Vizient® New analysis of cardiology data to inform care pathways Orthopedic service line trends in the non-acute market Cleveland Clinic's technology adoption process Medical Device | Volume 2, 2024 TechWatch
2 Vizient Tech Watch | Medical Device | Volume 2, 2024 We have all felt the pressure of inflation in today's market. It's certainly pervasive in healthcare, creating consistent pressure on both providers and suppliers to manage their financial sustainability. By acting as a convener in the industry, we aim to lower costs through optimized resource use, efficient operations and strong partnerships rooted in improving patient care. While hospital operating margins have continued to stabilize after COVID, every provider I have spoken with at recent events, like the Vizient Connections Summit and access24, is still pursuing very ambitious savings targets to control expenses. That is one motivation behind our shift to evolve from just a group purchasing organization (GPO) to more of a holistic spend management partner. For physician preference items, we're focused on helping healthcare providers maximize the impact of every dollar spent on medical devices and other items used in and around operating rooms and procedural areas. This edition of the Vizient Medical Device Tech Watch contains important clinical, operational and financial information. It also has data and expertise for your cardiovascular, orthopedic and surgical service lines. It's exciting to share the greater category specialization of our team members. We recognize that each service line has its own unique challenges. The investment in subject matter expert capabilities, coupled with working together in more innovative ways, lowers the cost to serve by creating market share alignments for our medical technology partners while delivering value to our providers and better outcomes for patients. Care delivery excellence and financial sustainability Bonnie Lai, PhD SVP / General Manager, Vizient Physician Preference Item Spend Management
3 Vizient Tech Watch | Medical Device | Volume 2, 2024 Contents Coronary artery bypass: Assessing procedural techniques and variable costs................................................................................ 4 Six tips for assessing perfusion services in pursuit of greater clinical and financial performance. ............................................ 8 Data analysis supports use of new advancements for venous thromboembolism ..................................................................... 12 Five questions regarding surgical robot adoption................. 16 Seven factors affecting orthopedic procedures in non-acute settings ....................................................................................... 20 Internal leg lengthening: Advancements lead to improved care for children with congenital femoral deficiency............ 24 Leading health system shares their proven process for new technology adoption.................................................................. 28 Tackling the complexities of preference item evaluation and contracting.................................................................................. 30
4 Vizient Tech Watch | Medical Device | Volume 2, 2024 In the U.S., heart disease is the leading cause of death among adults, with coronary artery disease (CAD) being the most common type. CAD accounted for over 370,000 deaths in the U.S. in 2022, and risk factors that contribute to this disease continue to grow. CAD prevalence is expected to continue to rise, with one in 10 expected to be diagnosed with CAD by 2050, according to the American Heart Association.1 CAD occurs when a coronary artery is narrowed by plaque buildup that severely restricts blood flow and oxygen delivery to the heart muscle. Revascularization strategies consist of two main techniques: PCI and CABG. Percutaneous coronary intervention (PCI) is a method to treat CAD by inserting a stent into the obstructed vessel, using a catheter without requiring open heart surgery.2 PCIs make up roughly 85% of overall coronary revascularizations (CABG and PCIs) and are forecasted to grow 6% over the next decade as the number of patients with stable CAD (and myocardial infarction) continues to grow due to increased risk factors.3 An additional method of treating stable CAD is to reroute the patient’s blood around the blockage with a CABG procedure that requires open-heart surgery. Coronary artery bypass: Assessing procedural techniques and variable costs Key points • Surgical techniques and their implications: The on-pump technique is used for most coronary artery bypass grafting (CABG) procedures. The off-pump technique, though less common, can reduce complications and recovery times but demands highly skilled surgeons and a few specialized products. • Supply cost analysis: The average cost of coronary artery bypass surgery is nearly $24,000 per case. A significant portion is attributed to supply costs, including graft products and surgical supplies. Reducing variation in CABG supplies can be both a clinical standardization opportunity and a source of financial sustainability.
5 Vizient Tech Watch | Medical Device | Volume 2, 2024 CABG procedures are forecasted to grow slightly due to the aging of the population, along with increasing risk factors like obesity and lack of physical activity, which continue to contribute to cardiovascular procedural demand. While the decision on which revascularization technique to use will be patient-specific and utilize a multidisciplinary team approach (Cardiac Surgeon and Interventional Cardiology), there are some important clinical data to leverage. Longterm data, like SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery trials), FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus), etc., shows that patients with triple vessel CAD, diabetes, left main disease and other high-risk populations have a higher survival rate and better outcomes with CABG than with PCI.3,4 Figure 1. Cardiovascular disease and inpatient cardiac surgery forecast 1,5 The growing demand for cardiology services, evolving care pathways and general margin compression result in an elevated need to evaluate the financial sustainability of important procedural offerings like CABG. Many factors impact the cost of performing a CABG procedure, including the procedural techniques and the supplies used. There is a wide range of variation, case costs and procedure profitability across healthcare providers. Procedural techniques and clinical considerations Bypass surgery is a symphony of complex steps that occur in a specific order to provide the safest, most efficient process possible. To understand the variation in supplies used – and therefore supply-related costs – let’s first dive into the different procedural techniques. A CABG can be performed either on-pump, using a cardiopulmonary bypass machine, or off-pump (aka the “beating heart technique”). The on-pump technique includes connecting the patient to a heart and lung machine. This allows the surgeon to stop the heart, providing a motionless, bloodless field for attaching the bypass grafts. The off-pump technique doesn't use the heart lung machine, and the patient’s heart is allowed to continue beating throughout the entire operation. Currently, the on-pump technique is used most often for a CABG procedure. The patient is connected to the bypass machine and the heart is stopped. The motionless, bloodless field ensures patient safety during the manipulation of the heart and ensures optimum conditions for the surgeon to attach each bypass graft. Surgeons encounter challenges while operating on a beating heart beyond those experienced in an on-pump setting. Moving or manipulating a beating heart, for better exposure or visualization, for example, affects the patient’s hemodynamic performance. The patient’s heart rate, blood pressure and conduction system can all be negatively impacted. The surgeon needs a relatively bloodless and motionless field to attach the bypass conduit onto the heart. This would seem impossible on a beating heart, but specialized surgical devices help the surgeon and team isolate small areas of the heart and provide a safe balance between patient stability and motion isolation. There are many devices on the market, but overall, they serve two functions: isolate movement (known as stabilizers) and position the apex of the heart (known as positioners). The devices that assist the surgeon to perform bypass are another variable. Several years ago, it was expected that off-pump would take over as the gold standard due to reduced risk, fewer complications and shorter recovery times. However, the additional complexities of operating on a beating heart lead to a steeper learning curve for physicians, which has hindered the procedural technique growth. Some surgeons do specialize in the off-pump technique and prefer this as their main choice when there’s an option. Determining whether a CABG procedure will be performed on a bypass machine is determined by the surgeon in collaboration with the anesthesia and surgical teams and considers different patient factors such as patient anatomy, renal and lung function and aortic disease. In general, stabilizers are used on every off-pump case, whereas positioners are less commonly utilized. Intraoperative complications can create the need to convert an off-pump procedure to an on-pump case in a relatively short time. Therefore, the pump and perfusion staff are typically present in all CABG cases, in the event a conversion is needed. The most common conduits used to bypass the blocked native artery are the patient’s greater saphenous vein(s), left internal mammary artery (LIMA), right internal mammary artery (RIMA) or a portion of the radial artery. Cardiovascular disease of population by 2050 10% CABG inpatient increase over 10 years +4% Note: Analysis excludes 0–17 age groups. Sources: Impact of Change®, 2024; HCUP National Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP) 2019. Agency for Healthcare Research and Quality, Rockville, MD; Claritas Pop-Facts®, 2024; Sg2 Analysis, 2024. Sources: Impact of Change®, 2024; HCUP National Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP) 2019. Agency for Healthcare Research and Quality, Rockville, MD; Proprietary Sg2 All-Payer Claims Data Set, 2022; The following 2022 CMS Limited Data Sets (LDS): Carrier, Denominator, Home Health Agency, Hospice, Outpatient, Skilled Nursing Facility; Claritas Pop-Facts®, 2024; Sg2 Analysis, 2024.
6 Vizient Tech Watch | Medical Device | Volume 2, 2024 Routinely, the patient’s LIMA is used to bypass blockages in the left anterior descending (LAD) coronary artery because of its proven longevity to maintain patency and the essential nature of a patent LAD. Another critical step in a CABG procedure is how the greater saphenous vein and radial artery are harvested. Endoscopic vessel harvesting (EVH) is the most widely used technique to access and remove the vein during CABG procedures. This technique, which often falls to the highly skilled Physician’s Assistant (PA), Advanced Practice Nurse (APRN) or Registered Nurse First Assist (RNFA), involves making a small incision in the leg, then using an EVH device to create a tunnel, identify the vein, ligate the side branches and free it from surrounding tissue. Before the invention of EVH devices, the operator would make a long incision in the leg and remove the vein under direct visualization. EVH reduces postoperative pain and complications related to healing and infections. Product supply costs for a coronary artery bypass Based on an analysis of data from the Vizient® Clinical Data Base, an average coronary artery bypass surgery costs nearly $24,000 per case (Figure 2), with supply costs contributing around 20% of that number.5 Figure 2. Cost per case for coronary artery bypass, 2023 discharges5 Figure 3 shows a breakdown of the supply costs. Coronary artery bypass supplies account for 28% of the total, including vein harvesting kits and off-pump supplies. The scopes and cables used with these disposables add to the cost of performing these procedures. Figure 3. Supply cost per case for CABG procedures4 Endoscopic vein harvesting kits are the single largest portion of supply cost, accounting for nearly a quarter of the total. Kit costs have increased steadily over the past 24 months. Figure 4. Vein harvest kit unit cost trends (Sept. 2022 – Aug. 2024) 4 As the data shows, EVH devices are costly and also require capital to function. For example, to visualize the harvesting process, EVH devices have a tunnel where a rigid endoscope is placed. It is then connected to a camera and cable system that connects to A/V equipment in the operating room. During the EVH process, cautery is used to dissect and ligate the surrounding vessels and tissues. This also requires a cable that can either be reusable or disposable, depending on the manufacturer. Some of the components vary by manufacturer. EVH kits are currently one-time use. Whether these will be reprocessed in the future, like other medical devices, is yet to be seen. Moreover, the EVH technique itself will continue to be the standard of care, as the benefits described above outweigh the risks and increased procedural cost. Aesthetics alone, due to the reduced number and size of incisions required, lead to a better patient experience. MSDRG 236 coronary bypass w/o cardiac cath w/o MCC Cost per case Room & board Supplies Surgery Pharmacy Other services $- $5K $10K $15K $20K $25K $30K Data from the Vizient Procedural Analytics used by permission of Vizient, Inc. All rights reserved. Data from the Vizient Supply Analytics used by permission of Vizient, Inc. All rights reserved. MSDRG 236. Data from Vizient Procedural Analytics used by permission of Vizient, Inc. All rights reserved. CABG procedures Cost per case Coronary artery bypass graft products Surgical products/sutures/custom packs All other Trauma stemal closure $- $.5K $1K $1.5K $2K $2.5K $5K $3K $3.5K $4K $4.5K Vein harvest kits or systems Average unit price $1,200 $1,150 $1,100 $1,050 $1,000 2022 Oct 2022 Nov 2022 Dec 2023 Jan 2023 Feb 2023 Mar 2023 Apr 2023 May 2023 Jun 2023 Jul 2022 Aug 2022 Sep 2022 Oct 2022 Nov 2022 Dec 2024 Jan 2024 Feb 2024 Mar 2024 Apr 2024 May 2024 Jun 2024 Jul 2024 Aug
7 Vizient Tech Watch | Medical Device | Volume 2, 2024 Off-pump positioners and stabilizers are additional major drivers of overall case cost. There are a variety of these available on the market, and the cost among them varies, creating a potential opportunity for cost savings by reducing the number of suppliers used. This may require a willingness on the part of the surgeons to try new devices, depending on the savings opportunities available. While these devices and associated costs are unavoidable when offering this technique to the community, potential cost optimization should be evaluated as an opportunity. Conclusion CABG procedures are complex and there’s great variability inherent to this foundational cardiac surgery. The average cost per case is substantial, with significant cost contributions from both supplies and patient outcomes. The choice between on-pump and off-pump techniques, as well as the use of specialized devices like EVH kits and stabilizers, further influences the overall cost. As the prevalence of coronary artery disease continues to rise, it’s crucial for healthcare providers to have strategic conversations with multiple stakeholders (supply chain, physicians, strategy, quality, finance, operations, etc.) to evaluate and improve both the financial and clinical aspects of CABG procedures to ensure cardiac surgery program sustainability and improved patient outcomes. 1 Maddox K. Health Economics of Cardiovascular Disease in the United States. AHA Journals. Published Aug. 5, 2024. Accessed Oct. 7, 2024. Health Economics of Cardiovascular Disease in the United States | Circulation (ahajournals.org) 2 Heart Disease Facts. CDC. Published May 15, 2024. Accessed Oct. 7, 2024. Heart Disease Facts | Heart Disease | CDC 3 O’Riordan M. PCI vs CABG at 10 Years: MAIN-COMPARE and SYNTAXES Shine Light on Long-Term Outcomes. Tctmd. Published Sept. 25, 2018. Accessed Oct. 7, 2024. PCI vs CABG at 10 Years: MAIN-COMPARE and SYNTAXES Shine Light on Long-term Outcomes | tctmd.com 4 Impact of Change®, 2024; HCUP National Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP) 2019. Agency for Healthcare Research and Quality, Rockville, MD; Proprietary Sg2 All-Payer Claims Data Set, 2022; The following 2022 CMS Limited Data Sets (LDS): Carrier, Denominator, Home Health Agency, Hospice, Outpatient, Skilled Nursing Facility; Claritas Pop-Facts®, 2024; Sg2 Analysis, 2024. 5 Vizient, Inc. Vizient Clinical Data Base. . Accessed Oct. 7, 2024. https://www.vizientinc.com. References The new CMS bundled care program, Transforming Episode Accountability Model (TEAM), targets five common, costly procedures, including CABG. Many hospitals will be required to participate in this program and will be responsible for the cost and quality of care from surgery through the first 30 days after leaving the hospital. Quality performance on these measures will generate a composite score, potentially impacting the reconciliation payment or repayment amount for these procedures by 10-15%.
8 Vizient Tech Watch | Medical Device | Volume 2, 2024 Healthcare organizations (HCOs) may overlook perfusion services when seeking ways to improve performance in cardiovascular, transplant, surgery and critical care services. Developing a deeper understanding of this vital service line may help HCOs improve performance and quality of care. Looking at the not-so-distant past of heart surgery The era of heart surgery was born out of pioneers who were determined to push back against the standards of the day. A now ironically famous quote summarizes the common perception in the late 1800's in 1896.1 "Surgery of the heart has probably reached the limits set by nature to all surgery. No method, no new discovery, can overcome the natural difficulties that attend a wound of the heart," said English surgeon Stephen Paget. Thanks to the determination of a community of scientists and physicians, research persisted in the face of adversity. In 1953, Dr. John H Gibbon Jr. (with the help of IBM engineers and funding) invented the first heart-lung machine and put it to use on May 6 of that year, where he successfully performed the first intracardiac surgery on a human to close a septal defect. The nine-hour operation was a success and the patient was discharged home 13 days later.2,3 Today, the heart-lung machine, also known as a bypass machine or cardiopulmonary bypass (CPB) machine, is used around the world every day. While the early machines took multiple operators to monitor and control, now they're typically under the purview of one person, the perfusionist. Six tips for assessing perfusion services in pursuit of greater clinical and financial performance Key points • Perfusion may be overlooked as a performance improvement opportunity, due to its complex nature. • Staffing, supplies, contracting and data management all require frequent evaluation to ensure clinical excellence and financial sustainability.
9 Vizient Tech Watch | Medical Device | Volume 2, 2024 Defining the components and clinical roles in perfusion During heart surgery, perfusionists use the heart-lung machine to keep blood flowing to the body's tissues. They also control levels of oxygen and carbon dioxide in the blood and control temperature. Perfusionists are also responsible for measuring select laboratory values, including clotting tests (activated clotting time, heparin concentration, thromboelastography) and routine labs such as hemoglobin and hematocrit and electrolytes. CPB machines provide a bloodless, motionless field for cardiac surgery, incorporating an extracorporeal circuit to provide physiological support. Venous blood is drained into a reservoir, filtered, oxygenated and sent back to the body using a centrifugal pump. Other applications of perfusion services include extracorporeal membrane oxygenation and auto-transfusion, known as cell saver. Components of perfusion • Extracorporeal membrane oxygenation (ECMO) • During ECMO, blood is pumped outside the body to a heart-lung machine that removes carbon dioxide and sends oxygen-filled blood back to tissues in the body. ECMO is used to support life in multiple critical care situations • Cell saver, also known as autotransfusion or intraoperative blood salvage, is a device used during surgery to collect and prepare the patient’s blood for reinfusion during or after the procedure. Importance of roles and relationships During procedures requiring CPB, the perfusionist, the surgeon and the anesthesia provider work in concert, demonstrating an elevated level of trust and precise communication that helps to ensure high quality care and outcomes for the patient. Perfusion supplies: extensive options and procurement channels Cardiac surgery encompasses many specific procedures including coronary artery bypass grafting, valve repair and/ or replacement, aortic aneurysm repair and congenital defect repair. Due to the variation of operations, the supplies required to assist the surgical team are quite extensive. Perfusion supplies may enter an HCO through the supply chain, the operating room, the intensive care unit, or through a third-party contractor or perfusion services company. Performing an assessment to understand the supplies on hand, where the supplies originated, how supplies entered the HCO and the financial trail is key to identifying opportunities for savings and efficiency improvements. The below list encompasses supplies often seen in perfusion packs and additional commonly used perfusion products. Commonly used perfusion supplies • Oxygenator • Venous reservoir • Centrifugal pump and probe • Arterial filter • Pre-bypass filter • Retrograde one-way valve • Sat/HCT cell • Tubing subpacks (pump and table) • Gas filter • Purge line • Vacuum relief valve • Pressure separators (displays) • Rapid prime line Additional supplies • Aortic Root Vent • Left ventricular (LV) vent • Cardioplegia delivery: • Antegrade • Retrograde • Ostial • Handheld • Multi-perfusion Set • Y Adapter • Cardioplegia Line • Tubing Connectors • Suction: • Drop In • Rigid • Coronary • Cannulas: arterial and venous The extensive list of supplies is further compounded by individual product variations. For example, cannulas alone, the disposable piece that attaches to the bypass circuit, can represent over twenty different varieties. In fact, some perfusion-related product manuals reach over one hundred pages. Tip: Variation in products and procurement channels add layers of complexity, prohibiting full visibility. Consider using a performance improvement tool and/or creating a process flow diagram to understand the full perfusion supply scope and pain points at your organization.
10 Vizient Tech Watch | Medical Device | Volume 2, 2024 Perfusion services: staffing, contracting and management Perfusion technologists, with specialized training and certification, critical care RNs (ECMO monitoring) and surgical nurses (autotransfusion) deliver or monitor perfusion. Staffing may be provided by the HCO or outsourced to a third-party perfusion services company. In some HCOs there's a combination of hospital staffing and perfusion services company staffing. To understand and provide consistent and safe staffing requires ongoing training and education, and technologists obtaining national certification upon hire or within six months of hire. Outsourcing perfusion services HCOs may partner with a perfusion services company to provide part or all of the organization’s perfusion needs. This may include full staffing, data management, supply purchasing and management, autotransfusion (ATS), ECMO monitoring, CPB and capital equipment. Perfusion services companies may provide neuromonitoring services, too. Contracts with multiple amendments provide service parameters but add much complexity to an already intricate service. Different departments and leaders may manage pieces of this challenging service, but no one entity or team may understand the entire service. This leads to variation in management, contracting, staffing and supply chain — potentially opening the door for gaps in service and quality. Variation leads to additional costs as well. Data sources and monitoring To understand baseline performance, perfusion metrics should be reviewed at a minimum on a quarterly basis. Deciding how to corral perfusion data can be a major challenge. Start with how perfusion technologists document their work in procedures. Do they use the electronic health record (EHR), or is documentation through the perfusion contractor’s proprietary system? How is the data reported? Perfusion supply data may go through the HCO’s supply chain system or through a contractor’s system; depending on how supplies are purchased, how they enter the HCO and where they are used. Often setting up a specific department code for perfusion assists HCO’s identify perfusion-related spend. Perfusion companies may offer their own proprietary data management systems and provide them to HCOs at a cost. The data collected may or may not help the organization track important quality, efficiency, regulatory, supply and staffing costs over time. Data monitoring may include: • Key performance indicators • Clinical quality indicators • Staffing plans and costs • Cardiovascular surgery data — number of cases, case times, time on and off pump, lab values, length of stay, returns to operating room and more as required by the HCO’s cardiovascular program. • Research-specific data monitoring In-house perfusion staffing Perfusion services may be managed as a hospital department, including a manager, staff, supplies and equipment. Perfusion may be part of the department of surgery or cardiovascular services. The challenge here is primarily staffing. Recruiting highly qualified perfusion technologists for this crucial service is difficult. HCOs may turn to a third-party contractor for staffing services to ensure via the contract that the service is staffed. HCOs hiring their own perfusionists will need to assess their prospective staffing market and determine an effective hiring pipeline. This may include hiring contract staff when necessary. Staffing costs for this in-demand position can top registered nurse salaries. Tip: Learn who delivers perfusion services in your HCO, their perfusion education level and national certification status. Tip: Consider partnering with a perfusion school and agree to function as a clinical site for the educational program. This may provide an opportunity to hire the best graduates. Tip: Compile all perfusion service line related contracts, supplier agreements, capital equipment agreements and any staffing contracts. Review the details to determine the full cost of outsourcing, where there may be duplication and decide on a regular review timeline and monthly metrics to monitor performance. Tip: Assess the perfusion data points: Surgeons, department heads and finance need information. Determine whether using the HCO’s internal systems, a perfusion company’s assets and/or a Vizient performance improvement tool yields greater value in managing perfusion.
11 Vizient Tech Watch | Medical Device | Volume 2, 2024 1 Swarup I, O'Donnell JF. An Overview of the History of Orthopedic Surgery. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):E434—E438. PMID: 28005119. 2 John Gibbon Heart-Lung Machine. National Inventors Hall of Fame. Accessed Sept. 24, 2024. NIHF Inductee John Gibbon Invented the Heart Lung Machine 3 Seal B. A Fix for the Unfixable: Making the First Heart-Lung Machine. Science History Institute. Accessed Sept. 24, 2024. A Fix for the Unfixable: Making the First Heart-Lung Machine | Science History Institute References Quality and safety considerations Cardiopulmonary bypass is a life-sustaining process and technology. However, the patient is at significant risk if proper procedures and monitoring are not followed from preparation until the patient is safely removed from bypass. Like other high-risk procedures in HCOs, there are key performance indicators, recommended processes and checks and balances to ensure the safest possible outcome. Perfusion professional associations provide helpful information on national perfusion standards, key performance indicators, staffing templates and articles. Conclusion Perfusion services play a critical role in the success of cardiovascular, transplant, surgery and critical care services. Despite its complexity, it offers significant opportunities for performance improvement in healthcare organizations. By focusing on staffing, supplies, contracts, quality and data management, healthcare organizations can improve both clinical and financial results. They can also use professional associations and performance improvement tools. Understanding and optimizing perfusion services can lead to better quality of care and operational efficiency. Tip: Learn about perfusion professional associations American Society of Extracorporeal Technology (AMSECT), American Academy of Cardio-pulmonary perfusion (AACP), and the American Board of Cardiovascular Perfusion (ABCP) Things to consider when assessing perfusion services • Perfusion is about more than disposable supplies • Cardiovascular (CV) and operating room workflows, including perfusion, scope and setup, are often neglected performance improvement opportunities • Perfusion services companies have little incentive to negotiate better pricing for HCOs • HCOs fear the unknown of perfusion services, which often influences decision-making • An influential CV surgeon as the project champion is key to successful change management in perfusion • Perfusion information management systems are proprietary and owned by perfusion companies. They track data, including private health information, for the benefit of the outsourced company.
12 Vizient Tech Watch | Medical Device | Volume 2, 2024 Venous thromboembolism (VTE) is a major cause of morbidity and mortality, with about 10 million cases per year globally.1 VTE includes deep vein thrombosis (DVT), marked by thrombus in the deep veins of the lower leg and pulmonary embolism (PE), marked by thrombi migrating to the pulmonary arteries. VTE is the number one cause of preventable death in hospitalized patients. Prophylaxis with anticoagulants, when given as recommended by international guidelines, is effective but is often underutilized.2,3 In the United States, it’s estimated that nearly a third of hospitalized patients are at risk of developing VTE. Up to 600,000 cases of VTE are diagnosed per year, with 100,000 deaths. In addition to short-term mortality caused by PE, as many as 50% of patients who survive the acute event will suffer long-term effects such as shortness of breath, exercise intolerance and right heart failure.4 Despite anticoagulation, about 50% of patients with DVT will develop post-thrombotic syndrome in the first year, characterized by leg pain, heaviness, swelling and venous ulcers.5 Evolving treatment alternatives for venous thromboembolism Acute pulmonary embolus compromises oxygenation and puts increased pressure on the right ventricle, which can ultimately fail, leading to death or severe adverse outcomes. All therapeutic options in the acute phase try to clear the clots from the pulmonary vascular system.6 Data analysis supports use of new advancements for venous thromboembolism Key points • VTE is a significant health concern and the leading cause of preventable death in hospitalized patients, signaling a need for innovative treatment options. • Data analysis found potential ways to improve patient outcomes and health system efficiencies for VTE and PE using computer-assisted vacuum thrombectomy. VTE is the #1 cause of preventable death in hospitalized patients.
13 Vizient Tech Watch | Medical Device | Volume 2, 2024 Anticoagulation with either unfractionated or lowmolecular-weight heparin is the first line of treatment for most patients with PE, but high-risk patients and those with signs of hemodynamic compromise may need more aggressive therapy. These groups of patients may benefit from an intravenous injection of medication to dissolve the clot (thrombolytic therapy), but bleeding complications are a significant risk.7 Catheter-directed thrombolysis dissolves clots using the localized infusion of thrombolytic medication through a catheter placed with its tip embedded in the clot, reducing the bleeding risk somewhat.8 It is often combined with mechanical aspiration to provide suction through a catheter to remove the clot. Interventions for the treatment of patients with submassive pulmonary embolism (with or without thrombolysis) have shown promise, and large bore thrombectomy for DVT has become increasingly used due to increasing availability of thrombectomy devices, the ability to achieve clot removal in a single session and the desire to avoid long-term post-thrombotic symptoms.9,10 In 2014, Penumbra launched the Indigo® Aspiration System for the removal of clots from peripheral arteries and veins and for the treatment of pulmonary embolism. The EXTRACT-PE prospective multicenter study showed that for patients with submassive PE, the Indigo Aspiration System alone without thrombolytic therapy improved indices of right heart function while maintaining safety.8 Penumbra has further improved the safety and efficacy of their system with the development of computer-assisted vacuum thrombectomy (CAVT). CAVT uses a sensor at the catheter tip to find the clot faster. It automatically stops suction (and its attendant blood loss) when the clot has been completely captured in the catheter. Penumbra continues to support future clinical trials of CAVT. These studies include an evaluation of long-term functional outcomes and safety (STRIKE-PE) as well as the first randomized controlled trial comparing CAVT plus anticoagulation to anticoagulation alone. These studies are estimated to be completed in 2026.11,12 Study Design and Patient Selection To evaluate potential clinical, operational and financial benefits of CAVT, Penumbra engaged Sg2®, a Vizient company, to design and perform a retrospective clinical study comparing the use of CAVT, mechanical thrombectomy, thrombolytic therapy and anticoagulation alone to treat non-massive pulmonary embolism and DVT. The study relied on aggregated data from the Vizient® Clinical Data Base for discharge periods Q3 2020 to Q3 2023. Researchers analyzed patient encounters using a set of eligible diagnosis codes, procedure and primary discharge diagnoses to identify all known cases of patients receiving CAVT.13 Using propensity score matching, researchers matched each patient receiving CAVT with one patient who received each of the other interventions for the same disease state. Patients were matched for such factors as age, sex, insurance payer type, hospital type and co-morbidities. This created a case-control design with reduced selection bias to mimic that of a prospective randomized controlled trial. The study included 515 PE patients and 404 DVT patients who received CAVT. They were matched with an equal number of patients who received each of the other treatment modalities and were all included in the analysis. Results The aggregated data was analyzed for clinical, operational and financial aspects of care. Mortality, complication rates and 30-day readmission rates were all quite low for CAVT and were equivalent to other treatment modalities. Importantly, however, CAVT showed lower resource utilization and improved operating efficiency compared to other modalities. Mean length of stay was reduced by 1–3 days with CAVT, increasing hospital throughput and operational capacity. CAVT reduced ICU utilization compared with thrombolytics (for DVT + PE patients) and mechanical thrombectomy (DVT patients only). More DVT patients were discharged to home after CAVT than after anticoagulation. This is an important factor given the lack of available skilled nursing facility (SNF) beds in most communities. For PE patients, more CAVT patients were discharged to home than for all other treatment modalities. Financially, despite the higher initial costs associated with device expenses for CAVT cases, the increased reimbursements, primarily from Medicare, resulted in a positive contribution margin for the CAVT group. This indicates that the procedure is economically sustainable for hospitals. "The project’s results are a good start and provide directional support in favor of moving to a new treatment protocol,” said Collette Williams, senior vice president of strategic accounts, North America for Penumbra. Robert Lerman, MD, Vice President of Category Management- Cardiovascular for Vizient and a consulting cardiologist for the study, said, “The most important factor in evaluating any new medical technology is whether it meets or exceeds the clinical standard of care. Between this study and the clinical trials that preceded it, CAVT certainly appears to offer clinical benefits in both prospective trials and a real-world retrospective analysis. Ongoing studies will further define patient selection and will evaluate longterm outcomes, including patient reported outcomes.” Mean length of stay was reduced by 1-3 days with CAVT, increasing hospital throughput and operational capacity.
14 Vizient Tech Watch | Medical Device | Volume 2, 2024 Technology spotlight Penumbra’s Lightning Flash technology represents a fundamental change in how blood clots are removed from the body, including peripheral venous thrombus and PE. Cleared by the U.S. FDA in December 2022, the Lightning Flash system is designed to improve speed, safety and simplicity of intervention. The Lightning technology has been recognized as an innovative technology by the Centers for Medicare & Medicaid Services. It was given a unique ICD-PCS code for the technology: Extirpation of Matter using Computeraided Mechanical Aspiration. Source: 2024 Penumbra. All rights reserved. Used with permission of Penumbra. 1 Turetz M, Sideris AT, Friedman OA, et al. Epidemiology, Pathophysiology, and Natural History of Pulmonary Embolism. Semin Intervent Radiol. 2018 Jun;35(2):92-98. doi: 10.1055/s-0038-1642036. Epub 2018 Jun 4. PMID: 29872243; PMCID: PMC5986574. 2 Al-Hameed FM. Venous thromboembolism prophylaxis: Solutions are in our hands. Ann Thorac Med. 2011 Jul;6(3):105-6. doi: 10.4103/1817-1737.82434. PMID: 21760838; PMCID: PMC3131749. 3 Loffredo, L., Vidili, G., Sciacqua, A. et al. Asymptomatic and symptomatic deep venous thrombosis in hospitalized acutely ill medical patients: risk factors and therapeutic implications. Thrombosis J. 20, 72 (2022). https://doi.org/10.1186/s12959-022-00433-8 4 Klok FA, van der Hulle T, den Exter PL, Lankeit M, Huisman MV, Konstantinides S. The post-PE syndrome: a new concept for chronic complications of pulmonary embolism. Blood Rev. 2014 Nov;28(6):221-6. doi: 10.1016/j.blre.2014.07.003. Epub 2014 Aug 15. PMID: 25168205. 5 Kahn S, Mathes B. Post-thrombotic (postphlebitic) syndrome in adults. UpToDate. Published Feb. 28, 2024. Accessed on Sept. 9, 2024. Post-thrombotic (postphlebitic) syndrome in adults - UpToDate 6 Bryce YC, Perez-Johnston R, Bryce EB, Homayoon B, et al. Pathophysiology of right ventricular failure in acute pulmonary embolism and chronic thromboembolic pulmonary hypertension: a pictorial essay for the interventional radiologist. Insights Imaging. 2019 Feb 13;10(1):18. doi: 10.1186/s13244-019-0695-9. PMID: 30758687; PMCID: PMC6375098. 7 Chatterjee S, Chakraborty A, Weinberg I, Kadakia M, Wilensky RL, Sardar P, Kumbhani DJ, Mukherjee D, Jaff MR, Giri J. Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis. JAMA. 2014 Jun 18;311(23):2414-21. doi: 10.1001/jama.2014.5990. PMID: 24938564. 8 Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13. PMID: 33454291. 9 Avgerinos ED, Mohapatra A, Rivera-Lebron B, Toma C, Kabrhel C, Fish L, Lacomis J, Ocak I, Chaer RA; PERT Consortium. Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):126-132. doi: 10.1016/j.jvsv.2017.09.004. PMID: 29248101; PMCID: PMC6394224. 10 Yu Q, Badar W, Patel M, et al. Percutaneous Thrombectomy using a Computer Assisted Aspiration Device for Deep Vein Thrombosis, Journal of Vascular and Interventional Radiology (2024), doi: https://doi.org/10.1016/j.jvir.2024.08.023 11 Comparison of two pulmonary embolism treatments. ClinicalTrials.gov. Published July 18, 2024. Accessed Sept. 20, 2024. Study Details | Comparison of Two Pulmonary Embolism Treatments | ClinicalTrials.gov 12 Study of the long-term patient safety and outcomes of treating pulmonary embolism with the Indigo Aspiration System. ClinicalTrials.gov. Published April 1, 2024. Accessed Sept. 20, 2024. https://clinicaltrials.gov/study/NCT04798261 13 Vizient, Inc. Vizient Clinical Data Base. Accessed Sept. 20, 2023. Clinical Database | Healthcare Database Records (vizientinc.com) References
15 Vizient Tech Watch | Medical Device | Volume 2, 2024
16 Vizient Tech Watch | Medical Device | Volume 2, 2024 Surgery continues to drive hospital revenue, with Sg2®, a Vizient® company, projecting a growth rate of 3% for inpatient surgery and 19% for outpatient surgery over the next decade. A key question facing hospital leaders is: How many of these surgeries will be performed robotically? In recent years, robotic-assisted surgery has seen growth in key service lines, including general surgery, orthopedics, urology and gynecology. Looking forward, Sg2 is projecting further expansion in these areas, along with emerging applications in other specialties such as cardiothoracic surgery, neurosurgery and bariatrics. Currently, over 35 robotic systems are available across various surgical applications and more than 150 are in development. These next-generation robots are expected to bring advanced capabilities and will likely focus on more procedure-specific applications. If your organization is considering adopting robotic technology, here are some questions that warrant consideration. 1. How are shifting sites of care impacting robot adoption? Traditional robots, with their large footprints and required clearance, could be impeding the shift to ambulatory surgery centers (ASCs). Robotic procedures typically have higher supply costs and take longer, two things that don’t play well with the slim margins in ASCs. Besides the space and cost, physician preference for using surgical robots may keep some procedures in hospital-based surgical spaces. Five questions regarding surgical robot adoption Clinical, financial and operational considerations for determining if this technology is right for your organization Key points • Clinical Considerations: Robotic surgery should be reserved for cases with proven patient benefit; with strict privilege criteria to ensure surgeon proficiency. • Financial Considerations: Assess costs and benefits of the system, considering initial and ongoing expenses, ROI and the impact of attracting skilled surgeons and increasing patient volume. • Operational Considerations: Evaluate surgeons' views, provide training, ensure dedicated teams, manage OR schedules, track metrics and execute marketing for ROI.
17 Vizient Tech Watch | Medical Device | Volume 2, 2024 Robotics are, however, advancing to address application and space constraints. A few suppliers have a single chassis system that can be used for the hip, knee, shoulder and spine. Additionally, there's a handheld navigation device that functions similarly to the larger robotic platforms. It is an open platform and can be used with most manufacturers' implants. In a market where manufacturers are marketing directly to patients, and some organizations feel the need to have robotics to stay competitive, a single chassis platform may meet their needs. 2. Does purchasing this robot make sense for our organization? There are plenty of challenges with robotic assisted surgery (RAS), but no one should minimize the benefits that surgical robot systems bring to a health system’s recruitment strategy and its prestige in the eyes of prospective surgeons. It is up to health system leadership to determine whether the benefits outweigh the costs of buying the next, or first, system. There should be less focus on a single device or company and more emphasis on programmatic thinking to increase the chances of generating a return on investment. Considerations for investment and deployment: • Appetite for robotics. Ask for your surgeons’ opinions about the benefits and risks of robotic surgery technology. • Well-trained, experienced surgeons. Provide training and focus on improving recruitment and retention capabilities. Robots can be an aid in recruiting young surgeons who are trained with the technology. • Dedicated robotic OR teams. A physician champion and a reliable, consistent team in the OR are critical. The team must work especially well together during surgery and be familiar with the robotic setup, procedure and room turnaround. • OR schedules and staffing. Longer case times with robotic surgeries affects scheduling. • Key metrics. Track data and turn them into actionable insights to solidify a robotics program and pinpoint opportunities for expansion. • Marketing plans. Attract patients with education seminars and diversified advertising to help achieve a positive return on investment. • Alternative payment model incentives. These may influence the use of high-cost robotic surgery. 3. What are the foundational elements of a good robotics program? As you look ahead and plan for robotic use at your healthcare system, there are three key elements foundational to any robotics program: patient selection, privileged criteria and monitoring usage and outcomes. • Patient selection: Robotic surgery should be reserved for complex cases or super-obese patients with proven benefit. Given the price tag for robotic use across all procedures, providers should find the sweet spot where patient benefits outweigh procedure costs. • Privileging criteria: There is a learning curve associated with robotic use and outcomes. Establishing and maintaining strict privileging criteria will ensure surgeon proficiency and reduce operative time and improve patient outcomes. • Monitoring: Monitoring robotic usage and outcomes are necessary to validate cost, outcomes and increased access to minimally invasive surgery achieved through robotic utilization and to iterate on robotic strategies currently in place at your healthcare systems. While tracking internal data at your organization is necessary, peer-reviewed evidence should also play a role, albeit the quality and quantity is highly variable. Regardless, robotic utilization should be reserved and prioritized across procedures that confer both patient and physician benefit to optimize outcomes and costs. For example, robotic use in ventral hernia repair has shown some benefit in terms of recurrence rates and complications in addition to quality of life or postoperative pain for extremely complex cases. Vizient’s data demonstrates that providers are adopting robotics for inguinal hernia repair, which may reduce the technical complexity of the procedure while conferring some patient benefits in terms of recurrence and pain, but again, only in complex cases. However, on the other end of the spectrum, patient outcomes in gastrectomy procedures are similar between robotic and laparoscopic approaches, though the robotic approach may confer more of an ergonomic benefit for the physician.
18 Vizient Tech Watch | Medical Device | Volume 2, 2024 4. Is there a service line experiencing changes that might impact our strategy? Orthopedic robotics is one category experiencing regular advancements. Changes in technology and new entries into the market will offer new opportunities. Most orthopedic robotic platforms are closed systems, requiring the use of the robotic manufacturers' implants. Purchasing a robot versus alternative models such as placement, cost per click, or rental, which are dependent on multiple factors, is not advisable. With an estimated useful life of seven years, purchasing a robot would lock a hospital into using certain manufacturers' implants with little leverage for negotiations of the implant price. This can vary depending on the long-term strategy for the department. Given the shift to ambulatory sites of care with its limited space and tighter margins, robotic manufacturers are moving toward implant-agnostic or closed systems that are more compact and easier to use. 5. What innovations are on the horizon that might change market dynamics? The Da Vinci robot has dominated the market since its entry in 1997. While the Senhance product competes with the Da Vinci robot in U.S. markets, it has not displaced the market leader. While the competition is still working to penetrate the market, they are being strategic about their approach and innovating to be able to compete with Da Vinci for market share. • For example, a limitation of the Da Vinci robot is its size, and as the market is looking to move procedures to ASC, new robots like the Hugo (Medtronic) and Ottava (Johnson & Johnson) are introducing modular solutions or hardware integration designs, respectively, that are compatible with typical ASC facility designs. • Another point for the Di Vinci robot is its haptic feedback. The most recently approved Da Vinci robot has incorporated this feature, but the Hugo robot is also looking to incorporate this technology. • Artificial intelligence and machine learning are new technologies that will likely be incorporated into future iterations of robots, ideally assisting in realtime decision making, improving surgical planning and improving precision. • Building on current virtual trends, experts expect further advances in telesurgery, enabling surgeons to remotely perform procedures. While the overall trend toward robotic surgery is clear, its adoption will vary widely based on local conditions. Health systems must also balance the high costs of robotic technology with the reality that it doesn’t bring additional reimbursement. Despite these challenges, surgeon demand for RAS continues to drive investment, especially as health systems use robotic technology to attract and retain top surgical talent. Hospitals that lag in offering this technology often lose surgeons to competitors with better access to robotic systems.
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