Temporary Right Heart Support With Percutaneous Jugular Access

Temporary Right Heart Support With Percutaneous Jugular Access Stefan P. Wirtz, MD, Christoph Schmidt, MD, Hugo Van Aken, MD, PhD, Gerd Brodner, MD, PhD, Dieter Hammel, MD, PhD, Hans Heinrich Scheld, MD, PhD, and Elmar Berendes, MD, PhD Departments of Anesthesiology and Intensive Care, and Thoracic and Cardiovascular Surgery, University Hospital Münster, Münster, Department of Anesthesia, Intensive Care and Pain Management, Fachklinik Hornheide, Münster, Department of Thoracic and Cardiovascular Surgery, Zentralkrankenhaus Links der Weser, Bremen, Germany Purpose. Temporary right heart bypass has shown to improve hemodynamic stability and safety in beating heart revascularization. We sought to evaluate feasibility and safety of a right ventricular assist device percutaneously implanted in the right jugular vein. Description. The A-Med jugular coaxial cannula (A-Med Systems Inc, West Sacramento, CA) is designed for percutaneous implantation. Blood from the right heart is drained through the outer tube of this two-cannula device to a microcentrifugal pump and returned into the pulmonary artery through the inner tube. Evaluation. In 10 patients scheduled for elective coronary bypass grafting without cardiopulmonary bypass, a total of 27 coronary anastomoses were performed with right heart support. Arterial pressure was significantly higher with right heart support when the heart was dislocated to access posterior and posterolateral anastomosis sites. Implantation through the right internal jugular vein was feasible without complications in all patients and facilitated the procedure. Conclusions. This initial study suggests safety and feasibility of temporary right heart support using percutaneous jugular access for posterior and posterolateral coronary bypass grafting. (Ann Thorac Surg 2006;81:701 5) 2006 by The Society of Thoracic Surgeons Temporary right heart support (RHS) has been proposed to maintain cardiovascular stability in coronary artery bypass grafting without cardiopulmonary bypass (CPB) [1 4]. Initial multicenter experience of coronary revascularization procedures with temporary RHS suggested better exposure to anastomosis sites, reduced inotropic need, increased hemodynamic stability, reduced inflammatory response, myocardial, neurologic, renal injury, and transfusion needs compared with on-pump surgery [1, 5, 6]. Technology In contrast with cannulation of the right atrium, the A-Med jugular coaxial cannula (A-Med Systems Inc) is a novel two-cannula device that provides access to the right heart and pulmonary artery through the right internal jugular vein. This report describes the first clinical use of this jugular cannula for temporary RHS. Accepted for publication Aug 15, 2005. Address correspondence to Dr Wirtz, Department of Anesthesiology and Intensive Care, University Hospital Münster, Albert-Schweitzer-Straße 33, Münster, D-48149 Germany; e-mail: stw@uni-muenster.de. We performed a feasibility study to determine the hemodynamic effects, efficacy, and safety of this percutaneously implanted device in coronary artery bypass grafting without CPB. Technique Ten patients scheduled for elective beating heart myocardial revascularization were enrolled in the protocol. Ethics committee approval and written informed consent were obtained for each patient. Anesthetic management was standardized. Instrumentation included a radial catheter to continuously monitor arterial blood pressure, a transesophageal echocardiography probe and a central venous catheter in the left internal jugular vein. Each patient received 10 ml kg 1 saline before anesthetic induction and the same volume until skin incision. An additional single-lumen catheter was inserted through the right internal jugular vein. Surgical disinfection and draping included the right cervical region and the central venous catheter except for its distal end, which was covered by drapes to secure sterility. After a median sternotomy, a loading dose of 100 IU kg 1 of heparin was administered. The activated 2006 by The Society of Thoracic Surgeons 0003-4975/06/$32.00 Published by Elsevier Inc doi:10.1016/j.athoracsur.2005.08.003

702 WIRTZ ET AL Ann Thorac Surg RIGHT HEART SUPPORT WITH JUGULAR ACCESS 2006;81:701 5 Fig 1. Implantation of an A-Med jugular coaxial cannula (A-Med Systems Inc, West Sacramento, CA). A dilator has been introduced into the right jugular vein using a Seldinger wire. The J-shaped drainage cannula has been straightened for introduction by another larger dilator inserted. clotting time (ACT II [Medtronic, Minneapolis, MN]) was maintained above 300 sec by repeat bolus administration of heparin. An Ultrastiff Seldinger wire (Datascope Corp, Fairfield, NJ) was inserted through the distal end of the central venous catheter, which was cut through in the surgical field. Subsequently the outer (ie, the venous) cannula (8-mm in diameter) of the A-Med jugular coaxial cannula (A-Med Systems Inc) was advanced into the right ventricle using different dilators (Fig 1). The inner (ie, the arterial) cannula (6-mm in diameter) was deployed through the lumen of the outer cannula after removal of the dilators. The tip of the inner tube was positioned in the main pulmonary artery. Transesophageal echocardiography was used to monitor the procedure and guide positioning of the cannulas (Fig 2). The Fig 3. An A-Med jugular coaxial cannula (A-Med Systems Inc, West Sacramento, CA) connected to a miniature centrifugal pump. The wall of the tubes is reinforced by a metal mesh. coaxial cannula was connected to a microcentrifugal pump (A-Med PARAflow miniature centrifugal pump system [(A-Med Systems Inc]) (Figs 3, 4). Blood from the right heart was drained to the pump and returned into the pulmonary artery. The heart was positioned for optimal access to each anastomosis site with the lowest possible decrease of arterial blood pressure. Optimal positioning was accomplished without apical suction positioners using deep pericardial stitches, tilting, and rotating of the table, and the Medtronic Octopus system (Medtronic Corp, Minneapolis, MN) for regional stabilization. The target coronary artery was temporarily occluded with Silastic loops (Ethiloop; Ethicon Products, Norderstedt, Germany) proximally and distally to the anastomosis site. In patients with a balanced or left dominant coronary distribution, the left anterior descendent artery was bypassed first to ensure blood supply of the anterior and posterior walls of the left ventricle with the left internal mammary artery as bypass graft. Trans- Fig 2. Transesophageal echocardiogram showing mid-esophageal view of the right heart. The row of arrows point at the reflections of the inner cannula with its tip positioned in the pulmonary artery. The cannula causes mild tricuspid regurgitation. Fig 4. An implanted A-Med jugular coaxial cannula (A-Med Systems Inc, West Sacramento, CA) and a miniature centrifugal pump. (PA pulmonary artery; RV right ventricle.)

Ann Thorac Surg WIRTZ ET AL 2006;81:701 5 RIGHT HEART SUPPORT WITH JUGULAR ACCESS 703 Table 1. Patient Characteristics and Data From Their History a Age (yrs) 64.1 10.6 (range, 43 77) Gender (female/male) 2/8 Body mass index (kg cm 2 1 ) 30.3 2.6 (range, 27.1 34.6) Left ventricular ejection fraction (%) 57.6 11.4 (range, 39 70) Medical history (n) a History of tobacco use never: 6 current: 1 former: 3 Family history of CAD no: 4 yes: 3 unknown: 3 Diabetes/treatment no: 8 diet: 1 insulin: 1 Hypercholesterolemia no: 1 yes: 9 History of renal failure no: 9 yes: 1 without dialysis Hypertension never: 4 yes: 6 History of stroke no: 10 yes: 0 Chronic lung disease no: 9 mild: 0 severe: 1 Previous myocardial infarction no: 7 yes: 3 Previous heart surgery no: 10 yes: 0 Thrombolysis treatment no: 8 6 hrs: 0 6 hrs: 2 History of arrhythmia no: 8 yes: 2 Current NYHA functional class I: 1 II: 3 III: 4 IV: 1 Diseased coronary vessels 1: 0 2: 6 3: 4 Values are expressed as n or mean standard deviation or range. CAD coronary artery disease; NYHA New York Heart Association. esophageal echocardiography was used for monitoring of global and regional right and left ventricular function and structural integrity of the heart throughout the procedure. After protamine reversal, the jugular cannula was removed; the insertion site was digitally compressed, and the skin was surgically closed by suture. To assess hemodynamic effects of the RHS, pump flow for each anastomosis was adjusted to achieve a maximal arterial blood pressure after positioning of the heart and installing the stabilizer. Inotropes or vasopressor, or both, were administered if mean arterial blood pressure fell to less than 50 mm Hg. Three minutes after reaching stable hemodynamics (ie, heart rate and mean arterial pressure 5%), the following parameters were recorded: systolic, diastolic and mean arterial pressure, systolic pulmonary artery pressure, and pump flow. Tricuspid regurgitation velocity on spectral Doppler was used to calculate right ventricular systolic pressure and thus pulmonary artery systolic pressure in transesophageal echocardiography. Then the surgeon started grafting the coronary artery. On completion of each distal anastomosis, the pump was stopped and the same measurements were recorded again 1 minute later with otherwise unchanged conditions. The overall time of dislocation was measured. To determine facilitation of surgery, the cardiac surgeon who performed all procedures was asked to judge target access and visualization in four categories. In addition, the surgeon used three different categories to evaluate if the jugular cannula added to the technical ease of the procedure. To evaluate safety, the rate of major adverse events (defined as tricuspid and pulmonary valvular damage with significant increase [ 2 ] in regurgitation, perforation of the heart or pulmonary artery, cardiac arrhythmias requiring treatment, new onset of left ventricular failure, pulmonary edema, pulmonary embolism, blood loss requiring transfusion [hemoglobin, 8.5gdL 1 ]or death) and minor adverse events (defined as any untoward deviation from a patient s baseline condition including all new conditions or symptoms, or a worsening of a preexisting condition or symptom) were noted. Further data were registered, such as technical, devicerelated problems, number of patients requiring use of vasopressors, amount of time required for cannulation and RHS running time, patient characteristics, details from their medical history, and operative data such as number of grafts, conversion to CPB, postoperative requirement of circulatory support, and organ function during the intensive care unit stay. Data are presented as mean standard deviation, median, and range using GraphPad InStat (GraphPad Software Inc, San Diego, CA). Exposed anastomosis sites were summarized in two groups of similar cardiac position. Group 1 comprised sites on the anterior and anterolateral surface of the heart. Group 2 comprised sites on the posterior and posterolateral surface of the heart. Data were analyzed using paired t tests after testing for normal distributions with the Kolmogorov-Smirnov method. The 2 test was used to analyze categorical data. Pearson correlation between pump flows and systolic blood pressure was calculated. A p value of less than 0.05 was considered statistically significant. Clinical Experience Preoperative clinical characteristics are presented in Table 1. Five patients received two grafts, and 4 patients

704 WIRTZ ET AL Ann Thorac Surg RIGHT HEART SUPPORT WITH JUGULAR ACCESS 2006;81:701 5 Fig 5. Box plots of hemodynamic data with and without temporary right heart support of anastomosis sites on the posterior and posterolateral wall of the heart. received three grafts. In 1 patient, four anastomosis sites were exposed under RHS conditions. The left anterior descendent artery was grafted with a left internal mammary bypass in each patient. A total of 27 anastomosis sites were exposed for grafting, with an average of 2.7 per patient. Group 1 comprised 16 anastomoses (left anterior descending artery, 10; diagonal branch, 3; first oblique marginal branch, 3). Group 2 comprised 11 anastomoses (right coronary artery, 3; distal left circumflex artery, 2; second and third oblique marginal branch, 6). Mean pump flow to achieve optimal blood pressure in group 2 was 3.2 0.5 L min 1 (range, 2.5 4.0 L min 1 ). Pump flows and systolic blood pressures did not correlate (r 2 0.257; p 0.135). The heart was dislocated 17 4 minutes (range, 12 to 22 min). Comparison of hemodynamic data with and without RHS revealed significant differences in group 2 (ie, systolic, diastolic, and mean arterial blood pressure decreased significantly after pump stop [Fig 5]). There was no change in blood pressure with the heart in situ. In both groups, pulmonary artery pressure was significantly higher with RHS. A significant difference in vasopressor requirements could not be demonstrated. The cardiac surgeon s rating of target access and visualization was excellent in 7, good in 1, average in 2, and poor in 0 cases. According to the surgeon s judgment, the jugular cannula significantly attributed to the technical ease of the procedure in all 10 cases. Percutaneous insertion of the coaxial cannula through the right internal jugular vein was feasible without complications in all patients. Removal of the cannula was not associated with any complications, such as significant hematoma. All procedures could be completed without conversion to CPB. The right pleura did not have to be opened in any of the patients. No adverse events related to the use of RHS occurred during the procedures. In 3 patients, single premature ventricular contractions were noticed during implantation of the cannula. No other arrhythmias and changes in electrocardiogram or transesophageal echocardiography, such as new regional wall motion abnormalities, were seen throughout the study period. None of the patients required mechanical circulatory support by intraaortic counterpulsation or assist devices postoperatively. Average duration of the insertion was 13.3 3.7 minutes (range, 10 to 21 min). Mean pump time was 66.1 13.3 minutes (range, 48 to 81 min). Four hours postoperatively, the median of cardiac troponin I concentrations was 0.37 g L 1 (range, 0.22 0.37 g L 1 ) and 12 hours postoperatively 0.34 g L 1 (range, 0.13 to 3.41 g L 1 ); the median of creatine kinase muscle-brain isoenzyme activities (CK MB) was 4 IU L 1 (range, 1 to 11 IU L 1 ) after 4 hours, and 5.5 IU L 1 (range, 1 to 40 IU L 1 ) after 12 hours. Four hours postoperatively, the median of serum creatinine concentrations was 1.1 mg dl 1 (range, 0.8 to 1.9 mg dl 1 ) and the median of urea concentrations was 18 mg dl 1 (range, 16 to 31 mg dl 1 ). The median of times to extubation was 5.0 hours (range, 2 to 13 hours). Nine patients were transferred from the intensive care unit the next morning, with 1 patient being transferred 8 hours after the end of the procedure. In 3 patients the Seldinger J-wire kinked, and a second wire had to be used. In 1 patient, removal of the dilator from the outer cannula was difficult. The microcentrifugal pump was exchanged during the procedure by reason of unexpected noise. However, the new pump produced the same noise. These sound phenomena occurred in another case at 4,000 to 4,500 rpm with a pump flow of 3.0 L min 1. No reason could be identified for these noises, and they did not influence the function of the pump. Comment In OPCAB surgery, compression of the right ventricle during tilting maneuvers can lead to hemodynamic deterioration [4, 7]. Right heart support has been found to improve surgical access to the anastomotic area and restore hemodynamics during displacement of the heart [1, 5]. Thus the danger of incomplete revascularization threatening a favorable outcome can be reduced. So far, cannulation of the right atrium has been used to establish RHS. To minimize invasiveness, a cannula-incannula percutaneously implanted through the right internal jugular vein has been developed. The new jugular access provides potential advantages. The device is positioned outside the body, far away from the surgical field, avoiding interference with surgical activities. Any cardiac trauma associated with additional bleeding risks can be eliminated. In redo cases, avoiding direct cannulation of the right atrium is beneficial because of additional exposure difficulties due to tissue scarring and adhesions. Therefore we performed a feasibility study of temporary RHS with transjugular access for coronary artery bypass procedures without CPB at first in patients with preserved left ventricular function. Right heart support

Ann Thorac Surg WIRTZ ET AL 2006;81:701 5 RIGHT HEART SUPPORT WITH JUGULAR ACCESS 705 resulted in increased arterial and pulmonary blood pressure when anastomoses were performed on the posterior and posterolateral walls, which facilitated the procedure. For anterior and anterolateral anastomoses, arterial pressure remained unchanged and thus RHS does not seem to be advantageous as has been reported earlier [1]. Despite the remarkable diameter of the A-Med cannula (A-Med Systems Inc), no vascular or cardiac complications occurred in our study; both implantation and removal of the cannula were not associated with serious adverse events. The unexpected pump noise in 2 patients did not interfere with the system s function or patient safety. However the cause for this observation could not be found. Time for implantation was reasonable. Beyond this, in no single case was conversion to CPB necessary. Our findings are in accordance with results of others who found that RHS facilitated coronary bypass without CPB to posterior vessels, restored hemodynamics, provided an improved view to anastomotic sites, and reduced inflammatory response, and myocardial, neurologic, and renal injury compared with surgery performed with CPB [1, 5, 6, 8, 9]. However this treatment is expensive and many surgeons have developed sophisticated surgical techniques for complete off-pump revascularization in the last few years. However, for OPCAB to reach its full potential it must be widely applicable to most or all patients, and be achievable by most or all surgeons. Preservation of hemodynamic stability is of paramount importance, allowing the surgeon to complete an unhurried precise anastomosis and to achieve complete revascularization. Minimally invasive methods and devices to assist the circulation during the procedure have the potential to broaden applicability of this surgical technique. This issue is particularly important because OPCAB grafting has been found to be associated with more incomplete revascularization [10]. This study has certain limitations. It was designed as a feasibility study with a limited number of patients with preserved left ventricular function. It is still unclear as to who should be treated with RHS and who should be treated with conventional techniques. Safety, efficacy, and clinical benefit have to be confirmed by larger randomized trials with diverse patients. There should be particular concern in patients with moderate or severe left ventricular dysfunction because too much RHS pump flow could conceivably flood the left ventricle. The cardiac surgeon s ratings reflect the impression of 1 individual and thus may be biased. The transjugular cannula may also be a useful right ventricular assist device access in closed chest situations for patients with acute right ventricular failure (eg, after cardiac transplantation, pulmonary embolism, or major cardiac procedures). In conclusion, temporary RHS using a novel jugular cannula seems to be feasible and safe. Our initial experiences with the system should encourage clinicians to perform larger trials aiming at relevant outcome measurements and other indications. Disclosures and Freedom of Investigation None of the authors has a financial or other interest in the products or the distributor of these products (A-Med Jugular Coaxial Cannula and A-Med PARAflow miniature centrifugal pump system [A-Med Systems Inc, West Sacramento, CA]) or any other manufacturer of products mentioned in this article. None of the authors has any kind of association conflicting with the freedom of science. However, the right ventricular assist device and cannulas used in this study have been provided by the manufacturer intended for testing purposes in our institution for no charge. All other materials and equipment have been supplied by institutional funds. No third party has had any influence on the design of the study, the collection, analysis, and interpretation of data, the writing of this report, or the decision to submit this article for publication. Jugular cannulas and right ventricular assist device pumps were provided by A-Med Systems Inc, West Sacramento, CA, for study purposes. References 1. Mathison M, Buffolo E, Jatene AD, et al. Right heart circulatory support facilitates coronary artery bypass without cardiopulmonary bypass. Ann Thorac Surg 2000;70:1083 5. 2. Suematsu Y, Ohtsuka T, Miyaji K, et al. Right heart minipump bypass for coronary artery bypass grafting: experimental study. Eur J Cardiothorac Surg 2000;18:276 81. 3. Porat E, Sharony R, Ivry S, et al. Hemodynamic changes and right heart support during vertical displacement of the beating heart. Ann Thorac Surg 2000;69:1188 91. 4. Gründeman PF, Borst C, Verlaan CW, Meijburg H, Moues CM, Jansen EW. Exposure of circumflex branches in the tilted, beating porcine heart: echocardiographic evidence of right ventricular deformation and the effect of right or left heart bypass. J Thorac Cardiovasc Surg 1999;118:316 23. 5. Lima L, Jatene F, Buffolo E, et al. A multicenter initial clinical experience with right heart support and beating heart coronary surgery. Heart Surg Forum 2001;4:60 4. 6. Caputo M, Yeatman M, Narayan P, et al. Effect of off-pump coronary surgery with right ventricular assist device on organ function and inflammatory response: a randomized controlled trial. Ann Thorac Surg 2002;74:2088 95. 7. Mathison M, Edgerton JR, Horswell JL, Akin JJ, Mack MJ. Analysis of hemodynamic changes during beating heart surgical procedures. Ann Thorac Surg 2000;70:1355 60. 8. Lundell DC, Crouch JD. A miniature right heart support system improves cardiac output and stroke volume during beating heart posterior/lateral coronary artery bypass grafting. Heart Surg Forum 2003;6:302 6. 9. Lundell D, Crouch J. Off-pump coronary bypass grafting with right heart support is equally effective for hemodynamic support in patients with higher or lower risk variables. Heart Surg Forum 2003;6(Supp 1):S45. 10. Sabik JF, Gillinov AM, Blackstone EH, et al. Does off-pump coronary surgery reduce morbidity and mortality? J Thorac Cardiovasc Surg 2002;124:698 707. Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.