• SCAI TAVR Center
    Supported by:Medtronic

    April 2015 Journal Scan

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

    Incidence and Severity of Paravalvular Aortic Regurgitation With Multidetector Computed Tomography Nominal Area Oversizing or Undersizing After Transcatheter Heart Valve Replacement With the Sapien 3: A Comparison With the Sapien XT.

    Yang TH, Webb JG, Blanke P, Dvir D, Hansson NC, Nørgaard BL, Thompson CR, Thomas M, Wendler O, Vahanian A, Himbert D, Kodali SK, Hahn RT, Thourani VH, Schymik G, Precious B, Berger A, Wood DA, Pibarot P, Rodés-Cabau J, Jaber WA, Leon MB, Walther T, Leipsic J.
    JACC Cardiovasc Interv. 2015 Mar;8(3):462-71. doi: 10.1016/j.jcin.2014.10.014.

    • Authors' Conclusion: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.

    • Interpretation: This modest sized study corroborates other reports that the Sapien 3 THV is associated with a low rate of paravalvular aortic regurgitation. However the novel finding of this study is that the optimal area oversizing for Sapien 3 THV is 1-5%. Minimal oversizing could result in a lower risk of annular injury, including the rare but frequently fatal complication of annular rupture. These findings will need to be validated in larger studies.

     

    5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.

    Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Davidson MJ, Svensson LG; PARTNER 1 trial investigators, Akin J.
    Lancet. 2015 Mar 15. pii: S0140-6736(15)60308-7. doi: 10.1016/S0140-6736(15)60308-7.

    • Authors' Conclusion: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.

    • Interpretation: Despite the use of a first generation device, large bore delivery system, and an early learning curve, the PARTNER 1A trial demonstrates that TAVR and SAVR have similar rates of mortality, stroke, and repeat hospitalization at five years. Additionally, there were similar valve hemodynamics and no cases of structural valve deterioration requiring surgery. TAVR is an excellent alternative to SAVR in high risk patients. It is tantalizing to imaging the results of this trial with third generation devices, smaller delivery systems, greater operator experience, and up-to-date procedural and post-procedure management.

     

    5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial.

    Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, Webb JG, Mack MJ, Douglas PS, Thourani VH, Babaliaros VC, Herrmann HC, Szeto WY, Pichard AD, Williams MR, Fontana GP, Miller DC, Anderson WN, Smith CR; PARTNER trial investigators, Akin JJ, Davidson MJ.
    Lancet. 2015 Mar 15. pii: S0140-6736(15)60290-2. doi: 10.1016/S0140-6736(15)60290-2.

    • Authors' Conclusion: TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities.

    • Interpretation: The 5-year results of the PARTNER 1B trial demonstrates continued benefit of TAVR over standard therapy in terms of mortality, repeat hospitalization, and functional status. Not to be overlooked, however, is the 71.8% mortality rate at 5 years in TAVR patients. Refinement of patient selection is crucial so that appropriate inoperable patients are not denied therapy while at the same time TAVR is avoided in futile situations.    

     

    High-risk patients with inoperative aortic stenosis: use of transapical, transaortic, and transcarotid techniques.

    Thourani VH, Li C, Devireddy C, Jensen HA, Kilgo P, Leshnower BG, Mavromatis K, Sarin EL, Nguyen TC, Kanitkar M, Guyton RA, Block PC, Maas AL, Simone A, Keegan P, Merlino J, Stewart JP, Lerakis S, Babaliaros V.
    Ann Thorac Surg. 2015 Mar;99(3):817-25. doi: 10.1016/j.athoracsur.2014.10.012. Epub 2015 Jan 14.

    • Authors' Conclusion: In high-risk and inoperable patients who are not candidates for TF TAVR, careful selection of alternative access options can lead to excellent and comparable postoperative outcomes.

    • Interpretation: Although transfemoral TAVR is the dominant access strategy, particularly as sheath size decrease, there is still a role for non-femoral access. This paper supports the idea that all non-femoral access approaches are reasonable in the appropriately selected patient. 

     

    Peri-operative results and complications in 15,964 transcatheter aortic valve implantations from the German Aortic valve RegistrY (GARY).

    Walther T, Hamm CW, Schuler G, Berkowitsch A, Kötting J, Mangner N, Mudra H, Beckmann A, Cremer J, Welz A, Lange R, Kuck KH, Mohr FW, Möllmann H; GARY executive board.
    J Am Coll Cardiol. 2015 Mar 10. pii: S0735-1097(15)00844-X. doi: 10.1016/j.jacc.2015.03.034.

    • Authors' Conclusion: The all-comers GARY registry reveals good outcomes after T-AVI and a regression in complications. Survival of almost 60% in patients who suffer SVC or who require sternotomy, however, underlines the need for heart team-led indication, intervention, and follow-up care of T-AVI patients.

    • Interpretation: In this very large prospective registry of 15,964 TAVR patients the overall clinical and technical complication rates are low and have decreased with time. A very small number of patients (1.3%) required sternotomy, which suggests that a heart team approach is still relevant.  


    Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Valve Stenosis: One-year Results from the All-comers Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial.

    Thyregod HG, Steinbrüchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrøm T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Søndergaard L.
    J Am Coll Cardiol. 2015 Mar 5. pii: S0735-1097(15)00819-0. doi: 10.1016/j.jacc.2015.03.014.

    • Authors' Conclusion: In the NOTION trial, no significant difference between TAVR and SAVR was found for the primary outcome of the composite rate of death from any cause, stroke, or myocardial infarction after 1 year.

    • Interpretation: In this first randomized study of TAVR vs. SAVR in low risk patients, hard outcomes at 1 year (death, stroke, MI) were similar. However, aortic insufficiency rates and NYHA class were higher in the TAVR patients, potential harbingers for worse long-term outcomes. We must wait for longer term results and larger studies, and hopefully, the application of more advanced TAVR technology.

    Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry.

    Petronio AS, Giannini C, De Carlo M, Bedogni F, Colombo A, Tamburino C, Klugmann S, Poli A, Guarracino F, Barbanti M, Latib A, Brambilla N, Fiorina C, Bruschi G, Martina P, Ettori F.
    EuroIntervention. 2015 Mar 16;10(11). pii: 20140605-02. doi: 10.4244/EIJY15M03_05.

    • Authors' Conclusion: Our study indicates that, in experienced centres which have gone beyond their initial learning curve with TAVI, the use of local anaesthesia in a selected patient population can be associated with good clinical outcomes. Nevertheless, as severe procedural complications are possible, an anaesthesiologist should always be present as part of the team.

    • Interpretation: This observational study continues to push local anaesthesia as an attractive option for most TAVR procedures due to shorter procedure times, hospitalizations, and possibly even improved clinical outcomes--such as reduced acute kidney injury--compared to general anaesthesia. While this type of data—combined with clinical experience, common sense and cost pressure—will likely be sufficient to change practice for straightforward TAVR procedures, randomized studies with 30 day functional outcomes (both valve and patient function) will be necessary to determine the best approach in complicated TAVR procedures.


    Evaluation of aortic regurgitation after transcatheter aortic valve implantation: aortic root angiography in comparison to cardiac magnetic resonance.

    Frick M, Meyer CG, Kirschfink A, Altiok E, Lehrke M, Brehmer K, Lotfi S, Hoffmann R.
    EuroIntervention. 2015 Mar 16;10(11). pii: 20130914-01. doi: 10.4244/EIJY15M03_06.

    • Authors' Conclusion: There is only a moderate correlation between aortic root angiography and CMR in the classification of AR severity after TAVI. Alternative imaging including multimodality imaging as well as haemodynamic analysis should therefore be considered for intraprocedural AR assessment and guidance of TAVI procedure in cases of uncertainty in AR grading.

    • Interpretation: Carefully performed aortography can be useful in measuring intraprocedural AR immediately after TAVR as part of multi-modality (echo, hemodynamic) assessement, with the use of Sellers grade > 2 as a relatively accurate (sensitivity 71%, specificity 98%) indicator of moderate-severe AR.

    Infective Endocarditis Following Transcatheter Aortic Valve Implantation: Results from a Large Multicenter Registry.

    Amat-Santos IJ, Messika-Zeitoun D, Eltchaninoff H, Kapadia S, Lerakis S, Cheema A, Gutiérrez-Ibanes E, Munoz-Garcia A, Pan M, Webb JG, Herrmann H, Kodali S, Nombela-Franco L, Tamburino C, Jilaihawi H, Masson JB, Sandoli de Brito F, Ferreira MC, Correa Lima V, Mangione JA, Iung B, Durand E, Vahanian A, Tuzcu M, Hayek SS, Angulo-Llanos R, Gómez-Doblas JJ, Castillo JC, Dvir D, Leon MB, Garcia E, Cobiella J, Vilacosta I, Barbanti M, Makkar R, Barbosa Ribeiro H, Urena M, Dumont E, Pibarot P, Lopez J, San Roman A, Rodés-Cabau J.
    Circulation. 2015 Mar 9. pii: CIRCULATIONAHA.114.014089

    • Authors' Conclusion: The incidence of IE at 1-year after TAVI was of 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphyloccoci and enteroccoci were the most common agents. While most patients presented at least one complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.

    • Interpretation: Infective endocarditis on TAVR prosthetic valves occurs with similar frequency as surgical prosthetic valves. However, it is more commonly fatal (50% in hospital, 66% at one year) likely due to conservatively treated IE complications in this generally frail, high-risk population. Since TAVR IE might frequently be iatrogenic, there is a great need for careful prophylaxis and aseptic technique during and following TAVR. Whether more aggressive treatment of complications will reduce mortality rates is not clear, but should be considered.

    Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis.

    Frerker C, Schewel J, Schlüter M, Schewel D, Ramadan H, Schmidt T, Thielsen T, Kreidel F, Schlingloff F, Bader R, Wohlmuth P, Schäfer U, Kuck KH.
    EuroIntervention. 2015 Mar 9;10(11). pii: 20140827-01. doi: 10.4244/EIJY15M03_03.

    • Authors' Conclusion: TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.

    • Interpretation: In this series of 27 cardiogenic shock patients treated with TAVR, one year survival was a very reasonable 59%, with almost all deaths occurring in the 1st 30 days.

     

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