PADN-CFDA multi-center half-year follow-up data pre-announced positive clinical performance

Pulmonary arterial hypertension, because of its high mortality and intractability, has become the death of the patient's heart

According to the latest report from The Lancet, the number of people suffering from pulmonary arterial hypertension in the world will account for 1% of the world's total population in 2021, and there will be approximately 40 million patients with pulmonary arterial hypertension (PH)

Focusing on this intractable disease that plagues doctors around the world, on February 26, 2022, at the first academic conference of the Pioneer College of the National Standardized Pulmonary Vascular Disease Center of the Cardiovascular Disease Management Capability Assessment and Improvement Project (CDQI), the domestic pulmonary artery More than 20 experts in the field of hypertension gathered online to discuss the pre-announcement of the Chinese multi-center clinical research results of PADN, the world's only device therapy for pulmonary arterial hypertension

PADN, China's original therapy, has attracted worldwide attention since its inception, and has been certified as a breakthrough therapy by the FDA

In the first series of meetings of the Pioneer Academy, the main PI of the PADN study announced the half-year follow-up data of some patients in the CFDA study

PADN-CFDA multi-center half-year follow-up data pre-announced, with positive clinical performance

Pulmonary hypertension (PH) is an important disease in pulmonary vascular diseases, which can cause clinical and pathophysiological syndromes of increased pulmonary vascular resistance and pulmonary arterial pressure, and then develop right heart failure and even death, with high disability and fatality rate

Among them, type I pulmonary hypertension (PAH) includes congenital heart disease (CHD) related PAH, hereditary PAH (Heritable Pulmonary Arterial Hypertension, HPAH), drug and poison related PAH (Drug-Induced Pulmonary Hypertension, DPAH) Connective tissue disease (CTD) is the most common related factor in PAH

At this stage, the treatment of pulmonary arterial hypertension is still dominated by targeted drugs

However, the ceiling effect of targeted drugs may lead to a decline in efficacy, making the overall treatment effect unsatisfactory

In 2012, China's original PADN technology ushered in a new era of interventional therapy for pulmonary arterial hypertension

Since the birth of PADN, this Chinese original device therapy has attracted wide attention.

The PADN-CFDA domestic multicenter clinical study that included 128 PAH patients gave the latest answer

Professor Chen Shaoliang from Nanjing Hospital Affiliated to Nanjing Medical University combined his rich clinical experience to interpret some clinical research data of PADN-CFDA in detail

Many clinical experts who participated in the PADN-CFDA research at the scene expressed that the clinical research data of PADN-CFDA is very impressive, and they look forward to the release of the final results, so that the original technology can benefit more patients with pulmonary hypertension and improve the health resilience of patients

Clinical practice of pulmonary arterial hypertension, PADN combined with targeted drugs to treat various subtypes

Currently, there are various treatments for PAH, including drug therapy, lung transplantation, and interventional therapy

For patients with secondary PAH, timely diagnosis in the early stage and standardized treatment in the later stage will greatly improve the prognosis of patients

In complex clinical cases, how PADN can play a role, experts from the multi-center clinical trials conducted the analysis of clinical cases at the conference site
.

Connective tissue disease is a group of autoimmune diseases involving multiple systems and organs, including systemic lupus erythematosus, rheumatoid arthritis, etc.
One of the serious complications is PAH
.
CTD‑PAH has insidious clinical manifestations, difficult early diagnosis, and poor treatment effect.
It is one of the important factors for the death of patients with connective tissue diseases
.
Currently, drug therapy remains the main option for CTD-PAH
.
When the effect of drug treatment reaches the "ceiling" and pulmonary artery pressure cannot be controlled, can interventional therapy improve the prognosis of patients?

Professor Yang Zhenwen from the General Hospital of Tianjin Medical University shared his experience in the treatment of connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH).
A 40-year-old female patient has a history of mixed connective tissue disease for more than 10 years.
He suffered from pulmonary arterial hypertension and underwent PADN operation after clinical enrollment.
No adverse events such as pulmonary artery perforation and acute thrombosis occurred after operation.
The PASP (pulmonary artery systolic pressure) decreased by 12 mmHg at 6 months after the operation, and the MPAP (mean pulmonary artery pressure) was reduced by 12 mmHg.
) decreased by 5mmHg
.

In general, PADN surgery combined with drug therapy can further improve the hemodynamics and clinical conditions of CTD-PAH patients.
The treatment of CTD-PAH patients emphasizes the "double achievement" of immunosuppressive therapy for connective tissue disease and PAH-related therapy.

.

The same is secondary PAH, congenital heart disease-related pulmonary hypertension (CHD-PAH) is the most common cause of PAH in China, and many patients with congenital heart disease have lost the opportunity for surgery because of the combination of PAH
.

According to the hemodynamic characteristics, CHD‑PAH can be divided into dynamic type and resistance type
.
Although patients with dynamic PAH have PAH, their pulmonary vascular disease has not yet developed serious lesions, and the pulmonary artery pressure can be reduced to normal after the defect is closed.
It decreased to normal or increased instead, and persistent PAH occurred after surgery
.

The "Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension in China (2021 Edition)" proposed that the CHD-PAH treatment plan should be determined according to the PAH hemodynamics.
For patients with dynamic PAH, surgical closure of the defect is the fundamental method to solve PAH, and the defect should be carried out as soon as possible.
For resistance type PAH, long-term treatment with targeted drugs and combined heart-lung transplantation or lung transplantation combined with heart defect repair can be used
.

Therefore, the early diagnosis of CTD-PAH patients is equally important
.

In the clinical treatment of CTD-PAH patients, Professor Zhang Caojin shared a 63-year-old case of atrial septal defect
.
The patient had edema of both lower extremities for half a year and had undergone atrial septal repair before, and was included in the PADN-CFDA surgery group
.
Postoperative MPAP decreased by more than 10 mmHg, and PASP decreased by more than 13 mmHg; at 6-month follow-up, both MPAP and PASP were within the normal range
.

Through this case sharing, it is verified that for some CTD-PAH patients, on the basis of targeted drug therapy, combined with PADN and other surgical treatments, the patient's condition will be greatly improved
.

In conclusion, CTD-PAH has seriously threatened human health and requires earlier and aggressive clinical intervention, regular monitoring and management of patients
.
In the treatment of CTD-PAH patients, individualized treatment must be adhered to, so as to hope that the prognosis of patients can be comprehensively improved
.
At present, targeted drugs can create surgical opportunities for patients before surgery and improve patients' cardiac function after surgery.
As an innovative device therapy, PADN combined with targeted drugs will greatly improve the efficacy
.

When all etiologies are excluded, patients are classified as IPAH
.
The etiology of IPAH is unknown, the clinical symptoms are complex, and it is more common in female patients
.
IPAH disease progresses rapidly and the prognosis is poor.
It is the last "big battlefield" of cardiopulmonary department
.
For IPAH patients, the same emphasis is placed on early diagnosis and standardized treatment and management
.

Professor Guo Xiaomei from Tongji Hospital introduced: "Through family relationship analysis, we can only rule out familial pulmonary hypertension, but we cannot rule out some patients with genetic abnormalities or mutations
.
Among the more than 50 IPAH patients in our hospital, There are about 30 patients with gene mutations
.
Therefore, genetic factors account for a large proportion of IPAH patients, especially multiple site mutations in bone morphogenetic protein II can lead to the occurrence of PAH, and genetic testing is recommended for patients
.
”

Source of PH diagnosis flowchart: Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Arterial Hypertension (2021 Edition)

IPAH patients have no obvious symptoms in the early stage, and early clinical diagnosis is difficult.
It takes an average of 2 years from the onset of symptoms to the diagnosis of IPAH
.
Due to the lack of clear etiology and lack of specific clinical manifestations and diagnostic methods, the diagnosis of IPAH mainly relies on the exclusion of PAH-related diseases or causes
.

Professor Guo Xiaomei introduced that at present, the treatment methods for IPAH patients include targeted drug therapy and surgery, but more than one-third of patients discontinue or reduce the dose of targeted drugs because they cannot tolerate the side effects of targeted drugs.
When the ceiling is reached, the clinic needs innovative interventional therapy
.

Take a 57-year-old patient with complex PAH as an example, who suffered from "pulmonary hypertension, right ventricular insufficiency, atrial fibrillation, chronic erosive pneumonia" and was included in the PADN surgery group
.
The PVR (pulmonary vascular resistance) decreased by 71.
4% at 6 months postoperatively, and the 6MWD (6-minute walk distance) increased exponentially
.

In general, according to the specific conditions of IPAH patients, different stages of PAH and economic conditions, targeted drug therapy is the basis, and a variety of new technologies can be selected for comprehensive treatment, such as PADN surgery
.
At the same time, early diagnosis, comprehensive evaluation, standardized treatment, and close follow-up should be done for IPAH
.

The company behind the global original, Pamu Medical helps the exploration of pulmonary arterial hypertension therapy

The company that supports the research and development of PADN technology is a star enterprise in the industry, Pamu Medical.
Relying on pulmonary arterial hypertension technology, it has built a global OTM innovation technology platform
.

Previously, most of China's medical device innovations were imitative innovations and lacked underlying innovation capabilities
.
Palmer Medical has been targeting pulmonary arterial hypertension, a disease with unmet clinical needs, for ten years
.
The company already possesses the multi-dimensional compounding capability of global innovation
.

In 2019, the global sales of the original TOP8 therapeutic drugs for pulmonary arterial hypertension were around US$5 billion, a slight decline from the previous year, which did not include PDE-5 inhibitors and prostaglandins for anti-ED indications
.
The overall global pulmonary arterial hypertension drug market is expected to be around $10 billion in 2028
.
At the same time, from March 2021, the targeted drug for pulmonary arterial hypertension, Ambrisentan, will be included in the medical insurance list, further reducing the medication burden of PAH patients
.

Dr.
Lakshmi Dharmarajan, Senior Analyst of Cardiovascular & Metabolic Diseases at GlobalData, said that although the pulmonary arterial hypertension drug market has developed rapidly in recent years, there are still many patients whose clinical needs are not well met, and there is still no cure
.

The products of Pamu Medical are global original technologies with global competitiveness.
With the continuous advancement of products, it is expected to become an important supplementary therapy for the global pulmonary arterial hypertension market in the future
.

Previously, Pamu Medical has received more than 100 million yuan in financing, and has been favored by top funds such as OrbiMed, Cenova, Lilly Asia Fund (LAV), and GaoRong Capital
.

(Original abridged)