Improvement In Functional Class Research Articles

Peritoneal Ultrafiltration Is Associated with Improvement of Functional Class in Patients with Congestive Heart Failure

Peritoneal Ultrafiltration Is Associated with Improvement of Functional Class in Patients with Congestive Heart Failure

Tolerability and Effect of Angiotensin Receptor Neprilysin Inhibitors in Adult Congenital Patients with Systemic Right Ventricle

Introduction Adult Congenital Heart Disease (ACHD) patients have an increased mortality and morbidity from heart failure. Angiotensin Receptor-Neprilysin Inhibitors (ARNI) have emerged as a standard of therapy for adults with heart failure. However, the effects of these medicines have not been studied in ACHD patients. Hypothesis ARNI's are well tolerated and have beneficial cardiovascular effects in ACHD patients. Method Twenty-one ACHD patients with systemic right ventricle were prescribed ARNI at our institution. Demographics, vital signs, laboratory results, functional status, imaging data, and outcomes were collected by retrospective electronic review. Statistical analysis was performed using paired t test. Results Twenty-one patients with systemic right ventricle were treated with ARNI: 16 D-Transposition of great arteries (TGA) with atrial switch, 1 congenitally corrected TGA, and 1 Taussig Bing transposition type and atrial switch. Fifteen (71.4%) were male, mean age 39.8±6.5 years. Baseline RVEF was 33.4+/-8.6%. Baseline peak VO2 was 18.1+/-4.3 mL/min/kg. By functional status, 10 were in NYHA class II (50%), 7 in class III (35%), and 2 in class IV (one unknown). Median follow-up was 14.1 (9.4-27.8) months. All patients tolerated Entresto for at least six months. High dose Entresto was achieved in 4 (19%) patients, 3 (14.3%) were on moderate dose, and 14 (66.7%) were on low dose. Only 2 (9.5%) patients discontinued Entresto after 9 and 11 months due to hypotension. There was no significant change in creatinine (0.8±0.4 mg/dL versus 1.0±0.3 mg/dL, p=NS), no incidence of hyperkalemia, angioedema, or major side effect including death. Systolic blood pressure was 118.2+/-14.2 mmHg at baseline and decreased with ARNI use (112.4+/-16.4 mmHg at 0-3 months, 112.4+/-12.8mmHg at 3-6 months and 108.5+/-10.3mmHg at 6-12 months, p values by paired t test 0.02, NS, and NS respectively). Corresponding values for diastolic blood pressure were 74.5+/-9.6mmHg (baseline), 72.4+/-14.3mmHg, 62.8+/-10.1 and 70.45+/-10.9mmHg (p values by paired t test NS, 0.009, and NS respectively). Mean NYHA class improved from 2.65+/-0.74 to 2.21+/-0.71 (p=0.008 by paired t-test). 5/12 (42%) of patients had an improvement in peak oxygen consumption on cardiopulmonary stress test, though this was not statistically significant. (16.8+/-4.8 mL/kg/min versus baseline 18.1+/-4.3 mL/min/kg, p=NS). Conclusion ARNI's are safe and well tolerated in ACHD patients. It is associated with mild decrease in blood pressure and improvement in functional class. The study findings are promising and highlight the need for larger, prospective, multicenter studies.

De Novo Pulmonary Arterial Hypertension After Heart Transplantation

Background Orthotopic heart transplantation (OHT) recipients undergo scheduled right heart catheterizations (RHC) and biopsies. Some of these patients who have mixed connective tissue disease (MCTD) are at increased risk of developing pulmonary artery hypertension (PAH). The natural history and impact of immunosuppression on new-onset PAH is unknown. Case A 43 year old male required OHT after the development of lupus cardiomyopathy. Post-transplant he was treated with tacrolimus and mycophenolate. Three years later, he developed significant dyspnea on exertion. His serology was anti-nuclear antibody positive (1:2560, speckled). Over eight months, RHCs performed in the setting of endomyocardial biopsies for surveillance of rejection showed a dramatic change, from normal shortly after transplantation, to a markedly elevated PA pressure of 81/34 (mean 52) mmHg, pulmonary capillary wedge pressure of 7 mmHg, transpulmonary gradient of 45 mmHg, and pulmonary vascular resistance of 9.36 Wood units (Figure 1). The patient's constellation of symptoms and RHC findings supported a diagnosis of MCTD - PAH, despite ongoing immunotherapy. Severe PAH occurred incidentally while being monitored with RHC for another indication. He was treated with tadalafil, ambrisentan, and amlodipine with an improvement in functional class. Conclusions This case describes de novo development of PAH after OHT in a patient with MCTD, despite anti-rejection immunotherapy. This suggests a lack of efficacy of immunosuppression in preventing scleroderma-PAH and highlights the rapidity of onset of this disease. Figure 1. Results of serial right heart catheterizations

Outcomes of Atrioseptostomy with Stenting in Patients with Pulmonary Arterial Hypertension from a Large Single-Institution Cohort.

The aim of this study was to analyze results of stenting atrioseptostomy in patients with pulmonary arterial hypertension and a different level of risk for one-year mortality that is not well described. Patients that underwent atrioseptostomy with stenting were retrospectively divided in two groups: “intermediate” (n = 55) or “high” risk (n = 13), according to the 2015 ESC/ESR guideline. Results of atrioseptostomy were assessed during hospital period and at follow-up. Patients from “intermediate” risk group demonstrated lower mortality rate (10/55, vs. 6/13) during the course of the study period, as well as higher freedom from lung transplantation or Potts shunt. At discharge, patients of both groups presented improvement in functional class and mobility. Patients from “intermediate” risk group showed longer 6-min walking distance, and lower levels of brain natriuretic peptide. At the latest follow-up, stable position and full patency of stents with right-to-left or bidirectional shunt at atrial level and absence of syncope was confirmed in patients of both groups. Patients from the “intermediate” risk group demonstrated higher functional class, better performance of walking test, and lower levels of brain natriuretic peptide. Stenting atrioseptostomy reliably secured interatrial communication and improved clinical condition in patients with idiopathic pulmonary arterial hypertension. Mid-term results were better in “intermediate” risk group.

Percutaneous mitral valve repair in adults with congenital heart disease: Report of the first case-series.

Systemic atrioventricular valve regurgitation (AVVR) is frequently encountered in adults with congenital heart disease (CHD). Surgical intervention is the mainstay of therapy, but in a specific high-risk subset, percutaneous valve repair might offer a lower-risk alternative. Three patients with complex CHD and severe symptomatic AVVR underwent percutaneous mitral valve repair at a single center. All were deemed to be high-risk for surgery by a multidisciplinary CHD team and provided informed consent for the compassionate use of the MitraClip (Abbott, Santa Clara, CA). Three-dimensional heart models were generated for the procedure, which was performed by an adult CHD cardiologist (who provided imaging support) and an interventional cardiologist with expertise in CHD and percutaneous mitral valve repair. The first case was a 39 year-old-woman with [S,L,D] dextrocardia, double outlet right ventricle, mild tricuspid hypoplasia, and a secundum atrial septal defect, who was palliated at age 35 with a right bidirectional Glenn and later developed severe, symptomatic mitral regurgitation, and underwent placement of one MitraClip XTR device. Two patients with L-loop transposition of the great arteries each successfully underwent placement of two MitraClip XTR devices; one patient had a single-leaflet detachment of one of the clips with no change in regurgitation or clip position on follow-up. All patients had significant reduction of AVVR and improvement in NYHA functional class. Percutaneous atrioventricular valve repair in adults with CHD is feasible with the MitraClip but requires significant preprocedural planning and a multidisciplinary team that combines CHD and interventional therapeutic expertise.

Impact of Proportionality of Secondary Mitral Regurgitation on Outcome After Transcatheter Mitral Valve Repair

ObjectivesThe purpose of this paper was to evaluate the impact of proportionality of secondary mitral regurgitation (SMR) in a large real-world registry of transcatheter edge-to-edge mitral valve repair (TMVr) BackgroundDifferences in the outcomes of recent randomized trials of TMVr for SMR may be explained by the proportionality of SMR severity to left ventricular (LV) volume. MethodsThe ratio of pre-procedural effective regurgitant orifice area (EROA) to LV end-diastolic volume (LVEDV) was retrospectively assessed in patients undergoing TMVr for severe SMR between 2008 and 2019 from the EuroSMR registry. A recently proposed SMR proportionality scheme was adapted to stratify patients according to EROA/LVEDV ratio in 3 groups: MR-dominant (MD), MR-LV-co-dominant (MLCD), and LV-dominant (LD). All-cause mortality was assessed as a primary outcome, secondary heart failure (HF) outcomes included hospitalization for HF (HHF), New York Heart Association (NYHA) functional class, N-terminal pro–B-type natriuretic peptide (NT-proBNP), 6-min-walk distance, quality of life and MR grade. ResultsA total of 1,016 patients with an EROA/LVEDV ratio were followed for 22 months after TMVr. MR was reduced to grade ≤2+ in 92%, 96%, and 94% of patients (for MD, MLCD, and LD, respectively; p = 0.18). After adjustment for covariates including age, sex, diabetes, kidney function, body surface area, LV ejection fraction, and procedural MR reduction (grade ≤2+), adjusted rates of 2-year mortality in MD patients did not differ from those for MLCD patients (17% vs. 18%, respectively), whereas it was higher in LD patients (23%; p = 0.02 for comparison vs. MD+MLCD). The adjusted first HHF rate differed between groups (44% in MD, 56% in MLCD, 29% in LD; p = 0.01) as did the adjusted time for first death or HHF rate (66% in MD, 82% in MLCD, 68% in LD; p = 0.02). Improvement of NYHA functional class was seen in all groups (p < 0.001). Values for 6-min-walk distances, quality of life and NT-proBNP improved in most patients. ConclusionsMD and MLCD patients had a comparable, adjusted 2-year mortality rate after TMVr which was slightly better than that of LD patients. Patients treated with TMVr had symptomatic improvement regardless of EROA/LVEDV ratio.

Ventricular arrhythmias in patients with functional mitral regurgitation and implantable cardiac devices: implications of mitral valve repair with Mitraclip®.

BackgroundLimited information has been reported regarding the impact of percutaneous mitral valve repair (PMVR) on ventricular arrhythmic (VA) burden. The aim of this study was to address the incidence of VA and appropriate antitachycardia implantable cardiac defibrillator (ICD) therapies before and after PMVR.MethodsWe retrospectively analyzed all consecutive patients with heart failure with reduce left ventricular ejection fraction (LVEF), functional mitral regurgitation (FMR) grade 3+ or 4+ and an active ICD or cardiac resynchronizer who underwent PMVR in any of the eleven recruiting centers. Only patients with complete available device VA monitoring from one-year before to one year after PMVR were included. Baseline clinical and echocardiographic characteristics were collected before PMVR and at 12-months follow-up.ResultsNinety-three patients (68.2±10.9 years old, male 88.2%) were enrolled. PMVR was successfully performed in all patients and device success at discharge was 91.4%. At 12-month follow-up, we observed a significant reduction in mitral regurgitation severity, NT-proBNP and prevalence of severe pulmonary hypertension and severe kidney disease. Patients also referred a significant improvement in NYHA functional class and showed a non-significant trend to reserve left ventricular remodeling. After PMVR a significant decrease in the incidence of non-sustained ventricular tachycardia (VT) (5.0±17.8 vs. 2.7±13.5, P=0.002), sustained VT or ventricular fibrillation (0.9±2.5 vs. 0.5±2.9, P=0.012) and ICD antitachycardia therapies (2.5±12.0 vs. 0.9±5.0, P=0.033) were observed.ConclusionsPMVR was related to a reduction in arrhythmic burden and ICD therapies in our cohort.

Percutaneous treatment with Mitraclip for functional mitral regurgitation: medium-term follow up according to left ventricular function.

BackgroundFunctional mitral regurgitation (FMR) is a bad prognosis condition despite optimal medical treatment. Nowadays there is an open debate about the surgical versus percutaneous treatment. The main objective of this study is to evaluate the mid-term follow up clinical outcomes of patients with FMR treated with MitraClip® system, according to their left ventricular ejection fraction (LVEF).MethodsData was obtained from two experienced centers in transcatheter mitral valve repair (TMVR). All consecutive cases of severe FMR undergoing TMVR in both centers with the same inclusion criteria were included prospectively in this study and followed-up. Periodical follow-ups with clinical and echocardiographic evaluation were scheduled from the baseline procedure, at 3 months and then yearly.ResultsFrom October 2015 to October 2019, a total of 119 patients with FMR at 2 centers in Spain underwent TMVR with the MitraClip® procedure and were included in this study. The mean age was 73.8±8.9 years old and 32 patients (26.9%) were female. A 39.5% of cases [47] had a LVEF ≤30% (group 1) and 60.5% (72 cases) had a LVEF >30% (group 2). There was a similar distribution in cardiovascular risk factors, age and other diseases. All MitraClip® implantations were elective and procedural success was achieved in 110 patients (92.4%) with a similar distribution between the groups. There were no differences in procedural time and the number of implanted clips. The median follow-up was 22.6 months (IQR, 11.43–34.98 months). The primary combined endpoint occurred in the 41.6% of the global cohort, 57.5% in group 1 and 30.99% in group 2 (P=0.036). LVEF was associated to the main event in the multivariate analysis (HR 2.09, 95% CI: 1.12–3.89; P=0.02).ConclusionsThe MitraClip edge-to-edge technique is a safe and effective procedure for the treatment of FMR. In this study, patients with LVEF >30% treated with Mitraclip presented better clinical cardiovascular outcomes than those with a LVEF ≤30%. Regardless clinical outcomes, at the end of the follow-up, there was a sustained reduction in MR grades and an important improvement in NYHA functional class.

Natural history of severe tricuspid regurgitation: Outcomes after transcatheter tricuspid valve intervention compared to medical therapy

AimsWe aimed to identify the clinical characteristics and examine outcomes in patients with significant tricuspid regurgitation (TR) who received transcatheter tricuspid valve intervention (TTVI) compared with guideline directed medical therapy (GDMT). Methods and resultsBetween 2015 and 2019, 124 patients with symptomatic severe TR were assessed at St. Michael's Hospital. Seventy-one patients were ineligible and received GDMT only while 53 patients received TTVI and GDMT. During follow-up, TTVI was associated with significant improvements in NYHA functional class and 6-min walk distance (p < .001). GDMT patients had lower survival (46.9% vs 75.1%, p = .047) and lower freedom from heart failure hospitalization (HHF) and mortality (33.2% vs 62.7%, p = .027), higher incidences per 100 person-year of gastrointestinal bleeding [15.58 (95% CI 8.90–25.31) vs 4.24 (95% CI 0.85–12.37), p = .04] and acute kidney injury [36.98 (95% CI 26.17–50.76) vs 14.12 (95% CI 6.76–25.96), p = .001] compared with TTVI patients. ConclusionTTVI in addition to GDMT was effective at improving TR symptoms, functional status, and was associated with lower rates of all-cause mortality, the combined endpoint of HHF and mortality, AKI and GI bleeding. Future randomized controlled trials on TTVI are needed.

Cardiac Resynchronization Therapy in Patients With Nonischemic Cardiomyopathy Using LeftBundleBranch Pacing.

The aim of this study was to assess the feasibility and efficacy of left bundle branch pacing (LBBP) using a novel intraseptal technique to deliver cardiac resynchronization therapy (CRT) in patients with left bundle branch block (LBBB) and nonischemic cardiomyopathy. His bundle pacing to correct LBBB is a viable alternative approach to achieve CRT but is limited by suboptimal lead delivery and high thresholds. This was a prospective, multicenter study performed between June 2017 and August 2018 at 6 centers. Patients with nonischemic cardiomyopathy, complete LBBB, and left ventricular ejection fractions (LVEFs)≤50% who had indications for CRT and/or ventricular pacing in whom LBBP was attempted were included. Success rates, QRS duration, LVEF, left ventricular end-systolic volume, and improvement in functional class were assessed. LBBP was successful in 61 of 63 patients (97%, mean age 68 ± 11 years, 52.4% men). During LBBP, QRS duration narrowed from 169 ± 16 to 118 ± 12ms (p<0.001). Pacing threshold and R-wave amplitude remained stable at 1-year follow-up compared with implantation values (0.5 ± 0.15 V/0.5ms vs. 0.58 ± 0.14 V/0.5ms and 11.1 ± 4.9mV vs. 13.3 ± 5.3mV, respectively). LVEF increased significantly (33 ± 8% vs. 55 ± 10%; p<0.001), with a reduction in left ventricular end-systolic volume (123 ± 61ml vs. 67 ± 39ml; p<0.001). LVEF had normalized (≥50%) in 75% of patients at 1 year. New York Heart Association functional class improved significantly from 2.8 ± 0.6 at baseline to 1.4±0.6 at 1 year. No deaths or heart failure hospitalizations were observed during follow-up. LBBP is a feasible and effective method for achieving electric resynchronization of LBBB, with resultant improvements in left ventricular structure and function. Low and stable pacing thresholds may be advantageous over His bundle pacing for CRT in patients with LBBB and nonischemic cardiomyopathy.

Atrial fibrillation ablation in heart failure patients: improved systolic function after cryoballoon pulmonary vein isolation.

AimsAtrial fibrillation (AF) and heart failure (HF) are the most common cardiac diseases and often coexist leading to increased mortality and morbidity compared with AF patients without HF. As shown previously, AF ablation using radio frequency (RF) in HF patients leads to a reduction of AF burden, an increase of left ventricular ejection fraction (LVEF) and consequently to reduced hospitalization and mortality. Previous AF ablation studies on HF patients have been liberal about additional targets beyond pulmonary vein isolation (PVI). Thus, the aim of this study was to assess systematically the impact of a straightforward PVI‐only strategy on LVEF, NYHA functional class, and cardiovascular hospitalization rate in HF patients.Methods and resultsOut of 414 consecutive patients undergoing PVI, only with the cryoballoon 113 patients with reduced LVEF [mean: 38.4 ± 10.8%, reduced ejection fraction (rEF) group] and 301 patients with normal LVEF (>55%) at baseline were identified [normal ejection fraction (nEF) group]. Remarkably, even though freedom from arrhythmia recurrence after 1 year was significantly lower in the rEF group (64.9%) compared with the nEF group (71.2%, P = 0.036), mean LVEF improved from 38.4 ± 10.8% to 52.5 ± 17.2% (P < 0.001) after cryoballoon ablation in the rEF group. Accordingly, HF‐related symptoms as well as hospitalization rate declined significantly in the rEF group during follow‐up compared with baseline.ConclusionsThe results of the present study suggest that catheter ablation restricted to a straightforward PVI‐only strategy using the cryoballoon leads to improved left ventricular ejection fraction as well as improvement of NYHA functional class and increased freedom from cardiovascular rehospitalization.

Clinical outcomes and hemodynamic performance of Dafodil\u2122 aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial

BackgroundBioprosthesis has been increasingly implanted for the treatment of transvalvular disease across the world. A new Dafodil™ pericardial bioprosthesis (Meril Life Sciences Pvt. Ltd., India) recently approved by Conformité Européenne (CE) is a tri-leaflet, stented, bovine valve. The purpose of Dafodil-1 first-in-human trial was to evaluate clinical safety and performance (including hemodynamic parameters) of the Dafodil pericardial bioprosthesis in patients who underwent aortic or mitral valve replacement.MethodsThis prospective, multicenter clinical trial enrolled 60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India. Safety endpoints were early (≤30 days) and late (> 30 days) mortality and valve-related morbidity. The performance endpoints were hemodynamic performance, improvement in NYHA functional class, and change in the quality of life using SF-12v1 health survey.ResultsFrom July 2017 to July 2018, 60 patients underwent implantation of the Dafodil pericardial bioprosthesis. Post-operatively, NYHA functional class significantly improved in all the patients (Aortic: 90% NYHA class-I and 10% NYHA class-II; Mitral: 96.55% NYHA class-I and 3.45% NYHA class-II; P < 0.001). There was no death in aortic valve replacement patients till 12-month. In mitral valve replacement patients, early mortalities occurred in three patients, and late mortality occurred in one patient; none of these were valve-related. Freedom from all-cause mortality reported was 93.33% at 12-month. Mean aortic pressure gradient decreased from 52.71 ± 24.47 mmHg [with 0.89 ± 0.70 cm2 effective orifice area (EOA)] pre-operatively to 14.49 ± 6.58 mmHg (EOA: 1.85 ± 0.27 cm2) at 12-month. Overall, the mitral mean pressure gradient and EOA were 4.41 ± 1.69 mmHg and 2.67 ± 0.48 cm2, respectively, at 12-month. Significant improvement (P < 0.05) in the patients’ quality of life was reported at all follow-ups.ConclusionsThe clinical safety and performance of the Dafodil pericardial bioprosthesis were favourable at 12-month. Moreover, a study with a larger patient population and longer follow-up is warranted to further assess the device.Trial registrationDafodil-1 trial has been prospectively registered on 10/07/2017 under Clinical Trial Registry-India (http://www.ctri.nic.in). (Registration number: CTRI/2017/07/009008).

Prognostic Assessment of Right Ventricular Systolic Dysfunction on Post-Transcatheter Aortic Valve Replacement Short-Term Outcomes: Systematic Review and Meta-Analysis.

BackgroundRight ventricular systolic dysfunction (RVSD) is a known risk factor for adverse outcome in surgical aortic valve replacement. Transcatheter aortic valve replacement (TAVR), on the other hand, has been shown to be either beneficial or have no effect on right ventricular systolic function. However, the prognostic significance of RVSD on TAVR has not been clearly determined. We conducted a systematic review and meta‐analysis to define the impact of RVSD on outcomes in terms of 1‐year mortality in patients with severe aortic stenosis undergoing TAVR.Methods and ResultsAn extensive literature review was performed, with an aim to identify clinical studies that focused on the prognosis and short‐term mortality of patients with severe symptomatic aortic stenosis who underwent TAVR. A total of 3166 patients from 8 selected studies were included. RVSD, as assessed with tricuspid annular plane systolic excursion, fractional area change or ejection fraction, was found to be a predictor of adverse procedural outcome after TAVR (hazard ratio, 1.31; 95% CI, 1.1–1.55; P=0.002). Overall, we found that RVSD did affect post‐TAVR prognosis in 1‐year mortality rate.ConclusionsPatients with severe, symptomatic aortic stenosis and concomitant severe RVSD have a poor 1‐year post‐TAVR prognosis when compared with patients without RVSD. Right ventricular dilation and severe tricuspid regurgitation were associated with increased 1‐year morality post‐TAVR and should be considered as independent risk factors. Further evaluations of long‐term morbidity, mortality, as well as sustained improvement in functional class and symptoms need to be conducted to determine the long‐term effects.

An Overview of First 100 Cardiac Surgery Cases at a Newly Developed Satellite Center in Sukkur, Pakistan.

IntroductionThe aim of this research is to evaluate the in-hospital and early outcomes of the first 100 adult cardiac surgeries performed at a newly developed satellite center in Sukkur, Pakistan.MethodsThis is an audit of the first 100 adult cardiac surgeries performed at a newly developed satellite center of the National Institute of Cardiovascular Diseases (NICVD) at Sukkur, Pakistan, from March 2018 to November 2018 with 12 months of post-operative follow-up. Patients were offered off-pump coronary artery bypass (OPCAB), on-pump coronary artery bypass (ONCAB), mitral valve replacement (MVR), aortic valve replacement (AVR), minimally invasive cardiac surgery (MICS), and congenital adult congenital heart disease (ACHD) procedures by expert faculty of NICVD with a minimum of five years of post-fellowship experience.ResultsThe mean age was 47.11 ± 14.6 years, with a male predominance of 77%. Hypertension and smoking were the most common risk factors that were observed in 32% and 33%, respectively, followed by diabetes and dyslipidemia with a frequency of 20% and 9%, respectively. The mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) II for this patient cohort was 1.165 ± 0.50, with a maximum score of 2.3 in one patient. Out of 100 procedures, 51 were ONCAB, 19 were OPCAB, 16 were MVR, three were AVR, nine were ACHD, and two were MICS. Survival status post-operative as well as after one year was 100%. The frequency of post-operative bleeding was 7%, mean post-operative mechanical ventilation time was 213 ± 273 hours, and in-hospital stay was 5.41 ± 0.165 days. Lost to follow-up at one year was 4% (four). During the follow-up assessment, 39.5% of the patients had complained of mild-to-moderate intensity retrosternal pain and 4.2% had superficial surgical site infection of the sternal wound. A significant improvement in functional class was observed in 38.5% of patients, whereas 4.2% (four) had a significant drop in functional class post-operatively.ConclusionProviding tertiary care and early cardiac surgical facility to the people of Sukkur at their doorstep, in a newly developed satellite center, has resulted in improved outcomes, early quality treatment facility, and avoidance of long travel time.

863Leadless endocardial pacing improves symptoms in patients with failed conventional CRT implant in long term follow up

Abstract Funding Acknowledgements EBR Systems, Inc OnBehalf WiSE-CRT and LV-SELECT study and POST-M REGISTRY Background The WiSE-CRT (Wireless stimulation endocardial) system has advantages over conventional epicardial CRT. Whenever conventional CRT failed to implant or failed to echocardiographic response, the WiSE-CRT was implanted as part of the WiSE CRT study (N = 13), as part of the LV-SELECT study (N = 35) or as part of the POST-M REGISTRY (N = 117) over the last 8 years. All these studies have reported high rates of clinical and echocardiographic response compared to conventional CRT. Objectives The purpose of this analysis was to determine the safety and clinical response in the largest available number of implanted patients (pts) with long term follow up of 2 years and the first, second and third generation of WiSE-CRT devices. Method All pts undergoing a WiSE-CRT implantation as part of the WiSE CRT study (N = 13), as part of the LV-SELECT study (N = 35) or as part of the POST-M REGISTRY (N = 117) were analysed (N = 165). Pts were followed-up for 24 months and considered CRT responders if an improvement in NYHA ≥ 1 class from baseline (pre-implant) was achieved. Results In total, 165 pts were implanted, demographics include: 68.2 ± 9.6 year’s old, 81.8% male, 49.7% with history of AFib and 54.5% non-ischaemic aetiology. The mean intrinsic QRS duration was 165.0 ± 32.3 msec (28 pts pace-maker dependent). 161 pts had the system successfully implanted with no major complications, 3 (1.8%) pts developed a pericardial effusion and 1 (0.6%) electrode was lost during implantation and recovered surgically. During the 24-month follow-up period, 20 (12.1%) pts died from any cause, 4 (2.4%) pts developed TIA or Stroke and 15 (9.1%) pts had pocket or transmitter infection. There was a significant improvement in NYHA functional class in 63.6% pts and an average improvement of -26.1 (-45.1, -7.1) msec in QRS duration. Conclusion Despite a history of failed conventional CRT implantation, pts undergoing CRT upgrades with a WiSE-CRT have a high success rate and a complication rate similar to previously described. In addition endocardial LV pacing led to symptomatic improvements in 64% of patients reaching the 24 month of follow up. Abstract Figure 1: Forest Plot NYHA Responder Rat

Phenotype and Outcomes of Pulmonary Hypertension Associated with Neurofibromatosis Type 1.

Rationale: Pulmonary hypertension (PH) associated with neurofibromatosis type 1 (NF1) is a rare and largely unknown complication of NF1.Objectives: To describe characteristics and outcomes of PH-NF1.Methods: We reported the clinical, functional, radiologic, histologic, and hemodynamic characteristics, response to pulmonary arterial hypertension (PAH)-approved drugs, and transplant-free survival of patients with PH-NF1 from the French PH registry.Measurements and Main Results: We identified 49 PH-NF1 cases, characterized by a female/male ratio of 3.9 and a median (minimum-maximum) age at diagnosis of 62 (18-82) years. At diagnosis, 92% were in New York Heart Association functional class III or IV. The 6-minute-walk distance was 211 (0-460) m. Pulmonary function tests showed low DlCO (30% [12-79%]) and severe hypoxemia (PaO2 56 [38-99] mm Hg). Right heart catheterization showed severe precapillary PH with a mean pulmonary artery pressure of 45 (10) mm Hg and a pulmonary vascular resistance of 10.7 (4.2) Wood units. High-resolution computed tomography images revealed cysts (76%), ground-glass opacities (73%), emphysema (49%), and reticulations (39%). Forty patients received PAH-approved drugs with a significant improvement in functional class and hemodynamic parameters. Transplant-free survival at 1, 3, and 5 years was 87%, 54%, and 42%, respectively, and four patients were transplanted. Pathologic assessment showed nonspecific interstitial pneumonia and major pulmonary vascular remodeling.Conclusions: PH-NF1 is characterized by a female predominance, a low DlCO, and severe functional and hemodynamic impairment. Despite a potential benefit of PAH treatment, prognosis remains poor, and double-lung transplantation is an option for eligible patients.

Pulmonary arterial hypertension with below threshold pulmonary vascular resistance.

Pulmonary vascular resistance (PVR) >3 Wood units is a criterion of the haemodynamic definition of pulmonary arterial hypertension (PAH). However, this cut-off is conservative and arbitrarily defined. Data is lacking on the natural history, response to therapy and survival of patients diagnosed with precapillary pulmonary hypertension (PH) with mild or borderline elevation of PVR.In Australia, PAH therapy could be prescribed solely on mean pulmonary arterial pressure (PAP) and pulmonary arterial wedge pressure (PAWP) criteria. Using the Australian and New Zealand Pulmonary Hypertension Registry, we aimed to study a population diagnosed with PAH between January 2004 and December 2017 with the pre-defined haemodynamic characteristics of mean PAP ≥25 mmHg, PAWP ≤15 mmHg and PVR <3 Wood units.Eighty-two patients met the pre-defined haemodynamic inclusion criteria (mean age 63±11 years; 67 females). Underlying aetiologies included idiopathic disease (n=39), connective tissue disease (CTD; n=42) and HIV infection (n=1). At diagnosis, mean PAP was 27 mmHg (interquartile range (IQR) 25-30 mmHg), PAWP 13 mmHg (IQR 11-14 mmHg) and PVR 2.2 Wood units (IQR 1.9-2.7 Wood units). Baseline 6-min walk distance (6MWD) was 352 m (IQR 280-416 m) and 77% of subjects were in New York Heart Association (NYHA) functional class 3 or 4. All patients were commenced on initial monotherapy with an endothelin receptor antagonist (ERA; n=66) or phosphodiesterase type-5 inhibitor (PDE5i; n=16). At first re-evaluation, 6MWD increased by 46 m (IQR 7-96 m) and 35% of subjects demonstrated improvement in NYHA functional class. After a median follow-up of 65 months (IQR 32-101 months), 18 out of 82 subjects (22.0%) had died, with estimated 1-year and 5-year survival rates of 98% and 84%, respectively. Death attributed to PAH occurred in six out of these 18 patients (33.3%, 7% of total cohort).Patients with precapillary PH and "borderline" PVR falling outside the current definition have adverse outcomes. Such patients appear to respond to PAH therapy; however, this requires further study in randomised trials.

Optimal Medical Treatment vs. Invasive Approach in Patients with Significantly Obstructive Coronary Artery Disease and Ischemia

Stable ischemic heart disease (SIHD) is a condition that develops in subjects after myocardial infarction. Evidence suggests that optimal medical treatment (OMT) is not inferior to intervention (INT) using percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). To compare clinical outcomes in subjects with SIHD who only received OMT and those who received INT+OMT. We retrospectively examined subjects with SIHD who underwent myocardial perfusion study-SPECT/CT in a reference center in Mexico. We assigned two branches: INT+OMT (subjects with previous PCI or CABG) and OMT (subjects with antiplatelet drugs, β-blockers, renin-angiotensin-system blockade, nitrates, calcium-channel blockers, and aggressive lipid-lowering therapy). Clinical outcomes at follow-up were angina relief, functional class improvement, hospitalization, myocardial reinfarction and death from any cause. We included 100 subjects; 51 with OMT and 49 with INT+OMT. 54 subjects had 1 affected vessel and 46 more than 2. INT+OMT group had up to 14 fold likelihood (95% CI: 3.38-63.35) of achieving angina relief and 2.2 fold likelihood (95% CI: 0.92-5.57, p=0.077) for functional class improvement. No differences were found in hospitalization, myocardial infarction and death from any cause compared to OMT. Subjects with OMT have no higher risk of adverse clinical outcomes compared to INT+OMT. However, the INT+OMT provides angina relief and functional class improvement compared to OMT.

Catheter ablation of atrial fibrillation in heart failure: clinical, prognostic, and echocardiographic outcome.

Catheter ablation (CA) for atrial fibrillation (AF) in heart failure (HF) patients is associated with a lower rate of cardiac events compared with medical therapy. This study deals with the clinical, echocardiographic, and prognostic outcomes in these patients. Prognostic scores, as MAGGIC (Meta-analysis Global Group in Chronic Heart Failure) score, may help to predict the outcomes. From a single center, 47 patients with AF, HF, and left ventricular ejection fraction (LVEF) < 50% underwent CA. The primary endpoints were NYHA functional class, LVEF, and MAGGIC score. The median age of patients was 59years; 49% had paroxysmal AF. At 12months, a significant improvement of NYHA class (median before II [interquartile range (IQR) II-III] vs median after I [IQR I-II]) and of LVEF (median before 44% [IQR 37-47] vs median after 55% [IQR49-57]) was observed (p value < 0.001). The MAGGIC 1-year and 3-year probability of death was estimated before (mean score 13 [IQR 11-17]) and at 12-month (mean score 11 [IQR 8-13]), showing a significant decrease in the probability of death (p value <0.001). At 12-month, a lower LVEF was associated with more HF hospitalizations (p value 0.035). Coronary artery disease (CAD) (HR 5, p value 0.035) and MAGGIC score (HR 1.2, p value 0.030) were predictors of HF hospitalization. CA for AF in HF patients was associated with a significant improvement of NYHA functional class and LVEF and a higher life expectation. CAD history, LVEF < 40%, and MAGGIC score before ablation were predictors of HF hospitalization.

Rapid-Deployment Aortic Valves for Patients With a Small Aortic Root: A Single-Center Experience

Aortic valve replacement in patients with a small aortic root is a matter of concern in terms of prosthesis-patient mismatch. We evaluated the survival and hemodynamic performance after implantation of a small rapid-deployment aortic valve (EDWARDS INTUITY valve system sizes 19 and 21 mm). Between May 2010 and November 2018, 659 consecutive patients with severe aortic stenosis who received a rapid-deployment valve were included in a prospective and ongoing database. A small aortic bioprosthesis (sizes 19 mm and 21 mm) was implanted in 217 (32.9%) patients (mean age 74.9 ± 7.9 years, 85.3% women). Preoperative characteristics, operative parameters, and postoperative outcomes were assessed. Mean gradients at discharge and 1 year were 14.8 ± 5.6 mm Hg and 13.6 ± 4.9 mm Hg, respectively. Mean effective orifice area and the indexed effective orifice area at discharge were 1.55 ± 0.36 cm2 and 0.87 ± 0.22 cm2/m2, respectively, and prosthesis-patient mismatch occurred in 77 (35.5%) patients (25.8% moderate and 9.7% severe). Perioperative mortality was 1.8% (n= 4 of 217) and overall survival at 1 year and 5 years was 91% and 79%, respectively. The presence of any prosthesis-patient mismatch degree did not have a significant influence on overall survival (hazard ratio, 0.95; 95% confidence interval, 0.75-1.19; P= .638). At the last follow-up, mean New York Heart Association functional class was 1.5 ± 0.7 vs 2.8 ± 0.6 at baseline (P < .001). Surgical aortic valve replacement with rapid-deployment valves has shown improved results concerning hemodynamic performance, with decreased rates of prosthesis-patient mismatch. We observed excellent early-term and midterm survival and a significant improvement in functional class in this subgroup of patients with a small annulus.