Outcomes of Combined Transcatheter Aortic Valve Replacement and Peripheral Vascular Intervention in the United States

ObjectivesThe aim of this study was to compare the prevalence and real-world outcomes of patients who require peripheral vascular intervention during the same hospitalization as transcatheter aortic valve replacement (TAVR) compared with TAVR alone.BackgroundThere are limited data on the prevalence and outcomes of combined TAVR and percutaneous peripheral vascular intervention.MethodsAll patients who underwent TAVR in 2016 and 2017 were identified using the Nationwide Readmissions Database. Outcomes of patients undergoing TAVR alone were compared with those of patients undergoing combined TAVR and peripheral intervention, TAVR and peripheral intervention with and without a history of peripheral artery disease, and alternative-access TAVR with transfemoral TAVR in individuals undergoing peripheral intervention. The primary outcome was in-hospital mortality.ResultsA total of 99,654 hospitalizations were identified, among which 4,397 patients (4.42%) underwent peripheral intervention during the same admission as TAVR. Patients who required peripheral intervention had increased mortality (4.2% vs 1.5%; P < 0.001), stroke (3.5% vs 1.8%; P < 0.001), acute kidney injury (17.6% vs 10.8%; P < 0.001), blood transfusion (16.0% vs 11.3%; P < 0.001), 30-day readmission (16.3% vs 12.1%; P < 0.001), median length of stay (4 days [IQR: 2-8 days] vs 3 days [IQR: 2-5 days]; P < 0.001), and hospitalization charges. Compared with patients undergoing peripheral intervention to facilitate transfemoral TAVR, alternative-access TAVR was associated with increased mortality (4.6% vs 3.0%; P = 0.036), acute kidney injury (22.7% vs 14.3%; P < 0.001), median length of stay (5 days [IQR: 3-10 days] vs 4 days [IQR: 2-7 days]; P < 0.001), and 30-day readmission (18.1% vs 15.5%; P = 0.012).ConclusionsPeripheral vascular intervention may be used to facilitate transfemoral access or as a bailout for vascular complications during TAVR. Combined TAVR and peripheral intervention is associated with an increased risk for adverse events, though outcomes are better compared with alternative-access TAVR using a nonfemoral approach.     

Commissural Versus Coronary Optimized Alignment During Transcatheter Aortic Valve Replacement

ObjectivesThe aims of this study were to determine the rate of noncentered coronary ostia and their risk for coronary overlap (CO) and to develop an improved orientation strategy for transcatheter aortic valve replacement (TAVR) devices taking into account anatomical cues to identify patients at risk for CO regardless of commissural alignment and compute an alternative, CO-free TAVR rotation angle for those patients.BackgroundCommissural alignment during TAVR reduces CO risk. However, eccentricity of coronary ostia from the center of the sinus of Valsalva may result in CO even after perfect alignment of TAVR commissures.MethodsBaseline computed tomography from TAVR candidates helped identify distance from commissures to the right coronary artery (RCA) and the left coronary artery (LCA). Then, for each case, a virtual valve was simulated with ideal commissural or coronary alignment, and the degree of CO was determined. On the basis of the potential BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) efficacy, 3 groups were defined: no risk for CO (>35° from neocommissure to coronary ostia), moderate risk (20°-35°), and severe risk (≤20°).ResultsComputed tomographic studies from 107 patients were included. After excluding 7 patients (poor quality or bicuspid valve), 100 patients were analyzed. The RCA showed greater eccentricity compared with the LCA (18.5° [IQR: 3.3°-12.8°] vs 6.5° [IQR: 3.3°-12.8°]; P < 0.001). The mean intercoronary angle was 140.0° ± 18.7° (95% CI: 136.3°-143.7°). Thirty-two patients had moderate to severe risk for CO (≤35°) despite ideal commissural alignment. Greater coronary eccentricity (cutoff for RCA, 24.5°; cutoff for LCA, 19°) and intercoronary angle >147.5° or <103° were associated with greater risk for moderate to severe CO despite commissural alignment (area under the curve: 0.97; 95% CI: 0.91-0.99). If optimal coronary alignment was simulated, this prevented severe CO in all cases and reduced moderate CO from 27% to 5% (P < 0.001).ConclusionsOne third of patients would have CO during TAVR-in-TAVR despite commissural alignment; a 6-fold decrease in this risk was achieved with optimized coronary alignment. Coronary eccentricity and intercoronary angle were the main predictors.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Outcomes Following Shock Aortic Valve Replacement: Transcatheter Versus Surgical Approaches

ObjectivesTo compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) for patients in shock.BackgroundThere are minimal data on the clinical and echocardiographic outcomes for patients in shock that undergo TAVR and no data comparing these outcomes to similar patients undergoing SAVR.MethodsThis is a single center, retrospective cohort study of patients having Society of Thoracic Surgeons (STS)-defined urgent or emergent AVR for aortic stenosis with clinical signs and symptoms of shock. Inclusion criteria were based on the Society of Cardiovascular Angiography & Interventions (SCAI) shock consensus statement and included: the need for inotropic or vasopressor agents, mechanical ventilation, continuous renal replacement therapy or newly initiated hemodialysis, and/or utilization of mechanical hemodynamic support. Clinical and echocardiographic outcomes for TAVR and SAVR were compared.ResultsThirty-seven patients met the inclusion criteria for this study (17 TAVR, 20 SAVR). TAVR patients had a higher STS Predicted Risk of Mortality (PROM) score of 22.3% compared to 11.8% for SAVR patients (p = 0.001). No significant differences were found in baseline echocardiographic results. TAVR procedures required less procedure room time (185.9 min TAVR, 348.5 min SAVR, p < 0.001) and fewer intraoperative packed red blood cell (pRBC) transfusions (0.2 units TAVR, 3.4 units SAVR, p < 0.001). TAVR patients also had lower rates of prolonged postoperative ventilation compared to SAVR patients (38.5% TAVR, 75.0% SAVR, p = 0.047). TAVR and SAVR had similar rates of mortality at discharge (2 TAVR, 1 SAVR, p = 0.584), 30-days (2 TAVR, 1 SAVR, p = 0.584), and 1-year (8 TAVR, 5 SAVR, p = 0.149).ConclusionsDespite a higher risk TAVR group, patients in shock undergoing either TAVR or SAVR have similar 30-day mortality. At one year, SAVR patients have a numerically better, though not statistically significant, survival. These findings support the use of TAVR for patients in shock with aortic stenosis.     

Incidence,Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States

ObjectivesThis study sought to evaluate the incidence and outcomes of endocarditis after transcatheter aortic valve replacement (TAVR).BackgroundData about endocarditis after TAVR are limited.MethodsThe study investigated Medicare patients who underwent TAVR from 2012 to 2017 and identified patients admitted with endocarditis during follow-up using a validated algorithm. The main study outcome was all-cause mortality.ResultsOf 134,717 patients who underwent TAVR, 1868 patients developed endocarditis during follow-up (incidence 0.87%/year), with majority of infections (65.0%) occurring within 1 year. Incidence of endocarditis declined in recent years. The most common organisms were Staphylococcus (22.0%), Streptococcus (20.0%), and Enterococcus (15.5%). Important predictors for endocarditis were younger age at TAVR, male sex, prior endocarditis, end-stage renal disease, repeat TAVR procedures, liver and lung disease, and post-TAVR acute kidney injury. Thirty-day and 1-year mortality were 18.5% and 45.6%, respectively. After adjusting for comorbidities and procedural complications, endocarditis after TAVR was associated with 3-fold higher risk of mortality (44.9 vs. 16.2 deaths per 100 person-years; adjusted hazard ratio [aHR]: 2.94; 95% confidence interval [CI]: 2.77 to 3.12; p < 0.0001). End-stage renal disease (aHR: 2.12; 95% CI: 1.72 to 2.60), endocarditis complicated by cardiogenic shock (aHR: 2.50, 95% CI: 1.56 to 4.02), ischemic stroke (aHR: 1.56; 95% CI: 1.07 to 2.28), intracerebral hemorrhage (aHR: 1.67; 95% CI: 1.01 to 2.76), acute kidney injury (aHR: 1.44; 95% CI: 1.27 to 1.63), blood transfusion (aHR: 1.28; 95% CI: 1.09 to 1.50), staphylococcal (aHR: 1.71; 95% CI: 1.49 to 1.97), and fungal endocarditis (aHR: 1.72; 95% CI: 1.23 to 2.39) (p < 0.05 for all) portended higher mortality following endocarditis.ConclusionsThe incidence of endocarditis after TAVR is low and declining. However, it is associated with poor prognosis with one-half the patients dying within 1 year.     

Incidence and Outcomes of Acute Coronary Syndrome After Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to address a knowledge gap by examining the incidence, timing, and predictors of acute coronary syndrome (ACS) after transcatheter aortic valve replacement (TAVR) in Medicare beneficiaries.BackgroundEvidence about incidence and outcomes of ACS after TAVR is scarce.MethodsWe identified Medicare patients who underwent TAVR from 2012 to 2017 and were admitted with ACS during follow-up. We compared outcomes based on the type of ACS: ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina. In patients with non–ST-segment elevation ACS, we compared outcomes based on the treatment strategy (invasive vs. conservative) using inverse probability weighting analysis.ResultsOut of 142,845 patients with TAVR, 6,741 patients (4.7%) were admitted with ACS after a median time of 297 days (interquartile range: 85 to 662 days), with 48% of admissions occurring within 6 months. The most common presentation was NSTEMI. Predictors of ACS were history of coronary artery disease, prior revascularization, diabetes, valve-in-TAVR, and acute kidney injury. STEMI was associated with higher 30-day and 1-year mortality compared with NSTEMI (31.4% vs. 15.5% and 51.2% vs. 41.3%, respectively; p < 0.01). Overall, 30.3% of patients with non–ST-segment elevation ACS were treated with invasive approach. On inverse probability weighting analysis, invasive approach was associated with lower adjusted long-term mortality (adjusted hazard ratio: 0.69; 95% confidence interval: 0.66 to 0.73; p < 0.01) and higher risk of repeat revascularization (adjusted hazard ratio: 1.29; 95% confidence interval: 1.16 to 1.43; p < 0.001).ConclusionsAfter TAVR, ACS is infrequent (<5%), and the most common presentation is NSTEMI. Occurrence of STEMI after TAVR is associated with a high mortality with nearly one-third of patients dying within 30 days. Optimization of care is needed for post-TAVR ACS patients and if feasible, invasive approach should be considered in these high-risk patients.     

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Complex Coronary Artery Disease

ObjectivesThe aim of this study was to compare, in a cohort of patients with complex coronary artery disease (CAD) and severe aortic stenosis (AS), the clinical outcomes associated with transfemoral transcatheter aortic valve replacement (TAVR) (plus percutaneous coronary intervention [PCI]) versus surgical aortic valve replacement (SAVR) (plus coronary artery bypass grafting [CABG]).BackgroundPatients with complex CAD were excluded from the main randomized trials comparing TAVR with SAVR, and no data exist comparing TAVR + PCI vs SAVR + CABG in such patients.MethodsA multicenter study was conducted including consecutive patients with severe AS and complex CAD (SYNTAX [Synergy Between PCI with Taxus and Cardiac Surgery] score >22 or unprotected left main disease). A 1:1 propensity-matched analysis was performed to account for unbalanced covariates. The rates of major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, nonprocedural myocardial infarction, need for new coronary revascularization, and stroke, were evaluated.ResultsA total of 800 patients (598 undergoing SAVR + CABG and 202 undergoing transfemoral TAVR + PCI) were included, and after propensity matching, a total of 156 pairs of patients were generated. After a median follow-up period of 3 years (interquartile range: 1-6 years), there were no significant differences between groups for MACCE (HR for transfemoral TAVR vs SAVR: 1.33; 95% CI: 0.89-1.98), all-cause mortality (HR: 1.25; 95% CI: 0.81-1.94), myocardial infarction (HR: 1.16; 95% CI: 0.41-3.27), and stroke (HR: 0.42; 95% CI: 0.13-1.32), but there was a higher rate of new coronary revascularization in the TAVR + PCI group (HR: 5.38; 95% CI: 1.73-16.7).ConclusionsIn patients with severe AS and complex CAD, TAVR + PCI and SAVR + CABG were associated with similar rates of MACCE after a median follow-up period of 3 years, but TAVR + PCI recipients exhibited a higher risk for repeat coronary revascularization. Future trials are warranted.     

Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses

ObjectivesA large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.BackgroundValve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.MethodsUnadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).ResultsBioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.ConclusionsStentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.     

Delayed Coronary Obstruction After Transcatheter Aortic Valve Replacement

Background

Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR).