• SCAI TAVR Center
    Supported by:Medtronic

    November 2014 Journal Scan

    Presented by Kreton Mavromatis, MD, FSCAI and George Hanzel, MD, FSCAI

    Feasibility and Exploratory Efficacy Evaluation of the Embrella Embolic Deflector System for the Prevention of Cerebral Emboli in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTAVI-C Pilot Study.

    Rodés-Cabau J, Kahlert P, Neumann FJ, Schymik G, Webb JG, Amarenco P, Brott T, Garami Z, Gerosa G, Lefèvre T, Plicht B, Pocock SJ, Schlamann M, Thomas M, Diamond B, Merioua I, Beyersdorf F, Vahanian A. 
    JACC Cardiovasc Interv. 2014 Oct;7(10):1146-55. 
    • Authors' Conclusion: “This study showed the feasibility and safety of using the EED system in TAVR procdures.  The EED system did not prevent the occurrence of cerebral microemboli during TAVR or new transient ischemic lesions as evaluated by DW-MRI, but it was associated with a reduction in lesion volume.  Further studies are warented to determine the efficacy of using the EED system during TAVR procedure.”

    • Interpretation: Stroke is an important complication of TAVR and efforts to reduce this complication are necessary.  In this small study, employing the Embrella Embolic Deflector (EED) system, there were, surprisingly and concerning, an increased number of new lesions detected by DW-MRI, although the volume per lesion was lower, in the EED group compared with the non-EED group.  Interestingly, all lesions resolved by 30 days, suggesting that these small lesions represented ischemia and not infarction.  These finding are counterintuitive and therefore much larger studies are critical to determine whether the EED system reduces the risk of clinically relevant strokes.  

    Costs of Periprocedural Complications in Patients Treated With Transcatheter Aortic Valve Replacement: Results From the Placement of Aortic Transcatheter Valve Trial.

    Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, Petersen JL 2nd, Douglas PS, Svensson LG, Gada H, Thourani VH, Kodali SK, Mack MJ, Leon MB, Cohen DJ; on behalf of the PARTNER Investigators.
    Circ Cardiovasc Interv. 2014 Oct 21. pii: 
    • Authors' Conclusion: “In the PARTNER trial, periprocedural complicaitons were frequent, costly, and accounted for ~25% of non-implant-related hospital costs.  Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency.”

    • Interpretation: In this analysis of the PARTNER trial 49% of patients suffered a complication (1 in 21.4%, 2 in 10.0%, and ≥3 in 17.5%).  Complications were associated with a $12,475 increase in hospital costs (~25% of non-implant-related costs).  Although reduction in complications will help reduce costs, the impact would be modest.  Reduction in device and overall procedure costs will be essential to decrease the cost of TAVR.

    Predictors and clinical implications of atrial fibrillation in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

    Barbash IM, Minha S, Ben-Dor I, Dvir D, Torguson R, Aly M, Bond E, Satler LF, Pichard AD, Waksman R.
    Catheter Cardiovasc Interv. 2014 Oct 17. 
    • Authors' Conclusion: “Baseline and postprocedure AF are common in AS patients indergoing TAVI.  However, only postprocedure AF is associated with a prolonged and more complicated hospital course.  AF is associated with poor long-term, but not short-term, mortality.”

    • Interpretation: In this study of 371 patients baseline AF was common and seen in 39% of patients while new-onset AF occurred in 20% of patients without baseline AF.  Baseline AF was associated with worse 1 year mortality but not in-hospital mortality compared with patients without AF.  New-onset AF was associated with increased mortality both in-hospital and at 1-year.  What is unclear is whether AF is causative or whether its associated comorbidities lead to increased complications and mortality.  Additional studies are required to help elucidate this.

    CoreValve implantation for severe aortic regurgitation: a multicentre registry.

    Testa L, Latib A, Rossi ML, De Marco F, De Carlo M, Fiorina C, Oreglia J, Petronio AS, Ettori F, De Servi S, Klugmann S, Ussia GP, Tamburino C, Panisi P, Brambilla N, Colombo A, Presbitero P, Bedogni F.
    EuroIntervention. 2014 Oct 22;10(6):739-45.
    • Authors' Conclusion: “CRS-TAVR for AR is associated with a significantly higher mortality compared to CRS-TAVR for AS. Considering the ominous prognosis of these patients when treated medically, TAVR may be a reasonable choice in selected patients. In this regard, conventional risk scores have an inadequate predictive value.”

    • Interpretation: This study is a comparison of 26 pure AR patients with 1531 AS patients treated with Corevalve from a large multicenter Italian registry. The pure AR patients were “sicker” than the AS patients, with more advanced heart failure, more pulmonary hypertension, and were likely more “inoperable” than the AS patients, limiting the value of the long-term mortality comparison. However, the higher device failure rate (33% vs. 4%), valve-in-valve rate (19% vs. 4%) and paravalvular leak > 2+ rate (23% vs. 4%) highlights the challenges of treating even carefully-selected pure AR patients with the currently available technology using AS-derived treatment strategies.

    Extent and distribution of calcification of both the aortic annulus and the left ventricular outflow tract predict aortic regurgitation after transcatheter aortic valve replacement.

    Buellesfeld L, Stortecky S, Heg D, Gloekler S, Meier B, Wenaweser P, Windecker S.
    EuroIntervention. 2014 Oct 22;10(6):732-8
    • Authors' Conclusion: “Calcifications of the aortic annulus and LVOT are frequent in patients undergoing TAVR, and both the distribution and the severity of calcifications appear to be independent predictors of aortic regurgitation after device implantation.”

    • Interpretation: This study joins a growing number which show an important impact of valvular/perivalvular calcium, as detected by CT, on post-procedural aortic regurgitation. In particular, this study shows 1) that while nearly all patients have cusp calcification, 2/3 of patients have annular calcification and 1/3 have LVOT calcification, 2) that annular and LVOT calcium, independently predict paravalvular regurgitation, and 3) that moderate-severe LVOT calcium (protruding > 1 mm and/or involving more than 50% of the cusp sector) and asymmetric LVOT calcium may be most predictive (OR 5.4 and 5 respectively) of paravalvular regurgitation.

    Blood transfusion is associated with impaired outcome after transcatheter aortic valve implantation.

    Seiffert M, Conradi L, Terstesse AC, Koschyk D, Schirmer J, Schnabel RB, Wilde S, Ojeda FM, Reichenspurner H, Blankenberg S, Schäfer U, Treede H, Diemert P.
    Catheter Cardiovasc Interv. 2014 Oct 8. 
    • Authors' Conclusion: “Blood transfusions were frequently required after TAVI even in the absence of overt bleeding or access site complications and were identified as an independent predictor of impaired mid-term outcome. Optimization of baseline factors, strict blood conservation strategies, and individualized antiplatelet or anticoagulant regimens may improve outcome after TAVI.”

    • Interpretation: In this study 33% of TAVR patients received blood transfusions despite the lack of any overt bleeding. This study suggests that 1) optimizing hemoglobin levels pre-TAVR (ie treating iron deficiency anemia), 2) conserving blood peri-TAVR, 3) minimizing combined anti-coagulation/anti-platelet therapy post-TAVR (consider either anti-coagulation or anti-platelet therapy) and 4) having lower hemoglobin “triggers” for transfusion may improve post-TAVR outcomes by reducing blood transfusions. Further study is warranted.

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