Tchantchaleishvili, Vakhtang

We sought to characterize the long-term patency of various graft types in patients undergoing coronary artery bypass grafting. A comprehensive literature search identified 139 studies including 56,827 patients who underwent isolated coronary artery bypass grafting surgery. The mean patient age was 62 years (95% confidence interval: 60–63), and 80% (95% confidence interval: 79–82) were male. Patency outcomes were analyzed for each graft type, and parametric extrapolation was performed based on mean patency and mean follow-up time per conduit. The left internal mammary artery (LIMA) demonstrated the highest mean patency at 96% with a mean follow-up of 3.2 years, followed by the right internal mammary artery (RIMA) at 94% (2.8 years), gastroepiploic artery (GEA) at 93% (1.7 years), and radial artery (RA) at 89% (3.7 years). The saphenous vein graft had the lowest mean patency at 82% with a mean follow-up of 3.5 years. Extrapolated 20-year patency rates were 77% for LIMA, 64% for RIMA, 54% for RA, 42% for GEA, and 33% for saphenous vein graft. Arterial grafts demonstrated superior long-term patency compared to vein grafts. LIMA remains the primary conduit of choice, while RIMA, followed by RA and GEA, may be appropriate secondary arterial conduits depending on patient-specific factors. Vein grafts had the poorest long-term patency.

Abstract Background Hemocompatibility‐related adverse events (HRAE) negatively influence survival. However, no study has examined the impact of these events on health‐related quality of life (HRQOL) and functional outcomes following continuous‐flow left ventricular assist device implantation (CF‐LVAD). We assessed the impact of HRAE events on HRQOL and hypothesized that HRAE's adversely impact HRQOL and functional outcomes. Methods INTERMACS database identified patients undergoing primary CF‐LVAD implantation from 2008 to 2017. HRAEs included stroke, non‐surgical bleeding, hemolysis, and pump thrombosis and were identified as defined in the literature. HRAEs were further stratified as Tier 1–2 and disabling stroke events. Time‐series analysis was executed for HRAE patients with values pre‐HRAE, post‐HRAE, and closest to 12 months follow up. Local polynomial regression curves modeling individual patients were superimposed into “spaghetti” plots. Results All HRQOL and functional metrics improved in patients over time, despite HRAE complications. However, these patient metrics were significantly reduced compared to the non‐HRAE cohort. Advanced data visualization techniques noted a decline after experiencing an HRAE with a subsequent recovery to baseline levels or higher. Six‐minute walk test (6MWT) was noted to be most affected in the post‐HRAE period but recovered similar to other metrics. Conclusions The burden of HRAE following CF‐LVAD implantation did not negatively impact the quality of life. However, the 6MWT did not increase in the post‐HRAE period in all HRAE patients. Improvement of heart failure symptoms after CF‐LVAD coupled with optimal management following the HRAE act to preserve the enhanced quality of life.

Introduction: Various risk models have been used to predict mortality after implantation of continuous-flow ventricular assist devices (CF-VADs). Discriminatory power and predictive accuracy vary, and there is a need to develop and validate a contemporary risk score in a large multicenter patient cohort. Hypothesis: We sought to develop an early mortality risk score utilizing a large voluntary research registry of patients implanted with CF-VADs, with the focus on increased discriminatory power. Methods: From May 2004 to May 2015, 1150 patients in the Mechanical Circulatory Support Research Network (MCSRN) registry were randomly divided into equal-sized derivation and validation samples (n=575, each group). Candidate predictors from the derivation sample were subjected to backward stepwise logistic regression until the model with lowest Akaike information criterion value was identified for predicting 90-day mortality. A risk score was developed based on the variables and their respective regression coefficients in the final model. Discriminatory power of the risk score was evaluated using receiver operating characteristic analysis, and calibration was assessed using Hosmer-Lemeshow goodness of fit test. Results: Overall 90-day mortality was 9.4% (n=99). The final logistic regression model consisted of 9 predictors: Age at implant, preoperative mechanical ventilation, serum total bilirubin, hemoglobin, tricuspid valve regurgitation severity, left ventricular end-diastolic diameter, cardiac index, pulmonary capillary wedge pressure, and destination therapy (DT) as an indication for pump placement. The area under the curve was 0.86 in the derivation sample (95% CI, 0.75-0.97) and 0.75 in the validation sample (95% CI, 0.63-0.86). Hosmer-Lemeshow goodness of fit test yielded insignificant values in both samples (p=0.75, p=0.58) consistent with good calibration. Conclusions: The proposed 90-day mortality MCSRN risk score provides highest-to-date discriminatory power when compared to already published models. The risk score is applicable to a contemporary large cohort of patients implanted with CF-VADs for either indication (bridge or DT).

Abstract Prothrombin complex concentrate (PCC) administration has increased among cardiac surgery patients in recent years; however, use in LVAD implantation/exchange is not widespread due to the fear of thrombotic complications. The purpose of this study was to compare the clinical outcomes of patients undergoing LVAD implantation/exchange with intraoperative PCC administration versus traditional transfusion practices alone. Adult LVAD implants/exchanges at our institution between 2015 and 2018 were included. Patients were categorized as receiving intraoperative PCC or no‐PCC (traditional). The primary outcome was the need for allogenic transfusion and transfusion volume at 48 hours after initial intensive care unit (ICU) admission. Secondary outcomes included metrics of morbidity and mortality. A total of 160 patients (39 PCC, 121 traditional) were analyzed. In unadjusted analysis, patients in the PCC group received lower intraoperative transfusion volumes compared to the traditional group although not statistically significant (1464 mL [IQR 796, 4876] vs. 2568 mL [IQR 1292, 3606]; P value .37). In the fully adjusted analysis, patients in the PCC group had increased odds of transfusion within 48 hours of ICU admission (OR 4.06, 95% CI: 1.35‐12.20; P < .01); however, there was no significant difference in transfusion volumes ( P = .09). Patients receiving PCCs had higher incidence of deep vein thrombosis (10.3% vs. 0%; P < .01) and 30‐day mortality (17.9% vs. 4.1%; P < .01). LVAD pump thrombosis occurred in 2.6% versus 0.8% in the PCC and traditional groups, respectively; P = .98. Patients undergoing LVAD implantation and exchange represent a complex surgical cohort. The results of this study suggest that the intraoperative PCC use during LVAD implant/exchange was associated with reduced intraoperative transfusions. Intraoperative PCC use was, however, associated with higher odds of postoperative transfusion, although transfusion volumes were not significantly different. While the deep vein thrombosis and 30‐day mortality rates were higher in the PCC group, these results are likely related to the degree of surgical and patient complexity rather than PCC use itself. Further studies are needed to assess PCC use in this surgical cohort.

Treatment of giant cell myocarditis (GCM) can require bridging to orthotopic heart transplantation (OHT) or recovery with mechanical circulatory support (MCS). Since the roles of MCS and immunotherapy are not well-defined in GCM, we sought to analyze outcomes of patients with GCM who required MCS. A systematic search was performed in June 2019 to identify all studies of biopsy-proven GCM requiring MCS after 2009. We identified 27 studies with 43 patients. Patient-level data were extracted for analysis. Median patient age was 45 (interquartile range (IQR): 32–57) years. 42.1% (16/38) were female. 34.9% (15/43) presented in acute heart failure. 20.9% (9/43) presented in cardiogenic shock. Biventricular (BiVAD) MCS was required in 76.7% (33/43) of cases. Of the 62.8% (27/43) of patients who received immunotherapy, 81.5% (22/27) used steroids combined with at least one other immunosuppressant. Cyclosporine was the most common non-steroidal agent, used in 40.7% (11/27) of regimens. Immunosuppression was initiated before MCS in 59.3% (16/27) of cases, after MCS in 29.6% (8/27), and not specified in 11.1% (3/27). Immunosuppression started prior to MCS was associated with significantly better survival than MCS alone (p = 0.006); 60.5% (26/43) of patients received bridge-to-transplant MCS; 39.5% (17/43) received bridge-to-recovery MCS; 58.5% (24/41) underwent OHT a median of 104 (58–255) days from diagnosis. GCM recurrence after OHT was reported in 8.3% (2/24) of transplanted cases. BiVAD predominates in mechanically supported patients with GCM. Survival and bridge to recovery appear better in patients on immunosuppression, especially if initiated before MCS.

Abstract Various risk models with differing discriminatory power and predictive accuracy have been used to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. There remains an unmet need for a contemporary risk score for continuous flow (CF)‐LVADs. We sought to independently validate and compare existing risk models in a large cohort of patients and develop a simple, yet highly predictive risk score for acute, severe RVF. Data from the Mechanical Circulatory Support Research Network (MCSRN) registry, consisting of patients who underwent CF‐LVAD implantation, were randomly divided into equal‐sized derivation and validation samples. RVF scores were calculated for the entire sample, and the need for a right ventricular assist device (RVAD) was the primary endpoint. Candidate predictors from the derivation sample were subjected to backward stepwise logistic regression until the model with lowest Akaike information criterion value was identified. A risk score was developed based on the identified variables and their respective regression coefficients. Between May 2004 and September 2014, 734 patients underwent implantation of CF‐LVADs [HeartMate II LVAD, 76% ( n = 560), HeartWare HVAD, 24% ( n = 174)]. A RVAD was required in 4.5% ( n = 33) of the patients [Derivation cohort, n = 15 (4.3%); Validation cohort, n = 18 (5.2%); P = 0.68)]. 19.5% of the patients ( n = 143) were female, median age at implant was 59 years (IQR, 49.4–65.3), and median INTERMACS profile was 3 (IQR, 2–3). RVAD was required in 4.5% ( n = 33) of the patients. Correlates of acute, severe RVF in the final model included heart rate, albumin, BUN, WBC, cardiac index, and TR severity. Areas under the curves (AUC) for most commonly used risk predictors ranged from 0.61 to 0.78. The AUC for the new model was 0.89 in the derivation and 0.92 in the validation cohort. Proposed risk model provides very high discriminatory power predicting acute severe right ventricular failure and can be reliably applied to patients undergoing placement of contemporary continuous flow left ventricular assist devices.

Despite the growing acceptance of left ventricular assist device (LVAD) therapy to improve survival and quality of life in heart failure (HF) patients, uncertainties persist regarding the definition of a successful implant. We sought to define an innovative approach to assess success and subsequently compare preoperative variables affecting outcomes. From January 2007 to 2015, 278 patients underwent LVAD implantation. Median age at implant was 62 years and 81% patients were males. Indication for support was bridge-to-transplantation in 36% patients and the etiology of HF was ischemic in 49% patients. Based on clinically relevant and accepted standards, we defined successful LVAD implant as someone who was alive or transplanted at 2 years, had two or less readmissions in the first year, had no major adverse events in the first year, and had a New York Heart Association class of ≤ II at 6 months. Follow-up was obtained for a median of 1.7 years for a total of 605 patient-years-of-support. Based on our criteria, 81/278 (29%) patients were defined as having a successful implant. Univariate predictors of LVAD failure included destination therapy indication (hazard ratio [HR] = 2.11 [1.24, 3.58]), ischemic cardiomyopathy (HR = 1.73 [1.02, 2.94]), and a higher left ventricular ejection fraction (HR = 1.54 [1.07, 2.22]). After multivariable analysis, only destination therapy indication (HR = 2.2 [1.28, 3.78]) was found to be independently predictive of success failure. Despite an overall trend toward improved outcomes on device therapy, our criteria classified only one-third of patients as successful. Continued improvements in adverse event profiles, appropriate patient selection, and optimal time of implantation, together hold the key to improve outcomes after LVAD therapy.

Pump thrombosis is a major adverse event in patients supported on continuous-flow left ventricular assist devices (CF-LVAD). The aim of this systematic review and meta-analysis was to determine the outcomes of various treatment approaches for pump thrombosis, including surgical as compared to medical therapy. Electronic search was performed to identify all studies in the English literature addressing surgical and medical management of pump thrombosis in the modern CF-LVAD era. All identified articles were systematically assessed for inclusion and exclusion criteria. In the meta-analysis, because of significant overlap of the data, reports based on trials, registries, and individual cohort studies were analyzed separately. Forty-three studies were included in the analysis (2 trials, 4 registry reports, and 37 individual cohort studies). 2,281/28,728 (10.6%) patients developed pump thrombosis, of which 44.4% and 55.1% were supported on the HeartWare and HeartMate II, respectively. To avoid overlap in studies and to seek more granular data, pooled individual cohort studies were found to be representative of the entire population, and further in-depth analysis of this category was performed. Of the 610/5,545 (11.8%) patients with pump thrombosis in these individual cohort studies, 225 patients had surgical pump exchange, and 186 were treated medically. Surgical therapy resulted in higher success as compared to medical therapy (81.3% vs. 45.4%; p < 0.001), lower 30 day mortality rate (16.7% vs. 34.5%; p = 0.013) and recurrence rate (11.8% vs. 38.3%; p < 0.001). Meta-regression of all studies demonstrates a possible temporal increase of pump thrombosis rate (p = 0.040). Surgical pump exchange is superior to medical therapy with a higher success rate of pump thrombosis resolution, lower mortality rate, and lower recurrence rate. Randomized controlled prospective studies are needed to compare these clinical approaches and their resultant outcomes to guide decision-making for the management of CF-LVAD thrombosis.

Background Diabetes mellitus (DM) is a risk factor for morbidity and mortality in patients with heart failure. The effect of DM on post–left ventricular assist device (LVAD) implantation outcomes is unclear. This study sought to investigate whether patients with DM had worse outcomes than patients without DM after LVAD implantation and whether LVAD support resulted in a better control of DM. Methods and Results We retrospectively reviewed 341 consecutive adults who underwent implantation of LVAD from 2007 to 2016. Patient characteristics and adverse events were studied and compared between patients with and without DM. One hundred thirty-one patients (38%) had DM. Compared with patients without DM, those with DM had higher rates of ischemic cardiomyopathy, LVAD implantation as destination therapy, and increased baseline body mass index. In a proportional hazards (Cox) model with adjustment for relevant covariates and median follow-up of 16.1 months, DM was associated with increased risk of all-cause mortality (hazard ratio, 1.73; 95% confidence interval: 1.18–2.53; P =0.005) and increased risk of nonfatal LVAD-related complications, including a composite of stroke, pump thrombosis, and device infection (hazard ratio, 2.1; 95% confidence interval: 1.35–3.18; P =0.001). Preoperative hemoglobin A1c was not significantly associated with mortality or adverse events among patients with DM. LVAD implantation resulted in a remarkable decrease in hemoglobin A1c levels (7.4±1.9 pre-LVAD versus 6.0±1.5 and 6.3±1.4 after 3 and 12 months post-LVAD, respectively; P <0.0001) and a significant reduction in requirements of DM medications. Conclusions DM is associated with increased rates of all-cause mortality and major adverse events despite favorable glycemic control after LVAD implantation.