Endovascular management of femoral access-site and access-related vascular complications following percutaneous coronary interventions (PCI)

AbstractMechanical circulatory support (MCS) devices are increasingly used to provide hemodynamic stability for patients with severe coronary artery disease, comorbidities, and/or impaired hemodynamics during high-risk percutaneous coronary interventions (PCI). Vascular access site complications, particularly those due to the use of large-bore sheaths, may limit outcomes in these patients. The aim of this study was to investigate the incidence and predictors of vascular complications in protected high-risk PCIs. Therefore, we included patients undergoing high-risk PCI with an Impella device from January 2016 to August 2018. Vascular complications were graded according to ‘Valve Academic Research Consortium-2’, a definition routinely used in transcatheter valve implantation procedures. In total, 61 patients (mean age 72 ± 11 years, 79% male, SYNTAX score 33 ± 7) were included, and angiographic- and fluoroscopic-guided vascular access was used for Impella implantation in all patients. Major vascular complications occurred in 5 male patients (8%). All major vascular complications were treated conservatively without the need for surgical intervention, and only one patient received a transfusion of three erythrocyte concentrates. Regression analysis revealed that patients with peripheral arterial disease of the lower extremities are at higher risk of major vascular complications. In conclusion, the utilization of Impella using a standardized protocol for angiographic- and fluoroscopic-guided vascular access was associated with a low rate of vascular complications.

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Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study

Clinical Medicine Insights Cardiology ◽

10.4137/cmc.s31932 ◽

2015 ◽

Vol 9 ◽

pp. CMC.S31932 ◽

Cited By ~ 4

Author(s):

Michael Behnes ◽

Melike Ünsal ◽

Ursula Hoffmann ◽

Christian Fastner ◽

Ibrahim El-Battrawy ◽

...

Keyword(s):

Vascular Complications ◽

Classification Systems ◽

Radial Compression ◽

Percutaneous Coronary Interventions ◽

Cardiac Events ◽

Bleeding Events ◽

Access Site ◽

Arterial Access ◽

Coronary Interventions ◽

Percutaneous Coronary

Background Bleeding events after percutaneous coronary interventions (PCI) are associated with patients' age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes. Methods The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up. Results Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015. Conclusions The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.

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Abstract 016: Endovascular Management of Major Vascular Access Site Complications During Transcatheter Aortic Valve Implantation (TAVI).

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.10.suppl_3.016 ◽

2017 ◽

Vol 10 (suppl_3) ◽

Author(s):

Muhammad U Majeed ◽

Kelly D Green ◽

Marat Fudim ◽

Mark A Robbins ◽

David X Zhao

Keyword(s):

Vascular Access ◽

Vascular Complications ◽

Covered Stents ◽

Endovascular Management ◽

Access Site ◽

Femoral Access ◽

Access Site Complication ◽

Small Series ◽

Significant Difference ◽

Endovascular Approach

Background: Major vascular access site complications remain a challenge in the field of TAVI and are associated with higher 30 day mortality. However, outcomes following endovascular management with covered stents for such complications are not well established. Methods: We reviewed the one year data of patients who underwent TAVI at our institution with a Sapien valve by percutaneous femoral approach. Identified were patients who suffered major vascular complications according to the definitions set forth by the Valve Academic Research Consortium. We then compared the outcome of patients managed by an endovascular approach with a population whose femoral access site complications were managed surgically/endovascularly (85.7% surgically), as reported from the Partner trial. Results: A total of 16 patients experienced Major Vascular complications. TAVI was aborted on 2 patients due to access site complication. Excluded were 3 patients who had benign small ascending aortic dissections after successful valve deployment and 3 patients who were managed surgically. Ten remaining patients were managed by a pure endovascular approach with covered stents. Four of these patients suffered ilio-femoral dissection, 4 had perforation and 2 had both perforation and dissection. No significant difference was observed in pre and post procedure creatinine (1.01 vs 1.14, p=0.16) and none required dialysis within 30 days, as compared with 8.1% in Partner trial. We observed no statistically significant difference between the Partner trial cohort and our patients in 30 day all cause mortality (14.1% vs 10%, p=1), stroke rate (4.8% vs 0%, p=1), access site hematoma (22.9% vs 0%, p=0.1), retroperitoneal bleed (9.5% vs 0%, p=0.6), pseudoaneurysm (3.4% vs 0%, p=1), and gastrointestinal ischemia (1.6% vs 0%). No access site infection, stent thrombosis, or stenosis leading to limb ischemia were noted clinically at 30 day follow-up. Conclusion: Many patients with major vascular complications during TAVI can be treated with a pure endovascular approach. In our small series we observed no difference in concurrent complications when an endovascular repair can be rapidly initiated as compared to a primary surgical approach.

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Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol

BMJ Open ◽

10.1136/bmjopen-2020-038042 ◽

2020 ◽

Vol 10 (7) ◽

pp. e038042

Author(s):

Thomas A Meijers ◽

Adel Aminian ◽

Koen Teeuwen ◽

Marleen van Wely ◽

Thomas Schmitz ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Vascular Complications ◽

Coronary Intervention ◽

Ethics Committee ◽

Bleeding Complications ◽

Access Site ◽

Femoral Access ◽

Coronary Syndrome ◽

Percutaneous Coronary ◽

Coronary Lesions

IntroductionThe radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required. With slender technology, transradial PCI may be increasingly applied in patients with complex coronary lesions when large bore guiding catheters are mandatory and might be a safer alternative as compared with the transfemoral approach.Methods and analysisA total of 388 patients undergoing complex PCI will be randomised to radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator. The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Procedural success and major adverse cardiovascular events up to 1 month will also be compared between both groups.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting center (‘Medisch Ethische Toetsing Commissie Isala Zwolle’, ‘Commissie voor medische ethiek ZNA’, ‘Comité Medische Ethiek Ziekenhuis Oost-Limburg’, ‘Comité d’éthique CHU-Charleroi-ISPPC’, ‘Commission cantonale d'éthique de la recherche CCER-Republique et Canton de Geneve’, ‘Ethik Kommission de Ärztekammer Nordrhein’ and ‘Riverside Research Ethics Committee’). The trial outcomes will be published in peer-reviewed journals of the concerned literature.Trial registration numberNCT03846752.

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