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Section of Cardiac Surgery, University of Michigan Health System, Cardiovascular Center—Room 5161, 1500 E Medical Center Dr, SPC #5864, Ann Arbor, MI 48109-5864
(Email: fpagani{at}umich.edu).
Maltais and colleagues [1] have reported an alternative treatment paradigm for postinfarction ventricular septal defect (VSD) using a catheter-based percutaneous closure method with the Amplatzer device (AGA Medical Corp, North Plymouth, MN). They demonstrated an overall mortality of 42% for patients undergoing device closure, which was not significantly different from the cohort of patients treated with surgical closure. The authors should be congratulated for attempting to devise an alternative treatment option to a very difficult surgical problem [2].
Experience with catheter-based methods of closure of a postinfarction VSD is limited and primarily derived from anecdotal case reports. Recently, Holzer and colleagues [3] reported 18 patients (16 with successful device deployment) with a 30-day mortality of 28%. These patients were at relatively low risk, with only 10% in cardiogenic shock at the time of the procedure. Bialkowski and colleagues [4] reported 19 patients (procedural success obtained in 14 patients), 11 of whom were between 3 and 12 weeks after the myocardial infarction. None of the patients with an acute postinfarction VSD who were treated survived the procedure. These data suggest that the optimal timing of intervention with a device, or the optimal patient population to intervene upon, is not yet established.
The study by Maltais and colleagues [1] comprised higher-risk patients undergoing device closure. In their report, 9 patients received initial treatment with device therapy, whereas 3 received device therapy for treatment of a residual VSD after initial surgical correction. Of the 9 patients that received initial device therapy, 2 (22%) died of procedural complications (right ventricular perforation with tamponade and a second from device embolization at day 3), and 3 (33%) required subsequent surgical procedures: 2 for closure of a residual VSD after device closure (1 of these occurring 8 months after device closure) and 1 coronary artery bypass grafting (CABG) at late follow-up. In the device group, 3 additional patients died of multisystem organ failure within 30 days of the procedure for a total mortality of 42% (5 patients) for this cohort.
Several important observations from the study by Maltais and colleagues [1] are evident. First, procedural complications related to device therapy were substantial. Second, until further clinical experience is obtained, the optimal patient population to intervene upon—acute presentation with shock vs late with stable hemodynamics—is unknown and not adequately defined by their experience. The role of adjuvant revascularization at the time of surgical closure of the VSD has been important to improving long-term survival in this patient population [5]. The importance of this observation is also reinforced in their report, where 62% of patients in the surgical arm underwent CABG of the culprit lesion, and patients additionally received CABG for all vessels with stenoses exceeding 70%, when appropriate. The effect of this important observation needs to be considered in any new algorithm of a catheter-based percutaneous therapy.
Finally, the lack of statistical significance in survival between the two cohorts of patients is not definitive proof of the equivalence of the therapies given the limited sensitivity of statistical analyses in this size cohort to identify meaningful clinical differences in survival. Age, presence of shock, left ventricular ejection fraction, and location of the VSD were also shown not to be relevant variables predicting survival, factors that are commonly accepted to be of clinical importance [2].
Arguably, the study by Maltais and colleagues [1], despite having a number of important limitations, raises the feasibility of an alternative approach to the well-established surgical paradigm for the treatment of postinfarction VSD. The difficulty will be in assessing the appropriate place of this catheter-based therapy in a rigorous scientific fashion given the relatively low incidence of this problem.
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