Eur J Cardiothorac Surg 2006;29:S245-S250
© 2006 Elsevier Science NL
Septal anterior ventricular exclusion operation (Pacopexy) for ischemic dilated cardiomyopathy: treat form not disease
Tadashi Isomura
a
,
*
,
Taiko Horii
a
,
Hisayoshi Suma
b
,
Gerald D. Buckberg
c
,
d
, the RESTORE Group
a Hayama Heart Center, 1898 Shimoyamaguchi, Hayama, Kanagawa 240-0116, Japan
b The Cardiovascular Institute, Tokyo, Japan
c Option on Bioengineering, California Institute of Technology, Pasadena, CA, USA
d David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
Received 3 February 2006;
received in revised form 28 February 2006;
accepted 1 March 2006.
* Corresponding author. Tel.: +81 468 75 1717; fax: +81 468 75 3636. (Email: t-isomura{at}hayamaheart.gr.jp).
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Abstract
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Objective: Restoration of left ventricle size and shape is an effective surgical procedure in patients with dilated cardiomyopathy. This report defines early and intermediate results following the reshaping of the left ventricle from spherical to ellipsoid configuration in patients with ischemic cardiomyopathy, employing a technique for LV restoration (LVR) that uses form rather than disease as the endpoint for oblique patch placement. Methods: Between 1998 and 2004, a cohort of 83 patients with dilated ischemic cardiomyopathy underwent an operation to reshape the left ventricle. In 54 patients the Dor procedure was done, and 29 underwent the septal anterior ventricular exclusion (SAVE) procedure to emphasize the elliptical shape, whereby patch placement followed an oblique trajectory between the LV apex and septum below the aortic valve. Ventricular form, rather than the disease scar marked the suture placement site endpoint to create an ellipse. The mean age was 58 ± 27, but SAVE patients had larger end systolic volume index (135 ± 38 vs 95 ± 25*). Overall preoperative NYHA functional class III was in 69% and IV in 31 patients, but more SAVE patients were in class IV (38% vs 28%*). The procedures were elective in 72 and emergent in 11, with similar entry criteria for each procedure. Results: In combination with LVR operation, mitral surgery was performed in 49/83 and tricuspid annuloplasty in 23/83 patients, but these procedures were more common after SAVE (59% vs 44%* and 45% vs 19%*, respectively), because of larger LV volumes in SAVE patients; 2.8 ± 1.3 coronary artery bypass grafts were used. Perioperative use of IABP or LVAD was 15 and 1, respectively in 83 patients. Hospital death was in 1/11 or 9% after emergent operations and 3/72 or 4% in elective procedures, with no difference between groups. After discharge from the hospital, NYHA class improved to class I or II in 57 patients, class III/IV in 14 patients, with 10 late deaths. The 5-year survival rate after the elective operation was 80.3% in SAVE and with elective operation and 77.4% in the Dor procedure. Conclusion: The SAVE or Pacopexy technique is easy to reshape the dilated left ventricle from spherical to ellipsoid form after the LVR, and the resultant improved configuration may contribute to the overall results for patients with ischemic dilated cardiomyopathy.
Key Words: Congestive heart failure • Ischemic cardiomyopathy • SAVE • Pacopexy • Helical heart
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1. Introduction
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Restoration of left ventricle has been performed to treat left ventricular aneurysm [1,2]; ventricular size is reduced as the procedure excludes the non-functional ventricular. In 1998, Dor et al. [3] reported that endoventricular circular patch plasty (EVCPP) could be an alternative treatment to heart transplantation for patients with ischemic cardiomyopathy (ICM). Late results were improved in the overall population, but higher late mortality was observed in ischemic patients when there was a large preoperative end systolic volume, and the exclusion patch was placed over the scarred region, leaving a larger postrestoration LV volume [4].
In 1995, Batista introduced partial left ventriculectomy to treat patients with non-ischemic dilated cardiomyopathy, but results were variable due to non-specific exclusion of the lateral wall [5], which might have contained important viable muscle [6–8]. Intraoperative echo mapping was introduced to overcome this problem in site selection [6,9], and early and long-term results were improved by site selecting in non-ischemic disease in a manner that matched exclusion of ischemic scar in ischemic dilated cardiomyopathy. To accomplish this task, the septal anterior ventricular exclusion (SAVE) or Pacopexy technique was developed to reconstruct elliptical form when there was septal involvement, with patch placement in an oblique direction between the apex and the septum just below the aortic valve [8].
This paper shall use these form-related principles to compare results in applying this SAVE procedure in ischemic patients, whereby the decision for patch placement is made to rebuild an elliptical form. With ischemic disease, this site of patch placement is into normal muscle that is the septal scar, and postoperative shape matches the elliptical configuration aimed in non-ischemic disease with the SAVE or Pacopexy procedure. This site differs from the Dor procedure where the patch site is at the scar, and early and late comparisons will be made.
Results will also be presented for the overall population, and then subdivided into elective and urgent procedures because early and late survivals may be impacted severely by high mortality in urgent procedures. This analysis is made because expected results from elective operations in the high-risk dilated heart failure population may be offset by reporting collaborative urgent and elective cases together.
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2. Methods
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Between 1998 and 2004, 29 patients with ischemic cardiomyopathy underwent the SAVE procedure and 54 underwent the Dor operation to reshape the left ventricle (Table 1
). The mean age was 58 ± 27. There were 77 men and 5 women. Preoperative NYHA functional class was in class III for 69% and in class IV for 31% patients. Table 2
shows the differences in ventricular volumes in this patient cohort, as LV end systolic volume index (LVESVI) was 135 ± 38 ml/m2 and 95 ± 25 ml/m2 in the SAVE and Dor patients, respectively; normal LVESVI is 25 ml/m2. More SAVE patients were in class IV (38% vs 28%, p
< 0.05) as preoperative LVESVI was higher.
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Table 1. Preoperative characteristics of patients undergoing the SAVE or Dor procedure for ischemic cardiomyopathy
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Congestive heart failure symptoms were controlled with full medication in 72 patients; however, 11 patients received emergent operation because of uncontrollable heart failure. The preoperative coronary anatomy shared a single lesion in 20, double in 19 and triple in 44 patients (Table 1). In elective operations, left ventricular motion was examined by cine-MRI, ventriculogram, and color kinesis of cardiac echogram. The elective operation was in 72/83 patients (87%) and emergent operation was in 11/83 patients (13%, with no differences between procedures).
Supplemental procedures were undertaken, as 49/83 patients underwent mitral valve procedures (33 repairs and 8 replacements), and 23/83 had tricuspid annuloplasty (Table 3
). Mitral and tricuspid procedures were more common after SAVE (59% vs 44%, p
< 0.05 and 45% vs 19%, p
< 0.05, respectively) on account of larger LV volumes. Twenty-five had cryoablation. Perioperative intraaortic balloons were used in 15 patients and LVAD was needed in one patient.
2.1 Operative procedures (Fig. 1)
Following initiation of cardiopulmonary bypass and blood cardioplegic heart arrest, complete coronary revascularization was performed, and mitral repair for mitral regurgitation via left atriotomy or tricuspid surgery via right atriotomy was performed, if necessary. The aortic cross clamp was then released to allow the heart to start beat, since LV restoration was always performed in the beating heart, and perfusion pressure was kept above 75 mmHg to ensure ongoing coronary perfusion.
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Fig. 1. Septal anterior ventricular exclusion (SAVE) operation was performed by (A) placing multiple mattress stitches with 0-Tycron along to the exclusion line extending from apex to septum, just beneath the aortic valve; (B) suture placement into patch, from Teflon pledget to patch along septum, from lateral wall to patch on free wall; (C) completed procedure via open ventricle; and (D) closure of ventriculotomy, with resultant conical configuration.
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The left ventricle was opened from apex to the base along to the left anterior descending artery. While kinesis of the left ventricular wall had been examined by preoperative examination, palpation of the left ventricular muscle during its contraction allowed differentiation between scar and normal muscle. However, scar was not the determinant of the site for patch trajectory for the SAVE procedure as these hearts were approximately five-fold larger than normal (e.g. LVESVI 135 ml/m2 vs 25 ml/m2 for the SAVE procedure).
For the septal anterior ventricular exclusion (SAVE) operation, multiple mattress stitches with 0-Tycron were placed along to the exclusion line of the septum, with a direction that proceeded from the apex to a septal site 1 cm below the aortic valve. Sutures were placed above the scar. The anterior lateral wall exclusion direction was also performed in similar fashion with multiple mattress sutures, as shown in Fig. 1. The Haemashield patch was trimmed to create a longitudinal shape, approximately 3 cm x 8 cm, and placed along the site of the exclusion, with sutures placed 1 cm from the patch edge to leave a patch rim outside these sutures to leave a rim outside these sutures.
The Dor procedure was done in the traditional way with use of only the scar to define site of patch placement. The incised left ventricle was closed with double layers of mattress sutures and then over sewn with a running over-and-over suture. Cardiopulmonary bypass was then weaned uneventfully.
Postoperative kinesis and left ventricular volume was examined in all patients, together with the measurement of cardiac output, PA pressure, LV volume, or LVEDP. These data were compared with those before the operation as shown in Table 2. All patients were followed up and re-examined for left ventricular dynamics every 6 months after the operation. The same follow-up was made in the entire cohort of the 83 patients undergoing LVR for ischemic disease.
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3. Results
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In combination with the SAVE operation, mitral surgery was performed in 17/29 patients and tricuspid annuloplasty was accomplished in 10/29 patients, and 2.7 ± 1.3 coronary grafts were placed per patient. Cryoablation for ventricular tachyarrhythmia (VT) was applied in 10 patients. Less mitral and tricuspid procedures were done patients undergoing the Dor procedure (25/54 and 13/54, respectively; p
< 0.05), and 15/54 underwent cryoablation.
Perioperative use of IABP or LVAD was required in 15 and 1 patient, respectively, with no difference. Hospital death was in 1/11 (9%) among emergent operations and deaths were in 3/72 (4%) in elective operations. Postoperative left ventriculograms or MRI were performed, and ventricular shape became ellipsoid after the SAVE operation as shown in the left side image of Fig. 2
. In contrast, postoperative shape was more spherical when the restoration was done by restricting the patch placement to the scar during endoventricular circular patch plasty (EVCPP) or the Dor procedure, as shown as the right side image in Fig. 2.
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Fig. 2. Postoperative left ventriculograms of patients undergoing the SAVE or Dor procedure. Ventricular shape became ellipsoid after the SAVE operation as shown in the left image. In contrast, postoperative shape was more spherical (right image) when the restoration was done by restricting the patch placement to the scar, using endoventricular circular patch plasty (EVCPP).
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Hemodynamic improvement was observed after SAVE, as LVEF increased from 23 ± 6% to 31 ± 7% and LVESVI fell from 135 ± 39% to 96 ± 25%, as shown in Table 2, with similar changes after the Dor procedure. Overall hospital death rate was 3/11 or 9% after emergent operations and 3/72 or 4% in elective procedures. There was no death following SAVE in elective patients and one death after emergent procedure. The results of the Dor procedure were not different, with three deaths followed elective Dor procedures, including ventricular tachycardia (VT) in one, and two from congestive heart failure; no deaths followed urgent procedures.
NYHA class improved to class I/II in 57 patients who were in class III/IV preoperatively. Conversely, 11 patients remained in class III/IV with 10 late deaths. Three deaths followed the SAVE procedure (VT in one, renal failure in one and cerebral infarction in one), and seven deaths followed discharge after the Dor procedure (VT in two, CHF in four and cancer in one as shown in Table 4
). The 5-year survival rate after the elective operation was 80.3% in the SAVE procedure and 77.4% in the Dor procedure (Fig. 3
).
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Fig. 3. Hospital and late follow-up mortality (between 1998 and 2004) after elective operation for ventricular restoration using the SAVE and Dor procedures.
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The overall experience with ventricular restoration for dilated ischemic cardiomyopathy between 1997 and 2004 in 128 patients is shown in Fig. 4
. Results from the SAVE and the Dor procedures are combined, and data are presented for elective and emergent procedures. The higher mortality from emergent procedures accounts for the total number (Total) that combines both indications (emergent/elective). Five-year survival rate after the operation was 68.5% in elective operation, and the early mortality accounted for the 47.7% long-term survival after emergency operation.
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Fig. 4. Overall hospital and late follow-up mortality (between 1997 and 2004) between in a 128 patients treated for ischemic dilated cardiomyopathy (including the SAVE and Dor procedures). Note, higher early mortality in emergent procedures, compared with elective operation (total combines elective and emergent results).
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4. Discussion
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Until the employment of ventricular restoration, heart transplantation was the only established surgery in patients with end-stage dilated cardiomyopathy (DCM). The geometric changes in this process involve conversion of the normally elliptical LV chamber into a sphere shape. In ischemic dilated cardiomyopathy, a scar exists at the site of infarction; there is stretch of the remote compensatory muscle with remodeling dilation. This report deals with patients with ejection fraction below 30% and excessive ventricular volumes. Restoration was done by employing a novel method of restoration, the SAVE or Pacopexy procedure that converts the sphere into an elliptical chamber or in the standard endoventricular circular patch plasty method described by Dor [10]. The operative process in SAVE uses an oblique oval patch and rebuilds the form to address the restoration process, and this rebuilding concept is not restricted to only excluding the scarred region. For both procedures, the early and late results show marked reduction in volume, improved ejection fraction, and prolonged survival with a better NYHA status.
Use of restoration for ischemic disease follows the fundamental studies by Dor, who advised placing an endoventricular patch on the scar and demonstrated remarkable results, especially in some patients who would otherwise have required transplantation [3]. Results following ventricular restoration in ischemic disease exceed those obtained after coronary grafting alone, where prognosis is inferior to transplantation [11]. However, the recent report of Di Donato et al. [4] shows that despite improvement by restoration, higher late mortality occurs when the early LVESVI is large (>120 ml/m2) as a bigger chamber is left if the limits of restoration are linked to placing the patch at the edge of the scar. More dilated remote muscle is retained by using the scar to restrict the extent of patch placement.
The SAVE or Pacopexy operation reflects an alternate procedure [6] that was initially developed to deal with non-ischemic cardiomyopathy and is linked to two factors. First, recent studies using intraoperative echo showed the importance of site selection for patch placement in non-ischemic disease [9], and thereby exposed a serious pitfall of the Batista et al. [12] procedure that assumed that a global disease exists and only excludes the lateral wall. The consequent low output syndrome resulting from excluding the best muscle became clear, and this new identification of predominant septal involvement led to the expansion of the original Dor procedure to exclude the entire septum from the apex to just below the aortic valve. The second observation involves linking this novel procedure to the spatial observations of Torrent-Guasp, who described the helical ventricular myocardial band [13]. The elliptical shape formed by the overlapping ascending and descending segments of the apical loop accounts for the natural helix formation, and flattening of these loops by spherical formation is the underpinning of failure. The SAVE or Pacopexy technique was described [7,6] to rearrange these fibers.
An important technical consideration in ischemic dilated cardiomyopathy is that the patch is placed into the septum just below the aortic valve, a site selection that may or may not contain scar. The objective of the SAVE or Pacopexy technique is to reconstruct form, rather than to focus only upon disease. The patch acts as an intraventricular curtain with contracting muscle folded upon its surface. This concept of creating an elliptical form has also been described in the past by Guilmet et al. [14] and more recently by Calafiore et al. [15] and Matsui et al. [16].
The importance of volume reduction is emphasized by Yamaguchi et al. [17] who analyzed left ventricular volume and operative results with CABG alone in patients with ischemic cardiomyopathy in 1992, and concluded that left ventricular end systolic volume index greater than 100 ml/m2 was an independent predictive risk factor for the development of postoperative congestive heart failure. He expanded this observation by recently adding restoration and observing markedly improved late results [17]. The value of reconstructing the apex while rebuilding the helix as described by Torrent-Guasp to generate an elliptical shape [18] is emphasized because factors responsible for ejection and suction during the cardiac cycle are linked to the ascending and descending segments of the muscle band as shown by recent sonomicrometer studies [19]. Koyama et al. [20] described, in 2003, the importance of the apex of the left ventricle for cardiac function, after restoration of the left ventricle in DCM in experimental studies.
In these concepts for restoration of the left ventricle and our results after SAVE operation, we found that the cardiac function of the dilated left ventricle seemed to improve by reducing the volume and reforming the shape of the left ventricle. With the use of the EVCPP technique as described by Dor et al., the volume of the left ventricle is reduced by exclusion of antero-septal wall; however, the shape of left ventricle seemed to become spherical as in Fig. 2. This configuration is due to the use of scar as the site of patch placement, rather than making elliptical ventricular form the keynote objective for optimal return of ventricular function. The tendency for better earlier results and less cardiovascular events during the first 2–3 years after SAVE versus Dor procedure may imply some benefit from the more elliptical shape, but this hypothesis needs subsequent testing.
The data were separated into overall results, with a breakdown into elective and emergent procedures. The impact of less favorable results in urgent patient is shown in Fig. 4 that defines our overall ischemic cardiomyopathy experience. This observation shows that a favorable prognosis can be expected in high-risk ischemic patients undergoing either the traditional Dor or the new SAVE operation. The observed higher mortality in urgent cases suggests that some future consideration may be given to the use of an LVAD for circulatory support during this earlier time frame, thereby making LVAD as a ‘bridge to restoration.’
The 80.3% 5-year survival for SAVE/Pacopexy cohort and 77.4% after the Dor procedure, in the patients undergoing elective procedures, offer a sharp contrast to the expectations in the class III/IV patients who do not undergo restoration. These long-term benefits are comparable to those following heart transplantation, yet these patients are free of the secondary vascular and neoplastic complications of the supportive drugs needed in transplantation patients. Restoration is not a substitute for pharmacologic therapy for heart failure, but rather creates a more favorable geometric form to allow a better substrate for these agents.
The cumulative findings that postoperative volume of the left ventricle has decreased approximately 30%, coupled with improved long-term survival, suggest that the SAVE technique provides an easy way to reshape the dilated left ventricle in ischemic cardiomyopathy. The more elliptical form that results from this procedure implies that the goal in ischemic cardiomyopathy with a large chamber may change from excluding only the disease to rebuilding a conical ventricular form. Consequently, the intraventricular guideposts for reconstruction that usually involves patch placement may alter from current attention that is directed only at the visible scar to the creation of a more natural form that may place sutures beyond the obvious disease.
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Footnotes
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Read at 10th RESTORE meeting in San Francisco, California. April 9, 2005.
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Abstract
1. Introduction
