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BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.
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OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.
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Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Anciano de 80 o más Años , Bioprótesis/efectos adversos , Cateterismo Cardíaco/métodos , Femenino , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Falla de Prótesis , Sistema de Registros , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
OBJECTIVES: To determine the 4D Flow Cardiac Magnetic Resonance (CMR) thresholds that achieve the best agreement with transthoracic echocardiography (TTE) for grading mitral regurgitation (MR). METHODS: We conducted a single-center prospective study of patients evaluated for chronic primary MR in 2016-2020. MR was evaluated blindly by TTE and 4D Flow CMR, respectively by two cardiologists and two radiologists with decades of experience. MR was graded with both methods as mild, moderate, or severe. 4D Flow CMR measurements included MR regurgitant volume per beat (RV) and mitral anterograde flow per beat (MF). RF was obtained as the ratio RV/MF. Additionally, MF was compared to left ventricular stroke volume (LVSV) by cine-CMR. RESULTS: We included 33 patients in the initial cohort and 33 in the validation cohort. Inter-observer agreement was excellent for 4D Flow CMR ICC = .94 (95% CI, .86-.97, p < 0.0001). Using recommended TTE thresholds (30 ml, 60 ml, 30%, 50%), agreement was moderate for RV and RF. The best agreement between 4D Flow CMR and TTE was obtained with CMR thresholds of 20 and 40 ml for RV (κ = .93; 95% CI, .8-1) and 20% and 37% for RF (κ = .90; 95% CI, .7-.9). In the validation cohort, agreement between TTE and 4D Flow CMR was good with the optimal thresholds (κ = .78; 95% CI, .61-.94). CONCLUSION: We propose CMR thresholds that provide a good agreement between TTE and CMR for grading MR. Further studies are needed to fully validate 4D-Flow CMR accuracy for primary MR quantification.
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Insuficiencia de la Válvula Mitral , Ecocardiografía/métodos , Humanos , Imagen por Resonancia Cinemagnética/métodos , Espectroscopía de Resonancia Magnética , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Estudios Prospectivos , Reproducibilidad de los Resultados , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: To report the authors' initial experience of transcarotid transcatheter aortic valve replacement (TAVR) managed with ultrasound-guided intermediate cervical plexus block. DESIGN: A single-center prospective study. SETTING: A teaching hospital in Paris, France. PARTICIPANTS: All consecutive patients undergoing a transcarotid TAVR were included. INTERVENTIONS: The ultrasound-guided intermediate cervical plexus block was performed in 28 of 31 patients. In 3 patients, the procedure was scheduled under general anesthesia: 2 because of failure of previous transfemoral procedures under local anesthesia, and 1 for an emergency procedure in a pulmonary edema context. MEASUREMENTS AND MAIN RESULTS: Anesthesia and all perioperative parameters were recorded, as well as any complications after the procedure. Twenty-eight patients were managed with intermediate cervical plexus block and light sedation without any anesthesia-related complication. No conversion to general anesthesia was required. The use of vasopressor was only required in 11% of the patients. In 2 patients, a loss of consciousness after the common carotid artery cross-clamping test occurred, leading to the use of a temporary femoral-carotid shunt; no other change in consciousness was recorded during the procedure. CONCLUSIONS: Ultrasound-guided intermediate cervical plexus block appeared to be an alternative anesthetic technique for carotid TAVR, providing adequate surgical conditions, continuous neurologic monitoring, and arterial pressure stability.
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Estenosis de la Válvula Aórtica , Bloqueo del Plexo Cervical , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Bloqueo del Plexo Cervical/efectos adversos , Francia , Humanos , Estudios Prospectivos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
BACKGOUND: Performing functional testing (FT) or a computed tomography angiogram (CCTA) before invasive coronary angiogram (ICA) is recommended for coronary artery disease (CAD). We aimed to evaluate, in a real life setting, the rate of strictly normal ICA following a positive noninvasive test result. METHODS: We included all patients who underwent an ICA with a prior positive FT or CCTA. Patients were categorized in 5 subgroups, according to pretest probability (PTP) of having a CAD. Main results of ICA were defined as normal ICA, nonobstructive CAD (non-oCAD), and obstructive CAD (oCAD). RESULTS: For 4,952 patients who underwent ICA following either a positive FT (3276, 66.2%) or CCTA (1676, 33.8%) result, the PTP was (1) low (<15%; nâ¯=â¯968, 19.5%), (2) lower intermediate (15%-35%; nâ¯=â¯1336, 27.0%), (3) higher intermediate (35%-50%; nâ¯=â¯806, 16.3%), (4) high (50%-65%; nâ¯=â¯806, 17.7%), and (5) very high (> 65%; nâ¯=â¯965, 19.5%). ICA showed no CAD (819 patients, 16.5%), non-oCAD (1,193 patients, 24.1%), or oCAD (2940 patients, 59.4%). Without considering the PTP values, CCTA compared to FT showed less frequently normal ICA (7% vs 16.5%), and more frequently CAD (non-oCAD 27.9% vs 22.2%; oCAD 65.1% vs 56.4%) (all Pâ¯<â¯.0001). When we considered the different PTP values, CCTA always showed lower rates of normal ICA than the FT. In low- and lower intermediate-risk patients, CCTA detected more frequently oCAD compared to FT (Pâ¯<â¯.001). CONCLUSIONS: CCTA is a better alternative than FT to limit unnecessary ICA regardless of PTP value, without missing abnormal ICA.
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Angiografía por Tomografía Computarizada , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Anciano , Angiografía Coronaria/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting. METHODS: Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier). CONCLUSION: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.
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Clopidogrel/uso terapéutico , Enfermedad Coronaria/terapia , Infarto del Miocardio/prevención & control , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Ticlopidina/uso terapéutico , Anciano , Angiografía Coronaria , Humanos , Infarto del Miocardio/etiologíaRESUMEN
Differences in the benefits of conscious sedation (CS) and general anesthesia (GA) during transfemoral aortic valve implantation (TAVI) are unclear.We aimed to assess differences in procedural and clinical outcomes based on the type of anesthesia received during TAVI.We analyzed SOURCE 3 Registry data for patients who received the SAPIEN 3 valve by type of anesthesia used during TAVI.Of the 1694 TAVI patients, 1027 received CS and 667 received GA. Patients were similar at baseline (81.5 years; Society of Thoracic Surgeons risk score 7.0). Compared with the GA group, the CS group had fewer intra-procedural transesophageal echocardiography (TEE) and post implantation dilatations performed, and less contrast medium was used. The CS group had significantly less kidney injury at 7 days post-procedure than the GA group (0.4% versus 1.5%, P = 0.014). Moderate paravalvular leaks (PVL) occurred more frequently in the CS group versus the GA group (2.2% versus 0.8%; P = 0.041). No severe PVL were reported. Median total hospital length of stay (LOS) after TAVI was 10 days in the CS group and 11 days in the GS group. At 30 days, all-cause death was 2.1% in CS and 1.7% in GS (P = 0.47), and myocardial infarction was 0.2% in CS and 0.1% in GS (P = 0.83).Our analyses found no significant major outcome differences between CS and GA during TAVI.
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Anestesia General/estadística & datos numéricos , Sedación Consciente/estadística & datos numéricos , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , MasculinoRESUMEN
BACKGROUND: The pathomechanisms underlying very late stent thrombosis (VLST) after implantation of drug-eluting stents (DES) are incompletely understood. Using optical coherence tomography, we investigated potential causes of this adverse event. METHODS AND RESULTS: Between August 2010 and December 2014, 64 patients were investigated at the time point of VLST as part of an international optical coherence tomography registry. Optical coherence tomography pullbacks were performed after restoration of flow and analyzed at 0.4 mm. A total of 38 early- and 20 newer-generation drug-eluting stents were suitable for analysis. VLST occurred at a median of 4.7 years (interquartile range, 3.1-7.5 years). An underlying putative cause by optical coherence tomography was identified in 98% of cases. The most frequent findings were strut malapposition (34.5%), neoatherosclerosis (27.6%), uncovered struts (12.1%), and stent underexpansion (6.9%). Uncovered and malapposed struts were more frequent in thrombosed compared with nonthrombosed regions (ratio of percentages, 8.26; 95% confidence interval, 6.82-10.04; P<0.001 and 13.03; 95% confidence interval, 10.13-16.93; P<0.001, respectively). The maximal length of malapposed or uncovered struts (3.40 mm; 95% confidence interval, 2.55-4.25; versus 1.29 mm; 95% confidence interval, 0.81-1.77; P<0.001), but not the maximal or average axial malapposition distance, was greater in thrombosed compared with nonthrombosed segments. The associations of both uncovered and malapposed struts with thrombus were consistent among early- and newer-generation drug-eluting stents. CONCLUSIONS: The leading associated findings in VLST patients in descending order were malapposition, neoatherosclerosis, uncovered struts, and stent underexpansion without differences between patients treated with early- and new-generation drug-eluting stents. The longitudinal extension of malapposed and uncovered stent was the most important correlate of thrombus formation in VLST.
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Vasos Coronarios/patología , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/tendencias , Trombosis/diagnóstico , Trombosis/etiología , Tomografía de Coherencia Óptica/métodos , Anciano , Vasos Coronarios/cirugía , Estudios Transversales , Stents Liberadores de Fármacos/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Falla de Prótesis , Factores de TiempoRESUMEN
BACKGROUND: No randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndromes. METHODS: We conducted a multicenter, randomized study involving 240 patients with non-ST-segment elevation acute coronary syndromes to compare OCT-guided PCI (use of OCT pre- and post-PCI; OCT-guided group) to fluoroscopy-guided PCI (angiography-guided group). The primary end point was the functional result of PCI assessed by the measure of post PCI fractional flow reserve. Secondary end points included procedural complications and type 4a periprocedural myocardial infarction. Safety was assessed by the rate of acute kidney injury. RESULTS: OCT use led to a change in procedural strategy in 50% of the patients in the OCT-guided group. The primary end point was improved in the OCT-guided group, with a significantly higher fractional flow reserve value (0.94±0.04 versus 0.92±0.05, P=0.005) compared with the angiography-guided group. There was no significant difference in the rate of type 4a myocardial infarction (33% in the OCT-group versus 40% in the angiography-guided group, P=0.28). The rates of procedural complications (5.8%) and acute kidney injury (1.6%) were identical in each group despite longer procedure time and use of more contrast medium in the OCT-guided group. Post-PCI OCT revealed stent underexpansion in 42% of patients, stent malapposition in 32%, incomplete lesion coverage in 20%, and edge dissection in 37.5%. This led to the more frequent use of poststent overdilation in the OCT-guided group versus the angiography-guided group (43% versus 12.5%, P<0.0001) with lower residual stenosis (7.0±4.3% versus 8.7±6.3%, P=0.01). CONCLUSIONS: In patients with non-ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher postprocedure fractional flow reserve than PCI guided by angiography alone. OCT did not increase periprocedural complications, type 4a myocardial infarction, or acute kidney injury. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01743274.
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Síndrome Coronario Agudo/terapia , Reserva del Flujo Fraccional Miocárdico/efectos de los fármacos , Infarto del Miocardio/terapia , Infarto del Miocardio sin Elevación del ST/terapia , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Síndrome Coronario Agudo/complicaciones , Anciano , Angiografía Coronaria/métodos , Stents Liberadores de Fármacos/efectos adversos , Femenino , Reserva del Flujo Fraccional Miocárdico/fisiología , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Tomografía de Coherencia Óptica/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: In-hospital mortality of ST-segment-elevation myocardial infarction (STEMI) has decreased drastically. In contrast, prehospital mortality from sudden cardiac arrest (SCA) remains high and difficult to reduce. Identification of the patients with STEMI at higher risk for prehospital SCA could facilitate rapid triage and intervention in the field. METHODS: Using a prospective, population-based study evaluating all patients with STEMI managed by emergency medical services in the greater Paris area (11.7 million inhabitants) between 2006 and 2010, we identified characteristics associated with an increased risk of prehospital SCA and used these variables to build an SCA prediction score, which we validated internally and externally. RESULTS: In the overall STEMI population (n=8112; median age, 60 years; 78% male), SCA occurred in 452 patients (5.6%). In multivariate analysis, younger age, absence of obesity, absence of diabetes mellitus, shortness of breath, and a short delay between pain onset and call to emergency medical services were the main predictors of SCA. A score built from these variables predicted SCA, with the risk increasing 2-fold in patients with a score between 10 and 19, 4-fold in those with a score between 20 and 29, and >18-fold in patients with a score ≥30 compared with those with scores <10. The SCA rate was 28.9% in patients with a score ≥30 compared with 1.6% in patients with a score ≤9 (P for trend <0.001). The area under the curve values were 0.7033 in the internal validation sample and 0.6031 in the external validation sample. Sensitivity and specificity varied between 96.9% and 10.5% for scores ≥10 and between 18.0% and 97.6% for scores ≥30, with scores between 20 and 29 achieving the best sensitivity and specificity (65.4% and 62.6%, respectively). CONCLUSIONS: At the early phase of STEMI, the risk of prehospital SCA can be determined through a simple score of 5 routinely assessed predictors. This score might help optimize the dispatching and management of patients with STEMI by emergency medical services.
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Muerte Súbita Cardíaca/etiología , Infarto del Miocardio/patología , Adulto , Anciano , Anciano de 80 o más Años , Área Bajo la Curva , Dolor en el Pecho/etiología , Muerte Súbita Cardíaca/epidemiología , Electrocardiografía , Servicios Médicos de Urgencia , Femenino , Mortalidad Hospitalaria , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Análisis Multivariante , Infarto del Miocardio/complicaciones , Estudios Prospectivos , Curva ROC , Factores de Riesgo , Encuestas y Cuestionarios , TeléfonoRESUMEN
BACKGROUND: Stent thrombosis (ST) may be triggered by different phenomena, including underlying device abnormalities and modification of the antiplatelet therapy (APT) regimen. This work investigated the characteristics of APT regimens and their relationships with ST mechanisms among a large cohort of patients evaluated by optical coherence tomography (OCT).MethodsâandâResults:A prospective multicenter registry was screened for patients with confirmed ST. OCT was performed after the initial intervention to the culprit lesion. ST was classified as acute (AST), subacute (SAST), late (LST) and very late (VLST). OCT records were analyzed in a central core laboratory. A total of 120 patients (median age 62 years, 89% male) were included in the study. VLST was the clinical presentation in 75%, LST in 6% and SAST+AST in 19% of the patients. Single APT (SAPT) was given in 61%, double APT (DAPT) in 27% and no APT in 12% of the cases at the time of the ST. A recent (≤15 days) APT modification was reported in 22% of the patients. An underlying mechanical abnormality was identified by OCT in 96.7% of the cases. Ruptured neoatherosclerotic lesions were significantly more frequent in patients without APT compared with the others. CONCLUSIONS: ST mostly occurs in patients receiving DAPT or SAPT. Any underlying mechanical abnormality of ST can be involved, irrespective of the APT regimen.
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Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents/efectos adversos , Trombosis/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/farmacología , Estudios Prospectivos , Sistema de Registros , Trombosis/etiología , Tomografía de Coherencia ÓpticaRESUMEN
AIMS: Angiography has limited value for identifying the causes of stent thrombosis (ST). We studied a large cohort of patients by optical coherence tomography (OCT) to explore ST characteristics and mechanisms. METHODS AND RESULTS: A prospective multicentre registry was screened for patients with confirmed ST. Optical coherence tomography was performed after initial intervention to the culprit lesion (in 69% of cases in a deferred procedure). Stent thrombosis was classified as acute (AST), sub-acute (SAST), late (LST), and very late (VLST). Optical coherence tomography records were analysed in a central core lab. The analysis included 120 subjects aged 61.7 [51.4-70.7]; 89% male. Very late ST was the clinical presentation in 75%, LST in 6%, SAST in 15%, and AST in 4% of patients. Bare metal stents (BMS) were used in 39%, drug-eluting stents (DES) in 59% and bioresorbable vascular scaffolds in 2% of the cases. Optical coherence tomography identified an underlying morphological abnormality in 97% of cases, including struts malapposition (34%), neoatherosclerotic lesions (22%), major stent underexpansion (11%), coronary evagination (8%), isolated uncovered struts (8%), edge-related disease progression (8%), and neointimal hyperplasia (4%). Ruptured neoatherosclerotic lesions were more frequent with BMS than with DES (36 vs. 14%, P = 0.005), whereas coronary evaginations were more frequent with DES than with BMS (12 vs. 2%, P = 0.04). LST + VLST were mainly related to malapposition (31%) and neoatherosclerosis (28%), while prominent mechanisms for AST + SAST were malapposition (48%) and underexpansion (26%). CONCLUSION: In patients with confirmed ST, OCT imaging identified an underlying morphological abnormality in 97% of cases.
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Trombosis Coronaria/etiología , Stents Liberadores de Fármacos , Oclusión de Injerto Vascular/etiología , Síndrome Coronario Agudo/terapia , Anciano , Anticoagulantes/uso terapéutico , Trombosis Coronaria/diagnóstico por imagen , Femenino , Oclusión de Injerto Vascular/diagnóstico por imagen , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complicaciones Posoperatorias/diagnóstico por imagen , Estudios Prospectivos , Falla de Prótesis , Sistema de Registros , Tomografía de Coherencia Óptica/métodosRESUMEN
BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).
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Estenosis de la Válvula Aórtica/terapia , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas/métodos , Sistema de Registros , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/complicaciones , Cateterismo Cardíaco/métodos , Femenino , Francia/epidemiología , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Hemorragia/epidemiología , Hemorragia/etiología , Humanos , Incidencia , Masculino , Análisis Multivariante , Estudios Prospectivos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND: To date, no randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of coronary angioplasty for non-ST-segment elevation acute coronary syndromes. METHODS: DOCTORS is a randomized, prospective, multicenter, open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for non-ST-elevation acute coronary syndromes. Patients (n = 250) will be randomized to undergo OCT-guided angioplasty (use of OCT to optimize procedural result, including change to strategy with the possibility of additional interventions) or angioplasty under fluoroscopy alone. The primary end point is the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) measured at the end of the procedure. Secondary end points include safety of OCT in the context of angioplasty for ACS, percentage of patients in whom OCT reveals suboptimal result of stenting, percentage of patients in whom a change in procedural strategy is decided based on OCT data, correlation between quantitative measures by OCT and FFR, determination of a threshold for quantitative OCT measure that best predicts FFR ≥ 0.90, and identification of OCT variables that predict postprocedure FFR. Adverse cardiac events (death, recurrent myocardial infarction, stent thrombosis, and repeat target lesion revascularization) at 6 months will be recorded. CONCLUSION: The DOCTORS randomized trial (ClinicalTrials.gov NCT01743274) is designed to investigate whether use of OCT yields useful additional information beyond that obtained by angiography alone and, if so, whether this information changes physician strategy and impacts on the functional result of angioplasty as assessed by FFR.
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Síndrome Coronario Agudo/terapia , Angioplastia Coronaria con Balón , Stents , Tomografía de Coherencia Óptica , Síndrome Coronario Agudo/fisiopatología , Reserva del Flujo Fraccional Miocárdico , Humanos , Proyectos de InvestigaciónRESUMEN
OBJECTIVES: To evaluate practices for the protection from radiation of patients during coronary angiography (CA) and percutaneous coronary intervention (PCI), and to update reference values for the main radiation dose parameters. BACKGROUND: Few multicenter data from large populations exist on radiation doses to patients during CA and PCI. METHODS: RAY'ACT is a multicenter, nationwide French survey, with retrospective analysis of radiation parameters routinely registered in professional software from 33,937 CAs and 27,826 PCIs performed at 44 centers from January 1, through December 31, 2010. RESULTS: Kerma-area product (KAP) was registered in 91.7% (44/48) of centers and in 91.5% of procedures for CA (median, 27.2 Gy·cm(2) , interquartile range [IQR], 15.5-45.2) and 91.1% for PCI (median, 56.8 Gy·cm(2) , IQR, 32.8-94.6). Fluoroscopy time was registered in 87.5% (42/48) of centers and in 83.1% of procedures (median, 3.7 min, IQR, 2.3-6.3 for CA; 10.3 min, 6.7-16.2 for PCI). Variability across centers was high. Old equipment and routine left ventriculography were more common and number of registered frames and frame rate were higher in centers delivering high doses. The radial route was associated with lower doses than the femoral route (median KAP 26.8 Gy·cm(2) [15.1-44.25] vs. 28.1 [16.4-46.9] for CA, respectively; and 55.6 Gy·cm(2) [32.2-92.1] vs. 59.4 [24.6-99.9] for PCI, respectively; P < 0.01). CONCLUSIONS: This survey showed a very high rate of compliance with dose registration during CA and PCI in French nonacademic hospitals. Updated diagnostic reference values are established for the main dose parameters (KAP, 45 Gy·cm(2) for CA, 95 Gy·cm(2) for PCI).
Asunto(s)
Angiografía Coronaria , Intervención Coronaria Percutánea , Dosis de Radiación , Traumatismos por Radiación/prevención & control , Radiografía Intervencional , Anciano , Angiografía Coronaria/efectos adversos , Angiografía Coronaria/normas , Femenino , Arteria Femoral/diagnóstico por imagen , Fluoroscopía , Francia , Adhesión a Directriz , Encuestas de Atención de la Salud , Humanos , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/normas , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina , Valor Predictivo de las Pruebas , Arteria Radial/diagnóstico por imagen , Traumatismos por Radiación/etiología , Radiografía Intervencional/efectos adversos , Radiografía Intervencional/normas , Valores de Referencia , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de TiempoRESUMEN
Severe tricuspid regurgitation (TR) is a common pathology in the daily practice of a cardiologist. This disease entity is associated with significant morbidity and mortality if left untreated. Classically, surgical repair or replacement were the only therapeutic options present and were often not performed due to high postprocedural mortality. Transcatheter tricuspid valve intervention has emerged as a novel and effective therapeutic option for the treatment of significant TR. Several devices have been developed with different mechanisms of action. In this review, we will provide an overview of transcatheter edge-to-edge repair of TR using the TriClip device (Abbott, Santa Clara, CA, USA).
RESUMEN
BACKGROUND: No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions. METHODS: Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. RESULTS: The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. CONCLUSIONS: A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.
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Implantación de Prótesis Vascular/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Stents Liberadores de Fármacos , Ultrasonografía Intervencional/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio , Estudios Prospectivos , Medición de Riesgo , Análisis de Supervivencia , Trombosis , Resultado del TratamientoRESUMEN
The CARDIO-ARSIF registry has been continuously collecting comprehensive data on coronary angiography and percutaneous coronary interventions (PCI) performed in the 36 catheterization laboratories across the Île-de-France region since 2000. Over the period from 2003 to 2022, this registry has recorded information from more than 330,000 patients, encompassing more than one million procedures. Among these procedures, 58% consisted of coronary angiography, 13% were percutaneous coronary interventions (PCI), and the remaining 28% were PCI performed on an ad-hoc basis. This extensive dataset serves as a valuable resource for both qualitative and quantitative assessments of practices and the relevance of procedures in the field of coronary invasive cardiology. The results of these analyses undergo annual validation by a dedicated scientific committee and are shared with the teams of investigators. The exploitation of this data has led to scientific publications, with one notable finding being a consistent reduction in the radiation doses received by patients, regardless of the type of procedure.
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Cardiología , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Sistema de Registros , Francia/epidemiologíaAsunto(s)
Válvula Aórtica/cirugía , Enfermedades de las Válvulas Cardíacas/cirugía , Anastomosis Interna Mamario-Coronaria/métodos , Válvula Aórtica/diagnóstico por imagen , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/etiología , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Humanos , Masculino , Arterias Mamarias/diagnóstico por imagen , Arterias Mamarias/efectos de la radiación , Persona de Mediana Edad , Placa Aterosclerótica/diagnóstico por imagen , Radioterapia/efectos adversos , Reoperación , Vena Safena/trasplante , Tomografía de Coherencia Óptica , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/cirugíaRESUMEN
CONTEXT: Short-term exposure to high levels of air pollution may trigger myocardial infarction (MI), but this association remains unclear. OBJECTIVE: To assess and quantify the association between short-term exposure to major air pollutants (ozone, carbon monoxide, nitrogen dioxide, sulfur dioxide, and particulate matter ≤10 µm [PM(10)] and ≤2.5 µm [PM(2.5)] in diameter) on MI risk. DATA SOURCES: EMBASE, Ovid MEDLINE in-process and other nonindexed citations, and Ovid MEDLINE (between 1948 and November 28, 2011), and EBM Reviews-Cochrane Central Register of Controlled Trials and EBM Reviews-Cochrane Database of Systematic Reviews (between 2005 and November 28, 2011) were searched for a combination of keywords related to the type of exposure (air pollution, ozone, carbon monoxide, nitrogen dioxide, sulfur dioxide, PM(10), and PM(2.5)) and to the type of outcome (MI, heart attack, acute coronary syndrome). STUDY SELECTION: Two independent reviewers selected studies of any study design and in any language, using original data and investigating the association between short-term exposure (for up to 7 days) to 1 or more air pollutants and subsequent MI risk. Selection was performed from abstracts and titles and pursued by reviewing the full text of potentially eligible studies. DATA EXTRACTION: Descriptive and quantitative information was extracted from each selected study. Using a random effects model, relative risks (RRs) and 95% CIs were calculated for each increment of 10 µg/m(3) in pollutant concentration, with the exception of carbon monoxide, for which an increase of 1 mg/m(3) was considered. DATA SYNTHESIS: After a detailed screening of 117 studies, 34 studies were identified. All the main air pollutants, with the exception of ozone, were significantly associated with an increase in MI risk (carbon monoxide: 1.048; 95% CI, 1.026-1.070; nitrogen dioxide: 1.011; 95% CI, 1.006-1.016; sulfur dioxide: 1.010; 95% CI, 1.003-1.017; PM(10): 1.006; 95% CI, 1.002-1.009; and PM(2.5): 1.025; 95% CI, 1.015-1.036). For ozone, the RR was 1.003 (95% CI, 0.997-1.010; P = .36). Subgroup analyses provided results comparable with those of the overall analyses. Population attributable fractions ranged between 0.6% and 4.5%, depending on the air pollutant. CONCLUSION: All the main air pollutants, with the exception of ozone, were significantly associated with a near-term increase in MI risk.