Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry.

Intraoperative antithrombotic drug removal by haemoadsorption is a novel strategy to reduce perioperative bleeding in patients on antithrombotic drugs undergoing cardiac surgery. The international STAR registry reports real-world clinical outcomes associated with this application. All patients underwent cardiac surgery before completing the recommended washout period. The haemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit. Patients on P2Y12 inhibitors comprised group 1, and patients on direct-acting oral anticoagulants (DOAC) group 2. Outcome measurements included bleeding events according to standardised definitions and 24-hour chest-tube-drainage (CTD). 165 patients were included from 8 institutions in Austria, Germany, Sweden, and the UK. Group 1 included 114 patients (62.9 ± 11.6years, 81% male) operated at a mean time of 33.2 h from the last P2Y12 inhibitor dose with a mean CPB duration of 117.1 ± 62.0 min. Group 2 included 51 patients (68.4 ± 9.4years, 53% male), operated at a mean time of 44.6 h after the last DOAC dose, with a CPB duration of 128.6 ± 48.4 min. In Group 1, 15 patients experienced a BARC-4 bleeding event (13%), including 3 reoperations (2.6%). The mean 24-hour CTD was 651 ± 407mL. In Group 2, 8 patients experienced a BARC-4 bleeding event (16%) including 4 reoperations (7.8%). The mean CTD was 675 ± 363mL. This initial report of the ongoing STAR registry shows that the intraoperative use of a haemoadsorption device is simple and safe, and may potentially mitigate the expected high bleeding risk of patients on antithrombotic drugs undergoing cardiac surgery before completion of the recommended washout period.Clinical registration number: ClinicalTrials.gov identifier: NCT05077124.

Patient-tailored silicone plug for HeartMate 3™ left ventricular assist device explantation.

Patient-tailored silicone plug for HeartMate 3™ left ventricular assist device explantation in two successive males proceeded successfully. Given medical therapeutic advancements, FDA-approved plug systems designed by LVAD manufacturers themselves will be necessary for the near future to provide a safe and simple device explantation alternative that fulfills all regulatory standards.

Recovery of a dilated left ventricle after cessation of cocaine and HVAD™ explantation using a titanium plug.

The ultimate goal in the treatment of end-stage heart failure is the recovery of cardiac function following mechanical assistance of the left ventricle. The HVAD™ pump (HeartWare Inc.) left ventricular assist device (LVAD) can be explanted without resternotomy. This article demonstrates that the use of a custom-made mechanical plug (manufactured by INNOVO Solutions GmbH), which can be inserted into the LVAD's sewing ring, is feasible. This mechanical plug explicitly designed for device explantation is a viable alternative to the current standard of care. This article adopts a less invasive technique to explant the pump. The following case illustrates this technique.

Successive surgical repair of a progressive aortic dissection in a case of Loeys-Dietz Syndrome.

INTRODUCTION: The Frozen Elephant Trunk technique is a well-established treatment for aortic dissections (Stanford Type A) involving the aortic arch and descending aorta. The Thoraflex™ Hybrid prosthesis (Vascutek Ltd.), consisting of a proximal flexible conduit and a distal self-expanding covered stent, has consistently shown positive results in the treatment of this condition. CASE DESCRIPTION: The following is a description of such a staged reconstruction using the Thoraflex™ Hybrid Ante-Flo™ device, performed in a patient previously diagnosed with Loeys-Dietz Syndrome. After clamping the aorta proximally, an incision was taken at the distal end of the stent. Here, the distal end of the new prosthesis was inserted into the true lumen of the descending aorta and the stent was deployed. Following this, a bypass was established via the left atrium, and blood was returned to the lower body using the perfusion arm of the prosthesis with the proximal part of the descending aorta clamped. The collar of the prosthesis was sutured proximally to the aorta near the inlying previous stent. Air was removed via the perfusion arm of the prosthesis, which was then oversewn. DISCUSSION: To date, hybrid prostheses have only been used on the proximal aorta in patients with aortic aneurysms and aortic dissections (Stanford Type A). CONCLUSION: Using the described technique, it is possible to reconstruct the aortic anatomy using the available prostheses with accuracy and minimal complications.

Retrograde washout of prepump LVAD thrombosis in a patient on HeartWare™ support.

The success of the left ventricular assist device (LVAD) as a treatment for terminal left-side heart failure is still restrained by some severe complications associated with mechanical circulatory support. Pump thrombus still affects many patients. It is associated with high morbidity and mortality. The therapeutic options include augmentation of anticoagulation and antiplatelet medication, intravenous or catheter-guided thrombolysis, and pump exchange. Heart transplantation would be a desirable option in this population, but unfortunately, it is only theoretical given the increasing number of LVAD implants and decreasing number of organ donors. A retrograde washout maneuver may be a treatment option in prepump thrombosis in selected patients. Therefore, the decision should be made on an individual basis after balancing the risks and benefits of different treatment approaches. In this context, we report a case of retrograde washout of prepump thrombus in a patient who has been on HeartWare™ support for more than 3 years, with a successful bailout strategy.

Accuracy and Trending Ability of the Fourth-Generation FloTrac/EV1000 System in Patients With Severe Aortic Valve Stenosis Before and After Surgical Valve Replacement.

OBJECTIVE: Evaluate the accuracy and trending ability of the fourth-generation FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA) system in patients with severe aortic valve stenosis by comparing FloTrac/EV1000-derived cardiac output (CCO-FT) with continuous thermodilution pulmonary artery catheter (CCO-PAC) measurements before and after surgical valve replacement. DESIGN: Prospective clinical study. SETTING: Anesthesia for cardiac surgery, operating room, single-center university hospital. PARTICIPANTS: Twenty-five patients were included. After exclusion, 20 patients undergoing elective aortic valve replacement were analyzed. INTERVENTIONS: After induction of general anesthesia, CCO-FT and CCO-PAC values were recorded every 30 seconds before and after aortic valve replacement with a bioprosthesis under cardiopulmonary bypass (CPB). MEASUREMENTS AND MAIN RESULTS: Data were analyzed separately from skin incision to last suture and before and after CPB. Regression analyses, Bland-Altman analyses, and trending analyses (4-quadrant plot, polar plot) were performed. The percentage errors of the FloTrac/EV1000 were 69.7% and 59.3% before and after CPB, respectively. The concordance rates (CRs) and angular CRs of the FloTrac/EV1000 were 50.9% and 57.1%, and 48.7% and 61.9% before and after CPB, respectively. CONCLUSION: This study revealed a low level of agreement and poor trending ability of the FloTrac/EV1000 system compared to continuous thermodilution pulmonary artery catheter in patients with severe aortic stenosis. Although there was a slight improvement after surgical valve replacement and CPB, the results were not within acceptable limits to replace CCO-PAC in this patient population.

Amphetamine abuse as a rare cause of recurrent LVAD pump thrombosis.

We report a patient with recurrent left ventricular assist device (LVAD) thrombosis due to amphetamine addiction. The management of this complication is reviewed.

Single centre experience with prolonged waiting time on transplant list with "high-urgency" status.

INTRODUCTION: The waiting list for heart transplantation (HTx) in Eurotransplant area has grown to a record size of nearly 1,300 patients, whereas only around 600 hearts were transplanted last year. The prolonged time for patients awaiting HTx on the high-urgency (HU) status leads mostly to serious medical complications. OBJECTIVE: The aim of this study was to study the trend of changes in the frequency of ventricular assist device (VAD) implantation in patients on the HU status. METHODS: A total of 22 adult patients awaiting transplantation on the HU status at our hospital between January 2011 and December 2011 were analyzed, assessing risk profile, blood group, and complication rates in terms of VAD implantation or death. Results were compared with 16 consecutive patients who were on transplant list with the HU status between January 2010 and December 2010 at our institution. RESULTS: Mean age was 49.5 ± 12.1 (2010 group) years and 51.4 ± 10.7 years (2011 group; p = 0.62). Mean logEuroSCORES raised not significantly from 9.1 ± 6.3% (2010 group) to 10.7 ± 14.7% (2011 group; p = 0.68). Six patients died on the HU status and seven patients had to be supplied with a VAD in 2011. In comparison with the preceding year, only two patients died in 2010 and none of our patients on the HU status had to be provided with mechanical circulatory support. CONCLUSION: Because of the prolonged waiting time on the HU list, the earlier-mentioned data demonstrate a negative trend in transplant medicine. Especially when taking into consideration that five of seven patients who needed a VAD implantation during the HU waiting period had blood group O. Furthermore, the data derived from Eurotransplant show that the waiting period for patients with blood group O was considerably longer when compared with patients of the same average body height and weight but with other blood groups.

Endovascular stenting of an HVAD™ outflow graft pseudoaneurysm that exerts compression and kinking stenosis on the soft portion of the prosthesis.

Key Clinical Message: Complex presentations of MCS patients may necessitate a multidisciplinary approach involving HF cardiologists, CT surgeons, advanced cardiac imagers, and interventional cardiologists in order to define the optimal management strategy. Abstract: Left ventricle assist devices (LVADs) provide life-sustaining treatment for patients with terminal heart failure, but their intricacy allows for complications. One complication is LVAD outflow graft obstruction due to the graft's intraluminal thrombus or extraluminal compression. It may be treated endovascularly with stenting. We report an endovascular stenting of an outflow tract in HVAD™ (HeartWare Inc.) due to a pseudoaneurysm causing compression and kinking stenosis.

Rare Case Report: Left Atrial Sarcoma Obstructing the Left Ventricular Inflow.

Malignant cardiac tumors of the heart are extremely rare and may present tremendous diagnostic and therapeutic challenges. These tumors are able to infiltrate the heart and metastasize systemically. Early detection is often elusive as the clinical presentation is highly variable, posing significant diagnostic and therapeutic difficulties. Despite a multidisciplinary approach, the prognosis for patients with malignant cardiac tumors remains guarded. Early diagnosis and a multidisciplinary approach involving cardiac surgeons, oncologists and critical care specialists are crucial in the management of this disease. Further research is needed to better understand the pathomechanisms of tumor-related complications and to develop effective treatment strategies to improve patient outcomes. The rare case of a 78-year-old woman with left atrial tumor requiring emergency surgery for acutely developing mitral valve obstruction is presented. Pathology confirmed an undifferentiated pleomorphic sarcoma. This patient tragically did not survive, highlighting the difficulties of managing such a rare and deceptive heart disease.

High frequency of Tropheryma whipplei in culture-negative endocarditis.

"Classical" Whipple's disease (cWD) is caused by Tropheryma whipplei and is characterized by arthropathy, weight loss, and diarrhea. T. whipplei infectious endocarditis (TWIE) is rarely reported, either in the context of cWD or as isolated TWIE without signs of systemic infection. The frequency of TWIE is unknown, and systematic studies are lacking. Here, we performed an observational cohort study on the incidence of T. whipplei infection in explanted heart valves in two German university centers. Cardiac valves from 1,135 patients were analyzed for bacterial infection using conventional culture techniques, PCR amplification of the bacterial 16S rRNA gene, and subsequent sequencing. T. whipplei-positive heart valves were confirmed by specific PCR, fluorescence in situ hybridization, immunohistochemistry, histological examination, and culture for T. whipplei. Bacterial endocarditis was diagnosed in 255 patients, with streptococci, staphylococci, and enterococci being the main pathogens. T. whipplei was the fourth most frequent pathogen, found in 16 (6.3%) cases, and clearly outnumbered Bartonella quintana, Coxiella burnetii, and members of the HACEK group (Haemophilus species, Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, and Kingella kingae). In this cohort, T. whipplei was the most commonly found pathogen associated with culture-negative infective endocarditis.

Cytomegalovirus Donor Seropositivity Negatively Affects Survival After Heart Transplantation.

BACKGROUND: Prior studies have shown that cytomegalovirus (CMV) infection is a risk factor for the development of cardiac allograft vasculopathy (CAV) and is associated with reduced long-term survival after heart transplantation (HTx). The aim of this International Society for Heart and Lung Transplantation Transplant Registry study was to compare posttransplant survival in different CMV donor:recipient serologic combinations. METHODS: We performed a retrospective cohort study, using the International Society for Heart and Lung Transplantation Thoracic Transplant Registry, on 15 885 adult primary heart transplant recipients with known CMV serologic status between July 2004 and June 2014. Posttransplant survival and risk of developing CAV were compared across 4 groups: CMV-seronegative recipients (R-) receiving CMV-positive grafts (D+), intermediate-risk patients (D+R+ and D-R+), and low-risk patients (D-R-). RESULTS: Baseline characteristics (donor/recipient age, body mass index, recipient serum creatinine, blood group, donor cause of death, recipient diagnosis, and ischemic time) were mostly balanced between the groups. Kaplan-Meier survival analyses over a follow-up of 10 y revealed significantly worse survival for both D+ groups as compared to the CMV low-risk group (D+R+: 56.61% [95% confidence interval, 53.94-59.41] versus D-R-: 63.09% [59.74-66.64] P < 0.01 and D+R-: 57.69% [56.03-59.39] versus D-R-; P < 0.001), whereas recipient seropositivity alone was not associated with reduced survival (D-R+ versus D-R-P = 0.178). The risk of developing CAV after HTx was not significantly increased in D+ as compared to D- groups. CONCLUSIONS: In a large contemporary cohort, CMV status at the time of HTx was not associated with CAV development. However, there was a significant association between donor CMV seropositivity and reduced short- and long-term survival after HTx. Approaches to mitigate the impact of CMV on posttransplant survival are needed.

Results from a multicentre evaluation of plug use for left ventricular assist device explantation.

OBJECTIVES: Myocardial recovery allows for left ventricular assist device (LVAD) explantations after long-term support. Several surgical approaches, including interventional decommissioning, off-pump explantation using a custom-made plug and complete LVAD removal through redo sternotomy, have been described. We present the results from an evaluation of the long-term follow-up of patients who received a titanium sintered plug after LVAD explantation. METHODS: We performed a retrospective, European, multicentre analysis of patients who received a titanium sintered plug to seal the apical fixation ring after LVAD explantation. Data were collected from a questionnaire that included demographics, procedural details and follow-up information. RESULTS: Out of 54 contacted centres in 12 countries (n = 179 patients), a total of 68 patients were successfully included in the study. The median follow-up was 34 months (interquartile range: 17-58.5 months); 57 (84%) patients had >1-year follow-up. At the time of the last follow-up, 55 (81%) patients were alive, with a Kaplan-Meier 1-year survival of 90.1% (95% confidence interval: 84.0-98.1%) and a 5-year survival of 80.0% (95% confidence interval: 68.4-92.9%). One patient (1.5%) developed a plug infection originating from an infected part of the incorporated driveline and, after complete removal, is currently in good condition. No postoperative stroke has been reported after plug implantation. CONCLUSIONS: In this European multicentre study, the use of a custom-made titanium plug to close the apical fixation ring after LVAD explantation resulted in a low incidence of plug-related complications. With the volume of patients undergoing LVAD explantations after myocardial recovery increasing, the plug has evolved as a simple alternative to more invasive device explantation procedures or decommissioning with a high risk for infection of the remaining system or stroke.

Noninvasive control of adequate cerebral oxygenation during low-flow antegrade selective cerebral perfusion on adults and infants in the aortic arch surgery.

UNLABELLED: Real-time readings of the regional oxygen saturation (rSO(2)) using near-infrared spectroscopy (NIRS) during the aortic arch surgery can provide an early detection of perfusion or oxygenation abnormalities. BACKGROUND: Aortic arch repair techniques using low-flow antegrade selective cerebral perfusion have been standardized to a certain degree. However, some of the often-stated beneficial effects have never been proven. Especially, the existence of an adequate continuous flow in both cerebral hemispheres during the surgical procedure still remains unclear as the monitoring of an effective perfusion remains a nonstandardized technique. METHODS: Seventeen patients underwent surgical reconstruction of the aortic arch due to aortic aneurysm surgery (adult group n = 8 patients) or of the hypoplastic aortic arch due to hypoplastic left heart syndrome (HLHS) or aortic coarctation (infant group n = 9 patients) under general anesthesia and mild hypothermia (adult group 28 degrees C; infant group 25 degrees C). Mean weights were 92.75 +/- 14.00 kg and 4.29 +/- 1.32 kg, and mean ages were 58.25 +/- 10.19 years and 55.67 +/- 51.11 days in the adult group and the infant group, respectively. The cerebral O(2) saturation measurement was performed by continuous plotting of the somatic reflectance oximetry of the frontal regional tissue on both cerebral hemispheres (rSO(2), INVOS; Somanetics Corporation, Troy, MI, USA). RESULTS: During low-flow antegrade perfusion via innominate artery, continuous plots with similar values of O(2) saturation (rSO(2)) in both cerebral hemispheres were observed, whereas a decrease in the rSO(2) values below the desaturation threshold correlated with a displacement or an incorrect positioning of the arterial cannula in the right subclavian artery. CONCLUSIONS: Continuous monitorization of the cerebral O(2) saturation during aortic arch surgery in adults and infants is a feasible technique to control an adequate cannula positioning and to optimize clinical outcomes avoiding neurological complications related to cerebral malperfusion.

Reduction of INCOR® driveline infection rate with silicone at the driveline exit site.

Objectives: A silicone interface at skin level of left ventricular assist device (LVAD) may reduce the risk of driveline (DL) exit site infections when compared with other materials (e.g. velour). The purpose of this study was to evaluate the rate of DL exit site infection according to the presence of silicone or velour at the exit site with the redesigned INCOR, facilitating the positioning of silicone at the exit site. Methods: The rate of DL exit site infection and overall survival were compared between the two groups (silicone group, n = 16/velour group, n = 24) with 1-year follow-up postimplantation. Results: Risk factors for infection were more prevalent in the silicone group (obesity P = 0.33, prevalence of renal dysfunction P = 0.007, higher CRP levels P = 0.001). During the observation period, 6 patients developed a DL infection (25%) in the velour group, whereas 1 patient developed a DL infection in (6%) in the silicone group (P = 0.19). The event-per-patient year (EPPY) rates were 0.34 and 0.10 for velour group and silicone group, respectively (P = 0.30). All DL infections could be treated successfully by the antibiotic treatment, surgical debridement and ultimately high urgency heart transplantation, resulting in no direct DL infection-related mortality in this cohort. One-year survival was similar in both the groups (silicone 69 vs 75% in the velour group; P = 0.67). Conclusions: Fewer infections were observed at the exit site in case of a silicone-covered DL, without reaching statistical significance. More patients and longer observation periods are needed to demonstrate a statistical difference.

Increased transcript levels of TNF-alpha, TGF-beta, and granzyme B in endomyocardial biopsies correlate with allograft rejection.

OBJECTIVES: Endomyocardial biopsies are the criterion standard in diagnosing acute cardiac transplant rejection. This study sought to analyze mRNA expression profiles of various immuneresponse-related genes in endomyocardial biopsies of heart transplant patients and to correlate the results with histologic findings. MATERIALS AND METHODS: Forty-three biopsies obtained from 6 heart transplant recipients experiencing acute rejection were analyzed for granzyme B, CTLA4, IL-6, TGF-beta, and TNFa expression using real-time polymerase chain reaction. The results were compared with the histologic findings. Biopsies obtained before, during, and after acute rejection episodes were grouped according to the International Society of Heart and Lung Transplantation standard biopsy grading from 1990. Group 1 consisted of biopsies with International Society of Heart and Lung Transplantation grade 0 (n=12), group 2 of International Society of Heart and Lung Transplantation grade 1A (n=14), and group 3 of International Society of Heart and Lung Transplantation grades 1B, 2, 3A, and 4 (n=17). RESULTS: A strong correlation was seen between histologic groups and gene expression of granzyme B, which showed the highest overall transcript levels. CTLA4 was elevated in group 2, but no further increase in the rejecting group 3 was seen. For IL-6, TGF-beta, and TNFa gene expression was strongly elevated in group 3 compared with groups 1 and 2. On analysis of biopsies with International Society of Heart and Lung Transplantation, grade 0 and 1A, relative to the time point of rejection, we found a substantial increase in mRNA expression of all analyzed immune response-related genes before a rejection episode. The strongest up-regulation was seen for granzyme B, TNFa, and TGF-beta. CONCLUSIONS: Our data suggest that analyses of gene expression provides valuable information in diagnosing heart transplant rejection. Furthermore, analyses of granzyme B, TGF-beta, and TNFa might not only confirm an ongoing rejection episode, but also may have a positive predictive value.

Comparison of dual source computed tomography versus intravascular ultrasound for evaluation of coronary arteries at least one year after cardiac transplantation.

This study evaluated the ability of dual-source computed tomography (DSCT) to detect coronary allograft vasculopathy (CAV) in heart transplant recipients using intravascular ultrasound (IVUS) as the standard of reference. Thirty patients with heart transplants (81% men, mean age 40 years) underwent DSCT (330-ms gantry rotation, 2 x 64 x 0.6-mm collimation, 60- to 80-ml contrast agent, no additional beta blockers) before invasive coronary angiography including IVUS of 1 vessel. Detection of CAV by DSCT was qualitatively defined as the presence of any coronary plaque. Mean heart rate during dual-source computed tomographic scanning was 80 +/- 14 beats/min. Four hundred fifty-nine segments with a vessel caliber >or=1.5 mm according to quantitative coronary angiography were evaluated in 30 patients. Of these, 96% were considered to have excellent or good image quality. IVUS detected CAV in 17 of 30 patients (57%) and in 41 of 110 coronary segments (37%). Compared to IVUS, sensitivity, specificity, positive and negative predictive values for the detection of CAV by DSCT were 85%, 84%, 76%, and 91%, respectively. In conclusion, DSCT permits the investigation of transplant recipients concerning the presence of CAV with good image quality and high diagnostic accuracy.

Influence of inflow cannula length in axial-flow pumps on neurologic adverse event rate: results from a multi-center analysis.

BACKGROUND: The application of axial-flow pumps in patients with end-stage heart failure reveals a significantly reduced infectious complication rate as compared with rates observed with pulsatile devices. The remaining adverse event rate relates mainly to thromboembolic complications with neurologic consequences. We investigated the dependence of the neurologic adverse event rate on the length of the inflow cannula. METHODS: A total of 216 consecutive patients with an axial-flow pump (INCOR; Berlin Heart GmbH, Berlin, Germany) were included in a retrospective multi-center analysis. In 138 patients, a short inflow cannula (24-mm tip length into the left ventricle), and in 78 patients a long inflow cannula (tip length 34 mm) was applied. RESULTS: Patients with a long inflow cannula (LC) demonstrated a better survival rate than those with a short inflow cannula (SC) at the end of the observation period (LC, 63.4%; SC, 52.9%; p = 0.05). The thromboembolic adverse event rate was also significantly lower. Only 3 of the 78 patients (3.8%) with an LC had a thromboembolic adverse event (thromboembolic events per patient-year = 0.11) as compared with 32 (23.2%) of SC patients (thromboembolic events per patient-year = 0.50, p < 0.001). CONCLUSIONS: Patients with a long inflow cannula had a better survival rate and a lower incidence of cerebrovascular adverse events than patients with a short inflow cannula.

Axial flow pump support in a Marfan patient with an aortic mechanical heart valve: case report and literature review.

The presence of a mechanical heart valve in the aortic position is usually considered a contraindication for the use of cardiac assist devices. Only a few cases with the combination of mechanical circulatory support and valve prostheses have been reported in the literature to date, and the experience is even more limited in the new generation of miniaturized axial flow pumps. We present a case report of a patient with a mechanical aortic heart valve who was successfully supported with a continuous flow pump and discuss the literature available on this problem. Further on, the patient was weaned from his ventricular assist device after 456 days of support.