• SCAI TAVR Center
    Supported by:Medtronic

    October 2014 Journal Scan

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

    Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement with the Edwards Sapien Valve in the PARTNER trial: characterizing patients and impact on outcomes.

    Kodali S, Pibarot P, Douglas PS, Williams M, Xu K, Thourani V, Rihal CS, Zajarias A, Doshi D, Davidson M, Tuzcu EM, Stewart W, Weissman NJ, Svensson L, Greason K, Maniar H, Mack M, Anwaruddin S, Leon MB, Hahn RT.
    Eur Heart J. 2014 Oct 1. pii: ehu384. [Epub ahead of print]

    • Authors' Conclusion: “Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild and moderate/severe PVR predicted higher 1-year mortality.”

    • Interpretation: This is one of the largest and best controlled studies evaluating the impact of PVR on clinical outcomes. With PVR measured by an echo core lab, there was an increasing risk of death with increasing amounts of regurgitation, including even with mild regurgitation. This relationship existed despite extensive multivariable analysis (hazard ratios: mild 1.4, moderate-severe 2.2). Furthermore, there was also an association between the severity of PVR with less LV mass index reduction, increased LVED, reduced improvement in NYHA class and higher rates of rehospitalization. Therefore, this study provides the strongest evidence to date that there is a cause and effect relationship between even mild PVR and bad clinical outcomes due to heart failure.

    Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System: 30-Day Primary Endpoint Results From the REPRISE II Study.

    Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefèvre T, Lange R, Müller R, Redwood S, Allocco DJ, Dawkins KD.
    J Am Coll Cardiol. 2014 Sep 30; 64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.

    • Authors' Conclusion: REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR.

    • Interpretation: The Lotus valve is a 2nd generation transcatheter heart valve which has the advantages of being fully repositionable and retrievable and an “adaptive seal” designed to prevent paravalvular regurgitation, while being able to be deployed without rapid ventricular pacing. The 120 high risk AS patients who had it implanted in this study had a promising 100% procedural success rate with an impressively low moderate-severe regurgitation rate (1%), but nearly 30% needed a pacemaker.

    Incidence and Sequelae of Prosthesis-Patient Mismatch in Transcatheter Versus Surgical Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: A PARTNER Trial Cohort-A Analysis.

    Pibarot P, Weissman NJ, Stewart WJ, Hahn RT, Lindman BR, McAndrew T, Kodali SK, Mack MJ, Thourani VH, Miller DC, Svensson LG, Herrmann HC, Smith CR, Rodés-Cabau J, Webb J, Lim S, Xu K, Hueter I, Douglas PS, Leon MB.
    J Am Coll Cardiol. 2014 Sep 30; 64(13):1323-34. doi: 10.1016/j.jacc.2014.06.1195.

    • Authors' Conclusion: “In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe after SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM. Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation. TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival.”

    • Interpretation: This study reminds us of the importance to avoid PPM, regardless of SAVR or TAVR. As the choice of TAVR vs. SAVR increases in the intermediate risk AS patient, avoidance of PPM should play an important role. The advantage goes to TAVR in patients with smaller aortic annuli when compared to traditional SAVR practices. However, SAVR may also evolve, such as with greater use of stentless valves, to reduce the incidence of PPM.

    Transcatheter heart valve failure: a systematic review.

    Mylotte D, Andalib A, Thériault-Lauzier P, Dorfmeister M, Girgis M, Alharbi W, Chetrit M, Galatas C, Mamane S, Sebag I, Buithieu J, Bilodeau L, de Varennes B, Lachapelle K, Lange R, Martucci G, Virmani R, Piazza N.
    Eur Heart J. 2014 Sep 28. pii: ehu388. [Epub ahead of print]

    • Authors' Conclusion: Transcatheter heart valves are susceptible to failure modes typical to those of surgical bioprostheses and unique to their specific design. Transcatheter heart valve compression and late embolization represent complications previously unreported in the surgical literature.

    • Interpretation: While most prominent studies in the relatively new field of TAVR have focused on valve implantation, this excellent review highlights the other end-of-the-spectrum, valve failure. As the population of TAVR patients grows, awareness of the causes of valve failure—endocarditis, thrombosis, structural degeneration, as well as the rare embolization and compression—and potential methods of treatment, is very important.

    Impact of Aortic Valve Calcification, as Measured by MDCT, on Survival in Patients With Aortic Stenosis: Results of an International Registry Study.

    Clavel MA, Pibarot P, Messika-Zeitoun D, Capoulade R, Malouf J, Aggarval S, Araoz PA, Michelena HI, Cueff C, Larose E, Miller JD, Vahanian A, Enriquez-Sarano M.
    J Am Coll Cardiol. 2014 Sep 23; 64(12):1202-13. doi: 10.1016/j.jacc.2014.05.066..

    • Authors' Conclusion: “This large-scale, multicenter outcomes study of quantitative Doppler echocardiographic and MDCT assessment of AS shows that measuring AVC load provides incremental prognostic value for survival beyond clinical and Doppler echocardiographic assessment. Severe AVC independently predicts excess mortality after AS diagnosis, which is greatly alleviated by AVI. Thus, measurement of AVC by MDCT should be considered for not only diagnostic but also risk-stratification purposes in patients with AS.”

    • Interpretation: Aortic valve calcium score and aortic valve calcium index previously have been shown to be excellent metrics to determine aortic stenosis severity.  The present study extends these observations regarding stenosis severity to demonstrate that AVC is an independent predictor of mortality.  This study suggests that, in difficult cases, especially the > 30% of patients with low-flow low-gradient AS, AVC can both help diagnose severe AS and that referring those patients for aortic valve intervention will improve their survival.

    Transcatheter aortic valve implantation (TAVI) by centres with and without an on-site cardiac surgery programme: preliminary experience from the German TAVI registry.

    Eggebrecht H, Mehta RH, Haude M, Sack S, Mudra H, Hein R, Brachmann J, Gerckens U, Kuck KH, Zahn R, Sechtem U, Richardt G, Schneider S, Senges J.
    EuroIntervention. 2014 Sep 22; 10(5):602-8. doi: 10.4244/EIJV10I5A105.

    • Authors' Conclusion: “Only 12% of patients enrolled in the German TAVI registry underwent TAVI at hospitals without an on-site CS department. Overall patient characteristics appeared to be similar, although patients in non-CS centres appeared to be haemodynamically more stable and more often had a history of previous heart surgery. Despite longer procedures, complication rates were similar. These preliminary data in a modest number of patients suggest the feasibility of performing TAVI in appropriately selected patients at hospitals without CS but this requires confirmation in future studies involving a large number of patients.”

    • Interpretation: As TAVR as a treatment for AS expands in use, the issue of patients’ access to this procedure will grow in importance (just as it did for PCI). This study shows that, in a more mature TAVR market (Germany) TAVR is being performed and/or planned at hospitals without onsite cardiac surgery departments (but with visiting cardiac surgery teams during the time of the procedure) without obvious evidence of adverse sequelae. Whether it be this trend toward dissolution of the “heart team”, eliminating general anesthesia and TEE, or the performing TAVR in the cath lab using the “minimalist approach”, the simplification of the TAVR procedure in the name of expanding patient access and reducing costs will continue.

    Predictors and clinical impact of pre-existing and acquired thrombocytopenia following transcatheter aortic valve replacement.

    Flaherty MP, Mohsen A, Moore JB, Bartoli CR, Schneibel E, Rawasia W, Williams ML, Grubb KJ, Hirsch GA.
    Catheter Cardiovasc Interv. 2014 Sep 10. doi: 10.1002/ccd.25668. [Epub ahead of print]

    • Authors' Conclusion: “TAVR-related TP is predictable and classification by PTP and TP severity prior to TAVR allows for better risk stratification in predicting in-hospital clinical outcomes. Major TP in the presence of worsening TP is predictable and is associated with worse clinical outcomes.”

    • Interpretation: Thrombocytopenia is well described after both surgical AVR and TAVR.  Although the mechanism of thrombocytopenia following TAVR is unknown this, and other, studies suggest that it is a relatively common finding and is associated with adverse outcomes including increased bleeding and vascular complications.

    Can we predict post-procedural paravalvular leak after Edwards Sapien transcatheter aortic valve implantation?

    Watanabe Y, Lefèvre T, Arai T, Hayashida K, Bouvier E, Hovasse T, Romano M, Chevalier B, Garot P, Donzeau-Gouge P, Farge A, Cormier B, Morice MC.
    Catheter Cardiovasc Interv. 2014 Sep 9. doi: 10.1002/ccd.25665. [Epub ahead of print]

    • Authors' Conclusion: “The only predictors of PVL ≥ 2 after Edwards valve implantation are the valve diameter / CAAD and VCI. The PVL score could prove to be an excellent tool for predicting the risk of PVL.”

    • Interpretation: Although moderate or severe paravalvular regurgitation is infrequent (< 15%) it remains an important predictor of poor outcomes following TAVR.  Therefore, predicting and preventing paravalvular regurgitation is an important objective.  This study identified valve calcification index and valve diameter/calculated annulus average diameter as the two independent predictors of paravalvular regurgitation.  It remains to be seen whether this information could lead to alternate sizing strategies or device selection that could reduce paravalvular regurgitation. 

    Long-Term Outcomes of Inoperable Patients with Aortic Stenosis Randomized to Transcatheter Aortic Valve Replacement or Standard Therapy.

    Kapadia SR, Tuzcu EM, Makkar RR, Svensson LG, Agarwal S, Kodali S, Fontana GP, Webb JG, Mack M, Thourani VH, Babaliaros VC, Herrmann HC, Szeto W, Pichard AD, Williams MR, Anderson WN, Akin JJ, Miller DC, Smith CR, Leon MB.
    Circulation. 2014 Sep 9. pii: CIRCULATIONAHA.114.009834. [Epub ahead of print]

    • Authors' Conclusion: “TAVR resulted in better survival and functional status in inoperable patients with severe AS with durable hemodynamic benefit on long-term follow-up. However, high residual mortality even in successfully treated TAVR patients highlights the need for more strategic patient selection.”

    • Interpretation:  In this analysis of inoperable patients treated in the PARTNER trial TAVR was associated with a significant reduction in mortality at 3 years, 54.1% vs 80.9% with a number need to treat of 3.7.  Additionally, there was preserved valve function by echocardiography and sustained improvement in NYHA class.  Although TAVR significantly improves outcomes at 3 years for inoperable patients the mortality rate is very high reflecting patient age and comorbidities.  As highlighted by the authors, improved patient selection is critical to identify the most appropriate patients for TAVR.   

    Clinical impact of aortic regurgitation after transcatheter aortic valve replacement: insights into the degree and acuteness of presentation.

    Jerez-Valero M, Urena M, Webb JG, Tamburino C, Munoz-Garcia AJ, Cheema A, Dager AE, Serra V, Amat-Santos IJ, Barbanti M, Immè S, Alonso Briales JH, Al Lawati H, Benitez LM, Cucalon AM, Garcia Del Blanco B, Revilla A, Dumont E, Barbosa Ribeiro H, Nombela-Franco L, Bergeron S, Pibarot P, Rodés-Cabau J.
    JACC Cardiovasc Interv. 2014 Sep; 7(9):1022-32. doi: 10.1016/j.jcin.2014.04.012

    • Authors' Conclusion: “AR occurred very frequently after TAVR, but an increased risk of mortality at ∼2-year follow-up was observed only in patients with acute moderate to severe AR.”

    • Interpretation: Prior analyses suggest that even mild AR after TAVR is associated with increased mortality.  In this large study mortality was increased only in those patients with acute (defined as 1 grade increase in AR after TAVR) moderate to severe AR, but not in those with acute mild AR or chronic moderate or severe AR.  This study emphasizes the importance of minimizing worsening AR.  It is likely that future device designs will further minimize this problem.     

    Impact of Balloon Post-Dilation on Clinical Outcomes After Transcatheter Aortic Valve Replacement With the Self-Expanding CoreValve Prosthesis.

    Barbanti M, Petronio AS, Capodanno D, Ettori F, Colombo A, Bedogni F, De Marco F, De Carlo M, Fiorina C, Latib A, Testa L, Bruschi G, Poli A, Giannini C, Curello S, Maffeo D, Sgroi C, Martina P, Gulino S, Patanè M, Ohno Y, Attizzani GF, Immè S, Cannata S, Gentili A, Rossi A, Tamburino C.
    JACC Cardiovasc Interv. 2014 Sep; 7(9):1014-21. doi: 10.1016/j.jcin.2014.03.009.

    • Authors' Conclusion: This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.

    • Interpretation: In this study of 1,374 CoreValve implants balloon post-dilation was performed in 19.8%.  The salient findings are that BPD reduced AR to mild or less in 63% of patients and there was no increased risk of complications, including valve embolization, annular rupture, or stroke.  This suggests that post-dilation should be considered in patients with moderate or severe AR following TAVR.

    Cerebrovascular Events Post-Transcatheter Aortic Valve Replacement in a Large Cohort of Patients: A FRANCE 2 Registry Substudy.

    Tchetche D, Farah B, Misuraca L, Pierri A, Vahdat O, Lereun C, Dumonteil N, Modine T, Laskar M, Eltchaninoff H, Himbert D, Iung B, Teiger E, Chevreul K, Lievre M, Lefevre T, Donzeau-Gouge P, Gilard M, Fajadet J.
    JACC Cardiovasc Interv. 2014 Sep 6. pii: S1936-8798(14)01165-0. doi: 10.1016/j.jcin.2014.04.018. [Epub ahead of print]

    • Authors' Conclusion: “CVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE.”

    • Interpretation:This is real world registry is one of the largest studies of cerebrovascular events associated with TAVR, showing a rate of ~4.0%, with 2.2% having a major stroke and 01.6% having a minor stroke (the rest were TIAs) ~50% of strokes occurred within 2 days, with the majority of the rest within 2 weeks. Since these are only clinically-noted strokes reported by the TAVR team, it is likely that subtler strokes may have gone unrecorded. Notably, there were no differences based on valve type, with both Corevalve and Sapien and Sapien XT represented. This information should prove very useful in counselling patients, and should set a standard upon which improvement should be focused upon.

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