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BACKGROUND: Available studies have already identified age, heart rate (HR) and systolic blood pressure (SBP) as strong predictors of early mortality in acute pulmonary embolism (PE). MATERIAL AND METHODS: One-hundred-seventy patients, with acute PE confirmed on computed tomography angiography (CTA) were enrolled. Thrombolysis In Myocardial Infarction (TIMI) risk index (TRI) was calculated using the formula [heart rate (HR) x (AGE/102)/ systolic blood pressure (SBP)]. Study outcomes were 30-day mortality and/or clinical deterioration. RESULTS: Receiver operating characteristics (ROC) curve revealed that a TRI ≥45 was highly specific for both outcomes (AUC 0.91, 95% CI 0.83-0.98, p<0.0001) with a positive predictive value (PPV) and negative predictive value (NPV) of 8.3 and 96% for 30-day mortality while PPV and NPV for 30-day mortality and/or clinical deterioration were 21.1 and 98.2%, respectively. Multivariate regression analysis showed that TRI ≥45 was an independent predictor of 30-day mortality (O.R. 22.24, 95% CI 2.54-194.10, p=0.005) independently from positive cTnI and RVD (O.R. 9.57, 95% CI 1.88-48.78, p=0.007; OR 24.99, 95% CI 2.84-219.48, p=0.004). Similarly, 30-day mortality and/or clinical deterioration was predicted by TRI ≥45 (O.R. 11.57, 95% CI 2.36-56.63, p=0.003) and thrombolysis (3.83, 95% CI 1.04-14.09, p=0.043), independently from age, RVD and positive cTnI. Cox regression analysis confirmed the role of TRI as independent predictor for both outcomes. Mantel-Cox analysis showed that after 30-day follow-up there was a statistically significant difference in the distribution of survival between patients with and without TRI ≥45 [log rank (Mantel-Cox) chi-square 17.04, p<0.0001]. CONCLUSIONS: Thrombolysis In Myocardial Infarction (TIMI) risk index (TRI) predicted both 30-days mortality (all-causes) and/or clinical deterioration in patients with acute PE.
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Heparina/administración & dosificación , Embolia Pulmonar/tratamiento farmacológico , Medición de Riesgo/métodos , Terapia Trombolítica/métodos , Enfermedad Aguda , Anciano , Anticoagulantes/administración & dosificación , Angiografía por Tomografía Computarizada , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Masculino , Pronóstico , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidad , Curva ROC , Tasa de Supervivencia/tendencias , Factores de TiempoRESUMEN
BACKGROUND/PURPOSE: Multiple BRSs and specifically the Absorb scaffold (BVS) (Abbott Vascular, Santa Clara, CA USA) have been often used to treat long diffuse coronary artery lesions. We evaluate by a computational fluid dynamic(CFD) study the impact on the intravascular fluid rheology on multiple bioabsorbable scaffolds (BRS) by standard overlapping versus edge-to-edge technique. METHODS/MATERIALS: We simulated the treatment of a real long significant coronary lesion (>70% luminal narrowing) involving the left anterior descending artery (LAD) treated with a standard or edge-to-edge technique, respectively. Simulations were performed after BVS implantations in two different conditions: 1) Edge-to-edge technique, where the scaffolds are kissed but not overlapped resulting in a luminal encroachment of 0.015cm (150µm); 2) Standard overlapping, where the scaffolds are overlapped resulting in a luminal encroachment of 0.030cm (300µm). After positioning the BVS across the long lesion, the implantation procedure was performed in-silico following all the usual procedural steps. RESULTS: Analysis of the wall shear stress (WSS) suggested that at the vessel wall level the WSS were lower in the overlapping zones overlapping compared to the edge-to-edge zone (∆=0.061Pa, p=0.01). At the struts level the difference between the two WSS was more striking (∆=1.065e-004 p=0.01) favouring the edge-to-edge zone. CONCLUSIONS: Our study suggested that at both vessel wall and scaffold struts levels, there was lowering WSS when multiple BVS were implanted with the standard overlapping technique compared to the "edge-to-edge" technique. This lower WSS might represent a substrate for restenosis, early and late BVS thrombosis, potentially explaining at least in part the recent evidences of devices poor performance.
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Implantes Absorbibles , Simulación por Computador , Enfermedad de la Arteria Coronaria/cirugía , Reestenosis Coronaria/etiología , Estenosis Coronaria/cirugía , Trombosis Coronaria/etiología , Modelos Cardiovasculares , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Stents , Velocidad del Flujo Sanguíneo , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Circulación Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/fisiopatología , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/fisiopatología , Trombosis Coronaria/diagnóstico por imagen , Trombosis Coronaria/fisiopatología , Humanos , Diseño de Prótesis , Reología , Factores de Riesgo , Resultado del TratamientoRESUMEN
AIM: To assess feasibility and 1-year outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (nano-crush technique) in a series of patients with large (≥2.5mm) complex coronary bifurcation. METHODS: From January 2015 to June 2016, patients referred for large (≥2.5mm) complex coronary bifurcation percutaneous coronary interventions (PCI) were enrolled to receive Orsiro (Biotronik Inc., Bulack, Switzerland) double stenting using a very minimal crush technique (nano-crush). Per our institutional protocol, follow-up was conducted by physical examination at 1, 6, 12month and yearly whereas angiographic control was eventually scheduled at 6-8months on the basis of symptoms recurrence or/and positive induced ischemia tests. RESULTS: Fifty-two patients (15 females mean age 77.2±6.2years) were enrolled. Mean angles between main branch and side branch were 63.6±21.3°. The mean diameter and length of implanted stents were 3.8±0.4mm and 27.1±8.7mm in main branch and 2.8±0.3mm and 22.1±.7.1mm in side branch. Immediate success was 100%. Clinical follow-up was available for 100% of patients: at a mean follow-up of 12.0±2.6months, no patient death, or acute myocardial infarction or target vessel revascularization were observed. Angiographic follow-up was available in 25/52 patients (48%) at a mean time from the procedure of 7.2±0.5months and showed no significant angiographic restenosis. CONCLUSIONS: The revascularization of complex large (≥2.5mm) coronary bifurcation disease using the nano-crush technique and the ultrathin polymer biodegradable stent appeared feasible in our small study with promising 1year outcomes.
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Implantes Absorbibles , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Polímeros/química , Anciano , Anciano de 80 o más Años , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Estudios de Factibilidad , Femenino , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Proyectos Piloto , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
BACKGROUND AND OBJECTIVES: Provisional and culotte are the most commonly used techniques in left main (LM) stenting. The impact of different post-dilation techniques on fluid dynamic of LM bifurcation has not been yet investigated. The aim of this study is to evaluate, by means of computational fluid dynamic analysis (CFD), the impact of different post-dilation techniques including proximal optimization technique (POT), kissing balloon (KB), POT-Side-POT and POT-KB-POT, 2-steps Kissing (2SK) and Snuggle Kissing balloon (SKB) on flow dynamic profile after LM provisional or culotte stenting. METHODS: We considered an LM-LCA-LCX bifurcation reconstructed after reviewing 100 consecutive patients (mean age 71.4 ± 9.3 years, 49 males) with LM distal disease. The diameters of LAD and LCX were modelled according to the Finnet's law as following: LM 4.5 mm, LAD 3.5 mm, LCX 2.75 mm, with bifurcation angle set up at 55°. Xience third-generation stent (Abbot Inc., USA) was reconstructed and virtually implanted in provisional/cross-over and culotte fashion. POT, KB, POT-side-POT, POT-KB-POT, 2SK and SKB were virtually applied and analyzed in terms of the wall shear stress (WSS). RESULTS: Analyzing the provisional stenting, the 2SK and KB techniques had a statistically significant lower impact on the WSS at the carina, while POT seemed to obtain a neutral effect. In the wall opposite to the carina, the more physiological profile has been obtained by KB and POT with higher WSS value and smaller surface area of the lower WSS. In culotte stenting, at the carina, POT-KB-POT and 2SK had a very physiological profile; while at the wall opposite to the carina, 2SK and POT-KB-POT decreased significantly the surface area of the lower WSS compared to the other techniques. CONCLUSION: From the fluid dynamic point of view in LM provisional stenting, POT, 2SK and KB showed a similar beneficial impact on the bifurcation rheology, while in LM culotte stenting, POT-KB-POT and 2SK performed slightly better than the other techniques, probably reflecting a better strut apposition.
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The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.
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Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/efectos de los fármacos , Stents Liberadores de Fármacos , Infarto del Miocardio sin Elevación del ST/terapia , Paclitaxel/administración & dosificación , Sirolimus/administración & dosificación , Ultrasonografía Intervencional , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Proliferación Celular , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neointima , Infarto del Miocardio sin Elevación del ST/diagnóstico por imagen , Paclitaxel/efectos adversos , Valor Predictivo de las Pruebas , Diseño de Prótesis , Sistema de Registros , Sirolimus/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05)...
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Paclitaxel , Sirolimus , Stents Liberadores de FármacosRESUMEN
OBJECTIVES: The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry. BACKGROUND: The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions. METHODS: This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months. RESULTS: A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm. CONCLUSION: Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.
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Síndrome Coronario Agudo/terapia , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Sirolimus , Anciano , Reestenosis Coronaria/epidemiología , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Diseño de Prótesis , Sistema de RegistrosRESUMEN
BACKGROUND: Detailed anatomic variants of the interatrial septum in patients with right-to-left shunt and contribution of specific anatomies to the risk of ischaemic recurrences has not yet been comprehensively classified. OBJECTIVE: To report a classification of the anatomic variants of the interatrial septum as observed by intracardiac echocardiography and its correlation with clinical and functional characteristics. METHODS: We retrospectively reviewed the medical and instrumental data of 520 consecutive patients (mean age 44±15. 5 years, 355 women) who had over a 10-year period undergone intracardiac echocardiography and right-to-left shunt catheter-based closure. The four main features used to analyse were: (a) diameter of the oval fossa, (b) presence and length of the channel, (c) presence and degree of atrial septal aneurysm, and (d) rim thickness. The presence of Eustachian valve was also tabulated. RESULTS: The combinations of interatrial septum anatomical features were classified into six main anatomical subgroups. Recurrent embolism, multiple ischaemic foci on brain magnetic resonance imaging, high grade shunt, and permanent shunt before transcatheter closure procedure were associated with type 2, type 4, and type 6. Type 4 anatomical subtype (OR 4.1, 1.5-8 [95% CI], p<0.001) and type 2+presence of Eustachian valve (OR 4.3, 1.6-9 [95% CI], p<0.001) were the strongest predictors of recurrent ischaemic events before transcatheter closure. CONCLUSION: Our study showed that interatrial septum anatomy greatly differs among patients with right-to-left shunt, as well as the risk of ischaemic recurrences in different anatomies.
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Tabique Interatrial/diagnóstico por imagen , Ecocardiografía/métodos , Embolia Paradójica/etiología , Endosonografía/métodos , Defectos del Tabique Interatrial/complicaciones , Adulto , Cateterismo Cardíaco , Embolia Paradójica/diagnóstico por imagen , Embolia Paradójica/fisiopatología , Femenino , Estudios de Seguimiento , Atrios Cardíacos/diagnóstico por imagen , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/fisiopatología , Humanos , Masculino , Estudios Retrospectivos , Factores de TiempoRESUMEN
BACKGROUND: Hostile anatomy of the subclavian artery (severe tortuosity and/or heavy calcification) remains a significant obstacle for the transradial approach during coronary angiography and interventions. OBJECTIVE: To assess impacts on fluoroscopy and procedural times, complications, and radial artery patency in patients with hostile subclavian anatomy by using multiple catheter-guide techniques. METHODS: We retrospectively reviewed the medical and equipment data of 4,580 consecutive patients (mean age 74.4 ± 26.7 years, 49.5% females) who have been referred for transradial coronary angiography and/or interventions within the last 3 years (September 2010-September 2013). In order to overcome the strangling hold of a hostile subclavian artery, 2 techniques have been used: (1) for a coronary angiography-only procedure, a double mother and child technique; (2) for percutaneous coronary intervention, a triple mother and child technique. RESULTS: Ninety-five patients (2.1%) from the entire study population exhibited a hostile subclavian artery. Fifty-two patients (1.1%) underwent coronary angiography only and 43 patients (1%) underwent interventions requiring the use of the above double or triple mother and child techniques, respectively. The 2 techniques were successful in 94.7% of patients (90/95 patients). The procedural time was significantly longer in the patients with hostile subclavian artery while there were no differences in the fluoroscopy time. The radial artery was patent at 30 days in 92.6% of patients (88/95 patients). CONCLUSION: Our data showed that in the presence of hostile subclavian anatomy, the mother and child techniques appeared safe and effective, allowing for the completion of the intended procedure.
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Calcinosis/fisiopatología , Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/métodos , Arteria Subclavia/fisiopatología , Anomalía Torsional/fisiopatología , Anciano , Cateterismo Cardíaco , Femenino , Fluoroscopía , Humanos , Masculino , Arteria Radial/fisiología , Estudios Retrospectivos , Factores de Tiempo , Grado de Desobstrucción Vascular/fisiologíaAsunto(s)
Circulación Coronaria , Foramen Oval Permeable/complicaciones , Atrios Cardíacos/anomalías , Defectos del Tabique Interatrial/clasificación , Hemodinámica , Terminología como Asunto , Adulto , Embolia Paradójica/etiología , Embolia Paradójica/fisiopatología , Femenino , Foramen Oval Permeable/diagnóstico , Foramen Oval Permeable/fisiopatología , Foramen Oval Permeable/terapia , Atrios Cardíacos/diagnóstico por imagen , Atrios Cardíacos/fisiopatología , Defectos del Tabique Interatrial/complicaciones , Defectos del Tabique Interatrial/diagnóstico , Defectos del Tabique Interatrial/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , UltrasonografíaRESUMEN
The aim of this study was to analyze the mechanisms of lumen enlargement in bifurcation lesions, as assessed by intravascular ultrasound (IVUS), after percutaneous treatment with classic provisional "T" stenting with conventional drug-eluting stents (DES) versus bifurcation dedicated BiOSS (Balton, Warsaw, Poland) stent. In this prospective study between Jan and Dec/11, 32 patients with single de novo coronary bifurcation lesions suitable for treatment with BiOSS stents were randomized (1:1). IVUS method included pre- and post-procedure analysis in the parent vessel. Vessel, lumen and plaque cross-sectional areas were determined at the target lesion [minimum lumen area (MLA) site], proximal limb, distal limb, and "window"-defined as the segment between the carina (flow divider) and the vessel wall at the level of the side branch inflow. All lesions were treated with provisional approach and only 1 case in BiOSS group had a stent implanted in the side branch. Angiographic and IVUS results including MLA at the target site and proximal/distal references were similar. However, mean window length-largest diameter within the window, was similar at baseline, but BiOSS measured significantly longer at postprocedure (2.21 ± 0.37 vs. 1.76 ± 0.52 mm, p = 0.01). In addition, the magnitude of changes in vessel (27 ± 24% vs. 9 ± 10%, p = 0.01) and plaque (2 ± 26% vs. -2 ± 26%, p = 0.02) areas at the window were significantly different for DES versus BiOSS groups, respectively. The contribution of vessel extension for lumen enlargement represented 54 versus 43%, 130 versus 46%, 98 versus 80% and 51 versus 19% of the result achieved at the proximal limb, window, distal limb and MLA sites for DES versus BiOSS, respectively; as for plaque re-distribution, results were 36 versus 57%, -30 versus 54%, 2 versus 20%, and 49 versus 81%, at the proximal limb, window, distal limb and MLA sites, respectively. These results suggest different mechanisms of lumen enlargement comparing conventional DES versus BiOSS dedicated bifurcation stent, which can impact side branch compromise during procedure.
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Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Intervención Coronaria Percutánea/instrumentación , Stents , Ultrasonografía Intervencional , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polonia , Valor Predictivo de las Pruebas , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The best treatment strategy for coronary bifurcation stenosis is still unknown. Dedicated bifurcation stents are the most promising solution. AIM: To evaluate the safety and short-term efficacy of a new stent dedicated for coronary bifurcation stenosis. METHODS: A new bifurcation optimisation stent system (BiOSS, Balton, Poland) is made of 316L stainless steel and is coated with a mixture of biodegradable lactate polymer and paclitaxel (1 µg/mm(2)). The stent consists of two parts, with different diameters according to Murray law connected by two 1.5 mm long bridges. BiOSS is mounted on a dedicated bifurcation balloon (Bottle, Balton, Poland) with markers of the proximal and the distal stent edge, and a third marker at the mid part showing the proximal end of its smaller distal part. The stent delivery is a rapid exchange system. Provisional T-stenting is the obligatory strategy. In order to optimise the result, Bottle balloon (nominal pressure: 10 atm) is inflated with mid marker positioned at the side branch ostium. Double antiplatelet therapy was planned for 12 months. Forty five patients with non-left main bifurcation stenosis (the n-LMB group), as well as 15 patients with left main (LM) bifurcation stenosis (the LMB group), were included in the prospective, feasibility and safety assessment registry. An intravascular ultrasound control is obligatory for all LM patients and strongly recommended for the remaining patients. Patients with ST-elevation myocardial infarction (STEMI) and Medina type 001 bifurcation lesions were excluded from the registry. The primary end-points of the study were: death, MI, in-stent thrombosis and target lesion revascularisation (in-hospital and one, three, six, and 12 months after the intervention). An angiographic control is planned at nine months in all patients. Here, we present the results of a three-month follow-up. RESULTS: The average age of the enrolled patients (63% males) was 67 ± 11 years. Thirty five (58%) patients had hypertension, and 16 (27%) were diabetic (five on insulin treatment). Almost half of the patients (29, 48%) had previous non-ST- -elevation acute coronary syndrome treated with percutaneous coronary intervention. Six (10%) patients had previous coronary artery bypass grafting. In the LMB group (n = 15), there were: six with Medina type 111; five with type 010; three with type 110; and one with type 011 bifurcation lesions. In the n-LMB group (n = 45), the dominant vessel was left anterior descending (n = 26, 58%), followed by left circumflex (n = 15, 33%) and right coronary artery (n = 4, 9%). Medina type 111 lesions were present in 48% of patients. Intravascular ultrasound was performed in 37 (62%) cases. All BiOSS stents were implanted successfully (avg. pressure 12 atm), without any periprocedural complications. There were only seven (14%) cases with a second stent implanted within a side branch. There were four periprocedural increases of troponin interpreted as MI. At one month and at three months, all patients were uneventful (out-of hospital MACE rate 0%). CONCLUSIONS: The BiOSS bifurcation dedicated stent is a feasible device, with promising safety and short-term clinical effectiveness/profile.
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Implantación de Prótesis Vascular/instrumentación , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Paclitaxel/uso terapéutico , Moduladores de Tubulina/uso terapéutico , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polonia , Diseño de Prótesis/instrumentación , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: We sought to prospectively evaluate long-term follow-up results of intracardiac echocardiography-aided transcatheter closure of complex atrial septal defects (ASD) in the adults. DESIGN AND SETTINGS: Prospective multicenter registry in tertiary care hospitals. PATIENTS AND INTERVENTIONS: Over a 5-year period, we prospectively enrolled 56 patients (mean age 49 ± 16.7 years, 24 females) who have been referred to our center for catheter-based closure of complex secundum ASD (> 25 mm diameter, deficiency of ≥ 1 rim, multiple secundum ASD, multiperforated ASD, associated incomplete floor of the fossa ovalis with or without aneurysm, embryonic remnants of incomplete atrial septation). All patients were screened by means of transesophageal echocardiography before the operation. Eligible patients underwent intracardiac echocardiography study and closure attempt. RESULTS: Forty patients underwent a transcatheter closure attempt: transesophageal echocardiography-planned device type and size were modified in 32 patients (64%). Rates of procedural success, predischarge occlusion, and major complications rate were 100%, 90%, and 2%, respectively. On mean follow-up of 5.4 ± 1.8 years, the follow-up occlusion rate was 98%. During follow-up, only one case of permanent atrial fibrillation was observed. There were no cases of aortic/atrial erosion, device thrombosis, or new atrioventricular valve dysfunction. CONCLUSIONS: Intracardiac echocardiography-guided complex secundum ASD transcatheter closure is safe and effective and appears to have excellent long-term results, thus minimizing potential complications resulting from the complex anatomy.