Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis

Thourani, Vinod H.; Kodali, Susheel; Makkar, Raj; Herrmann, Howard C.; Williams, Mathew; Babaliaros, Vasilis; Smalling, Richard W.; Lim, Scott; Malaisrie, S. Chris; Kapadia, Samir; Szeto, Wilson Y.; Greason, Kevin L.; Kereiakes, Dean J.; Ailawadi, Gorav; Whisenant, Brian; Devireddy, Chandan; Leipsic, Jonathon; Hahn, Rebecca T.; Pîbarot, Philippe; Weissman, Neil J.; Jaber, Wael A.; Cohen, David J.; Suri, Rakesh M.; Tuzcu, E. Murat; Svensson, Lars; Webb, John G.; Moses, Jeffrey W.; Mack, Michael J.; Miller, D. Craig; Smith, Craig R.; Alu, Maria; Parvataneni, Rupa; D’Agostino, Ralph B.; Leon, Martin B.

doi:10.1016/s0140-6736(16)30073-3

Cited by 932 publications

(529 citation statements)

References 28 publications

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“…On the basis of the favorable outcomes of recent randomized clinical trials conducted in intermediate‐risk populations,2, 3 TAVR is progressively being offered to younger and lower‐risk patients. In this particular subset, life expectancy is expected to exceed that of initial candidates to TAVR (ie, elderly and very elderly patients at high or prohibitive surgical risk), which makes the question of long‐term prosthesis durability of crucial importance.…”

Section: Introductionmentioning

confidence: 99%

Incidence of Long‐Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement

Barbanti

Costa

Zappulla

et al. 2018

JAHA

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BackgroundLong‐term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long‐term (8‐year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement (TAVR) who reached at least 5‐year follow‐up.Methods and ResultsConsecutive patients with at least 5‐year follow‐up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio‐Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre‐TAVR) to 10.5±4.5 mm Hg (in‐hospital post‐TAVR) (P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow‐up. Bioprosthetic valve failure was observed in a total of 11 patients (8‐year cumulative incidence function: 4.51%; 95% confidence interval, 1.95%–8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8‐year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%–5.71%) and 13 patients (8‐year cumulative incidence function: 5.87%; 95% confidence interval, 3.06%–9.96%), respectively. Aortic valve reintervention (redo TAVR) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis.ConclusionsIn an aged population of patients with symptomatic severe aortic stenosis treated with first‐generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.

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Section: Introductionmentioning

confidence: 99%

Incidence of Long‐Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement

Barbanti

Costa

Zappulla

et al. 2018

JAHA

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“…This was initially offered as an alternative to surgical aortic valve replacement in patients with a high risk for cardiac surgery but has subsequently expanded to encompass intermediate‐risk populations 1, 2, 3. With improving expertise in patient selection and procedural competence, the TAVR technology is being increasingly offered to patients with higher age, frailty, and comorbidity profiles 4.…”

Section: Introductionmentioning

confidence: 99%

Periprocedural Cardiopulmonary Bypass or Venoarterial Extracorporeal Membrane Oxygenation During Transcatheter Aortic Valve Replacement: A Systematic Review

Vallabhajosyula

Patlolla

Sandhyavenu

et al. 2018

JAHA

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BackgroundThere are limited data on the use of venoarterial extracorporeal membrane oxygenation (VA‐ECMO) or cardiopulmonary bypass (CPB) to provide hemodynamic support periprocedurally during transcatheter aortic valve replacement. This study sought to evaluate patients receiving transcatheter aortic valve replacement with concomitant use of CPB/VA‐ECMO.Methods and ResultsWe systematically reviewed the published literature from 2000 to 2018 for studies evaluating adult patients requiring CPB/VA‐ECMO periprocedurally during transcatheter aortic valve replacement. Studies reporting short‐term and long‐term mortality were included. Given the significant methodological and statistical differences between published studies, meta‐analysis of the association of CPB/VA‐ECMO with mortality was not performed. Of the 537 studies identified, 9 studies representing 5191 patients met our inclusion criteria. Median ages were between 75 and 87 years with 33% to 75% male patients. Where reported, the Edwards SAPIEN™ transcatheter heart valve was the most frequently used. A total of 203 (3.9%) patients received periprocedural hemodynamic support with CPB/VA‐ECMO. Common indications for CPB/VA‐ECMO included left ventricular or aortic annular rupture, rapid hemodynamic deterioration, aortic regurgitation, cardiac arrest, and left main coronary artery obstruction. The use of CPB/VA‐ECMO was predominantly an emergent strategy and was used for durations of 1 to 2 hours. Short‐term mortality (in‐hospital and 30‐day) was 29.8%, and 1‐year mortality was 52.4%. Major complications such as bleeding, vascular injury, tamponade, stroke, and renal failure were noted in 10% to 50% of patients.Conclusions CPB/VA‐ECMO was used in 4% in the early experience of patients undergoing transcatheter aortic valve replacement, most commonly for periprocedural complications. There are limited data on preprocedural planned use of VA‐ECMO, and the characteristics of this population remain poorly defined.

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“…Data from the registry arm of the PARTNER 2 (Placement of Aortic Transcatheter Valves) study comparing TAVR with the Sapien 3 THV with a propensity‐matched surgical cohort demonstrated both noninferiority and superiority of TAVR versus SAVR for the composite outcome of death, stroke, and moderate/severe aortic regurgitation, with overall low complication rates using this newer THV (Table 1). 13 Comparable findings were revealed in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial using the self‐expanding CoreValve or Evolut R THV in intermediate‐risk patients 14. At 2 years, there was no difference in the composite outcome of all‐cause death or disabling stroke.…”

Section: Clinical Trials In Operable Patientsmentioning

confidence: 92%

“…The Sapien 3 valve features a sealing skirt, and the latest‐generation CoreValve Evolut PRO also incorporates a pericardial tissue wrap specifically designed to reduce PVL. However, the need for new PPM implantation remains the Achilles’ heel of TAVR, with 30‐day PPM rates of ≈10% for balloon‐expandable THV13 and ≈25% for self‐expanding THV14 (Table 1). In the SURTAVI trial, there was no difference in PPM rate between the CoreValve and Evolut R THV (25.5% versus 26.7%, respectively), although only 16% of patients in the study received the newer Evolut R THV.…”

Section: Potential Limitations Of Tavr In Operable Patientsmentioning

confidence: 99%

Transcatheter Aortic Valve Replacement in Intermediate‐ and Low‐Risk Patients

Rogers

Thourani

Waksman

2018

JAHA

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Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis

Cited by 932 publications

References 28 publications

Incidence of Long‐Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement

Incidence of Long‐Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement

Periprocedural Cardiopulmonary Bypass or Venoarterial Extracorporeal Membrane Oxygenation During Transcatheter Aortic Valve Replacement: A Systematic Review

Transcatheter Aortic Valve Replacement in Intermediate‐ and Low‐Risk Patients

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