STREAMLINING THE PROCESS FOR TAVR PROCEDURES

Transcription

1 Case Study STREAMLINING THE PROCESS FOR TAVR PROCEDURES How St. Francis Hospital, one of New York state s largest heart and vascular centers, improved the efficiency of TAVR procedure days CoreValve Transcatheter Aortic Valve Replacement

2 Case Study STREAMLINING THE PROCESS FOR TAVR PROCEDURES As a Leader in Cardiovascular Care, and a TAVR Pioneer, St. Francis is Focused on Expanding Access to TAVR Therapy Transcatheter aortic valve replacement (TAVR) is a rapidly growing therapy for the treatment of severe Aortic Stenosis (AS). TAVR employs a multidisciplinary team to evaluate and treat AS patients who are eligible for the therapy. This provides an excellent level of patient care, but also adds operational complexity which needs to be addressed and managed to ensure that the growing number of eligible patients have access to the therapy. St. Francis Hospital in Roslyn, New York is a leader in cardiovascular care and a TAVR pioneer. They have experienced rapid growth in their TAVR program over the past several years. As the demand for TAVR continues to grow, St. Francis decided they needed to proactively examine every aspect of their TAVR operation and seek ways to further streamline the process to expand their ability to treat more patients. The first step in this process was the creation of a multidisciplinary performance improvement team dedicated to analyzing their entire TAVR procedure. They ensured that the members of the team were actively involved in the everyday work of TAVR procedures to help guarantee that solutions were driven by the staff closest to the process. This team s goal was to identify ways to leverage Lean Sigma and change management methods to optimize TAVR cases so that more patients could be treated on the two days each week that their highly specialized Hybrid OR and Cath Lab Teams came together to perform TAVR procedures. Normally, these two teams function separately, so St. Francis needed an approach to optimize the TAVR procedure workflow when these two teams were blended. 1 At-A-Glance n Based in Roslyn, NY (Long Island) n Service line leaders for Catholic Health Services n New York State s only specialty designated cardiac center n In 2014: - 1,129 open-heart surgeries - 3,781 cardiac arrhythmia procedures: electrophysiology studies including ablations, pacemakers, and AICDs - 10,233 cardiac catheterizations, including all diagnostic, interventional, and peripheral vascular procedures n In 2015, St. Francis opened a new Heart Valve Center n More than 590 TAVR procedures as of October 2015

3 Project Facilitation Support from Medtronic The St. Francis team worked with the PRO CV Service from Medtronic, which specializes in redesigning and optimizing patient processes in cardiovascular organizations. Together with Medtronic, the St. Francis team created an effective structure and process to thoroughly review the dynamics of their TAVR procedure. Consultants from the Medtronic PRO CV Service facilitated a formal performance improvement project with St. Francis that followed a well-defined method for solving problems. The goal of this method was to break down barriers, identify and prioritize opportunities for continuous improvement, and ultimately expand St. Francis s capability to treat more patients. The PRO CV approach emphasizes the use of data analysis for improving, optimizing and stabilizing complex patient workflows. The multidisciplinary process improvement team at St. Francis was comprised of the following members (in alphabetical order): Administration Anesthesia Cardiothoracic Surgeon Cath Lab team Hybrid OR team ICU Interventional Cardiologist PACU Perfusion Radiology Surgical Nursing Medtronic PRO CV Master Black Belt consultants coordinated data gathering and facilitated several team meetings with the St. Francis process improvement team. They met many times to review operational data and brainstorm innovative approaches to streamline their TAVR procedure. The St. Francis team met regularly with leadership to ensure critical timelines and outputs were being met. What is Lean Sigma? Lean Sigma is a methodology used to streamline work processes and remove unnecessary or wasteful steps. This approach was first developed to improve manufacturing, but has been applied successfully to improve many work processes in hospitals and clinics. 2

4 Case Study PRO CV Lean Transformation Project Framework Assess 1.5 Days On-site Current State Data Collection Improve Sustain Project Closure 2-3 Days On-site Implement Improvements 1 Day On-site Improved State Data Collection 4-6 Weeks 4-6 Weeks 4-6 Weeks Medtronic PRO CV Service Medtronic PRO CV stands for Process Redesign and Optimization for CardioVascular services. It is a fee-based service focused on designing and implementing organizational efficiency solutions that increase access to care, improve patient quality of care, and drive operational and clinical effectiveness. What is a Current State Assessment? A Current State Assessment is an activity that helps organizations understand their current workflow in a way that helps them design procedures that are more efficient and productive. One of the outputs of a Current State Assessment is a Value Stream Map that outlines the steps in a workflow. Assessing their Current State and Value Stream One of the first deliverables for the Medtronic PRO CV and St. Francis team was an analysis called a Current State Assessment. This simply means observing a process or workflow to identify areas for improvement or streamlining. A Current State Assessment helped set a baseline against which to measure improvements. It also gave the team measurable data and shared understanding of the combined Hybrid OR/Cath Lab process during TAVR days. Another output of the Current State Assessment was a Value Stream Map which essentially broke down the TAVR day process into its critical, value-added elements. For St. Francis, that meant observing and documenting the separate procedural steps for their TAVR patient process and then measuring process times and variability across 19 consecutive TAVR patients. 3

5 Value Stream Steps of TAVR Procedures The graphic below illustrates the average TAVR patient flow at St. Francis on their TAVR procedure day at the beginning of the project, and the discrete steps or value stream of activities on that day. Value Stream Steps St. Francis Hospital TAVR Day for Patients (Composite data from 19 cases) PAC-U Hook-Up Wait Time Average TAVR Case Anesth Pacer 0 Minutes 100 Minutes 200 Minutes 300 Minutes Draping Time Out Implant Valve Close Access Finish Access Focus Areas for Increased Efficiency Based on the insights gleaned from the Current State Assessment and Value Stream Map, the St. Francis team analyzed and brainstormed ways to improve efficiency. They prioritized 3 key focus areas for the project as an output of that effort: 1. Optimizing staff time 2. Minimizing patient wait times 3. Streamlining clinical processes and protocols After a prioritization process, the St. Francis team implemented the following changes to address the needs of their growing TAVR program: 4

6 Case Study 1. Optimizing Staff Time Added a second anesthesiologist for faster case starts between the Hybrid OR and Cath Lab Implemented a cross-training plan to maximize staff capability during and between procedures Implemented a team lead to coordinate between physicians and other departments during TAVR procedures Held after-procedure team huddles to improve procedural communication Set up more formal patient handoff communication between pre-op/intra-op/ post-op activities 3. Streamlining Clinical Processes and Protocols Examined all clinical protocols, and optimized/ streamlined a number of them, including: Standardized order sets and checklists Optimized use of Swan-Ganz catheter Assessed for alternatives to general anesthesia Earlier confirmation of access site prior to case Standardized medication orders (aspirin, Plavix) Simplified OR table set up Improved staging of subsequent cases 2. Minimizing Patient Wait Times Standardized processes for admitting patients to the holding room, including: A new TAVR hand-off check list Only one holding area for TAVR patients vs. two Patient consents completed the day before the case 5

7 The Results* Through the efforts of the project team, and by streamlining the efficiency of their entire end-to-end procedural workflow, St. Francis made significant improvements in its TAVR procedural process which have led to: 10% reduction in median time in the TAVR patient process 38% to 54% reduction in number of staff needed during the TAVR procedure 15% reduction in patient waiting time in PACU holding area 50% to 100% increase in number of TAVR cases completed per day 2-4 additional TAVR patients were treated on average per week Forecasted potential annual savings of over $150,000 as a result of cross-training of staff The St. Francis team was also able to lower the overall variability of the entire time a patient spent during a TAVR cases by about 1 hour. The team reports that on most TAVR days, they can complete 4 relatively uncomplicated TAVR cases in about the same time it used to take them to do 2 cases. And by adding another hour at the beginning and end of their TAVR days, St. Francis is confident they will eventually be able to complete 10 relatively uncomplicated TAVR procedures each week vs. 4 at baseline. * Operational, Clinical and Financial impact calculations provided by St. Francis Hospital. Results may vary and depend on site implementation of recommendations. An Eye on Continuous Improvement As outlined in this case study, the approach and methods facilitated by the Medtronic PRO CV Service consultants with St. Francis Hospital can lead to efficiency improvements and cost savings for TAVR programs. As a leader in cardiovascular care, St. Francis is committed to continuous improvement of their TAVR procedure by using all methods at their disposal, including the Lean Sigma problem-solving and improvement approaches facilitated by the Medtronic PRO CV consultants. The hospital s process improvement team holds regular meetings to analyze the data they continue to measure, and look at ways to continue streamlining their TAVR procedures so that more patients can benefit more quickly from TAVR therapy. The project at St. Francis also created staff development improvements that continue to generate benefits. Because they use a blended Hybrid OR/Cath Lab for their TAVR procedures, they saw the benefit of formalizing a cross-training approach to increase the productivity and flexibility of their staff, including new hires, so that people can shift seamlessly from one role to another as needed on TAVR days. Finally, St. Francis says that their newly re-designed TAVR procedure can scale up as needed to meet the needs of their AS patients. With newer technologies and therapies on the horizon for these patients, St. Francis is confident that their new TAVR procedure process gives them a template that can be adapted and expanded to other therapies and technologies that demand a multidisciplinary approach. Operational, Clinical and Financial impact calculations provided by St. Francis Hospital. Results may vary and depend on site implementation of recommendations. 6

8 INDICATIONS The Medtronic CoreValve system is indicated for use in patients with symptomatic heart disease due to severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score 8% or at a 15% risk of mortality at 30 days). CONTRAINDICATIONS The CoreValve system is contraindicated for patients presenting with any of the following conditions: known hypersensitivity or contraindication to aspirin, heparin (HIT/ HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated ongoing sepsis, including active endocarditis preexisting mechanical heart valve in aortic position. WARNINGS General Implantation of the Medtronic CoreValve system should be performed only by physicians who have received Medtronic CoreValve training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter Aortic Valve (Bioprosthesis) Accelerated deterioration of the bioprosthesis may occur in patients presenting with an altered calcium metabolism. Precautions General The safety and effectiveness of the Medtronic CoreValve system have not been evaluated in the pediatric population. The safety and effectiveness of the bioprosthesis for aortic valve replacement have not been evaluated in the following patient populations: with a native valve lesion which does not meet the criteria for severe aortic stenosis (aortic valve area 1.0 cm 2 or aortic valve area index 0.6 cm 2 /m 2, a mean aortic valve gradient of 40 mm Hg, or a peak aortic-jet velocity 4.0 m/s) who are at moderate or low surgical risk (predicted perioperative mortality risk of <15%) with untreated, clinically significant coronary artery disease requiring revascularization with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support The safety and effectiveness of a CoreValve bioprosthesis implanted within a failed preexisting transcatheter or surgical bioprosthesis have not been demonstrated. Implanting a CoreValve bioprosthesis in a degenerated surgical bioprosthesis [transcatheter aortic valve in surgical aortic valve (TAV in SAV)] should be avoided in the following conditions. The degenerated surgical bioprosthesis presents with a: Significant concomitant perivalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (eg, wireform frame fracture) Partially detached leaflet that in the aortic position may obstruct a coronary ostium Stent frame with a manufacturer s labeled inner diameter <17 mm The safety and effectiveness of the bioprosthesis for aortic valve replacement have not been evaluated in patient populations presenting with the following: blood dyscrasias as defined: leukopenia (WBC <1000 cells/mm 3 ), thrombocytopenia (platelet count <50,000 cells/mm 3 ), history of bleeding diathesis or coagulopathy, or hypercoagulable states congenital bicuspid or unicuspid valve verified by echocardiography mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]) moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation hypertrophic obstructive cardiomyopathy new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation native aortic annulus size <18 mm or >29 mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17 mm or >29 mm transarterial access not able to accommodate an 18-Fr sheath sinus of valsalva anatomy that would prevent adequate coronary perfusion moderate to severe mitral stenosis severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram end-stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min symptomatic carotid or vertebral artery disease severe basal septal hypertrophy with an outflow gradient. Prior to Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. The bioprosthesis size must be appropriate to fit the patient s anatomy. Proper sizing of the device is the responsibility of the physician. Refer to Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed in below. Patients must present with access vessel diameters of 6 mm or an ascending aortic (direct aortic) access site 60 mm from the basal plane. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/ vertebrae) of >30 for right subclavian/axillary access or >70 for femoral and left subclavian/axillary access. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. During Use Adequate rinsing of the bioprosthesis with sterile saline, as described in the Instructions for Use, is mandatory before implantation. During rinsing, do not touch the leaflets or squeeze the bioprosthesis. If a capsule becomes damaged during loading or the capsule fails to close, replace the entire system (bioprosthesis, catheter, and CLS). Do not use a catheter with a damaged capsule. After a bioprosthesis has been inserted into a patient, do not attempt to reload that bioprosthesis on the same or any other catheter. During implantation, if resistance to deployment is encountered (e.g., the micro knob starts clicking or is tight or stuck), apply upward pressure to the macro slider while turning the micro knob. If the bioprosthesis still does not deploy, remove it from the patient and use another system. While the catheter is in the patient, ensure the guidewire is extending from the tip. Do not remove the guidewire from the catheter while the catheter is inserted in the patient. Once deployment is initiated, retrieval of the bioprosthesis from the patient (e.g., use of the catheter) is not recommended. Retrieval of a partially deployed valve using the catheter may cause mechanical failure of the delivery catheter system, aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery. During deployment, the bioprosthesis can be advanced or withdrawn as long as annular contact has not been made. Once annular contact is made, the bioprosthesis cannot be advanced in the retrograde direction; if necessary, and the frame has only been deployed 2/3 of its length, the bioprosthesis can be withdrawn (repositioned) in the antegrade direction. However, use caution when moving the bioprosthesis in the antegrade direction. Use the handle of the delivery system to reposition the bioprosthesis. Do not use the outer catheter sheath. Once deployment is complete, repositioning of the bioprosthesis (e.g., use of a snare and/or forceps) is not recommended. Repositioning of a deployed valve may cause aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery. Do not attempt to retrieve a bioprosthesis if any one of the outflow struts is protruding from the capsule. If any one of the outflow struts has deployed from the capsule, the bioprosthesis must be released from the catheter before the catheter can be withdrawn. Ensure the capsule is closed before catheter removal. If increased resistance is encountered when removing the catheter through the introducer sheath, do not force passage. Increased resistance may indicate a problem and forced passage may result in damage to the device and/or harm to the patient. If the cause of resistance cannot be determined or corrected, remove the catheter and introducer sheath as a single unit over the guidewire, and inspect the catheter and confirm that it is complete. Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. Postprocedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Postprocedure, administer anticoagulation and/or antiplatelet therapy per hospital protocol. Excessive contrast media may cause renal failure. Preprocedure, measure the patient s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. The safety and efficacy of implanting a second CoreValve bioprosthesis within the initial CoreValve bioprosthesis have not been demonstrated. However, in the event that a second CoreValve bioprosthesis must be implanted within the initial CoreValve bioprosthesis to improve valve function, valve size and patient anatomy must be considered before implantation of the second CoreValve bioprosthesis to ensure patient safety (e.g., to avoid coronary obstruction). In the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a postimplant balloon dilatation of the bioprosthesis may improve valve function and sealing. To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation. The balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus or, for surgical bioprosthetic valves, the manufacturer s labeled inner diameter. Refer to the specific balloon catheter manufacture s labeling for proper instruction on the use of balloon catheter devices. Note: Bench testing has only been conducted to confirm compatibility with NuMED Z-MED II TM Balloon Aortic Valvuloplasty catheters where CoreValve bioprosthesis device performance was maintained after dilation. Data on File. POTENTIAL ADVERSE EVENTS Potential risks associated with the implantation of the Medtronic CoreValve transcatheter aortic valve may include, but are not limited to, the following: death cardiac arrest coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) emergent surgery (e.g., coronary artery bypass, heart valve replacement, valve explant) multiorgan failure heart failure myocardial infarction cardiogenic shock respiratory insufficiency or respiratory failure cardiovascular injury (including rupture, perforation, or dissection of vessels, ventricle, myocardium, or valvular structures that may require intervention) ascending aorta trauma cardiac tamponade cardiac failure or low cardiac output prosthetic valve dysfunction including, but not limited to, fracture; bending (out-of-round configuration) of the valve frame; under-expansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement; regurgitation; stenosis thrombosis/embolus (including valve thrombosis) valve migration/valve embolization ancillary device embolization emergent percutaneous coronary intervention (PCI) emergent balloon valvuloplasty major or minor bleeding that may or may not require transfusion or intervention (including life-threatening or disabling bleeding) allergic reaction to antiplatelet agents, contrast medium, or anesthesia infection (including septicemia and endocarditis) stroke, TIA, or other neurological deficits permanent disability renal insufficiency or renal failure (including acute kidney injury) mitral valve regurgitation or injury tissue erosion vascular access related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, stenosis) conduction system disturbances (e.g., atrioventricular node block, left-bundle branch block, asystole), which may require a permanent pacemaker. Please reference the CoreValve Instructions for Use for more information regarding indications, warnings, precautions and potential adverse events. CAUTION Federal law (USA) restricts this device to sale by or on the order of a physician. This case study is not intended to be a recommendation by Medtronic for St. Francis Hospital. It is provided for general educational purposes only and should not be considered the exclusive source for this type of information. It is the professional responsibility of the practice or clinical practitioner to exercise independent judgment in a particular situation and treat patients based on their judgment and medical necessity. Results may vary. 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) medtronic.com CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. UC b EN Medtronic Minneapolis, MN. All Rights Reserved. Printed in USA. 02/2016 To learn more about the Medtronic PRO CV Service, visit