Blood type O heart transplant candidates have longer waitlist time and higher delisting under the new allocation system.

OBJECTIVE: Prior studies have examined the effect of blood type on heart transplantation (HTx) waitlist outcomes in cohorts through 2015. We aim to analyze the effect of blood type on contemporary waitlist outcomes with a new allocation system focus. METHODS: Adults listed for HTx between April 2015 and December 2020 were included. Survival to HTx and waitlist death/deterioration was compared between type O and non-type O candidates using competing risks regression. Donor/recipient ABO compatibility trends were further investigated. RESULTS: Candidates with blood type O (n = 7509) underwent HTx less frequently than candidates with blood type other than type O (n = 9699) (subhazard ratio [sHR], 0.56; 95% CI, 0.53-0.58) with higher rates of waitlist death/deterioration (sHR, 1.18; 95% CI, 1.04-1.34). Subgroup analyses demonstrated persistence of this trend under the new donor heart allocation system (HTx: sHR, 0.58; 95% CI, 0.54-0.62; death/clinical deterioration: sHR, 1.27; 95% CI, 1.02-1.60), especially among those listed at high status (1, 2, or 3) (HTx: sHR, 0.69; 95% CI, 0.63-0.75; death/deterioration: sHR, 1.61; 95% CI, 1.16-2.22). Among those listed at status 3, waitlist death/deterioration was modified by presence of a durable left ventricular assist device (left ventricular assist device: sHR, 1.57; 95% CI, 0.58-4.29; no left ventricular assist device: sHR, 3.79; 95% CI, 1.28-11.2). Type O donor heart allocation to secondary ABO candidates increased in the new system (14.5% vs 12.0%; P < .01); post-HTx survival remained comparable between recipients with blood type O and non-type O (log-rank P = .07). CONCLUSIONS: Further logistical considerations are warranted to minimize allocation inequity regarding blood type under the new allocation system.

Total ventricular mass oversizing +50% or greater was a predictor of worse 1-year survival after heart transplantation.

OBJECTIVES: Current donor-recipient size matching guidelines rely primarily on body weight, with no specified oversizing cutoff values. Recent literature has explored predicted total ventricular mass matching over body weight matching. We aim to explore the impact of total ventricular mass oversizing on heart transplant outcomes. METHODS: The United Network for Organ Sharing database was queried for adults who underwent primary heart transplant from 1997 to 2017. By using validated equations, donor-recipient total ventricular mass mismatch was calculated. Donor-recipient pairs were divided into 3 groups by total ventricular mass mismatch. Post-heart transplant 1-year survival was analyzed using the Kaplan-Meier method and Cox proportional hazards models. We also investigated post-heart transplant complications, independent predictors for mortality, donor-recipient sex mismatch, and donor-recipient body habitus in total ventricular mass mismatch greater than +50%. RESULTS: A total of 34,455 donor-recipient pairs were included. Fractional polynomial regression demonstrated increased the risk of mortality with higher total ventricular mass mismatch. Total ventricular mass mismatch of +48.3% maximized the Youden Index. Donor-recipient pairs were subsequently grouped by total ventricular mass mismatch as -20% to +30%, +30% to +50%, and greater than +50%. Total ventricular mass mismatch greater than +50% was an independent risk factor for 1-year mortality (hazard ratio, 1.40, P = .004) and was associated with increased postoperative stroke (P = .002). Some 80.3% of these recipients were smaller female patients with male donors. Total ventricular mass mismatch from +30% to +50% was not associated with worse survival (P = .17). CONCLUSIONS: Total ventricular mass mismatch greater than +50% is associated with worse 1-year survival, although this group comprises a small portion of heart transplant. total ventricular mass mismatch from +30% to +50% is not associated with worse survival. These outcomes should be considered in selecting donors and in efforts to expand the potential donor pool.

Trends in Outcomes of Heart Transplants Using Extended Criteria Donors: A United Network for Organ Sharing Database Analysis.

BACKGROUND: Although the use of extended criteria donors (ECDs) is traditionally avoided because of poorer outcomes, management of heart transplant (HTx) recipients has evolved over the past decades. We sought to examine the temporal trends in outcomes of ECDs in HTx. METHODS: We queried the United Network for Organ Sharing database for adult HTx recipients who fit the EXPAND Trial criteria for ECDs: ischemic time ≥ 4 hours, ejection fraction < 50%, age > 55 years, and history of coronary artery disease. Transplant years were stratified into the following 4 periods: (1) 2000 to 2004, (2) 2005 to 2009, (3) 2010 to 2014, and (4) 2014 to 2018. The 2-sample t test, Kaplan-Meier survival analysis, log-rank test, analysis of variance, multivariable Cox proportional hazards, and multinomial logistic regression were used to compare data between periods. RESULTS: Through periods 1 to 4, 39,028 patients were stratified as follows: 9217 (2942 ECDs, 31.9%), 9224 (2730 ECDs, 29.6%), 10,309 (2762 ECDs, 26.8%), and 10,278 (2190 ECDs, 21.3%). Transplants using ECDs in periods 1 and 2 had increased 1-year mortality compared with periods 3 and 4 (16.9% and 15.6% vs 11.9% and 10.9% respectively, P < .001). Later periods also demonstrated improved Karnofsky scores (P < .001). CONCLUSIONS: Although use of ECDs decreased across the periods, we noted significant improvement in 1-year survival rates and postoperative functional status.

Geographic Variation in Heart Transplant Extended Criteria Donors in the United States.

BACKGROUND: Recent research has explored the use of higher risk extended criteria donors (ECDs) as a means of expanding the donor pool for heart transplantation. Here we sought to explore the current geographic distribution and survival outcomes of ECD utilization in various regions across the United States. METHODS: The United Network for Organ Sharing database was retrospectively queried for adult primary heart transplantation from 2000 to 2019. The EXPAND trial definition of ECD was used: ischemic time ≥ 4 hours, ejection fraction < 50%, age > 55 years, and history of coronary artery disease. Geographic data and 2019 population estimates were obtained from the US Census Bureau. RESULTS: Of the 42 642 transplants included in our analysis, 11 750 (27.6%) used ECDs. Region utilization of ECDs ranged from 18.4% to 46.5% of transplants. Region 6 had the highest utilization rate at 46.5%; this was primarily driven by the number of transplants with ischemic time ≥ 4 hours. Region 6 encompasses the largest total area (1.08 million square miles) and smallest population density (15.6 people per square mile). Region 8 had the lowest marginal donor utilization rate at 18.4%. Regions with high utilization of low ejection fractions, older donors, and donors with coronary artery disease (ie, regions 1 and 2) were able to maintain an average utilization rate of ECDs by maintaining short ischemic times. CONCLUSIONS: Large discrepancies in the use of ECDs exist across the different United Network for Organ Sharing regions. This is primarily driven by longer ischemic times, likely guided by variance in population densities between different regions.

Interaction between ischemic time and donor age under the new donor heart allocation system: Effect on post-transplant survival.

BACKGROUND: Ischemic time (IT) under the new heart transplant (HTx) allocation system has increased compared to the old system. We investigated the effect of IT and donor age on post-HTx survival. METHODS: The United Network for Organ Sharing (UNOS) database was analyzed to identify adult HTx between October 2015 and August 2020. Recipients were stratified by donor age, transplantation era, and IT. Kaplan-Meier and log-rank tests were used to compare 180-day post-HTx mortality. Cox proportional hazards modeling and propensity score matching were performed to adjust for confounders. RESULTS: Under the new system (N = 3654), IT≥4 h led to decreased survival compared to IT < 4 h (91.4% vs. 93.7%; P = .02), although this decrease was undetectable among those with donors ≥39 years old (90.4% vs. 91.1%; P = .73). IT≥4 h led to decreased survival with donors < 39 years old (91.7% vs. 94.6%; P < .01). Under the old system (N = 5987), IT≥4 h resulted in decreased survival (89.8% vs. 93.9%; P < .01), including with donors ≥39 years old (86.9% vs. 92.4%; P < .01). CONCLUSIONS: IT≥4 h remains a risk for post-HTx mortality under the new system. However, the magnitude of this effect is blunted when donor age is ≥39 years, likely secondary to increased allocation of these organs to lower status, more stable recipients.

Prolonged waitlisting is associated with mortality in extracorporeal membrane oxygenation-supported heart transplantation candidates.

Objective: Heart transplantation (HTx) candidates supported with venoarterial extracorporeal membrane oxygenation (ECMO) may be listed at highest status 1 but are at inherent risk for ECMO-related complications. The effect of waitlist time on postlisting survival remains unclear in candidates with ECMO support who are listed using the new allocation system. Methods: Adult candidates listed with ECMO for a first-time, single-organ HTx from October 18, 2018, to March 21, 2021, in the Scientific Registry of Transplant Recipients database were included and stratified according to waitlist time (≤7 vs ≥8 days). Postlisting outcomes were compared between cohorts. Results: Among 175 candidates waitlisted for ≤7 days, 162 (92.6%) underwent HTx whereas 13 (7.4%) died/deteriorated compared with 41 (57.8%) and 21 (29.6%) of the 71 candidates waitlisted for ≥8 days, respectively (P < .01). Blood type O candidates (odds ratio [OR], 2.94; 95% CI, 1.54-5.61) were more likely to wait ≥8 days whereas candidates with concurrent intra-aortic balloon pump were less likely (OR, 0.30; 95% CI, 0.10-0.89). Obesity was additionally associated among those listed at status 1 (OR, 2.04; 95% CI, 1.00-4.17). Waitlisting for ≥8 days was independently associated with 90-day postlisting mortality conditional on survival to day 8 postlisting (hazard ratio, 5.59; 95% CI, 2.59-12.1). Candidates listed at status 1 showed similar trends (hazard ratio, 5.49; 95% CI, 2.39-12.6). There was no significant difference in 90-day post-HTx survival depending on whether a candidate waited for ≥8 days versus ≤7 days (92.7 vs 92.0%; log rank P = .87). Conclusions: Among ECMO-supported candidates, obtaining HTx within 1 week of listing might improve overall survival.

Durable Left Ventricular Assist Device as a Bridge to Heart Transplantation Under the New Donor Heart Allocation System.

The new donor heart allocation system prioritizes candidates supported by temporary devices. However, waitlist and posttransplant outcomes in candidates with durable left ventricular assist device (LVAD) remain to be elucidated. The United Network for Organ Sharing database was queried for adults listed from October 2015 to March 2020 for a single-organ, first-time heart transplant (HTx) with a durable LVAD. Waitlist removal within 1 year because of death or clinical deterioration and HTx was analyzed using competing risks regression. Candidates who underwent HTx within 1 year of listing were identified for examination of post-HTx survival using the Kaplan-Meier method and Cox proportional hazards models. Compared with candidates listed under the old system (n = 2,122), candidates listed under the new system (n = 1,562) were slightly younger ( p = 0.04) but had higher body mass index ( p < 0.01). Those listed under the new system were significantly less likely to experience waitlist removal because of death or clinical deterioration (subhazard ratio [HR] 0.68, 95% CI 0.52-0.90) but were also less likely to undergo HTx (sub-HR 0.91, 95% CI 0.83-0.998). Those who survived to HTx were more likely to experience death or need for re-HTx within 1 year of HTx under the new system (adjusted HR 1.50, 95% CI 1.11-2.03). Candidates with durable LVAD experience favorable waitlist outcomes under the new allocation system, although those who undergo HTx may be at increased mortality risk. Thus, candidates with a durable LVAD should be carefully selected for HTx listing under the new allocation system.

Microaxial Left Ventricular Assist Device Versus Intraaortic Balloon Pump as a Bridge to Transplant.

BACKGROUND: Heart transplantation (HTx) candidates supported by Impella (Abiomed, Danvers, MA) or intraaortic balloon pump (IABP), who demonstrate evidence of cardiogenic shock, may qualify for waitlist status 2 without exception under the new donor heart allocation system. However limited data comparing Impella versus IABP as a bridge to HTx exist. METHODS: The United Network for Organ Sharing database was queried for adults listed and/or transplanted between January 2014 and February 2020. Temporal trends regarding Impella and IABP use were analyzed using the Royston trend test and χ2 test. Waitlist mortality was examined using Fine-Gray competing risks analysis. Post-HTx 180-day survival was analyzed using the Kaplan-Meier method and Cox proportional hazards models. RESULTS: Impella use increased from 0.2% in 2014 to 2.6% in 2020 (P < .01) and from 0.4% to 2.2% (P < .01) under the new allocation system. IABP use increased from 4.9% in 2014 to 27.6% in 2020 (P < .01) and from 6.7% to 26.6% (P < .01) under the new allocation system. Post-HTx survival was similar between groups (adjusted hazard ratio, 0.82; 95% CI, 0.38-1.78) despite more preoperative ventilation (3.6% vs 1.1%, P = .01) and higher model for end-stage liver disease excluding international normalized ratio scores (12.4 vs 9.5, P < .01) among Impella-supported recipients. Under the new system Impella-supported candidates were at higher risk of waitlist delisting compared with IABP-supported candidates (subhazard ratio, 2.42; 95% CI, 1.19-4.92). CONCLUSIONS: Post-HTx survival is comparable between Impella-supported and IABP-supported recipients despite worse preoperative profiles among Impella-supported recipients. Higher risk of waitlist delisting among Impella-supported candidates under the new allocation system requires close attention.

Bridging With Extracorporeal Membrane Oxygenation Under the New Heart Allocation System: A United Network for Organ Sharing Database Analysis.

BACKGROUND: The effect of the new donor heart allocation system on survival following bridging to transplantation with venous-arterial extracorporeal membrane oxygenation remains unknown. The new allocation system places extracorporeal membrane oxygenation-supported candidates at the highest status. METHODS: The United Network for Organ Sharing database was queried for adults bridged to single-organ heart transplantation with extracorporeal membrane oxygenation from October 2006 to February 2020. Association between implementation of the new system and recipient survival was analyzed using Kaplan-Meier estimates, Cox proportional hazards models, and propensity score matching. RESULTS: Of 364 recipients included, 173 and 191 were transplanted under new and old systems, respectively. Compared with the old system, waitlist time was halved under the new system (5 versus 10 days, P<0.01); recipients also demonstrated lower rates of prior cardiac surgery (32.9% versus 44.5%, P=0.03) and preoperative ventilation (30.6% versus 42.4%, P=0.02). Unadjusted 180-day survival was 90.2% (95% CI, 84.7%-94.2%) and 69.6% (95% CI, 62.6%-76.1%) under the new and old systems, respectively. Cox proportional hazards analysis demonstrated listing and transplantation under the new system to be an independent predictor of post-transplant survival (adjusted hazard ratio, 0.34 [95% CI 0.20-0.59]). Propensity score matching demonstrated a similar trend (hazard ratio, 0.36 [95% CI, 0.19-0.66]). Candidates listed under the new system were significantly less likely to experience waitlist mortality or deterioration (subhazard ratio, 0.38 [95% CI, 0.25-0.58]) and more likely to survive to transplant (subhazard ratio, 4.29 [95% CI, 3.32-5.54]). CONCLUSIONS: Recipients transplanted following extracorporeal membrane oxygenation bridging to transplantation under the new system achieve greater 180-day survival compared with the old and demonstrate less preoperative comorbidity. Waitlist outcomes have also improved significantly under the new allocation system.

Left thoracotomy vs full sternotomy for centrifugal durable LVAD implantation: 1-year outcome comparison post-LVAD and post-heart transplantation.

Left ventricular assist device (LVAD) implantations have traditionally been approached through a full median sternotomy (FS). Recently, a minimally invasive left thoracotomy (LT) approach has been popularized. This study sought to compare the outcomes of FS and LT patients post-primary LVAD implantation and post-subsequent heart transplant (HT). This was a single-center retrospective study. 83 patients who underwent primary centrifugal durable LVAD implantation from January 2014 to June 2018 were included (FS, n = 41; LT, n = 42). 41 patients had a subsequent HT (FS, n = 19; LT, n = 22). Pre-operative patient demographics, intraoperative variables, post-operative 1-year survival, length of hospital stay, complications, and outcomes for LVAD implantation and following HT were analyzed. Intraoperative data showed that the LT group had a 23.4% longer mean LVAD implant surgical time (p < 0.01). One-year post-LVAD survival was similar between the two groups (p = 0.05). Complication rates, with the exception of the rate of hemorrhagic stroke (p = 0.04) post-LVAD implant were similar. One-year survival post-HT was similar between groups (p = 0.35). Complication rates and mean length of hospital stay were also similar (p = 1.0) post-HT. Our study demonstrated that LT approach does not negatively affect post-LVAD implantation or post-HT outcomes. Further, larger studies may determine more detailed effects of LT approach.

Right ventricular undersizing is associated with increased 1-year mortality.

OBJECTIVES: Right heart hemodynamic management is critical, because many post-heart transplantation (HTx) complications are related to right ventricular (RV) failure. However, current guidelines on size and sex matching rely primarily on weight matching, with recent literature using total ventricular mass (TVM), which places less emphasis on the impact of RV mass (RVM) matching. The aim of the present study was to analyze the relationship of RVM matching and survival after HTx. METHODS: We performed the retrospective analysis using the UNOS database of adult HTx performed between January 1997 and December 2017. Previously validated equations were used to calculate TVM and RVM. The percent difference in ventricular mass in the donor and recipient pair was used for the size mismatch. All donor-recipient pairs were divided into 4 RVM groups by their mismatch ratio. We analyzed RVM matching and explored how RVM undersizing impacted outcomes. The primary outcome measure was 1-year survival; secondary outcomes measured included stroke and dialysis within 1 year and functional status. RESULTS: A total of 38,740 donor-recipient pairs were included in our study. The 4 RVM match groupings were as follows: <0%, 0% to 20%, 20% to 40%, and >40%. Utilization of donors who were older and of female sex resulted in greater RVM undersizing. Survival analysis demonstrated patients with RVM undersizing had worse 1-year survival (P < .001). RVM undersizing was an independent predictor of higher 1-year mortality (hazard ratio, 1.23; 95% confidence interval, 1.11 to 1.34; P < .001). RVM undersizing was also associated with higher rates of dialysis within 1-year of transplantation and poorer postoperative functional status. CONCLUSIONS: RVM undersizing is an independent predictor for worse 1-year survival. Donors who are older and female have lower absolute predicted RVM and may be predisposed to RVM undersizing. RVM-undersized transplantation requires careful risk/benefit considerations.

Continuous-Flow Left Ventricular Assist Device Therapy in Adults with Transposition of the Great Vessels.

An increasing number of children with congenital heart disease are surviving into adulthood and subsequently developing end-stage heart failure. Two example populations are adults who have been previously operated on for congenitally corrected transposition of the great arteries (CCTGA) and transposition of the great arteries (TGA). Implantation of a continuous flow left ventricular assist device (CF-LVAD) in these patients can present unusual anatomical and physiologic challenges. In this report, we describe outcomes of CF-LVAD implantation in three such patients. These cases demonstrate the feasibility of implanting a CF-LVAD in patients who have undergone surgery for CCTGA and/or TGA.

Gastrointestinal Bleeding After HeartMate II or HVAD Implantation: Incidence, Location, Etiology, and Effect on Survival.

The number of patients on destination therapy is increasing as long-term survival on continuous-flow left ventricular assist device (CF-LVAD) therapy has improved. Gastrointestinal bleeding (GIB) is a common complication after CF-LVAD implantation, and its risk correlates with longer support time, emphasizing the importance of GIB management. The lower pulsatility of CF-LVADs may promote arteriovenous malformations, which amplify the bleeding risk. Here, we retrospectively analyzed the location, incidence, and survival effect of GIB events in HeartMate II (HM-II) and HeartWare Ventricular Assist Device (HVAD) recipients to provide specific details regarding these complications. From November 2003 to March 2016, 526 patients with chronic heart failure underwent primary implantation of an HM-II (n = 403) or HVAD (n = 123) CF-LVAD at our center. Of the 526 patients, 140 (26.6%) had a GIB event (HM-II: n = 100; HVAD: n = 40), 92 (17.5%) had a single GIB event, and 48 (9.1%) had multiple GIB events (range: 2-9 events). HVAD recipients had a higher incidence of both upper and lower GIB events (p < 0.001 and P = 0.002, respectively) than HM-II recipients. Arteriovenous malformation was the most common etiology for GIB (50 patients/72 events); for this group, the average time-to-event was 300.4 days, the recurrence rate was 34%, and the 90-day and 1-year survival rates were 88.3% and 66.7%, respectively. Age at implantation was the only predictor of GIB. In conclusion, our study provides detailed information about GIB events associated with current CF-LVADs. Additional studies are required to evaluate strategies to reduce the incidence of GIB morbidity.

Accuracy of Postoperative Risk Scores for Survival Prediction in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 Continuous-Flow Left Ventricular Assist Device Recipients.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.

Neurologic complications after the frozen elephant trunk procedure: A meta-analysis of more than 3000 patients.

OBJECTIVE: The frozen elephant trunk technique's safety regarding spinal cord ischemia has been questioned. We used a meta-analysis to determine the rates of adverse neurologic events and mortality. METHODS: We searched PubMed/Medline, Embase, Scopus, and Cochrane databases (inception to April 2018) to identify studies of neurologic events after the frozen elephant trunk procedure. Separate meta-analyses were conducted with random-effects models to assess frozen elephant trunk associations with spinal cord ischemia, stroke, operative mortality, and all adverse events combined. Subgroup analyses compared outcomes in patients with acute versus nonacute type A dissection and aneurysm and with different extents of coverage. RESULTS: Thirty-five studies (total N = 3154) met inclusion criteria. The pooled rates of the outcomes of interest were 4.7% (95% confidence interval, 3.5-6.2) for spinal cord ischemia, 7.6% (95% confidence interval, 5.0-11.5) for stroke, and 8.8% (95% confidence interval, 7.0-10.9) for operative mortality. The spinal cord ischemia event rate was higher with stent length 15 cm or greater or coverage to T8 or beyond than with stent length of 10 cm (11.6% vs 2.5%, P < .001). Adverse event rates in patients with acute type A aortic dissection versus nonacute dissection or aneurysm were as follows: mortality 9.2% versus 7.6% (P = .46), stroke 9.3% versus 6.6% (P = .51), and overall adverse events 22.0% versus 16.5% (P = .41). CONCLUSIONS: As the frozen elephant trunk procedure becomes more popular, accurate data regarding outcomes are vital. We associated the frozen elephant trunk technique with (nonsignificantly) more adverse events overall in acute type A dissection cases. Stent length of 10 cm was associated with significantly less risk of spinal cord ischemia. Using a stent 15 cm or greater or coverage extending to T8 or farther should be avoided.

Device exchange from Heartmate II to HeartWare HVAD.

BACKGROUND: Despite technological advancements, pump durability and pump-related complications continue to affect and adversely impact the lives of patients with end-stage heart failure on left ventricular assist device (LVAD) support. In an attempt to avoid recurrent LVAD-related complications, there may be circumstances where it is clinically advantageous to exchange a patient's device from HeartMate II to HeartWare HVAD. However, there is a paucity of data that describes the safety and feasibility of such an approach. OBJECTIVE: We present the largest single-center series of HeartMate II (HMII) to HeartWare (HVAD) device exchanges. METHODS: A retrospective review of 11 patients who underwent HMII to HVAD exchange from 2012 to 2017 was conducted to evaluate patient characteristics, incidence of postoperative complications, and survival. RESULTS: Eleven male patients (mean age 55 ± 14.4 years) underwent HMII to HVAD device exchange. One patient expired on postoperative day 7 secondary to sepsis. One patient was lost-to-follow-up after 23 months. An additional three patients died at 5, 7, and 24 months. Mean follow-up after device exchange was 1555 ± 311 days for the remaining six patients. None of the 11 study patients underwent LVAD explant, further device exchange, or heart transplant. CONCLUSION: Exchange of an HMII LVAD to an HVAD can be performed safely with acceptable perioperative morbidity and mortality.

Concomitant valve procedures in patients undergoing continuous-flow left ventricular assist device implantation: A single-center experience.

OBJECTIVE: Long-term support with continuous-flow left ventricular assist devices (CF-LVADs) has improved the outcomes of patients with end-stage heart failure. However, valve disease management in patients who undergo CF-LVAD implantation remains controversial. The aim of this study was to assess our single-center experience with patients who underwent a concomitant valve procedure during implantation of a CF-LVAD. METHODS: From November 2003 through March 2016, 526 patients underwent primary CF-LVAD implantation with a HeartMate II (St Jude Inc, St Paul, Minn; n = 403) or HeartWare (Medtronic, Minneapolis, Minn; n = 123) device at our center. Of those, 91 underwent a concomitant valve procedure during implantation (CF-LVAD+valve procedure group), whereas 435 did not (CF-LVAD-only group). We compared preoperative characteristics and short-term and mid-term survival rates between these groups. RESULTS: The concomitant valve procedures performed included 13 tricuspid valve repairs, 19 aortic valve repairs or replacements, 30 mitral valve repairs or replacements, and 29 double valve repairs or replacements. Survival rates at 1 month, 6 months, 12 months, and 24 months were 90.3%, 81.4%, 74.9%, and 67.4%, respectively, for the CF-LVAD-only group and 89.0%, 75.8%, 70.3%, and 65.9%, respectively, for the CF-LVAD+valve procedure group (P = .55). The results of Cox regression multivariable modeling showed that performing a concomitant valve procedure was not an independent predictor of mortality (hazard ratio, 1.29; 95% confidence interval, 0.96-1.74; P = .08). CONCLUSIONS: In our experience, performing a concomitant valve procedure during CF-LVAD implantation was not associated with an increased mortality rate. The decision to perform a concomitant valve procedure should be made primarily on the basis of clinical indications for the procedure.

A left ventricular end-diastolic dimension less than 6.0 cm is associated with mortality after implantation of an axial-flow pump.

OBJECTIVE: The effects of having a lower left ventricular end-diastolic dimension before HeartMate II (Thoratec Corp, Pleasanton, Calif) left ventricular assist device implantation remain unclear. We analyzed our single-center data on HeartMate II implantation to determine whether having a lower left ventricular end-diastolic dimension preoperatively was associated with inferior outcomes. METHODS: From November 2003 to March 2016, 393 patients with chronic heart failure underwent primary HeartMate II implantation. We compared the preoperative left ventricular end-diastolic dimension and associated survival outcomes of these patients to determine the left ventricular end-diastolic dimension cutoff for worse overall survival. Then, we compared the preoperative demographics, stroke rate, and mortality of patients with a left ventricular end-diastolic dimension above the cutoff for worse survival with those of patients with a left ventricular end-diastolic dimension below the cutoff. RESULTS: A Cox multivariate regression model showed that low left ventricular end-diastolic dimension was an independent predictor of mortality (hazard ratio, 1.49; P = .02). The Contal and O'Quigley method showed that overall survival postimplantation was decreased in patients with a left ventricular end-diastolic dimension less than 6.0 cm (n = 91). Kaplan-Meier analysis confirmed that the left ventricular end-diastolic dimension less than 6.0 cm group had lower overall survival than the left ventricular end-diastolic dimension 6.0 cm or greater group (P = .04). Furthermore, a competing-risk analysis showed that postoperative stroke was more common in the left ventricular end-diastolic dimension less than 6.0 cm group than in the left ventricular end-diastolic dimension 6.0 cm or greater group (P < .01). CONCLUSIONS: Overall survival was decreased and postoperative stroke was increased in HeartMate II recipients with a preoperative left ventricular end-diastolic dimension less than 6.0 cm. Future research should determine the left ventricular end-diastolic dimension cutoff values for safely implanting other support devices, and device designs should be improved to better accommodate the needs of patients with a limited left ventricle size.

Effect of concomitant mitral valve procedures for severe mitral regurgitation during left ventricular assist device implantation.

The effect of performing a concomitant mitral valve procedure (MVP) during continuous-flow left ventricular assist device (CF-LVAD) implantation has been reported for patients with moderate-to-severe mitral regurgitation (MR), but moderate MR is less of a clinical concern for CF-LVAD patients. There is a paucity of reports focusing on patients with severe MR. Thus, the purpose of this study was to analyze the effect of performing a concomitant MVP during CF-LVAD implantation in patients with severe preoperative MR. Between November 2003 and March 2016, 526 patients underwent primary implantation of a CF-LVAD at our center. Patients with severe MR who underwent a concomitant MVP were compared to those who did not in regard to overall survival, perioperative complications, postoperative echocardiography data, bridge-to-transplantation success, and CF-LVAD explantation. Of the 108 patients with severe MR, 26 underwent a concomitant MVP and 82 did not. These groups showed no difference in survival (p = 0.61). Additionally, the two groups had similar rates of postoperative right heart failure (p = 0.69) and readmissions (p = 0.42). The 24-month follow-up echocardiography results were also similar. Furthermore, the groups showed no difference in bridge-to-cardiac transplantation success (30.0% vs 25.0%, p = 0.80) or CF-LVAD explantation rates (0.0% vs 0.0%. p = 1.0). Our findings suggest that patients with severe MR who undergo a MVP during CF-LVAD implantation do not have superior outcomes to those who do not. However, assessments of other outcomes may show some benefits to performing concomitant MVPs.