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Treatment of paravalvular leak ‘a moving target’
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Percutaneous intervention for paravalvular leaks is an attractive option to surgical repair, but both techniques carry benefits and risks, according to two studies published in JACC: Cardiovascular Intervention.
Specifically, results from both studies indicate that surgery, compared with transcatheter repair techniques, may yield better outcomes but is associated with worse perioperative complications. Long-term mortality also appears to be similar between the two treatment strategies.
Consequently, treatment of paravalvular leak remains “a moving target” and will require more study in the future, Thomas Pilgrim, MD, and Anna Franzone, MD, PhD, both from Bern University Hospital in Switzerland, wrote in an editorial accompanying one of the studies.
Effects on mortality, HF
In the first study, Xavier Millán, MD, from the University of Montreal, and colleagues evaluated long-term outcomes of 231 patients who underwent surgical correction (n = 151) or transcatheter reduction (n = 80) for significant paravalvular leak from 1994 to 2014 at a single center. The paravalvular leak location was mitral in 70.6% of patients.
According to data on periprocedural outcomes, more patients who underwent surgical correction vs. transcatheter reduction had no or minimal paravalvular leak after treatment (99.3% vs. 50%). However, the researchers found no significant differences between the two treatment groups in rates of in-hospital all-cause death (6.6% vs. 2.5%), MI (2.3% vs. 0%) and cerebrovascular accident (4.6% vs. 0%).
Therefore, periprocedural success — defined as correction of regurgitation and freedom from periprocedural death, repeated intervention, MI and cerebrovascular accident during the index hospitalization — was more common in patients who underwent surgical correction vs. transcatheter reduction (80.1% vs. 55%; P < .001).
During a median follow-up of 3.5 years, surgical correction, compared with transcatheter reduction, was linked to a decrease in all-cause death or hospitalization for HF (HR = 0.28; 95% CI, 0.18-0.44). Results also revealed a tendency toward a reduction in all-cause mortality after surgical correction vs. transcatheter reduction (HR = 0.61; 95% CI, 0.37-1.02).
However, compared with the general population or patients undergoing their first surgical valve replacement, the risk for all-cause death was not normalized with transcatheter reduction or surgical correction, the researchers noted.
They concluded that although surgery is associated with higher perioperative mortality and morbidity, it is also linked to better long-term outcomes, mostly driven by decreased hospitalizations for HF.
In their editorial, Pilgrim and Franzone noted that the data show beneficial and harmful effects for both procedures. Coupled with the significant heterogeneity in the location of the paravalvular leak and the transcatheter technique applied, the study should be interpreted carefully.
“Surgical and transcatheter treatment may be, in fact, complementary rather than competing, depending on the etiology, localization, accessibility and size of the [paravalvular leak],” they wrote.
Surgery vs. transcatheter treatment
A second study conducted by Mohamad Alkhouli, MD, from Mayo Clinic College of Medicine in Rochester, Minnesota, and West Virginia University, and colleagues was limited to patients with mitral paravalvular leak.
Of 381 patients (mean age, 66 years) with mitral paravalvular leak seen at the Mayo Clinic from 1995 to 2015, 195 underwent transcatheter treatment and 186 underwent surgical treatment.
Most patients seen after the introduction of transcatheter repair techniques were treated with an integrated multidisciplinary approach that included surgical and transcatheter strategies, the researchers noted.
The surgical group, compared with the transcatheter group, had a higher rate of technical success, defined according to Paravalvular Leak Academic Research Consortium criteria (95.5% vs. 70.1%; P < .001).
In-hospital major adverse events, including stroke, vascular complications, renal failure requiring dialysis, pneumonia, prolonged ventilation, hemothorax, tamponade and device embolization requiring urgent surgery, occurred more frequently after surgery than transcatheter treatment (22.5% vs. 7.7%; P < .001), as did in-hospital death (8.6% vs. 3.1%; P = .027). In multivariate logistic regression analysis, however, only active endocarditis, chronic renal failure and severe mitral annular calcifications were predictors of in-hospital mortality in the overall cohort, according to the data.
There were no significant differences in reintervention rates between the transcatheter and surgical treatment groups (11.3% vs. 17.2%), and most reinterventions in the transcatheter treatment group occurred early due to residual leak or persistent hemolysis.
The researchers also found no differences in long-term survival between the transcatheter and surgical treatment groups (adjusted HR = 0.8; 95% CI, 0.6-1.1).
Similar to the study conducted by Millán and colleagues, the researchers noted that surgery resulted in a higher degree of leak reduction but was linked to greater periprocedural complications.
“Effective management of these patients requires an integrated team approach that includes both percutaneous and surgical treatment and weighs early vs. late treatment on the basis of clinical and anatomic factors,” they wrote.
The study underscores the importance of referring patients to an integrated multidisciplinary team that offers both treatment options, so anatomic factors, surgical risk and long-term benefits can be balanced, according to Ismail Bouhout, MD, MSc, from the University of Montreal, and Aly Ghoneim, MD, from McGill University in Montreal.
In their editorial, they noted that use of and experience with transcatheter paravalvular leak closure techniques have increased.
“The encouraging and accumulating results of this approach demand a well-conducted randomized trial that will better define its role in the current armamentarium in the management of symptomatic [paravalvular leak],” Bouhout and Ghoneim wrote.
They also concluded that more research on devices specifically designed for paravalvular leak closure will likely improve the success of the procedure and long-term outcomes. – by Melissa Foster
References:
Alkhouli M, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.07.046.
Bouhout I, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.08.032.
Millán X, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.08.013.
Pilgrim T, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.08.034.
Disclosures: Alkhouli, Bouhout, Franzone and Ghoneim report no relevant financial disclosures. Millán reports he was supported by a research grant from Nova Domus (Erasmus Mundus program of the European Union). Pilgrim reports he has received research grants to the institution from Edwards Lifesciences, Symetis and Biotronik. Please see the studies for all other authors’ relevant financial disclosures.