Considerations of Left Ventricular Assist Device Therapy in the United States' Prison System.

Left ventricular assist device therapy for advanced heart failure is contraindicated if a patient lives in an unsafe environment and recent guidelines declare that "legal history is pertinent for determining personal constraints or financial responsibilities due to parole requirements, pending charges, and possible imprisonment," implying that incarceration would be a contraindication. International guidelines and precedent in the United States establish that medical care for incarcerated persons should match access in the community. We present a case example and practical considerations for advanced heart failure programs faced with the challenge of partnering with patients with heart failure who may be incarcerated and their correctional health systems in the care of their chronic condition. We encourage the heart failure community to not let incarceration be a contraindication to left ventricular assist device therapy.

Veno-Arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock: An Introduction for the Busy Clinician.

Extracorporeal membrane oxygenation has evolved, from a therapy that was selectively applied in the pediatric population in tertiary centers, to more widespread use in diverse forms of cardiopulmonary failure in all ages. We provide a practical review for cardiovascular clinicians on the application of veno-arterial extracorporeal membrane oxygenation in adult patients with cardiogenic shock, including epidemiology of cardiogenic shock, indications, contraindications, and the extracorporeal membrane oxygenation circuit. We also summarize cannulation techniques, practical management and troubleshooting, prognosis, and weaning and exit strategies, with attention to end of life and ethical considerations.

PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure.

BACKGROUND: In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice. METHODS: PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12 weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting. RESULTS: Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083 pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; P = .027) and were more likely to have a ≥5-point and ≥20-point response (all P < .05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; P = .101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; P = .16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; P = .006). CONCLUSIONS: In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12 weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12 weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.

HAS-BLED and CHA2DS2-VASc scores as predictors of bleeding and thrombotic risk after continuous-flow ventricular assist device implantation.

BACKGROUND: HAS-BLED and CHA2DS2-VASc scores predict bleeding in patients on anticoagulation and thromboembolic (TE) risk in patients with atrial fibrillation, respectively. We hypothesized that these scores would be predictive of bleeding and TE complications following continuous-flow ventricular assist device (CF-VAD) implantation. METHODS AND RESULTS: Baseline HAS-BLED and CHA2DS2-VASc scores were retrospectively determined for 173 consecutive patients who underwent HeartMate II CF-VAD implantation at a single center from 2005 to 2011. Forty-three patients had bleeding (24.9%) and 22 had TE (12.7%) events over a 290 patient-year follow-up period. The mean ± SD HAS-BLED scores were 2.7 ± 1.0 and 1.9 ± 1.1 (P < .0001) in patients with and without bleeding, respectively. The CHA2DS2-VASc scores were 3.6 ± 1.4 and 2.9 ± 1.5 (P = .03) in patients with and without TE events, respectively. A HAS-BLED score of ≥ 3 was associated with a significantly higher risk of bleeding events compared with a score of <3 (42% vs 15%, respectively; hazard ratio [HR] 3.40, 95% confidence interval [CI] 1.82-6.32; P < .001). A CHA2DS2-VASc score of ≥ 3 was associated with a higher risk of TE events compared with a score of <3 (18% vs 4%, respectively; HR 4.02, 95% CI 1.19-13.6; P = .025). CONCLUSIONS: Baseline HAS-BLED and CHA2DS2-VASc scores of ≥ 3 conferred significantly higher risks of bleeding and TE, respectively, following HeartMate II implantation.

Survival in elderly patients supported with continuous flow left ventricular assist device as bridge to transplantation or destination therapy.

BACKGROUND: Published data on mechanical circulatory support for elderly patients in continuous flow devices are sparse and suggest relatively poor survival. This study investigated whether LVADs can be implanted in selected patients over the age of 65 years with acceptable survival compared with published outcomes. METHODS AND RESULTS: A single-center retrospective analysis was conducted in 64 consecutive patients ≥65 years of age implanted with a continuous-flow left ventricular assist device (CF-LVAD) as either bridge to transplantation or destination therapy from August 2005 to January 2012. Baseline laboratory and hemodynamic characteristics and follow-up data were obtained. Median survival was 1,090 days. Survival was 85%, 74%, 55%, and 45% at 6 months and 1, 2, and 3 years, respectively. Our cohort had a baseline mean Seattle Heart Failure Model (SHFM) score of 2.6 ± 0.9. Observed survival was significantly better than SHFM-predicted medical survival. Stratification by age subsets, renal function, SHFM, implantation intention, or etiology did not reveal significant differences in survival. The most common cause of death was sepsis and nonlethalcomplication was bleeding. CONCLUSIONS: Our experience with patients over the age of 65 receiving CF-LVADs suggests that this group demonstrates excellent survival. Further research is needed to discern the specific criteria for risk stratification for LVAD support in the elderly.

Heart transplantation in a patient with infective endocarditis bridged with Impella 5.5: a case report.

Background: Infective endocarditis (IE) is a feared complication after surgical valve replacement accounting for 10% to 30% of all cases of IE. Our case is unique as we present a decompensated heart failure patient with IE who urgently needed mechanical circulatory support (MCS) to stabilize while IE was treated. We used Impella to bridge him to sterile state before heart transplant was done. This case highlights the importance of different strategies for bridge to heart transplant in decompensated heart failure patients with endocarditis. Case summary: We describe a case of 62-year-old male who initially presented with severe shortness of breath with minimal exertion, weight gain, and lower extremity oedema diagnosed with acute on chronic systolic heart failure (HF) exacerbation (ACC stage D, NYHA class IV). Initial blood cultures and extensive work-up for IE were negative. He continued to decompensate haemodynamically despite inotropic support and the decision was to proceed with durable left ventricular assist device (LVAD) as bridge to orthotopic heart transplantation (OHT). Immediately prior to LVAD implantation, patient's blood cultures became positive for Cutibacterium acnes. Echocardiogram revealed IE on bioprosthetic aortic valve. Patient therefore underwent urgent aortic valve replacement (AVR) and was stabilized with Impella 5.5. Discussion: We highlight a case where MCS with Impella was used as a bridge to transplant in a decompensated HF patient who was septic. Patient was listed for OHT but was found to be septic due to IE and had to undergo AVR to achieve infection source control prior to undergoing heart transplant. Impella was used effectively to stabilize ACC stage D/NYHA class IV patient while he recovered from AVR and endocarditis before his blood cultures cleared up and he was listed for OHT. He successfully underwent OHT after 3 weeks.

Right Ventricular Assist Device Placement During Left Ventricular Assist Device Implantation Is Associated With Improved Survival.

Right ventricular failure (RVF) is a significant cause of mortality in patients undergoing left ventricular assist device (LVAD) implantation. Although right ventricular assist devices (RVADs) can treat RVF in the perioperative LVAD period, liberal employment before RVF is not well established. We therefore compared the survival outcomes between proactive RVAD placement at the time of LVAD implantation with a bailout strategy in patients with RVF. Retrospectively, 75 adult patients who underwent durable LVAD implantation at our institution and had an RVAD placed proactively before LVAD implantation or as a bailout strategy postoperatively due to hemodynamically unstable RVF were evaluated. Patients treated with a proactive RVAD strategy had lower Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and a higher proportion of these required temporary mechanical circulatory support (MCS) preoperatively. Preoperative hemodynamic profiling showed a low pulmonary artery pulsatility index (PAPi) score of 1.8 ± 1.4 and 1.6 ± 0.94 ( p = 0.42) in the bailout RVAD and proactive RVAD groups, respectively. Survival at 3, 6, and 12 months post-LVAD implantation was statistically significantly higher in patients who received a proactive RVAD. Thus, proactive RVAD implantation is associated with short- and medium-term survival benefits compared to a bailout strategy in RVF patients undergoing LVAD placement.

Practical Guidance for Hemodynamic Assessment by Right Heart Catheterization in Management of Heart Failure.

Heart failure is a clinical syndrome characterized by the inability of the heart to meet the circulatory demands of the body without requiring an increase in intracardiac pressures at rest or with exertion. Hemodynamic parameters can be measured via right heart catheterization, which has an integral role in the full spectrum of heart failure: from ambulatory patients to those in cardiogenic shock, as well as patients being considered for left ventricular device therapy and heart transplantation. Hemodynamic data are critical for prompt recognition of clinical deterioration, assessment of prognosis, and guidance of treatment decisions. This review is a field guide for hemodynamic assessment, troubleshooting, and interpretation for clinicians treating patients with heart failure.

Routine Versus Selective Distal Perfusion Catheter Use in Venoarterial Extracorporeal Membrane Oxygenation.

Although current studies support the use of prophylactic distal perfusion catheters (DPCs) to decrease limb ischemia in patients on venoarterial extracorporeal membrane oxygenation (VA ECMO), methods for monitoring limb ischemia differ between studies. We evaluated the safety of a selective rather than prophylactic DPC strategy at a single center with a well-established protocol for limb ischemia monitoring. Distal perfusion catheters were placed selectively if there was evidence of hypoperfusion at any point until decannulation. All patients were followed daily by vascular surgery with continuous regional saturation monitoring. Of 188 patients supported with VA ECMO, there were no significant differences in baseline characteristics between patients with upfront, delayed, and no DPC. Thirty day mortality was highest in patients with an upfront DPC (56% in the upfront DPC group, 19% in the delayed DPC group, and 22% in the no-DPC group, p < 0.001). The incidence of major bleeding, fasciotomy, and amputation in the entire cohort was 3.7%, 3.7%, and 0%, respectively. With strict adherence to a protocol for limb ischemia monitoring, a selective rather than prophylactic DPC strategy is safe and may obviate the risks of an additional arterial catheter.

Early vs. delayed mechanical circulatory support in patients with acute myocardial infarction and cardiogenic shock.

AIMS: Despite increased temporary mechanical circulatory support (tMCS) utilization for acute myocardial infarction complicated by cardiogenic shock (AMI-CS), data regarding efficacy and optimal timing for tMCS support are limited. This study aimed to describe outcomes based on tMCS timing in AMI-CS and to identify predictors of 30-day mortality and readmission. METHODS AND RESULTS: Patients with AMI-CS identified in the National Readmissions Database were grouped according to the use of tMCS and early (<24 h) vs. delayed (≥24 h) tMCS. The correlation between tMCS timing and inpatient outcomes was evaluated using linear regression. Multivariate logistic regression was used to identify variables associated with 30-day mortality and readmission. Of 294 839 patients with AMI-CS, 109 148 patients were supported with tMCS (8067 veno-arterial extracorporeal membrane oxygenation, 33 577 Impella, and 79 161 intra-aortic balloon pump). Of patients requiring tMCS, patients who received early tMCS (n = 79 906) had shorter lengths of stay (7 vs. 15 days, P < 0.001) and lower rates of ischaemic and bleeding complications than those with delayed tMCS (n = 32 241). Patients requiring tMCS had higher in-hospital mortality [odds ratio (95% confidence interval)] [1.7 (1.7-1.8), P < 0.001]. Among patients requiring tMCS, early support was associated with fewer complications, lower mortality [0.90 (0.85-0.94), P < 0.001], and fewer 30-day readmissions [0.91 (0.85-0.97), P = 0.005] compared with patients with delayed tMCS. CONCLUSION: Among patients receiving tMCS for AMI-CS, early tMCS was associated with fewer complications, shorter lengths of stay, lower hospital costs, and fewer deaths and readmissions at 30 days.

Review of vasodilators in acute decompensated heart failure: the old and the new.

Despite substantial improvements in treatment for chronic heart failure, morbidity and mortality for acute decompensated heart failure (ADHF) remain high. Treatment of ADHF is focused on controlling symptoms rather than improving long-term outcomes. The vasodilators nitroglycerin (NTG) and sodium nitroprusside (SNP) have been used in ADHF for decades, but, since the development of nesiritide 10 years ago, interest in new vasodilators has grown. Therapies that improve not only hemodynamics and symptoms but also long-term outcomes are in high demand, and numerous new vasodilatory agents have been investigated, including various natriuretic peptides, soluble guanylyl cyclase agents, renin-angiotensin-aldosterone system-modifying agents, and others. A review of the literature shows that few of them rise to the challenge set by NTG and SNP.

Survivors of veno-arterial membrane oxygenation have good long-term quality of life.

Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is used for the management of acute cardiogenic shock with improving short term survival. However, the long-term quality of life (QOL) of this patient population is not well characterized. We prospectively evaluated the QOL of adult patients who survived VA ECMO support for cardiogenic shock at our institution between October 2011 and January 2018 with the Minnesota Living with Heart Failure Questionnaire (MLWHFQ). We surveyed survivors at 3, 6, and 9 months after discharge, and annually for up to 5 years thereafter. A total of 64 patients were evaluated: mean age 54 ± 13 years, 73% male. There were 178 total surveys completed. MLWHFQ total scores significantly improved over time and this pattern was sustained (51.7 ± 25.3 at 3 months, vs 37.7 ± 23.6 at 6 months, vs 25.4 ± 21.3 at ⩾9 months (p < 0.01, p-trend < 0.01)). Most patients supported with VA ECMO for cardiogenic shock who survive to discharge demonstrate excellent quality of life, 6 months since index hospitalization, which is maintained over subsequent years.

Atropine augmentation of treadmill exercise stress echocardiography.

OBJECTIVES: Performance of exercise stress testing depends on adequate workload and is limited by patients' inability to reach target heart rate due to noncardiac illness or medications such as beta-blockers. This study aimed to assess the utility of atropine administration to augment the chronotropic response of patients undergoing treadmill exercise stress echocardiography. METHODS: In a retrospective study, we assessed the utility of atropine administration to augment the chronotropic response in 1,396 patients undergoing treadmill exercise stress echocardiography between January 2004 and January 2009, compared with a historical control group with no atropine augmentation. RESULTS: Atropine was well tolerated. The proportion of abnormal studies differed significantly between patients who underwent exercise with and without atropine augmentation (15% vs. 10%; P < 0.0001). Compared with the historical control group, the proportion of patients who achieved ≥85% of their target heart rates increased from 67% to 78% (P < 0.0001). CONCLUSIONS: While atropine augmentation is safe and feasible, further studies are required to determine whether it is an equivalent surrogate to achieving target heart rate through exercise alone.

Serotonergic antidepressants and hospitalization for bleeding in patients supported with a continuous flow left ventricular assist device.

BACKGROUND: Continuous flow left ventricular assist devices (CF -LVAD) improve survival in patients with advanced heart failure, but confer risk of bleeding complications. Serotonergic antidepressants (SA) are commonly used in heart failure patients receiving LVADs, but their inhibitory effect on platelet function may contribute to bleeding risk. METHODS: We performed a retrospective analysis of LVAD patients at our institution from 2016 -2019 comparing patients treated with SA after LVAD to those without SA. Demographic and clinical variables related to bleeding were collected on discharge from index hospitalization for CF-LVAD implantation and on admission for any bleeding event. The primary endpoint was incidence of bleeding requiring hospitalization after discharge. Secondary endpoints included overall number of admissions for bleeding, time to first hospitalization for a bleeding event, and incidence rate of hospitalizations for bleeding per patient year. RESULTS: 100 patients met inclusion criteria for the study. A total of 5 patients without a history of SA use and 31 patients who were prescribed SA after CF -LVAD implant were readmitted for a bleeding event after initial implant hospitalization (15% vs 46%, p = 0.004). Bleeding rate per person year (0.3 vs 0.61, p = 0.01) were significantly less in patients without SA use. Age-adjusted multivariable analysis found SA use to be associated with a hospitalization for bleeding (HR 2.3, 95% CI 0.99 -5.4). The higher incidence of hospitalization for bleeding was driven by non-gastrointestinal anatomical sites (6% vs 28%, p = 0.02) with a HR 7.7 (95% CI 0.96 -62). CONCLUSIONS: SA treatment after CF-LVAD implantation was associated with an increased risk for bleeding complications requiring hospitalization, particularly non-gastrointestinal bleeding.

Multidisciplinary shock team is associated with improved outcomes in patients undergoing ECPR.

OBJECTIVES: Veno-arterial extracorporeal membrane oxygenation (VA ECMO) has been increasingly used in cardiopulmonary resuscitation (ECPR) in select patients. Few centers have published their experience or outcomes with ECPR. The aim of our study was to evaluate outcomes of adult patients in cardiac arrest placed on VA ECMO in the catheterization laboratory. METHODS: We performed a retrospective analysis of adult patients in refractory cardiac arrest who underwent ECPR at the Minneapolis Heart Institute (MHI) at Abbott Northwestern Hospital from January 2012 to December 2017. Relevant data were obtained from electronic medical records, including arrest to ECMO flow time, total ECMO support time, and outcomes. RESULTS: Twenty-six adult patients underwent ECPR at the study site during the defined time period. Seven patients (27%) sustained cardiac arrest out of hospital, 19 patients arrested in-hospital with eight of those occurring in the catheterization laboratory. Seventeen (65%) patients had initial rhythm of ventricular fibrillation or tachycardia (VF/VT). All patients underwent mechanical CPR with LUCAS device. Overall 30 day and 6 month survival was 69%. Median time from arrest to ECMO flow was 46 mins (21,68) vs 61 mins (36,71) in survivors and non-survivors, respectively. Sixteen of 18 survivors discharged with a CPC score of 1 or 2. CONCLUSIONS: We demonstrate that adult patients in cardiac arrest initiated on VA ECMO in the cardiac catheterization laboratory and cared for by a multidisciplinary shock team in the critical care unit have superior long-term survival and functionally favorable neurologic recovery when compared to current literature.

Ischemic cardiac complications following G-CSF.

Granulocyte-colony stimulating factor (G-CSF) is commonly used in bone marrow transplant donors to increase the number of circulating progenitor cells. G-CSF has also been studied following myocardial infarction, but concern has been raised about the risks of G-CSF administration in patients with coronary artery disease. We present two cases of ischemic cardiac complications that are likely to be related to administration of G-CSF and provide a contemporary overview of the literature on the cardiovascular risks of G-CSF.

Management of the sensitized adult heart transplant candidate.

Heart transplant recipients sensitized to human leukocyte antigens comprise a challenging subgroup of patients. Sensitization has been associated with a variety of effects that determine short-term and long-term outcomes. These include a higher rate of acute rejection and graft loss, and a heightened risk for developing cardiac allograft vasculopathy. Because of improvements in both tissue typing and immunomodulatory therapies coupled with the growing population receiving mechanical circulatory support/LVAD, the percent of sensitized patients listed for heart transplantation has increased, inflicting a greater burden to the already scarce donor pool. Despite these potentially adverse developments, pre-transplant immunologic management has resulted in decreased waiting times and outcomes that were not possible over 10 yr ago. The following review will focus on the contemporary management of the sensitized heart transplant candidate and highlight therapies that have allowed the successful transplantation of this growing and challenging patient population, including several approaches in development.