Long-term Clinical Outcomes Research Articles

Effect of baseline and one-year follow-up anemia status on long-term clinical outcomes in patients with heart failure

Abstract Background Anemia is a significant comorbidity in heart failure (HF), influencing patient prognosis and quality of life. In patients with HF, fluctuations in anemia status can markedly impact long-term outcomes. Purpose The aim of this study was to evaluate the long-term prognosis of HF patients according to change in anemia status at the baseline and one-year follow-up. Methods Data were obtained from a multicenter cohort of patients hospitalized for acute heart failure (AHF) from 10 tertiary university hospitals between March 2011 to February 2014. Out of 5,625 AHF patients, the study population was consisted of 1,798 patients with available data on hemoglobin levels at baseline and one-year follow-up. Anemia is defined as hemoglobin levels below 13 g/dL for men and 12 g/dL for women. These patients were then categorized into four groups: group ‘anemia to anemia’; group 2 ‘no-anemia to anemia’; group 3 ‘anemia to no-anemia’; group4 ‘no-anemia to no-anemia’. Primary outcome was the composite incidence of cardiac death or HF readmission. Results Among 1,798 patients, 718 patients (39.9%) died during follow-up (mean 1169.1 ± 880.7 days, median 1057.5 days) and 816 patients (45.4%) developed primary outcome. The patients with baseline anemia had a worse clinical profile than those without anemia. The development of primary outcome tended to significantly decrease from group 1 to group 4 (55.6% vs. 48.1% vs. 40.2% vs. 36.3%, p for trend <0.001). In addition, the incidence of all-cause death, cardiac death, readmission due to cardiac cause, and HF readmission also tended to decrease significantly toward group 4. The cumulative cardiac death or HF readmission free survival rate showed significantly lowest in the group 1 (log-rank p-value < 0.001), and the survival rate increased from Group 1 to Group 4 (Figure). After adjusting for confounding factors, Cox regression analysis showed that anemia to anemia group was independently associated with a 1.368-fold increased risk of primary outcome compared to no-anemia to no-anemia group during follow-up (Hazard ratio [HR] 1.368, 95% confidence interval [CI] 1.110-1.701, p = 0.005). No-anemia to anemia group had also a 1.376-fold increased risk of primary outcome (HR 1.376, 95% CI 1.043-1.814, p = 0.024) compared with no-anemia to no-anemia group. Conclusions In conclusion, the risk of adverse clinical outcomes including cardiac death and HF readmission increased progressively in groups transitioning from no-anemia to anemia or consistently remaining anemic in AHF patients. Conversely, those who improved from anemia to non-anemia or remained non-anemic exhibited a decreased risk, highlighting the critical role of anemia status as a determinant of long-term prognosis. Clinicians should actively manage and monitor anemia as an essential component of treatment strategies to improve long-term outcomes in patients with HF.Kaplan-Meier Survival curve

Efficacy and severity of side-effects of rosuvastatin compared to other statins post-heart-transplantation

Abstract Introduction The International Society of Heart and Lung Transplantation (ISHLT) 2022 guideline recommends statin therapy in heart transplantation (HTx) patients, with the therapeutic low-density lipoprotein (LDL) target being <2.5 mmol/L. Particularly pravastatin is recommended, given proven beneficial effects on long-term clinical outcome and the low prevalence of side effects. Yet, in the general population, rosuvastatin has been shown to be even more potent. Purpose We investigated the lipid-lowering effect and severity of side-effects of rosuvastatin compared to less potent statins in HTx patients. Methods In this before-after study, we included all HTx patients whom were prescribed a change from the statin they were using to rosuvastatin, for better cardiovascular risk management and/or because of side-effects, between February 2018 and February 2023. We evaluated the weight, lipid profile and side-effects (including myalgia, cramps, stiffness and weakness) of these patients up to one year prior to and after the statin change. At the same time, side-effects were measured in a visual analogue scale (VAS) ranging from 0-10, with the average score of side-effects utilized for analysis. We compared the differences using a Wilcoxon signed rank test. Results Out of 299 HTx patients, we included 114 patients, with a median age of 58 [IQR 50-67] years at switch of whom 31 (27%) were females. Median time since HTx was 9 [IQR 5-15] years. The distribution and dosage of prescribed statins before and after switch can be found in Table 1. Compared to statins used prior to therapy change, rosuvastatin was associated with lower total cholesterol, LDL- and triglyceride levels, with high density lipoprotein (HDL) levels remaining the same (Table 2). No difference in bodyweight was found (Table 2). Before switch, 41 (36%) patients achieved the target of LDL-levels below 2.5 mmol/L. After switch, 86 (75%) patients achieved the target of LDL levels below 2.5 mmol/L. Rosuvastatin shows a trend towards a lower prevalence of side-effects (Table 2). Conclusion In HTx patients that were prescribed a change of statin due to better cardiovascular risk management and/or complaints of side-effects, rosuvastatin is related to a more favorable lipid profile, without additional side-effects, compared to other statins. Furthermore, many more patients achieve the guideline recommended LDL-target. Ongoing research should determine whether this translates to a better clinical outcome.

Remote monitoring of cardiac implantable electronic devices using smart device interface versus radiofrequency-based interface: a systematic review

Abstract Background Guidelines recommended remote monitoring (RM) in managing patients with Cardiac Implantable Electronic Devices (CIED). In recent years, smart device (phone or tablet) monitoring-based RM (SM-RM) was introduced. SM-RM is a specifically developed application (app) which can be downloaded from app stores using smart devices. The app uses Bluetooth low-energy to communicate automatically and securely with the patient’s CIED. The app then uses a cellular or Wi-Fi internet connection to transfer the data securely to the manufacturer’s repository. Purpose This study aims to systematically review SM-RM versus bedside monitor RM (BM-RM) using radiofrequency in terms of compliance, connectivity, and episode transmission time. Methods We conducted a systematic review, searching three international databases from inception until July 2023 for studies comparing SM-RM (intervention group) versus BM-RM (control group). Results Two propensity score-matched studies with a total of 21978 patients were retrieved (9642 patients in the SM-RM arm and 12336 patients in the BM-RM arm) (1, 2). There is significantly higher compliance among patients using SM-RM compared with patients using BM-RM in both pacemaker and defibrillator patients. There were higher enrolment rates and completed scheduled transmissions among SM-RM compared to BM-RM. Higher connectivity was also seen in patients with SM-RM, and more SM-RM patients transmitted at least once compared to BM-RM patients. Additionally, SM-RM patients had more patient-initiated transmissions compared to BM-RM patients. Younger patients (aged <75) had more patient-initiated transmissions, and a higher proportion had ≥10 such transmissions compared with older patients (aged ≥75) in both SM-RM and BM-RM groups. The episode transmission time of SM-RM patients was also shorter than that of BM-RM patients. Conclusion SM-RM is a step in the right direction, with good compliance, connectivity, and shorter episode transmission time. It allows patients to feel empowered and in control of their health. Further research on cost-effectiveness and long-term clinical outcomes can be carried out in the future.

Long-term clinical outcomes informed by artificial intelligence-enabled single-lead ECG detection of reduced ejection fraction

Abstract Background * Reduced left ventricular ejection fraction (LVEF) is linked to poor clinical outcomes (1, 2). * Despite its increasing prevalence, reduced LVEF is often undetected due to resource-limited echocardiography and lack of suitable point-of-care diagnostic tools. * Previous studies have shown that an artificial intelligence-enabled electrocardiogram (AI-ECG) algorithm can accurately identify patients with reduced LVEF, but may also offer novel insights on long-term prognosis (3, 4). Purpose We aimed to determine if an AI-ECG algorithm designed for detecting reduced LVEF can also independently predict 2-year major adverse cardiovascular events (MACE) and all-cause mortality. Method * A retrospective multicentre observational study investigating the ability of AI-ECG to predict long-term clinical outcomes (i.e. over two years' follow up). * Analysis included a total of 1,007 consecutive unselected patients attending for routine echocardiography, with a single-lead ECG recording performed at the same time. * An AI-ECG algorithm, designed to identify impaired LVEF, was applied to each single-lead ECG. * Occurrence of MACE and all-cause mortality associated with AI-ECG results (Figure 1) was investigated using Cox regression; evaluating performance of AI-ECG results as a classifier (0 or 1) and as a probability score (0 to 1). * The study was approved by the UK Health Research Authority (reference 21/LO/0051). Results * The mean age was 62.3 years. 52.4% of patients were male and 57.5% of patients were White. * Appropriately, patients with a positive AI-ECG had a higher MACE rate compared to those with a negative AI-ECG (34.2% vs. 11.9%; adjusted hazard ratio (aHR) 2.02; 95% CI, 1.46 – 2.81; p < 0.005), primarily driven by increased mortality (23% vs. 9.6%; p < 0.0001; aHR 1.65; 95% CI, 1.12 – 2.43) and heart failure hospitalization (14.5% vs. 1%; p < 0.0001) – Figure 2. * AI-ECG probability score (per 10% increase) was significantly associated with MACE (aHR 1.17; 95% CI, 1.09 – 1.25; p < 0.005) and all-cause mortality (aHR 1.11; 95% CI, 1.02 – 1.20; p = 0.01). * Importantly, sub-analysis of AI-ECG for those who have a normal LVEF (i.e. ≥50%) continued to show association between positive AI-ECG and MACE (27.2% vs. 11.9%; p < 0.0001; aHR 1.70, 95% CI 1.17 – 2.48) and all-cause mortality (20.4% vs. 9.6%; p < 0.0001; aHR 1.53, 95% CI 1.00 – 2.36). Conclusion An AI-ECG algorithm designed to identify impaired LVEF can identify patients at risk of MACE and all-cause mortality from single-lead ECG screening – regardless of their LVEF. Such results may enable further risk stratification for cardiovascular investigations through the simple addition of single-lead ECG recording.

1-year outcomes of patients presenting with acute coronary syndromes in Western Cape, South Africa: findings from the PERFUSION ACS registry

Abstract Background Cardiovascular disease(CVD), particularly acute myocardial infarction(MI), has emerged as a public health challenge in South Africa(SA), however, there is a paucity of data regarding long-term clinical outcomes such as CVD mortality, heart failure, stroke and recurrence of MI in this region. Purpose To determine 1-year major adverse cardiac outcomes among individuals discharged alive following admission for troponin-positive Acute Coronary Syndromes(ACS) in Western Cape, SA. Methods Between February 2021 and May 2022, 838 adults(≥18 years) with a diagnosis of ACS were prospectively enrolled into the investigator-initiated, multi-center PrEsentation, Rationale, and impact of reperFUSION for Acute Coronary Syndromes (PERFUSION ACS) registry. Participants were enrolled at a tertiary-care referral center and four secondary-level healthcare facilities. Key data elements were measured at index admission, including baseline demographics, risk factors, clinical presentation, complications, laboratory tests, revascularization strategies, and discharge medication. Survivors at discharge provided consent for 30-day and 12-month telephonic evaluations for major adverse cardiovascular events(MACE), which were captured on a web-based system that was centrally managed and analyzed. Results Of 838 participants, 39% were female, one-third were <55 years of age, 76% had a history of smoking, 74% had hypertension, 58% had dyslipidemia, and 56% were obese. STEMI accounted for 51% of cases, with NSTEMI in 49%. Baseline data for the cohort, stratified into two categories of MI, are provided in Table 1. Median duration from symptom onset to hospital presentation was 10.42 (±15.26) hours, with a majority(80%) presenting first to a non-PCI-capable facility. Among STEMI cases, two-thirds received thrombolysis(65%), primarily with Streptokinase; 49% underwent angiography via a pharmacoinvasive strategy, and 3% received primary percutaneous coronary intervention(PCI). Overall, 57% of patients with NSTEMI were treated with an invasive approach. The one-year all-cause mortality was 21%, with 88% attributable to cardiovascular disease-related death. Cumulative MACE rate at one year was 57%. Event rates for the individual MACE components were 32% for heart failure, 19% for non-fatal MI, and 6% for non-fatal stroke. 6% of participants died in-hospital, while 30-day mortality was 9%. There were no significant differences in all-cause mortality between STEMI and NSTEMI at 1 year. Conclusion Troponin-positive ACS are associated with a high rate of 12-month mortality and non-fatal major adverse cardiac events in Western Cape, SA. The concerning registry findings emphasize the need to prioritize ischemic heart disease prevention and management, and highlight important gaps in care which can serve as targets for improvement throughout the country.PERFUSION: Table 1PERFUSION: All-cause mortality and MACE

Clinical impact of Sarcopenia on long-term mortality in patients undergoing coronary bypass grafting

Abstract Background Sarcopenia is an aging-related condition characterized by loss of skeletal muscle mass and is an indicator of subclinical atherosclerosis. The relationship between sarcopenia and long-term clinical outcomes in patients with advanced coronary artery disease who have undergone coronary artery bypass grafting (CABG) is not fully understood. This study aimed to evaluate the prognostic implications of sarcopenia in patients undergoing CABG. Methods A total of 2,810 patients who underwent CABG were derived from the Samsung Medical Center institutional registry from 2007 to 2017 and classified according to the presence of sarcopenia. The skeletal muscle index (SMI) was calculated as L3 muscle area (cm2)/height (m)2 on computed tomography. Sarcopenia was defined as SMI ≤45 cm2/m2 in men and ≤38 cm2/m2 in women. The primary outcome was all-cause mortality during follow-up. Results The median follow-up was 8.7 years, and 924 patients (32.9%) had sarcopenia. Patients with sarcopenia were older and more frequently women. SMI was significantly correlated with age (R=-0.34, P<0.001), weight (R=-0.56, P<0.001), and body mass index (R=-0.52, P<0.001). SMI was significantly associated with risk of death on a restricted cubic spline curve (HR=1.04 per-1 decrease, 95% CI 1.03-1.05, P<0.001). Patients with sarcopenia had a higher incidence of long-term mortality than those without sarcopenia (survival rate 41.4% vs. 62.8%; adjusted HR=1.18, 95% CI 1.03-1.36, P=0.02). Subgroup analysis showed that the prognostic implication of sarcopenia on long-term survival was more evident in men (adjusted HR=2.01, 95% CI 1.72-2.35) than women (adjusted HR=1.28, 95% CI 0.98-1.68) (interaction P=0.006). Conclusions Sarcopenia, defined by SMI on computed tomography, was associated with long-term mortality after CABG. These results provide contemporary data to allow the evaluation of physical frailty in patients with advanced coronary artery disease before surgery.

Long-term outcomes of aortic stenosis patients with different flow/gradient patterns undergoing transcatheter aortic valve implantation

Abstract Background Few data exist on the comparative long-term outcomes of severe aortic stenosis (AS) patients with different flow-gradient patterns undergoing transcatheter aortic valve implantation (TAVI). This study sought to evaluate the impact of the pre-TAVI flow-gradient pattern on long-term clinical outcomes after TAVI. Methods Consecutive patients with severe AS undergoing TAVI in our institution were screened and prospectively enrolled. Patients were divided into four subgroups according to pre-TAVI flow/gradient pattern: (i) low flow—low gradient (LF-LG): stroke volume indexed (SVi) ≤ 35 mL/m2 and mean gradient (MG) < 40 mmHg); (ii) normal flow—low gradient (NF-LG): SVi > 35 mL/m2 and MG < 40 mmHg; (iii) low flow—high gradient (LF-HG): Svi 35 mL/m2 and MG ≥ 40 mmHg and (iv) normal flow—high gradient (NF-HG): SVi > 35 mL/m2 and MG ≥ 40 mmHg. Clinical follow-up was obtained at 12 months, and yearly thereafter until 5-year follow-up was complete for all patients. Results A total of 272 patients with complete echocardiographic and clinical follow-up were included in our analysis. Their mean age was 80 ± 7 years and the majority of patients (N = 138, 50.8%) were women. 62 patients (22.8% of the study population) were distributed in the LF-LG group, 98 patients (36%) were LF-HG patients, 95 patients (34.9%) were NF-HG, and 17 patients (6.3%) were NF-LG. There was a greater prevalence of comorbidities among LF-LG AS patients. One-year all-cause mortality differed significantly between the four subgroups of AS patients (log-rank p: 0.022) and was more prevalent among LF-LG patients (25.8%) compared to LF-HG (11.3%), NF-HG (6.3%) and NF-LG patients (18.8%). At 5-year follow-up, global mortality remained persistently higher among LF-LG patients (64.5%) compared to LF-HG (47.9%), NF-HG (42.9%), and NF-LG patients (58.8%) (log-rank p: 0.029) (Figure 1). At multivariable Cox hazard regression analysis, baseline SVi (HR: 0.951, 95% C.I.; 0.918–0.984), the presence of at least moderate tricuspid regurgitation at baseline (HR: 3.091, 95% C.I: 1.645–5.809) and at least moderate paravalvular leak (PVL) post-TAVI (HR: 1.456, 95% C.I.: 1.106–1.792) were significant independent predictors of late global mortality. Conclusions Patients with LF-LG AS have acceptable 1-year outcomes, but exhibit exceedingly high 5-year mortality following TAVI. The presence of low transvalvular flow and at least moderate tricuspid regurgitation at baseline and significant paravalvular leak post-TAVI were associated with poorer long-term outcomes in the entire cohort of AS patients.

Long-term clinical outcome of a novel bilateral capsulotomy with focused ultrasound in refractory obsessive-compulsive disorder treatment.

Magnetic resonance-guided focused ultrasound (MRgFUS) capsulotomy is a promising treatment for refractory obsessive-compulsive disorder (OCD); however, long-term clinical outcome studies are lacking. We aimed to investigate the long-term efficacy and safety of MRgFUS capsulotomy in patients with refractory OCD. Ten of the eleven patients who underwent MRgFUS capsulotomy for treatment-resistant OCD between 2013 and 2014 were included in this study. Clinical outcomes were assessed after 10 years of follow-up post-MRgFUS capsulotomy using tools such as neuropsychological test, the Frontal Systems Behavior Scale (FrSBe), and a locally developed MRgFUS-patient-centered outcomes questionnaire. After 10 years of follow-up, there was a mean improvement of 52.3% in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score. Seven out of the ten participants responded fully (Y-BOCS reduction ≥35% + CGI-I 1 or 2) to the procedure, two of whom achieved remission (Y-BOCS score ≤12 and CGI-S 1 or 2). Obsessive-compulsive symptoms and overall functioning significantly reduced and improved, respectively (Y-BOCS = 20.7 after 2 years vs. 16.4 after 10 years, p = 0.012; Global Assessment of Functioning = 57.4 after 2 years vs. 69.0 after 10 years, p = 0.011). The patients experienced significantly improved frontal lobe-related functions (FrSBe Sum before 91.0 ± 17.6 vs. after 78.6 ± 17.7, p < 0.05). No adverse effects, including cases of suicide and neurological deficits, were reported. The majority of the respondents were generally satisfied with MRgFUS capsulotomy. MRgFUS capsulotomy is an effective and safe treatment option for the treatment of severe refractory OCD with sustained efficacy even after 10 years.

A larger reduction of spatial mean QRS-T angle during cardiac resynchronisation therapy is associated with a lower risk of mortality and heart failure hospitalisation

Abstract Background Predicting clinical outcome in heart failure patients undergoing cardiac resynchronization therapy (CRT) remains challenging, necessitating improved risk stratification for CRT recipients. Previous studies have shown an association between large spatial peak and mean QRS-T angles and cardiovascular disease. Little is known, however, about their relation to clinical outcome following CRT. Purpose To investigate the association between spatial peak and mean QRS-T angles and long-term clinical outcome following CRT initiation. Methods All patients with native LBBB receiving CRT at a large-volume tertiary care center between 2015 and 2020 were retrospectively evaluated. Spatial peak and mean QRS-T angles were derived from digital pre- and post-CRT 12-lead ECGs that were processed using Glasgow algorithm and Kors’ regression transformation. The QRS-T angles and their change after CRT were analyzed in relation to the primary composite endpoint of heart failure hospitalisation or all-cause mortality using Cox regression analysis adjusted for clinical covariates (age, gender, CRT-P or CRT-D, secondary ICD indication, ischemic etiology, NYHA class, LVEF, diabetes, atrial fibrillation, baseline QRS duration, NT-proBNP, and eGFR). Results The study group comprised 250 patients (a median age [Q1–Q3] of 72.2 years [64.5–76.3]; 22% female; 58% New York Heart Association (NYHA) class III-IV; LVEF 27% [22–30]) who were followed over a median follow-up time of 4.5 years [3.2–5.8] after CRT implantation. The median post-CRT spatial peak and mean QRS-angles were 142° [116–160] and 152° [127–166], and the median angle was decreased by 16° [-0.6–41] and 14° [-0.4–38], respectively. Both a larger post-CRT mean QRS-T angle (HR 1.20, 95%CI 1.08-1.33, p=&amp;lt;.001) and peak QRS-T angle (HR 1.08, 95%CI 1.01-1.17, p=0.046) were associated with the primary endpoint. A larger reduction of mean QRS-T angle, but not peak QRS-T angle, was associated with a risk reduction (HR 0.87, 95%CI 0.79-0.95, p&amp;lt;0.003). In Kaplan-Meier analysis, patients with a post-CRT mean QRS-T angle above median had a higher risk of reaching the endpoint (log-rank p=0.002, Figure 1). Conclusion Our results show that a larger magnitude of the post-CRT spatial peak and mean QRS-T angles, and a larger reduction of the latter, are associated with long-term heart failure hospitalisation and death. These findings suggest that spatial QRS-T angle may have a potential role in refined risk stratification of CRT patients.Figure 1.K-M curve spatial mean QRS-T

Strategy optimization for the combined procedure of left atrial appendage occlusion plus catheter ablation in patients with atrial fibrillation (COMBINATION): a multi-center, randomized study

Abstract Background The long-term efficacy and safety of combining left atrial appendage closure (LAAC) plus catheter ablation (CA) in patients with atrial fibrillation (AF) in a single procedure have been established. However, the optimal combining strategy has not been well elucidated. Objective To determine the impact of different combining strategies on long-term clinical outcomes. Methods In this prospective multicenter study, patients with non-valvular AF referred for the combining procedure were randomly assigned to the ablation-first or occlusion-first groups at a 1:1 ratio. We evaluated the outcomes of LAAC with a Watchman device and CA using a contact-force sensing catheter during long-term follow-up. Results Of the 202 randomized patients, 194(96.0%) completed the trial with 97 patients in each group. Baseline characteristics were comparable between groups. All procedures were accomplished with acute successful LAAC and restoration of sinus rhythm. Incidences of periprocedural complications were similar. Higher chronic peri-device leak (PDL, 15.5% vs 5.2%, P=0.031) and device-related thrombus (DRT, 8.2% vs 1.0%, P=0.035) rates were observed in the ablation-first group. The event-free survival rate of the primary endpoint (composite of stroke/transient ischemic attack, thromboembolism, clinically-relevant bleeding, cardiovascular rehospitalization/death) was significantly higher in the occlusion-first group (83.5% vs 71.1%, log-rank P=0.036, HR 0.53, 95%CI 0.29-0.95) during a median 2.5-year follow-up. Patients with male gender and higher CHA2DS2-VASc score were at lower risk in the subgroup analysis. Long-term freedoms from AF (77.3% vs 63.5%, log-rank P=0.039) and atrial tachyarrhythmias (70.1% vs 55.7%, log-rank P=0.044) were higher in the occlusion-first group, respectively. Conclusions The occlusion-first approach is recommended for combined procedures where a plug-like device is implanted due to its superior long-term clinical benefits.Flowchart of the COMBINATION trialIncidences of primary endpoint

Peak VO2 is associated with cardiac functional response and long-term survival in patients with heart failure and atrial fibrillation undergoing catheter ablation

Abstract Background Contemporary guidelines recommend Catheter Ablation (CA) in patients with persistent Atrial Fibrillation (AF) with Heart Failure with reduced ejection fraction (HFrEF). It is challenging to prospectively predict who will respond. We have previously described the long-term survival outcomes of patients in this cohort.(1) However, the clinical characteristics associated with HF response and long-term clinical outcomes have not been reported. Objective To evaluate the association of HF parameters with cardiac functional response to CA and long-term survival after CA. Methods Post-hoc, long-term follow-up of mortality was undertaken in patients enrolled in the CAMTAF and ARC-HF RCTs. Both studies enrolled patients with persistent AF and HFrEF between 2005 and 2012 and randomised to first-time CA or medical therapy alone. Left ventricular ejection fraction (LVEF) and peak VO2 were measured in both studies at baseline and 12-month follow-up. The Universal Definition of HF response (LVEF improves by &amp;gt;10% points or to an LVEF &amp;gt;50%) was used.(2,3) Multi-variate logistic regression was used to determine features associated with HF response and Cox proportional hazards modelling for survival. Results 102 patients underwent randomisation with 52 assigned to CA. The mean age was 60.2 ±10.7 years with 93 (91.2%) male. The mean Baseline LVEF was 31 ±11% and peak VO2 was 1815 ±642mlmin-1. Baseline LVEF did not correlate significantly with Minnesota Living with Heart Failure (MLWHF) score (r=-0.11, p=0.29) whereas baseline peak VO2 did (r=-0.28, p&amp;lt;0.01). In patients randomised to CA, the median (IQR) improvement in LVEF was +8.4% (0, 15%). 22/52 (42.3%) patients were classified as Responders based on the Universal Criteria. Responders were younger (54.7 ±10.6 years vs 61.8 ±11.4, p=0.03) and had a higher mean HR on baseline Holter monitoring (89 ±14bpm vs 79 ±11bpm p&amp;lt;0.01) than non-responders. There was no significant difference in sex, baseline MLWHF scores, BNP levels or LVEF between groups (28±9% vs 31 ±9%, p=0.19). Responders had a significantly higher peak VO2 at baseline than Non-Responders (1972 ±668mlmin-1 vs 1556 ±580mlmin-1, p=0.03). On multivariate analysis, mean heart rate on Holter monitoring and peak VO2 were significantly associated with Responder status post-ablation. (Table 1a) During a median follow-up of 7.8 (3.9 –9.9) years, 34 (33.3%) patients died, including 17 (32.7%) patients in the CA arm. On univariate analysis, baseline peak VO2 was significantly greater of survivors at 5 years (1867 ±624 mlmin-1 vs 1259 ±497 mlmin-1, p&amp;lt;0.01). On multivariate Cox regression analysis, the peak VO2 at baseline was the only significant predictor of survival (Table 1b). Conclusion Peak VO2 at baseline was associated with baseline symptom status, the short-term LVEF response to CA and long-term survival and may be a useful stratification tool to aid patient selection for CA.1a. Regression for 6-month LVEF response1b. Regression for long-term mortality

Addressing disparities in the long-term mortality of non-ST segment myocardial infarction (NSTEMI) patients according to the presence of diabetes mellitus: a nationwide cohort study

Abstract Background Diabetes mellitus (DM) is an important risk factor for non−ST segment elevation myocardial infarction (NSTEMI). How DM is related to management and longer-term clinical outcomes in contemporary NSTEMI cohorts is not well described. Methods and Results We analysed data on 456,376 adults hospitalised with NSTEMI from the United Kingdom Myocardial Ischaemia National Audit Project (MINAP) registry, linked with Office for National Statistics (ONS) death registry. We compared outcomes and quality of care by DM status. People with DM were older (median age 74 vs. 73 years, p&amp;lt;0.001) and more commonly of Asian ethnicity (13% vs. 4%, p&amp;lt; 0.001). Those with DM underwent invasive coronary angiography (59% vs. 63%, p &amp;lt;0.001) or revascularization (PCI or CABG) (38% vs. 40%, p &amp;lt;0.001) less frequently. Mortality risks for people with DM were significantly higher at 30-days (HR: 1.06, CI; 1.04-1.09, p &amp;lt;0.001), 1-year, (HR: 1.17, CI; 1.15-1.18, p &amp;lt;0.001) and 5-years, (HR: 1.25, CI; 1.24-1.26, p &amp;lt;0.001), when compared to people without DM. In people with DM, higher-quality inpatient care, assessed by opportunity-based quality-indicator score category (OBQI; poor, fair, good or excellent), was associated with lower mortality rates (good: HR 0.70, CI 0.67-0.73, P&amp;lt;0.001; excellent: HR 0.59, CI 0.57- 0.62, P&amp;lt;0.001), when compared to people receiving poor quality care. In people with DM, "excellent-care", compared to those receiving poor quality care, was associated with the lowest mortality in diet-treated or insulin-treated subgroups (diet-treated: HR 0.55, CI 0.50-0.61, P&amp;lt;0.001)(insulin-treated: 0.60 CI 0.56-0.64, P&amp;lt;0.001). Conclusion People with DM experience wide disparities in inpatient care following NSTEMI. They have a higher risk of long-term mortality compared to people without DM, with some evidence that better quality inpatient care is linked to better survival.

Correlation of prosthesis position on mid-term pacing burden in patients with new permanent pacemaker after TAVI

Abstract Background Prior studies suggest a strong correlation of the final prosthesis position on the occurrence of new conduction disturbances resulting in permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI). A high burden right ventricular pacing (PPM stimulation rate of &amp;gt; 20 %) is associated with poor long-term outcomes. So far, data about predictors influencing the PPM stimulation rate after TAVI are scarce. Purpose Thus, the purpose of this study was to evaluate the influence of the three-dimensional transcatheter heart valve (THV) position, as well as device landing zone characteristics or peri-/post-procedural factors on the stimulation rate in patients with new implanted PPM as TAVI complication. Materials: We evaluated the final THV position of 387 patients (106 with self-expanding Evolut R THV, 281 with balloon-expandable Sapien 3 THV) using fusion imaging of pre- and post-TAVI computed tomography angiography (CTA) to obtain a three-dimensional reconstruction of the THV within the native annulus region. The length of the THV above and below the native annulus was measured within the fused images to assess the implantation depth. PPM stimulation rates were examined pre-discharge and after 3 months. Patient’s clinical long-term outcome was evaluated over 5 years via standardized questionnaire as well as contacting general practitioners. Results Out of the 387 patients 112 (29%) received a new PPM pre-discharge after TAVI between 2014 and 2022. They were grouped into patients with stimulations rate below and above 20%. A stimulation rate &amp;gt; 20% in the PPM control before discharge and after three months was detected in 69 % and 67 % of them, respectively. Using uni- and multivariate logistic regression analysis, only new occurred third degree atrioventricular blocks (p=0.007) was identified as predictor for high burden right ventricular pacing after PPM-implantation as well as after 3 months. The implantation depth of the THV showed no influence on the PPM stimulation rate – neither the mean value nor the exact implantation depth adjacent the left, right and non-coronary cusp (P=0.455, P=0.108 and P=0.932, respectively). There were no significant differences regarding MACE between both groups during long-term follow-up; only the degree of dyspnea 5 years after TAVI was significantly higher in patients with a stimulation rate &amp;gt; 20% (p=0.01). Conclusion We detected no correlation of the exact three-dimensional THV position on mid-term pacing burden in 112 patients implanted with a new PPM after TAVI using CTA fusion imaging. Only a new occurred third degree atrioventricular block was a predictor for a high burden right ventricular pacing (stimulation rate &amp;gt;20%). These results provide important insights into which patients actually require PPM implantation after TAVI.

Novel Antibacterial Resin Coating for Dental Provisional Crowns to Suppress Biofilms and Inhibit Secondary Caries

Provisional crowns are often used in dentistry for prolonged periods, but bacterial attachment and dental plaque often lead to gingival inflammation and secondary caries. The aims of this research were to develop a novel resin-based antibacterial provisional crown coating to prevent secondary caries and investigate the physical properties and antibacterial efficacy. The resin-based coating was prepared by addition of triethylene glycoldivinylbenzyl ether and urethane dimethacrylate, with the antibacterial monomer dimethylaminododecyl methacrylate (DMADDM) incorporated at different mass fractions. Surface characteristics including surface roughness and contact angle were assessed. The antibacterial effects were evaluated by 48 h biofilms of Streptococcus mutans (S. mutans) on provisional crowns coated with the resin-based coating. No statistically significant difference was observed in surface roughness across all groups (p &gt; 0.05), showing that adding DMADDM did not have a negative impact on surface roughness. The contact angle results revealed a significant difference in hydrophilicity between different concentrations of DMADDM (p &lt; 0.01), but overall hydrophilicity did not negatively affect the performance of the coating. The incorporation of 5% DMADDM demonstrated a significant antibiofilm effect on S. mutans biofilm CFU with a 4-log reduction compared to controls (p &lt; 0.01). Significant reductions of 4–5 folds were observed in biofilm metabolic activity and lactic acid production (p &lt; 0.01). The findings suggest that the novel coating material could enhance the long-term performance and clinical outcomes of provisional crowns, contributing to better patient oral health.

Conduction system pacing and atrioventricular node ablation for atrial fibrillation - a systematic review and meta-analysis

Abstract Background/Introduction Biventricular pacing (BVP) has been shown to reduce the risk of heart failure following atrioventricular node ablation (AVNA) for the management of medically refractory atrial fibrillation (AF) when compared with conventional right ventricular pacing.[1] Conduction system pacing (CSP) is an emerging cardiac synchronization alternative to BVP[2], however, its evidence in AVNA for AF is limited. Purpose To evaluate the effect of CSP on left ventricular ejection fraction (LVEF), QRS duration (QRSd), pacing threshold and New York Heart Association (NYHA) class score following AVNA for AF. Methods We conducted a literature review of PUBMED, MEDLINE, EMBASE, Cochrane Library, and Web of Science for randomized clinical trials (RCTs) and observational studies evaluating CSP (His bundle pacing and left bundle branch pacing) post AVNA for AF. Out of 14 studies comprising 1112 patients, we conducted meta-analyses evaluating the impact of CSP on LVEF and QRS. Ten studies were pooled to assess outcomes pre- and post-implantation of CSP following AVNA. Three observational studies and one RCT were included in the meta-analysis comparing outcomes in CSP versus BVP post AVNA. Results CSP resulted in a significant QRSd reduction (-11.01 ms, 95% CI 5.07 - 16.95, p &amp;lt;0.01), improved LVEF (+10.28%, 95% CI 7.03 - 13.52; p &amp;lt;0.01) and improved NYHA score (-1.09; 95% CI -1.41 - -0.78; p &amp;lt;0.01) during follow-up of 6-36 months (Figure 1) from baseline (peri-implantation). There was no significant pacing threshold rise (0.11V; 95% CI -0.14 - 0.36; p= 0.39) observed during the same period. CSP was associated with statistically significant shorter QRSd (-49.81ms; 95% CI, -70.57 - -29.06; p &amp;lt;0.01) when compared to BVP. For LVEF, there was a statistically significant improvement of +8.96% (95% CI 2.55 - 15.37%; p &amp;lt;0.01) with CSP versus BVP. Limited data prohibited comparison of threshold and NYHA outcomes between CSP and BVP. Conclusion Conduction system pacing appears effective in improving baseline LVEF, QRSd and NYHA score in AVNA for AF, and may be a viable alternative to further optimising LVEF and QRSd in comparison to BVP. Further studies are required to evaluate the long-term impact and clinical outcomes of CSP in post AVNA patients.

Tricuspid regurgitation in the context of severe concomitant left-sided valvular heart disease: patients characteristics and long-term clinical and interventional outcomes

Abstract Background The clinical features, therapeutical management and outcome of patients with significant tricuspid regurgitation (TR) in the context of multiple valvular disease (VD) are poorly defined. Purpose To assess the characteristics, management and long-term prognosis of a large cohort of patients with multiple VD, focusing on the context of significant TR and concomitant severe mitral or aortic disease. Methods Clinical and echocardiographic data were collected in 1183 patients with ≥moderate TR diagnosed at our centers from January 2012 to June 2020: after propensity score matching for age to create matched cohort with &amp;lt; 10% of absolute difference, 975 patients were included in this study and divided in 4 groups as shown in Figure 1. Primary endpoint was all-cause death (ACD), secondary endpoint was the composite of heart failure (HF) hospitalization+any valvular intervention. Results Patients with isolated TR (356, 37%) had more history of atrial fibrillation and were more often asymptomatic and with preserved left-ventricular ejection fraction (LVEF). TR+ severe MR patients (466, 48%) showed higher rates of concomitant coronary artery disease, NYHA class III/IV symptoms and larger left atrial volumes. The group of TR+ severe AS (131 patients, 13%) was characterized by older age, more comorbidities and lower LVEF. Patients with TR and severe AR (22, 2%) were younger, with larger LV dimensions and higher pulmonary pressures. Overall, in 37(4%) patients tricuspid intervention was performed: no differences were found between groups in term of frequency of concomitant or staged tricuspid valve surgical treatment (p=0.444 and p= 0.624, respectively), while left-valve only surgical treatment was more common among patients with TR and severe MR and left-valve transcatheter treatment among patients with TR and severe AS (both p&amp;lt;0.001). After a median follow-up of 2.8 years, the primary endpoint occured in 374 (38%) of patients, and was significantly more frequent in the group of patients with TR and severe AS (p&amp;lt;0.001, Figure 2). In this group, after multivariate analysis, indexed stroke volume remained independenty associated with ACD (OR 0.96, CI 0.93-0.98, p =0.040). Eventually, the secondary endpoint too was more common in patients with TR and severe AS (p&amp;lt;0.001, Figure 2). Conclusions In the context of significant TR, concomitant severe left-sided VD is common, and each subtype presents with different clinical features and echocardiographic phenotypes; in this scenario, TR was profoundly underteated. Long-term, patients with significant TR+ severe AS have considerable worse prognosis.Figure 1Figure 2

Long-term clinical and imaging outcomes of patients undergoing percutaneous femoral intervention following TAVI-related vascular access complications

Abstract Introdcution: Vascular access complications (VAC) are the most common in-hospital adverse event following transcatheter aortic valve implantation (TAVI). Often, ileo-femoral VAC requires bail-out percutaneous interventions with either prolonged balloon inflation and/or stent implantation. The long-term outcomes of these procedures have not been characterized. We aim to assess the clinical and imaging outcomes of patients who underwent bailout percutaneous vascular interventions due to VAC following TAVI. Methods Single-centre prospective study including all consecutive patients with a VAC following trans-femoral TAVI, between 2015-July 2023. VAC was defined as uncontrolled bleeding, acute occlusion or flow limiting stenosis of the femoral vessel leading to percutaneous treatment. Clinical and imaging follow-up was performed with bilateral arterial ultrasound (US) Doppler to assess patency and peak systolic velocity of common femoral arteries. Results A total of 1518 patients underwent TF-TAVI, of which 107 (7%) underwent concomitant ileo-femoral percutaneous angioplasty (PTA) intervention in the same day as TAVI. In patients submitted to PTA, 7 were treated to gain access for TAVI, and 100 (7%) were performed to treat vascular access complications. At a mean follow-up time of 23±3 months, 37 patients died (37%), 6 (16%) from in-hospital complications and 31 (84%) from non-vascular causes after discharge. From the surviving 63 patients (study group) – mean age 83±6 years-old, 29% male, 46% with previous peripheral arterial disease –, 24 underwent bilateral US. Unable to perform imaging on 39 patients due to geographical or mobility issues. At a mean follow-up time of 30±23 months, only 6 patients (10%) reported intermittent claudication, of which 4 (67%) had pre-TAVI symptoms. No patient had at rest symptoms or amputation history. All but one had patent vessel on US. The mean peak systolic velocity of the treated vessel and the contralateral vessel were 71.1±22.9cm/s and 73.1±23.8cm/s, respectively, with no statistically significant difference between them in each patient (mean difference 1.9±25.4, p=0.709). We found no statistically significant differences between peak systolic velocities between both vessels in each patient, accordingly with the treated vessel (Table 2). Conclusion This prospective study shows that patients submitted to percutaneous bailout iliofemoral interventions have a very low rate of lower limb adverse events with very good patency rates at mean follow up of 2.5 years.

Radiological indicators of chronicity in patients with acute symptomatic pulmonary embolism treated with ultrasound-assisted catheter-directed thrombolysis: a study of 180 consecutive cases

Abstract Background Radiological signs of chronic thrombi are present in up to 20% of patients that present acutely with pulmonary embolism (PE). Ultrasound-Assisted Catheter-Directed Thrombolysis (USAT) can swiftly reverse right ventricular dysfunction in patients with acute PE. Purpose To investigate the frequency of radiological signs of chronic PE and pre-existing chronic thromboembolic pulmonary hypertension in patients treated with USAT and their impact on early and long-term hemodynamic and clinical outcomes. Methods The index CT scans of patients receiving USAT for acute intermediate-high and high-risk PE at a tertiary academic institution (2017-2022) were adjudicated by three expert radiologists blinded for treatment scheme and outcomes. Changes in invasively-measured mean pulmonary artery pressure (mPAP) at 24 hours post USAT, presence of post-PE impairment (PPEI), and CTEPH diagnoses after at least 3 months were studied. A total of 15 radiological signs of chronicity were assessed, including 6 major criteria that have been previously validated to raise the suspicion of pre-existing CTEPH. In this study, acute-on-chronic PE was defined when at least 3 of the 6 validated radiological criteria for chronicity were present together with acute findings. Pre-existing CTEPH was defined based on the results of follow-up (vs. index) CT scan and on the anatomical consistency of pathology specimens after pulmonary endarterectomy. PPEI was defined by the presence of residual respiratory symptoms and right ventricular dysfunction during follow-up. Results Of 180 consecutive patients (median age 65 years, 61% men, 17% high-risk PE), 31 had at least 3 of 6 radiological criteria at the time of acute presentation; Table 1. The median modified Miller Score was 24 points and baseline mPAP was 35 mmHg in both groups. The absolute mPAP reduction after USAT was 11 (Q1-Q3: 5-17) mmHg in patients with &amp;lt;3 and 10 (Q1-Q3: 5, 17) mmHg in those with ≥3 criteria; Table 2. Three (1.7%) patients were diagnosed with CTEPH after a median of 3 months and underwent pulmonary endarterectomy: in all 3 patients, CTEPH was pre-existing. At least 3 of the 6 previously validated criteria were present in all CTEPH patients at index CT. In the 3 patients with acute PE on pre-existing CTEPH, the median baseline mPAP was much higher (median 53 mmHg) than in the remaining patient group and the absolute reduction after USAT was 9 mmHg, corresponding to a relative reduction of 19%. During follow-up, PPEI was more frequent in patients with &amp;lt;3 signs (n=4, 2.7%) than in those with ≥3 signs (n=4, 12.9%). Conclusion(s) The evaluation of six radiological parameters in initial CT scans successfully identified all cases of pre-existing CTEPH in patients presenting with acute PE. However, these parameters did not prove effective in determining which patients would benefit from USAT in terms of mPAP reduction.Baseline characteristicsHemodynamic and clinical outcomes

Clinical impact of helicopter transport with a physician in cardiogenic shock complicating acute coronary syndrome

Abstract Introduction Cardiogenic shock (CS) remains the leading cause of death in patients with acute coronary syndrome (ACS). Helicopter transport with a physician may improve the prognosis through reduction of the ischemic time and an early critical care. However, the impact of transfer of a physician-staffed helicopter and outcomes of CS complicating ACS is uncertain. Purpose The aim of the present study was to evaluate compare the clinical characteristics and long-term outcome between helicopter transport with a physician and ground transport in CS complicating ACS patients. Methods We retrospectively investigated 2324 consecutive patients with ACS who underwent primary percutaneous coronary intervention (pPCI) in our institution from January 2004 to December 2017. The primary outcome was cardiovascular (CV) death. Results Among the 2324 eligible patients, 273 ACS patients (11.7%) were complicated by CS. Of 273 CS complicating ACS, a total of 81 (29.7%) patients were transported by helicopter, 166 (60.8%) patients were transported by ambulance, and 26 (9.5%) patients did not use emergency medical service. The mean age was 71 years, 75% of patients were male, STEMI was seen in 87%, and mechanical circulatory support was used in 64%. Kaplan-Meier analysis showed that CV mortality up to 30 days was significantly lower with helicopter transport group compared those with ground transport (P = 0.0407). The rate of long-term CV death was comparable between groups (P = 0.19). Multivariate Cox regression analysis showed helicopter transport was significantly associated with lower 30-day CV mortality (adjusted HR 0.56, 95%CI 0.32-0.99, P = 0.0447). Conclusions Helicopter transport with a physician may improve cardiovascular outcomes of CS complicating ACS.Figure 1.Figure 2.

Clinical characteristics and long-term outcomes of patients with heart failure with supra-normal ejection fraction: data from LECRA-HF registry

Abstract Background Heart failure with preserved ejection fraction (HFpEF) remains insufficiently characterized subgroup of HF with increasing prevalence and limited treatment options. Relationship between clinically assessed left ventricular ejection fraction (LVEF) and survival showed that LVEF ≥65% is associated with higher mortality. Therefore, a novel category of heart failure with supra-normal left ventricular ejection fraction (HFsnEF) was introduced in 2019. However, clinical characteristics and long-term outcomes of HFsnEF patients remain insufficiently elucidated. Purpose We sought to characterize Polish HFsnEF patients and to provide their long-term mortality in comparison to HFpEF. Methods Of 1186 patients enrolled in the single-center Lesser Poland Cracovian Heart Failure (LECRA-HF) Registry between 2009 and 2019 and hospitalized due to HF decompensation 261 (22%) of them were those with LVEF ≥50%. 40 (15.3%) of them were classified as HFsnEF (LVEF ≥65%) and the remaining 221 (84.7%) as HFpEF. The data including patients’ demography, anthropometric measurements, cardiovascular risk factors, prior cardiological treatment and other comorbidities were collected. The long-term follow-up of all-cause mortality was obtained from the Polish National Death Registry. Results HFsnEF patients were less frequently hypertensive (75 vs 88.2%, P=0.026) and had higher baseline LVEF (65 [65-70] vs 55 [50-60] %, P&amp;lt;0.001) than HFpEF subjects. Furthermore, HFsnEF patients presented lower INR (1.1 [1-1.6] vs 1.3 [1.1-1.9], P=0.027) and total protein level (57 [25-63] vs (65.2 [60.2-69.9] g/L, P=0.008) on admission. HFsnEF patients were less frequently treated on discharge with mineralocorticoid receptor antagonists (25 vs 46.2%, P=0.013) as well as loop diuretics (60 vs 76%, P=0.017). The Kaplan-Meier analysis showed that all-cause mortality is higher in HFsnEF than in HFpEF (65.0 vs 55.2%, P=0.044, Figure 1). The independent predictors of long-term mortality were age and diagnosis of HFsnEF (HR 1.037, 95% CI 1.018-1.056 and HR 1.665, 95% CI 1.063-2.608, respectively). Conclusions Our findings indicate that every seventh Polish patient admitted with HFpEF could be classified as HFsnEF. Baseline characteristics of HFsnEF patients are different than HFpEF. Simultaneously, the HFsnEF diagnosis is associated with lower long-term survival.