Right Ventricular Diastolic Dysfunction

Study Overview
=================
Brief Summary
-----------------
Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated. Emphysema by increasing intrathoracic pressure appears to affect cardiac function. Interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by RMI) and the intensity of emphysema. Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload. To verify this hypothesis the investigators will perform KT loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction. The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.

Official Title
-----------------
Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)

Conditions
-----------------
COPD, Emphysema, Right Heart Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: At least 40 years A smoking history Smoking cessation ≥ 6 months FEV1/FVC ≤ 0,7 Severe emphysema (destruction ≥ 50%) Peak tricuspid regurgitation velocity < 2,8 m/s or presence of other echocardiographic PH signs 15% ≤ FEV1post ≤ 50% Residual volume ≥ 175% predicted TLC ≥ 100% predicted Optimal medical management 150m ≤ 6MWD ≤ 500m mMRC ≥ 2 Physical activity ≥ 2/Week (≥ 30minutes) Exclusion criteria: ≥2 hospitalizations/year for EACOPD Recent EACOPD (≤ 3months) ≥ 50ml mucus/day PAPm ≥35mmHg PaCO2 ≥ 55mmHg Bubble ≥ 1/3 hemithorax Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery Left ventricular ejection fraction ≤ 45%, unstable heart disease Life expectancy ≤ 1 year Contraindication to anesthesia Allergy to nitinol or silicone Corticotherapy ≥ 10mg/day Patient under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients<br>COPD patients with severe emphysema and right heart dysfunction | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the change in right diastolic cardiac function after reduction of emphysema | Estimate the change in right diastolic cardiac function after reduction of emphysema : assessed by the change in the slope end diastolic pressure volume relationship (EDPVR mmHg/ml) obtained by KT Loop procedure | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the change in right systolic heart function | Estimate the change in right systolic heart function before and after reduction of emphysema assessed by the cardiac output (L/min), the stroke volume (ml), the end systolic pressure (mmHg), the end systolic volume (mmHg), obtained by KT Loop procedure | 1 day | 
| Estimate the change in right cardiac contractility | Estimate the change in right cardiac contractility before and after reduction of emphysema assessed by the slope end systolic pressure volume relationship (mmHg/ml), obtained by KT Loop procedure. | 1 day | 
| Estimate ventriculo-arterial coupling | Estimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure | 1 day | 
| Evaluate the evolution of symptoms assessed | Evaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema. | 1 day | 
| Assessing exercice performance | Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema. | 1 day | 
| Evaluate the evolution of respiratory function | Evaluate the evolution of respiratory function before and after reduction of emphysema assessed by the FEV1 (Liters and % of predicted value), the FVC (Liters and % of predicted value), the RV (Liters and % of predicted value), the TLC (Liters and % of predicted value) obtained by spirometry/plethysmography. | 1 day |