Gupta, Bhanu

Abstract Introduction Left atrial-to-coronary sinus (LA-to-CS) shunting through the APTURE transcatheter shunt system aims to unload the LA while preserving the interatrial septum. This article aims to examine the 3-year health status, functional capacity, and clinical outcomes of the ALT-FLOW Early Feasibility Study (EFS). Methods Device safety, patency, and echocardiographic parameters, but also symptoms, health status, and exercise capacity were assessed in patients with left ventricular ejection fraction (LVEF) > 40% (n & 95). Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score predicted 3-year all-cause mortality was compared with observed mortality assessed by Kaplan–Meier analysis using adjudicated events. Predicted and observed HF hospitalization (HFH)-free survival rates were also compared. Results At 3 years, the safety profile remained stable with no new safety signals, and all implanted shunts remained patent. 76.3% of patients improved by at least one NYHA class, and mean KCCQ Overall Summary Scores increased by 25 points from baseline (P < .0001). The 6-min walk distance improved by an average of 39 m (P & .002). These benefits were consistent regardless of baseline pulmonary vascular resistance (PVR). Right heart echocardiographic parameters after 3 years were stable, though a reduction in TAPSE was observed, primarily in the high PVR subgroup. The observed 3-year survival was significantly higher than the MAGGIC-predicted survival (84.4% vs 70.2, respectively; P & .009), as well as the HFH-free survival (68.0% vs 24.0%, respectively; P < 0001). Conclusion In patients with HF and LVEF >40%, the APTURE LA-to-CS shunting confirmed an acceptable safety profile with stable right heart parameters and sustained improvements in symptoms, quality of life, and functional capacity at 3 years. Observed survival and HFH were superior to MAGGIC predictions.

Background: Patients suffering post operative myocardial infarction (PMI) have higher mortality and morbidity rates than observed with non-PMI subsets. Little is known about the true incidence of PMI and how PMI differs from non-PMI with regard to clinical presentation, management and outcome. Methods: We examined the incidence and outcomes of patients with PMI in 1212 subjects (≥65 years) undergoing hip fracture surgery from 1988 – 2002 using a population-based retrospective cohort study from the Rochester Epidemiology Project in Olmstead County, Minnesota. PMI was defined on the basis of cardiac biomarker and/or electrocardiographic evidence of definitive MI within 7 days post operatively. Results: PMI occurred in 170 (14.0%) patients yet only 36 (21.2 %) patients had one or more clinical symptoms suggesting coronary ischemia. One or more classic symptoms of myocardial infarction were present in 26 (15.3%) including shortness of breath (SOB) in 18 (10.6%), chest/arm pain in 11 (6.5%), nausea/vomiting in 8 (4.7%) and diaphoresis in 1 (0.6%). Delirium was present in 15 (8.8%) patients. Median hospital length of stay was longer (10.0 vs. 8 days, p<0.01) and the in-hospital mortality rate was significantly higher (14.1% vs. 1.6%, p<0.001) among patients who had PMI within 7 days. Conclusion: The clinical presentation of PMI differs from non-PMI in the elderly undergoing hip fracture surgery. Most patients were asymptomatic or had atypical clinical presentations. We observed a significantly higher rate of hospital mortality among those experiencing a PMI. Further studies are necessary to better understand the presentation, optimal management and prevention of PMI. Table 1. Study Population Table 2. Clinical Presentation and Outcomes in Patients with and without Post Operative MI This research has received full or partial funding support from the American Heart Association, National Center.

Abstract 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) &gt;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 &gt;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 &lt; 0.001). At baseline, 8% had New York Heart Association class I–II status and improved to 68% at 1 year (p &lt; 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 &lt; 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 &gt;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.

Abstract Background: Von Willebrand factor (VWF) is a multimeric glycoprotein synthesized in endothelium and megakaryocytes. Elevated total VWF antigen has been associated with arterial thrombosis, while in patients with left ventricular assist devices (LVAD), loss of high molecular weight multimers is associated with spontaneous bleeding. We hypothesized that the lower rotational speed of the Heartware LVAD would be associated with less severe disruption of VWF. Methods: A total of 22 patients were included. We compared samples from a) 17 patients with Heartmate II LVAD (HM II), 76% male, median age 67 (54-73) years, 24% non-white, 45 (33-59) months after implant, with b) 5 patients with Heartware (HW) LVAD, all male, age 64 (59-65) years, 20% non-white, 27 (14-29) months after implant. All patients received warfarin. All HW patients took aspirin, while 82% of HM II patients took aspirin. Samples were analyzed for VWF antigen, activity, platelet function analyzer-100 collagen adenosine diphosphate closure time (PFA) and VWF multimers by gel electrophoresis. Multimers were assessed qualitatively and quantitatively by dividing mers > 15 by mers 2-15 (multimer ratio) and with a normalized multimer ratio (multimer ratio of patient / normal plasma control from the same gel). Results: Although flow rates did not differ significantly between HM II and HW, 5.2 (4.6-6.5) versus 4.3 (4.2-5.4) liters per minute respectively, rotational speeds were very different, mean 9472 versus 2680 rpms, p<0.0001). There were no differences in hemoglobin, hematocrit, or platelet count at the time of sampling. Qualitative VWF multimers were abnormal in all patients, and PFA was non-clotting in 88% of HM II patients and 80% of HW patients. VWF activity to antigen ratio was not different: HM II 0.68 (0.63-0.74) versus HW 0.70 (0.63-0.71). However, VWF antigen was significantly higher in HM II patients, 199 (174-227) compared to HW, 139 (122-160), p=0.039 and the normalized VWF multimer ratio was significantly lower, suggesting greater loss of high molecular weight multimers in HM II, 0.43 (0.41-0.48) compared to HW, 0.53 (0.48-0.56), p=0.0025 (figure). Conclusion: The lower rotational speed associated with the Heartware LVAD appears to produce less elevation of VWF antigen, and slightly less loss of VWF high molecular weight multimers compared to the Heartmate II LVAD. Additional studies are needed to describe whether or not lower pump thrombosis rates and rates of spontaneous bleeding are associated with these differences. Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.

Objectives To determine the incidence and 1‐year outcomes of an elderly population with perioperative atrial arrhythmia (PAA) within 7 days of hip fracture surgery. Design Retrospective cohort study. Setting The Rochester Epidemiology Project (REP). Participants Elderly adults consecutive undergoing hip fracture repair from 1988 to 2002 in Olmsted County, Minnesota (N = 1,088, mean age 84.0 ± 7.4, 80.2% female). Measurements Baseline clinical variables were analyzed in relation to survival using Cox proportional hazards methods for comparison. Results Sixty‐one participants (5.6%) developed PAA within the first 7 days. During 1 year of follow‐up, 239 (22%) participants died. PAA was associated with greater mortality (45% vs 21%; hazard ratio (HR) = 2.8, 95% confidence interval (CI) = 1.9–4.2). Other mortality risk factors were male sex (HR = 2.0, 95% CI = 1.5–2.6), congestive heart failure (HR = 2.1, 95% CI = 1.7–2.8), chronic renal insufficiency (HR = 2.0, 95% CI = 1.5–2.8), dementia (HR = 2.9, 95% CI = 2.2–3.7), and American Society of Anesthesiologists risk Class III, IV, or V (HR = 3.3, 95% CI = 1.9–5.9). Conclusion Elderly adults undergoing hip fracture surgery who develop PAA within 7 days have significantly higher 1‐year mortality than those who do not. Further studies are indicated to determine whether prevention of PAA will reduce mortality in this population.