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BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long-term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation. METHODS AND RESULTS: Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta-analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62-1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71-1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61-1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58-1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all-cause death compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53-0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85-0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%). CONCLUSIONS: As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.
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INTRODUCTION: Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual-layer stents, among others. AREAS COVERED: This review provides a general overview of current embolic protection strategies for CAS. The phases of the procedure which can affect the early risk of stroke and how to reduce it with novel techniques and devices have been discussed. EXPERT OPINION: Innovations in device technologies have dramatically improved the safety and efficacy of CAS. To minimize the gap with surgery, a thorough, patient-oriented approach should be pursued. Endovascular technologies and techniques should be selected on an individual basis to address unique lesion characteristics and vascular anatomies. Meticulous pre-procedural planning, both clinical and anatomical, is needed to assess the embolic risk of each procedure. Only by having an in-depth understanding of the wide range of available endovascular devices and techniques, the operator will choose the most appropriate strategy to optimize CAS results.
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Estenosis Carotídea , Dispositivos de Protección Embólica , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/cirugía , Resultado del Tratamiento , Stents/efectos adversos , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/complicaciones , Arterias Carótidas/cirugía , Factores de RiesgoRESUMEN
INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).
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Endarterectomía Carotidea , Accidente Cerebrovascular , Humanos , Arterias Carótidas , Constricción Patológica , Endarterectomía Carotidea/efectos adversos , Stents , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Procedimientos Quirúrgicos Vasculares , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Carotid artery lesions are frequently composed of friable, thrombotic, ulcerated and/or hemorrhagic materials which can embolize during surgical or endovascular interventions. The use of embolic protection devices (EPD) during carotid angioplasty and stenting (CAS) has been proven to be associated with a reduction of the embolic load. Many studies indicate that the clinical results of CAS are comparable with the best surgical series, when EPD are routinely applied. The proximal EPD work by interrupting or reversing the blood flow in the common carotid artery/internal carotid artery (CCA/ICA). Once established the endovascular flow arrest/reversal, these systems have the advantages of promoting a protected crossing of the lesion and blocking both macro-emboli and micro-emboli. Moreover, proximal neuroprotection implies no manipulation of the device in the distal ICA, neither during device deployment nor during device retrieval, and reduces the risk of arterial spasm, dissection, or intimal damage. The choice between transfemoral and transcervical proximal EPD should account for different factors: local availability, operator expertise, and patient characteristics including anatomical features precluding flow arrest/reversal (e.g., incomplete circle of Willis), femoral access (e.g., unfavorable aortic arch anatomy), or transcervical access (e.g., diseased CCA).
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Estenosis Carotídea , Humanos , Constricción , Estenosis Carotídea/cirugía , Resultado del Tratamiento , Angioplastia/métodos , Arteria Carótida Interna/cirugía , StentsRESUMEN
OBJECTIVES: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. BACKGROUND: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. METHODS: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. RESULTS: The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. CONCLUSIONS: Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.
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Estenosis Carotídea , Dispositivos de Protección Embólica , Endarterectomía Carotidea , Accidente Cerebrovascular , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/terapia , Stents , Dilatación , Resultado del Tratamiento , Factores de Tiempo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Factores de RiesgoRESUMEN
Background: Single-cohort studies suggest that second-generation stents (SGS; "mesh stents") may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a "mesh stent" class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.
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OBJECTIVES: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. BACKGROUND: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. METHODS: Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. RESULTS: At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores. CONCLUSIONS: The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).
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Fármacos Cardiovasculares , Stents Liberadores de Fármacos , Enfermedad Arterial Periférica , Fármacos Cardiovasculares/efectos adversos , Arteria Femoral/diagnóstico por imagen , Humanos , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/diagnóstico por imagen , Sirolimus/efectos adversos , Stents , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.
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Cardiología , Stents , Arterias Carótidas , Humanos , Italia , Arteria Radial/diagnóstico por imagen , Arteria Radial/cirugía , Resultado del TratamientoAsunto(s)
Aneurisma Falso , Enfermedades de la Aorta , Procedimientos Quirúrgicos Cardíacos/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Anciano de 80 o más Años , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/fisiopatología , Aneurisma Falso/cirugía , Enfermedades de la Aorta/diagnóstico , Enfermedades de la Aorta/fisiopatología , Enfermedades de la Aorta/cirugía , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Dolor en el Pecho/diagnóstico , Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Diagnóstico Diferencial , Disnea/diagnóstico , Ecocardiografía Transesofágica/métodos , Electrocardiografía/métodos , Humanos , Masculino , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/cirugía , Resultado del TratamientoRESUMEN
Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.
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COVID-19 , Cardiología , Intervención Coronaria Percutánea , Hospitalización , Humanos , Tiempo de Internación , Pandemias/prevención & control , Intervención Coronaria Percutánea/efectos adversosRESUMEN
Acute ischemic stroke is among the leading causes of mortality and disability worldwide. Since 2015, as was the case for primary percutaneous coronary intervention for acute myocardial infarction, catheter-based reperfusion via mechanical thrombectomy (MT) has become the gold-standard treatment for acute ischemic stroke caused by large-vessel occlusion. Despite that, only a fraction of the world's population currently would be able to undergo MT in time, mostly because of the scarcity of 24/7 coverage by neurointerventionalists to deal with this enormous burden. Interventional cardiologists have thus been considered a logical option to aid in combating this vast demand to diminish the burden of acute ischemic stroke. However, despite some seemingly evident similarities between primary percutaneous coronary intervention and MT, for interventional cardiologists to enter this new field, they must be well trained and fully aware of all the clinical, technical, and environmental differences between these two scenarios. The main objective of this state-of-the-art paper is to serve as an introductory and comprehensive guide to familiarize the interventional cardiology community with the most critical technical aspects of MT.
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Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico/terapia , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Cardiólogos , Competencia Clínica , Conducta Cooperativa , Procedimientos Endovasculares/efectos adversos , Humanos , Comunicación Interdisciplinaria , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/fisiopatología , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/fisiopatología , Neurólogos , Grupo de Atención al Paciente , Intervención Coronaria Percutánea/efectos adversos , Trombectomía/efectos adversos , Flujo de TrabajoRESUMEN
The Stellarex® drug-coated balloon (DCB) is an over-the-wire dual lumen catheter with a distally premounted semi-compliant balloon, which has a low dose (2 µg/mm2 of the expanded balloon surface) paclitaxel coating. Its hybrid formulation, made of amorphous and crystalline paclitaxel combined with a polyethylene glycol excipient, provides maintenance of coating integrity and adequate drug release. This balanced combination of amorphous and crystalline paclitaxel is able to maintain drug on the surface during handling and balloon tracking, with an effective drug transfer to vessel wall in the lesion site. Clinical data associated with Stellarex balloon are growing and confirm clinical effectiveness over a long-term follow-up without any possible signal of a reduced safety for treated patients.
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Angioplastia de Balón/métodos , Excipientes/química , Paclitaxel/administración & dosificación , Angioplastia de Balón/efectos adversos , Materiales Biocompatibles Revestidos , Arteria Femoral/patología , Humanos , Enfermedad Arterial Periférica/etiología , Enfermedad Arterial Periférica/patología , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Factores de Tiempo , Resultado del TratamientoRESUMEN
In cases of COVID-19 acute respiratory distress syndrome, an excessive host inflammatory response has been reported, with elevated serum interleukin-6 levels. In this multicenter retrospective cohort study we included adult patients with COVID-19, need of respiratory support, and elevated C-reactive protein who received intravenous tocilizumab in addition to standard of care. Control patients not receiving tocilizumab were matched for sex, age and respiratory support. We selected survival as the primary endpoint, along with need for invasive ventilation, thrombosis, hemorrhage, and infections as secondary endpoints at 30 days. We included 64 patients with COVID-19 in the tocilizumab group and 64 matched controls. At baseline the tocilizumab group had longer symptom duration (13 ± 5 vs. 9 ± 5 days) and received hydroxychloroquine more often than controls (100% vs. 81%). The mortality rate was similar between groups (27% with tocilizumab vs. 38%) and at multivariable analysis risk of death was not significantly influenced by tocilizumab (hazard ratio 0.61, 95% confidence interval 0.33-1.15), while being associated with the use at baseline of non invasive mechanical or invasive ventilation, and the presence of comorbidities. Among secondary outcomes, tocilizumab was associated with a lower probability of requiring invasive ventilation (hazard ratio 0.36, 95% confidence interval 0.16-0.83; P = 0.017) but not with the risk of thrombosis, bleeding, or infections. The use of intravenous tocilizumab was not associated with changes in 30-day mortality in patients with COVID-19 severe respiratory impairment. Among the secondary outcomes there was less use of invasive ventilation in the tocilizumab group.
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Anticuerpos Monoclonales Humanizados/administración & dosificación , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Receptores de Interleucina-6/antagonistas & inhibidores , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , Anciano , Betacoronavirus/inmunología , COVID-19 , Estudios de Casos y Controles , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Infusiones Intravenosas , Interleucina-6/inmunología , Interleucina-6/metabolismo , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/inmunología , Neumonía Viral/mortalidad , Receptores de Interleucina-6/metabolismo , Síndrome de Dificultad Respiratoria/diagnóstico , Síndrome de Dificultad Respiratoria/inmunología , Síndrome de Dificultad Respiratoria/mortalidad , Estudios Retrospectivos , SARS-CoV-2 , Índice de Severidad de la Enfermedad , Análisis de Supervivencia , Resultado del Tratamiento , Tratamiento Farmacológico de COVID-19Asunto(s)
Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Infarto del Miocardio con Elevación del ST/diagnóstico , Anciano , Anciano de 80 o más Años , Betacoronavirus/aislamiento & purificación , COVID-19 , Angiografía Coronaria , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/virología , Ecocardiografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/virología , Factores de Riesgo , SARS-CoV-2 , Infarto del Miocardio con Elevación del ST/complicacionesRESUMEN
OBJECTIVES: The aim of this study is to assess long-term-outcomes of patients with concomitant CAD and COD treated with different revascularization strategies. BACKGROUND: Multisite artery disease is common and patients with combined disease have poor prognosis. The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. METHODS: This observational registry enrolled, between January 2006 and December 2012, 1022 consecutive patients from high volume institutions with concomitant CAD and COD suitable for endovascular, surgical, or hybrid revascularization in both territories selected by consensus of a multidisciplinary team. RESULTS: The cumulative incidence of 5-year major cardiovascular events (MACCE) including cardiovascular death, myocardial infarction (MI), or stroke in the overall population was 12%. The incidence of 5-year MACCE was not statistically different in the surgical, endovascular, or hybrid patients group (10.1% vs. 13.0% vs. 13.2%, P = .257, respectively). However, the hybrid group exhibited rates of myocardial infarction, chronic kidney disease, and cumulative incidence of all clinical events higher than the surgical group. After propensity score matching, the incidence of 5-year MACCE was similar in the three groups (13.0% vs. 15.0% vs. 16.0%, p = .947, respectively). CONCLUSIONS: An individualized revascularization approach of patients with combined CAD and COD yields very good results at long-term follow-up, despite the high risk of this multilevel population even when the baseline clinical features are equalized.
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Enfermedades de las Arterias Carótidas/cirugía , Revascularización Cerebral , Enfermedad de la Arteria Coronaria/cirugía , Efectos Adversos a Largo Plazo , Revascularización Miocárdica , Anciano , Enfermedades de las Arterias Carótidas/diagnóstico , Enfermedades de las Arterias Carótidas/epidemiología , Revascularización Cerebral/efectos adversos , Revascularización Cerebral/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/epidemiología , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/estadística & datos numéricos , Femenino , Humanos , Incidencia , Italia/epidemiología , Efectos Adversos a Largo Plazo/clasificación , Efectos Adversos a Largo Plazo/epidemiología , Efectos Adversos a Largo Plazo/etiología , Masculino , Persona de Mediana Edad , Revascularización Miocárdica/efectos adversos , Revascularización Miocárdica/métodos , Evaluación de Resultado en la Atención de Salud , Sistema de Registros/estadística & datos numéricos , Factores de RiesgoAsunto(s)
Aleaciones/química , Stents Liberadores de Fármacos , Arteria Femoral/patología , Enfermedad Arterial Periférica/cirugía , Arteria Poplítea/patología , Sirolimus/administración & dosificación , Anciano , Supervivencia sin Enfermedad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Diseño de Prótesis , Reproducibilidad de los Resultados , Resultado del TratamientoRESUMEN
OBJECTIVES: Treatment of aortic valve stenosis is evolving, indications for transcatheter approach (TAVI) have increased but also surgical valve replacement has changed with the use of minimally invasive approaches. Comparisons between TAVI and surgery have rarely been done with minimally invasive techniques (mini-SAVR) in the surgical arm. Aim of the present study is to compare mini-SAVR and TAVI in a multicenter recent cohort. METHODS: Evaluated were 2904 patients undergone mini-SAVR (2407) or TAVI (497) in 10 different centers in the period 2011-2016. The Heart Team approved treatment for complex cases. The primary outcome is the incidence of 30-day mortality following mini-SAVR and TAVI. Secondary outcomes are the occurrence of major complications following both procedures. Propensity matched comparisons was performed based on multivariable logistic regression model. RESULTS: In the overall population TAVI patients had increased surgical risk (median EuroSCORE II 3.3% vs. 1.7%, pâ¯≤â¯0.001) and 30-day mortality was higher (1.5% and 2.8% in mini-SAVR and TAVI respectively, pâ¯=â¯0.048). Propensity score identified 386 patients per group with similar baseline profile (median EuroSCORE II ~3.0%). There was no difference in 30-day mortality (3.4% in mini-SAVR and 2.3% in TAVI; pâ¯=â¯0.396) and stroke, surgical patients had more blood transfusion, kidney dysfunction and required longer ICU and hospital length of stay while TAVI patients had more permanent pace maker insertion. CONCLUSIONS: Mini-SAVR and TAVI are both safe and effective to treat aortic stenosis in elderly patients with comorbidities. A joint evaluation by the heart-team is essential to direct patients to the proper approach.
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Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular , Cardiólogos , Humanos , IsquemiaRESUMEN
AIMS: In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear. METHODS AND RESULTS: We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49). CONCLUSION: The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding.