Virtual reality to predict paravalvular leak in bicuspid severe aortic valve stenosis in transcatheter aortic valve implants.

OBJECTIVES: Severe aortic stenosis (AS) in bicuspid aortic valves (BAV) is associated with an increased risk of paravalvular leak (PVL) after a transcatheter aortic valve replacement (TAVR). Virtual reality (VR) has been shown to be an effective tool in surgical training, but its utility in clinical practice has not been studied. Here we present the first study to evaluate the use of VR simulation in pre-procedure planning and prediction of PVL in TAVR in patients with severe BAV AS. METHODS: Twenty-two patients with severe BAV AS undergoing TAVR between 2014 and 2018 at the University of Minnesota were included in the study. VR simulation of TAVR implants was performed and implants were analyzed for PVL. The primary endpoint was the percent circumference of valve malapposition in VR as compared to the severity of PVL on post-procedure echocardiography. RESULTS: The median age was 78.26 years (IQR 63.77-86.79) and 40.9% (n = 9) were female. Our VR model accurately predicted the presence and absence of PVL in all patients (17/17 and 5/5, respectively). The mean circumferential PVL was 3.73 % ± 7.71. The receiver operator characteristic curve showed an area under the curve of 0.83 (0.59-1.00, P = .03) for malapposition in the VR-TAVR simulated model. CONCLUSIONS: VR-TAVR implantation may predict PVL in severe BAV AS undergoing TAVR.

Left ventricular hemodynamics with veno-arterial extracorporeal membrane oxygenation.

BACKGROUND: There is considerable debate about the hemodynamic effects of veno-arterial extracorporeal membrane oxygenation (VA-ECMO). AIMS: To evaluate the changes in left ventricular (LV) function, volumes, and work in patients treated with VA-ECMO using invasive LV catheterization and three-dimensional echocardiographic volumes. METHODS: Patients on VA-ECMO underwent invasive hemodynamic evaluation due to concerns regarding candidacy for decannulation. Hemodynamic parameters were reported as means±standard deviations or medians (interquartile ranges) after evaluating for normality. Paired comparisons were done to evaluate hemodynamics at the baseline (highest) and lowest tolerated levels of VA-ECMO support. RESULTS: Twenty patients aged 52.3 ± 15.8 years were included. All patients received VA-ECMO for refractory cardiogenic shock (5/20 SCAI stage D, 15/20 SCAI stage E). At 3.0 (2.0, 4.0) days after VA-ECMO cannulation, the baseline LV ejection fraction was 20% (15%, 27%). The baseline and lowest VA-ECMO flows were 4.0 ± 0.6 and 1.5 ± 0.6 L/min, respectively. Compared to the lowest flow, full VA-ECMO support reduced LV end-diastolic volume [109 ± 81 versus 134 ± 93 mL, p = 0.001], LV end-diastolic pressure (14 ± 9 vs. 19 ± 9 mmHg, p < 0.001), LV stroke work (1858 ± 1413 vs. 2550 ± 1486 mL*mmHg, p = 0.002), and LV pressure-volume area (PVA) (4507 ± 1910 vs. 5193 ± 2388, p = 0.03) respectively. Mean arterial pressure was stable at the highest and lowest flows (80 ± 16 vs. 75 ± 14, respectively; p = 0.08) but arterial elastance was higher at the highest VA-ECMO flow (4.9 ± 2.2 vs lowest flow 2.7 ± 1.6; p < 0.001). CONCLUSIONS: High flow VA-ECMO support significantly reduced LV end-diastolic pressure, end-diastolic volume, stroke work, and PVA compared to minimal support. The Ea was higher and MAP was stable or minimally elevated on high flow.

TAVR Beyond Fetal Viability: An Alternative to Preterm Delivery in Symptomatic Severe Aortic Stenosis.

A patient with structural valve degeneration of an aortic bioprosthesis with stenosis stage 3 underwent valve-in-valve transcatheter aortic valve replacement (TAVR) at 29 weeks with improvement. This is the first reported TAVR in the third trimester. TAVR may be an alternative to preterm delivery in cases of symptomatic aortic stenosis.

Case Report: Correlation between pulmonary capillary wedge pressure and left-ventricular diastolic pressure during treatment with veno-arterial extracorporeal membrane oxygenation.

Background: Pulmonary capillary wedge pressure (PCWP) is often used as a surrogate for left-ventricular end-diastolic pressure in patients (LVEDP) who are on veno-arterial extracorporeal membrane oxygenation (V-A ECMO) support for cardiogenic shock and cardiac arrest. However, the correlation between PCWP and LVEDP is not clear in the setting of V-A ECMO usage. We sought to evaluate this correlation in this case series. Methods: Patients were referred to our cardiac catheterization laboratory for invasive hemodynamic studies to assess their readiness for VA-ECMO decannulation. All patients underwent simultaneous left and right heart catheterization. Using standard techniques, we measured PCWP and LVEDP simultaneously. Continuous variables were reported as medians with interquartile ranges. The correlation between PCWP and LVEDP was evaluated using simple linear regression and reported as R2. Results: Four patients underwent invasive hemodynamic studies 4 (2.5, 7) days after VA-ECMO cannulation. All four patients had suffered in-hospital cardiac arrest and had been put on VA-ECMO. At the baseline level of VA-ECMO flow of 4.1 (3.8, 4.4) L/min, the median LVEDP and PCWP were 6 (4, 7.5) mmHg and 12 (6.5, 16) mmHg, respectively. At the lowest level of VA-ECMO flow of 1.9 (1.6, 2.0) L/min, the median LVEDP and PCWP was 13.5 (8.5, 16) mmHg and 15 (13, 18) mmHg, respectively. There was a poor correlation between the simultaneously measured PCWP and LVEDP (R2 = 0.03, p = 0.66). Conclusions: The PCWP may not correlate well with LVEDP in patients treated with VA-ECMO, particularly at high levels of VA-ECMO support.

Transcatheter closure of a large post-myocardial infarction ventricular septal defect using the GORE cardioform ASD Occluder.

A 49-year-old man presented late with an anterior wall myocardial infarction (MI) status post-primary coronary intervention of the left anterior descending artery that resulted in no reflow of the vessel. The patient was transferred to our institution in cardiogenic shock.

Impact of age on survival for patients receiving ECPR for refractory out-of-hospital VT/VF cardiac arrest.

BACKGROUND: Extracorporeal cardiopulmonary resuscitation (ECPR) has been shown to improve neurologically favorable survival for patients with refractory ventricular tachycardia (VT)/ventricular fibrillation (VF) out-of-hospital cardiac arrest. Prior studies of the impact of age on outcomes in ECPR have demonstrated mixed results and we aim to investigate this relationship. METHODS: Patients treated with ECPR at the University of Minnesota Medical Center for refractory out-of-hospital VT/VF arrest from December 2015 to February 2023 were included. The primary endpoints included neurologically favorable survival to discharge. A receiver operating characteristic curve was used to determine an optimal predictive age limit with the highest accuracy for neurologically favorable survival. RESULTS: 391 consecutive patients were included: 22% (n = 86) were female and the mean age was 56.9 ± 11.8 years. Age was independently associated with neurologically favorable survival to discharge, with a 30% decrease in survival with every 10-year increase in age (OR 0.7 (0.57-0.87), p = 0.001. Among those with neurologically favorable survival to discharge, older patients had longer length of hospital stay compared to younger age groups (p = 0.002) while patients who failed to achieve neurologically favorable survival to discharge had similar length of stay independent of age (p = 0.51). CONCLUSIONS: Age is associated with neurologically favorable survival to discharge for patients receiving ECPR for refractory out-of-the-hospital VT/VF cardiac arrest. However, with a survival rate of 23% in the oldest age group, caution should be used when choosing age criteria for patient selection.

Effect of Combination of Balloon Pulmonary Angioplasty and Medical Therapy on Reverse Right Ventricular Remodeling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension.

INTRODUCTION: Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive and debilitating disorder that results from incomplete resolution of vascular obstructions resulting in pulmonary hypertension. Surgical pulmonary thromboendarterectomy (PTE) is the treatment of choice for CTEPH. Unfortunately, many CTEPH patients are ineligible for PTE or do not have access to an expert surgical center. Medical therapy imparts important symptomatic and exercise benefits for CTEPH patients, but it does not extend survival. Balloon pulmonary angioplasty (BPA) is an emerging transcatheter approach that is both safe and efficacious. However, the potential synergy between upfront BPA and medical therapy treatment approaches in patients with inoperable CTEPH is unknown. Here, we evaluated how the combination of BPA and medical therapy compared to medical therapy alone in a newly established BPA program. METHODS: Twenty-one patients with inoperable or residual CTEPH were evaluated in this single-center observational study. Ten patients underwent upfront BPA and medical therapy while 11 patients were treated with medical therapy alone. Hemodynamic and echocardiographic assessments were performed at baseline and at least 1 month after completion of therapy. Continuous variables were compared using t-test or Mann-Whitney U-test. Categorical variables were analyzed with Chi squared and Fisher's exact test where appropriate. RESULTS: Combination therapy significantly reduced mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR), but medical therapy only significantly lowered PVR. Comprehensive echocardiographic analysis revealed a more robust reverse right ventricular (RV) remodeling effect and augmentation of RV function with combination therapy. At the end of study, the combination therapy group had lower mPAP and PVR and better RV function. Importantly, there were no significant adverse effects in patients treated with BPA. CONCLUSION: Combination therapy significantly improves hemodynamics and RV function in inoperable CTEPH while carrying an acceptable risk profile, even in a newly developed program. Further studies comparing upfront combination therapy to medical therapy with larger, long-term, and randomized approaches should be considered.

Initial hospital length of stay and long-term survival of patients successfully resuscitated using extracorporeal cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest.

AIMS: The long-term outcomes of patients treated with extracorporeal cardiopulmonary resuscitation (ECPR) for refractory ventricular tachycardia/ventricular fibrillation (VT/VF) out-of-hospital cardiac arrest (OHCA) remain poorly defined. The purpose of this study was to describe the hospital length of stay and long-term survival of patients who were successfully rescued with ECPR after refractory VT/VF OHCA. METHODS AND RESULTS: In this retrospective cohort study, the length of index admission and long-term survival of patients treated with ECPR after OHCA at a single centre were evaluated. In a sensitivity analysis, survival of patients managed with left ventricular assist device (LVAD) implantation or heart transplantation during the same period was also evaluated. Between 1 January 2016 and 12 January 2020, 193 patients were transferred for ECPR considerations and 160 underwent peripheral veno-arterial extracorporeal membrane oxygenation cannulation. Of these, 54 (33.7%) survived the index admission. These survivors required a median 16 days of intensive care and 24 days total hospital stay. The median follow-up time of the survivors was 1216 (683, 1461) days. Of all, 79.6 and 72.2% were alive at 1 and 4 years, respectively. Most deaths within the first year occurred among the patients requiring discharge to a long-term acute care facility. Overall survival rates at 4 years were similar in the ECPR and LVAD cohorts (P = 0.30) but were significantly higher for transplant recipients (P < 0.001). CONCLUSION: This data suggest that the lengthy index hospitalization required to manage OHCA patients with ECPR is rewarded by excellent long-term clinical outcomes in an expert ECPR programme.

Physicians' perspectives and attitudes toward surgical bailout in transcatheter aortic valve replacement.

Objectives: The incidence of surgical bailout during transcatheter aortic valve replacement (TAVR) is ∼1%, with an associated 50% in-hospital mortality. We performed an exploratory qualitative study of TAVR team perceptions regarding routine surgical bailout planning with patients. Methods: We developed a semistructed interview guide to explore clinician perspectives on the TAVR consent process, managing intraoperative emergencies, and involving patients in surgical contingency planning. We interviewed surgeons, cardiologists, and anesthesiologists involved with TAVR in 4 hospitals. We performed qualitative thematic analysis via independent coding of salient quotations from the transcribed texts. Codes were categorized based on shared meaning and the final themes were derived by identifying key content, and examining its relational nature. Results: Thirteen interviews were conducted, identifying 4 major themes. Participants agreed that eliciting patient preference for bailout is crucial, particularly when surgical outcome is ambiguous. In those cases, participants offered criteria for determining which patients should be engaged in a more nuanced discussion. The ethos of specialty clinicians impacted anticipation and response to procedural emergencies. Finally, physician attitudes reflected strong emotional responses to patient death/morbidity, particularly in iatrogenic injury. Participants expressed anxiety with performing TAVR without surgical backup, while also demonstrating willingness to respect patients' wishes. Conclusions: The TAVR team supports engaging patients regarding potential surgical bailout and honoring their preferences in the event of complication. However, clinical judgment about the expected outcome of bailout would frame that discussion. Participants described the emotional weight of not pursuing bailout if indicated and the importance of good coping mechanisms.

The native aortic valve reduces paravalvular leak in TAVR patients.

Background: Paravalvular leak (PVL) is a frequent TAVR complication. Prospective identification of patients who are likely to develop PVL after TAVR would likely lead to improved outcomes. Prior studies have used geometric characteristics to predict the likelihood of PVL development, but prediction and quantification has not been done. One of the reasons is that it is difficult to predict the mechanical deformation of the native diseased aortic valve prior to implantation of the prosthetic valve, as existing calcifications likely contribute to the seal between the prosthetic valve and the aortic annulus. However, the relatively amount the native valve plays in preventing PVL is unknown. Methods: A retrospective chart review was conducted identifying patients with mild or greater PVL. One patient who had substantial PVL was identified and a 3D printed (pre-TAVR) aortic root was created. Balloon-expandable TAVR stent frames were implanted within the 3D printed root and a new model was created. Using this geometry, computational fluid dynamics (CFD) simulations were done to quantify PVL. The PVL flow path was iteratively decreased to simulate the space occupied by a crushed native aortic valve and PVL was quantified. Results: PVL was found to decrease as the space occupying the PVL area increased, demonstrating that the native aortic valve contributes to reducing regurgitation. CFD simulations demonstrated that within the patient analyzed, the native valve occupies between 3-40% of the PVL pathway. Conclusion: A priori techniques that predict the development of post TAVR PVL should account for the native diseased valve as our simulations demonstrate that it plays a role in reducing PVL.

Effects of a Mixed-Reality Headset on Procedural Outcomes in the Cardiac Catheterization Laboratory.

BACKGROUND: Mixed reality head-mounted displays (MR-HMD) are a novel and emerging tool in healthcare. There is a paucity of data on the safety and efficacy of the use of MR-HMD in the cardiac catheterization laboratory (CCL). We sought to analyze and compare fluoroscopy time, procedure time, and complication rates with right heart catheterizations (RHCs) and coronary angiographies (CAs) performed with MR-HMD versus standard LCD medical displays. METHODS: This is a non-randomized trial that included patients who underwent RHC and CA with MR-HMD between August 2019 and January 2020. Their outcomes were compared to a control group during the same time period. The primary endpoints were procedure time, fluoroscopy time, and dose area product (DAP). The secondary endpoints were contrast volume and intra and postprocedural complications rate. RESULTS: 50 patients were enrolled in the trial, 33 had a RHC done, and 29 had a diagnostic CA performed. They were compared to 232 patients in the control group. The use of MR-HMD was associated with a significantly lower procedure time (20 min (IQR 14-30) vs. 25 min (IQR 18-36), p = 0.038). There were no significant differences in median fluoroscopy time (1.5 min (IQR 0.7-4.9) in the study group vs. 1.3 min (IQR 0.8-3.1), p = 0.84) or median DAP (165.4 mGy·cm2 (IQR 13-15,583) in the study group vs. 913 mGy·cm2 (IQR 24-6291), p = 0.17). There was no significant increase in intra- or post-procedure complications. CONCLUSION: MR-HMD use is safe and feasible and may decrease procedure time in the CCL.

A retrospective study on the trends in surgical aortic valve replacement outcomes in the post-transcatheter aortic valve replacement era.

Background and Aims: Transcatheter aortic valve replacement (TAVR) is the mainstay of treatment of inoperable and severe high-risk aortic stenosis and is noninferior to surgical aortic valve replacement (SAVR) for low-risk and intermediate-risk patients as well. We aim to compare the valve size, area, and transaortic mean gradients in SAVR patients before and after the implementation of TAVR since being approved by the Food and Drug Administration  in 2011. Methods: Patients who underwent a bioprosthetic SAVR placement were divided into two groups based on the date of procedure: the early pre-TAVR implementation group (years 2011-2012) and the contemporary post-TAVR group (years 2019-2020). The primary endpoint was the mean gradient across the aortic valve within 16 months of surgery. The secondary endpoints included the difference in valve size and various aortic valve echocardiographic variables. Results: One hundred and thirty patients had their valves replaced in the years 2011-2012 and 134 in the years 2019-2020. The early group had a significantly higher mean gradient (median of 13 mmHg [interquartile range, IQR: 9.3-18] vs. 10 mmHg [IQR: 7.5-13.1], p = 0.001) and a smaller median effective orifice area index (0.8 cm2/m2 [IQR: 0.6-1] vs. 1.1 cm2/m2 [IQR: 0.8-1.3], p < 0.001). The median valve size was significantly smaller in the early group (median of 21 mm [IQR: 21-23] vs. 23 mm [IQR: 22.5-25], p < 0.001). Conclusion: In the contemporary era, surgical patients receive larger valves which translates into lower mean gradients, larger valve area, and lower rates of patient-prosthesis mismatch than in previous years before the routine introduction of TAVR.

Invasive hemodynamics are equivocal for functional outcomes after MitraClip.

OBJECTIVES: To evaluate invasive hemodynamics in assessing MC therapy success as well as evaluate its effectiveness as a predictor of functional outcomes. BACKGROUND: Mitral regurgitation grade is a poor predictor of functional outcomes after a MitraClip. There is a paucity of data on invasive hemodynamics as a predictor of outcomes. METHODS: Sixty-nine patients underwent MC between 2015 and 2018 at the University of Minnesota Medical Center and were retrospectively analyzed. Invasive hemodynamics were performed before and after device deployment with transesophageal echocardiographic guidance. Statistical analysis was performed using STATA version 16. Student's t test was used for continuous variables and Pearson's chi-squared test for categorical variables. Mann-Whitney test was performed for continuous variables where data were not normally distributed. Logistic and linear regression were used to investigate relationships between variables and outcomes. RESULTS: A total of 69 patients were included in the study. The mean age was 83 (75-87) years and 38 (55%) were male. Eighty-one percentage had >/= NYHA III symptoms. Eighty-seven percentage had severe MR. Pulmonary capillary wedge pressure was 20 (15-24). Overall, there was significant improvement in left atrial pressure including mean left atrial pressure index, MR, and NYHA class after MC (<.001). There was no significant association between invasive hemodynamics (including left atrial mean pressure index or its reduction rate) and functional outcomes (p = NS). MR grade was also not predictive of functional outcomes. CONCLUSION: Left atrial pressure may not be a significant predictor of functional outcomes, and, in isolation, may not be an improvement over MR grade.

Concomitant Respiratory Failure Can Impair Myocardial Oxygenation in Patients with Acute Cardiogenic Shock Supported by VA-ECMO.

Venous-arterial extracorporeal membrane oxygenation (VA-ECMO) treatment for acute cardiogenic shock in patients who also have acute lung injury predisposes development of a serious complication called "north-south syndrome" (NSS) which causes cerebral hypoxia. NSS is poorly characterized and hemodynamic studies have focused on cerebral perfusion ignoring the heart. We hypothesized in NSS the heart would be more likely to receive hypoxemic blood than the brain due to the proximity of the coronary arteries to the aortic annulus. To test this, we conducted a computational fluid dynamics simulation of blood flow in a human supported by VA-ECMO. Simulations quantified the fraction of blood at each aortic branching vessel originating from residual native cardiac output versus VA-ECMO. As residual cardiac function was increased, simulations demonstrated myocardial hypoxia would develop prior to cerebral hypoxia. These results illustrate the conditions where NSS will develop and the relative cardiac function that will lead to organ-specific hypoxia. Illustration of the impact of north-south syndrome on organ-specific oxygen delivery. Patients on VA-ECMO have two sources of blood flow, one from the VA-ECMO circuit and one from the residual cardiac function. When there is no residual cardiac function, all organs are perfused with oxygenated blood. As myocardial recovery progresses, blood supply from the two sources will begin to mix resulting in non-homogeneous mixing and differential oxygenation based upon the anatomical site of branching vessels.

Coronary artery disease burden relation with the presentation of acute cardiac events and ventricular fibrillation.

OBJECTIVES: Evaluate the differences in coronary artery disease (CAD) burden between patients with ischemic resuscitated, ischemic refractory VT/VF OHCA events and N/STEMI. BACKGROUND: Refractory out-of-hospital cardiac arrest patients presenting with initial shockable rhythms (VT/VF OHCA) have the highest mortality among patients with acute cardiac events. No predictors of VT/VF OHCA refractoriness have been identified. METHODS: A retrospective cohort design was used to assess baseline characteristics, clinical outcomes, and the angiographic severity of disease among patients with VT/VF OHCA undergoing emergent coronary angiography at the University of Minnesota Medical Center. The Gensini score was calculated for all patients to assess the angiographic burden of CAD. For patients with ischemia-related cardiac arrest, outcomes were further compared to an independent non-OHCA population presenting with N/STEMI. RESULTS: During the study period, 538 patients were admitted after VT/VF OHCA. Among them, 305 presented with resuscitated, and 233 with refractory VT/VF. 66% of resuscitated and 70% of refractory VT/VF had an underlying, angiographically documented, ischemic etiology. Ischemic resuscitated and refractory VT/VF had significant differences in Gensini score, (80.7 ± 3.6 and 127.6 ± 7.1, respectively, p < 0.001) and survival (77.3% and 30.0%, respectively, p < 0.001). Both groups had a higher CAD burden and worse survival than the non-OHCA N/STEMI population (360 patients). Ischemic refractory VT/VF was significantly more likely to present with chronic total occlusion in comparison to both N/STEMI and ischemic resuscitated VT/VF. CONCLUSION: Ischemia-related, refractory VT/VF OHCA has a higher burden of CAD and the presence of CTOs compared to resuscitated VT/VF OHCA and N/STEMI.

Patients treated with venoarterial extracorporeal membrane oxygenation have different baseline risk and outcomes dependent on indication and route of cannulation.

OBJECTIVES: To investigate the baseline risk of patients treated with Extracorporeal Cardiopulmonary Membrane Oxygenation (ECMO) in relation to cannulation strategy and indication for ECMO as well as the relation of cannulation strategy with survival and secondary hospitalization outcomes. METHODS: Severity of illness and predicted mortality risk were assessed in 317 patients. Central cannulation was used in 52 patients unable to wean off cardiopulmonary bypass after cardiac surgery. Peripheral cannulation was used in 179 patients for extracorporeal cardiopulmonary resuscitation (eCPR) and in 86 patients who received ECMO for refractory cardiogenic shock (RCS). RESULTS: Acute Physiology and Chronic Health Evaluation II (APACHE II) scores were significantly worse (P < 0.01) for peripheral ECMO eCPR (23.2) vs central ECMO (14.6) and vs peripheral ECMO for RCS (18.9). Survival After Venoarterial ECMO (SAVE) scores were significantly worse for peripheral ECMO for eCPR (-7.85) and RCS (-10.38) vs central ECMO (-3.97), and P < 0.01. Peripherally cannulated patients had significantly worse renal function. No significant difference existed for survival to discharge (peripheral ECMO for eCPR, 31%; central ECMO, 44%; peripheral ECMO for refractory cardiac shock, 39.5%; and P = 0.176), although centrally cannulated patients had significantly longer treatment durations compared with peripheral ECMO for eCPR. CONCLUSIONS: Peripherally cannulated patients with eCPR had significantly worse APACHE II and SAVE scores compared to peripherally cannulated RCS or patients with central ECMO, despite having similar mortality.

Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.

BACKGROUND: Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation. METHODS: For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18-75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565. FINDINGS: Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36-73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6-30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3-67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7-59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed. INTERPRETATION: Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment. FUNDING: National Heart, Lung, and Blood Institute.

Echocardiographic evaluation of cardiac recovery after refractory out-of-hospital cardiac arrest.

BACKGROUND: The mechanisms and degree of myocardial recovery during treatment with venoarterial extracorporeal membrane oxygenation (VA-ECMO) are unclear. We performed a descriptive study to evaluate myocardial recovery and changes in parameters of myocardial loading using echocardiography. METHODS: We retrospectively evaluated patients with refractory ventricular tachycardia/ventricular fibrillation out-of-hospital cardiac arrest who were treated with the Minnesota Resuscitation Consortium protocol. Left ventricular ejection fraction (LVEF), end-diastolic diameter (LVEDD), end-systolic diameter (LVESD), and fractional shortening were assessed using serial echocardiography. One-way analysis of variance (ANOVA) was used to compare parameters over six hospitalization stages. Two-way ANOVA was used to compare these parameters between patients that survived the index hospitalization and those that died. RESULTS: 77 patients had >1 echocardiographic turndown evaluations. Thirty-eight patients survived to discharge and 39 patients died. Of 39 in-hospital deaths, 17 patients died before VA-ECMO decannulation and 22 patients died after VA-ECMO decannulation. Among all patients, LVEF improved from 9.7 ±â€¯10.1% from the first echocardiogram after rewarming to 43.1 ±â€¯13.1% after decannulation (p < 0.001) and fractional shortening ratio improved from 0.14 ±â€¯0.12 to 0.31 ±â€¯0.14 (p < 0.001). The LVEDD and LVESD remained stable (p = 0.36 and p = 0.12, respectively). Patients that died had a lower LVEF by an average of 6.93% (95% confidence interval: -10.0 to -3.83, p < 0.001), but other parameters were similar. CONCLUSION: Refractory cardiac arrest patients treated with VA-ECMO experience significant recovery of ventricular function during treatment. We postulate that this primarily occurs via reduction of LV preload.

Comparison of Balloon Pulmonary Angioplasty and Pulmonary Vasodilators for Inoperable Chronic Thromboembolic Pulmonary Hypertension: A Systematic Review and Meta-Analysis.

Treatment options for chronic thromboembolic pulmonary hypertension (CTEPH) that is not amenable to thromboendarterectomy or is recurrent/persistent after thromboendarterectomy (inoperable CTEPH) include pulmonary vasodilators or balloon pulmonary angioplasty (BPA). We compared efficacy and safety outcomes of BPA with or without pulmonary vasodilators to pulmonary vasodilator therapy alone in patients with inoperable CTEPH. Observational and randomized trial data reporting outcomes for >5 patients with inoperable CTEPH were sought. Single-arm random effects meta-analyses were performed. The primary outcome was change in six-minute walk distance (6MWD). Secondary outcomes included safety; World Health Organization functional class (WHO FC); and change in mean pulmonary arterial pressure (mPAP), pulmonary vascular resistance (PVR), and cardiac index. Thirty-four studies with 1604 patients were eligible for analyses. Both treatments resulted in significant improvement in 6MWD (71.0 meters, 95% CI: 47.4-94.5 meters with BPA versus 47.8 meters, 95% CI: 34.5-61.2 meters with pulmonary vasodilators), PVR [-3.1 Wood Units (WU), 95% CI: -4.9 to -1.4 WU versus -1.6 WU, 95% CI: -2.4 to -0.8 WU] and mPAP (-14.8 mmHg, 95% CI: -18.2 to -11.5 mmHg versus -4.9 mmHg, 95% CI: -6.9 to -2.8 mmHg). Cardiac index was similar and most patients were WHO FC II and III after their respective interventions. More complications occurred in the BPA arm. In conclusion, BPA and pulmonary vasodilators both improve 6MWD and hemodynamics in patients with inoperable CTEPH. While BPA may offer greater functional and hemodynamic improvements, this technique carries the accompanying risks of an invasive procedure.