Postprocedural Bleeding Complications Research Articles

Hepatic and splenic venous access tract closure using the VASCADE vascular closure system following percutaneous intervention in patients with CHD.

Hepatic and splenic venous access are specialised techniques used to perform diagnostic and interventional procedures in the cardiac catheterisation laboratory. Bleeding events are the most commonly reported complication following hepatic or splenic venous access. The VASCADE Vascular Closure System (Cardiva Medical Inc. Santa Barbara, CA) is an approved device for closure of femoral vascular access tracts in patients ≥18 years of age. We report our experience using VASCADE to close the hepatic or splenic venous access site in the cardiac catheterisation laboratory. This is a single centre retrospective review of all patients who had percutaneous hepatic or splenic venous access obtained in the cardiac catheterisation laboratory from March 1, 2022 through October 30, 2023 and underwent tract closure with VASCADE. Ten patients (six male) underwent 16 procedures (median age and weight 3.5 years and 12.5 kg) with 15 hepatic and two splenic veins accessed. Successful closure of the access tracts with VASCADE was performed in all patients. There were no major adverse events related to closure of the access sites with VASCADE. VASCADE can be used following transhepatic and trans-splenic venous access in the cardiac catheterisation laboratory to safely close the access tract and potentially reduce the risk of post-procedural bleeding complications. Further evaluation in a larger cohort of patients is needed to ensure VASCADE is safe for use and provides adequate haemostasis following hepatic or splenic venous access, particularly in children.

Plasma transfusion in critically Ill patients with abnormal coagulation tests before invasive procedures: A propensity-adjusted cohort study

ObjectiveTo evaluate the association between plasma transfusion and bleeding complications in critically ill patients with an elevated international normalized ratios undergoing invasive procedures. MethodsA retrospective study was conducted to evaluate a consecutive sample of critically ill adult patients undergoing invasive procedures (N = 487) with an international normalized ratio ≥ 1.5 between January 1, 2019 and December 31, 2019. Among the followed patients, 125 were excluded due to incomplete case records and 362 were finally included in this investigation. The exposure was whether plasma had been transfused within 24 h before the invasive procedure. The primary outcome was the occurrence of postprocedural bleeding complications. Secondary outcomes included transfusion of red blood cells within 24 h of the invasive procedure, and additional patient-important outcomes such as mortality and length of stay. Tests were performed with univariate and propensity-matched analyses. ResultsOf the 362 study participants, 99 (27.3 %) received a preprocedural plasma transfusion. In the propensity score-matched analysis, the rate of the occurrence of postprocedural bleeding complications between two groups was not statistically different (OR, 0.605[95 % CI, 0.341–1.071]; P = .085). The rate of postoperative red blood cell transfusion in the plasma transfusion group was higher than that in the non-plasma transfusion group (35.5 % vs 21.5 %; P < .05). No statistically significant difference in mortality was observed between the two groups (29.0 % vs 31.6 %; P = .101). ConclusionsProphylactic plasma transfusion failed to reduce postprocedural bleeding complications in ill critically patients with a coagulopathy. Meanwhile, it was associated with increased red blood cell transfusion after invasive procedures. Findings suggest that abnormal preprocedural international normalized ratios should be managed more conservatively.

Risk Factors of Haematoma Formation Following Cardiac Implantable Electronic Device Procedures.

A single-centre cohort of 2,100 adults who consecutively underwent cardiac implantable electronic device procedures were retrospectively analysed to identify and quantify risk factors of perioperative pocket haematoma formation. Dual antiplatelet therapy was significantly associated with increased odds of haematoma formation (OR 11.7 for aspirin and clopidogrel, OR 11.8 for aspirin and ticagrelor and OR 104 for aspirin and prasugrel, p<0.05) on multivariate binomial logistic regression analysis. Aspirin monotherapy was also associated with increased bleeding risk (OR 3.02, p<0.01). Direct oral anticoagulants and warfarin were also each associated with increased odds of haematoma formation although to a lesser extent than dual anti platelet therapy (DAPT). Amongst oral anticoagulants, apixaban was associated with the lowest bleeding risk (OR 2.59, p=0.03) whilst dabigatran was associated with the highest (OR 3.81, p=0.04). There was a significant incremental reduction in bleeding risk by 8% per 10x103/μL increase in platelet count. DAPT was associated with increased odds of pocket haematoma formation following cardiovascular implantable electronic device (CIED) procedure. This likelihood was higher than with oral anticoagulation therapy. Timely medication reconciliation of P2Y12 inhibitors according to guidelines is important to avoid post-procedural bleeding complications. Perioperative policies which account for the half-life of withheld anticoagulant agents may help reduce the haematoma risk.

Safety of Diagnostic and Therapeutic Cardiac Catheterization in Cancer Patients With Acute Coronary Syndrome and Chronic Thrombocytopenia

Little data is available on the bleeding risk and outcomes of cancer patients with chronic thrombocytopenia who underwent cardiac catheterization. We sought to assess the safety of coronary angiography, percutaneous coronary intervention, and antiplatelet therapy in cancer patients with acute coronary syndrome (ACS) and chronic thrombocytopenia. We performed a retrospective study of patients with chronic thrombocytopenia who underwent cardiac catheterization for ACS between November 2009 and November 2015. Preprocedural platelet counts were classified into 3 groups: mild thrombocytopenia (50,000 to 100,000/µL), moderate thrombocytopenia (30,000 to 50,000/µL), and severe thrombocytopenia (<30,000/µL). Postprocedural bleeding complications and overall survival (OS) were recorded. A total of 98 patients were included. Mean platelet count on admission was 47.63 ± 29.85 K/µL. Severe thrombocytopenia was identified in 36 patients (36.7%), moderate thrombocytopenia in 20 patients (20.4%), and mild thrombocytopenia in 42 patients (42.9%). Aspirin therapy (alone or in combination with clopidogrel) was used in 66 patients (67.3%), whereas 27 patients (27.6%) were on dual antiplatelet therapy. One procedure-related retroperitoneal hematoma and 3 procedure-related small hematomas were identified. No cerebrovascular events related to the procedure or the antiplatelet therapy were noted. Moderate thrombocytopenia was associated with decreased OS, whereas aspirin, dual antiplatelet therapy, and statin use showed a trend of improved OS. In conclusion, we suggest that coronary angiography and percutaneous coronary intervention can be performed safely in cancer patients with chronic thrombocytopenia. Aspirin therapy and dual antiplatelet therapy should be considered in cancer patients with chronic thrombocytopenia and ACS.

TCT-825 Bleeding events are reduced and survival improved by use of radial access during primary percutaneous coronary intervention for patients receiving glycoprotein inhibitors

access during primary percutaneous coronary intervention for patients receiving glycoprotein inhibitors Control Number: 2917 Submission Type: Abstract Presentation Format: Poster Only New Device/Innovation: No Author(s): Adam J Brown, Nikil K Rajani, Liam M McCormick, Stephen P Hoole, Nick E West Institution(s): University of Cambridge, Cambridge, United Kingdom, Papworth Hospital, Cambridge, United Kingdom Presenter Poster: Dr Adam J Brown, MB BChir View Disclosure University of Cambridge Background: Use of glycoprotein IIb/IIIa inhibitors (GPI) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) is known to improve myocardial perfusion and reduce further ischemic events, but is associated with an increase in bleeding risk. Performing PPCI via radial access (rPPCI) is thought to reduce post-procedural bleeding complications and may improve overall survival. We sought to assess whether rPPCI is associated with improved outcomes in patients receiving GPI at our institution. Methods: Consecutive patients undergoing PPCI for STEMI over a four-year period were included. All patients were preloaded with 600mg clopidogrel and 300mg aspirin en-route to PPCI. Interventional strategy and GPI use were left to operator discretion. Patient data and outcome measures were obtained by interrogation of notes and national databases. Bleeding complications were categorized using Bleeding Academic Research Consortium (BARC) definitions. Results: 2,019 patients were included in the analysis (mean age 64.2±12.4yrs, 75.9% male), with 863 receiving GPI. Patients that received GPI were younger (62.7±11.8yrs vs. 64.8±12.6yrs, p< 0.001), more likely to be male (80.5% vs. 73.9%, p< 0.001) but had a higher incidence of cardiogenic shock (5.6% vs. 2.7%, p=0.002). Other baseline demographics were similar. Overall, BARC defined bleeding was more prevalent in those receiving GPI (BARC ≥2 3.0% vs. 0.7%, p< 0.001; BARC ≥3 2.6% vs. 0.2%, p< 0.001). However, patients undergoing rPPCI with GPI had lower bleeding rates when compared with femoral access (0.8% vs. 3.7%, p=0.05). For patients receiving GPI, rPPCI resulted in a significant improvement in 1-year survival (99.2% vs. 93.5%, p=0.01; OR 0.12, 95%CI 0.02-0.87, p=0.04). However, in patients not receiving GPI, no survival benefit for rPPCI was observed (94.4% vs. 93.7%, p=0.70; OR 0.87, 95%CI 0.44-1.71, p=0.69). Conclusions: rPPCI results in lower rates of bleeding and improved survival in patients receiving GPI during PPCI. rPPCI should be considered in patient groups where subsequent use of GPI is likely. CORONARY: STEMI and NSTEMI

Transradial approach to lower extremity interventions

Percutaneous interventions of the coronary and peripheral vessels have historically been performed using a femoral artery approach. There has been increasing recognition of post-procedural bleeding complications and its impact on short- and long-term mortality. Because of its now recognized safety, the transradial approach has recently emerged as a preferred method compared to the transfemoral approach. The limitations associated with the distance from the puncture site to the lesion location are being addressed as new tools are developed for the endovascular treatment of peripheral arterial disease. In this review, we discuss the many facets of the transradial approach to lower extremity endovascular interventions, highlighting its safety and efficacy. Approaches to special populations including individuals with prior surgical bypass, Leriche's syndrome, and those committed to chronic anticoagulation are also reviewed.

Immediate removal of femoral-sheath following protamine administration in patients undergoing intracoronary paclitaxel-eluting-stent implantation

Background: Immediate sheath-removal using post-procedural reversal of heparin with protamine reduces groin complications, shortens bed rest and hospital stay after percutaneous coronary intervention (PCI) with bare-metal stents. No data are available with newer and possibly more thrombogenic paclitaxel-eluting stents (PES). Aim: We assessed the safety and efficacy of post-procedural protamine administration after successful coronary PES implantation in elective PCI and in patients with acute coronary syndromes (ACS). Methods: A consecutive series of 291 patients received 0.5 mg of protamine per 100 units of heparin whenever the post-procedural ACT was > 180 seconds, followed by immediate removal of the sheath (protamine group). Outcomes were compared to a historic control group comprising 291 consecutive patients, who also underwent PCI with PES, but without reversal of anticoagulation by protamine (non protamine group). The incidence of post-procedural vascular complications and bleeding complications, as well as hospital stay, were compared; as were the incidence of major cardiac events at 24 h, 30 days and 6 months. Results: The post-procedural bleeding complications were significantly higher in the non-protamine group. Vascular complications were also more frequent in patients who were not treated with protamine. Hospitalisation length was significantly lower in the protamine group than in the non-protamine group (13.6 ± 7 h versus 20.41 ± 3.9 h; p < 0.001). The protamine-group patients also had a significantly reduced bed rest (10.3 h ± 5.6 h versus 18 h ± 3.5 h; p < 0.001). During hospitalisation, after PES implantation, no deaths or acute stent thrombosis were observed in either group. The overall incidence of thrombosis and major adverse cardiac events at follow-up were similar in the two groups. Conclusions: Immediate heparin neutralisation by protamine after successful PES implantation appears to be safe and feasible, also in patients with ACS. Use of protamine and early sheath removal after PCI confers early deambulation and may significantly limit healthcare cost, reduce vascular complications, bedrest, delayed discharge and patient discomfort.

Major bleeding after PCI. Where is our crystal ball?

Over the last three decades, there have been remarkable advances in percutaneous coronary intervention (PCI). Utilization of coronary stents and combination antiplatelet/antithrombotic therapy have led to significant improvements in revascularization success rates as well as marked reductions in thrombotic complications. Patients considering elective procedures are now routinely quoted a 800 000 PCI procedures are performed annually in Europe.1 In addition, PCI is being performed in increasingly complex patients, including the elderly and those with multiple co-morbidities, who are at higher risk for incurring procedural complications. However, with increased utilization of PCI, increased use of combinations of multiple antithrombotic agents, and the reduction in the occurrence of ischaemic/thrombotic complications of PCI, there has emerged recognition that post-procedural bleeding complications remain all too common and result in significant morbidity and mortality. In a retrospective analysis of >10 000 patients undergoing PCI at a single centre between 1991 and 2000, major bleeding occurred in 5.4% of patients and was associated with a 3.5-fold increased adjusted risk of in-hospital mortality.2 Similarly, in an analysis of >24 000 patients with acute coronary syndromes enrolled in the Global Registry of Acute Coronary Events (GRACE), major bleeding occurred in 5.5% of patients undergoing PCI and was associated with a significant increase in hospital death.3 Finally, it has been estimated that the incremental cost of prolonged hospitalization and treatment associated with bleeding complications exceeds US$10 000/hospital stay. … *Corresponding author. Tel: +33 1 40 25 86 68. E-mail address : gabriel.steg{at}bch.aphp.fr

Impact of female sex on outcome after percutaneous coronary intervention

Background Prior reports have suggested that women have increased mortality compared to men following percutaneous coronary intervention (PCI). It remains unclear if this difference is secondary to sex or other confounding variables. Methods We sought to examine the characteristics and outcomes of 18039 consecutive women and men undergoing PCI at The Cleveland Clinic Foundation from 1992–2002. Results Procedural success rates were similar in both sexes, but the female cohort had a greater incidence of access site hematoma (5% vs. 2%, P < .0001) and blood product transfusion (12% vs. 4%, P < .0001) following PCI. The rate of myocardial infarction (MI) at 1 year was slightly higher among females (10% vs. 9%, P = .004), but revascularization rates were not significantly different between sexes. One-year mortality was also higher in the female cohort (7% vs. 5%, P < .0001). After adjustment in a multivariate model, the Cox proportional hazard ratio for mortality in females was 1.01 (95% CI 0.93–1.11, P = .78). The hazard ratio for the combined endpoint of death or MI was 1.05 (95% CI 0.97–1.13, P = .23). Conclusions After adjustment for differences in comorbidities, the risk for long-term mortality is not significantly different between sexes following PCI. However, there is a greater incidence of post-procedural bleeding complications among women.

Percutaneous Tracheostomy Is Safe in Patients With Severe Thrombocytopenia

Severe thrombocytopenia has been described as a contraindication for percutaneous tracheostomy (PT). The objective of this study was to assess the safety of PT in mechanically ventilated patients with severe thrombocytopenia (defined by a platelet count of < 50 x 10(9) cells/L). Retrospective, single-center cohort study. Medical ICU of the University Hospital Hamburg-Eppendorf, Germany. Forty-two medical patients with acute respiratory failure and severe thrombocytopenia. Bedside PT under bronchoscopic guidance using the Griggs guidewire forceps technique. The mean (+/- SD) intubation time prior to undergoing PT was 6.7 +/- 3.9 days (range, 1 to 20 days). The mean platelet count was 26.4 +/- 11.6 x 10(9) cells/L (range, 1 x 10(9) to 47 x 10(9) cells/L). The median transfusion of platelets before the procedure in 40 of the 42 patients was 6 +/- 2.5 U (range, 3 to 12 U). Twenty-two patients (52%) had an additional coagulopathy (activated partial thromboplastin time [APTT], > 40 s; international normalized ratio, > 1.5). PT was safely performed in all 42 patients. Only two (5%) patients developed major postprocedural bleeding complications that required suturing. Both of these patients had an elevated APTT due to heparin therapy. When performed by experienced personnel, PT with bronchoscopic guidance has a low complication rate in patients with severe thrombocytopenia, provided that platelets are administered beforehand. However, in order to minimize bleeding complications heparin infusions should be temporarily interrupted during the procedure.

Relationship between activated clotting time during percutaneous intervention and subsequent bleeding complications

Background Approximately 50% of percutaneous coronary interventions in the United States are performed with unfractionated heparin and no IIb/IIIa agent. The operator must weigh the risks and benefits of more intensive anticoagulation during these percutaneous interventions. This study helps clarify the relationship between patient and procedural factors, such as the intensity of heparin anticoagulation as measured by activated clotting time (ACT), and the risk of blood loss and bleeding complications. Methods Four hundred twenty-nine patients undergoing elective or urgent percutaneous coronary intervention were followed up prospectively for 72 hours after intervention for clinical bleeding complications. Blood loss, defined as the difference between preprocedural and nadir postprocedural hematocrit adjusted for interval transfusions, was also tracked. In-laboratory ACTs, as well as other potential clinical and procedural predictors of blood loss and bleeding risk, were collected and analyzed. Results Maximum in-laboratory ACT was significantly related to blood loss as measured by the change in hematocrit (P =.017) and to the risk of major bleeding complications (P =.002). In multivariate analysis, patient age (P =.004), sex (P =.014), procedure length (P <.001), and additional interventions (P <.001) were significant, independent predictors of blood loss. Major bleeding complications were significantly, independently predicted by patient age (P <.001), additional interventions (P =.015), and maximum in-laboratory ACT (P <.001). Conclusions Compared with the other clinical and procedural predictors of bleeding complications, maximum in-laboratory ACT was second only to patient age in significance as a multivariate predictor of postprocedural bleeding complications. Maximum in-laboratory ACT was found to be the most significant modifiable univariate and multivariate predictor of clinical bleeding complications after percutaneous coronary intervention. Particularly in patients with nonmodifiable risk factors for blood loss and bleeding complications such as advanced age, female sex, and multiple and prolonged procedures, avoiding high intensity anticoagulation with unfractionated heparin is associated with lower bleeding risk. (Am Heart J 2002;144:501-7.)

Discontinuation of the Bleeding Time Test without Detectable Adverse Clinical Impact

The bleeding time (BT) test predicts a higher bleeding complication rate in populations at risk for inherited or acquired platelet dysfunction, but it is of limited assistance in evaluating individual patients. There are no reports of clinical outcomes after discontinuation of the BT test. Interviews with a subset of the physicians who had ordered the BT test before discontinuation of the test were conducted. The total number of platelet-aggregation tests, the mean number of monthly, unmodified platelet units transfused, the incidence of kidney biopsy complications, and the number of doses of 1-deamino-8-D-arginine vasopressin (DDAVP) administered 5 months before and after discontinuation of the BT test were compared. We recorded the rates of bleeding complications in the Major Surgery Risk Pool during the 12 months before and the 5 months after the discontinuation of the BT test. Clinicians reported they did not significantly change their preprocedural work-ups, postpone an invasive procedure, experience an increase in bleeding complications, or increase their use of blood products after discontinuation of the BT test. Platelet-aggregation tests (n = 9, before and after), platelet transfusions (P = 0.958), and DDAVP administration (before = 24; after = 10) did not increase after discontinuation of the BT test. The rate of postprocedural bleeding complications did not increase significantly in either Major Surgery Risk Pool cases (<3final sigma deviation from the mean rate) or in patients undergoing renal biopsies (P = 0.225 for decrease in hematocrit; P = 1.000 for the percentage of patients transfused) after discontinuation of the BT test. Our study failed to identify a clinically significant, negative impact of discontinuing the BT test.