Outcome of transcatheter aortic valve replacement in Israeli Jews and Arabs.

Background: Ethnic minorities may face disparities in access to health care and clinical outcomes. Transcatheter aortic valve replacement (TAVR) has an established role in treatment of patients with severe symptomatic aortic stenosis, however outcome of these procedures among different demographics within the multi-ethnic Israeli society is unknown. We sought to compare mortality following TAVR between Jewish and Arab patients in Israel. Methods: A prospective single-center TAVR registry in northern Israel was analyzed. We compared post-procedural survival among Arab and Jewish patients who underwent TAVR, presenting the estimated hazard ratio (HR) using Cox regression. Results: Of 923 subjects who underwent TAVR between 2010-2021, 172 (19%) were Arab and 751 (81%) were Jewish. The Arab patient population was younger (mean 77 vs. 81 years, P<0.001), had lower prevalence of coronary artery disease (34%, vs. 43%, P=0.02), hypertension (80% vs. 88%, P<0.01) and calculated procedural mortality (EuroScore II: mean 4.6 vs. 4.9, P=0.02), and higher percentage of females (65% vs. 53%, P=0.01), body mass index (mean 30 vs. 28, P<0.001) and creatinine clearance (mean 67 vs. 59 mL/min, P<0.001). Arab patients had similar post-procedural mortality compared to Jewish patients [7-day mortality: adjusted HR 1.51, 95% confidence interval (CI): 0.39-5.77, P=0.55; 30-day mortality: adjusted HR 1.79, 95% CI: 0.62-5.18, P=0.29; 1-year mortality: adjusted HR 1.24, 95% CI: 0.72-2.12, P=0.43]. Conclusions: Arab patients undergoing TAVR were younger and had lower predicted mortality than Jewish counterparts, however, these characteristics did not translate into improved post-procedural survival.

The impact of on-site cardiac surgical backup on clinical outcomes of acute coronary syndrome-analysis of the ACSIS national registry.

Background: The availability of advanced technologies for mechanical support in hospitals with on-site cardiac surgery (CS), along with the ability to perform urgent coronary artery bypass graft (CABG) surgery, may result in improved clinical outcomes in patients with acute coronary syndrome (ACS). Methods: We conducted a retrospective analysis of the bi-annually Acute Coronary Syndrome Israeli Survey (ACSIS) registry from the year 2000 to 2020, performed in hospitals with and without CS. Mortality rates and major adverse cardiac and cerebrovascular events (MACCE) rates are reported. We evaluated two periods of the study-early (2000-2010) vs. late (2011-2020). Propensity score matching was performed to reduce bias between the two groups. Results: The study included 16,979 patients (52.3% in the on-site CS group). Patients in the on-site CS group were more likely to undergo percutaneous coronary intervention (PCI), (odds ratio [OR], 1.26 [95% CI, 1.18-1.35]; p < 0.001) and CABG [OR, 1.91 (95%CI, 1.63-2.24); P < 0.001], and patients in hospitals without on-site CS had higher 30-day MACCE [OR, 1.17 (95% CI, 1.07-1.27); p < 0.0005]. Overall, there was no difference in 1-year mortality (hazard ratio [HR], 0.98 [95% CI, 0.89-1.08]; p = 0.71) between the groups. During the late period of the study, patients in the group without on-site CS had lower 30-day mortality [OR, 0.69 (95% CI, 0.49-0.97); P = 0.04], yet with no difference in 1-year mortality [HR, 0.81 (95% CI, 0.65-1.01); p = 0.07]. Conclusions: The availability of on-site CS resulted in variations in treatment modality, yet it did not affect the clinical outcomes of ACS. A trend to a better short-term outcomes was noted in hospitals without CS during the late period of the study, which warrants further investigation.

Strategy for Totally Percutaneous Management of Vascular Injury in Combined Transfemoral Transcatheter Aortic Valve Replacement and Endovascular Aortic Aneurysm Repair Procedures.

Minimally invasive treatment of severe aortic stenosis by transcatheter aortic valve replacement (TAVR) and infrarenal abdominal aortic aneurysm by endovascular aortic aneurysm repair (EVAR) requires large-bore vascular access. These percutaneous transfemoral interventions may be performed as a combined procedure, however, vascular injury may necessitate surgical vascular repair. We implemented a strategy designed to enable percutaneous vascular repair, with stent-graft implantation, if necessary, after these combined procedures. We identified all combined percutaneous TAVR and EVAR procedures which were performed at our institution. Patient and procedural characteristics and clinical outcomes were analyzed. Six consecutive patients underwent total percutaneous combined TAVR and EVAR procedures. In all cases, TAVR was performed first and was followed by EVAR. Both common femoral arteries served as primary access sites for delivery of the implanted devices and hemostasis was achieved by deployment of vascular closure devices. Secondary access sites included the right brachial artery in all patients and superficial femoral arteries in 50% of the patients. In all cases an "0.014" 300-cm length "safety" wire was delivered to the common femoral artery or descending aorta by way of a secondary access site to facilitate stent graft delivery. Successful device implantation was achieved in all cases. Vascular closure device failure occurred in 2 patients and was treated by stent graft implantation by way of the brachial and superficial femoral arteries, without need for surgical vascular repair. A strategy designed to facilitate percutaneous vascular repair after combined EVAR and TAVR procedures may enable a truly minimally invasive procedure.

Traumatic transcatheter aortic valve replacement.

A 76-year-old female with severe symptomatic aortic stenosis underwent cardiac CT angiography imaging. Severe calcification of the ascending aorta (porcelain aorta) (Figures 1A and 1B) precluded surgical aortic valve replacement. The aortic annular area, perimeter, and diameter were 372 mm2, 68.5 mm, and 20 mm, respectively. Transcatheter aortic valve replacement (TAVR) was performed with direct implantation of a 23 mm Sapien S3 valve (Edwards Lifesciences). The valve was delivered via the right femoral artery and a pigtail catheter was delivered to the aortic root via the left femoral artery. The balloon ruptured during valve implantation (Video).

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves.

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Recurrent Valve Migration During TAVR: Using One Valve to Anchor Another Valve.

This case describes management of recurrent valve migration during a TAVR procedure in a patient with a hypertrophic and hyperdynamic left ventricle. Since anchoring a valve in an optimal position within the aortic annulus was not possible, a valve was intentionally deployed deep within the left ventricular outflow tract. This valve was used as an anchoring site for an additional valve, which achieved an optimal hemodynamic result and clinical outcome outcome.

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.

BACKGROUND: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. METHODS: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. RESULTS: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P<0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P=0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P<0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P=0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P<0.001). CONCLUSIONS: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices.

BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

The Impact of Smoking Status 1 Year After ST-Segment Elevation Myocardial Infarction on Cardiovascular Events and Mortality in Patients Aged ≤60 Years.

Smoking is associated with increased risk for acute ST-elevation myocardial infarction (STEMI) at a young age. Although smoking is a modifiable risk factor, smoking cessation rates after STEMI are suboptimal. We investigated the association between smoking status 1 year after STEMI and adverse events in patients (n = 765) aged ≤60 years. Patients were categorized as: (1) nonsmokers, (2) quit smoking, and (3) continued/resumed smoking. The association between smoking status and risk for major adverse cardiovascular events (MACEs) was analyzed during a median follow-up of 8 years. At presentation with STEMI, the mean age was 51 ± 7 years (88% men) and 427 (56%) were smokers. A year after STEMI, 272 continued smoking, 35 quit but later resumed smoking (summed to a single group; n = 307), and 120 quit smoking. Continued smoking was associated with younger age, male gender, lower weight, and low socioeconomic status. Compared with nonsmokers, the adjusted hazard ratio (95% confidence interval) for myocardial infarction, stroke, unstable angina, death, and MACE was 2.51 (1.67 to 3.73), 2.07 (0.94 to 4.56), 3.73 (1.84 to 7.58), 2.52 (1.53 to 4.13), and 2.40 (1.80 to 3.22), accordingly, in those who continued to smoke. However, the adjusted hazard ratio was not significantly associated with these outcomes in patients who quit smoking (MACE: 1.20 [0.77 to 1.87], p=0.414; nonsignificant for individual end points). In conclusion, the prevalence of smoking in young and middle-aged patients presenting with STEMI is high and smoking cessation rates are low. A year after STEMI, those who continued to smoke had worse cardiovascular outcomes and death compared with nonsmokers; however, the long-term outcomes among those who quit smoking appear to be comparable with nonsmokers. The results highlight the contrast between health benefits of quitting smoking after STEMI and low abstinence rates in clinical practice.

Strategies for Facilitating Totally Percutaneous Transfemoral TAVR Procedures.

Transcatheter aortic valve replacement (TAVR) has transformed the treatment of aortic stenosis and should ideally be performed as a totally percutaneous procedure via the transfemoral (TF) approach. Peripheral vascular disease may impede valve delivery, and vascular access site complications are associated with adverse clinical outcome and increased mortality. We review strategies aimed to facilitate TF valve delivery in patients with hostile vascular anatomy and achieve percutaneous management of vascular complications.

Transbrachial Secondary Vascular Access in Transcatheter Aortic Valve Replacement Procedures: A Single-Centre Retrospective Analysis.

BACKGROUND: Transfemoral transcatheter aortic valve replacement (TAVR) procedures require secondary vascular access for inserting accessory catheters and performing percutaneous repair of femoral artery injury. Use of the transbrachial approach for secondary vascular access in TAVR procedures has not been reported. METHODS: This study identified 48 patients at the current institution who had undergone transfemoral TAVR utilising transbrachial secondary vascular access. Efficacy and safety of this strategy for achieving a successful totally percutaneous procedure were examined. Study endpoints were occurrence of vascular complications and bleeding related to transbrachial access, as well as periprocedural and 1-year mortality. RESULTS: Mean patient age was 80±7 years and Society of Thoracic Surgeons Predicted Risk of Mortality score was 10.6±3.1. Sizes of sheaths inserted into the brachial artery were 6 Fr (85%), 8 Fr (2%), and 9 Fr (13%). Transbrachial access was used for delivering stent grafts to the femoral artery in 13% of the patients, inflation of an occlusive balloon within the iliac artery in 10%, and treatment of iatrogenic femoral artery stenosis in 2%. Successful valve replacement was achieved in all cases. Brachial sheaths were removed by manual compression following administration of protamine sulfate. There were no major access site complications or VARC-3 type ≥2 bleeding related to the brachial vascular access. Brachial artery occlusion occurred in two patients (4%) who underwent surgical vascular repair. Two (2) additional patients developed mild arm ischaemia, which was treated conservatively. Periprocedural mortality was 0% and early mortality was 8%. CONCLUSIONS: Transbrachial secondary access in TAVR procedures was feasible and enabled percutaneous vascular repair in cases of femoral artery injury.

Totally Percutaneous Transfemoral Transcatheter Aortic Valve Replacement Despite Failure to Deploy a Vascular Closure Device: A Single-Centre Case Series.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is preferably performed as a completely percutaneous procedure via transfemoral access. Suture-mediated vascular closure devices are deployed prior to sheath insertion (pre-closure). Inability to perform pre-closure may necessitate surgical vascular repair of the femoral artery. Patients at increased risk of vascular surgery complications may benefit from a percutaneous method for achieving access site haemostasis. Stent graft implantation is commonly used for treating access site injury following TAVR. This study assessed the feasibility of a strategy of planned stent graft implantation within the femoral artery for achieving access site haemostasis in patients undergoing transfemoral TAVR and in whom vascular pre-closure was not possible. METHODS: A prospective institutional TAVR registry was retrospectively analysed and a cohort of patients were identified who were selected for transfemoral valve delivery and in whom pre-closure failed and access site haemostasis was achieved by stent graft implantation. RESULTS: This strategy was used for achieving access site haemostasis in 11 patients (1.5% of 744 patients undergoing transfemoral TAVR). These patients were considered to be at increased risk of vascular surgery complications due to advanced age, frailty, comorbidities, or immobility. Stent graft implantation achieved access site haemostasis in all patients. During follow-up, 30-day mortality was zero, 1-year mortality was 27%, and none of the patients required additional vascular interventions. CONCLUSION: The preliminary data suggest that planned stent graft implantation within the femoral artery may achieve access site haemostasis and enable a totally percutaneous TAVR procedure, despite failure to perform pre-closure with a suture-based vascular closure device.

Impact of glomerular filtration rate estimation on cardiovascular events in elderly patients undergoing coronary angiography.

BACKGROUND: Estimation of kidney function by glomerular filtration rate (eGFR) is affected by age and is important for decision making regarding treatment and prognosis of patients with cardiovascular disease. We investigated the impact of eGFR on long-term cardiovascular outcomes in an elderly population undergoing coronary angiography for evaluation or treatment of coronary artery disease. METHODS: GFR was estimated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation in 3690 elderly patients (aged 70-100 years) undergoing coronary angiography. Patients receiving maintenance dialysis were excluded. The association between eGFR and major adverse cardiovascular events (MACE) including myocardial infarction, ischemic stroke or death, was investigated. GFR was further calculated according to modification of diet in renal disease (MDRD) and the Cockcroft-Gault equations, and compatibility between estimations was analyzed. RESULTS: Cardiovascular comorbidities were more prevalent with the reduction in kidney function as was the proportion of patients presenting with acute coronary syndromes. The adjusted hazard ratio (95% confidence interval) for MACE during a mean follow-up of 5 years was 0.95 (0.77-1.16), 1.04 (0.84-1.29), 1.56 (1.16-1.84), 2.22 (1.65-2.97) and 3.74 (2.20-6.38) in patients with eGFR 60-89, 45-59, 30-44, 15-29 and <15 ml/min/1.73m2, respectively, compared to >90 ml/min/1.73m2. Reclassification of eGFR stages by MDRD (upward 23.8%, downward 0.4%) and Cockcroft-Gault (upward 4.3%, downward 28.1%) compared to CKD-EPI estimation, was noted. However, the association between eGFR stages and MACE was similar between equations. CONCLUSIONS: Kidney function, as manifested by eGFR, has a graded inverse association with the burden of cardiovascular comorbidities and long-term adverse events in elderly patients undergoing coronary angiography.

Incidence, Causes, and Outcomes Associated With Urgent Implantation of a Supplementary Valve During Transcatheter Aortic Valve Replacement.

Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective: To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures: Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures: Mortality at 30 days and 1 year. Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR. Conclusions and Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.

Heart Team/Guidelines Discordance Is Associated With Increased Mortality: Data From a National Survey of Revascularization in Patients With Complex Coronary Artery Disease.

BACKGROUND: Practice guidelines emphasize the role of the SYNTAX score (SS; Synergy Between PCI With TAXUS and Cardiac Surgery) in choosing between percutaneous coronary intervention and coronary artery bypass graft surgery in cases of complex coronary artery disease. There is paucity of data on the implementation of these recommendations in daily practice, and on the consequences of guideline discordant revascularization. METHODS: This was a retrospective analysis of a prospective national survey of consecutive real world patients undergoing coronary revascularization for complex coronary artery disease according to decisions of local heart team at each center. SS was calculated at a dedicated CoreLab, and patients were classified as heart team/guidelines agreement/discordant. RESULTS: Nine hundred seventy-nine patients (571 percutaneous coronary intervention and 408 coronary artery bypass graft) were included. Mean age was 65 years and the mean SS was 22. Heart team/guidelines discordance occurred in 170 (17.3%) patients. Independent predictors of heart team/guidelines discordance were age, admission to a center with no cardiac surgery service, SS, and previous percutaneous coronary intervention/myocardial infarction. A multivariate model based on these characteristics had a C statistic of 0.83. Thirty-day outcomes were similar in the agreement/discordance groups, however, heart team/guidelines discordance was associated with a significant increase in 3 year mortality (17.6% versus 8.4%; hazard ratio, 2.05; P=0.002) after multivariate adjustment. CONCLUSIONS: Heart team/guidelines discordance is not infrequent in real world patients with complex coronary artery disease undergoing revascularization. This is more likely to occur in elderly patients, those with more complex coronary disease (as determined by the SS), and those treated at centers with no cardiac surgery service. These patients have a higher risk for mid-term mortality.

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

BACKGROUND: 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. OBJECTIVES: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). METHODS: 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. RESULTS: 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 cm2 vs. 1.37 ± 0.5 cm2; 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). CONCLUSIONS: 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.

Treatment and Imaging Modalities of Giant Coronary Aneurysms Resulting from Kawasaki Disease and Presenting as Acute Inferior Wall Myocardial Infarction.

Giant coronary aneurysms are late sequelae of Kawasaki disease (KD). We describe a 53-year-old patient who presented with acute myocardial infarction and proximal aneurysms of all three coronary arteries. Coronary angiography demonstrated the aneurysms, but CT angiography allowed accurate assessment of the real dimensions of the aneurysms and making the decision on the preferred method of revascularization. The patient underwent coronary bypass surgery and is asymptomatic at follow-up.

Effect of Cerebrovascular and/or Peripheral Artery Disease With or Without Attainment of Lipid Goals on Long-Term Outcomes in Patients With Coronary Artery Disease.

Involvement of atherosclerosis in extracardiac vascular territories may identify coronary artery disease (CAD) patients at higher risk for adverse events. We investigated the long-term prognostic implications of polyvascular disease in patients with CAD, and further analyzed lipid goal attainment and its relation to patient outcomes. The study was a retrospective analysis of 10,297 patients who underwent coronary revascularization, categorized as having CAD alone (83.1%) or with multisite artery disease (MSAD) (16.9%) including cerebrovascular disease (CBVD) and/or peripheral artery disease (PAD). Incidence rates and hazard ratios (HR) for major adverse cardiovascular events (MACE) (myocardial infarction, ischemic stroke, or all-cause death) according to vascular territories involved, and in relation to most-recent lipid levels attained, were analyzed. Patients with MSAD were older with higher burden of co-morbidities. The rate of MACE (myocardial infarction, ischemic stroke, or all-cause death) and its individual components increased with the number of affected vascular beds. Adjusted HR (95% confidence interval) for MACE was 1.41 (1.24 to 1.59) in patients with CAD and CBVD, 1.46 (1.33 to 1.62) in CAD and PAD, and 1.69 (1.49 to 1.92) in those with CAD and CBVD and PAD, compared with CAD alone. Most-recent low-density lipoprotein cholesterol (LDL-C) levels <55 mg/dl and <70 mg/dl were attained by 21.8% and 44.6% of patients with CAD alone, in comparison to 22.7% and 43.3% in MSAD. Compared with patients with most-recent LDL-C > 100 mg/dl, attaining LDL-C < 70 mg/dl had an adjusted HR for MACE of 0.52 (0.47 to 0.57) in CAD only patients and 0.66 (0.57 to 0.78) in MSAD patients. In conclusion, the presence of CBVD and/or PAD in patients with CAD is associated with higher burden of co-morbidities and progressive increase in long-term MACE. More than half of CAD patients with or without MSAD do not achieve lipid goals, which are associated with a significantly lower risk for adverse events.

Impact of predilatation prior to transcatheter aortic valve implantation with the self-expanding acurate neo device (From the Multicenter NEOPRO Registry)

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on preBAV was available for 1,262 patients (99.9%). Primary endpoints were pre-discharge moderate-tosevere paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation (PPI), and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n=1,051) or without predilatation (n=211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs. 3.4%, p=0.214; 30-day PPI 9.0% vs. 8.0%, p=0.660; 30-day death or stroke 4.9% vs. 4.4%, p=0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification. (AU)