Sexual Quality of Life in Left Ventricular Assist Device Patients and Their Partners.

BACKGROUND: Living with a left ventricular assist device (LVAD) comes with potentially burdensome aspects posed by, for example, battery packs and device drivelines. We aim to describe the impact of living with a durable LVAD on sexual quality of life (QOL), depression, and anxiety in patients and their partners. METHODS AND RESULTS: In this single-center, prospective, observational study, patients ≥4 months after LVAD implantation and their partners completed the Sexual Activities in Left Ventricular Assist Device Patients or Partners questionnaire to assess their sexual QOL, the 8-item Patient Health Questionnaire (PHQ-8) to assess symptoms of depression and the 7-item Generalized Anxiety Disorder (GAD-7) to assess symptoms of anxiety. Sixty patients and 60 partners completed the questionnaires 2.3 ± 1.9 years after implantation. Eighty-seven percent of the patients and 13% of partners were male. The mean age of patients was 57.4 ± 13.3 years, with 90% living with their partner. Ten percent of patients and 18% of partners had a current diagnosis of a psychological condition, most frequently depression and/or anxiety. Overall, 49% of participants indicated the LVAD influenced their sexual activity (patients 53% vs partners 45%; P = .33). Disturbances from the driveline were the most common problem indicated. Twenty-four percent of participants had scored in the mild to moderate depression range on the PHQ-8 and 28% scored in the mild to severe anxiety range on the GAD-7. The median total GAD-7 (1 [interquartile range (IQR) 0-4.25] vs 2.5 [IQR 0-5]; P = .06) were comparable between patients and partners; whereas patients had a higher total PHQ-8 score (3 [IQR 0-5.25] vs 1 [IQR 0-3.25]; P = .02). A preference to receive information regarding sexuality while on LVAD support was indicated by 54% of participants and did not differ between patients and partners (P > .99). Written resources were the most commonly preferred source of information. CONCLUSIONS: LVADs severely affect the sexual QOL for patients and their partners. The presence of a driveline is a major cause for concern. Patients prefer receiving written information on how to improve their sexual QOL.

The impact of active cytomegalovirus infection on donor-derived cell-free DNA testing in heart transplant recipients.

BACKGROUND: Little is known about the relationship between cytomegalovirus (CMV) infections and donor-derived cell-free DNA (dd-cfDNA) in heart transplant recipients. METHODS: In our study, CMV and dd-cfDNA results were prospectively collected on single-organ heart transplant recipients. If the CMV study was positive, a CMV study with dd-cfDNA was repeated 1-3 months later. The primary aim was to compare dd-cfDNA between patients with positive and negative CMV results. RESULTS: Of 44 patients enrolled between August 2022 and April 2023, 12 tested positive for CMV infections, 25 were included as controls, and seven patients with a viral infection without CMV were excluded. Baseline characteristics did not differ significantly between CMV-positive and CMV-negative patients with the exception of a later median time post-transplant in the CMV-positive group (253 days vs. 120 days, p = .03). Dd-cfDNA levels were significantly higher in patients with CMV infections compared to those without (p < .001) with more patients in the CMV positive group showing dd-cfDNA results ≥.12% (75% vs. 8%, p < .001) and ≥.20% (58% vs. 8%, p = .002). Each 1 log10 copy/ml reduction in CMV viral load from visit 1 to visit 2 was associated with a.23% reduction in log10 dd-cfDNA (p = .002). CONCLUSION: Our findings suggest that active CMV infections may raise dd-cfDNA levels in patients following heart transplantation. Larger studies are needed to validate these preliminary findings.

Tricuspid regurgitation burden following transcatheter aortic valve replacement requiring early pacemaker implantation.

Background: Conduction abnormality requiring the implantation of a permanent pacemaker (PPM) is a well-known and clinically important complication of transcatheter aortic valve replacement (TAVR). However, PPM implantation may result in lead-associated tricuspid valve regurgitation (TR). This study sought to determine the incidence and progression of TR following PPM implantation after TAVR. Methods: This was a retrospective review of all echocardiograms of patients who underwent PPM following TAVR at the Baylor Scott & White hospitals from 2012 to 2021. The primary endpoint was TR progression at 30 days and 1 year. A subanalysis comparing the change in TR progression between small and large TAVR devices was also conducted. Secondary outcomes included all-cause death at 30 days and 1 year. Results: Out of the 2744 patients who underwent TAVR between April 2012 and August 2021, 177 patients (6.5%) subsequently received a new PPM. There was a statistically significant progression of TR at 1-year follow-up (McNemar's P value = 0.02). TR progression rates were comparable between the small and large valve groups at 1-year follow-up (4% vs 11%, P = 0.09, respectively). Conclusion: In this single healthcare system study, we demonstrated a significant progression of TR in patients with PPM post TAVR at 1 year.

Three-year outcomes of de novo tacrolimus extended-release tablets (LCPT) compared to twice-daily tacrolimus in adult heart transplantation.

BACKGROUND: Extended-release tacrolimus for prophylaxis of allograft rejection in heart transplant (HT) recipients is currently not FDA-approved. One such extended-release formulation of tacrolimus known as LCPT allows once-daily dosing and improves bioavailability compared to immediate-release (IR-) tacrolimus. We compared long-term efficacy and safety of LCPT to IR-tacrolimus applied de novo in adult OHT recipients. METHODS: 25 prospective recipients on LCPT at our center from 2017 to 2019 were matched 1:2 with historical control recipients treated with IR-tacrolimus based on age, gender, and baseline creatinine. The primary composite outcome of death, acute cellular rejection, and/or new graft dysfunction within 3 years following transplant was compared between groups using non-inferiority analysis. RESULTS: LCPT demonstrated non-inferiority to IR-tacrolimus, with a primary outcome risk reduction of 16% (90%CI, -37%, -1%, non-inferiority p = 0.002) up to 3 years following heart transplant. Up to 3-years post-transplant, 14 patients remained on once-daily LCPT and 10 patients were switched to IR-tacrolimus due to lack of insurance coverage. There were no significant differences in the rate of chronic kidney disease requiring dialysis, cytomegalovirus requiring treatment, cardiac allograft vasculopathy, and malignancy within 3 years following transplant. CONCLUSION: LCPT is non-inferior in efficacy to IR-tacrolimus in heart transplantation with a similar safety profile. Narrowly-constrained FDA labels specific to kidney transplant remain a barrier to consistent access to many immunosuppressant medications for recipients of non-kidney solid organs. We recommend the FDA consider developing facile pathways for expanding the approved label of extended-release tacrolimus formulations to heart transplant recipients.

Early elevated donor-derived cell-free DNA levels in heart transplant recipients following precision-controlled cardiac transport system or ice-cooled organ transport.

BACKGROUND: Recent innovations in temperature-controlled cardiac transportation allow for static hypothermic preservation of transplant organs during transportation. We assessed differences in donor-derived cell-free DNA (dd-cfDNA) using the SherpaPak cardiac transport system (SCTS) and traditional ice transportation. METHODS: Single-organ heart transplant recipients between January 2020 and January 2022 were included if they had dd-cfDNA measures ≤6 weeks post-transplant along with the baseline biopsy at 6 weeks as part of the surveillance protocol and no biopsy-confirmed rejection ≤90 days. Elevated dd-cfDNA ≥.20% were compared between groups using logistic regression including a subject effect. RESULTS: Of 65 hearts transplanted, 30 were transported with SCTS and 35 on ice. Recipient characteristics were similar between groups. Donors in the SCTS group were older (34 vs. 40 years, p = .04) with a longer total ischemic time (171 vs. 212 min, p = .002). Recipients in the SCTS group had a greater risk of elevated dd-cfDNA unadjusted and adjusted for donor age, and prolonged ischemic times > 3.5 h (Unadjusted odds ratio: 4.9, 95%-CI: 1.08-22.5, p = .039 and Adjusted odds ratio: 5.5, 95%-CI: 1.03-29.6, p = .046). Primary graft dysfunction rates and 1-year mortality were comparable between groups. CONCLUSION: Elevated dd-cfDNA in patients procured with SCTS may indicate that graft injury was not negated relative to ice transport. However, there were no clinical differences noted in short or long-term outcomes including mortality despite a longer ischemic time in the SCTS group.

Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 30-Day Outcomes of the DIPRA Study.

Background Proximal radial artery (pRA) access for cardiac catheterization is safe but can jeopardize subsequent use of the artery because of occlusion. Distal radial artery (dRA) access in the anatomical snuffbox preserves the radial artery, but safety and potential detrimental effects on hand function are unknown. Methods and Results In the DIPRA (Distal Versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention) study, a single-center trial, 300 patients were randomized 1:1 to cardiac catheterization through dRA or pRA. The primary end point of change in hand function from baseline to 30 days was a composite of the QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) questionnaire, hand-grip test, and thumb forefinger pinch test. Secondary end points included access feasibility and complications; 254 of 300 patients completed follow-up at 30 days; of these, 128 were randomized to dRA and 126 to pRA with balanced demographic and procedural characteristics. Both groups had similar rates of access site bleeding (dRA 0% versus pRA 1.4%; P=0.25). Six patients with dRA failed access compared with 2 patients with pRA. Radial artery occlusion occurred in 2 pRA versus none in dRA. There were no significant differences in change in hand function, median hand-grip (dRA 0 [-3.2, 3.3] versus pRA 0.7 [-2.3, 3.3] kg; P=0.21), pinch-grip (dRA -0.3 [-1.2, 0.5] versus pRA 0 [-0.9, 0.9] kg; P=0.09), and QuickDASH (dRA 0 [-4.6, 2.3] versus pRA 0 [-4.6, 2.3] points, P=0.96). There was no significant difference in the composite of hand function between pRA and dRA. Conclusions dRA is a safe strategy for cardiac catheterization with a low complication rate. Compared with pRA, there is no increased risk of hand dysfunction at 30 days. Registration URL: https://www.ClinicalTrials.gov. Unique identifier: NCT04318990.

Rejection! Or is it? Correlation among molecular microscope diagnostic system, histopathology and clinical judgement following heart transplantation.

PURPOSE: Little is known about clinical decision making among discordant findings concerning for rejection with endomyocardial biopsy (EMBx) and Molecular Microscope Diagnostic System (MMDx) in patients following heart transplantation. METHODS: Two hundred and twenty-eight corresponding EMBx and MMDx specimens from 135 adult heart transplant patients were retrospectively reviewed. Rejection was classified as t-cell mediated rejection ≥2R and/or antibody mediated rejection ≥1. Clinical decision making among concordant and discordant cases of EMBx and MMDx results were reviewed. RESULTS: Patient characteristics were comparable between concordant and discordant patient groups (median age 60 yrs., 76% male, and 71% White). A total of 167/228 specimens (73%) were concordant for no rejection with 98% agreement in clinical decision making and 25/228 (11%) concordant for rejection with 64% agreement in clinical decision making. Among the 36/228 (16%) discordant samples, clinical decision-making agreed on treatment for rejection in five of the MMDx samples and three of the EMBx samples. CONCLUSIONS: MMDx can be an additional tool to diagnose rejection not detected by the traditional EMBx and influence clinical decision making in guiding appropriate treatment. Ongoing investigation into the clinical utility of MMDx is warranted to determine the significance of discordant findings among diagnostic modalities when assessing for rejection.

Alert! Does Prolonged Temporary Support Induce an Immunological Response?

Little is known about the development of human leukocyte antigen antibodies with use of the temporary transvalvular pump 5.5 mechanical circulatory support device. This case reports a patient who developed de novo antibodies prior to his heart transplantation and remains free of any episodes of rejection post transplantation to date. (Level of Difficulty: Advanced.).

Bioimpedance Spectroscopy in Heart Transplantation: Posttransplant Changes in Body Composition and Effects in Outcomes.

BACKGROUND: Bioimpedance spectroscopy yields measurements of fat-free mass, fat mass, phase angle, and other measures. Bioimpedance spectroscopy has been validated as a preoperative assessment tool in cardiac surgical studies, in which low phase angle predicted morbidity and mortality. No studies have evaluated bioimpedance spectroscopy following heart transplantation. METHODS: We evaluated body composition, nutrition status (Subjective Global Assessment, body mass index, midarm muscle circumference, and triceps skinfolds), and functional status (handgrip strength and 6-min walk test) in 60 adults. Body composition measurements via a 256-frequency bioimpedance spectroscopy device included fat and fat-free mass as well as phase angle calculated at 50 kHz. Testing was completed at baseline and 1, 3, 6, and 12 mo following heart transplantation. Mortality and hospital readmissions were analyzed. RESULTS: Phase angle and fat mass increased while fat-free mass decreased; grip strength and 6-min walk test improved after transplantation (all P < 0.001). Improvement in phase angle in the first month postoperatively was associated with reduced risk of readmission. Low perioperative and 1-mo phase angles were associated with prolonged posttransplant length of stay (median: 13 versus 10 d, P = 0.03), increased infection-related readmissions (40% versus 5%, P = 0.001), and increased 4-y mortality (30% versus 5%, P = 0.01). CONCLUSIONS: Phase angle, grip strength, and 6-min walk test distance improved after heart transplantation. Low phase angle appears to be associated with suboptimal outcomes and may be a feasible and affordable method to predict outcomes. Further research should ascertain whether preoperative phase angle can predict outcomes.

Safety and efficacy of ProtekDuo right ventricular assist device: A systemic review.

BACKGROUND: Right ventricular failure is associated with increased morbidity and mortality. The ProtekDuo (Livanova, Uk) is a dual-lumen cannula that allows for percutaneous right ventricular support and may be connected to a centrifugal blood pump such as the TandemHeart or LifeSparc (Livanova, UK). This systematic review aims to evaluate the safety and efficacy of ProtekDuo right ventricular support and evaluate potential clinical variables that can influence outcomes. METHODS: PubMed, MEDLINE, SCOPUS, EMBASE, and the Cochrane Library were systematically searched. Studies meeting inclusion criteria, where ProtekDuo was used as the right ventricular assist device with reported numerical death counts for mortality as outcome measures. The primary endpoints were in-hospital 30-day and 1-year mortality rates. Secondary endpoints included ICU length of stay, conversion rates to surgical RVADs, ProtekDuo wean rates, duration of use of ProtekDuo, and adverse event rates. RESULTS: Of 49 studies reviewed, 7 met inclusion criteria with study periods between October 2014 and November 2019. ProtekDuo was utilized due to RV failure post-LVAD insertion in 64.8% (68/105) of patients. In-hospital mortality, 30-day mortality, and 1-year mortality ranged between 9%-46%, 15%-40%, and 19%-40%, respectively. Weaning from ProtekDuo and conversion to surgical RVAD ranged between 24%-91% and 11%-35%, respectively. The ICU stay average ranged from 15.8 to 36 days and ProtekDuo mean support duration ranged from 10.5 to 58 days. CONCLUSION: The ProtekDuo cannula is increasingly utilized as a right ventricular support device. Despite the sparse retrospective data available with variable patient characteristics and study design, percutaneous RV mechanical support via ProtekDuo cannula is a safe and feasible option.

Outcomes After Supratentorial Craniotomy for Primary Malignant Brain Tumor Resection in Adult Patients: A National Surgical Quality Improvement Program Analysis.

BACKGROUND: The rate of complications remains significant after craniotomy for supratentorial primary malignant brain tumors despite recent advances. OBJECTIVE: The goal of this study is to characterize factors associated with these complications. METHODS: Data were extracted from the National Surgical Quality Improvement Program database from 2016 to 2019. Patients who underwent a craniotomy for resection of supratentorial primary malignant brain tumors were included. Covariates included demographics/comorbidities, preoperative laboratory values, American Society of Anesthesiologists (ASA) classification, operative time, and postoperative complications. Multivariable logistic regression with backward and forward selection was used to evaluate independent predictors of death, prolonged hospitalization, postoperative stroke with neurologic deficit (CVA), and unplanned readmission. Predictive fit of the model was evaluated using the area under the receiver operating curve (AUC). RESULTS: Of 8965 included cases, the 30-day postoperative risks were 1.9% for CVA, 10.1% for unplanned readmission, 1.2% for prolonged hospitalization, and 2.4% for death. Age, ASA category, disseminated cancer, preoperative functional dependence, and postoperative respiratory complications were predictors of 30-day mortality (AUC, 0.83; P < 0.001). CVA was best predicted by increased operation time (P < 0.001), age, ASA category, and recent weight loss (AUC, 0.63; P = 0.009). Prolonged hospitalization was predicted by nonelective surgery status, time from admission to surgery, reintubation, and postoperative sepsis (AUC, 0.78; P < 0.001). Unplanned readmission was predicted by chronic steroid use, postoperative thrombotic complications after surgery, organ/space surgical site infection, deep vein thrombosis, postoperative systemic sepsis, and septic shock (AUC, 0.68; P < 0.001). CONCLUSIONS: Our study identifies predictors of major 30-day complications after craniotomy for this subset of patients with brain tumor.

The Utility of Home Sleep Apnea Testing in the Advanced Heart Failure Populations.

Untreated sleep disorders form a risk of coronary artery disease, hypertension, obesity, and diabetes mellitus. Access to polysomnography is limited, especially during the COVID-19 pandemic, with home sleep apnea testing (HSAT) being a potentially viable alternative. We describe an HSAT protocol in patients with advanced heart failure (HF). In a single-center, observational analysis between 2019 and 2021 in patients with advanced HF and heart transplant (HT), 135 screened positive on the STOP-Bang sleep survey and underwent a validated HSAT (WatchPAT, ZOLL-Itamar). HSAT was successful in 123 patients (97.6%), of whom 112 (91.1%; 84 HF and 28 HT) tested positive for sleep apnea. A total of 91% of sleep apnea cases were obstructive, and 63% were moderate to severe. Multivariable linear regression showed that the apnea hypopnea index was 34% lower in the HT group than in the HF group (p = 0.046) after adjusting for gender, and that this effect persisted in White patients but not among African-Americans. Patient characteristics were similar between groups, with coronary artery disease, diabetes mellitus, and hypertension as the most prevalent co-morbidities. In conclusion, sleep apnea remains prevalent in patients with HF with a high co-morbidity burden. HSAT is a feasible and effective tool for screening and diagnosis in this population.

Effectiveness and Safety Profile of Remote Pulmonary Artery Hemodynamic Monitoring in a "Real-World" Veterans Affairs Healthcare System.

Ambulatory hemodynamic monitoring has demonstrated the ability to reduce heart failure-related hospitalization, regardless of left ventricular ejection fraction; however, real-world data in a Veterans Affairs patient population are limited. The present study retrospectively reviewed 53 patients with New York Heart Association class III heart failure, regardless of left ventricular ejection fraction, implanted with a pulmonary artery pressure sensor (CardioMEMS) at our single Veterans Affairs institution. Heart failure-related hospitalizations were assessed in patients for 6 and 12 months after the implantation of the device and compared with the 6- and 12- month periods before implantation in the same patient cohort. Pulmonary arterial pressures and medication doses were also recorded at baseline, 6- months, and 12- months and procedural safety data were also assessed. Implantation of a remote pulmonary artery pressure sensor was associated with a 52% (95% confidence interval 30% to 68%, p <0.001) and a 44% (95% confidence interval 24% to 59%, p <0.001) reduction in heart failure-related hospitalization at 6 and 12 months after implant, respectively, compared with the 6- and 12-month preimplant periods. Mean pulmonary arterial pressures also demonstrated significant reductions from baseline to 6 and 12 months after implant. A total of 3 procedure-related adverse events were noted. In conclusion, pulmonary artery pressure sensor implantation is relatively safe and associated with significant reductions in heart failure-related hospitalization and decreased mean pulmonary artery pressures in patients within the Veterans Affairs system with New York Heart Association class III symptoms, regardless of ejection fraction.

Evolving the surveillance and workup of heart transplant rejection: A real-world analysis of the Molecular Microscope Diagnostic System.

The Molecular Microscope Diagnostic System (MMDx) analyzes RNA transcripts of transplanted heart tissue to differentiate among T cell-mediated rejection (TCMR), antibody-mediated rejection (AMR), injury, and healthy tissue. However, little is known about its performance in relation to other modalities in a real-world heart transplant population. We evaluated whether MMDx performs in agreement with other validated modalities. Two hundred and twenty-eight corresponding endomyocardial biopsies (EMBx) and MMDx specimens from 135 adult heart transplant patients were retrospectively reviewed with correlating donor-derived cell-free DNA (dd-cfDNA). Rejection was classified on EMBx in 29 specimens (TCMR ≥ 2R and/or AMR ≥ 1), on MMDx in 56 specimens, and in 74 values with dd-cfDNA ≥0.20%. Despite moderate agreement between EMBx and MMDx (84% agreement, Cohen's kappa, 0.48, p < .001), systematic differences were observed (McNemar's test, p < .001) where MMDx classified 32 of 37 discordant cases as rejection. MMDx and dd-cfDNA demonstrated slight agreement (72% agreement, Cohen's kappa, 0.39, p < .001); however, systematic differences were also apparent where MMDx classified 12 of 50 discordant specimens as rejection when dd-cfDNA was <0.20% (McNemar's test, p < .001). Our findings provide insight on the performance of MMDx relative to other modalities in a heart transplant cohort and have implications on the surveillance and workup of allograft rejection in heart transplantation.

Trends in Hospital Admissions for Systolic and Diastolic Heart Failure in the United States Between 2004 and 2017.

Heart failure (HF) affects 6 million people in the United States and costs $30 billion annually. It is unclear whether improvements in length of stay and mortality over the last few decades hold true for both systolic and diastolic HF. To better assess the epidemiological and economic burden of HF, we assessed the trends in outcomes and costs for both systolic and diastolic HF. We identified hospitalizations for systolic and diastolic HF in the National Inpatient Sample database and evaluated trends over the period from 2004 to 2017, adjusting for demographics and co-morbidities. The proportion of patients admitted with an exacerbation of systolic HF increased from 42% to 63% over the study period. We found an overall decreasing trend between 2004 and 2011 in the length of stay for HF in general with a sharper decrease in diastolic than systolic HF. Inpatient mortality decreased between 2004 and 2007 and stabilized between 2008 and 2016. Systolic HF was associated with higher mortality than diastolic HF. The total inflation-adjusted cost did not change significantly over the study period, with systolic HF costing, on average, $3,036 more than diastolic HF per admission. In conclusion, systolic HF overtook diastolic HF, accounting for most HF hospitalizations in 2008. The higher hospitalization costs for systolic HF relative to diastolic HF may have resulted, in part, from greater use of advanced support devices in patients with systolic HF.

A system-wide extracorporeal membrane oxygenation quality collaborative improves patient outcomes.

OBJECTIVE: Extracorporeal membrane oxygenation (ECMO) use in adult patient populations has grown rapidly with wide variation in practices and outcomes. We evaluated the impact on patient outcomes, resource use, and costs of an initiative to coordinate and standardize best practices across ECMO programs within a large integrated health care system. METHODS: The ECMO Collaborative Project brought clinicians and service-line leaders from 4 programs within a single health care system together with operational subject matter experts tasked with developing and implementing standardized guidelines, order sets, and an internal database to support an automated quarterly report card. Patient outcomes, resource use, and financial measures were compared for the 16 months before (January 2017 to April 2018; "precollaborative," n = 185) versus the 14 months after (November 2018 to December 2019, "postcollaborative," n = 243) a 6-month implementation and blanking period. Subset analyses were performed for venoarterial ECMO, venovenous ECMO, and extracorporeal cardiopulmonary resuscitation. RESULTS: Survival to discharge/transfer increased significantly (in-hospital mortality hazard ratio, 0.75; 95% confidence interval [95% CI], 0.58-0.99) for the postcollaborative versus the precollaborative period (107/185, 57.8% vs 113/243, 46.5%, P = .03), predominantly due to improvement among patients receiving venoarterial ECMO (hazard ratio, 0.61; 95% CI, 0.41-0.91). The percentage of patients successfully weaned from ECMO increased from 58.9% (109/185) to 70% (170/243), P = .02. Complication rates decreased by 40% (incidence rate ratio, 0.60; 95% CI, 0.49-0.72). No significant changes were observed in ECMO duration, intensive care unit or hospital length of stay, or cost-per-case; payment-per-case and contribution-margin-per-case both decreased significantly. CONCLUSIONS: The ECMO Collaborative Project improved survival to discharge/transfer, weaning rates and complications, without additional costs, through coordination and standardization across ECMO programs within a health care system.

Observed elevated donor-derived cell free DNA in orthotopic heart transplant recipients without clinical evidence of rejection.

Donor-derived cell free DNA (dd-cfDNA) has rapidly become part of rejection surveillance following orthotopic heart transplantation. However, some patients show elevated dd-cfDNA without clinical evidence of rejection. With the aim to provide a clinical description of this subpopulation, we retrospectively analyzed 35 cardiac transplant recipients at our center who experienced elevated (≥.20%) dd-cfDNA in the absence of clinical rejection, out of a total 106 recipients who had dd-cfDNA results available during the first year. The median time to first elevated dd-cfDNA level was 46 days, and the highest dd-cfDNA recorded within 1 year was .31% [inter-quartile range, .23-.45]. Twenty-two (63%) patients experienced infections (cytomegalovirus (CMV) or other), and 16 (46%) presented with de novo donor-specific antibodies. Cluster analysis revealed four distinct groups characterized by (a) subclinical rejection with 50% CMV (n = 16), (b) non-CMV infections and the longest time to first elevated dd-cfDNA (187 days) (n = 8), (c) right ventricular dysfunction (n = 6), and (d) women who showed the youngest median age (45 years) and highest median dd-cfDNA (.50%) (n = 5). Continued prospective analysis is needed to determine if these observations warrant changes in patient management to optimize the utilization of this vital non-invasive graft surveillance tool.

Distal Versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention: Design and Rationale of the DIPRA Trial.

BACKGROUND: Radial artery (RA) catheterization is the access of choice over femoral artery access for most interventional vascular procedures given its safety and faster patient recovery. There has been growing interest in distal radial artery (dRA) access as an alternative to the conventional proximal radial artery (pRA) access. Preserving the RA is important which serves as a potential conduit for future coronary artery bypass surgery, dialysis conduit or preserve the artery for future cardiovascular procedures. The dRA runs in close proximity to the radial nerve, which raises the concern of potential detrimental effects on hand function. STUDY DESIGN: The Distal versus Proximal Radial Artery Access for cardiac catheterization and intervention (DIPRA) trial is a prospective, randomized, parallel-controlled, open-label, single center study evaluating the outcomes of hand function and effectiveness of dRA compared to pRA access in patients undergoing cardiac catheterization. The eligible subjects will be randomized to dRA and pRA access in a (1:1) fashion. The primary end point is an evaluation of hand function at one and twelve months follow-up. Secondary end points include rates of access site hematoma, access site bleeding, other vascular access complications, arterial access success rate, and RA occlusion at one and twelve months follow up. CONCLUSION: Effects of dRA on hand function remains unknown and it's use questionable in the presence of a widely accepted pRA. DIPRA trial is designed to determine the safety and effectiveness of dRA for diagnostic and interventional cardiovascular procedures compared to the standard of care pRA.