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Percutaneous Closure of PFO in Patients with Reduced Oxygen Saturation at Rest and during Exercise: Short- and Long-Term Results

Percutaneous Closure of PFO in Patients with Reduced Oxygen Saturation at Rest and during... Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 9813038, 8 pages https://doi.org/10.1155/2020/9813038 Research Article Percutaneous Closure of PFO in Patients with Reduced Oxygen Saturation at Rest and during Exercise: Short- and Long-Term Results 1 2 1 2 Ce´line De Cuyper , Tristan Pauwels , Eric Derom , Michel De Pauw, 2 3 4 4 Danie¨l De Wolf, Paul Vermeersch, An Van Berendoncks, Bernard Paelinck , and Gae¨lle Vermeersch Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium Department of Cardiology, Ghent University Hospital, Ghent, Belgium Department of Cardiology, Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium Department of Cardiology, Antwerp University Hospital, Edegem, Belgium Correspondence should be addressed to Eric Derom; eric.derom@Ugent.be Received 18 August 2019; Accepted 13 February 2020; Published 20 March 2020 Academic Editor: Patrizia Presbitero Copyright © 2020 Ce´line De Cuyper et al. )is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. A patent foramen ovale (PFO) is a rare cause of hypoxemia and clinical symptoms of dyspnea. Due to a right-to-left shunt, desaturated blood enters the systemic circulation in a subset of patients resulting in dyspnea and a subsequent reduction in quality of life (QoL). Percutaneous closure of PFO is the treatment of choice. Objectives. )is retrospective multicentre study evaluates short- and long-term results of percutaneous closure of PFO in patients with dyspnea and/or reduced oxygen saturation. Methods. Patients with respiratory symptoms were selected from databases containing all patients percutaneously closed between January 2000 and September 2018. Improvement in dyspnea, oxygenation, and QoL was investigated using pre- and post- procedural lung function parameters and two postprocedural questionnaires (SF-36 and PFSDQ-M). Results. )e average follow- up period was 36 [12–43] months, ranging from 0 months to 14 years. Percutaneous closure was successful in 15 of the 16 patients. All patients reported subjective improvement in dyspnea immediately after device deployment, consistent with their im- provement in oxygen saturation (from 90± 6% to 94 [92–97%] on room air and in upright position) (p< 0.05). Both ques- tionnaires also indicated an improvement of dyspnea and QoL after closure. )e two early and two late deaths were unrelated to the procedure. Conclusion. PFO-related dyspnea and/or hypoxemia can be treated successfully with a percutaneous intervention with long-lasting benefits on oxygen saturation, dyspnea, and QoL. event, such as a pneumonectomy with a shift of the medias- 1. Introduction tinum, aortic root aneurysm or elongation, kyphosis, and unilateral paralysis of the diaphragm [5]. )ese mechanical A foramen ovale is a flap-like opening between the right and left atrium of the heart during fetal life. It normally closes distortions may change the position of the atrial septum rel- during infancy but remains patent (patent foramen ovale or ative to the inferior vena cava, thereby significantly increasing PFO) in approximately 25% of humans. A minority of subjects the degree of shunting [6]. In symptomatic patients with PFO, with a PFO may develop clinical symptoms [1–4] such as a percutaneous closure is the treatment of choice [3, 5, 7]. paradoxical embolus and is suspected to be even related to )e aim of the current retrospective study was to migraine and sleep apnea. More rarely, it may cause profound evaluate patients suffering from PFO-related dyspnea the hypoxia and symptoms of dyspnea. Symptoms can occur late short- and long-term effects of percutaneous closure on in life and may be precipitated by a cardiac or extracardiac dyspnea, physiological outcome, and quality of life. 2 Journal of Interventional Cardiology participate without any justification had no impact on future 2. Materials and Methods care. Patients were informed that they could withdraw from 2.1. Study Design and Patient Data. A multicentre study was the study at any stage without victimization or denial of performed in three Belgian hospitals: Ghent University treatment. Hospital (UZGent), University Hospital of Antwerp (UZA), and ZNA Middelheim, Antwerp (ZNA). Listings from the 2.4. Statistical Analysis. IBM SPSS Statistics 24 (Statistical catheterization laboratories and the billing section of the hospital’s pharmacist were used to identify potential cases. Package for the Social Sciences; IBM Corporation, Armonk NY) was used to process the parameters and questionnaires )ese were subsequently cross-referenced to exclude dou- bles and completed with cases that some cardiologists re- mentioned above, assess their distribution, calculate the averages, standard deviations, and quartiles, run the Wil- membered. To be included in the study, the indication for PFO closure had to be dyspnea and/or hypoxemia in all the coxon tests, and create the charts. patients in order to include as many patients as possible. )e Shapiro–Wilk test, histograms, Q-Q plots, and Patients with other indications for closure, for example, boxplots were used to assess normality. Normally distributed paradoxical embolus, decompression sickness in divers, or data were expressed as mean (±SD) and nonnormally dis- migraine, were excluded. Patient characteristics, such as age, tributed data as mean and quartiles [Q –Q ]. )e Wilcoxon 1 3 gender, cardiovascular risk factors, and duration of com- signed-rank test was used to analyze the difference between plaints, were obtained by consulting the local electronic pre- and postprocedural parameters. patient database or the paper patient files, classified and Since no questionnaires before closure have been taken, stored in a database to assess the pre- and postoperative scores after PFO closure were compared with SF-36 scores of clinical status. a Dutch standard population (by Kruijshaar et al. [10]) and with scores of a patient group with advanced COPD (by Janssen et al. [11]). 2.2. Measurement of QoL. Data on QoL were obtained prospectively by sending the patients the validated trans- 3. Results lations in Dutch of two questionnaires by email: the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 3.1. Selection of Patients. Between January 2000 and Sep- and the Pulmonary Functional Status and Dyspnea Ques- tember 2018, 1.287 patients underwent percutaneous PFO tionnaire, Modified version (PFSDQ-M). closure at UZGent, UZA, and ZNA. )e SF-36 is a set of generic, coherent, and easily ad- Identification of patients in UZGent was based on two ministered quality-of-life measures, consisting of eight do- lists: one from the catheterization lab (99 patients) and one mains: physical functioning, role limitations due to physical from the pharmacist (135 patients). Doubles were excluded, problems, bodily pain, general health, vitality, social func- 109 medical files remained, and only those patients in tioning, and role limitations due to emotional problems and whom dyspnea and/or hypoxemia was the indication for mental health. For each domain, the score ranges from 0 PFO closure were retained. )is ultimately led to the in- (worst) to 100 points (best). )e results can be compared clusion of six patients (Figure 1). Five of these returned with the averages in the Medical Outcomes Study [8]. their questionnaires. )e mental disability (not related to )e PFSDQ-M was developed to quantify the experi- PFO closure) of the sixth patient prevented her to fill in the enced change in performing ADL compared with the period questionnaires. before disease onset and symptoms of dyspnea and fatigue Cardiologists in charge of the catheterization laboratory related to ADL. )e questionnaire analyzes ten common at UZA provided data required for the present study. Two activities, for example, putting on a shirt and climbing the out of 387 patients underwent percutaneous PFO closure stairs. Scores range from 0 (no dyspnea) to 10 points (severe because of severe dyspnea. One patient had undergone the dyspnea). PFSDQ-M has been translated into eight lan- intervention before the digitalization of patient records. A guages and is used internationally to evaluate dyspnea [9]. case report with few demographic and functional data was )e design of the study was approved by the Ethics the only source related to this patient and questionnaires Committee of UZGent, UZA, and ZNA on the following were not sent due to missing contact details. As the other dates, respectively: August 4, 2017; March 26, 2018; and May patient passed away, QOL was not obtained either. 9, 2018. )e dataset of ZNA contained 791 PFO closures since January 1, 2000, from which eight patients were included in 2.3. Data Processing and Confidentiality. Data collection of this study, of whom three had already passed away. Of the the three hospitals was performed in the same way. First, the remaining five patients, only three filled in the question- informed consent was sent to the patients. After their ap- naires, whereas the treating physicians of the remaining two proval, the retrospective data were retrieved from the patients claimed that they were still in very good physical electronic patient database and the SF-36 and PFSDQ-M condition and did not exhibit any dyspnea. )e lack of questionnaires were sent. )ose who did not answer within digitalization of patient records caused the data from the one month received a reminder by email or by phone. three deceased patients to not be as extensive as most of the All patients signed an informed consent to participate digitalized files. For one of these, some data were retrieved and collected data were kept confidential. Refusing to from a case report (personal communication) [12]. Journal of Interventional Cardiology 3 Assessed for eligibility (n = 234) (i) Catheterization lab (n = 99) (ii) Pharmacist (n = 135) Enrollment Excluded (n = 228) (i) Not meeting inclusion criteria (n = 103) (ii) Doubles (n = 125) Selected (n = 6) Invitation (i) Firstly: received invitation to participate by post (n = 6) (ii) Secondly: questionnaires sent a second time by post (n = 4) (iii) Lastly: patients contacted by telephone (n = 1) (iv) Did not received invitation (due to wrong contact information) (n = 0) Agreed participation (i) Permitted to use their medical data (n = 6) (ii) Did not fill in questionnaires (due to mentally handicapped) (n = 1) (iii) Declined to participate (n = 0) (iv) Do not speak Dutch (n = 0) Analysis Analysed (n = 6) (i) Excluded from analysis (n = 0) Figure 1: Consort diagram UZGent. Eventually, the database contained data of 16 patients, of Table 1: Used devices. whom 12 were still alive and 8 filled in the two question- Occlutech Figulla flex II occluder 6 (37.50) naires. )e devices used to close the PFO are listed in Table 1. AMPLATZER septal occluder 3 (18.75) Nit-occlud 2 (12.50) Hyperion PFO occluder 1 (6.25) 3.2. Patients’ Baseline Characteristics and Follow-Up. STARFlex occluder 1 (6.25) Baseline characteristics of the 16 patients, expressed either as Values are n (%). mean± SD or mean [quartile 1–quartile 3], are presented in Table 2. Mean age [Q1–Q3] at time of closure was 59 [50–75] years and 50% of patients were female. Mean (±SD) New York Heart Association Functional Classification (NYHA) Table 2: Baseline characteristics. was 3.0± 0.8. Age, years 59 [50–75] )e most relevant associated medical conditions are Male/female 8/8 summarized in Table 3. Pneumonectomy was the most Alive n � 10 common surgical procedure (n � 2). )e average duration Unknown n � 1 [Q1–Q3] of dyspnea before percutaneous intervention was 6 BMI, kg/m [10] 25.2± 3.70 [1–8] months, ranging from a few days to 24 months. NYHA functional class [7] 3.0± 0.8 )e average follow-up period was 36 [12–42] months, NYHA functional class (I/II/III/IV) 0/2/3/2 with a range of 0–181 months and 6 patients being lost to Duration dyspnea, months [9] 6 [1–8] follow-up. Two early deaths were caused by acute respiratory Follow-up, months 36 [12–42] failure on top of a preexisting chronic respiratory failure of Spontaneous shunt [12] n � 6 pulmonary etiology and bronchial cancer. Among the two Cardiovascular risk factors Hypertension [8] n � 3 late deaths, one was attributed to a carcinoid tumor and the Tobacco use, pack-years 10 [0–15] other one being of unknown origin. Normally distributed values are mean± SD; nonnormally distributed values are mean [Q –Q ]. Numbers between brackets indicate number of patients 1 3 3.3. Postprocedural Physiological Outcomes. 14 of 15 patients from whom data that were obtained. BMI � body mass index; NYHA � New with successful closure reported complete resolution of their York Heart Association. 4 Journal of Interventional Cardiology Table 3: Most relevant associated conditions. patient experienced pain at the femoral access site and had a transient reduction in hemoglobin shortly after the proce- Congenital malformations 7 dure, which was uneventful. Long-term adverse events Pectus excavatum 1 suggesting device malfunction were not reported. Pectus carinatum 1 Kyphoscoliosis 1 Diaphragmatic hernia 2 3.4. Quality of Life. Mean scores of the patients after PFO Pulmonary hypoplasia 1 closure for the different domains of the SF-36 are shown in Dextroversion 1 Figure 2. Mean score was 57.5/100 for physical functioning, Pulmonary pathology 15 65.6/100 for role limitations due to physical health, and 59.3/ Obstructive diseases 6 COPD 1 100 for general health. Overall, all scores after closure Asthma 2 exceeded the threshold of 50 points, which corresponds with Air trapping and hyperinflation 1 the general population norm according to Kruijshaar et al., Emphysema 1 thus indicating a favorable change in QoL [10]. Health status Alpha-1 antitrypsin deficiency 1 after PFO closure was lower compared to the standard Restrictive lung disease 9 population, but better than in the COPD population. )e Fibrothorax 1 lower score in QoL compared to that of the standard Pneumonia 2 population could in part be attributed to 2 out of the 8 Pneumonectomy 2 patients with severe osteoporosis and dyspnea due to a poor Interstitial lung disease 1 physical condition. )ese comorbidities negatively affected Unspecified restrictive disease 1 Elevated right hemidiaphragm 2 the averages, since the remaining 6 patients reported scores Cardiovascular pathology 10 that approximated the averages of the standard population. Pericarditis 1 QoL as assessed with SF-36 of patients after PFO closure Endocarditis lenta 1 invariably exceeded that seen in COPD patients [11]. Unfolded aorta 1 )e PFSDQ-M questionnaire, used to evaluate the change Dilated ascending aorta 1 in dyspnea when performing activities of daily life, increased DVT 1 by 2.05± 2.56 points after closure, which corresponded to a CVA 1 slight improvement. When asked about the current degree of Atrial fibrillation 1 dyspnea and fatigue experienced during most days of the year, Coronary artery bypass grafting 1 the average scores for dyspnea and fatigue were 1.90± 1.97 Acute myocardial infarct 1 and 2.71± 3.48, respectively, corresponding to a mild degree Edema lower limbs 1 Oncologic pathology 4 of fatigue and dyspnea in daily life. Lung carcinoma 2 Benign tumor breast 1 4. Discussion Carcinoid carcinoma 1 Platypnea-orthodeoxia syndrome 2 )is study of the impact of percutaneous PFO closure in 15 Reflux esophagitis/Barrett’s esophagus 3 of the 16 patients not only demonstrates that the inter- Epilepsy 2 vention leads to an immediate improvement in oxygen Values are n. COPD � chronic obstructive pulmonary disease; DVT �deep saturation and reduction of dyspnea after device deployment vein thrombosis; CVA � cerebrovascular accident. but is the first to evaluate the long-term effect of percuta- neous PFO closure on QoL. dyspnea complaints after closure. One patient had an initial Over the last two decades, only five case series regarding improvement, but three months after closure she experi- percutaneous PFO closure in patients with dyspnea have enced shortness of breath again, which was ultimately not been published (Table 5). Only two of these contained considered as a consequence of her PFO. Moreover, oxygen substantially more patients than the present series saturation improved statistically significantly (p � 0.014) [5, 13–16]. )ese studies are not completely comparable to immediately after device deployment (preprocedure: the current one, as some series contain only patients with 90.2± 6%; postprocedure: 94.0% [92%–97%] on room air). platypnea-orthopnea syndrome (POS), while others in- Percutaneous closure of a PFO had, however, no substantial cluded only patients with hypoxemia [5, 13–16]. Our study impact on the other outcomes such as PaO , PaCO or included all patients with PFO-related dyspnea and/or 2 2 hypoxemia. Moreover, the present study—in contrast with pulmonary function parameters, although a trend toward statistical significance (p � 0.08) was seen for PaO the previous series—has a mean duration of follow-up of 36 (Table 4). months (range: 0 months–14 years) and ranged between 11 In one of the 16 patients a small residual clinically ir- and 26 months in the previous ones. )is longer follow-up relevant left-to-right shunt across the occluder device could period of up to 14 years not only allowed concluding the be identified. )at patient was readmitted for a redo pro- long-term safety of PFO closure in a context of dyspnea and/ cedure, which was not successful because of technical issues. or hypoxemia, but also convincingly demonstrates that the Repeat interventions were not required in the remaining 15 beneficial effects of PFO closure in terms of QoL do not wean patients and major complications were not recorded. One away after several years. Journal of Interventional Cardiology 5 Table 4: Pre- and postprocedural parameters. Before PFO closure After PFO closure p value SaO standing (%) 90.2± 6.3 94.0 [92.0–97.0] 0.014 Unknown n � 3 n � 5 PaO (mmHg) 64.9± 14.4 77.8± 16.4 0.080 Unknown n � 6 n � 6 PaCO (mmHg) 33.7 [28.5–38.2] 36.8± 6.3 0.686 Unknown n � 6 n � 11 SaO standing after 6MWT (%) 82.8 [77.0–87.8] 92.7± 4.0 0.109 Unknown n � 12 n � 13 FEV1 (% of predicted) 92.0± 40.9 95.6± 55.6 0.271 Unknown n � 7 n � 9 FVC (% of predicted) 101.8 [75.8–127.2] 104.4± 44.6 0.237 Unknown n � 7 n � 9 Tiffeneau-Pinelli index (FEV1/FVC) (%) 77.6± 21.9 81.7± 29.5 0.866 Unknown n � 6 n � 9 PEF (% of predicted) 100.9± 30.7 97.7± 32.5 0.173 Unknown n � 8 n � 10 DLCO (% of predicted) 67.0± 14.4 64.6± 23.1 0.893 Unknown n � 8 n � 10 Normally distributed values are mean± SD; nonnormally distributed values are mean [Q –Q ]. SaO � oxygen saturation; PaO � partial pressure of oxygen; 1 3 2 2 PaCO � partial pressure of carbon dioxide; 6MWT �six-minute walk test; FEV1 � forced expiratory volume in 1 second; FVC � forced vital capacity; PEF � peak expiratory flow; DLCO � diffusing capacity for carbon monoxide. SF-36 scores in a dutch standard population, a dutch COPD poplution and aer PFO c ft losure Physical functioning Physical role functioning Emotional role functioning Vitality Mental health Social role functioning Bodily pain General health perceptions 0 20 40 60 80 100 Score Dutch standard population Dutch COPD population After PFO closure Figure 2: Statistical analysis of SF-36 questionnaire in 8 patients after PFO closure. A slight impairment in quality of life (QoL) is seen in comparison to a standard population. Scores after PFO closure are superior to the scores from patients with advanced COPD. Surprisingly, patient-reported outcomes have never been )e improvement in SaO seen in the current study was investigated in this population. Our findings support that smaller than what has been reported in previous studies PFO closure is not only an effective treatment of respiratory [5, 13–16]. In these studies, however, preprocedural mean symptoms but also yields long-lasting beneficial effects. SaO was lower, and, hence, there was more room for More specifically, QoL assessed with the SF-36 indicated that improvement. )e improvements in SaO observed in the most patients after PFO closure experienced a QoL which current study did not translate into significant changes in exceeds that of COPD patients and almost equaled that of a PaO . )is could be attributed to the small sample size or a standard population. few confounding factors such as the scatter of the SF-36 domain 6 Journal of Interventional Cardiology Table 5: Published series of PFO closure because of dyspnea or desaturation. Absolute Mean Number of Mean age Closure Major in-hospital Author Year increase in follow-up Follow-up results patients (years) rate complications SaO2 period 7 late deaths Guerin ´ [13] 2005 78 67 97% 10% 2 unrelated deaths 16 m (unrelated to procedure) 2 unrelated deaths, 1 Shah [14] 2016 52 66 100% 14% 26 m 2 late AF AF, 1 VF Mojadidi 2015 17 63 94% 16% - 11 m 64.8% improvement [5] Current 2 early and 2 late 2018 16 59 94% 4% None 36 m study deaths (unrelated) Ilkhanoff 2005 10 63 100% 9% 1 TIA — — [15] Zavalloni 100% after 1 TIA, 3 repeat 2013 6 63 17% 1 unrelated death 3 m [16] redo interventions —, missing; SaO oxygen saturation; AF, atrial fibrillation; VF, ventricular fibrillation; TIA, transient ischemic attack. 2, the questionnaires. All questionnaires were sent to the pa- preprocedural PaO and the comorbidities mentioned in the next paragraph. Nevertheless, a trend toward a statistical tients at the same point of time, causing vast differences in time interval between PFO closure and assessment of QoL. significance (p � 0.08) was observed. PFO can be the cause of dyspnea in patients having a Moreover, confounding factors, such as the comorbidities normal SaO . In a part of the patients, the respiratory center described in Table 3, might have affected QoL measurement, will react on hypoxemia, causing hyperventilation and particularly since a PFO-specific questionnaire has not been dyspnea. Dyspnea increases the tidal volume and thus developed so far, and the results of the SF-36 and PFSDQ-M normalizes the arterial saturation. As the reaction of the questionnaires are sensitive to pick up reductions in QoL respiratory center on hypoxemia can differ, other patients due to a variety of symptoms caused by other diseases. For will not react on hypoxemia and not become dyspneic [17]. example, the eventual score of the SF-36 questionnaire in a A large number of patients included in the present study patient with severe osteoporosis was definitely more affected by that aforementioned disorder than by a PFO-related suffered from severe cardiopulmonary comorbidities, a finding also reported in other studies. Interestingly, pneu- dyspnea. Finally, missing parameters in the study pop- ulation, a typical feature of retrospective studies, render the monectomy, ascending aorta aneurysm (or dilation), and right hemidiaphragm elevation were also reported in the interpretation of some of the physiological data somewhat four other studies, but not in that of Ilkhanoff [5, 13–16]. problematic. Since it is very unlikely that randomized However, in the latter study, almost all patients suffered controlled studies will ever be conducted in patients un- from chronic pulmonary disease and congestive heart dergoing a PFO closure because of dyspnea and/or hyp- failure. oxemia, cardiologists in charge of such patient should be )e technique of percutaneous PFO closure has been invited to design a national or even international multicentre reported to be safe, and the present data confirm this finding cohort study in which relevant data on procedural outcome [5, 13–16]. Indeed, no major procedure-related complica- in patients with a closed PFO would be collected prospectively. tions were observed and the overall mortality was not related to the intervention. It is reasonable to attribute our success )e limited sample size did not allow for a statistical comparison of the QoL between the patients with low rate and safety data of the PFO closing technique to the large experience of the catheterization laboratories of the three saturation and those with normal saturation before the institutions involved, as these have performed more than intervention. )e aim was to include all patients with PFO- 1200 similar procedures over the last 18 years. related dyspnea and low oxygen saturation. )e mentioned comparison is beyond the scope of the current study. 4.1. Limitations. Although the long duration of follow-up definitely represents a strength, this study has several lim- 5. Conclusion itations. Firstly, this is a cross-sectional, retrospective study. Moreover, PFO-related dyspnea can be considered as an In conclusion, patients with PFO and reduced oxygen sat- “orphan disorder,” and it is very unlikely that a randomized uration at rest and during exercise benefit from percuta- clinical trial will ever be conducted to prove the efficacy of neous PFO closure. )e PFO closure not only resulted in PFO closure in patients with respiratory symptoms. A immediate increase in systemic arterial saturation and im- second limitation of our study is that some parameters were mediate improvement of the patients’ dyspnea status. )e lacking due to the incompleteness of several patient records procedure is safe and leads to a long-lasting improvement of or death. As a consequence, only eight patients could fill in dyspnea and QoL during long time follow-up. Overall, Journal of Interventional Cardiology 7 percutaneous PFO closure can be recommended to patients Conflicts of Interest suffering from PFO-related dyspnea and/or hypoxemia at )e authors declare that there are no conflicts of interest rest or during exercise. regarding the publication of this paper. Abbreviations Acknowledgments 6MWT: Six-minute walk test )e authors truly thank Mme. De Buyser of the Biostatistics BMI: Body mass index unit of the Faculty of Medicine and Health Sciences of Ghent COPD: Chronic obstructive pulmonary disease University for valuable recommendation to analyze the data. CVA: Cerebrovascular accident Furthermore, the authors thank Karlien Geenens, Anja DLCO: Diffusing capacity of the lung for carbon Delporte, and Stefanie Vermeersch for their assistance in monoxide sending and receiving the questionnaires and the pharma- DVT: Deep vein thrombosis cists for providing them patient lists. )e authors also wish FEV1: Forced expiratory volume in one second to thank Suzanne Lareau for providing them the PFSDQ-M FVC: Forced vital capacity and all respondents who filled in the surveys. )is research NYHA: New York Heart Association Functional was performed without financial funding. Classification PaCO : Arterial partial pressure of carbon dioxide References PaO : Arterial partial pressure of oxygen PEF: Peak expiratory flow [1] C. 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Percutaneous Closure of PFO in Patients with Reduced Oxygen Saturation at Rest and during Exercise: Short- and Long-Term Results

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References (19)

Publisher
Hindawi Publishing Corporation
Copyright
Copyright © 2020 Céline De Cuyper et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ISSN
1540-8183
eISSN
0896-4327
DOI
10.1155/2020/9813038
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Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 9813038, 8 pages https://doi.org/10.1155/2020/9813038 Research Article Percutaneous Closure of PFO in Patients with Reduced Oxygen Saturation at Rest and during Exercise: Short- and Long-Term Results 1 2 1 2 Ce´line De Cuyper , Tristan Pauwels , Eric Derom , Michel De Pauw, 2 3 4 4 Danie¨l De Wolf, Paul Vermeersch, An Van Berendoncks, Bernard Paelinck , and Gae¨lle Vermeersch Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium Department of Cardiology, Ghent University Hospital, Ghent, Belgium Department of Cardiology, Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium Department of Cardiology, Antwerp University Hospital, Edegem, Belgium Correspondence should be addressed to Eric Derom; eric.derom@Ugent.be Received 18 August 2019; Accepted 13 February 2020; Published 20 March 2020 Academic Editor: Patrizia Presbitero Copyright © 2020 Ce´line De Cuyper et al. )is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. A patent foramen ovale (PFO) is a rare cause of hypoxemia and clinical symptoms of dyspnea. Due to a right-to-left shunt, desaturated blood enters the systemic circulation in a subset of patients resulting in dyspnea and a subsequent reduction in quality of life (QoL). Percutaneous closure of PFO is the treatment of choice. Objectives. )is retrospective multicentre study evaluates short- and long-term results of percutaneous closure of PFO in patients with dyspnea and/or reduced oxygen saturation. Methods. Patients with respiratory symptoms were selected from databases containing all patients percutaneously closed between January 2000 and September 2018. Improvement in dyspnea, oxygenation, and QoL was investigated using pre- and post- procedural lung function parameters and two postprocedural questionnaires (SF-36 and PFSDQ-M). Results. )e average follow- up period was 36 [12–43] months, ranging from 0 months to 14 years. Percutaneous closure was successful in 15 of the 16 patients. All patients reported subjective improvement in dyspnea immediately after device deployment, consistent with their im- provement in oxygen saturation (from 90± 6% to 94 [92–97%] on room air and in upright position) (p< 0.05). Both ques- tionnaires also indicated an improvement of dyspnea and QoL after closure. )e two early and two late deaths were unrelated to the procedure. Conclusion. PFO-related dyspnea and/or hypoxemia can be treated successfully with a percutaneous intervention with long-lasting benefits on oxygen saturation, dyspnea, and QoL. event, such as a pneumonectomy with a shift of the medias- 1. Introduction tinum, aortic root aneurysm or elongation, kyphosis, and unilateral paralysis of the diaphragm [5]. )ese mechanical A foramen ovale is a flap-like opening between the right and left atrium of the heart during fetal life. It normally closes distortions may change the position of the atrial septum rel- during infancy but remains patent (patent foramen ovale or ative to the inferior vena cava, thereby significantly increasing PFO) in approximately 25% of humans. A minority of subjects the degree of shunting [6]. In symptomatic patients with PFO, with a PFO may develop clinical symptoms [1–4] such as a percutaneous closure is the treatment of choice [3, 5, 7]. paradoxical embolus and is suspected to be even related to )e aim of the current retrospective study was to migraine and sleep apnea. More rarely, it may cause profound evaluate patients suffering from PFO-related dyspnea the hypoxia and symptoms of dyspnea. Symptoms can occur late short- and long-term effects of percutaneous closure on in life and may be precipitated by a cardiac or extracardiac dyspnea, physiological outcome, and quality of life. 2 Journal of Interventional Cardiology participate without any justification had no impact on future 2. Materials and Methods care. Patients were informed that they could withdraw from 2.1. Study Design and Patient Data. A multicentre study was the study at any stage without victimization or denial of performed in three Belgian hospitals: Ghent University treatment. Hospital (UZGent), University Hospital of Antwerp (UZA), and ZNA Middelheim, Antwerp (ZNA). Listings from the 2.4. Statistical Analysis. IBM SPSS Statistics 24 (Statistical catheterization laboratories and the billing section of the hospital’s pharmacist were used to identify potential cases. Package for the Social Sciences; IBM Corporation, Armonk NY) was used to process the parameters and questionnaires )ese were subsequently cross-referenced to exclude dou- bles and completed with cases that some cardiologists re- mentioned above, assess their distribution, calculate the averages, standard deviations, and quartiles, run the Wil- membered. To be included in the study, the indication for PFO closure had to be dyspnea and/or hypoxemia in all the coxon tests, and create the charts. patients in order to include as many patients as possible. )e Shapiro–Wilk test, histograms, Q-Q plots, and Patients with other indications for closure, for example, boxplots were used to assess normality. Normally distributed paradoxical embolus, decompression sickness in divers, or data were expressed as mean (±SD) and nonnormally dis- migraine, were excluded. Patient characteristics, such as age, tributed data as mean and quartiles [Q –Q ]. )e Wilcoxon 1 3 gender, cardiovascular risk factors, and duration of com- signed-rank test was used to analyze the difference between plaints, were obtained by consulting the local electronic pre- and postprocedural parameters. patient database or the paper patient files, classified and Since no questionnaires before closure have been taken, stored in a database to assess the pre- and postoperative scores after PFO closure were compared with SF-36 scores of clinical status. a Dutch standard population (by Kruijshaar et al. [10]) and with scores of a patient group with advanced COPD (by Janssen et al. [11]). 2.2. Measurement of QoL. Data on QoL were obtained prospectively by sending the patients the validated trans- 3. Results lations in Dutch of two questionnaires by email: the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 3.1. Selection of Patients. Between January 2000 and Sep- and the Pulmonary Functional Status and Dyspnea Ques- tember 2018, 1.287 patients underwent percutaneous PFO tionnaire, Modified version (PFSDQ-M). closure at UZGent, UZA, and ZNA. )e SF-36 is a set of generic, coherent, and easily ad- Identification of patients in UZGent was based on two ministered quality-of-life measures, consisting of eight do- lists: one from the catheterization lab (99 patients) and one mains: physical functioning, role limitations due to physical from the pharmacist (135 patients). Doubles were excluded, problems, bodily pain, general health, vitality, social func- 109 medical files remained, and only those patients in tioning, and role limitations due to emotional problems and whom dyspnea and/or hypoxemia was the indication for mental health. For each domain, the score ranges from 0 PFO closure were retained. )is ultimately led to the in- (worst) to 100 points (best). )e results can be compared clusion of six patients (Figure 1). Five of these returned with the averages in the Medical Outcomes Study [8]. their questionnaires. )e mental disability (not related to )e PFSDQ-M was developed to quantify the experi- PFO closure) of the sixth patient prevented her to fill in the enced change in performing ADL compared with the period questionnaires. before disease onset and symptoms of dyspnea and fatigue Cardiologists in charge of the catheterization laboratory related to ADL. )e questionnaire analyzes ten common at UZA provided data required for the present study. Two activities, for example, putting on a shirt and climbing the out of 387 patients underwent percutaneous PFO closure stairs. Scores range from 0 (no dyspnea) to 10 points (severe because of severe dyspnea. One patient had undergone the dyspnea). PFSDQ-M has been translated into eight lan- intervention before the digitalization of patient records. A guages and is used internationally to evaluate dyspnea [9]. case report with few demographic and functional data was )e design of the study was approved by the Ethics the only source related to this patient and questionnaires Committee of UZGent, UZA, and ZNA on the following were not sent due to missing contact details. As the other dates, respectively: August 4, 2017; March 26, 2018; and May patient passed away, QOL was not obtained either. 9, 2018. )e dataset of ZNA contained 791 PFO closures since January 1, 2000, from which eight patients were included in 2.3. Data Processing and Confidentiality. Data collection of this study, of whom three had already passed away. Of the the three hospitals was performed in the same way. First, the remaining five patients, only three filled in the question- informed consent was sent to the patients. After their ap- naires, whereas the treating physicians of the remaining two proval, the retrospective data were retrieved from the patients claimed that they were still in very good physical electronic patient database and the SF-36 and PFSDQ-M condition and did not exhibit any dyspnea. )e lack of questionnaires were sent. )ose who did not answer within digitalization of patient records caused the data from the one month received a reminder by email or by phone. three deceased patients to not be as extensive as most of the All patients signed an informed consent to participate digitalized files. For one of these, some data were retrieved and collected data were kept confidential. Refusing to from a case report (personal communication) [12]. Journal of Interventional Cardiology 3 Assessed for eligibility (n = 234) (i) Catheterization lab (n = 99) (ii) Pharmacist (n = 135) Enrollment Excluded (n = 228) (i) Not meeting inclusion criteria (n = 103) (ii) Doubles (n = 125) Selected (n = 6) Invitation (i) Firstly: received invitation to participate by post (n = 6) (ii) Secondly: questionnaires sent a second time by post (n = 4) (iii) Lastly: patients contacted by telephone (n = 1) (iv) Did not received invitation (due to wrong contact information) (n = 0) Agreed participation (i) Permitted to use their medical data (n = 6) (ii) Did not fill in questionnaires (due to mentally handicapped) (n = 1) (iii) Declined to participate (n = 0) (iv) Do not speak Dutch (n = 0) Analysis Analysed (n = 6) (i) Excluded from analysis (n = 0) Figure 1: Consort diagram UZGent. Eventually, the database contained data of 16 patients, of Table 1: Used devices. whom 12 were still alive and 8 filled in the two question- Occlutech Figulla flex II occluder 6 (37.50) naires. )e devices used to close the PFO are listed in Table 1. AMPLATZER septal occluder 3 (18.75) Nit-occlud 2 (12.50) Hyperion PFO occluder 1 (6.25) 3.2. Patients’ Baseline Characteristics and Follow-Up. STARFlex occluder 1 (6.25) Baseline characteristics of the 16 patients, expressed either as Values are n (%). mean± SD or mean [quartile 1–quartile 3], are presented in Table 2. Mean age [Q1–Q3] at time of closure was 59 [50–75] years and 50% of patients were female. Mean (±SD) New York Heart Association Functional Classification (NYHA) Table 2: Baseline characteristics. was 3.0± 0.8. Age, years 59 [50–75] )e most relevant associated medical conditions are Male/female 8/8 summarized in Table 3. Pneumonectomy was the most Alive n � 10 common surgical procedure (n � 2). )e average duration Unknown n � 1 [Q1–Q3] of dyspnea before percutaneous intervention was 6 BMI, kg/m [10] 25.2± 3.70 [1–8] months, ranging from a few days to 24 months. NYHA functional class [7] 3.0± 0.8 )e average follow-up period was 36 [12–42] months, NYHA functional class (I/II/III/IV) 0/2/3/2 with a range of 0–181 months and 6 patients being lost to Duration dyspnea, months [9] 6 [1–8] follow-up. Two early deaths were caused by acute respiratory Follow-up, months 36 [12–42] failure on top of a preexisting chronic respiratory failure of Spontaneous shunt [12] n � 6 pulmonary etiology and bronchial cancer. Among the two Cardiovascular risk factors Hypertension [8] n � 3 late deaths, one was attributed to a carcinoid tumor and the Tobacco use, pack-years 10 [0–15] other one being of unknown origin. Normally distributed values are mean± SD; nonnormally distributed values are mean [Q –Q ]. Numbers between brackets indicate number of patients 1 3 3.3. Postprocedural Physiological Outcomes. 14 of 15 patients from whom data that were obtained. BMI � body mass index; NYHA � New with successful closure reported complete resolution of their York Heart Association. 4 Journal of Interventional Cardiology Table 3: Most relevant associated conditions. patient experienced pain at the femoral access site and had a transient reduction in hemoglobin shortly after the proce- Congenital malformations 7 dure, which was uneventful. Long-term adverse events Pectus excavatum 1 suggesting device malfunction were not reported. Pectus carinatum 1 Kyphoscoliosis 1 Diaphragmatic hernia 2 3.4. Quality of Life. Mean scores of the patients after PFO Pulmonary hypoplasia 1 closure for the different domains of the SF-36 are shown in Dextroversion 1 Figure 2. Mean score was 57.5/100 for physical functioning, Pulmonary pathology 15 65.6/100 for role limitations due to physical health, and 59.3/ Obstructive diseases 6 COPD 1 100 for general health. Overall, all scores after closure Asthma 2 exceeded the threshold of 50 points, which corresponds with Air trapping and hyperinflation 1 the general population norm according to Kruijshaar et al., Emphysema 1 thus indicating a favorable change in QoL [10]. Health status Alpha-1 antitrypsin deficiency 1 after PFO closure was lower compared to the standard Restrictive lung disease 9 population, but better than in the COPD population. )e Fibrothorax 1 lower score in QoL compared to that of the standard Pneumonia 2 population could in part be attributed to 2 out of the 8 Pneumonectomy 2 patients with severe osteoporosis and dyspnea due to a poor Interstitial lung disease 1 physical condition. )ese comorbidities negatively affected Unspecified restrictive disease 1 Elevated right hemidiaphragm 2 the averages, since the remaining 6 patients reported scores Cardiovascular pathology 10 that approximated the averages of the standard population. Pericarditis 1 QoL as assessed with SF-36 of patients after PFO closure Endocarditis lenta 1 invariably exceeded that seen in COPD patients [11]. Unfolded aorta 1 )e PFSDQ-M questionnaire, used to evaluate the change Dilated ascending aorta 1 in dyspnea when performing activities of daily life, increased DVT 1 by 2.05± 2.56 points after closure, which corresponded to a CVA 1 slight improvement. When asked about the current degree of Atrial fibrillation 1 dyspnea and fatigue experienced during most days of the year, Coronary artery bypass grafting 1 the average scores for dyspnea and fatigue were 1.90± 1.97 Acute myocardial infarct 1 and 2.71± 3.48, respectively, corresponding to a mild degree Edema lower limbs 1 Oncologic pathology 4 of fatigue and dyspnea in daily life. Lung carcinoma 2 Benign tumor breast 1 4. Discussion Carcinoid carcinoma 1 Platypnea-orthodeoxia syndrome 2 )is study of the impact of percutaneous PFO closure in 15 Reflux esophagitis/Barrett’s esophagus 3 of the 16 patients not only demonstrates that the inter- Epilepsy 2 vention leads to an immediate improvement in oxygen Values are n. COPD � chronic obstructive pulmonary disease; DVT �deep saturation and reduction of dyspnea after device deployment vein thrombosis; CVA � cerebrovascular accident. but is the first to evaluate the long-term effect of percuta- neous PFO closure on QoL. dyspnea complaints after closure. One patient had an initial Over the last two decades, only five case series regarding improvement, but three months after closure she experi- percutaneous PFO closure in patients with dyspnea have enced shortness of breath again, which was ultimately not been published (Table 5). Only two of these contained considered as a consequence of her PFO. Moreover, oxygen substantially more patients than the present series saturation improved statistically significantly (p � 0.014) [5, 13–16]. )ese studies are not completely comparable to immediately after device deployment (preprocedure: the current one, as some series contain only patients with 90.2± 6%; postprocedure: 94.0% [92%–97%] on room air). platypnea-orthopnea syndrome (POS), while others in- Percutaneous closure of a PFO had, however, no substantial cluded only patients with hypoxemia [5, 13–16]. Our study impact on the other outcomes such as PaO , PaCO or included all patients with PFO-related dyspnea and/or 2 2 hypoxemia. Moreover, the present study—in contrast with pulmonary function parameters, although a trend toward statistical significance (p � 0.08) was seen for PaO the previous series—has a mean duration of follow-up of 36 (Table 4). months (range: 0 months–14 years) and ranged between 11 In one of the 16 patients a small residual clinically ir- and 26 months in the previous ones. )is longer follow-up relevant left-to-right shunt across the occluder device could period of up to 14 years not only allowed concluding the be identified. )at patient was readmitted for a redo pro- long-term safety of PFO closure in a context of dyspnea and/ cedure, which was not successful because of technical issues. or hypoxemia, but also convincingly demonstrates that the Repeat interventions were not required in the remaining 15 beneficial effects of PFO closure in terms of QoL do not wean patients and major complications were not recorded. One away after several years. Journal of Interventional Cardiology 5 Table 4: Pre- and postprocedural parameters. Before PFO closure After PFO closure p value SaO standing (%) 90.2± 6.3 94.0 [92.0–97.0] 0.014 Unknown n � 3 n � 5 PaO (mmHg) 64.9± 14.4 77.8± 16.4 0.080 Unknown n � 6 n � 6 PaCO (mmHg) 33.7 [28.5–38.2] 36.8± 6.3 0.686 Unknown n � 6 n � 11 SaO standing after 6MWT (%) 82.8 [77.0–87.8] 92.7± 4.0 0.109 Unknown n � 12 n � 13 FEV1 (% of predicted) 92.0± 40.9 95.6± 55.6 0.271 Unknown n � 7 n � 9 FVC (% of predicted) 101.8 [75.8–127.2] 104.4± 44.6 0.237 Unknown n � 7 n � 9 Tiffeneau-Pinelli index (FEV1/FVC) (%) 77.6± 21.9 81.7± 29.5 0.866 Unknown n � 6 n � 9 PEF (% of predicted) 100.9± 30.7 97.7± 32.5 0.173 Unknown n � 8 n � 10 DLCO (% of predicted) 67.0± 14.4 64.6± 23.1 0.893 Unknown n � 8 n � 10 Normally distributed values are mean± SD; nonnormally distributed values are mean [Q –Q ]. SaO � oxygen saturation; PaO � partial pressure of oxygen; 1 3 2 2 PaCO � partial pressure of carbon dioxide; 6MWT �six-minute walk test; FEV1 � forced expiratory volume in 1 second; FVC � forced vital capacity; PEF � peak expiratory flow; DLCO � diffusing capacity for carbon monoxide. SF-36 scores in a dutch standard population, a dutch COPD poplution and aer PFO c ft losure Physical functioning Physical role functioning Emotional role functioning Vitality Mental health Social role functioning Bodily pain General health perceptions 0 20 40 60 80 100 Score Dutch standard population Dutch COPD population After PFO closure Figure 2: Statistical analysis of SF-36 questionnaire in 8 patients after PFO closure. A slight impairment in quality of life (QoL) is seen in comparison to a standard population. Scores after PFO closure are superior to the scores from patients with advanced COPD. Surprisingly, patient-reported outcomes have never been )e improvement in SaO seen in the current study was investigated in this population. Our findings support that smaller than what has been reported in previous studies PFO closure is not only an effective treatment of respiratory [5, 13–16]. In these studies, however, preprocedural mean symptoms but also yields long-lasting beneficial effects. SaO was lower, and, hence, there was more room for More specifically, QoL assessed with the SF-36 indicated that improvement. )e improvements in SaO observed in the most patients after PFO closure experienced a QoL which current study did not translate into significant changes in exceeds that of COPD patients and almost equaled that of a PaO . )is could be attributed to the small sample size or a standard population. few confounding factors such as the scatter of the SF-36 domain 6 Journal of Interventional Cardiology Table 5: Published series of PFO closure because of dyspnea or desaturation. Absolute Mean Number of Mean age Closure Major in-hospital Author Year increase in follow-up Follow-up results patients (years) rate complications SaO2 period 7 late deaths Guerin ´ [13] 2005 78 67 97% 10% 2 unrelated deaths 16 m (unrelated to procedure) 2 unrelated deaths, 1 Shah [14] 2016 52 66 100% 14% 26 m 2 late AF AF, 1 VF Mojadidi 2015 17 63 94% 16% - 11 m 64.8% improvement [5] Current 2 early and 2 late 2018 16 59 94% 4% None 36 m study deaths (unrelated) Ilkhanoff 2005 10 63 100% 9% 1 TIA — — [15] Zavalloni 100% after 1 TIA, 3 repeat 2013 6 63 17% 1 unrelated death 3 m [16] redo interventions —, missing; SaO oxygen saturation; AF, atrial fibrillation; VF, ventricular fibrillation; TIA, transient ischemic attack. 2, the questionnaires. All questionnaires were sent to the pa- preprocedural PaO and the comorbidities mentioned in the next paragraph. Nevertheless, a trend toward a statistical tients at the same point of time, causing vast differences in time interval between PFO closure and assessment of QoL. significance (p � 0.08) was observed. PFO can be the cause of dyspnea in patients having a Moreover, confounding factors, such as the comorbidities normal SaO . In a part of the patients, the respiratory center described in Table 3, might have affected QoL measurement, will react on hypoxemia, causing hyperventilation and particularly since a PFO-specific questionnaire has not been dyspnea. Dyspnea increases the tidal volume and thus developed so far, and the results of the SF-36 and PFSDQ-M normalizes the arterial saturation. As the reaction of the questionnaires are sensitive to pick up reductions in QoL respiratory center on hypoxemia can differ, other patients due to a variety of symptoms caused by other diseases. For will not react on hypoxemia and not become dyspneic [17]. example, the eventual score of the SF-36 questionnaire in a A large number of patients included in the present study patient with severe osteoporosis was definitely more affected by that aforementioned disorder than by a PFO-related suffered from severe cardiopulmonary comorbidities, a finding also reported in other studies. Interestingly, pneu- dyspnea. Finally, missing parameters in the study pop- ulation, a typical feature of retrospective studies, render the monectomy, ascending aorta aneurysm (or dilation), and right hemidiaphragm elevation were also reported in the interpretation of some of the physiological data somewhat four other studies, but not in that of Ilkhanoff [5, 13–16]. problematic. Since it is very unlikely that randomized However, in the latter study, almost all patients suffered controlled studies will ever be conducted in patients un- from chronic pulmonary disease and congestive heart dergoing a PFO closure because of dyspnea and/or hyp- failure. oxemia, cardiologists in charge of such patient should be )e technique of percutaneous PFO closure has been invited to design a national or even international multicentre reported to be safe, and the present data confirm this finding cohort study in which relevant data on procedural outcome [5, 13–16]. Indeed, no major procedure-related complica- in patients with a closed PFO would be collected prospectively. tions were observed and the overall mortality was not related to the intervention. It is reasonable to attribute our success )e limited sample size did not allow for a statistical comparison of the QoL between the patients with low rate and safety data of the PFO closing technique to the large experience of the catheterization laboratories of the three saturation and those with normal saturation before the institutions involved, as these have performed more than intervention. )e aim was to include all patients with PFO- 1200 similar procedures over the last 18 years. related dyspnea and low oxygen saturation. )e mentioned comparison is beyond the scope of the current study. 4.1. Limitations. Although the long duration of follow-up definitely represents a strength, this study has several lim- 5. Conclusion itations. Firstly, this is a cross-sectional, retrospective study. Moreover, PFO-related dyspnea can be considered as an In conclusion, patients with PFO and reduced oxygen sat- “orphan disorder,” and it is very unlikely that a randomized uration at rest and during exercise benefit from percuta- clinical trial will ever be conducted to prove the efficacy of neous PFO closure. )e PFO closure not only resulted in PFO closure in patients with respiratory symptoms. A immediate increase in systemic arterial saturation and im- second limitation of our study is that some parameters were mediate improvement of the patients’ dyspnea status. )e lacking due to the incompleteness of several patient records procedure is safe and leads to a long-lasting improvement of or death. As a consequence, only eight patients could fill in dyspnea and QoL during long time follow-up. Overall, Journal of Interventional Cardiology 7 percutaneous PFO closure can be recommended to patients Conflicts of Interest suffering from PFO-related dyspnea and/or hypoxemia at )e authors declare that there are no conflicts of interest rest or during exercise. regarding the publication of this paper. Abbreviations Acknowledgments 6MWT: Six-minute walk test )e authors truly thank Mme. De Buyser of the Biostatistics BMI: Body mass index unit of the Faculty of Medicine and Health Sciences of Ghent COPD: Chronic obstructive pulmonary disease University for valuable recommendation to analyze the data. CVA: Cerebrovascular accident Furthermore, the authors thank Karlien Geenens, Anja DLCO: Diffusing capacity of the lung for carbon Delporte, and Stefanie Vermeersch for their assistance in monoxide sending and receiving the questionnaires and the pharma- DVT: Deep vein thrombosis cists for providing them patient lists. )e authors also wish FEV1: Forced expiratory volume in one second to thank Suzanne Lareau for providing them the PFSDQ-M FVC: Forced vital capacity and all respondents who filled in the surveys. )is research NYHA: New York Heart Association Functional was performed without financial funding. Classification PaCO : Arterial partial pressure of carbon dioxide References PaO : Arterial partial pressure of oxygen PEF: Peak expiratory flow [1] C. 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Published: Mar 20, 2020

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