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Objective: A new approach called the loop technique has been proven safe and effective for repeated intraoperative transvenous left ventricular (LV) lead dislocations during cardiac resynchronization therapy (CRT) in a 3-year follow-up. This study aimed to report on the 5-year safety and effectiveness of the loop technique. Methods: This study was a prospective cohort study. Forty-four patients who underwent CRT device implantation at the Cardiology Department of Shaanxi Provincial People's Hospital between January 2013 and June 2019 were included. Data on patient demographics, medical history, laboratory test results, and echocardiography images at admission were collected. The loop technique was performed with repeated intraoperative dislocations of the LV lead. The intraoperative CRT parameters were also recorded. All patients were followed for 5 years. Several auxiliary examinations were performed during follow-up. Results: The 44 patients were divided into the traditional operation group (n=36, 81.8%) and loop technique group (n=8, 18.2%). The baseline patient characteristics were almost balanced. During the 5-year follow-up, 8 (22.2%) patients in the traditional operation group and 2 (25.0%) patients in the loop technique group died. No lead dislocation or other complications related to CRT were observed. There were no significant differences in mortality rate (P=0.87), cardiac function (P=0.56), echocardiographic indices, threshold (P=0.58), or impedance (P=0.22) of the LV lead. There were no significant differences in the threshold and impedance between postoperative, 3-year, and 5-year follow-ups in the loop technique group (P=0.53). Conclusion: The loop technique is an ideal solution for repeated intraoperative LV lead dislocation during CRT implantation.
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Severe left ventricular outflow tract obstruction (LVOTO) of hypertrophic cardiomyopathy is an acutely life-threatening, must-not miss, cardiology emergency that infrequently presents to the emergency department (ED). Patients with this condition usually manifest chest pain, syncope, cardiogenic shock, and severe ischemia. LVOTO is easy misdiagnosed as acute coronary syndrome. In our patient, the ECG showed a significant ST-segment depression and a 0/0 mmHg blood pressure when the peak left ventricular outflow tract gradient was abruptly increased by provocable activities. However, the patient had normal coronaries on cardiac catheterization, and, upon being immediately treated with intravenous esmolol, his symptoms were relieved and blood pressure was normal after 30 minutes. This case highlights, not only that early and exact diagnosis of LVOTO is crucial, but also the importance of the therapeutic strategies used.
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BACKGROUND: Premature ventricular contractions (PVCs) can lead to impairment of left ventricular function. The noninvasive myocardial work technique, which incorporates left ventricular afterload, represents a new method for assessing left ventricular functional. AIM: The aim of this study is to explore the value of noninvasive myocardial work technique in assessing left ventricular systolic function in patients with PVCs. METHODS: Compare the clinical data, two-dimensional echocardiography parameters, and myocardial work parameters of 66 patients with PVCs and 35 healthy volunteers and explore the relevant risk factors for postoperative recurrence in patients with PVCs. RESULTS: In patients with PVCs compared to the control group, they exhibit enlargement of left atrial diameter (LAD) and left ventricular internal dimension in diastole (LVIDd), as well as thickening of the left ventricular wall. The global work waste (GWW) increases, while the global work efficiency (GWE) decreases. There is a significant negative correlation between the PVC burden and GWE (r = -0.70, p <0.01), and a significant positive correlation between the PVC burden and GWW (r = 0.58, p <0.01). GWE is a sensitive indicator for predicting the recurrence of PVCs after radiofrequency ablation. Patients with GWE <91.5%, global longitudinal strain (GLS) <15.5%, and ejection fraction (EF) <62.5% have a higher postoperative recurrence rate. CONCLUSION: PVCs can cause impairment of left ventricular systolic function. GWE is the most sensitive indicator for predicting postoperative recurrence in patients with PVCs. Patients with GWE <91.5%, GLS <15.5%, and EF <62.5% have a higher postoperative recurrence rate.
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AIMS: Left ventricular hypertrophy (LVH) is frequently detected via echocardiography in individuals with Fabry disease (FD), sometimes leading to confusion with hypertrophic cardiomyopathy (HCM) of other aetiologies. Considering this diagnosis challenge, FD should be included in the list of differential diagnosis for patients presenting with LVH. To address this concern, we conducted a prospective screening study in China, using dried blood spot (DBS) testing, to evaluate patients with unexplained LVH. METHODS: Our study was designed as a nationwide, multicentre prospective investigation. A total of 1015 patients from 55 different centres who were diagnosed with LVH by echocardiography were screened in the study from September 2022 to December 2023. Demographic information, biochemistry data, echocardiography parameters and clinical observations were meticulously collected from all participants. The DBS method was used to assess α-galactosidase A (α-Gal A) activity in males and both α-Gal A and globotriaosylsphingosine (lyso-Gb3) levels in females. RESULTS: The final screening population included 906 patients (589 males, 65%) with LVH, characterized by a mean maximal myocardial thickness of 14.8 ± 4.6 mm and an average age of 56.9 ± 17.2 years. In total, 43 patients (38 males, 5 females) exhibited low α-Gal A activity measurement (<2.2 µmol/L), while 21 patients (10 males, 11 females) presented low α-Gal A activity or elevated lyso-Gb3 levels (>1.1 ng/mL). Among these patients, eight individuals (7 males and 1 female) were genetically confirmed to harbour pathogenic GLA mutations, resulting in a total prevalence of 0.88%. Compared with patients without FD, patients with FD tended to have proteinuria (75% vs. 21.2%, P = 0.001), family history of HCM (37.5% vs. 2.3%, P < 0.01) and neuropathic pain (37.5% vs. 4.4%, P < 0.01) but lower systolic blood pressure (118.5 ± 12.5 vs. 143.3 ± 29.3 mmHg, P = 0.017). Five mutations were previously recognized as associated with FD while the remaining two, p.Asp313Val (c.938A>T) and c.547+3A>G, were deemed potentially pathogenic. Subsequent familial validation post-diagnosis identified an additional 14 confirmed cases. CONCLUSIONS: This pioneering screening study for FD among Chinese patients with unexplained LVH using DBS measurement, revealed an FD detection rate of 0.88%. Our findings confirmed that the combined measurement of lyso-Gb3 and α-Gal A activity is beneficial for primary screening of FD in patients with LVH. Given the availability of efficacious therapies and the value of cascade screening in extended families, early detection of FD in LVH patients is clinically important.
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BACKGROUND: Heart failure (HF) can coexist with atrial fibrillation in up to 60 % of cases, increasing rates of hospitalizations and death. This study analyzed the clinical characteristics, treatment, hospitalization, and mortality of patients with HF and atrial fibrillation based on left ventricular ejection fraction (LVEF). METHODS: A retrospective cohort study included patients from an outpatient HF clinic at Medellín (Colombia) between 2020-2022. Patients were classified into two groups according to LVEF: reduced (LVEF≤40 %) and mildly reduced or preserved ejection fraction (LVEF>40 %). The evaluated outcomes were hospitalization and mortality during follow-up. Values for B-type natriuretic peptide (BNP), LVEF and functional class according to the New York Heart Association (NYHA) were also analyzed at admission and during the last follow-up visit. RESULTS: The study included 185 patients, with 51.9% being male. The median age of the participants was 80 years (interquartile range [IQR] 74 - 86). There was an overall improvement in the NYHA functional class, BNP levels, and LVEF compared with the baseline values, irrespective of left systolic function. Atrial fibrillation ablation was performed in 3.2 % of patients, and cardiac device implantation with atrioventricular node ablation in 29 %. No statistically significant differences were found in terms of hospitalization and mortality regarding left systolic function. CONCLUSION: Compressive optimal treatment for patients with HF and atrial fibrillation requires pharmacological treatment, ablation strategies, cardiac devices, cardiovascular rehabilitation and close follow-up. In this cohort, hospitalization and mortality rates were similar according to LVEF categories and there was improvement in NYHA functional class and BNP level.
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OBJECTIVE: The resiliency of patients who have advanced heart failure (HF) and undergo a physical stressor such as heart transplantation or left ventricular assist device implantation has yet to be studied in the physical, cognitive, and psychosocial domains. The primary aim of this pilot study was to assess the feasibility of a multidomain resiliency assessment in patients who have advanced HF and require surgery. METHODS: A battery of assessments in each of the domains was completed at baseline before surgical intervention, after intensive care discharge, and 3 and 6 months after surgery. Feasibility was assessed through completion rates, time required to complete the assessments, and qualitative feedback from assessors. RESULTS: Although various completion rates were noted at different time points, high completion rates were seen for grip strength, the modified Fried frailty phenotype, and the Montreal Cognitive Assessment. Additionally, when controlled for patients who were medically restricted from physical function, the Short Physical Performance Battery, gait speed, and the 30-second chair stand test also had high completion rates. A trend toward return to baseline status or an improvement in baseline status was observed in all physical and cognitive assessments and most psychosocial assessments at 3 and 6 months. Minimal change was noted in the Brief Resilience Scale questionnaire. CONCLUSION: This pilot study demonstrates that a multidomain assessment of resiliency is feasible in patients with advanced HF. Future studies are needed to help determine specific assessments or patient factors that would help predict positive postsurgical outcomes in this population. IMPACT: This study has implications for clinical practice on the most feasible assessments in multiple domains for patients who have advanced HF and are being evaluated for heart transplantation or left ventricular assist device.
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BACKGROUND: Coronary interventions reduce morbidity and mortality in patients with acute coronary syndrome. However, the risk of mortality for patients with coronary artery disease (CAD) additionally depends on their systemic endothelial health status. The 'Endothelial Activation and Stress Index' (EASIX) predicts endothelial complications and survival in diverse clinical settings. OBJECTIVE: We hypothesized that EASIX may predict mortality in patients with CAD. METHODS: In 1283 patients undergoing coronary catheterization (CC) and having a diagnosis of CAD, EASIX was measured within 52 days (range - 1 year to - 14 days) before CC and correlated with overall survival. In an independent validation cohort of 1934 patients, EASIXval was measured within 174 days (+ 28 days to + 11 years) after CC. RESULTS: EASIX predicted the risk of mortality after CC (per log2: hazard ratio (HR) 1.29, 95% confidence interval: [1.18-1.41], p < 0.001) in multivariable Cox regression analyses adjusting for age, sex, a high-grade coronary stenosis ≥ 90%, left ventricular ejection fraction, arterial hypertension and diabetes. In the independent cohort, EASIX correlated with EASIXval with rho = 0.7. The long-term predictive value of EASIXval was confirmed (per log2: HR 1.53, [1.42-1.64], p < 0.001) and could be validated by integrated Brier score and concordance index. Pre-established cut-offs (0.88-2.32) associated with increased mortality (cut-off 0.88: HR training: 1.63; HR validation: 1.67, p < 0.0001 and cut-off 2.32: HR training: 3.57; HR validation: 4.65, p < 0.0001). CONCLUSIONS: We validated EASIX as a potential biomarker to predict death of CAD patients, irrespective of the timing either before or after catheterization.
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The Impella CP is a percutaneously inserted temporary left ventricular assist device used in clinical practice and in translational research into cardiogenic shock, perioperative cardiac surgery, acute cardiac failure and mechanical circulatory support. Fluoroscopic guidance is usually used for insertion of an Impella, thus limiting insertion to within catheterization laboratories. Transthoracic, transoesophageal and intracardiac echocardiography have been reported to guide Impella CP implantation with identified specific limitations stemming from the surgical, anatomical and equipment factors. We conducted translational prospective descriptive feasibility investigation as a part of two other hemodynamic Impella studies. It showed the successful application of epicardial echocardiographic scanning for implantation of Impella CP devices in ovine models, from which details of the technique and identified pitfalls are described with practical solutions for future investigators and clinicians. Many described findings are relevant to any other echocardiographic techniques when adequate imaging of the Impella and relevant anatomical structures is achievable.
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In patients previously hospitalised for COVID-19, a 12-week high-intensity interval training (HIIT) intervention has previously been shown to increase left ventricular mass (LVM) immediately after the intervention. In the present study, we examined the effects of the same HIIT scheme on LVM, pulmonary diffusing capacity, symptom severity and functional capacity at 12-month follow-up. In this investigator-blinded, randomised controlled trial, 12 weeks of a supervised HIIT scheme (4 × 4 min, three times a week) was compared to standard care (control) in patients recently discharged from hospital due to COVID-19. At inclusion and at 12-month follow-up, LVM was assessed by cardiac magnetic resonance imaging (cMRI, primary outcome), while pulmonary diffusing capacity for carbon monoxide (DLCOc, secondary outcome) was examined by the single-breath method. Symptom severity and functional status were examined by the Post-COVID-19 Functional Scale (PCFS) and King's Brief Interstitial Lung Disease (KBILD) questionnaire score. Of the 28 patients assessed at baseline, 22 completed cMRI at 12-month follow-up (12.4 ± 0.6 months after inclusion). LVM was maintained in the HIIT but not the standard care group, with a mean between-group difference of 9.68 [95% CI: 1.72, 17.64] g (P = 0.0182). There was no differences in change from baseline to 12-month follow-up between groups in DLCOc % predicted (-2.45 [-11.25, 6.34]%; P = 0.578). PCFS and KBILD improved similarly in the two groups. In individuals previously hospitalised for COVID-19, a 12-week supervised HIIT scheme resulted in a preserved LVM at 12-month follow-up but did not affect pulmonary diffusing capacity or symptom severity.
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BACKGROUND: Bridging from temporary microaxial left ventricular assist device (tLVAD) to durable left ventricular assist device (dLVAD) is playing an increasing role in the treatment of terminally ill heart failure patients. Scant data exits about the best implantation strategy. The aim of this study is to analyze differences in dLVAD implantation technique and effects on patient outcomes. METHODS: Data from 341 patients (19 European centers), between 01/2017 and 10/2022, who underwent bridge to bridge implantation from tLVAD to dLVAD were retrospectively analyzed. The outcomes of the different implantation techniques on cardiopulmonary bypass (CPB), extracorporeal life support (ECLS) or tLVAD were compared. RESULTS: Durable LVAD implantation was performed employing CPB in 70% of cases (n = 238, group 1), ECLS in 11% (n = 38, group 2) and tLVAD in 19% (n = 65, group 3).Baseline characteristics showed no significant differences in age (p = 0.140), BMI (p = 0.388), creatinine (p = 0.659), Meld score (p = 0.190) and rate of dialysis (p = 0.110). Group 3 had significantly less patients with preoperatively invasive ventilation and cardiopulmonary resuscitation before tLVAD implantation (p = 0.009 and p < 0.001 respectively). Concomitant procedures were performed more often in group 1 and 2 compared to group 3 (24%, 37% and 5%, respectively, p < 0.001).The 30-day mortality showed a significant better survival after inverse probability of treatment weighting in group 3, but the 1-year mortality showed no significant differences between groups (p = 0.012 and 0.581, respectively).Post-operative complications like rate of RVAD implantation or re-thoracotomy due to bleeding, post-operative respiratory failure and renal replacement therapy showed no significant differences between groups.Freedom from first adverse event like stroke, driveline infection or pump thrombosis during follow-up was not significantly different between groups.Post-operative blood transfusion within 24-hours were significantly higher in groups 1 and 2 compared to surgery on tLVAD support (p < 0.001 and p = 0.003, respectively). CONCLUSIONS: In our analysis, the transition from tLVAD to dLVAD without further circulatory support did not show a difference in post-operative long-term survival, but a better 30-day survival was reported. The implantation by using only tLVAD showed a reduction in post-operative transfusion rates, right heart failure and the re-thoracotomy rate without increasing the risk of postoperative stroke or pump thrombosis. In this small cohort study, our data supports the hypothesis that we could demonstrate dLVAD implantation on tLVAD is a safe and feasible technique in selected patients.
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Most acquired and inherited cardiomyopathies are characterized by regional left ventricular involvement and nonischemic myocardial scars, often with a disease-specific pattern. Irrespective of the etiology and pathophysiological mechanisms, myocardial disorders are invariably associated with cardiac fibrosis, which contributes to dysfunction and electrical instability. Accordingly, cardiac magnetic resonance plays a central role in the diagnostic work-up and prognostic risk stratification of cardiomyopathies, particularly with the increasing correlation between genetic background and specific disease phenotype. Starting from pattern and distribution of myocardial fibrosis at cardiac magnetic resonance, we provide a practical regional atlas of nonischemic myocardial scar to guide the diagnostic approach to nonischemic cardiomyopathies.
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BACKGROUND: Prior studies characterizing worsening heart failure events (WHFE) have been limited in using structured healthcare data from hospitalizations, and with little exploration of sociodemographic variation. The current study examined the impact of incorporating unstructured data to identify WHFE, describing age-, sex-, race and ethnicity-, and left ventricular ejection fraction (LVEF)-specific rates. METHODS: Adult members of Kaiser Permanente Southern California (KPSC) with a HF diagnosis between 2014-2018 were followed through 2019 to identify hospitalized WHFE. The main outcome was hospitalizations with a principal or secondary HF discharge diagnosis meeting rule-based Natural Language Processing (NLP) criteria for WHFE. In comparison, we examined hospitalizations with a principal discharge diagnosis of HF. Age-, sex-, and race and ethnicity-adjusted rates per 100 person-years (PY) were calculated among age, sex, race and ethnicity (non-Hispanic (NH) Asian/Pacific Islander [API], Hispanic, NH Black, NH White) and LVEF subgroups. RESULTS: Among 44,863 adults with HF, 10,560 (23.5%) had an NLP-defined, hospitalized WHFE. Adjusted rates (per 100 PY) of WHFE using NLP were higher compared to rates based only on HF principal discharge diagnosis codes (12.7 and 9.3, respectively), and this followed similar patterns among subgroups, with the highest rates among adults ≥75 years (16.3 and 11.2), men (13.2 and 9.7), and NH Black (16.9 and 14.3) and Hispanic adults (15.3 and 11.4), and adults with reduced LVEF (16.2 and 14.0). Using NLP disproportionately increased the perceived burden of WHFE among API and adults with mid-range and preserved LVEF. CONCLUSION: Rule-based NLP improved the capture of hospitalized WHFE above principal discharge diagnosis codes alone. Applying standardized consensus definitions to EHR data may improve understanding of the burden of WHFE and promote optimal care overall and in specific sociodemographic groups.
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Whether left ventricular structure and function is associated with sodium dietary intake and renal handling while considering blood pressure (BP) remains unclear. Consecutive untreated patients referred for ambulatory BP monitoring were recruited. Standard echocardiography was performed to measure left ventricular structure and function. Fractional excretion of lithium (FELi) and fractional distal reabsorption rate of sodium (FDRNa) were calculated as markers of proximal and distal tubular sodium handling, respectively. The 952 participants (51.0% women; mean age, 50.8 years) included 614 (64.5%) ambulatory hypertension and 103 (10.8%) left ventricular hypertrophy. There were significant interactions of urinary sodium excretion with FELi (P ≤ 0.045), but not FDRNa (P ≥ 0.36), in relation to left ventricular posterior wall thickness (LVPW), mass (LVM) and mass index (LVMI), but not functional measurements. Only in tertile 1 of FELi, the multivariate-adjusted regression coefficients for urinary sodium excretion reached statistical significance (P ≤ 0.049), being 0.16 ± 0.05 mm, 4.32 ± 1.48 g, and 1.64 ± 0.83 g/m2 for LVPW, LVM and LVMI, respectively. In mutually adjusted analyses, the regression coefficient for LVMI was statistically significant for FELi, FDRNa and 24-h systolic BP, being -2.17 ± 0.49, -1.95 ± 0.54, and 2.99 ± 0.51 g/m2, respectively (P < 0.001). Multivariable analysis of variance showed that sodium renal handling indexes (P ≥ 0.14), but not sodium urinary excretion (P = 0.007), were similarly as 24-h BP associated with LVMI. Heat maps on left ventricular hypertrophy provided a graphical confirmation of the findings. Sodium dietary intake and renal handling interact to be associated with left ventricular structure. Renal handling indexes were similarly in size as, jointly in action with and independently of 24-h BP.
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BACKGROUND: Gated SPECT is an established technique for assessment of left ventricular function in cardiovascular disease patients. However, there is little information about the influence of diabetes mellitus on gated SPECT parameters. This study was established to assess gated SPECT parameters in Diabetes Mellitus (DM) and non-diabetes mellitus (non-DM) patients with normal Myocardial Perfusion Imaging (MPI). METHODS: In this analytical cross-sectional study, 314 patients (157 DM, 157 non-DM) with normal MPI were enrolled. Prevalence of risk factors for CAD like hypertension (HTN), and dyslipidemia were found to be significantly higher (p <0.01) in DM patients compared to non-DM. RESULTS: No statistically significant difference was observed among the TID, ESV, EDV, PFR, TTPF, and Wall Thickness (WT) parameters between DM and non-DM patients. Wall motion (Wm) in DM patients was significantly higher compared to non-DM patients. (3.9 ± 0.51 vs. 2.69 ± 0.48 for DM and non-DM patients, respectively, p-value:0.01). Also, there was no significant difference in Wm in the two groups with and without HTN. This shows the independent effect of DM on the Wm. CONCLUSION: This study believes that the Wm parameter should be noted for the early diagnosis or prevention of heart disease in DM patients. These findings can indicate the gradual changes in the movements of the left ventricle and the beginning of the progression of diabetic cardiomyopathy.
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Premature ventricular contractions with right bundle branch block morphology induced during left bundle branch (LBB) pacing (LBBP) lead implantation serve as a marker indicating that the lead is close to or has reached the LBB region. However, no reports to date have described accelerated idioventricular rhythm (AIVR) induced by LBBP lead deployment. We herein describe a patient who underwent LBBP for complete atrioventricular block. The patient's intrinsic escape rhythm was overtaken by AIVR induced immediately after LBBP lead deployment. AIVR is another marker indicating that the lead has reached the LBB region.
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INTRODUCTION: Evidence on myocardial deformation, detected by speckle tracking echocardiography (STE), in patients with acromegaly is scanty. AIM: The aim of the present meta-analysis was to provide an updated information on left ventricular (LV) systolic function assessed by global longitudinal strain (GLS) in patients with acromegaly and preserved LVEF. METHODS: Following the PRISMA guidelines, systematic searches were conducted across bibliographic databases (Pub-Med, OVID, EMBASE and Cochrane library) to identify eligible studies from inception up to June 30-2024. Clinical studies published in English reporting data on LV mechanics in patients with acromegaly and controls were included. The statistical difference of the echocardiographic variables of interest between groups such as LVEF and global longitudinal strain (GLS) was calculated by standardized mean difference (SMD) with 95% confidence interval (CI) by using random-effects models. RESULTS: Seven studies including 288 patients with acromegaly and 294 healthy individuals were considered for the analysis. Pooled average LVEF values were 64.6 ± 1.5% in the healthy control group and 64.0 ± 1.3% in the acromegaly group (SMD: - 0.21 ± 0.22, CI -0.62/0.22, p = 0.34); the corresponding values of GLS were - 19.1.1 ± 1.2% and - 17.5 ± 1.2% (SMD: -0.52 ± 0.27, CI - 1.05/0.01, p = 0.05). No difference was found between the two groups for both global circumferential strain (GCS) and global radial strain (GRS). CONCLUSIONS: Our findings suggest that patients with acromegaly in which LVEF is completely comparable to healthy controls show an impairment in GLS of borderline statistical significance. Whether GLS assessment can actually unmask early alterations of systolic function in patients with acromegaly better than LVEF will need to be investigated by future studies.
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Instead of the ventricles, atria may be the cardiac structures mainly compressed during cardiopulmonary resuscitation (CPR). This study aimed to assess the prevalence and the mechanical characteristics of atrial compression, named the "atrial pump mechanism", in patients undergoing CPR. A retrospective cohort study was conducted on patients with witnessed refractory out-of-hospital cardiac arrest who were admitted to a tertiary referral center for extracorporeal CPR. The area of maximal compression (AMC) by chest compressions was assessed by transesophageal echocardiography. Right atrial wall excursion (RAWE), left atrial fractional shortening (LAFS), right ventricular fractional area change (RVFAC), and left ventricular fractional shortening (LVFS) were measured. Common carotid and middle cerebral artery peak velocities were assessed using color-Doppler imaging as markers of cardiac outflow and cerebral perfusion. Forty patients were included in the study. Five (12.5%) had AMC over the atria. The atrial pump pattern was characterized by marked atrial compression with higher RAWE and LAFS values compared to the other patients (p < 0.001). Common carotid Doppler and transcranial Doppler-velocity patterns were detectable in all patients with open left ventricular outflow tract, without differences between patients. CPR was successful in four patients (80%) with atrial pump compared to 14 (40%) with no atrial pump mechanism (p = 0.155). In this series of selected patients with witnessed cardiac arrest, the prevalence of the atrial pump mechanism was not negligible. It may contribute to forward blood flow and the maintenance of cerebral perfusion during prolonged cardiopulmonary resuscitation.
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BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial. OBJECTIVES: The authors report the 5-year trial outcomes. METHODS: The National Heart, Lung, and Blood Institute LAMPOON trial was a prospective, multicenter, single-arm safety and feasibility study of LAMPOON and transseptal SAPIEN 3 TMVR in annuloplasty rings (valve-in-ring) or native mitral annular calcification (MAC) (valve-in-MAC). All subjects had high predicted risk for LVOT obstruction. Subjects were not excluded for excessive frailty or comorbidity. The primary endpoints were technical success and safety at 30 days. Secondary clinical and echocardiographic endpoints were assessed at 1 year and clinical follow-up at 5 years. RESULTS: Thirty subjects were enrolled between June 2017 and June 2018, equally between the valve-in-MAC and valve-in-ring arms. At 30 days, LAMPOON was successful in all 30 subjects, with no strokes, 1 (3%) death, and 1 (3%) moderate LVOT obstruction. Eighteen (65%) survived to 1 year, and 7 (25%) survived to 5 years. Six (20%) were hospitalized for heart failure in the first year. From baseline to 1 year, there was a 24-point improvement in Kansas City Cardiomyopathy Questionnaire score and a 60-m improvement in 6-minute walk distance. There was no significant change in N-terminal pro-brain natriuretic peptide. At 1 year, LVOT gradients remained low. CONCLUSIONS: LAMPOON enabled TMVR despite the risk for LVOT obstruction. There were no long-term complications associated with LAMPOON. The selection of inoperable patients limited assessment of long-term survival following TMVR. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194).
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BACKGROUND: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed cause of heart failure (HF). METHODS: This epidemiology study assessed the international prevalence of ATTR-CM among patients aged ≥60 years with a history of HF, left ventricular ejection fraction (LVEF) >40%, an end-diastolic interventricular septum thickness (IVST) ≥12 mm, but without diagnosed amyloidosis, history of LVEF ≤40%, cardiomyopathy of known cause, severe valvular, or coronary heart disease. ATTR-CM was determined using cardiac scintigraphy alongside exclusionary testing for light chain amyloidosis. The study was terminated early due to slow recruitment, without safety concerns. RESULTS: Overall, 56/315 (18%; 95% CI: 13.7-22.5) patients with evaluable scintigraphy had ATTR-CM, with a numerically higher prevalence in: Europe (24%) vs. other regions (9% Asia; 5% North America); at specialist vs non-specialist centres (26% vs. 11%); in males vs. females (24% vs. 10%); and in older vs. younger patients (e.g. >40% among those ≥85 years). Other risk markers (p<.05) included a history of carpal tunnel syndrome, higher N-terminal pro B-type natriuretic peptide concentration, and higher end-diastolic IVST. CONCLUSIONS: ATTR-CM was diagnosed in 18% (95% CI: 13.7-22.5) of evaluable patients with HF, LVEF >40%, and risk markers for ATTR-CM, but no previous diagnosis of amyloidosis. Recruitment bias may have contributed to regional variability. NCT04424914.