Sheath Removal Research Articles

Comparison of low dose versus standard dose heparin for radial approach in elective coronary angiography?

ObjectiveThe aim of this study is to evaluate the efficacy and safety of two doses of heparin, a low dose (2500IU) and a standard dose (5000IU) in patients who underwent transradial coronary angiography (TRCAG). MethodsA total of 459 consecutive patients were included in the present study, 217 in the 2500-IU heparin group and 242 in the 5000-IU heparin group. Radial artery patency was evaluated one month after the TRCAG with Doppler ultrasonography. ResultsThe RAO was observed in 15 (3.3%) patients. The RAO was significantly higher in 2500IU heparin group than 5000IU heparin group (5.5% vs 1.2% p=0.010, respectively). Female gender (Odds ratio (OR)=66.135, p=0.002, 95% confidence interval (CI)=4.584–954.131), sheath removal time (OR=1.496, p<0.001, 95% CI=1.254–1.784) and administration of 2500IU heparin (OR=9.758, p=0.034, 95% CI=1.195–79.695) were the independent predictors of RAO in multivariate regression analysis. While the presence of hypertension was independently associated with radial artery patency in multivariate regression analysis (OR=0.022, p=0.005, 95% CI=0.002–0.307). ConclusionThe patients in the standard dose heparin group had lower RAO rates compared to low dose group in this study. This suggests that using the current technique, standard dose of heparin is still required for transradial diagnostic angiography.

Safety and efficacy outcomes of protamine administration for heparin reversal following cryoballoon-based pulmonary vein isolation.

Anticoagulation with heparin is required during catheter ablation of atrial fibrillation (AF) to reduce systemic thromboembolism. In this study, we aim to compare safety and efficacy outcomes between patients who receive protamine administration for reversal of heparin and those who do not, following cryoballoon-based pulmonary vein isolation (PVI) for AF. Patients with symptomatic paroxysmal or persistent AF despite ≥1 antiarrhythmic drug(s) were scheduled for PVI per the recent consensus recommendations. Some patients were administered protamine at the end of the procedure depending on the operator's choice. Among 380 patients [48.2% male, 56 (20-86) years] that were enrolled, 188 patients received protamine at the end of the procedure. Baseline characteristics did not differ between groups (p > 0.05). Mean protamine dose was 39.1 ± 6.4 mg. Only 1 patient developed rash following protamine infusion. Hospital stay was significantly shorter in patients who were administered protamine (1 [1-5] vs. 2 [1-7] days, p < 0.001). Hematoma/pseudoaneurysm or femoral AV fistula requiring surgical or interventional repair in the femoral access site occurred in 2 (1.1 %) patients who received protamine and 12 (6.3%) patients who did not (p = 0.011). Deep vein thrombosis was seen in 1 patient in whom protamine was not administered (p = 0.499). To the best of our knowledge, this is one of the largest series showing that protamine administration for heparin reversal in patients undergoing cryoballoon-based PVI allows quicker sheath removal and minimizes the risk of potential vascular complications without causing an increase in thrombotic events.

Favorable Single-Operator Experience with VasoSeal , a Vascular Closure Device with Extravascular Collagen in a Large High-Risk Cohort of Patients Undergoing Percutaneous Coronary Interventions

BACKGROUND: Prolonged duration of manual or mechanical compression at the site of femoral artery access after sheath removal upon completion of coronary procedures followed by extended period of bed rest has significant logistical and practical problems for both patients and hospital staff. The availability of vascular closure devices (VCDs) has ushered in a new era in the routine clinical practice in the catheterization laboratory. AIM: The aim of this prospective study was to assess the effectiveness and safety of the use of the VCD VasoSeal, a collagen plug, in patients undergoing cardiac catheterization and/or percutaneous coronary intervention (PCI). PATIENTS AND METHODS: VasoSeal was employed over 2.5 years in 388 consecutive patients mostly presenting with acute coronary syndromes and subjected mainly to PCI procedures performed via transfemoral arterial access. All the patients who underwent PCI were given 7,000 IU of heparin intravenously during the procedure and had been receiving or were acutely loaded with dual antiplatelet therapy (aspirin and clopidogrel). The majority (90.7%) of patients also received a platelet glycoprotein IIb/IIIa inhibitor during and for 12-14 hours after the procedure. The sheaths were removed at the end of the procedure and hemostasis achieved with VasoSeal. RESULTS: Deployment of the VCD was successful in 99.2%. Complete hemostasis without bleeding or hematoma was obtained in 95.4% of cases (370/388). In 3 patients VasoSeal could not be or was partially deployed. The mean time required for the placement of VasoSeal was 1 min. The mean time-to-hemostasis was 3 min. The mean time-to-mobilization was 3 hours. Only one patient developed a pseudoaneurysm of the right common femoral artery; the lesion was treated with ultrasonography -guided compression. In addition, 13 small local hematomas and 2 large inguinal hematomas (one requiring blood transfusion) were recorded. In 2 cases retroperitoneal bleeding occurred, requiring blood transfusion in one of them. Local infection (cellulitis) responding to antibiotic treatment was observed in 2 patients. No patient required local surgical intervention. CONCLUSION: VasoSeal was a safe collagen closure device characterized by a high success rate of deployment and highly successful hemostasis with few manageable complications in a very high-risk patient cohort undergoing PCI under heavy anticoagulation and antiplatelet drug therapy. In these patients this vascular closure device reduced the time-to-hemostasis and time-to-mobilization and the incidence of complications.

Suprasternal direct aortic approach transcatheter aortic valve replacement avoids sternotomy and thoracotomy: first-in-man experience†.

Direct aortic deployment of a transcatheter aortic valve eliminates the need to traverse the aortic arch with the valve delivery system, enables placement of large sheaths in the aorta and innominate artery, provides maximal precision during deployment and ensures a safe, conventional surgical aortotomy closure. We describe the initial experience with the Suprasternal Aortic Access System (SuprAA System, Aegis Surgical Ltd, Dublin, Ireland) for direct transaortic/innominate valve delivery. Patients with severe, symptomatic aortic stenosis who were candidates for transcatheter aortic valve replacement (TAVR) via a direct transaortic approach were enrolled in the SuprAA-TAVR First-in-Man Study. Under general anaesthesia, the innominate artery and aortic arch were exposed in each patient, using the SuprAA System via a 2.5-cm incision directly above the sternal notch. The TAVR delivery sheath was positioned and the transcatheter valve deployed routinely under fluoroscopic guidance. Upon sheath removal, haemostasis at the aortotomy site was confidently secured using a double purse-string suture closure. All were extubated immediately. A meta-analysis of the direct aortic approach was done for comparison. Four male patients (mean 82.5 years) underwent SuprAA-TAVR (2 CoreValve; 2 SAPIEN). Anatomical visualization was excellent and suprasternal valve deployment was accurate regardless of sheath size with 100% Valve Academic Research Consortium-2 procedural success. The average total procedure time was 109.5 min without perioperative wound or vascular complications. The SuprAA System provides direct aortic/innominate access without sternal or thoracotomy incision. Patient recovery to normal activity is maximized, sheath size limitations are eliminated and valve deployment is precise. This innovative system creates a new and exciting minimally invasive approach for high-risk patients with aortic stenosis.

Evaluation of a Structured Training Program for Arterial Femoral Sheath Removal After Percutaneous Arterial Catheter Procedures by Assistant Personnel

After cardiac catheterization procedures, arterial closure can be achieved by manual compression (MC), using external mechanical compression devices, or by applying vascular closure devices (VCDs) with comparable vascular access site-related complication rates. The aim of the present study was to assess vascular access site-related complications during the implementation of structured sheath removal and MC by paramedics after catheterization procedures. After an observational phase of 3 months to assess the baseline complication rate, a structured 4-level training program was implemented to train assistant personnel, in this case paramedics, in the management of sheath removal by MC. Access site-related complication rates after sheath removal were assessed prospectively and MC by paramedics compared with MC by physicians and application of VCDs. To account for imbalances in procedure- and patient-related risk factors of access-site complications, propensity score-based matching analysis was performed (ClinicalTrials.gov identifier NCT00825331). All consecutive percutaneous transfemoral arterial cardiac catheterization procedures were prospectively assessed over a period of 8 months (n = 3,503). MC was performed in 2,315 cases, of which 180 were performed by paramedics and 2,135 by physicians; VCDs were applied in 1,188 procedures. Rates of access site-related complications were significantly lower for paramedics compared with physicians (p = 0.03) and similar between paramedics and VCDs (p = 0.77). In conclusion a structured program for paramedics to be trained in sheath removal after percutaneous cardiac catheterization procedures can be readily implemented during clinical routine with low in-hospital complication rates.

Pericardial Effusion Following Drain Removal after Percutaneous Epicardial Access for an Electrophysiology Procedure

To determine the frequency and predictors of pericardial effusion following epicardial sheath removal. Pericardial effusion can occur following cardiac surgical or interventional procedures including percutaneous epicardial access (EpiAcc), which is increasingly used as part of electrophysiology ablation procedures. A retrospective analysis of the Mayo Clinic comprehensive electronic medical record was performed from all patients who underwent planned EpiAcc as part of an electrophysiology ablation procedure between January 1, 2004 and June 30, 2013. Of 144 patients (mean age 51.3 ± 15.5 years, 68% male) who underwent planned EpiAcc as part of an electrophysiology ablation (95.8% pericardial access success rate), seven (4.9%) developed a postoperative pericardial effusion requiring repeat EpiAcc. Inferior access was utilized in 74 (51.4%) patients. Patients with pericardial effusion tended to be younger (41.1 years vs 51.8 years, P = 0.08) and were more likely to have undergone inferior approach access (85.7% vs 49.6%, P = 0.06) than those who did not develop postoperative pericardial effusion. Seventy-one percent of patients with postoperative pericardial effusion versus 32.1% of patients without postoperative pericardial effusion had a preprocedure ejection fraction ≥55% (P = 0.03). There were no procedural-related deaths, and no difference in mortality between groups. Postoperative pericardial effusion requiring repeat access/drainage was relatively infrequent, occurring in 4.9% of patients shortly after epicardial procedures. While the majority occur early and therefore require close observation, some patients may present in a delayed manner.

What are the benefits and harms of pain relief used during the removal of the femoral sheath after percutaneous coronary intervention?

What are the benefits and harms of pain relief used during the removal of the femoral sheath after percutaneous coronary intervention?

Early sheath removal after percutaneous coronary intervention using Assiut Femoral Compression Device is feasible and safe. Results of a randomized controlled trial

Abstract Objective This study was performed to evaluate the feasibility and safety of early sheath removal after percutaneous coronary intervention (PCI) using a locally designed Assiut Femoral Compression Device (AFCD2) vs. manual compression (MC). Background Due to antithrombotic therapy before, during, and after PCI, the arterial femoral sheath is generally not removed early after PCI. Patients and methods This was a randomized, controlled trial. We enrolled all patients undergoing PCI at Assiut University Hospitals from September, 2013 to December, 2013. At the end of PCI, the arterial hemostasis method was randomly assigned 1:1 to AFCD2 vs. MC. The sheaths were removed 2 h after PCI, instead of conventional 6 h, in the AFCD2 arm. Results The trial assigned 100 patients (mean age 57 ± 9 years, 75% men) to AFCD2 (n = 50) vs. MC (n = 50). Both groups were comparable regarding baseline characteristics. Concerning the primary effectiveness end point, there was significantly shorter mean time-to-ambulation with AFCD2 (8.2 ± 1.42 h) vs. MC (12.02 ± 0.22 h; p = Conclusion Our results indicate that AFCD2 is a simple and effective alternative to MC for hemostasis following PCI. Early sheath removal 2 h post PCI is feasible, safe, and improves the patient’s comfort.

61 * PCA for PVI: first report of successful use of patient controlled analgesia for AF ablation

Background: General anaesthesia (GA) is the gold standard for AF ablation (AFA) but approximately 50% of cases are performed under conscious sedation (CS). Compared to GA, CS is associated with inferior clinical results, In addition, pateints frequently experience pain and anxiety. However, financial and logistical restrictions mean that universal use of GA is unlikely in the foreseeable future. Accordingly, a pressing need exists to develop an alternative to current CS regimes. Technique: Remifentanil is a potent ultra-short-acting synthetic opioid with has rapid onset and offset. The remifentanil patient controlled analgesia (PCA) system is an established technique on labour wards with a good safety profile and high patient satisfaction. In both AF ablation and labour, recurring short episodes of intense visceral pain are interspersed with less painful periods. We performed a safety and feasibility study of PCA for PVI and provide our experience of our initial six cases, the first such cases to be reported. Methods: After IV paracetamol and midazolam premedication, patients received a background Remifentanil infusion (0.05-0.07mcg/kg/min) with 20mcg boluses on demand via the PCA with 2 minute lockout. An anesthetist and anaesthetic assistant were present throughout and blood pressure sedation level and respiratory parametres were closely monitored. Results: 5 of the 6 patients male with a mean age of 60.3 years (range 47-71). 3 were redo procedures and 5 had persistent AF. Two patients underwent electrical cardioversion. The mean remifentanyl dose was 864.5 mcg (403-1411) with an infusion time of 145.2 (96-180) minutes. Median PCA demands were 11 (2-59) against 6.5 (2-22) delivered. Mean midazolam dosage was 2.4mg (1.5-3.5). No serious complications occurred. Mild was treated with ondansetron. Using a 10cm Visual Analogue Scale (10=best) operators and patients scored the technique very favourably. Although patients did report some pain, 3 reported only a single episode, and 2 more reported between 0-15 minutes of pain. The most frequently reported site of pain was the groin, relating to insertion, manipulation or removal of venous sheaths. In response we extended the remifentanyl provision to cover these events. All patients reported that they would have PCA for a future PVI and those who had previously experienced CS stated a preference for PCA. Conclusion: This first report is encouraging that PCA may be a safe and effective alternative to CS achieving high satisfaction ratings from both clinicians and patients. After further protocol refinement we plan a multi-centre trial and would welcome expressions of interest. | Mean scores (range) | Comfort | Anxiety | Worst Pain | |:------------------- | ------------- | ------------- | ------------- | | Patient | 7.8 (2.6-9.3) | 7.8 (4.7-9.5) | 4.8 (1.3-8.3) | | Nurse | 8.8 (7.6-9.5) | 7.9 (5.4-9.4) | 9.0 (6.4-9.9) | | Cardiologist | 9.2 (8.4-9.9) | 9.5 (9.0-9.8) | 8.4 (5.0-9.6) | | Anesthetist | 8.5 (7.0-9.6) | 8.0 (5.0-9.4) | 7.0 (5.2-9.1) |

On-Cell Surface Cross-Linking of Polymer Molecules by Horseradish Peroxidase Anchored to Cell Membrane for Individual Cell Encapsulation in Hydrogel Sheath.

Hydrogel sheaths were fabricated on the surfaces of individual mammalian cells through the cross-linking of polymer molecules catalyzed by horseradish peroxidase (HRP) in aqueous solution. For confining the progress of the cross-linking only on the cell surface, HRP was anchored to the cell membrane by soaking the cells in the solution containing the HRP conjugated with a biocompatible anchor molecule for cell membrane. The hydrogel sheath of about 1 μm thickness was obtained by soaking the cells with the anchored HRP in aqueous solution containing polymers possessing phenolic hydroxyl (Ph) moieties and H2O2 for 10 min. The hydrogel sheaths could be made from a variety of polymers possessing Ph moieties, for example, derivatives of polysaccharide, protein, and synthetic polymer. Cytocompatibility of the on-cell surface enzymatic hydrogel sheath formation was confirmed from the viability of the enclosed cells (>90%) and subsequent normal growth after removal of the hydrogel sheath.

Femoral Micropuncture or Routine Introducer Study (FEMORIS)

Objectives: The Micropuncture® 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture. Methods: This was a single-center, multiple-user trial. Four hundred and two patients undergoing possible or definite percutaneous coronary intervention (PCI) were randomized 1:1 to an 18-gauge versus a 21-gauge needle. Patients and personnel pulling the sheaths and performing the follow-up were blinded. The primary end point was a composite of access bleeding. Events were tabulated following sheath removal, ≤24 h after the procedure and at the follow-up (at 1-2 weeks). End points were blindly adjudicated. Results: The event rate overall was 12.4% and did not differ significantly between groups, although the 21-gauge needle was found to reduce events by more than one third. An exploratory subgroup analysis of prespecified variables indicated that: patients who did not undergo PCI or elective procedures, female patients and those with a final sheath size of ≤6 Fr all had a significant or near-significant reduction of complications with Micropuncture. Conclusions: Although no significant differences between the use of the 18- and 21-gauge needles were observed, there was a 50-75% reduction with Micropuncture in several subgroups. The study was terminated prematurely. Access site complications may be reduced by the use of the 21-gauge needle, particularly when the risk of bleeding is not high. Further multicenter data will be required to confirm these hypothesis-generating observations.

Abstract 366: Procedure Change To Reduce Radial Artery Compression Device Bleeding Following Radial-approach Angiography: A Single Centre’s Preliminary Results.

Background: Radial access is an increasingly common approach to coronary angiography whereby a radial artery compression device (RACD) is applied to achieve haemostasis following sheath removal. Current procedure recommends the removal of 5mL of air at 5-minutely intervals from the RACD; 45 minutes post angiogram sheath removal and 2 hours post PCI (Percutaneous Coronary Intervention) sheath removal. Haemostasis failure at the puncture site however was frequently reported and required re-insertion of air. Patients reported increased discomfort and, in 44% of elective cases, post-procedure stay was increased and discharge delayed by 30-180 minutes as a result of prolonged recovery time. Methods: Hospital procedure was revised to remove 3mL volume (air) at 5-minutely intervals from the RACD instead of 5mL. The RACD was also to remain untouched for 60 minutes post angiogram sheath removal and remained at 2 hours untouched post PCI sheath removal. A retrospective audit was conducted pre- and post-procedure change and included patients undergoing radial-access angiogram or PCI Results: A total of 258 cases were reviewed; 158 angiogram and 100 PCI. Initial volume of air used to achieve haemostasis was 10-18mLs and heparin dose administered was 2000-10,000units. Prior to procedure change, 5mL (air) was removed from the RACD and subsequently haemostasis failure occurred in 43.8% (35) of angiogram patients and 55.1% (27) of PCI patients. Following implementation of the 3mL procedure, haemostasis failure was reported in 12.8% (10) of angiogram patients and 19.6% (10) of PCI patients. Conclusion: Whilst total time taken to remove the RACD marginally increased, decreasing the volume of air removed from 5mL to 3mL significantly reduced the incidence of haemostasis failure. This effect was achieved without adjustment of anticoagulation dose or initial volume of air inserted into the RACD.

Outcomes after Arterial Endovascular Procedures Performed in Patients with an Elevated International Normalized Ratio

Patients treated with anticoagulants frequently require urgent vascular procedures and elevated prothrombin time/international normalized ratio (INR) is traditionally thought to increase access site bleeding complications after sheath removal. We aimed to determine the safety of percutaneous arterial procedures on patients with a high INR in the era of modern ultrasound-guided access and closure device use. Patients undergoing arterial endovascular procedures at a single institution between October 2010 and November 2012 were reviewed (n = 1,333). We retrospectively analyzed all patients with an INR > 1.5. Venous procedures, lysis checks, and cases with no documented INR within 24 hr were excluded. Sixty-five patients with 91 punctures were identified. A comparison group was then generated from the last 91 patients intervened on with INR < 1.6. Demographics, intraoperative data, and postoperative complications were compared. The demographics were similar. More Coumadin use and higher INR were found in the study group (71/91 and 0/91, P = 0.001; 2.3 and 1.1 sec, P = 0.001, respectively), but there was more antiplatelet use in the control group (68/91 and 51/91, P = 0.01). Intraoperatively, the sheath sizes, protamine use, closure device use, ultrasound guidance, brachial access, and procedure types were not statistically different. Sheath sizes ranged from 4 to 22F in the study group and 4 to 20F in the control group. Paradoxically, heparin was administered more frequently in the study group (64/91 and 50/91, P = 0.046). Bleeding complications occurred more commonly in the study group (3/91 and 1/91, P = 0.62), but this failed to reach significance and the overall complication rate in both groups was low. Endovascular procedures may be performed safely with a low risk of bleeding complications in patients with an elevated INR. Ultrasound guidance and closure device use may allow these cases to be performed safely, but a larger series may be needed to confirm this.

Early Removal of the Arterial Sheath After Percutaneous Coronary Intervention Using the Femoral Approach: Safety and Efficacy Study

Introducao: Avaliamos a seguranca e eficacia do uso de protamina, guiada pelo tempo de coagulacao ativado, para a remocao imediata do introdutor arterial femoral em pacientes submetidos a intervencao coronaria percutânea com heparina nao fracionada, com o objetivo de propor um algoritmo para a pratica clinica. Metodos: Estudo prospectivo, com pacientes consecutivos, com angina estavel ou com sindrome coronariana aguda de baixo ou moderado risco. Comparamos os pacientes com a retirada precoce do introdutor arterial aqueles nos quais o introdutor foi retirado de acordo com o protocolo convencional. A decisao pela remocao precoce ou convencional do introdutor foi deixada a criterio do operador. Resultados: O grupo de remocao precoce (n = 149) apresentou menor tempo de manuseio do sitio de puncao que o grupo de remocao convencional (58,3 ± 21,4 minutos vs. 355 ± 62,9 minutos; p < 0,01), principalmente devido a reducao do tempo ate a retirada do introdutor (42,3 ± 21,1 minutos vs. 338,6 ± 61,5 minutos; p < 0,01), sem impacto sobre a duracao da compressao femoral (16,0 ± 3,6 minutos vs. 16,4 ± 5,1 minutos; p = 0,49). Nao houve trombose hospitalar de stent e nem diferenca significativa na incidencia de eventos vasculares ou hemorragicos. A incidencia de outras hemorragias, que levaram a hospitalizacao prolongada, foi menor no grupo de remocao precoce (1,3% vs. 5,1%; p = 0,05). Conclusoes: O uso seletivo de uma abordagem, para a remocao imediata do introdutor femoral guiada pelo tempo de coagulacao ativado e a administracao de protamina, e seguro e eficaz em pacientes submetidos a intervencao coronaria percutânea pela via femoral.

Early Removal of the Arterial Sheath After Percutaneous Coronary Intervention Using the Femoral Approach: Safety and Efficacy Study

ABSTRACT Introduction We evaluated the safety and efficacy of protamine administration, guided by activated clotting time, for the immediate femoral arterial sheath removal in patients undergoing percutaneous coronary intervention with unfractionated heparin in order to propose an algorithm for clinical practice. Methods Prospective study with consecutive patients with stable angina or low-to-moderate risk acute coronary syndrome. We compared patients with an early removal of the arterial sheath to those whose sheath removal was based on a standard protocol. Results The early removal group (n = 149) had lower access manipulation time than the conventional group (58.3 ± 21.4 minutes vs. 355.0 ± 62.9 minutes; p p p = 0.49). There was no stent thrombosis during hospitalization and no significant differences in the incidence of major vascular or bleeding events. The incidence of other bleeding events leading to a prolonged in-hospital length of stay was lower in the early removal group (1.3% vs. 5.1%; p = 0.05). Conclusions: The selective use of an approach for immediate femoral sheath removal, based on activated clotting time guidance and protamine administration, is a safe and effective option in patients undergoing percutaneous coronary intervention by femoral access.

Transbrachial approach — taken from the history

E mail: matias.trbusic@gmail.com Purpose: Radial arterial approach has become the default option for coronary procedures in our cath lab (>90%). However, there are situations when radial arterial approach is not possible (e.g. congenital anomalies, tortuous configurations, radioulnar loop, weak or absent radial pulse secondary to the previous puncture or catheterization). In such situations, a common second-line approach is used (femoral or ulnar). Many clinicians considered transbrachial (TB) angiography as a high-risk and an obsolete procedure. In literature, the complication rate was unacceptably high (up to 36%). The aim of this retrospective investigation was to evaluate the safety and efficiency of TB approach as an alternative to radial approach, especially after the unsuccessful radial artery puncture. Method: During the period of two years, TB coronary angiography in the antecubital region was performed in 25 patients with stable and unstable angina or valvular heart disease. In 12 patients, diagnostic procedure was followed by a coronary intervention. Reasons for TB approach were weak or absent radial pulse (12 cases) or unsuccessful radial artery puncture (13 cases). Procedures were performed by three experienced transradial invasive cardiologists (transradial success more than 95%). The catheter size was 6 Fr in all patients. Anticoagulation protocol was used while following the guidelines (aspirin, clopidogrel, unfractionated heparin) but without glycoprotein IIb/IIIa receptor inhibitors. Major complications were defined as vascular complications requiring blood transfusion or surgery or permanent neurological deficit in the lower limb. Minor complications were defined as vascular complications not requiring blood transfusion or surgery and transient neurological deficit in the lower limb. A standard post-procedural protocol was the removal of the artery sheath 3 hours after the diagnostic procedure, 6 hours after PCI and manual puncture site compression for 10 minutes. Results: Overall success rate was 96% (24/25). There were no major complications and we noticed only two minor complications (8%), both hematomas. Conclusion: TB approach, when used by dedicated transradialists, seems to be easily feasible, safe, and effective. Local vascular complications could be avoided by the cautious and sensitive puncture technique. Other important factors include the use of 6 Fr catheters, defensive anticoagulation and careful observation by the nursing team after the sheath withdrawal. TB approach has all advantages of the arm approach over the femoral (early ambulation, patient preference, suitable for patients with severe occlusive aortoiliac disease and for patients with difficulty when lying down).

Heparin has No Place as an Anticoagulant in PCI – A Protagonist’s View

Unfractionated heparin is the standard anticoagulant of choice for patients undergoing percutaneous coronary intervention. However it has signifi cant pharmacologic limitations such as need for frequent laboratory monitoring of anticoagulation status and unpredictable response in acute infl ammatory states. Low molecular weight heparin such as enoxaparin has emerged as a feasible alternative with clinical studies of its use in both elective and emergency PCI indicating that it is just as effective, and has higher safety profi le. With its more predictable anticoagulant response, greater bioavailability, practical clinical benefi ts including early sheath removal; and potential cost saving, enoxaparin has made itself a preferred alternative in modern PCI.

Transcatheter aortic valve implantation through carotid artery access under local anaesthesia

Trans-femoral and transapical are the most commonly used accesses for transcatheter aortic valve implantation (TAVI). However, when these approaches are unsuitable, alternative accesses are needed. We report a series of 19 patients undergoing TAVI through common carotid artery (CCA) access under local anaesthesia in order to assess its feasibility and safety. From November 2008 to September 2013, 361 patients underwent TAVI at our institution. Nineteen of them (14 men) with mean age 82.2 ± 6.2 years, EuroSCORE 25.2 ± 15.7, Society of Thoracic Surgeons score 11.9 ± 5.1 and with severe peripheral arteriopathy were unsuitable for usual approaches and underwent TAVI through CCA access under local anaesthesia. Preoperative computed tomography assessed suitable carotid artery anatomy. Common carotid cross-clamping test allowed verifying patient's neurological status stability. An 18-Fr or 20-Fr sheath inserted into the CCA down into the ascending aorta was used for the delivery catheter. Valve implantation procedures were as usual. After sheath removal, the CCA was surgically purged and repaired. Feasibility and safety end points (VARC-2) were collected up to 30 days. Transcarotid insertion of the delivery sheath was successful in all cases (8 right, 11 left) and accurate deployment of the device was achieved in 18 patients (4 Edwards SAPIEN XT and 14 Medtronic CoreValve). There was 1 intraoperative death by annulus rupture during preimplant balloon valvuloplasty, and 1 in-hospital death due to multisystem organ failure. There was no myocardial infarction, stroke or major bleeding. Third-degree atrioventricular block requiring pacemaker implantation occurred in 3 patients. No vascular access-site, access-related or other TAVI-related complication occurred. Echocardiography revealed good prosthesis functioning with none, mild and moderate paravalvular leak in, respectively, 8, 9 and 1 patients. Patient ambulation was immediate after TAVI and hospital stay was 4.6 ± 2.3 days. TAVI through the CCA approach under local anaesthesia is feasible and safe. It allows continuous clinical neurological status monitoring with low risk of stroke, bleeding events, vascular access-site and access-related complications and immediate patient ambulation. It appears to be a valuable alternative access for patients who cannot undergo trans-femoral TAVI.

A New Hemostasis Tool after Percutaneous Angioplasty: The Hemcontm Pad Hemostasis Device

Objective: This prospective, randomized study compared the efficacy of the HemConTM pad to that of manual compression for peripheral artery puncture in peripheral artery disease. Methods: This study was a prospective single center, investigation in 50 consecutive patients undergoing interventional procedures for peripheral artery disease. After completion of catheter procedure a 1:1 randomization to HemConTM pad versus conventional manually pressure (control) was performed. Before the removal of the artery sheath (4 to 6Fr), a blood examination was taken for activated clotting time (ACT). The femoral sheath was removed at the patient’s bed immediately after the procedure. Slightly blood was allowed to exit from the access site and pressure with HemConTM pad or directory was then applied manually for 2×ACT seconds. After the time the operator released the compression. If the bleeding continued, additional compression was continued until complete hemostasis. Before and after hemostasis blood pressure and the total time to hemostasis were recorded. We checked puncture site and performed ultra sound detecting abnormality before discharge. Results: We have successful hemostasis in 48 of 50 patients (96% success); two patients had been converted into over size sheath (10Fr) during catheter procedure. The average time to successful hemostasis following sheath removal was significant shorter with the HemConTM pad by 53% compared to the conventional manual compression (681 ± 243 vs. 362 ± 82 seconds, p<0.001). In duplex ultrasound examination, there were no thromboses in access site artery. Conclusion: The HemConTM pad is effective at decreasing average time to hemostasis. This device may save the time for physician and the cost for hospital. Furthermore, this device can contribute to patient comfort, reduce the time to compression, and promise to a planned discharge.

A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations

We evaluated the safety and efficacy after hemostasis with our locally designed Assiut femoral compression device (AFCD) versus manual compression after diagnostic coronary angiography at Assiut University Hospitals. Previous clinical studies have indicated that FCD can be used for achievement of hemostasis after coronary angiography (CA). This study investigated the safety and efficacy of AFCD in achieving hemostasis after CA compared with manual compression in a cohort of consecutive patients. A total of 162 patients were followed after CA was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with AFCD (n. 56) or with manual compression (n. 106) as a hemostasis option after sheath removal. As regard safety, the use of AFCD was associated with similar occurrence of minor bleeding compared with manual compression (25% vs. 26%, p, 0.8). There was no significant difference in occurrence of major bleeding compared with manual compression (1% vs. 2%, p, 0.5). None of our patient had a pseudoaneurysm, site infection or arteriovenous fistulae with either hemostasis technique. The use of AFCD was associated with a more frequent occurrence of vasovagal manifestation compared with manual compression (5.4% vs. 1%, p, 0.04). As regard efficacy, the device application was easy in 84% with good fixation and stability in 90% of patients. Success in complete hemostasis was 91% with rapid learning curve. There was no difference in total duration of compression to reach full hemostasis with AFCD versus manual compression (13 ± 4 min vs. 12.5 ± 4 min., p, 0.4). In this early experience with our locally designed AFCD after CA, their use was associated with similar efficacy and safety profile compared with hemostasis using manual compression.