Catheterization and Cardiovascular Interventions 76:993–997 (2010)
`
`Complications Associated with Left Ventricular
`Puncture
`
`Sridevi R. Pitta, MBBS, Allison K. Cabalka, MD, and Charanjit S. Rihal,* MD
`
`Objective: To report complications in a consecutive series of patients undergoing per-
`cutaneous left ventricular apical puncture (LVAP) and sheath placement for diagnostic
`or interventional procedures. Background: Percutaneous LVAP is only rarely used to
`provide hemodynamic data in the presence of mechanical prosthetic valves. Recently,
`LVAP has been used to facilitate complex interventional procedures such as paravalvu-
`lar leak closures. These frequently necessitate placement of 4–6 F sheaths, rather than
`smaller needles. Optimal technique and outcomes are largely unknown for this uncom-
`mon procedure. Methods: We retrospectively analyzed 32 patients undergoing LVAP
`with echocardiographic and fluoroscopic guidance at our institution between 2002 and
`2009. These patients were referred to the cardiac catheterization laboratory for hemo-
`dynamic assessment to rule out prosthetic dysfunction and or to facilitate paravalvular
`leak closure. Sheaths ranged from 4 to 6 F were removed at the end of the procedure
`after reversing any anticoagulation. No specific closure devices were used for hemo-
`stasis. Frequency of access site complications associated with LVAP recorded.
`Results: Apical access site related complications were higher in patients requiring
`LVAP for intervention than for diagnostic purposes (25% vs. 12.5%). Hemothorax was
`the most frequent serious complication occurring in 6 (19%) patients and frequently
`required intervention 5(16%). Three patients had local bleeding with no drop in hemo-
`globin or need for intervention. Conclusions: LVAP is associated with a significant inci-
`dence of access-related complications. There is a need for safe and reliable methods
`of closing percutaneous LVAP access sites.
`VC 2010 Wiley-Liss, Inc.
`
`Key words: complications; left ventricular apical puncture; hemodynamics; hemothorax
`
`INTRODUCTION
`
`METHODS
`
`Percutaneous left ventricular apical puncture (LVAP)
`is a rarely used procedure, but has been performed to
`provide hemodynamic data and/or left ventricular angi-
`ography in the presence of mechanical prosthetic
`valves [1–3]. More recently, LVAP has been used to
`facilitate complex interventional procedures, such as
`paravalvular leak closure [4]. Interventional procedures
`typically require larger size sheaths. This technique is
`not without complications and an earlier series from
`our institution of 20 LVAP for hemodynamic assess-
`ment demonstrated a complication rate of 30%. All
`were minor complications [2]. Review of 38 patients
`from Mass General hospital from 1989 to 2000 indi-
`cated an 8% complication rate [5]. Other series of
`complications of LVAP after diagnostic or interven-
`tional catheterizations are limited to small case series
`and range of complications varied depending on defini-
`tions [4,6]
`The purpose of this study is to report our more
`recent experience in a consecutive series of patients
`with prosthetic valves undergoing percutaneous LVAP
`for either diagnosis or intervention.
`
`VC 2010 Wiley-Liss, Inc.
`
`We identified all cases of direct LVAP between
`2002 and July 2009. Patients were referred to the car-
`diac catheterization laboratory for hemodynamic and
`angiographic assessment to rule out prosthetic dysfunc-
`tion or for paravalvular leak closure. Procedures were
`performed under echocardiographic and fluoroscopic
`guidance. Size of sheaths depended on the choice of
`the operator and ranged between 4 and 6 F. Smaller
`
`Division of Cardiovascular Diseases and Department of Inter-
`nal Medicine, Mayo Clinic, Rochester, Minnesota
`
`Conflict of interest: Nothing to report.
`
`*Correspondence to: Charanjit S. Rihal, MD, Division of Cardiovas-
`cular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN
`55905, USA. E-mail: rihal@mayo.edu
`
`Received 27 April 2010; Revision accepted 28 April 2010
`
`DOI 10.1002/ccd.22640
`Published online 6 October 2010 in Wiley Online Library
`(wileyonlinelibrary.com)
`
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`

`
`994
`
`Pitta et al.
`
`size sheaths were generally used for diagnostic pur-
`poses with larger sheaths used to facilitate paravalvular
`leak closure. Preparation involved holding oral anticoa-
`gulation prior to the procedure (target INR < 1.5) and
`discontinuing intravenous heparin for 4 hr before the
`procedure. However, all
`interventional patients were
`actively anticoagulated at time of apical puncture. The
`chest was palpated for the maximal apical impulse and
`draped with sterile technique. After identifying the left
`ventricular apex by examination and transthoracic
`echocardiography (TTE) with the angle of approach
`
`landmarks for LV apical puncture: sche-
`Fig. 1. Anatomical
`matic representation of heart and its relationship to surround-
`ing anatomical structures.
`
`being noted by two-dimensional imaging, 1% lidocaine
`was injected subcutaneously and intracostally to pro-
`vide local anesthesia. Care was taken to avoid the neu-
`00
`rovascular bundle. An 18 or 21 gauge Angiocath (6
`Teflon Catheter System, Becton-Dickson, San Jose,
`CA) needle was advanced with the presence of ectopic
`beats typically indicating contact with LV epicardium.
`The needle was advanced into the LV (Fig. 1) and
`pressure recorded. After cannulating the LV, the wire
`was advanced and the needle exchanged for a 4-F
`sheath or higher based on operator choice. However, in
`18 patients, patients after withdrawing the needle and
`stylet, the sheath was directly connected for pressure
`measurement without upsizing. To facilitate paravalvu-
`lar defect closure, either a 10 or 15-mm gooseneck
`VR Snare Kit, EV3, Plym-
`snare (Amplatz GooseNeck
`outh, MN) was used to snare the antegrade transeptal
`wire (Fig. 2). This wire was then exteriorized through
`the apical sheath, establishing an external rail to facili-
`tate crossing of the defect with the delivery catheter
`through which the closure device was placed. At the
`end of the procedure, the sheath was removed after
`reversing any anticoagulation. No closure devices were
`used for hemostasis. Data were retrospectively ana-
`lyzed for
`in-hospital complications. Complications
`associated with left ventricular puncture were defined
`as (1) new pericardial effusion identified on TTE or
`transesophageal echocardiogram (TEE); (2) new pleu-
`ral effusion identified by chest X-ray, TTE, TEE, or
`chest computerized tomography; (3) external bleeding
`at the access site; (4) chest pain of pleuritic or pericar-
`ditic nature; (5) death.
`
`Fig. 2. Fluoroscopic image of LV puncture with snare: LV cannulated using the 18 gauge
`needle and upsized to a 4-F sheath or higher based on operator choice. During the paravalv-
`ular leak closure, a 10-mm gooseneck snare was used to snare the antegrade transseptal
`wire (Fig. 2A). Transseptal wire is exteriorized to the chest wall, establishing an arterial ve-
`nous rail and assisting in the placement of the closure device (Fig. 2B).
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
`ENDOHEART AG, EX. 2002 Page 2
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
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`

`
`Complications Associated with Left Ventricular Puncture
`
`995
`
`TABLE I. Summary of Literature on Left ventricular Apical Puncture
`
`Author
`
`Morgan et al. [3]
`Ommen et al. [2]
`Walters et al. [5]
`Lim et al. [4]
`Brown et al. [6]
`
`Year
`
`1989
`1998
`2003
`2008
`2009
`
`Number of patients Diagnostica
`
`Intervention
`
`Total complications
`
`Majorb
`
`Minorc
`
`Hemostasis
`
`112
`20
`38
`6
`5
`
`112
`20
`38
`1
`0
`
`None
`None
`None
`5d
`5e
`
`25 (23%)
`6 (30%)
`3 (8%)
`1 (17%)
`2 (40%)
`
`3 (2.6%)
`None
`2 (5%)
`1 (17%)
`1 (20%)
`
`22 (20%)
`6 (30%)
`1 (3%)
`None
`1 (20%)f
`
`Manual
`Manual
`Manual
`Purse string suture
`Surgical & deviceg
`
`aLVAP performed for hemodynamic evaluation.
`bMajor complications defined as pericardial tamponade and moderate to large hemothorax effusions requiring interventions.
`cMinor complications: pleuritic or pericarditic chest pain, ventricular tachycardia, bradycardia, hypotension, vasovagal reaction.
`dIndication: Paravalvular leak (n ¼ 4), VSD (n ¼ 1).
`eIndication: Paravalvular leaks (n ¼ 3), ventricular tachycardia ablation (n ¼ 1), fontan conduit leak (n ¼ 1).
`fLeft anterior descending coronary artery was punctured and dissected requiring coronary stent.
`gMinithoracotomy (n ¼ 3), percutaneous (n ¼ 2), surgical closure (n ¼ 4), closure device (Prostar XL TM, Perclose Europe, Berkshire, UK).
`
`RESULTS
`
`We identified 32 patients who underwent LVAP;
`there were 18 males and 14 females, and age range
`between 35 and 83 years. All patients had had prior
`
`cardiac surgeries (n ¼ 32). Direct LVAP was per-
`
`formed for hemodynamic assessment of prosthetic
`valve dysfunction in 19 (59%) patients and to facilitate
`paravalvular
`leak closure
`in 13 (41%) patients.
`Twenty-four patients had both mechanical aortic and
`mitral valves, 1 patient had mechanical valves in aor-
`tic, mitral, and tricuspid positions, one mechanical
`
`valve in either aortic or mitral (n ¼ 4), bioprosthetic
`aortic and mitral (n ¼ 2), and mechanical aortic and
`bioprosthetic tricuspid valve (n ¼ 1).
`
`Inhospital Complications
`
`Access site-related complications occurred in 12
`(37%) patients undergoing LVAP. Patients requiring
`LV puncture for intervention had a higher complication
`rate than for diagnostic purposes (25% vs. 12.5%).
`Hemothorax was the most frequent serious complica-
`tion, occurring in 6 (19%) patients (Fig. 3). Five
`patients developed large effusions and one patient had
`a small effusion,
`three required a chest
`tube, one
`required thoracotomy, and one needed ultrasound-
`guided thoracentesis. Four patients with hemothorax
`required multiple transfusions of packed red blood
`cells. Hemothorax was identified the day of the proce-
`dure in all but one patient. This patient experienced
`acute bleeding with hemothorax the day after a proce-
`dure and after being dismissing in stable condition.
`This occurred after using a snowblower, and presenting
`with chest pain, pallor, and respiratory distress. A large
`left hemothorax required chest tube drainage and blood
`transfusion. Four patients had small pericardial effu-
`sions by TTE or TEE, but none developed tamponade
`or required urgent pericardial aspiration. Three patients
`had chest wall or access site bleeding with no drop in
`hemoglobin or requiring any intervention. Chest wall
`
`pain characteristic of pericarditic or pleuritic occurred
`in 4 (12%). The complications are detailed in Figure 4.
`There were no deaths related to the procedure; how-
`ever, three patients subsequently died during hospitali-
`zation. One patient died from severe hypoxia and mul-
`tiorgan failure, one from advanced heart failure, and a
`third died from multiorgan failure after undergoing
`open heart surgery for the fifth time.
`
`DISCUSSION
`
`The key finding in our study was that left ventricular
`puncture is associated with a significant number of se-
`rious access-related complications, particularly hemo-
`thorax. Experience with LVAP is limited to a small se-
`ries of patients or to case reports. In the majority of
`the cases, LVAP was performed for assessing hemody-
`namics. Morgan et al. [3] has classified LVAP associ-
`ated complications into major (pericardial tamponade
`and pneumothorax) and minor complications (pericar-
`dial effusion, pericardial pain, bradycardia, hypoten-
`sion, and pleuritic pain). However, this classification
`did not
`include hemothorax. We further classified
`LVAP-associated complications into major (large to
`moderate hemothorax requiring intervention, pericar-
`dial tamponade); all other access-related complications
`are categorized as minor. Review of the literature (ta-
`ble 1) showed major complications ranging between 3
`and 5% in earlier series, when LVAP was primarily
`used for diagnostic purposes. Major complications
`increased to 17–20% in the interventional era. In our
`series, major complications occurred in 5 (16%)
`patients, and all these patients developed large hemo-
`thorax requiring intervention. Potential
`sources of
`hemothorax could be the puncture site bleeding, lacera-
`tion of a coronary artery, a pleural artery, or intercostal
`vessel trauma. All patients were previously anticoagu-
`lated, and all patients undergoing interventional proce-
`dures were actively anticoagulated with heparin, which
`would inherently increase the risk of bleeding. Pointing
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
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`
`

`
`996
`
`Pitta et al.
`
`Fig. 3. Chest radiographs: preprocedure chest X-ray showing no evidence of pleural effusion
`(Fig. 3A). Postprocedure chest X-ray showing large left sided pleural effusion (Fig. 3B).
`
`from previous surgery, and systolic contraction sealing
`the puncture site after catheter removal.
`It is evident that complications vary among different
`studies and depend upon the indication for procedure,
`size of the access sheath, and type of hemostasis used
`for sheath removal. Thus far,
`there is no validated,
`safe, and reliable method of closing the percutaneous
`LVAP access site, but devices available for femoral
`puncture closure may or may not be applicable for the
`LV apex. Lim et al. [4] performed purse string sutures
`to the superficial skin after sheath removal in all eight
`
`patients undergoing LVAP (n ¼ 6) or right ventricular
`puncture (n ¼ 2) with good success. Only one patient
`
`developed hemothorax due to intercostal vein trauma.
`This was the first study using LVAP for interventional
`purposes and using large sheaths ranging from 6 to 9 F
`[4]. In another series, four patients had direct surgical
`closure of the puncture site and one patient had suc-
`cessful closure using percutaneous vascular occlusion
`device (Prostar XL, Perclose, Europe, Berkshire, UK)
`[6]. Use of closure devices is a novel idea, and further
`studies need to be conducted using newer devices and
`techniques
`to obtain better hemostasis
`to reduce
`access-related complications.
`
`CONCLUSIONS
`
`We conclude that LVAP is associated with a signifi-
`cant incidence of access-related complications, particu-
`larly in patients requiring LVAP for interventional pur-
`poses. There is a need for a safe and reliable method
`of closing percutaneous LVAP access sites.
`
`Fig. 4. Frequency distribution of access related complica-
`tions: distribution of access related left ventricular apical
`puncture complications.
`
`the needle superior to the rib can avoid intercostal ves-
`sel trauma. In addition, selective performing coronary
`angiography helps to avoid significant marginal or left
`anterior descending artery injury. Animal experiments
`by Semple et al. [7] have shed some insight into the
`potential cause bleeding from the left ventricle. This
`study noted that guidewire acted like a ‘‘saw’’ and
`could have been a major culprit for the bleeding. It
`also demonstrated that fewer punctures, smaller cathe-
`ter, necessity for speed in exchanging the catheters
`over guidewire. Another
`interesting finding in this
`study was that retrosternal pain tends to be severe and
`occurs to occur earlier in the procedure; pleuritic pain
`is less severe, and occurs toward the end of the proce-
`dure. The pain is related to the extravasation of blood
`[7]. Relatively low incidence of pericardial effusion is
`thought be from left ventricular hypertrophy, scarring
`
`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
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`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`

`
`Complications Associated with Left Ventricular Puncture
`
`997
`
`REFERENCES
`
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`
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`Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
`Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
`
`ENDOHEART AG, EX. 2002 Page 5
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530