Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients

Reardon, Michael J.; Mieghem, Nicolás M. Van; Popma, Jeffrey J.; Kleiman, Neal S.; Søndergaard, Lars; Mumtaz, Mubashir; Adams, David H.; Deeb, G. Michael; Maini, Brijeshwar; Gada, Hemal; Chetcuti, Stanley; Gleason, Thomas G.; Heiser, John; Lange, Rüdiger; Merhi, William; Oh, Jae K.; Olsen, Peter Skov; Piazza, Nicolò; Williams, Mathew; Windecker, Stephan; Yakubov, Steven J.; Grube, Eberhard; Makkar, Raj; Lee, J. S.; Conte, John V.; Vang, Eric; Nguyen, Huong Lan Thi; Chang, Yao-Chuan; Mugglin, Andrew S.; Serruys, Patrick W.; Kappetein, Arie Pieter

doi:10.1056/nejmoa1700456

Cited by 2,419 publications

(1,647 citation statements)

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“…The issue of cerebrovascular complications in the context of the TAVI procedure is well known since the first reports, and it was confirmed by the major randomized trials that compared TAVI versus surgery in high‐ and moderate‐risk patients 1, 2, 3, 4, 5, 6. These trials focused on the rate of “clinically relevant” cerebrovascular accidents and obviously prompted the ideation and introduction of EPD currently in use or under investigation.…”

Section: Discussionmentioning

confidence: 97%

“…In the past decade, transcatheter aortic valve implantation (TAVI) triggered a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis 1, 2, 3, 4, 5, 6. Nonetheless, along with groundbreaking efficacy results, data concerning the risk of cerebrovascular complications have been consistently reported in studies using either diffusion‐weighted magnetic resonance imaging (DW‐MRI) or high‐intensity transient signals as assessed by transcranial Doppler 7, 8, 9, 10.…”

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confidence: 99%

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Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Testa

Latib

Casenghi

et al. 2018

JAHA

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BackgroundThe use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation. Available evidence from single studies is inconclusive. The aim of the present meta‐analysis was to assess the safety and efficacy profile of current EPD.Methods and ResultsMajor medical databases were searched up to December 2017 for studies that evaluated patients undergoing transcatheter aortic valve implantation with or without EPD. End points of interest were 30‐day mortality, 30‐day stroke, the total number of new lesions, the ischemic volume per lesion, and the total volume of lesions. Eight studies involving 1285 patients were included. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. The use of EPD was not associated with significant differences in terms of 30‐day mortality (odds ratio 0.43 [0.18–1.05], P=0.3) but it was associated with a lower rate of 30‐day stroke (odds ratio 0.55 [0.31–0.98], P=0.04). No differences were detected with respect to the number of new lesions (standardized mean difference −0.19 [−0.71 to 0.34], P=0.49). The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, −0.52 [−0.85 to −0.20], P=0.002) and smaller total volume of lesions (standardized mean difference, −0.23 [−0.42 to −0.03], P=0.02).ConclusionsThe use of EPD is not associated with a reduced rate of mortality and new ischemic cerebral lesions. The use of EPD during transcatheter aortic valve implantation seems to be associated with a lower 30‐day stroke rate, although this result is driven by a single nonrandomized study. The use of EPD is associated with a smaller volume of ischemic lesions, and smaller total volume of ischemic lesions.

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Section: Discussionmentioning

confidence: 97%

mentioning

confidence: 99%

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Testa

Latib

Casenghi

et al. 2018

JAHA

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“…If transcatheter heart valve (THV) durability up to 5 years is already a well‐established reality, with low rates of structural valve dysfunction (SVD) demonstrated in large and methodologically rigorous studies,4, 5, 6, 7, 8 data on clinical outcomes and THV integrity after 5 years remain extremely scarce 9. An important challenge when reporting the rates of SVD (and comparing them with those of previous studies) deals with its definition.…”

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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“…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: 93%

“…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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Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients

Abstract: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Cited by 2,419 publications

References 20 publications

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

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

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

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