Use of a Subcutaneous Implantable Pleural Port in the Management of Recurrent Malignant Pleurisy: Five-Year Experience Based on 168 Subcutaneous Implantable Pleural Ports

Abstract

Introduction:

The authors report their experience in the use of subcutaneous implantable pleural port (SIPP) catheters for the treatment of symptomatic recurrent malignant pleurisy.

Materials and methods:

Single-center, prospective follow-up of 137 patients (168 SIPPs).

Results:

No SIPP placement failures were observed. All but 3 of the 125 evaluable patients obtained complete or partial relief of their dyspnea. Seventy-six patients (60.3%) were receiving chemotherapy. Spontaneous pleurodesis was observed within 2 months in 46 patients (36.8%). Twenty-six patients (20.8%) died during the month following SIPP placement. Forty-one patients (32%) survived for more than 6 months. The overall median survival time was 344 days. Three infectious complications (1 empyema, 2 cellulitis) and 3 mechanical complications were observed. The role of pleurodesis as prognostic factor was assessed. Seventy-one patients survived for more than 2 months, 36 with pleurodesis, 35 without pleurodesis, requiring repeated pleural aspiration. The difference observed between the two groups by the 120th day was no longer significant when chemotherapy was taken into account.

Conclusion:

SIPP is a safe and effective option for the outpatient management of recurrent malignant effusions and could be considered as first-line treatment in all patients with bilateral, compressive pleural effusion or poor lung reexpansion.

Introduction

Malignant pleural effusion is the most common cause of exudative pleural effusion after the age of 60. The most common primary cancers are lung cancer in men and breast cancer in women. These two cancers represent more than one half of all cases of malignant pleurisy.

Patients with malignant pleurisy experience dyspnea, cough, and/or chest pain, which can significantly impair their quality of life. These patients have a very poor prognosis with a short median survival between 3 and 12 months, depending on the type of cancer and the stage of the disease.

Treatment options for malignant pleurisy are currently limited, as chemotherapy is usually ineffective to control pleural effusion; that is, except for cancers such as small cell lung cancer, lymphoma, and breast cancer,. Simple surveillance is recommended in asymptomatic patients, and various techniques can be proposed in symptomatic patients: repeated pleural aspiration, placement of a pleural drain with intrapleural instillation of a pleurodesis agent, videothoracoscopic talc pleurodesis, indwelling pleural catheter placement, pleuroperitoneal shunt, or pleurectomy.¹ The two techniques most commonly used are repeated evacuating pleural aspiration and videothoracoscopic talc pleurodesis. An emerging technique is the PleurX^® indwelling pleural catheter (CareFusion, San Diego, CA).^2–7 The choice of technique is determined by several factors: clinical features, recurrent nature of the effusion, performance status, primary tumor, expected response to systemic therapy, and quality of lung reexpansion after needle pleural aspiration. The most effective and least invasive method must always be preferred in these patients in a palliative setting.

A new approach to the management of malignant pleurisy was tested at Institut Curie. This alternative therapeutic option was evaluated for patients with end-stage malignancies by Monsky et al.⁸ We report our clinical experience with the subcutaneous implantable pleural port (SIPP) documenting the convenience and safety of this drainage system. Our hospital is a tertiary cancer center for breast cancer that has no thoracic surgery unit. This device is used exclusively for evacuating aspiration and is not used to instill pleurodesis agents or chemotherapy.

Patients and Methods

SIPPs were introduced in our center in August 2005. To evaluate this new treatment approach, a prospective database was developed. First results with 29 patients and 34 SIPPs included in this series were published.⁹ Our Institutional review board approved this study in September 2005.

Patients

A series of 137 patients (120 women and 17 men) with symptomatic, recurrent malignant pleurisy treated by indwelling pleural catheter were followed prospectively between August 20, 2005 and January 1, 2010. The mean age of these patients was 62 years (range: 16 to 92 years). In the majority of the cases, the primary tumor was breast cancer (100 patients), followed by lung cancer (20 patients), gynecological cancer (9 patients), osteogenic sarcoma (3 patients), pancreatic cancer (2 patients), head and neck cancer (2 patients), and renal cancer (1 patient). The decision to use an indwelling pleural catheter was taken during the weekly chest disease multidisciplinary consultation meeting benefiting the presence of two thoracic surgeons. All patients suffered from dyspnea, previously improved by needle pleural aspiration, and were ineligible for videothoracoscopic talc pleurodesis because of their poor performance status or short life expectancy. A SIPP was placed in 5 patients eligible for videothoracoscopic talc pleurodesis. These patients were beginning chemotherapy at the time of SIPP placement, and the medical oncologist preferred to avoid deferral of chemotherapy for videothoracoscopic talc pleurodesis.

Indwelling pleural catheter placement

Indwelling pleural catheter placement was performed after providing the patient with oral information and after obtaining the patient's informed consent. SIPP placement was performed under sedation with fluoroscopic guidance. The decision to perform SIPP placement under sevoflurane sedation with spontaneous breathing was justified by two reasons: to ensure the best possible comfort for patients in a palliative setting and to allow supine positioning of these patients with dyspnea and often severe pain.

A Celsite^® ST 8.5F (Laboratoires Braun, France) implantable access port was used. The distal 18 cm of the catheter was fenestrated at 1.5-cm intervals.

After local anaesthesia of the skin with 2 to 10 mL of 1% lidocaine, a guide was inserted according to the Seldinger technique in the mid-axillary line between the third and fifth intercostal spaces. The guide was directed toward the base of the lung under fluoroscopic guidance. A subcutaneous compartment was then created in the mid-axillary line over the tenth, eleventh, or twelvth rib. The sheath dilator was advanced along the guidewire, and the catheter connected to the port was then introduced over a distance of 26 to 30 cm. The implantation was performed by an anesthetist skilled in central venous port implantation.

A first evacuating pleural aspiration was performed before waking the patient to ensure correct functioning of the system. This pleural aspiration was limited to a maximum of 1500 mL of fluid. An anteroposterior and lateral chest x-ray was then performed to confirm the catheter position. When the effusion was partly evacuated and in the case of persistent dyspnea, a second aspiration was performed before discharging the patient (6 hours after placement and/or the following morning).

The procedure was performed either as an outpatient procedure and the patients were discharged in the evening of the procedure, or during conventional hospitalization. Evacuation of pleural aspirations was performed with a closed system to limit the risk of infection (evacuation was performed with a Huber needle connected to tubing and a drainage bottle). The closed system could only be broken when medically indicated, in patients who experienced chest pain during previous aspirations, to inject 40 mL of 1% lidocaine and 10 mL of ropivacaine (7.5 mg/mL) into the pleural cavity or to perform disobstruction maneuvers. These disobstruction maneuvers were the same as those used for implantable venous access devices. Urokinase was instilled through the catheter at a dose of 100,000 IU diluted in 5 to 10 mL of normal saline.¹⁰ There were no increased bleeding. Aspiration was performed after placing an EMLA (lidocaine prilocaine) patch over the port.

Evacuation of pleural aspiration was performed in the hospital at the patient's request, as required by respiratory discomfort, either by a doctor or by a nurse (after establishing an aspiration protocol and in the presence of a doctor). As this procedure is not an authorized nursing procedure in our country, it cannot be performed at the patient's home.

Results

During the period from August 20, 2005 to January 1, 2010, 168 SIPPs (including 26 bilateral SIPPs, 2 ipsilateral SIPPs, and 3 repeat placements) were placed in 137 patients with recurrent symptomatic malignant pleurisy. No SIPP placement failures or placement complications were observed. Twelve patients (16 SIPPs) were lost to follow-up shortly after SIPP placement (patients coming from other institutions).

All but 3 patients obtained complete or partial improvement in their dyspnea. Pulmonary embolism was demonstrated in 2 of the 3 patients not improved by SIPP. Of the remaining 125 patients who were not lost to follow-up, 76 (60.3%) were receiving chemotherapy at the time of SIPP placement or after SIPP placement allowing improvement of the general state and dyspnea. Pleurodesis with lung reexpansion was observed within 2 months in 46 patients (36.8%) (Fig. 1). Twenty-six patients (20.8%) died during the first month, 14 in the hospital or the palliative care unit, whereas 41 patients (32 %) survived for more than 6 months (Table 1).

FIG. 1.

Pleurodesis.

Table 1.

Population Including Disease Type, Treatment Exposure, Pleurodesis, Death during the First Month, and Survival for More Than 6 Months

Disease type	Number of patients	Improvement in their dyspnea	Pleurodesis	Chemotherapy	Death during the first month	Survival more than 6 months
Breast	91	88	33	58	14	36
Lung	17	17	4	11	8	3
Gynecological	9	9	3	3	2	1
Osteogenic sarcoma	3	3	1	3	1	1
Pancreatic	2	2	2	0	1	0
Head and neck	2	2	2	0	0	0
Renal	1	1	1	1	0	0

One-year mortality was 83%. The overall median survival time following insertion was 334 days (range 285–382).

The role of pleurodesis as prognostic factor is suggested in the literature²⁷ and was assessed. Seventy-one patients (58 with breast cancer [81.6%]) survived more than 2 months: 36 with pleurodesis, 35 without pleurodesis, requiring repeated pleural aspirations sometimes once a week, most of the time once a month. Thirty (83.3%) of the 36 patients with pleurodesis and 23 (65.7%) of the 35 patients without pleurodesis received chemotherapy. Survival curves are shown in Fig. 2. With a median follow-up of 738 days, a difference with a better prognostic with pleurodesis was observed between the two groups by the 120th day (Breslow-Day test). However, this difference was no longer significant when chemotherapy was taken into account, as illustrated by the survival curves of Fig. 3.

FIG. 2.

Survival as a function of pleurodesis.

FIG. 3.

Survival as a function of pleurodesis in the CT group.

No case of catheter dysfunction resulting in permanent obstruction was observed. However, disobstruction maneuvers had to be performed on some SIPPs. No bleeding complications were observed after injection of urokinase.

We used to keep in place the SIPPs even for patients with pleurodesis, but six ports of patients with pleurodesis and discomfort were removed without any difficulties.

Five patients developed loculated pleurisy and enlargement of the pleural space, making subsequent aspirations ineffective. No tumor seeding along the catheter or port was observed. Pain at the end of aspiration was easily prevented by using ant-nociceptive agents. Four infectious complications were observed: one case of infectious pleuropneumonia treated by antibiotics, one case of skin infection over the puncture site in a context of febrile aplasia 20 days after SIPP placement, one case of Eschericia coli catheter-related infection with local cellulitis and one case of Staphylococcus aureus empyema requiring surgical drainage. Three mechanical complications were observed: one extrusion of the port in a malnourished patient 100 days after SIPP placement in which the SIPP was easily replaced, and two port-catheter disconnections detected radiologically, in which the catheters were left in the pleural cavity.

This innovation was rapidly adopted throughout the institution: 5 SIPPs and 19 thoracoscopies in 2005, 25 SIPPs and 10 thoracoscopies in 2006, 25 SIPPs and 5 thoracoscopies in 2007, 42 SIPPs and 8 thoracoscopies in 2008, 44 SIPPs and 6 thoracoscopies in 2009.

Discussion

Malignant pleurisy is a common medical problem that is not always satisfactorily managed. Few treatment options are available in patients with symptomatic malignant pleurisy and these consist of either repeated pleural aspiration or videothoracoscopic drainage and talc pleurodesis, or use of a PleurX pleural catheter system.^1–8

Repeated pleural aspiration is associated with a considerable risk of iatrogenic complications such as pneumothorax, empyema, and loculated pleurisy, making aspiration increasingly difficult or even impossible and ineffective.^11–13 Quality of life is severely impaired (dyspnea can become suddenly worse requiring health care structures able to perform emergency aspiration).

Videothoracoscopic drainage and talc pleurodesis are indicated in some patients (exclusion of patients with bilateral effusion, poor lung reexpansion after aspiration, very poor performance status, and patients presenting a contraindication to general anaesthesia). This procedure requires hospitalization for an average of 6 days. The perioperative mortality rate is less than 0.5%. Although there are rare immediate complications such as empyema and acute respiratory distress due to infection or re-expansion pulmonary edema, later complications such as pain are not uncommon. Success rates vary according to the history of pleurisy and the extent of pleural carcinomatosis.

The ideal therapeutic approach would be an outpatient procedure suitable for patients with malignant pleurisy, providing immediate and lasting improvement of symptoms with the fewest possible adverse effects and avoiding repeated invasive and/or painful procedures.

A review of the literature reveals a third approach to the management of malignant pleurisy that consists of implantation of a tunneled pleural catheter.^14–19 This catheter is composed of a distal element placed in the intrapleural space, a central element tunneled subcutaneously, and an external proximal part connected to a drainage bag or bottle for drainage of pleural fluid. This catheter (PleurX) is a small diameter, flexible silicone catheter 66 cm long with fenestrations over the distal 24 cm. The proximal extremity comprises a safety valve to prevent inadvertent passage of air or pleural fluid when the catheter is not connected to a drainage bottle.

Data in the literature concerning tunneled pleural catheters^{14–20,23,28} confirm that the use of an indwelling pleural catheter is a useful alternative in terms of efficacy and safety for the outpatient management of malignant pleurisy, particularly in patients with a low Karnofsky index, bilateral pleural effusion, or poor lung reexpansion after needle pleural aspiration. The indwelling pleural catheter could have the same advantages as tunneled pleural catheters, associated with improved comfort and a lower infectious risk. The results of this study are encouraging in terms of reduction of the infectious risk, as only 4 infectious complications were observed, including 2 cases of local cellulitis and 1 case of empyema with removal of the material in 3 cases (3/152) (1.31%). The PleurX complication rates reported in the literature range from 2% to 16%. The PleurX catheter-related infection rate was 3/63 (4.7%) for Cases et al.,²¹ 1/63 (1.5%) for Murthy et al.,²² 3/40 (7.5%) for Burgers et al.,²³ 5/109 (4.6%) for Tremblay and Michaud,¹⁹ and 5/100 (5%) for Putnam et al.¹⁷ Musani et al.¹⁵ reported 3 cases of empyema requiring removal of the material in a series of 24 patients (12.5%). Sioris et al.²⁴ reported 3 out of 51 cases (5.8%) and Mahmood and Bower²⁵ reported 3 out of 49 cases (6.1%). Van den Toorn et al.¹⁶ reported 1 case of empyema and 1 case of localized infection in 17 patients. Inversely, Warren et al.²⁶ reported an empyema rate of 0.3% and a localized infection rate of 1.3% in 295 patients. But, when risk is expressed per 1000 catheter-day, our rate is very low (0.16), and Warren and colleagues' rate is 0.57 and Tremblay and Michaud's rate is 0.85.

One hundred twenty-two of the 125 patients obtained complete or partial improvement of their dyspnea after SIPP placement. Pleural aspiration was only performed once or twice in 12 patients, who died less than 1 month after SIPP placement, raising the question of the real benefit of SIPP compared with repeated conventional needle pleural aspirations needle in these patients. Future studies must define more reliable selection criteria for patients with a very short life expectancy in whom useless invasive procedures must be avoided.

The spontaneous pleurodesis rate in this study (46 out of 125 patients) can probably be explained by the fact that the frequency of pleural aspiration was determined by the severity of respiratory symptoms experienced by the patient and was not systematically repeated until complete pleural drainage. In these patients in the palliative setting, pleural aspiration is advisable only upon patient's request and when dyspnea is considered to be disabling, so as to limit repeated visits to the hospital. However, if aspiration was performed at home, more frequent aspirations could be performed, perhaps resulting in greater pleurodesis rates. Aelony,²⁷ in response to the article by Tremblay and Michaud,¹⁹ suggested that PleurX could reduce the survival time compared with talc pleurodesis via several mechanisms (loss of protein and lymphocytes with impaired host-versus-tumour defences, specific effect of talc). The present study, without providing the level of proof of a comparative trial, suggests that the presence or absence of pleurodesis in patients receiving chemotherapy is not a prognostic factor of survival.

The first goal of this study was to show that the technique was safe and was accompanied some times with pleurodesis. Improvement of dyspnea was only declarative. A second study started with documentation of decreased O₂ requirements, a dyspnea scale, and scoring of quality of life. Monsky et al.⁸ with 14 pleural ports reported a high degree of quality-of-life improvement and a high degree of convenience and comfort both for patients and nurses.

The rapid adoption of this innovative technique in our institution can be attributed to logistic factors that favor the easy use of the indwelling pleural catheter.

In conclusion, indwelling pleural port catheter is a safe and effective technique for the outpatient management of recurrent malignant pleurisy. Candidate patients include: patients with bilateral pleural effusion, patients where effusion is not accompanied by satisfactory lung reexpansion, patients with compressive pleural effusion, and patients who are unable to support general anaesthesia or in whom repeated needle aspirations would be difficult (e.g., obese patients, anxious patients, patients with a solitary lung).

Footnotes

Author Disclosure Statement

No competing financial interests exist.

References

Antunes

, Neville

, Duffy

, Ali

. on behalf of the BTS Pleural Disease Group, a subgroup of the BTS Standards of Care Committee. BTS guidelines for the management of malignant pleural effusions. Thorax, 2003; 58:29–38.

Spector

, Pollak

. Management of malignant pleural effusions. Semin Respir Crit Care Med, 2008; 29:405–413.

Haas

, Sterman

, Musani

. Malignant pleural effusions: management options with consideration of coding, billing, and a decision approach. Chest, 2007; 132:1036–1041.

Heffner

, Klein

. Recent advances in the diagnosis and management of malignant pleural effusions. Mayo Clin Proc, 2008; 83:235–250[Erratum in: Mayo Clin Proc 2009;84:847.]

Neragi-Miandoab

. Surgical and other invasive approaches to recurrent pleural effusion with malignant etiology. Support Care Cancer, 2008; 16:1323–1331.

Khaleeq

, Musani

. Emerging paradigms in the management of malignant pleural effusions. Respir Med, 2008; 102:939–948.

Bazerbashi

, Villaquiran

, Awan

, Unsworth-White

, Rahamim

, Marchbank

. Ambulatory intercostal drainage for the management of malignant pleural effusion: A single center experience. Ann Surg Oncol, 2009; 16:3482–3487.

Monsky

, Yoneda

, MacMillan

, Deutsch

, Dong

, Hourigan

, Schwartz

, Magee

, Duffield

, Boak

, Cernilia

. Peritoneal and pleural ports for management of refractory ascites and pleural effusions: Assessment of impact on patient quality of life and hospice/home nursing care. J Palliat Med, 2009; 12:811–817.

Daniel

, Kriegel

, Di Maria

, Patrubani

, Levesque

, Livartowski

, Esteve

. Use of a pleural implantable access system for the management of malignant pleural effusion: The Institut Curie experience. Ann Thorac Surg, 2007; 84:1367–1370.

10.

Hsu

, Soong

, Feng

, Liu

. Intrapleural urokinase for the treatment of loculated malignant pleural effusions and trapped lungs in medically inoperable cancer patients. J Thorac Oncol, 2006; 1:460–467.

11.

Boland

, Gazelle

, Girard

, Mueller

. Asymptomatic hydropneumothorax after therapeutic thoracentesis for malignant pleural effusions. AJR Am J Roentgenol, 1998; 170:943–946.

12.

Roberts

, Neville

, Berrisford

, Antunes

, Ali

. BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax, 2010; 65,Suppl 2:ii32–ii40.

13.

Yoneda

, Mathur

, Gasparini

. The evolving role of interventional pulmonary in the interdisciplinary approach to the staging and management of lung cancer. Part III: Diagnosis and management of malignant pleural effusions [review] Clin Lung Cancer, 2007; 8:535–547.

14.

Lombardi

, Zustovich

, Nicoletto

, Donach

, Artioli

, Pastorelli

. Diagnosis and treatment of malignant pleural effusion: A systematic literature review and new approaches. Am J Clin Oncol, 2009; 33:420–423.

15.

Musani

, Haas

, Seijo

, Wilby

, Sterman

. Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters. Respiration, 2004; 71:559–566.

16.

Van Den Toorn

, Schaap

, Surmont

VFM

, Pouw

, Van der Rijt

KCD

, Van Klaveren

. Management of recurrent malignant pleural effusions with a chronic indwelling pleural catheter. Lung Cancer, 2005; 50:127–127.

17.

Putnam

, Walsh

, Swisher

, Roth

, Suell

, Vaporciyan

, Smythe

, Merriman

, Deford

. outpatient management of malignant pleural effusion by a chronic indwelling pleural catheter. Ann Thorac Surg, 2000; 69:369–375.

18.

Putnam

, Light

, Rodriguez

, Ponn

, Olak

, Pollak

, Lee

, Payne

, Graeber

, Kovitz

. A randomized comparison of indwelling pleural catheter and doxycycline pleurodesis in the management of malignant pleural effusions. Cancer, 1999; 86:1992–1999.

19.

Tremblay

, Michaud

. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest, 2006; 129:362–368.

20.

Warren

, Kalimi

, Khodadadian

, Kim

. Management of malignant pleural effusions using the Pleur(x) catheter. Ann Thorac Surg, 2008; 85:1049–1055.

21.

Cases

, Seijo

, Disdier

, Lorenzo

, Cordovilla

, Sanchis

, Lacunza

, Sevillano

, Benito-Sendín

. [Use of indwelling pleural catheter in the outpatient management of recurrent malignant pleural effusion] Arch Broncopneumol, 2009; 45:591–596.

22.

Murthy

, Okereke

, Mason

, Rice

. A simple solution for complicated pleural effusions. J Thorac Oncol, 2006; 1:697–700.

23.

Burgers

, Olijve

, Baas

. [Chronic indwelling pleural catheter for malignant pleural effusion in 25 patients] Ned Tijdschr Geneeskd, 2006; 150:1618–1623.

24.

Sioris

, Sihvo

, Salo

, Räsänen

, Knuuttila

. Long-term indwelling pleural catheter (PleurX) for malignant pleural effusion unsuitable for talc pleurodesis. Eur J Surg Oncol, 2009; 35:546–551.

25.

Mahmood

, Bower

. Treatment of infection associated with tunnelled pleural catheters. J Bronchol Intervent Pulmonol, 2010; 17:69–72.

26.

Warren

, Kim

, Liptay

. Identification of clinical factors predicting Pleurx catheter removal in patients treated for malignant pleural effusion. Eur J Cardiothorac Surg, 2008; 33:89–94.

27.

Aelony

. Talc pleurodesis and acute respiratory distress syndrome. Lancet, 2007; 370:387author reply 387.

28.

Qureshi

, Collinson

, Powell

, Froeschle

, Berrisford

. Management of malignant pleural effusion associated with trapped lung syndrome. Asian Cardiovasc Thorac Ann, 2008; 16:120–123.