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1.
Catheter Cardiovasc Interv ; 103(5): 758-765, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38415891

RESUMO

BACKGROUND: Ultrasound-assisted thrombolysis (USAT) and large-bore-thrombectomy (LBT) are under investigation for the treatment of intermediate-high and high-risk pulmonary embolisms (PE). Comparative studies investigating both devices are scarce. AIMS: This study aimed to compare the safety and efficacy of the two most frequently used devices for treatment of acute PE. METHODS: This multicenter, retrospective study included 125 patients undergoing LBT or USAT for intermediate- or high-risk PE between 2019 and 2023. Nearest neighbor propensity matching with logistic regression was used to achieve balance on potential confounders. The primary outcome was the change in the right to left ventricular (RV/LV) ratio between baseline and 24 h. RESULTS: A total of 125 patients were included. After propensity score matching, 95 patients remained in the sample, of which 69 (73%) underwent USAT and 26 (27%) LBT. The RV/LV ratio decrease between baseline and 24 h was greater in the LBT than in the USAT group (adjusted between-group difference: -0.10, 95% CI: -0.16 to -0.04; p = 0.001). Both procedures were safe and adverse events occurred rarely (10% following USAT vs. 4% following LBT; p = 0.439). CONCLUSION: In acute intermediate-high and high-risk PE, both LBT and USAT were feasible and safe. The reduction in RV/LV ratio was greater following LBT than USAT. Further randomized controlled trials are needed to confirm these findings.


Assuntos
Fibrinolíticos , Embolia Pulmonar , Humanos , Fibrinolíticos/efeitos adversos , Ativador de Plasminogênio Tecidual/efeitos adversos , Terapia Trombolítica/efeitos adversos , Terapia Trombolítica/métodos , Estudos de Coortes , Estudos Retrospectivos , Resultado do Tratamento , Embolia Pulmonar/terapia , Embolia Pulmonar/tratamento farmacológico , Trombectomia , Doença Aguda
2.
Artigo em Inglês | MEDLINE | ID: mdl-39087741

RESUMO

BACKGROUND: Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. AIMS: We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). METHODS: In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. RESULTS: TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. CONCLUSION: PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

3.
J Endovasc Ther ; : 15266028241241246, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38561973

RESUMO

PURPOSE: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. MATERIALS AND METHODS: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. RESULTS: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. CONCLUSIONS: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. CLINICAL IMPACT: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

4.
Respiration ; 102(3): 247-256, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36693327

RESUMO

BACKGROUND: Pleural infection represents a significant clinical challenge worldwide. Although prompt drainage of pleural fluid is thought to play a key role in pleural infection management, the optimal size of intrapleural catheter has yet to be defined. OBJECTIVES: The aim of this systematic review and meta-analysis was to summarize data on efficacy and complications of small-bore drain (SBD), defined as ≤14F, in comparison to large-bore drain (LBD) in patients with pleural infection. METHOD: We searched MEDLINE and Embase for all studies reporting outcomes of interest published up to October 2021. Two authors reviewed selected full text to identify studies according to predefined eligibility criteria. Summary estimates were derived using the random-effects model. RESULTS: Twelve original studies were included for qualitative analysis and 7 of these for quantitative analysis. The surgical referral rate of SBD and LBD were, respectively, 0.16 (95% confidence interval [CI], 0.12-0.21) and 0.20 (95% CI, 0.10-0.32), the pooled mortality were 0.12 (95% CI, 0.05-0.21) and 0.20 (95% CI, 0.10-0.32), and the length of hospital stay was 24 days in both groups. Data on complications suggest similar proportions of tube dislodgement. Intensity of pain was evaluated in one study only, reporting higher scores for LBD. CONCLUSIONS: This systematic review and meta-analysis provide the first synthesis of data on performance of SBD and LBD in management of pleural infection, and, overall, clinical outcomes and complications did not substantially differ, although the limited number of studies and the absence of dedicated randomized trials does limit the reliability of results.


Assuntos
Empiema Pleural , Doenças Pleurais , Humanos , Reprodutibilidade dos Testes , Doenças Pleurais/terapia , Empiema Pleural/cirurgia , Tubos Torácicos , Drenagem/métodos
5.
Pol J Radiol ; 88: e47-e52, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36819218

RESUMO

Purpose: Endovascular procedures such as endovascular aneurysm repair or transcatheter aortic valve implantation have become very common because of reduced patient traumatisation and the ability to use shorter or local anaesthesia. In these procedures large-bore sheath devices are used. Access with percutaneous closure is an alternative method to surgical cutdown in groins. The aim of the study was to assess the correlation between sheath size and unsuccessful haemostasis. In addition, the effectiveness of haemostasis after a percutaneous procedure and the number and type of complications were evaluated. Material and methods: There were 202 patients included in the study. Patients with abdominal aortic aneurysm were qualified to percutaneous aortic stentgraft implantation with Perclose Proglide preclosure technique. Results: There were 384 access sites performed with 12F to 22F sheaths during aortic stentgraft implantation with Perclose Proglide (Abbott Vascular, Santa Clara, CA, USA) preclosure technique. High effectiveness of haemostasis (98%), low percentage of short- and mid-term complications (2.6%), and infinitesimal number of surgical conversions (n = 5) were stated in the study. There was no correlation between diameter of used introducer sheath and lack of haemostasis observed (Fisher-Freeman-Halton test; p = 0.122). No relationship between diameter of introducer sheath and number of closure devices was observed (c2 = 2.436; df = 5; p = 0.786). Conclusions: Large-bore device percutaneous procedures with closure devices are effective and safe. High effectiveness of haemostasis (98%) was observed in the study group, with a low percentage of complications (2.6%). There was no correlation between size of the vascular access and the lack of haemostasis found in the study.

6.
Rev Cardiovasc Med ; 23(10): 329, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39077135

RESUMO

Background: Transradial artery (TRA) access for percutaneous coronary intervention (PCI) was associated with lower risks of major bleeding and vascular complications compared to transfemoral artery access. Use of large-bore ( ≥ 7-Fr) guiding catheters through TRA approach increased the likelihood of radial artery occlusion (RAO). This study aimed to investigate whether use of the thin-walled 7-Fr Glidesheath Slender, allowing PCI with large-caliber guiding catheters, is superior to standard 7-Fr Cordis sheath with respect to periprocedural RAO within 24 hours after transradial coronary intervention (TRI) in complex lesions. Methods: A prospective randomized, controlled, single-blinded (patient-blinded) trial was conducted, randomizing 504 patients with TRI for complex lesions to either 7-Fr Glidesheath Slender or conventional 7-Fr Cordis sheath. The primary outcome was defined as the incidence of periprocedural RAO with Doppler ultrasound during the first 24 hours after TRI. Results: The incidence of early RAO was 10.3% for 7-Fr Glidesheath Slender and 13.5% for conventional 7-Fr sheath (p = 0.271). The procedural success rate for Glidesheath Slender was 92.9% and for Cordis sheath was 93.7% (p = 0.722). There was no signficiant difference between treatment arms in terms of local hematoma and radial spasm, whereas use of the Glidesheath Slender was associated with significantly less pain during the procedure (numeric rating scale [NRS], 2.27 ± 0.75 vs. 2.45 ± 0.95, p = 0.017). The assessment of radial artery in ultrasound parameters after complex TRI was improved with Glidesheath Slender. Conclusions: Among patients with complex coronary lesions undergoing TRI, 7-Fr Glidesheath Slender was not superior to conventional 7-Fr in the prevention of periprocedural RAO within 24 hours following complex PCI, without reducing RAO occurrence. Clinical Trial Registration: NCT04748068.

7.
Catheter Cardiovasc Interv ; 99(5): 1702-1711, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35266287

RESUMO

BACKGROUND: Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era. METHODS: The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression. RESULTS: Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p < 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p < 0.001), ECMO (aOR: 5.35, p < 0.001), or a combination of MCS devices (aOR: 3.47, p < 0.001) was associated with higher odds of vascular complications. CONCLUSIONS: In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications.


Assuntos
Coração Auxiliar , Doença Arterial Periférica , Feminino , Coração Auxiliar/efeitos adversos , Humanos , Balão Intra-Aórtico/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Resultado do Tratamento
8.
Catheter Cardiovasc Interv ; 100(2): 274-278, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35686535

RESUMO

BACKGROUND: Massive or high-risk pulmonary embolism (PE) is a potentially life-threatening diagnosis with significant morbidity and mortality if treatment is delayed. Extracorporeal membrane oxygenation (ECMO) and large bore thrombectomy (LBT) in isolation have been used to stabilize and treat patients with massive PE, however, literature describing the combination of both modalities is lacking. We present a case series involving 9 patients who underwent combined ECMO and LBT and their outcomes. METHODS: This was a retrospective chart review of patients with confirmed PE, who underwent LBT and ECMO. We retrospectively captured clinical, therapeutic, and outcome data at the time of pulmonary embolism response team (PERT) activation and during the follow-up period for up to 90 days. RESULTS: Nine patients who had PERT activation with confirmed PE diagnosis have undergone combined LBT and ECMO initiation since the advent of our PERT program. The median age was 57 (range 28-68) years. Six patients out of 9 (55%) had cardiac arrest before therapy. All patients exhibited right heart strain on computed tomography and echocardiogram. The median ECMO duration was 5 days (range 2.3-11.6 days), with mean hospitalization of 16.1 days (range 1.5-30.9). Mortality was 22% at 90-day follow-up period. CONCLUSION: Patients with massive pulmonary embolism who suffer cardiac arrest have significant morbidity and mortality. ECMO in combination with LBT is a viable treatment option for patients with significant hemodynamic compromise.


Assuntos
Oxigenação por Membrana Extracorpórea , Parada Cardíaca , Embolia Pulmonar , Adulto , Idoso , Parada Cardíaca/terapia , Humanos , Pessoa de Meia-Idade , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/terapia , Estudos Retrospectivos , Trombectomia/efeitos adversos , Resultado do Tratamento
9.
Catheter Cardiovasc Interv ; 100(6): 1039-1042, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36229978

RESUMO

Complex and higher-risk indicated percutaneous coronary interventions at times require mechanical circulatory support, most often with Impella devices. The use of such devices traditionally required additional arterial access site(s), increasing risk of vascular complications. The Single-access for Hi-risk percutaneous coronary intervention (SHiP) technique was described to overcome this issue but was limited to the use of 7F guides. Larger 8F guides often provide incremental support and space compared to 7F guides, sometimes needed in complex procedures. We described a modified SHiP technique using an 8 Fr guide delivered sheathless using Rotaglide.


Assuntos
Coração Auxiliar , Intervenção Coronária Percutânea , Humanos , Artéria Radial , Angiografia Coronária/métodos , Resultado do Tratamento , Desenho de Equipamento
10.
J Endovasc Ther ; 29(3): 336-342, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-34560827

RESUMO

PURPOSE: Percutaneous mechanical circulatory support (pMCS) with the Impella® device is routinely used in cardiogenic shock and high risk percutaneous coronary interventions (PCI). However, safety and feasibility to close the large bore access (LBA) post-hoc remain a challenge. MATERIALS AND METHODS: In patients with planned termination of Impella therapy, corresponding LBA closure was attempted using an undersized AngioSeal® device, which was deployed after insertion of a 0.035 in J-wire through the guidewire access port. Cross-over angiographic visualization before and after deployment as well as in-hospital follow up were performed to assess closure success and screening for short-term adverse events. RESULTS: We evaluated 17 patients (68 year old, IQR 58-76, 71% male) in whom 14 F LBA closure after pMCS using the Impella CP® was achieved with an undersized AngioSeal® device. Clinical indication for pMCS was cardiogenic shock in 94% and protected PCI in 6%. Impella CP® devices were withdrawn after a median of 4 days (IQR 3-6 days). Primary hemostasis was achieved in the majority of patients (14/17; 82%) while single cross-over balloon inflation led to hemostasis in the remaining patients. One patient suffered acute ischemia later in the course of the disease, but this was not directly related to the closure device. In this study, no major bleeding or other device-related adverse events were observed. CONCLUSION: The 8 F AngioSeal® vascular closure device has been safely used for removal of the Impella CP® microaxial pump in most cases of predominantly normal weight patients. This technique may be considered feasible for post-hoc LBA closure in the context of pMCS, especially when preclosure options are not suitable or unavailable.


Assuntos
Coração Auxiliar , Intervenção Coronária Percutânea , Dispositivos de Oclusão Vascular , Idoso , Estudos de Viabilidade , Feminino , Coração Auxiliar/efeitos adversos , Humanos , Masculino , Estudos Retrospectivos , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Resultado do Tratamento
11.
Eur Heart J Suppl ; 24(Suppl J): J37-J42, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36518892

RESUMO

Despite the routine use of percutaneous mechanical circulatory support (pMCS) with the Impella heart pump, vascular and bleeding complications may occur during removal with or without pre-closure. To safely close the large-bore access (LBA), post-hoc selection of the appropriate treatment of vascular complications is critical to patient recovery and survival. Femoral artery access is typically utilized for LBA, and percutaneous axillary artery access is a common alternative, especially in the instance of severe peripheral artery disease. Optimization of patient outcomes and efficiency of pMCS can be achieved with adequate arterial access using state-of-the-art techniques. Impella removal techniques with or without pre-closure will be addressed as well as the management of large-bore femoral access complications. In addition, treatment strategies to manage patient deterioration during a protected high-risk percutaneous coronary intervention will be provided.

12.
Curr Cardiol Rep ; 24(4): 355-364, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35239082

RESUMO

PURPOSE OF REVIEW: Vascular access and closure is a key part of endovascular procedures, and access site-related complications are an independent predictor of adverse procedural outcomes. The purpose of this review is to discuss the methods of vascular closure including manual compression, vascular closure devices (VCDs) for both arterial and venous arteriotomies, their mechanisms, and access site-related complications. RECENT FINDINGS: Various VCDs have been approved over the last three decades. These devices have different mechanisms to achieve hemostasis and are generally categorized into active and passive approximators. Studies have largely found that they are non-inferior to manual compression. Uncomplicated vascular closure is pertinent to avoid adverse procedure-related outcomes. The emergence of VCDs has reduced time to hemostasis, facilitating early ambulation and discharge and reducing hospitalization cost with comparable complication rate to manual compression. Nonetheless, they should be used in favorable vascular anatomy and are not intended to reduce complications.


Assuntos
Procedimentos Endovasculares , Dispositivos de Oclusão Vascular , Artéria Femoral , Técnicas Hemostáticas/efeitos adversos , Humanos , Punções , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos
13.
J Cardiovasc Electrophysiol ; 32(5): 1440-1448, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33772931

RESUMO

BACKGROUND: Transfemoral venous access (TFV) is the cornerstone of minimally invasive cardiac procedures. Although the presence of inferior vena cava filters (IVCFs) was considered a relative contraindication to TFV procedures, small experiences have suggested safety. We conducted a systematic review of the available literature on cardiac procedural success of TFV with IVCF in-situ. METHODS: Two independent reviewers searched PubMed, EMBASE, SCOPUS, and Google Scholar from inception to October 2020 for studies that reported outcomes in patients with IVCFs undergoing TFV for invasive cardiac procedures. We investigated a primary outcome of acute procedural success and reviewed the pooled data for patient demographics, procedural complications, types of IVCF, IVCF dwell time, and procedural specifics. RESULTS: Out of the 120 studies initially screened, 8 studies were used in the final analysis with a total of 100 patients who underwent 110 procedures. The most common IVCF was the Greenfield Filter (36%), 60% of patients were males and the mean age was 67.8 years. The overall pooled incidence of acute procedural success was 95.45% (95% confidence interval = 89.54-98.1) with no heterogeneity (I2 = 0%, p = 1) and there were no reported filter-related complications. CONCLUSION: This systematic review is the largest study of its kind to demonstrate the safety and feasibility of TFV access in a variety of cardiac procedures in the presence of IVCF.


Assuntos
Cardiologia , Embolia Pulmonar , Filtros de Veia Cava , Idoso , Remoção de Dispositivo , Humanos , Masculino , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Filtros de Veia Cava/efeitos adversos , Veia Cava Inferior/diagnóstico por imagem , Veia Cava Inferior/cirurgia
14.
Catheter Cardiovasc Interv ; 98(3): 586-587, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34498392

RESUMO

The MANTA is a new, easy-to-use, collagen plug-based vascular closure device specifically designed for large-bore arteriotomy closure. The authors report on their experience comparing the MANTA device with the Perclose ProGlide technique in patients undergoing transcatheter aortic valve replacement. They found similar rates of success and vascular complications with both devices, suggesting that MANTA is a suitable option for these patients. It remains to be determined whether one device will emerge as the ideal choice for most patients. Device cost is a significant barrier to widespread adoption, but price has decreased recently.


Assuntos
Cateterismo Periférico , Dispositivos de Oclusão Vascular , Cateterismo Periférico/efeitos adversos , Artéria Femoral , Técnicas Hemostáticas/efeitos adversos , Humanos , Resultado do Tratamento
15.
Catheter Cardiovasc Interv ; 98(6): E918-E921, 2021 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-34197677

RESUMO

Contemporary direct ("fully percutaneous") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a "fully upper extremity" (FUE) bailout approach, as a refinement to previously described direct TAx technique.


Assuntos
Braço , Punções , Artéria Axilar/diagnóstico por imagem , Artéria Axilar/cirurgia , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Humanos , Resultado do Tratamento , Extremidade Superior
16.
Catheter Cardiovasc Interv ; 98(3): 572-577, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33539651

RESUMO

OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.


Assuntos
Dispositivos de Oclusão Vascular , Artéria Femoral/cirurgia , Humanos , Suturas , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration
17.
J Endovasc Ther ; 27(3): 414-420, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32193971

RESUMO

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.


Assuntos
Aorta Torácica/cirurgia , Aneurisma Aórtico/cirurgia , Implante de Prótese Vascular , Cateterismo Periférico , Procedimentos Endovasculares , Hemorragia/prevenção & controle , Hemostasia , Técnicas Hemostáticas/instrumentação , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Aneurisma Aórtico/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Cateterismo Periférico/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Hemorragia/sangue , Hemorragia/etiologia , Técnicas Hemostáticas/efeitos adversos , Humanos , Masculino , América do Norte , Estudos Prospectivos , Punções , Fatores de Tempo , Resultado do Tratamento
18.
BMC Neurol ; 20(1): 434, 2020 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-33250061

RESUMO

BACKGROUND: A large-bore aspiration catheter can be employed for recanalization of acute basilar artery occlusion. Here we compare the results of mechanical thrombectomy using a stent retriever (SR) and manual aspiration thrombectomy (MAT) using a large-bore aspiration catheter system as a first-line recanalization method in acute basilar artery occlusion (BAO). METHODS: The records of 50 patients with acute BAO who underwent mechanical thrombectomy were retrospectively reviewed. Patients were assigned to one of two groups based on the first-line recanalization method. The treatment and clinical outcomes were compared. RESULTS: Sixteen (32%) patients were treated with MAT with a large-bore aspiration catheter and 34 (68%) with a SR as the first-line treatment method. The MAT group had a shorter procedure time (28 vs. 65 min; p = 0.001), higher rate of first-pass recanalization (68.8% vs. 38.2%, p = 0.044), and lower median number of passes (1 vs 2; p = 0.008) when compared with the SR group. There was no significant difference in the incidence of any hemorrhagic complication (6.3% vs. 8.8%; p = 0.754) between the groups. However, there were four cases of procedure-related subarachnoid hemorrhage (SAH) in the SR group and one death occurred due to massive hemorrhage. CONCLUSIONS: Selection of MAT using a large-bore aspiration catheter for acute BAO may be a safe and effective first-line treatment method with higher first-pass recanalization rate and shorter procedure time than SR.


Assuntos
Procedimentos Endovasculares/instrumentação , Acidente Vascular Cerebral/cirurgia , Trombectomia/instrumentação , Idoso , Arteriopatias Oclusivas/complicações , Artéria Basilar/patologia , Catéteres , Procedimentos Endovasculares/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Stents , Trombectomia/métodos , Resultado do Tratamento
19.
J Card Surg ; 35(11): 3088-3098, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32741006

RESUMO

Over the last two decades, the medical community witnessed an outstanding and accelerated development on minimally invasive therapies. The definition of what constitutes large bore access is subject to discussion, however within the field it is generally accepted to reflect a catheter diameter exceeding 8-French. We sought in this review to explore the evolution, characteristics and vascular compatibility of the current commercially available devices, analyze the devices along with access site-specific complications rates and finally review the present methods for percutaneous vascular closure.


Assuntos
Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Cateteres Cardíacos , Procedimentos Endovasculares/métodos , Coração Auxiliar , Humanos , Balão Intra-Aórtico , Procedimentos Cirúrgicos Minimamente Invasivos/instrumentação , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Substituição da Valva Aórtica Transcateter/métodos , Dispositivos de Oclusão Vascular
20.
J Card Surg ; 33(5): 270-273, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29696676

RESUMO

The last decade has witnessed a tremendous growth in the type and complexity of transcatheter cardiovascular interventions that require large-bore access. While the common femoral artery has become the main route for these interventions, sizable cohorts of patients are unsuitable for transfemoral access due to vascular disease or small vessel caliber. Percutaneous axillary access has emerged as a feasible alternative in these patients. We provide a step-by-step guide for transaxillary large-bore access and closure for patients requiring transcatheter interventions.


Assuntos
Estenose da Valva Aórtica/cirurgia , Artéria Axilar , Cateterismo Cardíaco/métodos , Estenose Coronária/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Estenose da Valva Aórtica/complicações , Estenose Coronária/complicações , Feminino , Artéria Femoral , Ventrículos do Coração , Coração Auxiliar , Hemostasia Cirúrgica/métodos , Humanos , Resultado do Tratamento
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