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Ann Thorac Surg 2007;84:1367-1370
© 2007 The Society of Thoracic Surgeons


New Technology

Use of a Pleural Implantable Access System for the Management of Malignant Pleural Effusion: The Institut Curie Experience

Catherine Daniel, MD, Irène Kriegel, MD*, Sophie Di Maria, MD, Gabriela Patrubani, MD, Regine Levesque, Alain Livartowski, MD, Marc Esteve, MD

Institut Curie, Paris, France

Accepted for publication April 11, 2007.

* Address correspondence to Dr Kriegel, 26 rue d’Ulm, Cédex 05, Institut Curie, Paris, 75248, France (Email: irene.kriegel{at}curie.net).


    Abstract
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 Abstract
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 Clinical Experience
 Results
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 Footnotes
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Purpose: Malignant pleural effusion has a very poor prognosis, raises problems of medical management, and impairs quality of life. The authors report the first experience of a pleural implantable access system for the treatment of recurrent symptomatic malignant pleural effusion.

Description: Prospective follow-up of 29 patients between August 20, 2005 and August 1, 2007 in a single center. Thirty-four pleural implantable access systems were placed in 29 patients (23 patients with breast cancers, 4 patients with bilateral placements, and 1 patient with a replacement) under sedation after the decision of a multidisciplinary meeting.

Evaluation: Twenty-eight patients obtained partial or complete relief of their dyspnea. Six patients underwent pleurodesis after a maximum of 2 months. Fifteen patients were receiving chemotherapy at the time of placement. Seven patients died at the Institut Curie or in a palliative care unit without returning home. The other 22 patients presented a total of 280 days of hospitalization for 2,717 days of catheter implantation. No placement failures were observed in this series. Two infectious complications (infectious pneumonia and skin infection over the puncture site) and two mechanical complications (expulsion of the port and disconnection between the port and the catheter) were observed and easily treated. One patient had loculation of the pleural cavity develop after 16 thoracenteses making further thoracentesis ineffective.

Conclusions: The pleural implantable access system is an interesting alternative in terms of efficacy and safety for the outpatient management of malignant pleural effusion. It presents a number of advantages in terms of comfort and infectious risk compared with tunnelled pleural catheters.


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Malignant pleural effusion is the most frequent cause of exudative pleural effusion after the 60 years of age. Patients with malignant pleural effusion present with dyspnea, cough, or chest pain, or a combination of these symptoms, which can significantly alter their quality of life. These patients have a very poor prognosis with a short median survival ranging between 3 and 12 months.


    Technique
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Treatment options for malignant pleural effusion are currently limited. Watchful waiting is recommended in asymptomatic patients. Various techniques can be proposed in symptomatic patients, such as repeated thoracentesis, placement of a pleural drain with intrapleural instillation of a pleurodesis agent, thoracoscopy with talc pleurodesis, pleural catheter placement, pleuroperitoneal shunt, or pleurectomy [1]. The most effective and least invasive method must always be preferred in these palliative care patients.

A new approach to the management of malignant pleural effusion has been tested at the Institut Curie. We report our experience with the use of a pleural implantable access system. We believe that one similar experience has been reported in the literature on 6 patients [2].


    Clinical Experience
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Patients
A series of 29 patients (mean age of 27 women and 2 men, 52 years; range, 16 to 80 years) undergoing placement of a pleural implantable access system for recurrent symptomatic malignant pleural effusion were followed prospectively between August 20, 2005 and August 1, 2007. In the great majority of cases, the primary cancer was breast cancer (23 patients), with ovarian cancer (2 patients), lung cancer (3 patients), and osteogenic sarcoma (1 patient). Our institutional review board approved this study in September 2005. The decision to perform implantable access system placement was made during the weekly multidisciplinary chest disease meeting. All patients were dyspneic and had to present a history of improvement of dyspnea after needle thoracentesis. In 2 patients, implantable access system placement was performed for rapidly recurring compressive pleural effusion. These 2 patients were receiving chemotherapy at the time of implantable access system placement, and the medical oncologist preferred not to defer chemotherapy to allow videothoracoscopic talc pleurodesis. Apart from these 2 patients, videothoracoscopic talc pleurodesis was contraindicated in all other patients because of their poor general status or limited life expectancy, or both.

Pleural Implantable Access System Placement
Pleural implantable access system placement was performed after providing the patient with oral information and after the patient had given his or her informed consent. Implantable access system placement was performed under sedation with local anesthesia and with hospitalization on the evening of the procedure. We could only place the patient under local anesthesia, even at the bedside, but we chose sedation to privilege patient comfort.

A Celsite ST 305 H 8.5 F (B Braun Medical France, Boulogne, France) implantable port was used in every case. Orifices were drilled every 1.5 cm over the distal 18 cm of the catheter. The guidewire was inserted according to the Seldinger technique in the midaxillary line between the third and fifth intercostal spaces, then directed toward the base of the lung under image intensifier guidance. A subcutaneous compartment was then performed in the midaxillary line over the tenth rib (Fig 1). The sheath dilator was advanced over the guidewire and the catheter that was connected to the port was then introduced to a depth of 26 to 30 cm. Pleural fluid was removed with a Huber needle connected to a tube and a suction drainage bottle. A first thoracentesis was performed before the patient’s recovery to ensure correct functioning of the system. This thoracentesis was limited to a maximum of 1,500 mL of pleural fluid. Thoracentesis was performed in a closed system to reduce the risk of infection to a minimum.


Figure 1
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Fig 1. Diagram of the subcutaneous compartment performed in the midaxillary line over the tenth rib.

 
Thoracentesis was then performed in the hospital at the patient’s request, depending on the degree of respiratory distress, either by a doctor or by a nurse (after establishing a thoracentesis protocol and in the presence of a doctor). As this procedure is not registered on the list of approved nursing procedures, it could not be performed at the patient’s home.


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During the period from August 20, 2005 to August 1, 2007, 34 pleural implantable access systems, including 4 bilateral devices, were placed in 29 patients for the management of recurrent symptomatic malignant pleural effusion. A second homolateral implantable access system was placed in 1 patient (ie, a woman) after expulsion of the port. No placement failures were observed in this series.

Fifteen of the 29 patients were receiving chemotherapy at the time of placement of the implantable access system. Apart from the patient who died 11 days after placement, all other patients obtained partial or complete improvement of their dyspnea, which was the primary objective of this procedure.

Six patients were treated by pleurodesis with return of the lung against the chest wall after a mean interval of 1 month. These 6 patients were receiving chemotherapy for metastatic breast cancer. The first patient had spontaneous pleurodesis develop after three thoracenteses during the first fortnight after placement, and the device was easily removed 321 days after placement. The second patient who had pleurodesis develop 2 months after placement of the device and after five thoracenteses presented with recurrent malignant pleural effusion 291 days after placement. Thoracenteses through the pleural implantable access system were easily resumed.

The number of aspirations performed varied between 1 and 28 (mean, 4) during a time period of 11 to 330 days.

No complications were observed immediately after placement.

One patient had empyema with Propionibacterium acnes infection of the pleural fluid develop; this patient also had homolateral lobar pneumonia due to the same microorganism. The pleural implantable access system could not be directly implicated in this infection and was left in place. Adapted antibiotic therapy ensured rapid cure of the infection.

One implantable access system was removed due to secondary skin infection over the puncture site in a context of febrile aplasia 20 days after placement.

Two mechanical complications were observed:

1 Expulsion of the implantable port in a malnourished patient 100 days after placement. The implantable access system was easily replaced.
2 Disconnection of the port detected radiologically in 1 patient with pleurodesis. The port was removed and the catheter was left in place in the pleural cavity.

Disobstruction procedures were required in 4 patients, but no permanent obstruction was observed in any of the patients. The removal of obstructions was always obtained by simple operations (ie, rinsing, heparinized serum).

In 1 patient, pleural loculation after 16 thoracenteses made subsequent thoracentesis ineffective. This patient did not need any further intervention.

No case of tumor seeding along the catheter or the port was observed [3].

On January 8, 2007, 21 of the 29 palliative care patients had died. Thirteen of these patients had a survival greater than 1 month (range, 30 to 330 days), 6 patients survived more than 6 months, and 8 died less than 1 month after implantable access system placement. Thoracentesis through the implantable access system was performed at least twice in 7 of these 8 patients.

Seven patients died at Institut Curie or in a palliative care unit without returning home. The other 22 patients presented a total of 280 days of hospitalization for 2,717 days of catheter implantation. In the great majority of cases, the reasons for hospitalization were a course of chemotherapy or alteration of the general state requiring assessment and renutrition. No hospitalization was related to a complication of the device.


    Comment
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In light of our experience and the literature data concerning the tunnelled pleural catheter [4–8], the use of a pleural implantable access system can be considered to be an interesting treatment option in terms of efficacy and safety for the outpatient management of malignant pleural effusion. The pleural implantable access system could provide the same advantages as the tunnelled pleural catheter, combined with improved patient comfort and a lower risk of infection. This preliminary study is encouraging in terms of reduction of the risk of infection, as only two infectious complications were observed. The case of infectious pneumonia rapidly resolved in response to antibiotics without removing the device, while the skin infection over the puncture site in a context of febrile aplasia required removal of the device.

Twenty eight of the 29 patients obtained partial or complete improvement of their dyspnea after placement of the device. Our low spontaneous pleurodesis rate (ie, 6 of 29 patients) can probably be explained by the fact that thoracentesis was not systematically performed until complete drainage of the pleura, but according to the degree of respiratory distress experienced by the patient. In these palliative care patients, thoracentesis should only be performed at the patient’s request when he or she considers dyspnea to be disabling in order to limit repeated trips to the hospital.

Only one or two thoracenteses were performed in 5 of 29 patients who died less than 1 month after placement, which raises the question of the real benefit of the implantable access system in these patients compared with conventional repeated needle thoracentesis. Future studies should try to identify criteria allowing selection of patients with a very short life expectancy in whom useless invasive procedures should be avoided.

A phase II single-center study will be initiated shortly to evaluate the implantable access system in the management of malignant pleural effusion with improvement of dyspnea as the primary objective and to evaluate the capacity of repeated systematic thoracentesis during the first 2 weeks after placement of the device to induce pleurodesis as the secondary objective.

Later on, a subsequent study should focus on the difference between the two devices (tunnelled pleural catheter and port) in regard to comfort and infectious risk.


    Disclosures and Freedom of Investigation
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No funds were used to perform the evaluation. The tested technology was purchased. The authors indicate they had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.


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Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.


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  1. Antunes G, Neville E, Duffy J, Ali N, Pleural Disease Group, Standards of Care Committee BTS guidelines for the management of malignant pleural effusions Thorax 2003;58(Suppl 2):ii29-ii38.[Free Full Text]
  2. Reed DN, Vyskocil JJ, Rao V. Subcutaneous access ports with fenestrated catheters for improved management of recurrent pleural effusions Am J Surg 1999;177:145-146.[Medline]
  3. Shoji T, Tamaka F, Yanagihara K, Inui K, Wada H. Phase II study of repeated intrapleural chemotherapy using implantable access system for management of malignant pleural effusion Chest 2002;121:821-824.[Medline]
  4. Musani AI, Haas AR, Seijo L, Wilby M, Sterman DH. Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters Respiration 2004;71:559-566.[Medline]
  5. Van Den Toorn LM, Schaap E, Surmont VFM, Pouw EM, Van der Rijt KCD, Van Klaveren RJ. Management of recurrent malignant pleural effusions with a chronic indwelling pleural catheter Lung Cancer 2005;50127–7.
  6. Putnam JB, Walsh GL, Swisher SG, et al. Outpatient management of malignant pleural effusion by a chronic indwelling pleural catheter Ann Thorac Surg 2000;69:369-375.[Abstract/Free Full Text]
  7. Putnam JB, Light RW, Rodriguez RM, et al. A randomized comparison of indwelling pleural catheter and doxycycline pleurodesis in the management of malignant pleural effusions Cancer 1999;86:1992-1999.[Medline]
  8. Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion Chest 2006;129:362-368.[Medline]




This Article
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