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Rethinking the gold standard for correction of paravalvular leak

Williams, Mathew R; Koeckert, Michael S; Grossi, Eugene A
PMID: 26809423
ISSN: 1097-685x
CID: 1929582

Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Placement of Aortic Transcatheter Valve (PARTNER) Trial

Biviano, Angelo B; Nazif, Tamim; Dizon, Jose; Garan, Hasan; Fleitman, Jessica; Hassan, Dua; Kapadia, Samir; Babaliaros, Vasilis; Xu, Ke; Parvataneni, Rupa; Rodes-Cabau, Josep; Szeto, Wilson Y; Fearon, William F; Dvir, Danny; Dewey, Todd; Williams, Mathew; Mack, Michael J; Webb, John G; Miller, D Craig; Smith, Craig R; Leon, Martin B; Kodali, Susheel
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

Short-term outcomes in adult cardiac surgery in the use of del Nido cardioplegia solution

Ota, Takeyoshi; Yerebakan, Halit; Neely, Robert C; Mongero, Linda; George, Isaac; Takayama, Hiroo; Williams, Mathew R; Naka, Yoshifumi; Argenziano, Michael; Bacha, Emile; Smith, Craig R; Stewart, Allan S
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

Indications and Utility of Percutaneous Balloon Aortic Valvuloplasty in Older Adults

Jhaveri, Amit; Williams, Mathew; Blaum, Caroline; Dodson, John A.
ISI:000218596000014
ISSN: 2196-7865
CID: 5265832

Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry

Nazif, Tamim M; Dizon, José M; Hahn, Rebecca T; Xu, Ke; Babaliaros, Vasilis; Douglas, Pamela S; El-Chami, Mikhael F; Herrmann, Howard C; Mack, Michael; Makkar, Raj R; Miller, D Craig; Pichard, Augusto; Tuzcu, E Murat; Szeto, Wilson Y; Webb, John G; Moses, Jeffrey W; Smith, Craig R; Williams, Mathew R; Leon, Martin B; Kodali, Susheel K
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

Prognostic value of serial B-type natriuretic peptide measurement in transcatheter aortic valve replacement (from the PARTNER Trial)

O'Neill, Brian P; Guerrero, Mayra; Thourani, Vinod H; Kodali, Susheel; Heldman, Alan; Williams, Mathew; Xu, Ke; Pichard, Augusto; Mack, Michael; Babaliaros, Vasilis; Herrmann, Howard C; Webb, John; Douglas, Pamela S; Leon, Martin B; O'Neill, William W
B-type natriuretic peptide (BNP) levels have shown a correlation with outcomes in studies of aortic valve surgery. Results from multicenter trials of BNP in transcatheter aortic valve surgery (TAVR) are lacking. The aim of this study was to investigate the prognostic role of serial measurement of BNP in transfemoral TAVR. A total of 1,097 patients who underwent TAVR via transfemoral access were analyzed by tertile of baseline BNP. Of those, 933 with BNP levels at 30 days were divided into 2 groups on the basis of increases (334 patients) or decreases or no change (599 patients) in BNP compared with baseline. Patients in the low-tertile BNP group had a lower rate of death at 1 year than those in the higher tertile group (15.0% vs 23.0%, p<0.01) which was not significant in multivariate analysis. Over 1 year, BNP decreased from 1,258.13±2,988.33 to 594.37±1,087.30 (p<0.01) in the entire group. Patients in the BNP-rise group had higher rates of death at 1 year (20.3% vs 11.4%, p<0.01) and an overall increase in moderate or severe aortic regurgitation over 1 year (p<0.01). Multivariate predictors of 1-year mortality were moderate or severe aortic regurgitation (hazard ratio 2.04, 95% confidence interval 1.36 to 3.05, p<0.01), increase in BNP at 30 days (hazard ratio 1.82, 95% confidence interval 1.26 to 2.62, p<0.01) and Society of Thoracic Surgeons score (hazard ratio 1.05, 95% confidence interval 1.01 to 1.10, p=0.03). In conclusion, increase in BNP at 30 days from baseline and moderate or severe aortic regurgitation at 30 days in patients who undergo transfemoral TAVR are independently associated with 1-year mortality. Increase in BNP at 30 days should prompt evaluation for causes of elevated wall stress, including aortic regurgitation.
PMID: 25863422
ISSN: 1879-1913
CID: 3572162

Reversibility of chronic kidney disease and outcomes following aortic valve replacement†

Najjar, Marc; Yerebakan, Halit; Sorabella, Robert A; Guglielmetti, Laura; Vandenberge, John; Kurlansky, Paul; Williams, Mathew R; Argenziano, Michael; Smith, Craig R; George, Isaac
OBJECTIVES/OBJECTIVE:Chronic kidney disease (CKD) is prevalent in patients undergoing aortic valve replacement (AVR). We sought to evaluate the impact of AVR on estimated glomerular filtration rate (eGFR) levels and determine the impact of reversibility of CKD on postoperative outcomes. METHODS:We retrospectively reviewed 2169 patients who underwent isolated AVR between 2000 and 2012. eGFR was calculated using the CKD-EPI formula. Based on preoperative eGFR, patients were divided into three groups: NoCKD (eGFR >60, n = 1417), ModCKD (eGFR = 30-60, n = 619) and SevCKD (eGFR = 15-30, n = 86). End-stage renal disease patients (eGFR <15 and/or dialysis, n = 47) were excluded from the study. RESULTS:Before AVR, eGFR in the NoCKD, ModCKD and SevCKD groups was 81.3 ± 14.2, 48.9 ± 8.10 and 25.3 ± 4.12 ml/min/1.73 m(2), respectively. NoCKD patients showed a decline in eGFR during the first month postoperatively; thereafter, eGFR remained stable over 1 year. ModCKD and SevCKD patients demonstrated an initial improvement in eGFR, which peaked at 1 week postoperatively. In ModCKD, eGFR stabilized at a slightly lower level thereafter out to 1-year follow-up. In SevCKD, eGFR declined slightly out to 6 months postoperatively. Regardlessly, eGFR in ModCKD at 1 year and in SevCKD at 6 months postoperatively demonstrated sustained improvement over baseline eGFR. Reversibility of CKD was associated with a better long-term survival in the ModCKD group (P < 0.001) and short-term survival in the SevCKD group (P = 0.018). CONCLUSIONS:AVR confers a marked initial improvement in eGFR, which is sustained in patients with ModCKD and SevCKD, and is associated with a better survival. The reversible nature of CKD in certain patients warrants careful consideration during preoperative risk scoring and stratification.
PMID: 26180091
ISSN: 1569-9285
CID: 3572182

Feasibility and safety of continuous retrograde administration of Del Nido cardioplegia: a case series

Najjar, Marc; George, Isaac; Akashi, Hirokazu; Nishimura, Takashi; Yerebakan, Halit; Mongero, Linda; Beck, James; Hill, Stephen C; Takayama, Hiroo; Williams, Mathew R
BACKGROUND:Del Nido (DN) cardioplegia, a calcium-free, hyperkalemic solution containing lidocaine and magnesium has been developed to help reduce intracellular calcium influx and the resulting myocyte damage in the immediate postischemic period following cardiac arrest. DN cardioplegia has been used for pediatric cardiac surgery but its use in complex reoperative surgery has not been studied. We specifically report the outcomes of patients undergoing reoperative cardiac surgery after previous coronary artery bypass grafting with a patent internal mammary artery (IMA). METHODS:Patients undergoing reoperative cardiac surgery with prior coronary bypass grafting surgery were studied between 2010 and 2013. Fourteen patients were identified who required continued retrograde cardioplegia administration. In all cases, an initial antegrade dose was given, followed by continuous retrograde administration. Demographics, co-morbidities, intra-operative variables including cardioplegia volumes, post-operative complications, and patient outcomes were collected. RESULTS:The mean age of all patients was 73.3+/-6.7 years, and 93 % were male. Aortic cross clamp time and cardiopulmonary bypass times were 81+/-35 and 151+/-79 mins, respectively. Antegrade, retrograde and total cardioplegia doses were 1101+/-398, 3096+/-3185 and 4367+/-3751 ml, respectively. An average of 0.93+/-0.92 inotropes and 1.50+/-0.76 pressors were used on ICU admission after surgery. ICU and total hospital lengths of stay were 5.5+/-7.4 and 9.6+/-8.0 days, respectively. Complications occurred in two patients (14 %) (pneumonia and prolonged mechanical ventilation) and new arrhythmias occurred in five patients (36 %) (four new-onset atrial fibrillation and one pulseless electrical activity requiring 2 min of chest compression). No perioperative myocardial infarctions were noted based on electrocardiograms and cardiac serum markers. Postoperatively, left ventricular function was preserved in all patients whereas two patients (14 %) had mild decrease in right ventricular function as assessed by echocardiography. No mortality was observed. CONCLUSION/CONCLUSIONS:Del Nido cardioplegia solution provides acceptable myocardial protection for cardiac surgery that requires continuous retrograde cardioplegia administration. DN cardioplegia's administration in a continuous retrograde fashion with a patent IMA is believed to provide adequate myocardial protection while avoiding injuring the IMA through dissection and clamping.
PMCID:4662002
PMID: 26612068
ISSN: 1749-8090
CID: 3572192

Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes

Kodali, Susheel; Pibarot, Philippe; Douglas, Pamela S; Williams, Mathew; Xu, Ke; Thourani, Vinod; Rihal, Charanjit S; Zajarias, Alan; Doshi, Darshan; Davidson, Michael; Tuzcu, E Murat; Stewart, William; Weissman, Neil J; Svensson, Lars; Greason, Kevin; Maniar, Hersh; Mack, Michael; Anwaruddin, Saif; Leon, Martin B; Hahn, Rebecca T
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

Implementation of a moderate sedation protocol for transfemoral transcatheter aortic valve replacement: A review at 6 months [Meeting Abstract]

Neuburger, P; Potosky, R; Ursomanno, P; Abdallah, R; Saric, M; Benenstein, R J; Staniloae, C S; Slater, J; Querijero, M; Williams, M
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