%), and the median NET density was 19% (95% CI, 13%-22%; P < .001). All thrombi from patients with COVID-19 were composed of fibrin and polymorphonuclear cells. None of them showed fragments of atherosclerotic plaque or iron deposits indicative of previous episodes of plaque rupture. CONCLUSIONS AND RELEVANCE: In this small case series of patients with COVID-19 and myocardial infarction, NETs seem to play a major role in the pathogenesis of STEMI in COVID-19 disease. Our findings support the idea that targeting intravascular NETs might be a relevant goal of treatment and a feasible way to prevent coronary thrombosis in patients with severe COVID-19 disease.
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BACKGROUND: In catheter-based procedures, acute kidney injury (AKI) is a frequent, serious complication ranging from 10% to 30%. In MitraClip (Abbott Vascular, Santa Clara, California), a usually contrast-free procedure, there is scarce data about its real incidence and impact. OBJECTIVES: This study aimed to evaluate incidence, predictive factors, and midterm outcomes of AKI in patients with significant mitral regurgitation (MR) undergoing transcatheter valve repair with MitraClip. METHODS: A total of 721 patients undergoing MitraClip were included. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, or the need for hemodialysis during index hospitalization. RESULTS: The mean age of the patients was 72 ± 11 years (28.3% women). Median estimated glomerular filtration rate (eGFR) was 43.7 ml/min/1.73 m2 (interquartile range: 30.9 to 60.1 ml/min/1.73 m2), and was <60 ml/min/1.73 m2 in 74.9% of the patients. AKI after MitraClip occurred in 106 patients (14.7%). Baseline hemoglobin (<11 g/dl) (odds ratio [OR]: 1.97; p = 0.003), urgent procedure (OR: 3.44; p = 0.003), and absence of device success (OR: 3.37; p < 0.001) were independent predictors of AKI. Patients with AKI had worse outcomes compared to those without AKI, including a higher proportion of in-hospital bleeding events (3.8% vs. 0.8%; p = 0.011), 2-year all-cause mortality (40.5% vs. 18.7%; p <0.001), and major adverse cardiac events (63.6% vs. 23.5%; p <0.001). Combination of AKI with significant residual MR after the procedure conferred even worst outcomes (2-year all-cause mortality 50.0% vs. 19.6%; p = 0.001, and major adverse cardiac events 70.0% vs. 18.9%; p < 0.001). CONCLUSIONS: Despite being a "zero-contrast" procedure, one-sixth of patients undergoing transcatheter mitral valve repair had AKI, linked to device failure or other severe conditions. The occurrence of AKI was associated with worse outcomes, highlighting the importance to detect and reduce this complication in high-risk population.
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Lesión Renal Aguda/mortalidad , Anuloplastia de la Válvula Mitral/efectos adversos , Insuficiencia de la Válvula Mitral/cirugía , Complicaciones Posoperatorias/mortalidad , Lesión Renal Aguda/etiología , Anciano , Anciano de 80 o más Años , Procedimientos Endovasculares , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Anuloplastia de la Válvula Mitral/instrumentación , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , España/epidemiologíaRESUMEN
AIMS: The MAGSTEMI trial showed larger endothelium-independent vasodilatation with magnesium-based bioresorbable scaffolds (MgBRS) than with sirolimus-eluting stents (SES). However, restenosis was more frequent with MgBRS. The aims of this study were to compare the healing pattern between MgBRS and SES and to describe the main causes of restenosis, as assessed by optical coherence tomography (OCT). METHODS AND RESULTS: Ninety-five consecutive patients from the randomised MAGSTEMI trial (MgBRS=48, SES=47) underwent OCT imaging at one year. Healing and bioresorption pattern were categorised into four groups: 1) indiscernible struts were observed in 33.3% versus 0% of patients (p<0.001); 2) struts integrated into the vessel wall in 22.9% versus 63.8% (p<0.001); 3) protruding struts in 37.5% versus 31.9% (p=0.568); and 4) protruding and malapposed struts in 6.3% versus 4.3% (p=0.663), respectively. MgBRS were not suitable for strut coverage analysis; SES presented with 5.6% uncovered struts. Scaffold discontinuities were observed in 10.4% and 0%, respectively (p=0.023). MgBRS presented smaller minimal lumen area (3.92±2.02 vs 6.31±1.71 mm²; p<0.001) and larger area stenosis (52.84±18.05 vs 25.02±14.58%; p<0.001). Scaffold measurements were only feasible in 50% of MgBRS, with the expansion index being smaller than in SES (0.58±0.16 vs 0.86±0.19; p<0.001). Scaffold collapse was observed in at least 50% of cases with MgBRS restenosis. CONCLUSIONS: Both MgBRS and SES exhibited a low degree of neointima healing, but lumen dimensions were smaller with MgBRS at one year. Although the advanced bioresorption state of MgBRS hampers the assessment of scaffold collapse, this seems to be the main mechanism of restenosis. Future generations of MgBRS should increase and prolong the radial force. CLINICAL TRIAL REGISTRATION: NCT03234348
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Stents Liberadores de Fármacos , Infarto del Miocardio con Elevación del ST , Implantes Absorbibles , Humanos , Pacientes , Diseño de Prótesis , Infarto del Miocardio con Elevación del ST/terapia , Sirolimus , Stents , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
The aim of this study is to propose national diagnostic reference levels (DRL) for updating in the field of interventional cardiology and to include technical details to help plan optimization. Medical physics experts and interventional cardiologists from 14 hospitals provided patient dose indicators from coronary angiography and percutaneous coronary interventions. Information about X-ray system dose settings and image quality was also provided. The dose values from 30,024 procedures and 26 interventional laboratories were recorded. The national DRLs proposed for coronary angiography and percutaneous coronary interventions were respectively 39 and 78 Gy·cm2 for air kerma area product (PKA), 530 and 1300 mGy for air kerma at reference point (Ka,r), 6.7 and 15 min of fluoroscopy time and 760 and 1300 cine images. 36% of the KAP meters required correction factors from 10 to 35%. The dose management systems should allow these corrections to be included automatically. The dose per image in cine in reference conditions differed in a factor of 5.5. Including X-ray system dose settings in the methodology provides an insight into the differences between hospitals. The DRLs proposed for Spain in this work were similar to those proposed in the last European survey. The poor correlation between X-ray systems dose settings and patient dose indicators highlights that other factors such as operation protocols and complexity may have more impact in patient dose indicators, which allows a wide margin for optimization. Dose reduction technology together with appropriate training programs will be determinant in the future reduction of patient dose indicators.
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Angiografía Coronaria/normas , Intervención Coronaria Percutánea/normas , Dosis de Radiación , Radiografía Intervencional/normas , Radioterapia/métodos , Fluoroscopía , Humanos , Estándares de Referencia , Valores de Referencia , España , Encuestas y CuestionariosRESUMEN
BACKGROUND: The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS: Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003). CONCLUSIONS: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.
Asunto(s)
Angioplastia Coronaria con Balón , Infarto del Miocardio con Elevación del ST/cirugía , Sirolimus/uso terapéutico , Andamios del Tejido , Implantes Absorbibles , Acetilcolina/farmacología , Anciano , Angiografía Coronaria , Reestenosis Coronaria/epidemiología , Stents Liberadores de Fármacos , Endotelio Vascular/efectos de los fármacos , Endotelio Vascular/fisiopatología , Femenino , Humanos , Incidencia , Magnesio , Masculino , Persona de Mediana Edad , Nitroglicerina/farmacología , Poliésteres , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Tamaño de la Muestra , Sirolimus/administración & dosificación , Trombectomía , Vasodilatación/efectos de los fármacos , Vasodilatadores/uso terapéutico , Sistema Vasomotor/fisiopatologíaRESUMEN
Significant mitral regurgitation (MR) may be present in up to half of patients with heart failure (HF) and it is associated with adverse cardiac remodeling and myocardial stretch. These are potential triggers for ventricular arrhythmias (VA) in patients with HF, and therefore MR may enhance electrical ventricular vulnerability. Our aim was to evaluate VA burden before and after percutaneous mitral valve repair (PMVR) in patients with implantable cardiac devices. We conducted a prospective registry of all consecutive patients (nâ¯=â¯34, age 69.0 ± 12.2 years, 77% male) with significant functional mitral regurgitation (FMR) who underwent MitraClip implantation in 2 centers between June 2014 and July 2018. VA burden was defined as the total number of events during device follow-up before and after PMVR. Among patients presenting VA during follow-up before or after PMVR, device success at hospital discharge was related to a significant reduction in the incidence of Nonsustained ventricular tachycardia (VT, pâ¯=â¯0.002) and any sustained VT or rapid VT/ventricular fibrillation (pâ¯=â¯0.034). Regarding implantable cardiac defibrillator (ICD) therapies, successful PMVR was related to a reduction in incidence of either antitachycardia pacing or appropriate shocks (pâ¯=â¯0.045) and in the occurrence of any defibrillation shocks (pâ¯=â¯0.045). Overall, effective repair lead to a significant reduction in the VA burden, with a significant decrease in the occurrence of any VA (pâ¯=â¯0.004) and any ICD therapies (pâ¯=â¯0.045). In conclusion, device success after PMVR was related to a reduction in overall arrhythmic burden and ICD therapies in our cohort.
Asunto(s)
Arritmias Cardíacas/complicaciones , Desfibriladores Implantables , Insuficiencia Cardíaca/complicaciones , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Arritmias Cardíacas/cirugía , Estudios de Cohortes , Femenino , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: Stroke recurrence despite optimal oral anticoagulation (OAC) might represent a novel indication for left atrial appendage occlusion (LAAO). The heterogeneity of these patients is generally high, as the presence of valvular atrial fibrillation (VAF) is common. The aim of this study was to explore the role of LAAO as an adjunctive therapy to OAC in patients with recurrent stroke despite optimal OAC. METHODS: The study screened consecutive patients who underwent percutaneous LAAO at nine centers between 2009 and 2017. Patients with recurrent stroke despite optimal OAC were selected and those with an absolute or relative contraindication to OAC were not included in the study. RESULTS: Among 837 patients who underwent LAAO between the study period, a total of 22 (2.6%) met the inclusion criteria. There was a high percentage of VAF (38%) and 59% presented more than one cardioembolic event before LAAO. All patients underwent successful implantation of the device and no procedural major adverse events were reported. In all but 3 patients, anticoagulation was continued after LAAO. With a median clinical follow-up of 1.8 years (range, 0.7-2.8 years), only 1 stroke and 1 transient ischemic attack were reported, translating into a significant reduction of cerebrovascular events before and after LAAO (2.0 ± 1.0 events vs 0.1 ± 0.3 events; P<.01). Imaging follow-up revealed only 1 case of device thrombosis. CONCLUSIONS: LAAO as an adjunctive therapy to OAC seems to be feasible and safe in patients with previous cardioembolic events despite optimal OAC. In our series, this strategy was associated with a low rate of cerebrovascular events after LAAO.