• SCAI TAVR Center
    Supported by:Medtronic

    February 2015 Journal Scan

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

    A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk.

    Schymik G, Heimeshoff M, Bramlage P, Herbinger T, Würth A, Pilz L, Schymik JS, Wondraschek R, Süselbeck T, Gerhardus J, Luik A, Gonska BD, Tzamalis P, Posival H, Schmitt C, Schröfel H.
    Catheter Cardiovasc Interv. 2015 Jan 30. doi: 10.1002/ccd.25866
    • Authors' Conclusion: ”In this large, single center, real world dataset there was no difference in mortality between patients undergoing TAVI or SAVR during a 3 year follow-up but there was a TAVI related increase in major vascular complications, new pacemaker implantation and aortic insufficiency and a SAVR related increased bleeding risk.”

    • Interpretation: This propensity-matched comparison of TAVR and SAVR in low-intermediate operative risk patients (logistic Euroscore ~8) with AS shows differences in perioperative complications but similar long-term (3 year) outcomes. This study joins other prospective, observational studies supporting TAVR in lower risk patient populations, but provides the longest follow-up to date. For higher level scientific evidence, we must await the Corevalve RCT, Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI).

    Transcatheter Aortic Valve Implantation in the UK: Temporal Trends, Predictors of Outcome and 6 Year Follow Up: A Report from the UK TAVI Registry 2007 to 2012.

    Ludman PF, Moat N, de Belder MA, Blackman DJ, Duncan A, Banya W, MacCarthy PA, Cunningham D, Wendler O, Marlee D, Hildick-Smith D, Young CP, Kovac J, Uren NG, Spyt T, Trivedi U, Howell J, Gray H; on behalf of the UK TAVI Steering Committee and the National Institute for Cardiovascular Outcomes Research.
    Circulation. 2015 Jan 30. pii: CIRCULATIONAHA.114.013947
    • Authors' Conclusion: “We analyzed TAVI in an entire country, with follow up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer term outcomes improved, and patients were discharged earlier. Peri-procedural stroke, non-femoral access and post-procedure aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.”

    • Interpretation: Interesting findings in this whole-country TAVR registry spanning 2007-2012 with ~4000 patients shows relatively stable patient selection (no “risk creep”), procedural technique (~70% transfemoral, ~87% general anesthesia) , and patient outcomes (with the exception of need for pacemaker which decreased) after the 2 years (2007-8). However, careful perusal of this article will give insights into the nuanced evolution TAVR in the real world.

    Use of a balloon-expandable transfemoral sheath in a TAVI cohort with complex access site - a propensity score matched analysis.

    Sedaghat A, von Dobbeler C, Sontag B, Sinning JM, Fimmers R, Mellert F, Schiller W, Welz A, Grube E, Nickenig G, Hauptmann KE, Werner N.
    EuroIntervention. 2015 Jan 30. pii: 20141002-04. doi: 10.4244/EIJY15M01_10
    • Authors' Conclusion: “The use of a balloon-expandable large-bore sheath in patients with a high risk for vascular complications due to complex access-site anatomy proved to be feasible and safe. However, circumferential calcifications and sheath-to-artery ratios account for vascular access complications even in patients treated with the balloon-expandable sheath.”

    • Interpretation: While balloon-expandable sheaths may be “feasible and safe” (with safety a controversial conclusion in this small study) relative to routine sheaths in severe PAD patients undergoing TAVR, similar rates and types of major vascular access complications still occur. Until randomized comparisons are performed, the better-studied alternative access routes (transapical, transaortic, caval-aortic, subclavian) should remain the primary option for the patients with severe PAD needing TAVR.

    Transfemoral Implantation of Transcatheter Heart Valves After Deterioration of Mitral Bioprosthesis or Previous Ring Annuloplasty.

    Bouleti C, Fassa AA, Himbert D, Brochet E, Ducrocq G, Nejjari M, Ghodbane W, Depoix JP, Nataf P, Vahanian A.
    JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):83-91. doi: 10.1016/j.jcin.2014.07.026
    • Authors' Conclusion: “This single-center series suggests that transfemoral THV implantation for deterioration of mitral bioprosthesis or surgical repair is feasible in selected patients and improves early hemodynamic and midterm functional status.”

    • Interpretation: The operators in this single-center French study demonstrate in 17 consecutive patients that transfemoral/transseptal mitral valve-in-valve or valve-in-ring is feasible with reasonable outcomes for a high-risk population. Those operators/centers highly experienced in the transseptal procedures may well want to consider this option over the higher morbidity transapical approach until more comparison studies are available.

    Predictors and Clinical Outcomes of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: The PARTNER (Placement of Aortic Transcatheter Valves) Trial and Registry.

    Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office.
    JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
    • Authors' Conclusion: “PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year.”

    • Interpretation: Important findings unique to the largest study so far of PPM implantation after TAVR is that prosthesis/LVOT diameter ratio predicts the need for PPM in addition to preexisting RBBB, and PPM implantation is associated with higher rates of rehospitalization. This study therefore strengthens the potential deleterious clinical importance of TAVR-associated PPM as well as provides additional information about how to avoid it.

    The "chimney approach" for transcatheter aortic valve implantation: a strategy for trans axillarian bareback approach in patients with no other access options.

    Biasco L, De Backer O, Holme S, Søndergaard L, Jönsson A.
    Catheter Cardiovasc Interv. 2015 Jan 19. doi: 10.1002/ccd.25840
    • Authors' Conclusion: “In this initial experience, the axillarian bareback approach technique allowed a safe and successful TAVI implant in a subgroup of patients with a high risk of procedural complications due to the presence of a patent LIMA-LAD or vessels of small caliber. Considering the increasing number of patients referred for TAVI, in the next future the axillarian bareback approach could represent a safer alternative to direct cannulation in patients with severe aortic stenosis with no other access options.”

    • Interpretation: The axillary approach is an attractive alternate access site but may not be suitable in patients with a patent LIMA-LAD graft since placement of an 18 F sheath may induce ischemia. The bareback technique described in this small series might reduce profile enough to preserve bypass graft flow. Additional studies are required to confirm these results and define the lower limits of subclavian size required for this technique.

    Clinical results with the 31 mm CoreValveª in large aortic annuli: the importance of implantation technique.

    Ussia GP, Sarkar K, Cammalleri V, Marchei M, Muscoli S, De Vico P, Rubino D, De Persis F, Macrini M, Romeo F.
    EuroIntervention. 2015 Jan 22;10(9):e1-8. doi: 10.4244/EIJV10I9A182.
    • Authors' Conclusion: “The 31 mm CRS can be safely implanted in patients with complex aortic valve disease, large annuli and dilated left ventricles.”

    • Interpretation: The 31 mm CoreValve does not increase procedural risk and significantly increases the number of patients who can be treated with TAVR.

    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 Jan 14. pii: S0003-4975(14)01982-1. doi: 10.1016/j.athoracsur.2014.10.012
    • 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: This series suggests that in-hospital outcomes are similar between the transapical, transaortic, and transcarotid approaches. However, the small numbers of transaortic and transcarotid cases makes drawing firm conclusions challenging. An excellent algorithm is provided to help select the most appropriate access routine in TAVR patients.

    Incidence and Mechanisms of Cerebral Ischemia After Transcatheter Aortic Valve Implantation Compared With Surgical Aortic Valve Replacement.

    Alassar A, Soppa G, Edsell M, Rich P, Roy D, Ster IC, Joyce R, Valencia O, Barrick T, Howe F, Moat N, Morris R, Markus HS, Jahangiri M.
    Ann Thorac Surg. 2015 Jan 10. pii: S0003-4975(14)01924-9. doi: 10.1016/j.athoracsur.2014.09.054.
    • Authors' Conclusion: “At 3 months follow-up, overall cognitive score was higher in AVR compared with TAVI, adjusted for baseline score. However, there was no difference in cerebral embolic load, ischemic lesions, and oxygen desaturation.”

    • Interpretation: Many early studies revealed a higher risk of clinical stroke with TAVR compared with SAVR although more recent studies show a significant reduction in stroke risk with TAVR. This moderately-sized series comparing neurological outcomes in TAVR vs SAVR revealed similar rates of cerebral embolization by transcranial Doppler, total number and volume of new lesions by DW-MRI, and procedural oxygen desaturation although neurocognitive testing seemed to favor SAVR. The overall results of this study suggest that, with current transcatheter heart valve profile, deployment technique and patient selection, TAVR and SAVR have similar neurological outcomes.

    Multicenter Evaluation of Transcatheter Aortic Valve Replacement Using either SAPIEN XT or CoreValve: Degree of Device Oversizing by Computed-Tomography and Clinical Outcomes.

    Dvir D, Webb JG, Piazza N, Blanke P, Barbanti M, Bleiziffer S, Wood DA, Mylotte D, Wilson AB, Tan J, Stub D, Tamburino C, Lange R, Leipsic J.
    Catheter Cardiovasc Interv. 2015 Jan 9. doi: 10.1002/ccd.25823.
    • Authors' Conclusion: “Optimal clinical performance of CoreValve and SAPIEN XT appears to be reached with different degrees of oversizing. Certain annular sizes that allow for only moderate or large oversizing, but not both, appear to benefit from a device specific approach.”

    • Interpretation: Paravalvular leak can be minimized by systematically oversizing transcatheter heart valves, although aggressive oversizing with balloon expandable devices increase the risk of annular rupture. Since balloon expandable and self-expanding transcatheter heart valves have different sizing ranges it is intuitive that the devices may have differential results in borderline cases. This study suggests that in moderate oversizing (5-20% by area or 2.5-9.5% by perimeter) that balloon expandable devices may be better (less need for post-dilation and stroke) and in large oversizing (20.1-35% by area or 9.6-16.2% by perimeter) self-expanding devices may be superior (less annular rupture). Further studies are required to confirm an individualized algorithm for device selection. However, this may be less relevant in the near future with the approval of Sapien 3 (as well as other devices such as Lotus) that requires less aggressive oversiving owing to a fabric cuff that minimized paravalvualar leak.

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