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Showing papers by "Michael J. Mack published in 2018"


Journal ArticleDOI
TL;DR: Among patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy, transcatheter mitral‐valve repair resulted in a lower rate of hospitalization forHeart failure and lower all‐cause mortality within 24 months of follow‐up than medical therapy alone.
Abstract: Background Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor Transcatheter mitral-valve repair may improve their clinical outcomes Methods At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group) The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 880% Results Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 t

1,758 citations


Journal ArticleDOI
TL;DR: This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly.
Abstract: Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

307 citations


Journal ArticleDOI
TL;DR: TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement, and these results inform trial design of TMVR in lower-risk patients with severe mitral valves regurgitation.

209 citations


Journal ArticleDOI
TL;DR: Comparison with the benchmark NV-TAVR shows ViV-TAvr to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery.

137 citations


Journal ArticleDOI
23 Jan 2018-JAMA
TL;DR: Older patients with AF undergoing cardiac surgery with and without concomitant S-LAAO was associated with a lower risk of thromboembolism and the use of surgical left atrial appendage occlusion, and these findings provide definitive evidence.
Abstract: Importance The left atrial appendage is a key site of thrombus formation in atrial fibrillation (AF) and can be occluded or removed at the time of cardiac surgery There is limited evidence regarding the effectiveness of surgical left atrial appendage occlusion (S-LAAO) for reducing the risk of thromboembolism Objective To evaluate the association of S-LAAO vs no receipt of S-LAAO with the risk of thromboembolism among older patients undergoing cardiac surgery Design, Setting, and Participants Retrospective cohort study of a nationally representative Medicare-linked cohort from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2012) Patients aged 65 years and older with AF undergoing cardiac surgery (coronary artery bypass grafting [CABG], mitral valve surgery with or without CABG, or aortic valve surgery with or without CABG) with and without concomitant S-LAAO were followed up until December 31, 2014 Exposures S-LAAO vs no S-LAAO Main Outcomes and Measures The primary outcome was readmission for thromboembolism (stroke, transient ischemic attack, or systemic embolism) at up to 3 years of follow-up, as defined by Medicare claims data Secondary end points included hemorrhagic stroke, all-cause mortality, and a composite end point (thromboembolism, hemorrhagic stroke, or all-cause mortality) Results Among 10 524 patients undergoing surgery (median age, 76 years; 39% female; median CHA2DS2-VASc score, 4), 3892 (37%) underwent S-LAAO Overall, at a mean follow-up of 26 years, thromboembolism occurred in 54%, hemorrhagic stroke in 09%, all-cause mortality in 215%, and the composite end point in 257% S-LAAO, compared with no S-LAAO, was associated with lower unadjusted rates of thromboembolism (42% vs 62%), all-cause mortality (173% vs 239%), and the composite end point (205% vs 287%) but no significant difference in rates of hemorrhagic stroke (09% vs 09%) After inverse probability–weighted adjustment, S-LAAO was associated with a significantly lower rate of thromboembolism (subdistribution hazard ratio [HR], 067; 95% CI, 056-081;P Conclusions and Relevance Among older patients with AF undergoing concomitant cardiac surgery, S-LAAO, compared with no S-LAAO, was associated with a lower risk of readmission for thromboembolism over 3 years These findings support the use of S-LAAO, but randomized trials are necessary to provide definitive evidence

125 citations



Journal ArticleDOI
TL;DR: A comprehensive update of the evidence for the differences in the biological effects of off‐ and on‐pump surgery and the comparison of the clinical and angiographic results of the 2 techniques is provided.
Abstract: Off‐pump coronary artery bypass surgery (OPCAB) has been performed for >30 years. The promotion of OPCAB was based on its potential benefits over some of the limitations of traditional on‐pump coronary artery bypass surgery (ONCAB) by avoiding the trauma of cardiopulmonary bypass (CPB) and by minimizing aortic manipulation. As such, reductions in early mortality and perioperative neurological events, renal failure, blood product transfusions, and hospital length of stay were expected according to the OPCAB proponents. In contrast, critics of OPCAB remain concerned about incomplete and/or poorer quality coronary revascularization with a potential increase in the need for repeat revascularization and late mortality. Despite 3 decades of debate, 115 randomized trials, and >60 meta‐analyses comparing on‐ and off‐pump coronary artery bypass grafting (CABG), controversy on both the role of and indications for OPCAB remains vigorous. In this review, we provide a comprehensive update of the evidence for the differences in the biological effects of off‐ and on‐pump surgery and the comparison of the clinical and angiographic results of the 2 techniques. Furthermore, we critically address the relevant technical aspects of OPCAB, the importance of surgeon experience, and the difference in the costs for the 2 procedures.

57 citations


Journal ArticleDOI
TL;DR: Despite similar early-peaking (<1 day post-procedure) neurological risk profiles, SAVR is associated with a higher risk of early major stroke than TF-TAVR, and periprocedural strategies are needed to reduce stroke risk after aortic valve procedures.

48 citations


Journal ArticleDOI
TL;DR: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR, which may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.
Abstract: Objectives The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. Background A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. Methods The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. Results Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p Conclusions The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

44 citations


Journal ArticleDOI
TL;DR: The negative impact of CKD on long-term outcome following PCI appears to be stronger when compared to CABG, especially in the CKD patients with diabetes and extensive coronary disease.
Abstract: Aims: The aim of this study was to investigate short-term and five-year follow-up results from patients randomised to coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with paclitaxel-eluting stents in the SYNTAX trial, focusing on patients with chronic kidney disease (CKD). Methods and results: Baseline glomerular filtration rate estimates (eGFR) were available in 1,638 patients (PCI=852 and CABG=786). The Kidney Disease: Improving Global Outcomes (KDIGO) threshold was used to define staging of CKD. At five years, death was significantly higher in patients with CKD compared to patients with normal kidney function after PCI (26.7% vs. 10.8%, p<0.001) and CABG (21.2% vs. 10.6%, p=0.005). Comparing PCI with CABG, there was a significant interaction according to kidney function for death (pint=0.017) but not the composite endpoint of death/stroke/MI (pint=0.070) or MACCE (pint=0.15). In patients with CKD, the rate of MACCE was significantly higher after PCI compared with CABG (42.1% vs. 31.5%, p=0.019), driven by repeat revascularisation (21.9% vs. 8.9%, p=0.004) and allcause death (26.7% vs. 21.2%, p=0.14). In patients with CKD who also had diabetes, PCI versus CABG was significantly worse in terms of death/stroke/MI (47.9% vs. 24.4%, p=0.005) and all-cause death (40.9% vs. 17.7%, p=0.004). Conclusions: During a five-year follow-up, adverse event rates were comparable between PCI and CABG patients with moderate CKD but significantly higher compared to the patients with impaired or normal kidney function. The negative impact of CKD on long-term outcome following PCI appears to be stronger when compared to CABG, especially in the CKD patients with diabetes and extensive coronary disease. ClinicalTrials.gov Identifier: NCT00114972

44 citations


Journal ArticleDOI
TL;DR: Gait speed is a simple tool to screen for frailty and identify older adults at risk for adverse events in the early and midterm postoperative periods.
Abstract: Background In older adults undergoing cardiac surgery, prediction of downstream risk is critical. Our objective was to determine the association of 5‐m gait speed with 1‐year mortality and repeat h...

Journal ArticleDOI
TL;DR: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates, and longer term follow-up will be needed to determine durability of S3 TAVR in this population.
Abstract: Objectives The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported. Methods From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium–2 outcomes were reported. Results Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. Conclusions TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

Journal ArticleDOI
TL;DR: In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data.
Abstract: Importance Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation. Objective To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement. Design, Setting, and Participants This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals. Main Outcomes and Measures Change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire–Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites. Results The KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points;P Conclusions and Relevance In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.

Journal ArticleDOI
TL;DR: Patients discharged with DAPT had a similar adjusted risk of mortality, stroke, and MI compared to antiplatelet monotherapy, although risk for bleeding was significantly higher and practice patterns varied significantly among hospitals.

Journal ArticleDOI
TL;DR: Hospitals with high SAVR volume are most likely to be fast adopters of TAVR, and patients treated in hospitals with high TavR volume had lower 30-day mortality, the effect of which was more pronounced when hospitals also had high S AVR volume.
Abstract: Importance The Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited. Objective To examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs. Design, Setting, and Participants This observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries. Main Outcomes and Measures The associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined. Results Among the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54;P Conclusions and Relevance Hospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Journal ArticleDOI
TL;DR: The incidence of V HD in US clinical practice is low, and VHD is not associated with increased cardiovascular events at 18 months, and patient and procedural predictors may help to identify patients at risk for VHD in whom surveillance or preventive strategies may be considered.

Journal ArticleDOI
TL;DR: Some of the key developments in CABG over the last 50 years are reviewed with a focus on ongoing quality initiatives that will continue to refine the optimal applications and outcomes of CABGs for the next 50 years.
Abstract: Coronary artery bypass grafting (CABG) remains one of the most commonly performed major surgical procedures worldwide and the most common procedure performed by cardiac surgeons. Rene Favaloro is widely credited with recognizing the true potential of CABG and subsequently popularizing the technique in a broad manner. Since the era of Favaloro in the late 1960s, the evolution of CABG can be understood through a series of quality initiatives that have defined which patients can benefit from the procedure and via which technique(s) they will derive the greatest benefit. Herein, we will review some of the key developments in CABG over the last 50 years with a focus on ongoing quality initiatives that will continue to refine the optimal applications and outcomes of CABG for the next 50 years.

Journal ArticleDOI
TL;DR: One-third of patients with clinical or echocardiographic indications suggestive of leaflet thrombosis were found to have evidence of Leaflet thROMbosis using 4DCT, which allowed tailored anticoagulation therapy with resolution of the thrombus in most patients and avoiding unnecessary antICOagulation in the remaining two-thirds of patients.

Journal ArticleDOI
TL;DR: CD was not associated with an increased risk of stroke or mortality at 30 day or 1 year, and Post-TAVR stroke seems to be because of mechanisms other than CD.
Abstract: Background—Stroke is a serious complication of both transcatheter aortic valve replacement (TAVR) and carotid artery disease (CD). The implications of CD in patients undergoing TAVR are unclear. Me...

Journal ArticleDOI
TL;DR: Using a comprehensive approach, a multidisciplinary process involving clinical personnel, data and quality managers, and research coordinators was able to determine survival status in 100% of patients who underwent TAVI.
Abstract: The Centers for Medicare and Medicaid Services National Coverage Determination requires centers performing transcatheter aortic valve implantation (TAVI) to report clinical outcomes up to 1 year. Many sites encounter challenges in obtaining complete 1-year follow-up. We report our process to address this challenge. A multidisciplinary process involving clinical personnel, data and quality managers, and research coordinators was initiated to collect TAVI data at baseline, 30 days, and 1 year. This process included (1) planned clinical follow-up of all patients at 30 days and 1 year; (2) query of health-care system-wide integrated data warehouse (IDW) to ascertain last date of clinical contact within the system for all patients; (3) online obituary search, cross-referencing for unique patient identifiers to determine if mortality occurred in remaining unknown patients; and (4) phone calls to remaining unknown patients or patients' families. Between January 2012 and December 2016, 744 patients underwent TAVI. All 744 patients were eligible for 30-day follow-up and 546 were eligible for 1-year follow-up. At routine clinical follow-up of 22 of 744 (3%) patients at 30 days and 180 of 546 (33%) patients at 1 year had unknown survival status. The integrated data warehouse query confirmed status-alive for an additional 1 of 22 patients at 30 days (55%) and 91 of 180 patients at 1 year (51%). Obituaries were identified for 23 of 180 additional patients at 1 year (13%). Phone contact identified the remaining unknown patients at 30 days and 1 year, resulting in 100% known survival status for patients at 30 days (744 of 744) and at 1 year (546 of 546). In conclusion, using a comprehensive approach, we were able to determine survival status in 100% of patients who underwent TAVI.

Journal ArticleDOI
TL;DR: There is a clear and unmet need for defining the training requirements of physicians intending to perform SHD interventions to ensure that future proceduralists will possess the appropriate cognitive and technical skill sets required to safely and effectively perform these interventions.
Abstract: Catheter-based therapies for congenital and structural heart diseases (SHDs) have come a long way since the pioneering work of Terry King in 1976 with the first percutaneous atrial septal defect closure, the first mitral balloon valvuloplasty by Kanji Inoue in 1984, and the first percutaneous valve replacements by Philipp Bonhoeffer and Alain Cribier in the early 2000s. More than 100 000 transcatheter aortic valve replacements (TAVRs) have been performed in the United States, and the yearly number of TAVR implants now exceeds that of isolated surgical aortic valve replacements.1 If the ongoing TAVR trials for low-risk patients demonstrate equivalence with surgery, we can expect another surge in demand for TAVR procedures. Similarly, percutaneous mitral valve repair procedures have now climbed to >15 000 in the United States.1 In addition, several percutaneous therapies for tricuspid and mitral valve repair and replacement are currently in the pipeline and will fuel continued growth in percutaneous therapies for SHD in the coming years. Recent Food and Drug Administration approvals of devices to close the left atrial appendage and patent foramen ovale further highlight this point. Furthermore, the number of adults with congenital heart disease (CHD) now exceeds the number of affected children, and many of these patients will require additional catheterization procedures.2 It is paradoxical that this nascent field has been devoid of formalized training paradigms. There is a clear and unmet need for defining the training requirements of physicians intending to perform SHD interventions. We need to ensure that future proceduralists will possess the appropriate cognitive and technical skill sets required to safely and effectively perform these …

Journal ArticleDOI
TL;DR: With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR.
Abstract: Objectives Evaluate the role of balloon aortic valvuloplasty (BAV) in improving candidacy of patients for transcatheter aortic valve replacement (TAVR). Background Patients who are not candidates for TAVR may undergo BAV to improve functional and clinical status. Methods 117 inoperable or high-risk patients with critical aortic stenosis underwent BAV as a bridge-to-decision for TAVR. Frailty measures including gait speed, serum albumin, hand grip, activities of daily living (ADL); and NYHA functional class before and after BAV were compared. Results Mean age was 81.6 ± 8.5 years and the mean Society of Thoracic Surgeons predicted risk of mortality was 9.57 ± 5.51, with 19/117 (16.2%) patients non-ambulatory. There was no significant change in mean GS post-BAV, but all non-ambulatory patients completed GS testing at follow-up. Albumin and hand grip did not change after BAV, but there was a significant improvement in mean ADL score (4.85 ± 1.41 baseline to 5.20 ± 1.17, P = 0.021). The number of patients with Class IV congestive heart failure (CHF) was significantly lower post BAV (71/117 [60.7%] baseline versus 18/117 [15.4%], P = 0.008). 78/117 (66.7%) of patients were referred to definitive valve therapy after BAV. Conclusions When evaluating frailty measures post BAV, we saw no significant improvement in mean GS, however, we observed a significant improvement in non-ambulatory patients and ADL scores. We also describe improved Class IV CHF symptoms. With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR.

Journal ArticleDOI
TL;DR: The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe is... as discussed by the authors.
Abstract: Background: The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe is...

Journal ArticleDOI
TL;DR: The authors review issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem.
Abstract: Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology. Early feasibility studies are an important component of the 21st Century Cures Act, enacted by Congress in 2016. Although regulatory processes have improved since the introduction of the Early Feasibility Studies Program, impediments at the hospital and clinical site level remain. In this paper, the authors review these issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem.

Journal ArticleDOI
TL;DR: Despite higher predicted surgical risk, the presence of TR was not a predictor of long-term outcomes, and in selected patients undergoing VIV transcatheter aortic valve replacement, it may be appropriate to conservatively manage concomitant TR.
Abstract: Objectives The aim of this study was to assess the implications of concomitant tricuspid regurgitation (TR) in patients undergoing valve-in-valve (VIV) transcatheter aortic valve replacement. Background Patients undergoing VIV transcatheter aortic valve replacement with concomitant TR may have worse outcomes, and optimal management remains undetermined. Methods The multicenter PARTNER 2 (Placement of Aortic Transcatheter Valves) VIV trial enrolled patients with symptomatic degenerated surgical aortic bioprostheses who were at high risk for reoperation. Outcomes were assessed between patients with mild or no TR versus moderate or severe TR. Results A total of 237 patients underwent VIV procedures (mean age 78.7 ± 10.8 years, mean Society of Thoracic Surgeons score 9.1 ± 4.8%). In this cohort, 162 patients (68.4%) had mild or no TR, and 75 patients (31.6%) had moderate or severe TR. Although there was no difference in New York Heart Association functional class III or IV symptomatic status (89.3% vs. 91.4%; p = 0.62) or moderate or severe right ventricular dysfunction (9.4% vs. 16.9%; p = 0.11), patients with moderate or severe TR were more likely to be at high surgical risk, with a Society of Thoracic Surgeons score of >8 (62.7% vs 46.9%; p = 0.02). There was no difference in a composite endpoint of death and rehospitalization between moderate or severe TR and mild or no TR, either at 30 days (10.7% vs. 9.9%; p = 0.85) or at 1-year follow-up (24.1% vs. 23.2%; p = 0.80). There was a significant reduction in overall moderate or severe TR from baseline at 30 days (31.1% vs. 21.1%; p = 0.002), which was sustained at 1-year follow-up (38.0% vs. 22.8%; p = 0.004). Conclusions Despite higher predicted surgical risk, the presence of TR was not a predictor of long-term outcomes. Importantly, there was significant reduction in TR severity at both short- and long-term follow-up. In selected patients undergoing VIV transcatheter aortic valve replacement, it may be appropriate to conservatively manage concomitant TR.

Journal ArticleDOI
TL;DR: The brief yet remarkable history of TAVR is reviewed and its role in the treatment of intermediate-surgical-risk patients is discussed and concerns of valve durability, procedure-related morbidity, and patient survivability require careful consideration.
Abstract: To determine what influences patients and physicians to choose between transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with severe, symptomatic aortic stenosis. Advances in transcatheter valve technology, techniques, and trials demonstrating non-inferiority compared to surgical aortic valve replacement (SAVR) have led to expanded eligibility of transcatheter aortic valve replacement (TAVR) to both intermediate-risk patients in clinical practice and low-risk patients in pivotal trials. Since lower-risk individuals tend to be younger and good operative candidates, concerns of valve durability, procedure-related morbidity, and patient survivability require careful consideration. Results from the PARTNER II intermediate risk trials and SURTAVI trials have given us insight into the benefits and potential risks of both treatment modalities. In this article, we review the brief yet remarkable history of TAVR and discuss its role in the treatment of intermediate-surgical-risk patients.

Journal ArticleDOI
23 Feb 2018
TL;DR: A prospective pilot study of three urinary biomarkers showed no association with AKI or creatinine after TAVI, and ongoing efforts to predict and modify the risk of AKI after T AVI remain challenging.
Abstract: Acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The biomarkers neutrophil gelatinase–associated lipo...

Journal ArticleDOI
22 Oct 2018
TL;DR: Limited experience showed that early stroke intervention with either treatment option may reduce the risk of complications and improve neurological outcomes.
Abstract: Stroke is a devastating complication in patients undergoing transcatheter aortic valve replacement (TAVR). We sought to determine whether early stroke intervention after TAVR would improve the neurological outcomes. Two patients experienced stroke immediately after TAVR, one treated with mechanical thrombectomy and localized lytic therapy and one treated with systemic lytic therapy. Our limited experience showed that early stroke intervention with either treatment option may reduce the risk of complications and improve neurological outcomes.

Journal ArticleDOI
20 Aug 2018
TL;DR: In the PARTNER 2A Trial, intermediate-risk patients with severe AS and BMI ≥ 35 kg/m2 undergoing TAVR experienced significantly lower cardiovascular mortality than similar patients undergoing SAVR.
Abstract: Background: Patients with severe aortic stenosis (AS) at intermediate surgical risk, treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) have simi...

Journal ArticleDOI
TL;DR: Surgical treatment of mitral regurgitation is a repair involving either resection of the diseased segment with reconstruction or increasingly by replacement of the elongated or ruptured cords with artificial cords of expanded polytetrafluoroethylene (ePTFE).