Faculty Bibliography
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243
Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes
AIM/OBJECTIVE:The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) remains uncertain. In this analysis, we sought to evaluate the impact of varying degrees of PVR on both mortality and changes in ventricular geometry and function. METHODS AND RESULTS/RESULTS:Clinical and echocardiographic outcomes of patients who underwent TAVR from the randomized cohorts and continued access registries in the PARTNER trial were analysed after stratifying by severity of post-implant PVR, which was graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). There were significant differences in baseline clinical and echocardiographic characteristics. After TAVR, all the patients demonstrated increase in left ventricular (LV) function and reduction in the LV mass index, although the magnitude of mass regression was lower in the moderate/severe PVR group. The 30-day mortality (3.1 vs. 3.4 vs. 4.5%, P = 0.56) and stroke (3.4 vs. 3.7 vs. 2.3%, P = 0.59) were similar in all groups (none/trace, mild, and moderate/severe). At 1 year, there was increased all-cause mortality (15.9 vs. 22.2 vs. 35.1%, P < 0.0001), cardiac mortality (6.1 vs. 7.4% vs. 16.3%, P < 0.0001) and re-hospitalization (14.4 vs. 23.0 vs. 31.3%, P < 0.0001) with worsening PVR. A multivariable analysis indicated that the presence of moderate/severe PVR (HR: 2.18, 95% CI: 1.57-3.02, P < 0.0001) or mild PVR (HR: 1.37, 95% CI: 1.14-1.90, P = 0.012) was associated with higher late mortality. CONCLUSION/CONCLUSIONS:Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild and moderate/severe PVR predicted higher 1-year mortality.
PMID: 25273886
ISSN: 1522-9645
CID: 3572132
Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry
OBJECTIVES/OBJECTIVE:The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). BACKGROUND:Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve. METHODS:The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM. RESULTS:Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year. CONCLUSIONS:PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894).
PMID: 25616819
ISSN: 1876-7605
CID: 3572152
Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients
BACKGROUND: The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk patients. METHODS: The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151). RESULTS: The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 (p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 (p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) (p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1. CONCLUSIONS: Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.
PMID: 25442986
ISSN: 0003-4975
CID: 1449782
Indications and Utility of Percutaneous Balloon Aortic Valvuloplasty in Older Adults
ISI:000218596000014
ISSN: 2196-7865
CID: 5265832
Implementation of a moderate sedation protocol for transfemoral transcatheter aortic valve replacement: A review at 6 months [Meeting Abstract]
BACKGROUND Transfemoral transcatheter aortic valve replacement (TF TAVR) can be performed under general anesthesia (GA) or moderate sedation (MS). Despite observational studies suggesting a shorter length of stay (LOS), shorter procedural time and a similar mortality rate with MS, only 5% of patients undergoing TF TAVR in the United States are done with this type of anesthesia. We reviewed the implementation of a MS for TF TAVR protocol at a single institution with no previous experience with this technique. METHODS Patients with severe obstructive sleep apnea (OSA), likely difficult intubation, inability to tolerate supine position due to musculoskeletal disease, or barriers to communication including altered mental status were performed under GA with intraoperative transesophageal echocardiography. All others received MS with an ilioinguinal nerve block and intraoperative transthoracic echocardiography. The MS for TF TAVR protocol was implemented on October 9th, 2014. The records of patients undergoing TF TAVR 6 months before and after protocol implementation were retrospectively reviewed. RESULTS In the pre protocol group 33 patients underwent TF TAVR under GA and no patients received MS. In the post protocol group, 97 underwent TF TAVR, 81 (83.5%) of which received MS. OSA was the most common reason for GA (N=10, 62.5%). Conversion from MS to GA occurred in 2 cases (2.5%) due to procedural complications, of which 1 resulted in death. All other cases involving MS were tolerated well and there were no anesthesia related complications. Post procedural LOS (3.2 days vs. 5.0 days, p=0.002) and procedure time (144.0 minutes vs. 96.1 minutes, p<0.001) were both significantly shorter in post protocol group. The post protocol group was also significantly less likely to require a skilled nursing facility upon discharge (24.2% vs. 8.2%, p=0.027). In hospital mortality was similar between groups (N=2 6.1% vs. N=3, 3.1%, p=0.601). (Table Presented) CONCLUSIONS The MS for TF TAVR protocol appears safe and can be rapidly implemented at institutions with no previous MS experience. This technique is feasible in the majority of patient undergoing TF TAVR. Post procedural LOS and procedural time are multifactorial, but this data further suggests MS may be beneficial in select patients
EMBASE:72065352
ISSN: 0735-1097
CID: 1841642
Surgical treatment of moderate ischemic mitral regurgitation
BACKGROUND:Ischemic mitral regurgitation is associated with increased mortality and morbidity. For surgical patients with moderate regurgitation, the benefits of adding mitral-valve repair to coronary-artery bypass grafting (CABG) are uncertain. METHODS:We randomly assigned 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus mitral-valve repair (combined procedure). The primary end point was the left ventricular end-systolic volume index (LVESVI), a measure of left ventricular remodeling, at 1 year. This end point was assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized as the lowest LVESVI rank. RESULTS:At 1 year, the mean LVESVI among surviving patients was 46.1±22.4 ml per square meter of body-surface area in the CABG-alone group and 49.6±31.5 ml per square meter in the combined-procedure group (mean change from baseline, -9.4 and -9.3 ml per square meter, respectively). The rate of death was 6.7% in the combined-procedure group and 7.3% in the CABG-alone group (hazard ratio with mitral-valve repair, 0.90; 95% confidence interval, 0.38 to 2.12; P=0.81). The rank-based assessment of LVESVI at 1 year (incorporating deaths) showed no significant between-group difference (z score, 0.50; P=0.61). The addition of mitral-valve repair was associated with a longer bypass time (P<0.001), a longer hospital stay after surgery (P=0.002), and more neurologic events (P=0.03). Moderate or severe mitral regurgitation was less common in the combined-procedure group than in the CABG-alone group (11.2% vs. 31.0%, P<0.001). There were no significant between-group differences in major adverse cardiac or cerebrovascular events, deaths, readmissions, functional status, or quality of life at 1 year. CONCLUSIONS:In patients with moderate ischemic mitral regurgitation, the addition of mitral-valve repair to CABG did not result in a higher degree of left ventricular reverse remodeling. Mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation but an increased number of untoward events. Thus, at 1 year, this trial did not show a clinically meaningful advantage of adding mitral-valve repair to CABG. Longer-term follow-up may determine whether the lower prevalence of mitral regurgitation translates into a net clinical benefit. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).
PMID: 25405390
ISSN: 1533-4406
CID: 5451212
Del Nido Cardioplegia can be safely administered in high-risk coronary artery bypass grafting surgery after acute myocardial infarction: a propensity matched comparison
OBJECTIVE:Del Nido (DN) cardioplegia solution provides a depolarized hyperkalemic arrest lasting up to 60 minutes, and the addition of lidocaine may limit intracellular calcium influx. Single-dose DN cardioplegia solution may offer an alternative myocardial protection strategy to multi-dose cold whole blood (WB) cardioplegia following acute myocardial infarction (AMI). METHODS:We retrospectively reviewed 88 consecutive patients with AMI undergoing coronary artery bypass (CABG) surgery with cardioplegic arrest between June 2010 to June 2012. Patients exclusively received WB (n = 40, June 2010-July 2011) or DN (n = 48, August 2011-June 2012) cardioplegia. Preoperative and postoperative data were retrospectively reviewed and compared using propensity scoring. RESULTS:No significant difference in age, maximum preoperative serum troponin level, ejection fraction, and STS score was present between DN and WB. A single cardioplegia dose was given in 41 DN vs. 0 WB patients (p < 0.001), and retrograde cardioplegia was used 10 DN vs. 31 WB patients (p < 0.001). Mean cardiopulmonary bypass and cross clamp times were significantly shorter in the DN group versus WB group. Transfusion rate, length of stay, intra-aortic balloon pump requirement, post-operative inotropic support, and 30-day mortality was no different between groups. One patient in the WB group required a mechanical support due to profound cardiogenic shock. CONCLUSIONS:DN cardioplegia may provide equivalent myocardial protection to existing cardioplegia without negative inotropic effects in the setting of acute myocardial infarction.
PMCID:4220058
PMID: 25359427
ISSN: 1749-8090
CID: 3572142
Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy
BACKGROUND:The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown. METHODS AND RESULTS/RESULTS:In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively (P<0.001; hazard ratio, 0.53; 95% confidence interval, 0.41-0.68; P<0.001). In survivors, there was significant improvement in New York Heart Association functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients versus 5.5% in patients undergoing standard therapy (hazard ratio, 2.81; 95% confidence interval, 1.26-6.26; P=0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P<0.001; hazard ratio, 0.60; 95% confidence interval, 0.46-0.77; P<0.001). Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomly assigned patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial. CONCLUSIONS:TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection. CLINICAL TRIAL REGISTRATION URL/BACKGROUND:http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
PMID: 25205802
ISSN: 1524-4539
CID: 5490192
Acquired thrombocytopenia after transcatheter aortic valve replacement: clinical correlates and association with outcomes
AIMS/OBJECTIVE:This study aimed to evaluate incidence and correlates for low platelet count after transcatheter aortic valve replacement (TAVR) and to determine a possible association between acquired thrombocytopenia and clinical outcomes. METHODS AND RESULTS/RESULTS:Patients undergoing TAVR from two medical centres were included in the study. They were stratified according to nadir platelet count post procedure: no/mild thrombocytopenia, ≥100 × 10(9)/L; moderate, 50-99 × 10(9)/L; and severe, <50 × 10(9)/L. A total of 488 patients composed of the study population (age 84.7 ± 7.5 years). At a median time of 2 days after TAVR, 176 patients (36.1%) developed significant thrombocytopenia: 149 (30.5%) moderate; 27 patients (5.5%) severe. Upon discharge, the vast majority of patients (90.2%) had no/mild thrombocytopenia. Nadir platelet count <50 × 10(9)/L was highly specific (96.3%), and a count <150 × 10(9)/L highly sensitive (91.2%), for predicting 30-day death (C-statistic 0.76). Patients with severe acquired thrombocytopenia had a significantly higher mortality rate at 1 year (66.7% for severe vs. 16.0% for no/mild vs. 20.1% for moderate; P < 0.001). In multivariate logistic regression, severe thrombocytopenia was independently associated with 1-year mortality (hazard ratio 3.44, CI: 1.02-11.6; P = 0.046). CONCLUSIONS:Acquired thrombocytopenia was common after TAVR and was mostly resolved at patient discharge. The severity of thrombocytopenia after TAVR could be used as an excellent, easily obtainable, marker for worse short- and long-term outcomes after the procedure.
PMID: 24598983
ISSN: 1522-9645
CID: 3572092
Journal of thoracic & cardiovascular surgery. 2014:148(4):1360-1369.e1.DOI: 10.1016/j.jtcvs.2014.01.015
Age alone should not preclude surgery: Contemporary outcomes after aortic valve replacement in nonagenarians
OBJECTIVES: Advanced age plays a major role in surgical risk algorithms; however, the outcomes data for the very elderly are lacking. We, therefore, evaluated the outcomes after surgical aortic valve replacement (SAVR) in nonagenarians (age, >90 years) at our institution during an 11-year period. METHODS: The demographics, procedural details, and in-hospital outcomes were retrospectively analyzed for 119 nonagenarians with symptomatic, severe aortic stenosis who had undergone SAVR or SAVR plus concomitant surgery from 2001 to 2012. The mean follow-up period was 915 +/- 832 days. RESULTS: The average age was 91.7 +/- 1.9 years (range, 90-98), and the mean Society of Thoracic Surgeons score was 8.9 +/- 5.7. The mean aortic valve gradient was 45 +/- 16 mm Hg, mean aortic valve area was 0.66 +/- 0.2 cm2, and mean ejection fraction was 49.8% +/- 11.8%; 47% underwent isolated SAVR. The average length of stay was longer than expected; however, the rates of prolonged ventilation (16.8%), new atrial fibrillation (43.7%), stroke (0.8%), and renal failure (5.9%) were acceptable. Three patients (2.5%) required reoperation for bleeding. Overall, the 30-day and 1-year mortality was 7.6% and 21.0%, respectively. The multivariate predictors of mortality at 1 year included previous myocardial infarction (hazard ratio, 2.79; 95% confidence interval, 1.21-6.45; P = .016), obstructive lung disease (hazard ratio, 3.90; 95% confidence interval, 1.66-9.15; P = .025), and diabetes (hazard ratio, 2.77; 95% confidence interval, 1.08-7.07; P = .033). The observed in-hospital mortality was lower than expected (observed/expected, 0.85). CONCLUSIONS: Excellent procedural and long-term outcomes can be achieved in nonagenarians, and age alone should not be a contraindication to SAVR in selected populations. Our sample cohort has validated the feasibility of a primary operative strategy in elderly patients with aortic stenosis and acceptable risk profiles.
PMID: 24560419
ISSN: 0022-5223
CID: 1066932
