Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Perioperative Individualized Goal Directed Therapy for Cardiac Surgery: A Historical-Prospective, Comparative Effectiveness Study.

INTRODUCTION: Cardiac surgery patients are at increased risk for post-operative complications and prolonged length of stay. Perioperative goal directed therapy (GDT) has demonstrated utility for non-cardiac surgery, however, GDT is not common for cardiac surgery. We initiated a quality improvement (QI) project focusing on the implementation of a GDT protocol, which was applied from the immediate post-bypass period into the intensive care unit (ICU). Our hypothesis was that this novel GDT protocol would decrease ICU length of stay and possibly improve postoperative outcomes. METHODS: This was a historical prospective, QI study for patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB). Integral to the QI project was education towards all associated providers on the concepts related to GDT. The protocol involved identifying patient specific targets for cardiac index and mean arterial pressure. These targets were maintained from the post-CPB period to the first 12 h in the ICU. Statistical comparisons were performed between the year after GDT therapy was launched to the last two years prior to protocol implementation. The primary outcome was ICU length of stay. RESULTS: There was a significant decrease in ICU length of stay when comparing the year after the protocol initiation to years prior, from a median of 6.19 days to 4 days (2017 vs. 2019, p < 0.0001), and a median of 5.88 days to 4 days (2018 vs. 2019, p < 0.0001). Secondary outcomes demonstrated a significant reduction in total administered volumes of inotropic medication(milrinone). All other vasopressors demonstrated no differences across years. Hospital length of stay comparisons did not demonstrate a significant reduction. CONCLUSION: These results suggest that an individualized goal directed therapy for cardiac surgery patients can reduce ICU length of stay and decrease amount of inotropic therapy.

Likelihood of Aortic Valve Preservation During Repair of Acute Type A Aortic Dissection.

BACKGROUND: We sought risk factors for replacement of the aortic valve with or without the root (AVR/root) in the setting of acute type A aortic dissection (ATAD) repair. METHODS: All ATAD repairs at our institution from January 2005 to June 2018 were reviewed. Baseline characteristics were recorded. For patients with aortic valve preservation, we documented the degree of aortic insufficiency (AI) postoperatively and on subsequent echocardiograms when available. Logistic regression was used to determine the association between preoperative characteristics and the odds ratio of AVR/root. RESULTS: 206 patients underwent repair of ATAD. Thirty-four were excluded for no documented AI grading. Forty-six underwent AVR/root during repair of the ATAD (including 40 root replacements). Of 126 that did not undergo AVR/root, 42 (33.33%) had follow-up echocardiograms at a median of 68 months postoperatively, 2 required reintervention for valve insufficiency. An increase in the degree of AI, bicuspid valve morphology, size of the aortic root, and connective tissue disorder was significantly associated with increased risk of AVR/root. Of 130 patients without connective tissue disorder, bicuspid aortic valve, aortic root aneurysm or intimal root tear, the rate of valve preservation was 65/65 (100%), 25/29 (86.2%), and 22/40 (55%) for those presenting with mild, moderate, and severe AI, respectively. CONCLUSION: The degree of preoperative AI, bicuspid valve morphology, size of the aortic root, and connective tissue disorder significantly correlate with the failure of aortic valve preservation in patients with ATAD. The vast majority of tricuspid valves in patients without connective tissue disorder or aortic root pathology can be salvaged.

Likelihood of Aortic Valve Preservation During Repair of Acute Type A Aortic Dissection.

BACKGROUND: We sought risk factors for replacement of the aortic valve with or without the root (AVR/root) in the setting of acute type A aortic dissection (ATAD) repair. METHODS: All ATAD repairs at our institution from January 2005 to June 2018 were reviewed. Baseline characteristics were recorded. For patients with aortic valve preservation we documented the degree of aortic insufficiency (AI) postoperatively and on subsequent echocardiograms when available. Logistic regression was used to determine the association between preoperative characteristics and the odds ratio of AVR/root. RESULTS: A total of 206 patients underwent repair of ATAD. Thirty-four were excluded for no documented AI grading. Forty-six underwent AVR/root during repair of the ATAD (including 40 root replacements). Of 126 that did not undergo AVR/root, 42 (33.33%) had follow-up echocardiograms at a median of 68 months postoperatively and 2 required reintervention for valve insufficiency. Increase in degree of AI, bicuspid valve morphology, size of the aortic root, and connective tissue disorder were significantly associated with increased risk of AVR/root. Of 130 patients without connective tissue disorder, bicuspid aortic valve, aortic root aneurysm, or intimal root tear, the rate of valve preservation was 65/65 (100%), 25/29 (86.2%), and 22/40 (55%) for those presenting with mild, moderate, and severe AI, respectively. DISCUSSION: Degree of preoperative AI, bicuspid valve morphology, size of the aortic root, and connective tissue disorder significantly correlate with failure of aortic valve preservation in patients with ATAD. The vast majority of tricuspid valves in patients without connective tissue disorder or aortic root pathology can be salvaged.

Bullet embolization from an aorto-caval fistula to the heart.

Bullet emboli to the heart as a result of penetrating trauma are rare. We report a case of a 19-year old male who suffered a gunshot wound to the abdomen, resulting in an aorto-caval fistula and subsequent venous embolization of the bullet to the right ventricle. Successful surgical removal of the foreign body under cardiopulmonary bypass was performed.

Aortic root surgery does not increase the operative risk of acute type A aortic dissection.

Controversy exists regarding aortic root reconstruction in the management of acute type A aortic dissection (AAD). One hundred fifty-four patients (mean age 56.9 ± 11.3 years) with AAD had surgical repair between 1996 and 2007. Group 1 (n = 110) required no aortic root surgery. Seventy-one patients had ascending aortic replacement. The aortic valve was repaired in 37 patients (34%) and replaced in one. Group 2 (n = 44) had aortic root surgery. Thirty-four patients had composite root replacement, and seven had a valve-sparing root replacement. Root reconstruction and separate valve replacement was accomplished in three. Hemiarch replacement was included in 39 (35.4%) Group 1 patients and in 12 (27.9%) Group 2 patients. Forty-nine of the 154 patients presented in cardiogenic shock. Multiple risk factors for operative mortality were analyzed. The overall operative mortality was 9.7 per cent: 11 per cent for Group 1 and 6.8 per cent for Group 2 (P = NS). By multivariate analysis, preoperative shock (P = 0.03, odds ratio [OR] = 5.48), postoperative ventricular arrhythmias (P = 0.002, OR = 4.62), and packed red blood cell transfusion (P = 0.002, OR = 1.15) were independent predictors of hospital death. Prompt surgical treatment of AAD before cardiogenic shock ensues can improve the outcome of patients. When indicated, aortic root surgery can be performed without increased mortality and morbidity.