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1.
World J Cardiol ; 14(5): 307-318, 2022 May 26.
Article in English | MEDLINE | ID: mdl-35702324

ABSTRACT

BACKGROUND: For patients with cardiovascular disease, blood pressure variability (BPV), distinct from hypertension, is an important determinant of adverse cardiac events. Whether pre-operative BPV adversely affects outcomes after percutaneous coronary intervention (PCI) is to this point unclear. AIM: To investigate the relationship between blood pressure variability and outcomes for patients post-PCI. METHODS: Patients undergoing PCI in a single state in 2017 were studied (n = 647). Systolic and diastolic BPV, defined as both the largest change and standard deviation for the 3-60 mo prior to PCI was calculated and patients with more than ten blood pressure measurements in that time were included for analysis (n = 471). Adverse outcomes were identified up to a year following the procedure, including major adverse cardiac events (MACE), myocardial infarction, cerebrovascular accident, death, and all-cause hospitalization. RESULTS: Visit-to-visit systolic BPV, as measured by both standard deviation and largest change, was higher in patients who had myocardial infarction, were readmitted, or died within one year following PCI. Systolic BPV, as measured by largest change or standard deviation, was higher in patients who had MACE, or readmissions (P < 0.05). Diastolic BPV, as measured by largest change, was higher in patients with MACE and readmissions (P < 0.05). CONCLUSION: As BPV is easily measured and captured in the electronic medical record, these findings describe a novel method of identifying at-risk patients who undergo PCI. Aggressive risk modification for patients with elevated BPV and known coronary artery disease is indicated.

2.
J Cardiovasc Pharmacol Ther ; 25(6): 523-530, 2020 11.
Article in English | MEDLINE | ID: mdl-32476465

ABSTRACT

BACKGROUND: Direct-acting oral anticoagulants are indicated for the treatment of nonvalvular atrial fibrillation, but their use in patients after undergoing cardiac surgery is poorly defined despite a high prevalence of postoperative atrial fibrillation in this population. METHODS: Patients diagnosed with postoperative atrial fibrillation were prospectively randomized to warfarin or apixaban. Safety, efficacy, and economic outcomes were evaluated until their 4- to 6-week postoperative appointment. RESULTS: While this pilot study was not powered to determine a difference in safety or efficacy, adverse event rates were similar to the published literature. It was noted that a patient's course of therapy when utilizing apixaban was significantly less costly than warfarin when including medication, bridging, and laboratory expenses. CONCLUSION: Apixaban and warfarin both appeared to be safe and effective for anticoagulation throughout the duration of this pilot study in treating postoperative atrial fibrillation after coronary artery bypass grafting. Apixaban was associated with significantly less expense when bridging and monitoring costs were included in addition to medication expense.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Coronary Artery Bypass/adverse effects , Factor Xa Inhibitors/administration & dosage , Pyrazoles/administration & dosage , Pyridones/administration & dosage , Warfarin/administration & dosage , Administration, Oral , Aged , Anticoagulants/adverse effects , Anticoagulants/economics , Atrial Fibrillation/diagnosis , Atrial Fibrillation/economics , Atrial Fibrillation/etiology , Coronary Artery Bypass/economics , Cost-Benefit Analysis , Drug Costs , Drug Monitoring , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/economics , Female , Humans , Male , Middle Aged , North Dakota , Pilot Projects , Prospective Studies , Pyrazoles/adverse effects , Pyrazoles/economics , Pyridones/adverse effects , Pyridones/economics , Time Factors , Treatment Outcome , Warfarin/adverse effects , Warfarin/economics
4.
Heart Asia ; 10(2): e010994, 2018.
Article in English | MEDLINE | ID: mdl-29765465

ABSTRACT

OBJECTIVES: In patients with symptomatic aortic valve disease who are at intermediate to high risk for open surgical aortic valve replacement, transcatheter aortic valve replacement (TAVR) decreases overall mortality and improves quality of life. Hypertension (HTN) after TAVR has been associated with improved cardiac function and short-term survival but its effect on survival over 1 year is unclear. Our study aims to evaluate the effect of HTN following TAVR on short-term and long-term clinical and echocardiographic outcomes. METHODS: A retrospective chart review case-control study of 343 consecutive patients who underwent TAVR between August 2012 and November 2016 was performed to elucidate the relationship between HTN and post-TAVR outcomes. RESULTS: 193 patients who underwent TAVR (56.2%) developed or had a worsening of their HTN after TAVR. The development of post-TAVR HTN was associated with a significantly better overall survival at 1 year (89% vs 67%, p<0.001) and 2 years (72% vs 46%, p=0.002). Patients with increased blood pressure also had a significant lower in hospital cardiovascular mortality (1% vs 12%, p<0.001). However, the development or worsening of their HTN after TAVR was associated with an increase in heart failure (HF) exacerbations and diuretic use. CONCLUSIONS: The development or worsening of HTN after TAVR is associated with improved overall survival despite an increase in postprocedural HF exacerbations and antihypertensive medication utilisation. The outcomes of this study could be important in postoperative management of patients who underwent TAVR.

5.
J Extra Corpor Technol ; 49(4): 299-303, 2017 12.
Article in English | MEDLINE | ID: mdl-29302121

ABSTRACT

The AngioVac suction cannula and circuit were designed for the percutaneous removal of soft thrombus and emboli in procedures requiring extracorporeal circulatory support. We describe a modification of the AngioVac suction catheter and cardiopulmonary bypass (CPB) circuit to effectively remove thrombus while maintaining the ability to rapidly initiate full CPBs during a medical crisis. This article will discuss the design concepts of the modified circuit as well as procedural protocols and considerations. The design modifications of incorporating an oxygenator, reservoir, and bridge allow for an increased flexibility that allows adaption to veno-venous extracorporeal membrane oxygenation or full CPB support when required for oxygenation or hemodynamic support.


Subject(s)
Cardiopulmonary Bypass/instrumentation , Embolectomy/instrumentation , Heart-Lung Machine , Oxygenators , Cardiopulmonary Bypass/methods , Embolectomy/methods , Equipment Design , Extracorporeal Circulation/instrumentation , Extracorporeal Circulation/methods , Extracorporeal Circulation/standards , Extracorporeal Membrane Oxygenation/instrumentation , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/standards , Heart-Lung Machine/standards , Humans , Length of Stay , Oxygenators/standards , Retrospective Studies , Suction , Thrombosis/prevention & control , Thrombosis/therapy
6.
Heart Surg Forum ; 16(2): E60-9, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23625478

ABSTRACT

OBJECTIVE: Oral P2Y12 platelet receptor inhibitors are a cornerstone of reducing complications in patients with acute coronary syndromes or coronary stents. Guidelines advocate discontinuing treatment with P2Y12 platelet receptor inhibitors before surgery. Cangrelor, a short-acting, reversible, intravenously administered P2Y12 platelet inhibitor is effective in achieving appropriate platelet inhibition in patients who are awaiting coronary artery bypass grafting (CABG) and require P2Y12 inhibition. The objective of this study was to assess the effects of preoperative cangrelor on the incidence of perioperative complications, which are currently unknown. METHODS: Patients (n = 210) requiring preoperative clinical administration of thienopyridine therapy were randomized in a multicenter, double-blinded study to receive cangrelor or placebo while awaiting CABG after discontinuation of the thienopyridine. Optimal platelet reactivity, which was defined as <240 P2Y12 platelet reaction units, was measured with serial point-of-care testing (VerifyNow). Pre- and postoperative outcomes, bleeding values, and transfusion rates were compared. To quantify potential risk factors for bleeding, we developed a multivariate logistic model. RESULTS: The differences between the groups in bleeding and perioperative transfusion rates were not significantly different. The rate of CABG-related bleeding was 11.8% (12/102) in cangrelor-treated patients and 10.4% (10/96) in the placebo group (P = .763). Transfusion rates for the groups were similar. Serious postoperative adverse events for the cangrelor and placebo groups were 7.8% (8/102) and 5.2% (5/96), respectively (P = .454). CONCLUSIONS: Compared with placebo, bridging patients with cangrelor prior to CABG effectively maintains platelet inhibition without increasing post-CABG complications, including bleeding and the need for transfusions. These data suggest cangrelor treatment is a potential strategy for bridging patients requiring P2Y12 receptor inhibition while they await surgery.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Blood Transfusion/statistics & numerical data , Coronary Artery Bypass/statistics & numerical data , Postoperative Hemorrhage/epidemiology , Postoperative Hemorrhage/prevention & control , Premedication/statistics & numerical data , Pyridines/administration & dosage , Adenosine Monophosphate/administration & dosage , Administration, Oral , Adult , Aged , Aged, 80 and over , Drug Therapy, Combination/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Injections, Intravenous , Male , Middle Aged , Placebo Effect , Platelet Aggregation Inhibitors/administration & dosage , Prevalence , Purinergic P2Y Receptor Antagonists/administration & dosage , Risk Assessment , Treatment Outcome , United States/epidemiology
8.
Anesth Analg ; 113(1): 19-30, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21346163

ABSTRACT

BACKGROUND: Few studies describe an association of perioperative blood pressure stability with postoperative outcome. We tested the hypothesis that systolic blood pressure (SBP) variability in patients undergoing cardiac surgery is associated with 30-day mortality. METHODS: Perioperative blood pressure variability was evaluated in the 1512 patients who were randomized and had perioperative hypertension in the ECLIPSE trials. Blood pressure variability was assessed as the product of magnitude × duration of SBP excursions outside defined SBP ranges (area under the curve). SBP ranges were analyzed from 65 to 135 mm Hg intraoperatively and 75 to 145 mm Hg pre- or postoperatively, up to 105 to 135 mm Hg intraoperatively and 115 to 145 mm Hg pre- or postoperatively, with the narrower ranges defined by progressively increasing the lower SBP limit by 10 mm Hg increments. Multiple logistic regression was used to assess the association of blood pressure variability with 30-day mortality obtained from the primary ECLIPSE trial results. RESULTS: Increased SBP variability outside a range of 75 to 135 mm Hg intraoperatively and 85 to 145 mm Hg pre- and postoperatively is significantly associated with 30-day mortality. The odds ratio was 1.16 (95% confidence interval, 1.04-1.30) for 30-day mortality risk per incremental SBP excursion of 60 mm Hg × min/h. The predicted probability of 30-day mortality increased for low-risk patients from 0.2% to 0.5%, and for high-risk patients from 42.4% to 60.7% if the area under the curve increased from 0 to 300 mm Hg × min/h. CONCLUSIONS: Perioperative blood pressure variability is associated with 30-day mortality in cardiac surgical patients, proportionate to the extent of SBP excursions outside the range of 75 to 135 mm Hg intraoperatively and 85 to 145 mm Hg pre- and postoperatively. Predicted mortality was greater for high-risk patients than for low-risk patients.


Subject(s)
Blood Pressure/physiology , Cardiac Surgical Procedures/mortality , Perioperative Care/mortality , Postoperative Complications/mortality , Aged , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/trends , Female , Humans , Male , Middle Aged , Perioperative Care/trends , Postoperative Complications/physiopathology , Prospective Studies , Survival Rate/trends , Treatment Outcome
9.
J Card Surg ; 23(6): 655-8, 2008.
Article in English | MEDLINE | ID: mdl-18793221

ABSTRACT

OBJECTIVE: Bivalirudin has a short elimination half-life of approximately 25 to 30 minutes, but no antidote is available. We assessed the effect of four different strategies of modified ultrafiltration after cardiopulmonary bypass on the bivalirudin elimination and postoperative blood loss. METHODS: Five groups of seven patients undergoing elective "on-pump" coronary artery bypass grafting were enrolled in this controlled randomized investigation. The filtration strategies varied with regard to the filtration flow, the filtrate volume, the addition of vacuum suction to the filter system, and the performance of hemodiafiltration. Filtration was started after weaning from cardiopulmonary bypass (CPB). The cumulative postoperative blood drainage at 12 hours was recorded. RESULTS: Bivalirudin half-life in the control group was 0.6 +/- 0.11 hours, and the blood loss was 958 +/- 472 mL. Hemofiltration with a constant flow of 300 mL/m(2) body surface area/min and a filtrate volume of 3000 mL reduced the elimination half-life significantly to 0.47 +/- 0.11 hours. Adding the process of dialysis to hemofiltration resulted in a half-life of 0.52 +/- 0.04 hours and reduced the 12-hour postoperative blood loss significantly, compared to the control group, to 444 +/- 220 mL. The other strategies failed to augment the bivalirudin elimination and postoperative drainage effectively. CONCLUSION: Zero-balanced modified hemodiafiltration without addition of vacuum suction is effective in improving the elimination of bivalirudin after CPB and reducing the postoperative blood loss. Zero-balanced hemodiafiltration should be considered for the augmented elimination of bivalirudin in complex surgical procedures with a high risk of bleeding complications. However, larger investigations are warranted to confirm these results.


Subject(s)
Anticoagulants/pharmacokinetics , Coronary Artery Bypass/adverse effects , Hemodiafiltration/methods , Hirudins/pharmacokinetics , Peptide Fragments/pharmacokinetics , Postoperative Hemorrhage/prevention & control , Female , Humans , Male , Middle Aged , Partial Thromboplastin Time , Prospective Studies , Recombinant Proteins/pharmacokinetics , Risk Assessment , Risk Factors , Time Factors
10.
Anesth Analg ; 107(4): 1110-21, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18806012

ABSTRACT

BACKGROUND: Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of clevidipine (CLV) with nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery. METHODS: We analyzed data from three prospective, randomized, open-label, parallel comparison studies of CLV to NTG or SNP perioperatively, or NIC postoperatively in patients undergoing cardiac surgery at 61 medical centers. Of the 1964 patients enrolled, 1512 met postrandomization inclusion criteria of requiring acute treatment of hypertension based on clinical criteria. The patients were randomized 1:1 for each of the three parallel comparator treatment groups. The primary outcome was the incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days. Adequacy and precision of BP control was evaluated and is reported as a secondary outcome. RESULTS: There was no difference in the incidence of myocardial infarction, stroke or renal dysfunction for CLV-treated patients compared with the other treatment groups. There was no difference in mortality rates between the CLV, NTG or NIC groups. Mortality was significantly higher, though, for SNP-treated patients compared with CLV-treated patients (P=0.04). CLV was more effective compared with NTG (P=0.0006) or SNP (P=0.003) in maintaining BP within the prespecified BP range. CLV was equivalent to NIC in keeping patients within a prespecified BP range; however, when BP range was narrowed, CLV was associated with fewer BP excursions beyond these BP limits compared with NIC. CONCLUSIONS: CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery.


Subject(s)
Antihypertensive Agents/therapeutic use , Calcium Channel Blockers/therapeutic use , Cardiac Surgical Procedures , Hypertension/drug therapy , Pyridines/therapeutic use , Acute Disease , Aged , Aged, 80 and over , Antihypertensive Agents/adverse effects , Blood Pressure/drug effects , Calcium Channel Blockers/adverse effects , Female , Humans , Hypertension/physiopathology , Intraoperative Complications/drug therapy , Male , Nicardipine/adverse effects , Nicardipine/therapeutic use , Nitroglycerin/adverse effects , Nitroglycerin/therapeutic use , Nitroprusside/adverse effects , Nitroprusside/therapeutic use , Perioperative Care , Postoperative Complications/drug therapy , Preoperative Care , Pyridines/adverse effects
12.
Heart Surg Forum ; 11(1): E24-9, 2008.
Article in English | MEDLINE | ID: mdl-18270134

ABSTRACT

Anticoagulation with unfractionated heparin has been the standard of care for more than a half-century for patients undergoing cardiac surgery. The risk of heparin-induced adverse reactions dictates the need for a safe and effective alternative, particularly in off-pump coronary artery bypass (OPCAB) surgery, an approach associated with a perioperative prothrombotic condition that may negatively influence graft patency. Between March 2003 and January 2005, 243 consecutive patients underwent OPCAB with bivalirudin (0.75 mg/kg bolus with 1.75 mg/kg per hour infusion). There were 171 men (70.4%) and 72 women (29.6%). The mean age was 64.9 +/- 10.9 years (age range 32-88 years). There were 147 patients (60.5%) with 3-vessel disease; 46 (18.9%) had substantial (>50%) stenosis of the left main coronary artery; 104 (42.8%) had a moderately reduced (0.30 to 0.50) ejection fraction; and 9 (3.7%) had a severely reduced (<0.30%) ejection fraction. Five patients (2.1%) required conversion to cardiopulmonary bypass and subsequently received heparin. Postoperative complications included perioperative myocardial infarction in 6 patients (2.5%), stroke in 3 (1.2%), prolonged ventilation in 4 (1.6%), reoperation for bleeding in 3 (1.2%), renal insufficiency in 14 (5.8%), atrial fibrillation in 26 (10.7%), low cardiac output in 3 (1.2%), and deep sternal infection in 1 (0.4%). Blood products were used in 117 patients (48.1%). The overall hospital mortality rate was 0.4% (1 of 243). Bivalirudin is a safe and effective anticoagulant that may be routinely used as an alternative to heparin and protamine in patients undergoing OPCAB. This is evidenced by low hospital mortality and morbidity rates. Further follow-up is warranted to discern the influence of bivalirudin on long-term clinical outcomes.


Subject(s)
Coronary Artery Bypass, Off-Pump , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Peptide Fragments/therapeutic use , Thrombin/antagonists & inhibitors , Treatment Outcome , Adult , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Coronary Artery Bypass , Female , Fibrinolytic Agents/adverse effects , Health Status Indicators , Heparin/adverse effects , Hirudins/adverse effects , Humans , Male , Middle Aged , Peptide Fragments/adverse effects , Postoperative Complications , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Retrospective Studies , Risk Factors
13.
Ann Thorac Surg ; 84(3): 836-9, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17720385

ABSTRACT

BACKGROUND: This study assessed the use of bivalirudin as an alternative anticoagulant in patients with heparin-induced thrombocytopenia-thrombotic syndrome (HIT/TS) or antiplatelet factor four-heparin (anti-PF4/H) antibodies undergoing off-pump coronary artery bypass (OPCAB). METHODS: In a prospective, open-label, multicenter study, fifty-one patients with documented anti-PF4/H antibodies and (or) HIT/TS underwent OPCAB with bivalirudin anticoagulation (0.75 mg/kg i.v. bolus, 1.75 mg/kg/hour infusion). Procedural success (absence of death, Q-wave myocardial infarction, repeat revascularization, and stroke), bleeding, and transfusion at day seven/discharge, thirty days, and twelve weeks were assessed. RESULTS: Thirty-five patients (67%) were included with positive anti-PF4/H antibodies and no thrombocytopenia or thrombosis, eleven patients (22%) had thrombocytopenia, and five patients had clinical HIT/TS (10%). Procedural success at seven days/discharge was achieved in forty-seven patients (92%), while procedural success at thirty days and twelve weeks was 88%. There were no deaths. Chest tube output over the first twenty-four hours was 936 +/- 525 mL and twenty-five patients received a red blood cell transfusion during their hospitalization. Two patients required reexploration for persistent postoperative hemorrhage. CONCLUSIONS: Bivalirudin was an effective alternative anticoagulant for patients with HIT/TS or circulating anti-PF4/H antibodies undergoing OPCAB, with high rates of procedural success and an acceptable incidence of bleeding or transfusions.


Subject(s)
Antibodies/blood , Anticoagulants/therapeutic use , Coronary Artery Bypass, Off-Pump/methods , Heparin/adverse effects , Peptide Fragments/therapeutic use , Platelet Factor 4/immunology , Thrombocytopenia/chemically induced , Aged , Female , Heparin/immunology , Hirudins , Humans , Male , Middle Aged , Prospective Studies , Recombinant Proteins/therapeutic use
14.
J Cardiovasc Pharmacol Ther ; 12(1): 54-60, 2007 Mar.
Article in English | MEDLINE | ID: mdl-17495258

ABSTRACT

Platelet glycoprotein IIb-IIIa antagonists reduce cardiac events in acute coronary syndromes (ACSs), but their use is limited during coronary artery bypass grafting (CABG) because of bleeding concerns. Patients with ACS, however, are at increased risk for cardiac events after CABG. The use of short-acting glycoprotein IIbIIIa inhibitor eptifibatide in patients with ACS undergoing CABG was investigated. Fifteen patients with ACS and undergoing CABG with cardiopulmonary bypass were enrolled. One withdrew before surgery. Patients received heparin and eptifibatide preoperatively. Eptifibatide concentration and receptor occupancy (RO) at termination of infusion were similar in the two groups. Immediately before surgery, eptifibatide levels in the 2-hour group were twice that in the 4-hour group, and platelet RO was higher. Cessation of eptifibatide 4 hours before surgery results in less bleeding and transfusions than 2 hours before surgery. The optimal balance between bleeding and platelet inhibition is approximately 60% platelet RO. Further investigation of upstream therapy should target this threshold.


Subject(s)
Cardiopulmonary Bypass/methods , Coronary Artery Bypass/methods , Peptides/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Aged , Eptifibatide , Erythrocyte Transfusion/statistics & numerical data , Female , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Infusions, Intravenous , Male , Middle Aged , Peptides/administration & dosage , Peptides/blood , Platelet Aggregation Inhibitors/administration & dosage , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Platelet Transfusion/statistics & numerical data , Postoperative Complications/prevention & control , Preoperative Care/methods , Treatment Outcome
15.
Ann Thorac Surg ; 83(2): 572-7, 2007 Feb.
Article in English | MEDLINE | ID: mdl-17257990

ABSTRACT

BACKGROUND: The coronary artery bypass grafting (CABG) heparin-induced thrombocytopenia thrombosis syndrome (HITTS) on- and off-pump safety and efficacy (CHOOSE-ON) trial was designed as a safety and efficacy trial of bivalirudin for use in anticoagulation during cardiopulmonary bypass (CPB) in patients with confirmed or suspected HIT and (or) antiplatelet factor 4/heparin (anti-PF4/H) antibodies. METHODS: In an open-label, multicenter trial, 50 patients were enrolled prospectively. The primary study endpoint was in-hospital acute procedural success, defined as the absence of death, Q-wave myocardial infarction (MI), repeat operation for coronary revascularization, and stroke at day seven after surgery or hospital discharge, whichever occurred first. The secondary study endpoints were procedural success, defined as the absence of death, Q-wave MI, repeat operation for coronary revascularization, and stroke, at 30 days and 12 weeks after surgery. Perioperative blood loss, transfusions, and the incidence of major bleeding events were also captured. RESULTS: There were 49 patients treated with bivalirudin of which 43 had acute HIT and thrombosis syndrome (HITTS) with antibodies at time of surgery. Procedural success in-hospital or at 7 days was achieved in 46 (94%) patients. At day 30 procedural success was achieved in 42 (86%) patients, and after 12 weeks in 40 (82%) patients. Mean intraoperative blood loss was 575 +/- 524 mL, and mean 24-hour postoperative blood loss was 998 +/- 595 mL. Forty-one (84%) patients received transfusions before day 7 or discharge with a mean of 5.6 +/- 3.8 units of red blood cells, 8.6 +/- 7.2 units of platelets, and 6.0 +/- 4.7 units of fresh frozen plasma. No differences in outcome among bivalirudin-treated patients were observed between those in the overall group and those with moderately impaired renal function (n = 10). CONCLUSIONS: The current investigation expands the experience of safe and effective anticoagulation with bivalirudin during CPB to patients with confirmed or suspected HIT and anti-PF4/H antibodies, including in the setting of impaired renal function.


Subject(s)
Antibodies/blood , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Cardiopulmonary Bypass , Heparin/adverse effects , Peptide Fragments/therapeutic use , Thrombocytopenia/chemically induced , Thrombosis/chemically induced , Acute Disease , Aged , Aged, 80 and over , Anticoagulants/immunology , Blood Loss, Surgical , Erythrocyte Transfusion/statistics & numerical data , Female , Heparin/immunology , Heparin/therapeutic use , Hirudins , Humans , Intraoperative Care , Male , Middle Aged , Recombinant Proteins/therapeutic use , Syndrome , Thrombocytopenia/immunology , Time Factors , Treatment Outcome
16.
Anesth Analg ; 103(3): 540-4, 2006 Sep.
Article in English | MEDLINE | ID: mdl-16931658

ABSTRACT

In the EVOLUTION OFF trial, we evaluated the safety and efficacy of bivalirudin during off-pump coronary artery bypass grafting as compared with heparin-protamine. In this subanalysis of EVOLUTION OFF data of bivalirudin-treated patients, we assessed the pharmacokinetics (PK) and effectiveness of bivalirudin anticoagulation to achieve target activated clotting time (ACT)+ values. Data from 101 patients were assessed. A bolus of 0.75 mg/kg of bivalirudin was followed by a continuous infusion of 1.75 mg x kg(-1) x h(-1) during the grafting procedure. An ACT+ value of >300 s was the target. In four patients, PK data for bivalirudin were obtained. Only in exceptional cases were repeat fractional boluses or an increase of the infusion rate required. Assessment of the PK data showed a mean concentration of bivalirudin after the initial bolus of 11.0 +/- 0.53 microg/mL and a mean concentration during infusion of 11.2 +/- 2.32 microg/mL. Pearson's correlation between bivalirudin concentrations and ACT+ values was 0.92. Bivalirudin PK data consistently exceeded concentrations of 6.5 microg/mL, which have been evaluated as effective during percutaneous coronary intervention. The correlation between bivalirudin levels and ACT+ values was good, and the target ACT+ values were almost always achieved. These results suggest that bivalirudin, given according to the current protocol, provides reliable and effective anticoagulation during off-pump coronary artery bypass graft surgery.


Subject(s)
Anticoagulants/pharmacology , Coronary Artery Bypass, Off-Pump/adverse effects , Coronary Artery Bypass, Off-Pump/methods , Coronary Artery Bypass/methods , Heparin/pharmacokinetics , Hirudins/pharmacokinetics , Peptide Fragments/pharmacokinetics , Protamines/pharmacokinetics , Aged , Female , Humans , Male , Middle Aged , Myocardial Revascularization , Postoperative Complications/etiology , Recombinant Proteins/pharmacokinetics , Time Factors
17.
J Card Surg ; 21(3): 286-8, 2006.
Article in English | MEDLINE | ID: mdl-16684064

ABSTRACT

BACKGROUND: The presence of antibodies directed against heparin necessitates the use of an alternative anticoagulant in patients undergoing cardiac surgery. Bivalirudin is a short-acting direct thrombin inhibitor that has been used successfully in routine cardiac surgical cases. Experience in complicated cases requiring extended cardiopulmonary bypass is limited, however. We report the successful use of bivalirudin in a patient who underwent complex cardiac surgery. METHOD: A 42-year-old patient with aortic regurgitation due to endocarditis who had heparin antibodies underwent a Ross procedure for aortic valve replacement using bivalirudin as anticoagulant during cardiopulmonary bypass (CPB). Bivalirudin was given with a bolus of 1 mg/kg and a continuous infusion of 2.5 mg/kg/hours during CPB. Monitoring of bivalirudin was performed using the ecarin clotting time (ECT). RESULTS: After 128 minutes of extracorporeal circulation, the patient was weaned from CPB without problems. After termination of CPB, modified ultrafiltration (MUF) was commenced. Perioperatively, six units of fresh frozen plasma were transfused. The 12-hour postoperative blood loss was 550 mL. The postoperative course was uneventful and the patient was discharged from hospital after 5 days. CONCLUSION: Bivalirudin can be safely used for anticoagulation during CPB even in complex cardiac surgery.


Subject(s)
Anticoagulants/therapeutic use , Antithrombins/therapeutic use , Aortic Valve Insufficiency/surgery , Autoantibodies/blood , Cardiopulmonary Bypass/methods , Heart Valve Prosthesis Implantation/methods , Heparin/immunology , Peptide Fragments/therapeutic use , Adult , Aortic Valve Insufficiency/blood , Aortic Valve Insufficiency/immunology , Follow-Up Studies , Hirudins , Humans , Male , Recombinant Proteins/therapeutic use
18.
J Thorac Cardiovasc Surg ; 131(3): 533-9, 2006 Mar.
Article in English | MEDLINE | ID: mdl-16515902

ABSTRACT

OBJECTIVES: Unfractionated heparin and its antidote, protamine sulfate, allow for rapid and reversible anticoagulation during cardiac surgery with cardiopulmonary bypass, yet limitations exist, including a variable dose-response, dependence on a cofactor for anticoagulant effect, and antigenic potential. This trial was performed to evaluate the safety and efficacy of bivalirudin as an alternative to heparin with protamine reversal in on-pump cardiac surgery. METHODS: We conducted a randomized, open-label, multicenter trial comparing heparin with protamine reversal to bivalirudin in patients undergoing cardiac surgery with cardiopulmonary bypass. The primary objective was to demonstrate comparable rates of in-hospital procedural success defined as freedom from death, Q-wave myocardial infarction, stroke, or repeat revascularization. Twenty-one institutions enrolled 101 patients randomized to bivalirudin and 49 patients to heparin treatment. RESULTS: The primary end point of procedural success was not significantly different between the bivalirudin arm and the heparin/protamine arms at 7 days, 30 days, or 12 weeks' follow-up. Adequate anticoagulation was achieved in all patients. Secondary end points including mortality, 24-hour blood loss, overall incidence of transfusions, and duration of surgery were similar between the two arms. CONCLUSIONS: Bivalirudin is a safe and effective anticoagulant for patients undergoing a wide range of cardiac surgical procedures with cardiopulmonary bypass. Procedural success rates with bivalirudin were similar to rates in patients receiving heparin anticoagulation, with no difference in mortality. Avoidance of blood stasis and attention to the intraoperative medical management of patients is critical for successful use of bivalirudin during cardiopulmonary bypass.


Subject(s)
Anticoagulants/therapeutic use , Cardiopulmonary Bypass , Heparin Antagonists/therapeutic use , Heparin/therapeutic use , Peptide Fragments/therapeutic use , Protamines/therapeutic use , Aged , Anticoagulants/adverse effects , Female , Heparin/adverse effects , Hirudins , Humans , Male , Middle Aged , Postoperative Complications/chemically induced , Postoperative Complications/prevention & control , Recombinant Proteins/therapeutic use , Thrombocytopenia/chemically induced , Thrombocytopenia/prevention & control , Thrombosis/chemically induced , Thrombosis/prevention & control
19.
J Thorac Cardiovasc Surg ; 131(3): 686-92, 2006 Mar.
Article in English | MEDLINE | ID: mdl-16515924

ABSTRACT

OBJECTIVES: Unfractionated heparin has many shortcomings, including indirect and partial inhibition of thrombin, antibody formation, and platelet activation. Bivalirudin, a short-acting direct thrombin inhibitor, avoids these limitations and has superior outcomes during percutaneous revascularization. This trial was performed to evaluate the safety and efficacy of bivalirudin in off-pump coronary artery bypass grafting. METHODS: An open-label, multicenter randomized trial compared heparin with protamine reversal to bivalirudin in patients undergoing off-pump coronary artery bypass. The primary objective was safety as demonstrated by similar rates of procedural success defined as freedom from a composite of death, myocardial infarction, stroke, and repeat revascularization. Twenty-one institutions randomized 105 patients to receive bivalirudin and 52 patients to receive heparin. RESULTS: The mean age was 65 years for both groups. The bivalirudin group had more grafts: 3.0 +/- 1 versus 2.5 +/- 1. Procedural success rates at 30 days were identical in bivalirudin- and heparin-treated patients (93%). Operative times, total blood loss, reoperations for bleeding, and major adverse events were not significantly different. Strokes were more frequent in the heparin group: 5.5% versus 0; P = .05. Mortality was 2% in each group. Repeat revascularization was required in 3% of bivalirudin- and 2% of the heparin-treated patients. CONCLUSIONS: For patients undergoing off-pump coronary artery bypass grafting, bivalirudin was an effective anticoagulant, without excessive bleeding and with a safety profile similar to that of heparin. Further trials are warranted to assess whether anticoagulation with bivalirudin improves clinical outcomes.


Subject(s)
Anticoagulants/therapeutic use , Coronary Artery Bypass, Off-Pump , Heparin Antagonists/therapeutic use , Heparin/therapeutic use , Peptide Fragments/therapeutic use , Protamines/therapeutic use , Aged , Coronary Artery Bypass, Off-Pump/adverse effects , Female , Hirudins , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Recombinant Proteins/therapeutic use
20.
J Extra Corpor Technol ; 37(3): 296-302, 2005 Sep.
Article in English | MEDLINE | ID: mdl-16350384

ABSTRACT

Bivalirudin is a short-acting direct thrombin inhibitor that has been used in cardiac surgical patients with heparin-induced thrombocytopenia (HIT) or suspected HIT. Although no direct thrombin inhibitor is indicated for anticoagulation during cardiac surgery in patients with heparin-induced thrombocytopenia (HIT) or suspected HIT, use of heparin-alternatives are increasing as the awareness of HIT increases. Reports of anticoagulation with bivalirudin are sporadic, however, with variable dosing and management strategies. In this report, we describe our management techniques for cardiopulmonary bypass with bivalirudin based upon our personal experience. Although the reported clinical experience with bivalirudin in cardiac surgery is reviewed, operative techniques for the perfusionist/surgeon team are discussed in detail. We recognize that the use of bivalirudin during cardiopulmonary bypass is evolving and modifications of technique will undoubtedly occur as further data and experience accumulate.


Subject(s)
Anticoagulants/therapeutic use , Antithrombins/pharmacology , Antithrombins/therapeutic use , Cardiopulmonary Bypass/methods , Extracorporeal Circulation/methods , Peptide Fragments/therapeutic use , Anticoagulants/pharmacology , Drug Monitoring , Hirudins/pharmacology , Humans , Peptide Fragments/pharmacology , Recombinant Proteins/pharmacology , Recombinant Proteins/therapeutic use , Thrombocytopenia/chemically induced
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