RESUMEN
BACKGROUND: Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue. AIM: To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus. METHODS AND RESULTS: The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2 DS2 -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded. CONCLUSIONS: In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Trombosis , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/diagnóstico por imagen , Humanos , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Trombosis/diagnóstico por imagen , Trombosis/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: Aim of this study was to evaluate the clinical impact of the culprit plaque features assessed by optical coherence tomography (OCT) in patients with acute coronary syndrome (ACS). METHODS: The OCT-FORMIDABLE register enrolled retrospectively all consecutive patients who perform OCT on culprit plaque in patients with ACS in nine European centres. The primary endpoint was the prevalence of culprit plaque rupture (CPR) in patients experiencing major adverse cardiovascular events (MACEs). Secondary endpoint was the prevalence necrotic core with macrophage infiltrations (NCMI) in the patients experiencing MACEs. RESULTS: Two-hundred and nine patients were included in the study. Mean age was 60.1 ± 12.9 years old, 19.1% were females. Main clinical presentation was ST-elevation myocardial infarction (55%). At OCT analysis, CPR was observed in 71.8% patients, while 31.6% presented NCMI. During follow-up (12.6 ± 14.5 months), 11% of the patients experienced MACEs. The presence of CPR (HR 3.7,1.4-9.8, P < .01) and NCMI (HR 3.3,1.6-6.6, P < .01) were independent predictors for MACEs, while dual antiplatelet therapy with prasugrel/ticagrelor at discharge (HR 0.2,0.1-0.6, P < .01) were protective. The protective impact of new antiplatelet drugs was reported only in patients with CPR while in patients without any of the baseline clinical or procedural features impacted on MACEs. CONCLUSIONS: CPR and the presence of NCMI are independent predictors of worse outcome. Patients with CPR seem to benefit more of an intensive therapy, both from a pharmacological and interventional point of view. (NCT02486861).
Asunto(s)
Síndrome Coronario Agudo/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Placa Aterosclerótica , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Tomografía de Coherencia Óptica , Síndrome Coronario Agudo/epidemiología , Síndrome Coronario Agudo/patología , Síndrome Coronario Agudo/terapia , Anciano , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/patología , Europa (Continente)/epidemiología , Femenino , Humanos , Macrófagos/patología , Masculino , Persona de Mediana Edad , Necrosis , Valor Predictivo de las Pruebas , Prevalencia , Pronóstico , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Rotura Espontánea , Infarto del Miocardio con Elevación del ST/epidemiología , Infarto del Miocardio con Elevación del ST/patología , Infarto del Miocardio con Elevación del ST/terapiaRESUMEN
OBJECTIVES: We aimed to investigate procedural feasibility and outcomes associated with planned rotational atherectomy (RA) for severely calcified coronary lesions. BACKGROUND: Limited data are available addressing the benefits of planned RA compared to provisional RA. METHODS: Between 2002 and 2013, all patients with calcified lesions treated by RA were enrolled. Of these, patients treated with planned RA (358 patients) were compared to those treated with provisional RA (309 patients). RESULTS: In-hospital major adverse cardiovascular events (MACE) were tended to be better in the planned RA group (unadjusted OR: 0.76; 95% CI: 0.44-1.31, P = 0.32, and adjusted OR: 0.59; 95% CI: 0.33-1.05, P = 0.07). The number of pre-dilation balloon catheters was significantly lower in the planned RA group (1.17 ± 0.60 vs. 1.47 ± 0.76, P < 0.001). Procedure time, fluoroscopy time, and contrast volume used were all significantly reduced in the planned RA group compared to the provisional RA group (procedure time; 65.2 ± 36.8min vs. 84.4 ± 43.1min, P < 0.001, fluoroscopy time; 33.1 ± 22.9min vs. 51.2 ± 29.6min, P < 0.001, and contrast volume; 232.9 ± 141.6ml vs. 302.9 ± 150.3ml, P < 0.001). The incidence of MACE at 1-year was significantly higher amongst the unadjusted population, whereas the difference was less marked between groups after propensity-score adjustment (unadjusted HR: 1.78; 95% CI: 1.16-2.74, P = 0.01, and adjusted HR: 1.44; 95% CI: 0.92-2.26, P = 0.11). CONCLUSIONS: Planned RA appears to be safe and was associated with a reduction in procedural and fluoroscopy times, contrast volume, and the number of pre-dilation balloon catheters used. If there is a strong likelihood of requiring RA for the treatment of severely calcified lesions, operators should have a low threshold for adopting a planned RA strategy. © 2016 Wiley Periodicals, Inc.
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Aterectomía Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Complicaciones Posoperatorias/epidemiología , Sistema de Registros , Calcificación Vascular/cirugía , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Estudios Cruzados , Stents Liberadores de Fármacos , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Italia/epidemiología , Masculino , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Factores de Tiempo , Calcificación Vascular/diagnósticoRESUMEN
BACKGROUND: Rotational atherectomy (RA) is relatively contraindicated in patients with lesions ≥25 mm of length. Aim of this study was to evaluate RA safety and efficacy in this subset of patients with new technology and devices. METHODS AND RESULTS: From April 2002 to August 2013, the ROTATE registry included all consecutive patients undergoing RA in 8 centres. They were divided into shorter lesion group (SLG, lesions < 25 mm) and longer lesion group (LLG, lesions ≥ 25 mm). The angiographic success (AS) was the primary end point. Procedural complications (PC), a composite end point of procedural perforation, slow flow/no flow, and in-hospital major acute cardiovascular events (MACE), were secondary end points, along with death, nonfatal MI, target lesion revascularization, and MACE during follow-up. Sensitivity analysis was performed according to generation of DES. 1186 patients were included: 51.5% in SLG and 48.4% in LLG. Mean age was 70.4 ± 9.3 years, 64.5% were male. AS and PC did not differ between the two groups (93% vs 91%, p = 0.24 and 9.8 vs 9.4%, p = 0.84). During follow-up (27.6 ± 22.9 months), MACE did not differ between the two groups (28% vs 29.1%, p = 0.95). At multivariate analysis chronic kidney disease, male gender increased risk of MACE (HR 1.94, IQR 1.29-2.0, p = 0.01, HR 0.52, IQR 0.34-0.79, p = 0.01) while second-generation DES seemed protective (HR 0.53, IQR 0.31-0.88, p = 0.02). Data were confirmed at sensitivity analysis for second-generation DES (759 pts, 63.9%). No differences were found in this subpopulation between the two groups in term of AS, PC, and long-term MACE (93.6% vs 93.5%, p = 0.28, 11.9% vs 9.4%, p = 0.32 and 25.5% vs 23.9%, p = 0.72, respectively). CONCLUSIONS: Treating coronary lesions ≥ 25 mm length with RA does not impact short- and long-term outcome, in particular, in patients with second-generation DES. © 2016 Wiley Periodicals, Inc.
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Aterectomía Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/métodos , Sistema de Registros , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: The clinical impact of invasive hemodynamic support with Impella in patients with cardiogenic shock (CS) remains to be defined. METHOD: Only studies including patients treated with Impella in CS were selected. The primary endpoint was short term mortality, while secondary endpoints were major vascular complications and major bleeding. RESULTS: 17 studies and 3933 patients were included in the analysis. Median age was 61.9 (IQR 59.2-63.5) years, CS was mainly related to acute coronary syndrome (ACS): 79.6% (IQR 75.1-79.6). Thirty-day mortality was 47.8% (CI 43.7-52%). Based on metaregression analysis, the Impella 5.0 (point estimate -0.006, 95% CI -0.01 - - 0.02, p < 0.01) and the Impella CP (point estimate -0.007, 95% CI -0.01 - - 0.03, p < 0.01) devices were related to a higher survival rate, whereas the Impella 2.5 was not. Furthermore, a correlation with reduced mortality was found when Impella was initiated in CS not complicated by cardiac arrest (CA), and before revascularization, (point estimate 0.01, 95% CI 0.002-0.02, p < 0.01 and point estimate -0.02, 95% CI 0.023-0.01, p < 0.001 respectively). The vascular complication and major bleeding rate were 7.4% (95% CI 5.6-9.6%) and 15.2% (95% CI 10.7-21%) respectively, and were associated with older age and comorbidities, while the implantation of an Impella CP/2.5 L was associated with fewer complications. CONCLUSIONS: Despite the use of Impella the 30 day mortality of CS still remains high. Our data suggest that the use of an Impella CP, initiation of Impella prior to PCI and in patients without cardiac arrest was correlated with outcome improvements.
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Corazón Auxiliar , Intervención Coronaria Percutánea , Anciano , Hemodinámica , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/terapia , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
Device loss or entrapment during percutaneous coronary interventions (PCI) is a rare circumstance whose incidence has decreased over time mainly because of device improvements. Nevertheless, they still represent fearful complications also and above all because the operators may be unfamiliar with rescue and retrieval techniques. The devices that most frequently experience loss or entrapment are stents, followed by angioplasty balloons, burrs for rotational atherectomy, guidewires and microcatheters. In this review we will illustrate the risk factors for device loss and the main retrieval techniques, as described in the literature or stemmed from our experience as high-volume PCI center.
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Remoción de Dispositivos/métodos , Cuerpos Extraños/terapia , Intervención Coronaria Percutánea/efectos adversos , Falla de Equipo , Cuerpos Extraños/complicaciones , Humanos , Intervención Coronaria Percutánea/instrumentación , Factores de Riesgo , Stents/efectos adversosRESUMEN
BACKGROUND: Non-invasive ischaemia tests and biomarkers are widely adopted to rule out acute coronary syndrome in the emergency department. Their diagnostic accuracy has yet to be precisely defined. METHODS: Medline, Cochrane Library CENTRAL, EMBASE and Biomed Central were systematically screened (start date 1 September 2016, end date 1 December 2016). Prospective studies (observational or randomised controlled trial) comparing functional/imaging or biochemical tests for patients presenting with chest pain to the emergency department were included. RESULTS: Overall, 77 studies were included, for a total of 49,541 patients (mean age 59.9 years). Fast and six-hour highly sensitive troponin T protocols did not show significant differences in their ability to detect acute coronary syndromes, as they reported a sensitivity and specificity of 0.89 (95% confidence interval 0.79-0.94) and 0.84 (0.74-0.9) vs 0.89 (0.78-0.94) and 0.83 (0.70-0.92), respectively. The addition of copeptin to troponin increased sensitivity and reduced specificity, without improving diagnostic accuracy. The diagnostic value of non-invasive tests for patients without troponin increase was tested. Coronary computed tomography showed the highest level of diagnostic accuracy (sensitivity 0.93 (0.81-0.98) and specificity 0.90 (0.93-0.94)), along with myocardial perfusion scintigraphy (sensitivity 0.85 (0.77-0.91) and specificity 0.92 (0.83-0.96)). Stress echography was inferior to coronary computed tomography but non-inferior to myocardial perfusion scintigraphy, while exercise testing showed the lower level of diagnostic accuracy. CONCLUSIONS: Fast and six-hour highly sensitive troponin T protocols provide an overall similar level of diagnostic accuracy to detect acute coronary syndrome. Among the non-invasive ischaemia tests for patients without troponin increase, coronary computed tomography and myocardial perfusion scintigraphy showed the highest sensitivity and specificity.
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Síndrome Coronario Agudo/sangre , Dolor en el Pecho/sangre , Vasos Coronarios/diagnóstico por imagen , Imagen de Perfusión Miocárdica/métodos , Tomografía Computarizada por Rayos X/métodos , Síndrome Coronario Agudo/diagnóstico por imagen , Biomarcadores/sangre , Dolor en el Pecho/diagnóstico por imagen , Ecocardiografía de Estrés/métodos , Servicio de Urgencia en Hospital , Prueba de Esfuerzo/métodos , Femenino , Glicopéptidos/sangre , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Cintigrafía/métodos , Sensibilidad y Especificidad , Troponina T/sangreRESUMEN
Heavily calcified unprotected left main (ULM) disease continues to be a challenging situation and represent a high-risk subset for interventional cardiologist. To date, there are limited data investigating the results after rotational atherectomy (RA) in this setting. The aim of this study was to investigate the in-hospital and 1-year outcomes after RA of heavily calcified ULM lesions. A retrospective cohort analysis was performed on all calcified patients with ULM (n = 86) enrolled in the multicenter international ROTATE registry (overall patients, n = 962). End points of the study were the in-hospital and 1-year incidence of major adverse cardiovascular events (MACE): a composite of death, myocardial infarction, and target-vessel revascularization in the ULM versus non-ULM group. Patients in the ULM group were older (p = 0.01) and more frequently with diabetes (p = 0.001) compared with the non-ULM group, whereas intravascular ultrasound guidance was higher, even if not systematic, in the ULM group (p <0.001). No difference was reported between ULM versus non-ULM groups in terms of in-hospital MACE (5.8% vs 8%). At 1 year, MACE rate was higher in ULM versus non-ULM (26.4% vs 14.9%, p = 0.002) mostly driven by target-vessel revascularization (20.3% vs 12.7%, p = 0.05). Even definite/probable stent thrombosis rate was higher in the ULM group (3.9% vs 0.8%). All these events were subacute and 2/3 (75%) were fatal. In conclusion, our multicenter experience shows that RA followed by stent implantation in patients with heavily calcified ULM narrowing is feasible and associated with good in-hospital results. Patient (age and diabetes) and procedural aspects (relatively low intravascular ultrasound guidance) may affect the worse subacute mid-term prognosis in the more complex ULM group.
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Síndrome Coronario Agudo/cirugía , Aterectomía Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Placa Aterosclerótica/cirugía , Sistema de Registros , Calcificación Vascular/cirugía , Síndrome Coronario Agudo/etiología , Anciano , Anciano de 80 o más Años , Enfermedad de la Arteria Coronaria/complicaciones , Trombosis Coronaria/epidemiología , Femenino , Mortalidad Hospitalaria , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Revascularización Miocárdica/estadística & datos numéricos , Placa Aterosclerótica/complicaciones , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Resultado del Tratamiento , Calcificación Vascular/complicacionesRESUMEN
AIMS: The aim of this multicentre study was to investigate the in-hospital and midterm outcomes of rotational atherectomy (RA) followed by metallic stent implantation. METHODS AND RESULTS: Between 2002 and 2013, 1,176 de novo lesions with calcified coronary lesions treated by RA and metallic stent implantation at nine institutions were assessed. Patients with ST-segment elevation myocardial infarction (STEMI) within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis were excluded from the current analysis. In-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16.0% at one-year and 24.9% at two-year follow-up, both driven by target vessel revascularisation (13.5% at one year and 19.8% at two years). Multivariable analysis revealed that dialysis was an independent predictor for both in-hospital MACE (OR 2.33, 95% CI: 1.11-4.87, p=0.03) and follow-up MACE (HR 4.14, 95% CI: 2.87-5.96, p<0.001), whilst drug-eluting stent (DES) use was associated with a reduction in follow-up MACE (HR 0.42, 95% CI: 0.26-0.67, p<0.001). CONCLUSIONS: RA appears to be safe and effective with acceptable in-hospital and follow-up MACE considering the severity of patient and lesion characteristics. DES implantation following RA was associated with a reduction in MACE during the follow-up period.
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Angioplastia Coronaria con Balón , Aterectomía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/métodos , Aterectomía Coronaria/efectos adversos , Angiografía Coronaria/efectos adversos , Stents Liberadores de Fármacos/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Resultado del TratamientoRESUMEN
AIMS: The safety and efficacy of rotational atherectomy (RA) in patients presenting with non-ST-elevation myocardial infarction (NSTE-ACS) remain to be defined. The aim of our study was to assess the safety and efficacy of RA in NSTE-ACS patients with reference to both short- and long-term follow-up. METHODS AND RESULTS: This was an observational retrospective registry which enrolled all consecutive patients undergoing RA, comparing patients with stable angina (SA) and NSTE-ACS. In addition, ACS patients were matched with those not undergoing RA. The primary endpoint was angiographic success. Procedural complications and in-hospital MACE were secondary endpoints along with MACE during follow-up. One thousand three hundred and eight patients were included: 37% (484) with an NSTE-ACS diagnosis and 63% (824) in the SA group. Angiographic success did not differ between the groups (98.8% vs. 99.2%, p=0.57). By univariate analysis procedural complications were more frequent in the NSTE-ACS group (11.3% vs. 8.0%, p=0.04). In-hospital MACE rates were comparable (5.7% vs. 5.8%, p=0.93); by multivariate analysis NSTE-ACS patients showed a non-significant trend towards a higher risk of adverse events (HR 2.39, CI: 0.96-5.96, p=0.061). MACE after a median of 27.9 months was significantly higher in the NSTE-ACS group compared with the SA group (32.4% vs. 24.2%, log-rank p<0.001), results confirmed by multivariate analysis. After propensity score matching, NSTE-ACS patients undergoing RA had similar outcomes to ACS patients who did not undergo RA (16% vs. 13%, log-rank p=0.14). CONCLUSIONS: Rotational atherectomy has similar safety and angiographic outcome in patients with NSTE-ACS or SA. The higher rate of adverse cardiac events at follow-up in NSTE-ACS patients undergoing RA is comparable with a matched population of NSTE-ACS patients not undergoing RA.