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Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial

Pibarot, Philippe; Salaun, Erwan; Dahou, Abdellaziz; Avenatti, Eleonora; Guzzetti, Ezequiel; Annabi, Mohamed-Salah; Toubal, Oumhani; Bernier, Mathieu; Beaudoin, Jonathan; Ong, Géraldine; Ternacle, Julien; Krapf, Laura; Thourani, Vinod H; Makkar, Raj; Kodali, Susheel K; Russo, Mark; Kapadia, Samir R; Malaisrie, S Chris; Cohen, David J; Leipsic, Jonathon; Blanke, Philipp; Williams, Mathew R; McCabe, James M; Brown, David L; Babaliaros, Vasilis; Goldman, Scott; Szeto, Wilson Y; Généreux, Philippe; Pershad, Ashish; Alu, Maria C; Xu, Ke; Rogers, Erin; Webb, John G; Smith, Craig R; Mack, Michael J; Leon, Martin B; Hahn, Rebecca T
Background: The objective of this study is to compare echocardiographic findings in low risk patients with severe aortic stenosis (AS) following surgical (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The Placement of Aortic Transcatheter Valves 3 (PARTNER 3) trial randomized 1000 patients with severe AS and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline, and at 30 days and 1 year post-procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate/severe aortic regurgitation (AR) was low and not statistically different between TAVR vs. SAVR groups (30 days: 0.8% vs. 0.2%; p=0.38). However, mild AR was more frequent following TAVR vs. SAVR (30 days: 28.8% vs. 4.2 %; p<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 vs. 11.6±5.0 mmHg; p=0.12) and aortic valve area (1.72±0.37 vs. 1.76±0.42 cm2; p=0.12) were similar in TAVR vs. SAVR. The percentage of severe prosthesis-patient mismatch (PPM) at 30 days was low and similar between TAVR and SAVR (4.6 vs. 6.3%, p=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR vs. SAVR at 1 year (3.7±0.8 vs. 3.9±0.9 mmHg/mL/m2 ; p<0.001). Tricuspid annulus plane systolic excursion (TAPSE) decreased and the percentage of moderate/severe tricuspid regurgitation increased from baseline to 1 year in SAVR, whereas remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low TAPSE, but not moderate/severe AR or severe PPM, were associated with increased risk of the composite endpoint of mortality, stroke and re-hospitalization at 1 year. Conclusions: In patients with severe AS and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate/severe AR compared with SAVR, but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe PPM, and LV mass regression were similar in TAVR versus SAVR. SAVR was associated with significant deterioration of RV systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low TAPSE were associated with worse outcome at 1 year whereas AR or severe PPM were not. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02675114.
PMID: 32272848
ISSN: 1524-4539
CID: 4379032

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

Makkar, Raj R; Thourani, Vinod H; Mack, Michael J; Kodali, Susheel K; Kapadia, Samir; Webb, John G; Yoon, Sung-Han; Trento, Alfredo; Svensson, Lars G; Herrmann, Howard C; Szeto, Wilson Y; Miller, D Craig; Satler, Lowell; Cohen, David J; Dewey, Todd M; Babaliaros, Vasilis; Williams, Mathew R; Kereiakes, Dean J; Zajarias, Alan; Greason, Kevin L; Whisenant, Brian K; Hodson, Robert W; Brown, David L; Fearon, William F; Russo, Mark J; Pibarot, Philippe; Hahn, Rebecca T; Jaber, Wael A; Rogers, Erin; Xu, Ke; Wheeler, Jaime; Alu, Maria C; Smith, Craig R; Leon, Martin B
BACKGROUND:There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS:We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS:At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS:Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
PMID: 31995682
ISSN: 1533-4406
CID: 4294232

Three Generations of Self-Expanding Transcatheter Aortic Valves: A Report From the STS/ACC TVT Registry

Forrest, John K; Kaple, Ryan K; Tang, Gilbert H L; Yakubov, Steven J; Nazif, Tamim M; Williams, Mathew R; Zhang, Angie; Popma, Jeffrey J; Reardon, Michael J
OBJECTIVES/OBJECTIVE:The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves. BACKGROUND:Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems. METHODS:Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference. RESULTS:Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO). CONCLUSIONS:Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status.
PMID: 31973793
ISSN: 1876-7605
CID: 4271392

The "Eyeball Test" for Risk Assessment in Aortic Stenosis: Characterizing Subjective Frailty Using Objective Measures

Green, Philip; Chung, Christine J.; Oberweis, Brandon S.; George, Isaac; Vahl, Torsten; Harjai, Kishore; Liao, Ming; Jaquez, Luz; Hawkey, Marian; Khalique, Omar; Hahn, Rebecca T.; Williams, Mathew R.; Kirtane, Ajay J.; Leon, Martin B.; Kodali, Susheel K.; Nazif, Tamim M.
ISI:000672624600011
ISSN: 2474-8706
CID: 5368582

Modifed cabrol patch repair for right atrial rupture secondary to permeating angiosarcoma [Meeting Abstract]

Ranganath, N; Schubmehl, H; Smith, D E; Williams, M R; Hisamoto, K
Objective: Cardiac angiosarcomas often present as multicentric right atrial masses that sometimes manifest as atrial rupture. We present a modifed Cabrol patch repair in a patient with right atrial rupture on imaging who was diagnosed intraoperatively with permeating angiosarcoma.
Method(s): A previously healthy 60-year-old man presented with dyspnea and was found to have subsegmental pulmonary emboli and a pericardial effusion with negative cytology. Three months later, his symptoms recurred and cardiac magnetic resonance imaging demonstrated right atrial destruction and thrombus compressing the right ventricle. Given the lack of diagnosis and potential progression to tamponade, he was taken to the operating room for right atrial repair. Before opening the pericardium, femoral cardiopulmonary bypass was initiated. The right atrium, atrioventricular groove, and anterior right ventricular wall were occupied by bleeding, friable tissue (Figure CC-1a). Frozen section revealed a spindle-cell neoplasm. Given the impossibility of performing an oncologic resection, the right atrium was contained with a modifed Cabrol patch, mimicking the function previously provided by the pericardium. Additional patches covered the surface of the actively bleeding tumor (Figure CC-1b).
Result(s): The patient recovered well and was discharged home 1 week later. Final pathology diagnosed angiosarcoma. He is 7 months postdischarge and completed 14 rounds of paclitaxel-based chemotherapy with moderate radiological improvement.
Conclusion(s): As oncologic resection was impossible, a modifed Cabrol patch repair to mimic the function previously provided by pericardium and to control tumor-associated bleeding was the best decision. While this patient may not have received hemodynamic beneft, we provided a defnitive diagnosis allowing for targeted chemotherapy treatment
EMBASE:632150780
ISSN: 1559-0879
CID: 4523892

Between a rock and a hard place: How to use antithrombotics in patients undergoing transcatheter aortic valve replacement

Grossman, Kelsey; Williams, Mathew R.; Ibrahim, Homam
Transcatheter aortic valve replacement (TAVR) has become the preferred method for management of severe aortic stenosis in patients who are at high and intermediate surgical risk, and has recently gained approval from the Food and Drug Administration in the US for use in patients at low risk for surgery. Thrombocytopenia and thromboembolic events in patients undergoing TAVR is associated with increased morbidity and mortality, and yet there is insufficient evidence supporting the current guideline-mediated therapy for antithrombotics post-TAVR. In this article, the authors review current guidelines for antithrombotic therapy in patients undergoing TAVR, studies evaluating antiplatelet regimens, and studies evaluating the use of platelet function testing after TAVR. They also offer a potential link between thrombocytopenia and antiplatelet treatments in patients undergoing TAVR.
SCOPUS:85086916412
ISSN: 1758-3896
CID: 4510092

Survival after myocardial infarction with non-obstructive coronary arteries (MINOCA)-A comprehensive systematic review and meta-analysis [Meeting Abstract]

Pasupathy, S; Lindahl, B; Litwin, P; Tavella, R; Williams, M; Air, T; Marfella, R; Bainey, K; Alzuhairi, K; Reynolds, H; Johnston, N; Kerr, A; Beltrame, J
Introduction: Myocardial Infarction (MI) with Non-Obstructive Coronary Arteries (MINOCA) is now a recognised MI subtype. A 2013 systematic review of MINOCA literature indicated that MINOCA prognosis is favourable compared to those with MI and obstructive coronary artery disease (MICAD), but healthy controls were not included. With the growth of recent literature and evaluation of MINOCA prognosis, we performed an in-depth analysis of MINOCA prognosis, in relation to 1-year all-cause mortality and 1-year re-infarction compared with MICAD patients and a healthy cohort.
Method(s): An unrestricted literature search was conducted on the terms "MI", "non-obstructive", "angiography" and "prognosis" using PubMed and Embase. Publications with non-consecutive recruitment, less than 100 MINOCA patients or selection bias (i.e. restricted age group) were excluded. MINOCA & MICAD were defined as the presence of an MI (as per the universal criteria) in the absence & presence of CAD (i.e. epicardial vessel with a stenosis >=50% on angiography), respectively. The healthy cohort was defined as those with no history of cardiovascular diseases. Unpublished data were accumulated via the MINOCA Global Collaboration. Data from the included studies were pooled and analysed using DerSimonian-Laird random-effects meta-analysis. Heterogeneity was assessed using Cochran's Q and I2 statistics. Odds ratios (ORs), mean differences and 95% confidence intervals (CI) were calculated for proportion and continuous data respectively.
Result(s): The search identified 2889 unique publications, of which 27 included prognosis data. Of the 563660 consecutive MI patients, the overall pooled prevalence of MINOCA wasat 8.7% (95% CI: 7.5%-9.9%). The 1- year mortality and 1-year re-infarction data by diagnosis are presented in the table.
Conclusion(s): This pooled analysis shows that MINOCA accounts for almost one in ten MI presentations. The risks of re-infarction and death among MINOCA patients are much higher than in healthy controls, but lower than for MICAD patients. Efforts are needed to improve understanding of the optimal management and secondary prevention strategies in this unique and heterogeneous population. (Table Presented)
EMBASE:630049732
ISSN: 0195-668x
CID: 4245522

Health Status after Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis

Baron, Suzanne J; Magnuson, Elizabeth A; Lu, Michael; Wang, Kaijun; Chinnakondepalli, Khaja; Mack, Michael; Thourani, Vinod H; Kodali, Susheel; Makkar, Raj; Herrmann, Howard C; Kapadia, Samir; Babaliaros, Vasilis; Williams, Mathew R; Kereiakes, Dean; Zajarias, Alan; Alu, Maria C; Webb, John G; Smith, Craig R; Leon, Martin B; Cohen, David J
BACKGROUND:In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and re-hospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES/OBJECTIVE:This study sought to compare health status outcomes of TAVR vs. surgery in low-risk patients with severe AS. METHODS:Between 3/2016 and 10/2017, 1000 low-risk AS patients were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 Trial. Health status was assessed at baseline, 1, 6 and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D. The primary endpoint was change in KCCQ-Overall Summary (KCCQ-OS) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS:At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p<0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p<0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥ 75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p=0.03) and 12 months (87.3% vs. 82.8%; p=0.07). CONCLUSIONS:Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.
PMID: 31577923
ISSN: 1558-3597
CID: 4116302

Prophylactic percutaneous left ventricular assist device in pregnancy [Case Report]

Westcott, Jill M; Yaghoubian, Yasaman; Williams, Mathew R; Roman, Ashley S; Hughes, Francine; Rosner, Mara
Pregnancy-associated cardiomyopathy can present earlier in gestation than traditionally defined peripartum cardiomyopathy. Management and optimal delivery timing for these patients are not well defined. We present the case of a 30-year-old primigravid at 26 weeks who presented with new onset ventricular tachycardia, biventricular cardiac failure, and severe mitral regurgitation. She was medically stabilized for two weeks prior to delivery with modest improvement in her condition. Due to concern for life-threatening cardiac failure and pulmonary edema at the time of delivery, a percutaneous left ventricular assist device was inserted immediately prior to cesarean delivery. She remained on mechanical circulatory support for 36 h. We discuss considerations regarding use of a percutaneous left ventricular assist device as a novel therapy to support the hemodynamic changes following delivery in parturients with decompensated heart failure.
PMCID:6734636
PMID: 31523273
ISSN: 1753-495x
CID: 4085712

Comparison of a Complete Percutaneous versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results from the Randomized SURTAVI Trial

Søndergaard, Lars; Popma, Jeffrey J; Reardon, Michael J; Van Mieghem, Nicolas M; Deeb, G Michael; Kodali, Susheel; George, Isaac; Williams, Mathew R; Yakubov, Steven J; Kappetein, Arie P; Serruys, Patrick W; Grube, Eberhard; Schiltgen, Molly B; Chang, Yanping; Engstrøm, Thomas
BACKGROUND:For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach. METHODS:The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years. RESULTS:Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). CONCLUSIONS:For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG. CLINICAL TRIAL REGISTRATION/BACKGROUND:URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.
PMID: 31476897
ISSN: 1524-4539
CID: 4068982