Prophylactic Retrograde Distal Common Femoral Access as a Bail-out Strategy in Patients with Increased Risk for Femoral Access Complication During Transfemoral Aortic Valve Replacement

ObjectiveSeveral patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) have complex peripheral arterial disease (PAD) that increases risk of vascular complications and failure of vascular closure device (VCD). Endovascular bailout of failed VCD is performed through contralateral femoral access. Further due to multiple different anatomic reasons the contralateral femoral access and “up and over” approach is unavailable for endovascular bailout of the VCD failure. We evaluated a novel bailout technique of obtaining an additional access in ipsilateral common femoral artery (CFA) or superficial femoral artery (SFA) distal to the main CFA access used for TAVR device.MethodsWe prospectively identified patients who were at high risk for VCD failure and had unavailable contralateral CFA approach from the pre-TAVR evaluation with multislice CT angiography. The data was collected prospectively for the TVT registry and retrospectively reviewed. All patients had an additional distal access obtained in the CFA or proximal SFA under direct fluoroscopy guidance after achieving main CFA access for TAVR. Using an inner 0.021″ micro-dilator from the 4-Fr micropuncture mini stick max access kit (AngioDynamics, Marlborough, MA) and a 200 cm long 0.018″ wire, the distal access was secured in place through the TAVR procedure. After completing the TAVR if the VCD gained successful hemostasis, the 0.021″ dilator was removed with manual pressure. If the VCD failed to achieve hemostasis, the distal access was upsized to a 7 Fr sheath for carrying out endovascular repair of the TAVR access. If the distal access was upsized to 7 Fr, that access was treated with VCD. The patients were monitored for acute in-hospital complication and followed for 6 months.ResultsDuring 2017 & 2018, 97.4% of 186 TAVRs were performed via femoral approach at our center. Six patients met the criteria for high-risk access and non-availability of the contralateral “up and over” approach. Of the 6 patients enrolled in this prospective study, 3 required endovascular management of TAVR access because of failed VCDs and were treated with covered stents using the distal ipsilateral access. The remaining 3 patients had successful use of VCDs for the TAVR access and the prophylactic access with 0.021″ dilator was managed with manual pressure. None of the six patients suffered any further vascular complication or bleeding. At the 6-month follow up no vascular complications or clinically driven events were identified from the TAVR access or additional distal ipsilateral access.ConclusionThis novel technique of prophylactic ipsilateral distal femoral access can provide an alternative bailout strategy for patients at high risk of closure device failure and unavailable contralateral femoral approach during transfemoral TAVR.     

Gender related differences in predictors of vascular complications: role of vessel size and BMI

Women undergoing cardiac catheterization have an increased risk of vascular complications (VC) compared to men. Whether this is due to gender differences in common femoral artery (CFA) anatomy remains unknown. Therefore, we examined angiographic features of CFA to identify differences in predictors of VC between the genders. A case control study design enrolled 59 (30 women and 29 men) consecutive patients with VC and 59 age, gender and procedure matched controls from 2004 to 2009. VC were defined as hematoma >6 cm, any access site related bleeding requiring transfusion or injury requiring mechanical intervention. Quantitative angiography was performed on all femoral angiograms. Univariate and multivariate regression was performed to define clinical and angiographic predictors of VC. Among all patients, cases had significantly lower BMI than controls (28.4 ± 7.7 vs. 32.0 ± 6.7, p ≤ 0.01) and were more than twice likely to have CFA reference vessel diameter <5.5 mm (p = 0.04). This finding was entirely driven by the inverse relationship between BMI, CFA and VC among women. On multivariate analysis, BMI was a potent predictor of VC (OR 0.94; 95 % CI 0.89–0.99; p = 0.04). When comparing men and women, BMI and CFA size were predictors of VC among women only. Among men, site of arteriotomy and diabetes mellitus predicted risk of VC. Smaller BMI correlates with smaller CFA diameter and both are predictive of increased risk of VC. This may explain the female predisposition to VC. Risk stratification for bleeding and VC should address these gender specific findings.     

Anesthetic ointment only (lidocaine/prilocaine) instead of injectable local lidocaine in trans‐radial catheterization: A viable no‐needle alternative

Objective

The aim of the present study was to assess the level of access site pain in patients undergoing transradial coronary catheterization by using topical application of an anesthetic ointment (lidocaine/prilocaine—AO) compared to standard local anesthesia (LA) by means of injectable lidocaine.

Methods

We prospectively studied 444 patients undergoing elective trans‐radial coronary angiography. The quality of analgesia was assessed using a visual analogue scale (VAS) immediately after the puncture and 30 min after the removal of the sheath. The number and duration of attempts before successful sheath insertion, as well as artery spasm, were compared between the two groups.

Results

Pain levels measured by VAS were found to be similar between the two groups during sheath insertion (VAS: AO: 4.84 ± 1.0 vs 4.82 ± 1.2, P = NS), as well as 30 min after sheath removal (VAS: AO: 0.07 ± 0.5 vs LA: 0.15 ± 0.6, P = NS). The time to obtain radial access was also not affected by the use of anesthetic ointment (AO: 62.24 ± 25.7 s vs LA: 64.04 ± 18.78 sec, P = NS). The rate of clinical or angiographic radial artery spasm was similar (8‐10%) between the groups (P = NS)

Conclusion

Use of a local anesthetic ointment, versus injectable lidocaine, in trans‐radial cardiac catheterization as means of local anesthesia, was found to be equally effective in terms of pain, artery spasm, or artery cannulation speed.

     

Infection des abords vasculaires et interventions cardiaques percutanées : un risque significatif ?

Vascular access site infections are infrequent and rarely reported as a potential complication of percutaneous cardiac intervention. A case of access site infection is reported with a literature review. Femoral access is mainly concerned in some circumstances: delayed sheath withdrawal, vascular complications (hematoma, false-aneurysm, arteriovenous fistula), or use of hemostatic closure device. These infectious complications are always serious requiring medical and surgical treatment and potentially associated with life-threatening complications. Preventive measures should be applied in order to reduce the risks: optimisation of femoral punctures with the support of echography guidance, avoid a new puncture in a area with hematoma, femoral angiographic evaluation and strict aseptic precautions with vascular closure devices, and obviously preferential choice of radial access.     

Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998-2003.

OBJECTIVES: To evaluate the adjusted risk of vascular complications after manual compression and vascular closure devices for femoral artery access site management in a large contemporary cohort, using propensity score analysis. BACKGROUND: Vascular closure devices (VCD) allow early ambulation after cardiac procedures involving femoral artery access, but whether the benefit of use of vascular closure devices (VCD) is offset by reduced safety in contemporary practice remains uncertain. Methods: Twenty one thousand eight hundred and forty one consecutive diagnostic cardiac catheterization (n = 13,124) and percutaneous coronary intervention procedures (n = 8,717) performed via a femoral access at a single site (WFUBMC) between 1998 and 2003 were evaluated. VCD's were used based on operator preference. Propensity to receive a vascular closure device (VCD) was calculated. The relative incidence of vascular complications was evaluated by logistic regression models, using the propensity score as a covariate. RESULTS: Overall, the unadjusted incidence of any vascular complication was 1.3% for VCD use and 1.4% for manual compression, p = NS. The propensity score-adjusted odds ratio for any vascular complication comparing VCD (n = 8,707) to manual compression (n = 13,034) was 0.86 (0.67-1.11) for all procedures, 0.80 (0.53-1.21) for diagnostic procedure, and 0.90 (0.65-1.26) for interventional procedures. CONCLUSIONS: In this large single-center, contemporary observational study, the risk-adjusted occurrence of vascular complications following VCD use for femoral artery access management is not increased by VCD use. Thus, in the current era, the benefit of VCD use is not offset by reduced safety.     

Novel Collagen Vascular Plug for Femoral Arteriotomy Sealing: Acute and Chronic In Vivo Studies

Background: The current use of collagen vascular hemostasis devices to percutaneously seal femoral arteriotomy sites is limited by a significant incidence of vascular complications. The purpose of the present study was to assess the efficacy of new collagen plug specifically designed to avoid these complications by accurately gauging the depth of the femoral artery and by minimizing the risk of intra-arterial collagen deployment. Methods: The hemostasis device used in this study consists of a multicomponent collagen plug with an external rigid collagen tube lined by an inner layer of absorptive sponge collagen. Placement of this plug is facilitated with a specialized two-lumen dilator, which localizes the arterial surface using a “bleedback” mechanism from one of the lumens, and prevents the placement of collagen through the arteriotomy site. The acute efficacy of this device was assessed in 26 adult dogs in which 36 collagen plugs were used to seal 8Fr femoral arteriotomies. An additional 16 arteriotomies treated with standard manual compression served as study controls. Following plug placement or manual compression, all puncture sites were observed for bleeding and hematoma formation over a 45-minute period. Patency of each instrumented artery was assessed with serial femoral angiography and localization of each plug was confirmed with surgical cutdown at the puncture site. The chronic efficacy of this device was assessed in three pigs in which three collagen plugs were used to seal 8Fr femoral arteriotomies. The three animals were subsequently sacrificed at 7,14, and 30 days, respectively, for histologic analysis. Results: In acute animals, all 36 plugs were successfully placed without evidence of vascular compromise or intra-arterial collagen deployment. In nonanticoagulated animals, hemostasis was achieved within 5 minutes in 10 of 10 plugs placed with a skin-to-arlery distance > 1.8 cm, in 4 of 7 plugs with a skin-to-artery distance of 1.2–1.7 cm, and in 0 of 9 plugs with a skin-to-artery distance < 1.2 cm. In anticoagulated animals, hemostasis within 5 minutes was demonstrated with 8 of 10 plugs with a skin-to-artery distance > 1.8 cm; small hematomas occurred in the remaining two animals in the setting of a PTT > 100 seconds. Time to hemostasis was significantly less for collagen plugs than manual compression in both nonanticoagulated animals (plug 17 ± 16 minutes; manual compression 28 ± 5 minutes; P < 0.03) and anticoagulated animals (plug 6 ± 2 minutes; manual compression 42 ± 4 minutes; P < 0.01). Chronic studies demonstrated femoral artery patency in all three pigs. Histologic analysis demonstrated progressive collagen resorption with no difference between collagen plug placement or manual compression at 30 days. Conclusions: The local hemostasis device utilized in this study resulted in accurate placement of a collagen plug immediately adjacent to the arteriotomy site with no evidence of acute or chronic vascular compromise or intra-arterial collagen deposition. Hemostasis with shorter compression times than with standard manual techniques was achieved at puncture sites in which the skin-to-artery distance was > 1.8 cm and the anticoagulation profile was not excessive. At 1 month postplacement, there is no histologic difference between plug use and standard manual compression. (J Interven Cardiol 1996;9:25–33)     

Angiographic predictors of femoral access site complications: implication for planned percutaneous coronary intervention.

This study examined the relationship between the femoral arteriotomy location and the risk of femoral access site complications after diagnostic and interventional cardiac catheterization procedures. One of the most common complication of cardiac catheterization and percutaneous coronary intervention (PCI) involves the vascular access site. The femoral approach is the most frequent site of vascular access during invasive cardiac procedures. This approach is associated with vascular complications, such as retroperitoneal bleeding, which can be life-threatening. If angiographic predictors of retroperitoneal bleeding can be identified, this complication could be avoided. A prospective cohort of 33 patients with femoral access site complications was subgrouped based on the angiographic arteriotomy site. Concurrent patients without complications were randomly selected to form a control group. Study and control patients were compared on presenting risk factors and outcomes. Logistic regression analysis was used to identify independent predictors for femoral access site complications. Arteriotomy location above the most inferior border of the inferior epigastric artery in patients undergoing PCI was associated with 100% of all retroperitoneal bleeds (P < 0.001). Low, high middle, and high femoral arteriotomy sites were associated with 71% of all vascular access complications. The combination of these locations for the femoral arteriotomy was an independent predictor of adverse vascular access site complications beyond traditional risk factors (odds ratio = 28.7; CI = 6.73-122.40; P < 0.0001). Vascular complications occurred more frequently in patients who were of older age (72 vs. 66 years; P < 0.001). The location of the femoral arteriotomy site assessed by a femoral angiogram is predictive of life-threatening complications. Patients undergoing PCI with an arteriotomy above the most inferior border of the inferior epigastric artery are at an increased risk for retroperitoneal bleeding. This complication may be avoided by risk-stratifying patients prior to intervention with a femoral angiogram.     

Use of Angio-Seal closure device when the arteriotomy is above or below the common femoral artery

Background:

The majority of vascular complications during diagnostic coronary angiography occur while accessing the femoral artery. Angio‐Seal vascular closure devices are indicated for closure of arteriotomies of the femoral artery, but not when the puncture site is above or below the femoral artery.

Hypothesis:

Under certain circumstances, use of the Angio‐Seal closure device above or below the common femoral artery may be safe and effective.

Methods:

Consecutive patients at a single high‐volume medical center having documented high or low arteriotomies were closed using an Angio‐Seal closure device. Patients were chosen when they received a single arterial puncture, the arteriotomy was away from branch vessels, and the diameter of the artery at the site of sheath entry was of large enough caliber to suggest placement would be successful. Patients were then followed longitudinally for complications.

Results:

Sixty‐two patients had non–femoral artery sheath placement. Twenty‐two patients had “high” puncture sites, and 40 patients had “low” puncture sites. All were successfully closed using the Angio‐Seal vascular closure device and had no complications.

Conclusions:

Although not approved for placement in areas above or below the femoral artery, off‐label use of the Angio‐Seal arteriotomy closure may be safely performed when patient characteristics are favorable. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose. Neither author has a conflict of interest with St. Jude Medical or with the Angio‐Seal device.     

New sheath for vascular access and subcutaneous drug administration: Multicenter clinical trial for pain prevention after cardiac catheterization

A new vascular sheath design (anesthesia infusion sleeve, or AIS) was developed to enable administration of local anesthetics or other medications into the subcutaneous tissue around an arterial or venous insertion site without any additional needle sticks or manipulation. Design, animal testing, and an initial small single-site clinical study have previously been published. The current study was multicenter and randomized 80 patients to use of a standard sheath for vascular access or the AIS. Pain associated with sheath placement, postprocedure pain, and pain associated with sheath removal before and during manual compression was recorded. Baseline pain was identical in both the standard and AIS groups. Pain during infiltration and with initial femoral artery compression was significantly lower in the AIS group. A quality of life questionnaire indicated that the AIS sheath was associated with less discomfort and was preferred over a standard sheath in patients who had had a previous procedure performed. The AIS represents a simple addition to standard sheath design, offering superior pain control during removal compared to the standard technique, without the need for systemic analgesics or additional needle punctures. Cathet Cardiovasc Diagn 40:81–83, 1997. © 1997 Wiley-Liss, Inc.     

Frequency,Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A Patient-Level Meta-Analysis

Background/purposeThe MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications.Methods/materialsThis patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting.ResultsEight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17–76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46–4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17–4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26–4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype.ConclusionsLarge-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.     

Safety and Effectiveness of MANTA Vascular Closure Device After Large-Bore Mechanical Circulatory Support: Real-World Experience

BackgroundReal world safety and effectiveness of MANTA vascular closure device (VCD) for large bore arteriotomy closure after decannulation of mechanical circulatory support (MCS) devices is not known.MethodsAll consecutive patients who underwent large bore arteriotomy closure with MANTA VCD following decannulation of MCS between February to October 2019 at a large tertiary care academic medical center were included. Safety and effectiveness of MANTA VCD was assessed on immediate post-closure angiogram for 23 access sites, and immediate post-closure duplex arterial ultrasound or manual vascular examination for 1 access site each. Technical success was defined as achievement of arteriotomy closure in absence of major bleeding or access site endovascular or surgical intervention.ResultsA total of 25 MANTA VCD were placed in 22 unique patients by 7 different operators. A 14 Fr or 18 Fr MANTA VCD was used in 15 (60%) and 10 (40%) of deployments, respectively via transfemoral (n = 23, 92%) or transaxillary (n = 2, 8%) access. Technical success was achieved in 24 of 25 (96%) cases. Minor access site bleeding occurred in 3 patients (12%) and failure of MANTA VCD with major access site bleeding occurred in 1 patient (4%) requiring endovascular balloon tamponade. No cases of retroperitoneal bleeding, collagen plug embolization, covered stent placement, or surgical vascular repair were observed.ConclusionIn this single center experience, the use of MANTA VCD for large bore arteriotomy closure following percutaneous decannulation of MCS devices appears to be safe and effective. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed.     

A comparison of the transradial and the transfemoral approach in chronic total occlusion percutaneous coronary intervention

Background: Transradial coronary intervention is a safe and effective method of percutaneous revascularization. Furthermore, the indications for transradial percutaneous coronary intervention (PCI) are expanding. However, there is limited data on the efficacy and the safety of the transradial approach for chronic total occlusion (CTO) PCI. Methods: We examined 468 patients who underwent CTO PCI between January 2003 and December 2005, and compared the radial (318 patients) and the femoral (150 patients) approach. Results: Baseline demographics, lesion location, and the vessel treated were similar in both groups. Angiographic success was 82% in radial versus 86% in femoral group, P = 0.28, similar in both groups. Total fluoroscopy time (24.49 ± 13.18 vs. 24.07 ± 14.12 min, P = 0.36), total procedure time (54.22 ± 25.35 vs. 60.23 ± 28.15 min, P = 0.23), and the use of total contrast volume (395.54 ± 180.25 vs. 406.15 ± 173.98 ml, P = 0.27) were similar in radial and femoral group, respectively. In hospital MACE [radial: 12 MI (3.8%) vs. femoral: 1 death (0.7%) and 5 MI (3.5%), P = 0.26] were similar in both groups. Access site vascular complications [radial: 11 (3.5%) vs. femoral: 17 (11.3%), P ≤ 0.001] were significantly less in radial group. Conclusions: The radial approach in CTO PCI is as fast and successful as the femoral approach with comparable in hospital MACE. However, there are far less access site complications with radial approach. © 2008 Wiley‐Liss, Inc.     

A comparative evaluation of arterial blood flow and the healing response after femoral artery closure using angio-seal STS Plus and StarClose in a porcine model

Objectives: This study prospectively evaluated the acute and chronic arterial blood flow and vascular pathology after vessel closure using two commonly used closure devices controlled by deploying both devices in each animal. Background: Several vessel closure systems are approved for clinical use; however, few direct comparisons have ever been performed and no randomized case controlled study has been published using FDA‐approved devices. Methods: Ninteen Sous Scroufulae pigs underwent bilateral percutaneous arteriotomies using ultrasound‐guided 6 Fr sheath insertion in both common femoral arteries. The femoral access site was then closed using either an Angio‐Seal STS Plus?, an absorbable collagen sponge, or StarClose?, a self‐closing nitinol clip. Angiograms and ultrasound of the site were performed prior to closure and immediately afterwards. At follow‐up, ultrasound was performed at the site and the specimens were sent for histopathology. Results: Baseline femoral artery diameters (centimeters) were similar in both groups by U/S (5.2 ± 0.3, 5.3 ± 0.3) and quantitative angiography (4.6 ± 0.7, 4.6 ± 0.8) . Postdeployment angiograms showed a vessel diameter stenosis of 65%± 24% with Angio‐Seal (n = 18) and 50%± 22% with StarClose (n = 18), P = 0.04. 2D U/S performed immediately postdeployment showed vessel diameter stenosis of 59%± 33.0 with Angio‐Seal (n = 19), and 35%± 20 with StarClose (n = 19), P = 0.01. At 7‐, 30‐, and 60‐day follow‐up, no appreciable differences in the vessel diameter were observed by U/S. At early follow‐up (7 and 30 days), Angio‐Seal arteriotomy closure sites were associated with higher inflammatory and hemorrhage scores, but no difference was seen at late (60‐day) follow‐up. Conclusions: The StarClose closure device is associated with less short‐term vessel injury compared to Angio‐Seal STS Plus; however, this difference was not statistically significant after 60 days.     

Brachial artery catheterization employing a side arm sheath

A major complication of left heart catheterization via the brachial artery is occlusion at the cutdown site. This is particularly a problem when patients with severe atherosclerosis are catheterized in laboratories where the brachial approach is not routinely used. A method of brachial artery catheterization is described which employs a continuously flushed side arm sheath in order to minimize local trauma to the artery from catheter exchange and manipulation. In 15 consecutive atherosclerotic patients catheterized by this method there were no complications, and all arteriotomies were closed easily with immediate restoration of a good radial pulse. This contrasts with the preceding 33 consecutive brachial catherizations employing standard technique in similar patients in whom four patients required surgical repair, and an additional six patients required more than one closure attempt and/or catheter thrombectomy to restore a good pulse. In our laboratory the brachial sheath technique has facilitated arterial repair and reduced local complications.     

Usefulness of subcutaneous nitrate for radial access

Objectives: We made the hypothesis that adjunction of nitrate to lidocaine for local anesthesia may facilitate accessibility of radial access. Background: Transradial approach is associated with a clear decrease in the rate of access bleeding when compared with femoral approach. The diffusion of this technique remains limited due to the small size and the spastic profile of this artery. Methods: Eighty‐four consecutive patients undergoing coronary procedures using radial approach were randomly assigned between two types of local anesthesia (double blind): 5 ml lidocaine (group L)—5 ml lidocaine + 0.5 mg dinitrate isosorbide (group LN). The primary endpoint was the duration of radial puncture (from beginning of local anesthesia to sheath insertion) and the total number of punctures. Results: Sixty‐two men and 22 women (mean age 59 ± 8 y.o.) were included. Mean ± SEM access duration was 3:33 ± 3:11 min in group L when compared with 2:26 ± 1:20 min in group LN (P < 0.05). Mean number of puncture was 1.50 ± 1.0 in group L when compared with 1.16 ± 0.5 in group LN (P = 0.05). There were no differences between two groups concerning pain score during anesthesia and sheath insertion. There was no difference between two groups concerning the rate of hypotensive and vagal reactions. Radial spasm occurred in four patients in group L and only one in the group LN. Conclusion: Local anesthesia using lidocaine plus nitrate is feasible and improves the accessibility of radial access. © 2008 Wiley‐Liss, Inc.     

A Novel Fluoroscopic-guided Technique With Micropuncture Needle for the Common Femoral Artery Access

BackgroundRandomized trials demonstrated that the rate of access to the center of the CFA was low and not different with fluoroscopy vs. anatomic landmarks. We investigated the role a novel fluoroscopic-guided technique with the micropuncture needle (MPN) for the common femoral artery (CFA) access.MethodsA MPN was advanced to the center of pubis in the 20° ipsilateral right- or left anterior oblique view for the CFA access in 150 patients undergoing cardiac catheterization. After the CFA puncture and guidewire advancement, if the MPN tip was within pelvic-femoral line (the line between pelvic brim and inferior border of the femoral head), a sheath was inserted into the CFA and femoral angiography was performed. The acceptable sites of CFA access were defined zone III, as the sheath position in the middle third of the CFA; Zone II, between the pelvic brim and Zone III; and Zone IV, between the femoral bifurcation and Zone III. High or low access sites were zones I and V, respectively.ResultsThe primary-end point, the CFA access to the center of CFA (zone III) was significantly higher than zones II and IV (64% vs. 13% and 23%; P < 0.001, respectively). The MPN tip was high or low in 17 and 11 patients (19%), respectively, which was readvanced to the center of pubis using fluoroscopy; this resulted in CFA access in 100% of patients. There were no bleeding complications; the baseline and next day hemoglobin levels were 13.0 ± 2.0 g/dl vs. 12.4 ± 1.9 g/dl, respectively; P = NS.ConclusionsThe use of this novel fluoroscopic-guided technique with the MPN resulted in access to the CFA in all patients and to the center of the CFA in the majority of patients. There was no significant hemoglobin drop or bleeding complications after the procedure.     

Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual compression (Femostop) in transcatheter coronary interventions requiring Abciximab (ReoPro)

Transcatheter coronary interventions requiring abciximab (ReoPro) are associated with vascular access site complications. Several devices have been developed to aid in the closure of the femoral arteriotomy, including collagen plug devices (VasoSeal, Angio-Seal), percutaneous suture closure (Perclose), and aids to manual compression (Femostop). In 185 patients who received abciximab plus aspirin and heparin for transcatheter coronary interventions, we compared femoral arteriotomy closure by three different methods: VasoSeal, Perclose, and Femostop. A composite endpoint of late complications defined as an access site-related bleed or hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis was compared. VasoSeal was initially successful in 41/52 patients (78.8%). The 11 patients who failed to have adequate hemostasis with VasoSeal required manual compression aided by Femostop, but had no late complications. There was one access site infection and one fatal retroperitoneal hematoma unrelated to the vascular access site (surgically explored). There were no late complications. Perclose was successful in 48/56 patients (85.7%). One Perclose failure required surgical repair for an extensive arteriotomy. The other Perclose failure required manual compression aided by Femostop, but had no late complications. There were no access site infections requiring intravenous antibiotics. There was one retroperitoneal bleed that extended the patient's hospital stay and for which a blood transfusion was required. Femostop was successful in 77/77 patients (100%). There were no infections. Late complications occurred in four patients. These included three episodes of bleeding or hematomas requiring blood transfusion, and one pseudoaneurysm. Conclusion: In patients receiving abciximab in addition to aspirin and heparin, VasoSeal and Perclose are at least as safe as Femostop when used to achieve homeostasis after sheath removal. VasoSeal and Perclose have a significantly lower initial rate of successful hemostasis than Femostop. The numbers of late complications between the VasoSeal, Perclose, and Femostop groups were not significantly different. In those patients in whom VasoSeal or Perclose failed, no late complications occurred. Access site infections were no different between VasoSeal, Perclose, and Femostop. Cathet. Cardiovasc. Intervent. 47:143–147, 1999. © 1999 Wiley-Liss, Inc.     

Arteriotomy site complication during transcatheter aortic valve replacement: Ipsilateral wire protection and bailout

Major vascular complications still occur in ~4.2% of transcatheter aortic valve replacement (TAVR) procedures. These complications are a major safety drawback of TAVR when compared to surgical aortic valve replacement (SAVR).Contemporary strategies designed to minimize and effectively treat vascular complications are of immense importance to a successful TAVR program. This review discusses strategies to optimize TAVR access and device choice along with TAVR access complication management.Iliac complications are less frequently encountered and can be managed effectively via the TAVR sheath over the TAVR wire employing ipsilateral proximal iliac balloon occlusion and endovascular repair. The more common arteriotomy site complications and access site closure failure require prophylactic or bail-out common femoral to superficial femoral artery wiring. Suggested is a novel method of ipsilateral arteriotomy site protection that is safe, simple and does not require additional resources. Ipsilateral wiring can also be done prophylactically or as a bailout in case of arteriotomy site complication.     

Use of a low‐profile,compliant balloon for percutaneous aortic valvuloplasty

Objectives : To determine the safety and immediate efficacy after balloon aortic valvuloplasty (BAV) with a new, low‐profile balloon. Background : BAV has a continuing role in the management of high‐risk patients with severe aortic stenosis (AS). BAV with traditional noncompliant balloons requires a large femoral arteriotomy and is associated with high rates of access site complications. Methods : We retrospectively reviewed medical records of 20 consecutive patients undergoing BAV for severe AS. Retrograde transfemoral BAV was performed with a low‐profile, compliant valvuloplasty balloon. Before and after BAV, transaortic gradients were measured invasively and by echocardiography, and aortic valve area (AVA) calculated. Access site complications, functional class and survival were recorded. Results : Patients were 79 ± 12 years old and had an estimated mortality from open aortic valve replacement of (12.5 ± 9.6)%. By catheterization, mean aortic gradient fell from 44 ± 15 to 29 ± 10 mm Hg (P < 0.001) and AVA increased from 0.63 ± 0.22 to 0.89 ± 0.33 cm² (P < 0.001). New York Heart Association functional class improved from 3.5 ± 0.7 to 2.7 ± 0.8. Procedural mortality was 0%. There were no vascular complications or significant worsening of aortic regurgitation. Conclusion : Transfemoral BAV using a low‐profile compliant balloon is feasible with acceptable immediate results and safety. © 2009 Wiley‐Liss, Inc.