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1.
Article in English | MEDLINE | ID: mdl-38769727

ABSTRACT

BACKGROUND: The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time. AIMS: This study aimed to examine whether these changes impacted clinical outcomes. METHODS: EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+ SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared. RESULTS: Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43). CONCLUSION: During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV.

2.
Article in English | MEDLINE | ID: mdl-38797580

ABSTRACT

BACKGROUND: Outflow graft obstruction (OGO) is an uncommon yet life-threatening complication in patients with left ventricular assist devices (LVADs). In this retrospective, single-center case series, we identify the baseline demographics and presenting features of patients who develop LVAD OGO and the procedural details and outcomes surrounding percutaneous endovascular intervention (PEI). METHODS: We conducted a retrospective review of patients with LVADs at our institution between January 2010 and February 2023 who developed OGO and were treated with PEI. Details of the PEI including procedure time, fluoroscopy time, contrast use, stent size, number of stents, change in gradient, and change in flow after intervention were collected. RESULTS: A total of 12 patients who had 14 cases of OGO were identified from January 2010 to February 2023. The average age at presentation was 64.78 years. Nine of the 14 cases occurred in male patients. Eleven of the 14 cases occurred with Heartware devices (2 recurrences), 2 in Heartmate 2 and 1 in Heartmate 3. Notable procedural details include a mean procedure time of 90.86 min and mean contrast use of 162.5 mL. The initial gradient across the OGO was reduced by an average of 72 %, to a mean post-PEI of 11.57 mmHg. The average number of stents to achieve this gradient was around 2.08, with the most common stent diameter being 10 mm. Thirty-day mortality after PEI was 7 % (1/14) in this high-risk patient population. CONCLUSION: In our single-center experience, PEI can be a safe and effective treatment for LVAD OGO.

3.
Article in English | MEDLINE | ID: mdl-38719633

ABSTRACT

BACKGROUND: High-sensitivity troponin (hsTnI) is correlated with cardiac mortality; however, studies on the relationship of markedly elevated hsTnI with in-hospital mortality after cardiac surgery are sparse. Therefore, we aimed to define this relationship in order to help guide in-hospital, acute management of post-surgical patients. METHODS: We retrospectively analyzed all cardiac surgeries completed at our institution between January 2020 and June 2022 in which a peak hsTnI was noted to be >35× upper limit of normal (ULN = 34 ng/L). The primary outcome was in-hospital death. Subgroup analysis was performed to assess differences between coronary artery bypass grafting (CABG) and other cardiac surgeries. RESULTS: A total of 1382 cases met inclusion criteria. The patients' mean age was 64.8 years and 68.2 % were male. Median peak hsTnI after surgery was 4202 ng/L (interquartile ratio: 2427-7654). Univariate analysis of troponin level with mortality found that for every 1000 ng/L increase in hsTnI, odds of in-hospital death increased by 3.8 % (odds ratio [OR]: 1.038; 95 % confidence interval [CI] 1.027-1.050; p < 0.0001). In a multivariate model, troponin (OR 1.02; 95 % CI 1.01-1.04; p = 0.004) maintained a significant association with in-hospital death. CABG was associated with a lower risk of in-hospital death for any given hsTnI level up to 60,000 ng/L compared to other cardiac surgeries. CONCLUSION: Increasing hsTnI level is associated with increasing probability of in-hospital mortality and, therefore, serves as an additional, objective measure of risk to help guide in-hospital clinical management.

4.
J Am Heart Assoc ; 13(11): e032291, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38818933

ABSTRACT

BACKGROUND: Hemoglobin (Hgb) drop without bleeding is common among patients undergoing transcatheter aortic valve replacement; however, the clinical implications of significant Hgb drop have not been fully evaluated. METHODS AND RESULTS: Consecutive patients undergoing transcatheter aortic valve replacement at our institution from 2011 to 2021 were retrospectively reviewed. Three groups were assessed: no Hgb drop and no bleed (NoD-NoB [reference group]), Hgb drop with bleed, and Hgb drop and no bleed (D-NoB). Hgb drop was defined as ≥3 g/dL decrease from pre- to post-transcatheter aortic valve replacement. Outcomes of interest were in-hospital death and 1-year all-cause mortality. A total of 1851 cases with complete Hgb data were included: NoD-NoB: n=1579 (85.3%); D-NoB: n=49 (2.6%); Hgb drop with bleed: n=223 (12.6%). Compared with NoD-NoB, the D-NoB group was older (81.1 versus 78.9 years of age) with higher preprocedure Hgb (12.9 versus 11.7 g/dL). In-hospital death rate was higher among patients with D-NoB versus NoD-NoB (4.5% versus 0.8%, P<0.001) and similar to Hgb drop with bleed (4.5% versus 4.1%, P=0.999). Predictors of in-hospital death were D-NoB (odds ratio [OR], 3.45 [95% CI, 1.32-8.69]) and transfusion (OR, 10.6 [95% CI, 4.25-28.2]). Landmark survival analysis found that D-NoB experienced 1-year mortality rate comparable to NoD-NoB, whereas Hgb drop with bleed had higher midterm mortality (hazard ratio [HR], 3.2 [95% CI, 1.83-5.73]), and transfusion continued to impact mortality (HR, 2.5 [95% CI, 1.79-3.63]). CONCLUSIONS: Hgb drop without bleeding is common among patients undergoing transcatheter aortic valve replacement and may represent a higher risk of periprocedural death. Blood transfusion increases short- and midterm mortality risk in patients with and without bleeding, supporting a restrictive transfusion strategy.


Subject(s)
Aortic Valve Stenosis , Hemoglobins , Hospital Mortality , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Male , Female , Aged, 80 and over , Aged , Retrospective Studies , Hemoglobins/metabolism , Hemoglobins/analysis , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Risk Factors , Treatment Outcome , Risk Assessment/methods
5.
Article in English | MEDLINE | ID: mdl-38631936

ABSTRACT

BACKGROUND: Coronary microvascular dysfunction (CMD) is a prevalent condition among patients with cardiovascular risk factors, leading to a reduced quality of life and an increased risk of major adverse cardiovascular events. Novel invasive techniques have emerged to more accurately diagnose CMD. However, CMD's natural history remains poorly understood due to limited data. To address this knowledge gap, the Coronary Microvascular Disease Registry (CMDR) was established with the primary aim of standardizing comprehensive coronary functional testing and understanding of CMD. DESIGN: CMDR is a prospective, multicenter registry enrolling an unlimited number of consecutive subjects who undergo comprehensive invasive hemodynamic assessment of the entire coronary arterial vasculature. Patients undergoing acetylcholine provocation test for coronary vasospasm will also be included. Follow-up assessments will be conducted at 30 days and annually for up to 5 years. The primary endpoint is Canadian Cardiovascular Society angina grade over time. Secondary endpoints, including all-cause mortality, cardiovascular death, acute myocardial infarction, stroke, hospitalizations, medication changes, and subsequent coronary interventions, will be analyzed to establish long-term safety and clinical outcomes in patients undergoing invasive CMD assessment. SUMMARY: CMDR aims to characterize the clinical and physiologic profile of patients undergoing comprehensive invasive coronary functional testing, simultaneously providing crucial longitudinal information on the natural history and outcomes of these patients. This will shed light on CMD's course and clinical implications, which, in turn, holds the potential to significantly improve diagnostic and treatment strategies for CMD patients, ultimately leading to the enhancement of their overall prognosis and quality of life. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, NCT05960474.

6.
Catheter Cardiovasc Interv ; 103(6): 917-923, 2024 May.
Article in English | MEDLINE | ID: mdl-38605682

ABSTRACT

The advent of excimer laser coronary atherectomy (ELCA) nearly four decades ago heralded a novel way to treat complex lesions, both coronary and peripheral, which were previously untraversable and thus untreatable. These complex lesions include heavily calcified lesions, ostial lesions, bifurcation lesions, chronic total occlusions, in-stent restenosis (including stent underexpansion), and degenerative saphenous vein grafts. We discuss the technology of ELCA, its indications, applications, and complications, and suggest the "MAXCon ELCA" technique for better outcomes without increased risk. Lastly, we present a case of MAXCon ELCA effectively treating a complex lesion.


Subject(s)
Atherectomy, Coronary , Coronary Angiography , Coronary Artery Disease , Lasers, Excimer , Humans , Contrast Media , Coronary Artery Disease/therapy , Coronary Artery Disease/diagnostic imaging , Lasers, Excimer/therapeutic use , Saline Solution/administration & dosage , Treatment Outcome
8.
Cardiovasc Revasc Med ; 58: 45-49, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37393190

ABSTRACT

PURPOSE: Explore gender disparities in patients undergoing transseptal puncture (TSP) for selected transcatheter cardiac intervention procedures. METHODS: Patients who underwent TSP from January 2015 through September 2021 were reviewed. Primary outcomes were procedural and in-hospital major adverse events. Secondary endpoints were procedural success and hospitalization length of stay (LOS) >1 day. Unadjusted and multivariable-adjusted logistic regression analyses were performed to assess gender differences for in-hospital adverse events. RESULTS: The study cohort comprised 510 patients (mean [SD] age, 74 [14.0] years); 246 women (48 %) underwent TSP for left atrial appendage occlusion (LAAO) or transcatheter edge-to-edge-repair (TEER). Compared with men, women were younger, had higher CHA2DS2-VASc scores, and were more likely to have had a prior ischemic stroke, but were less likely to have paroxysmal atrial fibrillation. After multivariable adjustment, there were no differences between genders in aborted or canceled procedures (odds ratio [OR]: 0.43; 95 % confidence interval [CI]: 0.10-1.96; p = 0.277), any adverse events (OR: 1.00; 95 % CI: 0.58-1.70; p = 0.98), major adverse events (OR: 1.60; 95 % CI: 0.90-2.80; p = 0.11), or death (OR: 1.00; 95 % CI: 0.20-5.00; p = 0.31). Subgroup analysis for LAAO procedures showed that at 30 days, women had higher rates of adverse events, major adverse cardiac events, and LOS >1 day. CONCLUSIONS: Men and women showed no differences in procedural success and in-hospital adverse outcomes in unadjusted analysis and after multivariable adjustment, despite women having a higher risk profile among patients undergoing TSP. However, compared with men, women undergoing LAAO experienced a higher rate of in-hospital adverse events irrespective of TSP.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Ischemic Stroke , Stroke , Humans , Male , Female , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/complications , Cardiac Catheterization/adverse effects , Cardiac Catheterization/methods , Ischemic Stroke/etiology , Time Factors , Treatment Outcome , Stroke/etiology
9.
Cardiovasc Revasc Med ; 59: 76-80, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37689575

ABSTRACT

BACKGROUND: Computed tomography with fractional flow reserve (CT-FFR) is increasingly common in assessing coronary artery disease. CASE PRESENTATION: We report five cases of discrepancies that led to changes in treatment. CONCLUSIONS: This report highlights discordant findings between modalities, which should be considered during the diagnostic assessment of chest pain.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Humans , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/therapy , Coronary Angiography/methods , Sensitivity and Specificity , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Tomography, X-Ray Computed/methods , Computed Tomography Angiography/methods , Predictive Value of Tests , Retrospective Studies
10.
Cardiovasc Revasc Med ; 59: 9-13, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37550124

ABSTRACT

BACKGROUND/PURPOSE: The cusp overlap technique has standardized implantation for self-expanding valves with the goal of achieving more consistent implantation depths and lowering permanent pacemaker (PPM) implantation rates. We retrospectively compared short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve implanted using the cusp overlap technique vs. the traditional coplanar technique in a large tertiary referral center. METHODS: We conducted a retrospective study among PPM-naïve patients who underwent TAVR using the CoreValve Evolut PRO/PRO+. We compared in-hospital PPM rates in patients who underwent TAVR using the cusp overlap technique vs. the coplanar technique. Additional outcomes included in-hospital all-cause mortality, stroke, major vascular complications, annular rupture, and >mild paravalvular leak. Furthermore, we compared outcomes over time to see whether there was evidence of a learning curve. RESULTS: Of the 528 patients included, 270 underwent TAVR using the coplanar technique and 258 underwent TAVR using the cusp overlap technique. The rate of new PPM implantation did not differ between cohorts (17.0 % vs. 16.7 %; p = 0.910). Additionally, rates of in-hospital all-cause mortality (0.0 % vs. 0.4 %; p = 0.328), stroke (3.7 % vs. 1.6 %; p = 0.124), major vascular complications (0.7 % vs. 1.2 %; p = 0.617), annular rupture (0.4 % vs. 0.0 %; p = 0.328) and >mild paravalvular leak (0.0 % vs. 0.4 %; p = 0.444) were similar. Our secondary analysis did not identify any evidence of a learning curve. CONCLUSIONS: The cusp overlap technique may not yield a reduction in PPM rates when compared with the coplanar technique. Other confounders should be explored to further minimize in-hospital PPM rates.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Pacemaker, Artificial , Stroke , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Retrospective Studies , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Treatment Outcome , Risk Factors , Prosthesis Design
11.
Int J Cardiol ; 395: 131431, 2024 Jan 15.
Article in English | MEDLINE | ID: mdl-37832606

ABSTRACT

BACKGROUND: Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. METHODS: The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. RESULTS: A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). CONCLUSION: In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. CLINICAL TRIAL REGISTRY: LRT 1.0: NCT02628899 LRT 2.0: NCT03557242.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Stroke , Thrombosis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology , Stroke/etiology , Thrombosis/etiology , Treatment Outcome , Prosthesis Design , Risk Factors
14.
JACC Cardiovasc Interv ; 16(18): 2211-2227, 2023 09 25.
Article in English | MEDLINE | ID: mdl-37758379

ABSTRACT

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC). OBJECTIVES: The aim of this study was to evaluate 5-year outcomes among these patients. METHODS: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. RESULTS: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. CONCLUSIONS: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.


Subject(s)
Calcinosis , Cardiomyopathies , Heart Valve Diseases , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Vascular Diseases , Humans , Aged , Aged, 80 and over , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Prospective Studies , Quality of Life , Treatment Outcome , Cardiac Catheterization/methods , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/etiology , Calcinosis/surgery , Vascular Diseases/etiology
15.
Am J Cardiol ; 206: 108-115, 2023 11 01.
Article in English | MEDLINE | ID: mdl-37690148

ABSTRACT

Subclinical leaflet thrombosis occurs with transcatheter heart valves (THVs) and could be associated with structural valve deterioration. The current guidelines recommend the use of antiplatelet agents after transcatheter aortic valve replacement (TAVR) but not the routine use of oral anticoagulation. Our study examines the effects of short-term warfarin therapy on THV hemodynamics at 24 months after TAVR in low-risk patients. Low-risk patients who underwent TAVR were randomly allocated 1:1 to receive low-dose aspirin (n = 50) or low-dose aspirin plus warfarin (n = 44). After 30 days of treatment, ongoing medication regimens, including anticoagulation, were at the physicians' discretion. Follow-up after a period of 24 months was available for clinical and echocardiographic outcomes. At the 24-month mark, follow-up echocardiography of the randomly allocated patients revealed just 1 additional case of new structural valve deterioration in the aspirin group (compared with the occurrence within 30 days), based on the Valve Academic Research Consortium 3 definitions. There were also no differences in mean pressure gradients (11.5 ± 0.5 mm Hg vs 11.05 ± 4.0 mm Hg, p = 0.6) or peak velocity (2.2 ± 0.5 m/s vs 2.1 ± 0.4 m/s, p = 0.7) between the groups. A composite end point (mortality, stroke, and myocardial infarction) did not show any difference between the groups at long-term follow-up (p = 0.07). In conclusion, in low-risk patients who underwent TAVR, short-term anticoagulation with warfarin did not impact clinical outcomes or THV hemodynamics by echocardiography at 24 months.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Warfarin/therapeutic use , Aspirin/therapeutic use , Aortic Valve/surgery , Follow-Up Studies , Anticoagulants/therapeutic use , Aortic Valve Stenosis/etiology , Heart Valve Prosthesis/adverse effects , Treatment Outcome
16.
JACC Case Rep ; 18: 101915, 2023 Jul 19.
Article in English | MEDLINE | ID: mdl-37545687

ABSTRACT

We present a case of post-myocardial infarction free-wall rupture in a critically ill patient presenting to the emergency department. Through our case we highlight the prompt evaluation, diagnosis, and management necessary to improve survival in a patient with this life-threatening condition. (Level of Difficulty: Beginner.).

17.
Cardiovasc Revasc Med ; 56: 1-6, 2023 11.
Article in English | MEDLINE | ID: mdl-37453813

ABSTRACT

BACKGROUND: The Evolut FX system is the most recent generation of self-expandable transcatheter heart valve (THV) technology. This study aims to report the early experience and outcomes associated with this system. METHODS: Our analysis included 200 consecutive patients who underwent transcatheter aortic valve replacement at our center from 2022 to 2023. The first cohort comprised the last 100 patients who received the Evolut PRO+ THV, while the second cohort included the first 100 patients who received the Evolut FX THV. The primary endpoints of the study were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, which included technical success (at exit from procedure), device success (at discharge or at 30 days), and early safety (at 30 days). RESULTS: The study groups demonstrated no significant differences in baseline characteristics, including co-morbidities, pre-procedural imaging, and echocardiography. VARC-3 technical success rate was 99 % for both valves. The VARC-3 device success rate for the Evolut FX was 92 % compared to 97 % for the Evolut PRO+ (p = 0.12), and VARC-3 early safety rate was 80.1 % for the Evolut PRO+ vs. 81.5 % for the Evolut FX (p = 0.82). The in-hospital permanent pacemaker implantation rate for the Evolut FX was 12 % compared to 9 % for the Evolut PRO+ (p = 0.21). There were no differences in clinical outcomes, such as mortality or stroke, between the two groups. CONCLUSIONS: The Evolut FX THV performed well when used for patients with severe aortic stenosis, demonstrating high success with low complication rates when compared to an earlier generation of self-expanding THV.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Prosthesis Design , Treatment Outcome , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Risk Factors
18.
Int J Cardiol ; 389: 131196, 2023 10 15.
Article in English | MEDLINE | ID: mdl-37479148

ABSTRACT

BACKGROUND: The self-expanding CoreValve Evolut PRO/PRO+ transcatheter aortic valve was designed to overcome the limitations of its forerunner, Evolut R. Evolut PRO/PRO+ offers the lowest delivery profile for 23-29 mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R. METHODS: We analyzed 300 patients enrolled in the EPROMPT Registry against a historical control cohort of 242 patients who received Evolut R. The two arms were matched (1:1) via propensity-score methodology by accounting for differences in Society of Thoracic Surgeons Predicted Risk of Mortality scores, yielding 440 patients. The endpoints included in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30 days and 1 year. RESULTS: After propensity-score matching, cardiac death (0.5% vs. 0.5%, p = 0.995), stroke (1.6% vs. 2.8%, p = 0.410), life-threatening bleeding (1.1% vs. 3.3%, p = 0.139), major vascular complications (0.5% vs. 0.9%, p = 0.653), and pacemaker implantation (16.9% vs. 13.6%, p = 0.345) were comparable between the Evolut PRO/PRO+ and Evolut R groups. Likewise, the rates of all-cause mortality were similar both at 30 days (0.5% vs. 1.4%, p = 0.315) and 1 year (1.8% vs. 4.1%, p = 0.159). The rates of moderate paravalvular leak (5.7% vs. 2.6%, p = 0.402), and mean gradient (7.27 ± 3.25 mmHg vs. 8.84 ± 4.36 mmHg, p = 0.105) were also comparable between groups at 1 year. CONCLUSION: Our largest-to-date observational study suggests that the Evolut PRO/PRO+ system is safe and effective in treating severe aortic stenosis, with commensurate 30-day and 1-year mortality and similar 1-year echocardiographic hemodynamic outcomes in comparison to Evolut R.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Prosthesis Design , Treatment Outcome , Postoperative Complications/etiology , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Risk Factors
19.
Circ Cardiovasc Interv ; 16(5): e012655, 2023 05.
Article in English | MEDLINE | ID: mdl-37192308

ABSTRACT

BACKGROUND: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years. METHODS: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years. RESULTS: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56±5.54 mm Hg and aortic valve area 1.69±0.52 cm2) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94±5.01 mm Hg versus 12.3±5.57 mm Hg; P=0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years. CONCLUSIONS: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02628899.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Stroke , Thrombosis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Prospective Studies , Risk Factors , Heart Valve Prosthesis/adverse effects , Treatment Outcome , Hemodynamics , Stroke/etiology , Stroke/surgery , Thrombosis/etiology
20.
J Am Coll Cardiol ; 81(21): 2115-2127, 2023 05 30.
Article in English | MEDLINE | ID: mdl-37225366

ABSTRACT

Mechanical prosthetic heart valves, though more durable than bioprostheses, are more thrombogenic and require lifelong anticoagulation. Mechanical valve dysfunction can be caused by 4 main phenomena: 1) thrombosis; 2) fibrotic pannus ingrowth; 3) degeneration; and 4) endocarditis. Mechanical valve thrombosis (MVT) is a known complication with clinical presentation ranging from incidental imaging finding to cardiogenic shock. Thus, a high index of suspicion and expedited evaluation are essential. Multimodality imaging, including echocardiography, cine-fluoroscopy, and computed tomography, is commonly used to diagnose MVT and follow treatment response. Although surgery is oftentimes required for obstructive MVT, other guideline-recommended therapies include parenteral anticoagulation and thrombolysis. Transcatheter manipulation of stuck mechanical valve leaflet is another treatment option for those with contraindications to thrombolytic therapy or prohibitive surgical risk or as a bridge to surgery. The optimal strategy depends on degree of valve obstruction and the patient's comorbidities and hemodynamic status on presentation.


Subject(s)
Bioprosthesis , Heart Valve Prosthesis , Thrombosis , Humans , Thrombosis/diagnosis , Thrombosis/etiology , Thrombosis/therapy , Heart Valve Prosthesis/adverse effects , Anticoagulants/therapeutic use , Heart Valves
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