1. Cosimo Lequaglie Dpt. of Thoracic Surgery IRCCS-CROB Cancer Center Rionero in Vulture, ITALY From Research to Clinical Practice How the Innovation May Improve the Thoracic Surgeon’s Skill

2. Nowsadays: the evolution... Surgical technique is evolved and the available means can allow an effective and safe postoperative chest drainage.

3. The digital chest tube airflowmeter AIRFIX ® TEUP’s Ltd., Deutshlandsberg, A, 2002 “A data acquisition system digitizes the output signal of a “mass airflow sensor” and continuously sends measurement values to a processor. Only the “netto” flux into one direction is recorded as air-leak. The amount of air moving into the opposite direction (shift of intrapleural dead space) is subtracted from the leakage. Sensor parameters are stored in the Elettrically Erasable Memory Area (EEROM) of a microcontroller” Anegg U, Lindenmann J, Matzi V et al., AIRFIX ® : The first digital postoperative chest tube airflowmetry – A novel method to quantify air leakage after lung resection. Eur J Cardiothorac Surg 2006;29:867-872

4. : Micro Electronic Mechanical System (MEMS) sensors providing a digital measurement and recording of air flows (ml*min -1 /l*h -1 ) and pressures: maximum, minimum, differential (pe MAX - pi MIN ) (cmH 2 O). Controller Unit: Micro Electronic Mechanical System (MEMS) sensors providing a digital measurement and recording of air flows (ml*min -1 /l*h -1 ) and pressures: maximum, minimum, differential (pe MAX - pi MIN ) (cmH 2 O).. Controller single use only. Liquid Crystal Display: showing measurement data at the bedside of the patient: “real time” (instantaneous) flows (up) and pressures (down), 1-3-6 hours airflow averages. Liquid Crystal Display: showing measurement data at the bedside of the patient: “real time” (instantaneous) flows (up) and pressures (down), 1-3-6 hours airflow averages. The Controller Unit recorded data every 2 min. The Controller Unit recorded data every 2 min. b a Digi Vent TM - Millicore AB, Danderyd, Sweden

5. COLLECTION CHAMBER Canister capacity: 2000 ml Canister capacity: 2000 ml One-way dry valve One-way dry valve Pressure reducing valve Pressure reducing valve Mechanical suction regulator Mechanical suction regulator Liter/hour air flow accumulation button Liter/hour air flow accumulation button Flashing hi/lo pressure alarm (> 5 cm H 2 0; 5 cm H 2 0; < - 40 cmH 2 0) Digi Vent TM - Millicore AB, Danderyd, Sweden

6. The C.U. displays real time flow and pressure readings, but the data downloaded in Excel are the last actual measured readings in 2 minutes increments. The C.U. displays real time flow and pressure readings, but the data downloaded in Excel are the last actual measured readings in 2 minutes increments. The data on the Controller Unit are not erased by the download process. The data on the Controller Unit are not erased by the download process. One, three and six hours air flow averages displayed on the C.U. just while attached to the collection chamber. One, three and six hours air flow averages displayed on the C.U. just while attached to the collection chamber. Graph form of C.U. data images are automatically saved as jpeg files. Graph form of C.U. data images are automatically saved as jpeg files. Digi Vent TM – More Advantages

7. Air leak in the same patient: the progressive divergent pressure curves anticipates the visual appearance of the air leak. The curves show the expiratory (dark blue) and inspiratory (blue) pressures. You can observe an initial interspace among “ep” and “ip” in the first 12 post-operative hours (p.o.): after a preassure plateau, and finally a progressive divergence of the curves from the 2 nd p.o. day (a): the superior curve (electric blue) shows the differential pressure (Δp = ep-ip); (b): the superior curve (yellow) underlines an air leak in the first 12 hours, no leak until to the 3 rd p.o. day, and a late leak anticipates from a differential pressure in increase. ab Rita Daniela Marasco, Gabriella Giudice, and Cosimo Lequaglie. How to distinguish an active air leak from a pleural space effect. Asian Cardiovasc Thorac Ann 2012;20:682-688

8. So-called pleural space: you can observe a great differential pressure in a (blue electric) without air leak in b (yellow curve). Large swinging endopleural pressures (Δp>25 cmH2O) for poor elastic serosa in empyema and pleural effusions. a b

9. Increasing air leak >500 ml/min The converging curves show the complete re-expansion of the lung and the possibility to remove the chest drain

10. Obstructed clot drain: in the same patient from the 1 st p.o. day, sudden reduction of the differential pressure (blue electric) and convergence of e.p. and i.p. curves in low (dark blue and blue). a): this corresponds to the disappearance of air flow (yellow) after an evident air leak at the beginning; b): this happens when there is an obstruction of the chest tube, to example from clot in the drain or kinging during the night. a b

11. Measurement and recording air flows (l/min). Measurement and recording air flows (l/min). Vacuum unit on defalult negative pressures (-5 up to - 100 cmH 2 O). Vacuum unit on defalult negative pressures (-5 up to - 100 cmH 2 O). Rechargeable battery up to 12 hrs Rechargeable battery up to 12 hrs Canister capacity: 2000 ml Canister capacity: 2000 ml Pump off mode not provided. Pump off mode not provided. Water seal valve available. Water seal valve available. ATMOS E201 Thorax - MedizinTechnik, Lenzkirch, Germany

12. a INTELLIGENT THERAPY INTELLIGENT THERAPY OPTIMIZED CARE OPTIMIZED CARE The 1 st digital chest drain with portable suction pump and downloading data on board The 1 st digital chest drain with portable suction pump and downloading data on board THOPAZ - Medela, Baar, CH

13. The 1 st DRENTECH ® REDAX had an adjustable vacuum control unit with a water seal chamber and an obvious analogue detection. In any case with a sucking pump. a The DRENTECH ® MOBILE REDAX had an adjustable vacuum control unit with a water seal chamber and an obvious analogue detection. All time visibility for air leak monitoring. Capacity volume 2550 ml. Sucking pump from -10 up to -60 cmH 2 O.

14. Measurement and recording air flows (ml/min) and endopleural pressures (cmH 2 O), until 99 hours. Measurement and recording air flows (ml/min) and endopleural pressures (cmH 2 O), until 99 hours. Vacuum unit on default negative pressures (-10 up to -60 cmH 2 O). Vacuum unit on default negative pressures (-10 up to -60 cmH 2 O). Pump off mode not provided. Pump off mode not provided. Water seal valve available. Water seal valve available. Speedy passage DRENTECH ® PALM REDAX

15. Detection and recording air flows (ml/min) plus endopleural pressures (cmH 2 O or KPa), until 99 hours. Mini USB-key port. Detection and recording air flows (ml/min) plus endopleural pressures (cmH 2 O or KPa), until 99 hours. Mini USB-key port. Vacuum unit on default negative pressures (-10 up to -60 cmH 2 O). Vacuum unit on default negative pressures (-10 up to -60 cmH 2 O). Rechargeable battery up to 36 hrs Rechargeable battery up to 36 hrs Pump off mode provided. Pump off mode provided. Water seal for the collection chamber. Water seal for the collection chamber. D RENTECH ® PALM EVO REDAX

16. Characteristics of the digital devices mostly profits the postoperative clinical evaluation Value of “real time” air leak (up-date every minute). This parameter is the quantification of the bubbles that the surgeon is usual to appraise in the box with water valve. The advantage consists in the objective evaluation of the leak, without the usual problems owed to the subjective interpretation of the quantity and frequency of the bubbles. Value of the “intrapleural” pressure (measured on board) in real time. This measurement represents the equivalent of the excursion of the meniscus in the water valve. The pressure trend is visualized in graphic format with an oscillating bar on the display. The variations follow the each respiratory acts of the patient. Mean value per hour of the air leaks, adjourned every hour. Such parameter represents an important help of evaluation because it shows a clear and objective evaluation of the air leak, without the “trouble” of the inevitable variations caused by many “istant” factors. These values are memorized and revisable for 99 hours directly on PALM EVO. Course of the air leak and the intrapleural pressure in graphic format. This possibility is useful to appraise “to glimpse” the evolution of the 2 parameters in the time.

17. Characteristics of the digital devices mostly profits the postoperative clinical evaluation Value of the air leaks “in real time” (up-date every minute). This parameter is the quantification of the bubbles that the surgeon is usual to appraise in the box with water valve. The advantage consists in the objective evaluation of the leak, without the usual problems owed to the subjective interpretation of the quantity and frequency of the bubbles. Value of the “intrapleural” pressure (measured on board) in real time. This measurement represents the equivalent of the excursion of the meniscus in the water valve. The pressure trend is visualized in graphic format with an oscillating bar on the display. The variations follow the each respiratory acts of the patient. Mean value per hour of the air leaks, adjourned every hour. Such parameter represents an important help of evaluation because it shows a clear and objective evaluation of the air leak, without the “trouble” of the inevitable variations caused by many “istant” factors. These values are memorized and revisable for 99 hours directly on PALM EVO. Course of the air leak and the intrapleural pressure in graphic format. This possibility is useful to appraise “to glimpse” the evolution of the 2 parameters in the time.

18. Characteristics of the digital devices mostly profits the postoperative clinical evaluation Value of the air leaks “in real time” (up-date every minute). This parameter is the quantification of the bubbles that the surgeon is usual to appraise in the box with water valve. The advantage consists in the objective evaluation of the leak, without the usual problems owed to the subjective interpretation of the quantity and frequency of the bubbles. Value of the “intrapleural” pressure (measured on board) in real time. This measurement represents the equivalent of the excursion of the meniscus in the water valve. The pressure trend is visualized in graphic format with an oscillating bar on the display. The variations follow the each respiratory acts of the patient. Mean value per hour of the air leaks, adjourned every hour. Such parameter represents an important help of evaluation because it shows a clear and objective evaluation of the air leak, without the “trouble” of the inevitable variations caused by many “istant” factors. These values are memorized and revisable for 99 hours directly on PALM EVO. Course of the air leak and the intrapleural pressure in graphic format. This possibility is useful to appraise “to glimpse” the evolution of the 2 parameters in the time.  Pleural Pressures cmH 2 O LLL: air leak: air flow ml/min

19. Because our Cancer Research Institute testing all the “digital thoracic drains” has chosen and modified PALM EVO Extreme simplicity of use: The digital drain has been inserted in the routine use with very brief “learning curve”, both for the surgeon and the nurse. Such characteristic is facilitated by the presence of the unidirectional water valve that allows always the “analogical” evaluation of the leaks. Availability of all the necessary information to the management of the patient in postoperative period: They are directly present and utilizable on the instrument for 99 hours (over 4 days) from the beginning of the drain. It is not necessary to effect some transfer of the data to a PC; such possibility is optional for following elaborations or for the recording. It is a “true” chest drain: Good ability of collect, water valve, handle for the transport and the fixing. Versatility of the tool that allows, in every moment, to be able to work in aspiration or in ”real” gravity or, even, to be connected to the aspiration checked to wall: this is a great advantage if it is considered that the thoracic patient can be transferred often for other diseases or complications to other departments.

20. What does it mean that PALM EVO works in “real” gravity ? Today the devices on the market don't allow the digital drain for gravity, there is always a certain aspiration. This last, to practice an effect on the pleural cavity, doesn't allow further the evaluation of the excursion of the intrapleural pressures. The “Pump-off” function of the PALM EVO allows to eliminate whatever intervention from the aspirant pump: the drain proceeds completely to gravity. The air coming from the patient is expelled through a special valve for which the drain is always active without any risk for the patient.

21. Why to know the trend and the value of the intrapleural pressure ? The intrapleural pressure is related to the pulmonary expansion in the pleural cavity. In the traditional systems, such parameter is entirely appraisable in real time observing the meniscus of the water in the unidirectional valve. Increased excursions are usually related to the presence of a “ real pleural space” in the chest, usually caused by an incomplete pulmonary expansion.The PALM EVO device allows to appreciate the trend of such pressures during the whole postoperative period; the maximum and minimum pressure trend has contemporarily shown on the same graph. In our and other colleague experience, the examination of such trend can be predictive of the beginning of a prolonged air leak (PAL). In every case the progressive expansion can be appreciated especially in the cases of compromise or emphysematous pulmonary parenchyma. The intrapleural pressure is related to the pulmonary expansion in the pleural cavity. In the traditional systems, such parameter is entirely appraisable in real time observing the meniscus of the water in the unidirectional valve. Increased excursions are usually related to the presence of a “ real pleural space” in the chest, usually caused by an incomplete pulmonary expansion. The PALM EVO device allows to appreciate the trend of such pressures during the whole postoperative period; the maximum and minimum pressure trend has contemporarily shown on the same graph. In our and other colleague experience, the examination of such trend can be predictive of the beginning of a prolonged air leak (PAL). In every case the progressive expansion can be appreciated especially in the cases of compromise or emphysematous pulmonary parenchyma. RIGHT LOWER LOBECTOMY (carcinomatous abscess of the lung)  Pleural Pressures cmH 2 O

22. Utility of the available parameters by the digital devices ? Superfluous complication or real aid to the treatment of the patient ? As for other situations, it is not essential that the physician uses “all and always” the available performances. The use of the PALM EVO functions is extremely simplified and modular: the physician can make trust on the parameters that will mostly hold profits in a particular moment or in another situation, without necessarily consulting the others. To example: the simplest and useful parameter is, without doubt, the value of the hour-average air leak. The PALM EVO doesn't result to be “intrusive”, neither it has been planned for modifying the habits and the “modus operands” of the physician, on the contrary to suit itself for this. In a different context, the physician can progressively deepen the use of the instrument making trust on the other functionalities. In this view we can affirmed that the device is a real aid for the physician.

23. Why to use a “digital device”?  The adoption of a “digital device” in the management of the thoracic patient is of great utility since it furnishes certain elements and “objective” to analyze the p.o. period and to appraise the most opportune actions to undertake: appraise the best moment for the removal of the drains avoiding further verifications, like the “provocative clamping” causes of more duration of the hospital stay best continuity results in the management of the patient (change turn of the physicians and the nurses) the physician has all the data that the device also picks up in his absence.  Today also, the physician is founded on the news during the “examination round ward” or that he draws by the colleagues on the medical record. A “digital device” allows to have a “continuous” control improving the general monitoring of the patient. oral narration

24. Why to employ really the digital drain REDAX PALM EVO ?  All the advantages before illustrated are available in simple, sure and immediate way.  The device facilitates the physician and nurse management to advantage of the safety of the patient (the touch screen facilitates the consultation from the physician but, being normally off, it doesn't influence the management from the nurses).  The device allows a complete mobility of the patient for a fast recovery and relieving the load of job of the hospital personnel.  The PALM EVO has unique and innovative characteristics that to today make it the available most complete system on the market.  Finally, the cost of purchase and exercise is competitive in comparison to other devices.

25. Thank you