Hepatitis B in Heart Transplant Donors and Recipients: A Systematic Review and Meta-Analysis.

INTRODUCTION: Expanding the heart donor pool to include patients with hepatitis B virus (HBV) could help ameliorate the organ shortage in heart transplantation. We performed a systematic review and meta-analysis to evaluate the management and recipient outcomes of D+/R- and D-/R+ heart transplants. METHODS: An electronic search was performed to identify all relevant studies published on heart transplants involving HBV+ donors and/or HBV+ recipients. A comparison was performed between two groups where heart transplants were performed a) D+/R- (n = 98) versus b) D-/R+ (n = 65). RESULTS: Overall, 13 studies were selected, comprising 163 patients. Mean patient age was 55 y (95% CI: 39, 78) and 79% (69, 86) were male. Active post-transplant HBV infection requiring antiviral treatment occurred in 11% (1, 69) of D+/R- recipients and 33% (9, 71) of D-/R+ recipients. Post-transplant antiviral therapy was given to 80% (6, 100) of D+/R- recipients compared to 72% (42, 90) of D-/R+ recipients (P = 0.84). Hepatitis-related mortality was observed in no D+/R- recipients and 7% (2, 27) of D-/R+ recipients. Survival 1-y post-transplant was comparable between both groups at 83% (83, 92) and 81% (61, 92) for D+/R- and D-/R+ transplants, respectively. CONCLUSIONS: Our review found that HBV D+/R- heart transplantation was associated with fewer active hepatitis infections and lower hepatitis-related mortality than D-/R+ transplantation, with comparable survival at 1 y. Additional studies utilizing HBV nucleic acid testing (NAT) to compare outcomes with HBsAg+ and anti-HBc+ donors are crucial to reach more definitive conclusions about the risk of donor-derived infections in this context.

Continuous-flow left ventricular assist devices associated survival awaiting heart and heart-kidney transplant.

BACKGROUND: Improvement in continuous-flow left ventricular assist device (CF-LVAD) technology has translated to better outcomes for patients on CF-LVAD support as a bridge-to-transplant. However, data are lacking regarding the subset of CF-LVAD patients with renal failure awaiting simultaneous heart-kidney transplant (HKTx). We sought to better understand the characteristics and outcomes of patients in this group. METHODS: The United Network for Organ Sharing (UNOS) database was used to identify adult patients listed for heart transplant (HTx) or HKTx from January 1, 2009 to March 31, 2017. Patients were followed from time on waitlist to either removal from waitlist or transplantation. Demographic and clinical data for HTx and HKTx patients were assessed. Kaplan-Meier analysis assessed waitlist and post-transplant survival. For waitlisted patients, both death and removal from the waitlist due to deteriorating medical condition were considered events. RESULTS: Overall, 26 638 patients registered for transplant were analyzed. 25 111 (94%) were listed for HTx, and 1527 (6%) for HKTx. 7683 (29%) patients listed for HTx had CF-LVAD support. For those listed for HKTx, 441 (28%) underwent dialysis alone, 256 (17%) had CF-LVAD support alone, and 85 (6%) were treated with both CF-LVAD and dialysis. 15 567 (58%) underwent HTx, and 621 (2%) underwent HKTx. In these groups, post-transplant survival was similar (p = 0.06). Patients listed for HKTx treated with both dialysis and CF-LVAD had significantly worse waitlist survival compared to HKTx recipients (p < 0.001). CONCLUSION: Post-transplant survival is comparable between HTx and HKTx, and early survival is similar between HTx patients and those listed for HTx with CF-LVAD support. However, outcomes on the waitlist for HKTx in CF-LVAD patients on dialysis is significantly worse compared to HKTx recipients. This highlights the need to better account for this patient population when allocating organs.

Utilization and outcomes of V-AV ECMO: A systematic review and meta-analysis.

BACKGROUND: Veno-arterial-venous extracorporeal membrane oxygenation (V-AV ECMO) is a less commonly used configuration of ECMO. We sought to understand the indications, utilization patterns, and outcomes of V-AV ECMO by quantitatively pooling the existing evidence from the literature. METHODS: Electronic search was performed to identify all relevant studies reporting V-AV ECMO usage. Five studies comprising 77 patients were selected and cohort-level data were extracted for further analysis. RESULTS: Mean patient age was 61 (95% CI: 55.2, 66.5) years and 30% (23/77) were female. The majority of cases [91% (70/77)] were transitioned to V-AV ECMO from another pre-existing ECMO configuration: V-A ECMO in 55% (42/77) vs. V-V ECMO in 36% (28/77), p = 0.04. Only 9% (7/77) of cases were directly placed on V-AV ECMO. The mean duration of hospital stay was 42.3 (95% CI: 10.5, 74.2) days, while ICU mortality was 46% (29, 64). Transition to durable left ventricular assist device was performed in 3% (2/64) of patients, while 3% (2/64) underwent heart transplantation. V-AV ECMO was successfully weaned to explantation in 33% (21/64) of patients. CONCLUSION: V-AV ECMO is a viable option for optimizing cardiopulmonary support in selected patients. Survival to weaning or bridging therapy appears comparable to more common ECMO configurations.

Evaluation of donor heart for transplantation.

Cardiac transplantation is considered the gold-standard treatment option for patients suffering from end-stage heart failure refractory to maximum medical therapy. A major determinant of graft function and recipient survival is a comprehensive evaluation of the donor allograft. Challenges arise when designing and implementing an evidence-based donor evaluation protocol due to the number of influential donor-specific characteristics and the complex interactions that occur between them. Here, we present our systematic approach to donor evaluation by examining the impact that relevant donor variables have on graft function and recipient outcomes.

Outcomes of percutaneous temporary biventricular mechanical support: a systematic review.

Percutaneous biventricular assist devices (BiVAD) are a recently developed treatment option for severe cardiogenic shock. This systematic review sought to identify indications and outcomes of patients placed on percutaneous BiVAD support. An electronic search was performed to identify all appropriate studies utilizing a percutaneous BiVAD configuration. Fifteen studies comprising of 20 patients were identified. Individual patient survival and outcomes data were combined for statistical analysis. All 20 patients were supported with a microaxial LVAD, 12/20 (60%) of those patients were supported with a microaxial (RMA) right ventricular assist device (RVAD), and the remaining 8/20 (40%) patients were supported with a centrifugal extracorporeal RVAD (RCF). All patients presented with cardiogenic shock, and of these, 12/20 (60%) presented with a non-ischemic etiology vs 8/20 (40%) with ischemic disease. For the RMA group, RVAD support was significantly longer [RMA 5 (IQR 4-7) days vs RCF 1 (IQR 1-2) days, p = 0.03]. Intravascular hemolysis post-BiVAD occurred in three patients (27.3%) [RMA 3 (33.3%) vs RCF 0 (0%), p = 0.94]. Five patients received a durable left ventricular assist device, one patient received a total artificial heart, and one patient underwent a heart transplantation. Estimated 30-day mortality was 15.0%, and 78.6% were discharged alive. Both strategies for percutaneous BiVAD support appear to be viable options for severe cardiogenic shock.

Cardiac transplantation after heparin-induced thrombocytopenia: A systematic review.

PURPOSE: Heparin-induced thrombocytopenia (HIT) presents a unique challenge in patients requiring orthotopic heart transplantation (OHT). We sought to pool the existing evidence in a systematic review. METHODS: Electronic search was performed to identify all relevant studies on OHT in patients with HIT. Patient-level data for 33 patients from 21 studies were extracted for statistical analysis. RESULTS: Median patient age was 51 [IQR 41, 55] years, with 75.8% (25/33) males. All patients had a clinical diagnosis of HIT, and anti-PF4/Heparin antibodies were positive in 87.9% (29/33). Median lowest reported platelet count was 46 × 109 /L [27.2, 73.5]. Intraoperatively, 61% (20/33) of patients were given unfractionated heparin (UFH), while 39% (13/33) were given alternative anticoagulants. The alternative agent subgroup required more antifibrinolytics [54% (7/13) vs 10% (2/20), P = .02] and clotting factors [69.2% (9/13) vs 15.0% (3/20), P < .01]. Perioperative thrombosis occurred more [53.8% (7/13) vs 0% (0/20, P < .01) in alternate agent subgroup. More patients in the alternate agent subgroup required post-operative transfusions [54% (7/13) vs 0% (0/20), P < .01]. Thirty-day mortality of 15.2% (5/33) was comparable between the subgroups. CONCLUSION: Heparin use during OHT may be associated with less adverse effects compared to use of other anticoagulants with no difference in 30-day mortality.

Impact of mechanical circulatory support on donor heart allocation: past, present, and future.

The United Network for Organ Sharing (UNOS) recently revised its heart allocation policy to address numerous shortcomings of the previous system. Implemented in 2018, the changes sought to reduce waiting list mortality, clearly define urgency status based on objective physiologic variables, decrease exemption requests, and introduce geographic modifications to ensure organ distribution favors the highest urgency candidates. In large part, UNOS policy revisions were driven by the growing use of continuous flow left ventricular assist devices (CF-LVADs) and the relevant device complications that led to an unacceptably high number of status exemptions. The new 6-tiered system assigns a comparatively lower urgency status to patients supported on CF-LVADs and higher urgency to patients supported on short-term mechanical circulatory assist (MCA) such as extracorporeal membrane oxygenation (ECMO) and intraaortic balloon pump (IABP) counterpulsation. LVAD use as bridge to transplant (BTT) therapy increased steadily throughout the preceding decade due to technological improvements and increased physician familiarity, but the recent policy changes introduce incentives for physicians to withhold this life-saving therapy in order to achieve higher urgency status for their patients. This paper will explore the technological evolution of MCA and the pertinent clinical trials that have led to their FDA approval as BTT and destination therapy. A review of the inception and development of the donor allocation system will be provided before examining available post-policy outcome data. Finally, we will highlight successes and shortcomings of the implemented changes before commenting on areas to potentially expand upon the existing policy.

Tricuspid regurgitation associated with implantable electrical device insertion: A systematic review and meta-analysis.

BACKGROUND: Implantable cardioverter defibrillator (ICD) and permanent pacemaker (PPM) lead placement may worsen or result in tricuspid regurgitation (TR). While the association between lead placement and the incidence of TR has been established, current understanding of this problem remains incomplete. This systematic review and meta-analysis sought to pool the existing evidence to better understand the occurrence and severity of TR associated with cardiac implantable electrical device (CIED) insertion. METHODS: An electronic search was performed to identify all relevant studies published from 2000 to 2018. Overall, 15 studies were selected for the analysis comprising 4019 patients with data reported on TR development following ICD or PPM lead placement. Demographic information, perioperative clinical variables, and clinical outcome measures, including pre and postoperative echocardiographic TR grade changes, were extracted and pooled for systematic review. RESULTS: Mean patient age was 69 years [95% CI: 64.62-73.59], and 63% [95% CI: 57-68] were male. Devices implanted included ICD in 57% [95%CI: 43-70] and PPM in 41% [95%CI: 31-52]. The most common indications for pacemaker implantation were sick sinus syndrome in 22% [95% CI: 22-37] and AV block in 21% [95%CI:12-34. The commonest indications for ICD implantation were primary and secondary prevention of sudden cardiac death. Atrial fibrillation was present in 37% [95%CI: 28-46] and congestive heart failure in 15% [95%CI: 2-57]. Baseline distribution of TR grades were as follows: grade 0/1 TR in 89% [95%CI: 82-93], grade 2 TR in 8% [95%CI: 5-13], grade 3 TR in 2% [95%CI: 0-7] and grade 4 TR in 2% [95%CI: 1-4]. Post-procedure, grade 0/ 1 TR decreased to 68% [95% CI: 51-81] (p < 0.01), grade 2 TR increased to 21% [15-28] (p < 0.01), grade 3 TR increased to 13% [95%CI: 5-32] (p = 0.02), and grade 4 TR increased to 7% [95%CI: 5-9] (p < 0.01). CONCLUSION: ICD and PPM lead placement is associated with increased TR post-procedure. Further studies are warranted to evaluate changes in TR grade in the long term.

Driveline damage and repair in continuous-flow left ventricular assist devices: A systematic review.

With mounting time on continuous-flow left ventricular assist device (CF-LVAD) support, patients occasionally sustain damage to the device driveline. Outcomes associated with external and internal driveline damage and repair are currently not well documented. We sought to evaluate the outcomes of driveline damage and its repair. Electronic search was performed to identify all relevant studies published over the past 20 years. Fifteen studies were selected for analysis comprising of 55 patients with CF-LVAD dysfunction due to driveline damage. Demographic and perioperative variables along with outcomes including survival rates were extracted and pooled for the systematic review. Most patients (53/55) were supported on HeartMate II LVAD (Abbott Laboratories, Abbott Park, IL). Internal damage was more commonly reported than external damage [69.1% (38/55) vs. 30.9% (17/55), P = .01]. Median time to driveline damage was 1.9 years [IQR 1.0, 2.5]. Most patients presented with a CF-LVAD alarm [94.5% (52/55)] and patients with internal driveline damage had a significantly higher rate of alarm activation compared to that observed for those with external damage [38/38 (100%) vs. 14/17 (82.4%), P = .04]. Patients with internal driveline dysfunction were more likely to experience component wear compared to those with external driveline dysfunction [10/38 (26.3%) vs. 0/17 (0%), P = .05]; 14.5% of patients (8/55) underwent external repair of the driveline, 5.5% (3/55) were treated with rescue tape, and 5.5% (3/55) were placed on an ungrounded cable, indicating a short-to-shield event had occurred. A total of 49.1% of patients (27/55) underwent CF-LVAD exchange, 5.5% (3/55) were weaned off the CF-LVAD to explant, and 5.5% (3/55) underwent emergent heart transplantation. The median length of hospital stay was 12 days [IQR 7, 12] and 30-day mortality rate was 14.5% (8/55). Driveline damage was more commonly reported at an internal location and despite being a well-recognized complication, mortality still appears high.

Utilization of extracorporeal life support for diffuse alveolar damage and diffuse alveolar hemorrhage: A systematic review.

Modern extracorporeal life-support (ECLS) technology has been successfully utilized to treat patients with diffuse alveolar damage (DAD) and diffuse alveolar hemorrhage (DAH); however, reports in the literature remain scarce. We sought to pool existing evidence to better characterize ECLS use in these patients. An electronic search was conducted to identify all studies in the English literature reporting the use of ECLS for DAD/DAH. Thirty-two articles consisting of 38 patients were selected, and patient-level data were extracted and pooled for analysis. Median patient age was 36 [IQR: 27, 48] years, and the majority (63.2%) were female. Most common etiological factors included granulomatosis with polyangiitis (8/38, 21.1%), systemic lupus erythematosus (8/38, 21.1%), Goodpasture's syndrome (4/38, 10.5%), and microscopic polyangiitis (4/38, 10.5%). Immunologic markers included anti-neutrophil cytoplasmic antibody (ANCA) in 15/38 (39.5%), anti-nuclear antibody (ANA) in 6/38 (15.8%), and anti-glomerular basement membrane (anti-GBM) antibodies in 4/38 (10.5%). DAH was present in 32/38 (84.2%) of cases and DAD without evidence of DAH was present in 6/38 (15.8%) of cases. ECLS strategies included extracorporeal membrane oxygenation of veno-venous type (VV-ECMO) in 28/38 (73.7%), veno-arterial type (VA-ECMO) in 5/38 (13.2%), and one case of right ventricular assist device with oxygenator (RVAD-ECMO). Heparin was utilized in 18/38 (47.4%) of cases with no difference in use between DAH versus no DAH (P = .46) or VA- versus VV-ECLS (P = 1). Median duration of ECLS was 10 [5, 14] days. Pre- versus post-ECLS comparison of blood gases showed improvement in median PaO2 (49 [45, 59] mm Hg vs. 80 [70, 99] mm Hg, P < .001), PaO2:FiO2 ratio (48.2 [41.4, 54.8] vs. 182.0 [149.4, 212.2], P < .01), and pulse oximetry values (76% [72, 80] vs. 96% [94, 97], P = .086). Overall, 94.7% (36/38) of patients survived to decannulation while 30-day mortality was 10.5% (4/38) with no differences between VA- and VV-ECMO (P = 1 and P = .94, respectively). DAD/DAH occurs in a younger, predominantly female population, and tends to be associated with systemic autoimmune processes. ECLS, independent of its type, appears to result in favorable short-term survival.

Survival outcomes of stenting outflow graft stenosis in continuous-flow left ventricular assist devices: a systematic review.

Stenosis in the continuous-flow left ventricular assist device (CF-LVAD) outflow graft is caused by various factors. We discuss indications for percutaneous intervention of outflow graft complications and evaluate the use of this treatment in re-establishing adequate CF-LVAD flow. An electronic search was performed to identify all studies in the English literature reporting CF-LVAD outflow graft stenting. Twenty-one studies consisting of 26 patients were included. Patient-level data were extracted for statistical analysis. Median patient age was 59 years [45.8-67.0] and 65.4% (17/26) were male. 58.3% (14/24) of patients had HeartWare HVAD, 37.5% (9/24) had HeartMate II LVAD, and 4.2% (1/24) had HeartMate III LVAS. Median time from device placement to outflow graft stenting was 24.0 months [7.8-30.4]. 76.9% of patients (20/26) presented with heart failure. Complications of the CF-LVAD outflow graft included thrombosis in nine patients (34.6%), stenosis in nine patients (34.6%), kinking in three patients (11.5%), pseudoaneurysm in one patient (3.8%), external graft compression in one patient (3.8%), and bronchial-arterial fistula in one patient (3.6%). Immediate flow improvement occurred in 23/26 patients (88.5%), with the remaining 11.5% (3/26) requiring additional procedures. Pre- and post-intervention flows were 2.9 L/min [2.0-3.5] and 4.7 L/min [4.1-4.8] respectively (p = 0.01). Of patients, 96.2% (25/26) were discharged with a median time to discharge of 4 days [3.0-5.0]. The 30-day mortality was 6.7% (1/15). Overall mortality during the median follow-up of 90 days was 9.5% (2/21). Outflow graft stenting appears to effectively alleviate CF-LVAD outflow graft obstruction and is associated with low overall mortality.

Right atrial versus right ventricular HeartWare HVAD position in patients on biventricular HeartWare HVAD support: A systematic review.

In patients with biventricular heart failure or refractory right heart failure following HeartWare HVAD placement, off-label placement of a right-sided HeartWare HVAD has been described both in the right ventricular (RV) and right atrial (RA) positions. We sought to evaluate and compare the outcomes of right-sided HeartWare HVAD using the RA versus RV approach. An electronic search was performed in the English literature to identify all reports of left- and right-heart support with HeartWare HVAD. Of the 1,288 articles identified, 13 articles with 56 cases met inclusion criteria. Patient-level data were extracted and analyzed. The median patient age was 52 years (IQR 33.0-59.0) and 40/50 (80.0%) were male. Overall, 21/56 patients (37.5%) had RA HVAD, while 35/56 (62.5%) had RV HVAD. Most underwent concomitant HVAD placement [RA: 17/21 (81.0%) vs. RV: 31/35 (88.6%), P = .69]. In those who did not, the median time between left and right HVAD was 10 days (IQR 7-14) for RA HVAD and 12 days (IQR 8-30) for RV HVAD (P = .77). The median time of support was 351 days (IQR 136-626) for RA HVAD compared to 135 days (IQR 61-244) for RV HVAD (P = .02). Pump thrombosis occurred at a similar rate [RA: 3/10 (30.0%) vs. RV: 6/20 (30.0%), P = 1], as did GI bleeding [RA: 10/35 (28.6%) vs. RV: 5/21 (23.8%), P = .94] during the follow-up time period. Kaplan-Meier analysis when censored for transplant showed higher survival with RA HVAD compared to RV HVAD (P = .036), with an estimated survival at 1 year of 91.7% (95% CI 77.3-100.0) in RA HVAD versus 66.2% (95% CI 48.9-89.6) for RV HVAD. RA HVAD appears to be a viable option for durable right-sided support with outcomes at least comparable to RV HVAD.

Ventricular arrhythmias following continuous-flow left ventricular assist device implantation: A systematic review.

Ventricular arrhythmias (VA) are not uncommon after continuous-flow left ventricular assist device (CF-LVAD) implantation. In this systematic review, we sought to identify the patterns of VA that occurred following CF-LVAD implantation and evaluate their outcomes. An electronic search was performed to identify all articles reporting the development of VA following CF-LVAD implantation. VA was defined as any episode of ventricular fibrillation (VF) or sustained (>30 seconds) ventricular tachycardia (VT). Eleven studies were pooled for the analysis that included 393 CF-LVAD patients with VA. The mean patient age was 57 years [95%CI: 54; 61] and 82% [95%CI: 73; 88] were male. Overall, 37% [95%CI: 19; 60] of patients experienced a new onset VA after CF-LVAD implantation, while 60% [95%CI: 51; 69] of patients had a prior history of VA. Overall, 88% of patients [95%CI: 78; 94] were supported on HeartMate II CF-LVAD, 6% [95%CI: 3; 14] on HeartWare HVAD, and 6% [95%CI: 2; 13] on other CF-LVADs. VA was symptomatic in 47% [95%CI: 28; 68] of patients and in 50% [95%CI: 37; 52], early VA (<30 days from CF-LVAD) was observed. The 30-day mortality rate was 7% [95%CI: 5; 11]. Mean follow-up was 22.9 months [95%CI: 4.8; 40.8], during which 27% [95%CI: 17; 39] of patients underwent heart transplantation. In conclusion, approximately a third of patients had new VA following CF-LVAD placement. VA in CF-LVAD patients is often symptomatic, necessitates treatment, and carries a worse prognosis.

Device exchange versus nonexchange modalities in left ventricular assist device-specific infections: A systematic review and meta-analysis.

No standardized treatment algorithm exists for the management of continuous-flow left ventricular assist device (CF-LVAD)-specific infections. The aim of this systematic review and meta-analysis was to compare the outcomes of CF-LVAD-specific infections as managed by device exchange to other treatment modalities not involving device exchange. Electronic search was performed to identify all studies in the English literature relating to the management of CF-LVAD-specific infections. All identified articles were systematically assessed for selection criteria. Thirteen studies with 158 cases of CF-LVAD-specific infection were pooled for analysis. Overall, 18/158 (11.4%) patients underwent CF-LVAD exchange, and 140/158 (88.6%) patients were treated with non-exchange modalities. The proportion of patients with isolated driveline infections or pump or pocket infections did not differ significantly between the groups. During a mean follow-up of 290 days, there were no significant differences in the overall mortality [exchange 17.6% (4.3-50.6) vs. non-exchange 23.3% (15.8-32.9), P = 0.67] and infection recurrence rates [exchange 26.7% (8.7-58.0) vs. non-exchange 38.6% (15.4-68.5), P = 0.56]. In the setting of CF-LVAD-specific infections, device exchange does not appear to confer an advantage in the overall mortality and infection recurrence as compared to non-exchange modalities.

Comparison of total artificial heart and biventricular assist device support as bridge-to-transplantation.

BACKGROUND: The use of left ventricular assist devices (LVAD) has increased significantly in the last decade. However, right heart dysfunction remains a problem despite the improved outcomes with continuous-flow LVADs. Surgical options for bridge to transplantation (BTT) in patients with biventricular failure are total artificial heart (TAH) or biventricular support (BiVAD). This study examines the differences in pre- and post-transplantation outcomes and survival in patients with TAH or BiVAD support as BTT. METHODS: The United Network of Organ Sharing database was retrospectively queried from January 2005 to December 2014 to identify adult patients undergoing heart transplantation (n = 17,022). Patients supported with either TAH (n = 212) or BiVAD (n = 366) at the time of transplantation were evaluated. Pre- and post-transplantation Kaplan-Meier survival curves were examined. Cox regression model was used to study the hazard ratios of the association between TAH versus BiVAD support and post-transplant survival. RESULTS: The median age of the study groups was 49.8 ± 12.9 (TAH) and 47.2 ± 13.9 (BiVAD) years (range 18-74 years). There were more men, 87% versus 74%, in the TAH group (p < 0.0001) with greater body mass index, 27.3 ± 5.2 versus 25.6 ± 4.7 (p < 0.0001), compared to those with BiVADs. Creatinine was higher, 1.7 + 1.2 versus 1.3 + 0.8 mg/dL (p < 0.0001), in the TAH group before transplant. The 30-day, one-, and three-year post-transplantation survival was 88%, 78%, and 67%, respectively, for patients with TAH support versus 93%, 83%, and 73% (p = 0.06) for patients with BiVAD support. Cox regression model shows pre-transplant creatinine (HR = 1.21, p = 0.008) is associated with a lower post-transplant survival. TAH is not associated with a worse post-transplant survival (p = 0.1). There was no difference in wait-list survival in patients supported with TAH or BiVAD (p = 0.8). CONCLUSION: Although there has been a recent increase in the use of the TAH as BTT, BiVAD support remains a viable option with similar post-transplant survival.

Factors Related to Pump Thrombosis With the Heartmate II Left Ventricular Assist Device.

BACKGROUND: Recent reports suggested that HeartMate II (HMII) thrombosis rates may be higher in implants after 2011. We characterize events at HMII centers (>100 HMII implants) whose device thrombosis rates are equivalent or lower than reported by INTERMACS. METHODS: Seven centers pooled implants from 2011 through June 2013 to examine pump thrombus and identify characteristics and clinical strategies that potentially mitigate the risk. A total of 666 patients (age 59 ± 13 years; 81% male) were studied (support duration: 13.7 ± 8.3 months, cumulative: 759 patient years). Median target INR was 2.25 (range 2.0 to 2.5), and median pump speed was 9200 rpm (range 8600 to 9600). Pump thrombus was suspected with clinical evidence (e.g., hemolysis, positive ramp test) requiring intervention (e.g., anticoagulation therapy, pump exchange) or patient death. RESULTS: Suspected pump thrombus occurred in 24/666 (3.6%) patients within three months of implant. At six months, 38/666 (5.7%) had suspected pump thrombus including 24 (3.6%) resulting in pump exchange or death. Stroke (hemorrhagic: 0.049, and ischemic: 0.048 events/patient year) and survival (six months: 88 ± 1%; 1 year: 81 ± 2%) were consistent with national averages. Suspected pump thrombus patients were younger (55 ± 13 vs. 59 ± 13, p = 0.046) and had more females (31.6% vs. 18.3%, p = 0.054). There was no difference in indication, etiology of heart failure, or body size. CONCLUSIONS: This analysis demonstrates low HMII thrombus events. Minimization of risk factors by uniform implant techniques and consistent post-op management may reduce device thrombosis. A larger scale multicenter evaluation may better elucidate the difference in thrombus events between centers.

Traumatic ventricular septal defect and flail tricuspid valve: successful management by an extracorporeal membrane oxygenator-supported hybrid approach.

We report the successful management of a critically ill patient with a traumatic ventricular septal defect (VSD) and flail tricuspid valve sustained in a motorcycle accident. Multiple orthopedic injuries prevented emergency cardiac surgery. The patient was stabilized by venous arterial extracorporeal membrane oxygenator support which allowed initial orthopedic repair. Repair of his cardiac injuries was then accomplished using a hybrid approach of percutaneous VSD closure using an Amplatzer post myocardial infarction VSD occluder which was also coil embolized followed by surgical tricuspid valve replacement.

Infection following CF-LVAD exchange for non-infectious indications: A systematic review and meta-analysis.

INTRODUCTION: Patients on continuous flow left ventricular assist devices (CF-LVADs) often require CF-LVAD exchange. The purpose of this study was to investigate the incidence of infection following CF-LVAD exchange performed for non-infectious indications. METHODS: An electronic literature search was performed to identify all studies of patients undergoing CF-LVAD exchange for pump thrombosis or device malfunction. Of 2,698 articles identified, 6 studies with 81 total patients met the inclusion criteria. Cohort-level data were pooled for meta-analysis. RESULTS: Mean patient age was 60 years (95% CI: 41-78), and 74% were male (95% CI: 61-84). Pump thrombosis was the most common indication for exchange in 70% of patients (95% CI: 47-86). Other indications were driveline fracture and electrical malfunction in 21% (95% CI: 5-56) and 12% (95% CI: 4-33) of patients, respectively. Prior to exchange, 95% of patients were on HeartMate II (HM2) LVADs (95% CI: 86-98) and average duration of support for these patients was 27.1 months (95% CI: 9.3-44.8). The majority were placed on a HM2 following exchange (88% (95% CI: 45-98)) versus HM3 (12% (95% CI: 2-55)). Follow-up was an average of 16.4 months (95% CI: 6.8-26.0). Following exchange, 16 of 81 patients developed infection, with pooled mean incidence of 24% (95% CI: 14-38). 30-day mortality was 14% (95% CI: 7-26). Survival at follow-up was 65% (95% CI: 52-76). CONCLUSIONS: Infection following CF-LVAD exchange can occur at rates higher than those observed with primary implantation; therefore, effective strategies need to implemented early and consistently to help lower infections rates and help improve outcomes following exchange.

Next Generation Development of Hybrid Continuous Flow Pediatric Total Artificial Heart Technology: Design-Build-Test.

To address the unmet clinical need for pediatric circulatory support, we are developing an operationally versatile, hybrid, continuous-flow, total artificial heart ("Dragon Heart"). This device integrates a magnetically levitated axial and centrifugal blood pump. Here, we utilized a validated axial flow pump, and we focused on the development of the centrifugal pump. A motor was integrated to drive the centrifugal pump, achieving 50% size reduction. The motor design was simulated by finite element analysis, and pump design improvement was attained by computational fluid dynamics. A prototype centrifugal pump was constructed from biocompatible 3D printed parts for the housing and machined metal parts for the drive system. Centrifugal prototype testing was conducted using water and then bovine blood. The fully combined device ( i.e. , axial pump nested inside of the centrifugal pump) was tested to ensure proper operation. We demonstrated the hydraulic performance of the two pumps operating in tandem, and we found that the centrifugal blood pump performance was not adversely impacted by the simultaneous operation of the axial blood pump. The current iteration of this design achieved a range of operation overlapping our target range. Future design iterations will further reduce size and incorporate complete and active magnetic levitation.

Surgical ventricular reconstruction for ischemic cardiomyopathy-a systematic review and meta-analysis of 7,685 patients.

Background: Surgical ventricular reconstruction (SVR) has been used to control adverse ventricular remodeling and improve cardiac function in ischemic cardiomyopathy. The purpose of this systematic review and meta-analysis was to collect and analyze all available evidence on the utilization and efficacy of SVR. Methods: An electronic database search was performed to identify all retrospective and prospective studies on SVR for ischemic cardiomyopathy in the English literature from 2000 through 2020. A total of 92 articles with a collective 7,685 patients undergoing SVR were included in the final analysis. Results: The mean patient age was 61 years (95% CI: 59-63) and 80% (78-82%) were male. Congestive heart failure was present in 66% (54-78%) and angina in 58% (45-70%). Concomitant coronary artery bypass grafting was undertaken in 92% (90-93%) while 21% (18-24%) underwent mitral valve repair. Pre vs. post-SVR, significant improvement was seen in left ventricular ejection fraction (LVEF) [29.9% (28.8-31.2%) vs. 40.9% (39.4-42.4%), P<0.01], left ventricular end-systolic (LVESD) and end-diastolic diameters (LVEDD) [LVESD: 49.9 mm (48.1-51.7) vs. 45 mm (42.8-47.3), P<0.01, LVEDD: 63.8 mm (62-65.6) vs. 58.23 mm (56.6-60), P<0.01], and left ventricular end-systolic (LVESVI) and end-diastolic volume indices (LVEDVI) [LVESVI: 83.9 mL/m2 (79.3-88.4) vs. 46.8 mL/m2 (43.5-50.1), P<0.01; LVEDVI: 119.9 mL/m2 (112.1-127.6) vs. 79.6 mL/m2 (73.6-85.7), P<0.01]. Mean New York Heart Association class improved from 3 (2.8-3.1) to 1.8 (1.5-2) (P<0.01). The 30-day mortality was 4% (3-5%) while late mortality was 19% (9-34%) at a mean follow-up of 27.5 [21-34] months. Conclusions: In patients with ischemic cardiomyopathy, SVR reduces left ventricular volumes and improves systolic function leading to symptomatic improvement.