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The Importance of Maintaining Patency of Atrial Septal Defects in Selected Conditions Rebecca Macrae Lead for ACHD Echocardiography Barts Heart Centre London, UKOverview 1. Indications for atrial septal defect closure 2. When might we wish to avoid closure ? 3. In what scenarios may we wish to create an ASD ? 4. What is the latest evidence ?CASE STUDY ü 27 yr old female ü Presented with palpitations ü Incomplete RBBB on ECG ü Echo – secundum ASD, dilated right heart, no evidence of PHT Management options A. Close defect (surgical or percutaneous) B. Plan to close – but wait until patient is older C. No interventionGuidelines CASE STUDY Management Options A. Close defect B. Plan to close, wait until patient is older ü 75 year old female C. Balloon test ASD ü Dyspneoa closure in cath lab and measure LA pressure ü HTN and atrial fibrillation ü Referred for echo Echo parameters ü Small ASD ü LVEF 55% ü Mildly dilated RV size with good function ü Diastolic assessment; LA volume 90ml/m2, PASP 50mmHg, average E/e’ 20 ü Heart Failure with Preserved Ejection Fraction (HFpEF)Guidelines **Raised LV filling pressures** Heart Failure – A Global Issue Groenewegen et al., 2020 European Journal of Heart Failure Owan et al., 2006 Approximately 64.3 million people are living with heart failure worldwide Increased LV stiffness Elevated LV filling pressures Associated with increased mortality in both HFpEF and HFrEF Elevated LA pressure groups Pulmonary oedema and dyspnoea on exertionYoon & Hyeon Eom 2019Joo Park et al. 2021 Clinical research in CardiologyL e t ’s C R E s e A T E p ta a n l d at e f e ria ct !! l The Atrial Flow Regulator Litwin et al., 2022. Structural Heart N E W S T U A V D I A E S IL A B L E 64 patients >40yrs old Prospective Non-randomized EF >40%, Open-label PCWP >15mmHg/ Single arm study >25mmHg during exercise NHYA II-IV Primary Outcome Right heart catheter Measures: (CO, RAP, PASP, PCWP) Safety of device Rest & supine bike Functional capacity and exercise (baseline/ 6 months) clinical status (at 6 months) Rahman et al. Circulation. 2019;140:1805–1816 RESULTS Median NYHA class improved Mean MLWHF from III to II score reduced P<0.0001 from 49 to 36 P<0.0001 Subjective testing by unblinded participants and investigators, may be subject to unintentional bias Supine exercise Mean 6-min duration walk distance improved from improved from 313m to 345m 7.3 to 8.2mins P=0.0023 p=0.0275 **No procedural or major adverse complications during 6 months f/up** Cardiac output Cardiac output significantly significantly increased at rest increased at peak P<0.0001 exercise P<0.0001 No difference in Mean 20W exercise PCWP mean PCWP at rest reduced from 32mmHg to (17mmHg versus 29mmHg 17mmHg) p=0.24 P=0.012 Mean peak exercise Mean PCWP normalised PCWP reduced from for workload reduced 34mmHg to from 84 mm Hg/W/kg to 32mmHg 69 mm Hg/W/kg P=0.025 p=0.0001Conclusions • AFR implant is feasible in HFpEF patients • Improvements in PCWP, NHYA class and 6MWT at 6 months suggest potential clinical efficacy. • Fthe efficacy and safety of the AFR.th longer f/up period are needed to finally determineA prospective, non-randomised, multicentre, first-in-man study in symptomatic HF patients with HFrEF or HFpEFRESULTS PCWP All patients < 5 mmHg (-12, 0) P = 0.0003 HFpEF <5 mmHg (−12.5, −1.5) P =0.0004 HFrEF <4 mmHg (-9,0) P = 0.1 NT-pro BNP Highly variable at baseline and during follow-up No significant changes up to 1 year [+20 pg/mL (−214, 264), P = 0.3] NYHA class Significant decrease by 1 (−1, 0), P < 0.0001 at 1 year follow up across both groups Unblinded participants may be subject to unintentional bias 6MWD Improved significantly +50 m (−33, 113), P = 0.0198 At 1 year follow upConclusions • AFR implant is feasible in HFrEF and HFpEF patients • PCWP reduction and improvement in symptomatology, quality of life and exercise capacity suggest potential clinical efficacy. • Future randomised control studies with longer f/up period are needed to finally determine the efficacy and safety of the AFR.626 patients Random assignment Primary endpoints Secondary end points -Hierarchical -Total HF events (24 Symptomatic HF Atrial shunt device composite of CV months) (n=314) death or non-fatal -Change in NYHA class EF >40% ischemic stroke (12 months) PCWP>25mmHg or (12m) during exercise Sham procedure -Rate of total HF -Change in KCCQ score (n=312) events (24m) (12 months) -Change in KCCQ score (12m)The primary efficacy endpoint (win ratio 1·0 [95% CI 0·8–1·2]; p=0·85) did not differ between the groups, and there were no differences between groups in the individual components of the primary endpointImprovement in both groups almost certainly limits the potential to see a treatment effect. SUB-GROUP ANALYSIS Differential effect of shunt device treatment by prespecified groups Forest plot of treatment effect on recurrent HF Men, RA volume index >29.7ml/m2 and PASP > 70mmHg at 20W of exercise had worse heart failure event outcomes with the device, favouring sham control These groups probably draw the summary effect toward the null hypothesis Post Hoc analysis Patients with peak exercise PVR <1·74 Wood units (n=382) appeared to benefit from the shunt (p=0·032) with significantly less HF events and a change in KCCQ score when compared to patients with peak exercise PVR >1·74 Wood units (n=188) Conclusions ü Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in this HF population ü Sub group and post Hoc analysis identify sub groups that demonstrate worse heart failure events with AFR ü More to be done….SUMMARY ü AFR appears to be a safe intervention ü AFR is associated with significant and reductions in PCWP and improved 6MWD, NYHA class ü AFR does not appear to reduce the total rate of heart failure events or improve health status in HF patients with EF >40%• Disappointing neutral results • Fortunately, important lessons emerge from these trials that provide necessary insight for future studies • Particularly in this important HF population with currently limited viable treatment options