transcatheter aortic valve implantation; transcatheter aortic valve replacement (TAVI, TAVR, CoreValve system)
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Indications
- symptomatic aortic stenosis in intermediate-high surgical risk patients (FDA-approved)[4][5][6][38]*
- 5-year mortality rate 68% with TAVR & 62% with surgery in high risk patients[15]
- superior to balloon aortic valvuloplasty in inoperable patients (mortality 72% vs 94%)[15]
- TAVR compares favorably with surgery in low-risk patients[39][63]
- early TAVR superior to clinical surveillance due to a reduction in hospitalizations[66]
- aortic insufficiency[50][64]
* no difference between TAVR & open surgery in death, stroke, or MI at 1 year in patients >= 70 years of age (13% vs 16%)[16] (5.4% vs 10.0%)[63]
* selected low-risk surgical candidates can have good short-term outcomes with TAVR[35]
* TAVR provides durable function through at least 5 years & up to 8 year years in low-risk patients[37]
* similar outcomes vs surgical AVR* at 5 years in patients with severe aortic stenosis.
* in elderly >=70 years with severe, symptomatic aortic stenosis at moderately increased operative risk, TAVI is noninferior to surgery for all-cause mortality at 1 year
* a dedicated device for aortic insufficiency safe & effective[64]
- all-cause mortality at 1 year is 8%[64]
- residual aortic insufficiency none or trace in 92% of patients at 1 year[64]
Contraindications
- not approved for patients with
- may be less effective in patients with pulmonary hypertension[22]
- 1-year mortality of TAVR in patients with ESRD is 37%[41]
Procedure
- a bioprosthetic aortic valve is placed through left-sided cardiac catheterization
- balloon-expandable (BE) & self-expandable (SE) devices are FDA-approved
- the BE device has a better success rate than the SE device (96% vs 76%)[10]
- less-frequent moderate or severe aortic regurgitation (4% vs 18%)) with the BE device
- less need for a second valve (0.8% vs.5.8% with the BE device
- new permanent pacemaker implantation more comon with the SE device (38% vs 17%)
- stroke rate more common with the BE device (5.8% vs 2.6%)
- no difference in procedural or 30-day mortality
- no difference in symptom improvement[10]
- the BE device has a better success rate than the SE device (96% vs 76%)[10]
- median length of stay is 6 days[8]
- rapid atrial pacing to 120/min at the time of the procedure might assist in predicting need for implantation of a pacemaker[47]
- inducible Wenckebach block predicts need for permanent pacemaker[47]
- apparently the bioprosthetic aortic valve has a distal stent[60]
* Meditronic's CoreValve system[13]
* 3rd generation transcatheter aortic valve FDA-approved June 2015[17]
* mechanically expanded (not yet FDA-approved) valve (MEV [Lotus]) non-inferior to self-expanding valve[34]
Complications
- risk of stroke
- risk of stroke 2%[8][19]
- risk of stroke 2.5% at 30 days & 4.1% at 1 year[14]
- risk of stroke higher in women than men
- ~75% of patients sustained silent brain infarcts according to diffusion-weighted MRI before & after TAVI[51]
- risk for vascular complications (16.2% vs. 1.1%)*[1][3]
- risk of major vascular injury 6.4%[8]
- decreased risk of major bleeding (9.3% vs. 19.5%)*
- (4%)[19]
- most frequent short-term adverse events
- heart block, vascular complications, renal failure (5.5%), & aortic regurgitation (8.5%)[7][8] (5%)[19]
- need for permanent pacemaker (38% vs 2%)*
- aortic regurgitation (16% vs 1%)
- atrial fibrillation less common than with SAVR (6%)[16][19]
- risk for atrial fibrillation 14% after TAVR & 31% after[42]
- endocarditis[26]
- risk factors:
- younger males
- diabetes mellitus, COPD, post-TAVR aortic regurgitation
- occurs median of 5 months after TAVR
- healthcare-associated in ~50%
- most common infectious agents: Enterococcus, S aureus
- 2-year mortality ~67%[26]
- risk factors:
- valve & leaflet thrombosis is common[25]
- post TAVR anticoagulation may be prudent (no data)
- frequent need for a new permanent pacemaker after TAVR (11%)[19]
- long-term mortality or hospitalization for heart failure not affected by need for pacemaker[12]
- mortality
- 7% at 30 days & 24% at 1 year[14]
- 2.2% at 30 days with > 25% of deaths out-of-hospital[25]
- in-hospital mortality 4.0-5.4%; 30 day mortality 7.6%[8][19] vs 2.2%*
- risk of mortality at 1 year was linked to older age, male sex, end-stage renal disease, & severe COPD[14]
- 1-year mortality of TAVR in patients with ESRD is 37%[41]
- 30-day & 1-year death rates significantly higher among nonagenarians than younger patient (8.8% vs. 5.9% & 24.8% vs. 22.0%, respectively)[20]
- GRS11[22] cites frailty as a risk factor, thus gait speed as performance measure predicts 1 year mortality[23], while age >=90 years does not (ref[20] not cited by[22])
- osteosarcopenia is associated with 3-fold increase in 1-year mortality[65]
- prior depression associated with increased 3-year mortality 34% vs 22%[67]
- depression may increase 1 year mortality[33]
- no data on age, weight loss, & rate of disease progression as predictors of morbidity or mortality after TAVR[22]
- 1/5 of patients readmitted early after hospital discharge
- respiratory causes & heart failure are major factors
- early readmissions are mainly related to periprocedural bleeding events
- most late readmissions were secondary to baseline patient comorbidities[18][28]
- poor outcome in 38% of patients at 1 year owing to death (19%), persistently poor quality of life (17%), or declining quality of life (5%)[29]
- predictors of worse 1-year health status include
- older age, severe lung disease, worse baseline health status, prior stroke, nonfemoral access[29]
- predictors of worse 1-year health status include
- structural valve deterioration less frequent after self-expanding TAVR than open surgery (2.2% vs 4.4%)[59]
- redo TAVR as safe as initial TAVR[61]
- surgical aortic valve repair after TAVR associated with 10-21% mortality[49]
* compared with standard surgical AVR (SAVR)
Management
- RAS inhibitor associated with lower mortality (12.5 vs 14.9%) & lower risk for heart failure hospitalization (12.0 vs 13.8%) in patients with heart failure[36]
- dual antiplatelet therapy for 3-6 months[44]
Notes
- significantly reduces mortality, repeat hospitalization, & cardiac symptoms, despite higher incidence of stroke & vascular complications[1][4]
- all cause mortality 43% vs 68% at 2 years[4]
- similar rates of survival compared with standard AVR[2]
- similar risk for stroke or mortality at 5 years compared with standard AVR[45]
- improved health-related quality of life relative to standard AVR[3]
- difference at 30 days, but no difference at 1 year[2] improves clinical outcomes but has modest effect on psychological & general health measures[9]
- compared with balloon angioplasty, TAVI is associated with
- a higher incidence of major strokes (5.0% vs 1.1%) & major vascular complications (16.2% vs 1.1%) at 30 days
- higher incidence of major bleeding
- better outcomes regarding symptoms
- decreased need for re-intervention (balloon angioplasty, repeat TAVI, AVR)
- lower mortality (30.7% vs 50.7%) at 1 year[1]
- survival benefit of TAVR in high-risk patients after 1 year
- mortality 14% vs 19% for standard AVR
- 30-day risk of stroke not higher vs standard AVR (5% vs 6%)[11]
- TAVR noninferior to surgical aortic valve replacement at 2 & 5 years in patients with intermediate level of surgical risk[21][57]
- death or disabling stroke at 2 years 12.6% for TAVR vs 14.0% for surgery[30]
- more often associated with major vascular complications, & paravalvular aortic regurgitation (5.3% at 1 year[30], but less often associated with acute renal failure, severe bleeding, & new-onsetatrial fibrillation[21]
- TAVR more often associated with new permanent pacemakers (29% of patients without a pre-existing device)
- mean aortic-valve area at 2 years larger after TAVR (2.2 cm2) than after surgery (1.7 cm2)[30]
- Lotus valve with comparable outcomes to the CoreValve/EvolutR[58]
- more adverse procedural events, but similar overall outcomes for TVAR vs surgery for bicuspid vs tricuspid aortic valves[31]
- in-hospital complications higher in nonagenarians than in younger patients
- improvement in quality of life similar for nonagenarians compared with younger patients[20]
- blacks & Hispanics may be underrepresented in TAVR[43]
- repeat TAVR is safe & provides acceptable outcomes[46]
More general terms
Additional terms
References
- ↑ 1.0 1.1 1.2 1.3 Leon MB et al Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. PMID: https://www.ncbi.nlm.nih.gov/pubmed/20961243
video of the TAVI procedure http://dx.doi.org/10.1056/NEJMoa1008232 (subscription required) - ↑ 2.0 2.1 2.2 Smith CR et al. for the PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011 Jun 9; 364:2187 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21639811
Schaff HV. Transcatheter aortic-valve implantation - At what price? N Engl J Med 2011 Jun 9; 364:2256. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21639812 - ↑ 3.0 3.1 3.2 Reynolds MR et al. for the Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 2011 Nov 1; 124:1964. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21969017
- ↑ 4.0 4.1 4.2 4.3 Makkar RR et al. for the PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012 Mar 26 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22443478 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1202277
Kodali S et al. for the PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic- valve replacement. N Engl J Med 2012 Mar 26 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22443479 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1200384 - ↑ 5.0 5.1 Kodali SK et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 366:1686 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22443479 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1200384
Makkar RR et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 366:1696 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22443478 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1202277 - ↑ 6.0 6.1 Gilard M et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012 May 3; 366:1705 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22551129
- ↑ 7.0 7.1 Khatri PJ et al. Adverse effects associated with transcatheter aortic valve implantation: A meta-analysis of contemporary studies. Ann Intern Med 2013 Jan 1; 158:35 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23277899
- ↑ 8.0 8.1 8.2 8.3 8.4 8.5 Mack MJ et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA 2013 Nov 20; 310:2069. PMID: https://www.ncbi.nlm.nih.gov/pubmed/24240934
Bonow RO. Improving outlook for elderly patients with aortic stenosis. JAMA 2013 Nov 20; 310:2045. PMID: https://www.ncbi.nlm.nih.gov/pubmed/24240930 - ↑ 9.0 9.1 Kim CA, Rasania SP, Afilalo J et al Functional Status and Quality of Life After Transcatheter Aortic Valve Replacement: A Systematic Review. Ann Intern Med. 2014;160(4):243-254 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24727842 <Internet> http://annals.org/article.aspx?articleid=1829792
- ↑ 10.0 10.1 10.2 Abdel-Wahab M et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: The CHOICE randomized controlled trial. JAMA 2014 Mar 30 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24682026 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1854355
Tuczu EM and Kapadia SR. Selection of valves for TAVR: Is the CHOICE clear? JAMA 2014 Mar 30 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24682010 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1854354 - ↑ 11.0 11.1 Popma JJ et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014 Mar 13; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24657695 <Internet> http://www.sciencedirect.com/science/article/pii/S0735109714013965
Adams DH et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014 Mar 29; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24678937 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1400590 - ↑ 12.0 12.1 Urena M et al. Permanent pacemaker implantation after transcatheter aortic valve implantation: Impact on late clinical outcomes and left ventricular function. Circulation 2014 Mar 18; 129:1233 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24370552 <Internet> http://circ.ahajournals.org/content/129/11/1233
- ↑ 13.0 13.1 Meditronic's Press Release. June 12, 2014 Medtronic CoreValve System Receives FDA Approval for Patients at High Risk for Surgery. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1939539&highlight=
- ↑ 14.0 14.1 14.2 14.3 Holmes DR et al Clinical Outcomes at 1 Year Following Transcatheter Aortic Valve Replacement. JAMA. 2015;313(10):1019-1028 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25756438 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2190986
- ↑ 15.0 15.1 15.2 Kapadia SR et al 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. March 15, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25788231 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2960290-2/abstract
Mack MJ et al 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. March 15, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25788234 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2960308-7/abstract
Kappetein AP PARTNERs in the future of surgical aortic valve replacement. Lancet. March 15, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25788233 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2960568-2/abstract - ↑ 16.0 16.1 16.2 Thyregod HG et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: One-year results from the all-comers Nordic Aortic Valve Intervention (NOTION) randomized clinical trial. J Am Coll Cardiol 2015 May 26; 65:2184. PMID: https://www.ncbi.nlm.nih.gov/pubmed/25787196
Tuzcu EM et al. Well-intended NOTION, ahead of practice. J Am Coll Cardiol 2015 May 26; 65:2195. PMID: https://www.ncbi.nlm.nih.gov/pubmed/25998665 - ↑ 17.0 17.1 FDA News Release. June 17, 2015 FDA approves SAPIEN 3 THV artificial heart valve. Third generation of valve contains design change to minimize leakage. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451678.htm
- ↑ 18.0 18.1 Nombela-Franco L et al. Predictors of Readmission After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2015 Nov 8:1748 PMID: https://www.ncbi.nlm.nih.gov/pubmed/26476610
- ↑ 19.0 19.1 19.2 19.3 19.4 19.5 19.6 Holmes DR Jr, Nishimura RA, Grover FL et al. Annual outcomes with transcatheter valve therapy: From the STS/ACC TVT Registry. J Am Coll Cardiol 2015 Dec 29; 66:2813. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26652232
Nombela-Franco L, Trigo MD, Morrison-Polo G et al. Incidence, causes, and predictors of early (<=30 days) and late unplanned hospital readmissions after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2015 Nov; 8:1748. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26476610
Reinohl J, Kaier K, Reinecke H et al. Effect of availability of transcatheter aortic-valve replacement on clinical practice. N Engl J Med 2015 Dec 17; 373:2438 PMID: https://www.ncbi.nlm.nih.gov/pubmed/26672846 - ↑ 20.0 20.1 20.2 20.3 20.4 Arsalan M et al. Should transcatheter aortic valve replacement be performed in nonagenarians?: Insights from the STS/ACC TVT Registry. J Am Coll Cardiol 2016 Mar 29; 67:1387. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27012397
Weintraub WS. TAVR in nonagenarians: Pushing the boundaries. J Am Coll Cardiol 2016 Mar 29; 67:1396 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27012398 - ↑ 21.0 21.1 21.2 Leon MB et al. for the PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609-1620. Apr 2; PMID: https://www.ncbi.nlm.nih.gov/pubmed/27040324
Moat NE. Will TAVR become the predominant method for treating severe aortic stenosis? N Engl J Med 2016 Apr 2; PMID: https://www.ncbi.nlm.nih.gov/pubmed/27040006 - ↑ 22.0 22.1 22.2 22.3 22.4 Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
Geriatric Review Syllabus, 10th edition (GRS10) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2019
Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022 - ↑ 23.0 23.1 Green P, Woglom AE, Genereux P et al The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience. JACC Cardiovasc Interv. 2012 Sep;5(9):974-81. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22995885 Free PMC Article
- ↑ FDA News Release. August 18, 2016 FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517281.htm
- ↑ 25.0 25.1 25.2 Hansson NC, Grove EL, Andersen HR et al. Transcatheter aortic heart valve thrombosis: Incidence, predisposing factors, and clinical implications. J Am Coll Cardiol. 2016 Aug 18. pii: S0735-1097(16)34936-1 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27580689 <Internet> http://content.onlinejacc.org/article.aspx?articleID=2546337
- ↑ 26.0 26.1 26.2 Regueiro A, Linke A, Latib A et al Association Between Transcatheter Aortic Valve Replacement and Subsequent Infective Endocarditis and In-Hospital Death. JAMA. 2016;316(10):1083-1092 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27623462 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2552209
- ↑ Otto CM, Kumbhani DJ, Alexander KP et al 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis. A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016 Dec 21 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28063810 <Internet> http://www.onlinejacc.org/content/early/2016/12/21/j.jacc.2016.12.006
- ↑ 28.0 28.1 Kolte D, Khera S, Sardar MR et al. Thirty-day readmissions after transcatheter aortic valve replacement in the United States: Insights from the Nationwide Readmissions Database. Circ Cardiovasc Interv 2017 Jan; 10:e004472. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28034845 <Internet> http://circinterventions.ahajournals.org/content/10/1/e004472
Swaminathan RV, Rao SV. Hospital readmission as a transcatheter aortic valve replacement performance measure: Too soon? Circ Cardiovasc Interv 2017 Jan; 10:e004752 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28034847 <Internet> http://circinterventions.ahajournals.org/content/10/1/e004752 - ↑ 29.0 29.1 29.2 Arnold SV, Spertus JA, Vemulapalli S et al. Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: A report from the STS/ACC Transcatheter Valve Therapy Registry. JAMA Cardiol 2017 Feb 1; [e-pub]. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28146260 <Internet> http://jamanetwork.com/journals/jamacardiology/article-abstract/2600165
- ↑ 30.0 30.1 30.2 30.3 Reardon MJ, Van Mieghem NM, Popma JJ et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017 Mar 17 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28304219
- ↑ 31.0 31.1 Yoon SH, Bleiziffer S, De Backer O et al. Procedural and clinical outcomes in transcatheter aortic valve replacement for bicuspid versus tricuspid aortic valve stenosis. J Am Coll Cardiol. 2017 Mar 15. pii: S0735-1097(17)36041-2. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28330793 Free Article <Internet> http://www.sciencedirect.com/science/article/pii/S0735109717360412
- ↑ 32.0 32.1 32.2 Medical Knowledge Self Assessment Program (MKSAP) 17, 18. Cardiovascular Medicine. American College of Physicians, Philadelphia 2015, 2018.
- ↑ 33.0 33.1 33.2 Drudi LM, Ades M, Turkdogan S et al Association of Depression With Mortality in Older Adults Undergoing Transcatheter or Surgical Aortic Valve Replacement. JAMA Cardiol. Published online January 17, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29344620 https://jamanetwork.com/journals/jamacardiology/fullarticle/2669918
Patel A, Leon MB. Is Depression an Important New Mortality Risk Factor After Aortic Valve Replacement or Simply a Component of the Geriatric Disease Spectrum? JAMA Cardiol. Published online January 17, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29344626 https://jamanetwork.com/journals/jamacardiology/article-abstract/2669917 - ↑ 34.0 34.1 Feldman TE, Reardon MJ, Rajagopal V et al. Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis: The REPRISE III randomized clinical trial. JAMA. 2018 Jan 2;319(1):27-37. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29297076 https://jamanetwork.com/journals/jama/article-abstract/2667721?redirect=true
- ↑ 35.0 35.1 Waksman R, Rogers T, Torguson R et al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol 2018 Aug 9. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/30170075 <Internet> http://www.onlinejacc.org/content/early/2018/08/09/j.jacc.2018.08.1033
- ↑ 36.0 36.1 Inohara T, Manandhar P, Kosinski AS et al. Association of renin-angiotensin inhibitor treatment with mortality and heart failure readmission in patients with transcatheter aortic valve replacement. JAMA 2018 Dec 4; 320:2231-2241. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30512100
- ↑ 37.0 37.1 Sondergaard L, Ihlemann N, Capodanno D et al. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol 2019 Feb 12; 73:546. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30732707 https://www.sciencedirect.com/science/article/pii/S0735109718393975
Blackman DJ, Saraf S, MacCarthy PA et al. Long-term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol 2019 Feb 12; 73:537 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30732706 https://www.sciencedirect.com/science/article/pii/S0735109718393525 - ↑ 38.0 38.1 Dia A, Cifu AS, Shah AP et al Management of Patients With Severe Aortic Stenosis With Transcatheter Valve Replacement. JAMA. Published online March 25, 2019 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30907939 https://jamanetwork.com/journals/jama/fullarticle/2729546
- ↑ 39.0 39.1 Mack MJ, Leon MB, Thourani VH et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019 Mar 16; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30883058 https://www.nejm.org/doi/10.1056/NEJMoa1814052
Popma JJ, Deeb GM, Yakubov SJ et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019 Mar 16 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30883053 https://www.nejm.org/doi/10.1056/NEJMoa1816885 - ↑ 40.0 40.1 Makkar RR, Yoon SH, Leon MB et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA 2019 Jun 11; 321:2193. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31184741
Barker CM, Reardon MJ. Bicuspid aortic valve stenosis: Is there a role for TAVR? JAMA 2019 Jun 11; 321:2170. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31184722 - ↑ 41.0 41.1 41.2 Szerlip M, Zajarias A, Vemalapalli S et al. Transcatheter aortic valve replacement in patients with end-stage renal disease. J Am Coll Cardiol 2019 Jun 11; 73:2806-2815. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31171086
Bayliss G. TAVR in patients with end-stage renal disease and critical aortic stenosis: Hard choices. J Am Coll Cardiol 2019 Jun 11; 73:2816. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31171087 - ↑ 42.0 42.1 Kalra R, Patel N, Doshi R, Arora G, Arora P. Evaluation of the incidence of new-onset atrial fibrillation after aortic valve replacement. JAMA Intern Med 2019 Jun 3 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31157821 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2734630
- ↑ 43.0 43.1 Alkhouli M, Holmes DR Jr, Carroll JD et al. Racial disparities in the utilization and outcomes of TAVR: TVT registry report. JACC Cardiovasc Interv 2019 May 27; 12:936. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31122351 https://www.sciencedirect.com/science/article/pii/S1936879819306636
- ↑ 44.0 44.1 Dangas GD et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2019 Nov 16; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31733180 https://www.nejm.org/doi/10.1056/NEJMoa1911425
De Backer O et al. Reduced leaflet motion after transcatheter aortic-valve replacement. N Engl J Med 2019 Nov 16; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31733182 https://www.nejm.org/doi/10.1056/NEJMoa1911426 - ↑ 45.0 45.1 Makkar RR, Thourani VH, Mack MJ et al Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med 2020. Jan 29. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31995682 https://www.nejm.org/doi/full/10.1056/NEJMoa1910555
- ↑ 46.0 46.1 Landes U, Webb JG, De Backer O et al. Repeat transcatheter aortic valve replacement for transcatheter prosthesis dysfunction. J Am Coll Cardiol 2020 Apr 28; 75:1882. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32327098 https://www.sciencedirect.com/science/article/abs/pii/S0735109720344582
Thourani VH, Edelman JJ, Meduri CU. TAVR in TAVR: The future is now. J Am Coll Cardiol 2020 Apr 28; 75:1894 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32327099 https://www.sciencedirect.com/science/article/abs/pii/S0735109720345551 - ↑ 47.0 47.1 47.2 Krishnaswamy A, Sammour Y, Mangieri A et al. The utility of rapid atrial pacing immediately post-TAVR to predict the need for pacemaker implantation. JACC Cardiovasc Interv 2020 Apr 8; PMID: https://www.ncbi.nlm.nih.gov/pubmed/32305392 https://www.sciencedirect.com/science/article/abs/pii/S193687982030337X
Reichlin T, Pilgrim T. Functional assessment of the conduction system: The key to early discharge after TAVR? JACC Cardiovasc Interv 2020 Apr 10 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32305397 https://www.sciencedirect.com/science/article/abs/pii/S1936879820305239 - ↑ Lou N ViV TAVR: Device, Implantation Choices Matter Long Term - Worse outcomes tied to smaller original surgical valve, TAVR valve type, existing severe PPM. MedPage Today June 26, 2020 https://www.medpagetoday.com/meetingcoverage/europcr/87303
- ↑ 49.0 49.1 Jawitz OK et al. Reoperation after transcatheter aortic valve replacement: An analysis of the Society of Thoracic Surgeons Database. JACC Cardiovasc Interv 2020 Jul 13; 13:1515. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32535005 Free PMC article https://www.sciencedirect.com/science/article/abs/pii/S193687982030978X
MacGillivray TE, Reardon MJ. Reoperation after transcatheter aortic valve replacement: Breaking up is hard to do. JACC Cardiovasc Interv 2020 Jul 13; 13:1526 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32535009 https://www.sciencedirect.com/science/article/abs/pii/S1936879820310463 - ↑ 50.0 50.1 Alharbi AA et al. Transcatheter aortic valve replacement vs surgical replacement in patients with pure aortic insufficiency. Mayo Clin Proc 2020 Dec; 95:265 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33276838 https://www.mayoclinicproceedings.org/article/S0025-6196(20)30853-3/fulltext
- ↑ 51.0 51.1 Woldendorp K et al. Silent brain infarcts and early cognitive outcomes after transcatheter aortic valve implantation: A systematic review and meta-analysis. Eur Heart J 2021 Feb 1; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33517376 https://academic.oup.com/eurheartj/advance-article-abstract/doi/10.1093/eurheartj/ehab002/6124789
- ↑ Anwaruddin S et al. Evaluating out-of-hospital 30-day mortality after transfemoral transcatheter aortic valve replacement: An STS/ACC TVT analysis. JACC Cardiovasc Interv 2021 Feb 8; 14:261 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33541537 https://www.sciencedirect.com/science/article/abs/pii/S1936879820321579
- ↑ Davidson LJ, Davidson CJ Transcatheter Treatment of Valvular Heart Disease. A Review. JAMA. 2021;325(24):2480-2494 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34156404 https://jamanetwork.com/journals/jama/fullarticle/2781245
- ↑ Huang L, Zhou X, Yang X et al. The impact of preoperative frailty status on outcomes after transcatheter aortic valve replacement: an update of systematic review and meta-analysis. Medicine (Baltimore). 2018;97(51):e13475 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30572446 PMCID: PMC6320183 Free PMC article https://journals.lww.com/md-journal/Fulltext/2018/12210/The_impact_of_preoperative_frailty_status_on.25.aspx
- ↑ Ofori-Asenso R, Chin KL, Sahle BW et al. Frailty confers high mortality risk across different populations: evidence from an overview of systematic reviews and meta-analyses. Geriatrics (Basel). 2020;5(1):17 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32178338 PMCID: PMC7151473 Free PMC article https://www.mdpi.com/2308-3417/5/1/17
- ↑ The UK TAVI Trial Investigators Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis. A Randomized Clinical Trial. JAMA. 2022;327(19):1875-1887. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35579641 https://jamanetwork.com/journals/jama/fullarticle/2792251
- ↑ 57.0 57.1 Van Mieghem NM et al. Self-expanding transcatheter vs surgical aortic valve replacement in intermediate-risk patients: 5-year outcomes of the SURTAVI randomized clinical trial. JAMA Cardiol 2022 Oct 1; 7:1000. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36001335 PMCID: PMC9403849 (available on 2023-08-24) https://jamanetwork.com/journals/jamacardiology/fullarticle/2795673
- ↑ 58.0 58.1 Rizik DG, Rajagopal V, Makkar RR et al Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR. A Secondary Analysis of the REPRISE III Randomized Clinical Trial. JAMA Netw Open. 2022;5(10):e2238792 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36301543 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2797783
- ↑ 59.0 59.1 O'Hair D, Yakubov SJ, Grubb KJ et al Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023;8(2):111-119. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36515976 PMCID: PMC9857153 (available on 2023-12-14) https://jamanetwork.com/journals/jamacardiology/fullarticle/2799709
- ↑ 60.0 60.1 FDA Device Recall. Jyl 27, 2023 Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-all-impella-left-sided-blood-pumps-risk-motor-damage-after-contact-transcatheter
- ↑ 61.0 61.1 61.2 Makkar RR et al. Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: A registry study. Lancet 2023 Aug 31;S0140-6736(23)01636-7 [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37660719 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01636-7/fulltext
- ↑ Mack MJ, Leon MB, Thourani VH et al. Transcatheter aortic-valve replacement in low-risk patients at five years. N Engl J Med 2023 Nov 23; 389:1949. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37874020 Clinical Trial https://www.nejm.org/doi/10.1056/NEJMoa2307447
- ↑ 63.0 63.1 63.2 Blankenberg S, Seiffert M, Vonthein R et al. Transcatheter or surgical treatment of aortic-valve stenosis. N Engl J Med 2024 Apr 8; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38588025 https://www.nejm.org/doi/10.1056/NEJMoa2400685
- ↑ 64.0 64.1 64.2 64.3 64.4 Vahl TP, Thourani VH, Makkar RR et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): A prospective, multicentre, single-arm study. Lancet. 2024 Apr 13;403(10435):1451-1459. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38552656 Clinical Trial. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02806-4/abstract
- ↑ 65.0 65.1 Solla-Suarez P et al. Osteosarcopenia and mortality in older adults undergoing transcatheter aortic valve replacement. JAMA Cardiol 2024 May 15; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38748410 PMCID: PMC11097099 (available on 2025-05-15) https://jamanetwork.com/journals/jamacardiology/fullarticle/2818813
O'Gara PT et al. Osteosarcopenia and mortality after transcatheter aortic valve replacement. JAMA Cardiol 2024 May 15; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/38748416 https://jamanetwork.com/journals/jamacardiology/fullarticle/2818815 - ↑ 66.0 66.1 Genereux P et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med 2024 Oct 28; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/39466903 https://www.nejm.org/doi/10.1056/NEJMoa2405880
Loganath K et al. Early intervention in patients with asymptomatic severe aortic stenosis and myocardial fibrosis: The EVOLVED randomized clinical trial. JAMA 2024 Oct 28; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39466640 PMCID: PMC11519785 (available on 2025-04-28 https://jamanetwork.com/journals/jama/fullarticle/2825540 - ↑ 67.0 67.1 Baz L, Mobius-Winkler S, Diab M et al Depression in Patients With Symptomatic Aortic Stenosis Predicts 3-Year Mortality After Transcatheter Aortic Valve Implantation. JACC Adv. 2024 Nov 15;3(12):101389. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39624575 PMCID: PMC11609447 Free PMC article.
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transcatheter aortic valve implantation/replacement patient information