**10. Outcomes: Predictors of Survival**

risk. The posterior ventricular wall is repaired with the second patch using mattress sutures. Occasionally, depending on the size and quality of free wall myocardium, the free-edges can be approximated and closed primarily (and re-enforced with a pericardial or felt strip) rath‐

Closure of the ventriculotomy is performed by folding the free edge of the patch to the edge of the ventricle to exclude it from the circulation. The ventriculotomy repair is then closed with a primary closure re-enforced with strips of either Teflon felt or pericardium. Exclusion of the necrotic myocardium from the left ventricular is also important in minimizing the risk of small debris breaking off at any point and causing a systemic embolism. Biologic glues can be liberally used for small suture leaks, but it should be avoided in more significant

Regardless of the location of the ventriculotomy, it cannot be emphasized enough the im‐ portance of a tension free closure. Any unnecessary tension through injured or friable myo‐ cardium may predispose to catastrophic and potentially fatal post-operative bleeding once the ventricle becomes pressurized. In extreme cases involving extensive myocardial (free wall and septal) damage, temporary mechanical support with either extra-corporeal mem‐ brane oxygenation (ECMO) or a left ventricular assist device may help unload the ventricle to assist in recovery. The hypothesis behind this approach is by reducing the LV pressure, it will encourage recovery, reduce the pressure on the repair, and allow for further decision making in patients in whom there is extensive ventricular destruction and residual ventricu‐

Although the benefits of concomitant revascularization on long-term outcomes are debata‐ ble, complete coronary revascularization, if possible, is typically advocated [23]. As with other risk models for outcomes after surgery (e.g. EuroScore and STS models), it is the need for revascularization and the extent of underlying CAD that defines the long-term outcome rather than the actual performing of the procedure. Overall, the paradigm of complete and/or optimal revascularization should apply in cases of PI-VSD management. It is hard to refute the benefits of revascularization in the setting of an already acutely and chronically

The post-operative management of patients following successful repair should be similar to that of other high-risk cardiac surgery patients. However, there are several key princi‐ ples that must be remembered. As these patients often present and are taken to the oper‐ ating room in acute decompensated heart failure, strict attention to optimizing biventricular function is critical. Post-operative left ventricular dysfunction is common and there should be a low threshold for placement of an intra-aortic balloon pump (IABP), particularly if one was not placed pre-operatively. While, as discussed below, the use of an IABP is often

er than using a second patch.

306 Principles and Practice of Cardiothoracic Surgery

bleeding as this might suggest a less than stable closure.

lar function may not be adequate to support physiologic needs [19].

**8.5. General Principles**

ischemic myocardium.

**9. Post-operation Management**

The increasing rarity of PI-VSD implies that few centers are able to report an extensive ser‐ ies. Even though several large single center experiences and outcomes have been reported, most summarize years of experience and may not take into consideration the improvements in peri-operative management, surgical skills, and – probably most importantly – the clinical judgment necessary for the management of these critically ill patients.

In the GUSTO trial in which 41,021 patients were randomized to different strategies of re‐ perfusion during AMI, 84 developed a PI-VSD. 34 of these were managed surgically, with 31 (90%) undergoing early treatment and 3 (10%) undergoing delayed surgery. Survival in the surgical group was 53% at 30 days and 47% at 1 year. Conversely, for those treated medical‐ ly, as an indicator of the lethality of this problem, survival at 30 days and 1 year was 6% and 3%, respectively [13]. All patients who presented in Class III or IV heart failure died.

Deja and colleagues reported their experience with 117 patients from the Glenfield General Hospital in England. In their series, there were 76 anterior defects and 34 posterior defects. The mean age was 65 ± 8 years and 43 of the 117 were females. One third of patients were in cardiogenic shock at the time of presentation. The average time from AMI to the develop‐ ment (or diagnosis) of a PI-VSD was 6 days. The time interval from the point of diagnosis to surgical intervention was 9 days. The overall mortality was 37% and this does not include the 6.4% intra-operative mortality. Forty percent had evidence of a residual left-right shunt with 13 patients undergoing early re-operation. In patients undergoing re-operative surgery, mortality was 30%. Table 1 summarizes their overall results. The predictors of post-opera‐ tive mortality included:

**Favorable Predictors**

Pre-Op catheterization Anterior rupture **Unfavorable Predictors**

IABP

Age Gender Pre-Op IABP

MI: Myocardial infarction.

Stroke/Coma Renal failure Re-Op for bleeding **No effect on outcome**

Pre-Op Lytic therapy Concomitant CABG Residual shunt

**Favorable Predictors**

**Unfavorable Predictors**

Pre-Op catheterization Need for CABG

**No effect on outcome** Anterior rupture

Renal Failure requiring dialysis

Time from MI to Operating Room

Younger age

Pre-Op IABP

Residual shunt

Post-Op stroke Pre-Op Lytic therapy Post-Op IABP Re-Op for bleeding

**Table 3.** Predictors of Long-Term (> 30 day) Survival. See above for legend.

Short time from MI to Diagnosis

Short time from Diagnosis to Operating Room Short time from MI to Operating Room

**Table 2.** Predictors of short-term (< 30-day) survival based on National Swedish Experience (Adapted from Jeppsson et al. Euro J Cardiothor Surg 2005;27:216-221). CABG: Coronary artery bypass surgery, IABP: Intra-aortic balloon pump,

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The obvious criticism of this report is the long interval from the time of diagnosis to the time of surgery as earlier intervention, as advocated, might have resulted in less end-organ dam‐ age in an already compromised patient (Deja MA, 2002).


**Table 1.** Post-Operative Complications Following Surgical Repair (From Deja MA, 2002)

National registry data has proven useful to define the real-world experiences with this un‐ common problem. In a report from Sweden, outlining the national experience with 189 pa‐ tients, several factors were found to be predictive of favorable vs. unfavorable short (< 30 days) and long-term (> 30 days) outcomes (Tables 2 and 3) [27].


cardiogenic shock at the time of presentation. The average time from AMI to the develop‐ ment (or diagnosis) of a PI-VSD was 6 days. The time interval from the point of diagnosis to surgical intervention was 9 days. The overall mortality was 37% and this does not include the 6.4% intra-operative mortality. Forty percent had evidence of a residual left-right shunt with 13 patients undergoing early re-operation. In patients undergoing re-operative surgery, mortality was 30%. Table 1 summarizes their overall results. The predictors of post-opera‐

The obvious criticism of this report is the long interval from the time of diagnosis to the time of surgery as earlier intervention, as advocated, might have resulted in less end-organ dam‐

2 %

Overall surgical mortality (%) 37% Intra-operative mortality (%) 6.4 %

Re-exploration/bleeding 5 % Average ICU Stay 4.8 days Average Ventilator Time 40 hours Major inotropic support 90 % Use of Intra-aortic balloon pump 75 % Tracheostomy 5% Continuous renal replacement 16 % Stroke 5 % Residual shunt 40%

National registry data has proven useful to define the real-world experiences with this un‐ common problem. In a report from Sweden, outlining the national experience with 189 pa‐ tients, several factors were found to be predictive of favorable vs. unfavorable short (< 30

tive mortality included:

**1.** shock at time of surgery,

308 Principles and Practice of Cardiothoracic Surgery

**3.** need for concomitant CABG, and

(ECMO)

**2.** clinical deterioration while awaiting surgery,

age in an already compromised patient (Deja MA, 2002).

**4.** pre-operative renal failure (as a marker for shock and organ failure).

Need for extra-corporeal membrane oxygenation

**Table 1.** Post-Operative Complications Following Surgical Repair (From Deja MA, 2002)

days) and long-term (> 30 days) outcomes (Tables 2 and 3) [27].

**Table 2.** Predictors of short-term (< 30-day) survival based on National Swedish Experience (Adapted from Jeppsson et al. Euro J Cardiothor Surg 2005;27:216-221). CABG: Coronary artery bypass surgery, IABP: Intra-aortic balloon pump, MI: Myocardial infarction.


**Table 3.** Predictors of Long-Term (> 30 day) Survival. See above for legend.

The Italians also presented their experience with the outcomes of 58 patients treated be‐ tween 1992 and 2000 [10]. The mean age was 73 years. Thirty-six percent presented in acute renal failure, 33% were in atrial fibrillation, and 22% were insulin dependent diabetics. Most (57%) were in NYHA Class IV heart failure and 41% were in cardiogenic shock. Intra-aortic balloon pumps were used in only 20% of patients. Sixty percent had associated significant mitral regurgitation. The timing of surgery was 14 ± 12 days from the acute event with 76% undergoing surgery within the first 3 weeks and 31% within the first 24 hours. A key point is again emphasizing the importance of early diagnosis and surgery before the onset of shock and organ failure (Table 4).

emergent surgery (odds ration: 10.23) and a delayed treatment (OR: 4.03) were the only pre‐ dictors of early post-operative or operative mortality. Long-term survival was 76.5 ± 7.8 and 56.1 ± 11.5% at 5 and 10 years suggesting a reasonable outcome for this catastrophic prob‐

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However, patients with residual myocardium at risk from incomplete revascularization

A review of the Society of Thoracic Surgeons National Database has also provided some val‐ uable insight into the management and outcomes of the problem of PI-VSD. Arnaoutakis retrospectively reviewed all adult patients who underwent surgical repair of a PI-VSD be‐ tween 1999 and 2010 [3]. In this review, there were 2,876 patients – reflecting probably the largest series reviewed. In this cohort, 56.5% were males, almost half (49.7%) underwent emergent surgical intervention, and 65% had a pre-operative IABP. One third (33%) had un‐ dergone a previous percutaneous coronary intervention and 7.5% had undergone a previous CABG. The annual incidence of PI-VSD was relatively constant and ranged from 232-297 cases/year and implies that few reporting centers have a significant experience with this complex problem - of the 666 centers reporting data to the database the experience ranged from 0.09 to 3.7 cases/center/year. Consistent with previous reports, the overall operatively mortality was 42.9%. They found an inverse relationship between the timing of surgery and survival. Patients operated on within 6 hours of presentation had a 54% mortality. Survival was ~50% for the patients operated on between 1 and 7 days. However, of the 513 patients operated on >21 days after presentation had a <20% mortality – again, suggesting that those who present late and remain hemodynamically stable have a better long-term prognosis. Furthermore, when classified as elective, survival was 87% versus 20% for salvage opera‐ tions. Refractory cardiac failure was the most common cause of death post-operatively. Clearly, maintaining hemodynamic and physiologic stability is key to a good outcome. Ta‐

> **Favorable Unfavorable FAVORABLE FACTORS UNFAVORABLE FACTORS** Male gender Older age Hypertension Chronic kidney disease Smoking Need for pre-operative IABP

Chronic lung disease Pre-operative shock Pre-operative NYHA Class IV Previous CABG Pre-operative beta-blocker Triple vessel CAD Pre-operative lipid agent Lower Ejection Fraction Elective repair Salvage surgery Short bypass time Longer aortic cross-clamp time

**Table 5.** Adopted from Society for Thoracic Surgeons National Registry Database on favorable vs. unfavorable

lem. No significant predictors of long-term survival were found in their analysis.

tended to have a worse long-term prognosis [32].

ble 5 lists the predictors of a good outcome.

predictors of survival after repair of PI-VSD in 2,876 patients.


**Table 4.** Italian Registry Data. Legend: CPB: Cardiopulmonary bypass, IABP: Intra-aortic balloon pump, LVEF: Left ventricular ejection fraction, sPAP: Systolic pulmonary artery pressure. Table adapted from Cerin et al. Inter Soc Cardiovasc Surg 2003;11:149-154

In a series of 50 patients, operated on over 19 years (1983-2002), Mantovani et al reported their single center experience. The mean age of 66 ± 9 years (range: 45-81) who presented with either anterior (n=30, 60%) or posterior (n=20, 40%) PI-VSDs. Most patients developed their defects within the first week (76%) with an average of 4 days post-AMI. Only 2 patients presented after 2 days. Cardiac catheterization was performed in 98% of patients. Coronary angiography revealed single vessel disease in 51% of patients, double vessel disease in 35%, and 14% had triple vessel disease. Pre-operative IABP was used in 56% of patients and 74% underwent surgery within 2 days of diagnosis of a PI-VSD. Operative mortality (within 30 days) was 36% with 6 operative deaths. Posterior defects were associated with 50% mortali‐ ty versus 25% for anterior. Other univariate risk factors for early death included:

cross-clamp time >100 minutes (p=0.035);

emergent surgery (p=0.02); and delayed surgical intervention (>3 days post diagnosis, p=0.0055).

Interestingly, in their experience factors not associated with operative/post-operative mor‐ tality included: gender, extent of CAD (single vs. triple vessel disease), need for CABG, age (>65 years), or the year of operation (before/after 1992). In a logistic regression analysis, only emergent surgery (odds ration: 10.23) and a delayed treatment (OR: 4.03) were the only pre‐ dictors of early post-operative or operative mortality. Long-term survival was 76.5 ± 7.8 and 56.1 ± 11.5% at 5 and 10 years suggesting a reasonable outcome for this catastrophic prob‐ lem. No significant predictors of long-term survival were found in their analysis.

The Italians also presented their experience with the outcomes of 58 patients treated be‐ tween 1992 and 2000 [10]. The mean age was 73 years. Thirty-six percent presented in acute renal failure, 33% were in atrial fibrillation, and 22% were insulin dependent diabetics. Most (57%) were in NYHA Class IV heart failure and 41% were in cardiogenic shock. Intra-aortic balloon pumps were used in only 20% of patients. Sixty percent had associated significant mitral regurgitation. The timing of surgery was 14 ± 12 days from the acute event with 76% undergoing surgery within the first 3 weeks and 31% within the first 24 hours. A key point is again emphasizing the importance of early diagnosis and surgery before the onset of

> Time to OR (days) 11 ± 8 21 ± 13 % to OR < 24hrs 43 % 18 % Pre-operative Shock 57 % 28 % Pre-operative sPAP (mmHg) 56 ± 14 42 ± 11 CPB time (time) 126 ± 35 95 ± 28 Post-operative IABP 90 % 39 % Post-operative LVEF (%) 29 ± 2 45 ± 2 Post-operative Renal Failure 66 % 25 %

**Table 4.** Italian Registry Data. Legend: CPB: Cardiopulmonary bypass, IABP: Intra-aortic balloon pump, LVEF: Left ventricular ejection fraction, sPAP: Systolic pulmonary artery pressure. Table adapted from Cerin et al. Inter Soc

ty versus 25% for anterior. Other univariate risk factors for early death included:

In a series of 50 patients, operated on over 19 years (1983-2002), Mantovani et al reported their single center experience. The mean age of 66 ± 9 years (range: 45-81) who presented with either anterior (n=30, 60%) or posterior (n=20, 40%) PI-VSDs. Most patients developed their defects within the first week (76%) with an average of 4 days post-AMI. Only 2 patients presented after 2 days. Cardiac catheterization was performed in 98% of patients. Coronary angiography revealed single vessel disease in 51% of patients, double vessel disease in 35%, and 14% had triple vessel disease. Pre-operative IABP was used in 56% of patients and 74% underwent surgery within 2 days of diagnosis of a PI-VSD. Operative mortality (within 30 days) was 36% with 6 operative deaths. Posterior defects were associated with 50% mortali‐

emergent surgery (p=0.02); and delayed surgical intervention (>3 days post diagnosis,

Interestingly, in their experience factors not associated with operative/post-operative mor‐ tality included: gender, extent of CAD (single vs. triple vessel disease), need for CABG, age (>65 years), or the year of operation (before/after 1992). In a logistic regression analysis, only

**Non-Survivors (n=30) Survivors (n=28)**

shock and organ failure (Table 4).

310 Principles and Practice of Cardiothoracic Surgery

Cardiovasc Surg 2003;11:149-154

cross-clamp time >100 minutes (p=0.035);

p=0.0055).

However, patients with residual myocardium at risk from incomplete revascularization tended to have a worse long-term prognosis [32].

A review of the Society of Thoracic Surgeons National Database has also provided some val‐ uable insight into the management and outcomes of the problem of PI-VSD. Arnaoutakis retrospectively reviewed all adult patients who underwent surgical repair of a PI-VSD be‐ tween 1999 and 2010 [3]. In this review, there were 2,876 patients – reflecting probably the largest series reviewed. In this cohort, 56.5% were males, almost half (49.7%) underwent emergent surgical intervention, and 65% had a pre-operative IABP. One third (33%) had un‐ dergone a previous percutaneous coronary intervention and 7.5% had undergone a previous CABG. The annual incidence of PI-VSD was relatively constant and ranged from 232-297 cases/year and implies that few reporting centers have a significant experience with this complex problem - of the 666 centers reporting data to the database the experience ranged from 0.09 to 3.7 cases/center/year. Consistent with previous reports, the overall operatively mortality was 42.9%. They found an inverse relationship between the timing of surgery and survival. Patients operated on within 6 hours of presentation had a 54% mortality. Survival was ~50% for the patients operated on between 1 and 7 days. However, of the 513 patients operated on >21 days after presentation had a <20% mortality – again, suggesting that those who present late and remain hemodynamically stable have a better long-term prognosis. Furthermore, when classified as elective, survival was 87% versus 20% for salvage opera‐ tions. Refractory cardiac failure was the most common cause of death post-operatively. Clearly, maintaining hemodynamic and physiologic stability is key to a good outcome. Ta‐ ble 5 lists the predictors of a good outcome.


**Table 5.** Adopted from Society for Thoracic Surgeons National Registry Database on favorable vs. unfavorable predictors of survival after repair of PI-VSD in 2,876 patients.

In a multi-variate analysis of the clinical characteristics, the following variables were found to be predictors of post-operative death:

**11. Controversial Topics**

**11.1. Percutaneous Closure devices**

Successful application of less invasive non-surgical options and closure devices in children with congenital VSDs has prompted enthusiasm for the use of similar closure devices in pa‐ tients with PI-VSDs. The role of such devices has been proposed for both the primary clo‐

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However, because of the appeal of a less-invasive, non-surgical, option for these critically ill patients, investigators continue to try and define the role of septal occluder devices in pa‐ tients with PI-VSDs. Attia recently reviewed the literature of such devices [5]. Thirty manu‐ scripts were reviewed, but only 5 studies, consisting of approximately 100 patients, were felt to provide some insight into a "best practice" recommendation – despite numerous case re‐ ports. The general recommendations were that 1) surgical management still should be con‐ sidered the 'gold standard' for patients with PI-VSDs but occluder devices might have a role in small defects (< 15 mm diameter) and in patients who present late (> 3.5 weeks after the index event). Attia also suggested a potential role in attempting to minimize a significant shunt in patients who are too ill to survive surgery as temporizing and potential means of

While conceptually promising, the complex nature of acute defects as compared to congeni‐ tal defects has tempered some of the early enthusiasm as early experiences were discourag‐ ing and improvements in outcomes were not observed [35]. Difficulties in covering not only the actual defect, but also the residual necrotic myocardium predisposed to early recurrence. Challenges remain in the technology because of problems positioning the devices and ade‐

Despite advances in surgical and post-operative management, operative mortality is still high and depending on clinical presentation can vary between 10-60%[14]. Even with early inter‐ vention, biventricular failure is often a significant factor in early post-operative deaths. Short and long-term mechanical support, beyond intra-aortic balloon counterpulsation, is a reason‐ able option in patients with post-operative ventricular (left, right, or bi) failure and who are felt to be salvageable. Short-term support may be required as a bridge to recovery, while longterm device therapy may be indicated for those with irreversible ventricular failure. Since early acute co-morbidities and associated cardiogenic shock predict poor outcomes, there is some evidence and support for pre-operative biventricular mechanical support to allow for clini‐

In cases in which there is extensive ventricular infarction and acute heart failure, associat‐ ed free-wall rupture, or when there is excessive bleeding or tension from the ventriculoto‐ my, temporary left ventricular support should be considered. With LVAD inflow drainage from the left atrium, the LV is unloaded (i.e. 'atrialized') and may allow time as a bridge

cal optimization and stabilization as a bridge to definitive repair [11].

sure of acute defects and to assist in the closure of recurrent or residual shunts [41].

stabilizing a patient prior to urgent surgical intervention.

quately covering potentially complex defects.

**11.2. Mechanical Support**


**11.** Pre-operative mitral regurgitation

Of all of the variables, the strongest predictor of a poor outcome was pre-operative renal failure requiring dialysis. Interestingly, favorable variables included a history of hyperten‐ sion, congestive heart failure, and need for concomitant CABG. The authors emphasized pa‐ tients, due to their physiologic status, who required earlier intervention tended to have worse outcome. Obviously, the controversies regarding the balance between the timing of intervention and clinical optimization continue.

Unfortunately, there is little data reporting long-term survival. In their report of 68 patients undergoing surgery for PI-VSD between 1988 and 2007, Fukushima and colleagues from Brisbane, Australia provide some valuable insight and predictors of long-term outcomes [21]. In their report, 85% of patients underwent urgent surgery within 48 hours of diagnosis, 71% had concomitant CABG, and 30-day mortality was 35%. The mean follow-up was 9.2 years. Overall short-time outcomes and predictors of survival were similar to previous re‐ ports (as discussed above). The actuarial survival at 1 year was 67%, 63% at five years, 51% at 10 years, and 36% at 15 years. However, freedom from main adverse coronary events of the survivors was 91%, 61%, 40%, and 19% at 30 days, 1 year, 5 years, and 15 years respec‐ tively. At 5 years, freedom from congestive heart failure was 70% and 85% for ventricular arrhythmias – while at 10 years, 54% were free of heart failure and 71% from arrhythmias. For the cumulative survival analysis, there were 43 patients alive a 1 year, 34 at 5 years, 22 at 10 years, and 6 at 15 years.
