02/06/2020  iData Research  Articles, Cardiology, COVID-19 Industry Insights, Vascular Access

According to the latest vascular access device market analysis by iData Research, there are over 2.7 million peripherally inserted central catheter (PICC) insertion procedures performed each year in the United States. The overall US vascular access market was valued at $4.8 billion by 2020 and is expected to reach $5.7 billion in 2026.

PICC insertions were one of the foundational procedures performed in vascular access in 2019. Though the devices make up only a small fraction of the total insertion procedures, their relatively high cost makes the segment a large portion of the total market.

Tip-location technology is a significant factor contributing to the strength of the overall PICC market. It allows clinicians to confirm that the tip of the PICC line is correctly placed in the patient’s superior vena cava. Not only does this save hospitals time and money by eliminating the need for a confirmatory X-rays, but it also leads to safer and faster PICC insertions.

The rising demand for tip-location technologies also benefits the key competitors in this space. Companies, such as Becton Dickinson (BD) and Teleflex, are not only able to generate increased revenue from the sale of their tip-location systems but also charge a higher cost for the compatible PICC products. BD’s Sherlock 3CG® tip confirmation system and Teleflex’s Arrow® VPS G4 device are the key products experiencing a noticeable increase in demand.

In the US, PICCs are usually sold in kits with tip-location disposables. However, the selling prices of these kits end up being more expensive to hospitals. This significant driving factor has allowed PICCs to form such a large fraction of the total vascular access device market.

In spite of that, PICCs do face competition from other product areas. For instance, Central venous catheters (CVCs) present an alternative option with a similar dwell time while also terminating in the patient’s heart.

Unlike PICCs, a CVC is inserted centrally and often in the patient’s jugular, which allows them to have higher flow rates. However, CVCs have been shown to lead to higher rates of infection and catheter-related complications. This factor has been a key driver in the vascular access market in recent years and has supported the surge of PICCs.

PICCs also face competition from midline catheters. Midlines are also inserted peripherally into a patient’s lower arm, but the distal tip of the device terminates earlier, usually in a patient’s upper arm. Midlines have been growing in popularity recently since they offer a lower-cost alternative to a PICC when intermediate dwell times are required (7-10 days).

Without using a midline, clinicians would either have to insert multiple peripheral intravenous catheters (PIVCs) or use a costly PICC for short dwell time. Midlines are one of the fastest-growing segments within vascular access and will likely cannibalize PICC market share to some degree. However, PICCs are still expected to remain a notable portion of the total market.

PICC insertions comprise less than 2% of the total vascular access procedures performed each year. However, they are also an integral component of the vascular access market’s infrastructure. The devices are high-cost long-dwelling catheters that support increased sales in other market segments, such as accessories and capital equipment.

Register to receive a free Vascular Access Devices and Accessories Market Report Suite for U.S. 2020-2026 synopsis

Despite competition from other devices, PICC lines are expected to remain an integral component of the vascular access market. The latest market analysis indicates that the PICC line insertion procedures will grow at a moderate growth rate of 0.4% to reach 2.8 million procedures by 2026.

  New bedside PICC program enhances patient safety 

Patented Biomaterial Platform Used in Peripherally Inserted Central Catheter (PICC) Designed to Virtually Eliminate Thrombus Accumulation

NEWS PROVIDED BY

Access Vascular, Inc. 

Mar 03, 2020, 08:00 ET

BEDFORD, Mass., March 3, 2020 /PRNewswire/ -- Access Vascular, Inc. today announced it has received FDA clearance for the second generation of its HydroPICCTM peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs1 and which may provide the potential to reduce catheter occlusions.

PICCs have become an increasingly popular choice over traditional central venous lines due to ease of use, decreased risk, reduced cost and ability to be placed by non-physicians;2 however, traditional PICCs are more than twice as likely to experience catheter-related thrombus leading to significant patient complications3 and associated costs. Standard PICCs are comprised of polyurethanes or silicones that absorb proteins,4 which attract thrombus. The inherent characteristics of these materials may also cause phlebitis and catheter-related infections, as well as other PICC line complications.5

HydroPICC is comprised of Access Vascular's patented biomaterial platform that combines the superior mechanical properties of polyurethanes with the intrinsically low thrombogenicity of hydrogel. The lubricious and hydrophilic material is designed to repel protein and thrombus development, prevent catheter occlusion, reduce infections and add flexibility to the catheter. The company plans to develop a variety of thrombus-resistant venous catheters and devices from the biomaterial to address the $4.4 billion venous access market, including midlines, peripherally inserted venous catheters, ports, central venous catheters and dialysis catheters. The biomaterial also has the future potential to incorporate sustained delivery of such therapeutics as anti-infectives, analgesics/anesthetics or anti-inflammatories.

"The importance of improving the biocompatibility of materials that reside within the intravascular space cannot be overemphasized. Despite attention to optimal site choice and catheter to vein ratios, patients often develop fibrin sheaths that inhibit catheter functionality. They also commonly develop venous thrombus, sometimes with associated blood stream infections, that use these depositions as basecamps for biofilm formation," said Gregory J. Schears, MD, a professor of anesthesiology in Rochester, Minnesota and medical advisor to Access Vascular. "A material that could combat these issues has the potential to significantly improve vascular access throughout the body."

The second-generation device is easy to insert and integrates new features that streamline placement time based on clinician feedback gleaned from the commercial experience of the first-generation catheter.

The company will focus on generating clinical evidence at a limited number of commercial sites in the U.S. in 2020. Last year, the company was awarded a group purchasing agreement for a Breakthrough Technology contract with Premier, the leading improvement company uniting an alliance of approximately 4,000 U.S. hospitals and 165,000 other providers to transform healthcare. The agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for HydroPICC. 

"We are excited about the potential of our biomaterial to address significant and underserved clinical needs in venous access," said Access Vascular CEO James Biggins. "Clinician response to HydroPICC has been strong and we look forward to working closely with key clinical leaders and centers to integrate the new technology into their practices to the betterment of both the care team and their patients."

About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and are capable of long-term thrombus resistance and infection protection. 

The Intensive Care Unit (ICU) at St. Joseph’s Health Centre is a safe haven for quality care. Machines beep faintly as clinicians closely monitor the conditions of patients who are coping with serious illnesses or injuries. Those patients are being cared for around-the-clock by a dedicated team striving to improve their condition and, eventually, get them well enough to go back home.

The last thing you want to do with a fragile patient is take them out of that acute care setting.

With this in mind, St. Joseph’s Health Centre has launched a bedside program in our ICU for the insertion of a special type of intravenous access.

MORE: AN OPIOID CRISIS?

“We have had the support of the hospital to implement a new bedside peripherally inserted central catheter (PICC) program, where instead of having sick patients that are in the hospital come to (Diagnostic Imaging) to have this special intravenous inserted, we actually take our equipment to the patient,” explains Dr. Wendy Thurston, Chief of Diagnostic Imaging at St. Joe’s.

PICC lines are a type of intravenous access meant for long-term use. Each PICC line is a long, thin tube that is inserted by interventional radiology specialists through a vein in the upper arm. The tip of the tube is advanced through the vein until it ends in a large blood vessel near the heart. The lines are typically inserted using ultrasound and fluoroscopy. Fluoroscopy is an imaging technique that uses x-rays to obtain real-time moving images of the patient’s internal body.

Patients in areas such as the ICU have PICC lines inserted for various reasons, such as long-term intravenous access, nutrition, antibiotic usage or chemotherapy.

“If you’re going for chemotherapy with a regular intravenous, the chemotherapy burns your veins,” explains Lori Debono, a Registered Nurse at St. Joe’s who spearheaded our bedside PICC program alongside Dr. Thurston. “The PICC lines protect your veins.”

The PICC lines can also provide nutrients when people have surgery and can’t eat, she adds. “It acts as a substitute.”

MORE: THE DAY THE EMERGENCY WARD CALLED 911

When it comes to patient safety, those are some obvious benefits to using PICC lines – and our new beside program takes that safety focus one step further.

Debono has been the first staff member inserting PICCs at the bedside – a process she says cuts down on delays in treatment and the waiting times that crop up when you’re bringing patients down to the interventional radiology room.

Having the entire procedure done in a patients’ room decreases their level of discomfort. And, with the bedside program, it’s just one nurse inserting the PICC – speeding things up for the patient and reducing the amount of staff and time previously required to bring an ICU patient down several floors to Diagnostic Imaging (DI). In other words, a win-win situation.

“Staff say loud and clear that (the new bedside program) is safer for patients and provides better patient care and lower wait times,” says Julie Ann Ninnis, Patient Care Manager for the ICU.

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Previously, when ICU patients would be shuttled down to DI, they’d often need a respiratory therapist on hand for the short trip to keep them breathing properly – since they wouldn’t be hooked up to an ICU ventilator. Staff would also be lugging the patient’s intravenous pole and other necessary equipment into an elevator. Overall, the medically necessary trip for a PICC line insertion was disruptive for the patient.

“When patients are sick and they have to be moved within the hospital, there’s an increase in adverse events that happen,” says Dr. Thurston. “And now the PICC lines are being done at the bedside, so it’s just been a positive thing for everybody – the patients, the interventional suite, and our hospital.”

Eventually, Dr. Thurston and Debono would love to see the bedside program spread to other units in the health centre. But in the meantime, for some of our sickest patients in the ICU, it’s already making a difference.

“I just can’t explain how great it is that we no longer have to move patients out of (the ICU), an area with all the necessary services and safety nets,” says Ninnis. “It’s much better to have the (PICC line) service come to the patient.”

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Mark R. Hunter, BScN, RN, VA-BC™, CRNI®

Greater than 90% of hospitalized patients receive some form of peripheral intravenous therapy for the delivery of fluids, medication, or parenteral nutrition. Nurses are the largest group of clinicians responsible for the placement and management of peripheral intravenous therapies. The literature suggests that many graduate nurses lack the confidence, knowledge, and ability to not only place peripheral intravenous catheters, but also adequately maintain peripheral intravenous sites. This fact, combined with the increasing acuity of hospitalized patients with multiple comorbidities, makes peripheral intravenous placement and management even more challenging. This drove a team of researchers to explore the current state of peripheral intravenous education in health care institutions and examine potential gaps in ongoing professional development and competency assessment.

A convenience sample of United States and Canadian health care institution representatives were recruited to participate in a 12-item web-based questionnaire regarding peripheral intravenous education and staff competency. Participants were recruited via the Association for Vascular Access listserv, newsletter, and annual meeting. Members were also asked to forward the recruitment e-mail to other health care institutions to ensure a representative sample.

A total of 611 health care institution representatives participated in the study. The large majority (80%) worked in a health care institution with more than 150 beds. Over half (67%) indicated that they provide peripheral intravenous education to their staff using varying modalities to deliver the education. The majority (54%) of health care institutions reported spending between 1 and 5 hours on peripheral intravenous education while, alarmingly, 38% reported spending less than 1 hour on peripheral intravenous education for their staff. Despite these numbers, over half of the participants (58%) believe peripheral intravenous education is a shared responsibility between pre-licensure nursing schools and health care institutions.

The study highlights the varying level of peripheral intravenous education and competency evaluation of staff working in health care institutions. The results suggest the need for an evidence-based, standardized peripheral intravenous curriculum that could be used in both health care institutions and nursing education programs.

Currently, there are inconsistencies in the peripheral intravenous education and competency programs used in health care institutions. The authors will use the results of this study to design and examine the effects of a standardized, evidence-based peripheral intravenous curriculum to assist health care professionals responsible for peripheral intravenous education and competency assessment. Given the risk for complications from peripheral intravenous therapy, it is hoped that improved peripheral intravenous education will reduce potential complications and improve patient outcomes.

Peripheral intravenous (PIV), PIV research, PIV education and competency, PIV curriculum, NursingJump to SectionIntroductionBackgroundMethod  Design  Data CollectionResults  PIV Content Coverage and Competency Assessment  Vascular Access/Infusion TeamDiscussionConclusion  Limitations  Future ResearchReferences

Venous access for the delivery of intravenous fluids, medications, nutrient delivery, or blood sampling is the most frequently performed (over 1.4 billion annually) invasive procedure in the United States.1 Greater than 90% of hospitalized patients receiving some form of peripheral intravenous therapy (PIV) for the delivery of fluids, medication, or parenteral nutrition.2 Unfortunately, PIV catheters are prone to complications. Competent care delivered by an educated clinician is a key facet to minimizing adverse outcomes.3, 4, 5 This is important as complications can increase length of stay and injuries, which increase patient costs. This fact, combined with the increasing acuity of hospitalized patients with multiple comorbidities, makes PIV placement and management even more challenging.

Nurses are the largest group of clinicians that insert PIV catheters.4 While other clinicians may start PIV catheters, nurses are the predominant health care professionals responsible for the placement and management of PIVs.4 The literature suggests that many graduate nurses (GNs) lack the confidence, knowledge, and ability to not only place PIV catheters but also adequately maintain PIV sites.5, 6, 7 While the research demonstrates varying knowledge among graduate nurses, less is known about the level and type of PIV education being delivered to experienced nurses and GNs working in health care organizations.

These facts drove a team of researchers to explore the current state of PIV education in health care institutions and examine potential gaps in ongoing professional development and competency assessment. The purpose of this descriptive study was to understand the current state of PIV education and competency assessment in United States (US) and Canadian health care institutions.

Jump to SectionIntroductionBackgroundMethod  Design  Data CollectionResults  PIV Content Coverage and Competency Assessment  Vascular Access/Infusion TeamDiscussionConclusion  Limitations  Future ResearchReferences

A review of literature regarding PIV education was conducted resulting in 23 relevant articles (Table 1). PIV therapy is one of the top 3 skills GNs felt uncomfortable performing.6 Even experienced nurses have expressed a lack of confidence in their PIV catheter skills.8 Some studies demonstrated that delivery of a didactic PIV education program in combination with hands-on training resulted in significant improvements in PIV therapy outcomes.4, 8, 9, 10, 11, 12 In fact, many (50-57%) GNs, although receiving PIV education in nursing school, never had the opportunity to place a PIV catheter.9, 10, 13 Once employed, 11% of nurses developed their PIV skills via the “see one, do one, teach one” method.10 The literature reinforced concerns regarding the inconsistencies in PIV education and the limited opportunities for psychomotor PIV training for many new GNs.

Aug 16, 2018

By Michelle DeVries, MPH, CIC, VA-BC

Despite increasing studies and interest in understanding complication rates for all vascular access devices, many infection prevention programs still limit their scope to only CLABSI surveillance within the constraints of National Healthcare Safety Network (NHSN) protocols. By broadening our focus, we have an opportunity to improve the care and outcomes of devices that impact almost every patient who entrusts us with their inpatient care (as well as our outpatient infusion clinics and home health care patients).

Last year, Mermel heightened awareness of the role that PIVs may place in serious infections when he estimated that a third of catheter related Staphylococcus aureus (S. aureus) infections may be coming from peripheral IVs (Mermel, 2017). This echoes the sentiment shared by Jim Davis and the Pennsylvania Patient Safety Authority. Pennsylvania requires reporting of all hospital acquired infections, so has a much more robust data set than most. In reviewing the bacteremias without central lines and comparing it with the S. aureus isolates they estimate that the leading cause of S. aureus bacteremias in hospitalized, acut- care adults in the state may be the peripheral catheter (Davis, 2014).

Kovacs similarly found that 36 percent of primary S. aureus bacteremias over a four-year period occurred in patients without central lines (Kovacs, Fatica, Butler, Gordon and Fraser, 2016). The SHEA Compendium also acknowledged that peripheral devices (both venous and arterial) carry with them a risk of infection, independent of central venous catheters, yet most programs are not actively monitoring (Marschall, et al., 2014). The 2016 Infusion Therapy Standards of Practice call for us to perform surveillance on these devices regularly (Gorski L, 2016). Including all devices allows us to begin to offer comparisons on risk that allow us understand performance beyond what we have may have traditionally included in our programs (Alexandrou, et al., 2018) (Mushtaq et al., 2018).

How do we begin to address these findings and recommendations in our own organizations? As a starting point, ensuring that a standardized protocol is used will help allow us to begin creating a systematic process by which we can eventually compare and trend our performance as we do with central lines. For 20 years I have followed the NHSN (formerly NNIS) protocols. At their core they are laboratory-confirmed bloodstream infections (LCBI) definitions. We frequently think of them at CLABSI definitions, but the core definition is not specific to CLABSI. The actual document title is “Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and Non-central Line Associated Bloodstream Infection)."

In fact, during the last two years of NHSN annual training, they suggest identifying whether LCBI has been met, then whether it is primary or secondary and then as the final step whether it was related to a central line. Our team has followed that strategy for years, at the end capturing all devices in place leading up to the infection and “attributing” it to the line(s) present the day of or day before infection criteria are met as long as there has been access for more than two calendar days. When more than one device is present and paired cultures or other conclusive data is not available, we err by attributing (for surveillance purposes only, not clinical treatment decisions) to the line with the higher published rate of infection (i.e., CVC > PIV > midline). We share infection data not only on our central lines, but from short peripheral catheters and midlines as well. We acknowledge it is an imprecise definition, but wholly support the value of standardization. Further drill down on infections for contributing factors is conducted through an Apparent Cause Analysis facilitated by one of our infection preventionists (who is also a DNP, ACNS-BC, CIC, VA-BC and former nursing professor) who engages from line staff to recall and share memories of care and perhaps lapses in the days prior to the infection. During those discussions aspects of all lines present are included to give the broadest approach for reviewing possible opportunities for improvement. We engage staff to critically review the “why” behind the device choices and also include insertion staff and other involved departments to try to capture the fullest understanding.

Infection preventionists, and many of us with specialized training, function within the broader function of hospital epidemiology – looking at the distribution and determinants of disease (in our case complication) within our patient population. When it comes to understanding the risks of all of our devices, we look beyond just those that develop an infection, knowing that preventing precursors to infection (poor site selection, non-intact dressings, occluded catheters, etc.) can help impact the incidence. Collaborating with our vascular access team, we have also created sustainable methods for capturing non-infectious complications from these devices as well to help with more fully understanding device risk. We work together to review (and compare across device types) issues such as completion of therapy, percent of patients discharged with lines in place, infiltration, occlusion, phlebitis and other potentially preventable complications.

While our organizations are required to report outcomes measures (i.e., CLABSI, MRSA Lab-ID, and C. diff Lab-ID), it would behoove us to spend considerable efforts monitoring process measures in an effort to correct deficiencies before they lead to an infection, rather than waiting to conduct a huddle only after significant patient harm has occurred. Within our organization, we achieve this (with the support and guidance of the executive team) through multi-disciplinary process measures rounding. Rather than falling as a siloed activity for the infection prevention team (which is where its origins were within our facility), every inpatient unit is expected to round and document their findings within a shared spread sheet. A screen shot of one of the data entry sheets is shown below. A data dictionary is provided to staff in an effort to ensure consistency in how measures are evaluated. Last year the organization opted to add some of the process measures to the unit score card, in addition to standardized device utilization ratios and standardized infection ratios. Each unit can access the elements of performance on their own patients, plus the aggregate data is presented monthly to Infection Control Committee. Taking it even a step further, every month, the Infection Prevention team coordinates inclusive rounding when vendors (representatives, clinical specialists, engineers, leadership, etc.) are welcomed and round with the hospitals’ infection prevention team at the bedside to see how products are performing. The team is frequently joined by professional development and nursing leadership as well as members of the vascular access team. It provides front line staff with a chance to pose their questions to internal and external experts on every component of their care of central as well as peripheral lines and helps build collaboration on amongst providers of our bundle elements.

There is much remaining work to be done to feel as that we have done everything possible to make vascular access as safe as possible for all patients. Consideration of expanding infection surveillance as well as process measure analysis across all devices can help identify opportunities for further study. Partnering with our vascular access teams individually at our organization, but also through active involvement with local and national organizations such as the Association for Vascular Access (AVA) can help us go even further in creating a complication-free possibility for our patients.

Michelle DeVries is a member of the speaker’s bureau for Access Scientific, Becton Dickinson, Eloquest and Ethicon. She is a director at large with the Vascular Access Certification Corporation, an adjunct research fellow with the Alliance for Vascular Access and Teaching and Research (Griffith University, Health Institute Queensland) and the senior infection control officer at Methodist Hospitals in Gary Ind.