Safety of transradial cardiac catheterization in patients with endstage ...

Catheterization and Cardiovascular Interventions 00:00–00 (2013)

Original Studies Safety of Transradial Cardiac Catheterization in Patients with End-Stage Liver Disease Evan Jacobs,1 MD, Vikas Singh,1 MD, Abdulla Damluji,1 MD, MPH, Neil R. Shah,1 MD, Jessica L. Warsch,1 MD PhD, Ravi Ghanta,2 MD, Paul Martin,2 MD, Carlos E. Alfonso,1 MD, Claudia A. Martinez,1 MD, Mauro Moscucci,1 MD, and Mauricio G. Cohen,1* MD Background: Transradial access may be advantageous for patients with end-stage liver disease (ESLD) who need to undergo left heart catheterization (LHC). We aimed to assess the safety of transradial cardiac catheterization in patients listed for orthotopic liver transplantation. Methods: This is a retrospective analysis of consecutive adult patients with the diagnosis of ESLD, who underwent LHC via transradial access as part of a pre-operative liver transplantation evaluation. All the patients also underwent right heart catheterization (RHC) via brachial or femoral vein. The primary outcome measure was procedure-related major bleeding. Secondary outcomes included access site minor bleeding, in-hospital mortality, radial access failure, and acute kidney injury. Results: A total of 82 consecutive patients with ESLD, who underwent LHC via transradial access, were enrolled in the study. All patients also underwent RHC (n 5 45 via brachial and n 5 37 via femoral vein). The median age was 59 (54, 67) years old, and 58% were male. History of coronary artery disease or heart failure was present in 17% of patients. The median MELD score was 19 (13, 24.5), baseline hemoglobin was 10.5 mg/dL (9.4, 11.8), INR was 1.4 (1.2, 1.8) and platelets were 74,000 (53,000, 117,000)/ mm3. The most common etiology of liver failure was viral hepatitis (51%), followed by alcoholic cirrhosis (24%) and non-alcoholic steatohepatitis (21%). Angiographically significant coronary artery disease was present in 17 (21%) patients. Major bleeding and acute kidney injury each occurred in two patients (2.4%). There were no instances of vascular complications. There were no deaths attributable to complications from cardiac catheterization. Conclusion: Upper extremity right and left heart catheterization appears to be a safe method to evaluate coronary anatomy and hemodynamics C 2013 Wiley V in a severely ill population of patients with ESLD awaiting transplant. Periodicals, Inc.

Key words: cardiac catheterization; transradial; liver disease; bleeding and transplant

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From the Cardiovascular Division, Department of Medicine, and the Elaine and Sydney Sussman Cardiac Catheterization Laboratory, University of Miami Hospital, Miller School of Medicine, Miami, Florida 2 Division of Gastroenterology and Hepatology, University of Miami Hospital, Miller School of Medicine, Miami, Florida Conflict of interest: Nothing to report. Evan Jacobs and Vikas Singh contributed equally to this manuscript and share the first authorship. C 2013 Wiley Periodicals, Inc. V

*Correspondence to: Mauricio G. Cohen, MD, University of Miami Hospital, 1400 NW 12th Avenue, Suite 1179 Miami, FL 33136. E-mail: [email protected] Received 7 February 2013; Revision accepted 19 May 2013 DOI: 10.1002/ccd.25043 Published online in Wiley Online Library (wileyonlinelibrary.com).

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INTRODUCTION

Advances in surgical technique and donor matching have improved outcomes in patients undergoing orthotopic liver transplantation. As a result, higher risk patients with multiple cardiovascular risk factors and other chronic conditions are now considered candidates [1]. The incidence of coronary artery disease in patients with end-stage liver disease (ESLD) has been reported to be in the range of 5–27% [2–7]Additionally, studies have also shown that 5–26% of all liver transplant candidates have at least one critical coronary lesion [3,5,8]. A case–control study to assess the safety of left heart cardiac catheterization (LHC) in ESLD suggested that patients with ESLD had more complications including higher incidence of pseudoaneurysms, greater reductions in hemoglobin levels, increased need for postprocedural blood product transfusions, and higher rates of major bleeding [9]. Most complications were related to vascular access, which was transfemoral in 95% of the reported series. In recent years, there has been increasing interest in transradial access for cardiac catheterization. A large study including 32,822 non-ESLD patients, demonstrated that transradial access for coronary interventions was associated with a 50% reduction in transfusion rate when compared to femoral access [10]. This transformed into a significant reduction in 30-day and 1-year mortality, odds ratio ¼ 0.71 (95% CI 0.61–0.82) and 0.83 (0.71–0.98), respectively (both P < 0.001) [10]. Although a large multicenter randomized clinical trial did not show a significant difference in major bleeding between transradial and transfemoral approaches, it did demonstrate a 63% reduction in vascular access complications with a trans-radial approach [11]. It is apparent that transradial access may be advantageous for patients with ESLD who need to undergo cardiac catheterization. To date, there is a paucity of data examining the safety of transradial catheterization in patients with ESLD. We aimed to assess the safety of transradial cardiac catheterization in patients with ESLD listed for orthotopic liver transplantation.

METHODS

We performed a retrospective analysis of all cardiac catheterizations performed between February 2008 and July 2010 to identify patients with ESLD being evaluated for liver transplantation. All consecutive adult patients (18 years of age) with the diagnosis of ESLD, who underwent cardiac catheterization via transradial access as part of a pre-operative liver transplantation evaluation met inclusion criteria. These

patients also routinely undergo right heart catheterization (RHC) via brachial or femoral vein. Radial arterial access was obtained using a micropuncture IV catheter using either back-wall or anterior wall technique and a 13-cm hydrophilic-coated sheath. Catheter selection was at the discretion of the physician performing the procedure. Femoral arterial access was obtained using conventional technique with largebore needles. Venous access in the upper extremity was obtained either in the antecubital or brachial vein. To access the antecubital vein, an 18 gauge catheter was inserted in the antecubital fossa. In the catheterization laboratory, the IV catheter was exchanged for a 5F sheath using a short 0.02100 wire. If the superficial veins were not accessible, a tourniquet was placed in the upper arm and ultrasound guidance was used to access the brachial vein with a micropuncture needle (Fig. 1). Once venous access was secured, a 5 French 120 cm long balloon-tipped catheter was advanced into the superior vena cava with or without the use of a 0.02500 guide wire. Femoral venous access was obtained using standard technique and 6 or 7 F introducers. The primary outcome measure was procedure-related major bleeding, defined by Bleeding Academic Research Consortium (BARC) criteria 3A or greater (Fig. 2) [12]. Relevant procedural variables collected included access site, sheath size, number of sheaths used, concurrent RHC, fluoroscopy time, volume of contrast used, and LHC findings. Angiographically significant lesions were defined as those 70% stenosis. Secondary outcomes included access site minor bleeding, in-hospital mortality, radial access failure (transition to femoral access), and acute kidney injury (AKI). AKI defined as a 0.5 mg/dL increase in serum creatinine if the baseline serum creatinine was 1.9 mg/dL, a 1.0 mg/dL increase in serum creatinine if the baseline serum creatinine was 2.0–4.9 mg/dL, and a 1.5 mg/dL increase in serum creatinine if the baseline serum creatinine was 5.0 mg/dL. Additionally, blood products administration (i.e., fresh frozen plasma, platelets, or cryoprecipitate) within the first 24 hr after the procedure was also examined. All data abstraction was performed by systematic review of the electronic medical records. Descriptive statistics, including proportions for binary and categorical data, and median and inter-quartile range (IQR) for continuous data, were presented. Comparisons were performed using Wilcoxon rank sum, Student’s t, and chi-square tests, appropriately. Statistical significance was defined as a two-sided P < 0.05. All analyses were performed using Stata 11.0 software (Stata Corporation, College Station, TX). The Institutional Review Board at the University of Miami approved the study.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

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Fig. 1. Trans-Radial Artery Access and Sheath Introduction. (A) The right arm is placed in an abducted position and (B) right radial artery is prepped and draped in a sterile fashion. After use of sparing local anesthesia, (C) the right radial artery is canulated approximately 1–2 cm proximal to the radial styloid using a micropuncture system at 30- to 45-degree angulation. Subsequently, (D–E) the ultrasound is used to confirm

placement in the right radial artery to allow safe introduction and advancement of the guide wire. Once fully advanced, the hydrophilic sheath is introduced into the right radial artery. After the sheath is positioned and flushed, (F) the catheter can be introduced safely for the radial procedure. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

RESULTS

Of the 82 subjects, 17 (21%) had angiographically significant coronary artery disease (Table II). PCI was performed in three patients (3.7%) without complications. There were five (6%) cases in which attempts at radial access were unsuccessful with need for crossover to femoral access. All procedures in patients with prior coronary artery bypass grafting (CABG) were performed via transradial access without the need for crossover. Major bleeding occurred in two patients (2%), however neither event was related to the radial arterial site. There were two venous access site bleeds; one in the groin, and one at the site of a peripherally inserted central catheter (PICC line). The individual characteristics of the two patients with major bleeding are shown in

A total of 82 consecutive patients who had undergone LHC via the transradial approach were identified. All patients also underwent RHC (n ¼ 45 via brachial and n ¼ 37 via femoral vein). Baseline characteristics are depicted in Table I. The median age was 59 (54, 67) years old, and 58% were male. A history of coronary artery disease or heart failure was present in 17% of patients. The median MELD score was 19 (13, 24.5) and baseline hemoglobin was 10.5 mg/dL (9.4, 11.8). The median baseline INR was 1.4 (1.2, 1.8) and platelets were 74,000 (53,000, 117,000)/mm3. The most common etiology of liver failure in this cohort was viral hepatitis (51%), followed by alcoholic cirrhosis (24%), and non-alcoholic steatohepatitis (21%).


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Fig. 2. Bleeding Academic Research Consortium definition for major bleeding.

Table III. To assess the highest-risk group, we conducted a sensitivity analysis excluding patients with platelet count 50,000/mm3 and INR 1.8, yielding a 0% major bleeding rate and a 95% upper confidence limit of 17 and 19%, respectively. There were no instances of intracranial, retroperitoneal, genitourinary, or gastrointestinal hemorrhages. There were no occurrence of hematomas, pseudoaneurysms, or arteriovenous fistulas recorded. Secondary outcomes are summarized in Table IV. There were no deaths attributable to complications of arterial catheterization. Out of the entire cohort, six (7%) patients expired during their hospitalization due to progression of liver disease. Only six patients required alternative blood products (FFP, cryoprecipitate, or platelets) during the immediate post-procedural period, however, the need for blood products could not be directly attributed to procedural complications, as many of these patients were already anemic and required transfusions. Two patients (2.4%) developed

AKI. Fifteen percent of patients underwent transradial diagnostic LHC as an outpatient, and were discharged home on the same day. DISCUSSION

Our results suggest that right and left diagnostic cardiac catheterization via transradial arterial access and antecubital/brachial venous access is safe in patients with ESLD and may result in a lower risk of procedure related major bleeding than tranfemoral access. Only 2.4% of the patients who underwent transradial LHC, as part of a pre-transplant workup, met the final endpoint of BARC 3A or greater major bleeding. There were no instances of bleeding or hematoma noted at the radial site. The performance of left-heart catheterization in patients with ESLD has already been described.9 In that study, 95% of cirrhotic subjects were catheterized via the transfemoral approach with a major bleeding


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TABLE I. Characteristics of 82 End Stage Liver Disease Patients Who Underwent Trans-Radial Catheterization

TABLE II. Characteristics of the 82 Trans-Radial Catheterization Procedures

Characteristics

Trans-Radial Procedure Characteristics

Demographic and baseline data Age, median [IQR] years Male, N (%) Race, N (%) White Black Hispanic Body mass index (BMI), median [IQR] kg/cm2 Mean arterial blood pressure, median [IQR] mm Hg Smoking, N (%) Hypertension, N (%) Dyslipidemia, N (%) Diabetes mellitus, N (%) History of MI or CHF, N (%) Prior PCI or CABG, N (%) Ascites, N (%) Viral hepatitis, N (%) History alcohol abuse, N (%) NASH, N (%) Hepatic encephalopathy, N (%) Esophageal varices, N (%) Spontaneous bacterial peritonitis, N (%) Hepatocellular carcinoma, N (%) Baseline transfusion data Required pre-operative blood products, N (%) Platelet transfusions, N (%) Fresh frozen plasma, N (%) Red blood cells, N (%) 2 units of PRBC Single donor platelet transfusion, N (%) Fresh frozen plasma, N (%) Cryoprecipitate, N (%) Nadir hemoglobin, median [IQR] mg/dL Hospital Outcomes Acute kidney injury, N (%) Same day discharge, N (%) In-hospital mortality, N (%) Length of stay, median [IQR] day

2 (2) 2 (2) 4 (5) 1 (1) 2 (2) 3 (4) 1 (1) 10 [9, 11] 2 (2) 12 (15) 6 (7) 1 [1, 5]

Percent may not add to 100% due to rounding. Abbreviations: IQR ¼ interquartile range; PRBC ¼ Packed Red Blood Cell.


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significant lesion. This prevalence is within the previously reported range of 5–25%.3,5,8 This finding suggests the need for aggressive cardiovascular risk stratification in candidates for liver transplant. However, the optimal method has not been established and practices vary across institutional transplant programs [14]. RHC is routinely performed at our institution as a part of pre-operative liver transplantation evaluation. In our study, this was performed by brachial (n ¼ 45) or femoral (n ¼ 37) veins based on operator’s preference. Historically portopulmonary hypertension is an important complication of cirrhosis, present in up to 8% of adult candidates [15]. A mean pulmonary artery pressure >35 mm Hg not amenable to medical therapy is a contraindication to liver transplant. In this study, however, the findings of routine RHC did not influence the decision making for liver transplant which questions the utility of this procedure in routine practice during the pre-transplant work-up. A transthoracic Doppler echocardiogram with a sensitivity of 97% and specificity of 77% may perhaps be a better screening test for diagnosing moderate to severe pulmonary hypertension in patients undergoing evaluation for liver transplantation [16]. RHC may be reserved for confirming the diagnosis of pulmonary hypertension when there is evidence of elevated right sided pressures on transthoracic echocardiogram. This finding is especially important because the two major bleeds in our study were from venous access sites. This was a retrospective, observational study with known inherent limitations. The present study did not directly compare transradial and transfemoral LHC in patients with ESLD. The lack of a control group in this study prevented us from drawing a conclusion on superiority of transradial over transfemoral approach however; our data suggests the usefulness of future studies directly comparing the two approaches. Finally, this was a single-center study, with a relatively small sample size. A larger, randomized study in ESLD patients is needed to more definitively demonstrate the safety of right and left cardiac catheterization using upper extremity in comparison with groin access. However, this study would be difficult to perform due to already available data demonstrating decreased bleeding rates and vascular complications with transradial access in the setting of PCI [13,17,18].

CONCLUSION

Upper extremity right and left heart catheterization appears to be a safe method for defining coronary anatomy and hemodynamics in a severely ill population of patients with ESLD awaiting transplant.

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