Longitudinal cardiac dimensions in patients undergoing LVAD implantation.

BACKGROUND: In conventional left ventricular assist devices (LVAD), a separate outflow graft is sutured to the ascending aorta. Novel device designs may include a transventricular outflow cannula crossing the aortic valve (AV). While transversal ventricular dimensions are well investigated in patients with severe heart failure, little is known about the longitudinal dimensions. These dimensions are, however, particularly critical for the design and development of mechanical circulatory support (MCS) devices with transaortic outflow cannula. METHODS: In an explorative retrospective cohort study at the University Medical Center Freiburg, Germany, the longitudinal cardiac dimensions of patients undergoing computed tomography angiography (CTA) before and, if available, after LVAD implantation were analyzed. Among others, the following dimensions were assessed: (a) apex to AV, (b) apex to mitral valve, (c) AV to sinotubular junction (STJ), (d) apex to STJ, (e) apex to brachiocephalic artery (BCA), and (f) AV to BCA. RESULTS: In total, 44 LVAD patients (36 male, age 55.8 years, height 1.75 m) were included. The longitudinal cardiac dimensions were (a) 114.5 ± 12.1 mm, (b) 108.0 ± 12.4 mm, (c) 20.9 ± 2.9, (d) 135.4 ± 13.4 mm, (e) 206.0 ± 18.3, and (f) 91.5 ± 9.8 mm. Postoperatively, (a) and (b) decreased by 31.5% and 39.5%, respectively (N = 14). CONCLUSIONS: Longitudinal cardiac dimensions may be reduced by up to 40% after LVAD implantation. A better knowledge of these dimensions and their postoperative alterations in LVAD patients may improve surgical planning and help to design MCS devices with transventricular outflow cannula.

Ultra-high-resolution photon-counting detector CT in evaluating coronary stent patency: a comparison to invasive coronary angiography.

OBJECTIVES: To determine the diagnostic accuracy of ultra-high-resolution photon-counting detector CT angiography (UHR PCD-CTA) for evaluating coronary stent patency compared to invasive coronary angiography (ICA). METHODS: Consecutive, clinically referred patients with prior coronary stent implantation were prospectively enrolled between August 2022 and March 2023 and underwent UHR PCD-CTA (collimation, 120 × 0.2 mm). Two radiologists independently analyzed image quality of the in-stent lumen using a 5-point Likert scale, ranging from 1 ("excellent") to 5 ("non-diagnostic"), and assessed all coronary stents for the presence of in-stent stenosis (≥ 50% lumen narrowing). The diagnostic accuracy of UHR PCD-CTA was determined, with ICA serving as the standard of reference. RESULTS: A total of 44 coronary stents in 18 participants (mean age, 83 years ± 6 [standard deviation]; 12 women) were included in the analysis. In 3/44 stents, both readers described image quality as non-diagnostic, whereas reader 2 noted a fourth stent to have non-diagnostic image quality. In comparison to ICA, UHR PCD-CTA demonstrated a sensitivity, specificity, and accuracy of 100% (95% CI [confidence interval] 47.8, 100), 92.3% (95% CI 79.1, 98.4), and 93.2% (95% CI 81.3, 98.6) for reader 1 and 100% (95% CI 47.8, 100), 87.2% (95% CI 72.6, 95.7), and 88.6% (95% CI 75.4, 96.2) for reader 2, respectively. Both readers observed a 100% negative predictive value (36/36 stents and 34/34 stents). Stent patency inter-reader agreement was 90.1%, corresponding to a substantial Cohen's kappa value of 0.72. CONCLUSIONS: UHR PCD-CTA enables non-invasive assessment of coronary stent patency with high image quality and diagnostic accuracy. CLINICAL RELEVANCE STATEMENT: Ultra-high-resolution photon-counting detector CT angiography represents a reliable and non-invasive method for assessing coronary stent patency. Its high negative predictive value makes it a promising alternative over invasive coronary angiography for the rule-out of in-stent stenosis. KEY POINTS: • CT-based evaluation of coronary stent patency is limited by stent-induced artifacts and spatial resolution. • Ultra-high-resolution photon-counting detector CT accurately evaluates coronary stent patency compared to invasive coronary angiography. • Photon-counting detector CT represents a promising method for the non-invasive rule-out of in-stent stenosis.

Outcome of patients supported with the HeartMate 3 after extracorporeal life support: On behalf of the Durable Mechanical Circulatory Support After Extracorporeal Life Support Study Group.

OBJECTIVES: The Durable Mechanical Circulatory Support System After Extracorporeal Life Support registry is a multicenter registry of patients who were bridged from extracorporeal life support to a durable mechanical circulatory support system. Although numerous studies have highlighted the favorable outcomes after implantation of the HeartMate 3 (Abbott), the objective of our study is to examine the outcomes of patients who received HeartMate 3 support after extracorporeal life support. METHODS: Data of patients undergoing HeartMate 3 implantation from January 2016 to April 2022 at 14 centers were collected and evaluated. Inclusion criteria were patients with extracorporeal life support before HeartMate 3 implantation. The outcome was reported and compared with patients receiving other types of pumps. RESULTS: A total of 337 patients were bridged to durable mechanical circulatory support system after extracorporeal life support in the study period. Of those patients, 140 were supported with the HeartMate 3. The other types of pumps included 170 HeartWare HVADs (Medtronic) (86%), 14 HeartMate II devices (7%), and 13 (7%) other pumps (7%). Major postoperative complications included right heart failure requiring temporary right ventricular assist device in 60 patients (47%). Significantly lower postoperative stroke (16% vs 28%, P = .01) and pump thrombosis (3% vs 8%, P = .02) rates were observed in the patients receiving the HeartMate 3. The 30-day, 1-year, and 3-year survivals in patients receiving the HeartMate 3 were 87%, 73%, and 65%, respectively. CONCLUSIONS: In this critically ill patient population, the survivals of patients who were transitioned to the HeartMate 3 are deemed acceptable and superior to those observed when extracorporeal life support was bridged to other types of durable mechanical circulatory support systems.

Training in Aortic Arch Surgery as a Blueprint for a Structured Educational Team Approach: A Review.

Background and objectives: The treatment of pathologies of the aortic arch is a complex field of cardiovascular surgery that has witnessed enormous progress recently. Such treatment is mainly performed in high-volume centres, and surgeons gain great experience in mastering potential difficulties even under emergency circumstances, thereby ensuring the effective therapy of more complex pathologies with lower complication rates. As the numbers of patients rise, so does the need for well-trained surgeons in aortic arch surgery. But how is it possible to learn surgical procedures in a responsible way that, in addition to surgical techniques, also places particular demands on the overall surgical management such as perfusion strategy and neuro-protection? This is why a good training programme teaching young surgeons without increasing the risk for patients is indispensable. Our intention was to highlight the most challenging aspects of aortic arch surgery teaching and how young surgeons can master them. Materials and Methods: We analysed the literature to find out which methods are most suitable for such teaching goals and what result they reveal when serving as teaching procedures. Results: Several studies were found comparing the surgical outcome of young trainees with that of specialists. It was found that the results were comparable whether the procedure was performed by a specialist or by a trainee assisted by the specialist. Conclusions: We thus came to the conclusion that even for such a complex type of intervention, the responsible training of young surgeons by experienced specialists is possible. However, it requires a clear strategy and team approach to ensure a safe outcome for the patient.

Stroke Complications in Patients Requiring Durable Mechanical Circulatory Support Systems After Extracorporeal Life Support.

Stroke is one of the leading complications following durable mechanical circulatory support (MCS) implantation. The aim of this multicenter study was to investigate stroke complications in patients requiring durable MCS following extracorporeal life support (ECLS). Data of 11 high volume MCS centers were collected and evaluated to identify patients who underwent durable MCS implantation after ECLS support between January 2010 and August 2018. The primary outcome was stroke following durable MCS implantation. Univariate and multivariate logistic regression analyses were performed to determine predictors of stroke. Overall, 531 patients met the inclusion criteria. Only patients who were supported with continuous flow pumps were included in this study accounting for 495 patients (median age 54 years old [interquartile range 47-60]). A total of 136 patients (27%) developed postoperative stroke on device during the follow-up (48% ischemic and 52% hemorrhagic) after a median durable MCS support of 320 [32-1,000] days, accounting for 0.17 events per patient-year. Of 133 patients with known date of stroke, a total of 47 (10%) developed stroke during the first 30 days (64% ischemic and 36% hemorrhagic), and 86 patients developed stroke after 30 days (38% ischemic and 62% hemorrhagic) of durable MCS support (late stroke). Survival rate was significantly lower in patients with hemorrhagic stroke ( p = 0.00091). Stroke appears to be a common complication in patients transitioned to durable MCS support after ECLS. Hemorrhagic stroke is a more common type of late stroke and is associated with inferior outcomes.

A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device.

BACKGROUND: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study. METHODS: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases. RESULTS: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%). CONCLUSIONS: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.

[Implantation of mechanical circulatory support systems and heart transplantation in patients with end-stage heart failure : Consensus paper of the DGK, DGTHG]. / Implantation mechanischer Unterstützungssysteme und Herztransplantation bei Patienten mit terminaler Herzinsuffizienz : Konsensuspapier DGK, DGTHG.

The treatment of patients with advanced heart failure requires interdisciplinary care in a qualified heart failure team, especially prior to and in the follow-up of mechanical circulatory support (MCS) implantation and heart transplantation (HTx). The basic prerequisite is the early specialized evaluation of symptomatic patients even under optimized heart failure treatment. Diagnostics and treatment are initially aimed at improving the prognosis. If the prerequisites for MCS or HTx treatment are present, possible contraindications and problems have to be evaluated in order to achieve an optimal risk-benefit ratio for the abovementioned complex treatments with limited resources. The optimal treatment is still HTx if the conditions are right, so this should be sought in all potential patients. At the same time, the optimal individual transplantation window should not be missed. The provision of a MCS system is a treatment performed with very good results for patients with exclusion criteria for HTx or with hemodynamic instability that prevents a longer waiting time for a donor organ. Short-term and medium-term survival is now comparable to HTx when carefully indicated. Timely implantation before the onset of manifest end-organ damage is crucial. Optimized implementation of advanced treatment requires professional structures that enable effective interdisciplinary cooperation between different sectors of health care.

Rationale and Initiative of the Impella in Cardiac Surgery (ImCarS) Register Platform.

OBJECTIVES: Cardiac support systems are being used increasingly more due to the growing prevalence of heart failure and cardiogenic shock. Reducing cardiac afterload, intracardiac pressure, and flow support are important factors. Extracorporeal membrane oxygenation (ECMO) and intracardiac microaxial pump systems (Impella) as non-permanent MCS (mechanical circulatory support) are being used increasingly. METHODS: We reviewed the recent literature and developed an international European registry for non-permanent MCS. RESULTS: Life-threatening conditions that are observed preoperatively often include reduced left ventricular function, systemic hypoperfusion, myocardial infarction, acute and chronic heart failure, myocarditis, and valve vitia. Postoperative complications that are commonly observed include severe systemic inflammatory response, ischemia-reperfusion injury, trauma-related disorders, which ultimately may lead to low cardiac output (CO) syndrome and organ dysfunctions, which necessitates a prolonged ICU stay. Choosing the appropriate device for support is critical. The management strategies and complications differ by system. The "heart-team" approach is inevitably needed.However despite previous efforts to elucidate these topics, it remains largely unclear which patients benefit from certain systems, when is the right time to initiate (MCS), which support system is appropriate, what is the optimal level and type of support, which therapeutic additive and supportive strategies should be considered and ultimately, what are the future prospects and therapeutic developments. CONCLUSION: The European cardiac surgical register ImCarS has been established as an IIT with the overall aim to evaluate data received from the daily clinical practice in cardiac surgery. Interested colleagues are cordially invited to join the register. CLINICAL REGISTRATION NUMBER: DRKS00024560. POSITIVE ETHICS VOTE: AZ 246/20 Faculty of Medicine, Justus-Liebig-University-Gießen.

Development of a Novel Adapter to Enable Less-Invasive Left Ventricular Assist Device Implantation via the Left Ventricular Apex.

The first prototype of an adapter to enable left ventricular assist device (LVAD) implantation solely via the left ventricular (LV) apex and without requiring cardiopulmonary bypass (CPB) was tested in healthy and acutely failing pig hearts. The adapter consists of a fixation, blood guiding, and connecting module fitting to a HeartMate 3 (HM3; Abbott, Chicago, IL) pump. Implantation was performed via a left thoracotomy in five pigs (96 ± 18 kg). Invasive blood pressure was measured before (CTRL), 30 minutes after HM3 initiation (HM3_CTRL), during acute heart failure (HF) induced by rapid pacing (CTRL_HF), and 5 minutes after initiating HM3 support (HM3_HF). To further estimate the LVAD performance, blood pressure amplitudes were calculated in the healthy heart without (CTRL) and with HM3 support (HM3_CTRL) as: systolic-diastolic blood pressure. Our adapter implantation and connection to the HM3 pump succeeded in all animals. Compared to the normal beating healthy heart, blood pressure amplitudes were significantly smaller during HM3 support (CTRL: 41 ± 5 mm Hg vs. HM3_CTRL: 20 ± 4 mm Hg; p < 0.05). Under HF conditions, mean blood pressure returned to normal values after pump initiation (CTRL_HF: 29 ± 6 mm Hg, HM3_HF: 83 ± 24 mm Hg). The adapter prototype allowed safe, straightforward, and less-invasive LVAD implantation solely via the LV apex without using CPB and support of the LV during acute HF in the pig heart.

Composition of the surgical team in aortic arch surgery-a risk factor analysis.

OBJECTIVES: The aim of this study was to analyse the influence of varying experiences within each surgical team to identify team-related risk factors on clinical outcomes after total aortic arch replacement. METHODS: Each surgeon was rated from 1 to 5, and a surgical team's score was calculated (operating surgeon + assisting surgeon = team score) by relying on each member's experience. A composite end point (mortality, stroke or spinal cord injury) was defined. RESULTS: Total aortic arch replacement was performed in 264 patients by 19 cardiovascular surgeons. Analysis revealed that the composite end point was attained more frequently when the team score was <7 (n = 23; 29%) than >7 (n = 35; 19%) (P = 0.015). There was a significant difference depending on the surgeon's experience [3 = 23 (35%); 4 = 9 (22%); 5 = 26 (17%); P = 0.008] and whether he was equally experienced (n = 9, 45%) or not as the assisting surgeon (n = 49, 20%; P = 0.015). Logistic regression revealed age >70 years [OR 2.93 (1.52-5.66); P = 0.001], previous stroke [OR 3.02 (1.36-6.70); P = 0.007], acute type A aortic dissection [OR 2.58 (1.08-6.13); P = 0.033], previous acute kidney injury [OR 2.27 (1.01-5.14); P = 0.049] and 2 surgeons with the same experience [OR 4.01 (1.47-10.96); P = 0.007] as predictors for the composite end point. CONCLUSIONS: Total aortic arch replacement is equally safe whether an experienced surgeon carries it out or assists the procedure. A less experienced team may raise the risk for postoperative complications. Our data suggest an association of equally experienced surgeons in a team with worse outcomes than teams possessing different experience levels.

Ex-Vivo Preservation with the Organ Care System in High Risk Heart Transplantation.

OBJECTIVE: Ex vivo organ perfusion is an advanced preservation technique that allows graft assessment and extended ex situ intervals. We hypothesized that its properties might be especially beneficial for high-risk recipients and/or donors with extended criteria. METHODS: We reviewed the outcomes of 119 consecutive heart transplant patients, which were divided into two groups: A (OCS) vs. B (conventional). Ex vivo organ perfusion was performed using the Organ Care System (OCS). Indications for OCS-usage were expected ischemic time of >4 h or >2 h plus given extended donor criteria. RESULTS: Both groups included mostly redo cases (A: 89.7% vs. B: 78.4%; p = 0.121). Incidences of donors with previous cardiac arrest (%) (A: 32.4 vs. B: 22.2; p < 0.05) or LV-hypertrophy (%) (A: 19.1 vs. B: 8.3; p = 0.119) were also increased in Group A. Ex situ time (min) was significantly longer in Group A (A: 381 (74) vs. B: 228 (43); p < 0.05). Ventilation time (days) (A: 10.0 (19.9) vs. B: 24.3 (43.2); p = 0.057), postoperative need for ECLS (%) (A: 25.0 vs. B: 39.2; p = 0.112) and postoperative dialysis (chronic) (%) (A: 4.4 vs. B: 27.5; p < 0.001) were numerically better in the OCS group, without any difference in the occurrence of early graft rejection. The 30-d-survival (A: 92.4% vs. B: 90.2%; p = 0.745) and mid-term survival were statistically not different between both groups. CONCLUSIONS: OCS heart allowed safe transplantation of surgically complex recipients with excellent one-year outcomes, despite long preservation times and unfavourable donor characteristics. Furthermore, we observed trends towards decreased ventilation times and fewer ECLS treatments. In times of reduced organ availability and increasing recipient complexity, OCS heart is a valuable instrument that enables otherwise infeasible allocations and contributes to increase surgical safety.

Endovascular treatment of traumatic aortic rupture using iliac extension stent-grafts in patients with small aortic diameters.

OBJECTIVES: To evaluate outcomes after thoracic endovascular aortic repair in young patients sustaining traumatic blunt aortic injury (BAI) using iliac extension stent-grafts because of small aortic diameters measuring <24 mm. METHODS: Retrospective analysis regarding clinical presentation, trauma management, endovascular techniques and outcome of patients with a small descending aorta involving an iliac extension stent-graft to treat traumatic BAI. RESULTS: Among 48 patients who suffered a BAI and underwent thoracic endovascular aortic repair, 7 received iliac extension stent-grafts. They were 27.4/[standard deviation (SD): -13.1] years old and 6 out of 7 were male. The iliac extension stent-graft was used as distal stent-graft, and a thoracic stent-graft was used in most patients as proximal extension. We achieved overall technical success in all patients during a procedure lasting 92.6 (SD: 54.9) min. One patient died 2 days after the endovascular procedure of hypoxic brain injury, and another died after 17 days of liver failure. That patient had also suffered a spinal cord injury following the procedure, as the stent-graft had been deployed in Ishimaru Zone 2, and the carotid to subclavian bypass had to be omitted because of his critical condition. Control computed tomographic angiographs was available in 6 patients after 7.7 (SD: 5.1) days and showed no endoleak. The surviving patients were discharged after 18.4 (SD: 13.4) days. CONCLUSIONS: Treating traumatic BAI using iliac extension stent-grafts in young patients with small aortic diameters is feasible. We observed no mortality caused by the BAI or related to endovascular therapy within this small patient cohort.

Left ventricular assist device implants in patients on extracorporeal membrane oxygenation: do we need cardiopulmonary bypass?

OBJECTIVES: Implanting a durable left ventricular assist device (LVAD) in a patient on extracorporeal life support (ECLS) is challenging. The goal of this study was to compare the results of patients from a European registry who had a durable LVAD implanted with or without transition from ECLS to cardiopulmonary bypass (CPB). METHODS: A total of 531 patients on ECLS support who had an LVAD implant between January 2010 and August 2018 were analysed; after 1:1 propensity score matching, we identified and compared 175 patients in each group. RESULTS: The duration of preoperative ECLS was 7 [standard deviation (SD) 6] vs 7 (SD 6) days in patients with or without CPB (P = 0.984). The surgical time was longer in the CPB group [285 (SD 72) vs 209 [SD 75] min; P ≤ 0.001). The postoperative chest tube output was comparable [1513 (SD 1311) vs 1390 (SD 1121) ml; P = 0.3]. However, re-exploration for bleeding was necessary in 41% vs 29% of patients with or without CPB (P = 0.01) and a significantly higher number of packed red blood cells and fresh frozen plasma [8 (SD 8) vs 6 (SD 4) units; P = 0.001 and 6 (SD 7) vs 5 (SD 5) units; P = 0.03] were administered to patients operated on with CPB. A postoperative mechanical right ventricular support device was necessary in 50% vs 41% of patients (P = 0.08). The stroke rate was not significantly different (P 0.99). No difference in survival was observed. CONCLUSIONS: Omitting CPB for an LVAD implant in patients on ECLS is safe and results in shorter operating time, less re-exploration for bleeding and fewer blood products. However, no survival benefit is observed.

Left ventricular assist device implantation causes platelet dysfunction and proinflammatory platelet-neutrophil interaction.

Blood flow through left ventricular assist devices (LVAD) may induce activation and dysfunction of platelets. Dysfunctional platelets cause coagulation disturbances and form platelet-neutrophil conjugates (PNC), which contribute to inflammatory tissue damage. This prospective observational cohort study investigated patients, who underwent implantation of a LVAD (either HeartMate II (HM II) (n = 7) or HeartMate 3 (HM 3) (n = 6)) and as control patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) (n = 10). We performed platelet and leukocyte flow cytometry, analysis of platelet activation markers, and platelet aggregometry. Platelet CD42b expression was reduced at baseline and perioperatively in HM II/3 compared to CABG/AVR patients. After surgery the platelet activation marker ß-thromboglobulin and platelet microparticles increased in all groups while platelet aggregation decreased. Platelet aggregation was more significantly impaired in LVAD compared to CABG/AVR patients. PNC were higher in HM II compared to HM 3 patients. We conclude that LVAD implantation is associated with platelet dysfunction and proinflammatory platelet-leukocyte binding. These changes are less pronounced in patients treated with the newer generation LVAD HM 3. Future research should identify device-specific LVAD features, which are associated with the least amount of platelet activation to further improve LVAD therapy.

Balancing normalcy and safety: health-related needs in patients with a ventricular assist device within their home environment.

AIMS: Ventricular assist device (VAD) implantation has become a well-established treatment strategy for patients suffering from advanced heart failure. Ventricular assist device treatment attempts to ameliorate the symptom burden but may create new challenges in patients' lives. Lacking are insights into perceived challenges and health-related needs of patients with VAD within their home environment. Our study aimed to explore the perceived health-related needs of patients living with a VAD in their home environment. METHODS AND RESULTS: We used a qualitative approach based on a hermeneutic, directed content analysis design. Telephone-based interviews were conducted with 10 patients with VAD from a single cardiology centre in Germany. Data collection and analyses were carried out using content-structuring content analyses. Normalcy and safety were identified as overarching themes: participants expressed a need to balance daily activities between striving for normalcy and maintaining safety. Underlying necessities reflecting this balance were categorized as functional, social, and mental health-related needs. Learning by doing, social-, and peer support were described as relevant requisites. Fulfilling these health-related needs could aid patients living with VAD in achieving the sense of normalcy and safety they seek. CONCLUSION: Balancing health-related needs with striving for normalcy and safety, emerged as a new core concept for patients with VAD. Thus, being cognizant of this balance when caring for these patients, could facilitate coping after VAD implantation through increasing acceptance of limitations to daily functions by enhancing individual safety. A supportive social environment, including peer support, becomes vital in self-management programs preparing patients with VAD for their home environment.

Impact of extra-corporeal life support (ECLS) cannulation strategy on outcome after durable mechanical circulation support system implantation on behalf of durable MCS after ECLS Study Group.

BACKGROUND: The literature on outcomes of patients requiring durable mechanical circulatory support (MCS) after extra-corporeal life support (ECLS) is limited. The aim of this study was to investigate the impact of preoperative ECLS cannulation on postoperative outcome after durable MCS implantation. METHODS: The durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent durable MCS implantation after ECLS between January 2010 and August 2018 in eleven high volume European centers. Patients who underwent the implantation of total artificial heart, pulsatile pumps, or first-generation pumps after ECLS were excluded from the analysis. The remaining patients were divided into two groups; central ECLS group (cECLS) and peripheral ECLS group (pECLS). A 1:1 propensity score analysis was performed to identify two matched groups. The outcome of these two groups was compared. RESULTS: A total of 531 durable MCS after ECLS were implanted during this period. The ECLS cannulation site was peripheral in 87% (n=462) and central in 13% (n=69) of the patients. After excluding pulsatile pumps and total artificial heart patients, a total of 494 patients remained (pECLS =434 patients, cECLS =60 patients). A 1:1 propensity score analysis resulted in 2 matched groups (each 55 patients) with median age of 54 years (48-60 years) in cECLS group and 54 years (43-60 years) in pECLS group. HeartWare HVAD (Medtronic, Minneapolis, MN) was implanted in the majority of the patients (cECLS =71% vs. pECLS =76%, P=0.67). All postoperative morbidities were comparable between the groups. The thirty-day, one year and long-term survival was comparable between the groups (P=0.73). CONCLUSIONS: The cannulation strategy of ECLS appears to have no impact on the post-operative outcome after durable MCS implantation.

First in man evaluation of a novel circulatory support device: Early experience with the Impella 5.5 after CE mark approval in Germany.

BACKGROUND: The Abiomed Impella 5.5 (Danvers, MA) is a newly developed axial flow transaortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula. Impella 5.5 is intended for longer use and was approved for 30 days in 2018. This study evaluated the first-in-man series at six high-volume mechanical circulatory support centers in Germany after CE approval. METHODS: The first 46 consecutive patients worldwide underwent implantation in six German centers between March 2018 and September 2019 for post-CE approval evaluation. The primary end-point was 30 days and 90 days all-cause mortality. RESULTS: The mean age of patients was 59.0 ± 11.5 years, and 43 (93.4%) were men. Half of the patients had acute on chronic heart failure. The main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (47.8%). The mean support time was 15.5 ± 24.2 days (range 0-164, median 10 days (IQR = 7-19)) with a total of 712 patient-days on support. The 30 days and 90 days survival rates were 73.9% (95% CI: 63.3-88.9%) and 71.7% (95% CI: 60.7-87.1%), respectively. Additionally, 16 patients (34.8%) were weaned from the device for native heart recovery, and 19 (41.3%) were bridged to a durable device. Fifteen patients (32.6%) were mobilized to a chair, and 15 (32.6%) were ambulatory. We only noted one stroke and found no other thromboembolic complications. No aortic valve damage was observed in the study cohort. Finally, seven patients (15.2 %) had pump thrombosis, and nine (19.6 %) underwent device exchange. Sixteen patients (34.8 %) suffered from bleeding requiring transfusions during the whole treatment course. In ten patients (21.7%), the inflow cannula dislocated into the aortic root. CONCLUSIONS: The first version of the Impella 5.5 presents promising early outcomes for patients with acute heart failure and expands the spectrum of available devices. The adverse event profile is favorable for short-term devices. Dislocations have been addressed by design changes. With increasing experience with this device, our study suggests that the indications for use will expand to other cardiac shock etiologies and may improve myocardial recovery and survival in patients with cardiogenic shock.