Performance of Surgical Risk Scores to Predict Mortality after Transcatheter Aortic Valve Implantation

AbstractBackground:Predicting mortality in patients undergoing transcatheter aortic valve implantation (TAVI) remains a challenge.Objectives:To evaluate the performance of 5 risk scores for cardiac surgery in predicting the 30-day mortality among patients of the Brazilian Registry of TAVI.Methods:The Brazilian Multicenter Registry prospectively enrolled 418 patients undergoing TAVI in 18 centers between 2008 and 2013. The 30-day mortality risk was calculated using the following surgical scores: the logistic EuroSCORE I (ESI), EuroSCORE II (ESII), Society of Thoracic Surgeons (STS) score, Ambler score (AS) and Guaragna score (GS). The performance of the risk scores was evaluated in terms of their calibration (Hosmer–Lemeshow test) and discrimination [area under the receiver–operating characteristic curve (AUC)].Results:The mean age was 81.5 ± 7.7 years. The CoreValve (Medtronic) was used in 86.1% of the cohort, and the transfemoral approach was used in 96.2%. The observed 30-day mortality was 9.1%. The 30-day mortality predicted by the scores was as follows: ESI, 20.2 ± 13.8%; ESII, 6.5 ± 13.8%; STS score, 14.7 ± 4.4%; AS, 7.0 ± 3.8%; GS, 17.3 ± 10.8%. Using AUC, none of the tested scores could accurately predict the 30-day mortality. AUC for the scores was as follows: 0.58 [95% confidence interval (CI): 0.49 to 0.68, p = 0.09] for ESI; 0.54 (95% CI: 0.44 to 0.64, p = 0.42) for ESII; 0.57 (95% CI: 0.47 to 0.67, p = 0.16) for AS; 0.48 (95% IC: 0.38 to 0.57, p = 0.68) for STS score; and 0.52 (95% CI: 0.42 to 0.62, p = 0.64) for GS. The Hosmer–Lemeshow test indicated acceptable calibration for all scores (p > 0.05).Conclusions:In this real world Brazilian registry, the surgical risk scores were inaccurate in predicting mortality after TAVI. Risk models specifically developed for TAVI are required.

Surgical risk tests related to cardiopulmonary postoperative complications: comparison between upper abdominal and thoracic surgery

PURPOSE: To investigate if tests used in the preoperative period of upper abdominal or thoracic surgeries are able to differentiate the patients that presented cardiopulmonary postoperative complications. METHODS: Seventy eight patients, 30 submitted to upper abdominal surgery and 48 to thoracic surgery were evaluated. Spirometry, respirometry, manovacuometry, six-minute walk test and stair-climbing test were performed. Complications from immediate postoperative to discharge from hospital were registered. RESULTS: The postoperative complications rate was 17% in upper abdominal surgery and 10% in thoracic surgery. In the univariate regression, the only variable that kept the correlation with postoperative complications in the upper abdominal surgery was maximal expiratory pressure. In thoracic surgery, the maximal voluntary ventilation, six-minute walk test and time in stair-climbing test presented correlation with postoperative complications. After multiple regression only stair-climbing test continued as an important risk predictor in thoracic surgery. CONCLUSION: The respiratory pressure could differentiate patients with complications in upper abdominal surgery, whereas in thoracic surgery, only spirometric values and exercise tests could differentiate them.

Clinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality

Objectives The aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased surgical risk. Background Elderly patients with comorbidities are at considerable risk for SAVR. Methods Since July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry. Results Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p < 0.001) and had a lower predicted peri-operative risk (p < 0.001). Unadjusted rates of all-cause mortality at 30 months were lower for SAVR (22.4%) and TAVI (22.6%) compared with MT (61.5%, p < 0.001). Adjusted hazard ratios for death were 0.51 (95% confidence interval: 0.30 to 0.87) for SAVR compared with MT and 0.38 (95% confidence interval: 0.25 to 0.58) for TAVI compared with MT. Medical treatment (<0.001), older age (>80 years, p = 0.01), peripheral vascular disease (<0.001), and atrial fibrillation (p = 0.04) were significantly associated with all-cause mortality at 30 months in the multivariate analysis. At 1 year, more patients undergoing SAVR (92.3%) or TAVI (93.2%) had New York Heart Association functional class I/II as compared with patients with MT (70.8%, p = 0.003). Conclusions Among patients with severe AS with increased surgical risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased risk.

Clinical outcomes of patients with estimated low or intermediate surgical risk undergoing transcatheter aortic valve implantation

AimsTranscatheter aortic valve implantation (TAVI) is an established treatment alternative to surgical aortic valve replacement in high-risk and inoperable patients and outcomes among patients with estimated low or intermediate risk remain to be determined. The aim of this study was to assess clinical outcomes among patients with estimated low or intermediate surgical risk undergoing TAVI.Methods and resultsBetween August 2007 and October 2011, 389 consecutive patients underwent TAVI and were categorized according to the Society of Thoracic Surgeons (STS) score into low (STS < 3%; n = 41, 10.5%), intermediate (STS ≥3% and ≤8%, n = 254, 65.3%), and high-risk (STS > 8%; n = 94, 24.2%) groups for the purpose of this study. Significant differences were found between the groups (low risk vs. intermediate risk vs. high risk) for age (78.2 ± 6.7 vs. 82.7 ± 5.7 vs. 83.7 ± 4.9, P < 0.001), body mass index (28.1 ± 6.1 vs. 26.5 ± 4.9 vs. 24.4 ± 4.6, P < 0.001), chronic renal failure (34 vs. 67 vs. 90%, P < 0.001), all-cause mortality at 30 days (2.4 vs. 3.9 vs. 14.9%, P = 0.001), and all-cause mortality at 1 year (10.1 vs. 16.1 vs. 34.5%, P = 0.0003). No differences were observed with regards to cerebrovascular accidents and myocardial infarction during 1-year follow-up.ConclusionIn contemporary practice, TAVI is not limited to inoperable or STS-defined high-risk patients and should be guided by the decision of an interdisciplinary Heart Team. Compared with patients at calculated high risk, well-selected patients with STS-defined intermediate or low risk appear to have favourable clinical outcomes.

A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients

This study sought to compare all-cause mortality in patients at intermediate surgical risk undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).

Matched-pair analysis of endovascular versus open surgical repair of abdominal aortic aneurysms in young patients at low risk

PURPOSE: To compare clinical outcomes of endovascular and open aortic repair of abdominal aortic aneurysms (AAAs) in young patients at low risk. It was hypothesized that endovascular aneurysm repair (EVAR) compares favorably with open aneurysm repair (OAR) in these patients. MATERIALS AND METHODS: Twenty-five patients aged 65 years or younger with a low perioperative surgical risk profile underwent EVAR at a single institution between April 1994 and May 2007 (23 men; mean age, 62 years+/-2.8). A sex- and risk-matched control group of 25 consecutive patients aged 65 years or younger who underwent OAR was used as a control group (23 men; mean age, 59 years+/-3.9). Patient outcomes and complications were classified according to Society of Vascular Surgery/International Society for Cardiovascular Surgery reporting standards. RESULTS: Mean follow-up times were 7.1 years+/-3.2 after EVAR and 5.9 years+/-1.8 after OAR (P=.1020). Total complication rates were 20% after EVAR and 52% after OAR (P=.0378), and all complications were mild or moderate. Mean intensive care unit times were 0.2 days+/-0.4 after EVAR and 1.1 days+/-0.4 after OAR (P<.0001) and mean lengths of hospital stay were 2.3 days+/-1.0 after EVAR and 5.0 days+/-2.1 after OAR (P<.0001). Cumulative rates of long-term patient survival did not differ between EVAR and OAR (P=.144). No AAA-related deaths or aortoiliac ruptures occurred during follow-up for EVAR and OAR. In addition, no surgical conversions were necessary in EVAR recipients. Cumulative rates of freedom from secondary procedures were not significantly different between the EVAR and OAR groups (P=.418). Within a multivariable Cox proportional-hazards analysis adjusted for patient age, maximum AAA diameter, and cardiac risk score, all-cause mortality rates (odds ratio [OR], 0.125; 95% CI, 0.010-1.493; P=.100) and need for secondary procedures (OR, 5.014; 95% CI, 0.325-77.410; P=.537) were not different between EVAR and OAR. CONCLUSIONS: Results from this observational study indicate that EVAR offers a favorable alternative to OAR in young patients at low risk.

Predictable drill-free screw positioning with a graduated 3-dimensional radiographic-surgical guide: A preliminary report

Introduction: Mini-implants are placed in restricted sites, requiring an accurate surgical technique. However, no systematic study has quantified technique accuracy to reliably predict the surgical risks. Therefore, a graduated 3-dimensional radiographic-surgical guide (G-RSG) was proposed, and its inaccuracy and risk index (RI) were estimated. Methods: The sample consisted of 6 subjects (4 male, 2 female), who used mini-implant anchorage. Ten drill-free screws (DFS) were placed by using the G-RSG. The central point of the mesiodistal septum width (SW) was the selected implant site on the presurgical radiograph. The distances between DFS and the adjacent teeth (5-DFS and 6-DFS) were measured to evaluate screw centralization and inaccuracy degree (ID). These distances were statistically compared by independent t tests, and inaccuracy was determined by the expression ID = (5-DFS-6-DFS)/2, which represents deviation of the mini-implant`s final position regarding the central point initially selected. Then SW, ID, and screw diameter (SO) were combined to estimate the surgical risk with RI expressed by RI = SO/SW-ID. Results: The 5-DFS and 6-DFS distances were not significantly different. The ID of the G-RSG was 0.17 mm. The low ID ensured a safe RI (<1) in spite of the restricted SW. Conclusions: The G-RSG accuracy allowed fine prediction of the final DFS position in the inter-radicular septum, with a low RI, which is a helpful tool to estimate surgical risks. (Am J Orthod Dentofacial Orthop 2009; 136: 722-35)

Results of the surgical treatment of chronic atrial fibrillation

OBJECTIVE: Report clinical experience in surgical treatment of atrial fibrillation (AF) by Cox-maze procedure. METHODS: 61 patients underwent surgical treatment for AF. Two had primary AF and 59 AF secondary to heart disease (2 atrial septal defects, 57 mitral). Ages ranged from 20 to 74 years (mean = 49). There were 44 females (72%). The surgical technique employed was Cox 3 without cryoablation. The patients were follow-up in specific at patient clinics and underwent periodical ECG, exercise tests, echocardiogram and Holter monitoring. RESULTS: In-hospital mortality was 4.9% and late mortality 1.6%. A temporary pacemaker was used in 28 (46%) and a definitive in 7 patients (11.4%). On hospital discharge, AF remained in 17%; 63.9% had sinus rhythm, 6.9% atrial rhythm, 1.7% junctional rhythm, and 10.3% had pacemaker rhythm. In the last evaluation, AF was present in 19.5%; (70.5% sinus rhythm, 4% atrial rhythm, 2% atrial tachycardia, and 4% pacemaker rhythm). There was no report of thromboembolic episodes. Chronotropic response was considered adequate in 19%, intermediate in 29%, and inadequate in 42%. In Holter monitoring, the mean heart rate was 82±8 bpm, with a minimum of 57±7 bpm and maximum of 126±23 bpm, with supraventricular extrasystoles in 2.3±5.5% of the total heartbeats and ventricular extrasystoles in 0.8±0.5%. In the echocardiogram, the A wave was present in the left atrium in 87.5%. CONCLUSION: Maze procedure is effective and has acceptable surgical risk. Atrial or sinus rhythms remain stable with a small but remarkable frequency of atrial and ventricular arrhythmias. Left atrial contraction is present, although attenuated, as well as the chronotropic response to exercise.

Medical treatments and risk factors for resection surgery in Crohn's disease: results from the Swiss IBD Cohort Study

Background: Surgery has been previously reported to be necessary in up to 80% of Crohn's disease (CD) patients, and up to 65% of patients needed reoperation after 10 years. Prevention of surgery is therefore a particularly important issue for these patients. Treatment options are controversial and data on them are scarce. This study reports medical treatments and main clinical risk factors in CD patients having undergone one or several surgeries. Risks for being free from surgery were also assessed. Methods: Retrospective cohort study, using data from patients included in the Swiss IBD cohort study from November 2006 to July 2011. History of resective surgeries, clinical characteristics and drug regimens were collected through detailed medical records. Univariate and multivariate analyses for clinical and therapeutic factors were performed. Cox regression was made to estimate free-of-surgery risks for different phenotypes and drugs. Results: Out of 1138 CD patients in the cohort, 721 (63.4%) were free of surgery at inclusion; 203 (17.8%) had 1 surgery and 214 (18.8%) >1 surgery. Main risk factors for surgery were disease duration 5-10 years (OR=2.92; p<0.001) and >10 years (OR=10.45; p<0.001), as well as stricturing (OR=8.33; p<0.001) or fistulizing disease (OR=7.34; p<0.001). Risk factors for repeated surgery was disease duration >10 years (OR=2.55; p=0.006) or fistulizing disease (OR=3.79; p<0.001). At inclusion, 107 patients (25.7%) had at least one anti-TNF alpha, 168 (40.3%) at least one immunosuppressive agent, and 41 (9.8%) at least 5-ASA or antibiotics. 64 (15.3%) were not exposed to any medical treatment. Kaplan-Meier curves showed that the risk of being free of surgery was 65% after 10 years, 42% after 20 years and 23% after 40 years. Surgical risks were four resp. five time higher for fistulizing and stricturing phenotypes (Hazard ratio (HR) =4.2; p<0.001; resp. HR=4.7; p<0.001) compared to inflammatory phenotype. Surgical risk was 4 times lower (HR=0.27; p=0.063) in CD patients under anti-TNF alpha compared to those under other or no drugs. Conclusion: The risk of having resective surgery was confirmed to be very high for CD in our cohort. Duration of disease, fistulizing and stricturing disease pattern enhance the risk of surgery. Anti-TNF alpha tends to lower this risk.

Periocular basal cell carcinoma: cost of topical immunotherapy versus estimated cost of surgical treatment

Purpose: The objective of this study was to compare the estimated cost of clinical and surgical treatment for basl cell carcinoma of the eyelid. Methods: This was a pilot study of 12 patients with basal cell carcinoma receiving treatment with 5% imiquimod cream at the ocular plastic surgery center, medical school University of Sao Paulo (HC-FMUSP, Brazil). The cost of clinical treatment was estimated based on the time of treatment and amount of medication consumed by patients in the home setting. The cost of surgical treatment was estimated by ophthalmologists with experience in reconstructive plastic surgery based on analysis of images of the same patients. Surgeons responded to a questionnaire with four questions about surgical technique, surgical materials required, estimated duration of surgery and type of anesthesia. Results: Immunotherapy lasted from 8 to 12 weeks. All patients reported each cold-stored sachet with 5% imiquimod cream lasted 3 days. According to the institution, a box with 12 sachets costs BRL 480.00. Patients required 1.58-3.11 boxes for complete treatment, corresponding to a total cost of BRL 758.40-1,492.80. Based on image analysis, surgeons evaluated surgery would require 1-3 hours. The estimated cost of surgery room and staff was BRL 263.00, to which the cost of supplies was added. Thus, the total cost of surgical treatment was BRL 272.61-864.82. On the average, immunotherapy was 57,64% more costly than surgical treatment. Conclusions: Malignant eyelid tumors are a common finding in clinical ophthalmology. Surgery is still the treatment of choice at our institution, but immunotherapy with 5% imiquimod cream may be indicated for patients with multiple lesions or high surgical risk and for patients declining surgery for reasons of fear or esthetic concerns. The ability to estimate costs related to the treatment of malignant eyelid tumors is an important aid in the financial planning of health care institutions. Further studies should evaluate the possibility of institutions equating the cost of immunotherapy and surgical treatment by acquiring similar but less expensive medications.

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study

Background Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or “inoperable” patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. Objective The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. Methods All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. Results Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% ± 13.9% vs STS 6.7% ± 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES ≥15%, 16% had an STS ≥10%, and 40% had an LES ≥20% or STS ≥10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. Conclusions Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.

Recent developments for surgical aortic valve replacement: the concept of sutureless valve technology

Aortic stenosis has become the most frequent type of valvular heart disease in Europe and North America and presents in the large majority of patients as calcified aortic stenosis in adults of advanced age. Surgical aortic valve replacement has been recognized to be the definitive therapy which improves considerably survival for severe aortic stenosis since more than 40 years. In the most recent period, operative mortality of isolated aortic valve replacement for aortic stenosis varies between 1–3% in low-risk patients younger than 70 years and between 4 and 8% in selected older adults. Long-term survival following aortic valve replacement is close to that observed in a control population of similar age. Numerous observational studies have consistently demonstrated that corrective surgery in symptomatic patients is invariably followed by a subjective improvement in quality of life and a substantial increase in survival rates. More recently, transcatheter aortic valve implantation (TAVI) has been demonstrated to be feasible in patients with high surgical risk using either a retrograde transfemoral or transsubclavian approach or an antegrade, transapical access. Reported 30-day mortality ranges between 5 and 15%) and is acceptable when compared to the risk predicted by the logistic EuroSCORE (varying between 20 and 35%) and the STS Score, although the EuroScore has been shown to markedly overestimate the effective operative risk. One major concern remains the high rate of paravalvular regurgitation which is observed in up to 85% of the patients and which requires further follow-up and critical evaluation. In addition, long-term durability of these valves with a focus on the effects of crimping remains to be addressed, although 3-5 year results are promising. Sutureless biological valves were designed to simplify and significantly accelerate the surgical replacement of a diseased valve and allow complete excision of the calcified native valve. Until now, there are 3 different sutureless prostheses that have been approved. The 3f Enable valve from ATS-Medtronic received CE market approval in 2010, the Perceval S from Sorin during Q1 of 2011 and the intuity sutureless prosthesis from Edwards in 2012. All these devices aim to facilitate valve surgery and therefore have the potential to decrease the invasivness and to shorten the conventional procedure without compromise in term of excision of the diseased valve. This review summarizes the history and the current knowledge of sutureless valve technology.

The SURTAVI model: proposal for a pragmatic risk stratification for patients with severe aortic stenosis

Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement (SAVR) for patients with symptomatic severe aortic stenosis (AS) and a high operative risk. Risk stratification plays a decisive role in the optimal selection of therapeutic strategies for AS patients. The accuracy of contemporary surgical risk algorithms for AS patients has spurred considerable debate especially in the higher risk patient population. Future trials will explore TAVI in patients at intermediate operative risk. During the design of the SURgical replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial, a novel concept of risk stratification was proposed based upon age in combination with a fixed number of predefined risk factors, which are relatively prevalent, easy to capture and with a reasonable impact on operative mortality. Retrospective application of this algorithm to a contemporary academic practice dealing with clinically significant AS patients allocates about one-fourth of these patients as being at intermediate operative risk. Further testing is required for validation of this new paradigm in risk stratification. Finally, the Heart Team, consisting of at least an interventional cardiologist and cardiothoracic surgeon, should have the decisive role in determining whether a patient could be treated with TAVI or SAVR.

Aid decision algorithms to estimate the risk in congenital heart surgery

Background and objective: In this paper, we have tested the suitability of using different artificial intelligence-based algorithms for decision support when classifying the risk of congenital heart surgery. In this sense, classification of those surgical risks provides enormous benefits as the a priori estimation of surgical outcomes depending on either the type of disease or the type of repair, and other elements that influence the final result. This preventive estimation may help to avoid future complications, or even death. Methods: We have evaluated four machine learning algorithms to achieve our objective: multilayer perceptron, self-organizing map, radial basis function networks and decision trees. The architectures implemented have the aim of classifying among three types of surgical risk: low complexity, medium complexity and high complexity. Results: Accuracy outcomes achieved range between 80% and 99%, being the multilayer perceptron method the one that offered a higher hit ratio. Conclusions: According to the results, it is feasible to develop a clinical decision support system using the evaluated algorithms. Such system would help cardiology specialists, paediatricians and surgeons to forecast the level of risk related to a congenital heart disease surgery.

Technical modifications in stabilisers and in bar removal in the Nuss procedure

Pectus excavatum is a congenital deformity that can require surgical treatment. Since Nuss proposed a correction technique, several modifications have been proposed in order to achieve more safety and efficiency in the placement and removal of both bars. Our objective is to describe the technique of placing and removing the bars by proposing three technical modifications: two in bar placement and one in the bar removal. We describe two cases where Nuss bars were placed and one case where the bar was removed as per the technical modification proposed herein. According to the original technique, bar stabilisers. were placed close to the lateral bar edges. We propose a more medial position in order to reduce bar displacement. New stabilisers were designed with central grooves in the posterior surface, which allow better sliding. The technical modification suitable for bar removal was the use of a protective film around the bars to protect the surrounding tissues from the sharp edges, and thereby minimise the risk of injuries. All the proposed modifications were performed without any additional surgical risk or perioperative complication. These three technical modifications can be easily and safety performed, and seem to reduce the risk of bleeding with no additional perioperative complications. (C) 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.