Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve ...replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% P = .0145 for death and 19.2% vs 8.5% P = .0008 for acute kidney injury). Conclusions In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.
Background Right-side heart sarcomas tend to be bulky, infiltrative, and difficult to treat. We have previously examined our outcomes with right heart sarcomas. Surgical resection with R0 margins ...showed better survival than positive margins but in only one third of cases could R0 status be achieved. The hypothesis for this study was that preoperative neoadjuvant chemotherapy would shrink the tumor margins and allow an increase in R0 resection, and hence, better survival. Methods Review of our cardiac tumor database from 1990 to 2015 yielded 133 primary cardiac sarcoma cases. Of these, we identified 44 patients with primary right-side heart sarcomas. Prospective database and retrospective data collection and clinical outcomes were evaluated for all 44 patients. Primary outcomes included 30-day mortality and morbidity and long-term survival. We used univariate and multivariate analyses to identify independent predictors of overall survival. Results There were 27 male and 17 female patients with a mean age of 41 ± 12.7 years (range, 15 to 67). Seventy-three percent of the patients (32 of 44) received neoadjuvant chemotherapy. The most common tumor histology was angiosarcoma in 30 of 44 (68%). Thirty-day mortality was 4.5%, and statistically similar between the two groups. The median survival of patients who had R0 resection was 53.5 months compared with 9.5 months for R1. Neoadjuvant chemotherapy led to a doubling of survival (20 versus 9.5 months). Conclusions Neoadjuvant chemotherapy followed by radical surgery is a safe and effective strategy in patients with primary right-side heart sarcoma. This multimodality treatment enhances resectability (R0 resection) that translates into improved patient survival.
Causes of death from the randomized CoreValve US Pivotal High-Risk Trial Gaudiani, Vincent, MD; Deeb, G. Michael, MD; Popma, Jeffrey J., MD ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
06/2017, Letnik:
153, Številka:
6
Journal Article
Recenzirano
Odprti dostop
Abstract Objective Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial. Methods An independent clinical events committee adjudicated causes of death, followed by post hoc ...hierarchical classification. Baseline characteristics, early outcomes and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days). Results Differences in the rate of death were evident only during the recovery period (31-120 days), whereas 15 patients undergoing transcatheter aortic valve replacement (TAVR) (4.0%) and 27 surgical aortic valve replacement (SAVR) patients (7.9%) died ( P = .025). This mortality difference was largely driven by higher rates of technical failure, surgical complications, and lack of recovery following surgery. From 0 to 30 days, the causes of death were more technical failures in the TAVR group and lack of recovery in the SAVR group. Mortality in the late period (121-365 days) in both arms was most commonly ascribed to other circumstances, comprising death from medical complications from comorbid disease. Conclusions Mortality at 1 year in the CoreValve US Pivotal High-Risk Trial favored TAVR over SAVR. The major contributor was that more SAVR patients died during the recovery period (31-121 days), likely affected by the overall influence of physical stress associated with surgery. Similar rates of technical failure and complications were observed between the 2 groups. This suggests that early TAVR results can improve with technical refinements and that high-risk surgical patients will benefit from reducing complications.
Abstract Objectives The aim of this study was to determine the relationship between aortoventricular (AoV) angulation on clinical outcomes after self-expanding transcatheter aortic valve replacement ...(TAVR) in patients with severe aortic stenosis who were deemed suboptimal for surgery. Background Multidetector computed tomographic (MDCT) imaging of the aortovalvular complex has become a prerequisite for case planning with self-expanding TAVR. The effect of aortic angulation, an index of an unfolded or “horizontal” aorta, on procedural outcome after self-expanding TAVR is not known. Methods The clinical course of 3,578 patients who received implants in the CoreValve US Clinical Trials and who had prospective MDCT estimation of the AoV angle before the procedure was reviewed. Clinical site echocardiogram assessments were used to determine the degree of residual aortic regurgitation 24 to 48 h after the procedure and at 30 days. On the basis of the measurement of the AoV angle on MDCT, patients were categorized into septiles, ranging from the lowest septile of an AoV angle <37.0° to the highest AoV angle septile of >55.0°. Results Patients were elderly (age 83.3 ± 7.8 years) and were at high risk for surgical valve replacement (Society of Thoracic Surgeons Predicted Risk of Mortality 8.8 ± 4.7). Greater degrees of AoV angulation were correlated with older age (p < 0.0001). Although procedure time was 6.9 min longer in the highest septile (59.4 ± 35.9 min vs. 52.5 ± 35.3 min in the lowest septile; p = 0.004), there were no linear trends (p > 0.05) in the frequencies of device success, procedural success, frequencies of moderate or greater aortic regurgitation at 30 days, number of valves implanted, or need for balloon post-dilation or new pacemakers among the AoV angle septiles. Conclusions The degree of AoV angulation does not affect early clinical outcomes self-expanding transcatheter aortic valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement Medtronic CoreValve® U.S. Pivotal Trial; NCT01240902 )
Abstract The objective of this study was to compare outcomes in women following surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) utilizing a ...self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for surgical AVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in TAVR patients (33.3% versus 45.3%; P = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared to SAVR patients (12.7% versus 21.8%; P = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs. 24.2%; P = 0.04). Quality of life (QoL), as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared to females undergoing SAVR, with both cohorts experiencing improved QoL. Further studies specifically in women are warranted to validate these findings.
Background End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated ...with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. Methods The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. Results Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm2 , mean gradient 9.33 mm Hg) Conclusions Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.
Abstract Objectives This study sought to explore the impact of balloon post-dilation (BPD) on outcomes in the CoreValve US Clinical Trials. Background BPD following transcatheter aortic valve ...replacement (TAVR) has been used in selected cases to optimize hemodynamic results. Methods Procedural details of 3,532 patients were examined to determine whether BPD was performed after self-expanding TAVR. “Best practice” guidelines recommended BPD for treatment of suboptimal intraprocedural valve function, primarily manifested by moderate or severe residual aortic regurgitation (AR). Results Procedural BPD was performed in 782 patients (22%) patients. The most common (58.1%) indication was greater than or equal to moderate AR following valve deployment. Greater baseline aortic valve gradients (p < 0.001), higher grades of baseline AR (p < 0.001), larger annular diameters (p < 0.001), and lower device to annular ratios (p < 0.001) were more common in patients who underwent BPD. BPD was performed less often with the 26-mm valve (17.9%) compared to the 31 mm (38.1%) (p < 0.05). BPD reduced moderate or severe AR by 75.6% from 58.1% to 14.2%. Thirty-day and 1-year clinical events were similar in the 2 groups, although acute kidney injury was more common in patients undergoing BPD (p = 0.026). In-hospital major adverse cardiovascular and cerebrovascular event rates were 9.3% in the BPD group versus 7.5% for others (p = NS). There was no increase in neurological events. Conclusions BPD of the self-expanding bioprosthesis was performed in 22% of patients in the CoreValve US Clinical Trials most commonly to reduce the degree of residual AR. BPD was effective in acutely improving valve performance without an associated increase in neurologic events. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 ; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement; NCT01531374 )
Abstract Objectives This study was designed to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following ...transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients. Methods High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment. Results The 30-day, 1-year, and 2-year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR ( P = .46, .11, and .05, respectively). All-cause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years ( P = .29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke post-TAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke. Conclusions This study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR.
Background Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are treatment options for aortic stenosis in patients with prior coronary artery bypass graft ...surgery. We assessed the major clinical outcomes of such patients enrolled in the CoreValve High Risk (CHR) study. Methods Of the 795 CHR study patients, 226 had prior coronary artery bypass graft surgery; 115 underwent TAVR and 111 underwent SAVR. The primary endpoint was a comparison of all-cause mortality at 1 year. Important secondary clinical endpoints were assessed. Results At 1 year, all-cause mortality was 9.6% for TAVR versus 18.1% for SAVR ( p = 0.06); cardiovascular mortality was 7.0% for TAVR versus 13.8% for SAVR ( p = 0.09). A combination of The Society of Thoracic Surgeons risk score greater than 7 and age greater than 80 years was a significant predictor of mortality, with TAVR demonstrating a survival advantage ( p = 0.03). No differences were seen for stroke. The SAVR group had longer intensive care unit and hospital stays, increased incidence of acute kidney injury, life-threatening or disabling bleeding, and major adverse cardiac and cerebrovascular events ( p < 0.05). Pacemaker implantation and paravalvular regurgitation were greater with TAVR at all timepoints. Conclusions For patients with prior coronary artery bypass graft surgery and aortic stenosis, TAVR offers a significant morbidity advantage and a strong trend toward improved survival over SAVR at 1 year.
Background Cardiac paragangliomas are an extremely rare subset of chromaffin cell tumors that develop from neural crest cells. Methods Between March 2004 and October 2010, 7 male patients from our ...two institutions who underwent surgical resection of cardiac paraganglioma were retrospectively reviewed. Results In 5 patients, paragangliomas originated from the roof of the left atrium, and in 2 patients, they originated from the aortic root. Hospital mortality was 14%. Conclusions Complete surgical resection remains the mainstay of therapy and can be curative, but carries a significant risk of intraoperative bleeding and usually requires cardiopulmonary bypass and often complex resection techniques, including cardiac autotransplantation.
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