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Hang Zhang, Shao-Liang Chen
2019 JACC: Cardiovascular Interventions  
This study is not a completely sham-controlled study because sildenafil prescription became a discriminator of the true PADN versus the sham PADN procedure. It is difficult to understand the selection of sildenafil as a comparator arm. Pulmonary arterial hypertension (PAH) therapies including sildenafil have long been studied in PH-LHD with adverse clinical results (2,3). The use of PAH therapies is not recommended for PH-LHD according to the recent European Society of Cardiology/ European
more » ... ratory Society PH guidelines (4). A growing body of evidence indicates a potential role of left ventricular (LV) assist devices only to achieve reductions in pulmonary artery systolic pressure and pulmonary vascular resistance in PH-LHD. The investigators defined heart failure (HF) with preserved ejection fraction (EF) as LVEF $50% and HF with reduced EF as LVEF <50%. LVEF 40% to 49% (HF with mid-range EF) is a totally different entity. Only 65% to 70% of HF with reduced EF had received angiotensin-converting enzyme inhibitors/ angiotensin receptor blockers/beta-blockers. A very limited time for the run-in period for stabilization was permitted. Optimization of medical therapy with angiotensin-converting enzyme inhibitors/ angiotensin receptor blockers/beta-blockers/sacubitril has been missed in the follow-up. Sildenafil might have potentially increased the congestive state of the patients. Heart rate control should have had a huge impact on the results because one-half the patients had atrial fibrillation. It is unacceptable to give aspirin plus clopidogrel in the era of new oral anticoagulants. The heart rate would slow down after PADN. There is not any detailed information about the effects of PADN. Considering the PADN application site is in the vicinity of the superior cardiac plexus, the innervation of the heart might have been affected, and an eventual chronotropic effect would confound the results. The essential factors for the development of PH-LHD are LV end-diastolic pressure and functional mitral regurgitation, on which PADN may not have any possible effect. Better designed randomized studies are clearly needed to further define which patients might be most likely to respond to this innovative approach.
doi:10.1016/j.jcin.2019.02.023 pmid:31000019 fatcat:bj565qppizbmzjb24to3a4akvu