Author + information
- Received March 17, 2011
- Revision received May 24, 2011
- Accepted May 31, 2011
- Published online August 1, 2011.
- Vladimir Jelnin, MD,
- Yuriy Dudiy, MD,
- Bryce N. Einhorn,
- Itzhak Kronzon, MD,
- Howard A. Cohen, MD and
- Carlos E. Ruiz, MD, PhD⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Carlos E. Ruiz, Lenox Hill Heart and Vascular Institute of New York, 130 East 77th Street, 9th Floor Black Hall, New York, New York 10021-10075
Objectives This study sought to evaluate the safety of percutaneous direct left ventricular access for interventional procedures.
Background Experience with percutaneous access of the left ventricle (LV) for interventional procedures has been limited and associated with a high percentage of major complications. We report our clinical experience with percutaneous direct LV access for interventional procedures.
Methods Between March 2008 and December 2010, there were 32 percutaneous transapical punctures in 28 consecutive patients (16 males, mean age 68.2 ± 10.8 years). The delivery sheath sizes ranged from 5- to 12-F.
Results All transapical punctures were successfully performed, and safe closure of the access sites was achieved. Total procedural time was 153.6 ± 49.4 min for procedures converted from conventional approaches to a transapical approach, 129.5 ± 29.6 min for the transapical approach with trans-septal rail support, and 109.3 ± 41.4 min for the planned transapical approach. Fluoroscopy time was 61.3 ± 26.1 min, 29.7 ± 20.8 min, and 27.4 ± 21.4 min, respectively. Fluoroscopy time for closure of mitral paravalvular leaks was reduced by 35%, from 42.6 ± 29.9 min to 27.4 ± 15.6 min. Complications were observed in 2 patients (7.1%).
Conclusions With meticulous planning, transapical puncture is safe. The transapical access provides a more direct approach to the LV targets for intervention and leads to a significant decrease in the procedural and fluoroscopy times. Device closure of the direct LV access site is a reliable and safe method of hemostasis. Placement of a closure device should be considered if sheaths larger than 5-F are used. Although we used this technique only for paravalvular leak and LV pseudoaneurysm closure, it may have application for other percutaneous structural heart interventions.
For more than half a century, transapical left ventricular (LV) access has been used for diagnostics and hemodynamic assessment (1). Recently, direct LV access has also been used for interventional procedures (2–6). The largest experience has been gained from the direct surgical exposure of the LV through a mini-thoracotomy, mostly for transcatheter aortic valve implantation as well as for other interventions, although information about the safety of this approach is scarce. The experience with percutaneous access of the LV for interventional procedures has also been limited and associated with a high percentage of major complications (3–5). In this paper, we report our single-center clinical experience on percutaneous direct LV access and closure of the access site for different transcatheter interventions.
Between March 2008 and December 2010, 32 procedures with direct LV access were performed in 28 patients undergoing percutaneous closure of mitral paravalvular leak or LV pseudoaneurysm repair. Sixteen patients (57%) were males, and the mean age was 68.2 ± 10.8 years. Twenty-six patients underwent paravalvular leak repair, and 2 patients underwent repair of post-myocardial infarction LV pseudoaneurysm.
Fourteen patients had 1 prosthetic valve (2 mechanical, 12 biological), and 12 patients had 2 prosthetic valves (9 with both mechanical, 2 with both biological, and 1 with a mechanical aortic valve and a biological mitral valve). Patients exhibited a multitude of comorbidities: all patients had congestive heart failure, 18 (64%) had systemic hypertension, 12 (43%) had pulmonary hypertension, 11 (40%) experienced atrial fibrillation, 6 (21%) had a permanent pacemaker, 13 (46%) had extensive coronary artery disease, and 8 (31%) had previous coronary artery bypass graft surgery. All patients were in New York Heart Association functional class II to IV.
All procedures were performed in the dedicated structural heart catheterization laboratory under general anesthesia. Patients were advised of the procedural risks and options as well as the off-label use of all closure devices. Signed informed consent was obtained from all patients before the procedure. This retrospective study was approved by Lenox Hill Hospital's institutional review board.
All patients had 2-dimensional echocardiographic evaluation before each procedure. Two-dimensional and real-time 3-dimensional (3D) transesophageal echocardiogram (TEE) was used throughout each procedure. An Philips iE-33 with the ×7-T to 2-T 3D TEE probe (Philips Healthcare, Andover, Massachusetts) was used. Three-dimensional modalities included live real-time, real-time 3D zoom, and full-volume acquisition with and without color flow imaging.
Images were obtained and recorded during each stage of the procedure. The operator used the information thus obtained to guide the catheters and devices throughout the procedure (Fig. 1).
At the end of the procedure, careful echocardiographic evaluation was performed to exclude complications such as pericardial effusion, intracardiac clot, and so forth.
Computed tomography angiography
All patients underwent cardiac computed tomographic angiography (CTA) (256-slice iCT scanner, Philips Healthcare, Cleveland, Ohio) using helical scan mode with retrospective electrocardiogram-gated multiphase reconstruction (16 phases with 6.25% interval increments from RR interval) before the procedure. An Aquarius workstation (V-126.96.36.199, TeraRecon Inc., San Mateo, California) was used for 3D/4D volume rendering reconstruction for selecting the optimal entry point from the chest wall into the LV cavity. This included location of the cardiac apex, papillary muscles, and coronary arteries in relation to the chest wall, and the extension of the lung tissue over the LV cavity (Figs. 2 and 3).⇓ After the target entry point was selected and measurements obtained, an ink mark was placed on the skin of the patient.
During the procedure, pre-acquired CTA (4D volume rendering) was displayed in the catheterization laboratory adjacent to the fluoroscopy image, using a grayscale preset that simulates the fluoroscopy image. The reconstructed images were rotated and angulated according to the movement of the fluoroscopy image intensifier, allowing the CTA and the fluoroscopy images to be congruent throughout the procedure. This technique was used for transapical access as well as for intervening on the targeted defects.
More recently, we have also instituted the use of a prototype software “HeartNavigator” (Philips Healthcare, Best, the Netherlands) that allows overlay of a pre-acquired CTA image with live fluoroscopy. After coregistration, the overlaid 3D CTA images track the fluoroscopy image. Multiple target points marked on the CTA image can therefore be accurately projected on the live fluoroscopy indicating the entry point at the skin level, as well as into the myocardial surface, that can guide the needle access (Fig. 4).
Technique of direct LV access
All procedures were performed under general anesthesia. The puncture site was marked with ink on the patient's skin, according to measurements obtained from the CTA analysis. If the anterior border of the left lung overlapped the desired puncture site on the LV (Fig. 2B) the anesthesiologist was asked to deflate the left lung to minimize exposure of the lung tissue. A selective coronary angiogram was also used for patients in whom the CTA revealed proximity of the coronary arteries to the puncture site. The transapical puncture was accomplished by accessing the LV cavity percutaneously with a 21-gauge micropuncture needle (Cook Medical, Bloomington, Indiana).
The procedures were guided by live fluoroscopy and monitored with TEE. During the puncture, contrast was injected through the needle to monitor the entry into the LV cavity. After cannulating the LV, a 0.018-inch guidewire was advanced through the needle, and the needle was exchanged for a 5-F radial sheath (Cook Medical). Appropriate delivery sheaths were then introduced according to the interventional needs and ranged from 5- to 12-F.
Technique for closure of the direct LV access
In 4 patients with a transapical access sheath of 5-F, the access site was not closed. As previously reported, the closure of a transapical access site in 1 patient was performed using 2 0.052-inch Gianturco Coils (Cook Medical) (7). In 1 patient, the LV access was closed using a 6-mm Amplatzer Muscular VSD Occluder (AGA Medical Corporation, Plymouth, Minnesota). All other transapical accesses were closed using a 6-mm to 4-mm Amplatzer Duct Occluder (AGA Medical Corporation). The implantation of the closure device is performed under real-time fluoroscopy guidance. The device is delivered through the delivery sheath, and after the opening of the distal disk, the device is pulled back until resistance is felt and the flat disk conforms to the endocardial surface. The proper position of the device can be confirmed by fluoroscopy when visual elongation of the body of the device during each systolic contraction is noted. Before device release, echocardiographic confirmation of the device placement is obtained, and contrast injected through the delivery sheath confirms the pericardial position of the sheath. After device release, Surgiflo (Ethicon, Somerville, New Jersey) is injected through the delivery sheath, to fill the track from the epicardium to the skin.
All transapical accesses were successful, with no complications associated with the percutaneous LV puncture. In all 4 patients with 5-F access sheaths, no device closure of the access site was performed, and there were no complications observed in this group. In all other patients, the access site was successfully closed. There was 1 instance of a small pericardial effusion documented by echocardiography that required no further intervention. There was 1 procedure-related death in a patient with suprasystemic pulmonary hypertension who developed pulseless electrical activity (electromechanical dissociation) after transapical paravalvular leak closure and transapical puncture closure. Two-dimensional echocardiography and emergency thoracotomy did not show any pericardial effusion.
Two patients had repeat transapical access for closure of additional paravalvular leaks. In an additional 2 patients, a double transapical access, for simultaneous deployment and release of 2 closure devices for a crescent-shaped paravalvular leak, was performed (Fig. 5).
The patients that underwent paravalvular leak closure procedures were divided into 3 groups. Group A included 6 patients in whom the primary intended retrograde (arterial) and/or trans-septal (venous) approaches failed and procedures were converted to the transapical approach. Group B included 10 patients in whom a direct transapical approach combined with trans-septal access to create a venous–LV apical rail was initially planned. Group C included 10 patients in whom a solo transapical approach was used. Average fluoroscopy time was 61.3 ± 26.1 min for group A, 29.7 ± 20.8 min for group B, and 27.4 ± 21.4 min for group C. Total procedural time was 153.6 ± 49.4 min for group A, 129.5 ± 29.6 min for group B, and 109.3 ± 41.4 min for group C (Fig. 6).
All patients were clinically followed up to 33 months (average 13.8 ± 9.7 months, range 1 to 33 months) post-procedure. There were no long-term complications observed resulting from the transapical puncture or puncture site closure during this period.
Since the 1950s, percutaneous transapical puncture has been used mostly for diagnostic purposes. Braunwald (8) reported an overall cooperative experience in 1968 of LV puncture in 260 patients, with only 8 patients (3.1%) suffering major complications. Havranek and Sherry (9) reported overall procedure-related mortality of 0.5%, cardiac tamponade in 1.4%, and pleural complications in 2.7% in a review of >1,100 procedures in the literature. However, these results for diagnostic LV punctures were all from puncture needles and cannot be applied, therefore, to LV access for interventional procedures. A recent series by Pitta et al. (5) showed that the overall complication rate for direct LV access was 37.5%; however, the complication rate for those undergoing interventional procedures was 62% (8 of 13 patients). The most common complication was a hemothorax that they suggested could be caused by bleeding from the LV puncture site or laceration of the coronary, pleural, or intercostal vessels during the access.
In our study, complications were observed in 2 patients (7.1%): 1 instance of small pericardial effusion and 1 electromechanical dissociation that resulted in death in a patient with suprasystemic pulmonary hypertension. Cause of death remains unknown; however, electromechanical dissociation in patients with severe pulmonary hypertension has been previously described (10,11).
In our experience, the integration of previously acquired CTA images has been very useful for the planning and execution of direct needle entry into the LV cavity in an accurate and safe manner. In some patients, the transgastric TEE views may allow visualization of the anterior LV wall to guide the needle access. However, usefulness of this imaging modality is somewhat limited because of poor exposure of the LV apex. Therefore, a careful selection of the access site based on multi-imaging information is recommended to minimize complications associated with “blind puncture.”
On the basis of our results, it seems prudent to recommend closure of the LV access site, especially if the sheaths used are 6-F or larger. We believe that the main contributor to our low complication rate for transapical cardiac interventions compared with previous reports (3–5) is due to the closure of the puncture site. Our method of closure has proven to be effective and reliable for sheath sizes up to 12-F.
Although the longest follow-up is 36 months, a longer follow-up period is necessary before a definitive conclusion about the safety of using these devices for sealing the LV access can be reached.
In our series of paravalvular leak closure (12), the transapical approach resulted in a 35% decrease in the fluoroscopy time (27.4 ± 15.6 min compared with a total 42.6 ± 29.9 min) when compared with conventional arterial or venous access (Fig. 7). Furthermore, analysis within the transapical group showed that the planned transapical approach (group C) resulted in the shortest fluoroscopy and procedural times when compared with the converted and combined trans-septal procedures (groups A and B).
Thus, the direct LV access for these types of cardiac interventions may become a preferred route if, indeed, the procedural and fluoroscopy times are shorter and the complication rates are acceptable.
This study includes only patients that had previous cardiac operations, thus the risk of tamponade in these patients is decreased.
The presented long-term follow-up is based on clinical or phone call follow-up. The CTA was not obtained in all patients at late follow-up, and therefore, we cannot exclude late LV pseudoaneurysm formation at the site of puncture site closure.
With meticulous planning, transapical puncture is safe. The transapical access provides a direct approach to the LV targets for certain interventional procedures and leads to a significant decrease of the procedural and fluoroscopy times. Device closure of the direct LV access site is a reliable and safe method of hemostasis. Placement of a closure device should be considered if sheaths larger than 5-F are used. Although we used this technique only for paravalvular leak and LV pseudoaneurysm closure, it may have application for other percutaneous structural heart interventions.1,2,3,4,6,7,8,10,11,12
Dr. Kronzon has received speaking honoraria from Philips Healthcare and is a research grant recipient from GE Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- computed tomographic angiography
- left atrium
- left ventricle/ventricular
- transesophageal echocardiography
- Received March 17, 2011.
- Revision received May 24, 2011.
- Accepted May 31, 2011.
- American College of Cardiology Foundation
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