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transcatheter aortic valve implantation; transcatheter aortic valve replacement (TAVI, TAVR, CoreValve system)

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] - 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 - bicuspid aortic value [32] - TAVR in bicuspid AS associated with similar prognosis as tricuspid AS & device success with new generation devices [33] - similar 1-year outcomes with TAVR in bicuspid & tricuspid aortic valves [40] - significant aortic regurgitation - mitral valve disease [32] - 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] - 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] - 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] - 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] - depression may increase 1 year mortality [33] - 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] - median time to redo 29 months [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) a higher incidence of major strokes (5.0% vs 1.1%) & major vascular complications (16.2% vs 1.1%) at 30 days b) higher incidence of major bleeding c) better outcomes regarding symptoms d) decreased need for re-intervention (balloon angioplasty, repeat TAVI, AVR) e) 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 - death (6.5% vs. 4.5%) - stroke (2.7% vs. 2.1%) - major vascular site complications (1.0% vs. 0.7%) - major bleeding (8.1% vs. 6.8%) [20] - 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]

Related

aortic valvular stenosis (AS)

General

aortic valve replacement (AVR)

References

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