Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1-year results.

AIMS: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND RESULTS: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population. CONCLUSIONS: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.

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.

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.

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.

Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.

BACKGROUND: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option. OBJECTIVES: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF. METHODS: A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise. RESULTS: Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices. CONCLUSIONS: In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.

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.

Peak troponin predicts successful weaning from VA ECMO in patients with acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: In patients treated for refractory cardiogenic shock (RCS) following acute myocardial infarction (AMI), predicting successful weaning from veno-arterial extracorporeal membrane oxygenation (VA ECMO) has important implications for decision-making and prognosis. METHODS: We performed a retrospective review of adult VA ECMO patients with RCS complicating AMI at our institution from 2010 to 2019. We evaluated use of peak troponin I as a predictor of successful decannulation. RESULTS: Sixty-two patients were analyzed; mean age 61.1 ± 9.8 years, 73% males, 62% presented with STEMI. Forty-five patients were successfully weaned (group I). Seventeen patients did not wean (group II); seven patients received a durable LVAD, 10 died. Patients from group I had significantly lower peak troponin I (89 vs 434 ng/mL, p = 0.0001). Receiver operating characteristic curves showed a peak troponin I cutoff of 400 ng/mL correctly classified patients by weaning status 90% of the time, with associated sensitivity of 71% and specificity of 98%. With each 50 ng/mL increase in troponin I, the likelihood of weaning decreased by 33%. CONCLUSIONS: Peak troponin I above 400 ng/mL may be helpful in predicting unsuccessful weaning from VA ECMO support for refractory cardiogenic shock following myocardial infarction and facilitate triage decisions regarding need for advanced therapies.

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.

Temporal changes in patient characteristics and outcomes in ST-segment elevation myocardial infarction 2003-2018.

BACKGROUND: We sought to describe changes in demographic variables, process of care measures, and outcomes of patients treated in a regional ST-segment elevation myocardial infarction (STEMI) program over the last 15 years. METHODS: We describe demographic variables, process of care measures, and outcomes of patients treated in the program in various 5-year time periods: 2003-2007 (n = 1,821), 2008-2012 (n = 1,968), and 2013-2018 (n = 2,223). The primary outcome measures were in-hospital and 30-day mortality. RESULTS: Among 6,012 STEMI patients treated from 2003 to 2018 we observed a significant increase in mean age at presentation (62 ± 14 to 64 ± 13 years) and diabetes (14-22%, p < .01). The proportion of patients with cardiogenic shock (CS) and cardiac arrest (CA) pre-PCI increased significantly from 9.5% to 11.1% and 8.5% to 12.7% (p < .05), respectively. The median door-to-balloon (D2B) times decreased from 98 to 93 min and total ischemic time decreased from 202 to 185 min (all p < .05). Despite increased patient complexity, the proportion of nontransfer and transfer patients achieving D2B times consistent with guideline recommendations remained unchanged (for nontransfer patients 79-82%, p = .45 and for transfer patients 65-64%, p = .34). Among all STEMI patients, in-hospital mortality increased during the study period from 4.9 to 6.9% (p = .007) but remained stable (<2%) when CA and CS patients were excluded. CONCLUSIONS: Over the last 15 years, short-term STEMI mortality has increased despite improvements in care delivery metrics. Patients with CA and/or CS now represent 10% of STEMI patients and are responsible for 80% of deaths. Therefore, efforts to improve STEMI mortality, and metrics for assessing STEMI programs, should focus on these patients.

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.

Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire: Initial Psychometrics of a New Instrument.

BACKGROUND: Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. OBJECTIVE: We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. METHODS: In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. RESULTS: Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79-.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). CONCLUSION: Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed.

Cardiogenic Shock Management: International Survey of Contemporary Practices.

BACKGROUND: Limited data exist on current cardiogenic shock (CS) management strategies. METHODS: A 48-item open- and closed-ended question survey on the diagnosis and management of CS. RESULTS: A total of 211 respondents (3.2%) completed the survey, including 64% interventional cardiologists, 14% general cardiologists, 11% advanced heart failure cardiologists, 5% intensivists, 3% cardiothoracic surgeons; the remainder were internists, emergency medicine, and other physicians. Nearly half (45%) reported practicing at sites without advanced heart failure support/resources, with neither durable ventricular assist devices nor heart transplant available; 16% practice at sites without on-site cardiac surgery and 6% do not offer 24/7 percutaneous coronary intervention (PCI) coverage. The majority (70%) practice in closed intensive care units with multidisciplinary rounding (73%), cardiologists frequently involved in patient care (89%), and involving cardiology-intensivist co-management (41%). Over half (55%) reported use of CS protocols, 61% reported routine arterial line use, 25% reported routine use of pulmonary artery catheter use to guide management and 9% did not. The preferred vasopressor and/or inotrope was norepinephrine (68%). For coronary angiography and PCI, 53% use transradial access, 72% only revascularize the culprit vessel, and 44% institute mechanical circulatory support (MCS) prior to revascularization. Percutaneous MCS availability was as follows: intra-aortic balloon pump (92%), Impella (78%), peripheral veno-arterial extracorporeal membrane oxygenation (66%), and TandemHeart (28%). Most respondents (58%) do not use a scoring system for risk stratification and most (62%) reported that CS-specific cardiac rehabilitation programs were unavailable at their sites. CONCLUSION: Wide variation exists in the care delivered and/or resources available for patients with CS. Our survey suggests opportunities for standardization of care.

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.

Effects of a Consensus-Based Pulmonary Embolism Treatment Algorithm and Response Team on Treatment Modality Choices, Outcomes, and Complications.

Pulmonary embolism (PE) treatment depends on disease severity and risk of complications. Physician and institutional expertise may influence the use of reperfusion therapy (RT) such as systemic thrombolysis (SL) and catheter-directed interventions (CDI). We aimed to investigate the effects of a consensus-based treatment algorithm (TA) and subsequent implementation of PE response team (PERT) on RT modality choices and patient outcomes. A cohort of PE patients admitted to a tertiary care hospital between 2012 and 2017 was retrospectively evaluated. Demographics, clinical variables, RT selections, and patient outcomes during 3 consecutive 2-year periods (baseline, with TA, and with TA+PERT) were compared. Descriptive statistics were used for data analysis. A total of 1105 PE patients were admitted, and 112 received RT. Use of RT increased from 4.7% at baseline to 8.2% and 16.1% during the TA and TA+PERT periods. The primary RT modality transitioned from CDI to SL, and reduced-dose SL became most common. Treatment selection patterns remained unchanged after PERT introduction. Hospital length of stay decreased from 4.78 to 2.96 and 2.81 days (P < .001). Most of the hemorrhagic complications were minor, and their rates were similar across all 3 periods and between SL and CDI. No major hemorrhages occurred in patients treated with reduced-dose SL. In conclusion, TA and PERT represent components of a decision support system facilitating treatment modality selection, contributing to improved outcomes, and limiting complications. Treatment algorithm emerged as a factor providing consistency to PERT recommendations.