Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Mini-Incision Direct Festoon Access, Cauterization, and Excision (MIDFACE): A 12-Year Analysis of a Novel Festoon Surgery.

BACKGROUND: Surgical festoon management often entails aggressive dissection, flaps, unsightly scars, prolonged recovery, and high recurrence rates. The authors present outcomes with subjective and objective evaluation of an office-based, novel, minimally invasive (1-cm incision) festoon repair: mini-incision direct festoon access, cauterization, and excision (MIDFACE). METHODS: Charts of 75 consecutive patients from 2007 to 2019 were evaluated. Photographs of 39 patients who met inclusionary criteria were evaluated by three expert physician graders for festoon and incision visibility (339 randomly scrambled preoperative and postoperative photographs taken with and without flash and from four different views: close-up, profile, full-frontal, and worm's eye) using paired t tests and Kruskal-Wallis tests for statistical evaluation. Surveys returned by 37 of 75 patients were evaluated for patient satisfaction and possible contributing factors to festoon formation or exacerbation. RESULTS: There were no major complications in the 75 patients who underwent MIDFACE. Physician grading of photographs of 39 patients (78 eyes, 35 women; four men; mean age, 58 ± 7.7 years) demonstrated statistically significant sustained improvement in festoon score postoperatively up to 12 years regardless of view or flash. Incision scores were the same preoperatively and postoperatively, indicating incisions could not be detected by photography. Average patient satisfaction score was 9.5 on a Likert scale of 0 to 10. Possible factors for festoon formation or exacerbation included genetics (51%), pets (51%), prior hyaluronic acid fillers (54%), neurotoxin (62%), facial surgery (40%), alcohol (49%), allergies (46%), and sun exposure (59%). CONCLUSION: MIDFACE repair results in sustained improvement of festoons with an office-based, minimally invasive procedure with high patient satisfaction, rapid recovery, and low recurrence. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement.

OBJECTIVE: The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days. METHODS: Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life. RESULTS: By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score >2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01). CONCLUSIONS: Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

BACKGROUND: Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery. METHODS: The Cardiothoracic Surgical Trials Network trial of the safety and effectiveness of a Venous External Support (VEST) device is a randomized, multicenter, within-patient trial comparing VEST-supported versus unsupported saphenous vein grafts in patients undergoing CABG. Key inclusion criteria are the need for CABG with a planned internal mammary artery to the left anterior descending and two or more saphenous vein grafts to other coronary arteries. The primary efficacy endpoint of the trial is SVG intimal hyperplasia (plaque + media) area assessed by intravascular ultrasound at 12 months post randomization. Occluded grafts are accounted for in the analysis of the primary endpoint. Secondary confirmatory endpoints are lumen diameter uniformity and graft failure (>50% stenosis) assessed by coronary angiography at 12 months. The safety endpoints are the occurrence of major adverse cardiac and cerebrovascular events and hospitalization within 5 years from randomization. CONCLUSIONS: The results of the VEST trial will determine whether the VEST device can safely limit SVG intimal hyperplasia in patients undergoing CABG as treatment for coronary atherosclerotic disease.

Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation.

BACKGROUND: Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain. OBJECTIVES: The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery. METHODS: Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years. RESULTS: Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04). CONCLUSIONS: After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe Ischemic Mitral Regurgitation: A Randomized Clinical Trial From the Cardiothoracic Surgical Trials Network

BACKGROUND: The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe ischemic mitral regurgitation (MR) randomized to mitral valve repair or replacement. However, replacement provided more durable correction of MR and fewer cardiovascular readmissions. Yet, costeffectiveness outcomes have not been addressed. METHODS AND RESULTS: We conducted a cost-effectiveness analysis of the surgical treatment of ischemic MR based on the CTSN trial (n=126 for repair; n=125 for replacement). Patient-level data on readmissions, survival, qualityof- life, and US hospital costs were used to estimate costs and quality-adjusted life years per patient over the trial duration and a 10-year time horizon. We performed microsimulation for extrapolation of outcomes beyond the 2 years of trial data. Bootstrap and deterministic sensitivity analyses were done to address parameter uncertainty. In-hospital cost estimates were $78 216 for replacement versus $72 761 for repair (difference: $5455; 95% uncertainty interval [UI]: −7784­21 193) while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI: −16 253­17 172), respectively. Quality-adjusted life years at 2 years were 1.18 for replacement versus 1.23 for repair (difference: −0.05; 95% UI: −0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in cardiovascular readmission rates with replacement increased, and survival minimally improved compared with repair. At 5 years, cumulative costs and quality-adjusted life years showed no difference on average, but by 10 years, there was a small, uncertain benefit for replacement: $118 023 versus $119 837 (difference: −$1814; 95% UI: −27 144 to 22 602) and qualityadjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI: −0.87 to 1.08). After 10 years, the incremental cost-effectiveness of replacement continued to improve. CONCLUSIONS: Our cost-effectiveness analysis predicts potential savings in cost and gains in quality-adjusted survival at 10 years when mitral valve replacement is compared with repair for severe ischemic MR. These projected benefits, however, were small and subject to variability. Efforts to further delineate predictors of long-term outcomes in patients with severe ischemic MR are needed to optimize surgical decisions for individual patients, which should yield more cost-effective care. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00807040.

Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation.

BACKGROUND: In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. METHODS: We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. RESULTS: At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group. CONCLUSIONS: In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).

Diabetes and the Association of Postoperative Hyperglycemia With Clinical and Economic Outcomes in Cardiac Surgery.

OBJECTIVE: The management of postoperative hyperglycemia is controversial and generally does not take into account pre-existing diabetes. We analyzed clinical and economic outcomes associated with postoperative hyperglycemia in cardiac surgery patients, stratifying by diabetes status. RESEARCH DESIGN AND METHODS: Multicenter cohort study in 4,316 cardiac surgery patients operated on in 2010. Glucose was measured at 6-h intervals for 48 h postoperatively. Outcomes included cost, hospital length of stay (LOS), cardiac and respiratory complications, major infections, and death. Associations between maximum glucose levels and outcomes were assessed with multivariable regression and recycled prediction analyses. RESULTS: In patients without diabetes, increasing glucose levels were associated with a gradual worsening of outcomes. In these patients, hyperglycemia (≥180 mg/dL) was associated with an additional cost of $3,192 (95% CI 1,972 to 4,456), an additional hospital LOS of 0.8 days (0.4 to 1.3), an increase in infections of 1.6% (0.5 to 2.8), and an increase in respiratory complications of 2.6% (0.0 to 5.3). However, among patients with insulin-treated diabetes, optimal outcomes were associated with glucose levels considered to be hyperglycemic (180 to 240 mg/dL). This level of hyperglycemia was associated with cost reductions of $6,225 (-12,886 to -222), hospital LOS reductions of 1.6 days (-3.7 to 0.4), infection reductions of 4.1% (-9.1 to 0.0), and reductions in respiratory complication of 12.5% (-22.4 to -3.0). In patients with non-insulin-treated diabetes, outcomes did not differ significantly when hyperglycemia was present. CONCLUSIONS: Glucose levels <180 mg/dL are associated with better outcomes in most patients, but worse outcomes in patients with diabetes with a history of prior insulin use. These findings support further investigation of a stratified approach to the management of patients with stress-induced postoperative hyperglycemia based on prior diabetes status.

Costs associated with health care-associated infections in cardiac surgery.

BACKGROUND: Health care-associated infections (HAIs) are the most common noncardiac complications after cardiac surgery and are associated with increased morbidity and mortality. Current information about their economic burden is limited. OBJECTIVES: This research was designed to determine the cost associated with major types of HAIs during the first 2 months after cardiac surgery. METHODS: Prospectively collected data from a multicenter, observational study of the Cardiothoracic Surgery Clinical Trials Network, in which patients were monitored for infections for 65 days after surgery, were merged with related financial data routinely collected by the University HealthSystem Consortium. Incremental length of stay (LOS) and cost associated with HAIs were estimated using generalized linear models, with adjustments for patient demographics, clinical history, baseline laboratory values, and surgery type. RESULTS: Among 4,320 cardiac surgery patients (mean age: 64 ± 13 years), 119 (2.8%) experienced a major HAI during the index hospitalization. The most common HAIs were pneumonia (48%), sepsis (20%), and Clostridium difficile colitis (18%). On average, the estimated incremental cost associated with a major HAI was nearly $38,000, of which 47% was related to intensive care unit services. The incremental LOS was 14 days. Overall, there were 849 readmissions; among these, 8.7% were attributed to major HAIs. The cost of readmissions due to major HAIs was, on average, nearly threefold that of readmissions not related to HAIs. CONCLUSIONS: Hospital cost, LOS, and readmissions are strongly associated with HAIs. These associations suggest the potential for large reductions in costs if HAIs following cardiac surgery can be reduced. (Management Practices and the Risk of Infections Following Cardiac Surgery; NCT01089712).

Infection in permanent circulatory support: experience from the REMATCH trial.

BACKGROUND: This analysis of the REMATCH Trial focuses on infection, which was an important source of morbidity and mortality. We use the information to suggest ways to decrease the incidence and effects of device-related infection. METHODS: Patients were randomized prospectively to receive left ventricular assist devices (LVADs) or optimal medical management (OMM) for end-stage heart failure. Infection variables included sepsis adjudicated as the cause of death; sepsis reported as a serious adverse event; percutaneous site or pocket infection; and pump housing, inflow- or outflow-tract infection. We compared the incidence and prevalence of events between groups and generated time-related descriptions. RESULTS: Survival with LVAD (n=68 patients) was superior to OMM survival (n=61 patients) with a 47% decrease in risk of death (p <0.001), but the aggregate adverse event rate was greater for patients with LVADs (risk ratio, 2.29; 95% confidence interval, 1.85-2.84). Freedom from sepsis in patients with LVADs was 58% at 1 year and 48% at 2 years after implantation with superior survival in non-septic patients (60% vs 39% at 1 year and 38% vs 8% at 2 years in non-septic vs septic patients with LVADs, p <0.06). Percutaneous site or pocket infection did not affect survival (p=0.86). The hazard for onset of sepsis peaked within the first 3 weeks after implantation. CONCLUSIONS: Survival is improved with permanent LVAD implantation compared with OMM therapy. However, infection causes substantial morbidity and mortality. Decreasing infections will increase survival and decrease morbidity in permanent LVAD recipients and will improve the risk-benefit ratio for permanent LVAD therapy.

Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000.

OBJECTIVE: To help understand past and future trends in vascular intervention, we examined changes in the rate of utilization, patient demographics, and length of stay from 1980 to 2000. METHODS: We reviewed the ICD-9 codes for all vascular procedures using the National Hospital Discharge Survey of non-federal United States hospitals (1980-2000). RESULTS: The number of vascular procedures performed in this country increased from 412,557 in 1980 to 801,537 in 2000 (per capita increase of >50%). This increase was most evident in elderly patients (>75 years, 67% per capita increase in discharges). Long hospital stays (> or =7 days) for vascular procedures fell 41%, and short hospital stays (<24 hours) increased 15% over the period of study. The frequency of abdominal aortic aneurysm repairs remained relatively constant. Except for an interval in the late 1980s, and a minor decrease from 1997 to 2000, the frequency of carotid endartarectomy rose dramatically (69%). Lower extremity revascularizations increased steadily until 1990 but then declined 12%. From 1995 to 2000, there was a 27% per capita decrease in the number of renal-mesenteric operations. Correspondingly, over the past 5 years there has been a 979% growth in the number of percutaneous/endovascular interventions. Despite a substantial number of interventions for lower extremity vascular disease, there was a concomitant increase in the number of major and minor amputations. CONCLUSION: Interventions for vascular disease have increased dramatically, with a major shift toward less invasive treatments, particularly for the renal and mesenteric vessels and the lower extremities. These trends in procedural use suggest that vascular surgeons need to embrace catheter-based approaches if they want to remain leaders in the treatment of peripheral vascular diseases.

Neurological events during long-term mechanical circulatory support for heart failure: the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) experience.

BACKGROUND: Progression of heart failure can lead to cardiac transplantation, but when patients are ineligible, long-term mechanical circulatory support may improve survival. The REMATCH trial showed that left ventricular assist devices (LVADs) prolonged survival in patients with end-stage disease, but with a significant number of adverse events. We report on the neurological outcomes in the REMATCH trial. METHODS AND RESULTS: We examined new neurological events in the 129 patients randomized to either LVAD placement (n=68) or medical management (n=61), classified as stroke, transient ischemic attack, toxic-metabolic encephalopathy, and other. There were 46 neurological events: 42 in 30 LVAD patients and 4 in 4 patients in the medical arm (chi2, 30/68 versus 4/61, P<0.001). Sixteen percent of the LVAD patients had a stroke, with a rate of 0.19 per year (95% CI, 0.10 to 0.33), many occurring in the postoperative period. The stroke rate in the medical arm was 0.052. A Kaplan-Meier survival analysis showed a 44% reduction in the risk of stroke or death in the LVAD group versus the optimal medical group (P=0.002). The mean interval from implantation to stroke was 221.8 days (+/-70.4 days). History of stroke, age, and sepsis were not stroke risk factors in the LVAD group. CONCLUSIONS: Fewer than half of the patients in the LVAD group had a neurological event, and there were few neurological deaths. Survival analysis combining stroke or death demonstrated a significant benefit for long-term circulatory support with an LVAD over medical therapy. Future trials will need to address prospectively all neurological outcomes, including neurocognitive function, and the role of long-term neuroprotection.

Surgical management of patients in the REMATCH trial.

The donor shortage makes cardiac transplantation a less than ideal treatment for end-stage heart failure. The utility of the left ventricular assist device (LVAD) as a permanent form of circulatory support has recently been established in the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial. In this report, we describe the surgical management of LVAD patients in REMATCH and their short-term outcomes. Between 1998 and 2001, 129 patients with end-stage heart failure, who were excluded from consideration for transplantation, were enrolled in the REMATCH clinical trial. Patients were randomized to two treatment arms: optimal medical management or HeartMate vented electric LVAD implantation. The primary end point of the study was death from any cause. Secondary end points included the incidence of serious adverse events, the duration of hospitalization, quality of life, and functional status. Sixty-eight patients received an LVAD, 55 (81%) of whom survived for longer than 1 month. The median intensive care unit and hospital lengths of stay (LOS) for those that survived at least 1 month were 15 and 34 days, respectively. Sixty-seven (99%) patients had a serious adverse event. The rates of perioperative bleeding, late bleeding, right heart failure, and sepsis were 0.42, 0.53, 0.15, and 0.53 events/patient-year, respectively. Factors predictive of a longer LOS for the implant hospitalization included sepsis, age, and late bleeding (p < 0.0001). The patients' New York Heart Association functional class improved significantly at 1 month compared with base line (p < 0.001). Functional class improved in LVAD-supported patients despite a high adverse event rate. Most adverse events occurred within 30 days of device implantation. Sepsis, age, and late bleeding were the major determinants of LOS.