Vascular Device Forum

Medical Malpractice focused on Free Standing Dialysis Access Maintenance Space

This topic is a little bit off course from what we generally talk about on VascularDeviceForum.com-ie upbeat optimism of new technology, creative energies and competition of the vascular device space. However, I know that once in a while, it's important to pull our heads out of the clouds and return to discuss the realities of day-to-day medical practice. Certainly one of those realities is the potential for medical malpractice lawsuit at any time.

 

Although, medical malpractice was on the front lines of healthcare issues and at critical proportions in many states, it seems that some efforts have been moderately successfull at stopping the hemorrhage (pardon the symbolism, but it is vasculardeviceforum.com after all).  The max exodus of physicians from certain hot beds like PA has equilibrated to some degree.

 

Today, I received a comment from an anonymous individual describing himself as an attorney specializing in medical malpractice. He seemed to suggest that the new wave of malpractice will focus on medical devices, suggesting that medical device misuse and malfunction offer the potential to tag the physician, hospital and deep pocketed medical device manufacturer. Additional, a single event of malfunction uncovered usually suggests that other events have occurred  but just have not been recognized or announced

 

Additionally, he suggested that the free standing facilities like vascular access maintenance centers are being closely observed for several reasons. These are dialysis access maintenance facilities usually managed by a company like Davita, Fresenius, Lifeline or American Access. Sometimes they are set up as an extension of practice or an Ambulatory Surgical Center (ASC).  Because the model is developing, oversite by various agencies is sometimes lacking and quality controls that are in place in hospital settings are sometimes lacking, Reporting of adverse events, best medical practices and actions to rectify issues may not be as stringent

 

Lastly, combined with the for-profit model, absence of economies of scale and close attention to expenses-medical practice may be altered in these circumstances.

 

While his comments seem quite plausible, I always like to believe that all healthcare practioners focus on patient interest. I then remembered a question that I received from a conference participant at a dialysis access maintenance talk. The question was from an access company administrator. He wanted to know why he had one facility that used two different balloon sizes on a particular dialysis access maintenance procedure while another facility routinely used one for the same procedure. The answer was quickly apparrent that once facility was using and inappropriately large balloon to "cut costs".

In all likelihood, if carefully done, it would have no consequences-but clearly it was not "standard medical practice". But it may be what happens when every piece of equipment used impacts the users bottom line

 

I would like to hear comments and questions about this provocative idea.

Vascular Closure Device New Generation Mynx

Endovascular Today reports the early results of the Mynx Closure Device. Closure technology is advancing with the "leave nothing behind" philosophy driving innovation. The Mynx® Vascular Closure Device Adopting extravascular closure technology in the catheterization lab. By Ameer Kabour, MD, FACC, FSCAI, and E. Dean Nukta, MD, Facp, FACC, FSCAI Can an extravascular sealant technology really do the job even in highly anticoagulated interventional procedures? The Mynx experience thus far suggests that it can. Early experience indicates that Mynx is effective in achieving immediate and durable hemostasis as evidenced by comparable outcomes in both diagnostic and interventional catheterization procedures. In our experience, Mynx has proven to be a clinically versatile closure technology that is suitable even in procedures in which peripheral disease, obesity, and bifurcation anatomy pose challenges with regard to arteriotomy access and closure. The most appealing features of the Mynx Vascular Closure Device are the complete lack of intraluminal components, the elegant and easily mastered deployment, and the virtual absence of patient discomfort. ■ Source

Finally: Some data on Atherectomy Silverhawk EV3

EV3 announced plans to assess atherectomy as a stand alone intervention using their device, the silverhawk device. Its been a long time coming to get some data on short and midterm results of percutaneous atherectomy using a core lab. It will be interesting to see the details of the study design and lesion inclusion. This comes on the heels of the launch of LifePath's G2 Jetstream device.

On thing is for sure, if the results are good, every atherectomy company will piggy back and if the results are bad-"Our device is better than EV3's"

 

EV3 Commences DEFINITIVE LE Postmarket Study of SilverHawk

April 30, 2009—ev3 Inc. (Plymouth, MN) announced that the first patients were enrolled in the company's DEFINITIVE LE postmarket study of stand-alone SilverHawk plaque excision therapy for the endovascular treatment of lower extremity peripheral arterial disease (PAD). DEFINITIVE LE is a prospective, multicenter, single-arm study that will evaluate the intermediate and long-term effectiveness of the therapy. The study is expected to enroll up to 800 patients from 50 clinical sites in the United States and Europe. It will evaluate 1-year patency in patients with claudication and 1-year limb salvage in patients with critical limb ischemia. A third-party review of the results by independent core labs will also be included in the study. James McKinsey, MD, and Lawrence Garcia, MD, are coprincipal investigators for DEFINITIVE LE.

According to ev3, the DEFINITIVE LE study represents the second study in the company's DEFINITIVE clinical study program to confirm the value of plaque excision with the SilverHawk system. A United States investigational device exemption study, called DEFINITIVE Ca++, is currently being conducted to evaluate the use of the SilverHawk-R LSC (RockHawk) plaque excision system and the SpiderFX embolic protection device in the endovascular treatment of moderate-to-heavily calcified peripheral artery lesions.

"DEFINITIVE LE will provide much needed guidance on the treatment of PAD using plaque excision in both above- and below-the-knee applications," commented Dr. Garcia. "Furthermore, this study will potentially add new insight on the optimal management of diabetic patients in this very difficult vascular territory."

Definitive Study

Cook Medical and Spectrum Technology in PICC Lines

We love breaking news of new disruptive vascular technology at VDF.com and Cook Medical appears to have one here. I spoke to the folks at Cook Medical (Bloomington IN) and they are very optimistic about the impact that this technology will have on patient outcomes.

 

Hospital acquired catheter infections in PICC lines are a significant concern both in terms of patient outcomes as well as healthcare cost considerations. Vascular line infections, considered an avoidable complication by the CMS as a result of the DRA, will be monitored closely by all healthcare facilities.

 

Industry studies suggest that there are approximately 3 million peripherally inserted central lines with an infection rate ranging from 4-7%. Factors associated with line infection include duration of use, patient comorbidities and insertion technique.

 

Current "anti septic" picc lines provide infection resistance for 4-5 days. New spectrum technology demonstrated zones of inhibition for approximately 63 days. This technology appears to represent a significant advance and a relatively underappreciated sector of patient care. If post release studies confirm these results, the technology will provide significant savings to healthcare.

 

Consider all of the pipeline applications for the use of this technology.

      Cook Medical Launches Spectrum Turbo-Ject Antibiotic PICC

May 11, 2009—Cook Medical (Bloomington, IN) announced the launch of the Spectrum Turbo-Ject percutaneously inserted central venous catheter (PICC). The Spectrum Turbo-Ject is an antibiotic-impregnated pressure injection PICC that is capable of accepting the contrast media injection rates required for CT scans while protecting against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject PICC is being offered in multiple catheter configurations with a range of flow rates to meet patients' needs. The device's features include maximum pressure-limit settings of 325 psi, 5-F single and double lumen with maximum flow rates of 7 and 5 mL/s, respectively, 4-F single lumen with a maximum flow rate of 4 mL/s, and 50- and 60-cm lengths. Additionally, Cook Medical is offering its PICC procedural tray, designed to efficiently supply the essential components for a clinician placing a PICC, whether bedside or in an interventional radiology lab. The tray provides the vital components for maximal sterile barrier precautions, which is a significant part of patient safety and infection control, the company stated.

According to Cook Medical, Spectrum technology has been shown to establish zones of inhibition > 15 mm for up to 63 days against the leading cause of CRBSIs. The combination of the antibiotics minocycline and rifampin that are impregnated within the material of the catheters provide broad-spectrum protection against gram positive, gram negative, and fungal organisms in both short- and long-term use. This combination has the ability to penetrate the biofilm that forms on all indwelling catheters while not promoting the growth of antibiotic-resistant strains of bacteria in patients receiving the catheters. The company noted that in October 2008, the Centers for Medicare & Medicaid Services eliminated reimbursement to hospitals for treating CRBSIs and other hospital-acquired infections.

Catheter Associated Infection- A never event Part I

Unless you haven't been at a staff meeting recently, you are probably well aware of the term "never event". A term used to describe a set of clinical outcomes that are designated as being avoidable hospital events. Pertinent to the vascular device community is the inclusion of vascular catheter infections. Vascular catheters and their respective uses are quite familiar to interventional radiologists, vascular surgeons, interventional nephrologists and cardiologists.

In our market economy, identified problems frequently present an opportunity for innovation. Innovation in catheter design will no doubt address some of these infection control dilemmas. Additionally, it will be interesting to follow the process of monitoring catheter infections in non hospital based settings. Today's post is an informative introduction of the background to the DRA of 2005. We'll follow up with a post on specific technology

The Issue

On February 8, 2006, President Bush signed the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA) which contained language[1] creating a system for quality adjustment of Medicare payments for inpatient hospital services. The law required the Secretary of Health and Human Services (HHS) to identify at least two hospital-acquired conditions which could have reasonably been avoided through the application of evidence based guidelines and would be subject to the adjustment in payment.

Background

 

The rate of growth in health care costs has made it necessary for payers of health care services to examine every avenue available to conserve health care dollars. According to the Congressional Budget Office (CBO), without any changes to federal law, total spending on health care will rise from 16 percent of the gross domestic product (GDP) in 2007 to 25 percent in 2025 and 49 percent in 2082, and net federal spending on Medicare and Medicaid will rise from four percent of the GDP to almost 20 percent over the same period. CBO sites inefficiency in the health care system as a principle variable contributing to the increased cost. They support this notion through an examination of the variation in health care cost across the country yet noting that the quality in health care is less variable.

The Institute of Medicine has estimated that medical errors cost $17 billion to $29 billion per year with most of the cost being shifted to outside payers such as Medicare. Research conducted by the Harvard School of Public Health[2] in 2006 found after examination of 14,732 discharge records from 24 hospitals in Colorado and Utah, the average cost per injury was $58,766 for all adverse events and $113,280 for negligent injury. They also concluded that 78 percent of the costs associated with all injuries were externalized to outside payers and 70 percent of costs associated with negligent injuries.

Federal Actions

Taking these factors into consideration, the DRA required CMS to select at least two hospital-acquired conditions that would be subject to a quality payment adjustment. CMS consulted with the Centers for Disease Control and Prevention (CDC) to identify the conditions proposed for reduced payment in FY 2009 and additional conditions that would be considered for reduced payment in subsequent years. The conditions were selected from a list of "never events" or conditions which had been identified by the National Quality Forum[3] in 2002. "Never events" are serious reportable events, which should never have happened and could have been prevented[4]. Specific criteria for selection of the conditions were provided as follows:

1. The condition must be associated with a high cost of treatment or high occurrence rates within hospital settings.
2. The condition results in higher payment to the facility when submitted as a secondary diagnosis.
3. The condition can reasonably be prevented by adoption and implementation of evidence-based guidelines.

Selected Conditions The first eight conditions, which were selected last year because they greatly complicate the treatment of the illness or injury that caused the hospitalization, resulting in higher payments to the hospital for the patient's care by both Medicare and the patient were: Object inadvertently left in after surgery Air embolism Blood incompatibility Catheter associated urinary tract infection Pressure ulcer (decubitus ulcer) Vascular catheter associated infection Surgical site infection-Mediastinitis (infection in the chest) after coronary artery bypass graft surgery Certain types of falls and traumas 2008 Additions Surgical site infections following certain elective procedures, including certain orthopedic surgeries, and bariatric surgery for obesity Certain manifestations of poor control of blood sugar levels Deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures.

CSII Cardiovascular Systerms reports blockbuster results for Q3 Diamondback

The number of hospitals using the Diamondback 360º system rose to 487 by the end of the third quarter, up from 400 at the end of the second quarter of fiscal 2009 and 106 at the end of the third quarter of fiscal 2008. Sales of disposable units also grew with nearly 4,600 units sold in the third quarter this fiscal year, compared to 2,300 units in the third quarter of fiscal 2008. The 90-day reorder rate for the quarter was strong at over 90 percent, and revenue generated from reorders comprised over 80 percent of total revenue for the quarter.

The fiscal third-quarter gross margin increased to 74 percent from 67 percent in the same period last year, driven by higher disposable volumes, product cost reductions and manufacturing efficiencies. Sales, general and administrative expenses grew 41 percent - a rate less than half of the revenue growth rate - to $14.3 million. The increase was due to expansion of the direct sales organization to nearly 100 professionals from 36 in March 2008. The sales team is expected to grow to just over 100 in the fiscal fourth quarter. CSI has continued to invest significantly in innovation and product development; however, research and development expenses declined 21 percent to $3.4 million due to the completion and timing of projects.

Source

Zilver PTX effective in treating SFA occlusions

 Cook Medical  and Angiotech Pharmaceuticals recently announced 2 year follow up for the Zilver PTX drug eluting (Palcitaxel) stent in the superficial femoral artery. The trial is created to assess the safety and effectiveness in treating PAD. Safety and effectiveness have previously been determined iin the coronary circulation only to be followed subsequently by concerns of acute thromboses which occurred at a higher rate relative to bare metal stents.

Paclitaxel, an anti-neoplastict agent, has shown a significant benefit in reducing in stent re-stenosis, the "achilles heal" of percutaneous stenting. Previous trials have shown questionable benefit of drug eluting stent technology in the infra inguinal circulation.

– Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today

announced its corporate partner, Cook Medical, reported data on two-year follow up that showed that 82

percent of patients who were treated with Cook Medical's Zilver® PTX™ drug-eluting peripheral stent (DES)

were free from reintervention at two-year follow up. The Zilver PTX Registry study, involving 792 patients

from across the world, is assessing the safety and efficacy of the Zilver PTX in treating PAD. The most recent

results were reported at the 31st International Symposium: Charing Cross Controversies Challenges Consensus.

“These results are extremely encouraging as it's the first time paclitaxel-coated stents have been used in the

treatment of blockages in arteries outside the heart,” said Zilver PTX global principal investigator, Dr. Michael

Dake, Professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and

Medical Director of the Cath/Angio Laboratories at Stanford University Medical Center. “Patients treated with

the Zilver PTX had a very low complication rate and required fewer reinterventions.”

Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study,

which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total

occlusions, in-stent restenosis). The corresponding event-free survival (EFS) rates were 87 percent and 78

percent, and freedom from TLR (target lesion revascularization) was 89 percent and 82 percent. Clinical

measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed

significant improvement at six and 12 months and were maintained through 24 months.

Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming

previously published results showing 99 percent completely intact stents with a mean follow up of 2.4 years in

the challenging superior femoral artery and popliteal arteries, including behind the knee locations.

One in five in the 65- to 75-year-old age group in the UK* has peripheral arterial disease (PAD). Yet only a

quarter of these people have any symptoms at all. The 'silent' nature of this condition can result in a number of

patients being diagnosed only when their condition has progressed to the severe stage. In patients with severe

PAD whose condition is not improving with risk-factor modification, exercise programs and pharmacological

therapy, invasive procedures may need to be carried out. These procedures include angioplasty, stenting or

surgery.

“We are impressed with both the efficacy and durability demonstrated by the Zilver PTX in the registry study

and believe we will see similar results in the US randomized trial which is currently ongoing,” said Dr. Bill

Hunter, President and CEO of Angiotech. “Our partner, Cook Medical, has been committed to continually

improving the efficacy and safety of peripheral DES and early results suggest that the self-expanding, Zilver

PTX stent will be an important treatment option for patients with PAD.”

In addition to the registry arm of the study, the 480 patient randomized component is designed to evaluate the

Zilver PTX across 45 trial sites in the United States, Japan and Europe. Of the 480 patients enrolled in the

randomized study, 240 received the Zilver PTX DES. Enrollment in the randomized study was completed in

2008. For more information, please visit www.zilverptxtrial.com.

New Applications for JetStream G2 from Pathway Medical threaten CSII, EV3

The Silverhawk device from EV3 and the Diamondback (Cardiovascular Systems Inc csii) now have additional pressure from the Jetstream G2 (Pathway Medical Technologies Inc) which has recently received 510 (k) clearance for removal of thrombus (mechanical thrombectomy) on the upper and lower extremities.

This represents a significant theoretical competitive advantage for the Jetstream G2 which now has multiple FDA approved applications for the treatment of Peripheral Arterial Disease (PAD).

From Medical News Today           

Pathway's newest peripheral atherectomy catheter, is capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus, with consistent results

 

Jetstream G2 consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. A highly efficient aspiration port located just proximal to the cutting blades continually removes excised tissue and thrombus from the treatment site to a collection bag located on the console. A fully recessed masticating system within the aspiration port helps break aspirated material into smaller pieces before removal. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. Active aspiration is a safety feature that minimizes the risk of distal embolization.

With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 maximizes treatment effectiveness. Jetstream G2 offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

The Atherectomy Space has over a short period of time rapidly evolved with iterations on the first generation Silverhawk device to the current JetStream which has multiple applications (atheroma, calcium, thrombus) with a single device. Although, I dont personally have experience with this G2 system, It's clear that if the device behaves as touted, it may be a revolutionary advance.