Heart Transplant Human Leukocyte Antigen Matching in the Modern Era.

BACKGROUND: Although numerous reports have studied the consequences of human leukocyte antigen (HLA) mismatching in renal transplantation, there are limited and outdated data analyzing this association in thoracic organ transplantation. Therefore, our study reviewed the impact of HLA mismatching at both the total and the loci levels in the modern-era heart-transplant procedure on survival and chronic rejection outcomes. METHODS: We performed a retrospective analysis of adult patients after heart transplant by using the United Network for Organ Sharing database from January 2005-July 2021. Total HLA and HLA-A, HLA-B and HLA-DR mismatches were analyzed. Survival and cardiac allograft vasculopathy were the outcomes of interest during a 10-year follow-up period using Kaplan-Meier curves, log-rank tests and multivariable regression models. RESULTS: A total of 33,060 patients were included in this study. Recipients with a high degree of HLA mismatching had increased incidences of acute organ rejection. There were no significant differences in mortality rates among any of the total or loci level groups. Similarly, there were no significant differences between total HLA mismatch groups in time to first cardiac allograft vasculopathy, though mismatching at the HLA-DR locus was associated with an increased risk of cardiac allograft vasculopathy. CONCLUSION: Our analysis suggests that HLA mismatch is not a significant predictor of survival in the modern era. Overall, the clinical implications of this study provide reassuring data for the continued use of non-HLA-matched donors in an effort to increase the donor pool. If HLA matching is to be considered for heart transplant donor-recipient selection, matching at the HLA-DR locus should take priority due to its association with cardiac allograft vasculopathy.

Extracorporeal membrane oxygenation as a bridge to lung transplantation: 5-year outcomes and bridge to decision in a large, older cohort.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) as a bridge to lung transplantation (BTT) has expanded considerably, though evidence-based selection criteria and long-term outcome data are lacking. The purpose of this study was to evaluate whether risk factors often used to exclude patients from ECMO BTT-specifically older age and not yet being listed for transplant-are validated by long-term outcomes. METHODS: To ensure minimum 5-year follow-up, a retrospective cohort study was performed of adult patients actively listed for lung transplantation at a high-volume center and bridged on ECMO between January 2012 and December 2017. Data was collected through January 1, 2023. RESULTS: Among 50 patients bridged on ECMO, 25 survived to transplant. Median age at listing was 58 (interquartile range [IQR], 42-65) in the transplanted group and 65 (IQR, 56.5-69) in the deceased group (P = 0.051). One-year, 3-year, and 5-year survival were 88% (22/25), 60% (15/25), and 44% (11/25), respectively, with eight patients still living at the time of review. Median time spent at home during the year post-transplant was 340 days (IQR, 314-355). Older age at listing was a negative predictor of survival on ECMO to transplant (odds ratio 0.92 [95% confidence interval, 0.86-0.99], P = 0.01). Thirteen patients were placed on ECMO prior to being listed and three were listed the same day as ECMO cannulation, with 10/16 transplanted. No significant difference in post-transplant survival was found between patients placed on ECMO prior to listing (n = 10) and those already listed (n = 15) (P = 0.93, log-rank). Serial post-transplant spirometry up to 5 years and surveillance transbronchial biopsy demonstrated good allograft function and low rates of cellular rejection. CONCLUSIONS: In one of the oldest cohorts of ECMO BTT patients described, favorable survival outcomes and allograft function were observed up to 5 years irrespective of whether patients were previously listed or bridged to decision. Despite inherent limitations to this retrospective, single-center study, the data presented support the feasibility of ECMO BTT in older and not previously listed advanced lung disease patients.

Concomitant Heart and Lung Surgery During Lung Transplantation.

INTRODUCTION: There is limited data concerning concomitant cardiac and lung surgery outcomes during lung transplantation (LTx). While some evidence suggests that cardiac surgery during LTx has no significant impact on surgical outcomes, scarce data examines the role of concomitant lung surgery (CLS). This study compares the survival outcomes of concomitant cardiac and lung surgeries during LTx. METHODS: A retrospective analysis of all single and double LTx patients from March 2012 to June 2023 at a single center was performed (n = 1099). Patients were stratified into three concomitant surgical groups: concomitant cardiac surgery (CCS), CLS, and no concomitant surgeries. Groups were compared on recipient demographics, diagnosis, and surgical intervention using analysis of variance and chi-square tests. Survival (5 y) was analyzed using Kaplan-Meier curves, log-rank test, and univariable Cox proportional hazard model where P value <0.05 was considered significant. RESULTS: In total, 1099 patients were analyzed in this study; 965 had no concomitant surgery, 100 had CCS (mode: coronary artery bypass grafting, n = 75), and 34 had CLS (mode: lung volume reduction surgery, n = 14). Between the three surgical groups, there was no significant difference in body mass index (P = 0.091), total ischemic time (P = 0.194), induction (P = 0.140), or cause of death (P = 0.240). Lung allocation score and length of stay were significantly higher in the concomitant surgical groups, especially the CLS group when compared to the no concomitant surgery group (P = 0.002, P = 004). Patients with no concomitant surgery had a higher incidence of single LTx and off-pump utilization than concomitant surgical groups (P < 0.001). Kaplan-Meier curves and log-rank tests found no significant difference in survival between groups (P = 0.849). This result is supported by Cox proportional hazard model with no significant difference in mortality risk between the CCS group (P = 0.522) and CLS group (P = 0.936) compared to no concomitant surgery during LTx. CONCLUSIONS: Our study provides promising data indicating that individuals undergoing concomitant heart or lung surgery during LTx have similar survival outcomes to those exclusively undergoing LTx. These results highlight the potential advantages of utilizing LTx to address concurrent thoracic surgical needs, such as coronary revascularization. This holds implications for optimizing patient care and decision-making when complex thoracic interventions are necessary.

Assessing the Role of Primary Heart Failure Etiology on Cardiac Transplant Outcomes.

BACKGROUND: There are diverse indications for heart transplantation (HTx), often categorized into ischemic (ICM) and nonischemic (NICM) cardiomyopathy. Although there is extensive research comparing the outcomes for these disease processes following certain therapeutic interventions, there are limited data on how recipient etiology impacts post-HTx survival. Our investigation seeks to identify this relationship. METHODS: We conducted a retrospective analysis using adult HTx patients from the United Network for Organ Sharing database between 2000 and 2021. Patients with a combined heart-lung transplant or previous HTx were excluded. ICM included coronary artery disease (CAD) and ischemic dilated cardiomyopathy. NICM included nonischemic dilated (NIDCM), hypertrophic (HCM), and restrictive (RCM) cardiomyopathy. Overall survival was analyzed using Kaplan-Meier curves, log-rank tests, and multivariable Cox regression models. RESULTS: A total of 42 268 patients were included in our study. Recipients with ICM were older and more likely to be males, obese, diabetics, and smokers. We found that patients with ICM had an increased incidence of transplant CAD (OR = 1.23, p < 0.001) and risk of mortality (hazard ratio [HR] = 1.22, p < 0.001) compared to NICM. When NICM was expanded, RCM had a similar hazard risk compared to ICM (HR = 1.03, p = 0.650), whereas both NIDCM (HR = 0.81, p < 0.001) and HCM (HR = 0.70, p < 0.001) had improved survival. CONCLUSION: Our study provides evidence to suggest that ICM has decreased survival when compared to NICM. When NICM was expanded, RCM was found to have an increased mortality risk similar to ICM, whereas NIDCM and HCM both had superior outcomes. The clinical implication of this investigation will allow clinicians to better understand the prognosis of certain patient groups.

A Multi-Center International Analysis of Lung Transplantation Outcomes in Patients With COVID-19.

INTRODUCTION: Lung transplantation has become increasingly utilized in patients with COVID-19. While several single-center and UNOS database studies have been published on lung transplants (LTs) for end-stage lung disease (ESLD) from Coronavirus disease 2019 (COVID-19), there is a lack of multi-center and international data. METHODS: This is a multicenter analysis from 11 high-volume lung transplant centers in the United States and Europe. Data were collected through the Multi-Institutional ECLS Registry and stratified by ESLD due to COVID-19 versus other etiologies. Demographics and clinical variables were compared using Chi-square test and Fisher's exact test. Survival was assessed by Kaplan-Meier curves and compared by log-rank test with propensity score matching. RESULTS: Of 1606 lung transplant recipients, 46 (2.9%) were transplanted for ESLD from COVID-19 compared to 1560 (97.1%) without a history of COVID-19. Among COVID-19 patients, 30 (65.2%) had COVID-19-associated ARDS and 16 (34.8%) had post-COVID-19 fibrosis. COVID-19 patients had higher lung allocation scores (78.0 vs. 44.4, p < 0.0001), had severely limited functional status (37.0% vs. 2.9%, p < 0.0001), had higher preoperative ECMO usage (65.2% vs. 5.4%, p < 0.0001), and spent less time on the waitlist (32 vs. 137 days, p < 0.0001). A 30-day survival was comparable between COVID-19 and non-COVID-19 patients before (100% vs. 98.7%, p = 0.39) and after propensity matching (p = 0.15). CONCLUSIONS: Patients who received LTs due to COVID-19 had short-term survival comparable to that of patients without COVID-19. Our findings support the idea that lung transplantation should be considered for select patients with ESLD due to COVID-19.

Impact of donor ventricular function on heart transplantation outcomes.

BACKGROUND: Some heart transplant (HTx) centers have expanded their donor eligibility criteria in response to the organ shortage; one area of active interest involves utilizing hearts with ventricular dysfunction. Our study seeks to identify if a relationship exists between donor left ventricular ejection fraction (LVEF) and ischemic time or donor age on HTx outcomes. METHODS: We performed a retrospective analysis on adult patients who had a HTx between 1996 and 2021 (n = 46,936). Donor LVEF (dLVEF) values were categorized into three groups: <50%, 50%-70%, and >70%. Ischemic time and donor age were stratified into four groups: ≤2.0, 2.1-3.0, 3.1-4.0, >4.0 h, and ≤30, 31-40, 41-50, >50 years, respectively. The outcome of interest was long-term survival. RESULTS: Multivariable survival analysis found a slight increase in overall mortality risk for patients with donor ejection fractions <50% (HR = 1.16, p = .013). However, subsequent subgroup investigation discovered that this elevated hazard was only applicable when ischemic time was prolonged to >3.0 h (3.1-4.0 h: HR = 1.23, p = .024; > 4.0 h: HR = 1.52, p < .001). There was no significant difference in survival between dLVEF groups when ischemic time was limited to ≤3.0 h or when stratified by donor age. CONCLUSION: HTx patients with a low donor ejection fraction have comparable survival to recipients with a normal dLVEF when ischemic time is limited to ≤3.0 h. Reduced dLVEF does not appear to be sensitive to advanced donor age. The clinical implications of our study may encourage the recruitment of more donor hearts for transplantation.

Lung Transplant Type and Donor Age in Idiopathic Pulmonary Fibrosis: A Single Center Study.

BACKGROUD: Idiopathic pulmonary fibrosis (IPF) accounts for a marked proportion of diagnoses on the US lung transplant (LTx) list. The effects of single (SLT) versus double LTx (DLT) and lung donor age on survival in IPF remain unclear and were investigated in this study. METHODS: We retrospectively assessed survival of LTx recipients with IPF at a single institution from February 2012-March 2020. Survival was analyzed and compared between LTx types (SLT and DLT), donor ages, and the combined groups (LTx type & donor age) using Kaplan-Meier survival analysis and compared by log-rank test. P-values less than 0.05 were considered significant. RESULTS: Of 744 LTx patients at our institution, 307 (41.3%) were diagnosed with IPF, of which 208 (67.8%) were SLT, and 97 (31.6%) were DLT (2 excluded patients underwent heart-lung transplantation). There was no significant difference in survival due to LTx type (P = 0.41) or for patients with donor age <50 or ≥50 y (P = 0.46). Once stratified by both LTx type and donor age, analysis showed no significant difference in survival between the four groups (P = 0.69). CONCLUSIONS: With ethical consideration for organ allocation, as the average age of the US population increases, donor lungs aged ≥50 are an increasingly useful resource in LTx. Our findings suggest donor age and LTx type do not significantly affect survival. Therefore, SLT, and donor lungs aged ≥50 ought to be more readily considered as non-inferior options for LTx in patients with IPF.

Anastomotic Suturing Techniques and Their Association With Post-Lung Transplantation Complications.

INTRODUCTION: Currently, standard practice is to use the continuous suturing technique on the bronchial anastomosis during lung transplantation. This study used a large cohort to investigate and contrast continuous and interrupted suturing techniques, comparing survival outcomes and occurrence of postoperative bronchial complications to examine if utilization of interrupted suturing has merit. METHODS: Survival outcomes of 740 single-center lung transplant recipients over 8 y (February 2012-March 2020) were compared by suturing techniques: either continuous or interrupted at the bronchial anastomosis. Clinical parameters and demographics were compared between two suturing groups, with P values < 0.05 considered significant. The groups were compared for postoperative morbidity, including need for bronchial interventions. Survival was compared using Kaplan-Meier curves and log-rank tests. Cox regression analysis was run with statistically significant variables to study association with survival. RESULTS: Of the 740 patients, 462 received the continuous suturing technique and 278 received the interrupted suturing technique. Most demographic and clinical data were not statistically significant between the two groups, and those that were significant were not associated with worse survival outcomes, with the exception of the variable diagnosis. Bronchial complications were comparable between the continuous and interrupted groups (12.6% versus 10.4%, P = 0.382). Extracorporeal membrane oxygenation (ECMO) use did not differ significantly between the two groups (P = 0.12). The Kaplan-Meier curve showed comparable survival between groups (P = 0.98), and Cox regression analysis showed that only diagnosis, bronchial complications, and ECMO utilization were associated with different survival outcomes. Chronic obstructive pulmonary disorder was shown to be associated with more favorable survival outcomes as opposed to idiopathic pulmonary fibrosis and the category "other". The need for ECMO and the occurrence of a bronchial complication were also associated with worse survival outcomes. CONCLUSIONS: Both techniques showed reasonable post-transplant outcomes, as our study demonstrated similar survival outcomes and bronchial complication rates.

Venoarterial Extracorporeal Membrane Oxygenation in Massive Pulmonary Embolism-Related Cardiac Arrest: A Systematic Review.

OBJECTIVE: Management of patients experiencing massive pulmonary embolism-related cardiac arrest is controversial. Venoarterial extracorporeal membranous oxygenation has emerged as a potential therapeutic option for these patients. We performed a systematic review assessing survival and predictors of mortality in patients with massive PE-related cardiac arrest with venoarterial extracorporeal membranous oxygenation use. DATA SOURCES: A literature search was started on February 16, 2020, and completed on March 16, 2020, using PubMed, Embase, Cochrane Central, Cinahl, and Web of Science. STUDY SELECTION: We included all available literature that reported survival to discharge in patients managed with venoarterial extracorporeal membranous oxygenation for massive PE-related cardiac arrest. DATA EXTRACTION: We extracted patient characteristics, treatment details, and outcomes. DATA SYNTHESIS: About 301 patients were included in our systemic review from 77 selected articles (total screened, n = 1,115). About 183 out of 301 patients (61%) survived to discharge. Patients (n = 51) who received systemic thrombolysis prior to cannulation had similar survival compared with patients who did not (67% vs 61%, respectively; p = 0.48). There was no significant difference in risk of death if PE was the primary reason for admission or not (odds ratio, 1.62; p = 0.35) and if extracorporeal membranous oxygenation cannulation occurred in the emergency department versus other hospital locations (odds ratio, 2.52; p = 0.16). About 53 of 60 patients (88%) were neurologically intact at discharge or follow-up. Multivariate analysis demonstrated three-fold increase in the risk of death for patients greater than 65 years old (adjusted odds ratio, 3.08; p = 0.03) and six-fold increase if cannulation occurred during cardiopulmonary resuscitation (adjusted odds ratio, 5.67; p = 0.03). CONCLUSIONS: Venoarterial extracorporeal membranous oxygenation has an emerging role in the management of massive PE-related cardiac arrest with 61% survival. Systemic thrombolysis preceding venoarterial extracorporeal membranous oxygenation did not confer a statistically significant increase in risk of death, yet age greater than 65 and cannulation during cardiopulmonary resuscitation were associated with a three- and six-fold risks of death, respectively.

Guiding therapeutic plasma exchange for antibody-mediated rejection treatment in lung transplant recipients - a retrospective study.

Antibody-Mediated Rejection (AMR) due to donor-specific antibodies (DSA) is associated with poor outcomes after lung transplantation. Currently, there are no guidelines regarding the selection of treatment protocols. We studied how DSA characteristics including titers, C1q, and mean fluorescence intensity (MFI) values in undiluted and diluted sera may predict a response to therapeutic plasma exchange (TPE) and inform patient prognosis after treatment. Among 357 patients consecutively transplanted without detectable pre-existing DSAs between 01/01/16 and 12/31/18, 10 patients were treated with a standardized protocol of five TPE sessions with IVIG. Based on DSA characteristics after treatment, all patients were divided into three groups as responders, partial responders, and nonresponders. Kaplan-Meier Survival analyses showed a statistically significant difference in patient survival between those groups (P = 0.0104). Statistical analyses showed that MFI in pre-TPE 1:16 diluted sera was predictive of a response to standardized protocol (R2  = 0.9182) and patient survival (P = 0.0098). Patients predicted to be nonresponders who underwent treatment with a more aggressive protocol of eight TPE sessions with IVIG and bortezomib showed improvements in treatment response (P = 0.0074) and patient survival (P = 0.0253). Dilutions may guide clinicians as to which patients would be expected to respond to a standards protocol or require more aggressive treatment.

Shared Care to Destination Therapy Left Ventricular Assist Device Site: a Novel Strategy to Start a Successful Mechanical Circulatory Support Program.

PURPOSE OF REVIEW: Heart failure is an important healthcare issue because of its high prevalence, mortality, and morbidity. Advanced heart failure therapies have improved significantly over the years with improved outcomes. Heart transplantation remains an elusive treatment option for most patients; hence, the need for alternative therapy has given rise to the use of mechanical circulatory support (MCS) devices, initially as bridge to transplantation, but with more recent use as destination therapy. This review focuses on the intricacies of establishing a successful left ventricular assist device (LVAD) program for destination therapy in the setting of a growing anticipated need for wider availability of such treatment options. RECENT FINDINGS: Guidelines have established the role of MCS in patients with advanced HF refractory to optimal guideline-directed medical therapy (GDMT) and cardiac device interventions. Multiple studies have shown generational improvement in the overall safety profile of MCS devices with the use of newer devices for destination therapy showing improved outcomes. Heart failure is a growing cardiovascular problem with an anticipated growing need for advanced HF therapies including MCS devices. A model of shared care LVAD to destination therapy implanting site should be considered as a strategy to start a successful LVAD program.

Elderly patients with multiple comorbidities: insights from the bedside to the bench and programmatic directions for this new challenge in lung transplantation.

In aging populations, many patients have multiple diseases characterized by acceleration of the aging process including cardiovascular diseases, metabolic diseases, and chronic kidney disease. Remarkable progress in minimally invasive, interventional therapies, such as percutaneous coronary intervention and transcatheter aortic valve replacement has enabled patients who were previously not transplant candidates because of co-existing problems to become potentially viable candidates for lung transplantation. Recently, we have observed an outstanding and steady increase in patients older 70 years of age with multiple comorbidities who are referred to our high-volume center as potential candidates for lung transplantation. However, the impact of diseases characterized by an accelerated aging process and their treatments on transplant outcomes remains unclear. This review aims to highlight these challenges in the current era of lung transplantation, review the prior literature, and discuss future directions with a multidisciplinary view including translational research, transplant medicine, and surgery, as well as from a programmatic and administrative standpoint.

Current precautions and future directions in lung transplantation during the COVID-19 pandemic - a single center cohort study.

The unprecedented public health emergency caused by the acute viral respiratory coronavirus disease (COVID-19) has drastically changed current practices in solid organ transplantation, markedly so for transplantation of the lungs, the major target of the virus. Although national and state authorities do not recommend postponing transplant procedures, most specialists are reluctant to proceed due to substantial uncertainty and increased risks in the midst of the pandemic. There is an urgent need for evidence-based directions to move forward. Here, we offer our insights as specialists at a high-volume center located in a geographical area with high infection rates.

Cardiac tamponade masquerading as headache: A diagnostic conundrum.

Cardiac tamponade and its protean presentations are well documented. Tamponade presenting after recent cardiac surgery in a patient on anticoagulation is not unknown. However, severe headache as a presenting feature of tamponade is not documented. We describe how one can be misled into investigating causes of headache while the real cause, tamponade, lies hidden.

Massive Air Embolism Caused by a Central Venous Catheter During Extracorporeal Membrane Oxygenation.

Extracorporeal membrane oxygenation (ECMO) has become an integral treatment option for patients as a bridge to transplant, management of post cardiotomy cardiogenic shock, and for rescue after cardiopulmonary arrest. Significant strides in ECMO technology and management cannot, however, replace the importance of maintaining and following a comprehensive safety checklist. We herein report a case of massive air entrainment from an inadvertently disconnected port of a central venous catheter (CVC) in the neck which culminated in an airlock of the ECMO circuit. Ascertaining the relative position of the tip of the CVC with respect to the venous cannula on chest X-ray, tightly securing all its ports, and appraising and educating the health-care team can prevent this rare but devastating complication of fatal air embolism.

Examining Mortality and Rejection in Combined Heart-Lung Transplantations.

Background There is a paucity of data on outcomes related to combined heart-lung transplantations (HLTs). Our objective was to identify variables associated with mortality and rejection in HLT. Methods The United Network for Organ Sharing database was reviewed for HLT performed between 1993 and 2008. Long-term survivors (survival > 5 years) were compared with short-term survivors (survival < 5 years). Factors associated with rejection were examined. Risk-adjusted multivariable Cox's proportional hazards regression analysis was performed to examine variables associated with mortality and rejection. Results Multivariable analysis revealed that recipient male gender was associated with mortality at 1 year (hazard ratio [HR]: 1.68, 95% confidence interval [CI]: 1.11-2.54, p = 0.01) and 5 years (HR: 1.41, 95% CI: 1.05-1.89, p = 0.02). Preoperative extracorporeal membrane oxygenation (ECMO) was associated with mortality at 1 year (HR: 7.55, 95% CI: 2.55-22.30, p < 0.01) and 5 years (HR: 3.14, 95% CI: 1.19-8.32, p = 0.02). Preoperative mechanical ventilation (MV) was associated with mortality at 1 year (HR: 3.51, 95% CI: 1.77-6.98, p < 0.01) and at 5 years (HR: 2.70, 95% CI: 1.51-4.85, p < 0.01). Multivariable analysis showed that male gender (HR: 1.78, 95% CI: 1.03-3.09, p = 0.04) and cytomegalovirus (CMV) positivity in the recipient and donor (HR: 3.09, 95% CI: 1.59-6.01, p < 0.01) were associated with rejection. Clinical infection in the donor (HR: 2.05, 95% CI: 1.16-3.61, p = 0.01) was also associated with rejection. Conclusion Survival was affected by recipient male sex and need for preoperative ECMO or MV. Risk factors for rejection included male sex, CMV positivity in the donor and recipient, and donor with clinical infection.

Ganciclovir-resistant cytomegalovirus infections among lung transplant recipients are associated with poor outcomes despite treatment with foscarnet-containing regimens.

Ganciclovir-resistant cytomegalovirus (CMV) infections are reported infrequently among lung transplant recipients receiving extended valganciclovir prophylaxis. We performed a single-center, retrospective review of ganciclovir-resistant CMV infections in a program that employed valganciclovir prophylaxis for ≥6 months after lung transplant. CMV infections were diagnosed in 28% (170/607) of patients. UL97 mutations were detected in 9.4% (16/170) of CMV-infected patients at a median of 8.5 months posttransplant (range, 5 to 21) and despite prophylaxis for a median of 7 months (range, 4 to 21). UL97 mutations were canonical; 25% (4/16) of strains carried concurrent UL54 mutations. Ganciclovir-resistant CMV was more likely with breakthrough infections (75% [12/16] versus 19% [30/154]; P = 0.00001) and donor positive/recipient negative (D+/R-) serostatus (75% versus 45% [69/154]; P = 0.03). The median whole-blood CMV load was 4.13 log10 copies/cm(3) (range, 2.54 to 5.53), and 93% (14/15) of patients had low-moderate immune responses (Cylex Immunoknow). Antiviral therapy was successful, failed, or eradicated viremia followed by relapse in 12% (2/16), 31% (5/16), and 56% (9/16) of patients, respectively. Eighty-seven percent (14/16) of patients were treated with foscarnet-containing regimens; toxicity developed in 78% (11/14) of these. Median viral load half-life and time to viremia eradication among foscarnet-treated patients were 2.6 and 23 days, respectively, and did not correlate with protection from relapse. Sixty-nine percent (11/16) of patients developed CMV pneumonitis, and 25% (4/16) died of it. Serum viral load was independently associated with death among foscarnet-treated patients (P = 0.04). In conclusion, ganciclovir-resistant CMV infections remained a major cause of morbidity and mortality following lung transplantation. Foscarnet-based regimens often eradicated viremia rapidly but were ineffective in the long term and limited by toxicity.

Cardiac device creativity and innovation under constraints: Exploring trends from the food and drug administration's device clearances and recalls.

BACKGROUND: Medical device expenditures have increased in the 21st century, with cardiac devices comprising an outsized portion of the market. Meanwhile, the disproportionate share of FDA recalls of cardiac devices is often overshadowed. Using the FDA 510(k) premarket notification pathway and FDA recalls issued from 2000 to 2020, this project seeks to engage our understanding of innovation and recalls in the cardiac device space. METHODS: 510(k) premarket notification submission dates, outcomes, and recalls from 1/1/2000 to 12/31/2019 were obtained from publicly available FDA data as a function of cardiac device innovation. We compared the annual number of 510(k) premarket clearances and FDA recalls from 1/1/2000 to 12/31/2009 to 1/1/2010 to 12/31/2019. RESULTS: We found 343 moderate risk cardiac medical devices cleared for sale between the years 2000 and 2020. Comparing the last 10 years of the study period to the first, the yearly number of cleared devices decreased 39.7 %, from 21.4 to just 12.9 (p = 0.0019), defying positive trends in U.S. GDP and healthcare expenditures. Meanwhile, the number of FDA recalls issued for these devices increased 94.5 % from 7.3 to 14.2 recalls per year (p = 0.031). 215 device recalls were issued; 78 % Class II and 16 % Class I which constitute serious, potentially fatal recalls. CONCLUSIONS: While United States healthcare spending continues to trend upward, there was a distinct decrease in the number of new and updated cardiac devices entering the market between 2000 and 2020. Meanwhile, recalls of these devices have uncomfortably increased. Together, these trends suggest cardiac device innovation has become risk averse.

The effect of donor-recipient sex matches on lung transplant survival: An analysis of the United Network for Organ Sharing database.

Objective: To investigate the impact of donor-recipient (DR) sex matches on survival after lung transplantation while controlling for size difference in the United Network of Organ Sharing (UNOS) database. Methods: We performed a retrospective study of 27,423 lung transplant recipients who were reported in the UNOS database (January 2005-March 2020). Patients were divided into groups based on their respective DR sex match: male to male (MM), male to female (MF), female to female, (FF), and female to male (FM). Kaplan-Meier curve and Cox regression with log-rank tests were used to assess 1-, 3-, 5-, and 10-year survival. We also modeled survival for each group after controlling for size-related variables via the Cox regression. Results: Kaplan-Meier curves showed overall significance at 1-, 3-, 5-, and 10-year end points (P < .0001). Estimated median survival time based on Kaplan-Meier analysis were 6.41 ± 0.15, 6.13 ± 0.18, 5.86 ± 0.10, and 5.37 ± 0.17 years for FF, MF, MM, and FM, respectively (P < .0001). After we controlled for size differences, FF had statistically significantly longer 5- and 10-year survival than all other cohorts. MF also had statistically significantly longer 5- and 10-year survival than FM. Conclusions: When variables associated with size were controlled for, FF had improved survival than other DR groups. A female recipient may experience longer survival with a female donor's lungs versus a male donor's lungs of similar size.

Three-Year Left Ventricular Assist Device Outcomes and Strategy After Heart Transplant Allocation Score Change.

The United Network for Organ Sharing (UNOS) adopted new criteria for the heart allocation score on October 18, 2018 to reflect the changing trends of candidates' mortality while awaiting transplant. We examined the impact of these policy changes on rates of left ventricular assist device (LVAD) implantation and outcomes after transplant from a relatively newer UNOS database. The UNOS registry was used to identify first-time adult heart recipients with LVAD at listing or transplant who underwent transplantation between January 1, 2016 and March 10, 2020. Survival data were collected through March 30, 2023. Those listed before October 18, 2018 but transplanted after were excluded. Patients were divided into before or after change groups. Demographics and clinical parameters were compared. Survival was analyzed with Kaplan-Meier curves and log-rank tests. A p <0.05 was considered significant. We identified 4,387 heart recipients with LVAD in the before (n = 3,606) and after (n = 781) score change eras. The after group had a lower rate of LVAD implantation while listed than the before group (20.4% vs 34.9%, p <0.0001), and were more likely to be female (25.1% vs 20.2%, p = 0.002); in both groups, most recipients (62.8%) were white. There was significantly farther distance from the donor hospital to transplant center in the after group (264.4 NM vs 144.2 NM, p <0.0001) and decreased waitlist days (84.9 ± 105.1 vs 369.2 ± 459.5, p <0.0001). Recipients in the after group were more likely to use extracorporeal membrane oxygenation (3.7% vs 0.5%, p <0.0001) and intravenous inotropes (19.1% vs 7.5%, p <0.0001) and receive a Centers for Disease Control and Prevention increased risk donor organ (37.9% vs 30.5%, p <0.0001). Survival at 3 years was comparable between the 2 groups. The allocation score change in 2018 yielded considerable changes in mechanical circulatory support device implantation strategy and outcomes. The rate of LVAD implantation decreased with increased utilization of temporary mechanical circulatory support devices.