Multicenter experience with valve-in-valve transcatheter aortic valve replacement compared with primary, native valve transcatheter aortic valve replacement.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) offers an alternative to reoperative surgical aortic valve replacement. The short- and intermediate-term outcomes after ViV TAVR in the real world are not entirely clear. PATIENTS AND METHODS: A multicenter, retrospective analysis of a consecutive series of 121 ViV TAVR patients and 2200 patients undergoing primary native valve TAVR from 2012 to 2017 at six medical centers. The main outcome measures were in-hospital mortality, 30-day mortality, stroke, myocardial infarction, acute kidney injury, and pacemaker implantation. RESULTS: ViV patients were more likely male, younger, prior coronary artery bypass graft, "hostile chest," and urgent. 30% of the patients had Society of Thoracic Surgeons risk score <4%, 36.3% were 4%-8% and 33.8% were >8%. In both groups many patients had concomitant coronary artery disease. Median time to prosthetic failure was 9.6 years (interquartile range: 5.5-13.5 years). 82% of failed surgical valves were size 21, 23, or 25 mm. Access was 91% femoral. After ViV, 87% had none or trivial aortic regurgitation. Mean gradients were <20 mmHg in 54.6%, 20-29 mmHg in 30.6%, 30-39 mmHg in 8.3% and ≥40 mmHg in 5.87%. Median length of stay was 4 days. In-hospital mortality was 0%. 30-day mortality was 0% in ViV and 3.7% in native TAVR. There was no difference in in-hospital mortality, postprocedure myocardial infarction, stroke, or acute kidney injury. CONCLUSION: Compared to native TAVR, ViV TAVR has similar peri-procedural morbidity with relatively high postprocedure mean gradients. A multidisciplinary approach will help ensure patients receive the ideal therapy in the setting of structural bioprosthetic valve degeneration.

Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial.

BACKGROUND: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. METHODS: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. RESULTS: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. CONCLUSIONS: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.

Anatomical Characteristics Associated With Hypoattenuated Leaflet Thickening in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND/PURPOSE: This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration. METHODS/MATERIALS: The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis. RESULTS: In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT. CONCLUSIONS: This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.

Feasibility of Coronary Access and Aortic Valve Reintervention in Low-Risk TAVR Patients.

OBJECTIVES: The aim of this study was to evaluate the feasibility of coronary access and aortic valve reintervention in low-risk patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter heart valve (THV). BACKGROUND: Younger, low-risk TAVR patients are more likely than older, higher risk patients to require coronary angiography, percutaneous coronary intervention, or aortic valve reintervention, but their THVs may impede coronary access and cause coronary obstruction during TAVR-in-TAVR. METHODS: The LRT (Low Risk TAVR) trial (NCT02628899) enrolled 200 subjects with symptomatic severe aortic stenosis to undergo TAVR using commercially available THVs. Subjects who received balloon-expandable THVs and who had 30-day cardiac computed tomographic scans were included in this study. In a subgroup, the feasibility of intentional THV crimping on the delivery catheter to pre-determine commissural alignment was tested. RESULTS: In the LRT trial, 168 subjects received balloon-expandable THVs and had 30-day cardiac computed tomographic scans, of which 137 were of adequate image quality for analysis. The most challenging anatomy for coronary access (THV frame above and commissural suture post in front of a coronary ostium) was observed in 9% to 13% of subjects. Intentional THV crimping did not appear to meaningfully affect commissural alignment. The THV frame extended above the sinotubular junction in 21% of subjects, and in 13%, the distance between the THV and the sinotubular junction was <2 mm, signifying that TAVR-in-TAVR may not be feasible without causing coronary obstruction. CONCLUSIONS: TAVR may present challenges to future coronary access and aortic valve reintervention in a substantial number of low-risk patients.

Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation.

We aimed to evaluate the burden of coronary artery disease (CAD) using the computed tomography (CT) Leaman score in low-risk transcatheter aortic valve implantation (TAVI) patients. The extent of CAD in low-risk patients with aortic stenosis who are candidates for TAVI has not been accurately quantified. The CT Leaman score was developed to quantify coronary CT angiography (CCTA) atherosclerotic burden and has been validated to evaluate the extent of CAD. CT Leaman score >5 has been associated with an increase in major adverse cardiac events over long-term follow-up. The study population included patients enrolled in the Low Risk TAVI trial who underwent CCTA before the procedure. For the CT Leaman score, we used 3 sets of weighting factors: (1) location of coronary plaques, (2) type of plaque, and (3) degree of stenosis. A total of 200 patients were enrolled in the Low Risk TAVI trial. Excluded were 31 patients who had no analyzable CCTA imaging. For the remaining 169 patients, the mean CT Leaman score was 6.27 ± 0.27, of whom 102 (60.4%) had CT Leaman score >5. Nearly all analyzed patients (97%) had coronary plaques. Furthermore, 33 patients (19.5%) had potentially obstructive coronary plaques (>50% stenosis by CCTA) in proximal segments. Most low-risk TAVI patients have significant CAD burden by CCTA. It should be a priority for future TAVI devices to guarantee unimpeded access to the coronary arteries for selective angiography and interventions.

Acute Kidney Recovery in Patients Who Underwent Transcatheter Versus Surgical Aortic Valve Replacement (from the Northern New England Cardiovascular Disease Study Group).

Acute kidney recovery (AKR) is a recently described phenomenon observed after transcatheter aortic valve replacement (TAVR) and is more frequent than acute kidney injury (AKI). To determine the incidence and predictors of AKR between surgical aortic valve replacement (SAVR) and TAVR, we examined patients with chronic kidney disease and severe aortic stenosis who underwent SAVR or TAVR procedure between 2007 and 2017; excluding age <65 or >90, dialysis, endocarditis, non-aortic valve stenosis, or patients died within 48-hours postprocedure. AKR was defined as an increase of estimated glomerular filtration rate (eGFR) >25% and AKI as decrease in eGFR >25% at discharge. Stroke, mortality, major bleeding, transfusion, and length of stay were examined. Multivariate logistic regression analysis was used to examine predictors of AKR. There were 750 transcatheter and 1,062 surgical patients and 319 pairs after propensity matching. AKR was observed in 26% TAVR versus 23.2% SAVR, p = 0.062. Highest recovery was in patients with eGFR <30 for both TAVR (33.7%) and SAVR (34.5%) patients. Independent predictors of AKR were ejection fraction <50% (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.02 to 2.71, p = 0.042), female gender (OR 1.66, 95% CI 1.1 to 2.5, p = 0.015), and obesity (OR 1.5, 95% CI 1.04-2.3, p = 0.032). Diabetes was a negative predictor of AKR (OR 0.55, 95% CI 0.36 to 0.84, p = 0.005). AKR was associated with improved secondary clinical outcomes compared with AKI. In conclusion, AKR is a generalizable phenomenon occurring frequently and similarly among transcatheter or surgical aortic valve patients. Diabetes is a negative predictor of AKR, possibly indicative of less reversible kidney disease.

Hemodynamics and Subclinical Leaflet Thrombosis in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: This analysis evaluated echocardiographic predictors of hypoattenuated leaflet thickening (HALT) in low-risk patients undergoing transcatheter aortic valve replacement and assessed 1-year clinical and hemodynamic consequences. HALT by computed tomography may be associated with early valve degeneration and increased neurological events. METHODS: Echocardiograms were performed at baseline, discharge, 30 days, and 1 year post-procedure. Four-dimensional contrast-enhanced computed tomography assessed HALT at 30 days. Independent core laboratories analyzed images. Doppler hemodynamic parameters were tested in a univariable regression model to identify HALT predictors. One-year clinical and hemodynamic outcomes were compared between HALT (+) and (-) patients. RESULTS: Analysis included 170 patients with Sapien 3 valves and diagnostic 30-day computed tomographies, of whom 27 (16%) had HALT. Baseline characteristics were similar between groups. After transcatheter aortic valve replacement, aortic flow was nonsignificantly reduced in patients who developed HALT. Regression analysis did not show significant association between baseline or discharge valve hemodynamics and development of HALT at 30 days. Patients with HALT had smaller aortic valve areas (1.4±0.4 versus 1.7±0.5 cm2; P=0.018) and Doppler velocity index (0.4±0.1 versus 0.5±0.1; P=0.003) than those without HALT at 30 days but not at 1 year. There was no difference in aortic mean gradient at 30 days. There was no difference between the groups in New York Heart Association class, 6-minute walk distance, and mortality at 1 year. CONCLUSIONS: There were no early hemodynamic predictors of HALT. At 30 days, patients with HALT had worse valve hemodynamics than those without HALT, but hemodynamic and clinical outcomes at 1 year were similar. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628899.

TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.

OBJECTIVES: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. METHODS: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. RESULTS: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). CONCLUSIONS: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.

Recovery of Kidney Dysfunction After Transcatheter Aortic Valve Implantation (from the Northern New England Cardiovascular Disease Study Group).

Acute Kidney Recovery (AKR) is a potential benefit of transcatheter aortic valve implantation (TAVI). We determined the incidence and predictors of AKR in a multicenter prospective registry of TAVI. After excluding patients on dialysis or who died within 48 hours postprocedure, we reviewed 1,502 consecutive patients underwent TAVI in Northern New England from 2012 to 2017. Patients were categorized into 3 groups based on the change in postprocedure estimated glomerular filtration rate (eGFR): Acute Kidney Injury (AKI, decrease in eGFR >25%), AKR (increase in eGFR >25%) or no change in kidney function on discharge creatinine following TAVI. We then focused in patients with baseline chronic kidney disease (CKD defined as eGFR ≤60 ml/min; n = 755) and developed multivariate predictor models to determine the clinical and procedural variables associated with AKR. For the TAVI cohort (n = 1,502), the overall incidence of AKR was 17.8%. AKR was threefold higher in patients with eGFR ≤60 ml/min as compared to those with eGFR >60 ml/min (26.6% vs 8.9%, p < 0.001). In the CKD population, hospital complications were similar among patients with no change in renal function and AKR; patients with AKI had a higher rate of hospital mortality, pacemaker implantation, length of hospitalization, and transfusions. Using multivariable logistic regression, moderate to severe lung disease, eGFR < 50 ml/min and previous aortic valve surgery were found to be independent predictors of AKR. Patients with diabetes mellitus, baseline anemia, and Society of thoracic surgeons score >6.1 were less likely to develop AKR. In conclusion, AKR occurred in 1 of 4 of all TAVI patients with baseline CKD and was a more frequent phenomena than AKI. Patients with decreased lung function, previous aortic valve surgery and worse baseline renal function were more likely to demonstrate AKR, whereas patients with diabetes mellitus, baseline anemia, and higher Society of thoracic risk scores were less likely to see improvements in renal function after TAVI.

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. METHODS: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration-approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. RESULTS: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting-adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. CONCLUSIONS: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899).

Comparison of carotid endarterectomy and stenting in real world practice using a regional quality improvement registry.

OBJECTIVE: Carotid artery stenting (CAS) vs endarterectomy (CEA) remains controversial and has been the topic of recent randomized controlled trials. The purpose of this study was to compare the practice and outcomes of CAS and CEA in a real world setting. METHODS: This is a retrospective analysis of 7649 CEA and 430 CAS performed at 17 centers from 2003 to 2010 within the Vascular Study Group of New England (VSGNE). The primary outcome measures were (1) any in-hospital stroke or death and (2) any stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery were excluded. Multivariate logistic regression was performed to identify predictors of stroke or death in patients undergoing CAS. RESULTS: CEA was performed in 17 centers by 111 surgeons, while CAS was performed in 6 centers by 30 surgeons and 8 interventionalists. Patient characteristics varied by procedure. Patients undergoing CAS had a higher prevalence of coronary artery disease, congestive heart failure, diabetes, and prior ipsilateral CEA. Embolic protection was used in 97% of CAS. Shunts were used in 48% and patches in 86% of CEA. The overall in-hospital stroke or death rate was higher among patients undergoing CAS (2.3% vs 1.1%; P = .03). Overall stroke, death, or MI (2.8% CAS vs 2.1% CEA; P = .32) were not different. Asymptomatic patients had similar rates of stroke or death (CAS 0.73% vs CEA 0.89%; P = .78) and stroke, death, or MI (CAS 1.1% vs CEA 1.8%; P = .40). Symptomatic patients undergoing CAS had higher rates of stroke or death (5.1% vs 1.6%; P = .001), and stroke, death, or MI (5.8% vs 2.7%; P = .02). By multivariate analysis, major stroke (odds ratio, 4.5; 95% confidence interval [CI], 1.9-10.8), minor stroke (2.7; CI, 1.5-4.8), prior ipsilateral CEA (3.2, CI, 1.7-6.1), age >80 (2.1; CI, 1.3-3.4), hypertension (2.6; CI, 1.0-6.3), and a history of chronic obstructive pulmonary disease (1.6; CI, 1.0-2.4) were predictors of stroke or death in patients undergoing carotid revascularization. CONCLUSIONS: In our regional vascular surgical practices, the overall outcomes of CAS and CEA are similar for asymptomatic patients. However, symptomatic patients treated with CAS are at a higher risk for stroke or death.

Recent changes in practice of elective percutaneous coronary intervention for stable angina.

BACKGROUND: The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial was designed to compare optimal medical therapy alone versus optimal medical therapy and percutaneous coronary intervention (PCI) for treatment of patients with stable coronary artery disease and showed equal efficacy for optimal medical therapy with or without PCI. The impact of results from the COURAGE trial on clinical practice is unknown. METHODS AND RESULTS: We analyzed 26 388 consecutive patients from the Northern New England Cardiovascular Disease PCI Registry who underwent PCI between January 2006 and June 2009. We identified a COURAGE-like patient group as patients who were undergoing (1) an elective procedure; (2) for an indication of stable angina; and (3) on the day of admission (ie, the date of admission was the same as the procedure date). All other PCI patients were placed in an "other indications" cohort. We compared temporal trends in overall volume in PCI for stable angina and for other indications, comparing quarterly time periods before and after release of COURAGE in March 2007. Over the study period, there was a statistically significant decrease in total PCI volume from 2064 in Quarter 1 2006 (before COURAGE) to 1708 in Quarter 3 2007 (after COURAGE) (P<0.01). These trends were sustained through June 2009, with an approximate 16% peak relative reduction in all PCI compared with before COURAGE. As a percentage of all PCI, stable angina reached a high of 20.9% before COURAGE and began to decrease immediately after publication of COURAGE in Quarter 2 2007 to 16.1% (P<0.01). Among patients undergoing PCI for stable angina, there was a significant 26% peak decrease in post-COURAGE PCI volumes compared with pre-COURAGE Quarter 1 2006 (P trend, 0.01), which was maintained through the end of the study period. CONCLUSIONS: Publication of results from the COURAGE trial was temporally associated with a significant and sustained decline in the use of PCI to treat patients with stable angina. The long-term impact of this change in practice on patient outcomes remains to be determined.

Visual assessment of procedural results following treatment with Sr-90 beta-radiation for instent restenosis.

BACKGROUND: Visual assessment (VA) of postprocedural % diameter stenosis (DS) is used routinely in clinical practice to determine the adequacy of coronary intervention. Although VA has been shown to underestimate final %DS after balloon angioplasty compared to quantitative coronary angiography (QCA), the impact of this effect on clinical outcomes following treatment with intracoronary radiation therapy (IRT) with Sr-90 for instent restenosis (ISR) is unknown. METHODS: To determine the effect of VA on the rate of major adverse cardiac events (MACEs) after IRT for ISR, we compared the clinical outcomes of 102 consecutive patients based on postprocedural %DS by QCA vs. %DS by VA. MACE was defined as death, M1 or need for target vessel revascularization (TVR). RESULTS: MACE rates for the 102 consecutive patients grouped according to postprocedural %DS by QCA and VA were compared. The mean %DS by QCA was 30.7%, while the mean %DS by VA was 12.5%. The mean %DS by VA across the QCA subgroups were 13.67%, 10.71% and 13.37%, respectively (P = .244). Fifty-two patients (51.0%) had %DS > 30% by QCA with the highest MACE percentage occurring in this subgroup. CONCLUSION: VA underestimated the %DS compared to QCA, and it was associated with worse MACE following treatment with Sr-90 for ISR.