Summary Background Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate ...risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement. Methods In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve 952 88% via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes. Findings At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of −9·2%; 90% CI −12·4 to −6; p<0·0001) and superior (−9·2%, 95% CI −13·0 to −5·4; p<0·0001) to surgical valve replacement. Interpretation TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients. Funding None.
Objective Patients undergoing cardiac surgery with a history of untreated atrial fibrillation have reduced survival compared with similar patients without atrial fibrillation. We sought to compare ...the midterm survival of patients who received concomitant surgical ablation treatment for atrial fibrillation (atrial fibrillation ablated) with that of matched patients without a history of atrial fibrillation (no atrial fibrillation). Methods We evaluated 3262 consecutive patients (813 25% with atrial fibrillation and 2449 75% without preoperative atrial fibrillation) undergoing cardiac surgery at a single institution from April 2004 to April 2009. Of patients with atrial fibrillation, 565 (70%) were treated with a concomitant surgical ablation procedure. Propensity scores were calculated on the basis of 37 known preoperative risk factors and yielded 744 patients. Midterm survival was compared between patients with atrial fibrillation ablation (n = 372) and patients without atrial fibrillation (n = 372). Survival was also compared between patients with successful vs unsuccessful ablation, and a matched analysis was performed at 1 year between the 2 groups. Results Mean follow-up was 2.7 ± 1.6 years. Patients without atrial fibrillation and patients with treated atrial fibrillation had similar early 30-day mortality (1.2% vs 0.3%, P = .37) and overall mortality rates (11.6% vs 9.4%, P = .344), respectively. Survival analysis showed no differences at 1, 3, and 5 years between the 2 groups (log-rank P = .22). At last follow-up, 78% of treated patients were free of atrial fibrillation. At 1 year, 68% of patients were free of atrial fibrillation and antiarrhythmic medication. Freedom from atrial fibrillation and antiarrhythmic medication at 1 year predicted improved midterm survival ( P = .03) compared with patients in atrial fibrillation or taking antiarrhythmic medication. Propensity-matched analysis after 1 year demonstrated improved survival for patients who were successfully treated ( P = .016). Conclusions Patients undergoing surgical treatment of atrial fibrillation had survival similar to that of patients without a history of atrial fibrillation. Those with successful sinus restoration had improved survival compared with those who were treated but remained in atrial fibrillation.
Frailty is a syndrome of older adults associated with increased morbidity and mortality. We aimed to assess the impact of frailty status on outcomes after transcatheter aortic valve implantation ...(TAVI). We reviewed all 191 patients who underwent a modified Fried frailty assessment before TAVI between February 2012 and September 2015 at a single academic medical center, and we assessed the impact of preoperative frailty status on morbidity, mortality, and health care utilization after TAVI. Frailty, pre-frailty, and nonfrailty were present in 33% (n = 64), 37% (n = 70), and 30% (n = 57) of patients, respectively. Slowness (75% vs 54%, p = 0.003) and low physical activity (55% vs 31%, p = 0.001) were more common in women than men. With increasing frailty status, the proportion of women increased (35% nonfrail, 44% pre-frail, and 66% frail, p = 0.002) and stature decreased (1.68 ± 0.11 m nonfrail, 1.66 ± 0.11 m pre-frail, 1.62 ± 0.12 m frail, p = 0.028). There was no difference in post-TAVI 30-day mortality, stroke, major vascular injury, major or life-threatening bleeding, respiratory failure, mean hospital length of stay, 30-day hospital re-admission, or overall survival between groups. The rate of discharge to a rehabilitation facility increased with increasing frailty status (14% nonfrail, 22% pre-frail, and 39% frail, p = 0.005). Frailty was independently associated with discharge to a rehabilitation facility (odds ratio 4.80, 95% confidence interval 1.66 to 13.85, p = 0.004). In conclusion, the safety of TAVI is not affected by frailty status, but patients with frailty are less likely to be discharged directly home after TAVI.
Topical hemostatic agents are used in conjunction with conventional procedures to reduce blood loss. They are often used in cardiothoracic surgery, which is particularly prone to bleeding risks. ...Variation in their use exists because detailed policy and practice guidelines reflecting the current medical evidence have not been developed to promote best surgical practice in this setting. To address this need, the Society for the Advancement of Blood Management convened an International Hemostatic Expert Panel. This article reviews the available literature and sets out evidence-based recommendations for the use of topical hemostatic agents in cardiothoracic surgery.
Background Severe symptomatic aortic stenosis (AS) is associated with high mortality without intervention. The impact of waiting time for aortic valve replacement (AVR), either surgically or ...transcatheter, has not been reported. Methods From January 2008 to December 2012, we identified 1,005 patients with severe symptomatic AS. AVR was recommended for 823 patients (82%). Of these 823 patients, 721 (87.6%) underwent AVR. We modeled overall survival (OS) since AVR recommendation or intervention date using Cox and multistate models. Results Overall, the median (first, third quartiles) waiting time until operation was 2.9 (1.3, 5.1) weeks. Mortality at these times was lower ( p < 0.001) in the AVR group (1.2%, 0.3%, 1.7%, respectively) than in the group that did not receive AVR (6.9%, 2.9%, 9.8%, respectively). Thirty-day mortality after AVR was 3.9% (3.2% surgical AVR SAVR and 7.0% transcatheter AVR TAVR). In patients receiving AVR, waiting time was not associated with increased mortality. Mortality while waiting for AVR was 3.7% and 11.6% at 1 and 6 months, respectively. Mortality while waiting for TAVR was higher than that for SAVR (1-, 6-, and 12-month mortality of 3.7%, 8.0%, and 9.6%, respectively, in SAVR group and 3.8%, 23.3%, and 27.5%, respectively, in TAVR group; p < 0.001). Conclusions Some patients do not receive AVR in a timely fashion, and prolonged waiting time for AVR is associated with mortality greater than the AVR operative mortality. Although waiting time was not associated with poor operative outcomes after AVR, many patients may die while waiting for AVR. Patients should receive AVR on a semiurgent, not elective, basis.
Statin therapy is associated with improved survival in patients at high risk for cardiovascular mortality, but the impact of statin therapy in patients treated with transcatheter aortic valve ...replacement (TAVR) is unknown. We reviewed 294 consecutive cases of TAVR performed at a single tertiary care medical center. We defined high-intensity statin therapy as atorvastatin 40 to 80 mg/day or rosuvastatin 20 to 40 mg/day. Study outcomes included post-TAVR adverse events, 30-day mortality, and overall survival. At the time of TAVR, 14% (n = 41) were on high-intensity statin therapy, 59% (n = 173) were on low- or moderate-intensity statin therapy, and 27% (n = 80) were not on statin therapy. There was no association between statin therapy and the rate of post-TAVR stroke, myocardial infarction, acute kidney injury, in-hospital mortality, or 30-day mortality. At 2 years, 83% of patients in the high-intensity statin group were alive, 70% in the low/moderate-intensity statin group were alive, and 57% in the no statin group were alive (log-rank p = 0.016). In a risk-adjusted model, high-intensity statin therapy was associated with a 64% reduction in all-cause mortality (hazard ratio 0.36, 95% CI 0.14 to 0.90, p = 0.029) compared with no statin therapy. In conclusion, statin therapy is associated with improved overall survival after TAVR in a dose-dependent manner.
Background The purpose of this study is to compare aortic hemodynamics and blood flow patterns using in-vivo four-dimensional (4D) flow magnetic resonance imaging (MRI) in patients after ...valve-sparing aortic root replacement (VSARR) and aortic root replacement with bioprosthetic valves (BIO-ARR). Methods In-vivo 4D flow MRI was performed in 11 patients after VSARR (47 ± 18 years, 6 bicuspid aortic valves, 5 trileaflet aortic valves), 16 patients after BIO-ARR (52 ± 14 years), and 10 healthy controls (47 ± 16 years). Analysis included three-dimensional blood flow visualization and grading of helix flow in the ascending aorta (AAo) and arch. Peak systolic velocity was quantified in 9 analysis planes in the AAo, aortic arch, and descending aorta. Flow profile uniformity was evaluated in the aortic root and ascending aorta. Results Peak systolic velocity (2.0 to 2.5m/second) in the aortic root and AAo in both VSARR and BIO-ARR were elevated compared with controls (1.1 to 1.3m/second, p < 0.005). Flow asymmetry in BIO-ARR was increased compared with VSARR, evidenced by more AAo outflow jets (9 of 16 BIO-ARR, 0 of 11 in VSARR). The BIO-ARR exhibited significantly ( p < 0.001) increased helix flow in the AAo as a measure of increased flow derangement. Finally, peak systolic velocities were elevated at the aortic root for BIO-ARR (2.5 vs 2.0m/second, p < 0.05) but lower in the distal AAo when compared with VSARR. Conclusions The VSARR results in improved hemodynamic outcomes when compared with BIO-ARR, as indicated by reduced peak velocities in the aortic root and less helix flow in the AAo by 4D flow MRI. Longitudinal research assessing the clinical impact of these differences in hemodynamic outcomes is warranted.
Background Controversy exists when performing surgical atrial fibrillation ablation whether there is an increase in postoperative complications using biatrial (BA) lesions compared with only left ...atrial (LA) lesions, and some studies indicate similar efficacy. This study compares the clinical outcomes of BA and LA ablation lesions in mitral valve surgery patients. Methods From 2004 through 2014, 2,137 patients had mitral valve surgery with or without other surgeries in a single center. Of those, 836 (39%) had preoperative atrial fibrillation, and of those, 724 (86%) underwent atrial fibrillation ablation surgery; 257 patients had BA lesion sets and 359 had LA lesion sets. Propensity score matching of BA and LA patients was performed. Results Baseline differences included more postoperative complications in the BA group, specifically, permanent pacemaker placement (13% versus 7%; p = 0.006). Freedom from atrial fibrillation off antiarrhythmic drugs (72% BA versus 75% LA; p = 0.50), postoperative ablation (7% BA versus 5% LA; p = 0.20), stroke (0.11 versus 0.11 per 10 person-years; p = 0.91), and survival were similar between the groups. After matching, patients in the LA group had a higher freedom from postoperative ablation ( p = 0.015), but no difference in freedom from atrial fibrillation off antiarrhythmic drugs (79% BA versus 69% LA; p = 0.09), and no difference in permanent pacemaker placement (10% versus 12%; p = 0.57). Conclusions Patients undergoing mitral surgery with LA or BA ablation had similar outcomes, survival, and complications. Limiting lesions to the LA is an effective alternative to BA ablation for patients undergoing ablation with concomitant mitral valve surgery.
Little is known about baseline diastolic dysfunction and changes in diastolic dysfunction grade after transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) and its impact on overall ...outcomes. The aim of this study was to describe baseline diastolic dysfunction and changes in diastolic dysfunction grade that occur with TAVR and their relationship to mortality and rehospitalization.
This was a single-center study evaluating all TAVRs from January 2012 to June 2014. We compared parameters of diastolic dysfunction grade on pre-TAVR and 1 month post-TAVR echocardiograms for all patients undergoing the procedure. Descriptive statistics, Kaplan-Meier time-to-event analysis, and multivariate logistic regression were used.
Of a sample size of 120 patients undergoing TAVR for symptomatic severe AS, 90 were included in the final analysis after excluding significant mitral valve disease. There were improvements in individual parameters of diastolic dysfunction grade such as lateral e' velocity, E/lateral e', and left atrial volume index (nonsignificant trend) in the setting of improvement in aortic valve area and gradients and functional class pre- and post-TAVR. Multivariate analysis revealed that baseline diastolic dysfunction grade, but not post-TAVR or changes in diastolic dysfunction grade, was associated with 1-year death (hazard ratio, 1.163; 95% CI, 1.049-1.277, P = .005) and combined death/cardiovascular hospitalization (hazard ratio, 1.174; 95% CI, 1.032-1.318; P = .018).
In this single-center retrospective study of patients with symptomatic severe AS who underwent TAVR, several diastolic function parameters improved on echocardiography, but baseline diastolic dysfunction grade remained the most important echocardiographic factor associated with adverse 1-year outcomes.
Objective We assessed the incidence and outcomes of graft-related secondary interventions (ie, open conversion or proximal or distal extensions) after elective thoracic endovascular aortic repair ...(TEVAR) for aneurysmal disease. Methods An institutional review of TEVAR for descending thoracic aortic aneurysms (DTAAs), between 2000 and 2011, was performed. Only elective TEVAR for DTAA using commercially available endografts was selected. Emergent cases, nonaneurysmal aortic pathology (ie, transection, pseudoaneurysm, dissection), and cases that used physician-modified devices were excluded. The incidence of unplanned graft-related secondary interventions was examined and outcomes were analyzed. Results During the study period, 83 patients underwent elective TEVAR for DTAA that met the inclusion criteria. Subsequent graft-related secondary interventions were required in eight patients (10%). The mean interval to the secondary intervention was 31.8 months. Endoleak was the most common indication. Patients who required secondary interventions were significantly younger (mean age, 58 ± 12 vs 69 ± 11 years; P < .05). Operative mortality (<30 day) was zero, with one aneurysm-related late death occurring at 2 years after the secondary intervention. Factors that predisposed the need for secondary interventions were fusiform morphology of the aneurysm ( P = .05) and extent of graft coverage in the proximal landing zone <3 cm ( P < .05). Size of the aneurysm treated and the type of device used were not significant factors leading to secondary intervention. Conclusions Intermediate and long-term results of elective TEVAR for DTAA demonstrate good durability, with acceptable rates of graft-related secondary interventions. Age, fusiform aneurysm morphology, and extent of proximal landing zones <3 cm were significant factors that led to subsequent secondary interventions.
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