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Transcatheter Aortic Valve Replacement with a Repositionable Self-expanding Bioprosthesis in Patients With Severe Aortic Stenosis at High Risk for Surgery: One-Year Results from the Evolut R US Pivotal Study [Meeting Abstract]

Popma, Jeffrey J.; Harrison, J. Kevin; Hughes, G. Chad; Kodali, Susheel; George, Isaac; Oh, Jae; Slater, James; Williams, Mathew; Gilbert, Colleen
ISI:000397332900038
ISSN: 0735-1097
CID: 3589362

EARLY OUTCOMES WITH THE EVOLUT R REPOSITIONABLE SELF-EXPANDING TRANSCATHETER AORTIC VALVE IN THE UNITED STATES [Meeting Abstract]

Williams, Mathew; Slater, James; Saric, Muhamed; Hughes, Chad; Harrison, Kevin; Kodali, Susheel; Kipperman, Robert; Brown, John; Deeb, G. Michael; Chetcuti, Stanley; Popma, Jeffrey
ISI:000375188703020
ISSN: 0735-1097
CID: 2962432

Cardiovascular Surgery in the Elderly

Yaffee, David W; Williams, Mathew R
The elderly population is the fastest growing demographic in Western countries. As the population ages, the incidence of age-related comorbidities such as diabetes mellitus, chronic obstructive pulmonary disease, peripheral vascular disease, renal disease, cerebrovascular disease, and cardiovascular disease increases. With cardiovascular disease occurring in approximately one-quarter of the population over the age of 75 years and more than half of all cardiac procedures performed on this age group, the number of potential elderly surgical candidates is increasing. However, data suggest that old age is associated with increased morbidity and mortality following cardiac surgery. Over the past 2 decades, improvements in myocardial protection, extracorporeal circulation, anesthesia, and surgical techniques have significantly reduced the morbidity and mortality associated with cardiac surgery. Although most prospective studies exclude elderly patients, data from large retrospective studies and subgroup analyses suggest that cardiac surgery is a viable option for many elderly patients with cardiovascular disease, with good outcomes observed in reasonable-risk candidates; moreover, there are a growing number of available less-invasive options for them when surgical risk becomes prohibitive. In this article, we discuss the current state of cardiovascular surgery in the elderly as well as emerging technologies on the horizon.
PMID: 28417859
ISSN: 1532-9488
CID: 2532322

Predictors of pacemaker implantation with a self-expanding repositionable transcatheter aortic valve [Meeting Abstract]

Meredith, I T; Popma, J J; Manoharan, G; Mchenry, B; Chenoweth, S; Forleo, M; Lambrecht, L J; Boulware, M; Williams, M
Aims: Opportunities remain to improve TAVI outcomes. We evaluated the associations of aortic valve calcification, suboptimal sizing and implant depth with the need for permanent pacemaker implantation (PPI) from the pooled Evolut R CE and US Studies Methods and results: All patients from the Evolut R CE Study (n=60) and the first 91 patients in the CoreValve Evolut R US Clinical Trial were combined. The 23 mm Evolut R self-expanding valve was only studied in US patients. Aortic valve calcium volumes were obtained by using 3mensio software (Pie Medical Imaging, Maastricht, The Netherlands) from pre-implant multislice computer tomography (MSCT) Aortic root dimensions were measured from pre-implant MSCT. Percent oversizing was defined as 100*[(valve perimeter - annulus perimeter)/annulus perimeter]. Recommended implant depth was 3-5 mm below the aortic annulus. Left coronary cusp and non-coronary cusp depth of implant were determined from site-read implant angiograms. The need for PPI was determined at the investigator"s discretion. The 30-day PPI rate was used for analyses. Univariable and multivariable analyses were conducted to determine predictors of PPI. Mean age was 83.7+/-6.6 years and 68.9% were women. The mean Society of Thoracic Surgeons score was 7.3+/-3.5% and 73.5% had New York Heart Association class III/IV symptoms. General anaesthesia was used in 72.8%, pre-TAVI balloon valvuloplasty was performed in 56.3%, and 24.5% underwent post-TAVI balloon valvuloplasty. Most patients were treated via the iliofemoral route (94.7%). Implanted valve sizes were 29 mm (62.9%), 26 mm (35.8%) and 23 mm (1.3%). A PPI was required in 20 patients (13.3%) at 30 days. A pre-existing conduction disturbance was present in 12 patients (right bundle branch block =7 atrioventricular block =5). The reasons for PPI were; 2nd or 3rd degree atrioventricular block (n=18), right bundle branch block (n=1) and tachy/brady syndrome (n=1). Implant depth was significantly greater in patients who received a new PPI (average depth of 6.6 mm vs. 4.1 mm, P<0.0001). Neither aortic valve calcification (PPI=551.6+/-285.7m 3 ; no PPI=585.9 +/- 435.5m 3 , p=ns) nor percent oversizing (PPI=19.6+/-7.5%; no PPI=19.3+/-5.8%; p=ns) appeared to influence the rate of new PPI. Preexisting right bundle branch block and left coronary cusp depth of implant >5 mm were significant predictors of new PPI Conclusions: We found that both pre-existing conduction defects and not achieving the recommended implant depth were correlated with the need for a new pacemaker
EMBASE:611935356
ISSN: 1969-6213
CID: 2258912

Rethinking the gold standard of correction for paravalvular leak: Why correct when you can prevent?

Yaffee, David W; Williams, Mathew R; Grossi, Eugene A
PMID: 27663523
ISSN: 1097-685x
CID: 2255082

Evaluation of Flow After Transcatheter Aortic Valve Replacement in Patients With Low-Flow Aortic Stenosis: A Secondary Analysis of the PARTNER Randomized Clinical Trial

Anjan, Venkatesh Y; Herrmann, Howard C; Pibarot, Philippe; Stewart, William J; Kapadia, Samir; Tuzcu, E Murat; Babaliaros, Vasilis; Thourani, Vinod H; Szeto, Wilson Y; Bavaria, Joseph E; Kodali, Susheel; Hahn, Rebecca T; Williams, Mathew; Miller, D Craig; Douglas, Pamela S; Leon, Martin B
Importance: Low-flow (LF) severe aortic stenosis (AS) is an independent predictor of mortality in patients undergoing aortic valve replacement (AVR). Little is known about improvement in flow after AVR and its effects on survival. Objective: To determine whether higher flow (left-ventricular stroke volume index [LVSVI]) after transcatheter AVR (TAVR) would indicate better clinical outcomes in this at-risk population. Design, Setting, and Participants: A substudy analysis of data from the Placement of Aortic Transcatheter Valves (PARTNER) randomized clinical trial and continued-access registry was conducted. A total of 984 participants with evaluable echocardiograms and baseline LF AS (LVSVI
PMID: 27437665
ISSN: 2380-6591
CID: 2185412

Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis

Kodali, Susheel; Thourani, Vinod H; White, Jonathon; Malaisrie, S Chris; Lim, Scott; Greason, Kevin L; Williams, Mathew; Guerrero, Mayra; Eisenhauer, Andrew C; Kapadia, Samir; Kereiakes, Dean J; Herrmann, Howard C; Babaliaros, Vasilis; Szeto, Wilson Y; Hahn, Rebecca T; Pibarot, Philippe; Weissman, Neil J; Leipsic, Jonathon; Blanke, Philipp; Whisenant, Brian K; Suri, Rakesh M; Makkar, Raj R; Ayele, Girma M; Svensson, Lars G; Webb, John G; Mack, Michael J; Smith, Craig R; Leon, Martin B
AIMS: Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). METHODS AND RESULTS: Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2. CONCLUSIONS: The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. TRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313.
PMID: 27190101
ISSN: 1522-9645
CID: 2112172

Robotic Transcatheter Mitral Valve Replacement Using the Sapien XT in the Setting of Severe Mitral Annular Calcification

Koeckert, Michael S; Loulmet, Didier F; Williams, Mathew R; Neuburger, Peter J; Grossi, Eugene A
We describe the use of the Sapien XT, placed in the mitral position using a totally endoscopic robotic approach in a 76-year-old man with extensive circumferential mitral calcifications and severe stenosis. The patient was at high risk for traditional open surgery and a large mitral valve annulus prevented safe transcatheter deployment due to size mismatch. Our novel approach offered a minimally invasive technique for native mitral valve replacement in a high-risk patient with anatomical constraints prohibitive to conventional approaches. doi: 10.1111/jocs.12737 (J Card Surg 2016;31:303-305).
PMID: 27059174
ISSN: 1540-8191
CID: 2100582

Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification

Eleid, Mackram F; Cabalka, Allison K; Williams, Matthew R; Whisenant, Brian K; Alli, Oluseun O; Fam, Neil; Pollak, Peter M; Barrow, Firas; Malouf, Joseph F; Nishimura, Rick A; Joyce, Lyle D; Dearani, Joseph A; Rihal, Charanjit S
OBJECTIVES: The study sought to examine the feasibility, safety, and intermediate-term outcomes in patients undergoing percutaneous transvenous transcatheter mitral valve implantation in failed bioprosthesis, ring annuloplasty, and calcific mitral stenosis. BACKGROUND: Surgical mitral valve replacement in patients with previous surgery or severe mitral annular calcification (MAC) is often associated with high or prohibitive risk. METHODS: Percutaneous transfemoral antegrade transseptal implantation of Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) was performed in 48 patients with degenerated mitral bioprosthesis (n = 33), previous ring annuloplasty (n = 9), and severe MAC (n = 6). RESULTS: The mean Society of Thoracic Surgeons risk score was 13.2 +/- 7.4% with a mean age 76 +/- 11 years. Acute procedural success was achieved in 42 of 48 patients (88%) in the overall group and 31 of 33 (94%) in the failed bioprosthetic mitral valve group and success rate of 11 of 15 (73%) in patients with failed annuloplasty rings and MAC. After successful procedure, no patients had > mild residual mitral prosthetic or periprosthetic regurgitation; mean transvalvular gradients were 6 +/- 2.5 mm Hg. Thirty-day survival free of death and cardiovascular surgery was 85% in the overall group and 91% in the failed bioprosthetic mitral valve subgroup. CONCLUSIONS: Transfemoral percutaneous transvenous mitral valve implantation in high-risk patients with degenerated bioprosthesis is safe, effective, and associated with rapid improvement in hemodynamics, short length of stays, and improved functional status. Percutaneous mitral valve implantation in patients with failed annuloplasty rings and severe MAC is a promising therapy with significant short-term morbidity and mortality that requires further study.
PMID: 27085576
ISSN: 1876-7605
CID: 2079852

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

Leon, Martin B; Smith, Craig R; Mack, Michael J; Makkar, Raj R; Svensson, Lars G; Kodali, Susheel K; Thourani, Vinod H; Tuzcu, E Murat; Miller, D Craig; Herrmann, Howard C; Doshi, Darshan; Cohen, David J; Pichard, Augusto D; Kapadia, Samir; Dewey, Todd; Babaliaros, Vasilis; Szeto, Wilson Y; Williams, Mathew R; Kereiakes, Dean; Zajarias, Alan; Greason, Kevin L; Whisenant, Brian K; Hodson, Robert W; Moses, Jeffrey W; Trento, Alfredo; Brown, David L; Fearon, William F; Pibarot, Philippe; Hahn, Rebecca T; Jaber, Wael A; Anderson, William N; Alu, Maria C; Webb, John G
Background Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. Methods We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. Results The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. Conclusions In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313 .).
PMID: 27040324
ISSN: 1533-4406
CID: 2065952