#Shanghai #USA #Pulnovo Medical #PADN #ESC 2026

Introduction

In a landmark announcement at the ESC 2026 Congress, Pulnovo Medical revealed innovative findings from their extensive clinical trial, PADN-HF-PH, targeting pulmonary hypertension (PH) associated with left heart failure (LHD). The results were published simultaneously in the prestigious New England Journal of Medicine (NEJM), marking a significant advancement in cardiovascular intervention strategies.

Study Overview

Led by prominent experts including Professor Shao-Liang Chen and Academician Yaling Han, the PADN-HF-PH trial was a randomized, controlled, multicenter study comprising 264 patients. The primary objective was to assess the safety and efficacy of pulmonary artery denervation (PADN) when added to guideline-directed medical therapy (GDMT) for patients suffering from PH-LHD.

Notably, the trial demonstrated multidimensional therapeutic benefits, such as a 51% reduction in the risk of clinical deterioration and a notable 35.5% decrease in recurrent clinical events, alongside sustained improvements in functional capacity.

Clinical Significance

Both hypertension and heart failure are known to exacerbate each other, leading to worsened symptoms and poor clinical outcomes. The common treatments primarily address heart failure but often fall short when it comes to managing PH. The PADN approach introduces an innovative tactic by directly targeting the pulmonary hypertension aspect.

Key Findings

1. Clinical Worsening Risks: The trial noted a striking 51% reduction in clinical worsening risk during a median follow-up of 338 days. The two-year incidence of clinical worsening was 25.7% for the PADN + GDMT group versus 51.5% for the GDMT-only group, demonstrating a clinically significant impact.
2. Cohesive Health Improvements: The primary composite endpoint comprised events such as death, heart or lung transplants, and hospitalizations for heart failure, reflecting concrete long-term health changes in patients.
3. Marked Reduction in Recurrences: The annualized rate of recurrent events stood at 36.3 per 100 patient-years in the PADN group versus 56.3 in the GDMT group, indicating a substantial decline in morbidity.
4. Enhanced Functional Capacity: Patients showed an average improvement of 24.8 meters in their six-minute walk distance (6MWD) at the 12-month mark, with 63% less risk of experiencing a 10% drop or more in their walking distance.
5. Quality of Life Enhancements: Improvements in the Kansas City Cardiomyopathy Questionnaire (KCCQ) and biomarkers such as NT-proBNP further illustrate the positive impact on patient health, validating the efficacy of the PADN procedure.
6. Safety Profile: The therapy demonstrated an excellent safety profile, with minimal complications during the intervention, underscoring its viability as a treatment option.

Conclusion

Overall, the PADN-HF-PH trial establishes a pivotal clinical paradigm toward treating PH associated with left heart failure, offering a fresh, evidence-based approach to care. The significant declines in clinical deterioration and hospitalizations, along with enhanced functional capacity and quality of life, reflect the promise of PADN in transforming therapeutic strategies.

About PADN Technology

PADN (Pulmonary Artery Denervation) represents an innovative, minimally invasive treatment designed to modulate excessive sympathetic nervous system activity, thereby improving pulmonary vascular remodeling and the progression of cardiopulmonary diseases. Recognized in numerous international clinical guidelines, PADN is featured among experimental interventions recommended by both the European Society of Cardiology and the European Respiratory Society.

About Pulnovo Medical

Pulnovo Medical continues to dedicate its efforts towards pioneering intervention therapies for pulmonary hypertension and heart failure, focusing on delivering clinically impactful solutions worldwide. For more information, please visit www.pulnovomed.com.