Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR ...may play a key strategy in treating patients in whom THVs fail.
The authors sought to examine outcomes following redo-TAVR.
The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.
Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke 1.4%, 7 valve malposition 3.3%, 2 coronary obstruction 0.9%, 20 new permanent pacemaker 9.6%, no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.
Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
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Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The ...choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.
The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).
Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.
For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm
vs. 1.37 ± 0.5 cm
; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).
In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
Fractional flow reserve (FFR), an index of the hemodynamic severity of coronary stenoses, is derived from invasive measurements and requires a pressure-monitoring guidewire and hyperemic stimulus. ...Angiography-derived FFR measurements (FFR
) may have several advantages. The aim of this study is to assess the diagnostic performance and interobserver reproducibility of FFR
in patients with stable coronary artery disease.
FFR
is a computational method based on rapid flow analysis for the assessment of FFR. FFR
uses the patient's hemodynamic data and routine angiograms to generate a complete 3-dimensional coronary tree with color-coded FFR values at any epicardial location. Hyperemic flow ratio is derived from an automatic resistance-based lumped model of the entire coronary tree. A total of 203 lesions were analyzed in 184 patients from 4 centers. Values derived using FFR
ranged from 0.5 to 0.97 (median 0.85) and correlated closely (Spearman ρ=0.90;
<0.001) with the invasive FFR measurements, which ranged from 0.5 to 1 (median 0.84). In Bland-Altman analyses, the 95% limits of agreement between these methods ranged from -0.096 to 0.112. Using an FFR cutoff value of 0.80, the sensitivity, specificity, and diagnostic accuracy of FFR
were 88%, 95%, and 93%, respectively. The intraclass coefficient between 2 blinded operators was 0.962 with a 95% confidence interval from 0.950 to 0.971,
<0.001.
There is a high concordance between FFR
and invasive FFR. The color-coded display of FFR values during coronary angiography facilitates the integration of physiology and anatomy for decision making on revascularization in patients with stable coronary artery disease.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03005028.
While mortality of acute coronary syndrome (ACS) is known to have steadily decline over the last decades, data are lacking regarding the complex sub-population of patients with both coronary artery ...disease and cancer. A large single-center percutaneous coronary intervention (PCI) registry was used to retrieve patients who had a known diagnosis of malignancy during PCI. Patients were divided into two groups according to the period in which PCI was performed (period 1: 2006–2011, period 2: 2012–2017). Cox regression hazard models were implemented to compare primary endpoint, defined as the composite outcomes of major adverse cardiac events (MACE) (which include cardiovascular death, myocardial infarction or target vessel revascularization) and secondary endpoint of all-cause mortality, between the two time periods. A total of 3286 patients were included, 1819 (55%) had undergone PCI in period 1, and 1467 (45%) in period 2. Both short- and long-term MACE and overall mortality were significantly lower in patients who underwent PCI at the latter period (2.3% vs. 4.3%,
p
< 0.001 and 1.1% vs. 3.2%,
p
< 0.001 after 30 days and 24% vs. 30%,
p
< 0.001 and 12% vs. 22%,
p
< 0.001 after 2 years, respectively). However, in a multivariate analysis, going through PCI in the latter period was still associated with lower rates of overall mortality (HR 0.708, 95% confidence interval CI 0.53–0.93,
p
= 0.014) but there was no significant difference in MACE (HR 0.83, 95% CI 0.75–1.42,
p
= 0.16). Patients with cancer undergoing PCI during our most contemporary period had an improved overall survival, but no significant differences were observed in the composite cardiovascular endpoints, compared to an earlier PCI period. The management of coronary patients with cancer disease remains challenging.
The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
MR is common in patients ...undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited.
The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared.
In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio HR: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score–matched cohort (91 patients’ pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097).
Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter AMTRAC Valve Registry AMTRAC; NCT04031274).
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Abstract Patients with advanced chronic renal dysfunction were excluded from randomized trials of transcatheter aortic valve replacement (TAVR). The potential impact of chronic renal disease on TAVR ...prognosis is not fully understood. We aim to evaluate outcomes within a large cohort of patients undergoing TAVR distinguished by renal function. Baseline characteristics, procedural data and clinical follow-up findings were collected from 10 high-volume TAVR centers in Europe, Israel and Japan. Data was analyzed according to renal function. Patients (n=1204) were divided into 4 groups according to pre-TAVR estimated glomerular filtration rate (eGFR): group I (eGFR >60) n=288 (female 45%), group II (eGFR 31-60) n=452 (female 61%), group III (eGFR ≤30) n=398 (female 61%) and group IV (dialysis) n=66 (female 31%). Mean Society of Thoracic Surgeons (STS) score was higher in patients with lower pre-procedural eGFR. All-cause mortality at 1-year was higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, 24.2% for group I, II, III and IV; respectively, p <0.001). Multivariate analysis demonstrated that eGFR ≤30, but not eGFR 31-60, was associated with increased risk of death (OR 3), bleeding (OR 5.2) and device implantation failure (HR 2.28). For each 10-mL/min decrease in eGFR, there was an associated relative increase in the risk of death (35%; p<0.001), cardiovascular death (14%; p=0.018), major bleeding 35% (p<0.001), and transcatheter valve failure (16%; p=0.007). Renal dysfunction was not associated with stroke or need for pacemaker implantation. In conclusion among patients undergoing TAVR, baseline renal dysfunction is an important independent predictor of morbidity and mortality.
The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe ...and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 ± 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AKI) stage ≥2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro–brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased pro-BNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction <30% (OR 6.7, 95% CI 3.5 to 12.7), and periprocedural acute myocardial infarction (OR 6.5, 95% CI 2.3 to 18.1) represented the predictors of midterm mortality. In conclusion, in this large meta-analysis of patients undergoing TAVI, we found that high pro-BNP levels and postprocedural AKI were the strongest independent predictors of both 30-day and 1-year mortality. These findings may contribute to a better understanding of the risk assessment process of patients undergoing TAVI.
Background Various hemodynamic changes occur following transcatheter aortic valve implantation (TAVI) that may impact therapeutic decisions. NICaS is a noninvasive bioimpedance monitoring system ...aimed at hemodynamic assessment. We used the NICaS system in patients with severe aortic stenosis (AS) to evaluate short-term hemodynamic changes after TAVI. Methods and Results We performed hemodynamic analysis using NICaS on 97 patients with severe AS who underwent TAVI using either self-expandable (68%) or balloon-expandable (32%) valves. Patients were more often women (54%) and had multiple comorbidities including hypertension (83%), coronary artery disease (46%), and diabetes (37%). NICaS was performed at several time points-before TAVI, soon after TAVI, at hospital discharge, and during follow-up. Compared with baseline NICaS measurements, we observed a significant increase in systolic blood pressure and total peripheral resistance (systolic blood pressure 132±21 mm Hg at baseline versus 147±23 mm Hg after TAVI,
<0.001; total peripheral resistance 1751±512 versus 2084±762 dynes*s/cm
, respectively,
<0.001) concurrent with a decrease in cardiac output and stroke volume (cardiac output 4.2±1.5 versus 3.9±1.3 L/min,
=0.037; stroke volume 61.4±14.8 versus 56.2±15.9 mL,
=0.001) in the immediate post-TAVI period. At follow-up (median 59 days interquartile range, 40.5-91) these measurements returned to values that were not different from the baseline. A significant improvement in echocardiography-based left ventricular ejection fraction was observed from baseline to follow-up (55.6%±11.6% to 59.4%±9.4%,
<0.001). Conclusions Unique short-term adaptive hemodynamic changes were observed using NICaS in patients with AS soon after TAVI. Noninvasive hemodynamic evaluation immediately following TAVI may contribute to the understanding of complex hemodynamic changes and merits favorable consideration.
Transcatheter aortic valve implantation (TAVI) is an established technique for the treatment of severe symptomatic aortic stenosis. Data on long-term TAVI outcomes, both hemodynamic and clinical, in ...real-world practice settings are limited. We aim to explore the long-term clinical results in patients with severe symptomatic aortic stenosis using multiple catheter-based options: 360 TAVI-treated patients were followed up for ≤5 years. The Medtronic CoreValve was used in 71% and the Edwards SAPIEN in 26%. The primary end point was all-cause mortality during follow-up. Outcomes were assessed based on the Valve Academic Research Consortium 2 criteria. The mean ± SD patient age was 82.1 ± 6.9 years (56.4% women). The Society of Thoracic Surgeons score was 7.5 ± 4.7. The clinical efficacy end point and time-related valve safety at 3 years was 50% and 81.7%, respectively. The calculated 3- and 5-year survival rates were 71.6% and 56.4%, respectively. Five-year follow-up data were obtained for 54 patients alive; 96.2% of alive patients were in the New York Heart Association class I and II, 4 years after TAVI. No gender differences in all-cause mortality rates were observed (p = 0.58). In multivariate analysis, hospitalization 6 months previous to TAVI (hazard ratio HR 1.92, 95% confidence interval CI 1.17 to 3.15, p = 0.01), frailty (HR 1.89, 95% CI 1.11 to 3.2, p = 0.02), acute kidney injury (HR 1.93, 95% CI 1.03 to 3.61, p = 0.04), and moderate or more paravalvular aortic regurgitation after TAVI (HR 4.26, 95% CI 2.54 to 7.15, p <0.001) were independent predictors for all-cause mortality. In conclusion, long-term outcomes of TAVI are encouraging. Prevention and early identification of paravalvular leak and acute renal failure after the procedure would improve short- and long-term outcomes.
Abstract Background Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe symptomatic aortic stenosis (AS) who are at prohibitive/high risk for surgical aortic valve ...replacement (SAVR). Patients with severe AS may experience acute decompensated heart failure (HF) that is resistant to medical therapy. We report our TAVI experience in treating patients with unstable AS who require urgent intervention for their aortic valve disease. Methods Patients were restrictively included in the urgent TAVI registry if they were admitted with acute refractory and persistent HF despite medical therapy and had TAVI performed during the same hospital stay. All others were included in the elective TAVI group. Results Between November 2008 and April 2015, 410 consecutive patients underwent TAVI at our centre—27 (6.6%) urgently. Patients operated on urgently were more likely to be frail and carry higher SAVR mortality risk based on The Society of Thoracic Surgeons Predicted Risk of Mortality/logistic EuroSCORE (LES) measures. Pulmonary edema was the most common clinical presentation. Preprocedural assessment used fewer imaging modalities, yet implantation success remained high and reached 96.3% using an additional valve (valve-within-valve) required in 3 patients, with no difference in periprocedural complications according to the Valve Academic Research Consortium-2 definitions. Although 30-day functional capacity was reduced, patients had similar 30-day mortality and major adverse cardiovascular event rates compared with patients who underwent elective TAVI. Conclusions Short-term outcome after urgent TAVI appears to be reasonable. For patients with severe AS who experience acute decompensated HF that is recalcitrant to optimal medical therapy and who are at high risk with SAVR, urgent TAVI may be a viable treatment strategy. Larger prospective studies and data on long-term outcomes are needed.
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