Bleeding Complications Related to Right Heart Catheterization in the Setting of Elevated INR

Abstract: Objectives. Right heart catheterization (RHC) provides cardiovascular hemodynamic information in a variety of clinical settings. RHC performed in the setting of coagulopathy may have the potential to increase bleeding complications; however, data currently are limited. This study was undertaken to determine bleeding complications during RHC with an elevated international normalized ratio (INR) value. Methods. A total of 312 patients who underwent RHC were retrospectively studied. Patients were divided into two groups: INR <1.8 (257 patients; median INR, 1.2; range, 0.8-1.7) and INR ≥1.8 (55 patients; median INR, 2.1; range, 1.8-4.0). There were 80 patients (31.1%) and 46 patients (83.6%) taking oral vitamin K antagonist (warfarin) in the INR <1.8 and ≥1.8 groups, respectively. Results. Overall bleeding complications related to the procedure were extremely low, occurring in 2 patients (0.6%). All bleeding complications occurred in the INR <1.8 group, and both patients developed a small-sized hematoma requiring prolonged manual pressure without further intervention (0.8% vs 0.0% in the INR <1.8 vs INR ≥1.8 groups, respectively; P>.99). Conclusion. Bleeding complications associated with RHC were extremely low when performed by experienced operators in the cardiac catheterization laboratory. Furthermore, these complications were not related to an elevated INR, as bleeding occurred in patients with INR <1.8. Performing RHC in patients with an elevated INR in the therapeutic range did not increase bleeding compared to lower INR values. 

J INVASIVE CARDIOL 2018;30(5):191-194. Epub 2018 February 15.

Key words: right heart catheterization, bleeding, international normalized ratio, INR, coagulopathy

Right heart catheterization (RHC) with the use of a pulmonary artery catheter provides cardiovascular hemodynamic information in a variety of clinical settings.^1-4 As with any invasive medical procedure, there are complication risks related to performing RHC; potential complications include arrhythmias, thromboembolism, air embolism, bleeding, vascular injury, and infection, among others.^5-9 There is particular concern for procedure-related morbidity in the clinical setting of coagulopathy, with the potential impact for bleeding. Coagulopathy can result from an iatrogenic cause due to anticoagulation therapy (eg, treatment for atrial fibrillation, deep venous thrombosis, pulmonary embolism, other) or from an underlying disease process (eg, liver disease, kidney disease, other). Although expert consensus recommendations on international normalized ratio (INR) value when performing left heart catheterization exist,¹⁰ recommendations are limited for performing RHC, which is a procedure that is accessed from the lower pressure venous system.^10,11 As a result, this study was undertaken to determine if there was an increased risk of bleeding when performing RHC with an INR <1.8 compared to INR ≥1.8.

Methods

This retrospective review identified 312 consecutive patients from The Ohio State University Cardiac Catheterization Laboratory DataBank (OSU-CCLDB) who underwent RHC in the cardiac catheterization laboratory. Patients were divided into two groups: INR <1.8 (257 patients) and INR ≥1.8 (55 patients). Given the lack of recommendations for INR value when performing RHC, current recommendations for INR value for performing a left heart catheterization were chosen as a surrogate based upon expert consensus thresholds.⁵ Patient demographics and clinical parameters were collated and analyzed. Patients who were taking a direct oral anticoagulant (DOAC) at the time of RHC were not included in this study. All individuals had labs drawn within 24 hours prior to the procedure.

Vascular access sites included internal jugular, femoral, brachial, or subclavian veins. Institutional protocol for sheath removal was standardized and included applying manual pressure for 10 minutes after sheath removal at all access sites in order to achieve hemostasis. A dedicated sheath-removal team performed all sheath removals. Following femoral vein sheath removal and achievement of hemostasis, bedrest while keeping the procedure leg straight for 1 hour was required. After brachial vein sheath removal and achievement of hemostasis, the procedure arm was kept straight for 1 hour. After jugular or subclavian vein sheath removal and achievement of hemostasis, bedrest for 10 minutes was required.

Bleeding complications were analyzed for both groups and defined as the following: (1) hematoma at access site; (2) bleeding at access site; (3) retroperitoneal bleeding; and (4) packed red blood cell transfusion. Bleeding complications were determined by reviewing the electronic medical records, including procedural reports, mandatory documentation by sheath-removal team, staff and faculty notes during hospital stay, clinic follow-up notes, transfusion records, and laboratory reports 30 days before and after the procedure. In addition, patients at discharge were instructed to call with the occurrence of any adverse events. Antiplatelet therapies were also determined for each group. The institutional review board approved the study.

Statistical analysis. Descriptive data are shown as mean ± standard deviation. To determine statistical significance between the two groups, Fisher’s exact test, Chi-square test, or Student’s t-test were used where appropriate. A P-value <.05 was considered statistically significant.

Results

Patient demographics and clinical parameters are shown in Table 1. There were 257 patients with a mean age of 59 ± 14 years who had an INR <1.8 and 55 patients with a mean age of 59 ± 12 years who had an INR ≥1.8 (P=.92). Mean INR was 1.2 ± 0.2 in the INR <1.8 group and 2.2 ± 0.4 in the INR ≥1.8 group (P<.001); median INR was 1.2 (range, 0.8-1.7) in the INR <1.8 group and 2.1 (range, 1.8-4.0) in the ≥1.8 group. Eighty patients (31.1%) in the INR <1.8 group and 46 patients (83.6%) in the INR ≥1.8 group were taking oral vitamin K antagonist (warfarin). There were significantly more females in the INR <1.8 group compared to the INR ≥1.8 group (50.2% vs 20.0%, respectively; P<.001). In addition, patients in the INR ≥1.8 group had significantly greater body surface area (2.2 ± 0.3 m² vs 2.0 ± 0.3 m² in the INR <1.8 group; P<.001). 

Internal jugular or femoral vein access was overall used in 294 patients (94.2%) (Table 2). Internal jugular vein access was used in 146 patients in the INR <1.8 group (56.8%) and 46 patients (83.6%) in the INR ≥1.8 group (P<.001). Femoral vein access was used in 97 patients (37.7%) in the INR <1.8 group and 5 patients (9.1%) in the INR ≥1.8 group (P<.001). Brachial or subclavian vein access was rare, and used in 18 patients (5.7%) overall.

Antiplatelet therapies are shown in Table 3. At least 1 antiplatelet medication was being taken by 168 patients (65.4%) in the INR <1.8 group and 43 patients (78.2%) in the INR ≥1.8 group (P=.08). Dual-antiplatelet therapy (aspirin plus clopidogrel) was being taken by 48 patients (18.7%) in the INR <1.8 group and 6 patients (10.9%) in the INR ≥1.8 group (P=.23).

Overall bleeding complications related to the procedure were extremely low, occurring in 2 patients (0.6%). Both bleeding complications occurred in the INR <1.8 group, which included 1 patient with an INR of 1.0 and 1 patient with an INR of 1.1. Both patients developed a small-sized hematoma at the access site (0.8% in the INR <1.8 group vs 0% in the INR ≥1.8 group; P>.99), with each patient requiring prolonged manual pressure at the access site without further intervention. In both these patients, the RHC was performed from the femoral vein. One patient was taking dual-antiplatelet therapy and the other patient was only taking aspirin. There was no access-site bleeding, retroperitoneal bleeding, or need for blood transfusion in either group. 

Discussion

Hemodynamic assessment can be useful in a variety of clinical settings and can be accurately determined by RHC.^1-4 Potential complications associated with RHC can include arrhythmias, bleeding, vascular injury, and thromboembolic events.^5-9 Occasionally in clinical practice, there is a need to perform RHC in the setting of a coagulopathy; however, there is often a perceived risk of increased bleeding. Coagulopathy can result from an iatrogenic cause due to oral anticoagulation use, such as oral vitamin K antagonists (eg, warfarin), or to an underlying disease process such as liver disease. There were 125 patients (40.4%) taking warfarin in this study, with 80 patients (31.1%) in the INR <1.8  group and 46 patients (83.6%) in the INR ≥1.8 group. Although the expert consensus recommendation for INR value when performing left heart catheterization is <1.8,¹⁰ the recommendation is limited for INR value when performing RHC, which is a procedure that is accessed from the lower pressure venous system.

This study demonstrated that overall bleeding complications with RHC were extremely rare, occurring in 0.6% of patients with INR values ranging from 0.8-4.0. Previous studies have demonstrated bleeding from venous access ranging from approximately 0%-4%, depending on the access site.^11-16 There were only 2 patients, both in the INR <1.8 group (median INR, 1.2; range, 0.8-1.7), who developed a small hematoma at the access site requiring prolonged manual pressure to achieve hemostasis. Once hemostasis was achieved, re-application of manual pressure to the access site was not required. Furthermore, no blood transfusions were required. There were no bleeding complications in the INR ≥1.8 group, which had a median INR of 2.1 (range, 1.8-4.0). There was a lower percentage of patients with femoral vein access in the INR ≥1.8 group compared to the INR <1.8 group, which may have contributed to a lower risk of bleeding; however, the overall numbers were too small to make any meaningful conclusion.^11-16 Furthermore, 67.6% of the overall patients were also taking at least 1 antiplatelet medication, including 65.4% in the INR <1.8 group and 78.2% in the ≥1.8 group, respectively. This demonstrates the relative safety of the procedure when performed by experienced operators regardless of coagulopathy including the use of warfarin and/or antiplatelet therapy. 

Study limitations. While this study does highlight the relative safety of RHC performed by experienced operators, there are some limitations. Bleeding complications that occurred beyond hospital stay may have been missed; however, if bleeding were to occur, it likely would be at the time of venous sheath removal or during the monitoring period in the postprocedure recovery unit. Moreover, laboratory values for a significant decrease in hemoglobin of >3 g/dL up to 30 days after the procedure were reviewed in the medical records. Although there were no bleeding complications in the INR ≥1.8 group, most of these procedures were performed with INR values in the therapeutic range of 2-2.9; the median INR was 2.1 and there were only 2 patients who had an INR >3.0; thus, the results must be interpreted with caution in the setting of severely elevated INRs.

Conclusion

Bleeding complications associated with RHC were extremely low when the procedures were performed by experienced operators in the cardiac catheterization laboratory. These complications were not related to an elevated INR, as bleeding occurred in patients with INR <1.8. Performing RHC in patients with an elevated INR in the therapeutic range did not increase bleeding compared to lower INR values. Thus, elevated INR in the therapeutic range should not preclude RHC, particularly when the information obtained may assist in patient management. 

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^*Joint first authors.

From the ¹Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio; and ²Florida Hospital Pepin Heart Institute, Tampa, Florida.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted November 5, 2017, provisional acceptance given November 8, 2017, final version accepted November 19, 2017.

Address for correspondence: Konstantinos Dean Boudoulas, MD, Associate Professor of Medicine, Department of Medicine, Section Head, Intervention Cardiology, Director, Cardiac Catheterization Laboratory, The Ohio State University, 473 W. 12th Avenue, Suite 200, Columbus, OH 43210. Email: kdboudoulas@osumc.edu