Antithrombotic drug removal with hemoadsorption during off-pump coronary artery bypass grafting.

BACKGROUND: Patients requiring coronary artery bypass grafting (CABG) are often loaded with antithrombotic drugs (AT) and are at an increased risk for perioperative bleeding complications. Active AT removal by a hemoadsorption cartridge integrated in the cardiopulmonary bypass circuit is increasingly used in this setting to reduce bleeding, and herein we describe the extension of this application in patients on AT undergoing off-pump coronary artery bypass (OPCAB). METHODS: Ten patients (80% male; mean age: 67.4 ± 9.2years) were treated with ticagrelor (eight patients), rivaroxaban and ticagrelor (one patient), and rivaroxaban (one patient) prior to OPCAB surgery. AT's were discontinued one day before surgery in nine patients and on the day of surgery in one patient, and all patients were also on aspirin. The cohort mean EuroSCORE-II was 2.9 ± 1.5%. A hemoadsorption cartridge was integrated into a dialysis device (n=4) or a stand-alone apheresis pump (n=6) periprocedural, for a treatment time of 145 ± 33 min. Outcome measures included bleeding according to Bleeding Academic Research Consortium (BARC)-4 and 24-hour chest-tube-drainage (CTD). RESULTS: Mean operation time was 184 ± 35 min. All patients received a left internal thoracic artery with a mean of 2.3 ± 0.9 total grafts. One patient had a BARC-4 bleeding event and there were no surgical re-explorations for bleeding. Mean 24-hours CTD was 680 ± 307mL. During follow-up of 19.5 ± 17.0 months, none of the patients died or required further reinterventions. No device-related adverse events were reported. CONCLUSIONS: Hemoadsorption via a stand-alone apheresis pump during OPCAB surgery was feasible and safe. This innovative and new approach showed favorable bleeding rates in patients on antithrombotic drugs requiring bypass surgery.

A New Apheresis Device for Antithrombotic Drug Removal during Off-Pump Coronary Artery Bypass Surgery.

Background and Objectives: The hemoadsorption device CytoSorb® (CytoSorbents Inc., Princeton, NJ, USA) has been shown to efficiently remove ticagrelor from whole blood in vitro. A promising clinical experience was made with the integration of the hemoadsorption cartridge on the cardiopulmonary bypass (CPB) circuit during cardiac surgery to reduce adverse events. Materials and Methods: In this report, we describe a novel approach using a new apheresis platform, PUR-01 (Nikkisio Co., Ltd., Tokyo, Japan), which was used as the extracorporeal circuit where CytoSorb® could be installed for the removal of ticagrelor during off-pump coronary artery bypass (OPCAB) procedures. Results: In a 74-year-old male (index case) with coronary artery disease and dual antiplatelet therapy, hemoadsorption was initiated with a skin incision for OPCAB surgery and was continued for 221 min to eliminate ticagrelor. The blood volume that had circulated through the CytoSorb® was 39.04 L in total. Thus far, this treatment strategy has been used in four cases with CHD and DAPT who needed OPCAB surgery. The intraoperative and postoperative courses were uneventful in all patients. No device-related adverse events occurred. Conclusions: The combination of the PUR-01 apheresis pump and hemoadsorption with the CytoSorb® column during OPCAB procedures appears to be safe and effective in eliminating antiplatelet drugs.

DefiPaceTM System, A New Device for Cardioversion of Atrial Fibrillation After Cardiac Surgery - Preliminary Results.

Objectives: Postoperative atrial fibrillation (POAF) is a frequent complication following cardiac surgery. This study examined the safety and efficacy of the new DefiPace TM system consisting of two bi-atrial temporary pacing and cardioversion electrodes, a ventricular electrode and the DefiPace TM device (combined external pacemaker and cardioverter) for low-energy atrial cardioversion. Methods: The temporary electrodes were placed on the left and right atrium during open heart surgery. Pacing thresholds and sensing were measured up to the 6th postoperative day. The satisfactory handling of the electrodes was measured with a visual analog scale (VAS) 1-10, with 10 being the best and 1 being the lowest. In case of POAF, R-wave synchronous low-energy shocks (0.5-10 J) were applied for cardioversion. Results: Temporary electrodes were implanted in 29 patients (age 65.6 ± 10.4 years; 21 males, 14 OPCAB, 15 on-pump cardiac operations). Left or right atrial pacing thresholds ranged from 1.9 ± 1.3 V/ms to 5.0 ± 3.3 V/ms and P-wave sensing from 0.9 ± 0.6 mV to 1.5 ± 0.7 mV. VAS for handling of electrodes: implantation 7.1 ± 0.8 and removal 8.4 ± 1.0. POAF was observed in four patients. Two patients had successful atrial cardioversion with 3.5 J and 4.5 J. One patient converted spontaneously, and one patient remained in PAOF. There were no device-related adverse events. Conclusions: The DefiPace TM system can be used safely in patients undergoing cardiac surgery.

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. METHODS: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. RESULTS: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). CONCLUSIONS: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

Ticagrelor and Rivaroxaban Elimination With CytoSorb Adsorber Before Urgent Off-Pump Coronary Bypass.

CytoSorb hemoadsorption (CytoSorbents Inc, Monmouth Junction, NJ) was performed shortly before an urgent off-pump coronary artery bypass operation in a 58-year-old man at high risk of bleeding as a result of treatment of coronary artery disease with ticagrelor and treatment of atrial fibrillation with rivaroxaban. The patient experienced dissection of the left anterior descending artery during a percutaneous coronary intervention. Preoperatively, CytoSorb hemoadsorption was applied to eliminate the coagulative active medications. His intraoperative and postoperative courses were uneventful, with adequate bleeding control. This case highlights a promising approach for managing antiplatelet drugs and anticoagulant agents such as ticagrelor and rivaroxaban before off-pump coronary artery bypass.

Sternal closure after median sternotomy: a new technique using titanium hooks and wires applied parasternally.

OBJECTIVES: Osteosynthetic closure of the chest after median sternotomy is usually performed with steel wires. We describe, for the first time, a case series in which titanium hooks were implanted from the sternal surface in patients who required secondary or additional stabilization. In comparison to the classic wires, the diameters of the hooks are approximately three times bigger and therefore reduce the risk of cutting through the bones. Additionally, there is no need to dissect retrosternal adhesions, which may reduce the risk of injuring mediastinal tissues. METHODS: The hooks are shaped like fishing hooks and can be inserted parasternally into the intercostal spaces. They can be pulled to the contralateral side of the sternum by the attached wires and then intertwined with a second hook. RESULTS: In 13 patients, the system was used to provide additional stabilization, while in two patients the hooks were implanted for exclusive stabilization of sternal fractures. In all cases but one, the implantation was able to eliminate the sternal problems. No infections, necrosis or bleeding of neighbouring tissues occurred. One patient developed chronic sternal infection, which necessitated explantation of the hooks. CONCLUSIONS: This sternal closure system using titanium hooks inserted parasternally is an effective alternative to conventional techniques and may increase stability of the breastbone and reduce the risk of injury to retrosternal tissues.

Partial inferior sternotomy and deep hypothermic circulatory arrest for rescue of a failed TAVI case: what does constitute 'inoperable'?

A 65-year-old male patient was considered inoperable by conventional means for a previous triple coronary artery bypass grafting with a patent in situ right internal mammary artery graft to the left anterior descending artery crossing the thorax at midline directly behind the sternum. Transcatheter aortic valve implantation failed due to loss of the prosthetic device in the left ventricular outflow tract. Mandatory conversion was accomplished by an inferior partial T-shape sternotomy and extracorporeal circulation draining from the right atrium and feeding into the right femoral artery. A conventional 27-mm aortic valve bioprosthesis was successfully implanted during deep hypothermic circulatory arrest. The patient recovered normally exhibiting no neurological or cardiocirculatory complications.

Transcatheter Edwards Sapien XT valve in valve implantation in degenerated aortic bioprostheses via transfemoral access.

OBJECTIVES: Surgical treatment of degenerated aortic bioprostheses is associated with an increased risk of morbidity and mortality, especially in elderly patients with significant co-morbidities. Therefore, transcatheter aortic valve implantation (TAVI) performed as valve in valve technique appears as an attractive alternative treatment option. We report of a case series of seven patients with dysfunctional bioprosthetic aortic heart valves who have been treated with TAVI via transfemoral access. METHODS AND RESULTS: Valve in valve implantation using the Edwards Sapien XT bioprostheses (Edwards Lifesciences LLC, Irvine, CA, USA) was performed in eight patients (3 men, 5 women, mean age 85.3 ± 6.1 years) with a high operative risk (logistic euroSCORE 27.2 ± 7.3). Six patients underwent TAVI because of high grade stenosis of the aortic bioprostheses, whereas two patients presented with high grade regurgitation. All patients suffered at least from NYHA class III dyspnea during admission. TAVI was successfully performed via transfemoral access under local anesthesia with mild analgesic medication in all cases. Mild aortic regurgitation occurred in three patients while no permanent pacemaker implantation was required. Major cardiac events or cerebrovascular events did not occur. One aneurysm spurium, with the need of one blood transfusion, occurred. All patients improved at least one NYHA class within 30 days. CONCLUSION: TAVI for degenerated aortic bioprostheses, using the Edwards Sapien XT valve via transfemoral access is a feasible option for patients at high surgical risk.

Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions.

In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions. One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6 ± 2.1 years, representing 3612 patient-years. During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P = 0.213) and 15.4% thromboembolic events (P = 0.064) in the Conv-T group. Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P = 0.03); grade III thromboembolic events: 0.6 versus 5.0% (P = 0.011)]. Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P < 0.001). Actuarial survival after 1, 5 and 10 years was 100, 99 and 97 with Self-M and 100, 95 and 81% with Conv-T, respectively (P < 0.001). Univariate risk factors for mortality were age (P = 0.008), type of operation (P = 0.021) and conventional OA (P < 0.001). In multivariate analysis, only conventional OA reached significance (P < 0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.

Mid-term outcomes of patients with PCI prior to CABG in comparison to patients with primary CABG.

The number of percutaneous coronary interventions (PCI) prior to coronary artery bypass grafting (CABG) increased drastically during the last decade. Patients are referred for CABG with more severe coronary pathology, which may influence postoperative outcome. Outcomes of 200 CABG patients, collected consecutively in an observational study, were compared (mean follow-up: 5 years). Group A (n = 100, mean age 63 years, 20 women) had prior PCI before CABG, and group B (n = 100, mean age 66, 20 women) underwent primary CABG. In group A, the mean number of administered stents was 2. Statistically significant results were obtained for the following preoperative criteria: previous myocardial infarction: 54 vs 34 (P = 0.007), distribution of CAD (P < 0.0001), unstable angina: 27 vs 5 (P < 0.0001). For intraoperative data, the total number of established bypasses was 2.43 +/- 1.08 vs 2.08 +/- 1.08 (P = 0.017), with the number of arterial bypass grafts being: 1.26 +/- 0.82 vs 1.07 +/- 0.54 (P = 0.006). Regarding the postoperative course, significant results could be demonstrated for: adrenaline dosage (0.83 vs 0.41 mg/h; [p is not significant (ns)]) administered in 67 group A vs 47 group B patients (P = 0.006), and noradrenaline dosage (0.82 vs 0.87 mg/h; ns) administered in 46 group A vs 63 group B patients (P = 0.023), CK/troponine I (P = 0.002; P < 0.001), postoperative resuscitation (6 vs 0; P = 0.029), intra aortic balloon pump 12 vs 1 (P = 0.003), and 30-day mortality (9% in group A vs 1% in group B; P = 0.018). Clopidogrel was administered in 35% of patients with prior PCI and in 19% of patients without prior PCI (P = 0.016). Patients with prior PCI presented for CABG with more severe CAD. Morbidity, mortality and reoperation rate during mid term were significantly higher in patients with prior PCI.

Blood type incompatible cardiac transplantation in young infants.

OBJECTIVE: Donor organ shortage in pediatric heart transplantation (HTx) is causing mortality rates of 30-50% on the waiting list. Due to immaturity of the immune system of newborns and infants, ABO-incompatible HTx may be an option to increase donor availability. We present our experience with ABO-incompatible HTx. METHODS: Three infants were transplanted ABO-incompatible since 12/2004: (1) hypoplastic left heart complex, (2) restrictive hypertrophic cardiomyopathy, (3) dilative cardiomyopathy. Age at HTx was 7, 5, and 3.5 months. All recipients had blood type O, donors were A, A, and B. Informed consent was given by parents, the ethics committee, and Eurotransplant. RESULTS: Preoperative isohemagglutinin titers were low (Patient 1: 1:4 for anti-A1, A2, B, Patient 2: 1:4, 1:1, 1:4 for anti-A1, A2, B, respectively, and Patient 3: 0 for all, but quick spin 1+ for all). Intraoperatively, plasma was separated from red blood cells and discarded up to six times until antibodies were eliminated. Immunosuppressive induction with ATG was started for 5 days. Basic immunosuppression consisted of tacrolimus, mycophenolate mofetil, and prednisone. Extubation was performed on days 15, 2, and 1, respectively. After a follow-up of 17, 16, and 12 months all patients are well, ventricular function is excellent without any acute rejection periods; Patient 1 is still on dialysis. Isohemagglutinin titers against donor blood type have disappeared in follow-up. CONCLUSIONS: ABO-incompatible cardiac transplantation shows good short-term results in young infants and seems to be a safe procedure to lower the mortality on the waiting list.

Mechanical circulatory support in pediatric patients with the MEDOS assist device.

Mechanical circulatory support is successfully applied to patients with low cardiac output. The MEDOS-System provides pulsatile ventricular assistance for patients of all age groups, including neonates. We report our experience with seven consecutive pediatric patients with the MEDOS-VAD. The indication was bridge to transplantation in all patients. Mean age was 7.3 +/- 6.5 years (range 0.75-16.9 years) and mean weight was 26.3 +/- 21.7 kg (range 5.9-60 kg). Perioperative survival was 100%; complications occurred in six patients (86%; two cerebral embolism/bleeding, two rethoracotomy, two exchange of pump chamber due to thrombus formation after 4 and 9 days). Mean duration of support was 20.4 +/- 10.8 days (range 6-38 days). Bilirubin decreased from 3.5 +/- 2.6 mg/d to 2.1 +/- 1.2 mg/d. Hospital mortality was three of seven patients who did not receive an organ offer in time. All patients who underwent subsequent heart transplantation (four of seven patients; 57%) were discharged from the hospital. Mechanical circulatory support with the MEDOS-System can be performed successfully in pediatric patients of any age. Secondary organ functions improve under this pulsatile circulatory assistance. Hemorrhage and thromboembolic events are the most frequent complications.

Mechanical circulatory support in infants and adults with the MEDOS/HIA assist device.

Mechanical circulatory support is successfully applied to patients with low cardiac output. The MEDOS/HIA-System provides pulsatile ventricular assistance for pediatric and adult patients. Our experience with 13 consecutive patients with the MEDOS is reported. Perioperative survival was 84.6%, complications occurred in 61% (31% thrombembolism, 23% rethoracotomy, 7% infections). Mean duration of support was 17.6 +/- 14.6 days (1-45 days). Bilirubin decreased from 3.9 +/- 2.3 to 2.7 +/- 1.6 mg/dL; creatinine from 1.6 +/- 1 to 1.4 +/- 0.8 mg/dL; lactate from 5.8 +/- 4.2 to 1.7 +/- 1.5 (P = 0.027; Wilcoxon). All patients who underwent subsequent heart transplantation (6 of 13; 46%) were discharged from hospital. For 38.5% of the patients no organ offer was received. Mechanical circulatory support with the MEDOS/HIA-System can be performed successfully for bridging to transplantation. Secondary organ functions improve under this pulsatile circulatory assistance. Hemorrhage and thromboembolic events are the most frequent complications.