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1.
Ann Surg ; 2024 Mar 14.
Article in English | MEDLINE | ID: mdl-38482684

ABSTRACT

OBJECTIVE: To evaluate whether a machine learning algorithm (i.e. the "NightSignal" algorithm) can be used for the detection of postoperative complications prior to symptom onset after cardiothoracic surgery. SUMMARY BACKGROUND DATA: Methods that enable the early detection of postoperative complications after cardiothoracic surgery are needed. METHODS: This was a prospective observational cohort study conducted from July 2021 to February 2023 at a single academic tertiary care hospital. Patients aged 18 years or older scheduled to undergo cardiothoracic surgery were recruited. Study participants wore a Fitbit watch continuously for at least 1 week preoperatively and up to 90-days postoperatively. The ability of the NightSignal algorithm-which was previously developed for the early detection of Covid-19-to detect postoperative complications was evaluated. The primary outcomes were algorithm sensitivity and specificity for postoperative event detection. RESULTS: A total of 56 patients undergoing cardiothoracic surgery met inclusion criteria, of which 24 (42.9%) underwent thoracic operations and 32 (57.1%) underwent cardiac operations. The median age was 62 (IQR: 51-68) years and 30 (53.6%) patients were female. The NightSignal algorithm detected 17 of the 21 postoperative events a median of 2 (IQR: 1-3) days prior to symptom onset, representing a sensitivity of 81%. The specificity, negative predictive value, and positive predictive value of the algorithm for the detection of postoperative events were 75%, 97%, and 28%, respectively. CONCLUSIONS: Machine learning analysis of biometric data collected from wearable devices has the potential to detect postoperative complications-prior to symptom onset-after cardiothoracic surgery.

2.
Lancet ; 401(10378): 773-788, 2023 03 04.
Article in English | MEDLINE | ID: mdl-36640801

ABSTRACT

Although substantial progress has been made in the prevention, diagnosis, and treatment of acute aortic dissection, it remains a complex cardiovascular event, with a high immediate mortality and substantial morbidity in individuals surviving the acute period. The past decade has allowed a leap forward in understanding the pathophysiology of this disease; the existing classifications have been challenged, and the scientific community moves towards a nomenclature that is likely to unify the current definitions according to morphology and function. The most important pathophysiological pathway, namely the location and extension of the initial intimal tear, which causes a disruption of the media layer of the aortic wall, together with the size of the affected aortic segments, determines whether the patient should undergo emergency surgery, an endovascular intervention, or receive optimal medical treatment. The scientific evidence for the management and follow-up of acute aortic dissection continues to evolve. This Seminar provides a clinically relevant overview of potential prevention, diagnosis, and management of acute aortic dissection, which is the most severe acute aortic syndrome.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Dissection , Humans , Aorta , Acute Disease , Aortic Aneurysm, Thoracic/surgery , Treatment Outcome
3.
World J Surg ; 48(4): 779-790, 2024 04.
Article in English | MEDLINE | ID: mdl-38423955

ABSTRACT

BACKGROUND: Previous meta-analyses combining randomized and observational evidence in cardiac surgery have shown positive impact of enhanced recovery protocols after surgery (ERAS) on postoperative outcomes. However, definitive data based on randomized studies are missing, and the entirety of the ERAS measures and pathway, as recently systematized in guidelines and consensus statements, have not been captured in the published studies. The available literature actually focuses on "ERAS-like" protocols or only limited number of ERAS measures. This study aims at analyzing all randomized studies applying ERAS-like protocols in cardiac surgery for perioperative outcomes. METHODS: A meta-analysis of randomized controlled trials (RCTs) comparing ERAS-like with standard protocols of perioperative care was performed (PROSPERO registration CRD42021283765). PRISMA guidelines were used for abstracting and assessing data. RESULTS: Thirteen single center RCTs (N = 1704, 850 in ERAS-like protocol and 854 in the standard care group) were selected. The most common procedures were surgical revascularization (66.3%) and valvular surgery (24.9%). No difference was found in the incidence of inhospital mortality between the ERAS and standard treatment group (risk ratio [RR] 0.61 [0.31; 1.20], p = 0.15). ERAS was associated with reduced intensive care unit (standardized mean difference [SMD] -0.57, p < 0.01) and hospital stay (SMD -0.23, p < 0.01) and reduced rates of overall complications when compared to the standard protocol (RR 0.60, p < 0.01) driven by the reduction in stroke (RR 0.29 [0.13; 0.62], p < 0.01). A significant heterogeneity in terms of the elements of the ERAS protocol included in the studies was observed. CONCLUSIONS: ERAS-like protocols have no impact on short-term survival after cardiac surgery but allows for a faster hospital discharge while potentially reducing surgical complications. However, this study highlights a significant nonadherence and heterogeneity to the entirety of ERAS protocols warranting further RCTs in this field including a greater number of elements of the framework.


Subject(s)
Cardiac Surgical Procedures , Enhanced Recovery After Surgery , Humans , Postoperative Complications/etiology , Randomized Controlled Trials as Topic , Perioperative Care/methods , Cardiac Surgical Procedures/adverse effects , Length of Stay , Meta-Analysis as Topic , Systematic Reviews as Topic
4.
Clin Transplant ; 37(6): e14978, 2023 06.
Article in English | MEDLINE | ID: mdl-36964943

ABSTRACT

Heart and lung transplant recipients require care provided by clinicians from multiple different specialties, each contributing unique expertise and perspective. The period the patient spends in the intensive care unit is one of the most critical times in the perioperative trajectory. Various organizational models of intensive care exist, including those led by intensivists, surgeons, transplant cardiologists, and pulmonologists. Coordinating timely efficient intensive care is an essential and logistically difficult goal. The present work product of the American Society of Transplantation's Thoracic and Critical Care Community of Practice, Critical Care Task Force outlines operational guidelines and principles that may be applied in different organizational models to optimize the delivery of intensive care for the cardiothoracic organ recipient.


Subject(s)
Intensive Care Units , Surgeons , Humans , Critical Care , Perioperative Care
5.
Eur J Vasc Endovasc Surg ; 66(6): 775-782, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37201718

ABSTRACT

OBJECTIVE: To describe the trends in management and outcomes of patients with acute type B aortic dissection in the International Registry of Acute Aortic Dissection. METHODS: From 1996 - 2022, 3 908 patients were divided into similar sized quartiles (T1, T2, T3, and T4). In hospital outcomes were analysed for each quartile. Survival rates following admission were compared using Kaplan-Meier analyses with Mantel-Cox Log rank tests. RESULTS: Endovascular treatment increased from 19.1% in T1 to 37.2% in T4 (ptrend < .001). Correspondingly, medical therapy decreased from 65.7% in T1 to 54.0% in T4 (ptrend < .001), and open surgery from 14.8% in T1 to 7.0% in T4 (ptrend < .001). In hospital mortality decreased in the overall cohort from 10.7% in T1 to 6.1% in T4 (ptrend < .001), as well as in medically, endovascularly and surgically treated patients (ptrend = .017, .033, and .011, respectively). Overall post-admission survival at three years increased (T1: 74.8% vs. T4: 77.3%; p = .006). CONCLUSION: Considerable changes in the management of acute type B aortic dissection were observed over time, with a significant increase in the use of endovascular treatment and a corresponding reduction in open surgery and medical management. These changes were associated with a decreased overall in hospital and three year post-admission mortality rate among quartiles.

6.
Circulation ; 143(5): e35-e71, 2021 02 02.
Article in English | MEDLINE | ID: mdl-33332149

ABSTRACT

AIM: This executive summary of the valvular heart disease guideline provides recommendations for clinicians to diagnose and manage valvular heart disease as well as supporting documentation to encourage their use. METHODS: A comprehensive literature search was conducted from January 1, 2010, to March 1, 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, Cochrane, Agency for Healthcare Research and Quality Reports, and other selected database relevant to this guideline. Structure: Many recommendations from the earlier valvular heart disease guidelines have been updated with new evidence and provides newer options for diagnosis and treatment of valvular heart disease. This summary includes only the recommendations from the full guideline which focus on diagnostic work-up, the timing and choice of surgical and catheter interventions, and recommendations for medical therapy. The reader is referred to the full guideline for graphical flow charts, text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in developing these guidelines.


Subject(s)
Cardiology , Heart Valve Diseases , Humans , American Heart Association , Cardiology/organization & administration , Heart Valve Diseases/therapy , United States
7.
Ann Surg ; 276(1): 200-204, 2022 07 01.
Article in English | MEDLINE | ID: mdl-32889881

ABSTRACT

OBJECTIVE: This manuscript describes the rationale and design of a randomized, controlled trial comparing outcomes with Warfarin vs Novel Oral Anticoagulant (NOAC) therapy in patients with new onset atrial fibrillation after cardiac surgery. BACKGROUND: New onset atrial fibrillation commonly occurs after cardiac surgery and is associated with increased rates of stroke and mortality. in nonsurgical patients with atrial fibrillation, NOACs have been shown to confer equivalent benefits for stroke prevention with less bleeding risk and less tedious monitoring requirements compared with Warfarin. However, NOAC use has yet to be adopted widely in cardiac surgery patients. METHODS: The NEW-AF study has been designed as a pragmatic, prospective, randomized controlled trial that will compare financial, convenience and safety outcomes for patients with new onset atrial fibrillation after cardiac surgery that are treated with NOACs versus Warfarin. RESULTS: Study results may contribute to optimizing the options for stroke prophylaxis in cardiac surgery patients and catalyze more widespread application of NOAC therapy in this patient population. CONCLUSIONS: The study is ongoing and actively enrolling at the time of the publication. The trial is registered with clinicaltrials.gov under registration number NCT03702582.


Subject(s)
Atrial Fibrillation , Cardiac Surgical Procedures , Stroke , Administration, Oral , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Humans , Prospective Studies , Stroke/etiology , Stroke/prevention & control , Warfarin/adverse effects , Warfarin/therapeutic use
9.
J Card Surg ; 37(2): 285-289, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34699088

ABSTRACT

OBJECTIVE: Aortic valve disease is a risk factor for atrial fibrillation (AF), and AF is associated with increased late mortality and morbidity after cardiac surgery. The evolution of alternative approaches to AF prophylaxis, including less invasive technologies and medical therapies, has altered the balance between risk and potential benefit for prophylactic intervention at the time of surgical aortic valve replacement (SAVR). Such interventions impose incremental risk, however, making an understanding of predictors of new onset AF that persists beyond the perioperative episode relevant. METHODS: We conducted a retrospective single-institution cohort analysis of patients undergoing SAVR with no history of preoperative AF (n = 1014). These patients were cross-referenced against an institutional electrocardiogram (ECG) database to identify those with ECGs 3-12 months after surgery. Logistic regression was used to identify predictors of late AF. RESULTS: Among the 401 patients (40%), who had ECGs in our institution 3-12 months after surgery, 16 (4%) had late AF. Patients with late AF were older than patients without late AF (73 vs. 65, p = .025), and underwent procedures that were more urgent/emergent (38% vs. 15%, p = .015), with higher predicted risk of mortality (2.2% vs. 1.3%, p = .012). Predictors associated with the development of late AF were advanced age, higher preoperative creatinine level and urgent/emergent surgery. CONCLUSIONS: The incidence of late AF 3-12 months after SAVR, is low. Prophylactic AF interventions at the time of SAVR may not be warranted.


Subject(s)
Aortic Valve Stenosis , Atrial Fibrillation , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Atrial Fibrillation/etiology , Humans , Retrospective Studies , Risk Factors , Treatment Outcome
10.
J Healthc Manag ; 67(5): 367-379, 2022.
Article in English | MEDLINE | ID: mdl-36074700

ABSTRACT

GOAL: For decades, hospitals performing cardiac surgery have carried the cost of implementing quality improvement activities and reporting quality outcomes. However, the financial return of such investments is unclear, which weakens the incentive for hospitals to invest in quality improvement activities. This study explored the relationship between a hospital's measured quality and its financial performance. METHODS: Using data from the American Hospital Association and Hospital Compare from 2014 to 2018, we performed an observational study of hospitals performing cardiac surgery. We used mixed-effects regression models with fixed-year effects and random intercepts to explore associations between measured quality and hospital financial performance. Our dependent variables were margins (profit divided by revenue) and financial distress; our independent variables included Patient Safety Indicator 90 (PSI-90) and hospital characteristics. PRINCIPAL FINDINGS: Our sample included 4,927 hospital-years from 1,209 unique hospitals. Hospitals in the worst-performing PSI-90 score quartile experienced a lower operating margin (-1.26%, 95% CI [-2.10 to -0.41], p = .004), a lower total margin (-0.92%, 95% CI [-1.66 to -0.17], p = .016), and an increased odds of financial distress in the next year (OR: 2.12, 95% CI [1.36-3.30], p = .001) when compared with the best-performing hospitals. PRACTICAL APPLICATIONS: Our exploration into financial distress provides managers with a better understanding of the relationship between a hospital's measured quality and its financial position. In reflecting on our findings, hospital leaders may consider viewing patient safety as a modifiable factor that can improve their organization's overall financial health. Our findings suggest that excellent safety performance may be both financially and clinically beneficial to hospitals.


Subject(s)
Cardiac Surgical Procedures , Hospitals , American Hospital Association , Humans , Patient Safety , Quality Improvement , United States
11.
J Card Surg ; 36(5): 1644-1648, 2021 May.
Article in English | MEDLINE | ID: mdl-33032369

ABSTRACT

The global pandemic of coronavirus 2019 (COVID-19) caused by coronavirus has had a profound impact on the delivery of health care in the United States and globally. Boston was among the earliest hit cities in the United States, and within Boston, the Massachusetts General Hospital provided care for more patients with COVID-19 than any other hospital in the region. This necessitated a massive reallocation of resources and priorities, with a near doubling of intensive care bed capacity and a halt in all deferrable surgical cases. During this crisis, the Division of Cardiac Surgery responded in a unified manner, dealing honestly with the necessity to reduce Intensive Care Unit resource utilization for the benefit of both the institution and our community by deferring nonemergent cases while also continuing to efficiently care for those patients in urgent or emergent need of surgery. Many of the interventions that we instituted have continued to support teamwork as we adapt to the remarkably fluid changes in resource availability during the recovery phase. We believe that the culture of our division and the structure of our practice facilitated our ability to contribute to the mission of our hospital to support the community in this crisis, and now to its recovery. We describe here the challenge we faced in Boston and some of the details of the structure and function of our division.


Subject(s)
COVID-19 , Delivery of Health Care , Humans , Massachusetts , Pandemics , SARS-CoV-2 , United States
12.
Ann Surg ; 272(2): e75-e78, 2020 08.
Article in English | MEDLINE | ID: mdl-32675503

ABSTRACT

AND BACKGROUND DATA: VV ECMO can be utilized as an advanced therapy in select patients with COVID-19 respiratory failure refractory to traditional critical care management and optimal mechanical ventilation. Anticipating a need for such therapies during the pandemic, our center created a targeted protocol for ECMO therapy in COVID-19 patients that allows us to provide this life-saving therapy to our sickest patients without overburdening already stretched resources or excessively exposing healthcare staff to infection risk. METHODS: As a major regional referral program, we used the framework of our well-established ECMO service-line to outline specific team structures, modified patient eligibility criteria, cannulation strategies, and management protocols for the COVID-19 ECMO program. RESULTS: During the first month of the COVID-19 outbreak in Massachusetts, 6 patients were placed on VV ECMO for refractory hypoxemic respiratory failure. The median (interquartile range) age was 47 years (43-53) with most patients being male (83%) and obese (67%). All cannulations were performed at the bedside in the intensive care unit in patients who had undergone a trial of rescue therapies for acute respiratory distress syndrome including lung protective ventilation, paralysis, prone positioning, and inhaled nitric oxide. At the time of this report, 83% (5/6) of the patients are still alive with 1 death on ECMO, attributed to hemorrhagic stroke. 67% of patients (4/6) have been successfully decannulated, including 2 that have been successfully extubated and one who was discharged from the hospital. The median duration of VV ECMO therapy for patients who have been decannulated is 12 days (4-18 days). CONCLUSIONS: This is 1 the first case series describing VV ECMO outcomes in COVID-19 patients. Our initial data suggest that VV ECMO can be successfully utilized in appropriately selected COVID-19 patients with advanced respiratory failure.


Subject(s)
Coronavirus Infections/therapy , Extracorporeal Membrane Oxygenation/methods , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/therapy , Academic Medical Centers , Adult , Betacoronavirus , COVID-19 , Female , Humans , Male , Massachusetts , Middle Aged , Pandemics , SARS-CoV-2 , Time Factors
14.
J Vasc Surg ; 72(2): 589-596.e3, 2020 08.
Article in English | MEDLINE | ID: mdl-32067876

ABSTRACT

OBJECTIVE: The timing of operative revascularization for patients with concomitant carotid artery stenosis and coronary artery disease remains controversial. We examined the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database to evaluate the association of combined carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG) with postoperative outcomes. METHODS: All patients undergoing CABG with known carotid stenosis of >80% were identified from 2011 to 2016. Individuals were stratified by use of cardiopulmonary bypass and whether a concomitant CEA was performed at the time of CABG. Multivariate logistic regression was used to model the probability of combined CABG and CEA. The resulting propensity scores were used to match individuals on the basis of clinical and operative characteristics to evaluate primary (30-day mortality and in-hospital transient ischemic attack and stroke) and secondary (STS morbidity composite events and length of stay) end points, with P < .05 required to declare statistical significance. RESULTS: After propensity score matching, 994 off-pump CABG patients (497 CABG only and 497 CABG-CEA) and 5952 on-pump CABG patients (2976 CABG only and 2976 CABG-CEA) were identified. For patients who received on-pump operations, those undergoing CABG-CEA had no observed difference in rate of in-hospital stroke (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.72-1.21; P = .6), higher incidence of STS morbidity composite events (OR, 1.15, 95% CI, 1.01-1.31; P = .03), longer length of stay (7.0 [interquartile range, 5.0-9.0] days vs 6.0 [interquartile range, 5.0-9.0] days; P < .005), and no observed difference in 30-day mortality (OR, 1.28; 95% CI, 0.97-1.69; P = .08) compared with those undergoing CABG only. For off-pump procedures, CABG-CEA patients had no observed difference in rate of in-hospital stroke (OR, 0.80; 95% CI, 0.37-1.69; P = .56) compared with those undergoing CABG only. CONCLUSIONS: Whereas the differences are relatively small, these data suggest that a combined CABG-CEA approach is unlikely to provide significant stroke reduction benefit compared with CABG only. However, comparison with staged approaches merits further investigation.


Subject(s)
Carotid Stenosis/surgery , Coronary Artery Bypass/adverse effects , Coronary Artery Disease/surgery , Endarterectomy, Carotid/adverse effects , Ischemic Attack, Transient/epidemiology , Stroke/epidemiology , Aged , Cardiopulmonary Bypass/adverse effects , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Coronary Artery Bypass/mortality , Coronary Artery Bypass, Off-Pump/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Databases, Factual , Endarterectomy, Carotid/mortality , Female , Humans , Incidence , Ischemic Attack, Transient/diagnosis , Ischemic Attack, Transient/mortality , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/mortality , Time Factors , Treatment Outcome , United States/epidemiology
15.
Anesth Analg ; 131(6): 1883-1889, 2020 12.
Article in English | MEDLINE | ID: mdl-33048912

ABSTRACT

BACKGROUND: Complete handover of anesthesia care to a second anesthesiologist has been demonstrated to be associated with worse short-term adverse outcomes among cardiac surgery patients, but little information from multi-institutional studies is available. METHODS: New York's cardiac surgery registry was used to identify patients who underwent cardiac surgery in New York between 2010 and 2016 with and without complete handovers of anesthesia care. A retrospective observational study with inverse probability treatment weighting (IPTW) based on the propensity score was used to adjust for differences in preoperative patient characteristics while comparing differences in the primary outcome (in-hospital/30 day mortality), major complications in the index admission or within 30 days of the index surgery, readmissions within 30 days, and length of stay. RESULTS: A total of 8.5% of the 103,102 cardiac surgery procedures involved complete handovers. After adjustment, there was a difference between patients with and without handovers in the primary outcome (2.86% vs 2.48%, adjusted risk ratio [ARR] = 1.15 [1.01-1.31]). There was no difference in readmissions within 30 days (13.7% vs 14.4%, ARR = 0.95 [0.90-1.00]), and the differences in complications and length of stay were not clinically meaningful (adjusted differences of <10%). CONCLUSIONS: Cardiac surgery patients in New York who had complete anesthesia handovers experienced higher short-term mortality rates, but there were no meaningful differences in other outcomes. Unnecessary handovers should be carefully monitored.


Subject(s)
Anesthesiologists , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/mortality , Patient Handoff , Postoperative Complications/etiology , Postoperative Complications/mortality , Aged , Anesthesiologists/trends , Cardiac Surgical Procedures/trends , Female , Humans , Male , Middle Aged , Mortality/trends , New York/epidemiology , Patient Handoff/trends , Registries , Time Factors , Treatment Outcome
16.
J Cardiothorac Vasc Anesth ; 34(2): 356-362, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31932021

ABSTRACT

OBJECTIVE: Extracorporeal membrane oxygenation (ECMO) as a rescue strategy during cardiopulmonary resuscitation (ECPR) is increasingly being used for nonresponders to conventional cardiopulmonary resuscitation. To identify patients most likely to benefit from ECPR, the authors investigated predictors of hospital discharge with good neurologic function. DESIGN: Retrospective cohort analysis. SETTING: Single institution academic medical center. PARTICIPANTS: Patients who underwent ECPR. INTERVENTIONS: Venoarterial ECMO initiation for witnessed refractory cardiac arrest from 2009-2019. MEASUREMENTS AND MAIN RESULTS: Baseline characteristics and post-ECMO outcomes were compared between patients who had good versus poor neurologic function at discharge. Good neurologic function was defined as a cerebral performance category 1 to 2, whereas poor neurologic function was defined as a cerebral performance category 3 to 5. Of 54 patients, 13 (24%) were discharged with good neurologic function and 41 (76%) had poor neurologic function (n = 38 in-hospital deaths; n = 3 discharged with severe disability.) Survivors with good neurologic function were younger (41 v 61 y; p = 0.03), more likely to arrest because of pulmonary embolism (46% v 10%; p = 0.01), and more likely to receive concurrent Impella (Abiomed, Danvers, MA) placement while on ECMO (38% v 12%; p = 0.03.) Young age was the most important predictor of good neurologic function (odds ratio 0.92 [0.87-0.97]; p = 0.004), with a threshold for improved survival around 60 years. For all patients, survival to discharge was 30%; however, among survivors with good neurologic function, 5-year survival was 100%. CONCLUSIONS: ECPR is associated with high rates of neurologic morbidity and mortality. However, in select patients, it may be an acceptable option with favorable long-term survival. Additional studies are indicated to further define the appropriate selection criteria for ECPR implementation.


Subject(s)
Cardiopulmonary Resuscitation , Extracorporeal Membrane Oxygenation , Heart Arrest , Cohort Studies , Heart Arrest/diagnosis , Heart Arrest/therapy , Humans , Middle Aged , Retrospective Studies , Survival Rate , Treatment Outcome
17.
J Card Surg ; 35(9): 2168-2174, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32652637

ABSTRACT

BACKGROUND: In this study, we compare the clinical characteristics, intraoperative management, and postoperative outcomes of patients with acute type A aortic dissection (ATAAD) between two academic medical hospitals in the United States and China. METHODS: From January 2011 to December 2017, 641 and 150 patients from Nanjing Drum Tower Hospital (NDTH) and Massachusetts General Hospital (MGH) were enrolled. Patient demographics, clinical features, surgical techniques, and postoperative outcomes were compared. RESULTS: The annual number of patients presenting with ATAAD at MGH remained relatively stable, while the number at NDTH increased significantly over the study period. The average age was 51 years at NDTH and 61 years at MGH (P < .001). The percentage of patients with known hypertension at the two centers was similar. The time interval from onset of symptoms to diagnosis was significantly longer at NDTH than MGH (11 vs 3.5 hours; P < .001). Associated complications at presentation were more common at NDTH than MGH. More than 90% of patients (91% NDTH and 92% MGH) underwent surgery. The postoperative stroke rate was higher at MGH (12% vs 4%; P < .001); however, the 30-day mortality rate was lower (7% vs 16%; P = .006). CONCLUSIONS: There was a significant increase in the number of ATAAD at NDTH during the study period while the number at MGH remained stable. Hypertension was a common major risk factor; however, the onset of ATAAD at NDTH was nearly one decade earlier than MGH. Chinese patients tended to have more complicated preoperative pathophysiology at presentation and underwent more extensive surgical repair.


Subject(s)
Aortic Dissection , Acute Disease , Aortic Dissection/epidemiology , Aortic Dissection/surgery , China/epidemiology , Hospitals , Humans , Massachusetts , Middle Aged , Retrospective Studies , Treatment Outcome , United States/epidemiology
18.
J Am Soc Nephrol ; 29(2): 670-679, 2018 02.
Article in English | MEDLINE | ID: mdl-29203473

ABSTRACT

AKI after cardiac surgery is associated with mortality, prolonged hospital length of stay, use of dialysis, and subsequent CKD. We evaluated the effects of THR-184, a bone morphogenetic protein-7 agonist, in patients at high risk for AKI after cardiac surgery. We conducted a randomized, double-blind, placebo-controlled, multidose comparison of the safety and efficacy of perioperative THR-184 using a two-stage seamless adaptive design in 452 patients between 18 and 85 years of age who were scheduled for nonemergent cardiac surgery requiring cardiopulmonary bypass and had recognized risk factors for AKI. The primary efficacy end point was the proportion of patients who developed AKI according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. The proportion of patients who developed AKI within 7 days of surgery was similar in THR-184 treatment groups and placebo groups (range, 74%-79%; P=0.43). Prespecified secondary end point analysis did not show significant differences in the severity of AKI stage (P=0.53) or the total duration of AKI (P=0.44). A composite of death, dialysis, or sustained impaired renal function by day 30 after surgery did not differ between groups (range, 11%-20%; P=0.46). Safety-related outcomes were similar across all treatment groups. In conclusion, compared with placebo, administration of perioperative THR-184 through a range of dose exposures failed to reduce the incidence, severity, or duration of AKI after cardiac surgery in high-risk patients.


Subject(s)
Acute Kidney Injury/etiology , Acute Kidney Injury/prevention & control , Bone Morphogenetic Protein 7/agonists , Cardiac Surgical Procedures/adverse effects , Oligopeptides/administration & dosage , Acute Kidney Injury/physiopathology , Aged , Aged, 80 and over , Double-Blind Method , Female , Humans , Male , Middle Aged , Oligopeptides/pharmacology , Perioperative Period , Severity of Illness Index , Treatment Failure
20.
J Card Surg ; 33(12): 778-786, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30525247

ABSTRACT

BACKGROUND: Structural valve deterioration (SVD) is a known limitation of bioprosthetic valves. Recent reports have suggested a concerning rate of early SVD in patients receiving a Mitroflow aortic bioprosthesis. We therefore compared the incidence of SVD and SVD requiring reoperation among patients receiving a Mitroflow versus a common contemporary bioprosthesis. METHODS: A retrospective cohort analysis was performed on 592 patients receiving a Mitroflow aortic bioprosthesis at our institution between 2010 and 2014. Patients were matched 1:1 using a coarsened exact matching algorithm with patients receiving a Carpentier-Edwards Magna Ease aortic bioprosthesis (Edwards Lifesciences, Irvine, CA) during the same period. The incidence of SVD (defined as a mean transprosthetic gradient ≥30 mmHg or moderate to severe intraprosthetic regurgitation), reoperation for SVD, and cumulative survival were compared between prosthesis types. RESULTS: The cumulative incidence of SVD at 5 years for all patients receiving a Mitroflow aortic bioprosthesis was 16% (13-21%) and 5% underwent reoperation for SVD. Implantation of a Mitroflow valve was associated with an increased risk of SVD compared to the comparator valve (hazard ratio [HR] 2.59 [1.69-3.98], P < 0.01). Older age had a protective effect against SVD (HR 0.95 [0.93-0.96], P < 0.01). Patients who received a Mitroflow valve had reduced long-term survival compared to those who received a comparator valve (P = 0.03). CONCLUSION: The Mitroflow aortic bioprosthesis is associated with increased rates of early SVD and reoperation for valvular dysfunction as well as reduced survival compared to a contemporary valve. Enhanced clinical and echocardiographic follow-up is advisable after Mitroflow implantation.


Subject(s)
Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis , Prosthesis Design , Prosthesis Failure , Reoperation/statistics & numerical data , Aortic Valve Stenosis/surgery , Echocardiography , Heart Valve Prosthesis/adverse effects , Heart Valve Prosthesis Implantation , Humans , Incidence , Proportional Hazards Models , Retrospective Studies , Risk Factors , Survival Analysis
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