Faculty Bibliography
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240
Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation
BACKGROUND:In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. METHODS:We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. RESULTS:At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group. CONCLUSIONS:In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).
PMID: 27040451
ISSN: 1533-4406
CID: 5451202
Rethinking the gold standard for correction of paravalvular leak
PMID: 26809423
ISSN: 1097-685x
CID: 1929582
Robotic Transcatheter Mitral Valve Replacement Using the Sapien XT in the Setting of Severe Mitral Annular Calcification
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
Predictors of pacemaker implantation with a self-expanding repositionable transcatheter aortic valve [Meeting Abstract]
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
Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients
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
EARLY OUTCOMES WITH THE EVOLUT R REPOSITIONABLE SELF-EXPANDING TRANSCATHETER AORTIC VALVE IN THE UNITED STATES [Meeting Abstract]
ISI:000375188703020
ISSN: 0735-1097
CID: 2962432
Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study
BACKGROUND: Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting. OBJECTIVE: To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial. DESIGN: Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894). SETTING: 25 hospitals in the United States, Canada, and Germany. PATIENTS: High-risk and inoperable patients (1220 women and 1339 men). INTERVENTION: TAVR. MEASUREMENTS: Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters. RESULTS: At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001). LIMITATION: Secondary analysis that included nonrandomized trial data. CONCLUSION: Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis. PRIMARY FUNDING SOURCE: Edwards Lifesciences.
PMID: 26903039
ISSN: 1539-3704
CID: 2056972
Multimodality Imaging of Bioprosthetic Percutaneous Balloon Valvuloplasty Followed by Valve-in-Valve Implantation for Mitral Stenosis Due to Commissural Leaflet Fusion
PMID: 26896889
ISSN: 1876-7605
CID: 1965272
Short-term outcomes in adult cardiac surgery in the use of del Nido cardioplegia solution
OBJECTIVES: Del Nido cardioplegia in adult cardiac surgery has not been studied although it has been in common use as a "single" dose cardioplegia in pediatric heart surgery. We retrospectively assessed the short-term (in-hospital) clinical outcomes of patients undergoing aortic valve replacement (AVR) using del Nido cardioplegia solution, comparing it to conventional multi-dose whole blood cardioplegia. METHODS: We switched our cardioplegia protocol from conventional whole blood cardioplegia exclusively to del Nido solution in May 2011. In 2011, 240 consecutive patients underwent isolated AVR. One hundred and seventy-eight of them were operated on with the use of del Nido cardioplegia (del Nido group) and whole blood cardioplegia (conventional group) was used in the other 62 patients. Isolated AVR was chosen as a cohort because of its relative simplicity and the similarity of surgical techniques among surgeons. Propensity-score matching identified 54 matched pairs for analysis. RESULTS: The retrograde cardioplegia technique was used in 19 cases (35.2%) in the del Nido group and 52 cases (96.3%) in the conventional group (p<0.001). Mean cardiopulmonary bypass time and mean aortic cross-clamp time were significantly shorter in the del Nido group compared to the conventional group: 71 +/- 16 min vs. 84 +/- 28 min (p<0.01), 52 +/- 14 min vs. 60 +/- 16 min (p<0.01), respectively. Postoperative inotropic support was required in 11 patients (20.4 %) in the del Nido group and 13 patients (24.1 %) in the conventional group (p=0.82) with no statistical difference. No patient required a postoperative intra-aortic balloon pump and in-hospital mortality was 0% in both groups. There was no significant difference in postoperative complications between the two groups. CONCLUSIONS: Short-term outcomes in adult cardiac surgery using del Nido solution were acceptable and comparable to conventional multi-dose whole blood cardioplegia. The del Nido cardioplegia technique was associated with shortened cross-clamp times and less frequent utilization of the retrograde cardioplegia delivery technique.
PMID: 26228274
ISSN: 1477-111x
CID: 1698632
Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Placement of Aortic Transcatheter Valve (PARTNER) Trial
BACKGROUND: This study sought to evaluate the impact of atrial fibrillation (AF) on clinical outcomes in patients undergoing transcatheter aortic valve replacement. METHODS AND RESULTS: Data were evaluated in 1879 patients with baseline and discharge ECGs who underwent transcatheter aortic valve replacement in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. A total of 1262 patients manifested sinus rhythm (SR) at baseline/SR at discharge, 113 SR baseline/AF discharge, and 470 AF baseline/AF discharge. Patients who converted from SR to AF by discharge had the highest rates of all-cause mortality at 30 days (P<0.0001 across all groups; 14.2% SR/AF versus 2.6% SR/SR; adjusted hazard ratio [HR]=3.41; P=0.0002) and over 2-fold difference at 1 year (P<0.0001 across all groups; 35.7% SR/AF versus 15.8% SR/SR; adjusted HR=2.14; P<0.0001). The presence of AF on baseline or discharge ECG was a predictor of 1-year mortality (adjusted HR=2.14 for SR/AF group and HR=1.88 for AF/AF groups; P<0.0001 for both groups versus SR/SR). For patients discharged in AF, those with lower ventricular response (ie, <90 bpm) experienced less 1-year all-cause mortality (HR=0.74; P=0.04). CONCLUSIONS: After transcatheter aortic valve replacement, the presence of AF at discharge, and particularly, the conversion to AF by discharge and higher ventricular response are associated with increased mortality. These data underscore the deleterious impact of AF, as well as the need for targeted interventions to improve clinical outcomes, in patients undergoing transcatheter aortic valve replacement. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
PMCID:4704130
PMID: 26733582
ISSN: 1941-7632
CID: 1900522
