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.

Bleeding and thrombotic events in post-cardiotomy extracorporeal life support.

OBJECTIVES: Haemorrhagic and thrombotic complications are known obstacles in extracorporeal life support (ECLS), and patients requiring post-cardiotomy (PC)-ECLS are particularly prone. The objective of this study was to characterize the incidence, type and clinical relevance of bleeding and thrombotic events in patients on PC-ECLS. METHODS: A total of 504 patients receiving PC-ECLS between 2000 and 2021 at a single centre were included in a retrospective analysis. Incidence and type of haemorrhagic and thrombotic complications in patients on PC-ECLS were assessed. Overall survival was compared, and perioperative risk factors for bleeding and thrombotic events were assessed by binary logistic regression. RESULTS: Of the 504 patients requiring PC-ECLS, 196 patients (38.9%) had 235 bleeding events [surgical site: n = 135 (26.8%); cannulation site: n = 68(13.4%); requiring surgical revision: n = 39 (7.7%); cannulation site change: n = 17 (3.4%); fatal cannulation site bleeding: n = 4(0.8%); intracranial haemorrhage: n = 11 (2.1%); gastrointestinal haemorrhage: n = 8 (1.6%); pulmonary haemorrhage: n = 8 (1.6%); and intra-abdominal/retroperitoneal haemorrhage: n = 5 (1%)]. Overall mortality was higher in patients with major bleeding complications than in patients without bleeding complications (P < 0.0001).A total of 74 patients (14.7%) had 84 thrombotic events [ischaemic stroke, n = 39 (7.7%); cannula/circuit thrombosis, n = 26 (5.2%); peripheral embolism, n = 11 (2.2%); device exchange for haemolysis, n = 8 (1.6%)]. Another 246 patients (48.8%) had at least 1 haemocompatibility-related adverse event. Preoperative dual antiplatelet therapy [adjusted odds ratio (OR): 1.83, 95% confidence interval (CI): 1.063-3.137] and ECLS duration (adjusted OR: 1.14, 95% CI: 1.086-1.197) were identified as independent risk factors for haemorrhage. Prior stroke/transient ischaemic attack (adjusted OR: 1.91, 95% CI: 1.08-3.83) and ECLS duration (adjusted OR: 1.09, 95% CI: 1.04-1.15) were identified as risk factors for thrombotic events. CONCLUSIONS: Bleeding complications in patients on ECLS are common and significantly impair survival. Nearly half of the patients were affected by any haemocompatibility-related event.

Three-month outcomes after the implantation of two HeartMate 3 devices in total artificial heart configuration.

BACKGROUND: Total artificial heart (TAH) implantation is a rarely performed procedure. Contrarily, left ventricular assist device (VAD) implantation is rather common in many centers. As transplantation is quantitatively limited cardiac replacement with artificial hearts is a viable alternative in the treatment of severe biventricular heart failure. An alternative to TAH is the implantation of two VADs in a TAH configuration. We hereby present the first multi-center study on 3-months outcomes of patients treated by cardiectomy and placement of two HeartMate 3s in a TAH configuration. METHODS: We retrospectively investigated a cohort of 15 patients that underwent HM3-TAH-implantation at three international institutions. Follow-up was 3 months after implantation. Baseline, intra- and postoperative parameters as well as survival data and adverse events were collected. RESULTS: A total of 1089 days on HM3-TAH were observed. Thirty-day survival after HM3-TAH implantation was 53% (8/15) and three month survival was 40% (6/15). The longest duration on device was 274 days. Causes of death were multi-organ failure, sepsis, and neurological adverse events. No technical complications were documented. Two patients remained on the device. Four patients (26%) were successfully bridged to transplantation. CONCLUSIONS: The implantation of two HeartMate 3s in a TAH configuration is a last resort and off-label concept in cases of extreme biventricular heart failure. In a diligently selected patient cohort, HM3-TAH implantation is a feasible method to increase the chance of survival in a severely ill patient cohort and successfully bridge patients to heart transplantation that would otherwise have died.

Fate of patients weaned from post-cardiotomy extracorporeal life support.

OBJECTIVES: Although post-cardiotomy extracorporeal life support (PC-ECLS) is a potentially life-saving resource for patients with cardiopulmonary failure after cardiac surgery, adverse outcomes have been reported even in successfully weaned patients. The goal of this study was to assess outcome in patients weaned from PC-ECLS. METHODS: Of 573 consecutive patients who received PC-ECLS at a single centre between 2000 and 2019, 478 patients were included in a retrospective analysis. Successful weaning was defined as survival >24 h after extracorporeal life support (ECLS) explantation. Mortality of patients on ECLS, as well as in-hospital mortality of weaned patients, was assessed. A binary logistic regression model with backward elimination was used to identify predictors for in-hospital mortality after successful ECLS explantation. RESULTS: Of 478 included patients, 120 patients (25.1%) died on ECLS or within 24 h after ECLS explantation. A total of 358 patients were successfully separated from ECLS and survived for >24 h (n = 352 weaned, n = 3 transitioned to durable left ventricular assist device and n = 3 transitioned to a heart transplant). A total of 35.5% of patients who were successfully weaned from ECLS did not survive until hospital discharge. In-hospital deaths of the whole cohort were 51.7% (247/478 patients). For patients who survived to discharge (231/478 patients, 48.3%), survival was 87% after 1 year and 68.9% after 5 years. CONCLUSIONS: In-hospital mortality of patients requiring PC-ECLS is high even in case of successful weaning. Longer ECLS duration, older age, female gender and low preoperative glomerular filtration rate were risk factors for in-hospital mortality after ECLS weaning. Survival of patients discharged after PC-ECLS was encouraging.

Impact of Less Invasive Left Ventricular Assist Device Implantation on Heart Transplant Outcomes.

Left ventricular assist device implantation without sternotomy (LIS) may simplify heart transplantation (HTX) by avoiding adhesions and eliminating the need for a re-sternotomy. This study investigates the impact of LIS LVAD implantation on HTX outcomes. A retrospective comparison of 46 patients undergoing HTX between 07/13 and 06/19 after conventional LVAD implantation with a full sternotomy (FS) and LIS LVAD implantation (LIS: n = 27 patients, 59%; FS: n = 19 patients, 41%) was performed. Endpoints were perioperative data including blood product use, de-novo formation of donor specific antibodies (DSAs) and survival. Patient demographics (mean age FS: 60.3 ± 9.3 years vs LIS 58.0 ± 7.7 years, P = 0.313; male gender FS: 84% vs LIS: 82%, P = 1.000; urgent HTX FS: 16% vs LIS 18%, P = 1.000) were comparable between LIS and FS patients. The primary finding was a significantly higher risk to develop de novo donor specific antibodies (DSAs) after HTX in patients of the FS group (FS: 36% vs LIS: 4%; P = 0.006). LIS patients had a significant reduction of intraoperative packed red blood cells (PRBCs) use (LIS: 4 (IQR 2-7) Units vs FS: 7 (IQR 4-8) Units; P = 0.045). Other adverse events rates and in-hospital mortality (LIS: 7% vs FS 5%, P = 1.000) were comparable between both groups. LIS LVAD reduces formation of donor specific antibodies after HTX.

Incidence, clinical relevance and therapeutic options for outflow graft stenosis in patients with left ventricular assist devices.

OBJECTIVES: We reviewed our institutional experience with outflow graft stenosis (OGS) in 3 contemporary left ventricular assist devices (LVAD). METHODS: Data from 347 consecutive adult recipients of LVAD [Medtronic HVAD (n = 184, 53.0%), Abbott HeartMate II (n = 62, 17.9%) and Abbott HeartMate 3 (n = 101, 29.1%)] implanted between March 2006 and October 2019 were analysed retrospectively. Primary study end points were the incidence of OGS necessitating treatment and survival on LVAD support. RESULTS: During the study period, 17 patients (4.9%) developed OGS requiring treatment with a probability of 0.6% at 1 year, 1.9% at 2 years, 3.8% at 3 years, 4.7% at 4 years and 5.9% at 5 years of LVAD support. Notably, in 13.8% of patients, a compression-related narrowing of the outflow graft with a probability of 1.5% at 6 months, 1.8% 1 year, 6.0% at 2 years, 12.3% at 3 years, 15.4% at 4 years and 16.6% at 5 years of LVAD support with no difference between devices (P = 0.26) was observed. There was a trend towards increased risk of mortality with OGS (hazard ratio 2.21, 95% confidence interval 0.87-5.51; P = 0.09). OGS preferentially occurred in segments of the outflow graft covered by a protective coating. CONCLUSIONS: OGS is a rare but potentially lethal complication during LVAD support. Modifications of pump design and implant techniques may be needed because OGS preferentially occurs within covered portions of the outflow graft. Systematic screening may be warranted.

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.

Access site complications of postcardiotomy extracorporeal life support.

OBJECTIVE: To assess the influence of primary arterial access in patients receiving peripheral postcardiotomy extracorporeal life support on associated complications and outcome. METHODS: Of 573 consecutive patients requiring PC-ECLS between 2000 and 2019 at a single center, 436 were included in a retrospective analysis and grouped according to primary arterial extracorporeal life support access site. Survival and rate of access-site-related complications with special emphasis on fatal/disabling stroke were compared. RESULTS: The axillary artery was cannulated in 250 patients (57.3%), whereas the femoral artery was used as primary arterial access in 186 patients (42.6%). There was no significant difference in 30-day (axillary: 62%; femoral: 64.7%; P = .561) and 1-year survival (axillary: 42.5%; femoral: 44.8%; P = .657). Cerebral computed tomography-confirmed stroke with a modified ranking scale ≥4 was significantly more frequent in the axillary group (axillary: n = 28, 11.2%; femoral: n = 4, 2.2%; P = .0003). Stroke localization was right hemispheric (n = 20; 62.5%); left hemispheric (n = 5; 15.6%), bilateral (n = 5; 15.6%), or infratentorial (n = 2; 6.25%). Although no difference in major cannulation site bleeding was observed, cannulation site change for bleeding was more frequent in the axillary group (axillary: n = 13; 5.2%; femoral: n = 2; 1.1%; P = .03). Clinically apparent limb ischemia was significantly more frequent in the femoral group (axillary: n = 12, 4.8%; femoral: n = 31, 16.7%; P < .0001). CONCLUSIONS: Although survival did not differ, surgeons should be aware of access-site-specific complications when choosing peripheral PC-ECLS access. Although lower rates of limb ischemia and the advantage of antegrade flow seem beneficial for axillary cannulation, the high incidence of right hemispheric strokes in axillary artery cannulation should be considered.

Relevance of Neutrophil Neprilysin in Heart Failure.

Significant expression of neprilysin (NEP) is found on neutrophils, which present the transmembrane integer form of the enzyme. This study aimed to investigate the relationship of neutrophil transmembrane neprilysin (mNEP) with disease severity, adverse remodeling, and outcome in HFrEF. In total, 228 HFrEF, 30 HFpEF patients, and 43 controls were enrolled. Neutrophil mNEP was measured by flow-cytometry. NEP activity in plasma and blood cells was determined for a subset of HFrEF patients using mass-spectrometry. Heart failure (HF) was characterized by reduced neutrophil mNEP compared to controls (p < 0.01). NEP activity on peripheral blood cells was almost 4-fold higher compared to plasma NEP activity (p = 0.031) and correlated with neutrophil mNEP (p = 0.006). Lower neutrophil mNEP was associated with increasing disease severity and markers of adverse remodeling. Higher neutrophil mNEP was associated with reduced risk for mortality, total cardiovascular hospitalizations, and the composite endpoint of both (p < 0.01 for all). This is the first report describing a significant role of neutrophil mNEP in HFrEF. The biological relevance of neutrophil mNEP and exact effects of angiotensin-converting-enzyme inhibitors (ARNi) at the neutrophil site have to be determined. However, the results may suggest early initiation of ARNi already in less severe HF disease, where effects of NEP inhibition may be more pronounced.

Psoas Muscle Area Predicts Mortality after Left Ventricular Assist Device Implantation.

Several risk scores and classifications are available to predict peri- and post-operative mortality of patients with end stage heart failure receiving Left Ventricular Assist Device (LVAD) therapy. Sarcopenia has been suggested as a sensitive predictor for post-operative mortality. We evaluated whether the psoas muscle area can predict mortality in patients undergoing LVAD implantation. The indexed psoas mean area (PMAi) was obtained by measuring the psoas muscle area at the superior endplate of the third lumbar vertebra correlated to body surface area of 106 adult patients undergoing LVAD implantation (Medtronic HVAD n = 41, Abbott HeartMate II n = 4, Abbott HeartMate 3 n = 61; mean age 65, IQR 12, 90.6% male; INTERMACS Level 1 24.5%; ischemic CMP 64.2%). Patients were divided in two groups: high/moderate and low muscle mass. The primary endpoint was 30-day mortality, assessed using a multivariate Cox proportional hazards model. Baseline characteristics did not differ between patients with high or moderate and low PMAi. Estimated survival calculated a significant higher 30-day mortality in patients with low PMAi (p = 0.04). Multivariable Cox proportional hazards regression analysis indicated low PMAi, history of previous cardiac surgery and levels of bilirubin as independent predictors of mortality in the first 30 days. In conclusion, indexed psoas muscle area predicts mortality after LVAD implantation and can be used as an additional tool for risk stratification.

Telocytes in the human ascending aorta: Characterization and exosome-related KLF-4/VEGF-A expression.

Telocytes (TCs), a novel interstitial cell entity promoting tissue regeneration, have been described in various tissues. Their role in inter-cellular signalling and tissue remodelling has been reported in almost all human tissues. This study hypothesizes that TC also contributes to tissue remodelling and regeneration of the human thoracic aorta (HTA). The understanding of tissue homeostasis and regenerative potential of the HTA is of high clinical interest as it plays a crucial role in pathogenesis from aortic dilatation to lethal dissection. Therefore, we obtained twenty-five aortic specimens of heart donors during transplantation. The presence of TCs was detected in different layers of aortic tissue and characterized by immunofluorescence and transmission electron microscopy. Further, we cultivated and isolated TCs in highly differentiated form identified by positive staining for CD34 and c-kit. Aortic-derived TC was characterized by the expression of PDGFR-α, PDGFR-ß, CD29/integrin ß-1 and αSMA and the stem cell markers Nanog and KLF-4. Moreover, TC exosomes were isolated and characterized for soluble angiogenic factors by Western blot. CD34+ /c-kit+ TCs shed exosomes containing the soluble factors VEGF-A, KLF-4 and PDGF-A. In summary, TC occurs in the aortic wall. Correspondingly, exosomes, derived from aortic TCs, contain vasculogenesis-relevant proteins. Understanding the regulation of TC-mediated aortic remodelling may be a crucial step towards designing strategies to promote aortic repair and prevent adverse remodelling.

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.

Impact of Venoarterial Extracorporeal Membrane Oxygenation on Alkaline Phosphatase Metabolism after Cardiac Surgery.

(1) Alkaline phosphatase (AP) is consumed during cardiopulmonary bypass (CPB). A high AP depletion leads to an impaired outcome after cardiac surgery. However, data is scarce on the postoperative course of AP under venoarterial ECMO (VA-ECMO) support. (2) A total of 239 patients with VA-ECMO support between 2000 and 2019 at the Department of Cardiac Surgery (Vienna General Hospital, Austria) were included in this retrospective analysis. Blood samples were collected at several timepoints (baseline, postoperative day (POD) 1-7, POD 14 and 30). Patients were categorized according to the relative AP drop (<60% vs. ≥60%) and ECMO duration (<5 days vs. ≥5 days). (3) Overall, 44.4% reached the baseline AP values within 5 days-this was only the case for 28.6% with a higher AP drop (compared to 62.7% with a lower drop; p = 0.000). A greater AP drop was associated with a significantly higher need for renal replacement therapy (40.9% vs. 61.9%; p = 0.002) and an impaired 1-year survival (51.4% vs. 66.0%; p = 0.031). (4) CPB exceeds the negative impact of VA-ECMO; still, ECMO seems to delay alkaline phosphatase recovery. A greater initial AP drop bears the risk of higher morbidity and mortality.

Reversal of pulmonary hypertension in paediatric patients with restrictive cardiomyopathy.

Left ventricular assist devices can reverse pulmonary hypertension in cardiac transplant candidates with heart failure with a reduced ejection fraction. Whether a similar approach is applicable in restrictive cardiomyopathy is uncertain. We report the successful implantation of a Medtronic HVAD left ventricular assist device in a bridge-to-candidacy concept in 2 paediatric patients with restrictive cardiomyopathy.

Concomitant cardiac surgery procedures during left ventricular assist device implantation: single-centre experience.

BACKGROUND: Additional cardiac pathologies including tricuspid or mitral valve regurgitation are common in left ventricular assist device (LVAD) recipients and whether to address them remains controversial. We present our institutional outcomes of concomitant cardiac procedures, other than temporary right ventricular (RV) support, at the time of LVAD implantation. METHODS: From 03/2006 to 06/2020, 352 adult patients {median age 60 [interquartile range (IQR): 52-66] years; INTERMACS level 1 29%; INTERMACS level 2 17%; INTERMACS level 3 23%, INTERMACS level 4-6 31%; male 86%} underwent continuous-flow LVAD [Medtronic HVAD® (HVAD) 50%; Abbott HeartMate IITM (HMII) 17%; Abbott HeartMate 3TM (HM3) 33%] implantation. Concomitant valvular procedures were performed in 86 patients (24%) and the majority of patients received the LVAD as bridge to candidacy (BTC) for transplant (74%). Primary study endpoints were short- and mid-term mortality, as well as need for temporary RV support. RESULTS: Tricuspid valve annuloplasty was the most frequent concomitant procedure (77%), followed by aortic valve replacements (AVRs) or Park's stitch (33%). Temporary RV support was common in the study cohort (35%) using either extracorporeal life support (ECLS, 37%) or a temporary RV assist device (RVAD, 63%). A less invasive (LIS) implantation technique was pursued in 12%. Thirty-day mortality was comparable between those with and without concomitant surgery (4% vs. 6%, P=0.426). In-hospital mortality was significantly higher for additional interventions (22% vs. 14%, P=0.05), whereas one-year survival was similar (71% vs. 79%, P=0.106). CONCLUSIONS: Concomitant cardiac procedures, especially tricuspid and aortic valve surgery, are frequent but are associated with a higher perioperative morbidity and mortality.

Implanting the HeartMate 6 (total artificial heart).

The HeartMate 3 is a ventricular assist device that supports the heart with a centrifugal continuous flow. It contains a fully levitated rotor to minimize hemolysis and was initially designed as an apical intrapericardial implant. It can be used as a bridge to a transplant, to recovery, or to destination therapy. After we excise the ventricles, we implant 2 HeartMate 3 devices as a total artificial heart (HeartMate 6). The patient was 35 years old when the devices were implanted and had been diagnosed with Yamaguchi syndrome (apical hypertrophic cardiomyopathy) at 13 years of age. Being listed for a transplant was not an option due to secondary pulmonary hypertension. Furthermore, the conventional method of apically implanting a left ventricular assist device was not possible due to the underlying pathology. A HeartMate 6 implant as a bridge to transplant therapy was planned. Additionally, a CardioMEMS HF System was implanted to monitor the pulmonary artery pressure. The video tutorial provides step-by-step instructions for implanting 2 HeartMate 3 devices as a total artificial heart.

Impact of a surgical approach for implantation of durable left ventricular assist devices in patients on extracorporeal life support.

BACKGROUND: The aim of this study was to evaluate the impact of the surgical approach on the postoperative outcome in patients who underwent left ventricular assist device (LVAD) implantation after having received veno-arterial extracorporeal life support (va-ECLS) using data from a European registry (ECLS-VAD). Five hundred and thirty-one patients were included. METHODS: A propensity score-adjusted outcome analysis was performed, resulting in 324 patients in the full sternotomy (FS) group and 39 in the less invasive surgery (LIS) group. RESULTS: The surgery lasted in median 236 min in the FS group versus 263 min in the LIS group (p = 0.289). The median chest tube output during the first 24 h was similar in both groups. Patients who underwent implantation with an FS required more blood products during the first 24 postoperative hours (median 16 vs. 12, p = 0.033). The incidence of revision due to bleeding was also higher (35.5 vs. 15.4%, p = 0.016). A temporary postoperative right ventricular assist device was necessary in 45.1 (FS) versus 23.1% (LIS) of patients, respectively (p = 0.067). No stroke occurred in the LIS group during the first 30 days after surgery (7.4% in the FS group). The incidence of stroke and of renal, hepatic, and respiratory failure during the follow-up was similar in both groups. The 30-day and one-year survival were similar in both groups. CONCLUSION: LIS for implantation of a durable LVAD in patients on va-ECLS implanted for cardiogenic shock is associated with less revision due to bleeding, less administration of blood products and absence of perioperative stroke, with no impact on survival.

Less Invasive Left Ventricular Assist Device Implantation Is Safe and Reduces Intraoperative Blood Product Use: A Propensity Score Analysis VAD Implantation Techniques and Blood Product Use.

Despite increasing popularity and multiple postulated benefits, less invasive (LIS) left ventricular assist device (LVAD) implantation has not been sufficiently compared with standard full sternotomy (FS). We report the outcomes of a propensity score analysis designed to compare LIS and FS LVAD implantation, with perioperative blood product use, adverse event rates, and mortality as primary objective. From September 2010 to August 2016, 159 consecutive patients received a Medtronic HVAD or Abbott HeartMate 3 LVAD via a FS or LIS approach. Outcomes were analyzed using proportional hazard Cox regression, with risk adjustment based on a LIS approach propensity score model computed from demographics, risk factors, and operative covariates. Seventy-five patients were matched and compared (HVAD 83% [n = 62]; LIS approach 43% [n = 32]; mean age 60 ± 12 years; 89% [n = 67] male; 48% [n = 36] ischemic cardiomyopathy [ICMP]; 37% [n = 28]). Patient groups were comparable with regard to preoperative patient characteristics. Less invasive LVAD implantation was successful in all patients with no intraoperative conversions. In-hospital mortality was 16% in both groups, despite 37% Interagency Registry for Mechanically Assisted Circulatory Support Level I patients. Overall, 28% of the LIS patients did not receive any blood products intraoperatively, whereas, in the FS group, only two patients (5%) did not require the administration of blood products (p = 0.000). This was also a significant finding in the overall perioperative phase in which seven LIS patients (22%) who not receive any blood products versus two FS patients (5%; p = 0.033). Otherwise, outcomes were comparable. Less invasive LVAD implantation is a feasible, safe, and reduces blood product use.

Transition From Temporary to Durable Circulatory Support Systems.

BACKGROUND: The decision to implant durable mechanical circulatory systems (MCSs) in patients on extracorporeal life support (ECLS) is challenging due to expected poor outcomes in these patients. OBJECTIVES: The aim of this study was to identify outcome predictors that may facilitate future patient selection and decision making. METHODS: The Durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent MCS implantation after ECLS between January 2010 and August 2018 in 11 high-volume European centers. Several perioperative parameters were collected. The primary endpoint was survival at 1 year after durable MCS implantation. RESULTS: A total of 531 durable MCSs after ECLS were implanted during this period. The average patient age was 53 ± 12 years old. ECLS cannulation was peripheral in 87% of patients and 33% of the patients had history of cardiopulmonary resuscitation before ECLS implantation. The 30-day, 1-year, and 3-year actuarial survival rates were 77%, 53%, and 43%, respectively. The following predictors for 1-year outcome have been observed: age, female sex, lactate value, Model of End-Stage Liver Disease XI score, history of atrial fibrillation, redo surgery, and body mass index >30 kg/m2. On the basis of this data, a risk score and an app to estimate 1-year mortality was created. CONCLUSIONS: The outcome in patients receiving durable MCS after ECLS remains limited, yet preoperative factors may allow differentiating futile patients from those with significant survival benefit.