Use of percutaneous mechanical circulatory support for right ventricular failure.

BACKGROUND: Utilization of right ventricular mechanical circulatory support (RV-MCS) devices has been limited by a lack of recognition of RV failure as well as a lack of availability and experience with RV-MCS. AIMS: We report a single-center experience with the use of percutaneous RV-MCS and report predictors of adverse outcomes. METHODS: This was a single-center retrospective cohort study. Data from consecutive patients who received RV-MCS for any indication between June 2015 and January 2022 were included. Data on baseline comorbidities, hemodynamics, and laboratory values were collected. The primary outcome was in-hospital mortality analyzed as a logistic outcome in a multivariable model. These variables were further ranked by their predictive value. RESULTS: Among 58 consecutive patients enrolled, the median age was 66 years, 31% were female and 53% were white. The majority of the patients (48%) were hospitalized for acute on chronic heart failure. The majority of the patients were SCAI SHOCK Stage D (67%) and 34 (64%) patients had MCS placed within 24 h of the onset of shock. Before placement of RV-MCS, median central venous pressure (CVP) and RV stroke work index were 20 mmHg and 8.9 g m/m2, respectively. Median serum lactate was 3.5 (1.6, 6.2) mmol/L. Impella RP was implanted in 50% and ProtekDuo in the remaining 50%. Left ventricular MCS was concomitantly used in 66% of patients. Twenty-eight patients (48.3%) died. In these patients, median serum lactate was significantly higher (4.1 [2.3, 13.0] vs. 2.2 [1.4, 4.0] mmol/L, p = 0.007) and a trend toward higher median CVP (24 [18, 31] vs. 19 [14, 24] mmHg, p = 0.052). In the multivariable logistic model, both serum lactate and CVP before RV-MCS placement were independent predictors of in-hospital mortality. Serum lactate had the highest predictive value. CONCLUSION: In our real-world cohort, 52% of patients treated with RV-MCS survived their index hospitalization. Serum lactate at presentation and CVP were the strongest predictors of in-hospital mortality.

FLAVOUR Study: FLow profiles And postoperative VasOplegia after continUous-flow left ventriculaR assist device implantation.

This study aims to associate the incidence of postoperative vasoplegia and short-term survival to the implantation of various left ventricular assist devices differing in hemocompatibility and flow profiles. The overall incidence of vasoplegia was 25.3% (73/289 patients) and 30.3% (37/122), 25.0% (18/72), and 18.9% (18/95) in the axial flow (AXF), centrifugal flow (CF), and centrifugal flow with artificial pulse (CFAP) group, respectively. Vasoplegia was associated with longer intensive care (ICU) and hospital length of stay (LOS) and mortality. ICU and in-hospital LOS and 1-year mortality were the lowest in the CFAP group. Post hoc analysis resulted in a p-value of 0.43 between AXF and CF; 0.35 between CF and CFAP; and 0.06 between AXF and CFAP. Although there is a trend in diminished incidence of vasoplegia, pooled logistic regression using flow profile and variables that remained after feature selection showed that flow profile was not an independent predictor for postoperative vasoplegia.

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

Medical and Surgical Management of Left Ventricular Assist Device-Associated Intracranial Hemorrhage.

OBJECTIVES: Management of left ventricular assist device (LVAD)-associated intracranial hemorrhage (ICH) is complicated by the competing concerns of hematoma expansion and the risk of thrombosis. Strategies include reversal or withholding of anticoagulation (AC) and neurosurgical (NSG) interventions. The consequences of these decisions can significantly impact both short- and long-term survival. Currently no guidelines exist. We reviewed medical and NSG practices following LVAD-associated ICH and analyzed outcomes. MATERIALS AND METHODS: Retrospective analysis of data collected between 2012-2018 was performed. Survival probability following ICH was calculated using the Kaplan-Meier method. RESULTS: Out of 283 patients, 32 (11%) had 34 ICHs: 16 intraparenchymal (IPH, 47%), 4 subdural (SDH, 12%), and 14 subarachnoid (SAH, 41%). IPH tended to occur sooner (median 138 [IQR 48 - 258] days post-LVAD placement) and be more neurologically devastating (mean GCS 11.4 [4.4]). Antithrombotics were reversed in 27 (79%); 1 thrombotic event occurred while off AC. Following resumption, re-hemorrhage occurred in 7 (25%), a median of 13 days (IQR 8-30) post-ICH. Five underwent NSG intervention and 6 (18%) went on to receive heart transplant. Overall, 30-day mortality was 26% (38% in IPH, 0% in SDH, and 29% in SAH), but rose to 44% at 6 months. CONCLUSION: ICH is a common post-LVAD complication with high short- and long-term mortality, though ICH subtypes may not be equally devastating. Despite this, some may benefit from neurosurgical intervention and do well following cardiac transplant. Anticoagulation is frequently reversed after ICH. Resumption however should be approached cautiously in patients with LVADs given their possible baseline coagulopathy.

Long-term Outcomes Associated With Permanent Pacemaker Implantation After Surgical Aortic Valve Replacement.

Importance: Prior studies investigating the long-term clinical outcomes of patients who have undergone permanent pacemaker implantation after aortic valve replacement reported conflicting results. Objective: To investigate long-term outcomes after primary surgical aortic valve replacement among patients who underwent postoperative permanent pacemaker implantation. Design, Setting, and Participants: This cohort study included all patients who underwent surgical aortic valve replacement in Sweden from 1997 to 2018. All patients who underwent primary surgical aortic valve replacement in Sweden and survived the first 30 days after surgical treatment were included. Patients who underwent preoperative permanent pacemaker implantation, concomitant surgical treatment for another valve, or emergency surgical treatment were excluded. Patients who underwent concomitant coronary artery bypass grafting or surgical treatment of the ascending aorta were included. Follow-up data were complete for all patients. Data were analyzed from October through December 2020. Exposures: Patients underwent implantation of a permanent pacemaker or implantable cardioverter defibrillator within 30 days after aortic valve replacement. Main Outcomes and Measures: The primary outcome was all-cause mortality. Results: Among 24 983 patients who underwent surgical aortic valve replacement, 849 patients (3.4%) underwent permanent pacemaker implantation within 30 days after surgical treatment and 24 134 patients (96.6%) did not receive pacemakers in that time. The mean (SD) age of the total study population was 69.7 (10.8) years, and 9209 patients were women (36.9%). The mean (SD) and maximum follow-up periods were 7.3 (5.0) years and 22.0 years, respectively. At 10 years and 20 years after surgical treatment, the Kaplan-Meier estimated survival rates were 52.8% and 18.0% in the pacemaker group, respectively, and 57.5% and 19.6% in the nonpacemaker group, respectively. All-cause mortality was statistically significantly increased in the pacemaker group compared with the nonpacemaker group (hazard ratio [HR], 1.14; 95% CI, 1.01-1.29; P = .03), and so was risk of heart failure hospitalization (HR, 1.58; 95% CI, 1.31-1.89; P < .001). No statistically significant increase was found in the risk of endocarditis in the pacemaker group. Conclusions and Relevance: This study found that there were increased risks of all-cause mortality and heart failure hospitalization among patients who underwent permanent pacemaker implantation after surgical aortic valve replacement, suggesting that these risks are important considerations, especially in an era when transcatheter aortic valve replacement is used in younger patients at lower risk of adverse surgical outcomes. These findings further suggest that future research should investigate how to avoid permanent pacemaker dependency after surgical and transcatheter aortic valve replacement.

Intra-Aortic Balloon Pump as a Bridge to Durable Left Ventricular Assist Device.

Left ventricular assist devices (LVAD) are increasingly being used as destination therapy in patients with Stage D heart failure. It has been reported that a majority of patients who receive a durable LVAD (dLVAD) present in cardiogenic shock due to decompensated heart failure (ADHF-CS). As it stands, there is no consensus on the optimal management strategy for patients presenting with ADHF. Bridging with intra-aortic balloon pumps (IABPs) continues to be a therapeutic option in patients with hemodynamic instability due to cardiogenic shock. The majority of data regarding the use of IABP in cardiogenic shock come from studies in patients presenting with acute myocardial infarction with cardiogenic shock and demonstrates that there is no benefit of routine IABP use in this patient population. However, the role of IABPs as a bridge to dLVAD in ADHF-CS has yet to be determined. The hemodynamic changes seen in acute myocardial infarction with cardiogenic shock are known to be different and more acutely impaired than those presenting with ADHF-CS as evidenced by differences in pressure/volume loops. Thus, data should not be extrapolated across these 2 very different disease processes. The aim of this review is to describe results from contemporary studies examining the use of IABPs as a bridge to dLVAD in patients with ADHF-CS. Retrospective evidence from large registries suggests that the use of IABP as a bridge to dLVAD is feasible and safe when compared with other platforms of temporary mechanical circulatory support. However, there is currently a paucity of high-quality evidence examining this increasingly important clinical question.

Improvements in Functional Status Among Survivors of Orthotopic Heart Transplantation Following High-risk Bridging Modalities.

BACKGROUND: The 2018 heart allocation change has resulted in greater frequency of high-risk bridging to orthotopic heart transplantation (OHT). Although survival has been studied in these patients, functional status outcomes are less established. This study evaluated changes in functional status of OHT survivors based on bridging strategy. METHODS: Adults (≥18 y) undergoing OHT between January 2015 and March 2020 were stratified by bridging modality: no bridging, inotropes only, intra-aortic balloon pump (IABP), temporary ventricular assist device (VAD), durable VAD, and extracorporeal membrane oxygenation (ECMO). Using paired analysis, the Karnofsky performance scale (0-100) was utilized to compare differences in function at listing, transplant, and follow-up. RESULTS: In total, 13 142 patients underwent OHT. At the time of both listing and transplant, patients requiring IABP, temporary VAD, and ECMO displayed the lowest functional status (each median 20) compared with other groups (P < 0.001). Among survivors, the median performance status at follow-up was ≥80 for all groups, indicating total functional independence with no assistance required. Substantial improvement in Karnofsky score occurred from transplant to follow-up in survivors bridged with IABP (40), temporary VADs (60), and ECMO (50) (each P < 0.001). Among survivors with at least 90-day follow-up, the median Karnofsky score was 90 regardless of bridging modality. CONCLUSIONS: Despite a higher mortality risk, critically ill patients who survive OHT after bridging with high-risk modalities experience acceptable functional status outcomes. These findings are important to place in the context of the impact that the 2018 allocation change has had on the landscape of OHT in the United States.

Effect of inferior vena cava filters on pulmonary embolism-related mortality and major complications: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Inferior vena cava (IVC) filters are often used. However, no clear consensus has been reached regarding the benefits and risks from randomized, controlled trials. Therefore, we investigated benefits and risks of IVC filter use. METHODS: The PubMed and Cochrane Library databases were searched from inception to October 31, 2019 to identify randomized, controlled trials for inclusion in our meta-analysis. The primary outcome was mortality related to pulmonary embolism (PE). The secondary outcomes were overall mortality, PE, deep vein thrombosis, and major bleeding. Risk ratios were pooled using the Mantel-Haenszel method with the fixed effects model for low heterogeneity. Otherwise, the random effects model was used. Risk differences were considered candidates of effect size if some of the data could not be pooled in the calculations. RESULTS: Seven articles with 1274 patients were included. We found no significant difference in mortality related to PE between the IVC filter and control groups within 3 months (risk difference, -0.01; 95% confidence interval, -0.03 to 0.00; P = .11) nor during the entire follow-up period with low heterogeneity (I2 = 0%). The new occurrence of PE within 3 months and during the whole follow-up period was lower in the IVC filter group than in the control group (0.81% vs 5.98%; risk ratio, 0.17; 95% CI, 0.04-0.65; P = .01; and 3.2% vs 7.79%; risk ratio, 0.42; 95% CI, 0.25-0.71; P = .001, respectively). No significant differences were found in the rates of the new occurrence of deep vein thrombosis, major bleeding, and mortality during the whole follow-up period between the two groups (P > .05). CONCLUSIONS: We found insufficient evidence to conclude that the use of IVC filters can reduce mortality. However, the use of IVC filters decreased the new occurrence of PE without increasing deep vein thrombosis or major bleeding.

Pulsatile ventricular assist device as a bridge to transplant for the early high-risk single-ventricle physiology.

BACKGROUND: The use of ventricular assist devices (VADs) as a bridge-to-transplant in patients with single-ventricle physiology post-stage one palliation has been associated with poor outcomes. We describe our center's successful experience in the use of paracorporeal pulsatile VADs in the palliation of high-risk single ventricle physiology before or after the first stage of palliation with an impetus on pre-palliation implant. METHODS: This is a single-center retrospective review of univentricular patients implanted with the Berlin Heart EXCOR VAD. Our center's approach includes early implantation of the Berlin Heart EXCOR with common atrial cannulation, a cardiac index between 3.5 and 5 L/min/m2, and a bivalirudin-based anticoagulation regimen. Patient-related data were collected postimplant at week 1 and months 1, 2, and 3. Post-transplant data, including neurological outcomes, were collected. RESULTS: Nine patients were supported. Survival to discharge post-transplant was 83% (5/6) in patients bridged-to-transplant and 33% (1/3) in patients bridged-to-decision. Six patients had no previous palliation. Median hospital stay before implantation was 111 days for nonsurvivors versus 20 days for survivors. The need for extracorporeal membrane oxygenation and cardiopulmonary resuscitation in nonsurvivors versus survivors was 1 in 3 versus 1 in 6 and 2 in 3 versus 1 in 6, respectively. There were no major central nervous system complications except for 1 significant hemorrhagic event. The pediatric overall performance category score on follow-up was normal to mild disability in 83% of survivors. Limitations include hemolysis and intermittent periods of infection and/or inflammation. CONCLUSIONS: The use of pulsatile paracorporeal VADs is a feasible option as a bridge-to-transplant in the peri-stage one high-risk single ventricle.

The Joint Association of Septicemia and Cerebrovascular Diseases with In-Hospital MortalityAmong Patients with Left Ventricular Assist Device in the United States.

OBJECTIVES: Left ventricular assist device (LVAD) is associated with complications such as cerebrovascular diseases (CEVD) as well as septicemia which is often preventable. With their use increasing in the U.S., identifying patients with LVAD who are at high risk for short-term mortality is essential for targeted effective patient management strategies to prevent adverse outcomes. We investigated the individual and joint association of CEVD and septicemia with the risk of in-hospital mortality in patients with LVAD in the U.S. MATERIALS AND METHODS: We used data from the National Inpatient Sample from 2004 to 2015 to identify patients ≥18 years of age who underwent LVAD implantation by means of International Classification of Disease, 9th Revision, codes. Multivariable hierarchical negative binomial regression models were used to estimate risk ratios (RR) and 95% confidence intervals (CI) for in-hospital mortality by CEVD-septicemia status. RESULTS: The mean age of the 4638 patients was 56 years, and 23% of them were women. Approximately 13% of patients had septicemia; 7% had CEVD and 2% had both conditions. In models adjusted for demographic, lifestyle/behavior factors and comorbid conditions, the risk of in-hospital mortality was almost threefold higher among patients with septicemia alone (RR=2.84, CI:2.24-3.60); two-and-half fold higher among patients with CEVD alone (RR=2.53, CI:1.85-3.48); and almost fourfold among patients with both septicemia and CEVD (RR=3.76, CI: 2.38-5.94, Pinteraction = <0.001) CONCLUSION: The presence of both septicemia and CEVD was associated with a substantially higher risk of in-hospital mortality among LVAD patients when compared to septicemia or CEVD alone.

Inpatient Cardiac Rehabilitation of LVAD Patients-Updated Recommendations from the Working Group of the German Society for Prevention and Rehabilitation of Cardiovascular Diseases.

Cardiac rehabilitation physicians are faced to an increasing number of heart failure patients supported by left ventricular assist devices (LVAD). Many of these patients have complex medical issues and prolonged hospitalizations and therefore need special cardiac rehabilitation strategies including psychological, social, and educational support which are actually poorly implemented.Cardiac rehabilitation with clear guidance and more evidence should be considered as an essential component of the patient care plan especially regarding the increasing number of destination patients and their long-term follow-up.In this article the working group for postimplant treatment and rehabilitation of LVAD patients of the German Society for Prevention and Rehabilitation of Cardiovascular Diseases has summarized and updated the recommendations for the cardiac rehabilitation of LVAD patients considering the latest literature.

Inferior Vena Cava Filter in Cancer Patients: On Whom Should We Be Placing Them?

BACKGROUND: Standard treatment for venous thromboembolism is anticoagulation; vena cava filter placement is an alternative in special situations. We aimed to evaluate the outcomes in patients with cancer undergoing filter placement in a cancer center during a 10-year period and assess which preoperatory variables were associated with poorer survival. METHODS: Retrospective unicenter analysis during a 10-year period was carried out in patients with cancer who had undergone placement of vena cava filter. Early deaths were those that occurred less than 30 days after the filter placement or that occurred during the same hospital stay of the placement. RESULTS: About 250 patients were analyzed. About 51.6% were females; 77.2% had proximal lower limb deep vein thrombosis; 34.8% had contraindications to anticoagulation; 32.8% presented bleeding after the onset of anticoagulation; and 18.4% had the filter implanted because they were going to undergo surgery and could not be anticoagulated immediately after. About 51.2% of the filters were removable. However, only 2 had the filter removed. About 59.2% had metastatic disease at the time of filter placement. About 31.2% fulfilled criteria for early death. Of those, 34 patients were put in palliative care after filter insertion (median, 13.5 days). Body mass index >18 kg/m2, the absence of metastatic disease, and filter placement during the same anesthesia of another surgery (especially if elective and curative) were associated with a higher chance of survival. CONCLUSIONS: Multidisciplinary evaluation (and possibly consideration for palliation) should take place before the decision to insert a vena cava filter in severe oncologic cases depending on overall status. Patients with a greater chance of survival at a 3 or 5 years interval seem to be those whose filters were placed in the perioperative context of other surgeries (specially elective and curative), who were not undernourished, and whose disease was not metastatic at that time. For patients who survived, an active investigation protocol for filter removal should be implemented.

Trends in utilization, mortality, and resource use after implantation of left ventricular assist devices in the United States.

OBJECTIVES: Adoption of implantable left ventricular assist devices has dramatically improved survival and quality of life in suitable patients with end-stage heart failure. In the era of value-based healthcare delivery, assessment of clinical outcomes and resource use associated with left ventricular assist devices is warranted. METHODS: Adult patients undergoing left ventricular assist device implantation from 2008 to 2016 were identified using the National Inpatient Sample. Hospitals were designated as low-volume, medium-volume, or high-volume institutions based on annual institutional left ventricular assist device case volume. Multivariable logistic regression was used to evaluate adjusted odds of mortality across left ventricular assist device volume tertiles. RESULTS: Over the study period, an estimated 23,972 patients underwent left ventricular assist device implantation with an approximately 3-fold increase in the number of annual left ventricular assist device implantations performed (P for trend <.001). In-hospital mortality in patients with left ventricular assist devices decreased from 19.6% in 2008 to 8.1% in 2016 (P for trend <.001) and was higher at low-volume institutions compared with high-volume institutions (12.0% vs 9.2%, P < .001). Although the overall adjusted mortality was higher at low-volume compared with high-volume institutions (adjusted odds ratio, 1.66; 95% confidence interval, 1.28-2.15), this discrepancy was only significant for 2008 and 2009 (low-volume 2008 adjusted odds ratio, 5.5; 95% confidence interval, 1.9-15.8; low-volume 2009 adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.8). CONCLUSIONS: Left ventricular assist device use has rapidly increased in the United States with a concomitant reduction in mortality and morbidity. With maturation of left ventricular assist device technology and increasing experience, volume-related variation in mortality and resource use has diminished. Whether the apparent uniformity in outcomes is related to patient selection or hospital quality deserves further investigation.

Association between serum lactate levels and mortality in patients with cardiogenic shock receiving mechanical circulatory support: a multicenter retrospective cohort study.

BACKGROUND: To evaluate the prognostic value of peak serum lactate and lactate clearance at several time points in cardiogenic shock treated with temporary mechanical circulatory support (MCS) using veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella CP®. METHODS: Serum lactate and clearance were measured before MCS and at 1 h, 6 h, 12 h, and 24 h post-MCS in 43 patients at four tertiary-care centers in Southern Brazil. Prognostic value was assessed by univariable and multivariable analysis and receiver operating characteristic (ROC) curves for 30-day mortality. RESULTS: VA-ECMO was the most common MCS modality (58%). Serum lactate levels at all time points and lactate clearance after 6 h were associated with mortality on unadjusted and adjusted analyses. Lactate levels were higher in non-survivors at 6 h, 12 h, and 24 h after MCS. Serum lactate > 1.55 mmol/L at 24 h was the best single prognostic marker of 30-day mortality [area under the ROC curve = 0.81 (0.67-0.94); positive predictive value = 86%). Failure to improve serum lactate after 24 h was associated with 100% mortality. CONCLUSIONS: Serum lactate was an important prognostic biomarker in cardiogenic shock treated with temporary MCS. Serum lactate and lactate clearance at 24 h were the strongest independent predictors of short-term survival.

Percutaneous left ventricular assist support is associated with less pulmonary congestion and lower rate of pneumonia in patients with cardiogenic shock.

OBJECTIVES: The aim of this study was to investigate the impact of acute left ventricular unloading by percutaneous left ventricular assist device on pulmonary congestion and pneumonia in patients with cardiogenic shock (CS). METHODS: In this retrospective study, we analysed patients with CS who received the Impella percutaneous left ventricular assist device (n=50) compared with those who received intra-aortic balloon pump (IABP) support (n=50). Pulmonary congestion was longitudinally assessed while on support by calculating characteristic findings on the chest X-ray using the Halperin score. The rate of pneumonia and early mortality were assessed as a secondary endpoint. RESULTS: The groups (Impella vs IABP) did not differ in terms of age, Sequential Organ Failure Assessment (SOFA) score, Acute Physiology, Chronic Health Evaluation (APACHE) II score or serum lactate levels. Pulmonary congestion decreased in patient treated with Impella at each time point postimplantation. No change in congestion status was observed in patients supported with IABP. Multivariate analysis indicated Impella support as an independent predictor for pulmonary decongestion (OR 4.06, 95% CI 1.15 to 14.35, p=0.030). The rate of early pneumonia was lower in the Impella group compared with the IABP group (54% vs 74%, p=0.037). Failure of pulmonary decongestion during mechanical circulatory support independently predicted early pneumonia (OR 0.28, 95% CI 0.12 to 0.70, p=0.006). CONCLUSION: Pulmonary decongestion may facilitate treatment of pneumonia in patients with CS. Left ventricular unloading by Impella device might support pulmonary decongestion, although a larger prospective trial in this patient population is required.

Septuagenarian population has similar survival and outcomes to younger patients after left ventricular assist device implantation.

BACKGROUND: Left ventricular assist device (LVAD) implantation may be an attractive alternative therapeutic option for elderly patients with heart failure who are ineligible for heart transplantation. AIM: We aimed to describe the characteristics and outcomes of elderly patients (i.e. aged≥70 years) receiving an LVAD. METHODS: This observational study was conducted in 19 centres between 2006 and 2016. Patients were divided into two groups-younger (aged<70 years) and elderly (aged≥70 years), based on age at time of LVAD implantation. RESULTS: A total of 652 patients were included in the final analysis, and 74 patients (11.3%) were aged≥70 years at the time of LVAD implantation (maximal age 77.6 years). The proportion of elderly patients receiving an LVAD each year was constant, with a median of 10.6% (interquartile range 8.0-15.4%) per year, and all were implanted as destination therapy. Elderly and younger patients had similar durations of hospitalization in intensive care units and total lengths of hospital stays. Both age groups experienced similar rates of LVAD-related complications (i.e. stroke, bleeding, driveline infection and LVAD exchange), and the occurrence of LVAD complications did not impact survival in the elderly group compared with the younger group. Lastly, when compared with younger patients implanted as destination therapy, the elderly group also exhibited similar mid-term survival. CONCLUSION: This work strongly suggests that selected elderly adults can be scheduled for LVAD implantation.

Survival Following Implantable Cardioverter-Defibrillator Implantation in Patients With Amyloid Cardiomyopathy.

Background Outcomes data in patients with cardiac amyloidosis after implantable cardioverter-defibrillator (ICD) implantation are limited. We compared outcomes of patients with ICDs implanted for cardiac amyloidosis versus nonischemic cardiomyopathies (NICMs) and evaluated factors associated with mortality among patients with cardiac amyloidosis. Methods and Results Using National Cardiovascular Data Registry's ICD Registry data between April 1, 2010 and December 31, 2015, we created a 1:5 propensity-matched cohort of patients implanted with ICDs with cardiac amyloidosis and NICM. We compared mortality between those with cardiac amyloidosis and matched patients with NICM using Kaplan-Meier survival curves and Cox proportional hazards models. We also evaluated risk factors associated with 1-year mortality in patients with cardiac amyloidosis using multivariable Cox proportional hazards regression models. Among 472 patients with cardiac amyloidosis and 2360 patients with propensity-matched NICMs, 1-year mortality was significantly higher in patients with cardiac amyloidosis compared with patients with NICMs (26.9% versus 11.3%, P<0.001). After adjustment for covariates, cardiac amyloidosis was associated with a significantly higher risk of all-cause mortality (hazard ratio [HR], 1.80; 95% CI, 1.56-2.08). In a multivariable analysis of patients with cardiac amyloidosis, several factors were significantly associated with mortality: syncope (HR, 1.78; 95% CI, 1.22-2.59), ventricular tachycardia (HR, 1.65; 95% CI, 1.15-2.38), cerebrovascular disease (HR, 2.03; 95% CI, 1.28-3.23), diabetes mellitus (HR, 1.55; 95% CI, 1.05-2.27), creatinine = 1.6 to 2.5 g/dL (HR, 1.99; 95% CI, 1.32-3.02), and creatinine >2.5 (HR, 4.34; 95% CI, 2.72-6.93). Conclusions Mortality after ICD implantation is significantly higher in patients with cardiac amyloidosis than in patients with propensity-matched NICMs. Factors associated with death among patients with cardiac amyloidosis include prior syncope, ventricular tachycardia, cerebrovascular disease, diabetes mellitus, and impaired renal function.

Dynamic Forecasts of Survival for Patients Living With Destination Left Ventricular Assist Devices: Insights From INTERMACS.

Background Left ventricular assist devices (LVADs) improve outcomes in patients with end-stage heart failure and are increasingly implanted for destination therapy. We describe dynamic estimates of event-free survival with conditional survival probabilities in a destination therapy LVAD population. Methods and Results We studied 8245 adult patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) implanted with a continuous-flow destination therapy LVAD. The composite primary end point was death, device exchange or removal, or heart transplantation. Conditional survival probabilities were calculated and stratified by implantation characteristics and nonfatal adverse events experienced within the first year after implant. Probabilities of surviving an additional 1 to 3 years were numerically higher after longer prior event-free survival. INTERMACS profile 1, extracorporeal membrane oxygenation support, prior or concomitant surgery, and dialysis within 48 hours of implantation were associated with significantly lower event-free survival in the first year but did not impact event-free survival beyond then. For patients who experienced a nonfatal adverse event within the first year, subsequent 1-year conditional survival was lower than in the absence of that event for stroke (65% [95% CI, 57%-73%] versus 75% [95% CI, 73%-77%]; P<0.001), device-related infection (64% [95% CI 57%-71%] versus 76% [95% CI, 74%-78%]; P<0.001), and pump thrombosis or malfunction (64% [95% CI, 57%-70%] versus 76% [95% CI, 74%-78%]; P<0.001). Conclusions Conditional survival in patients with destination therapy LVADs improves over time, even for patients with unfavorable implantation characteristics. However, LVAD-related complications including stroke, device-related infection, and pump thrombosis or malfunction have an enduring negative influence on dynamic estimates of long-term prognosis.