• SCAI TAVR Center
    Supported by:Medtronic

    December 2014 Journal Scan

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

    TAVI for low-flow, low-gradient severe aortic stenosis with preserved or reduced ejection fraction: a subgroup analysis from the German Aortic Valve Registry (GARY).

    Lauten A, Figulla HR, Möllmann H, Holzhey D, Kötting J, Beckmann A, Veit C, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Böhm M, Heusch G, Meinertz T, Neumann T, Welz A, Mohr FW, Hamm CW.
    EuroIntervention. 2014 Nov 20;10(7):850-9.
    • Authors' Conclusion: “Severe AS with a reduced transaortic flow and gradient is a common finding and is present in >30% of patients undergoing TAVI. Patients with low flow and impaired LV function have a significantly higher mortality within the first year after TAVI. In contrast, the outcome of patients with low flow and preserved EF is comparable to those with a high transvalvular aortic gradient.”

    • Interpretation: As in prior investigations patients with low EF low gradient AS have significantly higher procedural and 1 year mortality compared to patients with high gradients. The worse outcomes appear to be related to both LV systolic dysfunction and greater comorbidities. Interestingly patients with preserved EF low gradient AS had similar survival rates compared with the high gradient patients. This is at odds to a prior study that suggests that low flow itself drives increased mortality. Future studies will be required to clarify this controversy.

    Impact of low preprocedural transvalvular gradient on cardiovascular mortality following TAVI: an analysis from the FRANCE 2 registry.

    Amabile N, Agostini H, Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Laskar M, Caussin C. 
    EuroIntervention. 2014 Nov 20;10(7):842-9
    • Authors' Conclusion: “Presence of a low MTG prior to TAVI was associated with a greater risk of cardiovascular death up to one year following the procedure and could be used to identify patients at high risk for adverse cardiovascular outcomes following TAVI.”

    • Interpretation: Similar to the GARY registry, this analysis form the FRANCE 2 registry suggests that low EF low gradient patients that suffer worse outcomes than those with preserved EF low gradients or those patients with high gradient AS. Both of these studies suggest that low EF low gradient is predictor of adverse could be used to risk stratify patients during TAVR evaluation.

    Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR).

    Marcantuono R, Gutsche J, Burke-Julien M, Anwaruddin S, Augoustides JG, Jones D, Mangino-Blanchard L, Hoke N, Houseman S, Li R, Patel P, Stetson R, Walsh E, Y Szeto W, Herrmann HC.
    Catheter Cardiovasc Interv. 2014 Nov 20. 
    • Authors' Conclusion: “It is feasible to identify a large percentage of suitable patients preprocedure who are eligible for a fast track postprocedure care pathway. There was no evidence for compromise of care and successful completion of the pathway was associated with shorter length of stay and fewer direct costs.”

    • Interpretation: This study adds to the literature suggesting that a “fast track” approach to post-TAVR care is feasible, safe, and reduces length of stay and cost. However, patient selection was conservative and general anesthesia, TEE, and PA catheters were used in all patients. Likely both a “minimalist” approach to the procedure and a “fast track” strategy for post-TAVR care will be needed to reduce costs and maximize patient outcomes.

    Unravelling the (arte) fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.

    Tarantini G, Mojoli M, Purita P, Napodano M, D'Onofrio A, Frigo A, Covolo E, Facchin M, Isabella G, Gerosa G, Iliceto S.
    EuroIntervention. 2014 Nov 19. pii: 20141023-04.
    • Authors' Conclusion: “The S3-THV was associated with a higher incidence of PPMI compared with XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.”

    • Interpretation: This small study, similar to other preliminary data, shows that the Sapien 3 THV dramatically reduces paravalvular aortic regurgitation but at the cost of higher rate of pacemaker requirement. The rate of PPMI was 3.44% for Sapien XT (n=179) versus 20.68% for Sapien 3 (n=30). Similar to findings with CoreValve, this study suggests that low-implant (>8 mm) is associated with a much higher rate of PPMI. Larger analyses are required to confirm whether implant depth influences heart block. If so, higher Sapien 3 implantation will be necessary to minimize the risk of PPMI while reducing the important complication of paravalvular aortic regurgitation.

    Percutaneous paravalvular leak closure for symptomatic aortic regurgitation after CoreValve transcatheter aortic valve implantation.

    Arri SS, Poliacikova P, Hildick-Smith D.
    Catheter Cardiovasc Interv2014 Nov 10.
    • Authors' Conclusion: “This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038' lumen and can therefore be delivered down standard diagnostic catheters.”

    • Interpretation: The demonstrated closure technique is somewhat effective, best suited for paravalvular leak due to incomplete annular apposition due to rigid calcified nodules, and less so for valve malposition. This article also demonstrates the difficulty in assessing the severity of paravalvular leak in patients using standard echocardiographic techniques.

    Position of Edwards SAPIEN transcatheter valve in the aortic root in relation with the coronary ostia: Implications for percutaneous coronary interventions.

    Katsanos S, Debonnaire P, van der Kley F, van Rosendael P, Joyce E, de Graaf MA, Schalij MJ, Scholte AJ, Bax JJ, Ajmone Marsan N, Delgado V.
    Catheter Cardiovasc Interv. 2014 Nov 4.
    • Authors' Conclusion: “Full overlap of the coronary ostia by Edwards SAPIEN frame is infrequent and in most cases does not limit subsequent PCI.”

    • Interpretation: In addition, overlap of the coronary ostia does not seem to increase the incidence of peri-procedural myocardial infarction.

    TAVR-Associated Prosthetic Valve Infective Endocarditis: Results of a Large, Multicenter Registry.

    Latib A, Naim C, De Bonis M, Sinning JM, Maisano F, Barbanti M, Parolari A, Lorusso R, Testa L, Actis Dato GM, Miceli A, Sponga S, Rosato F, De Vincentiis C, Werner N, Fiorina C, Bartorelli A, Di Gregorio O, Casilli F, Muratori M, Alamanni F, Glauber M, Livi U, Nickenig G, Tamburino C, Alfieri O, Colombo A.
    J Am Coll Cardiol. 2014 Nov 18;64(20):2176-8.
    • Authors' Conclusion: “TAVR-prosthetic valve infective endocarditis (PIE) is associated with a very high mortality. Antimicrobial prophylaxis prior to any invasive procedure is recommended in all TAVR patients, even late after the procedure. In a post-TAVR patient with pyrexia and no obvious infectious source, clinicians should have a high index of suspicion of TAVR-PIE and perform a cautious search for potential causes of endocarditis. If diagnosed, these patients should be treated aggressively.”

    • Interpretation: This is the only large multicenter report on TAVR-PIE to date. It occurred in 1.13% of patients, with 28% (0.3%) during the first 60 days after implantation (despite periprocedural antimicrobial prophylaxis), 52% between 60 days and 1 year, and 20% after one year. Positive blood cultures (primarily staphylococci, enterococci, or streptococci) and echo (primarily vegetations) were seen in 73% and 86% respectively. Mortality was high at 62%.

    Outcomes After Transfemoral Transcatheter Aortic Valve Replacement: A Comparison of the Randomized PARTNER (Placement of AoRTic TraNscathetER Valves) Trial With the NRCA (Nonrandomized Continued Access) Registry.

    Fearon WF, Kodali S, Doshi D, Fischbein MP, Yeung AC, Tuzcu EM, Rihal CS, Babaliaros V, Zajarias A, Herrmann HC, Brown DL, Mack M, Teirstein PS, Whisenant BK, Makkar R, Kapadia S, Leon MB; PARTNER Trial Investigators.
    JACC Cardiovasc Interv. 2014 Nov;7(11):1245-51. doi: 10.1016/j.jcin.2014.05.033. Epub 2014 Nov 17
    • Authors' Conclusion: The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT.

    • Interpretation: Superior patient selection (reduced peripheral and cerebro-vascular, renal, and lung disease) advances in device technology (enhanced Retroflex 3 delivery system and the transapical approach), and enhanced procedural skills (reduced procedure time) likely resulted in improved outcomes for patients in the NRCA registry as compared to those in the randomized PARTNER trial. In particular, vascular complications and bleeding were substantially reduced, which translated into reduced death and a trend toward reduced cerebrovascular events.