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.
...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).
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.
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.
Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical ...(premarket approval TA PMA-TA) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR.
In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year.
Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients.
Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.
Previous coronary artery bypass grafting increases predicted operative risk for conventional valve replacement, according to the Society of Thoracic Surgeons risk algorithm. Additionally, the ...presence of coronary artery disease (CAD) has been demonstrated to increase procedural risk with conventional aortic valve replacement. Significant coexisting CAD requires preemptive percutaneous coronary intervention (PCI) in patients under consideration for transcatheter aortic valve implantation (TAVI). This study examined the impact of previous coronary artery bypass grafting or PCI on procedural outcomes and overall survival in patients having TAVI.
Two hundred and one high-risk patients were enrolled in two international feasibility studies from December 2005 to February 2008 for the treatment of aortic stenosis using TAVI. Thirty patients were excluded from analysis due to failure to successfully deploy the valve in the aortic annulus. Data were collected concurrently using an ad hoc database that included operative and long-term survival. Previous cardiovascular intervention prior to TAVI was used to identify the existence of concomitant CAD. Logistic regression along with Kaplan-Meier estimates were employed to establish the association between CAD and survival from TAVI.
Overall mortality after TAVI was significantly higher among the CAD group (35.7%) in contrast with the non-CAD patients (18.4%), p = 0.01. Logistic regression analysis found that patients who had CAD were 10.1 times more likely to die (95% confidence interval 2.1 to 174.8) within 30 days of the procedure than those who did not. Proportional hazards analysis established that the risk of dying at any point in time was 2.3 times higher among the patients with CAD (95% confidence interval 1.29 to 4.17). Kaplan-Meier survival curves demonstrate improved long-term survival among patients without CAD.
Coexisting coronary artery disease negatively impacts procedural outcomes and long-term survival in patients undergoing TAVI, and implies that risk assessment and anticipated outcomes might be inaccurate due to stratification as isolated aortic valve replacement rather than AVR+CABG. Comparison of procedural outcomes, based on operative approach without controlling for unequal distribution of CAD in the cohorts, are likely invalid.
The Society of Thoracic Surgeons Clinical Practice Guidelines are intended to assist physicians and other health care providers in clinical decision making by describing a range of generally ...acceptable approaches for the diagnosis, management, or prevention of specific diseases or conditions. These guidelines should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the same results. Moreover, these guidelines are subject to change over time, without notice. The ultimate judgment regarding the care of a particular patient must be made by the physician in light of the individual circumstances presented by the patient.
Objectives The logistic European System for Cardiac Operative Risk Evaluation (LES) score and the Society of Thoracic Surgeons (STS) score are validated to predict 30-day outcomes following surgical ...aortic valve replacement (SAVR) with or without coronary artery bypass grafting. Their performance when applied to patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. Methods We compared predicted and observed 30-day/in-hospital and 1-year mortality of patients undergoing TAVR in the first Placement of Aortic Transcatheter Valves trial and continued access registry (N = 2466). The performance of the LES and STS scores (prospectively calculated) was evaluated using standard assessments of discrimination and calibration. Performance of STS and LES scores among 307 patients undergoing SAVR from the high-risk cohort of the randomized trial were also examined. Results In patients undergoing TAVR, the observed 30-day/in-hospital mortality was 6.5%, whereas the predicted 30-day mortality was higher by both STS score (11.4% ± 3.9%) and LES score (26.6% ± 16.2%). The discrimination for both scores was poor for 30-day/in-hospital and 1-year mortality. Calibration was better for STS score than for LES at 1 year but poor for both at 30 days among TAVR cohort. These results were consistent among the subgroups of patients undergoing transfemoral and transapical access; however, the STS score had better performance among the high-risk patients who underwent SAVR at 30 days but not 1 year. Conclusions The STS and LES surgical risk scores overestimated 30-day/in-hospital mortality and were poor discriminators of post-TAVR mortality, but the calibration of the STS score was better in these high-risk patients. These data highlight the need for TAVR-specific risk models to optimize patient selection.
The introduction of transcatheter aortic valves has focused attention on outcomes after open aortic valve replacement (AVR) in very high-risk patients. This study analyzes the short-term and midterm ...outcomes of AVR in this patient cohort in the current surgical era.
A retrospective review was performed on 159 patients who underwent isolated, primary AVR with a STS PROM (Society of Thoracic Surgeons predicted risk of mortality) of 10% or greater from January 2002 to December 2007 at four US academic institutions. Patients with previous valve operations were excluded. A multivariable model was constructed to determine predictors of in-hospital mortality. Estimates of the cumulative event rate mortality were calculated by the Kaplan-Meier method.
The mean age of all patients was 76.1±11.2 years, most were men (92 of 159, 57.9%), and mean STS PROM was 16.3%±7.3%. Significant preoperative factors included the following: peripheral vascular disease, 33.3% (53 of 159); stroke, 23.3% (37 of 159); renal failure, 50.3% (80 of 159); New York Heart Association class III-IV heart failure, 78.0% (124 of 159); and previous coronary artery bypass grafting, 39.0% (62 of 159). Mean ejection fraction was 0.461±0.153 and median implanted valve size was 23 mm. Postoperative complications included the following: stroke, 4.4% (7 of 159); heart block, 5.0% (8 of 159); multisystem organ failure, 6.9% (11 of 159); pneumonia, 7.5% (12 of 159); and dialysis, 8.2% (13 of 159). Postoperative length of stay was 12.6±11.0 days and in-hospital mortality was 16.4% (26 of 159). One-, three-, and 5-year survival was 70.9%, 56.8%, and 47.4%, respectively.
In the current era, high-risk surgical patients undergoing open AVR have respectable short and mid-term survival. These results should serve as a benchmark for evaluating outcomes of transcatheter aortic valve implantation.
Transapical aortic valve implantation is a new minimally invasive technique for beating heart, off-pump, aortic valve implantation in high-risk patients.
The procedure involves antegrade aortic valve ...implantation using an oversizing technique with direct access and accurate positioning of a stent-based transcatheter xenograft. Procedural steps include placement of femoral arterial and venous access wires, anterolateral mini-thoracotomy, epicardial pacing, and apical pursestring suture placement. Valve positioning is performed under fluoroscopic and echocardiographic guidance during rapid ventricular pacing.
Patient screening, especially regarding native aortic annulus diameter and pattern of calcification, is essential for success. Since imaging is crucial, implantations are optimally performed in a hybrid operative theater by an experienced team of cardiac surgeons, cardiologists, and anesthetists.
The aim of this article is to outline the technical aspects of the new technique of minimally invasive transapical aortic valve implantation.
Objective Risk algorithms were used to identify a high-risk population for transcatheter aortic valve implantation instead of standard aortic valve replacement in patients with aortic stenosis. We ...evaluated the efficacy of these methods for predicting outcomes in high-risk patients undergoing aortic valve replacement. Methods Data were collected on 638 patients identified as having isolated aortic valve replacement between January 1, 1998 and December 31, 2006, using The Society of Thoracic Surgeons (STS) database. Long-term survival was determined from the Social Security Death Index or family contact. Operative risk was calculated using the STS Predicted Risk of Mortality, the EuroSCORE logistic and additive algorithms, and the Ambler Risk Score. Patients at or above the 90th percentile of risk (8.38% for STS, 33.47% for logistic, 12% for additive, 14.3% for Ambler) were identified as high risk. We then compared actual with predicted mortality and each algorithm’s ability to identify patients with the worst long-term survival. Results Operative mortality was 24 of 638 (3.76%). An additional 121 (19.0%) patients died during the follow-up study period (mean 4.2 ± 2.7 years). Overall mortality was 145 of 638 (22.7%). Expected versus observed mortality for the high-risk group by algorithm was 13.3% versus 18.8% for STS, 50.9% versus 15.6% for logistic, 14.0% versus 11.9% for additive, and 19.0% versus 13.4% by Ambler. Long-term mortality, per high-risk group, was 64.1% in the STS Predicted Risk of Mortality, 45.3% in the logistic, 45.2% in the additive, and 40.2% in Ambler Risk Score. Logistic regression showed that the STS algorithm was the most sensitive in defining the patients most at risk for long-term mortality. Conclusion The STS Predicted Risk of Mortality most accurately predicted perioperative and long-term mortality for the highest risk patients having aortic valve replacement.
Valve-in-a-Valve Concept for Transcatheter Minimally Invasive Repeat Xenograft Implantation Thomas Walther, Volkmar Falk, Todd Dewey, Jörg Kempfert, Fabian Emrich, Bettina Pfannmüller, Petra Bröske, ...Michael A. Borger, Gerhard Schuler, Michael Mack, Friedrich W. Mohr Valve-in-a-valve (VinV) implantation was developed to reduce the reoperative risk for degenerated xenografts. The VinV implantation was safely performed in 7 pigs on the beating heart. All valves were firmly positioned, and there were neither migration nor paravalvular or transvalvular leaks. In addition, good hemodynamic function and patent coronary arteries were confirmed in all animals. The VinV implantation is a promising new technique for minimally invasive beating heart repeat aortic or mitral valve replacement.
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