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.

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.

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.

[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.

Occlusion versus shunting during MIDCAB: effects on left ventricular function and quality of anastomosis.

BACKGROUND: Minimally invasive direct coronary artery bypass is an established clinical procedure for revascularization of the left anterior descending coronary artery. Mechanical stabilization and temporary occlusion is currently used to perform the anastomosis of the internal thoracic artery to the left anterior descending coronary artery. However, critical reduction of cardiac function can occur as a result of temporary ischemia. The purpose of this study was to evaluate whether ischemic sequelae can be avoided by using temporary intraluminal shunts and whether this alters early outcome. METHODS: Thirty-five patients underwent minimally invasive direct coronary artery bypass revascularization using a mechanical stabilizer. In group A (n = 20), the anastomotic site was temporarily occluded by tourniquets. In group B (n = 15), temporary intraluminal shunts were inserted into the anastomotic site without any occlusion of the left anterior descending coronary artery. Anastomosis of the internal thoracic artery to the left anterior descending coronary artery was performed in an identical fashion. A Swan-Ganz catheter was inserted, and transesophageal echocardiographic measurements were obtained for analysis of left ventricular (LV) function. Regional wall motion, cardiac index, stroke volume index, systolic and diastolic LV diameters, and fractional area change were measured during four periods: at the start of the operation (baseline), placement of the stabilizer (stabilization), left anterior descending coronary artery occlusion (occlusion) or insertion of temporary intraluminal shunts (shunt), and 30 minutes after reperfusion (reperfusion). Angiograms were obtained 4 to 6 days postoperatively. RESULTS: In group A, LV performance, cardiac index, stroke volume index, and fractional area change decreased during occlusion whereas systolic diameters increased. Almost two myocardial segments per patient developed severe hypokinesia in the perfusion area. These changes disappeared after 30 minutes of reperfusion, with increased LV function. In group B, LV function remained stable whereas hypokinetic wall motion was only detected in 2 patients. Early angiograms revealed 90% of the grafts were patent in group A versus 100% in group B. The need for percutaneous intervention during the first 6 months was 20% in group A versus 6.7% in group B. CONCLUSIONS: The use of temporary intraluminal shunts resulted in reduced acute ischemia and revealed wall motion abnormalities and maintained LV function. Furthermore, this technique suggests an improvement of early graft patency and a lower reintervention rate within the first 6 postoperative months. Thus, use of temporary intraluminal shunts appears to be superior to the occlusion technique early after minimally invasive direct coronary artery bypass procedures.