• SCAI TAVR Center
    Supported by:Medtronic

    July 2015 Journal Scan

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

    Comparison of Self-Expanding and Mechanically Expanded Transcatheter Aortic Valve Prostheses.

    Gooley RP, Talman AH, Cameron JD, Lockwood SM, Meredith IT.
    JACC Cardiovasc Interv. 2015 Jun;8(7):962-71.

    • Authors' Conclusion: "In this matched comparison of high surgical risk patients undergoing transcatheter aortic valve replacement, the use of the Lotus device was associated with higher rates of Valve Academic Research Consortium 2–defined device success compared with the CoreValve. This was driven by higher rates of correct anatomic positioning and lower incidences of moderate paraprosthetic regurgitation. The clinical significance of these differences needs to be tested in a large randomized, controlled trial."

    • Interpretation: In this study 50 consecutive patients treated with Lotus TAVR were compared with 50 matched patients treated with CoreValve TAVR.  Device success was higher with Lotus group than CoreValve (84% vs 64%; p = 0.02) and was driven mainly by lower rates of paravalvular AR and greater odds of implanting a single device in the correct position.  There was no difference in mortality, stroke, or PPM rates.  It is not possible to draw any strong conclusions from this relatively small, single center, nonrandomized trial. The ongoing large randomized REPRISE III trial is comparing these two devices and will give us greater insight into the possible advantages of one device versus the other.

    2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement.

    Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Qiao H, Popma JJ.
    J Am Coll Cardiol. 2015 Jun 2.

    • Authors' Conclusion: "In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years."

    • Interpretation: In the ACC/AHA guidelines TAVR is recommended as an alternative to SAVR in high risk patients.  This guideline recommendation should be questioned in light of the 2 year US CoreValve Trial findings.  Compared with SAVR, TAVR patients had a lower mortality rate (22.2% vs 28.6%; p < 0.05), lower stroke rate (10.6% vs 16.6%; p = 0.05), and equivalent functional outcomes.  Perhaps TAVR should be considered standard of care in this high risk cohort of patients.

    Propensity-Matched Comparisons of Clinical Outcomes After Transapical or Transfemoral Transcatheter Aortic Valve Replacement: A Placement of Aortic Transcatheter Valves (PARTNER)-I Trial Substudy.

    Blackstone EH, Suri RM, Rajeswaran J, Babaliaros V, Douglas PS, Fearon WF, Miller DC, Hahn RT, Kapadia S, Kirtane AJ, Kodali SK, Mack M, Szeto WY, Thourani VH, Tuzcu EM, Williams MR, Akin JJ, Leon MB, Svensson LG.
    Circulation. 2015 Jun 2;131(22):1989-2000.

    • Authors' Conclusion: "The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible."

    • Interpretation: In this propensity-matched analysis, 501 matched pairs were compared.  Compared with TF-TAVR patients undergoing TA-TAVR had higher mortality rates at six months (19% vs 12%) and longer hospital length of stay and prolonged recovery.  This suggests that the TA procedure itself confers higher risk, although it is possible that all variables were not adequately accounted for.  As delivery systems continue to become smaller the vast majority of patients should be treated via the TF approach.  In the small number of patients who are not TF candidates it will be important to determine the relative merits of the caval-aortic, transaortic, and subclavian approaches.

    Clinical impact and evolution of mitral regurgitation following transcatheter aortic valve replacement: a meta-analysis.

    Nombela-Franco L, Eltchaninoff H, Zahn R, Testa L, Leon MB, Trillo-Nouche R, D'Onofrio A, Smith CR, Webb J, Bleiziffer S, De Chiara B, Gilard M, Tamburino C, Bedogni F, Barbanti M, Salizzoni S, García Del Blanco B, Sabaté M, Moreo A, Fernández C, Ribeiro HB, Amat-Santos I, Urena M, Allende R, García E, Macaya C, Dumont E, Pibarot P, Rodés-Cabau J.
    Heart. 2015 Jun 9. pii: heartjnl-2014-307120. doi: 10.1136/heartjnl-2014-307120. [Epub ahead of print]

    • Authors' Conclusion: "Concomitant moderate-severe MR was associated with increased early and late mortality following TAVR.  A significant improvement in MR severity was detected in half of the patients following TAVR, and the degree of improvement was greater in those patients who received a BEV."

    • Interpretation: It is estimated that up to 15% of TAVR patients have moderate-severe MR.  In this meta-analysis of 8000 patients, over 500 had moderate-severe MR.  Although MR severity improved in 50% of patients, moderate-severe MR at baseline was associated with a significant increase in mortality (HR 1.32 at one year).  This is a challenging group to care for since they have increased mortality rates and less functional improvement after TAVR.  Moderate-severe MR should be one, among several, criteria used when determining patient eligibility for TAVR. Hopefully future studies will help identify which MR patients tend to have better survival rates and functional improvement.

    Myocardial injury following transcatheter aortic valve implantation: insights from delayed-enhancement cardiovascular magnetic resonance.

    Ribeiro HB, Larose É, de la Paz Ricapito M, Le Ven F, Nombela-Franco L, Urena M, Allende R, Amat-Santos I, Dahou A, Capoulade R, Clavel MA, Mohammadi S, Paradis JM, De Larochellière R, Doyle D, Dumont É, Pibarot P, Rodés-Cabau J.
    EuroIntervention. 2015 Jun 22;11(2):205-13.

    • Authors' Conclusion: "Although some increase in cardiac biomarkers of myocardial injury was systematically detected following TAVI, new myocardial necrosis as evaluated by CMR was observed only in patients undergoing the procedure through the TA approach, involving ~5% of the myocardium in the apex.

    Myocardial injury during transfemoral transcatheter aortic valve implantation: an intracoronary Doppler and cardiac magnetic resonance imaging study.

    Kahlert P, Al-Rashid F, Plicht B, Wild C, Westhölter D, Hildebrandt H, Baars T, Neumann T, Nensa F, Nassenstein K, Wendt D, Thielmann M, Jakob H, Kottenberg E, Peters J, Erbel R, Heusch G.
    EuroIntervention. 2015 May 28;11(1).

    • Authors' Conclusion: "" Myocardial injury after TAVI appears to be related more to hypoperfusion-induced ischaemia than to periprocedural microembolisation."

    • Interpretation: Like TAVR-related cerebral embolization, coronary embolization likely occurs during most TAVR cases but is mostly clinically inapparent, with late gadolinium enhancement on MRI suggesting focal infarction is unusual. Instead, troponin rises correlated with length of pacing. This suggests that the near universal myocardial injury that occurs during balloon-expandable TAVR is due to global ischemia/injury, and that strategies to avoid such hypoperfusion should be considered.

    The requirement of extracorporeal circulation system for transluminal aortic valve replacement: Do we really need it in the catheterization laboratory?

    Toutouzas K, Synetos A, Latsios G, Mastrokostopoulos A, Stathogiannis K, Drakopoulou M, Trantalis G, Tsiamis E, Tousoulis D.
    Catheter Cardiovasc Interv. 2015 May 6.

    • Authors' Conclusion: "Although the rates of conversion to open heart surgery are low, the identification of risk factors for acute severe complications is essential for the risk stratification of patients undergoing TAVR. The requirement, however, of the extracorporeal circulation system in the catheterization laboratory during the TAVR procedure is challenged with these data."

    Early discharge after transfemoral transcatheter aortic valve implantation.

    Barbanti M, Capranzano P, Ohno Y, Attizzani GF, Gulino S, Immè S, Cannata S, Aruta P, Bottari V, Patanè M, Tamburino C, Di Stefano D, Deste W, Giannazzo D, Gargiulo G, Caruso G, Sgroi C, Todaro D, Simone ED, Capodanno D, Tamburino C.
    Heart. 2015 Jun 15.

    • Authors' Conclusion: "Early discharge (within 72 h) after transfemoral TAVI is feasible and does not seem to jeopardise the early safety of the procedure, when performed in a subset of patients selected by clinical judgement. Patients undergoing TAVI in unstable haemodynamic compensation and patients experiencing bleeding after the procedure demonstrated to be poorly suitable to this approach, whereas increasing experience in post-TAVI management was associated with a reduction of LoS."

    • Interpretation: The march of the TAVR procedure towards becoming “PCI-like" continues; however, it is not there yet, and when or whether it will ever reach this destination remains under question.  Peri-procedural complications requiring surgical intervention and cardiopulmonary support are low but still important (1-2%). And while early discharge is possible in many cases (~25%), prolonged hospitalization requiring specialized medical attention remains common.

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