Use and performance of the evolut FX transcatheter aortic valve system.

BACKGROUND: The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated. METHODS: Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system. RESULTS: There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %). CONCLUSION: Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators.

Ultrathin bioresorbable polymer sirolimus-eluting stents in US patients undergoing coronary revascularization: 1-Year outcomes from the BIOFLOW VII trial.

BACKGROUND: Ultrathin strut coronary drug-eluting stents (DES) have demonstrated improved safety and efficacy in large contemporary trials. The evaluation of an ultrathin strut DES in a post-market United States (US) patient population was undertaken. OBJECTIVE: The purpose of this post-approval study is to confirm that the clinical performance of an ultrathin strut bioresorbable polymer sirolimus-eluting stent (BP SES) in clinical practice is similar to that observed with BP SES in the BIOFLOW V pivotal trial. METHODS: BIOFLOW VII is a prospective, multicenter, single-arm US post-market approval study to confirm the clinical performance of BP SES in a real-world setting. The primary endpoint of 1-year target lesion failure (TLF) was compared with a performance goal of 6.9% based on an adapted BIOFLOW V trial BP SES TLF rate and TLF rates from other US market-released DES utilizing the Society for Cardiovascular Angiography and Interventions definition for peri-procedural myocardial infarction (MI). Subjects undergoing percutaneous coronary intervention with BP SES were consented within 24 h post-index procedure with planned follow-up through 5 years. RESULTS: Among 556 enrolled patients, clinical demographics included: 34.7% female, 35.6% with diabetes mellitus, and 56.8% with acute coronary syndromes. The average stent length (mean ± standard deviation) was 20.2 ± 11.8 mm, and the mean number of stents per patient was 1.3 ± 0.6. Procedure success was 99.1% (551/556), and device success was 99.9% (689/690). Among 531 subjects included in the primary endpoint analysis, the 1-year rate of TLF rate was 1.7% (9/531), and the primary endpoint was met compared with the performance goal (p < 0.0001, 95% confidence interval: 0.69%, 3.43%). Rates of target vessel MI and clinically driven target lesion revascularization were 1.3% (7/531) and 0.9% (5/531), with no occurrence of cardiac death. Definite stent thrombosis was observed for two cases (0.4%; 2/556) with one acute (≤24 h) and one late (>30 days and ≤1 year) event. CONCLUSION: In a post-approval study, 1-year clinical outcomes with BP SES were consistent with prior trials supporting the safety and effectiveness of ultrathin BP SES.

Efficacy of nasal continuous positive airway pressure as a preferred airway management during intravenous sedation of patients undergoing transcatheter aortic valve replacement.

Background: As the incidence of aortic stenosis is increasing in correlation with the aging population, symptomatic patients commonly require valve replacement procedures. If left untreated, symptomatic aortic stenosis can lead to death in 2 to 3 years. Often, transcatheter aortic valve replacement (TAVR) procedures are performed with the assistance of oxygenation via nasal cannula. However, oxygenation achieved through a nasal continuous positive airway pressure (nCPAP) device could be a more optimized strategy for patients without any sacrifice in efficacy compared to nasal cannula. Methods: A retrospective chart review was conducted on 28 patients at Baylor University Medical Center who presented to the operating room for a TAVR between January and October 2021. Fourteen patients received oxygenation via nasal cannula (control group) and 14 received oxygenation with nCPAP. Information gathered included method of oxygenation, length of stay, episodes of hypoxia (defined as sustained oxygen saturation <92% for at least 1 minute), paravalvular leak, pacemaker placement, and mean atrial valve (AV) gradient before and after the procedure. Results: In the nCPAP group, the average length of stay was 2.79 days vs 2.71 days in the nasal cannula group. In the nCPAP group, no patient required a permanent pacemaker, while the nasal cannula group had a 40% rate of permanent pacemaker placement. The average preprocedure AV gradient was 51.14 in the nCPAP group and 42.57 in the nasal cannula group. The average postprocedure AV gradient was 8.5 in the nCPAP group and 5.36 in the nasal cannula group. Both groups had an intensive care unit admission rate of 0%. The rate of paravalvular leak was 35.7% in the nCPAP group and 28.6% in the nasal cannula group. The nCPAP group had an average of 0 episodes of hypoxia and the nasal cannula group had an average of 0.93 episodes of hypoxia. Conclusion: The findings demonstrate the viability of nCPAP as an effective method of oxygenation during intravenous sedation of TAVR patients when compared to oxygenation achieved via nasal cannula during TAVRs.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Comparison of Echocardiographic and Catheter Mean Gradient to Assess Stenosis After Transcatheter Aortic Valve Implantation.

Discordance exists between Doppler-derived and left heart catheterization (LHC)-derived mean gradient (MG) in transcatheter aortic valve implantation (TAVI). We compared echocardiographic parameters of prosthetic valve stenosis and LHC-derived MG in new TAVIs. In a retrospective, single-center study, intraoperative transesophageal echocardiogram (TEE)-derived MG, LHC-derived MG, and acceleration time (AT) were obtained before and after TAVI in 362 patients. Discharge MG, AT, and Doppler velocity index (DVI) using transthoracic echocardiogram (TTE) were also obtained. MG ≥10 mm Hg was defined as abnormal. During native valve assessment with pre-TAVI TEE and pre-TAVI LHC, Pearson correlation coefficient revealed a nearly perfect linear relation between both methods' MGs (r = 0.97, p <0.0001). Intraoperatively, after TAVI, Spearman correlation coefficient revealed a weak-to-moderate relation between post-TAVI TEE and LHC MGs (r = 0.33, p <0.0001). Significant differences were observed in categorizations between post-TAVI TEE MG and post-TAVI AT (McNemar test p = 0.0003) and between post-TAVI TEE MG and post-TAVI LHC MG (signed-rank test p <0.0001), with TEE MG more likely to misclassify a patient as abnormal. At discharge, 30% of patients had abnormal TTE MG, whereas 0% and 0.8% of patients had abnormal DVI and AT, respectively. Discharge TTE MG was not associated with death or hospitalization for heart failure at a median follow-up of 862 days. Post-TAVI Doppler-derived MG by intraoperative TEE was higher than LHC, despite being virtually identical before implantation. At discharge, patients were more likely to be classified as abnormal using MG than DVI and AT. Elevated MG at discharge was not associated with death or hospitalization for heart failure.

Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial.

Importance: Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms. Objective: To describe the final 5-year outcomes of the REPRISE III trial. Design, Setting, and Participants: This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021. Intervention: Lotus valve or CoreValve/EvolutR TAVR platforms. Main Outcomes and Measures: Valve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up. Results: A total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P < .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P < .001) and required the use of a second valve (1.0% vs 3.8%; P < .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P < .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups. Conclusions and Relevance: The REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective. Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.

Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke. METHODS: We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR. RESULTS: A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P = 0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site. CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.).

Hybrid intervention approach to coronary artery and valvular heart disease.

Coronary angiography is used to assess the burden of coronary artery disease prior to surgical valve repair/replacement and often leads to concomitant bypass and valve surgery. We sought to evaluate outcomes of an alternative, hybrid approach involving percutaneous coronary intervention (PCI) and valve surgery, assessing the rate of stent thrombosis as a primary outcome. We reviewed charts of consecutive patients who underwent planned PCI prior to surgical valve repair/replacement by a single surgeon from January 2008 to December 2016. We calculated rates of surgical complication, duration of dual antiplatelet therapy (DAPT) prior to surgery, and rates of stent thrombosis and in-stent restenosis. Twenty-four patients were included in this study. Surgery was performed a median of 52.5 days following PCI. DAPT was withheld an average of 8 days before and resumed an average of 4 days after surgery. Ninety-two percent of surgeries were minimally invasive. There were no bleeding complications, stent thromboses, or restenosis events. All patients survived the 1-year follow-up. For patients with mixed coronary and valvular heart disease, a heart team approach involving preoperative PCI followed by staged minimally invasive valvular surgery appears to be safe and warrants further exploration.

Characteristics and Outcomes in Patients Presenting With COVID-19 and ST-Segment Elevation Myocardial Infarction.

There is limited information regarding clinical characteristics and outcomes of patients with SARS-CoV-2 (COVID-19) disease presenting with ST-segment elevation myocardial infarction (STEMI). In this multicenter retrospective study, we reviewed charts of patients admitted with symptomatic COVID-19 infection and STEMI to a total of 4 hospitals spanning Italy, Lithuania, Spain and Iraq from February 1, 2020 to April 15, 2020. A total of 78 patients were included in this study, 49 (63%) of whom were men, with a median age of 65 [58, 71] years, and high comorbidity burden. During hospitalization, 8 (10%) developed acute respiratory distress syndrome, and 14 (18%) required mechanical ventilation. 19 (24%) patients were treated with primary Percutaneous Coronary Intervention (PCI) and 59 (76%) were treated with fibrinolytic therapy. 13 (17%) patients required cardiac resuscitation, and 9 (11%) died. For the 19 patients treated with primary PCI, 8 (42%) required intubation and 8 (42%) required cardiac resuscitation; stent thrombosis occurred in 4 patients (21%). A total of 5 patients (26%) died during hospitalization. 50 (85%) of the 59 patients initially treated with fibrinolytic therapy had successful fibrinolysis. The median time to reperfusion was 27 minutes [20, 34]. Hemorrhagic stroke occurred in 5 patients (9%). Six patients (10%) required invasive mechanical ventilation; 5 (9%) required cardiac resuscitation, and 4 (7%) died. In conclusion, this is the largest case series to-date of COVID-19 positive patients presenting with STEMI and spans 4 countries. We found a high rate of stent thrombosis, indicating a possible need to adapt STEMI management for COVID-19 patients.

Considerations for Management of Acute Coronary Syndromes During the SARS-CoV-2 (COVID-19) Pandemic.

Accumulating evidence suggests that influenza and influenza-like illnesses can act as a trigger for acute myocardial infarction. Despite these unprecedented times providers should not overlook acute coronary syndrome (ACS) guidelines, but may choose to modify the recommended approach in situations with confirmed or suspected COVID-19 disease. In this document, we suggest recommendations as to how to triage patients diagnosed with ACSs and provide with algorithms of how to manage the patients and decide the appropriate treatment options in the era of COVID-19 pandemic. We also address the inpatient logistics and discharge to follow-up considerations for the function of already established ACS network during the pandemic.

Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial.

AIMS: In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial. METHODS AND RESULTS: A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males. CONCLUSIONS: Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov NCT01586910.

The Case for Primary Prevention of Atherosclerotic Events from Study of a Single Patient.

This report describes a 64-year-old woman who presented with unstable angina pectoris, her first atherosclerotic event, and who underwent coronary bypass including endarterectomy of the entire right coronary artery which was diffusely and severely narrowed by atherosclerotic plaque. Preoperatively, she fulfilled none of the present-day criteria for lipid-lowering drug therapy. The report demonstrates the deficiency of present-day lipid-lowering drug guidelines and emphasizes the need to switch emphasis from decreasing risk of an atherosclerotic event to the prevention of arterial plaques, a goal which will require a much lower threshold of low-density lipoprotein cholesterol to initiate drug therapy.

Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial.

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long-term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre-specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.

Mitral stenosis produced by infective endocarditis involving a previously anatomically normal valve.

Described herein is a 63-year-old man who developed methicillin-sensitive Staphylococcus aureus endocarditis on a previously anatomically normal mitral valve. The resulting vegetations were so large that severe mitral stenosis resulted. The development of valve stenosis due exclusively to infective endocarditis is extremely rare.

First and recurrent events after percutaneous coronary intervention: implications for survival analyses.

Objectives. Using composite endpoints and/or only first events in clinical research result in information loss and alternative statistical methods which incorporate recurrent event data exist. We compared information-loss under traditional analyses to alternative models. Design. We conducted a retrospective analysis of patients who underwent percutaneous coronary intervention (Jan2010-Dec2014) and constructed Cox models for a composite endpoint (readmission/death), a shared frailty model for recurrent events, and a joint frailty (JF) model to simultaneously account for recurrent and terminal events and evaluated the impact of heart failure (HF) on the outcome. Results. Among 4901 patients, 2047(41.8%) experienced a readmission or death within 1 year. Of those with recurrent events, 60% had ≥1 readmission and 6% had >4; a total of 121(2.5%) patients died during follow-up. The presence of HF conferred an adjusted Hazard ratio (HR) of 1.32 (95% CI: 1.18-1.47, p < .001) for the risk of composite endpoint (Cox model), 1.44 (95% CI: 1.36-1.52, p < .001) in the frailty model, and 1.34 (95% CI:1.22-1.46, p < .001) in the JF model. However, HF was not associated with death (HR 0.87, 95% CI: 0.52-1.48, p = .61) in the JF model. Conclusions. Using a composite endpoint and/or only the first event yields substantial loss of information, as many individuals endure >1 event. JF models reduce bias by simultaneously providing event-specific HRs for recurrent and terminal events.

Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial.

Importance: To our knowledge, REPRISE III is the first large randomized comparison of 2 different transcatheter aortic valve replacement platforms: the mechanically expanded Lotus valve (Boston Scientific) and self-expanding CoreValve (Medtronic). Objective: To evaluate outcomes of Lotus vs CoreValve after 2 years. Design, Setting, and Participants: A total of 912 patients with high/extreme risk and severe, symptomatic aortic stenosis enrolled between September 22, 2014, and December 24, 2015, were randomized 2:1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, and Australia. The first 2-year visit occurred on October 17, 2016, and the last was conducted on April 12, 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years. Main Outcomes and Measures: All-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors included overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. Echocardiographic analyses included effective orifice area, mean gradient, and paravalvular leaks (PVLs). Results: Of 912 participants, the mean (SD) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8% (4.0%). At 2 years, all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 0.94; 95% CI, 0.69-1.26; P = .67) and all-cause mortality or disabling stroke was 22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P = .14). Overall stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); disabling stroke was more frequent with CoreValve vs Lotus (4.7% Lotus vs 8.6% CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P = .02). More Lotus patients received a new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P < .01) or had a valve thrombosis (3.0% vs 0.0%; P < .01) compared with CoreValve. More patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P < .01), valve migration (0.0% vs 0.7%; P = .05), or embolization (0.0% vs 2.0%; P < .01) than Lotus. Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve (improved by ≥1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 of 189 [75.7%]; P = .01; improved by ≥2 NYHA classes: 122 of 402 [37.3%] vs 65 of 305 [21.3%]). Conclusions and Relevance: After 2 years, all-cause mortality rates, mortality or disabling stroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm. Trial Registration: clinicaltrials.gov Identifier: NCT02202434.

Impact of Mitral Stenosis on Survival in Patients Undergoing Isolated Transcatheter Aortic Valve Implantation.

This study was performed to investigate the prevalence and impact on survival of baseline mitral stenosis (MS) in patients who underwent transcatheter aortic valve implantation (TAVI) due to the presence of severe symptomatic aortic stenosis. This retrospective study included 928 consecutive patients with severe, symptomatic aortic stenosis who underwent TAVI in 2 institutions, from January 2012 to August 2016. Mean follow-up was 40.8 ± 13.9 months. Based on the mean mitral gradient (MMG) at baseline, 3 groups were identified: MMG <5 mm Hg (n = 737, 81.7%); MMG ≥5 and <10 mm Hg (n = 147, 16.3%); MMG ≥10 mm Hg (n = 17, 1.9%). These latter were more frequently women, with a smaller body surface area, a higher prevalence of atrial fibrillation, chronic obstructive pulmonary disease, and previous history of coronary-artery bypass graft/percutaneous coronary intervention. At baseline, patients with MMG ≥10 mm Hg compared with ≥5 and <10 mm Hg and <5 mm Hg patients had a lower mitral valve area (2.4 ± 0.94 vs 2.1 ± 0.86 vs 1.5 ± 0.44 cm2), a lower prevalence of MR ≥2+ (5.9% vs 28.6% and 15.6%, p <0.0001), a higher prevalence of severe mitral annular calcium (70.6% vs 45.6% and 13.0%, p <0.0001) and a higher systolic pulmonary arterial pressure (50.6 ± 12.1 vs 47.2 ± 14.5 and 41.6 ± 14.4, p <0.0001). Despite the low prevalence of MMG ≥10 mm Hg, these patients had higher 5-year mortality compared with the other groups (adjusted hazard ratio 2.91, 95% confidence interval 1.17 to 7.20, p = 0.02). In conclusion, severe calcific MS is uncommon in patients who underwent TAVI. Its presence is associated with higher long-term mortality whereas moderate MS is not.

Event dependence in the analysis of cardiovascular readmissions postpercutaneous coronary intervention.

Recurrent hospitalizations are common in longitudinal studies; however, many forms of cumulative event analyses assume recurrent events are independent. We explore the presence of event dependence when readmissions are spaced apart by at least 30 and 60 days. We set up a comparative framework with the assumption that patients with emergency percutaneous coronary intervention (PCI) will be at higher risk for recurrent cardiovascular readmissions than those with elective procedures. A retrospective study of patients who underwent PCI (January 2008-December 2012) with their follow-up information obtained from a regional database for hospitalization was conducted. Conditional gap time (CG), frailty gamma (FG) and conditional frailty models (CFM) were constructed to evaluate the dependence of events. Relative bias (%RB) in point estimates using CFM as the reference was calculated for comparison of the models. Among 4380 patients, emergent cases were at higher risk as compared with elective cases for recurrent events in different statistical models and time-spaced data sets, but the magnitude of HRs varied across the models (adjusted HR [95% CI]: all readmissions [unstructured data]-CG 1.16 [1.09 to 1.22], FG 1.45 [1.33 to 1.57], CFM 1.24 [1.16 to 1.32]; 30-day spaced-CG1.14 [1.08 to 1.21], FG 1.28 [1.17 to 1.39], CFM 1.17 [1.10 to 1.26]; and 60-day spaced-CG 1.14 [1.07 to 1.22], FG 1.23 [1.13 to 1.34] CFM 1.18 [1.09 to 1.26]). For all of the time-spaced readmissions, we found that the values of %RB were closer to the conditional models, suggesting that event dependence dominated the data despite attempts to create independence by increasing the space in time between admissions. Our analysis showed that independent of the intercurrent event duration, prior events have an influence on future events. Hence, event dependence should be accounted for when analyzing recurrent events and challenges contemporary methods for such analysis.

Frequency of abnormal fractional flow reserve measurements among major coronary arteries.

BACKGROUND: Fractional flow reserve(FFR) is a validated tool for evaluating functional severity and guiding the revascularization of angiographically moderate coronary artery lesions. OBJECTIVE: To study if there is a higher frequency of positive FFR measurements in the left anterior descending(LAD) versus other major coronary arteries and also evaluate the differences in the total length of the stent placed. METHODS: A retrospective cohort study including all subjects (January 2011 to December 2015) who had fractional flow reserve (FFR) measured during coronary catheterization was conducted. Coronary catheterizations with FFR at a single tertiary care center were reviewed and FFR ≤ 0.80 post adenosine was deemed positive. The differences in the baseline characteristics and the degree of stenosis were compared between the different vessel groups. RESULTS: Of the 758 vessels included in the analysis, the majority were LAD(51.3%) followed by right coronary artery(RCA)(22.8%), Circumflex(22.2%), Left main(2.2%), and Ramus intermedius(1.5%). 25.1% of 758 vessels were FFR positive. The proportion of positive FFR were higher among LAD versus other vessels(33.2%vs.16.5%,p < 0.001), while no differences were noted between RCA and circumflex(p = 0.87) or other vessels excluding LAD(p = 0.69). Of 175 patients who received stents, no statistical difference was noted in the median[range] total length of the stent between LAD(22[9-64]) and the other coronary arteries (18[8-42])(p = 0.19). In patients with an FFR <0.75, we found that the stent length(median [range]) was significantly longer in LAD(28[9-42]) than the other coronary arteries(18[8-42])(p = 0.03). CONCLUSION: In our study, FFR was almost twice as likely to be positive in the LAD when compared to other major coronary arteries. Furthermore, there was a trend towards FFR positive LAD lesions needing longer stents than other coronary arteries. This data should encourage operators to evaluate moderate, long lesions in the LAD with FFR, as they have a higher probability of functional significance.