Reduction In NYHA Class Research Articles

USE OF SGLT2-i IN ELDERLY PATIENTS WITH HFrEF- REAL WORD DATA

Abstract Introduction SGLT2-i have been shown to improve prognosis in patients with reduced ejection fraction heart failure (HFrEF) in randomized clinical trials (RCTs). However, we have little data on the use of these drugs in clinical practice, both in terms of safety and efficacy profile, especially in elderly patients. Objectives To describe the characteristics of HFrEF outpatients who started SGLT2-I and evaluate tolerability and effect of therapy. Results We evaluated 42 patients, 32 M and 10 F, with a mean age of 78±8.2 years (62.1% over 75). At baseline, the mean EF was 34.5%± 6.0 and the patients' renal function calculated with CKD-EPI was 56.3±18.6 ml/min/m2. We followed at 6 months 36 patients. After 6 months of SGLT2i therapy, there was a significant reduction in NYHA class (NYHA I 30.6% vs 9.8%, NYHA III 13.9% vs 31.7%), a slight recovery in EF (38% vs 33% p-value = 0.039) and a decrease in diuretic dose (34 mg/day vs 64 mg/day, p-value 0.033). Despite a slight initial reduction in eGFR, like RCTs, there was recovery of renal function at 6 months. At 6 months, only 2 patients discontinued SGLT2i therapy due to urinary infection. Conclusions In our analysis after 6 months of SGLT2-i therapy in elderly patients, there was clinical improvement as evidenced by improvement in NYHA class and reduction in diuretic therapy. SGLT2-i have been shown to be relatively safe, with no adverse effects occurring and no significant worsening of renal function.

Abstract 19063: An Updated Meta-Analysis Comparing Left Bundle Branch Area Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy

Introduction: Left bundle branch area pacing (LBBAP) is a type of conduction system pacing that has been considered as an alternative to biventricular pacing (BVP) in patients requiring cardiac resynchronization therapy (CRT). Hypothesis: We performed a meta-analysis comparing the clinical and echocardiographic outcomes between LBBAP and BVP in patients requiring CRT. Methods: We performed a systematic literature review in Embase, PubMed, and SCOPUS for all the related articles until November 2022. The literature search yielded 44 publications, of which 6 studies fulfilled the inclusion criteria. The Inverse Variance random effects model was used for continuous variables to calculate Mean Difference (MD) and 95% confidence intervals (CI) and Mantel- Haenszel random effects model was used for dichotomous variables to calculate odds ratio (OR) and 95% confidence intervals (CI). Outcomes analyzed were changed in left ventricle ejection fraction (LVEF), left ventricle end-diastolic dimension (LVEDD), NYHA class, and QRS duration and patients with the echocardiographic response (as defined as LVEF improvement >5%) and heart failure hospitalizations. Results: Over a mean follow up of 8+/-2 months, LBBAP when compared to BVP resulted in significant difference in LVEF improvement (MD = 5.78 % (95% CI [4.75%, 6.80%], P<0.00001), QRS duration reduction (MD = -24.77 ms) (95% CI [-32.78, -16.77], P<0.00001), NYHA class reduction (MD = -0.43, 95% CI [-0.78, -0.08], P=0.02) and number of patients with echocardiographic response (OR = 2.94, 95% CI [1.40-6.14], P=0.004) at follow up. There was no significant difference in LVEDD reduction (MD = -0.5 mm, 95% CI [-3.36, 2.37], P=0.73) and HF hospitalization rates (OR = 0.42, 95% CI [0.11-1.61], P=0.21) between the 2 groups. Conclusions: LBBAP is an effective alternative to BVP in patients with an indication for CRT.

Clinical outcomes of conduction system pacing versus biventricular pacing for cardiac resynchronization therapy: A systematic review and meta-analysis.

Conduction system pacing (CSP) is observed to produce greater improvements in echocardiographic and hemodynamic parameters as compared to conventional biventricular pacing (BiVP). However, whether these surrogate endpoints directly translate to improvements in hard clinical outcomes such as death and heart failure hospitalization (HFH) with CSP remains uncertain as studies reporting these outcomes are scarce. The aim of this meta-analysis was to analyze the existing data to compare the clinical outcomes of CSP versus BiVP. A systematic search of the Embase and PubMed database was performed for studies comparing CSP and BiVP for patients indicated to receive a CRT device. The coprimary endpoints were all-cause mortality and HFH. Other secondary outcomes included change in left ventricular ejection fraction (LVEF), change in NYHA class, and increase in NYHA class ≥1. A random-effects model was chosen a priori to analyze the composite effects given the anticipated heterogeneity of included trials. Twenty-one studies (4 randomized and 17 observational) were identified reporting either primary outcome and were included in the meta-analysis. In total 1960 patients were assigned to CSP and 2367 to BiVP. Median follow-up time was 10.1 months (ranging 2-33 months). CSP was associated with a significant reduction in all-cause mortality (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.56-0.83) and HFH (OR 0.52, 95% CI: 0.44-0.63). Mean improvement in LVEF was also greater with CSP (mean difference 4.26, 95% CI: 3.19-5.33). Reduction in NYHA class was significantly greater with CSP (mean difference -0.36, 95% CI: -0.49 to -0.22) and the number of patients with an increase in NYHA class ≥1 was significantly greater with CSP (OR 2.02, 95% CI: 1.70-2.40). CSP was associated with a significant reduction in all-cause mortality and HFH when compared to conventional BiVP for CRT. Further large-scale randomized trials are needed to verify these observations.

Transthoracic echocardiography guidance of transcatheter tricuspid valve repair

Abstract Funding Acknowledgements Type of funding sources: None. Background Transcatheter edge-to-edge tricuspid valve repair (TTVR) for tricuspid regurgitation (TR) is an emerging treatment option in inoperable patients. TTVR is always guided by transesophageal echocardiography (TOE) and performed under general anesthesia. In patients with excellent acoustic window, transthoracic echocardiography (TTE) can also provide a comprehensive morphological understanding. Moreover, in TTVR there is no need for transseptal puncture. Purpose We investigated if TTVR can be successfully conducted by a novel TTE guiding approach, in conjunction with fluoroscopy, based on the concept of the 4 right-sided chamber views. Methods Thirty TTVR patients were assigned to a TTE (n=10) and a TOE group (n=20), depending on acoustic window and corresponding guidance. Multimodality imaging was paramount for procedural planning and included TTE, TOE and cardiac CT, from which the corresponding fluoroscopic angulations of the 4 right-sided chamber views were derived. Thus, interventionalists and cardiac imaging specialists were assessing the same chamber views from their respective imaging modality. TR severity and quality of life parameters were assessed at baseline and up to 12 months. Results Except for lower BMI (TTE 22.3±0.8 vs TOE 29.8±4.3, p<0.001), baseline characteristics were similar between groups e.g., age (81.7±3.9 vs 82.8±4.1, p = 0.483) or EuroSCORE II (11.9±10.3 vs 10.4±8, p = 0.692). Device success was achieved in all patients, with a total of 15 implanted clips in the TTE (clips / patient 1.5±0.7) vs 31 clips in the TOE group (1.5±0.6), and device times of 75±37.1 vs 65.7±31.3 minutes (p = 0.506). TR reduction was successful in all but one patient, in each group (90% vs 95%, p = 1.000). TR improvement was equal between-groups, with 2- or more grade reduction in 60% of cases, at 30 days. No device associated complications occurred. Nine patients in the TTE group and 17 in the TOE group completed one-year follow-up. Quality of life and functional capacity similarly improved in both groups, with NYHA class reduction in all survivals [100% (9/9) vs 95% (17/17), p = 1.000], and significant improvement in KCCQ score and 6-minute walk distance in each respective group (∆24.8±21.4 vs 20.1±13.6 points, p = 0.227; ∆93.5±100.4 vs 80.8±64 meters, p = 0.121). TR reduction impacted major organs e.g., liver and kidney. Thus, glomerular filtration rate (GFR) increased [TTE group 56.8±18.7 vs 64.6±14.9 ml/m2/1,73m2, p = 0.050; TOE group 50.7±19.9 vs 53.8±20.9, p = 0.347], while liver congestion parameters decreased e.g, aspartate aminotransferase (AST) [TTE group 28.6±7.5 vs 26.2±8.6 U/L, p = 0.274; TOE group 33.1±5.8 vs 23.6±9, p = 0.388]. Conclusions TTE guidance of TTVR is feasible in selected patients with excellent acoustic window and represents an alternative to TOE or, in combination, may facilitate transition to conscious sedation. Successful TTVR leads to improvement in quality of life, symptom control, and multiorgan function.

P85 REAL WORLD EXPERIENCE ON THE USE OF SGLT2–I IN ELDERLY PATIENTS WITH HFREF

Abstract SGLT2–i have been shown to improve prognosis in patients with heart failure with reduced ejection fraction (HFrEF) in randomized clinical trials (RCTs). However, at the moment, we have little data on the use of these drugs in clinical practice, both in terms of safety and efficacy profile. Objectives To describe the characteristics of HFrEF outpatients who started SGLT2–i in clinical practice; evaluate tolerability and the effect on clinical and biohumoral parameters. Methods We prospectively analyzed patients who started SGLT2–i in our Heart Failure clinic. The baseline characteristics, the variations of bio–humoral and clinical parameters were recorded, as well as the onset of adverse effects leading to drug suspension after one month. Results We evaluated 37 patients, with a mean age of 77.7± 8.5 years (65% over 75). The baseline characteristics of the population compared to that of the treatment arms of the RCTs are shown in Fig.1. Most patients were in NYHA II (62%), with ischemic etiology (65%), with reduced EF (mean 34.7± 5.1%) and nearly half of the patients received ICD or CRT–D (43.2%). At the one month follow–up, there was a significant reduction in NYHA class (Fig. 2)and furosemide dose (36.3 vs 53.2 mg, p<0.001), without a significant change in NTproBNP values ​​(2499 vs 2431 pg /mL, p=0.804). Furthermore, there was a reduction in systolic blood pressure (115 vs 120 mmHg, p=0.029) with no significant increase in the incidence of orthostatic hypotension (27% vs 21%, p=0.48). In line with the trials, there was a slight, non–significant worsening of renal function (CKD–EPI 52.9 vs 55.9 mL/min, p=0.10). At one month, no patients experienced any adverse effects leading to SGLT2–i discontinuation. Conclusions In this preliminary analysis, after one month of SGLT2–i therapy in elderly patients, there was a clinical and hemodynamic improvement as demonstrated by the improvement of the NYHA class and the reduction of the diuretic therapy. SGLT2–i have been shown to be relatively safe, with no adverse effects and no increased risk of orthostatic hypotension or significant worsening of renal function.

P311 PULSED INFUSIONS OF LEVOSIMENDAN IN OUTPATIENTS WITH ADVANCED HEART FAILURE

Abstract Background Several non–randomized studies and small registries showed the efficacy of pulsed levosimendan infusion in relief of symptoms and preventing hospitalization in patients with advanced heart failure excluded by age or comorbidity from heart transplant program Aim of the study to describe the experience of pulsed levosimendan infusion in patient with advanced heart failure followed by the Division of Cardiology at "Villa Sofia" Hospital in Palermo Materials and methods we collected data of patient with adavced heart failure (NYHA III–IV) with reduced ejection fraction, who underwent pulsed levosimendan infusione at Division of Cardiology at "Villa Sofia" Hospital. Reduction of NYHA class, body weight and Nt–pBNP were examined as outcome indicators Results Between July 2021 an December 2022, fifhteen levosimendan infusion were made in five patient with advanced heart failure. Levodimendan was adminestered for a 24–hours infusion, as therapeutic day–hospital regimen. in the population of analysis, the following mean parameters were recorded at admission: NYHA class 3.2, furosemide dose 390mg, Nt–pBNP 10710pg/ml, body weight 72.8Kg, glomerualr filtration rate (GFR MDRD) 44ml/min. At discharge, the following mean parameters were recorded: NYHA class 2.1, Nt–pBNP 9225pg/ml, body weight 70.7Kg. One patient dead of sudden cardiac death during follow–up, one patient refused to continue treatment, the remaining three patient are still on treatment. Conclusions In our center experience, pulsed levosimendan infusion in patient with advanced heart failure determined an improvement of clinical and instrumental signs of congestion. Patients treated reported a subjective improvement of symptoms and of quality of life, also as a consequence of the reduction of the hospitalizations for heart failure. Although data ara scarce, they can be considered representative of a pilot experience of an integrated modality of assistance for patient with advanced heart failure, in which the sinergy between cardiology ward, a strict follow–up at the heart failure outpatient clinic are essential to obtain a good outcome in patient with such high complexity and frailty.

177 TRANSCATHETER EDGE-TO-EDGE REPAIR OF SEVERE FUNCTIONAL MITRAL REGURGITATION TO OVERCOME ACUTE DECOMPENSATION IN A YOUNG MAN CANDIDATE TO HEART TRANSPLANTATION.

Abstract Background Chronic severe functional mitral regurgitation (FMR) is common in patients with HF as it reflects left ventricle dysfunction and portends poor prognosis. Case report A 42 years old man with cardiovascular risk factors (former smoker, obesity) but without previous cardiological history presented anterior ST-elevation myocardial infarction (STEMI) treated with primary PCI of the anterior descending artery. He developed severe ventricular dysfunction leading to congestive heart failure (HF) requiring early re-hospitalization for pulmonary edema. Despite optimal medical therapy patient remained symptomatic (NYHA class III, INTERMACS 6) with persistence of left ventricle ejection fraction (LVEF) depression, therefore he received an implantable cardiac defibrillator for primary prevention and was referred to our institution for further evaluation. Trans-esophageal echocardiography showed severe left ventricle dilatation and disfunction (EDD 6.9 cm, iEDV 113 ml/m2, LVEF 24%) and presence of severe FMR with EROA 37 mm2 and RV 44 ml. Right heart catheterization (RHC) revealed combined pulmonary hypertension (mean PA pressure 43 mmHg, PCWP 32 mmHg, PVR 4.6 WU) with severely reduced cardiac index obtained (CO 3.4 l/min, CI 1.9 l/min/m2). After infusion of inodilator (enoximone) a decrease of PA pressure and PVR was reported, concluding for reversible pulmonary hypertension. After screening for non-cardiac contraindications, the patient was listed for heart transplantation. Chances to get a donation with a short waiting list time were low because of patient's high BMI and blood group B. Therefore, after Heart Team evaluation, transcatheter edge-to-edge repair of the mitral valve (TEER) was performed as bridge to transplant. A single NTR clip was used, placed centrally between A2-P2 segments, reducing regurgitation from severe to mild. Patient was discharged on heart transplantation waiting list. At three months follow up he presented clinical improvement with reduction of NYHA class from III to II. RHC was repeated and showed normal filling pressures, reduction of pulmonary pressure (mPAP 20 mmHg) and increased cardiac output (CO 5.2 l/min, CI 2.5 l/min/m2). According to his preferences, the patient was suspended from the waiting list with indication to continue outpatient follow-up. At 1-year control he was stable in NYHA II class and the daily diuretic dose had been reduced, echocardiography showed severe LVEF depression (28%) with mild to moderate residual mitral regurgitation. Conclusions TEER recently emerged as an option for patients with FMR who are not suitable for surgery. Latest guidelines suggest its use in presence of specific criteria (LVEF 20-50%, ESD < 7 cm, sPAP <70 mmHg, hemodynamic stability, absence of right ventricle disfunction and severe TR) rarely fulfilled by patients with advanced HF requiring evaluation for transplant. On the other hand, access to surgical strategies for end stage HF is limited by scarce availability of donors and by temporary or definitive contraindications. Evidences are emerging that in this population TEER can improve hemodynamic profile and lead to reduction of pulmonary hypertension, providing temporary stability before definitive treatment or allowing candidacy. In this setting, TEER might be performed to reduce symptoms. Considering TEER as bridge strategy to transplant, candidacy or decision can expand the number of patients suitable for heart transplantation or delay urgency.

Abstract 14258: Left Bundle Branch Pacing for Cardiac Resynchronization Therapy in Heart Failure: A Systematic Review and Meta-Analysis

Introduction: : Cardiac resynchronization therapy (CRT) using a biventricular pacemaker (BVP) reduced mortality and rehospitalizations in patients with symptomatic heart failure (HF) with a left ventricular ejection fraction (LVEF) of less than 35% and concomitant left bundle branch block. However, 10-30% of BVP patients fail to show a clinical or echocardiographic response. Recently left bundle branch pacing (LBBP) has been studied as a more physiological alternative to BVP. The aim of this study is to summarize the available evidence on LBBP. Hypothesis: LBBP is an effective and feasible alternative option for CRT. Methods: Unrestricted searches of the PubMed, EMBASE, and Cochrane databases from inception till June 1, 2022, for studies examining the role of LBBP for CRT in HF patients. Data were analyzed using Revman 5.3 software. Mean Difference (MD), Odds Ratio (OR), and 95% Confidence interval (CI) were calculated using the random-effects model. Results: A total of 8 observational studies (3 single-armed, and 5 comparative studies) examined 756 HF patients who underwent CRT (551 LBBP vs 205 BVP). LBBP was successful in 87% of patients. Compared to baseline, LBBP was associated with a reduction in QRS duration (MD -53.5, 95%CI -69.77, -37.24), an increase in LVEF (MD 17%, 95%CI 13.38, 20.6), and a reduction in NYHA class (MD -1.4, 95%CI -1.56, -1.05). Compared to BVP, LBBP was associated with a significant reduction in QRS duration (MD -22.68, 95%CI -31, -14.35), improvement in LVEF (MD 7.58, 95%CI 5.21, 9.95), and a decrease in NYHA class (MD -0.55, 95% CI -0.73, -0.37) during a mean follow-up of 9.2 months. The super response rate, which is defined as an increase in LVEF of more than 20% or LVEF at or above 50% after CRT, was higher in LBBP compared to BVP (OR 2.98, 95%CI 1.65, 5.32). Conclusions: LBBP is a feasible and effective alternative for CRT. LBBP was associated with better electrical ventricular synchrony than BVP which was also translated into better echocardiographic and clinical outcomes in the short term. Our findings need to be further validated in larger randomized controlled trials with a long-term follow-up.

Transthoracic echocardiography guidance of transcatheter edge-to-edge percutaneous tricuspid valve repair: the TTE-TTVR pilot study and methodology proposal

Abstract Background Transcatheter tricuspid valve repair (TTVR) is an emerging option for treating high-grade tricuspid regurgitation (TR) [1], mostly performed by edge-to-edge repair, and always guided by transesophageal echocardiography (TOE). In patients with excellent acoustic window, transthoracic echocardiography (TTE) can also provide a comprehensive understanding of tricuspid valve (TV) morphology [2]. Also, in TTVR there is no need for transseptal puncture. Purpose We sought to determine if TTVR can be successfully conducted by a novel TTE guiding approach, in conjunction with fluoroscopy [3]. Methods 30 consecutive patients, scheduled for TTVR, were assigned to a TTE group (n=10), in the presence of excellent acoustic window, and a TOE group (n=20). On top of fluoroscopy, TTVR was guided exclusively by TTE in the first group, with TOE result confirmation solely upon clip release, due to safety reasons. The second group underwent classical TOE guidance. Understanding the 4 right heart chamber views (Fig. 1) and their respective fluoroscopic angulations was paramount. TR severity, parameters of quality of life and functional capacity were assessed and compared between-groups, at baseline and 30 days. Results Except for lower BMI (TTE 22.3±0.8 vs TOE 29.8±4.3, p<0.001), other baseline characteristics were very similar between groups, e.g., age (81.7±3.9 vs 82.8±4.1, p=0.483) or EuroSCORE II (11.9±10.3 vs 10.4±8, p=0.692).Device success was achieved in all patients, with a total of 15 implanted clips in the TTE group (mean no. of clips / patient 1.5±0.7) and 31 clips in the TOE group (1.5±0.6). Device time (75±37.1 vs 65.7±31.3 minutes, p=0.506) and fluoroscopy duration (16.3±10.5 vs 14.4±7.2 minutes, p=0.564) were also close. TR reduction was successful in all but one patient, in each group (90% vs 95%, p=1.000). TR improvement was equal between-groups, with 2 or more grade reduction in 60% of each group, at 30 days. Thus, grade IV/V and V/V TR, present in 60% of all patients at baseline, dropped to 10% (9/10 vs 18/20, p=1.000) by procedure end and follow-up (Fig. 2). No device associated complications occurred. By 30 days, there was one non-cardiac death and one major bleeding. At follow-up, all but one patient had at least one grade reduction in NYHA class (10/10 vs 19/20, p=1.000). Kansas City Cardiomyopathy Questionnaire score and 6-minute walk distance similarly improved (Δ20.7±14.9 vs 15.5±7.9 points, p=0.227; Δ80.5±60.1 vs 46.6±30.6 meters, p=0.121). A statistical in-group difference was also noticed in renal function improvement by follow-up [glomerular filtration rate (GFR) TTE group 56.8±18.7 vs 64.8±12.5 ml/m2/1.73 m2, p=0.028; TOE group 50.7±19.9 vs 62.2±25.9, p=0.001]. Conclusion TTE guidance of TTVR is feasible in selected patients with excellent acoustic window and could offer an alternative in case of high anesthetic risk. Similar procedural success and clinical outcomes, as with TOE guidance, can be achieved. Funding Acknowledgement Type of funding sources: None.

Long-term results of catheter ablation of atrial fibrillation in patients with a reduced left ventricular ejection fraction

Abstract Objective This study aims to evaluate long-term results after catheter ablation of atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF) and to evaluate sinus rhythm (SR) maintenance, clinical status, and echocardiographic parameters in the long-term follow-up period. Material and methods The study included 112 patients (75.5% men, age 59.5±11.5 years) with LV EF <50% underwent radiofrequency catheter ablation for paroxysmal (24%) or persistent (76%) AF. Patients after ablation were followed up for 38.4 (17.7–54.5) months for AF recurrence, functional class, and echocardiographic parameters. Results All patients underwent complete antral isolation of the pulmonary veins, and 95 (84.8%) underwent additional linear ablations in the left atrium. During the follow-up period, 48 (42.8%) patients experienced arrhythmia recurrence in the form of AF, atrial flutter, or ectopic atrial tachycardia. Repeated ablations were required in 35 (31.2%) patients. After ablation, antiarrhythmic drugs continued to be taken in 75 (66.9%) patients. During follow-up, NYHA class improved at least one class more often among patients in stable sinus rhythm than patients with recurrences (77.5% vs 51.2%, p=0.003). LV EF improved in patients maintaining sinus rhythm (36.6% vs 19.4%; P=0.016), and the degree of mitral regurgitation was significantly reduced (P<0.001) only in these patients. On multivariate analysis, maintenance of sinus rhythm was an independent predictor (odds ratio 4.56, 95% CI 1.69–9.94, P=0.002) of long-term clinical improvement (reduction in NYHA class ≥1 and relative improvement in LVEF ≥10%). Conclusions In patients with reduced LV EF, maintenance of sinus rhythm after ablation is associated with more significant clinical improvement. In the long-term period, the effectiveness of AF ablation in patients with reduced LVEF, as an improvement in the NYHA class and an increase in LVEF, is affected by a high rate of long-term recurrences. Funding Acknowledgement Type of funding sources: None.

Association of Repetitive Dosing of Levosimendan with Reduction of NYHA Class and NT-proBNP Levels in Decompensated Heart Failure: A Retrospective Cohort Study.

BackgroundThere is evidence that repetitive administration of levosimendan can improve outcome in chronic heart failure patients.ObjectiveThe aim of this retrospective study was to investigate the effect of therapy with levosimendan (LEV) additional to standard medical care in patients with symptomatic heart failure (HFrEF = heart failure with reduced ejection fraction) on NYHA class, NT-proBNP values, ejection fraction (EF) and body weight.Patients and Methods178 participating patients (125 male, 53 female; mean age of 73 ± 13 years) were grouped according to whether LEV was given once (group 1) or repetitively (group 2). In group 2 data were analysed for first treatment with LEV (group 2a) and for the following repetitive LEV treatments (group 2b). The differentiation was required to see if there were different results for the particular groups.ResultsRepetitive dosing was given between two and 11 times, leading to 47 repetitive applications of LEV and a total of 225 (178 once + 47 repetitive) applications. The mean time between the repetitive dosing was 133 days or 4.3 months. LEV in addition to standard medical treatment was associated with reduction of NT-proBNP levels from 9138 to 7051 pg/mL (p < 0.05). The corresponding values in group 2a and group 2b were 8790–4717 pg/mL (p < 0.05) as well as 13,681–7581 pg/mL (p < 0.05). The ejection fraction measured by echocardiography improved from 30 to 38% in group 1, from 31 to 45% in group 2a and from 30 to 35% in group 2b (p < 0.05). Addition of LEV was associated with significant reduction of NYHA class and bodyweight in all groups. No adverse side effects (e.g., rhythm disorder, hypotension, electrolyte disorder) were seen.ConclusionLEV may be useful as an additive to standard care of treatment for patients with acute de novo decompensation due to acute heart failure as well as to prevent further deterioration in patients with chronic heart failure disease at high risk for hospitalisation. Intraindividual changes in NT-proBNP levels may be useful in decision-making about the need for additional treatment options in patients with worsening heart failure.

Cardio-vascular remodelling during sacubitril/valsartan therapy in patients with heart failure and reduced ejection fraction

Abstract Funding Acknowledgements Type of funding sources: None. Background Sacubitril/valsartan (S/V) benefits in patients with heart failure and reduced ejection fraction (HFrEF) are partially related to cardiac reverse remodelling, in terms of volumes reduction and function improvement. Effects on vascular remodeling are less investigated. Purpose To evaluate cardiac and vascular remodelling in a cohort of patients with HFrEF after six months of therapy with S/V. Methods 50 patients with HFrEF eligible to start a therapy with sacubitril/valsartan were enrolled. Clinical evaluation and standard and advanced echocardiography were performed at baseline and after six months of follow up (FU). Standard left ventricular dimension and function parameters, global longitudinal strain (GLS) were calculated. Non-invasive pressure-volume curves (P-V loop) estimation was assessed with an off-line dedicated software using ST-E derived time-resolved LV volumes and brachial pressure as input. The following hemodynamic parameters were calculated based on P-V loop curves: left ventricular elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (VAC). Results At six months F/U, a reduction of NYHA class in the vast majority of patients was detected (NYHA Class ≥ II, baseline vs F/U = 100% vs 50%; p&amp;lt; 0,001). Systolic and diastolic blood pressure were lower, in comparison with baseline values (119 ± 16 vs 126 ± 11 mmHg; p = 0,002 and 71 ± 8 vs 78 ± 8 mmHg; p = 0,001, respectively). At echocardiographic evaluation, left ventricular end-diastolic and end-systolic volumes decreased (p&amp;lt; 0.001 and p&amp;lt; 0,001, respectively) and ejection fraction and GLS significantly improved (p&amp;lt; 0.001 and p &amp;lt; 0.001, respectively). Moreover, a significant reduction of Ea and a significant improvement of Ees and VAC were observed (p = 0.008, p&amp;lt; 0,001 and p&amp;lt; 0,001, respectively). Conclusion Therapy with S/V in HFrEF patients determines both cardiac and vascular remodelling reflecting the complex mechanisms behind clinical improvement. Abstract Figure.

The Effect of TAVR on Left Ventricular and Left Atrial Mechanics in Patients with Aortic Stenosis.

Background. Measures of adverse cardiac remodeling, left ventricular global longitudinal strain (LVGLS) and left atrial (LA) phasic function, are predictive of cardiac events in patients with severe aortic stenosis (AS). How these parameters of cardiac function change following TAVR requires further investigation. Methods. A number of 109 consecutive patients with symptomatic severe AS who were seen in the heart valve clinic between 2014 and 2019 for TAVR were included. All patients underwent echocardiographic assessment prior to and 30 days following TAVR, with LVGLS and LA phasic function evaluation using 2D speckle-tracking echocardiography. Heart failure hospitalization, and death were assessed at 12 months. Results. The mean age of the study cohort was 81 ± 7.3 years. Following TAVR, there was a significant reduction in NYHA class III/IV symptoms [89 (82%) vs. 12 (11%), p < 0.01], and median mean aortic valve gradient [44 mmHg (16) vs. 9 mmHg (7), p < 0.01]. There was no significant change in the median LVEF [62% (13) vs. 62% (6.0), p = 0.2]; however, the LVGLS significantly increased following TAVR [15 ± 3.5% vs. 18 ± 3.3%, p < 0.01]. The median LA reservoir, conduit and contractile function significantly improved following TAVR [22.0% (14.0) vs. 18.0% (14.0) p < 0.01, 8.9% (5.4) vs. 7.8% (4.8) p < 0.01, 12% (11.0) vs. 9.6% (11.0) p < 0.01, respectively]. The incidence of death or heart failure hospitalization at 12 months was low, and occurred in eight patients (7.3%). Conclusions. TAVR results in significant short-term reverse LV and LA remodeling, as shown by improvement in LV GLS and all three components of LA phasic function, despite no change in the LVEF. The findings indicate the possible utility of strain imaging for the assessment of global LV and LA function following TAVR.

511 Cardio-vascular remodelling during sacubitril/valsartan therapy in patients with heart failure and reduced ejection fraction

Abstract Aims Sacubitril/valsartan (S/V) benefits in patients with heart failure and reduced ejection fraction (HFrEF) are partially related to cardiac reverse remodelling, in terms of volumes reduction and function improvement. Effects on vascular remodelling are less investigated. To evaluate cardiac and vascular remodelling in a cohort of patients with HFrEF after 6 months of therapy with S/V. Methods and results 50 patients with HFrEF eligible to start a therapy with sacubitril/valsartan were enrolled. Clinical evaluation and standard and advanced echocardiography were performed at baseline and after 6 months of follow-up (FU). Standard left ventricular dimension and function parameters and global longitudinal strain (GLS) were calculated. Non-invasive pressure-volume curves (P-V loop) estimation was assessed with an off-line dedicated software using ST-E derived time-resolved LV volumes and brachial pressure as input. The following haemodynamic parameters were calculated based on P–V loop curves: left ventricular elastance (Ees), arterial elastance (Ea), and ventricular-arterial coupling (VAC). At 6 months F/U, a reduction of NYHA class in the vast majority of patients was detected (NYHA Class ≥ II, baseline vs. F/U = 100% vs. 50%; P &amp;lt; 0.001). Systolic and diastolic blood pressure were lower, in comparison with baseline values (119 ± 16 vs. 126 ± 11 mmHg; P = 0.002 and 71 ± 8 vs. 78 ± 8 mmHg; P = 0.001, respectively). At echocardiographic evaluation, left ventricular end-diastolic and end-systolic volumes decreased and ejection fraction and GLS significantly improved (Table). Moreover, a significant reduction of Ea and a significant improvement of Ees and VAC was observed (Table). 511 Table 1 Conclusions Therapy with S/V in HFrEF patients determines both cardiac and vascular remodelling reflecting the complex mechanisms behind clinical improvement.

Early symptomatic benefit indicates long-term prognosis after transcatheter mitral valve edge-to-edge repair in functional and degenerative etiology

BackgroundMitral regurgitation (MR) is common in patients with heart failure and constitutes an independent risk factor for adverse prognosis besides NYHA-class. The predictive value of dyspnea reduction after transcatheter mitral valve repair (TMVr) on outcome has not been investigated up to now. Methods and resultsWe enrolled 627 consecutive patients (47.0% female, 57.4% functional MR; median follow-up 486 days[IQR 157/961]; survival status available in 96.8%; symptoms assessed in n = 556 at baseline / n = 406 at 1 month) treated with isolated percutaneous mitral valve edge-to-edge repair in our center from 06/2010–03/2018 (exclusion of combined forms of TMVr) in a monocentric retrospective analysis. Survival was 97.6% at discharge, 73.9% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7-years. Before TMVr, NYHA-classes III/IV were found in 89.0%. Of these, 74.7% reported symptomatic relief (reduction in NYHA-class) one month after procedure (NYHA class recorded in 406 patients at 30 days). NYHA-classes III/IV were documented in 37.2% (p < 0.001) at 30 days and in 36.6% (p < 0.001) at 1 year without significant changes between the follow-ups. Dyspnea reduction was accompanied by significantly improved long-term survival (1 year, 89.1 vs 71.2%, p = 0.001, 2 years: 75.5 vs 58.7%, p = 0.039) and was identified as an independent predictor for lower mortality (1-year HR for increased mortality by missing symptomatic improvement 2.94 [95%CI 1.53–5.65], p = 0.001; long-term HR 1.95 [95%CI 1.29–2.94], p = 0.001) independently in both etiologies of MR. ConclusionTMVr by edge-to-edge therapy enables early and sustainable symptomatic improvement in nearly 75% of the symptomatic patients. The simple assessment of postinterventional changes in NYHA-class might serve as an independent predictor for mid- and long-term prognosis in both FMR and DMR.

Improvement of LV Reverse Remodeling Using Dynamic Programming of Fusion-Optimized Atrioventricular Intervals in Cardiac Resynchronization Therapy

Background: The patient-tailored SyncAV algorithm shortens the QRS duration (QRSd) beyond what conventional biventricular (BiV) pacing can. However, evidence of the ability of SyncAV to improve the cardiac resynchronization therapy (CRT) response is lacking. The aim of this study was to evaluate the impact of CRT enhanced by SyncAV on echocardiographic and clinical responses.Methods and Results: Consecutive heart failure (HF) patients from three centers treated with a quadripolar CRT system (Abbott) were enrolled. The total of 122 patients were divided into BiV+SyncAV (n = 68) and BiV groups (n = 54) according to whether they underwent CRT with or without SyncAV. Electrocardiographic, echocardiographic, and clinical data were assessed at baseline and during follow-up. Echocardiographic response to CRT was defined as a ≥15% decrease in left ventricular end-systolic volume (LVESV), and clinical response was defined as a NYHA class reduction of ≥1. At the 6-month follow-up, the baseline QRSd and LVESV decreased more significantly in the BiV+SyncAV than in the BiV group (QRSd −36.25 ± 16.33 vs. −22.72 ± 18.75 ms, P < 0.001; LVESV −54.19 ± 38.87 vs. −25.37 ± 36.48 ml, P < 0.001). Compared to the BiV group, more patients in the BiV+SyncAV group were classified as echocardiographic (82.35 vs. 64.81%; P = 0.036) and clinical responders (83.82 vs. 66.67%; P = 0.033). During follow-up, no deaths due to HF deterioration or severe procedure related complications occurred.Conclusion: Compared to BiV pacing, BiV combined with SyncAV leads to a more significant reduction in QRSd and improves LV remodeling and long-term outcomes in HF patients treated with CRT.

Sex differences in CRT device implantation rates, efficacy, and complications following implantation: protocol for a systematic review and meta-analysis of cohort studies

IntroductionThere is abundant evidence for sex differences in the diagnosis, implantation, and outcomes for cardiac resynchronization therapy (CRT) devices. Controversial data suggesting women are less likely to receive the device regardless of the greater benefit. The aim of this review is to assess sex differences in the implantation rate, clinical effectiveness, and safety of patients receiving CRT devices.MethodsWe will conduct a systematic literature search of MEDLINE, Embase, and Web of Science to identify cohort studies that meet our eligibility criteria. Title and full text screening will be conducted in duplicate independently. Eligible studies report clinical effectiveness or safety of patients receiving CRT device while providing sex-disaggregated data. Implantation rate will be extracted from the baseline characteristics tables of the studies. The effectiveness outcomes include the following: all-cause death, hospitalization, peak oxygen consumption (pVO2), quality of life (QoL), 6-min walk test, NYHA class reduction, LVEF, and heart failure hospitalization. The complication outcomes include the following: contrast-induced nephropathy, pneumothorax, pocket-related hematoma, pericardial tamponade, phrenic nerve stimulation, device infection, death, pulmonary edema, electrical storm, cardiogenic shock, and hypotension requiring resuscitation. Description of included studies will be reported in detail and outcomes will be meta-analyzed and presented using forest plots when feasible. Risk of bias will be assessed using the Newcastle-Ottawa Scale (NOS) by two review authors independently. GRADE approach will be used to assess the certainty of evidence.DiscussionThe aim of this review is to determine the presence of differences in CRT implantation between women and men as well as differences in clinical effectiveness and safety of CRT after device implantation. Results from this systematic review will provide important insights into sex differences in CRT devices that could contribute to the development of sex-specific recommendations and inform policy.Systematic review registrationPROSPERO CRD42020204804

Incidence and clinical relevance of persistent iatrogenic atrial septal defect after percutaneous mitral valve repair

Percutaneous mitral valve repair (PMVR) requires transseptal puncture and results in iatrogenic atrial septal defect (iASD). The impact of persistent iASD was previously investigated. However, data were diverse and inconclusive. 53 patients who underwent MITRACLIP were retrospectively included. Based on the presence of iASD in transesophageal echocardiography (TEE) after 6 months, patients were divided in two groups (iASD group vs. non-iASD group). Impact of iASD on outcome at 6 months and at two years was evaluated. Persistent iASD was detected in 62% of patients. Independent predictors for persistent iASD were female gender and reduced left ventricular ejection fraction. At 6-month follow-up, there was no difference in reduction of NYHA class (ΔNYHA = 1.3 ± 1 in iASD group vs. 0.9 ± 1 in non-iASD group, p = 0.171). There was a significant difference in right ventricular end diastolic diameter (RVEDd) (42 ± 8 mm in iASD-group vs. 39 ± 4 mm in non-iASD group, p = 0.047). However, right ventricular systolic function (TAPSE) (14 ± 7 mm in iASD group vs. 16 ± 8 mm in non-iASD group, p = 0.176) and right ventricular systolic pressure (RVSP) (40 ± 12 mmHg in iASD group vs. 35 ± 10 mmHg in non-iASD group, p = 0.136) were still comparable between both groups. At 2 years follow-up, there was no significant difference regarding rate of rehospitalization (24% vs 15%, p = 0.425) or mortality (12% vs 10%, p = 0.941) between both groups. Incidence of persistent iASD after MITRACLIP is markedly high. Despite the increase in right ventricular diameter in patients with persistent iASD, these patients were not clinically compromised compared to patients without persistent iASD.

Feasibility and effectiveness of transcatheter aortic valve implantation in adults with congenital heart disease

AimThis study sought to evaluate the feasibility and effectiveness of TAVI for treatment of aortic stenosis in the ACHD population. Methods and resultsReview of 802 patients that underwent TAVI from January 2008 to November 2019. 13 ACHD patients with different underlying congenital anatomy were identified (isolated bicuspid aortic valve was excluded and not defined as ACHD). The main endpoints were: paravalvular aortic regurgitation> grade 2 post-procedure, and all-cause 30-day mortality. Periprocedural and post-procedural complications were defined according to the UK TAVI registry. Median age was 66.7 years (range 29–84 years). Eleven patients had severe aortic stenosis (AS), 1 had both severe AS and severe aortic regurgitation (AR) and 1 had severe AR. Median hospital stay was 9 days (range 6–28 days). One patient required a pacemaker post-TAVI. No mortality or paravalvular AR > grade 2 at 30-days. Twelve patients had a reduction in NYHA class on their first post TAVI follow-up. ConclusionTAVI is viable option as an alternative to surgery for ACHD patients. Further experience with the use of TAVI in the ACHD patients is required to assess long-term outcomes in this unique group of patients.

P898 Role and evolution of the right ventricle in heart failure patients treated with cardiac resynchronization therapy delivered by left ventricle pacing alone

Abstract Funding Acknowledgements This work was supported by CREDO Project - ID: 49182, financed through the SOP IEC -A2-0.2.2.1-2013-1 cofinanced by the ERDF. Background Cardiac resynchronization therapy (CRT) is an effective treatment for patients with heart failure (HF) with reduced ejection fraction. Biventricular pacing is the most common mode of delivering CRT. However, several studies have demonstrated non-inferiority of LV pacing alone. There are several trials about the role and evolution of right ventricle (RV) systolic function in CRT patients delivered by biventricular pacing showing that RV function is an independent predictor of long-term outcome following CRT, and improvement in RV function after CRT. Purpose To examine if RV function and dimensions prior to CRT could have an impact on CRT response and assessment of the evolution of RV function after 1 year follow up in patients with LV pacing alone. Methods 22 patients with a mean age of 63 ± 10.6 years including 9 (40,9%) females and 13 man (59,1%), with HF (EF &amp;lt; 35%, LBBB &amp;gt; 120 ms, or non-LBBB &amp;gt; 150 ms, with NYHA II to IV) were enrolled and underwent CRT implantation LV pacing alone . Each patient benefited from standard two dimensional (2D) echocardiography, tissue Doppler imaging, with assessment of Left ventricular (LV) end-diastolic (LVEDV), and end-systolic volumes (LVESV), ejection fraction, RV maximum basal (RVD basal), TAPSE, fractional area change (FAC), and tricuspid lateral annular systolic velocity (S′) , RV TEI index , RV systolic pressure using Bernoulli equation, at inclusion before CRT and 12 ± 2 months after CRT implantation. Patients presenting with reductions of LVESV of &amp;gt;15% were termed volumetric responders for further statistical analysis and patients with reduction of NYHA class were termed clinical responders. Results 14 patients (63.63 %) cases were volumetric responders and 21 patients were clinical responders showing an improvement in NYHA class at one year. 1 patient died. Among echocardiographic parameters of RV: RVD basal , TAPSE , FAC , TEI index, RV systolic pressure (p &amp;lt; 0.01) were good predictors for volumetric response proving that a dilated RV with poor systolic function may be a predictor for non response to CRT even in patients with LV alone pacing. TAPSE and FAC have the best AUC for prediction of response to CRT therapy.We proposed cutoff values for predicting response versus non response to CRT therapy TAPSE 16.6mm (AUC 0.827, 95% CI, p &amp;lt; 0.05, sensibility 100%, specificity 71.4% ) and FAC 36% (AUC 0.826, 95%CI, p &amp;lt; 0.05, specificity 91%, sensibility 66%) and RVD basal 37,5mm (AUC 0.805, 95%CI, p = 0.03, sensibility 63%, specificty 85%). In volumetric non-responders, RV function improves at one year follow up with an increase in TAPSE (p = 0.008) and a decrease of RV TEI index (p = 0.04). Conclusions LV pacing alone CRT improves RV systolic function and may account for clinical benefit in patients without LV function improvement at one year follow-up. RV systolic function and dimensions before CRT implantation could predict response to LV pacing alone CRT therapy.