The systemic nature of CKD
What To Know About Pulmonic Regurgitation
Pulmonic regurgitation is when blood leaks back into the heart from the pulmonary artery due to weakness in the pulmonary valve.
It happens when a pulmonary valve does not close properly. The pulmonary valve is the mechanism that ensures blood leaving the heart does not come back into it.
Pulmonic regurgitation is not a disease but can result from various conditions, including lung disease, heart failure, and sickle cell disease.
In this article, we look at what pulmonic regurgitation is, why it occurs, and what to expect if it does.
Pulmonic regurgitation happens when the pulmonary heart valve is faulty and does not seal tightly. The leaky valve allows blood to flow back into the heart's right ventricle instead of moving on to the lungs to collect oxygen.
The pulmonic or pulmonary valve is one of four heart valves. The others are the tricuspid, the mitral, and the aortic valves.
Other names for regurgitation include backflow and insufficiency.
Pulmonic regurgitation usually results from an underlying condition, such as pulmonary hypertension or a heart defect a person was born with.
What are the other types of heart valve regurgitation?
The signs and symptoms of pulmonic regurgitation may not appear in the early stages. However, if the underlying disease progresses, a person may notice:
In some cases, pulmonic regurgitation or an underlying cause can lead to heart failure. If this happens, an individual may experience:
Pulmonic regurgitation happens when the valve that allows blood to leave the heart and travel to the lungs becomes leaky.
It can occur with the following conditions:
People most at risk of pulmonic regurgitation are those born with certain heart defects and people with pulmonary hypertension.
For those who underwent heart surgery as children, pulmonic regurgitation can appear at a young age. Pulmonary hypertension is more likely to affect older adults.
Symptoms do not always appear in the early stages of pulmonic regurgitation, but a doctor may suspect or notice signs of it when investigating an underlying cause.
Tests that can reveal pulmonic regurgitation include:
Treatment for pulmonic regurgitation will depend on the cause.
A person with a lesion or heart defect may benefit from surgery. A doctor may also recommend surgery for severe pulmonary regurgitation, with or without symptoms.
If the condition is not severe enough to warrant surgery, a doctor may prescribe medications to manage pulmonic regurgitation and related conditions, such as:
Is surgery the only way to fix a leaky heart valve?
The outlook for a person with pulmonic regurgitation will depend on the underlying cause and the severity of the regurgitation.
Mild to moderate pulmonic regurgitation is unlikely to affect how long a person will live.
However, those with severe pulmonic regurgitation may have an increased risk of:
Surgery can significantly reduce the risk of dying from pulmonic regurgitation in those with severe disease.
What is the life expectancy for someone with a leaky heart valve?
Pulmonic regurgitation is very common.
Still, some people living with pulmonic regurgitation can benefit from following any treatment plan as advised by their doctor.
People born with a faulty heart valve often have surgery in their early years, which may prevent any future problems. Some, however, may need ongoing monitoring or further treatment later in life.
For those with pulmonary hypertension, a doctor may recommend:
Pulmonary hypertension can pose a severe risk during pregnancy. Anyone considering pregnancy should first speak with a doctor.
How to strengthen the heart valves: Diet and other lifestyle tips.
Here are some questions people often ask about pulmonic regurgitation.
How serious is pulmonic regurgitation?Mild pulmonic regurgitation is not serious but will likely need monitoring. In time, it can become severe and possibly life threatening.
How do you treat pulmonic regurgitation?A doctor will start by treating the underlying cause, but they may also prescribe medications such as ACE inhibitors and diuretics if a person has symptoms. In some cases, a doctor may recommend surgery.
Can pulmonic regurgitation cause shortness of breath?Shortness of breath is one symptom that can occur with pulmonic regurgitation, particularly on exertion. Anyone who has shortness of breath that worsens with exercise should speak with a doctor.
Pulmonic or pulmonary regurgitation is when a leaky valve causes blood to flow back into the heart instead of moving forward to the lungs. It usually results from an underlying condition, such as a congenital heart defect or pulmonary hypertension.
Many people with mild pulmonic regurgitation have no symptoms. If it worsens, however, they may experience breathlessness, fatigue, and other symptoms. Severe pulmonary regurgitation can be life threatening and need medical attention.
Inhaled PAH Therapy Gets Tentative Go-Ahead From FDA
The tentative approval cannot take effect because a competing product was granted market exclusivity.
A new formulation of treprostinil (Yutrepia) could soon be available to patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) after the Food and Drug Administration (FDA) gave tentative approval to the product earlier this month.
The tentative approval is the latest twist in a years-long effort by Liquidia Corp. To gain permission to market its inhaled dry-powder formulation of treprostinil.1 The approval is tentative because, while the FDA said the therapy has met all regulatory standards for quality, safety, and efficacy, its approval cannot be finalized until market exclusivity for a competing product—United Therapeutics' Tyvaso DPI—expires on May 23, 2025.
FDAimage credit: monticellllo - stock.Adobe.Com
In a press release, Liquidia chief executive Roger Jeffs, PhD, said he was pleased that the FDA has now provided a "clear path" to approval for treprostinil.
"However, we are disappointed and disagree with the FDA's decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on May 23, 2022," Jeffs said.
Late last week, the company filed a lawsuit challenging the FDA's granting of new clinical investigation (NCI) market exclusivity to Tyvaso DPI because, they said, the formulation did not meet the criteria to represent a clinical innovation.2
"The FDA's action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice," Jeffs said, in announcing the lawsuit.
United Therapeutics markets both an inhalation solution formulation of treprostinil (Tyvaso) and an inhaled dry-powder formulation (Tyvaso DPI). The former is administered via nebulizer. The company has been involved in litigation with Liquidia and the FDA for several years over issues related to patents and exclusivity for their competing formulations.
In terms of the science, Yutrepia's tentative approval was tied to findings from the phase 3 open-label INSPIRE trial, in which adults with PAH were either transitioned from nebulized treprostinil to Yutrepia, or added Yutrepia to their current regimen of 2 or fewer non-prostacyclin oral therapies.3
The trial's objective was to evaluate the safety and tolerability of the formulation. Investigators said 29 of 121 patients who enrolled in the trial discontinued participation, with the most common reason being adverse events. They said that the discontinuation rate was favorable compared to studies of similar products. The most common adverse events reported in the trial were cough and headache, though only 2 episodes (both of headache) were deemed severe. Upper respiratory tract infection, dyspnea, dizziness, throat irritation, and diarrhea were also reported, though most cases were deemed mild or moderate.
By day 360, the investigators said, 96% of patients in the prostacyclin-naive group and 80% of patients in the transition group had titrated to a dose of at least 79.5 mcg, 4 times per day. Exploratory efficacy data indicated that patients in the trial remained stable or experienced improvement in their symptoms after one year.
Liquidia said Yutrepia should be more convenient than a nebulizer for many patients, since it is administered using a palm-sized device that allows for precise, uniform doses. The therapy is currently the subject of the ongoing ASCENT trial, which will evaluate its safety and tolerability in patients with PH-ILD.
References:
Mean Pulmonary Artery Pressure Over Cardiac Output Slope And HFpEF Characteristics
About 1 in 5 patients with unexplained dyspnea have pulmonary hypertension despite a negative diastolic stress test (DST), researchers reported in the Journal of the American Heart Association.
The prospective cohort study assessed the prevalence and clinical significance of pulmonary hypertension during exercise (exPHT), based on the slope of estimated mean pulmonary arterial pressure over cardiac output (mPAP/CO) and its association with DST in patients with suspected heart failure with preserved ejection fraction (HFpEF).
The participants were referred to a dyspnea clinic in Belgium from January 2016 to December 2022 owing to exertional dyspnea or fatigue and had available mPAP/CO slope data.
The patients were stratified into 3 groups:
All participants had a standardized dyspnea clinic workup, as well as laboratory testing for N-terminal pro-B-type natriuretic peptides (NT-proBNP), a spirometry test, a 12-lead ECG, transthoracic echocardiography at rest, and exercise echocardiography combined with a cardiopulmonary exercise test on a semisupine bicycle at a 45-degree angle.
"
…an exercise echocardiography showing a high mean pulmonary artery pressure over cardiac output slope…warrants further evaluation with invasive exercise hemodynamics to diagnose HFpEF, even when the DST is negative.
The cohort included 1936 patients (mean age, 64±15 years; 49% women). Among the participants, 38% had exPHT, defined as an mPAP/CO slope of higher than 3 mm Hg/L per min, and 22% had exPHT with a discordant, negative DST. The patients with exPHT and exE/e′ of less than 15 had a peak Vo2 as low as those with exE/e′ of 15 or higher (24%) and significantly lower compared with patients with exE/e′ of less than 15 and no exPHT (54%).
After adjustment for age, sex, and indexed left atrial volume (LAVi), mPAP/CO had a stronger association with exercise capacity than exE/e′. In addition, mPAP/CO was associated (P <.001) with worse exercise capacity regardless of the DST, and the association was greater in participants who had a lower exE/e′ vs those with increased values (P interaction <.001).
The mPAP/CO slope predicted Vo2 (mL/kg per min) independent of sex, age, LAVi, and exE/e′, regardless of whether HFpEF scores were low (18%), intermediate (64%), or high (17%).
The 2-point mPAP/CO slopes that were obtained with only peak and rest or only intermediate and rest mPAP and CO were comparable, which confirmed the linear relationship between mPAP and CO.
The mPAP/CO slope and exE/e′ independently predicted NT-proBNP and the logistic H2FPEF score, including after adjustment for age, sex, and LAVi.
Among participants with a low mPAP/CO slope (≤3 mm Hg/L per min), 22% had an exercise tricuspid regurgitation velocity (exTRV) of higher than 3.4 m/s. An increased exTRV was associated with greater peak Vo2, and the relationship was negative for mPAP/CO slope. NT-proBNP levels were not associated with exTRV.
The estimation of mPAP/CO slope was more clinically relevant compared with single-point exTRV values, according to the investigators.
Among several study limitations, patients with worse than mild pulmonary disease were excluded, and it is unknown whether the average exE/e′ is superior to septal exE/e′ for diagnosis and prognostication.
"In patients with negative HFpEF scores, an exercise echocardiography showing a high mean pulmonary artery pressure over cardiac output slope rather than maximal tricuspid regurgitation velocity during exercise warrants further evaluation with invasive exercise hemodynamics to diagnose HFpEF, even when the DST is negative," the study authors wrote.
Comments
Post a Comment