throbber
Document downloaded from http://www.revespcardiol.org, day 27/04/2012. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited.
`
`484
`
`Scientific letters / Rev Esp Cardiol. 2012;65(5):479–488
`
`The GuideLinerW Catheter in Complex Coronary Interventions
`
`Utilizacio´n del cate´ter GuideLinerW en angioplastias coronarias
`complejas
`
`To the Editor,
`
`Stent placement frequently poses considerable difficulty in
`coronary interventions, especially in tortuous or calcified arteries
`and chronic occlusions; this is evidenced by the fact that failed
`stent deployment still occurs in 2.7% to 3.3% of the interventions
`undertaken.1
`In complex angioplasty procedures of this type, different
`to resolve
`the problem of
`strategies have been emerging
`inadequate guiding catheter support, including the use of high-
`support guide wires and techniques involving buddy wires, buddy
`balloons, or anchoring balloons (inflation of an anchoring balloon
`in side branches). Deep intubation of the coronary artery is another
`of the strategies, but is limited by the possible occurrence of the
`dissection of proximal plaques or total occlusion of the vessel
`during maneuvers of this type.
`The GuideLinerW catheter (Vascular Solutions Inc., Minneapolis,
`Minnesota, United States) is a coaxial ‘‘mother and child’’ catheter,
`mounted on a monorail system, that extends the angioplasty
`guiding catheter and enables deep intubation of the coronary
`artery to achieve extra support and improve coaxial alignment. It
`has a distal end of 20 cm, consisting of a flexible extension with a
`radiopaque marker situated 2.7 mm from the tip and a coaxial
`exchange system 20 cm from the tip, joined to a 125-mm compact
`metal hypotube by means of a ring (Fig. 1). The flexible design of
`the catheter and the absence of a distal primary curve permit deep
`and theoretically atraumatic
`intubation of the coronary tree,
`increasing guiding catheter support, which enables selective
`injections and reduces the amount of contrast medium employed.
`In addition, it provides an extension to the guiding catheter that, on
`occasion, makes it possible to gain access to the ostia of hard-to-
`reach coronary arteries or coronary bypass grafts. It is compatible
`with standard guiding catheters (except those with a conical tip)
`and its lumen is 1 Fr smaller than that of the catheter utilized. We
`describe the initial experience with the use of the GuideLinerW in a
`single center.
`The GuideLinerW was employed in 7 complex elective coronary
`interventions. Three of them involved chronic occlusions of right
`coronary artery (including 1 case of complete stent occlusion),
`another 2 were procedures in highly calcified right coronary
`arteries, and the remaining 2 were interventions in circumflex and
`anterior descending coronary arteries. In 2 cases the GuideLinerW
`was used from the start of the procedure as the instrument of
`choice, and in the other 5 when standard measures to increase the
`degree of support had failed.
`sheath
`introducer
`A
`femoral approach using an 8-Fr
`was employed in every case; in 2 of them, the intervention was
`performed with bilateral access for contralateral injections (Fig. 1).
`Rotational atherectomy was carried out in 3 procedures, followed
`by the use of the GuideLinerW to advance the materials used in the
`angioplasty.
`The characteristics of the patients and of the interventions are
`shown in the Table 1.
`In 6 procedures, the GuideLinerW afforded adequate alignment
`of the catheter with the artery; however, in one case, deep vessel
`intubation was not achieved because the advance of the device was
`impeded by a stent implanted at a proximal level. In 4 cases, the
`GuideLinerW was considered key to the success of the intervention
`as it enabled the advance of the angioplasty materials, a maneuver
`that had not been achieved with other techniques. There were no
`complications related to the utilization of the device and the course
`
`of the patients was favorable, with a mean postintervention
`hospital stay of 3.8 days.
`There are few publications on the utilization of this catheter2–5
`and they have not reported complications associated with its use.
`rapid exchange and offers
`Its monorail design permits
`important advantages over
`its predecessors, the
`‘‘five-in-six
`mother and child’’ catheters Heartrail IIW (Terumo Corp., Tokyo,
`Japan), which had a coaxial system that made their utilization
`more demanding.5
`Its use is not recommended in vessels measuring less than
`2.5 mm or in saphenous vein grafts, although concerning the latter,
`the GuideLinerW was
`cases have been published
`in which
`especially useful as it provided good alignment with the graft.6
`For optimal use of this device, the following recommendations
`can be taken into account:
`
`
`
`
`
` The GuideLinerW should be inserted using a guiding catheter over
`a first angioplasty guide wire in such a way that the tip protrudes
`a maximum of 10 cm beyond the guiding catheter tip. Intubation
`of more than 20 cm can result in the introduction of the entire
`GuideLinerW into the coronary artery, a circumstance that could
`complicate
`its withdrawal.
`In addition, the connection to
`the flexible segment should be situated in the straight portion
`of the guiding catheter in order to facilitate the passage of
`devices along it.
` It is recommended that the stents be advanced over the first
`angioplasty guide wire inserted, given that the second guide wire
`may be positioned outside the GuideLinerW and interfere with
`the deployment of the stent.
`
`Despite the small number of cases, we consider that this
`catheter may be highly useful in complex coronary interventions,
`in which it provides extra support that considerably facilitates the
`advance of
`the materials used
`in angioplasty and avoids
`the potential complications associated with more aggressive
`techniques.
`
`A
`
`
`
`C
`
`
`B
`
`D
`
`E
`
`Figure 1. A and B, angioplasties to correct chronic total occlusion of right
`coronary artery involving bilateral access and the GuideLinerW catheter. C,
`selective intubation with GuideLinerW in a highly calcified right coronary
`artery. D and E, diagram.
`
`
`Page 1
`
`Teleflex Ex. 2170
`Medtronic v. Teleflex
`
`

`

`Document downloaded from http://www.revespcardiol.org, day 27/04/2012. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited.
`
`Scientific letters / Rev Esp Cardiol. 2012;65(5):479–488
`
`485
`
`Table 1
`Baseline Characteristics of the Patients in Which the GuideLinerW Was Employed and Description of the Procedure
`
`Age, years
`
`Sex
`
`Logistic EuroSCORE, %
`
`Ventricular dysfunction
`
`Clinical indication
`
`Patient 1
`
`Patient 2
`
`Patient 3
`
`Patient 4
`
`Patient 5
`
`Patient 6
`
`Patient 7
`
`69
`
`M
`
`8
`
`Yes
`
`68
`
`M
`
`15
`
`No
`
`74
`
`F
`
`8
`
`Yes
`
`72
`
`M
`
`30a
`
`Yes
`
`43
`
`M
`
`1
`
`No
`
`45
`
`M
`
`1
`
`No
`
`75
`
`M
`
`11a
`
`Yes
`
`Resting
`angina
`
`Non-Q-wave
`infarction
`
`Positive
`ischemia test
`
`Resting
`angina
`
`Resting
`angina
`
`Positive
`ischemia test
`
`Positive
`ischemia test
`
`CTO RC
`
`CX
`
`Target vessel
`
`LMC-AD
`
`Duration of procedure, min
`
`Fluoroscopy time, min
`
`Contrast medium volume, ml
`
`Length of hospital stay following
`angioplasty, days
`
`60
`
`12.8
`
`130
`
`14
`
`RC
`
`90
`
`39.9
`
`200
`
`2
`
`CTO RC
`
`220
`
`55
`
`230
`
`1
`
`RCb
`
`124
`
`43
`
`200
`
`7
`
`CTO RC
`
`240
`
`118
`
`370
`
`1
`
`180
`
`80
`
`320
`
`1
`
`55
`
`27.4
`
`270
`
`1
`
`AD, anterior descending coronary artery; CTO, chronic total occlusion; CX, circumflex coronary artery; F, female; LMC, left main coronary artery; M, male; RC, right coronary
`artery.
`a Patient no. 4 had chronic renal failure requiring hemodialysis, as well as severe peripheral arterial disease. Patient no. 7 had advanced chronic obstructive pulmonary
`disease.
`b Patient no. 4 had total occlusion of the right coronary artery stent; complete right coronary artery reconstruction was performed in a previous procedure.
`
`Leire Unzue´ ,* Felipe Herna´ ndez, Maria Teresa Vela´ zquez,
`Julio Garcı´a, Agustı´n Albarra´ n, and Javier Andreu
`
`Unidad de Hemodina´mica y Cardiologı´a Intervencionista, Hospital 12
`de Octubre, Madrid, Spain
`
`* Corresponding author:
`E-mail address: leireunzue@yahoo.es (L. Unzue´ ).
`
`Available online 12 October 2011
`
`REFERENCES
`
`series of experience with the Heartrail II catheter. J Invasive Cardiol. 2011;
`23:E43–6.
`2. Mamas MA, Fath-Ordoubadi F, Fraser DG. Distal stent delivery with Guideliner
`catheter: first
`in man experience. Catheter Cardiovasc
`Interv. 2010;76:
`102–11.
`3. Kumar S, Gorog DA, Secco GG, Di Mario C, Kukreja N. The GuideLiner ‘‘child’’
`catheter for percutaneous coronary intervention - early clinical experience.
`J Invasive Cardiol. 2010;22:495–8.
`4. Rao U, Gorog D, Syzgula J, Kumar S, Stone C, Kukreja N. The GuideLiner ‘‘child’’
`catheter. EuroIntervention. 2010;6:277–9.
`5. Mamas MA, Fath-Ordoubadi F, Fraser D. Successful use of the Heartrail III
`catheter as a stent delivery catheter following failure of conventional techniques.
`Catheter Cardiovasc Interv. 2008;71:358–63.
`6. Wiper A, Mamas M, El-Omar M. Use of the GuideLiner catheter in facilitating
`coronary and graft intervention. Cardiovasc Revasc Med. 2011;12:68.5–7.
`
`1. Hynes B, Dollard J, Murphy G, O’Sullivan J, Ruggiero N, Margey R, et al. Enhancing
`back-up support during difficult coronary stent delivery: single-center case
`
`doi: 10.1016/j.rec.2011.08.003
`
`Variegate Porphyria and Atrial Fibrillation: Acute Attack
`Induced by Propafenone
`
`Porfiria variegata y fibrilacio´n auricular: ataque agudo inducido
`por propafenona
`
`To the Editor,
`
`Porphyrias are metabolic bone diseases caused by deficiencies of
`enzymes involved in heme biosynthesis. Acute hepatic porphyrias
`(AHPs) can present as episodes of acute porphyria with abdominal
`pain, autonomic dysfunction
`(hypertension,
`tachycardia, and
`gastrointestinal disorders), and deep motor neuropathy. Variegate
`porphyria (VP) is a type of autosomal dominant hepatic porphyria
`secondary to protoporphyrinogen oxidase activity deficiency that
`can present acute neurological manifestations and/or cutaneous
`photosensitivity. Drugs are the factors most commonly implicated
`as triggers of acute attacks. We describe a patient with VP who
`received class
`Ic antiarrhythmic agents for paroxysmal atrial
`fibrillation (AF) and presented with
`an acute episode of
`porphyria, which consisted of acute abdomen and syndrome of
`inappropriate antidiuretic hormone secretion (SIADH).
`Our patient was a 40-year-old male with a history of VP
`diagnosed by skin biopsy and elevation of blood aminolevulinic
`
`acid and porphobilinogen and fecal protoporphyrins who had a
`relative with the same condition but no activity to date. The
`patient experienced various episodes of paroxysmal AF. He was
`initially treated with flecainide but later switched to propafenone
`due to digestive intolerance. One week after initiating propafe-
`none therapy, the patient began to have abdominal pain and
`bloody urine. He came to the emergency room and was referred
`to the internal medicine department for further study. During the
`examination, only the diffuse abdominal pain without accom-
`panying signs of peritonism was relevant. The laboratory workup
`showed normal kidney function, GOT, 41 U/L; GPT, 43 U/L;
`alkaline phosphatase, 50 IU/L; GGT, 50 IU/L; LDH, 539 IU/L;
`sodium, 111 mEq/L; and plasma osmolarity, 231 mOsm/L. The
`urinary tests showed urinary sodium of 109 mEq/L and elevated
`osmolarity. The heart, thyroid, and adrenal panels were normal.
`An abdominal ultrasound showed no relevant findings; the
`Hoesch test was positive. Porphyrin and porphyrin precursor
`determination in urine showed an increase in porphobilinogen,
`as well as delta-aminolevulinic acid, coproporphyrin, and
`in stools. Based on these findings and the
`protoporphyrins
`normalization of biochemical and clinical parameters once
`propafenone was discontinued, an attack of propafenone-
`induced VP with SIADH as a form of expression was diagnosed.
`Hematin (5 mg/kg/day) was given for 4 consecutive days, and
`
`
`Page 2
`
`Teleflex Ex. 2170
`Medtronic v. Teleflex
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket