Insurance-Based Disparities in Outcomes and ECMO Utilization for Hospitalized COVID-19 Patients.

BACKGROUND: The objective of this study was to examine insurance-based disparities in mortality, non-home discharges, and ECMO utilization in patients hospitalized with COVID-19. METHODS: Using a national database of U.S. academic medical centers and their affiliated hospitals, the risk-adjusted association between mortality, non-home discharge, and ECMO utilization and (1) the type of insurance coverage (private insurance, Medicare, dual enrollment in Medicare and Medicaid, and no insurance) and (2) the weekly hospital COVID-19 burden (0-5.0%; 5.1-10%, 10.1-20%, 20.1-30%, 30.1%-) was evaluated. Modelling was expanded to include an interaction between payer status and the weekly hospital COVID-19 burden to examine whether the lack of private insurance was associated with increases in disparities as the COVID-19 burden increased. RESULTS: Among 760,846 patients hospitalized with COVID-19, 214,992 had private insurance, 318,624 had Medicare, 96,192 were dually enrolled in Medicare and Medicaid, 107,548 had Medicaid, and 23,560 had no insurance. Overall, 76,250 died, 211,702 had non-home discharges, 75,703 were mechanically ventilated, and 2,642 underwent ECMO. The adjusted odds of death were higher in patients with Medicare (aOR 1.28; [95% CI: 1.21, 1.35]; P<0.0005), dually enrolled (aOR, 1.39; [1.30, 1.50]; P<0.0005), Medicaid (aOR, 1.28; [1.20, 1.36]; P<0.0005), and no insurance (aOR, 1.43; [1.26, 1.62]; P<0.0005) compared to patients with private insurance. Patients with Medicare (aOR, 0.47; [CI: 0.39, 0.58]; P <0.0005), dually enrolled (aOR, 0.32; [0.24, 0.43]; P<0.0005), Medicaid (aOR, 0.70; [ 0.62, 0.79]; P<0.0005), and no insurance (aOR, 0.40; [0.29, 0.56]; P<0.001] were less likely to be placed on ECMO than patients with private insurance. Mortality, non-home discharges, and ECMO utilization did not change significantly more in patients with private insurance compared to patients without private insurance as the COVID-19 burden increased. CONCLUSION: Among patients with COVID-19, insurance-based disparities in mortality, non-home discharges, and ECMO utilization were substantial, but these disparities did not increase as the hospital COVID-19 burden increased.

The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices.

The 14th Annual Report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) describes outcomes of 27,493 patients with a continuous-flow left ventricular assist device (LVAD) from the past decade (2013-2022). In 2022, 2517 primary LVADs were implanted, of which 2512 (99.8%) were fully magnetically levitated (Mag-Lev) devices. This shift to nearly exclusive use of a Mag-Lev device led us to examine its outcomes compared with contemporary (2018-2022) and historical (2013-2017) non-Mag-Lev cohorts. Patients supported by a Mag-Lev device (n = 10,920) had a higher 1- and 5-year survival of 86% (vs 79% and 81%, P < .0001) and 64% (vs 44% and 44%, P < .0001), respectively, than those receiving non-Mag-Lev devices during the contemporary and historical eras. Over 5 years, freedom from gastrointestinal bleeding (72% vs 60%, P < .0001), stroke (87% vs 67%, P < .0001), and device malfunction/pump thrombus (83% vs 54%, P < .0001), but not device-related infection (61% vs 64%, P = .93), was higher with Mag-Lev devices compared with non-Mag-Lev support during the contemporary era. In this large primacy cohort of real-world patients with advanced heart failure, this report underscores marked improvements in short- and intermediate-term survival and reduction of adverse events with a contemporary Mag-Lev LVAD.

Less Invasive Left Ventricular Assist Device Implantation Is Safe and Feasible in Patients With Smaller Body Surface Area.

OBJECTIVE: Smaller body surface area (BSA) frequently precludes patients from left ventricular assist device (LVAD) therapy. We sought to investigate the clinical outcomes in patients with small BSA undergoing less invasive LVAD implantation. METHODS: We conducted a retrospective review of 216 patients implanted with HeartMate 3 LVAD (Abbott, Chicago, IL) via less invasive surgery at our institution. Patients were dichotomized based on their preimplant BSA for comparison between small BSA (≤1.8 m2) and normal/large BSA (>1.8 m2). We analyzed patient perioperative characteristics and outcomes. RESULTS: In our study, small BSA was found in 32 patients (14.8%), while 184 patients (85.2%) had normal/large BSA. Women were more prevalent in the small BSA group (50.0% vs 13.0%, P < 0.001). Preoperative and intraoperative data showed comparable results. Major complications and hospital length of stay did not differ by BSA group. Patients with smaller BSA had significantly decreased pump parameters at discharge, including LVAD flow (4.11 ± 0.49 vs 4.60 ± 0.54 L/min, P < 0.001) and pump speed (5,200 vs 5,400 rpm, P < 0.001). Survival to discharge and within 6 months after implantation were similar between the groups. CONCLUSIONS: Our study results suggest that less invasive HeartMate 3 implantation can be safely performed and demonstrates equivalent outcomes in patients with smaller body habitus. Randomized trials are required to confirm our data.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Left atrial appendage exclusion with less invasive left ventricular assist device implantation.

OBJECTIVES: The objective of this single-center, pilot, prospective, and historical control study is to evaluate safety and feasibility outcomes associated with left atrial appendage exclusion (LAAE) concomitant with left ventricular assist device (LVAD) implantation via less invasive surgery (LIS) as a stroke prevention strategy. METHODS: A predefined number of 30 eligible subjects scheduled for LIS LVAD with LAAE were enrolled in the prospective arm between January 2020 and February 2021. Eligible retrospective LIS LVAD patients without LAAE were propensity-matched in a 1:1 ratio with the prospective arm subjects. The primary study objectives were to evaluate the safety, feasibility, and efficacy of the LAAE concomitant with LIS LVAD. RESULTS: Preoperative characteristics of patients in the Non-LAAE and LAAE groups were similar. LAAE was successfully excluded in all prospective patients (100%). Primary safety endpoints of chest tube output within the first 24 postoperative hours, Reoperation for bleeding within 48 h, and index hospitalization mortality demonstrated comparable safety of LAAE versus Non-LAAE with LIS LVAD. Cox proportional hazard regression demonstrated that LAAE with LIS LVAD was associated with 37% and 49% reduction in the risk of stroke and disabling stroke, respectively (p > .05). CONCLUSION: Results from our pilot study demonstrated the safety and feasibility of LAAE concomitant with LIS LVAD as a stroke prevention strategy. This is the first prospective study describing LAAE performed concomitantly to less invasive LVAD implantation. The efficacy of LAAE in long-term stroke prevention needs to be confirmed in future prospective randomized clinical trials.

Venoarterial-Extracorporeal Membrane Oxygenation Without Routine Systemic Anticoagulation Decreases Adverse Events.

BACKGROUND: Despite limited evidence, systemic anticoagulation is the current standard of care for patients supported on venoarterial-extracorporeal membrane oxygenation (VA-ECMO). We hypothesized that not anticoagulating patients on VA-ECMO would decrease complications. METHODS: We retrospectively reviewed adult patients supported on VA-ECMO at our institution. Patients were stratified based on anticoagulation strategy. The primary outcome was a composite of hemorrhagic and thrombotic complications. Secondary outcomes included blood product use, incidence of heparin-induced thrombocytopenia (HIT), hospital length of stay, and in-hospital mortality. RESULTS: From May 2011 through January 2018, there were 203 eligible patients supported on VA-ECMO, 35% (75 patients) were not anticoagulated. Overall complication rates were significantly lower for the no anticoagulation group (57% versus 76%; P = .007) including a trend toward fewer hemorrhagic complications (53% versus 63%; P = .178) without increased risk of thrombosis (13% versus 21%; P = .147). The anticoagulated group required more transfusions of packed red blood cells (12.8 versus 1.09; P = .002) and platelets (3.0 versus 1.3; P = .009) and showed a higher incidence of HIT (8% versus 0%; P = .015). No difference was found in overall mortality (72% versus 62%; P = .165). CONCLUSIONS: The absence of routine systemic anticoagulation for patients supported on VA-ECMO is not associated with higher mortality, pump failure, or thrombotic complications. Patients had a lower requirement for blood product transfusions, and there was no incidence of HIT. Patients supported on VA-ECMO without other indications for anticoagulation can be treated without systemic anticoagulation during their VA-ECMO course.

Complete Sternal-Sparing HeartMate 3 Implantation: A Case Series of 10 Consecutive Patients.

BACKGROUND: Left ventricular assist device (LVAD) therapy has been the standard of care for selected patients with advance heart failure. Even though considerable strides have been achieved with the introduction of the newest centrifugal pump, therapy is still burdened with significant perioperative complications. Smaller devices, along with improved techniques and instruments, have encouraged the adoption of minimally invasive cardiac surgery (MICS) techniques for LVAD implantation to improve perioperative outcomes. METHODS: We describe a technique for complete sternal-sparing (CSS) HeartMate 3 (Abbott Laboratories, Abbott Park, IL) left ventricular assist device (LVAD) implantation using bilateral thoracotomies and discuss early clinical outcomes of the first ten consecutive patients who underwent CSS implantation of the HeartMate 3 LVAD at our institution. RESULTS: The median length of stay in the intensive care unit was 3.5 days. No patients required reexploration for postoperative bleeding. There was no incidence of right ventricle failure, stroke, renal failure, hepatic failure, or myocardial infarction. The median length of hospitalization after LVAD implantation was 14.5 days (interquartile range, 12 to 17 days). CONCLUSIONS: Our early outcomes suggest that the CSS approach may reduce the incidence of right ventricular failure, bleeding, intubation time, and intensive care unit length of stay. Further studies are needed to fully elucidate the advantages of CSS LVAD implantation compared with median sternotomy.

Right Mini-thoracotomy Bentall Procedure.

OBJECTIVE: Bentall procedures are traditionally performed through a median sternotomy. The right mini-thoracotomy approach is increasingly used in aortic valve replacement. This approach has been shown to have decreased blood loss and hospital length of stay compared with sternotomy. A right mini-thoracotomy approach may also be beneficial in selected patients requiring aortic root surgery. We present our initial clinical experience of patients who have undergone a right mini-thoracotomy Bentall. METHODS: This is a single-center retrospective review of seven patients who underwent a primary elective right anterior mini-thoracotomy Bentall. A thoracoscope was used in each case. Automated suturing technology was used for annular suturing in three of the seven patients. Clinical outcomes evaluated include 30-day mortality, intensive care and hospital length of stay, time to extubation, operative times, as well as postoperative sequelae including stroke, infection, and bleeding. RESULTS: Median cardiopulmonary bypass, cross-clamp, and circulatory arrest time were 217, 153, and 28 minutes, respectively. Median time to extubation was 10 hours and median intensive care unit and hospital stay was 1 and 4 days, respectively. One patient had a wound infection and one returned to the operating room for bleeding. There were no in-hospital or 30-day mortalities. CONCLUSIONS: The Bentall procedure can be performed through a right anterior mini-thoracotomy in selected patients with excellent clinical results.

Video assisted right mini-thoracotomy for aortic root replacement.

Aortic root replacement is typically performed through a median sternotomy. The right anterior mini-thoracotomy approach has been shown to decrease hospital length of stay in aortic valve surgery when compared to sternotomy. This approach is rare in ascending aortic surgery due to technical challenges which include exposure and annular suture placement. Automated suturing technology is now available to facilitate the placement of annular sutures. The use of a camera greatly enhances visualization of the aortic root. A right anterior mini-thoracotomy is performed via a 5 cm incision in the right second intercostal space with a camera port placed lateral to the incision. Peripheral arterial and venous cannulation are performed. The aortic cross clamp is placed through a 5 mm incision in the third interspace anterior to mid axillary line. Histidine tryptophan ketoglutarate (HTK) cardioplegia is administered and deep hypothermic circulatory arrest is achieved followed by completion of the distal anastomosis with a 4-0 polypropylene running suture. After aortic leaflet removal, annular and prosthetic sutures are placed with shafted instruments or with automated suturing technology. Coronary button suturing and graft-to-graft anastomoses are performed with shafted instruments. Aortic root procedures can be performed safely through a right anterior mini-thoracotomy. The use of a camera and automated suturing technology may further facilitate this procedure, enabling more surgeons to offer this less invasive approach to patients.

Temporary mechanical circulatory support after orthotopic heart transplantation: a single-centre experience.

OBJECTIVES: There are various strategies in the use of temporary mechanical circulatory support following orthotopic heart transplant (OHT). We sought to examine the outcomes following different temporary mechanical circulatory support strategies for acute graft failure. METHODS: Patients who received an OHT between 2001 and 2015 at a single institution were retrospectively reviewed. Patients were divided into 2 groups based on the need for temporary mechanical circulatory support (TMCS). RESULTS: A total of 9.9% (19 of 192) of patients required TMCS following OHT. There were no significant differences in the preoperative demographics between groups. Six patients (32%) required a biventricular assist device, 9 patients (47%) required a right ventricular assist device and 4 patients (21%) required a veno-arterial extracorporeal membrane oxygenator. Perioperative morbidity was comparable between all groups. Our entire TMCS cohort had 94.7% 30-day and 61.1% 1-year survival. When compared with the OHT patients with no TMCS (97.1% at 30 days and 92.8% at 1 year), survival was inferior in TMCS patients ( P = 0.01 at 30 days, P < 0.001 at 1 year, P < 0.001 overall). CONCLUSIONS: Acute graft failure requiring TMCS has inferior overall survival. Larger, multi-institutional studies are needed to further elucidate these differences and identify the best TMCS mode.

Treatment of advanced or recurrent cervical cancer with Cisplatin or Cisplatin containing regimens: a cost effective analysis.

BACKGROUND: Trials have demonstrated improvements in survival with adding paclitaxel (P) or topotecan (T) to cisplatin (C) for the treatment of advanced cervical cancer. We sought to evaluate the cost effectiveness of these regimens. METHODS: A decision model was developed based on Gynecologic Oncology Group (GOG) protocols 169 and 179. Arm 1 is 6 cycles of cisplatin. Arm 2 is 6 cycles of CP while arm 3 is 6 cycles of CT. Parameters include overall survival (OS), cost and complications. Sensitivity analyses were performed. RESULTS: The incremental cost-effectiveness ratio (ICER) for C versus CP is $13,654/quality-adjusted life-year (QALY) gained. For CT compared to C, the ICER is $152,327/QALY. When compared simultaneously, CT is dominated. At a willingness to pay (WTP) threshold of $50,000/QALY, C is the preferred option but CP is acceptable. Sensitivity analyses suggest that CT would become the preferred option if it was to improve OS to 24 months (compared to 9.4 months). CONCLUSIONS: In this model, CP is an acceptable alternative to cisplatin for the treatment of these patients with an increase in cost of only $13,654/QALY. The addition of topotecan did not increase survival enough to justify the increased cost.