BackgroundLong-term clinical data on biodegradable-polymer (BP) drug-eluting stents (DES) are limited. The objective of this study was to assess the long-term safety and efficacy of the BP-DES SYNERGY compared to XIENCE V, a durable-polymer (DP)-DES.MethodsWe compared patients treated with BP-DES or DP-DES at our center from 2008 to 2020. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, Q-wave myocardial infarction (MI), and target vessel revascularization (TVR). Secondary endpoints were all-cause death, Q-wave MI, target lesion revascularization (TLR), and stent thrombosis (ST).ResultsA total of 4255 patients underwent propensity-score matching, and 380 patients from each cohort were matched. There was no significant difference between BP-DES and DP-DES concerning MACE (5-year estimates: 21.6% vs. 26.6%, log-rank p = 0.259). Furthermore, there was no difference in the TLR rate (5-year estimates: 7.3% vs. 8.6%, log-rank p = 0.781). All-cause death (5-year estimates: 13.6% vs. 12.9%, log-rank p = 0.72) and Q-wave MI (5-year estimates: 0.53% vs. 1.7%, log-rank p = 0.427) were also comparable between the two groups. Of note, the rate of very late ST was very low and similar between the groups (5-year estimates: 0.26% vs. 0.64%, log-rank p = 0.698).ConclusionBP-DES and DP-DES demonstrate similar safety and efficacy at 5-year follow-up. Both can be used for the effective treatment of coronary artery disease.
The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses.Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed.Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p < 0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p < 0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium.Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification.
Objectives Evaluate transcatheter heart valve (THV) geometry according to left ventricular outflow tract (LVOT) calcium degree and its impact on hemodynamics and outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a contemporary self-expanding THV. Background LVOT calcium remains challenging for contemporary THVs. LVOT calcium location and degree may affect THV deployment and impact flow patterns and shear stress, accelerating THV degeneration. Methods EPROMPT (CoreValve Evolut Pro Prospective Registry; NCT03423459) is a prospective, investigator-initiated, multicenter registry of patients undergoing TAVR using CoreValve Evolut PRO/PRO + THVs. A total of 107 patients were enrolled in EPROMPT's computed tomography (CT) cohort between January 2018 and October 2021. These patients underwent follow-up CT scan 30 days post-TAVR. We analyzed THV geometry and its interaction with the aortic root following deployment using 30-day post-TAVR CT in patients with none/mild versus moderate/severe LVOT calcium. Results Thirty-day THV inflows were less eccentric in the short axis in patients with none/mild versus moderate/severe LVOT calcium (1.16 +/- 0.09 vs. 1.21 +/- 0.12; p = 0.007). THV became more circular and was similar between both cohorts at the THV waist (1.08 +/- 0.06 vs. 1.09 +/- 0.11; p = 0.551), leaflet tips (1.03 +/- 0.04 vs. 1.05 +/- 0.09; p = 0.299), and THV outflow (1.04 +/- 2.2 vs. 1.03 +/- 2.7; p = 0.143). Thirty-day > mild paravalvular leak was low in both cohorts (1.5% vs. 2.4%; p = 0.724); mean gradients were similar (7.7 +/- 3.6 vs. 7.7 +/- 3.4 mmHg; p = 0.955). Conclusions Despite inflow deformities observed in patients with moderate/severe LVOT calcium, Evolut PRO/PRO + conforms to elliptical aortic annuli, maintaining circularity and proper function at the leaflets and outflow, even in patients with moderate/severe LVOT calcium.
Objectives We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. Background PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. Methods We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. Results We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (<= 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. Conclusions PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.
Left ventricular outflow tract (LVOT) calcium remains a challenge for transcatheter aortic valve implantation (TAVI) and is associated with an increased risk of debris embolization, permanent pacemaker requirement, and annular rupture. We report the results of the (EPROMPT) CoreValve Evolut PRO Prospective Registry, which sought to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter heart valve (THV) according to computed tomography-defined extent of LVOT calcium. The prospective, investigator-initiated, multicenter registry includes patients who underwent TAVI using the CoreValve Evolut PRO/PRO+ THV system. Analyzed patients were dichotomized on the basis of the severity of their LVOT calcium at baseline (none/mild vs moderate/severe). Patients were followed with 30-day clinical assessment and echocardiography. Of the 277 patients included, 177 had computed tomography-defined none/mild LVOT calcium (63.9%), and 100 had moderate/severe LVOT calcium (36.1%). Device success was similar in both cohorts (97.7% vs 95.0%; p = 0.217). Stroke rates were numerically higher in the moderate/severe LVOT calcium cohort (in-hospital and 30 day: 1.7% vs 4.0%; p = 0.240). Patients with none/mild LVOT calcium had higher rates of permanent pacemaker implantation (in-hospital: 21.5% vs 9.0%; p = 0.008 and 30-day: 22.0% vs 12.0%; p = 0.027). At 30 days, there were numerically higher rates of >mild paravalvular leak in patients with moderate/severe LVOT calcium (1.7% vs 4.0%; p = 0.240). Thirty-day mean gradients were similar (7.5 vs 7.6 mm Hg; p = 0.782). In conclusion, patients in the EPROMPT registry receiving the contemporary self-expanding CoreValve Evolut PRO/PRO+ THV demonstrated similar short-term outcomes and hemodynamics across the entire spectrum of LVOT calcium. (C) 2021 Published by Elsevier Inc.
BACKGROUND:Given enough time, transcatheter heart valves (THVs) will degenerate and may require reintervention. Redo transcatheter aortic valve implantation (TAVI) is an attractive strategy but carries a risk of coronary obstruction. AIMS:We sought to predict how many TAVIs patients could undergo in their lifetime using computed tomography (CT) simulation. METHODS:We analysed paired CT scans (baseline and 30 days post-TAVI) from patients in the LRT trial and EPROMPT registry. We implanted virtual THVs on baseline CTs, comparing predicted valve-to-coronary (VTC) distances to 30-day CT VTC distances to evaluate the accuracy of CT simulation. We then simulated implantation of a second virtual THV within the first to estimate the risk of coronary obstruction due to sinus sequestration and the need for leaflet modification. RESULTS:We included 213 patients with evaluable paired CTs. There was good agreement between virtual (baseline) and actual (30 days) CT measurements. CT simulation of TAVI followed by redo TAVI predicted low coronary obstruction risk in 25.4% of patients and high risk, likely necessitating leaflet modification, in 27.7%, regardless of THV type. The remaining 46.9% could undergo redo TAVI so long as the first THV was balloon-expandable but would likely require leaflet modification if the first THV was self-expanding. CONCLUSIONS:Using cardiac CT simulation, it is possible to predict whether a patient can undergo multiple TAVI procedures in their lifetime. Those who cannot may prefer to undergo surgery first. CT simulation could provide a personalised lifetime management strategy for younger patients with symptomatic severe aortic stenosis and inform decision-making. CLINICALTRIALS:gov: NCT02628899; ClinicalTrials.gov: NCT03557242; ClinicalTrials.gov: NCT03423459.
Improving screening of candidates for participation in sports requires accurate methods of identifying high-risk cardiovascular conditions (hr-CVCs) that predispose young people to sudden cardiac death (SCD). Most sports-related SCDs are potentially preventable if recognized before an adverse
Improving preparticipation screening of candidates for sports necessitates establishing the prevalence of high-risk cardiovascular conditions (hr-CVC) that predispose young people to sudden cardiac death (SCD). Our accurate, novel protocol chiefly involved the use of cardiac magnetic resonance (CMR) to estimate this prevalence. Middle and high school students from a general United States population were screened by means of questionnaires, resting electrocardiograms, and CMR to determine the prevalence of 3 types of hr-CVC: electrocardiographic abnormalities, cardiomyopathies, and anomalous coronary artery origin from the opposite sinus with intramural coronary course (ACAOS-IM). We examined the range of normal left ventricular size and function in the main study cohort (schoolchildren 11-14 yr old). We defined diagnostic criteria for hr-CVC and compared the cardiac measurements of these younger participants with those of older children whom we examined (age, 15-18 yr). From 5,169 completed diagnostic studies (mean participant age, 13.06 ± 1.78 yr), CMR results revealed 76 previously undiagnosed cases of hr-CVC (1.47% of the total cohort): 11 of dilated cardiomyopathy (14.5%), 3 of nonobstructive hypertrophic cardiomyopathy (3.9%), 23 ACAOS-IM cases (30.3%; 6 left-ACAOS and 17 right-ACAOS), 4 Wolff-Parkinson-White patterns (5.3%), 34 prolonged QT intervals (44.7%), and 1 Brugada pattern (1.3%). Cardiomyopathies were significantly more prevalent in the older children. Of note, we identified 959 cases (18.5%) of left ventricular noncompaction. If our estimate is accurate, only 1.47% of school-age sports participants will need focused secondary evaluations; the rest can probably be reassured about their cardiac health after one 30-minute screening study.
At the Center for Coronary Artery Anomalies, during the period Nov 2011 to Aug 2014, we completed our MRI-based screening survey protocol in a general population of young children, and we report the following prevalence data of the main high-risk cardiovascular conditions (hr-CVC) for sports -
Left ventricular assist device (LVAD) therapy improves survival, hemodynamic status, and end-organ perfusion in patients with refractory advanced heart failure. Hospital readmission is an important measure of the intensity of LVAD support care. We analyzed readmissions of 148 patients (mean age, 53.6 ± 12.7 yr; 83% male) who received a HeartMate II LVAD from April 2008 through June 2012. The patients had severe heart failure; 60.1% were in Interagency Registry for Mechanically Assisted Circulatory Support class 1 or 2. All patients were observed for at least 12 months, and readmissions were classified as planned or unplanned. Descriptive and multivariate regression analyses were used to identify predictors of unplanned readmission. Twenty-seven patients (18.2%) had no readmissions or 69 planned readmissions, and 121 patients (81.8%) had 460 unplanned readmissions. The LVAD-related readmissions were for bleeding, thrombosis, and anticoagulation (n=103; 49.1%), pump-related infections (n=60; 28.6%), and neurologic events (n=28; 13.3%). The readmission rate was 2.1 per patient-year. Unplanned readmissions were for comorbidities and underlying cardiac disease (54.3%) or LVAD-related causes (45.7%). In the unplanned-readmission rate, there was no significant difference between bridge-to-transplantation and destination-therapy patients. Unplanned readmissions were associated with diabetes mellitus (odds ratio [OR]=3.3; P=0.04) and with shorter mileage from residence to hospital (OR=0.998; P=0.046). Unplanned admissions for LVAD-related sequelae and ongoing comorbidities were common. Diabetes mellitus and shorter distance from residence to hospital were significant predictors of readmission. We project that improved management of comorbidities and of anticoagulation therapy will reduce unplanned readmissions of LVAD patients in the future.