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Ann Thorac Surg 2002;74:S1326-S1329
© 2002 The Society of Thoracic Surgeons


Supplement: Cardiothoracic Techniques and Technologies

Minimal access closure of patent foramen ovale: is it also recommended for patients with paradoxical emboli?

Ramzi K. Deeik, MDa*, Ryan M. Thomas, BSa, Pranya Sakiyalak, MDa, Sally Botkin, RN, MPHa, Bradford Blakeman, MDa, Mamdouh Bakhos, MDa

a Department of Thoracic and Cardiovascular Surgery, Loyola University Medical Center, Maywood, Illinois, USA

* Address reprint requests to Dr Deeik, Department of Thoracic and Cardiovascular Surgery, Loyola University Medical Center, 2160 South First Avenue, Building 110, Room 6243, Maywood, IL 60153, USA.

Presented at the Eighth Annual Cardiothoracic Techniques and Technologies Meeting 2002, Miami Beach, FL, Jan 23–26, 2002.


    Abstract
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
BACKGROUND: To investigate the outcome of the port-access approach for patent foramen ovale (PFO) closure and to identify the long-term risk of recurrent thromboembolic events in the paradoxical embolus subgroup after closure.

METHODS: Between 1997 and 2001, 31 patients underwent PFO closure using the port-access approach. Twelve of the 31 patients underwent PFO closure secondary to at least one paradoxical embolic event leading to either transient ischemic attack or cerebral infarction. All patients were followed longitudinally with office visits and telephone interviews.

RESULTS: The mean age was 47 years (range 18 to 85 years). All procedures were completed successfully without conversion to median sternotomy. The mean duration of aortic occlusion and cardiopulmonary bypass for all patients (n = 31) was 32 minutes (range 17 to 55 minutes) and 72 minutes (range 40 to 124 minutes), respectively. Postoperative complications included pneumonia/pulmonary embolus (n = 1), transient atrial fibrillation (n = 3, 9.7%), and exploration for bleeding (n = 3, 9.7%). No deaths were recorded. All patients were assessed using transesophageal echocardiography, and the closure of the PFO was documented. The average length of hospital stay was 3.8 days (range 2 to 10 days) for patients with paradoxical emboli. The mean follow-up period for the paradoxical embolus subgroup was 23 months (range 4 to 45 months). One patient was lost to follow-up. Neither transient ischemic attack nor cerebral infarction recurred during follow-up.

CONCLUSIONS: The port-access approach to PFO closure is a safe and effective procedure, with acceptable initial experience outcome and excellent low-risk rate of recurrent thromboembolic events.


    Introduction
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
A patent foramen ovale (PFO) is the most common abnormality of fetal origin found in adults, occurring in 10% to 15% of the normal population. A PFO has been increasingly recognized as a mediator of paradoxical embolism, allowing passage of air, thrombus, and fat [1]. Patients with PFO and paradoxical embolism are also at increased risk for recurrent thromboembolic events, with a combined cerebral infarction (CI) and transient ischemic attack (TIA) rate of 3.4% to 3.8% per year [2, 3].

Closure of PFO with the conventional midline sternotomy has been successfully performed, but it is associated with the risk of sternal wound problems and poor cosmetic results. To improve cosmetic results, different minimal invasive surgical approaches have recently been applied with good clinical results [4, 5]. Interventional cardiologists have developed percutaneous techniques for PFO closure in selected patients using a variety of devices. However, transcatheter procedures do not provide complete closure in all patients [6, 7]. The presence of a residual shunt, which is seen in up to 30% of patients after percutaneous closure [6, 8, 9], has been identified as a predictor for recurrent thromboembolic events [10]. The role of the minimally invasive port-access approach for PFO closure and its effect on thromboembolic event recurrence has not yet been determined. In the present study we assessed the long-term risk of recurrent thromboembolic events after the port-access approach for PFO closure, in patients with paradoxical embolism.


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Patients and procedures
In a 4-year period between 1997 and 2001, prospective data were maintained on 31 consecutive patients who underwent PFO closure using the port-access approach. Of these 31 patients, 12 underwent PFO closure secondary to at least one paradoxical embolic event leading to either TIA or CI. Of these 12 patients, 8 (67%) had TIA and 4 (33%) had CI. Ten of the 12 patients with paradoxical emboli had one TIA/CI event each before PFO closure and 2 patients had two events each; 1 of these 2 patients had two events in 1 week and the other had two events in 6 weeks. The mean time interval between the first event and surgical closure, for all patients with paradoxical emboli, was 39.3 weeks (range 0.5 to 208 weeks).

The indications for closure apart from the 12 patients with paradoxical emboli included heart failure in 3 patients, atrial arrhythmias in 6 patients, and syncope in 2 patients with atrial septal defect (ASD). Preoperative pulmonary artery pressure was elevated in 1 patient. One patient was found to have an ASD during a workup for pulmonary edema, which developed postpartum. The remaining patients were asymptomatic yet found to have ASD with left-to-right shunting and a QP/QS ratio (pulmonary flow to systemic flow) of more than 1.5:1.

Patients with aortic regurgitation or arteriosclerotic disease of the aorta or the femoral arteries were excluded as a contraindication to the safe use of the Heartport (Redwood City, CA) system for cardiopulmonary bypass (CPB). Patient informed consent was obtained regarding the procedure, and we discussed the possibility of conversion to a standard sternotomy approach.

Operative and postoperative data collected included aortic occlusion and CPB time, length of operation, length of postoperative hospital stay, and complications. All patients were followed longitudinally with office visits and telephone interviews. All patients completed a structured interview addressing recurrence of thromboembolism, current health status, and quality of life. Nine patients had neurologic examinations after a mean of 23 months (range 4 to 45 months).

Surgical technique
The patient is placed in the supine position with the right hemithorax elevated approximately 30 degrees. The patient is intubated with a double-lumen endotracheal tube to deflate the right lung. A transesophageal echocardiography (TEE) probe is placed to evaluate the position of the venous cannulas and the endoaortic balloon in the ascending aorta. External defibrillation pads are placed on the chest wall. A small (6 to 7 cm) right submammary incision is performed and the fourth intercostal space is entered. After systemic heparinization, a double-stage venous return cannula is placed in the femoral vein and advanced to the superior vena cava under TEE assistance and direct control using finger palpation. The pericardium is opened longitudinally anterior to the phrenic nerve. Moderate hypothermia (30°C) CPB is established using the Heartport system after cannulation of the right femoral artery. Correct placement of the endoaortic clamp (1 cm above the level of the sinotubular junction) is achieved by fluoroscopic and multiplane TEE assistance in all patients.

The inferior vena cava and superior vena cava are snared with an umbilical tape. The endoaortic balloon is inflated to occlude the ascending aorta and cold blood cardioplegic solution is delivered antegradely through the distal endoaortic clamp lumen. The balloon pressure is measured continuously and maintained between 250 and 340 mm Hg. After cardiac arrest, the right atrium is opened and the PFO is closed primarily with running suture technique. Before the suture is tied, the left side of the heart is filled with blood by ventilating the left lung. After the right atriotomy is closed with continuous suture, the endoaortic balloon is deflated. To completely remove air, suction is started through the distal lumen of the endoaortic clamp for further venting while the patient is placed in the Trendelenburg position. The patient is then weaned from the CPB and a single chest tube is inserted into the right pleural space.

Definitions
Transient ischemic attack was defined as a temporary neurologic deficit lasting 24 hours with complete resolution of symptoms. Cerebral infarction was defined as any new neurologic deficit lasting more than 24 hours. For simplicity, the term PFO included both ASD and PFO.


    Results
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Short-term results and periprocedural complications
The mean age of all patients was 47 years (range 18 to 85 years). The male-to-female ratio was 1:1.8. All procedures were completed successfully without conversion to median sternotomy. No major intraoperative complications were observed. Perioperative and intraoperative factors are presented in Table 1. The mean durations of aortic occlusion and CPB for all patients (n = 31) were 32 minutes (range 17 to 55 minutes) and 72 minutes (range 40 to 124 minutes), respectively. All patients were weaned from CPB without the use of inotropic agents. At the conclusion of the procedure all patients were assessed using TEE, and complete closure of the PFO was documented.


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Table 1. Perioperative and Intraoperative Factors

 
There was no operative mortality. There was no perioperative TIA or CI, myocardial infarction, or episode of hemodynamic instability. Morbidity included transient atrial fibrillation in 3 patients (9.7%). Three patients (9.7%) required reexploration for bleeding without enlarging the primary incision. Two had bleeding from intercostal arteries. One had no source of bleeding identified; however, the patient was on warfarin preoperatively. On the second postoperative day 1 patient developed a pneumothorax, which was observed and required no further intervention. One patient developed arm phlebitis that was successfully treated with local wound care and antibiotics. One patient had pneumonia and was treated with antibiotics. This same patient underwent anticoagulation therapy because of the finding of moderate probability for pulmonary embolus on the ventilation/perfusion scan.

The average length of hospital stay was 3.8 days (range 2 to 10 days) for the 12 patients with paradoxical emboli; 1 patient was dismissed within 48 hours of operation, and 7 patients were dismissed 72 hours after operation. The 1 patient who stayed in the hospital for 10 days was 85 years old who developed pulmonary complications of pneumonia and possible pulmonary embolus.

Follow-up and recurrent paradoxical embolism
The mean follow-up period was 23 months (range 4 to 45 months). One patient was lost to follow-up. During the observation period, no deaths were recorded and no TIA or CI recurred.


    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
The surgical closure of a PFO through a conventional midline sternotomy is a low-risk and highly successful procedure with a low probability of residual shunt, short hospital stays, and an excellent long-term result [11]. However, many patients are reluctant to have a residual long vertical scar in the midline of the chest because of cosmetic dissatisfaction, particularly in young asymptomatic female patients.

The objectives of surgical closure of a PFO/ASD are the reversal of hemodynamic abnormalities and the prevention of complications, including heart failure, atrial arrhythmias, and irreversible pulmonary hypertension, leading to improvement of symptoms. Another objective is to prevent recurrent thromboembolic events in patients with PFO and paradoxical emboli.

Over the past decade, PFO has been increasingly recognized as a mediator of paradoxical embolism. Patients with PFO and paradoxical embolism are also at increased risk for recurrent thromboembolic events, with a combined cerebrovascular accident and TIA rate of 3.4% to 3.8% per year [2, 3].

To minimize surgical trauma and improve cosmetic results, different minimally invasive surgical approaches have recently been applied with good clinical results [4, 5]. Also, in the last few years, the percutaneous technique performed by interventional cardiologists has become an accepted and attractive alternative to surgical PFO closure. At our institution, approximately 50% of patients with PFO underwent percutaneous closure during the same period of this study. The percutaneous technique has even become the standard technique for selected patients in some centers. However, the transcatheter percutaneous procedures do not provide complete closure in all patients. The success rate of the procedure is presently around 80% [12]. Failure due to device embolization or malposition resulting in a residual defect is seen in 4% to 20% [6, 7] and residual shunt is seen in up to 30% of patients [6, 8, 9]. The presence of a residual shunt has been identified as a predictor for recurrent thromboembolic events, with a relative risk of 4.2 [10]. This finding emphasizes the importance of achieving complete PFO closure in patients who have had a TIA or CI because of a paradoxical embolus. Once the diagnosis is made or suspected, the goal of treatment should be a definitive repair to minimize or even eliminate the risk of recurrent thromboembolic events.

The surgical closure of PFO using the standard approach, for the prevention of TIA or CI recurrence, has been performed in various centers with no early mortality and no stroke recurrence. The major objective of the minimal access approach rather than median sternotomy is to improve cosmetic results. In our study, using a minimal access approach, no mortality and no recurrent neurologic ischemic symptoms occurred. After the procedure, we have been able to document complete PFO closure by TEE in all patients. The absence of a midline sternotomy incision accounted for an excellent aesthetic result.

The mean age of our patient population with paradoxical embolus was 52 years (range 29 to 85 years), which is 10 years older than that of other series of PFO and paradoxical embolism [2, 3]. One observation in our study was that older age (older than 55 years) was not predictive of recurrent thromboembolic events after PFO closure. Although other causes of stroke appear to predominate in the elderly, the careful exclusion of known causes of stroke seems to minimize the risk of recurrent TIA or CI in elderly patients after PFO closure. However, this finding may have just been because of the small number of patients older than 55 years (n = 4) with paradoxical embolism in our study.

The most frequent morbidity was atrial fibrillation, but the most common complication requiring intervention was bleeding that necessitated reexploration in 3 of the 31 patients. The complication may have been related to the learning curve of the 3 surgeons performing this operation at our institution, as each surgeon had one reexploration. Two patients had bleeding from intercostal arteries. Meticulous attention to any intercostals bleeding during entry and closure in the remaining patients has essentially eliminated the risk of reexploration for bleeding from this source. One patient, who was on warfarin preoperatively, had no source of bleeding identified.

Patent foramen ovale closure using a minimal access approach is safe and effective, with acceptable initial experience outcomes. Increasing recognition of the role of PFO in recurrent TIA and CI at our institution has led to an increasing number of patients referred for a definitive repair. The procedure provides an excellent low-risk rate of recurrent thromboembolic events with good cosmetic results. We believe that a total endoscopic approach for ASD closure, using direct suturing, will be even more beneficial for the comfort of the patient with a less noticeable scar.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

  1. Caes F.L., Van Belleghem Y.V., Missault L.H., Coenye K.E., Van Nooten G.J. Surgical treatment of impending paradoxical embolism through patent foramen ovale. Ann Thorac Surg 1995;59:1559-1561.[Abstract/Free Full Text]
  2. Mas J.L., Zuber M., French Study Group on Patent Foramen Ovale, and Atrial Septal Aneurysm. Recurrent cerebrovascular events in patients with patent foramen ovale, atrial septal aneurysm, or both and cryptogenic stroke or transient ischemic attack. Am Heart J 1995;130:1083-1088.[Medline]
  3. Bogousslavsky J, Garazi S., Jeanrenaud X., Aebischer N., Van Melle G., Lausanne Stroke with Paradoxical Embolism Study Group.. Stroke recurrence in patients with patent foramen ovale: the Lausanne Study. Neurology 1996;46:1301-1305.[Abstract/Free Full Text]
  4. Black M.D., Freedom R.M. Minimally invasive repair of atrial septal defects. Ann Thorac Surg 1998;65:765-767.[Abstract/Free Full Text]
  5. Massetti M., Babatasi G., Rossi A., et al. Operation for atrial septal defect through a right anterolateral thoracotomy: current outcome. Ann Thorac Surg 1996;62:1100-1103.[Abstract/Free Full Text]
  6. Rickers C., Hamm C., Stern H., et al. Percutaneous closure of secundum atrial septal defect with a new self centering device ("angel wings"). Heart 1998;80:517-521.[Abstract/Free Full Text]
  7. Lloyd T.R., Rao P.S., Beekman R.H., 3rd, Mendelsohn A.M., Sideris E.B. Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial). Am J Cardiol 1994;73:283-291.
  8. Bohm J., Bittigau K., Kohler F., Baumann G., Konertz W. Surgical removal of atrial septal defect occlusion system-devices. Eur J Cardiothorac Surg 1997;12:869-872.[Abstract]
  9. Sievert H. Catheter closure of congenital shunts. Cor Europaeum 1998;7:59-73.
  10. Windecker S., Wahl A., Chatterjee T., et al. Percutaneous closure of patent foramen ovale in patients with paradoxical embolism: long-term risk of recurrent thromboembolic events. Circulation 2000;101:893-898.[Abstract/Free Full Text]
  11. Murphy J.G., Gersh B.J., McGoon M.D., et al. Long term outcome after surgical repair of isolated atrial septal defect. Follow up at 27 to 32 years. N Engl J Med 1990;323:1645-1650.[Abstract]
  12. Fischer G., Kramer H.H., Stieh J., Harding P., Jung O. Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer septal occluder. Eur Heart J 1999;20:541-549.[Abstract/Free Full Text]



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