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As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed. We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses. [Display omitted] [ABSTRACT FROM AUTHOR]

This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P <.001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients. [ABSTRACT FROM AUTHOR]

We sought to characterize outcomes in patients undergoing pulmonary thromboendarterectomy electively versus after acute presentation. This is a retrospective analysis of patients who underwent pulmonary thromboendarterectomy from October 2015 to April 2022. Patients were divided into 2 groups depending on elective surgery or surgery during the same hospitalization as their presentation. In total, 69 patients were included: 45 in the hospitalized group and 24 in the elective group. Patients in the hospitalized group were less likely to have chronic lung disease, history of pulmonary embolism and hypertension, be on anticoagulation and medication for pulmonary hypertension, and present with >1 month of respiratory symptoms. They were more likely to have worse preoperative right ventricular function. Among other demographics, risk factors for venous thromboembolism were similar between both groups. Thirteen patients in the hospitalized group required preoperative extracorporeal membrane oxygenation. There was no difference in disease classification and operative, cardiopulmonary bypass, and hypothermic circulatory arrest durations between both groups. Postoperative complications were similar between both groups, except for greater frequency of deep vein thrombosis in the hospitalized group (26.7% vs 4.2%, P =.03). In-hospital and intensive care unit length of stay were similar between both groups. Overall, in-hospital mortality was 4.3% and was similar between both groups; P =.28. Our series shows that pulmonary thromboendarterectomy can be safely performed in patients presenting acutely, with comparable postoperative complications and in-hospital mortality to an elective setting. Such patients present with worse right ventricular function, sometimes requiring temporary mechanical support. [Display omitted] [ABSTRACT FROM AUTHOR]

The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences). Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported. Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively. The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration. [ABSTRACT FROM AUTHOR]

There have been sporadic reports of ischemic spinal cord injury (SCI) during venoarterial extracorporeal membrane oxygenation (VA-ECMO) support. The authors observed a troubling pattern of this catastrophic complication and evaluated the potential mechanisms of SCI related to ECMO. This study was a case series. This study was performed at a single institution in a University setting. Patients requiring prolonged VA-ECMO were included. No interventions were done. This was an observational study. Four hypotheses of etiology were considered: (1) hypercoagulable state/thromboembolism, (2) regional hypoxia/hypocarbia, (3) hyperperfusion and spinal cord edema, and (4) mechanical coverage of spinal arteries. The SCI involved the lower thoracic (T7-T12 level) spinal cord to the cauda equina in all patients. Seven out of 132 (5.3%) patients with prolonged VA-ECMO support developed SCI. The median time from ECMO cannulation to SCI was 7 (range: 6-17) days.There was no evidence of embolic SCI or extended regional hypoxia or hypocarbia. A unilateral, internal iliac artery was covered by the arterial cannula in 6/7 86%) patients, but flow into the internal iliac was demonstrated on imaging in all available patients. The median total flow (ECMO + intrinsic cardiac output) was 8.5 L/min (LPM), and indexed flow was 4.1 LPM/m2. The median central venous oxygen saturation was 88%, and intracranial pressure was measured at 30 mmHg in one patient, suggestive of hyperperfusion and spinal cord edema. An SCI is a serious complication of extended peripheral VA-ECMO support. Its etiology remains uncertain, but the authors' preliminary data suggested that spinal cord edema from hyperperfusion or venous congestion could contribute. [ABSTRACT FROM AUTHOR]

Genetically engineered pigs are thought to be an alternative organ source for patients in end-stage heart failure unable to receive a timely allograft. However, cardiac xenografts exhibit growth and diastolic heart failure within 1 month after transplantation. Grafts function for up to 6 months, but only after administration of temsirolimus and afterload-reducing agents to reduce this growth. In this study we investigated the growth and hemodynamics of growth hormone receptor (GHR) knockout xenografts, without the use of adjuncts to prevent intrinsic graft growth after transplantation. Genetically engineered pig hearts were transplanted orthotopically into weight-matched baboons between 15 and 30 kg, using continuous perfusion preservation before implantation (n = 5). Xenografts included knockout of carbohydrate antigens and knockin of human transgenes for thromboregulation, complement regulation, and inflammation reduction (grafts with intact growth hormone, n = 2). Three grafts contained the additional knockout of GHR (GHR knockout grafts; n = 3). Transthoracic echocardiograms were obtained twice monthly and comprehensively analyzed by a blinded cardiologist. Hemodynamics were measured longitudinally after transplantation. All xenografts demonstrated life-supporting function after transplantation. There was no difference in intrinsic growth, measured using septal and posterior wall thickness and left ventricular mass, on transthoracic echocardiogram out to 1 month in either GHR knockout or GHR intact grafts. However, hypertrophy of the septal and posterior wall was markedly elevated by 2 months post transplantation. There was minimal hypertrophy out to 6 months in GHR knockout grafts. Physiologic mismatch was present in all grafts after transplantation, which is largely independent of growth. Xenografts with GHR knockout show reduced post-transplantation xenograft growth using echocardiography >6 months after transplantation, without the need for other adjuncts. Post-transplantation xenograft growth is a life-limiting phenomenon in recipients after cardiac xenotransplantation. In this study, genetically engineered hearts expressing multiple human transgenes, with or without intact growth hormone receptor, were transplanted orthotopically into weight-matched baboons after continuous perfusion preservation. Post-transplantation xenograft growth was investigated using echocardiography and physiologic mismatch was characterized. Results indicate markedly elevated heart rates and mean arterial pressures experienced by all transplanted xenografts. Growth hormone intact grafts showed marked post-transplantation xenograft growth compared with those with growth hormone receptor knocked out. This study demonstrates reduced xenograft growth after transplantation by using xenografts with multiple human transgenes and growth hormone receptor knockout. Implications include the possible elimination for the need for adjuncts to reduce post-transplantation cardiac xenograft growth. [Display omitted] [ABSTRACT FROM AUTHOR]

Donation after circulatory death (DCD) donors offer the ability to expand the lung donor pool and ex vivo lung perfusion (EVLP) further contributes to this ability by allowing for additional evaluation and resuscitation of these extended criteria donors. We sought to determine the outcomes of recipients receiving organs from DCD EVLP donors in a multicenter setting. This was an unplanned post hoc analysis of a multicenter, prospective, nonrandomized trial that took place during 2011 to 2017 with 3 years of follow-up. Patients were placed into 3 groups based off procurement strategy: brain-dead donor (control), brain-dead donor evaluated by EVLP, and DCD donors evaluated by EVLP. The primary outcomes were severe primary graft dysfunction at 72 hours and survival. Secondary outcomes included select perioperative outcomes, and 1-year and 3-years allograft function and quality of life measures. The DCD EVLP group had significantly higher incidence of severe primary graft dysfunction at 72 hours (P =.03), longer days on mechanical ventilation (P <.001) and in-hospital length of stay (P =.045). Survival at 3 years was 76.5% (95% CI, 69.2%-84.7%) for the control group, 68.3% (95% CI, 58.9%-79.1%) for the brain-dead donor group, and 60.7% (95% CI, 45.1%-81.8%) for the DCD group (P =.36). At 3-year follow-up, presence observed bronchiolitis obliterans syndrome or quality of life metrics did not differ among the groups. Although DCD EVLP allografts might not be appropriate to transplant in every candidate recipient, the expansion of their use might afford recipients stagnant on the waitlist a viable therapy. [Display omitted] [ABSTRACT FROM AUTHOR]

We report the intraoperative management of an orthotopic cardiac xenotransplant in a 57-year-old man with nonischemic cardiomyopathy requiring venoarterial extracorporeal membrane oxygenation. Transesophageal echocardiography was used for preharvest assessment. Continuous ex vivo perfusion of the heart was performed. Steps were taken to avoid potential xenozoonosis transmission to other patients and staff. Preclinical experience guided our intraoperative management in controlling hemodynamics and using prophylactic antiarrhythmic medications. Echocardiography aided in the diagnosis of aortic dissection in the patient after transplant. Intraoperative cardiac function was excellent. The patient was weaned from all mechanical support 4 days after transplant. [ABSTRACT FROM AUTHOR]

The COMMENCE trial was conducted to evaluate the safety and effectiveness of an aortic bioprosthesis with novel RESILIA tissue (Edwards Lifesciences, Irvine, Calif). Reports of early noncalcific valve failure resulting from thrombosis or leaflet tears in other valves warrant careful evaluation of early valve performance. Patients underwent clinically indicated surgical aortic valve replacement with the Edwards Pericardial Aortic Bioprosthesis, Model 11000A (Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), single-arm, Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee; echocardiograms were analyzed by an independent core laboratory. Between January 2013 and March 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years. Mean Society of Thoracic Surgeons predicted risk of mortality was 2.0% ± 1.8%. Follow-up duration was 3.7 ± 1.2 years, with a total of 2533 patient years of follow-up and a median follow-up of 4 years. Early all-cause mortality was 1.2%, thromboembolism 2.3%, all bleeding 1.0%, and major paravalvular leak 0.1%. One- and 4-year actuarial freedom from all-cause mortality was 97.7% (95% confidence interval, 96.5%-98.8%) and 91.9% (95% confidence interval, 89.7%-94.1%), respectively. At 4 years, New York Heart Association functional class improved compared with baseline in 63.0%, effective orifice area was 1.5 ± 0.5 cm2, and mean gradient was 11.0 ± 5.6 mm Hg. Freedom from moderate or greater transvalvular insufficiency was 99.7%. There were no events of structural valve deterioration. Safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue at 4 years are favorable. This novel tissue does not appear to result in unexpected early thrombosis events or noncalcific structural valve deterioration. [ABSTRACT FROM AUTHOR]

This study compares outcomes of conventional and less-invasive (LI) approaches for aortic valve replacement (AVR) using The Society of Thoracic Surgeons database. Between 2011 and 2017, we identified 122,474 patients undergoing isolated primary AVR. Patients were categorized into 3 groups: (1) full sternotomy (FS) (n = 98,549; 78%), (2) partial sternotomy (PS) (n = 17,306; 15%), and (3) right thoracotomy (RT) (n = 6619; 7%). The rate of LI-AVR increased from 17% in 2011 to 23% in 2016 (P <.001). Femoral cannulation was used in 1.5% of FS, 5.4% of PS, and 71% of RT patients (P <.001). Full sternotomy patients were older and had higher rates of preoperative renal failure, atrial fibrillation, and stroke, and had a higher NYHA function class, lower ejection fraction, and higher STS risk score. Total operative, cardiopulmonary bypass, and cross-clamp time were longest in RT-AVR patients and shortest in those who had FS-AVR. Overall, unadjusted operative mortality was 1.9% (1.05% among low-risk patients) and was not different among the 3 groups (1.97% FS, 1.77% PS, and 1.90% RT; P =.4). The rate of postoperative stroke was 1.2% and was not different among the 3 groups (1.2% FS, 1.3% PS, and 1.1% RT; P =.3). After risk adjustment, these differences remained nonsignificant. After risk adjustment, prolonged ventilation and atrial fibrillation were less common in PS-AVR patients. The adjusted risk for blood transfusion was lower in RT-AVR patients, as was the incidence of renal failure. Femoral cannulation was not associated with increased risk for stroke or mortality after LI-AVR. Less-invasive AVR is associated with an operative mortality and postoperative stroke rate similar to that of FS. Less-invasive AVRs should serve as a benchmark for comparison between transcatheter aortic valve replacement and surgical AVR in low-risk patients. [ABSTRACT FROM AUTHOR]

Resectional and artificial cordal repair techniques are effective strategies for degenerative mitral valve (MV) repair. However, resectional repair requires a tailored approach using various techniques, whereas cordal repair offers a simpler, easily reproducible repair. The approach described in this study approach has evolved from resectional to cordal over time, and outcomes are compared between the eras. Clinical and echocardiographic outcomes of all patients undergoing MV repair for degenerative mitral regurgitation (MR) from January 2004 to September 2017 were reviewed. Patients were stratified by era: from January 2004 to June 2011 (era 1; n = 405), resectional techniques were used in 62% and artificial cordal techniques were used in 38%. From July 2011 to September 2017 (era 2; n = 438), artificial cordal repair was used in 98% of patients. The primary outcome was repair failure, defined as greater than moderate MR or MV reoperation. Of 847 patients with degenerative MR, successful repair was achieved in 843 patients (99.5% repair rate). Leaflet prolapse was posterior in 66%, anterior in 8%, and bileaflet in 26%. Cardiopulmonary bypass time and cross-clamp times were shorter in era 2 (CPB: 109 [IQR, 92–128] minutes vs 97 [IQR, 76–121] minutes; P <.001; cross-clamp: 88 [IQR, 73–106] minutes vs. 79 [IQR, 61–99] minutes; P <.001). Predismissal echocardiography demonstrated no MR or trace MR in 95%, mild MR in 4.7%, and moderate MR in 0.3% of patients. Operative mortality was similar in the eras (0.5% vs 0.5%; P >.999). The rates of 5-year freedom from repair failure (95.1% vs 95.5%; P =.707), stroke (96.8% vs 95.3%; P =.538), and endocarditis (99.3% vs 99.7%; P =.604) were similar between the eras. Ar tificial cordal repair for all patients with degenerative MR simplifies MV repair and yields equivalent, excellent outcomes compared with a tailored resectional approach. [ABSTRACT FROM AUTHOR]

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has emerged as a promising initial support strategy for acute massive pulmonary embolism. However, it remains unclear which patients will ultimately require surgical pulmonary embolectomy (SPE) vs anticoagulation alone. All consecutive patients (2015-2018) with confirmed massive PE, placed on VA-ECMO utilizing a protocolized approach, were reviewed. Per protocol, patients were supported for 3 to 5 days before reevaluation of right ventricular (RV) function via echocardiography. If RV function recovered, VA-ECMO was discontinued with no further intervention (no-SPE group). In patients with persistent RV dysfunction, SPE was performed. Forty-five patients were identified, and 41 patients were treated per protocol. Seventy-three percent responded to anticoagulation alone, and 27% required SPE. Factors associated with SPE rather than decannulation with anticoagulation alone included prolonged shortness of breath, elevated N-terminal prohormone of brain natriuretic peptide, enlarged pulmonary artery diameter, and history of venous thromboembolism. A predictive algorithm was developed with a negative predictive value of 97% and a specificity of 97% for a low-risk score, and a positive predictive value of 100% and sensitivity of 67% for a high-risk score. Overall, 90-day survival was 97% in the no-SPE group and 100% in the SPE group. In this cohort, greater than 70% of patients who presented with massive PE and supported with VA-ECMO ultimately recovered with anticoagulation alone. Specific risk factors, likely related to thrombus chronicity, may be associated with lack of RV recovery, and can be utilized for consideration of early surgical intervention to minimize VA-ECMO duration. [ABSTRACT FROM AUTHOR]

Perioperative cardiac xenograft dysfunction (PCXD) was described by McGregor and colleagues as a major barrier to the translation of heterotopic cardiac xenotransplantation into the orthotopic position. It is characterized by graft dysfunction in the absence of rejection within 24 to 48 hours of transplantation. We describe our experience with PCXD at a single program. Orthotopic transplantation of genetically engineered pig hearts was performed in 6 healthy baboons. The immunosuppression regimen included induction by anti-CD20 monoclonal antibodies (mAb), thymoglobulin, cobra venom factor, and anti-CD40 mAb, and maintenance with anti-CD40 mAb, mycophenolate mofetil, and tapering doses of steroids. Telemetry was used to assess graft function. Extracorporeal membrane oxygenation was used to support 1 recipient. A full human clinical transplantation team was involved in these experiments and the procedure was performed by skilled transplantation surgeons. A maximal survival of 40 hours was achieved in these experiments. The surgical procedures were uneventful, and all hearts were weaned from cardiopulmonary bypass without issue. Support with inotropes and vasopressors was generally required after separation from cardiopulmonary bypass. The cardiac xenografts performed well immediately, but within the first several hours they required increasing support and ultimately resulted in arrest despite maximal interventions. All hearts were explanted immediately; histology showed no signs of rejection. Despite excellent surgical technique, uneventful weaning from cardiopulmonary bypass, and adequate initial function, orthotopic cardiac xenografts slowly fail within 24 to 48 hours without evidence of rejection. Modification of preservation techniques and minimizing donor organ ischemic time may be able to ameliorate PCXD. [ABSTRACT FROM AUTHOR]

Extracorporeal life support has traditionally been used as a supportive platform for patients with cardiopulmonary failure. Many of these patients require endovascular access for the performance of diagnostic or therapeutic procedures, and obtaining vascular access in these patients can be problematic. We sought to develop a novel system that allows the extracorporeal life support circuit to serve as an access point to the cardiovascular system. By using computer-aided design, modeling, and 3-dimensional printing, a novel adaptor that can be easily inserted and removed from an extracorporeal life support circuit was developed. A mock loop was used to measure flow and pressure at various pump speeds with insertion of guidewires and catheters through the adaptor. The ability of the system to enable performance of endovascular procedures in vivo was then tested in a porcine extracorporeal life support model. By using a small arterial cannula (15F) at 3500 RPM and 3.2 LPM, 15% and 24% decrements in circuit flow were observed when a 0.035" guidewire and 5F angiography catheter, respectively, were passed through the adaptor (P <.001). However, when using a larger arterial cannula (23F) at 3500 RPM and 4.7 LPM, only 3% and 5% decrements in flow were observed (P <.001), respectively, with intermediate changes when using 17F to 21F cannulas. In vivo testing confirmed that this system enables the performance of a variety of endovascular procedures, including left ventriculography, aortic root and coronary angiography, and descending aortography. This novel system successfully enables endovascular access through an extracorporeal life support circuit. This technology may transform extracorporeal life support from a purely supportive strategy to a platform for endovascular intervention. [ABSTRACT FROM AUTHOR]

Pulmonary embolism is a significant cause of morbidity and mortality. An important subpopulation of patients presenting with acute pulmonary embolism have concurrent undiagnosed chronic thromboembolic disease. We sought to further characterize this subpopulation, specifically in a cohort of patients referred for surgical pulmonary embolectomy. A retrospective review of all patients requiring surgical pulmonary embolectomy at a single center (2013-2017) was performed. Chart review and blinded examination of presenting computed tomographic pulmonary angiograms were done to identify clinical and radiographic features associated with acute on chronic disease. A predictive tool utilizing readily accessible variables was then constructed for risk stratification. A total of 90 patients were identified for analysis; 34 were treated by specifically trained pulmonary thromboendarterectomy surgeons. Twelve patients in the subgroup treated by pulmonary thromboendarterectomy surgeons were found to have acute on chronic disease confirmed by intraoperative endarterectomized specimen. On univariate analysis, degree of pulmonary artery and inferior vena cava dilation and duration of respiratory symptoms were statistically significant variables. Severe right ventricular hypertrophy, elevation in N-terminal pro-B-type natriuretic peptide, and unprovoked etiology were also associated with acute on chronic disease. A predictive tool weighing the presence of these features was created allowing for stratification into low-, moderate-, and high-risk patients. The positive predictive value of a high-risk score was 100%. In this cohort, the prevalence of acute on chronic thromboembolic disease was greater than 1 in 3. Readily available clinical and radiographic features were used to create a predictive tool for risk stratification. [ABSTRACT FROM AUTHOR]

Objective To compare the incidence of bleeding and thrombosis between adult venoarterial (VA) extracorporeal membrane oxygenation (ECMO) patients managed with an activated clotting time (ACT)-guided heparin anticoagulation protocol and activated partial thromboplastin time (aPTT) protocol. Design Retrospective cohort study. Setting Tertiary care, academic medical center. Participants Consecutive adult VA ECMO patients during a 6-year period. Interventions None. Measurements and Main Results Demographic, medical, transfusion, and ECMO data were collected for all patients. Primary study outcomes were bleeding and thrombosis. Secondary outcomes were stroke and in-hospital mortality. One hundred twenty-one patients were included in the cohort. Fifty patients had ACT monitoring, and 71 had aPTT monitoring. There was no difference in the incidence of bleeding or thrombosis between the 2 groups (78.0% v 67.6% for bleeding [p = 0.21] and 16.0% v 19.7% for thrombosis [p = 1.0]). After adjusting for age and total ECMO days, patients managed with ACT received approximately 30% more red blood cell, fresh frozen plasma, and platelet transfusion (all p < 0.05). Conclusion There is no apparent difference in the incidence rate of bleeding or thrombosis between VA ECMO patients managed with an ACT- or aPTT-guided heparin anticoagulation protocol. Patients managed with an ACT-guided protocol received more blood transfusion, which could reflect greater total bleeding. Future randomized controlled trials would help to elucidate optimal anticoagulation strategies for VA ECMO patients. [ABSTRACT FROM AUTHOR]

Background There has been renewed interest in surgical pulmonary embolectomy (SPE) for the treatment of pulmonary embolism, but the real-world incidence and outcomes of SPE have yet to be well described using a large, granular data set. We examined the modern experience with SPE in North America as reported to the Society of Thoracic Surgery Adult Cardiac Surgery Database (STS ACSD). Methods The STS ACSD was queried for all isolated SPE for the treatment of acute pulmonary embolism (2011 to 2015). Groups were stratified based on presentation: no cardiogenic shock (NCS), cardiogenic shock without arrest (CS), and cardiogenic shock with cardiac arrest (CS/CA). Preoperative characteristics, intraoperative variables, postoperative in-hospital complications, and operative mortality were compared. Multivariable logistic regression was performed to identify risk factors for in-hospital mortality. Results Of the 1,144 centers reporting during the study period, only 310 performed at least 1 SPE (overall mean, 0.42 ± 1.03 cases • year-1 • center-1). A total of 1,075 eligible SPE were identified (NCS = 719, CS = 203, CS/CA = 153). Median age was 57 years (interquartile range, 45 to 67), 54% were male, and preoperative thrombolysis was used in 8%. Overall, operative mortality was 16%, but increased with presenting acuity (NCS = 8%, CS = 23%, CS/CA = 44%, p < 0.001). Independent predictors of operative mortality included age, obesity, cardiogenic shock, preoperative arrest, chronic lung disease, unresponsive neurologic state, and prolonged cardiopulmonary bypass time. Conclusions SPE is uncommonly performed in North America, and, in selected patients, it may be associated with favorable outcomes. Nevertheless, significant mortality exists, and attention to patient presentation and other risk factors may help distinguish patients appropriate for SPE. [ABSTRACT FROM AUTHOR]

Background Venoarterial extracorporeal membrane oxygenation (VA-ECMO) support can be associated with significant deconditioning due to the requirement for strict bedrest as a result of femoral arterial cannulation. To address this issue, we evaluated our experience with ambulation in patients with peripheral femoral cannulation for VA-ECMO. Methods All patients that were peripherally cannulated for VA-ECMO over a 2-year period were retrospectively reviewed. Patients that ambulated at least once while supported with VA-ECMO were included in the analysis. The primary outcomes were safety and feasibility of ambulation, defined as the absence of major bleeding, vascular, or decannulation events. Results Of 104 patients placed on VA-ECMO, 15 ambulated with a femoral arterial cannula. Forty-six percent of patients were placed on VA-ECMO for decompensated heart failure, and 54% for massive pulmonary embolism. Twenty-seven percent of patients were cannulated during active cardiopulmonary resuscitation. The median length of time from cannulation to out of bed was 3 (range, 0 to 26) days. The median length of time from cannulation to initial ambulation was 4 (range, 1 to 42) days. The median distance of the first postcannulation walk was 300 feet. Neither flow nor speed decreased during or after ambulation. There were no major bleeding events, vascular complications, or decannulation events associated with ambulation. The median intensive care unit length of stay and hospital length of stay were 12 and 21 days, respectively. One-year survival was 100% for ambulating patients. Conclusions Ambulating patients supported with VA-ECMO, despite femoral arterial cannulation, appears feasible and safe in carefully selected patients. [ABSTRACT FROM AUTHOR]

Background Cardiac surgery for structural heart disease has poor outcomes in the presence of cardiogenic shock or advanced heart failure. We applied venoarterial extracorporeal membrane oxygenation (ECMO) to restore end-organ function and resuscitate patients before high-risk cardiac operation. Methods Twelve patients with cardiogenic shock and end-organ failure were evaluated for cardiac surgery. The average Society of Thoracic Surgeons mortality risk was 24% ± 13%. Patients were peripherally cannulated on ECMO for 7 ± 4 days, before undergoing operation for prosthetic mitral stenosis (n = 4), ruptured papillary muscle (n = 4), ischemic ventricular septal defect (n = 3), or severe aortic stenosis (n = 1). Results Mean age was 61 ± 8 years. Comorbidities included acute renal failure (n = 11), inotrope requirement (n = 10), intraaortic balloon pump (n = 8), severe acidosis (n = 6), high-dose vasopressor requirement (n = 8), and cardiac arrest (n = 1). With ECMO support, vasopressor requirement, central venous pressure, creatinine, lactate, pH, pulmonary hypertension, and The Society of Thoracic Surgeons mortality risk and EuroSCORE (European System for Cardiac Operative Risk Evaluation) II all improved significantly. Care was withdrawn in 1 patient on ECMO with initially unknown anoxic brain injury. No patients required dialysis at discharge. Complications included 1 permanent stroke. All operative patients survived to hospital discharge. Average length of follow-up was 420 days, with 2 patient deaths at 76 and 230 days and 6 patients surviving over 1 year. Conclusions ECMO can be used as a bridge to heart valve or septal defect surgery in severely decompensated patients. Through recovery of end-organ function, ECMO may allow surgical correction of structural heart disease in patients considered inoperable or convert a salvage situation to an elective operation. Visual Abstract [ABSTRACT FROM AUTHOR]

Background Current stratification systems for patients presenting with acute type A aortic dissection rely on signs of malperfusion to predict mortality. The authors sought to develop an algorithm to readily risk stratify these patients using admission characteristics. Methods Two hundred sixty-nine consecutive patients who underwent type A repair between 2002 and 2015 were reviewed for easily obtainable preoperative demographics and laboratory values deemed a priori as potential predictors of operative mortality. Multiple logistic regression analysis was performed to determine independent significance, and linear regression was performed to generate the concomitant regression expression of the variables significant on bivariate analysis. Results Operative mortality was 16% (43/269) and was 29% (34/119) among patients who presented with malperfusion. Upon multivariate analysis, creatinine (p = 0.008), liver malperfusion (p = 0.006), and lactic acid level (p = 0.0007) remained independent significant predictors. Regression coefficients allowed the generation of a risk score as 5.5 × (lactic acid [mmol/L]) + 8 × (creatinine [mg/dL]) ± 8 (+ if liver malperfusion presents, – if no liver malperfusion). Upon receiver-operating characteristic curve analysis this model generated a c -statistic of 0.75. Operative mortality among patients within the lowest tertile (risk score < 7) was 4%, whereas patients in the middle (7 to 20) and highest (≥20) tertiles had mortality rates of 14% 37%, respectively. Conclusions Although still requiring external validation, the innovative risk score presented necessitates knowledge of lactic acid, serum creatinine, and liver function tests. The algorithm predicts operative mortality with high accuracy and offers clinicians a novel tool to improve preoperative guidance and prognosis. [ABSTRACT FROM AUTHOR]

Background Throughout surgery, specialization in a procedure has been shown to improve outcomes. Currently, there is no evidence for or against subspecialization in coronary surgery. Tasked with the goal of improving outcomes after isolated coronary artery bypass grafting (CABG), our institution sought to determine whether the development of a subspecialized coronary surgery program would improve morbidity and mortality. Methods All isolated CABG operations at a single institution were retrospectively examined in two distinct periods, 2002 to 2013 and 2013 to 2016, before and after the implementation of a subspecialized coronary surgery program. Improved policies included leadership and subspecialization of a program director, standardization of surgical technique and postoperative care, and monthly multidisciplinary quality review. Outcomes were collected and compared. Results Between 2002 and 2013, 3,256 CABG operations were done by 16 surgeons, the most frequent surgeon doing 33%. Between 2013 and 2016, 1,283 operations were done by 10 surgeons, 70% by the coronary program director. CABGs done in the specialized era had shorter bypass and clamps times and increased use of bilateral internal mammary arteries. Blood transfusion and complication rates, including permanent stroke and prolonged ventilation, were significantly decreased after implementation of the coronary program. Likewise, overall operative mortality (2.67% vs 1.48%, p = 0.02) was significantly reduced. Conclusions Subspecialization in CABG and dedicated coronary surgery programs may lead to faster operations, increased use of bilateral internal mammary arteries, fewer complications, and improved survival after isolated CABG. [ABSTRACT FROM AUTHOR]

Background Thrombus located distal to the main or primary pulmonary arteries has been previously viewed as a relative contraindication to surgical pulmonary embolectomy. We compared outcomes for surgical pulmonary embolectomy for submassive and massive pulmonary embolism (PE) in patients with central vs peripheral thrombus burden. Methods All consecutive patients (2011 to 2016) undergoing surgical pulmonary embolectomy at a single center were retrospectively reviewed. Computed tomography angiography of each patient was used to define central PE as any thrombus originating within the lateral pericardial borders (main or right/left pulmonary arteries). Peripheral PE was defined as thrombus exclusively beyond the lateral pericardial borders, involving the lobar pulmonary arteries or distal. The primary outcome was in-hospital and 90-day survival. Results We identified 70 patients: 52 (74%) with central PE and 18 (26%) with peripheral PE. Preoperative vital signs and right ventricular dysfunction were similar between the two groups. Compared with the central PE cohort, operative time was significantly longer in the peripheral PE group (191 vs 210 minutes, p < 0.005). Median right ventricular dysfunction decreased from moderate dysfunction preoperatively to no dysfunction at discharge in both groups. Overall 90-day survival was 94%, with 100% survival in patients with submassive PE in both cohorts. Conclusions This single-center experience demonstrates excellent overall outcomes for surgical pulmonary embolectomy, with resolution of right ventricular dysfunction and comparable morbidity and mortality for central and peripheral PE. In an experienced center and when physiologically warranted, surgical pulmonary embolectomy for peripheral distribution of thrombus is technically feasible and effective. [ABSTRACT FROM AUTHOR]

Background Massive pulmonary embolism (PE) remains a highly fatal condition. Although venoarterial extracorporeal membrane oxygenation (VA-ECMO) and surgical pulmonary embolectomy in the management of massive PE have been reported previously, the outcomes remain less than ideal. We hypothesized that the institution of a protocolized approach of triage and optimization using VA-ECMO would result in improved outcomes compared with historical surgical management. Methods All patients with a massive PE referred to the cardiac surgery service between 2010 and 2017 were retrospectively reviewed. Patients were stratified by treatment strategy: historical control versus the protocolized approach. In the historical control group, the primary intervention was surgical pulmonary embolectomy. In the protocol approach group, patients were treated based on an algorithmic approach using VA-ECMO. The primary outcome was 1-year survival. Results A total of 56 patients (control, n = 27; protocol, n = 29) were identified. All 27 patients in the historical control group underwent surgical pulmonary embolectomy, whereas 2 of 29 patients in the protocol approach group were deemed appropriate for direct surgical pulmonary embolectomy. The remaining 27 patients were placed on VA-ECMO. In the protocol approach group, 15 of 29 patients were treated with anticoagulation alone and 14 patients ultimately required surgical pulmonary embolectomy. One-year survival was significantly lower in the historical control group compared with the protocol approach group (73% vs 96%; P = .02), with no deaths occurring after surgical pulmonary embolectomy in the protocol approach group. Conclusions A protocolized strategy involving the aggressive institution of VA-ECMO appears to be an effective method to triage and optimize patients with massive PE to recovery or intervention. Implementation of this strategy rather than an aggressive surgical approach may reduce the mortality associated with massive PE. [ABSTRACT FROM AUTHOR]

Background We previously investigated preoperative variables associated with qualitative inflow cannula malposition in the HeartMate II (Thoratec-Abbott, Abbott Park, IL) continuous-flow left ventricular assist device. In this report, we assess inflow cannula malposition quantitatively in recipients of both the HeartMate II and the HeartWare (Medtronic-HeartWare, Minneapolis, MN) and examine its association with device thrombosis. Methods Malposition was quantified based on angular deviation from a hypothetic ideal inflow cannula position in two orthogonal computed tomography imaging planes. Ideal position lies on a line from the apex to the center of the mitral valve. Positive anterior plane angulation indicates deviation toward the superior free wall; negative, toward the inferior wall. Positive lateral plane angulation indicates deviation toward the septum; negative, toward the lateral wall. Device thrombosis was assessed based on clinical criteria. Results Fifty-four HeartMate II patients and 68 HeartWare patients were analyzed. Inflow cannula deviation was significantly higher for HeartMate II than for HeartWare (anterior plane angle 36.7 ± 16.8 versus −18.7 ± 11.6 degrees, p < 0.001; lateral plane angle 23.7 ± 20.1 versus 0.2 ± 15.0 degrees, p < 0.001. Pump thrombosis occurred in 31% of HeartMate II patients and 2.9% of HeartWare patients ( p < 0.001). In a multivariate model, HeartMate II and increasing inflow cannula deviation toward the septum were associated with higher thrombosis risk (odds ratio 1.35 per 10-degree increase). Conclusions We found distinct device-dependent differences in inflow cannula positioning and thrombosis, with HeartWare showing both less malposition and less thrombosis. Malposition toward the ventricular septum may contribute to pump thrombosis through a vicious cycle of suction events, low flow, and speed reduction. [ABSTRACT FROM AUTHOR]

Background The management of massive pulmonary embolism remains challenging, with a considerable mortality rate. Although veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for massive pulmonary embolism has been reported, its use as salvage therapy has been associated with poor outcomes. We reviewed our experience utilizing an aggressive, protocolized approach of VA-ECMO to triage, optimize, and treat these patients. Methods All patients with a massive pulmonary embolism who were placed on VA-ECMO, as an initial intervention determined by protocol, were retrospectively reviewed. ECMO support was continued until organ optimization was achieved or neurologic status was determined. At that time, if the thrombus burden resolved, decannulation was performed. If substantial clot burden was still present with evidence of right ventricular (RV) strain, operative therapy was undertaken. Results Twenty patients were identified. Before cannulation, all patients had an RV-to-left ventricular ratio greater than 1.0 and severe RV dysfunction. The median duration of ECMO support was 5.1 days, with significant improvement in end-organ function. Ultimately, 40% received anticoagulation alone, 5% underwent catheter-directed therapy, and 55% underwent surgical pulmonary embolectomy. Care was withdrawn in 1 patient with a prolonged pre-cannulation cardiac arrest after confirmation of neurologic death. In-hospital and 90-day survival was 95%. At discharge, 18 of 19 patients had normal RV function, and 1 patient, who received catheter-directed therapy, had mild dysfunction. Conclusions VA-ECMO appears to be an effective tool to optimize end-organ function as a bridge to recovery or intervention, with excellent outcomes. This approach may allow clinicians to better triage patients with massive pulmonary embolism to the appropriate therapy on the basis of recovery of RV function, residual thrombus burden, operative risk, and neurologic status. [ABSTRACT FROM AUTHOR]

Background To determine if preoperative embolic stroke is associated with an increased risk of postoperative stroke among patients undergoing early operation for mitral valve (MV) infective endocarditis (IE), we compared outcomes among patients presenting with and without acute stroke. Methods From 2003 to 2015, 243 consecutive patients underwent surgery for active MV IE. Patients were categorized into 2 groups: 72% (174 of 243 patients) with no preoperative acute stroke (clinical, radiographic or both) and 28% (69 of 243 patients) with stroke. Both preoperative and postoperative strokes were confirmed in all patients with brain computed tomography or magnetic resonance imaging and comprehensive examination by a neurologist. Results Among patients presenting with stroke, 33% (23 of 69 patients) were asymptomatic and had only positive imaging findings. The median time from admission to operation was 5 days. The overall rate of new postoperative stroke was 4% (10 of 243 patients). The rate of postoperative stroke was not different between the 2 groups: 4% (7 of 174 patients) among patients with no preoperative stroke and 4% (3 of 69 patients) with stroke ( p = 0.9). One patient developed a hemorrhagic conversion of an acute infarct. Operative mortality was 7% (13 of 174 patients) among patients with no preoperative stroke and 7% (5 of 69 patients) among patients with stroke ( p = 0.9). Conclusions MV surgery for IE and acute stroke can be performed early with a low risk of postoperative neurologic complications. When indicated, surgical intervention for MV IE complicated by acute stroke should not be delayed. [ABSTRACT FROM AUTHOR]

Background In addition to severe hypoxia and hypercapnia, acute respiratory distress syndrome (ARDS) can present with substantial hemodynamic compromise, requiring inotropic or vasopressor support or both. Either venovenous (VV) or venoarterial (VA) extracorporeal membrane oxygenation (ECMO) can be offered in this situation. However, a contemporary comparison of these two cannulation strategies has yet to be well described. Methods The Extracorporeal Life Support Organization Registry was reviewed for all cases of adult ARDS in patients that required inotropic agents or vasopressors or both before ECMO initiation (2009 to 2013). Pre-ECMO clinical data, ECMO variables, and outcomes were compared, based on initial cannulation strategy (VV or VA ECMO). Results Of 717 ECMO runs, there were 591 VV ECMO and 126 VA ECMO cases. Over the study period, the proportion of VA ECMO cases decreased from 20% (n = 37 of 184, 2009 to 2010) to 19% (n = 59 of 312, 2011 to 2012) to 14% (n = 30 of 221, 2013). Conversion from VV ECMO to VA ECMO was 4%. VV ECMO was associated with less gastrointestinal bleeding and hemolysis, but overall rates of bleeding, stroke, and renal failure were similar. Survival to discharge was 58% for VV ECMO in contrast to 43% for VA ECMO ( p = 0.002). Multivariable regression analysis revealed VV ECMO to be an independent predictor of survival to discharge relative to VA ECMO. Conclusions In this review of ARDS patients requiring pre-ECMO hemodynamic support, VV ECMO was not associated with worse survival or complication rates compared with VA ECMO. These data suggest that, in appropriately selected patients, it may be reasonable to initially institute VV ECMO support, reserving VA ECMO for conversion for refractory hypotension. [ABSTRACT FROM AUTHOR]

Background Retransplantation has emerged as a therapeutic option for patients experiencing respiratory failure after single lung transplantation. However, outcomes associated with the surgical option (ipsilateral, contralateral, or bilateral lung retransplantation) has not been well evaluated. Methods The Organ Procurement and Transplantation Network database (1994 to 2012) was queried for all lung transplant procedures performed after an initial single lung transplantation. Donor and recipient demographics, before and after transplant characteristics, and outcomes were stratified by retransplant procedural choice and by interval between transplants. Risk factors for mortality were evaluated by Cox proportional hazards regression analysis. Results Of 325 prior single lung transplant recipients, 50 underwent ipsilateral, 175 contralateral, and 100 bilateral lung retransplantation. The number of retransplant procedures performed per year increased from 3 in 1994 to 31 in 2012, with an increasing proportion of contralateral retransplantation and declining proportions of ipsilateral and bilateral retransplantation. Survival was significantly better in the contralateral and bilateral retransplant groups than in the ipsilateral retransplant group at 30 days (94% and 89% versus 80%), 1 year (72% and 67% versus 50%), and 5 years (41% and 42% versus 20%). Ipsilateral retransplantation (hazard ratio 1.48; p = 0.042), mechanical ventilation before retransplant (hazard ratio 2.39; p < 0.001), and retransplantation performed in the first half of the study period (hazard ratio 1.45; p = 0.027) were associated with increased mortality. Conclusions After an initial single lung transplant, both the incidence of retransplantation and postoperative survival have increased with time. Although ipsilateral lung retransplantation may be the best available alternative in particular circumstances, this analysis suggests that contralateral or bilateral lung retransplantation may be preferable in patients for whom those options are medically sensible. [ABSTRACT FROM AUTHOR]

We describe the use of a decontamination protocol that allowed for successful lung transplantation in a patient with cystic fibrosis with necrotizing pneumonia from highly antibiotic-resistant pathogens (Burkholderia and Psuedomonas species). This strategy may allow for successful lung transplantation in patients with cystic fibrosis with multidrug-resistant infections previously considered nontransplantable. [ABSTRACT FROM AUTHOR]

Clinical protocols for stem cell-based therapies are currently under development for patients with hypoplastic left heart syndrome. An ideal cell delivery method should have minimal safety risks and provide a wide distribution of cells to the nonischemic right ventricle (RV). However, the optimal strategy for stem cell delivery to the RV has yet to be explored in a preclinical model, necessary for a hypoplastic left heart syndrome trial. Human c-kit+ cardiac stem cells (CSCs) were delivered to healthy Yorkshire swine through the proximal right coronary artery with a stop and reflow technique. The effect of premedication with antiarrhythmic (AA) medications in this model was retrospectively reviewed, with the primary outcome of survival 2 hours after infusion. A group underwent CSC delivery to the RV without prophylactic AA medication (no AA, n = 7), whereas the second group was premedicated with a loading dose and intravenous infusion of amiodarone and lidocaine (AA, n = 13). Cardiac biopsies were obtained from each chamber to ascertain the biodistribution of CSCs. Survival was significantly greater in the prophylactic AA group compared with the group without AA (13/13 [100%] vs 1/7 [14.3%], P < 0.0001). Cardiac arrest during balloon inflation was the cause of death in each of the nonmedicated animals. In the premedicated group, 9 (69.2%) pigs experienced transient ST segment changes in the precordial leads during CSC delivery, which resolved spontaneously. Most c-kit+ CSCs were distributed to lateral segments of the RV free wall, consistent with the anatomical course of the right coronary artery (lateral RV, 19.2 ± 1.5 CSCs/field of view vs medial RV, 10.4 ± 1.3 CSCs/field of view, P < 0.0001). Few c-kit+ CSCs were identified in the right atrium, septum, or left ventricle. Prophylactic infusion of AA enhances survival in swine undergoing intracoronary delivery of human c-kit+ CSCs to the RV. Additionally, intracoronary delivery results in a limited biodistribution of c-kit+ CSCs within the RV. Human clinical protocols can be optimized by requiring infusion of AA medications before cell delivery. [ABSTRACT FROM AUTHOR]