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@article{172495,
        author = {Rawal Umedmal and Minocha Dr. Pramod Kumar and Kothwala Dr. Deveshkumar and Shah Khusboo and Desai Mansi and Dave Arpit and Arya Manish},
        title = {Clinical Case Study on Assessing the Safety and Efficacy Of The Atrial Pressure Controller Device In Symptom Management For Patients With Pulmonary Arterial Hypertension And Heart Failure},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {11},
        number = {9},
        pages = {417-434},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=172495},
        abstract = {Objectives: To assess in retrospect the safety and effectiveness of atrial pressure controller device for symptom management in patients with pulmonary arterial hypertension and heart failure.
Methods: The study involved 14 patients (4 males, 10 females) with a mean age of 65 years (range 50-80 years old). All had a history of chronic heart failure (NYHA class III-IV). Baseline atrial pressure ranged from 18 to 25 mmHg (mean 21 mmHg). Co-morbidities included hypertension (10 patients), diabetes (7 patients), and previous myocardial infarction (4 patients), were treated with AFR with fenestration diameters of 8 and 10 mm, with device diameter is 21 or 23 mm and the distance between the LA and RA discs being 5 and 10 mm, respectively. Device requires a delivery system of 12 and 14 Fr.
Results: Study included 14 patients (4 male, 10 Females) with a mean age of 65 years (range 50–80 years), all with heart failure (NYHA class III–IV). Baseline atrial pressure ranged from 18 to 25 mmHg (mean 21 mmHg). Hypertension, diabetes, and a history of previous myocardial infarction were common. The mean study time was 45 minutes. Mean atrial pressure decreased from 21 mmHg to a maximum of 14 mmHg, after transplantation (p<0.01). Twelve patients reported a 30% reduction in symptoms and a 30% improvement in quality of life (QOL). The device-maintained target pressure (12–16 mmHg) in 13 patients. Minor complications included cardiac arrhythmias, which resolved without complications in three patients. There were no signs of infection or migration. After 6 months, 13 patients had improved stress management and decreased symptoms. In one patient, symptoms recurred after 4 months and he was treated with medication. There were no deaths.
Conclusion: The implantation of the ThoroughFare™ Atrial Pressure Controller is important in patients with severe idiopathic pulmonary hypertension and requires collaboration between pulmonologists and cardiologists due to its complexity. A good cardiac assessment suggests surgery in conjunction with other methods to resolve problems such as paddle advancement and septal puncture. Post-implantation evaluation using imaging and hemodynamic testing ensures that the device is functioning, and the patient is stable. Follow-up studies have shown that the device is effective, reduces cardiac chamber load, improves hemodynamics and reduces symptoms. The device is safe for all ages and genders, meets the needs of the treatment and permanently improves the management of the treatment.},
        keywords = {Pulmonary Artery Hypertension, Idiopathic Pulmonary Artery Hypertension, Interatrial Shunt, Atrial Flow Regulator.},
        month = {February},
        }