Periprocedural Bleeding Complications Research Articles

Role of Mechanical Circulatory Support in Complex High-Risk and Indicated Percutaneous Coronary Intervention: Current Indications, Device Options, and Potential Complications.

Improved expertise and technological advancements have enabled the safe and effective performance of complex and high-risk-indicated percutaneous coronary intervention (CHIP) in patients previously considered inoperable or high-risk. Mechanical circulatory support (MCS) devices play a crucial role in stabilizing hemodynamics during percutaneous coronary intervention (PCI) -related ischemia, thereby reducing the risk of major adverse events and achieving a more complete revascularization. However, the use of MCS devices in protected PCI is not without risks, including peri-procedural myocardial infarction (MI), bleeding, and access-related complications. Despite numerous observational studies, there is a significant lack of randomized clinical trials comparing different MCS devices in various CHIP scenarios and evaluating their long-term safety and efficacy profiles. This review aims to summarize the current evidence regarding the benefits of MCS devices during CHIPs, offer a practical guide for selecting appropriate devices based on clinical scenarios, and highlight the unanswered questions that future trials need to address.

Thromboelastography-Guided Correction of Coagulopathy Before Tunneled Central Venous Access in Critically Ill Patients With Liver Disease: A Propensity Score-Matched Study.

Optimal blood product transfusion strategies before tunneled central venous catheter (CVC) placement are required in critically ill coagulopathic patients with liver disease to reduce exposure to allogeneic blood products and mitigate bleeding and thrombotic complications. This study evaluated the safety and efficacy of a thromboelastography-guided transfusion strategy for the correction of coagulopathy in patients with liver disease compared with a conventional transfusion strategy (using international normalized ratio, platelet count, and fibrinogen) before tunneled CVC insertion. A retrospective propensity score-matched single-center cohort study was conducted at a quaternary care academic medical center involving 364 patients with liver disease (cirrhosis and acute liver failure) who underwent tunneled CVC insertion in the ICU. Patients were stratified into two groups based on whether they received blood product transfusions based on a thromboelastography-guided or conventional transfusion strategy. Primary outcomes that were evaluated included the volume, units and cost of blood products (fresh frozen plasma, cryoprecipitate, and platelets) when using a thromboelastography-guided or conventional approach to blood transfusions. Secondary outcomes included the frequency of procedure-related bleeding and thrombotic complications. The total number of units/volume/cost of fresh frozen plasma (12 U/3,000 mL/$684 vs. 32 U/7,500 mL/$1,824 [p = 0.019]), cryoprecipitate (60 U/1,500 mL/$3,240 vs. 250 U/6,250 mL/$13,500 [p < 0.001]), and platelets (5 U/1,500 mL/$2,610 vs. 13 units/3,900 mL/$6,786 [p = 0.046]) transfused were significantly lower in the thromboelastography-guided transfusion group than in the conventional transfusion group. No differences in the frequency of bleeding/thrombotic events were observed between the two groups. A thromboelastography-guided transfusion strategy for correction of coagulopathy in critically ill patients with liver disease before tunneled CVC insertion, compared with a conventional transfusion strategy, reduces unnecessary exposure to allogeneic blood products and associated costs without increasing the risk for peri-procedural bleeding and thrombotic complications.

Feasibility and safety values of activated clotting time-guided systemic heparinization in coil embolization for unruptured intracranial aneurysms.

This study aimed to evaluate the feasibility and safety values of activated clotting time (ACT)-guided systemic heparinization in reducing periprocedural thrombosis and bleeding complications during coil embolization of unruptured intracranial aneurysms. A total of 228 procedures performed on 213 patients between 2016 and 2021 were included in the retrospective analysis. The target ACT was set at 250 s. Logistic regression was performed to assess predictors for the occurrence of thrombosis and bleeding. Receiver operating characteristic (ROC) analyses were employed to determine the optimal cut-off values for ACT, heparinization, and procedure time. Most (85.1%) of procedures were stent-assisted embolization. The mean baseline ACT was 128.8 ± 45.7 s. The mean ACT at 20 min after the initial intravenous heparin loading of 78.2 ± 18.8 IU/kg was 185 ± 46.4 s. The mean peak ACT was 255.6 ± 63.8 s with 51.3% (117 cases) achieving the target ACT level. Peak ACT was associated with symptomatic thrombosis (OR per second, 1.008; 95% CI, 1.000-1.016; P = 0.035) (cut-off value, 275 s; area under ROC (AUROC), 0.7624). Total administered heparin dose per body weight was negatively associated with symptomatic thrombosis (OR per IU/kg, 0.972; 95% CI, 0.949-0995; P = 0.018) (cut-off value, 294 IU/kg; AUROC, 0.7426) but positively associated with significant bleeding (OR, 1.008 per IU/kg; 95% CI, 1.005-1.012; P <0 .001) (cut-off value, 242 IU/kg; AUROC, 0.7391). Procedure time was significantly associated with symptomatic thrombosis (OR per minute, 1.05; 95% CI, 1.017-1.084; P value = 0.002) (cut-off value, 158 min; area under ROC, 0.8338). This study demonstrated that ACT-guided systemic heparinization was feasible to achieve the target ACT value and proposes probable safety thresholds to prevent periprocedural complications through reducing procedure time during coil embolization of unruptured intracranial aneurysms in the stent era.

Peri-procedural management and incidence of bleeding events following musculoskeletal injections or aspirations in people on oral anticoagulation and antiplatelet therapy.

Corticosteroid injections and aspirations are common interventions for managing musculoskeletal and inflammatory conditions. However, there remains limited safety evidence to support injection decisions and peri-procedural management in people on anti-thrombotics, particularly for direct oral anticoagulants (DOACs). To investigate peri-procedural management and bleeding complications following musculoskeletal injections or aspirations with anti-thrombotic medication use. A prospective observational study was undertaken (October 2018-December 2020) in Orthopaedics, Rheumatology and Radiology specialities in two large UK healthcare providers. Data collection involved weekly identification of musculoskeletal procedures, emergency attendance or admission within 30days and follow-up questionnaires sent within 2weeks post-procedure. Descriptive statistics were used to analyse anticoagulant/anti-platelet use, peri-procedural management and bleeding complications. Of 5080 procedures, 237 of 1338 responses reported antithrombotic use: warfarin (n=36), DOACs (n=75) and antiplatelets (n=126). There were no self-report or electronic identification of clinically significant bleeding events/complications. Only local bruising was reported (8.6% vs. 0.2% with non-use), and only with medication continuation or international normalised ratio (INR) levels ≥3.8 or unknown. Only 3/72 DOAC use was interrupted. In this study, no clinically significant bleeding events or complications were reported or identified following musculoskeletal injections or aspirations, with only localised bruising reported. It was not universal practice to check INR levels and DOAC interruption was uncommon. Findings add evidence that musculoskeletal procedures appear to be low risk procedures for bleeding complications with antithrombotic continuation and when INR levels within lower target range. Research on intra-articular or soft tissue iatrogenic consequences would add to risk/benefit evaluations.

Safety of Prophylactic Anticoagulation During Bedside Procedures: A Prospective Multicenter Observational Study.

Bedside percutaneous dilatational tracheostomy (PDT) and percutaneous endoscopic gastrostomy (PEG) are common procedures performed in the intensive care unit (ICU). Venous thromboembolism (VTE) prophylaxis is frequently prescribed to ICU patients and it remains unclear whether pre-procedure discontinuation is necessary. This multi-center prospective observational study aimed to describe bleeding rates in patients undergoing bedside PEG or PDT who did or did not have VTE prophylaxis held. Decision to hold prophylaxis was made by the operating physician. The primary endpoint was the rate of peri-procedural bleeding complications. Secondary endpoints included quantification of held doses in the peri-procedural period, rate of venous thromboembolism, and characteristics associated with having prophylaxis held. 91 patients were included over a 2-year period. Patients were on average aged 54years, 40% female, mostly admitted to the trauma service (59%), and most commonly underwent bedside PDT (59%). Overall, 21% of patients had doses of pre-procedure prophylaxis held. Bleeding events occurred in 1 patient (1.4%) who had prophylaxis continued and in 1 patient (5.0%) who had prophylaxis held, a rate difference of 3.6% (95% CI-9.5%, 16.7%). One bleeding event was managed with bedside surgical repair and one with blood transfusion. There were 10 VTE events, all of whom had prophylaxis continued during the pre-procedure period but 3 had prophylaxis held after the procedure. Bleeding complications were rare and did not significantly differ depending on whether prophylaxis was held or not. Future research is required to confirm the lack of risk with continuing prophylaxis through bedside procedures.

Clinical outcomes up-to 10 years of asymptomatic incidental aortic dissections and large aortic aneurysms detected on computer tomography aortography (CTA) prior to transcatheter aortic valve implantation (TAVI)

Abstract Background/Introduction Computer tomography aortography (CTA) is performed routinely to aid planning of transcatheter aortic valve implantation (TAVI). Incidental findings are common, and may influence the decision to proceed with TAVI. The safety and long term outcomes of performing TAVI in patients with previously undiagnosed incidental CT findings of aortic dissections and large aortic aneurysms is currently unknown. Purpose To establish the frequency of incidental aortic dissections and large aortic aneurysms prior to TAVI, and subsequent clinical outcomes of patients. We hypothesize that transfemoral access is safe in patients with incidental finding of aortic dissection and large aortic aneurysms. Methods This was a retrospective study of 628 sequential TAVI patients in a large, UK tertiary centre between January 2010 and September 2020. Patients were evaluated in 3 groups as per pre-TAVI CTA: incidental aortic dissections, aortic aneurysm &amp;gt;4cm and all others (control group). Endpoints were procedural success, peri-procedural major bleeding and/or vascular complications and/or CVA, length of hospital stay, 30-day and 1-year mortality. Results 2.9% of patients (n=18) had incidental aortic dissection, of which 66.7% (n=12) were male, with a mean age of 86.7±4.4. 3.8% of patients (n=24) had aortic aneurysms &amp;gt;4 cm. 83.3% (n=20) of them were male and the mean age was 82.8±5.4. Transfemoral approach was favoured in 77.8% of patients in the dissection group and 83.3% of patients in the aneurysm group versus 93.3% in the control group. Procedural characteristics are summarised in Table 1. Vascular access complications, stroke, bleeding and length of hospital stay were comparable between all 3 groups (Table 1). Patients with dissection and large aneurysm had similar success rate of valve implantation compared to the control group (88.9% and 87.5% vs 97.1%, p=0.452). 30-day mortality in the dissection group was higher than the other 2 groups (21.1% vs 0% and 5.6%, p=0.004). Log-rank analysis revealed a higher incidence of MACE in the dissection group over 24 months compared to the other two groups (Figure 1). Conclusion A transfemoral approach appears to be a safe choice in patients with incidental findings of aortic dissection or aortic aneurysms &amp;gt;4cm, given no significant difference in terms of valve implant success, vascular injury, major bleeding or unplanned surgical repair. However, patients with stable previous aortic dissections have a significantly higher 30-day mortality and overall lower survival rate over 24 months. This important observation needs to be further investigated in a larger-scale, long-term follow up study, and may in future influence TAVI treatment planning. Funding Acknowledgement Type of funding sources: None. Figure 1. Survival curve

Procedural outcomes in patients with dual versus single antiplatelet therapy prior to transcatheter aortic valve replacement

The impact of uninterrupted dual antiplatelet therapy (DAPT) on bleeding events among patients undergoing transcatheter aortic valve replacement (TAVR) has not been well studied. We conducted an analysis of 529 patients who underwent transfemoral TAVR in our centre and were receiving either DAPT or single antiplatelet therapy (SAPT) prior to the procedure. Accordingly, patients were grouped into a DAPT or SAPT group. Following current guidelines, patients in the SAPT group were switched to DAPT for 90 days after the procedure. The primary endpoint of our analysis was the incidence of bleeding events at 30 days according to the VARC-2 classification system. Any VARC-2 bleeding complications were found in 153 patients (28.9%), while major/life-threatening or disabling bleeding events occurred in 60 patients (11.3%). Our study revealed no significant difference between the DAPT vs. SAPT group regarding periprocedural bleeding complications. Based on multivariable analyses, major bleeding (HR 4.59, 95% CI 1.64–12.83, p = 0.004) and life-threatening/disabling bleeding (HR 8.66, 95% CI 3.31–22.65, p < 0.001) events were significantly associated with mortality at 90 days after TAVR. Both pre-existing DAPT and SAPT showed a comparable safety profile regarding periprocedural bleeding complications and mortality at 90 days. Thus, DAPT can be safely continued in patients undergoing transfemoral TAVR.

Appropriate intraprocedural initial heparin dosing in patients undergoing catheter ablation for atrial fibrillation receiving uninterrupted non-vitamin-K antagonist oral anticoagulant treatment

BackgroundTo clarify the appropriate initial dosage of heparin during radiofrequency catheter ablation (RFCA) in patients with atrial fibrillation (AF) receiving uninterrupted nonvitamin K antagonist oral anticoagulant (NOAC) treatment.MethodsA total of 187 consecutive AF patients who underwent their first RFCA in our center were included. In the warfarin group (WG), an initial heparin dose of 100 U/kg was administered (control group: n = 38). The patients who were on NOACs were randomly divided into 3 NOAC groups (NG: n = 149), NG110, NG120, and NG130, and were administered initial heparin doses of 110 U/kg, 120 U/kg, and 130 U/kg, respectively. During RFCA, the activated clotting time (ACT) was measured every 15 min, and the target ACT was maintained at 250–350 s by intermittent heparin infusion. The baseline ACT and ACTs at each 15-min interval, the average percentage of measurements at the target ACT, and the incidence of periprocedural bleeding and thromboembolic complications were recorded and analyzed.ResultsThere was no significant difference in sex, age, weight, or baseline ACT among the four groups. The 15 min-ACT, 30 min-ACT, and 45 min-ACT were significantly longer in the WG than in NG110 and NG120. However, no significant difference in 60 min-ACT or 75 min-ACT was detected. The average percentages of measurements at the target ACT in NG120 (82.2 ± 23.6%) and NG130 (84.8 ± 23.7%) were remarkably higher than those in the WG (63.4 ± 36.2%, p = 0.007, 0.003, respectively). These differences were independent of the type of NOAC. The proportion of ACTs in 300–350 s in NG130 was higher than in WG (32.4 ± 31.8 vs. 34.7 ± 30.6, p = 0.735). Severe periprocedural thromboembolic and bleeding complications were not observed.ConclusionsFor patients with AF receiving uninterrupted NOAC treatment who underwent RFCA, an initial heparin dosage of 120 U/kg or 130 U/kg can provide an adequate intraprocedural anticoagulant effect, and 130 U/kg allowed ACT to reach the target earlier.Trial registration: Registration number: ChiCTR1800016491, First Registration Date: 04/06/2018 (Chinese Clinical Trial Registry http://www.chictr.org.cn/index.aspx).

The Iliofemoral tortuosity score predicts access and bleeding complications during transfemoral transcatheter aortic valve replacement: DataData from the VIenna Cardio Thoracic aOrtic valve registrY (VICTORY).

BackgroundArterial tortuosity is linked to a higher risk of adverse clinical events after transfemoral transcatheter aortic valve replacement (TF‐TAVR). Currently, there are no assessment tools that can quantify this variable in three‐dimensional space. This study investigated the impact of novel scoring methods of iliofemoral tortuosity on access and bleeding complications after TF‐TAVR.MethodsThe main access vessel was assessed between the aortoiliacal and femoral bifurcation in preoperative multislice computed tomography scans of 240 consecutive patients undergoing TF‐TAVR. Tortuosity was assessed by three methods: largest single angle, sum of all angles, and iliofemoral tortuosity (IFT) score [((true vessel length/ideal vessel length)‐1)*100]. The primary study endpoint was a composite of access and bleeding complications. The secondary study endpoints were 30‐day mortality and long‐term survival.ResultsAmong 240 patients, only the IFT score demonstrated a good positive correlation with the composite primary endpoint of access and bleeding complications (P = 0.031). A higher incidence of access and bleeding complications was found in patients with a higher IFT score (56 [36.8%] vs 17 [19.3%]; P = 0.003). In a multivariate logistic regression analysis, only the IFT score was a significant predictor of the primary endpoint (OR: 2.11; 95% CI: 1.09‐4.05; P = 0.026).ConclusionVascular tortuosity is an underestimated risk factor during TF‐TAVR. The IFT score is a valuable tool in risk stratification before TF‐TAVR, predicting periprocedural access and bleeding complications.

Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement

Background: There is no consensus on the benefit of red blood cell (RBC) transfusion after transcatheter aortic valve replacement. Methods: The multicenter Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry retrospectively included patients after transfemoral transcatheter aortic valve replacement; propensity score-matching identified pairs of patients with and without RBC transfusion. The primary end point was 30-day mortality; nonfatal myocardial infarction, cerebrovascular accident, and stage 2 to 3 acute kidney injury at 30 days were secondary end points. We repeated propensity score-matching according to the hemoglobin nadir, hemoglobin drop, and in the subgroup of uncomplicated patients, without major vascular complications or major bleeding. Results: Among 2587 patients, RBC transfusion was administered in 421 cases (16%). The primary end point occurred in 104 (4.0%) patients, myocardial infarction in 9 (0.4%), cerebrovascular accident in 38 (1.5%), and acute kidney injury in 125 (4.8%) cases. In the 842 propensity-matched patients, RBC transfusion was associated with increased mortality (hazard ratio, 2.07 [95% CI, 1.06–4.05]; P =0.034) and acute kidney injury (hazard ratio, 4.35 [95% CI, 2.21–8.55]; P &lt;0.001). Interaction testing between RBC transfusion and mortality was not statistically significant in the above-mentioned subgroups, and such association was not documented in the corresponding propensity score-matched cohorts. In the multivariable Cox proportional hazards regression model, major vascular complications ( P =0.044), major bleeding ( P =0.041), and RBC transfusion ( P =0.048) were independent correlates of 30-day mortality. Conclusions: RBC transfusion correlates with increased mortality and acute kidney injury early after transcatheter aortic valve replacement and is an independent predictor of 30-day mortality, irrespective of periprocedural major bleeding and vascular complications. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03740425.

Update Onyx embolization for plexiform arteriovenous malformation: Ante-grade drifting technique.

The conventional arteriovenous malformation (AVM) Onyx embolization technique is the extrusion Onyx injection technique, with blood-flow control after a certain distance casting through the head end of the microcatheter. This method has elevated periprocedural AVM bleeding complications. In this study, the authors reported safety and efficacy of an updated ante-grade drifting Onyx injection for plexiform AVM embolization. Between January 2016 and December 2018, 101 consecutive patients with plexiform AVMs were treated with ante-grade drifting Onyx injection. The patients' clinical status was classified using the modified Rankin Scale (mRS). To measure associations, logistic univariate or multivariate regression analyses were used. Complete AVM obliteration was achieved in 51.2% (52/101) of patients. Two (2/101, 2.0%) arterial perforations occurred without causing neurological deficits. In univariate and multivariate logistic regression analyses, younger patient age (odds ratio (OR) = 1.06, 95% confidence interval (CI) 1.01-1.12, p = 0.014), haemorrhagic presentation at admission (OR = 7.14, 95% CI 1.52-33.33, p = 0.013) and low Spetzler-Martin grade (OR = 10.00, 95% CI 3.45-25.00, p < 0.001) were significantly correlated with complete obliteration. Pretreatment mRS was correlated with perforation complication (OR = 3.44, 95% CI 1.05-11.29, p = 0.041) in univariate logistic regression analysis but not in multivariate logistic regression analysis (OR = 2.956, 95%CI 0.745, 11.731, p = 0.123). Patients' clinical status was significantly improved after endovascular AVM embolization. With ante-grade drifting Onyx injection, it was possible to prevent serious bleeding complications and elevated complete embolization rate in plexiform AVMs. Younger patient age, haemorrhagic presentation at admission and low AVM Spetzler-Martin grade were significantly correlated with complete obliteration. Although there is not enough statistical power to show that the pretreatment mRS and the arterial perforation complication have a significant correlation, but its OR value is large, and there may be more data in the future to obtain further conclusion.

457Efficacy and safety of uninterrupted periprocedural edoxaban in patients undergoing catheter ablation for atrial fibrillation: Prospective KYU-RABLE study

Abstract Background/Introduction Catheter ablation (CA) has been established as a first-line therapy in the treatment of non-valvular atrial fibrillation (NVAF), and uninterrupted direct oral anticoagulants (DOACs) have become mainstream for the management of periprocedural thromboembolic events. Since 2014, edoxaban has been used for anticoagulation therapy for AF in Japan. However, evidence for uninterrupted use of edoxaban during the periprocedural period of CA in NVAF patients is limited. Purpose KYU-RABLE is a prospective, multicenter, single-arm interventional study, conducted in 23 institutions in Japan to evaluate the efficacy and safety of uninterrupted periprocedural oral edoxaban in patients undergoing CA. The plasma concentration of edoxaban and its relation with plasma coagulative biomarker levels during the periprocedural period were also evaluated. Methods A total of 537 Japanese NVAF patients were enrolled in Japan from December 2017 to September 2018. Edoxaban 60mg (30 mg in patients indicated for dose adjustment) was administered once daily in the morning for at least 4 weeks before CA and continued for at least 4 weeks after CA. On the day of CA, edoxaban was administered immediately after confirmation of hemostat. The primary endpoint was the composite incidence of thromboembolism and major bleeding events during 4 weeks from the procedural day. Plasma concentration of edoxaban and plasma levels of coagulative biomarkers including D-dimer, soluble fibrin monomer complex (SFMC) and prothrombin fragment 1+2 (F1+2) were also measured. Results Among the total 513 patients who underwent CA, 75.2% had radiofrequency CA and 23.0% had cryoballoon CA. The majority of CA patients (65%) received edoxaban 60mg/day, while others (35%) received 30mg/day. As for the primary endpoint, one major bleeding (cardiac tamponade) event was observed and no thromboembolism occurred. Clinically relevant non-major bleeding events occurred in six patients (1.2%), the most were puncture site hemorrhage. The plasma concentration of edoxaban at CA was dependent upon the duration from last administration of edoxaban before CA. However, plasma levels of coagulative biomarkers (D-dimer, SFMC, F1+2) were maintained within appropriate range during the periprocedural period, irrespective of the edoxaban concentration. We also report changes of plasma levels of coagulative biomarkers in sub group analyses by CHADS2 scores and types of AF. Conclusion The KYU-RABLE study demonstrated the first evidence of the efficacy and safety of uninterrupted periprocedural edoxaban administered once daily on the morning for NVAF patients underwent CA. Edoxaban treatment was associated with a low risk of periprocedural bleeding and thromboembolic complications. Furthermore, these low event risks were considered to be associated with the maintained plasma level of coagulative biomarkers, regardless of the change in edoxaban plasma concentration. Acknowledgement/Funding Daiichi Sankyo Co. Ltd.

P1848Prevalence and outcomes in patients with Heyde syndrome after transcatheter aortic valve implantation, a single centre experience

Abstract Introduction Heyde syndrome is known as the association of severe aortic stenosis (AS) and recurrent gastrointestinal bleeding (GIB) from angiodysplasia. To date only few data exist regarding the prevalence of Heyde syndrome and results after transcatheter aortic valve implantation (TAVI) for the treatment of AS. Purpose We sought to evaluate the prevalence of Heyde syndrome in a routine clinical cohort of patients undergoing TAVI and analyze the effectiveness of treatment of AS regarding recurrent GIB in these patients. Methods We conducted a retrospective single-center analysis of 2545 consecutive patients who underwent TAVI for the treatment of AS in 2008–2017. Patients with a history of GIB were identified. The diagnosis of Heyde syndrome was defined as a clinical triad of presence of severe AS, a history of recurrent GIB, and an endoscopic diagnosis of angiodysplasia. GIB of unknown origin or related to other causes was defined as bleeding unrelated to angiodysplasia. Clinical outcomes of patients with Heyde syndrome were evaluated with emphasis on bleeding complications and recurrence of GIB. Results A history of GIB prior to TAVI was detected in 190 patients (7.5%) of the TAVI cohort. Among them, 143 patients had a GIB unrelated to angiodysplasia (5.6%) and 47 patients (1.8%) were diagnosed with Heyde syndrome. Median age and STS-PROM were 80.7 (75.3, 84.0) years and 4.7 (2.7, 9.0) respectively in Heyde patients. TAVI was successfully performed in all cases (66% endovascular access, 34% transapical access). The effective orifice areas increased from 0.8±0.1 cm2 to 2.1±0.5 cm2. Periprocedural major/life-threatening bleeding was found in 6 patients (12.8%), mainly access-related and none due to GIB. In 51% of Heyde-patients transfusion of 4.5±5.7 packed red blood cells was required during the index hospitalisation. During a mean follow-up of 12 months, recurrent GIB after TAVI was detected in 32% of patients with Heyde syndrome. In contrast only 18% of patients with GIB unrelated to angiodysplasia (Non-Heyde) had recurrent GIB after TAVI. In patients diagnosed with Heyde syndrome and recurrent GIB after TAVI the rate of residual mild or moderate paravalvular regurgitation was higher compared to those with an unremarkable course (73% vs. 37%, p=0.045). Figure 1. 1-year Follow-Up Conclusions A relevant number of patients presenting for treatment of AS can be diagnosed with Heyde syndrome. In these patients TAVI can be successfully performed with moderate incidence of periprocedural bleeding complications but significant transfusion rates. Regardless of successful treatment of AS, recurrent GIB was detected in a significant number of Heyde patients during follow-up. The possible association with residual paravalvular regurgitation requires further investigation to improve treatment options in patients with Heyde syndrome.

Radial Approach Expertise and Clinical Outcomes of Percutanous Coronary Interventions Performed Using Femoral Approach

We sought to evaluate the impact of experience and proficiency with radial approach (RA) on clinical outcomes of percutaneous coronary interventions (PCI) performed via femoral approach (FA) in the “real-world” national registry. A total of 539 invasive cardiologists performing PCIs in 151 invasive cardiology centers in Poland between 2014 and 2017 were included. Proficiency threshold was set at >300 PCIs during four consecutive years per individual operator. The majority of operators performed >75% of all PCIs via RA (449 (65.4%)), 143 (20.8%) in 50–75% of cases, 62 (9.0%) in 25–50% and only 33 (4.8%) invasive cardiologists were using RA in <25% of all PCIs. Operators with the highest proficiency in RA were associated with increased risk of periprocedural death, stroke and bleeding complications at access site during angiography via FA. Similarly, higher prevalence of periprocedural mortality during PCI with FA was observed in most experienced radial operators as compared to other groups. The detrimental effect of FA utilization by the most experienced radial operators was observed in both stable angina and acute coronary syndromes. Higher experience and utilization of RA might be linked to worse outcomes of PCIs performed via femoral artery in both stable and acute settings.

Bleeding Complications in Lower-Extremity Peripheral Vascular Interventions: Insights From the NCDR PVI Registry

ObjectivesThis study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs). BackgroundFew studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI. MethodsThe study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications. ResultsAmong 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin <12 g/dl, nonelective PVI, and critical limb ischemia on presentation. Procedural characteristics associated with bleeding included nonfemoral vascular access, use of thrombolytic therapy, PVI of the aortoiliac segment, and multilesion interventions, whereas use of closure devices was associated with less bleeding. All-cause in-hospital mortality was higher in patients who experienced bleeding than in those who did not (6.60% vs. 0.30%; p < 0.001; adjusted hazard ratio: 10.9; 95% confidence interval: 6.9 to 17.0). ConclusionsMajor bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

Changes in Periprocedural Bleeding Complications Following Percutaneous Coronary Intervention in The United Kingdom Between 2006 and 2013 (from the British Cardiovascular Interventional Society)

Major bleeding is a common complication after percutaneous coronary intervention (PCI), although little is known about how bleeding rates have changed over time and what has driven this. We analyzed all patients who underwent PCI in England and Wales from 2006 to 2013. Multivariate analyses using logistic regression models were performed to identify predictors of bleeding to identify potential factors influencing bleeding trends over time. 545,604 participants who had PCI in England and Wales between 2006 and 2013 were included in the analyses. Overall bleeding rates decreased from 7.0 (CI 6.2 to 7.8) per 1,000 procedures in 2006 to 5.5 (CI 4.7 to 6.2) per 1,000 in 2013. Increasing age, female sex, GPIIb/IIIa inhibitors use, and circulatory support were independently associated with increased risk of bleeding complications whereas radial access and vascular closure device use were independently associated with decreases in risk. Decreases in bleeding rates over time were associated with radial access site, and changes in pharmacology, but this was offset by greater proportion of ACS cases and the adverse patient clinical demographics. In conclusion, major bleeding complications after PCI have decreased due to changes in access site practice and decreased usage of GPIIb/IIIa inhibitors, but this is offset by the increase of patients with higher propensity to bleed. Changes in access site practice nationally have the potential to significantly reduce major bleeding after PCI.

Catheter ablation of left atrial arrhythmias on uninterrupted oral anticoagulation with vitamin K antagonists: What is the relationship between international normalized ratio, activated clotting time, and procedure-related complications?

Ablation of atrial fibrillation (AF) on uninterrupted phenprocoumon reduces periprocedural thromboembolic and bleeding complications. Heparin is administered intraprocedurally to achieve activated clotting times (ACT) of 300-400 seconds. We investigated the effect of international normalized ratio (INR) on ACT and intraprocedural heparin requirements. Moreover, safety of a target ACT of 250-300 seconds was investigated. We studied 949 patients referred for AF or left atrial tachycardia ablation. Patients were divided into Group 1 (n=249) with an INR<2 and Group 2 (n=700) with an INR ≥2. Mean INR was 1.7 ± 0.13 in Group 1 and 2.3 ± 0.25 in Group 2. Baseline, mean, minimum and maximum ACT were significantly lower in Group 1 (138 ± 17 seconds vs. 145 ± 21 seconds; 281 ± 28 seconds vs. 288 ± 29 seconds; 251 ± 36 seconds vs. 258 ± 34 seconds; 307 ± 32 seconds vs. 316 ± 40 seconds; P<0.05). Intraprocedural heparin requirements adjusted to body weight were lower in Group 1 (127 ± 41 U/kg vs. 122 ± 40 U/kg). Weak correlations between INR and baseline, mean, minimum and maximum ACT as well as intraprocedural heparin requirements were observed. No differences regarding major or minor complications were found. INR and periprocedural anticoagulation parameters had no influence on major complications. No thromboembolic complications were observed in both groups with a target ACT value of 250-300 seconds. There is only a weak correlation between INR, intraprocedural ACT, and intraprocedural heparin requirements. Periprocedural target ACT of 250-300 seconds seems safe and does not increase periprocedural bleeding and thromboembolic complications in patients undergoing RF ablation on uninterrupted phenprocoumon therapy.

Association of polymorphisms of platelet receptors GPIa (807C>T), GPVI (13254T>C), and P2Y12 (34C>T and H1/H2 haplotype) with increased risk of periprocedural bleeding in patients undergoing coronary angiography/percutaneous coronary intervention.

IntroductionPeriprocedural bleeding related to coronary angiography (CAG) or percutaneous coronary intervention (PCI) is associated with worse prognosis. Determining genetic variations associated with increased bleeding risk may help to identify high-risk patients.AimTo analyse the association between single nucleotide polymorphisms (SNPs) of crucial haemostatic platelet receptors (GPIa, GPVI, P2Y12) and the risk of periprocedural bleeding complications related to CAG/PCI.Material and methodsThe population consisted of 73 patients with ischaemic heart disease who developed bleeding complications within 30 days after CAG/PCI and 331 patients without bleeding. The frequency of SNPs of GPIa 807C/T, GPVI 13254T/C, P2Y12 32C/T, and P2Y12 H1/H2 haplotype was analysed using polymerase chain reaction (PCR) hybridization methods.ResultsThe prevalence of variant alleles GPIa 807T, GPVI 13254C, P2Y12 34T, and P2Y12 H2 haplotype in the total study population was 56.7%, 20.3%, 56.2%, and 24.3%, respectively. The presence of variant alleles was not related to increased risk of periprocedural bleeding: GPIa 807C/T (OR = 1.29, 95% CI: 0.75–2.24, p = 0.334), GPVI 12354T/C (OR = 0.82, 95% CI: 0.40–1.64, p = 0.551), P2Y12 34C/T (OR = 0.71, 95% CI: 0.42–1.22, p = 0.189), P2Y12 H1/H2 haplotype (OR = 0.69, 95% CI: 0.35–1.36, p = 0.258). The frequency of the homozygous form of P2Y12 H2 haplotype was higher in the group of patients who developed bleeding (OR = 2.79, 95% CI: 0.51–13.77, p = 0.161).ConclusionsNo significant association of the SNPs of GPIa 807C/T, GPVI 13254T/C, P2Y12 32C/T, and P2Y12 H1/H2 haplotype with increased risk of periprocedural bleeding was found in patients with ischaemic heart disease undergoing CAG/PCI.

Contemporary PCI Outcomes in the Elderly – A Single Centre Experience

Introduction: Despite increasing prevalence of cardiovascular disease in the elderly, they are often excluded from clinical revascularisation trials. Data on outcomes of contemporary PCI in the elderly is lacking. Objectives: To describe the clinical characteristics and outcomes of elderly patients undergoing PCI at St Vincent's Hospital Melbourne. Methods: We analysed 140 patients >80 years old who underwent PCI between September 2012 and December 2015, representing 9.7% of total PCIs performed over the same period of time. Clinical and procedural characteristics, in-hospital and 30-day outcomes are described. Results: The cohort had a mean age of 82.9±2.7 years and 59% were males. Medical comorbidities were diabetes (37%), previous MI (9%), cerebrovascular disease (12%) and peripheral vascular disease (10%). Mean baseline creatinine was 100±40 mmol/L. Presentation with STEMI, NSTEMI, and unstable angina were 10%, 32% and 57% respectively. Cardiogenic shock was present in 6%; 1 out of hospital cardiac arrest; 62% had multivessel disease. Procedural success rate was 99% with mean 1.5 stents per patient deployed and 80% received drug-eluting stents. 4% received glycoprotein IIb/IIIa inhibitors; 41% femoral approach; 9% suffered from periprocedural bleeding complications; and 4% developed contrast-induced nephropathy. In-hospital mortality was 3% (2 cardiac deaths, 1 anuric renal failure, 1 haemorrhagic stroke). There was no additional mortality or MACE event at 30 days. Conclusion: In a selected group of elderly patients, high PCI success rates can be achieved with favourable short-term outcomes. Further studies are warranted to examine the long-term outcomes of management strategies in this population.

Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.

Objective The hemodynamic benefits of catheter-directed thrombolysis for acute pulmonary embolism have not been clearly defined beyond the periprocedural period. The objective of this study is to report midterm outcomes of catheter-directed thrombolysis for treatment of acute pulmonary embolism. Methods Records of all patients undergoing catheter-directed thrombolysis for high- or intermediate-risk pulmonary embolism were retrospectively reviewed. Endpoints were clinical success, procedure-related complications, mortality, and longitudinal echocardiographic parameter improvement. Results A total of 69 patients underwent catheter-directed thrombolysis (mean age 59 ± 15 y, 56% male). Eleven had high-risk and 58 intermediate-risk pulmonary embolism. Baseline characteristics did not differ by pulmonary embolism subtype. Fifty-two percent of patients underwent ultrasound-assisted thrombolysis, 39% standard catheter-directed thrombolysis, and 9% other interventional therapy; 89.9% had bilateral treatment. Average treatment time was 17.7 ± 11.3 h with average t-Pa dose of 28.5 ± 19.6 mg. The rate of clinical success was 88%. There were two major (3%) and six minor (9%) periprocedural bleeding complications with no strokes. All echocardiographic parameters demonstrated significant improvement at one-year follow-up. Pulmonary embolism-related in-hospital mortality was 3.3%, and estimated survival was 81.2% at one year. Conclusions Catheter-directed thrombolysis is safe and effective for treatment of acute pulmonary embolism, with sustained hemodynamic improvement at one year. Further prospective large-scale studies are needed to determine comparative effectiveness of interventions for acute pulmonary embolism.