A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients.

BACKGROUND: The number of single ventricle patients undergoing Fontan palliation and surviving to adulthood worldwide has steadily increased in recent years. Nevertheless, the Fontan circulation is destined to fail. Ultimately, heart transplantation (HTx) remains the definitive treatment option. Due a shortage of organs, mechanical circulatory support in the form of ventricular assist devices (VADs) is widely used to bridge heart failure patients to HTx, but these devices have been mainly developed to address the needs of normal anatomies. A novel venous cannula has been developed as part of the EXCOR® VAD to provide subpulmonary support in these patients. Its clinical application is investigated in the "Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart" (RegiVe study, NCT04782232). METHODS: RegiVe is a multicenter, international, observational, prospective, non-randomized registry aiming to collect the routine clinical data of up to 20 patients. The primary endpoints address device performance and safety, while the secondary endpoints target organ status and overall safety (according to the Interagency Registry for Mechanically Assisted Circulatory Support - INTERMACS - definitions). Data analysis will be performed by means of descriptive statistics. RESULTS: RegiVe has received the favorable opinion of an independent ethics committee and enrollment has recently started. CONCLUSION: RegiVe is the first study evaluating the use of a medical device specifically developed for subpulmonary support of failing Fontan patients. The study will provide important insight and further information on this cohort and help to improve a dedicated VAD strategy.

Cavopulmonary support with a modified cannulation technique in a failing Fontan patient.

Failing Fontan patients present a unique challenge for mechanical circulatory support. We report on a 17-year-old patient with Fontan failure and preserved ventricular function who underwent mechanical cavopulmonary support using a novel cannulation technique.

Radial Artery Tonometry to Monitor Blood Pressure and Hemodynamics in Ambulatory Left Ventricular Assist Device Patients in Comparison With Doppler Ultrasound and Transthoracic Echocardiography: A Pilot Study.

Noninvasive measurements of blood pressure (BP) and cardiac output (CO) are crucial in the follow-up of continuous-flow left ventricular assist device (CF-LVAD) patients. For our pilot study, we sought to compare BP measurements between a tonometry blood pressure pulse analyzer (BPPA) (DMP-Life, DAEYOMEDI Co., Ltd., Gyeonggi-do, South Korea) and Doppler ultrasound in CF-LVAD patients, as well as to compare the BPPA estimated CO to LVAD calculated blood flow and to the patient's intrinsic CO estimated with transthoracic echocardiography (TTE). Ambulatory CF-LVAD patients (6 HeartMate, 26 HeartMate II), were included. According to TTE findings, patients were then subdivided in two groups: patients with an opening aortic valve (OAV) [n = 21] and those with an intermittent opening aortic valve (IOAV) [n = 11]. We found a very good correlation of systolic BP (SBP) measurements between the two methods, BPPA and Doppler ultrasound (r = 0.87, P < 0.0001). Bland-Altman plots for SBP revealed a low bias of -4.6 mm Hg and SD of ±4.7 mm Hg. In CF-LVAD patients with IOAV, the BPPA-CO had a good correlation with the LVAD-flow (r = 0.78, P < 0.0001), but in OAV patients, there was no correlation. After adding the patient's intrinsic CO, estimated from TTE in patients with OAV to the LVAD-flow, we found a very good correlation between the BPPA-CO and LVAD-flow + TTE-CO (r = 0.81, P = 0.002). Our study demonstrated that compared with the standard clinical method, Doppler ultrasound, the BPPA measured BP noninvasively with good accuracy and precision of agreement. In addition, tonometry BPPA provided further valuable information regarding the CF-LVAD patient's intrinsic CO.

Improvement of survival in low-weight children on the Berlin Heart EXCOR ventricular assist device support†.

OBJECTIVES: Publications on the paediatric Berlin Heart EXCOR ventricular assist device have revealed that low body weight <10 kg is a significant risk factor for mortality with children weighing <5 kg being at the highest risk. However, these studies are limited to implantation periods prior to 2011. Since then, progress has been made in the optimization of patient selection and management. This study investigated whether the survival of children weighing <10 kg supported with the EXCOR assist device has improved in recent years and sought to determine the risk factors for mortality. METHODS: The Berlin Heart EXCOR prospective registry (n = 1832) was retrospectively reviewed between 2000 and 2017 to compare the outcomes of different weight cohorts: A (<5 kg; n = 204), B (5-10 kg; n = 633) and C (>10 kg; n = 995) in different eras [era 1: January 2000-December 2012 (n = 1089) and era 2: January 2013-June 2017 (n = 743)]. RESULTS: Overall survival in groups A and B significantly increased from era 1 to era 2 (group A 51% vs 65%, P < 0.001; group B 74% vs 78%, P = 0.001), whereas it remained stable in group C (78% vs 73%). In era 2, the survival of group B was not significantly different from group C. On the multivariable analysis of children weighing <5 kg, congenital heart disease, preoperative extracorporeal life support and biventricular support were independently associated with increased mortality in era 1 [hazard ratio 2.04 (95% confidence interval 1.18-3.53); 2.44 (1.36-4.37) and 1.93 (1.11-3.34), respectively] but not in era 2. CONCLUSIONS: Paediatric EXCOR ventricular assist device therapy has significantly improved for patients weighing <10 kg. Withholding a ventricular assist device is not justified on the basis of the body weight alone.

Successful support of biventricular heart failure patients by new EXCOR® Adult pumps with bileaflet valves: a prospective study.

AIMS: The Berlin Heart EXCOR® Adult biventricular assist device (BiVAD) is an approved mechanical circulatory support for patients with end-stage biventricular heart failure. In this prospective post-market clinical follow-up study, we present the first clinical experience of the new EXCOR® Adult pump with bileaflet (BL) valves in Europe. METHODS AND RESULTS: After CE-mark approval in August 2014, a total of 12 patients were enrolled with a mean age of 44 years ± 11 (range 21-58 years). The majority of patients (n = 11) were in INTERMACS level 1 or 2. Eight patients had a median pre-operative extracorporeal life support (ECLS) of 6 days (range 1-37 days). Primary end point was survival, either to heart transplantation (HTx), recovery or alive at 12 months on device, whichever occurred first. Secondary end point was the number of adverse events throughout EXCOR® BiVAD support. Median support time up to last follow-up on EXCOR® BiVAD device was 248 days (range 57-381 days) and patient survival at 1 year was 92%. Half of the EXCOR® BiVAD patients (n = 6) were transplanted and five patients were still on support at 1 year post-implantation. Complications during EXCOR® BiVAD support were thoracic bleeding, exit site infection and ischemic cerebrovascular incidents in three cases, respectively. CONCLUSION: The new EXCOR® Adult pump with BL provides pulsatile high cardiac output with excellent outcome and successful bridging to HTx, particularly in critically ill patients with INTERMACS level 1 or 2 at the time of implantation.

Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCOR® 15-ml pump.

OBJECTIVES: The Berlin Heart EXCOR ® (EXCOR) paediatric ventricular assist device is used worldwide for mechanical support of infants and small children with end-stage heart failure. A clinically important gap between the smallest EXCOR blood pump (10 ml) and the next larger size (25 ml) limited the choice of pump size in patients with a body surface area (BSA) between 0.33 and 0.5 m 2 . We present the first clinical experience from the early product surveillance (EPS) of the new EXCOR 15-ml blood pump. METHODS: After CE and U.S. Food and Drug Administration approval in January 2013, 20 patients with a mean age of 1.6 years (range 0.5-3.5 years) and a mean BSA of 0.45 m 2 (range 0.33-0.59 m 2 ) were enrolled in the EPS. The main diagnosis was idiopathic cardiomyopathy in 13 patients; the majority ( n = 16) of children were in INTERMACS level 1 or 2. Data from high-volume paediatric transplant centres were collected prospectively for a defined follow-up period of 60 days after device implantation. RESULTS: Mean time on the EXCOR 15-ml blood pump was 43 days; the survival rate was 100% at the end of the EPS period. Seven patients underwent a heart transplant from the device; 2 children were weaned; and 11 patients remained on support. Infection of cannula exit sites occurred in 3 patients. Two patients had minor thromboembolic strokes but made a complete neurological recovery. CONCLUSIONS: The new EXCOR 15-ml blood pump demonstrated optimal ventricular assist device support of children with a BSA of 0.33-0.5 m 2 .

Benefits of ultra-fast-track anesthesia in left ventricular assist device implantation: a retrospective, propensity score matched cohort study of a four-year single center experience.

BACKGROUND: The use of left ventricular assist devices (LVADs) has gained significant importance for treatment of end-stage heart failure. Fast-track procedures are well established in cardiac surgery, whereas knowledge of their benefits after LVAD implantation is sparse. We hypothesized that ultra-fast-track anesthesia (UFTA) with in-theater extubation or at a maximum of 4 h. after surgery is feasible in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 3 and 4 patients and might prevent postoperative complications. METHODS: From March, 2010 to March, 2012, 53 LVADs (50 Heart Mate II and 3 Heart Ware) were implanted in patients in our department. UFTA was successfully performed (LVAD ultra ) in 13 patients. After propensity score matching, we compared the LVAD ultra group with a matched group (LVAD match ) receiving conventional anesthesia management. RESULTS: Patients in the LVAD ultra group had significantly lower incidences of pneumonia (p = 0.031), delirium (p = 0.031) and right ventricular failure (RVF) (p = 0.031). They showed a significantly higher cardiac index in the first 12 h. (p = 0.017); a significantly lower central venous pressure during the first 24 h. postoperatively (p = 0.005) and a significantly shorter intensive care unit (ICU) stay (p = 0.016). Kaplan-Meier analysis after four years of follow-up showed no significant difference in survival. CONCLUSION: In this pilot study, we demonstrated the feasibility of ultra-fast-track anesthesia in LVAD implantation in selected patients with INTERMACS level 3-4. Patients had a lower incidence of postoperative complications, better hemodynamic performance, shorter length of ICU stay and lower incidence of RVF after UFTA. Prospective randomized investigations should examine the preservation of right ventricular function in larger numbers and identify appropriate selection criteria.

Predictive Value of EuroSCORE II in Patients Undergoing Left Ventricular Assist Device Therapy.

Background Left ventricular assist devices (LVADs) are nowadays a widespread option for the effective treatment of heart failure. We hypothesized that the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) might be a superior tool in clinical decision making compared with other established score systems. Methods In this retrospective, single-center analysis, between 2008 and 2014, 40 consecutive patients were followed for up to 36 months after LVAD (Thoratec HeartMate II) implantation. Postoperative survival was correlated to the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels, Destination Therapy Risk Score (DTRS), HeartMate II Risk Score (HMRS), and EuroSCORE II. Results Overall, a positive outcome (survival, transplantation, or weaning) was reached in 87.5% (30 days), 70% (1 year), and 60% (2 and 3 years) of cases. Patients were categorized as high, medium, and low risk by use of the different scores. Within the created subgroups, the following 1-year positive outcomes were achieved-INTERMACS: high risk 58% versus low risk 68%; EuroSCORE II: high risk 17% versus low risk 89%; DTRS: high risk 44% versus low risk 75%; and HMRS: high risk 60% versus low risk 100%. After 1 year, the EuroSCORE II classification's area under the receiver operating characteristic curve (AUC) was superior (AUC = 0.78) and Fisher exact test revealed a significant predictive value for this classification (p = 0.0037) but not for INTERMACS levels, DTRS, or HMRS classifications. Conclusion These results support the assumption that EuroSCORE II risk classification may be useful to predict survival in LVAD patients. In our observation, it proved to be superior to INTERMACS, DTRS, and HMRS after 1 year.

Special Treatment and Wound Care of the Driveline Exit Site after Left Ventricular Assist Device Implantation.

OBJECTIVE: Despite good results following implantation of left ventricular assist devices (LVADs), infections of the driveline and device pocket remain a major problem for patients on long-term support. We present the data from heart failure patients treated with a Thoratec HeartMate-II LVAD (Thoratec Corporation, Pleasanton, California, United States). METHODS: From January 2008 to April 2011, in our institution, 40 heart failure patients (NYHA IV) were supported with a HeartMate-II LVAD. The driveline maintenance of 17 patients consisted of the use of Octenidine for the wound dressing, whereas merbromin was additionally used for local irrigation in 31 patients. The data concerning driveline infections were analyzed retrospectively. RESULTS: In our study, 95% of the entire cohort was free from infections of the system. Two patients in the conventional group (11.8%) developed a driveline infection at a mean of 130.5 days during 3,416 patient-days (0.21 infection/patient-years). In the Merbromid group (Co. New FaDem SRL Farmaceutici & Chimici, Giugliano, Campania, Italy), all patients were free from any driveline infections during the observation period. In a log-rank comparison, the difference reached statistical significance (p = 0.043). CONCLUSION: During our observation period, fewer infections were noted with merbromin treatment. A multicenter setting in a larger cohort should be performed to confirm these findings, although a (double-) blinded setting might be difficult to achieve.

Ultrasound-assisted treatment of sternocutaneous fistula in post-sternotomy cardiac surgery patients.

OBJECTIVES: Using an ultrasonic debridement system (low frequency, 25 kHz), we aimed to completely remove bacterial biofilms and preserve vital sternal tissue and to compare this procedure with conventional surgical therapy. METHODS: In this retrospective study, we evaluated 37 consecutive patients (25 males) between April 2011 and June 2013 in whom sternocutaneous fistula (SCF) was treated with the ultrasound-assisted wound (UAW) system (Group A, n = 18) or with conventional surgical therapy (Group B, n = 19). Treatment in Group A consisted of a complete dissection of the SCF followed by a multistep UAW debridement session after an interval of 3 days. Our final step in both groups was secondary wound closure with a musculocutaneous flap. RESULTS: Patients in both groups were categorized as high risk with respect to several of the known SCF risk factors. In both groups, a similar variety of bacteria were isolated: 61% were gram-positive species, 16.5% were gram-negative species and 10.5% were Candida albicans. Time to secondary wound closure following eradication was significantly shorter in Group A (10 ± 5.4 vs 15 ± 7.1 days in Group B, P = 0.012). Postoperative antibiotic treatment time (16 ± 9.3 vs 22 ± 10.7 days in Group B, P = 0.078) showed a trend in favour of Group A, but the mean hospitalization time (22 ± 12.0 vs 26 ± 14.3 days in Group B, P = 0.34) did not differ between groups. Recurrence of SCF tended to be less frequent in Group A (6 vs 21% in Group B, P = 0.46). In Group B, one infection-related death was noted. The mean follow-up time was 8 ± 2.7 (Group A) and 10 ± 5.7 (Group B) months. CONCLUSIONS: Ultrasonic debridement is a promising adjunct to SCF treatment. In combination with adequate surgical and antimicrobial therapy, we documented good mid-term results in our trial group.

The importance of intraoperative selenium blood levels on organ dysfunction in patients undergoing off-pump cardiac surgery: a randomised controlled trial.

INTRODUCTION: Cardiac surgery is accompanied by an increase of oxidative stress, a significantly reduced antioxidant (AOX) capacity, postoperative inflammation, all of which may promote the development of organ dysfunction and an increase in mortality. Selenium is an essential co-factor of various antioxidant enzymes. We hypothesized a less pronounced decrease of circulating selenium levels in patients undergoing off-pump coronary artery bypass (OPCAB) surgery due to less intraoperative oxidative stress. METHODS: In this prospective randomised, interventional trial, 40 patients scheduled for elective coronary artery bypass grafting were randomly assigned to undergo either on-pump or OPCAB-surgery, if both techniques were feasible for the single patient. Clinical data, myocardial damage assessed by myocard specific creatine kinase isoenzyme (CK-MB), circulating whole blood levels of selenium, oxidative stress assessed by asymmetric dimethylarginine (ADMA) levels, antioxidant capacity determined by glutathionperoxidase (GPx) levels and perioperative inflammation represented by interleukin-6 (IL-6) levels were measured at predefined perioperative time points. RESULTS: At end of surgery, both groups showed a comparable decrease of circulating selenium concentrations. Likewise, levels of oxidative stress and IL-6 were comparable in both groups. Selenium levels correlated with antioxidant capacity (GPx: r = 0.720; p<0.001) and showed a negative correlation to myocardial damage (CK-MB: r =  -0.571, p<0.001). Low postoperative selenium levels had a high predictive value for the occurrence of any postoperative complication. CONCLUSIONS: OPCAB surgery is not associated with less oxidative stress and a better preservation of the circulating selenium pool than on-pump surgery. Low postoperative selenium levels are predictive for the development of complications. TRIAL REGISTRATION: ClinicalTrials.gov NCT01409057.

Accuracy of the Masimo Pronto-7® system in patients with left ventricular assist device.

BACKGROUND: The Masimo Pronto-7® calculates hemoglobin (Hb) values using the pulsoximetry technique and a variety of mathematical algorithms analyzing the pulse waveform. Although this system has demonstrated a high level of accuracy in average patients, the performance might be altered in special patient populations. Regarding patients with left ventricular cardiac failure, a rotary blood pump generates a constant, continuous, non-pulsatile flow to improve effective cardiac output. Due to this alteration in both, blood flow and arterial blood pressure we hypothesized a reduced accuracy of the Masimo Pronto-7® to detect Hb in patients with left ventricular cardiac failure. To test our hypothesis, we evaluated the Pronto-7®SpHb system in outpatients after continuous-flow-left ventricular assist device (cf-LVAD) implantation (HeartMate II, Thoratec). METHODS: 21 cf-LVAD outpatients from the Clinic for Cardiac, Thoracic and Vascular Surgery were investigated during routine follow up examinations. After venous blood samples were drawn, the Pronto-7® sensor was attached to one randomly selected finger of one hand. The collected SpHb data were compared with Hb values measured by our central laboratory. The difference between the methods was determined using Bland - Altman analysis. The study was registered in the DRKS (DRKS00004415). RESULTS: In all cf-LVAD patients evaluated, the Pronto-7® successfully detected SpHb values. Using Bland - Altman analysis, a bias of 0.14 g/dl (95% upper and lower limits of agreement ± 2.76 g/dl) was calculated. CONCLUSION: The Pronto-7® overestimated the actual Hb value in cf-LVAD outpatients with the HeartMate II. Due to this, we conclude that the system is suitable for screening in routine examinations and further analysis can be performed if needed. However, its use as an emergency tool is questionable because of the increased inaccuracy when Hb values are critically low.

What is the significance of perioperative release of macrophage migration inhibitory factor in cardiac surgery?

Cardiac surgery is associated with release of the pleiotropic cytokine macrophage migration inhibitory factor (MIF). The trigger for MIF release has not yet been elucidated. Owing to its intrinsic antioxidative activity, MIF might reduce oxidative stress and protect from myocardial ischemia and reperfusion (I/R) injury. In the present study, patients scheduled for elective cardiac surgery (n=46) were randomized to undergo coronary artery bypass grafting either conventionally with cardiopulmonary bypass and cardioplegic arrest-induced I/R (cCABG) or in an off-pump procedure (OPCAB) with minimized I/R. We report that only patients who underwent cCABG exhibited a postoperative increase of MIF (p=0.024), while both groups showed an increase in interleukin-6. MIF release appears to be primarily mediated by I/R and to a lesser extent by inflammation. Endogenous peroxidase activity (p=0.021) and serum levels of thioredoxin (p=0.003) were significantly higher in patients who underwent cCABG after surgery. Interestingly, perioperative MIF release was associated with an enhanced antioxidant capacity and a significantly reduced postoperative incidence of atrial fibrillation (p=0.018) and acute kidney injury (p=0.048). The present study highlights the role of MIF increase during cardiac surgery in response to oxidative stress. Based on current observations, we hypothesize that intraoperative MIF secretion is due to I/R and enhances the antioxidant capacity in patients during cardiac surgery.

Massive respiratory dysfunction as sign of fulminant peripartum cardiomyopathy (PPCM).

OBJECTIVE: Case report of a 35-year-old gravida 3, para 2, at 40 + 6 weeks with massive respiratory dysfunction with need of oxygenation, requiring cesarean section. CASE REPORT: Postpartum investigations revealed pathological cardiomegaly with left ventricular failure (NYHAIV). Cardiac biopsy diagnosed postpartum dilatative cardiomyopathy. Despite medication with bromocriptine and levosimendan, cardiac function continued to decrease, requiring surgical intervention and implantation of an intracorporal, left ventricular assist device. Following surgery, cardiac function progressively improved and stabilized. OBJECTIVE: Peripartum cardiomyopathy (PPCM) is a rare, pregnancy-induced disease and requires an interdisciplinary approach for diagnostics and therapeutical treatment.

Prevention of sternal dehiscence with the sternum external fixation (Stern-E-Fix) corset--randomized trial in 750 patients.

BACKGROUND: The main objective of this study will be to determine the effects of a new advanced sternum external fixation (Stern-E-Fix) corset on prevention of sternal instability and mediastinitis in high-risk patients. METHODS: This prospective, randomized study (January 2009 - June 2011) comprised 750 male patients undergoing standard median sternotomy for cardiac procedures (78% CABG). Patients were divided in two randomized groups (A, n = 380: received a Stern-E-Fix corset postoperatively for 6 weeks and B, n = 370: control group received a standard elastic thorax bandage). In both groups, risk factors for sternal dehiscence and preoperative preparations were similar. RESULTS: Wound infections occurred in n = 13 (3.42%) pts. in group A vs. n = 35 (9.46%) in group B. In group A, only 1 patient presented with sternal dehiscence vs. 22 pts. in group B. In all 22 patients, sternal rewiring followed by antibiotic therapy was needed. Mediastinitis related mortality was none in A versus two in B. Treatment failure in group B was more than five times higher than in A (p = 0.01); the mean length of stay in hospital was 12.5 ± 7.4 days (A) versus 18 ± 15.1 days (B) (p=0.002). Re-operation for sternal infection was 4 times higher in group B. Mean ventilation time was relatively longer in B (2.5 vs. 1.28 days) (p = 0.01). The mean follow-up period was 8 weeks (range 6 - 12 weeks). CONCLUSIONS: We demonstrated that using an external supportive sternal corset (Stern-E-Fix) yields a significantly better and effective prevention against development of sternal dehiscence and secondary sternal infection in high-risk poststernotomy patients.

Low stroke rate and few thrombo-embolic events after HeartMate II implantation under mild anticoagulation.

OBJECTIVES: Bleeding and thrombo-embolism are two of the most threatening adverse events associated with the use of continuous flow left ventricular assist devices (LVADs) in the treatment of severe heart failure. We analysed our LVAD patients treated with the HeartMate II (HM II) device by following a low anticoagulation regimen. METHODS: Between 2008 and February 2011, we implanted 40 HM II LVADs in our institution. Intention to treat was bridge to transplant in 25, destination therapy in 9, bridge to candidacy in 5 cases and bridge to recovery in 1 case. Heparin was started only after 24 h postoperatively, and Phenprocumon (Phen) was started after removal of all chest drains. International normalized ratio (INR) target in the years 2008-2009 was 2.5, and 2.0-2.5 since 2010. Acetyl salicylic acid (ASA) was prescribed 50-100 mg/day only in patients <55 years or in case of severe atherosclerotic disease of the right coronary artery. All data were analysed consecutively concerning thrombo-embolic and bleeding events. RESULTS: Fifty-two percent of the patients were in INTERMACS level 1 or 2 at the time of implantation. The mean age was 58 ± 11 years, and the mean days under LVAD was 241 days (maximum: 1052 days). The survival rate was 87.5% after 30 years and 75% in the long term. Early postoperatively, no strokes or thrombo-embolic events occurred. In the long term, two patients suffered from ischaemic strokes, but recovered well. In both of these index events, the INR was lasting below 1.4. One of these two patients developed pump thrombosis additionally. Only three patients (ASA + Phen) developed gastrointestinal bleeding (7.5%). Two patients were withdrawn from Phen + ASA because of multiple angiodysplasia. CONCLUSIONS: Compared with the literature, even a mild anticoagulation protocol does not increase the risk of thrombotic events, but reduces bleeding events in the use of an HM II LVAD.

Feasibility and efficacy of bypassing the right ventricle and pulmonary circulation to treat right ventricular failure: an experimental study.

BACKGROUND: Right ventricular failure (RVF) and -support is associated with poor results. We aimed for a new approach of right - sided assistance bypassing the right ventricle and pulmonary circulation in order to better decompress the right ventricle and optimize left ventricular filling. METHODS: From a microaxial pump (Abiomed), a low resistance oxygenator (Maquet and Novalung) and two cannulas (28 and 27 Fr) a system was set up and evaluated in an ovine model (n = 7). Connection with the heart was the right and left atrium. One hour the system was operated without RVF and turned of again. Then a RVF was induced and the course with the system running was evaluated. Complete hemodynamic monitoring was performed as well as echocardiography, flow measurement and blood gas analysis. RESULTS: The overall performance of the system was reliable. Without RVF no relevant changes of hemodynamics occurred; blood gases were supra normal. In RVF a cardiogenic shock developed (MAP 35 ± 13 mmHg, CO 1,1 ± 0,7 l/min). Immediately after starting the system the circulation normalized (significant increase of MAP to 85 ± 13 mmHg, of CO to 4,5 ± 1,9). Echocardiography also revealed right ventricular recovery. After stopping the system, RVF returned. CONCLUSIONS: Bypassing the right ventricle and pulmonary circulation with an oxygenating assist device, which may offer the advantages of enhanced right ventricular decompression and augmented left atrial filling, is feasible and effective in the treatment of acute RVF. Long time experiments are needed.

[Current success and risks of mechanichal circulatory support]. / Herzinsuffizienz - Aktuelle Erfolge und Risiken der Mechanischen Kreislaufunterstützung.

The growing number of patients suffering from severe congestive heart failure (HF) worldwide still means a challenge for the therapeutic options, mainly in the older population. According to the rapid development in the possibilities for mechanical circulatory support (MCS), the increasing use of left ventricular assist devices (LVADs) as bridge to transplantation (BTT) or destination therapy (DT) reflects a change in the up-to-date therapy of HF. This article gives a broad overview concerning indications, patient selection, choice of the device and mainly a study update. It is clearly shown, that VAD therapy has become an effective tool in the treatment of HF, and that the modern continuous flow pumps have replaced the older, bulky, pulsatile devices, especially in the LVAD sector.

Pulmono-atrial shunt and lung assist to treat right ventricular failure.

In right ventricular failure (RVF) a decrease of right ventricular afterload and improvement of left atrial filling could be achieved by a pulmonary artery-left atrial (PA)-shunt. To avoid cyanosis, artificial oxygenation is necessary. In 11 pigs a PA-shunt was created. An interventional lung assist device (ILA) was installed from the femoral artery to vein in 5 pigs (serial in relation to native lung: Group I) and into the PA-shunt in 6 pigs (parallel: Group II). RVF was induced by pulmonary artery banding. Right ventricular performance was determined by pulse contour analysis, pressure - and flow measurements. In both groups a stable RVF was generated. In Group I cardiac output trended to increase but neither right ventricular filling pressures nor arterial pressure changed significantly. The PaO2 decreased significantly. In Group II cardiac output and arterial pressure increased significantly under a shunt flow of 2.3- 2.6 l/min and the animals recovered from cardiogenic shock. In conclusion a PA-shunt with a parallel lung assist can effectively reverse the deleterious effects of RVF.