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2.
Tex Heart Inst J ; 49(5)2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36269884

RESUMO

BACKGROUND: Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have an increased mortality risk, and vascular closure device (VCD) use is mandatory. The percutaneous MANTA VCD (Teleflex) is a novel collagen-based technology for closure of large-bore arteriotomies. We compared the MANTA VCD with the suture-based ProGlide VCD (Abbott Vascular). METHODS: A retrospective review was performed on all consecutive patients who underwent transfemoral TAVI in our center from January 1, 2015, to February 28, 2021, and 30-day outcomes were recorded. Major adverse cardiovascular events (MACE) were cardiac death, disabling stroke, and/or major VCs. Access site-related VCs were VCs related to the access site vessel from which the transcatheter valve was introduced and advanced. RESULTS: The MANTA VCD was used in 99 patients and the ProGlide in 224. There was 4.0% MACE in the MANTA group and 4.9% in the ProGlide group (P = .999). Overall VCs were 10.1% vs 7.6%, major VCs were 3.0% vs 2.2%, and minor VCs 7.1% vs 5.4%(P = .753). Access site-related VCs were 5.1% vs 5.8% in the (P = .999), and periprocedural vascular surgical intervention was needed in 6.1% of the MANTA group vs 2.2% of the ProGlide group (P = .099). CONCLUSION: There was no significant difference in MACE, mortality, cardiovascular mortality, VCs, access site-related VCs, periprocedural vascular surgical interventions, bleeding, or transfusion rate between the 2 groups. The MANTA VCD group had more periprocedural vascular surgical interventions which did not reach statistical significance.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Humanos , Dispositivos de Oclusão Vascular/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Artéria Femoral/cirurgia , Resultado do Tratamento , Colágeno , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia
3.
Catheter Cardiovasc Interv ; 100(5): 776-784, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36129818

RESUMO

BACKGROUND: The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. METHODS: We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. RESULTS: There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). CONCLUSION: In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.


Assuntos
Artéria Femoral , Dispositivos de Oclusão Vascular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Artéria Femoral/diagnóstico por imagem , Dispositivos de Oclusão Vascular/efeitos adversos , Técnicas Hemostáticas/efeitos adversos , Punções , Resultado do Tratamento
4.
Cardiovasc Ther ; 2022: 8569188, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36134143

RESUMO

Backgrounds: Manual compression (MC) and vascular closure device (VCD) are two methods of vascular access site hemostasis after cardiac interventional procedures. However, there is still controversial over the use of them and a lack of comprehensive and systematic meta-analysis on this issue. Methods: Original articles comparing VCD and MC in cardiac interventional procedures were searched in PubMed, EMbase, Cochrane Library, and Web of Science through April 2022. Efficacy, safety, patient satisfaction, and other parameters were assessed between two groups. Heterogeneity among studies was evaluated by I2 index and the Cochran Q test, respectively. Publication bias was assessed using the funnel plot and Egger's test. Results: A total of 32 studies were included after screening with inclusion and exclusion criteria (33481 patients). This meta-analysis found that VCD resulted in shorter time to hemostasis, ambulation, and discharge (p < 0.00001). In terms of vascular complication risks, VCD group might be associated with a lower risk of major complications (p = 0.0001), but the analysis limited to randomized controlled trials did not support this result (p = 0.68). There was no significant difference in total complication rates (p = 0.08) and bleeding-related complication rates (p = 0.05) between the two groups. Patient satisfaction was higher in VCD group (p = 0.002). Meta-regression analysis revealed no specific covariate as an influencing factor for above results (p > 0.05). Conclusions: Compared with MC, the use of VCDs significantly shortens the time of hemostasis and allows earlier ambulation and discharge, meanwhile without increase in vascular complications. In addition, use of VCDs achieves higher patient satisfaction and leads cost savings for patients and institutions.


Assuntos
Dispositivos de Oclusão Vascular , Artéria Femoral , Humanos , Pressão , Punções , Resultado do Tratamento
5.
Am J Cardiol ; 180: 116-123, 2022 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-35933223

RESUMO

Despite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p = 0.001). VCD failure rate were 7.5% and 3.9%, respectively (p = 0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p = 0.023; minor: 8.1% vs 4.4%, p = 0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p = 0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (Pinteraction = 0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Artéria Femoral/cirurgia , Humanos , Resultado do Tratamento , Ultrassonografia de Intervenção
6.
Sci Rep ; 12(1): 14060, 2022 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-35982200

RESUMO

To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24-69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01-0.50; p = 0.001), and there was no significant difference in vascular complications between the two groups (p = 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.


Assuntos
Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Idoso , Artéria Femoral/cirurgia , Hemorragia/etiologia , Hemorragia/terapia , Humanos , Unidades de Terapia Intensiva , Pessoa de Meia-Idade , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos
9.
EuroIntervention ; 18(10): 812-819, 2022 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-35903846

RESUMO

BACKGROUND: Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited. AIMS: We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI. METHODS: We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria. RESULTS: Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08). CONCLUSIONS: A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/cirurgia , Estudos Retrospectivos , Artéria Femoral/cirurgia , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos , Hemostasia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Técnicas Hemostáticas/efeitos adversos
11.
Catheter Cardiovasc Interv ; 100(1): 163-168, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35568977

RESUMO

OBJECTIVE: We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR). BACKGROUND: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited. METHODS: Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis. RESULTS: There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (>6 cm) following Perclose in each group. Six cases had small hematomas (<6 cm and >2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose. CONCLUSION: In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis.


Assuntos
Doenças das Valvas Cardíacas , Dispositivos de Oclusão Vascular , Doenças das Valvas Cardíacas/cirurgia , Hematoma/etiologia , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Técnicas de Sutura/efeitos adversos , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos
12.
J Vasc Surg ; 76(3): 788-796.e2, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35618194

RESUMO

OBJECTIVE: Vascular closure devices (VCDs) and manual compression (MC) are used to achieve hemostasis after peripheral vascular interventions (PVIs). We sought to compare perioperative outcomes between MC and four VCDs after PVI in a multicenter setting. METHODS: The Vascular Quality Initiative was queried for all lower extremity PVIs with common femoral artery access performed from 2010 to 2020. The VCDs included were MynxGrip (Cordis, Santa Clara, CA), StarClose SE (Abbott Vascular, Redwood City, CA), Angio-Seal (Terumo, Somerset, NJ), and Perclose ProGlide (Abbott Vascular). In a blinded fashion, these four VCDs (labeled A, B, C, and D) were compared to MC for baseline characteristics, procedural details, and outcomes (access site hematoma and stenosis/occlusion). Those with a sheath size >8F were excluded. Propensity score matching (1:1) was performed. Univariable and multivariable analyses were completed for unmatched and matched data. RESULTS: A total of 84,172 lower extremity PVIs were identified. Of these, 32,013 (38%) had used MC and 52,159 (62%) had used VCDs (A, 12,675; B, 6224; C, 19,872; D, 13,388). The average age was 68.7 years, and 60.4% of the patients were men. The most common indications for intervention were claudication (43.8%) and tissue loss (40.1%). Compared with MC, VCDs were used more often for patients with obesity, diabetes, and end-stage renal disease (P < .001 for all). VCDs were used less often for patients with hypertension, chronic obstructive pulmonary disease, coronary artery disease, prior percutaneous coronary and extremity interventions, and major amputation (P < .001 for all). VCD use was more common than MC during femoropopliteal (73% vs 63.8%) and tibial (33.8% vs 22.3%) interventions but less common with iliac interventions (20.6% vs 34.7%; P < .001 for all). Protamine was used less often with VCDs (19.1% vs 25.6%; P < .001). Overall, 2003 hematomas had developed (2.4%), of which 278 (13.9%) had required thrombin or surgical intervention. Compared with MC, the use of any VCD had resulted in fewer hematomas (1.7% vs 3.6%; P < .001) and fewer hematomas requiring intervention (0.2% vs 0.5%; P < .001). When divided by hemostatic technique, the rate of the development of any hematoma was as follows: MC, 3.6%; VCD A, 1.4%; VCD B, 1.2%; VCD C, 2.3%; and VCD D, 1.1% (P < .001). The rate of hematomas requiring intervention was as follows: MC, 0.5%; VCD A, 0.2%; VCD B, 0.2%; VCD C, 0.3%; and VCD D, 0.1% (P < .001). Access site stenosis/occlusion was similar between the MC and any VCD groups (0.2% vs 0.2%; P = .12). Multivariable analysis demonstrated that any VCD use and the use of the individual VCDs compared with MC were independently associated with the development of fewer hematomas. The incidence of access site stenosis/occlusion was similar between the use of any VCD and MC. The matched analysis revealed similar findings. CONCLUSIONS: Although the overall rates of hematomas requiring intervention were low regardless of hemostatic technique, VCD use, irrespective of type, compared favorably with MC, with significantly fewer access site complications after PVI.


Assuntos
Dispositivos de Oclusão Vascular , Idoso , Constrição Patológica/complicações , Feminino , Artéria Femoral/cirurgia , Hematoma/etiologia , Técnicas Hemostáticas/efeitos adversos , Humanos , Extremidade Inferior , Masculino , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos
13.
Catheter Cardiovasc Interv ; 100(2): 290-294, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35485730

RESUMO

Vascular closure devices (VCD) are effective at achieving hemostasis. VCD failure is attributed to underlying arterial disease, leading to a hazardous situation for obtaining contralateral femoral access. Radial-to-peripheral (R2P) access has emerged as a safe option to rescue these procedural complications. Here, we present two cases of VCD failure rescue utilizing R2P and outline this approach step-by-step.


Assuntos
Técnicas Hemostáticas , Dispositivos de Oclusão Vascular , Artéria Femoral/diagnóstico por imagem , Técnicas Hemostáticas/efeitos adversos , Humanos , Punções , Resultado do Tratamento
14.
Indian Heart J ; 74(3): 251-255, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35367458

RESUMO

INTRODUCTION: The comparative effectiveness of ProGlide® compared with MANTA® vascular closure devices (VCDs) in large-bore access site management is not entirely certain, and has only been evaluated in underpowered studies. This meta-analysis aimed to evaluate the outcomes of ProGlide® compared with MANTA® VCDs. METHODS: PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched systematically for relevant articles from the inception of the database until August 27, 2021. The outcomes of interest were all bleeding events, major bleeding, major and minor vascular complications, pseudoaneurysm, stenosis or dissection, and VCD failure. Risk ratios were used as point estimates of endpoints. All statistical analyses were carried out using R version 4.0.3. RESULTS: Four observational studies and 1 pilot randomized controlled trial (RCT) were included in the final analysis. There was no significant difference between the ProGlide® and MANTA® groups in the risk of all bleeding events, major/life-threatening bleeding, major vascular complications, minor vascular complications, pseudoaneurysms, and/or stenosis or dissection of the entry site vessel. However, the incidence of VCD failure was higher in the ProGlide® group compared with the MANTA® group (RR 1.94; 95% CI 1.31-2.84; I2 = 0%). CONCLUSION: In conclusion, both VCDs (ProGlide® and MANTA®) have comparable outcomes with regard to risk of bleeding, vascular complications, pseudoaneurysms, and/or stenosis or dissection of entry vessel. ProGlide® was however associated with higher device failure.


Assuntos
Falso Aneurisma , Dispositivos de Oclusão Vascular , Constrição Patológica , Artéria Femoral/cirurgia , Hemorragia/epidemiologia , Hemorragia/etiologia , Técnicas Hemostáticas , Humanos , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos
16.
Catheter Cardiovasc Interv ; 99(7): 2125-2130, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35420254

RESUMO

INTRODUCTION: The preferred approach for transcatheter aortic valve replacement (TAVR) is transfemoral. There has been widespread adoption of the Perclose ProglideTM device for vascular closure. Typically, two devices are deployed before upsizing the access sheath in the "preclose technique." Prior investigations have compared the use of a single device versus double device technique, but none have shown significant clinical benefit to either approach. METHODS: Five hundred and six patients underwent transfemoral TAVR (TF-TAVR) with single or double Perclose devices for vascular closure from July 2015 to February 2020. A retrospective review was conducted, and propensity-matched analyses were used to account for differences in baseline characteristics. RESULTS: In the matched analysis, there were 251 patients in the single Perclose group and 238 in the double. There was a statistically significant improvement in overall procedural success using the single closure device (94.6% vs. 88.5%, p = 0.009) This was defined as intraprocedural hemostatic control, lack of contrast extravasation, arterial dissection, occlusion, or stenosis >50% in the final crossover angiogram, as well as unimpaired limb perfusion without claudication throughout the index hospitalization. There was also a significant improvement in arterial dissection rates (0.6% vs. 4.6%, p = 0.004), stenosis >50% (1.3% vs. 4.4%, p = 0.028), and Valve Academic Research Consortium major vascular complications (1.8% vs. 4.9%, p = 0.038). CONCLUSION: A single Perclose device is a safe means of vascular closure during TF-TAVR and may have important clinical benefits compared to the commonly used two-device technique.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Constrição Patológica/complicações , Constrição Patológica/cirurgia , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Técnicas Hemostáticas/efeitos adversos , Humanos , Estudos Retrospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
18.
Eur J Cardiothorac Surg ; 61(6): 1348-1354, 2022 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-35445255

RESUMO

OBJECTIVES: Both surgical and percutaneous femoral accesses for the establishment of extracorporeal circulation are used in minimally invasive cardiac surgeries. The goal of this study was to compare the outcomes with the MANTA vascular closure device after percutaneous arterial decannulation via the surgical approach. METHODS: Between November 2018 and January 2021, a total of 490 consecutive patients underwent minimally invasive cardiac operations at our institution. Cannulation and decannulation of femoral vessels were under direct vision surgically or percutaneously. The MANTA system was used to close the femoral artery in all patients with percutaneous cannulation. Demographic, clinical and procedural data were collected retrospectively. RESULTS: Surgical cut-down and suture closure of the femoral artery was performed in 222 patients (45.3%); percutaneous access and closure with the MANTA system was used in 268 patients (54.7%). The surgical group presented a significantly higher incidence of any access site complication compared to the percutaneous group [18 patients (8.1%) vs 6 patients (2.2%); P = 0.003]. Lymph fistula and wound healing disorders occurred more frequently in the surgical group (3.2% vs 0% [P = 0.004] and 3.6% vs 0% [P = 0.002], respectively). Median procedural duration and stays in the intensive care unit were significantly lower in the percutaneous group {127 [interquartile range (IQR) 97-158] min vs 150 (IQR 117-185) min (P < 0.001) and 1 (IQR 1-2) day vs 2 (IQR 1-3) days (P = 0.008), respectively}. CONCLUSIONS: Percutaneous access and closure with the MANTA system are feasible, safe and associated with lower incidences of all-cause access site complications and shorter stays in the intensive care unit compared to surgical access and closure in minimally invasive cardiac surgeries.


Assuntos
Cateterismo Cardíaco , Artéria Femoral , Dispositivos de Oclusão Vascular , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Artéria Femoral/cirurgia , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Estudos Retrospectivos , Resultado do Tratamento
19.
Int J Cardiol ; 359: 7-13, 2022 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-35427700

RESUMO

BACKGROUND: Arterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost. AIMS: To evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). METHODS: A single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2. RESULTS: From May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications. CONCLUSION: This largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve. CLINICAL TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov. Unique identifier: NCT04392492.


Assuntos
Estenose da Valva Aórtica , Cateterismo Periférico , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Cateterismo Periférico/efeitos adversos , Artéria Femoral/cirurgia , Técnicas Hemostáticas , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos
20.
Cardiovasc Revasc Med ; 40S: 157-158, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35246410

RESUMO

Vascular closure devices (VCDs) are widely used as an alternative to manual compression of femoral puncture sites. In this report, we present a 73-year-old man who developed symptomatic venous stenosis related to VCD after pulmonary vein isolation. We performed percutaneous treatment with balloon angioplasty. This case suggests that balloon angioplasty with proper safety measures can be an option for treating venous stenosis related to VCDs.


Assuntos
Anormalidades Cardiovasculares , Dispositivos de Oclusão Vascular , Doenças Vasculares , Idoso , Constrição Patológica , Artéria Femoral/cirurgia , Técnicas Hemostáticas , Humanos , Masculino , Punções , Resultado do Tratamento , Doenças Vasculares/diagnóstico por imagem , Doenças Vasculares/etiologia , Doenças Vasculares/terapia
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