CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 1 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 1 of 29
`
`Clinical Technical Report:
`
`The Use of Catheters in a Coronary Application: A Clinical Literature Review
`
`Sponsor Identification:
`
`Sponsor Contact:
`
`Author Contact:
`
`Vascular Solutions, Inc
`6464 Sycamore Ct. N
`Minneapolis, MN 55369
`(763) 656-4300
`(763) 656-4250 Fax
`
`Gwen Gimmestad
`Senior Clinical Research Associate
`ggimmestad@vascularsolutions corn
`
`Gwen Gimmestad
`Senior Clinical Research Associate
`ggimmestad@vascularsolutions. corn
`
`Document Approvals
`
`Author
`
`Clinical
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`Regulatory
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`Documentation
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 2 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 2 of 29
`
`1.0
`
`Introduction
`
`1.1
`
`Background
`
`Coronary catheters have been utilized for nearly fifty years, with the initiation of
`
`the first selective coronary angiography in 1959, performed by Dr. Mason Sones
`
`and in 1977 with the advent of percutaneous transluminal coronary angioplasty
`
`(PTCA), first performed by Dr. Anreas Gruentzig. [3,9,11] Since that time
`
`coronary catheters have gained acceptance for use in a multitude of procedures
`
`including interventional procedures such as balloon angioplasty, balloon
`
`valvuloplasty and stenting. Advancements in coronary catheter technology have
`
`provided streamlined catheters with slimmer profiles, greater torque capabilities,
`
`and an increased tolerance to high inflation pressures in balloon catheters.
`
`Diagnostic and interventional procedures rely on the use of coronary catheters for
`
`a variety of functions including providing pressure measurements, detecting
`
`anatomical anamolies, injecting contrast, and positioning stents. Although a
`
`myriad of coronary catheters have been developed, which exhibit slight
`
`differences in function and physical appearance, in general, the risks associated
`
`with the use coronary catheters are low and remain fairly uniform between
`
`devices.
`
`To date Vascular Solutions, Inc. has developed, and is currently manufacturing
`
`types of catheters: The LangstonTM Dual Lumen Pigtail Catheter (used during
`
`diagnostic procedures to determine transvalvular, intravascular and
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 3 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 3 of 29
`intraventricular pressure gradients); the Twin-PassTm Dual Access Catheter (used
`
`during interventional procedures, especially PTCA procedures, in which the
`
`simultaneous use of two guidewires is required); the SkywayTM Guidewire
`
`Exchange Catheter (also used during interventional procedures providing a simple
`
`guidewire exchange system); and the GuideLiner Catheter Support System used
`
`to provide physicians with additional guide catheter support allowing access to
`
`more difficult anatomy.
`
`1.2
`
`Purpose
`
`While a variety of catheters are utilized during diagnostic and interventional
`
`cardiac procedures, many of the clinical effects and complications associated with
`
`the use of these catheters, regardless of the procedure, are comparable. This
`
`clinical literature review is intended to provide a general overview of the clinical
`
`effects and complications associated with the use of catheters in percutaneous
`
`endovascular procedures.
`
`2.0
`
`Investigational Product
`
`2.1
`
`Device Description
`
`Langston Dual Lumen Pigtail Catheter
`
`The Langston Dual Lumen Pigtail Catheter is intended for use as a pressure
`
`measurement catheter and for delivery of contrast media during angiographic
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 4 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 4 of 29
`studies. The Langston catheter consists of an inner, braided high pressure lumen
`
`which extends the entire length of the catheter, which can be used for pressure
`
`measurement and rapid delivery of contrast medium, and an outer lumen that ends
`
`approximately 12 cm proximal to the distal end of the catheter with side holes for
`
`pressure measurement only. A stopcock is attached to the proximal port of the
`
`outer lumen. The pigtail catheter and outer lumen are joined together using an
`
`adapter junction placed at the proximal end of the pigtail catheter. The adapter
`
`junction also incorporates a side port fitted with a stopcock assembly for fluid
`
`flow and pressure measurement within the outer tube. The distal end of the outer
`
`tube is perforated with side holes to allow simultaneous pressure measurement
`
`with the sideholes at the tip of the pigtail. The dual lumen pigtail catheter is to be
`
`deployed through standard 8F introducer sheaths and will accommodate standard
`
`0.038" (0.96 5 mm) diameter guidewires.
`
`Twin-Pass Dual Access Catheter
`
`The Twin-Pass Dual Access Catheters are designed for use in the coronary
`
`vasculature in conjunction with steerable guidewires. They are dual lumen
`
`catheters that allow for the delivery of a second coronary guidewire into distal
`
`coronary vasculature while leaving the initial guidewire in place.
`
`The Twin-Pass OTW (Over-The-Wire) Dual Access Catheter is a single lumen
`
`guidewire catheter with a dual lumen distal segment that allows for the delivery of
`
`an exchange length wire along side a previously inserted guidewire.
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 5 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 5 of 29
`
`The Twin-Pass RX (Rapid Exchange) Dual Access Catheter is a single lumen
`
`catheter with a dual lumen distal segment, two RX ports and a stiffening mandrel
`
`that allows for the delivery of a 2nd short guidewire while maintaining initial
`
`guidewire position in the distal coronary vasculature.
`
`Skyway Exchange Catheter
`
`The Skyway Guidewire Exchange Catheters are designed for use in the coronary
`
`vasculature in conjunction with steerable guidewires. The catheters allow for the
`
`exchange of one distally located guidewire for another one while maintaining
`
`access to the distal coronary vasculature.
`
`The Skyway OTW (Over-The-Wire) Guidewire Exchange Catheter is a single
`
`lumen catheter that allows the exchange of one exchange length guidewire for
`
`another while maintaining guidewire position in distal coronary vasculature.
`
`The Skyway RX (Rapid Exchange) Guidewire Exchange Catheter is a single
`
`lumen catheter with an RX port that allows for insertion of the catheter over a
`
`short guidewire. The catheter comes pre-loaded with a stiffening mandrel that
`
`provides support and pushability. Once the mandrel and the RX guidewire are
`
`removed, the OTW lumen can be used to deliver another guidewire.
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`GuideLiner Catheter System
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 6 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 6 of 29
`The GuideLiner Catheter Systems are designed for use in the coronary
`
`vasculature in conjunction with standard guide catheters. The GuideLiner
`
`Catheter System provides additional backup support for the existing guide
`
`catheter while maintaining access to the distal coronary vasculature. Further, it
`
`provides the physician additional guide catheter support without having to upsize
`
`the existing guide catheter.
`
`The GuideLiner OTW (Over-The-Wire) Catheter System is a single lumen
`
`catheter which is packaged with a 0.014" diameter guidewire compatible dilator
`
`with an atraumatic tip which provides steerability, while maintaining
`
`guidecatheter position in coronary ostium. Once the dilator has been removed a
`
`treatment catheter or stent delivery device can be advanced more distally due to
`
`the additional backup provided by the device.
`
`The GuideLiner RX (Rapid Exchange) Catheter System is a single lumen catheter
`
`with an RX port, located in the 0.014" guidewire compatible dilator, which allows
`
`for insertion of the catheter over a short guidewire. The pre-loaded stiffening
`
`dilator incorporates an atraumatic tip for steerability, while maintaining
`
`guidecatheter position in coronary ostium. Once the dilator has been removed a
`
`treatment catheter or stent delivery device can be advanced more distally due to
`
`the additional backup provided by the device.
`
`2.2
`
`Indications
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 7 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 7 of 29
`
`The Langston Dual Lumen Pigtail Catheter is indicated for delivery of contrast
`
`medium in angiographic studies and for simultaneous pressure measurement from
`
`two sites. This type of measurement is useful in determining transvalvular,
`
`intravalvular and intraventricular pressure gradients.
`
`The Twin-Pass Dual Access Catheters are intended to be used in conjunction with
`
`steerable guidewires in order to access discrete regions of the coronary and
`
`peripheral arterial vasculature, to facilitate placement of guidewires and other
`
`interventional devices, and for use during two guidewire procedures.
`
`The Skyway Guidewire Exchange Catheters are intended to be used in
`
`conjunction with steerable guidewires in order to access discrete regions of the
`
`coronary and peripheral arterial vasculature, and to facilitate placement of
`
`guidewires and other interventional devices.
`
`The GuideLiner Catheter System is intended for use in general and coronary
`
`applications. It provides a pathway through which therapeutic devices may be
`
`introduced.
`
`2.3
`
`Contraindications
`
`The Langston Dual Lumen Pigtail Catheter is contraindicated for use in:
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 8 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 8 of 29
`
`• Synthetic vascular grafts
`
`• Artificial heart valves
`
`Twin-Pass Dual Access Catheter
`
`• None known
`
`Skyway Exchange Catheter
`
`• None known
`
`GuideLiner Catheter Support System
`
`• Vessels <2mm in diameter
`
`3.0
`
`Prior Clinical Investigations
`
`There have been no prior clinical investigations performed on the Langston Dual
`
`Lumen Pigtail Catheter, the Twin-Pass Dual Access Catheter, Skyway Exchange
`
`Catheter or the GuideLiner Catheter Support System.
`
`4.0
`
`Review of Literature
`
`Diagnostic Procedures
`
`Cardiac catheterization procedures are generally indicated for one of four reasons:
`
`(1) to determine the presence of CAD; (2) to identify the extent and severity of
`
`coronary artery disease (CAD) and evaluate left ventricular function; (3) to
`
`provide assessment of the severity of valvular or myocardial disorders including
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 9 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 9 of 29
`aortic stenosis, mitral stenosis, and cardiomyopathy; or (4) as an adjunctive study
`
`to confirm noninvasive study results. Although there are no clearly defined
`
`contraindications for diagnostic catheterization procedures, there are certain
`
`populations that are at greater risk for complication following the diagnostic
`
`procedure including those patients with acute renal failure, severe uncontrolled
`
`hypertension, severe coagulopathy, severe anemia, allergy to radiographic
`
`contrast, active gastrointestinal bleeding, and acute stroke. [18] Diagnostic
`
`procedures are relatively safe, with mortality and overall complication rates
`
`between 0.1%-0.2% and 0.8% -1.8%, respectively, depending on the disease state
`
`of the patient as well as any underlying co-morbidities. [2] Although there has
`
`been no strict classification system for diagnostic or interventional procedure
`
`complications, generally complications may be classified into one of the
`
`following three groups: major adverse cardiac events, procedural complications,
`
`and device-related events. Major cardiac adverse events include myocardial
`
`infarction, stroke, and death, usually occur sometime during the post-procedure
`
`period, and are typically related to the severity of the disease state rather than the
`
`catheterization procedure itself [21] Procedural complications include those
`
`complications that occur during or directly following the procedure and are
`
`directly related to the procedure itself Procedural complications include vessel
`
`perforation or dissection, arrhythmias, stroke, vascular complication,
`
`nephropathy, and syncope. Device-related complications generally include
`
`guidewire or catheter fracture or breakage or device-related difficulties which
`
`cause vessel dissection or perforation.
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 10 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 10 of 29
`
`Diagnostic procedures have a very high rate of success however, quantitative
`
`measures related to this procedure are difficult to identify and we are therefore
`
`forced to rely on qualitative measures such as image quality and completion of the
`
`procedure. O'Sullivan et al. reported satisfactory coronary artery imaging in
`
`98.2% of diagnostic procedures performed using three types of 5 Fr coronary
`
`catheters including a left coronary catheter (Judkins 4), a right coronary catheter
`
`(Judkins 4), and pigtail catheters in 85% of the patients. There were no deaths
`
`within this patient population and the rate of major complications was very low
`
`(0.95%). These complications included myocardial infarction or emergency
`
`CABG (0.7%) and cardioversion or cardiac arrest (0.57%). [20]
`
`A larger prospective study of 2000 patients reported a 99.4% completion rate
`
`citing 12 procedures that could not be completed due to equipment failure
`
`(0.05%), failure of selective coronary artery catheterization (0.25%), and
`
`abandonment of the procedure due to bilateral iliac artery occlusion (0.30%). A
`
`variety of catheterization procedures was performed in this population including
`
`left heart catheter and coronary angiography (1785), coronary angiography
`
`without left heart catheter (115), left heart catheter without coronary angiography
`
`(4), right and left heart catheter and coronary angiography (85), right and left
`
`heart catheter without coronary angiography (2), and right heart catheter (3). The
`
`types of catheters used for each procedure was not reported. There were two
`
`deaths (0.10%) reported within this population. One patient developed
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 11 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 11 of 29
`cardiogenic shock following the catheterization, which revealed an occluded
`
`dominant right coronary artery and a subtotally occluded left main stem with no
`
`patent grafts and well-preserved left ventricular function. The patient died 6 hours
`
`after the procedure. The second patient died immediately following the
`
`catheterization procedure which revealed severe three vessel disease and a
`
`calcified ostial left main stem stenosis. The patient developed chest pain which
`
`eventually developed into ventricular fibrillation. He died following a prolonged
`
`attempt at resuscitation. Following his death a small catheter related dissection
`
`flap in the proximal left main stem was found. [21]
`
`Additional complications within this study population included myocardial
`
`infarction (0.10%), stroke and transient ischemic attack (0.25%), arrhythmia
`
`(0.40%), thromboembolism (0.20%), pseudoaneurysm (0.25%), hematoma
`
`(0.20%), deep vein thrombosis (0.10%), access site infection (0.05%), and
`
`contrast reaction (0.10%).
`
`A recent study by Ammann et al. in 2003 examined procedural complications in a
`
`total of 7,412 diagnostic procedures. The majority of the coronary angiography
`
`and ventriculography procedures were performed using right and left Judkins and
`
`pigtail catheters. Right heart catheterizations were performed using Swan-Ganz
`
`catheters and Cournand catheters. Procedural complications were noted in 0.8%
`
`of the patients, including 0.3% major and 0.5% minor complications. Major
`
`complications were defined as stroke (0.11%), perforation of the cardiac chamber
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 12 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 12 of 29
`(0.013%), dissection or occlusion of the coronary artery (0.2%), and dissection or
`
`hematoma of the peripheral vessel requiring intervention (0.03%). There were no
`
`deaths reported within this population. Minor complications included hematoma
`
`(0.04%), contrast allergy (0.09%), vagal reaction (0.13%), and arrhythmia
`
`(0.13%). Risk factors identified within this study included larger catheter size (7
`
`or 8 Fr), experience of the physician, heart failure patients, and combined right
`
`and left heart catheterizations. The low complication rates can be attributed to
`
`streamlined equipment and technique, as well as better contrast agents. [2]
`
`Omran et al. specifically looked at the incidence of cerebral embolism in patients
`
`undergoing cardiac catheterization in order to measure aortic valve stenosis. This
`
`type of complication is usually associated with crossing of the stenosed aortic
`
`valve which can lead to dislodgement of calcific valve particles. This prospective,
`
`randomized evaluation investigated the incidence of apparent and silent cerebral
`
`embolism in patients who were randomized to either undergo retrograde
`
`catheterization of the aortic valve (group 1) or catheterization without passage of
`
`the aortic valve (group 2). Pigtail catheters were used in most patients unless
`
`optimum placement could not be obtained and then a left Amplatz catheter or a
`
`multipurpose catheter was used. One hundred fifty-two (152) patients were
`
`randomized at a 2:1 ratio, with 101 randomized to Group I and 51 randomized to
`
`Group II. There were no deaths and a 3 % incidence of clinically relevant
`
`cerebral embolism leading to neurological deficits in Group I. Clinically silent
`
`cerebral embolisms were reported in 22% of the patients. There were no
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 13 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 13 of 29
`incidences of silent or clinically relevant cerebral embolism in those patients in
`
`which the aortic valve was not crossed (Group II). [19]
`
`According to the ACC/SCA&I Guidelines for Cardiac Angiography and
`
`Interventions, the complication rate for diagnostic cardiac angiography
`
`procedures at any given institution should not exceed 1%. [3] According to the
`
`American College of Cardiology, minor complications occur in less than 1% of
`
`the cardiac catheterization procedures. Major complications, although rare, can
`
`include myocardial infarction (heart attack), stroke, and death occurring in 0.17%
`
`of cardiac catheterization procedures. Diagnostic catheterization procedures
`
`generally result in fewer complications and a decreased incidence rate compared
`
`to interventional catheterization procedures, for which the ACC has a reported <
`
`3% major complication rate expectancy.
`
`Percutaneous Coronary Interventions
`
`The ACC/AHA Percutaneous Coronary Intervention Guidelines [24] have divided
`
`coronary intervention procedural complications into six categories including:
`
`death, MI, emergency coronary artery bypass graft (CABG) surgery, stroke,
`
`vascular complications, and contrast agent nephropathy. Vascular complications
`
`include bleeding (hematoma, retroperitoneal hematoma, blood loss requiring
`
`transfusion or prolonged hospital stay); occlusion (total obstruction of the artery,
`
`usually at the site of access, requiring surgical repair); dissection (disruption of
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 14 of 29
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`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 14 of 29
`the arterial wall resulting in splitting and separation of the intimal or subintimal
`
`layers); pseudoaneurysm; and AV fistula.
`
`These same guidelines detail specific factors associated with increased risk of
`
`adverse events following percutaneous coronary interventions including advanced
`
`age, female gender, unstable angina, congestive heart failure (CHF), diabetes, and
`
`multivessel CAD. In addition to these demographic and comorbid factors, patient
`
`anatomy plays a role in increased risk of the procedure. Patients with excessively
`
`tortuous vessels and total occlusions that are greater than 3 months old put the
`
`patient at increased risk.
`
`In general, women are at greater risk for complications following PCI for a
`
`variety of reasons. Most women experience the onset of coronary artery disease at
`
`an increased age compared to their male counterparts. In addition, women
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`generally have a higher incidence of hypertension, diabetes, and high cholesterol
`
`as well as comorbid diseases such as CHF and unstable angina. The increased
`
`incidence of vascular complications is often recognized as a result of the smaller
`
`vasculature in women compared to men.
`
`A study by Chui et al. examined over 18,000 patients who underwent PCI. This
`
`study demonstrated that women were more than twice as likely to have a post-
`
`procedural bleeding complication compared to men (hematoma: 5% vs. 2%;
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`pseudoaneurysm 0.6% vs. 0.3%; blood product transfusion 12% vs. 4%). In
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 15 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 15 of 29
`addition, women were more susceptible to contrast-induced nephropathy (3% vs
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`2%). [8]
`
`Vascular complications are also much higher in patients who have undergone
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`aggressive anticoagulation, as high as 14% with 3.5% requiring surgical repair.
`
`Factors related to the increase in vascular complications include thrombolytic or
`
`platelet inhibitor therapy, coexisting peripheral vascular disease, female gender,
`
`prolonged heparin use with delayed sheath removal, and older age.
`
`According to Andreoli et al. [1], The National Heart, Lung, and Blood Institute
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`Registry reports a 13.6% incidence of an acute coronary vascular event with
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`PTCA, including dissection, occlusion, spasm, embolism, perforation and rupture.
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`Major cardiac adverse events including myocardial infarction, emergency surgery
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`(CABG), and in-hospital death occurred in 9.4% of patients. Minor complications
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`including prolonged angina, bradycardia, transient ventricular arrhythmias, and
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`excessive blood loss was reported in 11.8% of patients.
`
`Berry et al. [5] reported hematomas at the femoral access site in 22% of cardiac
`
`catheterization procedures and 41% of percutaneous coronary intervention
`
`procedures. Of those 6% and 11% were hematomas > than 5cm.
`
`A comparison of single-vessel disease versus multi-vessel disease study was
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`investigated by Corpus, et al. [10] This retrospective review of 820 patients with
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 16 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 16 of 29
`either single-vessel or multi-vessel coronary artery disease compared clinical
`
`outcomes and major cardiac adverse events between the groups. Results from this
`
`study suggest that patients with multi-vessel disease typically have a higher
`
`incidence of hypertension (53% vs. 39%), diabetes (18% vs. 7.3%), and prior
`
`myocardial infarction (20.3% ns. 7.6%). In addition, these patients were typically
`
`older than those with single-vessel disease. Procedural complications for both
`
`groups consisted of cerebrovascular accident (SVD 0.8% vs MVD 0.0%); major
`
`bleed (7.3% vs. 4.6%); vascular complications (5.9% vs. 3.9%); and urgent
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`CABG (0.0% vs. 0.7%). In-hospital mortality was comparable between groups
`
`(5.6% vs. 5.3%). Although there were very few differences in procedural
`
`complications, notable differences were reported at 30-day and 1-year post-
`
`procedure. Specifically, rates of re-infarction are considerably higher in the multi-
`
`vessel disease group at both 30-days and 1-year post-op. In addition, 30-day and
`
`1-year post-procedure MACE were much higher in the multi-vessel disease group
`
`(15% vs. 22% at 30 days and 28% vs. 40% at one-year post-procedure).
`
`Coronary catheter device-related events include broken or fractured catheters and
`
`related embolism or thrombosis, and vessel dissection or perforation. Although
`
`these events are relatively rare, the associated morbidity can be severe. Karbhase
`
`et al. [14] reported on five (5) cases of broken catheters and two (2) cases of
`
`perforation (out of 8,000 cases (0.09%). Six of the seven patients underwent
`
`emergency surgery, the seventh refused surgery. Four of the six patients who
`
`underwent emergency surgery had smooth recoveries following removal of the
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 17 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 17 of 29
`catheter or suturing of the perforated vessel. The remaining two patients both
`
`experienced extended hospital stays due to infection. The patient who refused
`
`surgery following the broken catheter was evaluated one year later and at that
`
`time had experienced no adverse sequelae.
`
`A retrospective study by Corpus et al. examined 820 patients with acute
`
`myocardial infarction who were treated with primary PCI. These patients were
`
`stratified into two groups including those with single-vessel disease and those
`
`with multi-vessel disease. Vascular complications were documented in 5.9% of
`
`those undergoing treatment for single-vessel disease and 3.9% of patients
`
`undergoing treatment for multi-vessel disease. There were no cases of acute
`
`occlusion or vessel perforation within this group of patients. Significant
`
`differences between the two groups were seen in MACE at 30 days and 1 year.
`
`The presence of multi-vessel disease was associated with significantly worse
`
`outcomes in the rates of re-infarction, need for revascularization, mortality, and
`
`MACEs. [10]
`
`The ACC/AHA Percutaneous Coronary Intervention Guidelines cite vascular
`
`complications in up to 14% of patients following PCI, with 3.5% of those
`
`requiring surgical repair. [24] According to these guidelines, the major factors
`
`associated with vascular complications include thrombolytic or platelet —inhibitor
`
`therapy, coexisting peripheral vascular disease, female gender, prolonged heparin
`
`use with delayed sheath removal, and older age. In general the female gender and
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`Confidential - Attorneys' Eyes Only
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`EXHIBIT 30
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`CASE 0:19-cv-01760-PJS-TNL Document 189-30 Filed 12/06/19 Page 18 of 29
`
`Document Number: TR1159
`Vascular Solutions, Inc
`Report Date: August 26, 2005
`Clinical Technical Report
`The Use of Catheters in a Coronary Application Page 18 of 29
`elderly population (>75) are at increased risk for vascular complications. A study
`
`by Chui which examined over 18,000 consecutive patients undergoing PCI and
`
`compared genders determined that the female population is at significantly greater
`
`risk of vascular complications with hematomas and pseudoaneurysms occurring at
`
`twice the rate in the female population (5% and 0.6% respectively vs. 2% and
`
`0.3% respectively in the male population). A greater occurrence of contrast-
`
`induced nephropathy has been reported in women as well. These differences are
`
`most likely attributable to the increased comorbidities (including diabetes,
`
`hyperlipidemia, and hypertension) in women as well as the advanced age of
`
`women when they present for PCI procedures. [8] Vascular complications range
`
`from 1.6%-11.7% [17]. H