Cardiac Reverse Remodeling Mediated by HeartMate 3 Left Ventricular Assist Device: Comparison to Older Generation Devices.

Currently, the fully magnetically levitated left ventricular assist device (LVAD) HeartMate 3 (HM3) is the only commercially available device for advanced heart failure (HF) patients. However, the left ventricular (LV) functional and structural changes following mechanical unloading and circulatory support (MCS) with the HM3 have not been investigated. We compared the reverse remodeling induced by the HM3 to older generation continuous-flow LVADs. Chronic HF patients (n = 405) undergoing MCS with HeartWare Ventricular Assist Device (HVAD, n = 115), HM3 (n = 186), and HeartMate II (HM2, n = 104) at four programs were included. Echocardiograms were obtained preimplant and at 1, 3, 6, and 12 months following LVAD implantation. There were no differences in the postimplant serial LV ejection fraction (LVEF) between the devices. The postimplant LV internal diastolic diameter (LVIDd) was significantly lower for HM2 at 3 and 6 months compared with HVAD and HM3. The proportion of patients achieving "cardiac reverse remodeling responder" status (defined as LVEF improvement to ≥40% and LVIDD ≤5.9 cm) was 11.9%, and was similar between devices. HeartMate 3 appears to result in similar cardiac reverse remodeling as older generation CF-LVADs, suggesting that the fully magnetically levitated device technology could provide an effective platform to further study and promote cardiac reverse remodeling.

Machine Learning Multicenter Risk Model to Predict Right Ventricular Failure After Mechanical Circulatory Support: The STOP-RVF Score.

Importance: The existing models predicting right ventricular failure (RVF) after durable left ventricular assist device (LVAD) support might be limited, partly due to lack of external validation, marginal predictive power, and absence of intraoperative characteristics. Objective: To derive and validate a risk model to predict RVF after LVAD implantation. Design, Setting, and Participants: This was a hybrid prospective-retrospective multicenter cohort study conducted from April 2008 to July 2019 of patients with advanced heart failure (HF) requiring continuous-flow LVAD. The derivation cohort included patients enrolled at 5 institutions. The external validation cohort included patients enrolled at a sixth institution within the same period. Study data were analyzed October 2022 to August 2023. Exposures: Study participants underwent chronic continuous-flow LVAD support. Main Outcome and Measures: The primary outcome was RVF incidence, defined as the need for RV assist device or intravenous inotropes for greater than 14 days. Bootstrap imputation and adaptive least absolute shrinkage and selection operator variable selection techniques were used to derive a predictive model. An RVF risk calculator (STOP-RVF) was then developed and subsequently externally validated, which can provide personalized quantification of the risk for LVAD candidates. Its predictive accuracy was compared with previously published RVF scores. Results: The derivation cohort included 798 patients (mean [SE] age, 56.1 [13.2] years; 668 male [83.7%]). The external validation cohort included 327 patients. RVF developed in 193 of 798 patients (24.2%) in the derivation cohort and 107 of 327 patients (32.7%) in the validation cohort. Preimplant variables associated with postoperative RVF included nonischemic cardiomyopathy, intra-aortic balloon pump, microaxial percutaneous left ventricular assist device/venoarterial extracorporeal membrane oxygenation, LVAD configuration, Interagency Registry for Mechanically Assisted Circulatory Support profiles 1 to 2, right atrial/pulmonary capillary wedge pressure ratio, use of angiotensin-converting enzyme inhibitors, platelet count, and serum sodium, albumin, and creatinine levels. Inclusion of intraoperative characteristics did not improve model performance. The calculator achieved a C statistic of 0.75 (95% CI, 0.71-0.79) in the derivation cohort and 0.73 (95% CI, 0.67-0.80) in the validation cohort. Cumulative survival was higher in patients composing the low-risk group (estimated <20% RVF risk) compared with those in the higher-risk groups. The STOP-RVF risk calculator exhibited a significantly better performance than commonly used risk scores proposed by Kormos et al (C statistic, 0.58; 95% CI, 0.53-0.63) and Drakos et al (C statistic, 0.62; 95% CI, 0.57-0.67). Conclusions and Relevance: Implementing routine clinical data, this multicenter cohort study derived and validated the STOP-RVF calculator as a personalized risk assessment tool for the prediction of RVF and RVF-associated all-cause mortality.

Contemporary Management of Ischemic Mitral Regurgitation at Coronary Artery Bypass Grafting.

BACKGROUND: Recent guidelines for the treatment of moderate or severe ischemic mitral regurgitation (IMR) in patients undergoing coronary artery bypass grafting (CABG) have changed. This study assessed the real-world impact of changing guidelines on the management of IMR during CABG over time. We hypothesized that the utilization of mitral valve repair for IMR would decrease over time, whereas mitral valve replacement for severe IMR would increase. METHODS: Patients undergoing CABG in a statewide collaborative database (2011-2020) were stratified by severity of IMR. Trends in mitral valve repair or replacement were evaluated. To account for differences of the patients, propensity score-matched analyses were used to compare patients with and without mitral intervention. RESULTS: A total of 11,676 patients met inclusion criteria, including 1355 (11.6%) with moderate IMR and 390 (3.3%) with severe IMR. The proportion of patients undergoing mitral intervention for moderate IMR decreased over time (2011, 17.7%; 2020, 7.5%; Ptrend = .001), whereas mitral replacement for severe IMR remained stable (2011, 11.1%; 2020, 13.3%; Ptrend = .14). Major morbidity was higher for patients with moderate IMR who underwent mitral intervention (29.1% vs 19.9%; P = .005). In a propensity analysis of 249 well-matched pairs, there was no difference in major morbidity (29.3% with mitral intervention vs 23.7% without; P = .16) or operative mortality (1.2% vs 2.4%; P = .5). CONCLUSIONS: Consistent with recent guideline updates, patients with moderate IMR were less likely to undergo mitral repair. However, the rate of replacement for severe IMR did not change. Mitral intervention during CABG did not increase operative mortality or morbidity.

Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device.

BACKGROUND: Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. OBJECTIVES: The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. METHODS: The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. RESULTS: Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. CONCLUSIONS: A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955).

Outcomes of patients with acute type A aortic dissection and concomitant lower extremity malperfusion.

OBJECTIVE: The occurrence of acute lower limb ischemia (ALLI) is a serious risk within the context of aortic dissection repair. The aim of the present study was to examine the outcomes of patients with acute type A aortic dissection (ATAD) and concomitant lower extremity malperfusion. METHODS: We performed a retrospective medical record review at our tertiary referral center of patients who underwent ATAD repair from January 2002 to June 2018. We used univariate and multivariate analyses to compare the outcomes of patients with and without lower extremity malperfusion. The primary outcomes were 30-day and 1-year mortality. RESULTS: A total of 378 patients underwent ATAD repair during the study period. Their mean age was 57 years, 68% were men, and 51% were White. A total of 62 patients (16%) presented with concomitant ALLI, including 35 (9%) who presented with isolated ALLI and 27 (7%) who presented with ALLI and concomitant malperfusion of at least one other organ. Of the 62 patients with ALLI, 46 underwent only proximal aortic repair. Of the 378 patients, 6 died within the first 24 hours, and their limb perfusion was not assessed. Among the 40 patients who underwent isolated proximal repair and survived >24 hours, 34 (85%) had resolution of their ALLI. Of the 16 patients who underwent concomitant lower extremity peripheral vascular procedures, 10 had bypass procedures and 1 died within 24 hours due to refractory coagulopathy and hypotension. All six patients with adequate follow-up imaging studies had asymptomatic occlusion of the bypass graft with recanalization of the occluded native arteries. Patients who presented with any organ malperfusion had increased 30-day (odds ratio, 1.8; P = .04) and 1-year (odds ratio, 1.8; P = .04) mortality and decreased overall survival (P < .01). For the patients with isolated ALLI, no significant differences were found in 30-day or 1-year mortality or overall survival (P = .57). CONCLUSIONS: Proximal repair of ATAD resolves most cases of associated ALLI, and isolated ALLI does not affect short- or long-term survival. All patients with follow-up in our study who underwent extra-anatomic bypass developed asymptomatic graft occlusion, which could be attributed to competitive flow from the remodeled native arterial system. We believe that rapid and aggressive restoration of flow to the lower extremity is the best method to treat ALLI malperfusion syndrome. Close monitoring for the development of compartment syndrome is recommended.

A center experience with lung transplantation for COVID-19 ARDS.

COVID-19 can cause irreversible lung damage from acute respiratory distress syndrome (ARDS), chronic respiratory failure associated with post COVID-19 de novo fibrosis or worsening of an underlying fibrotic lung disease. Pregnant women are at increased risk for invasive mechanical ventilation, extracorporeal membrane oxygenation, and death. The Centers for Disease Control and Prevention reported more than 22,000 hospitalizations and 161 deaths for COVID-19 in pregnant women. Between August 2020 and September 2021, five patients underwent bilateral lung transplant (LT) for COVID-19 ARDS at the Henry Ford Hospital in Detroit, Michigan. De-identified demographics data, clinical characteristics, perioperative challenges, explanted lung pathology, and post-transplant outcomes are described. In post-hospitalization follow-up (median survival 273 days), we see improving endurance and excellent lung function. One patient did not survive to hospital discharge and succumbed to complications 5 months after LT. We report the first cases of bilateral LT in two postpartum women.

Repair of Bronchial Anastomosis Following Lung Transplantation.

BACKGROUND: Bronchial anastomotic complications are reported in 2 to 18% of patients after lung transplantation. The majority of complications can be managed with bronchoscopic intervention. When extensive dehiscence is present, surgical intervention can be entertained. MATERIALS AND METHODS: Between March 1, 2006, and December 31, 2019, our program performed 244 lung transplantations. We conducted a retrospective review of our patient cohort and identified patients who suffered from significant anastomotic complications that required surgical interventions. RESULTS: Twenty-eight and 216 patients underwent single and bilateral lung transplantations, respectively. Eighteen patients developed airway complications (7.4%). The incidence of anastomotic complications was 5.2% (24 complications for a total of 460 bronchial anastomoses). Four patients were managed conservatively. The majority of the bronchial anastomotic complications were managed endoscopically (eight patients). Four patients with associated massive air leak underwent repair of the bronchial anastomosis and two patients were retransplanted because they developed severe distal airway stenosis. CONCLUSION: Bronchial anastomotic complications are a major cause of morbidity in lung transplantation. The majority of cases can be managed bronchoscopically. In more severe cases associated with massive air leak or imminent massive hemoptysis from bronchopulmonary arterial fistula, surgical intervention is necessary. Aortic homograft interposition along with vascularized pedicle wrapping may be a viable option to re-establish airway continuity when tension-free bronchial anastomotic revision is not possible. In cases with smaller bronchial defects, primary repair with utilization of a vascularized flap can be effective as treatment option.

Incidence of Heparin-Induced Thrombocytopenia in Patients With Newly Implanted Mechanical Circulatory Support Devices.

BACKGROUND: Heparin exposure and device-related thrombocytopenia complicate the diagnosis of heparin-induced thrombocytopenia (HIT) in patients receiving mechanical circulatory support (MCS). To improve anticoagulation management for patients with newly implanted MCS devices, incidence of confirmed HIT needs to be further characterized. OBJECTIVES: The purpose of this study is to describe the incidence of HIT and clinical utility of the 4Ts score in patients with newly implanted MCS devices. METHODS: This is a retrospective analysis of MCS patients receiving unfractionated heparin from 2014 to 2017. The primary end point was incidence of laboratory-confirmed HIT. Strong positive, likely positive, low probability, and negative HIT categories were established based on heparin-induced platelet antibody (HIPA) and serotonin release assay (SRA). Secondary end points include characterization of platelet trends, argatroban use, incidence of HIT among each of the MCS devices, and utility of 4Ts score. RESULTS: A total of 342 patient encounters met inclusion criteria, of which 68 HIPA tests and 25 SRAs were ordered. The incidence of HIT was 0.88% (3/342) and 4.4% (3/68) in patients with suspected HIT. Of the 68 HIPA tests, 3 (4.4%) were considered strong positive and 3 of the 25 SRAs were positive. Median 4Ts score was 4 [2.5-4] and optical density 0.19 [0.11-0.54]. The positive predictive value for the 4Ts score was 0.15 (CI = 0.03-0.46) and negative predictive value, 0.93 (CI = 0.82-0.98). CONCLUSION AND RELEVANCE: HIT occurs infrequently with newly implanted MCS devices. The 4Ts score appears to have a high negative predictive value for ruling out HIT.

Predictors of Discharge Home Without Opioids After Cardiac Surgery: A Multicenter Analysis.

BACKGROUND: Whether all patients will require an opioid prescription after cardiac surgery is unknown. We performed a multicenter analysis to identify patient predictors of not receiving an opioid prescription at the time of discharge home after cardiac surgery. METHODS: Opioid-naïve patients undergoing coronary artery bypass grafting and/or valve surgery through a sternotomy at 10 centers from January to December 2019 were identified retrospectively from a prospectively maintained data set. Opioid-naïve was defined as not taking opioids at the time of admission. The primary outcome was discharge without an opioid prescription. Mixed-effects logistic regression was performed to identify predictors of discharge without an opioid prescription, and postdischarge opioid prescribing was monitored to assess patient tolerance of discharge without an opioid prescription. RESULTS: Among 1924 eligible opioid-naïve patients, mean age was 64 ± 11 years, and 25% were women. In total, 28% of all patients were discharged without an opioid prescription. On multivariable analysis, older age, longer length of hospital stay, and undergoing surgery during the last 3 months of the study were independent predictors of discharge without an opioid prescription, whereas depression, non-Black and non-White race, and using more opioid pills on the day before discharge were independent predictors of receiving an opioid prescription. Among patients discharged without an opioid prescription, 1.8% (10 of 547) were subsequently prescribed an opioid. CONCLUSIONS: Discharging select patients without an opioid prescription after cardiac surgery appears well tolerated, with a low incidence of postdischarge opioid prescriptions. Increasing the number of patients discharged without an opioid prescription may be an area for quality improvement.

Short- and mid-term outcomes in percutaneous mitral valve replacement using balloon expandable valves.

BACKGROUND: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC). METHODS: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON). RESULTS: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7]). CONCLUSION: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded.

Lung Transplantation for the Treatment of Vaping-Induced, Irreversible, End-Stage Lung Injury.

Recently, there has been a rise in the incidence of E-cigarette/Vaping-Associated Lung Injury (EVALI) in the United States, mostly involving tetrahydrocannabinol. Current treatment strategies for EVALI are aimed at controlling the inflammatory and infectious causes, in addition to supportive care. Although most patients improve with supportive measures, the long-term pulmonary effects of this illness are still not well defined. This report describes a case of EVALI resulting in progressive, irreversible destruction of the lung parenchyma that was treated with double lung transplantation.

Establishment and Implementation of Evidence-Based Opioid Prescribing Guidelines in Cardiac Surgery.

BACKGROUND: Despite the risk of new persistent opioid use after cardiac surgery, postdischarge opioid use has not been quantified and evidence-based prescribing guidelines have not been established. METHODS: Opioid-naive patients undergoing primary cardiac surgery via median sternotomy between January and December 2019 at 10 hospitals participating in a statewide collaborative were selected. Clinical data were linked to patient-reported outcomes collected at 30-day follow-up. An opioid prescribing recommendation stratified by inpatient opioid use on the day before discharge (0, 1-3, or ≥4 pills) was implemented in July 2019. Interrupted time-series analyses were performed for prescription size and postdischarge opioid use before (January to June) and after (July to December) guideline implementation. RESULTS: Among 1495 patients (729 prerecommendation and 766 postrecommendation), median prescription size decreased from 20 pills to 12 pills after recommendation release (P < .001), while opioid use decreased from 3 pills to 0 pills (P < .001). Change in prescription size over time was +0.6 pill/month before and -0.8 pill/month after the recommendation (difference = -1.4 pills/month; P = .036). Change in patient use was +0.6 pill/month before and -0.4 pill/month after the recommendation (difference = -1.0 pills/month; P = .017). Pain levels during the first week after surgery and refills were unchanged. Patients using 0 pills before discharge (n = 710) were prescribed a median of 0 pills and used 0 pills, while those using 1 to 3 pills (n = 536) were prescribed 20 pills and used 7 pills, and those using greater than or equal to 4 pills (n = 249) were prescribed 32 pills and used 24 pills. CONCLUSIONS: An opioid prescribing recommendation was effective, and prescribing after cardiac surgery should be guided by inpatient use.

Heart transplant recipients with confirmed 2019 novel coronavirus infection: The Detroit experience.

A chronic immunosuppressed state as in solid organ transplant recipients is a reported risk factor for the novel 2019 coronavirus infection. Patients with a history of orthotopic heart transplant (OHT) at a tertiary care transplant center in Detroit, Michigan were retrospectively reviewed from March until May 2020. Clinical parameters and outcomes of 5 OHT recipients and one combined heart-lung recipient with confirmed SARS-CoV-2 were obtained. The cohort was predominately African American males with median age of 59 years (interquartile range, 48.25-73.25). All patients were classified as having mild-moderate disease; none required intubation or ICU admission with no deaths. The most common presenting symptoms were fever and shortness of breath 83% (n = 5), followed by cough and chills 67% (n = 4). All admitted patients (n = 5) received hydroxychloroquine and 3 received high-dose steroids. Antimetabolites were held for 2 patients (33.3%). The calcineurin inhibitor trough goal was decreased in only 1 patient; 3 other patients, without change in goal, required calcineurin inhibitor dosage reduction. Two patients requiring readmission presented 7 and 23 days after initial symptoms onset. In conclusion, our experience with OHT patients infected by the SARS-CoV-2 virus did not have an elevated risk of severe infection. Impact of modifying immunosuppression remains unclear.

Extended post-ex vivo lung perfusion cold preservation predicts primary graft dysfunction and mortality: Results from a multicentric study.

BACKGROUND: Ex vivo lung perfusion (EVLP) allows for a reassessment of lung grafts initially deemed unsuitable for transplantation, increasing the available donor pool; however, this requires a pre- and post-EVLP period of cold ischemic time (CIT). Paucity of data exists on how the sequence of cold normothermic-cold preservations affect outcomes. METHODS: A total of 110 patients were retrospectively analyzed. Duration of 3 preservation phases was measured: cold pre-EVLP, EVLP, and cold post-EVLP. The donor and recipient clinical data were collected. Primary graft dysfunction (PGD) and survival were monitored. Risk of mortality or PGD was calculated using Cox proportional hazards and logistic regression models to adjust for baseline characteristics. RESULTS: Using the highest quartile, patients were stratified into extended vs non-extended pre-EVLP (<264 vs ≥264 minutes) and post-EVLP (<287 vs ≥287 minutes) CIT. The rates of 1-year mortality (8.4% vs 29.6%, p = 0.013), PGD 2-3 (20.5% vs 52%, p = 0.002), and PGD 3 (8.4% vs 29.6%, p = 0.005) at 72 hours were increased in the extended post-EVLP CIT group. After adjusting for baseline risk factors, the extended group remained an independent predictor of PGD ≥2 (odd ratio: 6.18, 95% CI: 1.88-20.3, p = 0.003) and PGD 3 (odd ratio: 20.4, 95% CI: 2.56-161.9, p = 0.004) at 72 hours and 1-year mortality (hazard ratio: 17.9, 95% CI: 3.36-95.3, p = 0.001). Cold pre-EVLP was not a significant predictor of primary outcomes. CONCLUSIONS: Extended cold post-EVLP preservation is associated with a risk for PGD and 1-year mortality. Pre-EVLP CIT does not increase mortality or high-grade PGD. These findings from a multicenter trial should caution on the implementation of extended cold preservation after EVLP.

Operative strokes after repair of acute type A dissections: predisposing factors and implications.

BACKGROUND: Type A aortic dissection is a surgical emergency with a high morbidity and mortality. Strokes occur in up to 25% and are among the most feared complications. This study aims to evaluate factors linked to stroke development and the implications of strokes on outcomes. METHODS: Patients from 2000-2014 were stratified based on the development of stroke. Factors were compared between the groups using chi-square or Fisher's exact tests for categorical variables, and independent two-group t-tests for continuous variables. Impact on survival at 30 days, 1 and 5 years were evaluated using the life-test method. RESULTS: Two hundred patients were analyzed. Forty (20%) developed a stroke. Preoperative factors associated with stroke were female gender (34% vs. 14% P=0.01), presentation with shock (32% vs. 17%; P=0.035), and history of stroke (64% vs. 17%; P<0.001). Femoral cannulation was the only technical variable associated with stroke (49% vs. 32%; P=0.035). Stroke patients had a higher rate of pneumonia (41% vs. 11%; P<0.001), respiratory failure (36% vs. 7%; P<0.001), hemodialysis requirement (38% vs. 16%; P=0.015), and longer hospital stay (23.9±17.8 days vs. 16.1±13.5 days; P=0.012). Stroke was associated with a lower survival probability at 30 days (0.73 vs. 0.89), 1 year (0.56 vs. 0.78), and 5 years (0.29 vs. 0.70) (P<0.001). CONCLUSIONS: Patients who developed stroke after type A dissection repair had higher complication rates and a higher mortality rate at 30 days, 1 year, and 5 years. Femoral cannulation was the only technical factor associated with a higher rate of strokes.

Outcomes based on blood pressure in patients on continuous flow left ventricular assist device support: An Interagency Registry for Mechanically Assisted Circulatory Support analysis.

BACKGROUND: An optimal blood pressure (BP) range to mitigate morbidity and mortality on left ventricular assist device (LVAD) support has not been clearly defined. METHODS: Average Doppler opening pressure, mean arterial pressure (MAP), and/or systolic blood pressure (SBP) were calculated in operative survivors (n = 16,155) of LVAD support in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). BP distributions were used to group patients into low (BP <25th percentile), normal (25-75th percentile), high (75th-95th percentile), and very high (>95th percentile). Associations between BP and adverse events were evaluated using Cox regression (hazard ratio[HR], 95% confidence interval). RESULTS: The median (25th, 75th) MAP, Doppler, and SBP (mm Hg) during continuous flow LVAD support were 84 (77, 90), 85 (80, 92), and 99 (90, 107) mm Hg, respectively. BP had a bimodal risk association with survival. At 3 years, survival was 58% ± 1.8% in those with low MAP (≤75 mm Hg) vs 70% ± 0.9%, 71% ± 1.5%, and 63% ± 3.0% in the those with normal, high, or very high average MAP, respectively. Patients with chronically low MAP (≤75 mm Hg), Doppler (≤80 mm Hg), and SBP (<90 mm Hg) had 35%-42% higher adjusted hazards of death than patients with normal or high BP (p ≤ 0.0001). Patients with MAP >100 mm Hg, Doppler ≥105 mm Hg, and SBP ≥120 mm Hg had 17%-20% higher adjusted hazards of death than those with normal pressures (p < 0.05). In patients on axial flow LVADs, elevated SBP (HR 1.08 [95% confidence interval, 1.04-1.13] per 10 mm Hg increase) but not MAP correlated with increased incident of stroke. CONCLUSIONS: In INTERMACS, BP extremes during LVAD support increase the risk for adverse events, supporting a MAP goal >75 mm Hg and <90 mm Hg. Hypotension conferred the highest risk for mortality. Excessive BP control should be avoided, and Doppler opening pressure should not be assumed to represent MAP in all patients.

Pulmonary Function Testing and Outcomes after Left Ventricular Assist Device Implantation.

BACKGROUND: Pulmonary function testing (PFT) is often done during workup prior to left ventricular assist devices (LVAD), but its utility for predicting outcomes and changes in pulmonary function post-LVAD is not well established. We assessed the association of baseline PFT metrics with outcomes after LVAD, and quantified the changes in PFTs post-LVAD. METHODS AND RESULTS: A retrospective study of 178 patients receiving continuous flow LVADs was conducted. A total of 129 subjects had baseline PFT data and 54 of these had repeat tests after LVAD. We collected PFT data (FEV1, FVC, FEV1/FVC ratios, and DLCO) at baseline and post-LVAD, and tested the association with survival, right heart failure, quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and functional capacity (six-minute walking distance [6MWD]). Proportional hazards and linear regressions determined relationships between baseline PFT data and survival time and functional outcomes, respectively. Paired t-tests compared pre- and post- LVAD PFT variables. There was no association of baseline PFT parameters with survival time post-LVAD (all P > .2), nor the incidence of perioperative RV failure (all P > .15). There were no significant associations of the baseline PFT metrics with the change in KCCQ or 6MWD.  There were statistically significant declines in FEV1, FEV1/FVC ratio, and DLCO after LVAD (P < .05). CONCLUSION: In this single center study, there was no relationship between baseline PFTs and post-LVAD outcomes, and PFT parameters often worsened after LVAD. Further studies are needed to determine whether PFTs are useful in this setting, and what, if any, impact LVAD therapy has on pulmonary function.

Open atrial transcatheter mitral valve replacement in patients with mitral annular calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.