Thopaz Thoracic Surgeon User Survey

Transcription

1 Thopaz Thoracic Surgeon User Survey Thopaz is a novel chest drainage system that enables data-driven treatment decisions. Precious life Progressive care

2 2 Thoracic Drainage System

3 A Thoracic Surgeon Statement: Thopaz digital chest drainage unit by Medela - simplified and efficient chest drainage. Thoracic Surgeon Survey Participants*: 3 Bernard K. Crawford, M. D., Assistant Professor of Cardiothoracic Surgery at NYU School of Medicine, Director of Thoracic Surgery at Tisch Hospital. Frank C. Detterbeck, M. D., Professor Surgery Chief of Thoracic Surgery; Yale School of Medicine; Director, Thoracic Oncology Program, Yale Cancer Center, New Haven, C.T. Dawn Jaroszewski, M. D., M. B. A., F. A. C. S., Associate Professor of Surgery, Division of Cardiothoracic Surgery, Mayo Clinic, Arizona. Robert J. Korst, M. D., Director of Thoracic Surgery, Medical Director of Blumenthal Cancer Center, Valley Health System, Ridgewood, NJ Benjamin E. Lee, M. D., Thoracic Surgeon, American Board of Thoracic Surgery, Valley Health System, Ridgewood, NJ Bernard J. Park, M. D., F. A. C. S., F. C. C. P., Chief of Thoracic Surgery, Hackensack University Medical Center, Assiciate Professor of Surgery, University of Medicine and Dentistry of New Jersey. Harvey I. Pass, M. D., Stephen E. Banner Professor of Thoracic Oncology, Vice Chairman Research, Professor of Cardiothoracic Surgery, Chief, Division of Thoracic Surgery, NYU School of Medicine. Scott I. Reznik, M. D., Chief, Section of General Thoracic Surgery, Scott & White Hospital, Temple, TX. *Each physician received nominal compensation for his or her participation.

4 Background 4 Thopaz by Medela, Inc. is the first commercially available digital chest drainage unit and was introduced in the USA in It features real time digital air leak display in milliliters per minute with patient therapy data storage and memory recall, dry suction control that monitors and regulates the set pressures automatically, audible and visual alarm indicators in case of adverse events, one way valve, and a low profile for patient ambulation with built in suction control when needed. Methodology The thoracic surgeons who participated in this survey have all used Thopaz in their individual practices. The physicians were asked via a formal written interview to relate its application in all thoracic procedures, discuss the benefits described above, quantify for their patients where Thopaz was used, how many days of early chest tube removal and discharge they have experienced versus their use of traditional analog units, summarize their overall use and impression of Thopaz in their practice, and finally whether or not they would recommend its use to their peer group and colleagues and why. Interviews are on file with Medela, Inc. Summary The eight surgeons collectively estimated treatment of 1,500 thoracic patients with a chest tube and drainage device for 12 months, ending October, Of this total they have used Thopaz on an estimated 1,233 of these 1,500 thoracic patients (82.2% of chest tube patients). The range of use for Thopaz by the eight surgeons was between 25% and 100% of their thoracic surgery chest tube patients. Seven of the surgeons reported earlier chest tube removal and patient discharge due to Thopaz versus use of a traditional water seal analog unit (consistent with the reported results of several clinical studies*). Six of the eight quantified a percentage of their Thopaz patients with early chest tube removal, as well as how many patient days were eliminated due to Thopaz use. Collectively these six reported early removal and discharge of 461 total hospital days earlier by use of Thopaz than a traditional water seal analog product for those total 1,233 Thopaz patients. The range of earlier removal is between one-half to two days average earlier tube removal for those patients. 1,500 Annual Chest Tube Cases 18% 267 Analog Chest Drain Patients 1,233 Thopaz Patients 82% *Surgeons reported a reduction of 461 total therapy days with the use of Thopaz. Fig. 1: Thopaz use with early chest tube removal. *Only six of eight surgeons provided data regarding early chest tube removal and discharge using Thopaz. *See references on last page of this document.

5 A decrease in patient days on a chest drainage unit also represents a major economic benefit in terms of reduced overall hospital costs. Savings can be calculated on an individual hospital basis. There is unanimous agreement with the following: - All surgeons provided a positive response to "overall use and impression" of Thopaz. - All would recommend the use of Thopaz to their peers and colleagues. 5 - The digital display, storage, and recall of data is a primary benefit of Thopaz. - All indicate ambulation, transport, mobility are enhanced with Thopaz. Additional responses concerning the primary indications for Thopaz, value of the regulated suction control feature, the potential to reduce the number of X-rays and the reaction of nurses and allied clinicians to the use of the product are discussed with quotations from all respondents. Annual Thopaz Use 100% 80% 60% 40% 20% 0% Dr. Crawford Dr. Pass Dr. Park Dr. Korst Dr. Lee Dr. Detterbeck Dr. Reznik Dr. Jaroszewski Fig. 2: Percentage of Total Thoracic Patients on Thopaz by Physician.

6 Surgeon Responses to Questions 6 How would you summarize your overall use and impression of Thopaz to date in your practice, and how do you perceive it in your future practice? Dr. Crawford: Very favorable. I use it on 95% of thoracic patients primarily because of the air leak diagnostics, visual read out, recall and storage of leak over time. Dr. Detterbeck: I think it is great and a new standard. Dr. Jaroszewski: Love it. It was long needed. Improves patient care and overall improves patient outcomes and reduces complications. Dr. Korst: I like seeing what the trend in the air leak is over time. Allows me to plan for pleurodesis, etcetera, if needed. Dr. Lee: I like the system. Think it is good for patients. Definitely not worse and potentially has significant benefit. Dr. Park: Satisfied and will continue to use it. Dr. Pass: Standard of care for me at this time except for pneumonectomy patients. Dr. Reznik: Very favorable. Simplifies chest tube management. Improves understanding of air leak and quantifies it exactly. Would you recommend to your peers and colleagues the use of Thopaz? If yes, explain. Dr. Crawford: Yes. Dr. Detterbeck: Yes. I think it is a new standard for lung surgery. Dr. Jaroszewski: Yes. Patients want to ambulate and go home early. Thopaz allows you to provide complete therapy without limiting activity and maximizes the opportunity for discharge. Dr. Korst: Yes. For air leak management. Dr. Lee: Yes. Good state of the art system. Portable, quiet, efficient. Cost is mildly increased but benefit may be worth it. Dr. Park: Yes. It streamlines post op care of the thoracic patient. Dr. Pass: Yes. But need to check cost with the hospital. Dr. Reznik: Yes. Gives peace of mind, makes communication with residents and nurses simpler.

7 What are the primary patient indications for which you most frequently use Thopaz? Dr. Crawford: All thoracic patients except decortifications. 95% of all patients. Dr. Detterbeck: Essentially all. Dr. Jaroszewski: Any patient where chest tube is anticipated to exceed 24 hours duration. 7 Dr. Korst: Anatomic lung resections but not pneumonectomy. Dr. Lee: Anatomic resections. Dr. Park: All lung resections, VATS, and thoracotomy procedures. Dr. Pass: Thoracotomy, not pneumonectomy. Dr. Reznik: Anatomic lung, wedge, lung biopsy, bullectomy. (Note Contraindications*: Thopaz cannot be used if a pressure greater than -100cmH2O or a flow of greater than 5 L/min is required; applying active suction would place the patient at risk.) A. Has digital read out, storage, and recall of the trend over time of the patient air leak in ml/minute provided a simplified and efficient therapy for earlier chest tube removal and patient discharge? B. If so, for approximately what percent of your patients have you experienced or projected earlier chest tube removal? C. How many days per patient would that represent? Dr. Crawford: (A) Yes. The read out of the air leak and charting in ml/minute has advantages as it is a continuous read out vs. the traditional water seal. (B) 50% of wedges % of lobes. This would average ½ day savings per patient. With Thopaz can pull tubes usually within 4-6 hours while with analog device it is next day. (C) ½ days per patient average. Dr. Detterbeck: (A) Yes (B) (C) 0.5 to 1.0 days average. Dr. Jaroszewski: (A) Yes. (B) 10%. Still in learning curve stage. (C) 1-2 days. *See end of document for detailed list of FDA cleared indications and contraindications.

8 Dr. Korst: (A) +/- (B) unclear 8 (C) unclear Dr. Lee: (A) Yes (B) 25% (C) 1 day. Dr. Park: (A) Yes. Primarily digital read out and quantitative assessment of air flow. (B) 50% (C) 1 to 2 days. Dr. Pass: (A) Yes. (B) 50% (C) lose 1 day. Dr. Reznik: (A) Yes (B) 75% (C) ¾ to 1 day.

9 There has been continuing debate over whether or not to use suction and when for selected patients. Some patients leave surgery with suction applied while others do not. Thopaz applies suction only when the patient has an air leak and does not apply suction when there is no air leak or normal intrapleural negative pressure exists. Also, there are audible and visual alarm indicators in case of a tube blockage or other problem. Has this feature provided simplified and efficient therapy for earlier chest tube removal and patient discharge? If so, for what percent of your patients have you experienced earlier chest tube removal and patient discharge? 9 Dr. Crawford: We have not studied that aspect of the device. Dr. Detterbeck: Distinct advantage. However our routine is to place the patient on water seal after 24 hours. The suction doesn t contribute to early removal. It is the digital read out and graph that allows this. Dr. Jaroszewski: No. Dr. Korst: Unclear. Dr. Lee: Yes. Hard to say precisely. Dr. Park: Yes. Same as above (air leak question). 50% Dr. Pass: Yes. Same as above (air leak question) 50%. Dr. Reznik: Yes. Safety alarms are useful for disconnection and occlusion. Same as air leak question. 75%. Thopaz as "Digital Seal" When the Thopaz pressure is set above normal physiological range (above -15cmH2O) and the patient has an air leak - unable to maintain negative pressure within the pleural space, the device regulates to the selected pressure (Thopaz running - solid blue line). When Thopaz is set below physiological median (-8 cmh2o) and the patient has no air leak with the ability to maintain negative pressure within the pleural space, the device observes, ready to step in if needed (pump not running per notable wave form on the blue line). Pressure (cmh20) Thopaz Regulating Pleural Space Thopaz Monitoring Pleural Space /12: /00: /12: /00: /12: /00: /12: /00: /12:00 Fig. 3 Flow (ml/min)

10 Has the Thopaz one-way valve, ability to regulate patient s intrapleural pressure, and light weight design of the product been of value for patient ambulation vs. traditional analog devices? If Yes, please explain. 10 Dr. Crawford: Yes. Portability for patients and nurses. Dr. Detterbeck: Yes. No question it increases mobility and pleasure. Dr. Jaroszewski: Definitely. The #1 reason we changed was the ability to ambulate and stay on suction if required. Dr. Korst: Yes. Easier to ambulate. Dr. Lee: Yes. Patients and nurses like it. Less noisy, too. Dr. Park: Yes. Portability enhances mobility. Dr. Pass: Yes. Easier to transport and do not need wall suction. Dr. Reznik: Yes. Easier to ambulate especially if suction is required. There is less of an issue with spillage, analog devices are very susceptible to being knocked over and spilling. Has your use of Thopaz enabled you to take fewer X-rays than you have used with analog devices? If no, does your initial experience indicate this may be possible with additional use of the product? Dr. Crawford: Not yet. Dr. Detterbeck: Not very much. Yes, but we need to work on changing our culture. Dr. Jaroszewski: We have protocol for CXR. Would plan to change if future experience occurs. Dr. Korst: No. Dr. Lee: No. Get daily X-rays usually. Dr. Park: No. Dr. Pass: No. Dr. Reznik: Yes for 60% of patients eliminate on average two X-rays.

11 What have been the experiences and reaction of allied nurses to the set-up, handling, and diagnostic features of Thopaz versus traditional units? Dr. Crawford: There has been a learning curve, and about 90% of the nurses are comfortable with the unit. Most prefer the unit to analog devices as it is easier to transport patients and monitor their oxygen saturations. 11 Dr. Detterbeck: They like it a lot. Tracking the devices and getting them cleaned and available for use is a situation. Dr. Jaroszewski: Nurses like it especially for the ambulation benefit. They are now more comfortable, but PA s especially learning curve has been very slow, and they continue to feel uncomfortable reading air leak. Dr. Korst: Good. Easier to ambulate. Dr. Lee: Initially difficult but now pretty good. Dr. Park: Generally positive. At times they have difficulty trouble shooting. Dr. Pass: Gradual acceptance and ease of use. Dr. Reznik: Nurses have been in favor once trained, overwhelmingly. Indications: The system is used when negative pressure is required in combination with a thoracic drainage catheter. Contraindications: Thopaz cannot be used if: - a pressure greater than -10 kpa (-100cmH2O) or a flow of more than 5 L/min is required; - applying active suction would put the patient at risk. Medela does not recommend connecting bilateral thoracic drains to one Thopaz unit. In such cases, the use of two Thopaz units is recommended. Literature references: The benefits of digital air leak assessment after pulmonary resection: Prospective and comparative study José M. Mier,* Laureano Molins, and Juan J. Fibla Impact of the learning curve in the use of a novel electronic chest drainage system after pulmonary lobectomy: a case-matched analysis on the duration of chest tube usage. Pompili Cecilia, Brunelli Alex, Salati Michele, Refai Majed, Sabbatini Armando. The quantification of postoperative air leaks Robert J. Cerfolio*, Ayesha S. Bryant Digital and Smart Chest Drainage Systems to Monitor Air Leaks: The Birth of a New Era? Robert J. Cerfolio, MDa, Gonzalo Varela, MD, PhDb, Alessandro Brunelli, MDc,* Benefits of digital thoracic drainage systems Debbie Danitsch, consultant nurse cardiothoracic

12 Medical Vacuum Technology for Healthcare Professionals Please contact us or your local Medela representative for details. Federal law restricts this device to sale or rental by or on the order of a physician. Thopaz is a trademark of Medela Inc. Medela is a registered trademark of Medela Holding AG. Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Medela UK Ltd. Huntsman Drive Northbank Industrial Park Irlam, Manchester M44 5EG UK Phone Fax info@medela.co.uk Medela AG/ / B Precious life Progressive care