Author + information
- Adam B. Greenbaum, MD∗ ( and )
- Tiberio M. Frisoli, MD
- ↵∗Address for correspondence:
Dr. Adam B. Greenbaum, 4th Floor, Clara Ford Pavilion, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, Michigan 48202.
Should paravalvular leaks (PVL) always be repaired using transcatheter techniques? In this issue of JACC: Cardiovascular Interventions, Wells IV et al. (1) report that, compared with surgery, transcatheter PVL repair had comparable success, but with a shorter operation; shorter length of stay; less major morbidity; and with a similar composite incidence of death, reintervention, and readmissions for heart failure through 1 year. The answer to our question now seems to be: Yes.
When patients with PVL develop worsening heart failure or severe hemolysis requiring transfusions, the current recommendation is for closure of the leak. The problem is not an uncommon one with prevalence as high as 5% to 17% (2,3). Importantly, repeat surgery is associated with high mortality rates with each subsequent operation less likely to be successful and more likely to be fatal (4). In 2000, Moore et al. (5) used a Gianturco coil (Cook Medical, Bloomington, Indiana) to close a mitral PVL in a child. In the time since, numerous transcatheter and hybrid techniques to deliver various “plugs” often of the Amplatzer family of products (St. Jude Medical, St. Paul, Minnesota) have been introduced and have become an increasingly attractive alternative to surgical closure (6). Yet to date, the recommended approach remains surgical closure. So why does surgical repair remain the preferred approach to the management of significant PVL? Maybe because to date there have been limited tools for, and poorly standardized approaches to, transcatheter closure and there has been little data comparing transcatheter techniques with surgical repair.
In now the largest U.S. study to date, Wells IV et al. (1) make a much-needed contribution to addressing these issues. In this retrospective study of 114 patients undergoing PVL closure of mechanical or bioprosthetic valves in the aortic, mitral, and/or pulmonic positions, no differences were found in 30-day clinical success; in the 1-year composite endpoint of death, reintervention for PVL, or readmission for heart failure; or in 30-day or 1-year survival between those undergoing transcatheter or surgical repair of the PVL. Yet, a transfemoral, transcatheter approach was associated with shorter intensive care unit and post-operative stays, less major morbidity (a composite of in-hospital stroke, renal failure requiring dialysis, seizure requiring medication, additional operation, prolonged ventilation, and cardiac arrest), fewer transfusions, lower rates of readmission through 30 days, and a trend toward reduced 1-year mortality. Although a retrospective study, the 2 groups were relatively well matched for age, surgical risk, comorbidities, New York Heart Association Heart Failure class, type and location of valve affected, and baseline echo findings. Additionally, these favorable outcomes were achieved in comparison with a surgical cohort that also had excellent outcomes when compared with historical control subjects with 30-day rates for procedural success and mortality of 95% and 7%, respectively, despite the inclusion of patients with active endocarditis and despite a high ratio of valve re-replacement as opposed to repair.
An ideal device for transcatheter PVL closure would have the appropriate size and shape to promote successful sealing of a PVL with a single device and would not interfere with valve leaflets or with vital structures (i.e., coronary ostia) with little risk of embolization. Currently, in the United States there are no devices specifically designed or approved for use in PVL closure or any with the above characteristics. Yet in this study, with “off label” use of “nondedicated” devices, a high rate of procedural and clinical success was achieved with transcatheter techniques and these rates were comparable with results to previous studies (7,8). The authors also describe their transition over time from a “waist” technique using the body of the device to fill the defect to a “cap” technique wherein the terminal disc of tightly woven nitinol is used to cover the defect. In a comparison of the 2, patients in which the “cap” technique was used had better 30-day outcomes, and a 20% absolute risk reduction in the 1-year primary composite endpoint. Had the “cap” technique been used from the onset, outcomes may have been even more favorable for transcatheter techniques.
Despite the promising data reported, some unresolved issues remain. Transcatheter closure for PVL can be time-consuming and technically challenging. There can be anatomic characteristics of the defect precluding closure (e.g., inability to cross defect with wire or to deploy device without interference with the valve or other structures); residual shunt and need for reintervention; hemolysis, which may be (at least temporarily) aggravated by a high-velocity jet crossing through the device; and/or device embolization. Although the comparison of 2 transcatheter techniques in this study provides some help in standardizing transcatheter approaches, the transition from 1 technique to another in this study itself highlights an important institutional learning curve at a single, large-volume academic center with skilled operators. In an “intention-to-treat analysis” including the earlier unsuccessful transcatheter procedures, success rates were still similar to those seen in other transcatheter repair studies, (7,8) and there was no statistical difference in 30-day clinical success or in the 1-year primary endpoints between transcatheter and surgical repair. However “intention-to-treat” analysis now revealed surgically treated patients had better 30-day PVL reduction and lower rates of re-intervention at 1 year (1). Whether similar outcomes can be uniformly achieved with this specific or other transcatheter techniques and at all programs remains less certain.
Another remaining issue is one of cost. Devices currently being used during PVL closure are expensive and although the number of devices required per case was not reported in this publication, more than one is often required. A successful procedure often also mandates (multimodality) imaging before, during, and after intervention. Pre-procedural computed tomography often plays a role in defining size and location of defects. Intraprocedurally, 3-dimensional transesophageal echocardiography is critical for characterization of leak size and course and to guide intervention. Although many centers approach transcatheter closure of PVL fully percutaneously (i.e., a transfemoral approach), some still prefer a hybrid surgical (transapical) approach. Whether the decrease in intensive care unit and overall hospital length of stay along with less readmissions of a transcatheter approach counterbalances its pre-procedural and procedural cost, and whether this even applies to hybrid surgical approaches has yet to be analyzed.
Although many questions remain and more data with larger multicenter studies and with longer follow-up would clearly be welcome, this study comparing an evolving transcatheter approach with well-executed surgical repair of PVL lends support to the contention that, short of active endocarditis, a transcatheter approach should be the preferred first-line intervention for PVL. If nothing else, very few procedural complications were reported with a transcatheter approach to PVL in this study and in the reported published data, and, maybe more importantly, a “transcatheter first” approach does not seem to preclude any subsequent surgical intervention in cases where it is unsuccessful. So should all PVL still be first approached with surgical repair? No more second chances.
↵∗ Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.
Dr. Greenbaum is a proctor for St. Jude Medical. Dr. Frisoli has reported that he has no relationships relevant to the contents of this paper to disclose.
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