Access Site Bleeding Research Articles

A Real-world, prospective, observational, Investigator Initiated Trial to evaluate early discharge following Angio-Seal™ vascular closure device in patients undergoing percutaneous coronary intervention.

BackgroundCardiac catheterization procedures such as percutaneous coronary intervention (PCI) are widely used but with complications of access site bleeding. Manual compression (MC )is the well accepted technique to control bleeding but time consuming (15-20 mins); vascular closure devices (VCDs) are used increasingly as an alternative to MC and require <5 minutes for deployment.We aimed to document the real-world experience with a bioabsorbable collagen closure device (Angio-Seal™ ) with absorbable traction suture in patients undergoing PCI. ObjectiveThe primary objective was time (hours) to discharge from hospital after the procedure; to document the incidence of vascular access site complications, time to ambulation and time to hemostasis were the secondary objectives. MethodThis was a prospective, observational, investigator-initiated clinical trial wherein adult patients who underwent PCI procedure through femoral access route, with deployment of Angio-Seal™ femoral closure device were included. ResultsAmongst the 100 patients enrolled, 68% were males. systemic hypertension (63%), and type-2 diabetes mellitus (37%) were the major comorbidities reported. Mean overall time from the end of procedure to hemostasis was 2.32±0.99min. Time to ambulation was 156.08±36.81min and to hospital discharge was 25.21±4.49 hours, One subject experienced hematoma. No other complications particularly pertaining to vascular access site were observed. ConclusionAngio-Seal™ is an effective and safe VCD and results in early ambulation, rapid hemostasis, and discharge in patients undergoing PCI.

Complex versus non-complex, should we adjust the antiplatelet strategy to the type of percutaneous coronary intervention? Results from a real world PCI population

Abstract Background/introduction Personalized dual antiplatelet treatment (DAPT) using risk stratification is key to minimize bleeding- and ischemic events after percutaneous coronary intervention (PCI). Known ischemic risk factors include complex procedures which are integrated in the recommendation for extended DAPT in patients with additional ischemic risk factors. Purpose We aimed to provide insight whether a complex PCI (CPCI) should be regarded as an individual risk factor, regardless of other risk factors, to adjust the antiplatelet strategy. Also, we determined the effect of DAPT duration and choice of P2Y12 inhibitor on outcomes. Methods We included patients from the South East (Zuid Oost) Netherlands Heart Registry (ZON-HR) and excluded patients using oral anticoagulants. This PCI registry prospectively collects baseline-, procedural- and follow-up data including medication use and the intended DAPT duration. Patients were stratified to non-CPCI or CPCI comprising of bifurcation lesions with two stents, venagraft PCI, chronic total occlusion (CTO) or ≥ 60mm stent. Analyses were conducted using Cox regression analysis. Multivariate analysis was performed to adjust for risk factors and baseline differences. Results We included 3691 patients (842 CPCI). Table 1 demonstrates the baseline characteristics and DAPT strategy. CPCI was more often required in patients with a high ischemic risk profile based on the extensiveness of atherosclerosis and comorbidities. Non-CPCI patients more often underwent PCI for acute coronary syndrome. Outcomes are presented in table 2. Compared to non-CPCI, CPCI increased the risk of major adverse cardiac and cerebral events (MACCE) in the second half of the year as opposed to bleeding events, which more often occurred in the first months after CPCI, driven by access site bleedings (73% in CPCI versus 56% in non-CPCI, p=0.01). All-cause mortality was higher during the overall follow-up period after a CPCI compared to non-CPCI. These findings remain significant when corrected for additional risk factors in both groups. In patients with CPCI, treatment with ticagrelor or prasugrel strongly reduced MACCE between 6-12 months when compared to clopidogrel (multivariate HR: 0.28, 95% CI: 0.08-0.98), but did not influence bleeding events or all-cause mortality. No effect of extended DAPT was observed. Conclusions A CPCI is an important ischemic risk factor that could be used for risk stratification to guide antiplatelet strategy. Treatment with ticagrelor or prasugrel strongly diminished the risk of MACCE without increasing the bleeding risk in patients with a CPCI. As the risk of MACCE increases between 6-12 months after PCI while the risk of bleeding events diminishes in this period, extended DAPT from 6 to 12 months could also be considered to provide extended protection.Table 1.Table 2

Cardiac amyloidosis and left atrial appendage closure: a multicenter retrospective study

Abstract Background Thromboembolic stroke risk remains a clinical challenge in cardiac amyloidosis (CA) patients with atrial fibrillation because of the increased prevalence of left atrial appendage thrombi irrespective of CHA2DS2-VASc score and a higher prevalence of factors that increase the risk of bleeding with anticoagulation. Left atrial appendage closure (LAAC) is an effective option in patients with atrial fibrillation and high bleeding risk; however, data describing a LAAC strategy for stroke prevention in patients with CA is limited. Among non-CA patients, procedural success and serious complication rates are around 98% and 3% respectively. Purpose In this multicenter retrospective study, we aimed to investigate whether left atrial appendage closure (LAAC) could reduce the risk of bleeding complications and ischemic cerebrovascular events in patients with CA. Methods In an international multi-center retrospective study, patients with CA that underwent LAAC were included. The diagnosis of CA was established on the basis of histologic confirmation or advanced multimodality cardiac imaging as per current consensus statements. Results A total of 28 patients (93% male; 87% ATTR-CA; 13% AL-CA; mean age 80 years) met inclusion criteria. At baseline, mean CHA2DS2-VASc and HAS-BLED scores were 4 and 3 respectively, mean left ventricular ejection fraction was 50%, and mean indexed left atrial volume was 58 mL/m2. 21% of patients had a prior history of ischemic stroke, 14% prior history of hemorrhagic stroke, 7% prior transient ischemic attack, and 54% had a prior history of major or minor bleeding. Procedural success was achieved in 26 patients (93%) with procedural complications occurring in 2 patients (vascular access site bleeding and cardiac tamponade). Regarding in-hospital and follow-up complications, 0% ischemic stroke, 0% hemorrhagic stroke, and major or minor bleeding in 4% of patients. During follow up, device thrombosis occurred in only 1 patient. Conclusion LAAC is a feasible and effective alternative to anticoagulation in patients with CA and excessive bleeding risk, with procedural success and complication rates similar to reported studies of non-CA patients.

Comparison of radial artery occlusion between traditional radial access and distal radial access for coronary angiography and intervention: A prospective cohort study

BackgroundThe radial approach is now recommended as the default strategy in diagnostic coronary angiography and percutaneous coronary intervention. Radial artery occlusion (RAO) is the most common complication that limits subsequent angiographic procedures through this access. Recently, distal radial access (DRA) has been recommended as an alternative access site. Despite lower RAO rates in DRA in some recent clinical trials, concerns remain regarding possible complications and limitations due to the small size of the distal radial artery. ObjectiveThe present study aimed to compare traditional radial access (TRA) and DRA concerning RAO in percutaneous coronary procedures. MethodsIn the present prospective cohort study, percutaneous coronary procedures were performed via DRA or TRA in 2 study groups. All consecutive participants underwent DRA from September 2021 to March 2022 and TRA from April 2022 to June 2022. Ultrasonography was performed preprocedurally in the DRA group, and patients with small distal artery diameters (<2 mm) were excluded. The same 6-Fr sheaths and standard air-filled compression devices were used in both groups. The primary endpoint was RAO in ultrasound sonography on the first postprocedural day, and the secondary endpoints were the success rate, access time, angiography time, radial artery spasms, and vascular access complications. ResultsA total of 298 patients were assigned to the DRA group and 278 to the TRA group. The RAO rate was significantly higher in the TRA group than in the DRA group (10.1 % vs 0.9 %; P = 0.0001; OR, 0.08, 95 % CI, 0.01–0.27). The success rate was significantly higher in the TRA group (96 % vs 90.2 %; P = 0.009). Access crossovers were done on 12 patients (4.0 %) in the TRA group and 24 patients (9.8 %) in the DRA group (P < 0.001). The mean access time was significantly lower in the TRA group than in the DRA group (1.9 min vs 2.9 min; P < 0.001). The mean angiography time did not significantly differ between the groups (10.2 min in the TRA group vs 9.9 min in the DRA group). The rate of radial artery spasms was not significantly different between the 2 groups (13.8 % in the TRA group vs 14.5 % in the DRA group). The rates of access site hematoma (12.4 % vs 2.3 %; P < 0.001) and bleeding (10.7 % vs 4.1; P = 0.005) were significantly higher in the TRA group. ConclusionsDRA was safe and feasible with lower rates of RAO and access site complications than TRA. Thus, it could be used as an alternative approach in percutaneous coronary procedures. However, the trade-off for these advantages of DRA is an increase in cross-over rate, and a decrease in puncture success rate.

Sex differences in transradial access failure in ST segment elevation myocardial infarction.

Transradial access (TRA) is now the default access site for PPCI, but technically is a more challenging approach mostly due to anatomic challenges connected to the RA. To assess the differences according to sex in radial artery (RA) access site characteristics during primary percutaneous coronary intervention (PPCI) for ST segment elevation myocardial infarction (STEMI). All 5092 consecutive STEMI patients from our center in the period from March 2011 until December 2017 were examined. The right proximal radial was the "intention-to-treat" access in all patients. Preprocedural RA angiography was performed in all patients. Clinical and procedure characteristics, type of radial anatomy variants, need to use another arterial access sites (the primary endpoint for this study), and procedure time were analyzed by sex. Using logistic regression, we selected predictors of radial crossover. Access site bleeding complications and vascular complications were also recorded. The STEMI population in this period included 1326 females and 3766 male patients. Females were older (65 ± 11 years) than males (59 ± 11 years, p < 0.0001). Among standard risk factors, hypertension and diabetes mellitus were more common in women and smoking less common. RA anomalies were more frequent in the females (8.8% vs. 6.5%, p < 0.0001), with complex RA loop and tortuous RA twice as frequent in women. Failure of TRA access as the initially chosen site occurred in 4.6% (61) of females versus 2.5% (97) of male STEMI patients (p = 0.0003). The most common subsequent access site was right ulnar access in both groups (57 and 61% respectively). Access site bleeding complications were more common in women 4.4% versus 3.2%, mirrored in hematomas with EASY score III to V. Clinical RA spasm (RAS) was significantly more frequent in females (5.7% vs. 2.2%, p < 0.0001). Multiple regression analysis identified 5 independent predictors for TRA access crossover: previous TRA, anomalous RA, RAS, along with female sex and diabetes. Female sex is a significant predictor of more complex TRA in STEMI. Understanding sex differences and predictors for TRA crossover will strengthen the use of different procedural modalities that can help in preserving a successful wrist access in female STEMI patients.

Scrotal hematoma: a rare complication of transfemoral percutaneous coronary intervention

BackgroundCardiac catheterization via the transfemoral approach can be associated with access site bleeding complications such as inguinal hematoma, pseudoaneurysm, arteriovenous fistula and retroperitoneal hematoma. Scrotal hematoma is a rare presentation of bleeding complications after transfemoral cardiac catheterization. We report a case of this rare complication.Case presentationA 63-year-old male with previous coronary artery bypass surgery underwent percutaneous coronary intervention via transfemoral approach. Few hours after removal of the femoral sheath, he developed a big scrotal hematoma and hemodynamic deterioration. The patient responded successfully to conservative treatment and discharged from hospital after three days in a stable condition.ConclusionsBleeding complications after transfemoral cardiac catheterization can rarely present as scrotal hematoma. The management of this complication is usually conservative, and only few cases may require surgical treatment.

The impact of liver cirrhosis on in-hospital outcomes among patients hospitalized for cardiogenic shock: A propensity score matched retrospective cohort study

BackgroundCardiogenic shock poses a critical challenge characterized by diminished cardiac output and organ perfusion. Timely recognition and risk stratification are essential for effective intervention. Liver cirrhosis adds complexity due to its diverse systemic manifestations. The effect of liver cirrhosis on in-hospital outcomes in cardiogenic shock remains underexplored. MethodsWe conducted a retrospective cohort study using the National Inpatient Sample database from 2016 to 2020, matching cirrhotic patients with non-cirrhotic counterparts using propensity scores. The Cochran-Mantel-Haenszel method was used to assess the impact of cirrhosis on in-hospital mortality and complications. Simple linear regression models were used to assess differences in length of stay and cost of hospitalization. ResultsThere were a total of 44,288 patients in the cohort, evenly distributed between the group with and without liver cirrhosis. Mean age of the cohort was 64 years (SD 12.5), 69.7 % were males, and 61.3 % were white. The overall in-hospital mortality rate in the cohort was 37.2 % with higher odds of in-hospital mortality in cirrhotic patients [OR = 1.3; 95 % CI (1.25, 1.35)]. Patients with cirrhosis exhibited increased risks of bowel ischemia, acute kidney injury, and sepsis compared to those without cirrhosis. Additionally, they had a heightened overall risk of major bleeding, particularly gastrointestinal bleeding, but a lower risk of intracranial hemorrhage and access site bleeding. Conversely, patients with cirrhosis had lower odds of deep vein thrombosis and pulmonary embolism, as well as arterial access site thrombosis and dissection, leading to reduced odds of peripheral angioplasty, thrombectomy, and amputation. Cirrhotic patients also had increased length of stay and cost of hospitalization. ConclusionLiver cirrhosis exacerbates outcomes in cardiogenic shock, necessitating tailored management strategies. Further research is warranted to optimize patient care and understand the underlying mechanisms.

Comprehensive prevention strategy for Impella access-site bleeding using a large-bore sheath and a percutaneous post-closure technique.

Comprehensive prevention strategy for Impella access-site bleeding using a large-bore sheath and a percutaneous post-closure technique.

Rapid haemostasis to achieve dressing longevity: evaluation trial results using StatSeal catheter exit site protection.

Peripherally inserted central catheters (PICCs) are vital in delivering intravenous therapy. Despite their advantages, PICCs can lead to complications such as catheter exit site bleeding, which can cause patient distress and increase infection risk. This study evaluated the efficacy of StatSeal, a topical haemostatic device, in managing PICC exit site bleeding. StatSeal uses a hydrophilic polymer and potassium ferrate to form a seal, reducing access site bleeding and minimising dressing changes. For this study, Patients were recruited at Frimley Health NHS Foundation Trust; the trial involved 177 patients with StatSeal, and shows that 99% did not require additional dressing changes within the standard 7-day period. The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, enhancing the efficiency of vascular access maintenance and potentially lowering associated healthcare costs. The trial emphasises the importance of innovative solutions such as StatSeal to advance PICC care and improve patient experience.

Importance of pseudoaneurysms after TAVI - a retrospective analysis of 2063 patients.

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/μl vs. 234×1000/μl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.

The Impact of Ipsilateral Implantable Cardioverter Defibrillator in Axillary Intra-Aortic Balloon Pump Support as Bridge to Heart Transplantation.

The axillary artery (AX) access for intra-aortic balloon pump (IABP) as a bridge to heart transplant (HT) allows mobility while awaiting a suitable donor. As end-stage heart failure patients often have an implantable cardioverter defibrillator (ICD) on the left side, the left AX approach may be avoided due to the perception of difficult access and proximity of two devices. We aimed to evaluate the outcomes of patients bridged to HT with a left-sided AX IABP with or without ipsilateral ICDs. We retrospectively reviewed HT candidates at our institution supported by left-sided axillary IABP from November 2019 to February 2024, dividing them into two groups based on the presence (Group ICD, n = 48) or absence (Group No-ICD, N = 19) of an ipsilateral left-sided ICD. The exposure time was defined as the time from skin incision to the beginning of anastomoses of a Dacron graft. Technical success was achieved in 100% of the cohort, with median exposure times for AX access similar between groups (ICD, 12 [7.8, 18.2] vs. No ICD, 11 [7, 19] min; p = 0.75). The rate of procedural adverse events, such as significant access site bleeding and ipsilateral limb ischemia, did not significantly differ between both groups. Device malfunction rates were comparable (ICD, 29.2%vs. No ICD, 15.8%; p = 0.35). Posttransplant, in-hospital mortality, severe primary graft dysfunction, and stroke rates were comparable in both groups. The presence of an ipsilateral left-sided ICD does not adversely impact the procedural efficacy, complication rates, or posttransplant outcomes of left-sided AX IABP insertion in HT candidates.

Effects of Transradial Access on In-Hospital Outcomes in Percutaneous Coronary Intervention for Coronary Artery Bypass Graft: Insights from the Japanese Nationwide Database

Due to its superior safety profile and improved outcomes, trans-radial percutaneous coronary intervention (TRI) has become the preferred access in percutaneous coronary intervention (PCI) of native coronary disease. This study investigated the impact of TRI on in-hospital outcomes after PCI for coronary artery bypass graft vessels (GV-PCI). We analyzed patients who underwent GV-PCI in 2019–2022 from the Japanese nationwide registry. Patients were categorized into the TRI and trans-femoral percutaneous coronary intervention (TFI) groups. We assessed the association of TRI and in-hospital outcomes. The primary outcome was a composite of in-hospital death and major bleeding. GV-PCI was performed in 2,295 Out of 972,370 total PCI procedures. The primary outcomes occurred in 29 patients (1.3%), including 17 deaths (0.7%). Major bleeding occurred in 12 patients (0.5%), and access site bleeding in seven patients (0.3%). The TRI group (N=1,521) showed lower crude rates of the primary outcome (0.9% vs. 1.9%, p = 0.039), major bleeding (0.3% vs. 1.0%, p = 0.027), and access site bleeding (0.1% vs. 0.6%, p = 0.047) compared to the TFI group (N=774). Univariable logistic regression demonstrated a significant association of TRI with reduced primary outcome (odd ratio (OR):0.47, 95% confidence interval (CI):0.22-0.98), major bleeding (OR:0.25, 95% CI:0.07-0.80), and access site bleeding (OR:0.20, 95% CI:0.03-0.94). In the multivariable analysis, TRI was still significantly associated with a decrease in major bleeding events (OR:0.29, 95% CI:0.07-0.93). In conclusion, the use of TRI was associated with a reduction in bleeding events when referenced to TFI in the context of GV-PCI.

Same-day discharge after large-bore access in percutaneous coronary intervention of chronic total coronary occlusions.

Same-day discharge (SDD) in patients undergoing percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) is appealing because of the increased patient comfort. However, data on SDD following large-bore vascular access are scarce. We investigated the feasibility and safety of SDD in patients undergoing large-bore CTO PCI. Between 2013 and 2023, 948 patients were prospectively enrolled in a single-centre CTO registry and underwent CTO PCI. SDD was pursued in all patients. Large-bore access was defined as the use of ≥7 French (Fr) sheaths in ≥1 access site. A logistic regression analysis was used to identify predictors for non-SDD. Clinical follow-up was obtained at 30 days. SDD was observed in 62% of patients. Large-bore access was applied in 99% of the cohort. SDD patients were younger and more often male, with lower rates of renal insufficiency and prior coronary artery bypass grafting. Local access site bleeding (odds ratio [OR] 8.53, 95% confidence interval [CI]: 5.24-13.87) and vascular access complications (OR 7.23, 95% CI: 1.98-26.32) made hospitalisation more likely, with vascular access complications occurring in 3%. At 30 days, the hospital readmission rate was low in both SDD and non-SDD patients (5% vs 7%; p=non-significant). Finally, SDD was not a predictor for major adverse cardiovascular events (MACE) at follow-up. Same-day discharge can be achieved in the majority of patients undergoing CTO PCI with large-bore (≥7 Fr) access. Similar low hospital readmission and MACE rates between SDD and non-SDD patients at 30 days demonstrate the feasibility and safety of SDD.

Safety and Efficacy of Percutaneous Pulmonary Valve Implantation: The Singapore Experience

Background: Right ventricular outflow tract (RVOT) dysfunction in adult congenital heart disease patients frequently requires repeated interventions. Percutaneous pulmonary valve implantation (PPVI) is being used increasingly to treat pulmonary stenosis (PS) and regurgitation (PR), improving symptoms, right ventricular haemodynamics and function and, indirectly, left ventricular filling and function. This article explores the authors’ early local experience with PPVI. Methods: Between 2017 and 2022, PPVI was attempted in 10 patients at a single tertiary centre, including six with PS and four with PR. Patients underwent multimodality imaging and dental clearance. PPVI was then performed. Patients were continued on lifelong single antiplatelet therapy and dental hygiene was reinforced. Results: Overall, there was an 80% success rate of Melody PPVI in the 10 adult congenital heart disease (ACHD) patients (mean age 35.8 ± 13.7 years; 60% male), with significant improvements in RVOT pathology, right ventricle function and pulmonary pressures. Melody PPVI was cancelled in one patient due to risk of coronary compression, and an Edwards S3 PPVI was implanted in another patient instead due to a large RVOT size causing stent embolisation. Two patients experienced complications of bleeding and stent fracture, both of which were conservatively managed and had good long-term outcomes. Conclusion: The authors present their early local experience with PPVI in ACHD patients at a single tertiary centre. PPVI has proven to be safe and efficacious, improving PS and PR, right and left ventricle function and pulmonary pressures. Nonetheless, precautions must be taken to minimise complications such as coronary compression, access site bleeding, device embolisation and stent fracture.

Temporary extracorporeal life support: single-centre experience with a new concept.

The combination of veno-arterial extracorporeal membrane oxygenation with a micro-axial flow pump (ECMELLA) is increasingly used for cardiogenic shock (CS) therapy. We report our experience with a novel single-artery access ECMELLA setup with either femoral (2.0) or jugular venous cannulation (2.1), respectively. Data from 67 consecutive CS patients treated with ECMELLA 2.0 (n = 56) and 2.1 (n = 11) from December 2020 and December 2022 in a tertiary cardiac center were retrospectively analyzed. The mean age was 60.7 ± 11 years, 56 patients (84%) were male. CS aetiology was acute on chronic heart failure (n = 35, 52%), myocardial infarction (n = 13, 19.5%), postcardiotomy syndrome (n = 16, 24%) and myocarditis (n = 3, 4.5%). Preoperatively 31 patients (46%) were resuscitated, 53 (79%) were on a ventilator and 60 (90%) were on inotropic support. The median vasoactive inotropic score was 32, and the mean arterial lactate was 8.1 mmol/l. In 39 patients (58%), veno-arterial extracorporeal membrane oxygenation was explanted after a median ECMELLA support of 4 days. Myocardial recovery was achieved in 18 patients (27%), transition to a durable left ventricular assist device in 16 (24%). Thirty-three patients (n = 33; 49%) died on support (25 on ECMELLA and 8 on Impella after de-escalation), 9 (13%) of whom were palliated. Axillary access site bleeding occurred in 9 patients (13.5%), upper limb ischaemia requiring surgical revision in 3 (4.5%). Axillary site infection occurred in 6 cases (9%), and perioperative stroke in 10 (15%; 6 hemorrhagic, 4 thromboembolic). ECMELLA 2.0/2.1 is a feasible and effective therapy for severe CS. The single-artery cannulation technique is associated with a relatively low rate of access-related complications.

Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 1-Year Outcomes

Proximal radial artery (PRA) access for cardiac catheterization is safe but can jeopardize subsequent use of the artery because of occlusion. Distal radial artery (DRA) access in the anatomical snuffbox preserves the RA but safety and potential detrimental effects on hand function are unknown. We aimed to assess hand function and complications after DRA and PRA. In this single-center trial, 300 patients were randomly allocated 1:1 to cardiac catheterization through DRA or PRA. The primary end point of change in hand function from baseline to 1 year was a composite of the Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, hand grip test, and thumb-forefinger pinch test. The secondary end points included access feasibility and complications. Of 216 patients with 1-year completed follow-up, 112 were randomly allocated to DRA and 104 to PRA, with balanced demographics and procedural characteristics. Both groups had similar access site bleeding rates (DRA 0% vs PRA 1.4%, p = 0.25). Radial artery occlusion occurred in 1 PRA patient versus 2 in DRA. There was no significant difference in change of hand function, median (interquartile range) hand grip (DRA 0.7 [-3 to 4.5] vs PRA 1.3 [-2 to 4.3] kg, p = 0.57), pinch grip (DRA -0.1 [-1.1 to 1] vs PRA -0.3 [-1 to 0.7] kg, p = 0.66), and Quick DASH (DRA 0 [-6.6 to 2.3] vs PRA 0 [-4.6 to 2.9] points, p = 0.58). The composite of hand function was comparable between PRA and DRA. In conclusion, DRA is a safe strategy for cardiac catheterization, with a low complication rate. Compared with PRA, there is no increased risk of hand dysfunction or radial artery occlusion at 1 year.

A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study.

Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality. The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI. All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these. Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively. Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.

Feasibility and Outcomes of a Cardiovascular Medicine Inclusive Extracorporeal Membrane Oxygenation (ECMO) Service

BackgroundThere has been a significant increase in the utilization of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in recent years. Cardiothoracic surgery teams have historically led VA-ECMO care teams, with little data available on alternative care models. MethodsWe performed a retrospective review of a cardiovascular medicine inclusive VA-ECMO service, analyzing patients treated with peripheral VA-ECMO at a large quaternary care center from 2018 to 2022. The primary outcome was death while on VA-ECMO or within 24 hours of decannulation. Univariate and multivariate analyses were used to identify predictors of the primary outcome. ResultsTwo hundred forty-four patients were included in the analysis (median age 61 years; 28.7% female), of whom 91.8% were cannulated by interventional cardiologists, and 84.4% were managed by a cardiology service comprised of interventional cardiologists, cardiac intensivists or advanced heart failure cardiologists. Indications for VA-ECMO included acute myocardial infarction (34.8%), decompensated heart failure (30.3%), and refractory cardiac arrest (10.2%). VA-ECMO was utilized during cardiopulmonary resuscitation in 26.6% of cases, 48% of which were peri-procedural arrest. Of the patients, 46% survived to decannulation, the majority of whom were decannulated percutaneously in the cardiac catheterization laboratory. There was no difference in survival following cannulation by a cardiac surgeon vs interventional cardiologist (50% vs 45%; P = .90). Complications included arterial injury (3.7%), compartment syndrome (4.1%), cannulation site infection (1.2%), stroke (14.8%), acute kidney injury (52.5%), access site bleeding (16%) and need for blood transfusion (83.2%). Elevated baseline lactate (odds ratio [OR], 1.13 per unit increase) and sequential organ failure assessment score (OR, 1.27 per unit increase) were independently associated with the primary outcome. Conversely, an elevated baseline survival after VA ECMO score (OR, 0.92 per unit increase) and 8-hour serum lactate clearance (OR, 0.98 per % increase) were independently associated with survival. ConclusionsThe use of a cardiovascular medicine inclusive ECMO service is feasible and may be practical in select centers as indications for VA-ECMO expand.

Platelet reactivity and activated clotting time predict hemorrhagic site complications in patients with chronic coronary syndromes undergoing percutaneous coronary interventions.

Radial access is preferred in patients with chronic coronary syndromes (CCSs) treated with ad hoc percutaneous coronary intervention (PCI). Antithrombotic and antiplatelet treatment before PCI may affect outcomes at vascular access sites. QuikClot Radial is a kaolin-based band that may shorten hemostasis time. Using point-of-care testing, we investigated the effect of antithrombotic and antiplatelet treatment on access-site complications. This prospective observational study included consecutive patients with CCS on chronic aspirin therapy referred for ad hoc PCI. The activated clotting time (ACT), global thrombosis test and VerifyNow P2Y 12 test were done sequentially after unfractionated heparin (UFH) and clopidogrel administration. Patients were monitored for radial artery patency, bleeding and local hematoma until discharge. We enrolled 40 patients [mean age, 68.8 ± 8.8 years; men, 30 (75%)] who received UFH (median dose, 8000 IU; interquartile range, 7000-9000 IU) and clopidogrel (600 mg). All radial arteries remained patent during follow-up. Local bleeding and hematomas were noted in 11 patients (27.5%) each. Patients with bleeding had lower mean platelet activity at 2 h [122.5 ± 51 platelet reactivity units (PRU) vs. 158.7 ± 43 PRU, P = 0.04] and higher ACT (216.9 ± 40 s vs. 184.6 ± 28 s, P = 0.006) than patients without bleeding. An ACT >196 s at 2 h predicted bleeding or hematoma (AUC, 0.72; 95% CI, 0.56-0.85, P = 0.008). Lower platelet activity and higher ACT after PCI were associated with higher bleeding risk at a vascular access site. Point-of-care testing of ACT after the procedure may help identify patients with CCS undergoing PCI who are at higher risk of access-site bleeding.

High bleeding risk mainly predicts non-access site bleeding events in the first month after percutaneous coronary intervention

Abstract Background/Introduction The majority of bleeding events after percutaneous coronary intervention (PCI) occur in the first month after PCI. To predict and anticipate on events during hospitalisation and in the first month, the CRUSADE- and ACUITY scores have been developed. In order to enhance the use of bleeding risk stratification, a consortium of PCI centres in the South East of the Netherlands has created and implemented a simple binary variant of the existing models. High bleeding risk (HBR) is defined by one of the following: eGFR&amp;lt; 30; anaemia (Hb &amp;lt; 7mmol/L); a spontaneous bleeding within one year before PCI; a history of intracranial haemorrhage. Purpose We evaluated the predictive value of our risk model and other risk factors for bleeding events in the first month after PCI and discriminated between access site- non-access site bleedings. Methods In an ongoing multicentre prospective PCI registry in the South East of the Netherlands collects baseline and follow-up data of all patients undergoing PCI. We compared access site- and non- access site bleedings between HBR and non HBR using the Kaplan Meier method and Cox regression. Also, we performed multivariate analysis of the separate factors of the model and other probable risk factors. Results We collected baseline and 30 day follow-up data in 3996 patients of which 357 with HBR (9%). Access site bleedings occurred in 3% of patients with HBR vs 2% without (sens. 0.13; spec. 0.98). Patients with HBR showed 5% non-access site bleedings versus 1% in non HBR (sens. 0.21; spec. 0.99). Survival curves and hazard ratios presented in figure 1 show that these differences are significant only for non-access site bleedings (HR: 4.2, 95% CI: 2.47-7.30). The multivariate analysis is presented in table 1. All bleeding events were predicted by age ≥ 60 and peripheral arterial disease. Furthermore, non-access site bleedings were predicted by anaemia and bleeding events in the previous year. Additional risk factors for access site bleedings were female sex and double access site punction. Conclusion The simplified risk model showed to be conservative in the determination of HBR as depicted by the sensitivity and specificity. However, it showed good discriminative value for non-access site bleedings which was driven by anemia and a history of bleedings. Furthermore, these results suggest that age ≥60 and peripheral arterial disease should be taken into consideration. Extra precaution for access site bleedings should also be taken in female patients and in the case of double access site punction.Figure 1Table 1