Surgical Explantation of Transcatheter Aortic Valve Bioprostheses: A Statewide Experience

BACKGROUND: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood. METHODS: Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant. RESULTS: Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%. CONCLUSIONS: TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy

Evolving trends in aortic valve replacement: A statewide experience

BackgroundTranscatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for the treatment of aortic stenosis in patients at intermediate, high, and extreme risk for mortality from SAVR. We examined recent trends in aortic valve replacement (AVR) in Michigan.MethodsThe Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS‐QC) database was used to determine the number of SAVR and TAVR cases performed from January 2012 through June 2017. Patients were divided into low, intermediate, high, and extreme risk groups based on STS predicted risk of mortality (PROM). TAVR patients in the MSTCVS‐QC database were also matched with those in the Transcatheter Valve Therapy Registry to determine their Heart Team‐designated risk category.ResultsDuring the study period 9517 SAVR and 4470 TAVR cases were performed. Total annual AVR volume increased by 40.0% (from 2086 to 2920), with a 13.3% decrease in number of SAVR cases (from 1892 to 1640) and a 560% increase in number of TAVR cases (from 194 to 1280). Greater than 90% of SAVR patients had PROM ≤8%. While >70% of TAVR patients had PROM ≤ 8%, they were mostly designated as high or extreme risk by a Heart Team.ConclusionsDuring the study period, SAVR volume gradually declined and TAVR volume dramatically increased. This was mostly due to a new group of patients with lower STS PROM who were designated as higher risk by a Heart Team due to characteristics not completely captured by the STS PROM score.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/145246/1/jocs13740_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/145246/2/jocs13740.pd

Perfusion Measures and Outcomes (PERForm) registry: First annual report

Background: The Perfusion Measures and Outcomes (PERForm) registry was established in 2010 to advance cardiopulmonary bypass (CPB) practices and outcomes. The registry is maintained through the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative and is the official registry of the American Society of Extracorporeal Technology. Methods: This first annual PERForm registry report summarizes patient characteristics as well as CPB-related practice patterns in adult (≥18 years of age) patients between 2019 and 2022 from 42 participating hospitals. Data from PERForm are probabilistically matched to institutional surgical registry data. Trends in myocardial protection, glucose, anticoagulation, temperature, anemia (hematocrit), and fluid management are summarized. Additionally, trends in equipment (hardware/disposables) utilization and employed patient safety practices are reported. Results: A total of 40,777 adult patients undergoing CPB were matched to institutional surgical registry data from 42 hospitals. Among these patients, 54.9% underwent a CABG procedure, 71.6% were male, and the median (IQR) age was 66.0 [58.0, 73.0] years. Overall, 33.1% of the CPB procedures utilized a roller pump for the arterial pump device, and a perfusion checklist was employed 99.6% of the time. The use of conventional ultrafiltration decreased over the study period (2019 vs. 2022; 27.1% vs. 24.9%) while the median (IQR) last hematocrit on CPB has remained stable [27.0 (24.0, 30.0) vs. 27.0 (24.0, 30.0)]. Pump sucker termination before protamine administration increased over the study period: (54.8% vs. 75.9%). Conclusion: Few robust clinical registries exist to collect data regarding the practice of CPB. Although data submitted to the PERForm registry demonstrate overall compliance with published perfusion evidence-based guidelines, noted opportunities to advance patient safety and outcomes remain

The Society of Thoracic Surgeons Adult Cardiac Surgery Database Version 273: More Is Better

BACKGROUND: With the introduction of version 2.73, several new patient risk factors are now captured in The Society of Thoracic Surgeons\u27 (STS) Adult Cardiac Surgery Database. We sought to evaluate the potential association of these risk factors with mortality. METHODS: We reviewed all patients with an STS predicted risk of mortality in our statewide quality collaborative database from July 2011 to September 2013 (N = 19,743). Univariate analyses were used to determine significant associations between mortality and the new risk factors in version 2.73. We then performed multivariable analysis, incorporating the STS predicted risk of mortality into our regression. RESULTS: In the univariate model, patients with illicit drug use, syncope, unresponsive neurologic state, cancer within the last 5 years, current smoking history, other tobacco use, or sleep apnea had no significant difference in mortality (p \u3e 0.05). Patients with liver disease, elevated Model for End-Stage Liver Disease score, mediastinal radiation, prolonged 5-meter walk test, home oxygen use, inhaled medications or bronchodilator therapy, decreased forced expiratory volume, and history of recent pneumonia had significant increases in operative mortality (p \u3c 0.05). In multivariable analysis incorporating the STS predicted risk models, liver disease, elevated Model for End-Stage Liver Disease score, prolonged 5-meter walk test, home oxygen use, bronchodilator therapy, and abnormal pulmonary function tests were independently predictive of mortality. CONCLUSIONS: Several of the new STS data variables were significantly associated with operative mortality after cardiac surgery. The addition of these patient factors improves our understanding of evolving patient demographics and comorbid conditions and their impact on perioperative risk. This will improve both shared decision making and assessments of provider performance

Failure to rescue: Variation in mortality after cardiac surgery

OBJECTIVES: Measures to prevent surgical complications are critical components of optimal patient care, and adequate management when complications occur is equally crucial in efforts to reduce mortality. This study aims to elucidate clinical realities underlying in-hospital variations in failure to rescue (FTR) after cardiac surgery. METHODS: Using a statewide database for a quality improvement program, we identified 62 450 patients who had undergone adult cardiac surgery between 2011 and 2018 in 1 of the 33 Michigan hospitals performing adult cardiac surgery. The hospitals were first divided into tertiles according to their observed to expected (O/E) ratios of 30-day mortality: low-mortality tertile (O/E 0.46-0.78), intermediate-mortality tertile (O/E 0.79-0.90) and high-mortality tertile (O/E 0.98-2.00). We then examined the incidence of 15 significant complications and the rates of death following complications among the 3 groups. RESULTS: A total of 1418 operative deaths occurred in the entire cohort, a crude mortality rate of 2.3% and varied from 1.3% to 5.9% at the hospital level. The death rates also diverged significantly according to mortality score tertiles, from 1.6% in the low-mortality group to 3.2% in the high-mortality group (P < 0.001). Hospitals ranked in a high- or intermediate-mortality tertile had similar rates of overall complications (21.3% and 20.7%, P = 0.17), while low-mortality hospitals had significantly fewer complications (16.3%) than the other 2 tertiles (P < 0.001). FTR increased in a stepwise manner from low- to high-mortality hospitals (8.3% vs 10.0% vs 12.7%, P < 0.001, respectively). Differences in FTR were related to survival after cardiac arrest, multi-system organ failure, prolonged ventilation, reoperation for bleeding and severe acute kidney disease that requires dialysis. CONCLUSIONS: This study demonstrates that timely recognition and appropriate treatment of complications are as important as preventing complications to further reduce operative mortality in cardiac surgery. FTR tools may provide vital information for quality improvement initiatives

The Midterm Impact of Transcatheter Aortic Valve Replacement on Surgical Aortic Valve Replacement in Michigan

BACKGROUND: We characterized the midterm impact of transcatheter aortic valve replacement (TAVR) on surgical aortic valve replacement (SAVR) volume, patient profiles, and outcomes in Michigan. METHODS: We analyzed data obtained after SAVR (n = 15,288) and TAVR (n = 1,783) using the Michigan Society of Thoracic and Cardiovascular Surgery Quality Collaborative from 2006 to 2015. During this period, 17 of 33 hospitals developed TAVR programs. RESULTS: Annual SAVR volume increased by 38.1% at TAVR hospitals and by 20.4% at non-TAVR hospitals, (p trend \u3c 0.001). In TAVR hospitals, the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) decreased before (4.7% ± 5.1%) and after (3.5% ± 3.6%) initiation of TAVR (p \u3c 0.001). Rates of 30-day mortality (pre-TAVR, 3.9% vs post-TAVR, 2.7%; p \u3c 0.001) and renal failure (pre-TAVR, 5.2% vs post-TAVR, 3.3%; p \u3c 0.001) but not stroke (pre-TAVR, 1.9% vs post-TAVR, 1.7%; p = 0.47) were lower after TAVR implementation. Length of stay decreased from 9.0 to 8.5 days (p \u3c 0.001). When analyzing high-risk patients undergoing SAVR (ie, PROM \u3e8%), neither mortality, stroke, nor renal failure was different (all p \u3e 0.15). Despite a reduction in the STS-PROM, non-TAVR hospitals did not display changes in mortality, stroke, or renal failure for either the entire or the high-risk SAVR cohorts after initiation of TAVR in Michigan. CONCLUSIONS: TAVR implementation in Michigan has dramatically increased overall SAVR volume. This phenomenon has occurred with a concomitant decrease in preoperative risk profile and has improved early SAVR outcomes, particularly at TAVR hospitals, but surprisingly not in patients considered at high preoperative risk. As TAVR use increases, these issues may be further clarified and elucidated

Red blood cells and mortality after coronary artery bypass graft surgery: an analysis of 672 operative deaths

BACKGROUND: Prior studies have implicated transfusion as a risk factor for mortality in coronary artery bypass graft surgery (CABG). To further our understanding of the true association between transfusion and outcome, we specifically analyzed the subgroup of patients who died after undergoing CABG. METHODS: A total of 34,362 patients underwent isolated CABG between January 2008 and September 2013 and were entered into a statewide collaborative database; 672 patients (2.0%) died and form the basis for this study. Univariate analysis compared preoperative and intraoperative variables, as well as postoperative outcomes, between those with and without transfusion in both unadjusted cohorts and those matched by predicted risk of mortality (PROM). Mortality was further evaluated with phase of care analysis. RESULTS: Of the 672 deaths, 566 patients (84.2%) received a transfusion of red blood cells. The PROM was 7.5% for the transfused patients versus 4.3% for those not transfused (p \u3c 0.001). Transfused patients were older, more often female, had more emergency, on-pump, and redo procedures, and had a lower preoperative and on-bypass nadir hematocrit. Most other demographics were similar between the groups. Postoperatively, transfused patients were ventilated longer, had more renal and multisystem organ failure, and were more likely to die of infectious and pulmonary causes after longer intensive care unit and overall lengths of stay. CONCLUSIONS: Significant differences in PROM and the postoperative course leading to death between those with and without transfusion suggest the role of transfusion may be secondary to other patient-related factors. Recognizing that the relationship between transfusion and outcome after CABG remains incompletely understood, these findings are suggestive of a complex interaction of many variables

Validation of a Perfusion Registry: Methodological Approach and Initial Findings

Although regional and national registries exist to measure and report performance of cardiac surgical programs, few registries exist dedicated to the practice of cardiopulmonary bypass (CPB). We developed and implemented a cardiovascular perfusion registry (Perfusion Measures and outcomes [PERForm] Registry) within the structure of the Michigan Society of Thoracic and Cardiovascular Surgeons (MSTCVS) to improve our understanding of the practice of CPB. The PERForm Registry comprises data elements describing the practice of CPB. Fourteen medical centers within MSTCVS have voluntarily reported these data on procedures in which CPB is used. We validated the case count among procedures performed between January 1, 2011 to December 31, 2011, and validated the values among 20 fields at three medical centers. We queried database managers at all 14 medical centers to identify the infrastructure that contributed to best overall data collection performance. We found that 98% of all records submitted to the PERForm and 95% of those submitted to the Society of Thoracic Surgeons (STS) matched. We found quite favorable agreement in our audit of select fields (95.8%). Those centers with the most favorable performance in this validation study were more likely to use electronic data capture, have a perfusionist as the STS database manager, and have involvement of the STS database manager in the PERForm or STS databases. We successfully and accurately collected data concerning cardiovascular perfusion among 14 institutions in conjunction with the MSTCVS. Future efforts will focus on expanding data collection to all MSTCVS participating institutions as well as more broadly outside of Michigan

Red Blood Cell Transfusions Impact Pneumonia Rates After Coronary Artery Bypass Grafting

BACKGROUND: Pneumonia, a known complication of coronary artery bypass grafting (CABG), significantly increases a patient\u27s risk of morbidity and mortality. Although not well characterized, red blood cell (RBC) transfusions may increase a patient\u27s risk of pneumonia. We describe the relationship between RBC transfusion and postoperative pneumonia after CABG. METHODS: A total of 16,182 consecutive patients underwent isolated CABG between 2011 and 2013 at 1 of 33 hospitals in the state of Michigan. We used multivariable logistic regression to estimate the relative odds of pneumonia associated with the use or number of RBC units (0, 1, 2, 3, 4, 5, and ≥ 6). We adjusted for predicted risk of mortality, preoperative hematocrit values, history of pneumonia, cardiopulmonary bypass duration, and medical center. We confirmed the strength and direction of these relationships among selected clinical subgroups in a secondary analysis. RESULTS: Five hundred seventy-six (3.6%) patients had pneumonia and 6,451 (39.9%) received RBC transfusions. There was a significant association between any RBC transfusion and pneumonia (adjusted odds ratio [ORadj], 3.4; p \u3c 0.001). There was a dose response between number of units and odds of pneumonia, with a ptrend less than 0.001. Patients receiving only 2 units of RBCs had a 2-fold (ORadj, 2.1; p \u3c 0.001) increased odds of developing pneumonia. These findings were consistent across clinical subgroups. CONCLUSIONS: We found a significant volume-dependent association between an increasing number of RBCs and the odds of pneumonia, which persisted after risk adjustment. Clinical teams should explore opportunities for preventing a patient\u27s risk of RBC transfusions, including reducing hemodilution or adopting a lower transfusion threshold in a stable patient