Improvement In NYHA Class Research Articles

Transcatheter edge-to-edge mitral valve repair in atrial functional mitral regurgitation: insights from the multi-center MITRA-TUNE registry

BackgroundA-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR). MethodsThe study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes. ResultsAfter reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371–21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057–16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up. ConclusionsMitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients.

Abstract 12557: Echo-Guided vs. Device-Based Strategies for Optimization of Cardiac Resynchronization Therapy and Long-Term Clinical Outcomes: A Meta-Analysis

Introduction: CRT optimizations has the potential to improve the 30% non-response rate. Randomized trials (RCTs) comparing device and echo-guided CRT optimization have been overall small and results have been conflicting. Methods: We searched the EMBASE and MEDLINE databases from January 2008 through September 2020 for RCTs and prospective observational studies that randomized patients to either echo-guided or device-based CRT optimization. Included studies had to report on at least one of the following outcomes of interest: all-cause mortality, heart failure hospitalization (HFH), NYHA class improvement, mean EF at follow up, LVEDD, 6MWD, and QoL. A meta-analyses on the outcomes of interest was performed using random effects models. Results: We included seven RCTs representing a total of 2,730 patients. Of those, 1,113 patients were randomized to echo-guided optimization, and 1,617 were randomized to device-based optimization. The mean age of patients was 64.5 years, and they were predominantly men (60%). In the device-based optimization group, there was 93 deaths (5.7%) and 142 HFH (5.1%). In the echo-guided optimization group, there was 57 deaths (10.2%) and 112 HFH (12.4%). On random effects meta-analysis, the device-based optimization group had a lower rate of HFH compared with the echo-guided optimization group (OR 0.81, 95% CL 0.70-0.95, Figure). However, differences in the following outcomes between the two groups were not statistically significant: all-cause mortality, mean follow up EF, LVEDD, NYHA class improvement, 6MWD improvement range or QoL. Conclusions: This meta-analysis suggests that echo-guided optimization of CRT is equivalent to device-based optimization in relation to the clinical outcomes of death, EF, LVEDD, NYHA and 6MWD but suggests that device-related optimization could reduce HFH. The latter merits further investigation in relation to different device-base optimization algorithms.

Abstract 9776: Cardiac Resynchronization Therapy Outcomes with Image-Guided Left Ventricular Lead Placement: A Meta-Analysis

Introduction: To improve CRT outcomes, image-guided approaches targeting left ventricular (LV) lead placement at the segment of latest mechanical activation have been compared to non-image-guided approaches with mixed results. A meta-analysis was conducted to assess the association between an image-guided approach and CRT outcomes. Methods: A systematic literature review was performed to identify RCTs and prospective observational studies of CRT from October 2008 through October 2020 that compared any image-guided versus any non-image-guided approach for LV lead placement. Two independent reviewers screened titles and abstracts then reviewed full text of identified studies. One reviewer abstracted data and a second over-read for accuracy. Meta-analyses were performed for NYHA class improvement and changes in LV end systolic volume, LV end diastolic volume, and LVEF using random effects models. Results: Of 5715 citations screened, 5 RCTs with a total of 818 patients met the inclusion criteria. Speckle tracking echocardiography (STE) was the primary imaging method in all studies, but 3 studies included CT, CMR, SPECT, and/or PET in addition to STE. The comparator arms were standard of care in 4 studies and an electrically guided approach in one. Mean age ranged from 66 to 72 years, 76% were male, and 53% had ischemic cardiomyopathy. Among 747 evaluable patients, concordant or adjacent LV lead was achieved in 348 of 386 (90%) in the image-guided arm and 291 of 361 (81%) in the control arm. At 6 months, the image-guided approach was statistically significantly associated with a NYHA class improvement, but no other statistically significant differences were found (Figure). Conclusion: An image-guided CRT approach was associated with significant Improvement in NYHA class but not in echocardiographic measures, possibly due to small sample size and high LV concordance with area of latest activation in both study arms - the latter of which merits further investigation.

Left Bundle Branch Area Pacing for CRT in RBBB: Results from International LBBAP Collaborative-Study Group

Background: Cardiac resynchronization therapy (CRT) using biventricular pacing (BVP) has limited efficacy in patients with heart failure (HF) and right bundle branch block (RBBB). Left bundle branch area pacing (LBBAP) has been reported as an alternative option for BVP-CRT. The aim of the study was to assess the feasibility and outcomes of LBBAP in patients with RBBB and indication for CRT in an international, multicenter, collaborative study. Methods: LBBAP was attempted in patients with LVEF<50%, RBBB and indications for CRT. Procedural, pacing and ECG parameters, clinical response (no HF hospitalization and improvement in NYHA class) and echocardiographic response (≥5% increase in ejection fraction) to LBBAP was assessed. Results: LBBAP was attempted in 121 patients and successful in 107 (88%). Age 74±12 years, female 25%, ischemic cardiomyopathy 49%, and ejection fraction 35±9%. QRS axis at baseline was normal in 24%, left axis 63%, right axis 13%. LBBAP threshold and R-wave amplitudes were 0.8±0.3V@0.5ms and 10±9mV at implant and remained stable during mean follow-up of 13±8 months. LBBAP resulted in significant narrowing of QRS duration (156±20ms to 150±24ms (p=0.01) with R-wave peak times in V6 of 85±16ms. LVEF improved from 35±9 to 43±12%(p<0.01). Clinical and echocardiographic response was observed in 60% and 61% of patients, respectively. Female gender and reduction in QRS duration with LBBAP were predictive of echocardiographic response and super-response. Conclusions: LBBAP is a feasible and safe alternative to BVP to deliver CRT in patients with RBBB. LBBAP provides low and stable pacing thresholds with favorable clinical and echocardiographic response.

Association of left atrial volume index with outcomes after transcatheter mitral valve repair for secondary mitral regurgitation: results from the EuroSMR registry

Abstract Background The benefit of transcatheter edge-to-edge mitral valve repair (TMVr) in heart failure patients with secondary mitral regurgitation (SMR) shows large heterogeneity. A potential explanation might be the burden and chronicity of left-ventricular backward failure which is reflected by left atrial (LA) size. Purpose To investigate the role of LA volume index (LAVi) in real-world SMR patients undergoing TMVr. Methods SMR patients in a European multicenter registry were evaluated. Outcomes were evaluated according to LAVi at baseline. Main analysis was performed for all-cause mortality; residual mitral regurgitation, improvement of NYHA class and heart failure hospitalization were analyzed for patients available. Results 823 included patients were divided according to LAVi into quintiles (≤42, 43–52, 53–62, 63–78, ≥79). A higher hazard for mortality occurred in the four upper quintiles compared to the lower quintile (HR [95% CI] 1.61 [1.08–2.4], 1.65 [1.11–2.46], 1.52 [1.02–2.26] and 1.35 [0.89–2.05]). The incidence of all-cause mortality per 100 patient-years was 14.6, 23, 23.9, 21.7 and 19.5, respectively. Consequently, a cut-off of 42ml/m2 was adopted, which was associated with a significantly higher hazard for mortality after a mean of 589 days (HR 1.54 [95%-CI 1.1–2.1], p=0.01). Technical success rate (postprocedural MR ≤2+) was higher in large LAVi group (95% vs. 91%, p=0.045). The endpoints of heart failure hospitalization, improvement of NYHA class were not different among groups. Multivariable Cox regression analysis including age, EF&amp;lt;30%, diabetes mellitus and NTproBNP showed LAVi &amp;gt;42ml/m2 to be an independent predictor of mortality. Conclusion LA dilatation defined by LAVi&amp;gt;42 ml/m2 was associated with higher mortality hazard in SMR patients undergoing TMVr after multivariable adjustment. Our findings warrant further study on whether timely TMVr intervention in patients with SMR and small LAVi can modify outcome. Funding Acknowledgement Type of funding sources: None.

Response and long-term outcomes with resynchronization therapy in atrial fibrillation

Abstract Background Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in selected patients (pts) with heart failure (HF). Pts with atrial fibrillation (AF) were excluded from major CRT trials. Studies suggested that pts with AF derive less benefit from CRT. Purpose To compare response and clinical outcomes after CRT in pts in AF or in sinus rhythm (SR). Methods Single-center retrospective study of consecutive pts submitted to CRT implantation (2007–2018). Major adverse cardiac events (MACE) included HF hospitalization or all-cause mortality. Clinical response was defined as NYHA class improvement without MACE in the 1st year of follow-up (FU). Left ventricle end-systolic volume reduction of &amp;gt;15% during the 1st year of FU designated echocardiographic (echo) response. Survival analysis with Kaplan-Meier method and Log-rank test was performed. Results 295 CRT pts (70.5% male, median age 68±16 years, 54.6% implanted with CRT-D) were included. 95 (32.6%) presented in AF. Pts with AF were older (72 vs 67, p=0.007), with higher prevalence of coronary disease (40.2% vs 24.2%, p=0.008), moderate to severe tricuspid regurgitation (21.7% vs 8.8%, p=0.011) and chronic kidney disease (33.0% vs 16.5%, p=0.003). AF pts had larger left atrial diameters (50.5 vs 44.6 mm, p&amp;lt;0.001) and higher baseline N-terminal pro B-type natriuretic peptide values (6738.6 vs 3179.4 pg/ml, p=0.044). There were no differences in terms of HF etiology (p=0.242) or type of device (p=0.127). Pts with AF presented more often with secondary prevention indications for CRT-D (45.0% vs 15.7%, p&amp;lt;0.001). Atrioventricular junction ablation (AVJA) was performed in 14.0% of AF pts. Median percentage of biventricular pacing (BiVp) was significantly lower in AF pts (97% vs 99%, p&amp;lt;0.001). NYHA class improvement (79.3% vs 78.9%, p=0.930) and echo response (65.4% vs 75.2%, p=0.269) were similar between pts in AF and in SR. The rate of clinical response was lower in AF pts (52.7% vs 66.5%, p=0.036). During a median FU of 3±5 years, occurrence of MACE (Log-rank test, p&amp;lt;0.001) and all-cause mortality (Log-rank test, p=0.011) were higher in AF pts – graph 1. When comparing AF pts submitted to AVJA with pts in SR, clinical (62.5% vs 66.5%, p=0.816) and echo (57.1% vs 75.2%, p=0.540) response were similar. Among pts achieving BiVp ≥98% (67.8%), no differences emerged in terms of clinical response (68.4% vs 70.5%, p=0.968) between patients in AF or in SR. Also, mortality was similar between groups (Log-rank test, p=0.214) – graph 2. MACE remained more frequent in the AF group (Log-rank test, p=0.029). Conclusions In this cohort, AF pts, despite having a higher comorbidity burden, showed similar NYHA class improvement and echo response to SR pts. Among pts with BiVp ≥98%, clinical response and all-cause mortality were also similar between groups. Further studies are warranted to select AF pts that benefit most from CRT. Funding Acknowledgement Type of funding sources: None. Graph 1Graph 2

Clinical outcome after MitraClip procedure: role of right ventricle

Abstract Background MitraClip system is a device for percutaneous edge-to-edge repair of the mitral valve in symptomatic patients with severe mitral regurgitation (MR) not eligible for surgery, but frequently heart failure symptoms remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in heart failure but little is known about its prognostic role in patients after MitraClip implantation. Purpose To identify echocardiographic predictors of clinical outcome after MitraClip procedure, with a particular focus on RV-PA coupling. Methods We retrospectively analyzed the data of patients with severe MR who underwent MitraClip implantation between April 2015 and October 2019 at our Institution. Echocardiographic data were assessed at baseline, 3 and 12 months after the procedure; RV to PA coupling was assessed using the ratio between tricuspid annular plane systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). Functional class was assessed at 12 months of follow-up. Significance level was set to 0.05 and SPSS was used for statistical analysis. Results 41 patients were included (age 77.1±7.3, 71% male, BMI 25.8±5.5). MR was primary, functional and mixed in 22, 76 and 2% of patients, respectively. 1/2/3 mitraclips were implanted in 39/56/5% of patients, respectively. Echocardiographic data at baseline, at 3 and 12 months follow-up are shown in Table. NYHA class at 12 months significantly correlated with TAPSE and PASP at 3 months follow-up echocardiogram (beta coefficient −0.83 and 0.78 respectively). On the contrary, NYHA class did not show a correlation with left ventricular ejection fraction (LVEF) or residual MR grade. At 12 months 44% of patients showed an improvement in NYHA class; these patients had a better TAPSE (22.7±1.3 vs 19.4±4.6 mm), a lower PASP (37.9±10.2 vs 48.5±12.9 mmHg) and a better TAPSE/PASP (0.61±0.2 vs 0.42±0.2) compared to patients who did not improve their functional class, while LVEF and residual MR did not differ. Conclusion In this sample of significant MR undergoing repair with MitraClip System, patients with functional class improvement at 12 months follow-up showed a better RV-coupling without difference in LV function and residual MR. Funding Acknowledgement Type of funding sources: None. Table 1

Thromboembolic risk is potentially reduced in mitral stenosis shortly after percutaneous mitral valvotomy

Abstract Background Rheumatic mitral stenosis (MS) is a problem in the developing countries. Left atrium (LA) and appendage (LAA) dysfunction are considered determinant factors for thrombus formation even in patients with sinus rhythm (SR). Percutaneous mitral valvotomy (PMV) is a well accepted therapeutic option. However, no available data considers patients with SR as a low risk group for the development of thrombus. Purpose Studying short term impact of PMV on P wave morphology, NT-pro BNP as well as LAA properties in patients with MS and SR. Methods A prospective study was conducted in a tertiary University hospital including 41 patients with symptomatic uncomplicated MS having favorable morphology with sinus Rhythm. P wave duration, amplitude and dispersion, NT-pro BNP, transthoracic and transesophageal echocardiography were carried out directly before and 1 month following PMV. Student t-test was used to compare the variables before and after PMV. Correlation was calculated using Pearson's correlation and multivariate regression analysis was used for prediction of unfavorable outcomes. Results After PMV, 36 (87.8%) patients had a favorable outcome manifested with improvement of NYHA class, valve area, estimated systolic pulmonary artery pressure (sPAP) as well as grade of spontaneous echo contrast (SEC). P wave duration, P wave amplitude and P wave dispersion decreased after PMV (14.97±2.65 vs. 13.21±2.36 ms, 4.01±1.01 vs. 2.51±0.71 ms and 4.01±1.01 vs. 2.51±0.71mv; P&amp;lt;0.001 respectively). NT pro-BNP also reduced (2.90±2.19 vs. 2.01±1.31 Pg/L; P&amp;lt;0.001). TEE PW of LAA showed increase of early (E LAA) and late (A LAA) emptying velocities after PMV (41.70±19.50 vs. 48.82±20.18 and 31.31±21.99 vs. 38.48±19.86 cm/s; P&amp;lt;0.001 respectively). By TDI, late wall motion (LAA A) velocity increased (7.41±2.50 vs. 8.23±3.01 cm/s; P&amp;lt;0.001) with an improvement of LAA ejection fraction post procedural (50.80±13.11 vs. 55.75±10.12%; P&amp;lt;0.001). Negative correlation between LAA EF and P wave amplitude (r=−0.40; P&amp;lt;0.001) as well as a correlation between reduction in NT pro-BNP and the improvement of both LAA A velocity and E LAA wave were noticed (r=0.55; P=0.02 and 0.01 respectively). The grade of SEC was negatively correlated with E LAA (r=−0.55, P=0.02). Only 5 patients (12.2%) had an unfavorable outcome. Four patients had severe mitral regurge (7.8%), only one patient (2.4%) was indicated for surgery. AF developed in one patient (2.4%). The grade of SEC remains the same in 3 patients (7.3%). Both baseline estimated sPAP and Wilkins score were predictors for unfavorable outcome; sPAP (odd's ratio= 4.08; 95% CI=1.01- 7.17; P=0.04); Wilkins score (odd's ratio= 1.59; 95% CI=1.22- 5.98; P=0.01). Conclusion PMV has a favorable rapid impact on LA and LAA properties in patients with MS and SR. Our data suggests that PMV could potentially contribute to lowering the risk of future thromboembolic events in those patients. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Assiut University Hospital

Clinical effects of the enhanced external counterpulsation therapy in patients with ischemic chronic heart failure exacerbation COVID-19

Abstract Objectives The aim of the study was to assess the effects of the enhanced external counterpulsation (EECP) therapy as a rehabilitation method in patients with ischemic chronic heart failure (CHF) after COVID-19. Methods 54 (n=54) stable symptomatic CHF (NYHA, functional class I-II; 35%≤LVEF≤50%) subjects (44 male and 10 female; mean age 61±9,8) with prior anamnesis of CAD, at least one myocardial infarction got the exacerbation of CHF after COVID-19 episode. They were randomized in a 2:1 manner into either 35 1-hour 250–300 mm Hg sessions of EECP (n=36; 30 male, 6 female) or Sham-EECP (n=18; 14 male, 4 female). All subjects had been received optimal CHF and CAD drug therapy. At baseline, a month and half a year after EECP course every subject was examined with echocardiography and 6-minute walk test. Results All 36 active EECP treatment group subjects improved by at least 1 NYHA class, 66% of them had no heart failure symptoms post treatment (p&amp;lt;0.01). 84% of treatment group pts. had sustained NYHA class improvement at half a year follow-up (p&amp;lt;0.01), compared with baseline. There was significant difference between LVEF 44±6,5% at baseline vs post-EECP LVEF 50±4,6% (p&amp;lt;0.01) in active EECP treatment group subjects. At the same time there were no significant changes of NYHA class and LVEF in Sham-EECP subjects. No one subject dies after half a year of follow up. Conclusions Enhanced external counterpulsation (EECP) therapy sustainably improves NYHA functional class and LVEF in patients with ischemic CHF exacerbation after COVID-19. Funding Acknowledgement Type of funding sources: None.

AMBULATORY PULMONARY ARTERY PRESSURE MONITORING REDUCES COSTS AND IMPROVES OUTCOMES IN SYMPTOMATIC HEART FAILURE: A SINGLE-CENTER CANADIAN EXPERIENCE

<h3>BACKGROUND</h3> Pulmonary artery pressure (PAP) monitoring with the CardioMEMS device reduces heart failure (HF) hospitalizations and improves quality of life in NYHA Class III HF. The aim of this study was to evaluate the CardioMEMS device in a real-world Canadian HF cohort and explore its economic impact. <h3>METHODS AND RESULTS</h3> 21 patients with NYHA Class III HF underwent CardioMEMS implantation at Foothills Medical Centre, Calgary, Alberta. Baseline, 3, 6, 9, and 12-month assessments of laboratory parameters, hemodynamics, 6-minute walk test (6-MWT) and Kansas City Cardiomyopathy Questionnaire (KCCQ12) scores were prospectively collected. Healthcare costs for the 1-year pre and post-implant were collected from administrative databases. Of 21 patients, 19 patients had useable data (1 unsuccessful implant, 1 pressure dampening due to small implant artery). There were no procedural complications. Mean age was 68.9 years, 45% were female, 10% HFpEF. Of those with HFrEF, mean LVEF at baseline was 31%. Over a mean follow-up of 10 months, there was an 85% reduction in HF ER visits (p=0.0003), 83% reduction in HF hospitalizations (p < 0.001), 79% decrease in all-cause hospitalizations (p=0.0006), 41% decrease in HF clinic visits (p=0.034), and a 151% increase in nurse clinician calls (p < 0.0001) observed. KCCQ-12 scores and 6-MWT at baseline vs. last follow-up were 45.7 vs. 47.1 (p=0.76) and 364.4 vs. 402.3 m (p=0.59), respectively. NT-proBNP and mean PAP at baseline vs. last follow-up were 2277.2 vs. 1509.9 pg/mL (p=0.28) and 31.5 vs. 24.4 mmHg (p=0.0024), respectively. NYHA class improved at least one class in 74% of patients. Fourteen patients have completed 1 year of follow-up. Table 1 outlines healthcare utilization costs 1-year pre and post-implant (n=14). Total measurable HF-related spending pre-implantation was $324 795. The cost of measurable HF spending in the year post-implantation was $108 763. When considering device cost, the net cost at 1-year was $386 558, equating to an additional $4 412 per patient. <h3>CONCLUSION</h3> CardioMEMS remote monitoring demonstrated reductions in PA pressures, hospitalizations, ER visits, clinic visits and improvement in NYHA class in NYHA III HF. There was no significant difference in KCCQ12 scores, 6MWT or NT-proBNP limited by short duration of follow up. Cost-parity was nearly achieved at 1-year post-implantation, driven predominantly by a significant reduction in hospitalization costs. Though further economic evaluation is needed, these results support the use of ambulatory PA pressure monitoring as a cost-effective method of HF management in a publicly funded healthcare system.

Impact of sacubitril/valsartan on implantable defibrillator eligibility in heart failure: a real-world experience.

Current guidelines recommend an implantable cardiac defibrillator (ICD) in patients with symptomatic heart failure and reduced ejection fraction (HFrEF; left ventricular ejection fraction [LVEF] ≤35%) despite ≥3 months of optimal medical therapy. Recent observations demonstrated that sacubitril/valsartan induces beneficial reverse cardiac remodeling in eligible HFrEF patients. Given the pivotal role of LVEF in the selection of ICD candidates, we sought to assess the impact of sacubitril/valsartan on ICD eligibility and its predictors in HFrEF patients. We retrospectively evaluated 48 chronic HFrEF patients receiving sacubitril/valsartan and previously implanted with an ICD in primary prevention. We assumed that ICD was no longer necessary if LVEF improved >35% (or >30% if asymptomatics) at follow-up. Over a median follow-up of 11 months, sacubitril/valsartan induced a significant drop in LV end-systolic volume (-16.7 ml/m2, p=0.023) and diameter (-6.8 mm, p=0.022), resulting in a significant increase in LVEF (+3.9%, p<0.001). As a consequence, 40% of previously implanted patients resulted no more eligible for ICD at follow-up. NYHA class improved in 50% of the population. A dose-dependent effect was noted, with higher doses associated to more reverse remodeling. Among patients deemed no more eligible for ICD, lower NYHA class (odds ratio (OR) 3.73 [95% CI 1.05; 13.24], p=0.041), better LVEF (OR 1.23 [95% CI 1.01; 1.48], p=0.032) and the treatment with the intermediate or high dose of sacubitril/valsartan (OR 5.60 [1.15; 27.1], p=0.032) were the most important predictors of status change. In symptomatic HFrEF patients, sacubitril/valsartan induced beneficial cardiac reverse remodeling and improved NYHA class. These effects resulted in a significant reduction of patients deemed eligible for ICD in primary prevention.

Baroreflex Activation Therapy (BAT) Effectiveness Among Heart Failure Patients: A Systematic Review and Meta-Analysis

Heart failure is promoted by the imbalance of sympathovagal, which increased sympathetic and decreased parasympathetic activity. BAT, an electrical stimulation technology, cause the baroreflex to be activated and balances the sympathovagal. Systematic review and meta-analysis were conducted, including published reports about the effectiveness of BAT in heart failure patients from PubMed, Embase, Cochrane, and Google Scholar to calculate the pooled standard mean difference and 95% confidence interval (95% CI) using either random or fixed effect model. Our search strategy identified 161 possible studies. Thirteen studies have been included as a full-text review. We excluded seven of these papers due to review, and our analysis has included six papers. Our combined analysis has shown that BAT is associated with an improvement in NYHA class compared to control (0.19[95%CI: 0.11-0.31], p = 0.000). Our pooled analysis also found that BAT, compared to control, was associated with 6-MHWD improvement, (-136.25[95%CI: -181.34 - -91.17], p = 0.000). Our pooled analysis also found that BAT, compared to control, was associated with HF hospitalization (-6.38[95%CI: -8.46 - -4.30], p = 0.000). BAT has a significant effect on improving NYHA Class, 6-minute hall walk distance, and decreasing HF patient's hospitalization days. Meanwhile, there is an insignificancy on LVEF and QoL improvement in HF patients. Future studies are still needed.

Baroreflex Activation Therapy (BAT) Effectiveness Among Heart Failure Patients: A Systematic Review and Meta-Analysis

Heart failure is promoted by the imbalance of sympathovagal, which increased sympathetic and decreased parasympathetic activity. BAT, an electrical stimulation technology, cause the baroreflex to be activated and balances the sympathovagal. Systematic review and meta-analysis were conducted, including published reports about the effectiveness of BAT in heart failure patients from PubMed, Embase, Cochrane, and Google Scholar to calculate the pooled standard mean difference and 95% confidence interval (95% CI) using either random or fixed effect model. Our search strategy identified 161 possible studies. Thirteen studies have been included as a full-text review. We excluded seven of these papers due to review, and our analysis has included six papers. Our combined analysis has shown that BAT is associated with an improvement in NYHA class compared to control (0.19[95%CI: 0.11-0.31], p = 0.000). Our pooled analysis also found that BAT, compared to control, was associated with 6-MHWD improvement, (-136.25[95%CI: -181.34 - -91.17], p = 0.000). Our pooled analysis also found that BAT, compared to control, was associated with HF hospitalization (-6.38[95%CI: -8.46 - -4.30], p = 0.000). BAT has a significant effect on improving NYHA Class, 6-minute hall walk distance, and decreasing HF patient's hospitalization days. Meanwhile, there is an insignificancy on LVEF and QoL improvement in HF patients. Future studies are still needed.

B-PO05-033 PACEMAKER IMPLANTATION AFTER SELECTIVE ALCOHOL SEPTAL ABLATION

Complete heart block (CHB) with permanent pacemaker (PPM) placement is a known risk of alcohol septal ablation (ASA) for hypertrophic cardiomyopathy. Historically, the incidence has been around 10% in all-comer populations. However, rates of 25% are reported in centers that selectively target older, higher risk patients (pts). Understanding predictors of CHB in this evolving cohort is important. Report baseline characteristics, associated factors (AF) of PPM placement, longer-term pacing need following ASA in a high-volume HCM center. 94 consecutive pts underwent ASA from 2/2017 to 12/2020. 25 were excluded due to prior septal reduction or device. Criteria for PPM included persistent post-ASA CHB >24 hours, recurrent pacing due to 2nd degree HB/ transient CHB >24 hours. 69 pts (mean age 65.7 ± 11 years, females 53.6%) were included. 19 (27.5%) required PPM prior to discharge, 6 (31.5%) of whom were prohibitive surgical risk for myectomy (20.3% PPM rate in pts not at prohibitive surgical risk). All had reduction in peak provoked gradient (pre-procedure mean 149.8 mm Hg vs. post-procedure mean 10.5 mmHg, p<0.01) and improved NYHA class. Comparison of baseline clinical, ECG, and procedural characteristics (e.g., peak troponin and gradient reduction) yielded no AF of PPM implantation, with exception of intraprocedural CHB (OR 12.4, 95% CI 3.4 - 45.3, p<0.0001). Post procedure PR prolongation >50 ms (OR 6.1, 95% CI 1.5 - 24.5, p = 0.01), first-degree AV block with RBBB and LAFB (OR 6.1, 95% CI 1.5 - 24.5, p = 0.01) and change in QRS axis >700 (OR 5.3, 95% CI 1.4 - 18.9, p= 0.01) was also associated with PPM. At 1 month, 16 pts (84.2%) required >1% RV pacing (mean 59.2%) suggesting appropriateness of PPM implantation. At 3 months 10 pts (52.6%) required pacing (mean 52.4%) indicating some late recovery. No procedural factors were associated with PPM following ASA with exception of intraprocedural CHB. Daily ECGs identified dynamic abnormalities associated with PPM. Short term follow up suggests PPM criteria are appropriate, with longer term follow up showing some recovery. As higher risk cohorts are targeted for ASA, PPM risk factors of long term pacing will be vital.

B-IN01-06 PERSONALIZED APPROACH FOR CARDIAC RESYNCHRONIZATION THERAPY (CRT) IMPLANTATION GUIDED BY REAL-TIME NON-INVASIVE 3D ELECTROCARDIOGRAPHIC MAPPING

The optimal approach for CRT implantation is not established. To evaluate the feasibility of CRT implantation under electrocardiographic mapping guidance. Thirty consecutive patients with left ventricular ejection fraction (LVEF) ≤35% and conduction delay (9 LBBB and 21 non-LBBB) were recruited. A 252-electrode vest (CardioInsight, Medtronic) was worn by the patient during the procedure to measure the total activation time (TAT) when different pacing combinations of biventricular pacing (BVP), His-bundle pacing (HBP) and/or left bundle branch pacing (LBBP) were tested. The combination that resulted in the shortest TAT would be chosen. Clinical response was defined by ≥1 NYHA class improvement and echocardiographic response by LV end-systolic volume reduction ≥15% and/or LVEF improvement ≥10% at 6-months follow-up. Final pacing configurations involved LBBP in 40%, HBP in 33%, BVP in 13% and RV or LV pacing alone in 13% of patients. Mean QRS duration shortened from 164±18ms to 128±18ms and LVEF improved from 26±6% to 39±14% (both p <0.01). Clinical and echocardiographic response rates were 80% and 73%, respectively. Super echocardiographic responder rate (final LVEF >45%) was 33%. Mean TAT (57ms vs. 87ms) was significantly lower and TAT reduction (42% vs. 12%) was significantly greater with final pacing-configuration compared to BVP, respectively (both p<0.01). Personalized approach for CRT implantation using real-time non-invasive electrocardiographic mapping was feasible and associated with better resynchronization results compared to BVP.

B-PO01-100 PERSONALIZED APPROACH FOR CARDIAC RESYNCHRONIZATION THERAPY (CRT) IMPLANTATION GUIDED BY REAL-TIME NON-INVASIVE 3D ELECTROCARDIOGRAPHIC MAPPING

The optimal approach for CRT implantation is not established. To evaluate the feasibility of CRT implantation under electrocardiographic mapping guidance. Thirty consecutive patients with left ventricular ejection fraction (LVEF) ≤35% and conduction delay (9 LBBB and 21 non-LBBB) were recruited. A 252-electrode vest (CardioInsight, Medtronic) was worn by the patient during the procedure to measure the total activation time (TAT) when different pacing combinations of biventricular pacing (BVP), His-bundle pacing (HBP) and/or left bundle branch pacing (LBBP) were tested. The combination that resulted in the shortest TAT would be chosen. Clinical response was defined by ≥1 NYHA class improvement and echocardiographic response by LV end-systolic volume reduction ≥15% and/or LVEF improvement ≥10% at 6-months follow-up. Final pacing configurations involved LBBP in 40%, HBP in 33%, BVP in 13% and RV or LV pacing alone in 13% of patients. Mean QRS duration shortened from 164±18ms to 128±18ms and LVEF improved from 26±6% to 39±14% (both p <0.01). Clinical and echocardiographic response rates were 80% and 73%, respectively. Super echocardiographic responder rate (final LVEF >45%) was 33%. Mean TAT (57ms vs. 87ms) was significantly lower and TAT reduction (42% vs. 12%) was significantly greater with final pacing-configuration compared to BVP, respectively (both p<0.01). Personalized approach for CRT implantation using real-time non-invasive electrocardiographic mapping was feasible and associated with better resynchronization results compared to BVP.

Outcome of alcohol septal ablation in mildly symptomatic patients with hypertrophic obstructive cardiomyopathy: A comparison with medical therapy.

ObjectiveThe aim of this study was primarily to determine efficacy after alcohol septal ablation (ASA) in mildly symptomatic patients (NYHA class II) with hypertrophic obstructive cardiomyopathy (HOCM), as compared to medical therapy.MethodsThis retrospective study included 163 mildly symptomatic patients with HOCM evaluated in Beijing Anzhen Hospital between March 2001 and August 2019, consisting of the medical group (n = 105) and the ASA group (n = 58). All‐cause mortality and HCM‐related death were mainly observed.ResultsFollow‐up was completed in 161 patients and the median follow‐up was 6.0 years. Compared to medically treated patients, patients post‐ASA had comparable survival free of all‐cause mortality (98.3% and 95.1% vs. 93.0% and 83.1% at 5 and 10 years, respectively; p = 0.374). Survival free of HCM‐related death was also similar between ASA and medical groups (98.3% and 95.1% vs. 94.3% and 86.2% at 5 and 10 years, respectively; p = 0.608). However, compared to medical therapy, ASA had advantages on the improvement of NYHA class (1.4 ± 0.6 vs. 2.1 ± 0.5, p = .000) and lower occurrence of new‐onset atrial fibrillation (AF) (7.8% vs. 20.4%, p = .048). Multivariate analysis demonstrated that resting LVOT gradient at the last clinical check‐up was an independent predictor of all‐cause mortality (HR = 1.021, 95%CI 1.002–1.040, p = .027).ConclusionThis registry suggests that mildly symptomatic patients with HOCM treated with ASA have comparable survival to that of medically treated patients, with the improvement of NYHA class and lower occurrence of new‐onset AF. All‐cause mortality is independently associated with resting LVOT gradient at the last clinical check‐up.

EFFECTIVENESS AND OUTCOMES OF H-ISDN IN ADDITION TO CONVENTIONAL THERAPY IN ACUTE HEART FAILURE PATIENTS WITH RENAL IMPAIRMENT

Objective:The primary objective of the study is todetermine whether the addition of H-ISDN to conventional therapy improves the cardiovascular outcomes and also to assess both short term(1 and 3 months) and long term outcomes(1 year). Materials and Methods:This is a prospective observational study.A total of 82 acute heart failure patients with renal impairment were divided into two groups based on exposure to H-ISDNGroup I-Patients on H-ISDN plus conventional therapyGroup II-Patients on conventional therapy. Followup of all the subjects to study the outcomes of improvement in NYHA class,rehospitalisation and mortality rate at 1 month,3 months and 1 year was done for both the groups. Results:We observed that out of the 82 acute heart failure patients with renal impairment,43 patients were receiving H-ISDN in addition to conventional therapy(Group I) and 39 patients were receiving conventional therapy(Group II) .The length of stay(6.03± 2.906 vs 6.93± 3.845) was shorter in the treated group when compared to the non treated group.A greater difference in reduced hospitalisation was seen at 3 months(2.32% vs 12.82%).The treated group had higher improvement in NYHA class at 1 month(67.44% vs 46.15%), 3 months(51.16% vs 41.02%) and 1 year (44.18% vs 20.51%P=0.023). Conclusion:Acute heart failure patients with renal impairment have poor prognosis. Randomised controlled trials are required to validate if the use of H-ISDN is associated with better outcomes in AHF patients.

Long-term reverse remodeling and clinical improvement by MultiPoint Pacing in a randomized, international, Middle Eastern heart failure study

PurposeCardiac resynchronization therapy (CRT) with multipoint left ventricular (LV) pacing (MultiPoint™ Pacing, MPP) has been shown to improve CRT response, although MPP response using automated pacing vector programming has not been demonstrated in the Middle East. The purpose of this study was to compare the impact of MPP to conventional biventricular pacing (BiV) using echocardiographic and clinical changes at 6-month post-implant.MethodsThis prospective, randomized study was conducted at 13 Middle Eastern centers. After de novo CRT-D implant (Abbott Unify Quadra MP™ or Quadra Assura MP™) with quadripolar LV lead (Abbott Quartet™), patients were randomized to either BiV or MPP therapy. In BiV patients, the LV pacing vector was selected per standard practice; in MPP patients, the two LV pacing vectors were selected automatically using VectSelect. CRT response was defined at 6-month post-implant by a reduction in LV end-systolic volume (ESV) ≥ 15%.ResultsOne hundred and forty-two patients (61 years old, 68% male, NYHA class II/III/IV 19%/75%/6%, 33% ischemic, 57% hypertension, 52% diabetes, 158 ms QRS, 25.8% ejection fraction [EF]) were randomized to either BiV (N = 69) or MPP (N = 73). After 6 months, MPP vs. BiV patients experienced greater ESV reduction (25.0% vs. 15.3%, P = 0.08), greater EF improvement (11.9% vs. 8.6%, P = 0.36), significantly greater ESV response rate (68.5% vs. 50.7%, P = 0.04), and significantly greater NYHA class improvement rate (80.8% vs. 60.3%, P = 0.01).ConclusionsWith MPP and automatic LV vector selection, more CRT patients in the Middle East experienced reverse remodeling and clinical improvement relative to conventional BiV pacing.

Clinical outcomes after upgrade to resynchronization therapy: a propensity-score matched comparative analysis

Abstract Funding Acknowledgements Type of funding sources: None. BACKGROUND Upgrade to resynchronization therapy (CRT) is common practice in Europe. However, guideline recommendations are discordant and randomized trials are lacking. Previous studies have shown worse outcomes in upgraded patients. AIM To compare clinical outcomes in a cohort of patients receiving de novo or upgrade to CRT. METHODS Single-center retrospective study of consecutive patients submitted to CRT implantation (2007-2018). Major adverse cardiac events (MACE) included heart failure hospitalization or all-cause mortality. Clinical response was defined as NYHA class improvement without MACE in the 1st year of follow-up (FU). Left ventricle end-systolic volume reduction of &amp;gt;15% designated echocardiographic (echo) response. Survival analysis with Kaplan-Meier method and Log-rank test was performed. Propensity-score matching (PSM) analysis was performed to adjust for possible confounder variables. RESULTS 295 CRT patients (70.5% male, mean age 67 ± 11 years, 72.5% non-ischemic cardiomyopathy, 54.6% implanted with CRT-D) were included. Fifty-six patients (19%) underwent an upgrade: 43 (78.2%) from a pacemaker and 12 (21.8%) from a defibrillator device. Indications for upgrade were mainly pacemaker dependency or pacing-induced LV dysfunction (76.6%) and de novo left bundle branch block (23.4%). Upgraded patients were older (70 vs 66 years, p=.034), with larger baseline QRS (185 ± 25 vs 163 ± 30 ms, p&amp;lt;.001) and higher rates of atrial fibrillation (58.2% vs 26.7%, p&amp;lt;.001), coronary artery disease (41.8% vs 26.2%, p=.033), moderate to severe valve disease (42.9% vs 22.6%, p=.003) and chronic kidney disease (36.4% vs 18.7%, p=.008). Upgraded patients more frequently received CRT-P (71.4% vs 39.3%, p&amp;lt;.001). CRT-D were more often implanted for secondary prevention (53.3% vs 20.2%, p=.011) in the upgrade group. There were no differences in procedural complications, clinical (59.3 vs 62.6%, p=.765) or echo (72.2% vs 71.9%, p=.970) response rates. During a median FU of 3 ± 5 years, all-cause mortality was similar among groups (Log-rank test, p=.688). MACE occurred more frequently in the upgrade group (Log-rank test, p=.025). No differences emerged in lead complications (8.9% vs 8.4%, p=.892) or device infection (1.8% vs 2.9%, p=.986). PSM analysis identified 106 matched pairs (56 upgrade/50 de novo patients), without baseline statistical differences. All-cause mortality (Log-rank test, p=.555) and MACE (Log-rank test, p=.574) were comparable between groups. CONCLUSION In this cohort, upgrade to CRT was comparable to de novo implantation in terms of clinical and echo response. Moreover, upgrade to CRT was not associated with higher complication rates. All-cause mortality and MACE were similar between groups.