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Meta-Analysis of Outcomes of Transcatheter Aortic Valve Implantation Among Patients With Low Gradient Severe Aortic Stenosis

      Transcatheter aortic valve implantation (TAVI) has emerged as an effective therapy for patients with severe aortic stenosis (AS). However, data on TAVI outcomes in patients with low gradient (LG) AS are limited. We performed a meta-analysis of studies comparing TAVI outcomes between patients with classic high gradient (HG) and LG AS through November 2018. The 30-day mortality, mid-term all-cause, and cardiovascular mortality at maximum follow-up were compared between patients with HG and LG AS (Pairwise meta-analysis), and between the three distinct groups of AS including HG, paradoxical low-flow low-gradient and low gradient with reduced ejection fraction (rEF-LG) (Network meta-analysis). Nineteen studies (n = 27,204 patients) met the inclusion criteria. The HG group had less 30-day, mid-term all-cause and cardiovascular mortality compared with the low-gradient AS group overall, (6% vs 7.5%, OR 0.76, 95% CI 0.66 to 0.87, I2 = 18%), (21% vs 29%, OR 0.59, 95% CI 0.52 to 0.67, I2 = 62%), and (12.6% vs 18.7%, OR 0.61, 95% CI 0.49 to 0.76, I2 = 62%), respectively, p <0.0001. These outcomes were confirmed in a trial sequential analysis in which the cumulative Z-curve crossed the conventional test boundary as well as the trial sequential monitoring boundary for all outcomes. The network meta-analysis revealed that patients with rEF-LG had similar outcomes to those with pLFLG, and both had worse outcomes than patients with classic HG AS. In conclusion patients with classic HG have better 30-day mortality, mid-term all-cause and cardiovascular mortality compared with LG patients following TAVI. Among patients with LG severe AS, TAVI outcomes were similar in patients with rEF-LG and pLFLG.
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      References

        • Leon MB
        • Smith CR
        • Mack MJ
        • Makkar RR
        • Svensson LG
        • Kodali SK
        • Thourani VH
        • Tuzcu EM
        • Miller DC
        • Herrmann HC
        • Doshi D
        • Cohen DJ
        • Pichard AD
        • Kapadia S
        • Dewey T
        • Babaliaros V
        • Szeto WY
        • Williams MR
        • Kereiakes D
        • Zajarias A
        • Greason KL
        • Whisenant BK
        • Hodson RW
        • Moses JW
        • Trento A
        • Brown DL
        • Fearon WF
        • Pibarot P
        • Hahn RT
        • Jaber WA
        • Anderson WN
        • Alu MC
        • Webb JG
        Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.
        N Engl J Med. 2016; 374: 1609-1620
        • 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
        • Akin J
        • Davidson MJ
        • Svensson LG
        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.
        Lancet. 2015; 385: 2477-2484
        • Elhmidi Y
        • Piazza N
        • Krane M
        • Deutsch MA
        • Mazzitelli D
        • Lange R
        • Bleiziffer S
        Clinical presentation and outcomes after transcatheter aortic valve implantation in patients with low flow/low gradient severe aortic stenosis.
        Catheter Cardiovasc Interv. 2014; 84: 283-290
        • Malkin CJ
        • Long WR
        • Baxter PD
        • Gale CP
        • Wendler O
        • Monaghan M
        • Thomas MT
        • Ludman PF
        • de Belder MA
        • Cunningham AD
        • Moat NE
        • Blackman DJ
        Impact of left ventricular function and transaortic gradient on outcomes from transcatheter aortic valve implantation: data from the UK TAVI Registry.
        EuroIntervention. 2016; 11: 1161-1169
        • Moher D
        • Shamseer L
        • Clarke M
        • Ghersi D
        • Liberati A
        • Petticrew M
        • Shekelle P
        • Stewart LA
        Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement.
        Syst Rev. 2015; 4: 1
        • Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)
        Final rule.
        Fed Regist. 2017; 82: 180-651
        • Brok J
        • Thorlund K
        • Gluud C
        • Wetterslev J
        Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses.
        J Clin Epidemiol. 2008; 61: 763-769
        • Abramowitz Y
        • Chakravarty T
        • Pibarot P
        • Maeno Y
        • Kawamori H
        • Anderson D
        • Mangat G
        • Nakamura M
        • Cheng W
        • Makkar RR
        Characteristics and outcome following transcatheter aortic valve replacement in patients with severe aortic stenosis with low flow.
        EuroIntervention. 2017; 13: e1428-e1435
        • 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
        Impact of low preprocedural transvalvular gradient on cardiovascular mortality following TAVI: an analysis from the FRANCE 2 registry.
        EuroIntervention. 2014; 10: 842-849
        • Biner S
        • Birati EY
        • Topilsky Y
        • Steinvil A
        • Ben Assa E
        • Sadeh B
        • Arbel Y
        • Halkin A
        • Abramowitz Y
        • Leshem-Rubinow E
        • Banai S
        • Keren G
        • Finkelstein A
        Outcome of transcatheter aortic valve implantation in patients with low-gradient severe aortic stenosis and preserved left ventricular ejection fraction.
        Am J Cardiol. 2014; 113: 348-354
        • Conrotto F
        • D'Ascenzo F
        • Stella P
        • Pavani M
        • Rossi ML
        • Brambilla N
        • Napodano M
        • Covolo E
        • Saia F
        • Tarantini G
        • Agostoni P
        • Marzocchi A
        • Presbitero P
        • Bedogni F
        • Salizzoni S
        • D'Amico M
        • Moretti C
        • Rinaldi M
        • Gaita F
        Transcatheter aortic valve implantation in low ejection fraction/low transvalvular gradient patients: the rule of 40.
        J Cardiovasc Med. 2017; 18: 103-108
        • Debry N
        • Sudre A
        • Amr G
        • Delhaye C
        • Schurtz G
        • Montaigne D
        • Koussa M
        • Modine T
        Transcatheter aortic valve implantation for paradoxical low-flow low-gradient aortic stenosis patients.
        Catheter Cardiovasc Interv. 2016; 87: 797-804
        • Gotzmann M
        • Lindstaedt M
        • Bojara W
        • Ewers A
        • Mugge A
        Clinical outcome of transcatheter aortic valve implantation in patients with low-flow, low gradient aortic stenosis.
        Catheter Cardiovasc Interv. 2012; 79: 693-701
        • Herrmann HC
        • Pibarot P
        • Hueter I
        • Gertz ZM
        • Stewart WJ
        • Kapadia S
        • Tuzcu EM
        • Babaliaros V
        • Thourani V
        • Szeto WY
        • Bavaria JE
        • Kodali S
        • Hahn RT
        • Williams M
        • Miller DC
        • Douglas PS
        • Leon MB
        Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis.
        Circulation. 2013; 127: 2316-2326
        • Kataoka A
        • Watanabe Y
        • Kozuma K
        • Nara Y
        • Nagura F
        • Kawashima H
        • Hioki H
        • Nakashima M
        • Yamamoto M
        • Takagi K
        • Araki M
        • Tada N
        • Shirai S
        • Yamanaka F
        • Hayashida K
        Prognostic impact of low-flow severe aortic stenosis in small-body patients undergoing TAVR: the OCEAN-TAVI Registry.
        JACC Cardiovasc Imaging. 2018; 11: 659-669
        • Lauten A
        • Figulla HR
        • Mollmann H
        • Holzhey D
        • Kotting J
        • Beckmann A
        • Veit C
        • Cremer J
        • Kuck KH
        • Lange R
        • Zahn R
        • Sack S
        • Schuler G
        • Walther T
        • Beyersdorf F
        • Bohm M
        • Heusch G
        • Meinertz T
        • Neumann T
        • Welz A
        • Mohr FW
        • Hamm CW
        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).
        EuroIntervention. 2014; 10: 850-859
        • Le Ven F
        • Freeman M
        • Webb J
        • Clavel MA
        • Wheeler M
        • Dumont E
        • Thompson C
        • De Larochelliere R
        • Moss R
        • Doyle D
        • Ribeiro HB
        • Urena M
        • Nombela-Franco L
        • Rodes-Cabau J
        • Pibarot P
        Impact of low flow on the outcome of high-risk patients undergoing transcatheter aortic valve replacement.
        J Am Coll Cardiol. 2013; 62: 782-788
        • Mangner N
        • Stachel G
        • Woitek F
        • Haussig S
        • Schlotter F
        • Hollriegel R
        • Adam J
        • Lindner A
        • Mohr FW
        • Schuler G
        • Kiefer P
        • Leontyev S
        • Borger MA
        • Thiele H
        • Holzhey D
        • Linke A
        Predictors of mortality and symptomatic outcome of patients with low-flow severe aortic stenosis undergoing transcatheter aortic valve replacement.
        J Am Heart Assoc. 2018; 7 (pii: e007977)
        • Puls M
        • Korte KP
        • Bleckmann A
        • Huenlich M
        • Danner BC
        • Schoendube F
        • Hasenfuss G
        • Jacobshagen C
        • Schillinger W
        Long-term outcomes after TAVI in patients with different types of aortic stenosis: the conundrum of low flow, low gradient and low ejection fraction.
        EuroIntervention. 2017; 13: 286-293
        • Reinthaler M
        • Schwabe A
        • Landmesser U
        • Chung R
        • Aggarwal S
        • Delahunty N
        • Frohlich G
        • Meier P
        • Roberts N
        • Pantazis A
        • Mullen MJ
        'Paradoxical' low-flow, low-gradient severe aortic valve stenosis: an entity with limited improvement following transcatheter aortic valve implantation.
        J Heart Valve Dis. 2014; 23: 441-449
        • Rodriguez-Gabella T
        • Nombela-Franco L
        • Auffret V
        • Asmarats L
        • Islas F
        • Maes F
        • Ferreira-Neto AN
        • Paradis JM
        • Dumont E
        • Cote M
        • Jimenez-Quevedo P
        • Macaya C
        • Pibarot P
        • Rodes-Cabau J
        Transcatheter aortic valve implantation in patients with paradoxical low-flow, low-gradient aortic stenosis.
        Am J Cardiol. 2018; 122: 625-632
        • Schewel J
        • Schewel D
        • Frerker C
        • Wohlmuth P
        • Kuck KH
        • Schafer U
        Invasive hemodynamic assessments during transcatheter aortic valve implantation: comparison of patient outcomes in higher vs. lower transvalvular gradients with respect to left ventricular ejection fraction.
        Clin Res Cardiol. 2016; 105: 59-71
        • Shah B
        • McDonald D
        • Paone D
        • Redel-Traub G
        • Jangda U
        • Guo Y
        • Saric M
        • Donnino R
        • Staniloae C
        • Robin T
        • Benenstein R
        • Vainrib A
        • Williams MR
        Outcomes after transcatheter aortic valve replacement in patients with low versus high gradient severe aortic stenosis in the setting of preserved left ventricular ejection fraction.
        J Interv Cardiol. 2018; 31: 849-860
        • Baron SJ
        • Arnold SV
        • Herrmann HC
        • Holmes Jr., DR
        • Szeto WY
        • Allen KB
        • Chhatriwalla AK
        • Vemulapali S
        • O'Brien S
        • Dai D
        • Cohen DJ
        Impact of ejection fraction and aortic valve gradient on outcomes of transcatheter aortic valve replacement.
        J Am Coll Cardiol. 2016; 67: 2349-2358
        • Smucker ML
        • Manning SB
        • Stuckey TD
        • Tyson DL
        • Nygaard TW
        • Kron IL
        Preoperative left ventricular wall stress, ejection fraction, and aortic valve gradient as prognostic indicators in aortic valve stenosis.
        Catheter Cardiovasc Diagn. 1989; 17: 133-143
        • Ozsoyler I
        • Lafci B
        • Emrecan B
        • Kestelli M
        • Bozok S
        • Ozbek C
        • Yesil M
        • Gurbuz A
        Aortic valve replacement in true severe aortic stenosis with low gradient and low ejection fraction.
        Heart Surg Forum. 2006; 9: E681-E685
        • Hachicha Z
        • Dumesnil JG
        • Bogaty P
        • Pibarot P
        Paradoxical low-flow, low-gradient severe aortic stenosis despite preserved ejection fraction is associated with higher afterload and reduced survival.
        Circulation. 2007; 115: 2856-2864
        • Levy F
        • Laurent M
        • Monin JL
        • Maillet JM
        • Pasquet A
        • Le Tourneau T
        • Petit-Eisenmann H
        • Gori M
        • Jobic Y
        • Bauer F
        • Chauvel C
        • Leguerrier A
        • Tribouilloy C
        Aortic valve replacement for low-flow/low-gradient aortic stenosis operative risk stratification and long-term outcome: a European multicenter study.
        J Am Coll Cardiol. 2008; 51: 1466-1472
        • Pai RG
        • Varadarajan P
        • Razzouk A
        Survival benefit of aortic valve replacement in patients with severe aortic stenosis with low ejection fraction and low gradient with normal ejection fraction.
        Ann Thorac Surg. 2008; 86: 1781-1789