RESUMEN
Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications.
Asunto(s)
Cateterismo Periférico , Remoción de Dispositivos , Arteria Femoral , Técnicas Hemostáticas , Punciones , Dispositivos de Cierre Vascular , Humanos , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/instrumentación , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Remoción de Dispositivos/efectos adversos , Factores de Riesgo , Resultado del Tratamiento , Hemorragia/prevención & control , Hemorragia/etiología , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/prevención & control , Dispositivos de Acceso Vascular , Diseño de Equipo , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentaciónRESUMEN
BACKGROUND: The trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications. CASE PRESENTATION: A 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography. CONCLUSION: We encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT.
Asunto(s)
Diagnóstico Tardío , Arteria Femoral , Hemorragia , Punciones , Humanos , Femenino , Anciano , Arteria Femoral/diagnóstico por imagen , Hemorragia/etiología , Hemorragia/terapia , Resultado del Tratamiento , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Valor Predictivo de las Pruebas , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/instrumentación , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversosRESUMEN
Peripherally inserted central catheters (PICCs) are vital in delivering intravenous therapy. Despite their advantages, PICCs can lead to complications such as catheter exit site bleeding, which can cause patient distress and increase infection risk. This study evaluated the efficacy of StatSeal, a topical haemostatic device, in managing PICC exit site bleeding. StatSeal uses a hydrophilic polymer and potassium ferrate to form a seal, reducing access site bleeding and minimising dressing changes. For this study, Patients were recruited at Frimley Health NHS Foundation Trust; the trial involved 177 patients with StatSeal, and shows that 99% did not require additional dressing changes within the standard 7-day period. The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, enhancing the efficiency of vascular access maintenance and potentially lowering associated healthcare costs. The trial emphasises the importance of innovative solutions such as StatSeal to advance PICC care and improve patient experience.
Asunto(s)
Vendajes , Cateterismo Periférico , Humanos , Femenino , Masculino , Anciano , Persona de Mediana Edad , Cateterismo Venoso Central/efectos adversos , Adulto , Anciano de 80 o más Años , Técnicas Hemostáticas/instrumentaciónRESUMEN
BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.
Asunto(s)
Cateterismo Periférico , Diseño de Equipo , Hemorragia , Técnicas Hemostáticas , Punciones , Arteria Radial , Humanos , Estudios Prospectivos , Masculino , Femenino , Anciano , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento , Cateterismo Periférico/efectos adversos , Factores de Tiempo , Hemorragia/prevención & control , Hemorragia/etiología , Quitosano , Hemostáticos/administración & dosificación , Hemostáticos/efectos adversos , Factores de Riesgo , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Vendajes , Trombosis/etiología , Trombosis/prevención & controlRESUMEN
INTRODUCTION: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking. METHODS: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation). RESULTS: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005). CONCLUSION: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.
Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Vena Femoral , Técnicas Hemostáticas , Punciones , Dispositivos de Cierre Vascular , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Masculino , Femenino , Ablación por Catéter/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento , Anciano , Factores de Tiempo , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Factores de Riesgo , Estudios Retrospectivos , Cateterismo Periférico/efectos adversos , Medición de Riesgo , Hemorragia/etiología , Hemorragia/prevención & controlRESUMEN
BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.
Asunto(s)
Procedimientos Endovasculares , Técnicas Hemostáticas , Técnicas de Sutura , Dispositivos de Cierre Vascular , Humanos , Estudios Prospectivos , Masculino , Femenino , Anciano , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Resultado del Tratamiento , Factores de Tiempo , Técnicas de Sutura/efectos adversos , Técnicas de Sutura/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Anciano de 80 o más Años , Diseño de Equipo , Punciones , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/instrumentación , Hemorragia/prevención & control , Hemorragia/etiología , Persona de Mediana Edad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Factores de Riesgo , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagenRESUMEN
AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.
Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Técnicas de Sutura , Humanos , Fibrilación Atrial/cirugía , Femenino , Masculino , Persona de Mediana Edad , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Estudios Prospectivos , Venas Pulmonares/cirugía , Técnicas de Sutura/efectos adversos , Anciano , Resultado del Tratamiento , Alemania , Factores de Tiempo , Dispositivos de Cierre Vascular , Ambulación Precoz , Técnicas Hemostáticas/instrumentaciónRESUMEN
BACKGROUND: Endovascular aortic surgery is increasingly becoming the standard treatment. Percutaneous access preclosing systems appear to be effective and notably the Proglide (PG). We aimed to prospectively assess the clinical effectiveness of combining ultrasound-guided femoral puncture with ultrasound-guided PG deployment. METHODS: Our single-center study consecutively included patients managed at a tertiary center from May to September 2023, undergoing endovascular aortic surgery. The placement of PG was performed under ultrasound guidance. Preoperative patient characteristics were evaluated using preoperative computed tomography scans. Clinical and technical success were defined, respectively, as the ability to achieve complete hemostasis confirmed by ultrasound 48 hr postprocedure and as the successful placement of a PG under ultrasound guidance contributing to final hemostasis. RESULTS: Twenty patients were included over a 6-month period, totaling 34 common femoral arteries (CFAs). Fourteen were male, with an average age of 72.8 ± 8.2 years. Among the 34 CFA, CFA had diameter of 12.05 ± 2.4 mm and a depth of 38.0 ± 13.4 mm. The mean introducer sheath diameter was 6.2 ± 1.5 mm with a sheath to femoral artery ratio of 0.54 ± 0.18. Successful Proglide placement under ultrasound guidance was achieved in 100% of cases. No PG failure occurred. Clinical and technical success were, respectively, of 95% and 100%. One small pseudoaneurysm was observed at 48 hr treated medically. No CFA access reintervention was required. CONCLUSIONS: The technique of ultrasound-guided PG deployment in aortic surgery is a safe and effective method for achieving hemostasis. It effectively prevents PG failures at a lower cost.
Asunto(s)
Procedimientos Endovasculares , Arteria Femoral , Técnicas Hemostáticas , Punciones , Ultrasonografía Intervencional , Humanos , Masculino , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Anciano , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Resultado del Tratamiento , Estudios Prospectivos , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Anciano de 80 o más Años , Persona de Mediana Edad , Cateterismo Periférico/efectos adversos , Dispositivos de Cierre Vascular , Hemostáticos/administración & dosificación , Hemostáticos/uso terapéutico , Factores de TiempoRESUMEN
BACKGROUND: Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. AIMS: The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. METHODS: This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. RESULTS: A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. CONCLUSION: This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.
Asunto(s)
Cateterismo Periférico , Arteria Femoral , Técnicas Hemostáticas , Punciones , Técnicas de Sutura , Reemplazo de la Válvula Aórtica Transcatéter , Dispositivos de Cierre Vascular , Humanos , Arteria Femoral/diagnóstico por imagen , Masculino , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Prospectivos , Anciano de 80 o más Años , Resultado del Tratamiento , Cateterismo Periférico/efectos adversos , Anciano , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Técnicas de Sutura/efectos adversos , Técnicas de Sutura/instrumentación , Factores de Riesgo , Factores de Tiempo , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Italia , Diseño de Equipo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Hemorragia/etiología , Hemorragia/prevención & controlAsunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Humanos , Masculino , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Cateterismo Periférico , Prótesis Valvulares Cardíacas , Técnicas Hemostáticas/instrumentación , Punciones , Reoperación , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del TratamientoRESUMEN
OBJECTIVES: Manual compression (MC) or vascular closure devices (VCDs) are used to achieve hemostasis after percutaneous transluminal angioplasty (PTA). However, limited data on the comparative safety and effectiveness of VCDs vs MC in patients with end-stage renal disease (ESRD) undergoing PTA are available. Accordingly, this study compared the safety and effectiveness of VCD and MC in patients with ESRD undergoing PTA. METHODS: This single-center retrospective cohort study included the data of patients with ESRD undergoing peripheral intervention at Chang Gung Memorial Hospital, Taiwan, from January 1, 2019, to June 30, 2022. The patients were divided into VCD and MC groups. The primary endpoint was a composite of puncture site complications, including acute limb ischemia, marked hematoma, pseudoaneurysm, and puncture site bleeding requiring blood transfusion. RESULTS: We included 264 patients with ESRD undergoing PTA, of whom 60 received a VCD and 204 received MC. The incidence of puncture site complications was 3.3% in the VCD group and 4.4% in the MC group (hazard ratio: .75; 95% confidence interval: .16-3.56 L P = 1.000), indicating no significant between-group difference. CONCLUSION: VCDs and MC had comparable safety and effectiveness for hemostasis in patients with ESRD undergoing peripheral intervention.
Asunto(s)
Técnicas Hemostáticas , Fallo Renal Crónico , Enfermedad Arterial Periférica , Punciones , Dispositivos de Cierre Vascular , Humanos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Fallo Renal Crónico/terapia , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/complicaciones , Persona de Mediana Edad , Resultado del Tratamiento , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Taiwán , Factores de Riesgo , Factores de Tiempo , Presión , Hemorragia/etiología , Anciano de 80 o más Años , Medición de RiesgoRESUMEN
OBJECTIVES: Patent hemostasis (PH) is essential for preventing radial artery occlusion (RAO) after trans-radial procedures; however, it remains unclear how it should be obtained. The aim of this multicenter randomized study was to evaluate whether the use of an adjustable device (AD), inflated with a pre-determined amount of air (AoA), was more effective than a non-adjustable device (non-AD) for achieving PH, thereby reducing the incidence of RAO. METHODS: We enrolled a total of 480 patients undergoing transradial procedure at 3 Italian institutions. Before the procedure, a modified Reverse Barbeau Test (mRBT) was performed in all patients to evaluate the AoA to be eventually inflated in the AD. After the procedure, patients were randomized into 2 groups: (1) AD Group, using TR-Band (Terumo) inflated with the pre-determined AoA; and 2) non-AD Group, using RadiStop (Abbott). An RBT was performed during compression to demonstrate the achievement of PH, as well as 24 hours later to evaluate the occurrence of RAO. RESULTS: PH was more often obtained in the AD Group compared with the non-AD Group (90% vs 64%, respectively, P less than .001), with no difference in terms of bleedings. RAO occurred more often in the non-AD Group compared with the AD Group (10% vs 3%, respectively, P less than .001). Of note, mRBT was effective at guiding AD inflation and identifying high-risk patients in whom PH was more difficult to obtain. CONCLUSIONS: The use of AD, filled with a predetermined AoA, allowed PH significantly more often compared with non-AD, providing a significantly reduced incidence of RAO.
Asunto(s)
Intervención Coronaria Percutánea , Arteria Radial , Humanos , Masculino , Femenino , Anciano , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/efectos adversos , Persona de Mediana Edad , Arteriopatías Oclusivas/prevención & control , Arteriopatías Oclusivas/etiología , Arteriopatías Oclusivas/diagnóstico , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Incidencia , Hemostasis/fisiología , Italia/epidemiología , Resultado del Tratamiento , Diseño de EquipoRESUMEN
PURPOSE: Mechanical circulatory support (MCS) using a venoarterial extracorporeal membrane oxygenation (VA-ECMO) device or a catheter-type heart pump (Impella) is critical for the rescue of patients with severe cardiogenic shock. However, these MCS devices require large-bore cannula access (14-Fr and larger) at the femoral artery or vein, which often requires surgical decannulation. METHODS: In this retrospective study, we evaluated post-closure method using a percutaneous suture-mediated vascular closure system, Perclose ProGlide/ProStyle (Abbott Vascular, Lake Bluff, IL, Perclose), as an alternative procedure for MCS decannulation. Closure of 83 Impella access sites and 68 VA-ECMO access sites performed using Perclose or surgical method between January 2018 and March 2023 were evaluated. RESULTS: MCS decannulation using Perclose was successfully completed in all access sites without surgical hemostasis. The procedure time of ProGlide was shorter than surgical decannulation for both Impella and VA-ECMO (13 min vs. 50 min; p < 0.001, 21 min vs. 65 min; p < 0.001, respectively). There were no significant differences in the 30-day survival rate and major adverse events by decannulation including arterial dissection requiring endovascular treatment, hemorrhage requiring a large amount of red blood cell transfusion, and access site infection. CONCLUSION: Our results suggest that the post-closure technique using the percutaneous suture-mediated closure system appears to be a safe and effective method for large-bore MCS decannulation.
Asunto(s)
Cateterismo Periférico , Oxigenación por Membrana Extracorpórea , Corazón Auxiliar , Técnicas Hemostáticas , Punciones , Dispositivos de Cierre Vascular , Humanos , Estudios Retrospectivos , Masculino , Femenino , Resultado del Tratamiento , Persona de Mediana Edad , Anciano , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/instrumentación , Factores de Tiempo , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/instrumentación , Remoción de Dispositivos/efectos adversos , Técnicas de Sutura/instrumentación , Técnicas de Sutura/efectos adversos , Arteria Femoral , Choque Cardiogénico/terapia , Choque Cardiogénico/mortalidad , Choque Cardiogénico/fisiopatología , Choque Cardiogénico/diagnóstico , Factores de Riesgo , Hemorragia/etiología , Hemorragia/prevención & controlRESUMEN
OBJECTIVES: To propose a contemporary management strategy for venous injury during anterior lumbar spinal exposure that incorporates endovascular treatment. METHODS: Vein injuries suffered by patients treated in a single practice were reviewed. A treatment algorithm based on these experiences was formulated. RESULTS: Between 2015 and 2018, 914 patients received anterior access procedures for indicated lumbar interbody fusions. Of these patients, 15 (1.6%) suffered minor vascular injuries treated with manual pressure or suture repair. Four (0.4%) patients undergoing anterior lumbar spine surgery suffered major venous injuries, all of whom received the indicated spinal hardware following endovascular rescue. Primary repair was attempted in three patients before endovascular control and not at all in one. Vascular access was obtained via the bilateral femoral veins in 2 patients, unilateral femoral in one, and bilateral femoral plus right internal jugular vein in one. Stent choice included both uncovered (5, 63%) and covered stents (3, 38%). Deep venous thrombosis occurred in 2 patient's post-treatment. 1 DVT was encountered in the setting of a covered stent and 1 uncovered stent thrombosis was treated with catheter-directed lysis 4 weeks post-operatively. Ultimately, 3 patients were therapeutically anticoagulated. Mean follow-up is 13 months (range 1-36) with duplex ultrasounds available at 6 months or later in 3 of 4 patients. There is no evidence of post-thrombotic syndrome in the 2 patients that developed DVT's or in-stent stenosis in the 3 patients with available follow-up imaging. CONCLUSIONS: Endovascular techniques are important adjuncts when controlling large-volume hemorrhage associated with venous tears during anterior spinal exposure. Adequate direct compression allowing occlusion balloon inflation are key steps to reduce blood loss. Covered and uncovered stents are both appropriate choices to treat injuries. Patients must be anticoagulated post-operatively and surveilled for the sequelae of venous insufficiency. With expedient hemostasis, the indicated spinal surgery may be safely completed.
Asunto(s)
Pérdida de Sangre Quirúrgica/prevención & control , Procedimientos Endovasculares , Técnicas Hemostáticas , Vena Ilíaca/lesiones , Vértebras Lumbares/cirugía , Fusión Vertebral/efectos adversos , Lesiones del Sistema Vascular/terapia , Adulto , Anticoagulantes/uso terapéutico , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Técnicas Hemostáticas/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Síndrome Postrombótico/tratamiento farmacológico , Síndrome Postrombótico/etiología , Stents , Resultado del Tratamiento , Lesiones del Sistema Vascular/diagnóstico , Lesiones del Sistema Vascular/etiología , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/etiología , Adulto JovenRESUMEN
BACKGROUND: A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device (ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach. MATERIALS AND METHODS: We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months. RESULTS: We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34% patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (P-0.005) CONCLUSION: In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice.
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Enfermedades de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Cateterismo Periférico/instrumentación , Procedimientos Endovasculares/instrumentación , Hemorragia/prevención & control , Técnicas Hemostáticas/instrumentación , Dispositivos de Acceso Vascular , Dispositivos de Cierre Vascular , Anciano , Anciano de 80 o más Años , Enfermedades de la Aorta/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Cateterismo Periférico/efectos adversos , Procedimientos Endovasculares/efectos adversos , Diseño de Equipo , Femenino , Arteria Femoral , Hemorragia/etiología , Técnicas Hemostáticas/efectos adversos , Humanos , Masculino , Punciones , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: To evaluate the feasibility and safety of the Mynx vascular closure device (VCD) for arteriotomy closure after stent placement near the common femoral artery (CFA) access site. METHODS: A total of 88 patients (73 men; mean age, 72 ± 9.2 years; 136 procedures) who underwent closure of CFA arteriotomy using the Mynx VCD after stent placement in proximal superficial femoral artery (SFA) with antegrade approach, or in common or external iliac artery with retrograde approach were retrospectively studied. Technical success and access site complication were evaluated. Body mass index (BMI), platelet count, international normalized ratio, prior history of ipsilateral CFA access, access direction, degree of CFA calcification, stent location and diameter, total procedure time, and sheath size were analyzed to evaluate their relationship with technical failure and development of bleeding complications. RESULTS: Technical success was achieved in 94.9% (129/136) patients. The mean time to hemostasis was 0.7 ± 1.8 min. Technical failure was significantly associated with low BMI (p = 0.001). Other variables presented no significant relationship with technical failure and development of complications. Ultrasonography on the day after the procedure revealed that 8 (5.9%) patients had hematoma. CONCLUSIONS: Mynx VCD for arteriotomy closure is feasible and provides hemostatic safety after stent placement near antegrade or retrograde CFA access. However, Mynx VCD may have a poor technical success rate among patients with low BMI.
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Arteria Femoral , Técnicas Hemostáticas , Dispositivos de Cierre Vascular , Anciano , Anciano de 80 o más Años , Femenino , Arteria Femoral/cirugía , Técnicas Hemostáticas/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Stents , Dispositivos de Cierre Vascular/efectos adversosRESUMEN
Recently, trans-radial intervention has gained popularity as a common procedure to reduce hemorrhagic complications. However, the cuff-type hemostatic device (TR Band) previously used at our institution required 6 h to achieve hemostasis. Since July 2016, we have been using the VasoSTAT, a new hemostatic device that could achieve hemostasis in 4 h. In a verification study, we found that prolonged activated clotting time (ACT) was related to transient hemorrhage occurrence after the hemostatic procedure. Therefore, we designed a hemostatic protocol based on ACT and evaluated its efficacy. In this retrospective and observational study, 78 and 111 patients used the VasoSTAT and TR Band, respectively, from July 2015 to May 2017. In the VasoSTAT group, the ACTs were significantly lower in the hemostasis success (246 ± 46 s) than in the failure group patients (327 ± 59 s) (P < 0.01). Therefore, we applied the hemostatic protocol to 271 patients from May 2017 to March 2020. The hemostasis success rate was 96% in the post-protocol applied group patients, which was significantly higher than the 82% success rate in the pre-protocol applied group patients (P < 0.01). VasoSTAT resulted in adequate hemostasis in 4 h. Further, ACT was predictive of adequate hemostasis.
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Hemorragia/terapia , Hemostasis , Técnicas Hemostáticas/instrumentación , Anciano , Anciano de 80 o más Años , Femenino , Hemorragia/sangre , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea , Estudios RetrospectivosRESUMEN
A retrospective risk-adjusted analysis was completed using data from the National Surgical Quality Improvement Program (NSQIP) to (1) compare the risks of post-operative hematoma for thyroid surgery using conventional cautery compared alternative energy devices (defined as LigaSure and Harmonic Scalpel), and (2) compare operative times for the same. The primary outcome variable was post-operative hematoma occurrence. The secondary outcome variable was operative time. The exposure variable was use of conventional or alternative sources of cautery. All adult patients who underwent a total thyroidectomy, subtotal thyroidectomy or completion thyroidectomy between 2016 and 2018 were included. Multivariable linear and logistic regression analyses were performed to control for potentially confounding variables. A total of 13,330 cases were analyzed; 4342 used conventional cautery, and 8988 used alternative sources. There was a statistically significant decrease in post-operative hematoma risk using alternative sources of cautery compared to conventional cautery (OR 0.75; 95% CI 0.58-0.98) (p = 0.04). Use of alternative sources of cautery added 4.95 min onto operative time (95% CI 2.45-7.45) which was statistically significant (p < 0.0001). After controlling for confounding variables, there was a statistically significant lower rate of post-operative hematoma in thyroidectomies performed using alternative sources of cautery compared to those performed with traditional hemostatic methods. Alternative sources of cautery increased operative time by 4.95 min.
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Cauterización/métodos , Hematoma/prevención & control , Técnicas Hemostáticas , Tempo Operativo , Tiroidectomía , Anciano , Cauterización/efectos adversos , Cauterización/instrumentación , Bases de Datos Factuales , Femenino , Hematoma/etiología , Técnicas Hemostáticas/efectos adversos , Técnicas Hemostáticas/instrumentación , Humanos , Masculino , Factores Protectores , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Tiroidectomía/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: We retrospectively evaluated vascular complications and wound infections after surgical or percutaneous transfemoral removal of temporary extracorporeal life support systems (ECLSs). METHODS: A total of 83 patients were weaned from ECLS between August 2015 and September 2020. We analyzed for a composite endpoint of vascular complications and wound infections requiring negative-pressure wound therapy. Patients were divided into two groups: percutaneous group using the MANTA vascular occlusion system (VCD; Teleflex, Morrisville, North Carolina, United States) (n = 23) and surgical group (n = 60). RESULTS: The median age in the entire cohort was 67 years. Vascular complications were seen in 20% (n = 12) in the surgical group and in 13% (n = 3) in the percutaneous group (p = 0.72). A total of 32% (n = 19) in the surgical group and 9% (n = 2) in the percutaneous group (p = 0.031) had wound infections. A composite endpoint of vascular complications and wound infections showed significantly more complications in the surgical group (52%, n = 31) as compared with the percutaneous group (22%, n = 5) (p = 0.020). The median duration in the intensive care unit was 13 days for the surgical group and 12 days for the percutaneous group without any significant difference in both groups (p = 0.93). CONCLUSIONS: Using the MANTA VCD for percutaneous removal of ECLS cannulas after weaning from ECLS is safe and reproducible. A composite endpoint of vascular complications and wound infections was significantly lower in the percutaneous removal group as compared with the surgical group.