• SCAI TAVR Center
    Supported by:Medtronic

    January 2015 Journal Scan

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

    Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement.

    Généreux P, Cohen DJ, Mack M, Rodes-Cabau J, Yadav M, Xu K, Parvataneni R, Hahn R, Kodali SK, Webb JG, Leon MB.
    J Am Coll Cardiol. 2014 Dec 23;64(24):2605-15
    • Authors' Conclusion: “Major late bleeding complications (MLBC) after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population.”

    • Interpretation: This study shows that MLBCs (>30 days) after TAVR occurs at in 6% the first year after TAVR, with the majority gastrointestinal (41%), neurological (16%) or related to falls (8%). Such bleeding is independently associated with a 4 fold increase in death, second only to major stroke a more powerful predictor. Atrial fibrillation (a surrogate of anti-coagulation) and moderate-to-severe paravalvular leak, which can cause an acquired thrombophilia, were major predictors of MLBCs. These observations drive home the importance of 1) studying the risk/benefits of various anti-thrombotic regimens post-TAVR, and 2) attempting to proactively minimize post-TAVR bleeding (eg proton-pump inhibitors) and 3) individualizing post-TAVR anti-thrombotic regimens.

    The Association of Transcatheter Aortic Valve Replacement Availability and Hospital Aortic Valve Replacement Volume and Mortality in the United States.

    Brennan JM, Holmes DR, Sherwood MW, Edwards FH, Carroll JD, Grover FL, Tuzcu EM, Thourani V, Brindis RG, Shahian DM, Svensson LG, O'Brien SM, Shewan CM, Hewitt K, Gammie JS, Rumsfeld JS, Peterson ED, Mack MJ. 
    Ann Thorac Surg. 2014 Dec;98(6):2016-22.
    • Authors' Conclusion: “Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve.”

    • Interpretation: This study suggests that starting a TAVR program may have a “halo” effect, increasing SAVR volumes, improving SAVR outcomes and improving overall AVR outcomes.

    Heart-rate adjustment of transcatheter haemodynamics improves the prognostic evaluation of paravalvular regurgitation after transcatheter aortic valve implantation.

    Jilaihawi H, Chakravarty T, Shiota T, Rafique A, Harada K, Shibayama K, Doctor N, Kashif M, Nakamura M, Mirocha J, Rami T, Okuyama K, Cheng W, Sadruddin O, Siegel R, Makkar RR.
    EuroIntervention. 2014 Dec 16.
    • Authors' Conclusion: “Prognostication of PVAR in the intermediate range of echocardiographic severity remains unreliable and is greatly enhanced by the integration of heart-rate-adjusted transcatheter haemodynamics.”

    • Interpretation: Sometimes distinguishing between <mild and >moderate AI immediately post-TAVR can be challenging, even with TEE, aortic angiography and hemodynamics. In fact, the use of the aortic regurgitation (AR) index (DBP-LVEDP/SBP) has been limited by its great variation with heart rate. This study demonstrates that a simple adjustment for heart rate (AR index multiplied by 80/heart rate) minimizes this variation, greatly improving the AI index’s ability to distinguish non-significant AI from the significant AI which should probably be reduced using additional intervention (post-dilation, valve-in-valve, or paravalvular leak “plugging”).

    Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease.

    Mylotte D, Lefevre T, Søndergaard L, Watanabe Y, Modine T, Dvir D, Bosmans J, Tchetche D, Kornowski R, Sinning JM, Thériault-Lauzier P, O'Sullivan CJ, Barbanti M, Debry N, Buithieu J, Codner P, Dorfmeister M, Martucci G, Nickenig G, Wenaweser P, Tamburino C, Grube E, Webb JG, Windecker S, Lange R, Piazza N.
    J Am Coll Cardiol. 2014 Dec 9;64(22):2330-9.
    • Authors' Conclusion: “TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.”

    • Interpretation: Bicuspid aortic valves (BAV) are found in approximately 1/5 of older AS patients, and even a higher proportion of AS younger patients. This very important subset of AS patients has been thus far excluded from TAVR randomized controlled trials (RCTs). This registry shows that TAVR is reasonable for inoperable patients with BAV AS, based on comparable short-term results with RCTs. However, the high proportion of BAV patients with significant paravalvular aortic regurgitation after TAVR suggests that surgical AVR should be should be preferred in intermediate risk and even some higher risk BAV AS patients, pending more studies and newer technology.

    Real-time magnetic resonance-guided aortic valve replacement using engager valve.

    Kindzelski BA, Li M, Mazilu D, Hunt T, Horvath KA.
    Ann Thorac Surg. 2014 Dec;98(6):2194-9.
    • Authors' Conclusion: “The Engager valve can be implanted transapically under rtCMR guidance with a modified, CMR-compatible delivery device in a preclinical model. Cardiovascular magnetic resonance allowed for accurate preplacement evaluation, real-time guidance, and postplacement functional assessment.”

    • Interpretation: This preclinical study in 10 Yucatan swine demonstrates the feasibility of real-time CMR to guide transapical TAVR. Theoretical benefits of CMR include elimination of radiation exposure and iodinated contrast media and superior assessment of implant landmarks and procedural complications.

    Arrhythmia Burden in Elderly Patients with Severe Aortic Stenosis as Determined by Continuous ECG Recording: Towards a Better Understanding of Arrhythmic Events Following Transcatheter Aortic Valve Replacement.

    Urena M, Hayek S, Cheema AN, Serra V, Amat-Santos IJ, Nombela-Franco L, Ribeiro HB, Allende R, Paradis JM, Dumont E, Thourani VH, Babaliaros V, Francisco Pascual J, Cortés C, García Del Blanco B, Philippon F, Lerakis S, Rodés-Cabau J.
    Circulation. 2014 Dec 2.
    • Authors' Conclusion: “Newly diagnosed arrhythmias were observed in about a fifth of TAVR candidates, led to a higher rate of cerebrovascular events and accounted for a third of arrhythmic events following the procedure. This high arrhythmia burden highlights the importance of an early diagnosis of arrhythmic events in such patients in order to implement the appropriate therapeutic measures earlier on.”

    • Interpretation: Of 435 patients who underwent 24-hour ECG monitoring prior to TAVR, 16% developed new onset arrhythmias (1/3 atrial fibrillation, 1/3 AV block, and 1/3 non-sustained VT). Approximately one third of patients who developed atrial fibrillation or required a pacemaker after TAVR had atrial fibrillation or AV block, respectively, on the pre-procedure monitor. This underscores the fact that TAVR patients are at high risk for arrhythmias, separate from the procedural factors that can provoke arrhythmias. The authors argue that pre-TAVR continuous ECG monitoring may identify patients with paroxysmal atrial fibrillation who should be treated with oral anticoagulation, possibly reducing cerebrovascular events, and patients who should undergo early pacemaker implantation, reducing length of stay.

    Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.

    Webb J, Gerosa G, Lefèvre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T.
    J Am Coll Cardiol.
    2014 Dec 2;64(21):2235-43.
    • Authors' Conclusion: “This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients.”

    • Interpretation: Paravalvular aortic regurgitation has been dubbed the “Achilles Heel” of TAVR, is moderate to severe in 10-15% of cases and is associated with increased mortality. The Sapien 3 transcatheter heart valve has a fabric cuff at the inflow segment of the stent frame designed to reduce paravalvular aortic regurgitation. In this study of 150 patients there was remarkably low 3.5% rate of moderate, and no patient with severe, paravalvular aortic regurgitation. Additionally, there were strikingly low rate of death, stroke, and vascular complications. Conversely, there was a higher than expected rate (13.3%) of new pacemaker implantation. There is preliminary evidence that higher implant position may mitigate against this higher need for pacemaker. In summary, the Sapien 3 transcatheter heart valve represents is an important technological step forward that will translate to improved outcomes for patients.

    Long-term outcomes associated with the transaortic approach to transcatheter aortic valve replacement.

    Lardizabal JA, Macon CJ, O'Neill BP, Desai H, Singh V, Martinez CA, Cohen MG, Heldman AW, O'Neill WW, Williams DB.
    Catheter Cardiovasc Interv. 2014 Dec 15.
    • Authors' Conclusion: “The outcomes associated with TAO TAVR compare favorably with TAP TAVR. Our results appear to corroborate the long-term safety and efficacy of the TAO approach in TAVR patients with inadequate iliofemoral access.”

    • Interpretation: Although the vast majority of TAVRs are currently performed via the transfemoral approach there are still an important minority of patients who require alternative access routes. This small study suggests that TAO TAVR has similar 30 day mortality rates but lower ICU length of stay (3 vs 6 days) compared with TAP TAVR. Additionally, one year survival is significantly lower with TAO TAVR than TAP TAVR. These data suggest that, in patients who require nonfemoral TAVR access and in the absence of a porcelain aorta, TAO TAVR may be preferred over TAP TAVR.

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