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1.
Ann Thorac Surg ; 2024 May 25.
Article in English | MEDLINE | ID: mdl-38802037

ABSTRACT

BACKGROUND: A recent multicenter trial showed a reduction in tricuspid regurgitation (TR) progression when tricuspid annuloplasty was performed at the time of surgery for degenerative mitral regurgitation (MR), but with a 14% pacemaker (PPM) rate. We present real-world outcomes at a high-volume center for degenerative MR surgery with/without tricuspid annuloplasty. METHODS: Patients undergoing first-time degenerative mitral surgery between 2011-2021 were identified (n=1,738). After excluding patients undergoing aortic, aortic valve, or tricuspid replacement procedures, patients were stratified into mitral surgery alone (n=1,068) versus mitral surgery plus tricuspid annuloplasty (n=417). Outcomes including operative mortality, new PPM implantation, and postoperative length of stay as well as risk-adjusted overall mortality were compared. RESULTS: Among 1,485 patients in this study, 98% underwent mitral repair. Compared to concomitant tricuspid annuloplasty patients, those undergoing mitral surgery alone were 6 years younger and had lower median STS PROM. Among concomitant tricuspid repair patients, 85% (355/417) had moderate or less preoperative TR, while 15% (61/417) had severe TR. Operative mortality was 1.4%. The incidence of new PPM implantation was 0.7% (7/1,068) in the mitral only group and 5.5% (23/417) in the concomitant tricuspid group (p<0.001). Although unadjusted cumulative survival was lower in the concomitant tricuspid group, after risk adjustment, concomitant tricuspid surgery was not associated with worse overall mortality (HR 0.80 [95% CI, 0.53-1.19], p=0.27). CONCLUSIONS: Concomitant tricuspid annuloplasty is safe, with no difference in mortality and a less than 6% PPM rate at a high-volume mitral center. These data provide real-world context for concomitant tricuspid annuloplasty.

3.
Semin Thorac Cardiovasc Surg ; 36(1): 37-46, 2024.
Article in English | MEDLINE | ID: mdl-37633624

ABSTRACT

Functional mitral regurgitation (FMR) is associated with increased mortality and has been considered a marker for advanced heart disease, yet the value of mitral valve repair (MVr) in this population remains unclear. This study aims to evaluate the impact of reducing FMR burden through surgical MVr on survival. Patients with severe FMR who underwent MVr with an undersized, complete, rigid, annuloplasty between 2004 and 2017 were assessed (n = 201). Patients were categorized based on grade of recurrent FMR (0-4). Time-to-event Kaplan-Meier estimations of freedom from death or reoperation were performed using the log-rank test. Cox proportional hazards models evaluated all-cause mortality and reported in hazards ratios (HR) and 95% confidence intervals (CI). Patients were categorized by postoperative recurrent FMR: 45% (91/201) of patients had grade 0, 29% (58/201) grade 1, 20% (40/201) grade 2, 2% (4/201) grade 3%, and 4% (8/201) grade 4. The cumulative incidence of reoperation with death as a competing risk was higher in patients with grades ≥3 recurrent FMR compared to grades ≤2 (44.6% vs 14.6%, subhazard ratio 3.69 [95% CI, 1.17-11.6]; P = 0.026). Overall freedom from death or reoperation was superior for recurrent FMR grades ≤2 compared to grades ≥3 (log-rank P < 0.001). Increasing recurrent FMR grade was independently associated with mortality (HR 1.30 [95% CI, 1.07-1.59] P = 0.009). Reduced postoperative FMR grade resulted in an incrementally lower risk of death or reoperation after MVr. These results suggest that achieving a durable reduction in FMR burden improves long-term survival.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Insufficiency , Humans , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/etiology , Treatment Outcome , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Proportional Hazards Models , Mitral Valve Annuloplasty/adverse effects
6.
J Thorac Cardiovasc Surg ; 165(1): 401-405, 2023 01.
Article in English | MEDLINE | ID: mdl-34862057
8.
Article in English | MEDLINE | ID: mdl-35618531

ABSTRACT

OBJECTIVE: Functional mitral regurgitation (FMR) is a cardiac pathology that causes the mitral valve to malfunction, leading to mitral regurgitation (MR). The optimal strategy for FMR remains unclear, and FMR outcomes are poor. All etiologies of FMR might not be the same, and subdividing patients with FMR caused by atrial (AFMR) versus ventricular FMR pathology might be important. Herein, we present outcomes of patients with AFMR to define this "new" population. METHODS: Data of patients who underwent mitral valve repair for MR from 2000 to 2020 were reviewed. Patients with degenerative/myxomatous disease, ejection fraction <50% (ventricular FMR), and miscellaneous etiologies including endocarditis and rheumatic disease were excluded to isolate a population of "pure" AFMR patients. Descriptive characteristics and outcomes data were analyzed. RESULTS: Among 123 total AFMR patients, mean preoperative left atrial dimensions were enlarged to 4.9 (95% CI, 4.7-5.0) cm, whereas mean preoperative left ventricular diastolic dimensions remained near normal at 5.0 (95% CI, 4.9-5.2) cm. Preoperative atrial fibrillation was noted in 61% (74/123). Echocardiogram was performed in 58% (71/123) of patients at a median of 569 (interquartile range, 75-1782) days after surgery. Of those, 72% (51/71) had trivial or no MR, 22% (16/71) mild, and only 6% (4/71) moderate or greater MR. Only 1.6% (2/123) required redo mitral valve reoperation. Estimated 5-year survival was 74%. CONCLUSIONS: Patients with AFMR do well after mitral valve repair using an annuloplasty ring, with low rates of reoperation, mortality, and recurrence of MR. Mitral annuloplasty should be considered the surgical therapy of choice for AFMR.

9.
J Heart Lung Transplant ; 41(4): 425-433, 2022 04.
Article in English | MEDLINE | ID: mdl-35168899

ABSTRACT

Infections are widely prevalent in left ventricular assist device (LVAD) recipients and associated with adverse events including mortality and rehospitalizations. Current evidence examining factors associated with infections in this setting predominantly comprises single-center observational data. We performed a scoping review to systematically summarize all existing studies examining patient-related factors associated with infections after LVAD implantation. Studies published between 01/06 and 02/19 were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of patient-related factors associated with infections among recipients of contemporary implantable, continuous flow LVADs. Key study characteristics were extracted by four independent reviewers and current literature described narratively. All analyses took place between February 2019 and May 2021. A total of 31 studies met inclusion criteria. All included studies were observational, and most commonly focused on driveline infections (n = 17). Factors studied most commonly included body composition (n = 8), diabetes and other comorbidities (n = 8), and psychosocial/socio-economic factors (n = 6). Studies were frequently single-center with heterogeneity in definition of infectious outcomes as well as exposure variables. Patient race and sex did not correlate with infection risk. There was no consistent association noted between obesity, diabetes, or psychosocial/socio-economic factors and infections in LVAD recipients. Two studies reported a significant association between malnutrition and hypoalbuminemia and post implant infections. This review summarizes 31 studies that described patient-related factors associated with infection after LVAD implantation. Patient related comorbidities, especially body composition and diabetes, were most commonly evaluated, but were not consistently associated with infections after LVAD implantation.


Subject(s)
Heart Failure , Heart-Assist Devices , Comorbidity , Heart-Assist Devices/adverse effects , Humans , Retrospective Studies
10.
Ann Thorac Surg ; 113(6): 2092-2096, 2022 06.
Article in English | MEDLINE | ID: mdl-34990573

ABSTRACT

PURPOSE: Severe mitral annular calcification (MAC) increases surgical complexity and is independently associated with increased operative mortality for mitral valve replacement (MVR). Recently we adopted ultrasonic emulsification/aspiration for annular decalcification to address these risks and describe our early experience with this new technology. DESCRIPTION: Excluding previous mitral valve surgery or endocarditis, 179 patients with MAC underwent MVR at a single institution between January 2015 and March 2020. Of these, 15 consecutive patients with severe MAC (≥50% of the annulus) underwent annular decalcification with ultrasonic emulsification/aspiration as an adjunct treatment during MVR from April 2019 to March 2020. EVALUATION: Mean patient age was 68 ± 12 years, and 72% (n = 128) were female. Mean preoperative left ventricular ejection fraction was 60% ± 11%, and mean mitral valve gradient was 9.1 ± 4.4 mm Hg. Concomitant procedures included antiarrhythmia (n = 52), aortic valve replacement (n = 32), and coronary artery bypass grafting (n = 20). There were no operative deaths or strokes in the group undergoing ultrasonic emulsification and aspiration. CONCLUSIONS: The use of ultrasonic emulsification and aspiration in severe MAC patients may help mitigate the risks of MVR and facilitate operative success in this challenging, high-risk population.


Subject(s)
Calcinosis , Heart Valve Diseases , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Aged , Aged, 80 and over , Calcinosis/complications , Female , Follow-Up Studies , Heart Valve Diseases/complications , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/surgery , Retrospective Studies , Stroke Volume , Treatment Outcome , Ultrasonics , Ventricular Function, Left
11.
Semin Thorac Cardiovasc Surg ; 34(1): 67-77, 2022.
Article in English | MEDLINE | ID: mdl-33865973

ABSTRACT

Mitral repair (MVr) is superior to replacement for degenerative disease; however, its benefit is less established for endocarditis. We report outcomes of repair or replacement for mitral/tricuspid endocarditis and identify predictors of MVr. Patients undergoing first-time surgery for mitral (n = 260) or tricuspid (n = 71) endocarditis between 1992 to 2018 were identified. Patients with aortic endocarditis were excluded. Primary outcome was all-cause mortality and secondary outcome was MVr. Patients were stratified into active and treated endocarditis separately for mitral and tricuspid groups. Predictors of MVr were assessed through multivariable logistic regression and adjusted likelihood of MVr through marginal effects estimates. A mitral specialist was defined by performing ≥25 annual degenerative MVr. Among 331 patients, 70% (181/260) of those with mitral valve endocarditis and 52% (37/71) of those with tricuspid endocarditis underwent repair. The MVr group compared with replacement had a higher proportion of elective acuity and less diabetes, hypertension, active endocarditis, cardiogenic shock, and dialysis. Estimated 5-year survival did not differ between repair versus replacement for active mitral (68 ± 14% vs 60 ± 14%, P = 0.34) or tricuspid endocarditis (60 ± 17% vs 61 ± 19%, P = 0.67), but was superior after repair for treated mitral endocarditis (86 ± 7% vs 51 ± 24%, P = 0.014). Independent predictors of mortality included dialysis for active and treated mitral endocarditis, and mitral replacement (vs MVr) for treated mitral endocarditis. The likelihood of MVr was 82 ± 5% for mitral specialists and 47 ± 9% for non-specialists (P < 0.001). MVr for endocarditis should be pursued, if feasible. Importantly, achieving MVr was driven not only by patient factors, but also surgeon experience.


Subject(s)
Endocarditis, Bacterial , Endocarditis , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Endocarditis/diagnosis , Endocarditis/surgery , Endocarditis, Bacterial/diagnosis , Endocarditis, Bacterial/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Retrospective Studies , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery
12.
J Thorac Cardiovasc Surg ; 163(2): 591-602.e1, 2022 Feb.
Article in English | MEDLINE | ID: mdl-32620398

ABSTRACT

OBJECTIVE: For degenerative mitral disease, repair is superior to replacement; however, the best operative strategy for rheumatic mitral disease remains unclear. We evaluated the association between decision-making in choosing repair versus replacement and outcomes across 2 decades of rheumatic mitral surgery. METHODS: Patients undergoing isolated, first-time rheumatic mitral surgery were identified. Era 1 (1997-2008) and Era 2 (2009-2018) were distinguished by intraoperative assessment of anterior leaflet mobility/calcification (Era 2) in deciding between mitral repair versus replacement. Primary outcome was a composite of death, reoperation, and severe valve dysfunction. RESULTS: Among 180 patients, age was 59 ± 14 years, and ejection fraction was 58% ± 10%. A higher proportion in Era 1 (n = 56) compared with Era 2 (n = 124) had preoperative atrial fibrillation (68% vs 46%; P = .006); the groups were otherwise similar. Primary indication was mitral stenosis in 69% (124 out of 180; pure = 35, mixed = 89) and did not differ by era (P = .67). During Era 1, 70% (39 out of 56) underwent repair, compared with 33% (41 out of 124) during Era 2 (P < .001). Freedom from death, reoperation, or severe valve dysfunction at 5 years was higher in Era 2 (72% ± 9%) than Era 1 (54% ± 13%; P = .04). Five-year survival was higher in Era 2 than Era 1, but did not differ between repair versus replacement. Five-year cumulative incidence of reoperation with death as a competing risk did not differ by era, but was higher after repair than replacement. CONCLUSIONS: Careful assessment of anterior leaflet mobility/calcification to determine mitral repair or replacement was associated with improved outcomes. This decision-making strategy may alter the threshold for rheumatic mitral replacement in the current valve-in-valve era.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Insufficiency/surgery , Mitral Valve Stenosis/surgery , Mitral Valve/surgery , Rheumatic Heart Disease/surgery , Adult , Aged , Aged, 80 and over , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Hemodynamics , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Annuloplasty/adverse effects , Mitral Valve Annuloplasty/mortality , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/physiopathology , Mitral Valve Stenosis/diagnostic imaging , Mitral Valve Stenosis/mortality , Mitral Valve Stenosis/physiopathology , Postoperative Complications/mortality , Postoperative Complications/surgery , Recovery of Function , Reoperation , Retrospective Studies , Rheumatic Heart Disease/diagnostic imaging , Rheumatic Heart Disease/mortality , Rheumatic Heart Disease/physiopathology , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Young Adult
13.
Ann Thorac Surg ; 114(4): 1307-1317, 2022 10.
Article in English | MEDLINE | ID: mdl-34619136

ABSTRACT

BACKGROUND: Although the current wide-scale adoption of the HeartMate 3 left ventricular assist device can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of left ventricular assist device clinical trial outcomes and evaluated the prognostic value of specific inclusion and exclusion criteria. METHODS: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) who underwent HeartMate 3 implantation (n = 4610) between August 2017 and March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models. RESULTS: Indications for HeartMate 3 implant included destination therapy (n = 2827, 61%), bridge to candidacy (n = 969, 21%), and bridge to transplant (n = 702, 15%). A total of 1941 recipients (42%) were trial-ineligible, with 1245 (27%) meeting one ineligibility criterion, 470 (10%) meeting two, and 226 (5%) meeting three or more. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17% ± 1% vs 10% ± 1%, P < .001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting one ineligibility criterion (15% ± 1%), two criteria (16% ± 2%), and three or more criteria (30% ± 3%). Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality. CONCLUSIONS: Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.


Subject(s)
Heart Failure , Heart-Assist Devices , Surgeons , Bilirubin , Creatinine , Heart Failure/surgery , Humans , Registries , Retrospective Studies , Treatment Outcome
14.
J Heart Lung Transplant ; 41(1): 95-103, 2022 01.
Article in English | MEDLINE | ID: mdl-34666942

ABSTRACT

BACKGROUND: The United States National Organ Procurement Transplant Network (OPTN) implemented changes to the adult heart allocation system to reduce waitlist mortality by improving access for those at greater risk of pre-transplant death, including patients on short-term mechanical circulatory support (sMCS). While sMCS increased, it is unknown whether the increase occurred equitably across centers. METHODS: The OPTN database was used to assess changes in use of sMCS at time of transplant in the 12 months before (pre-change) and after (post-change) implementation of the allocation system in October 2018 among 5,477 heart transplant recipients. An interrupted time series analysis comparing use of bridging therapies pre- and post-change was performed. Variability in the proportion of sMCS use at the center level pre- and post-change was determined. RESULTS: In the month pre-change, 9.7% of patients were transplanted with sMCS. There was an immediate increase in sMCS transplant the following month to 32.4% - an absolute and relative increase of 22.7% and 312% (p < 0.001). While sMCS use was stable pre-change (monthly change 0.0%, 95% CI [-0.1%,0.1%]), there was a continuous 1.2%/month increase post-change ([0.6%,1.8%], p < 0.001). Center-level variation in sMCS use increased substantially after implementation, from a median (interquartile range) of 3.85% (10%) pre-change to 35.7% (30.6%) post-change (p < 0.001). CONCLUSIONS: Use of sMCS at time of transplant increased immediately and continued to expand following heart allocation policy changes. Center-level variation in use of sMCS at the time of transplant increased compared to pre-change, which may have negatively impacted equitable access to heart transplantation.


Subject(s)
Health Equity , Health Policy , Heart Transplantation , Heart-Assist Devices , Tissue and Organ Procurement/statistics & numerical data , Tissue and Organ Procurement/standards , Adult , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Time Factors , United States
15.
J Heart Lung Transplant ; 41(1): 1-16, 2022 01.
Article in English | MEDLINE | ID: mdl-34801350

ABSTRACT

BACKGROUND: Infections are the most common complication in recipients of durable left ventricular assist devices (LVAD) and are associated with increased morbidity, mortality, and expenditures. The existing literature examining factors associated with infection in LVAD recipients is limited and principally comprises single-center studies. This scoping review synthesizes all available evidence related to identifying modifiable, non-patient factors associated with infections among LVAD recipients. METHODS: Published studies were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of factors associated with infections among recipients of contemporary, implantable, continuous flow LVADs. Key study characteristics were extracted by 4 independent reviewers and current literature described narratively. The Systems Engineering Initiative for Patient Safety (SEIPS) model was used to develop a taxonomy for non-patient related factors (e.g., tasks, tools, technologies, organization, and environment) associated with infections following LVAD implantation. All analyses took place between February 2019 and May 2021. FINDINGS: A total of 43 studies met inclusion criteria. The majority of included studies were observational (n = 37), single-center (n = 29), from the U.S. (n = 38), and focused on driveline infections (n = 40). Among the 22 evaluated sub-domains of non-patient related factors, only two: increasing center experience and establishing a silicone-skin interface at the driveline exit site, were identified as consistently being associated with a lower risk of infection. CONCLUSION: This review identified 43 studies that described non-patient related factors associated with infection in LVAD recipients. Only two factors were consistently associated with lower infection risk in LVAD recipients: increasing experience and establishing a silicone-skin interface at driveline exit site. The large variability in reporting across multiple studied interventions limited the ability to discern their effectiveness.


Subject(s)
Heart-Assist Devices/adverse effects , Prosthesis-Related Infections/etiology , Humans
16.
J Card Surg ; 36(12): 4684-4687, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34719818

ABSTRACT

PURPOSE: Timely and high-quality feedback is important in cardiothoracic (CT) surgery education. Feedback on operative proficiency is an area for improvement in CT surgery programs. Traditional evaluations significantly lag behind operative interactions. We hypothesized that use of the System for Improving and Measuring Procedural Learning (SIMPL) app would improve operative feedback for trainees. METHODS: Use of SIMPL was evaluated from December 2018 to January, 2021 within an academic CT surgery training program. Ratings include level of supervision, complexity of the operation, and trainee performance. Completion was limited to 72 h after the operation. Descriptive statistics of the users and ratings are presented. RESULTS: Over 28 months, 816 evaluations were completed, and of these, 495 had a rating from both the faculty and trainee. There were 19 trainees representing post-graduate years 1-8 and 19 faculty members who received or submitted at least one evaluation over the study period. The number of evaluations for each trainee ranged from 1 to 166 and from 1 to 81 for each of the faculty. The response rate for faculty ranged from 0% to 100%. "Active help" was the most common type of supervision (50.7% by the faculty, 60.4% from the trainees). CONCLUSIONS: Use of SIMPL within a CT surgery training program was feasible and engagement was observed from both trainees and faculty. SIMPL provided trainees with timely, concise feedback on operative performance. Further work will focus on correlating SIMPL ratings with pre-existing assessments of performance.


Subject(s)
Internship and Residency , Mobile Applications , Clinical Competence , Feasibility Studies , Humans , Smartphone
17.
JAMA Netw Open ; 4(1): e2032865, 2021 01 04.
Article in English | MEDLINE | ID: mdl-33416886

ABSTRACT

Importance: While wide-scale adoption of durable left ventricular assist devices (LVADs) can be attributed to favorable randomized clinical trial outcomes, restrictive selection criteria may be associated with a lack of generalizability to real-world experience. Objective: To estimate the proportion of LVAD recipients who are eligible for clinical trials and to assess whether an association exists between trial eligibility and mortality. Design, Setting, and Participants: This cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). To simulate a trial population, trial criteria from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) were mapped to INTERMACS variables. Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met. Follow-up in INTERMACS was complete for all patients through October 31, 2017. Data were analyzed from July 2019 through November 2020. Exposures: Undergoing durable LVAD implantation. Main Outcomes and Measures: Trial eligibility and postimplant mortality were analyzed using Kaplan-Meier estimates and Cox proportional hazards models. Results: Among 14 679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure. A total of 6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both). Patients who were trial-ineligible had increased risk of mortality compared with patients who were trial-eligible if they met 1 trial ineligibility criterion (hazard ratio [HR], 1.16 [95% CI, 1.08-1.24]; P < .001), 2 trial ineligibility criteria (HR, 1.51 [95% CI, 1.36-1.67]; P < .001), or 3 or more trial ineligibility criteria (HR, 2.09 [95% CI, 1.84-2.39]; P < .001). Among patients meeting only 1 ineligibility criterion, 4 criteria were independently associated with mortality: prior or ongoing mechanical circulatory support (HR, 1.63 [95% CI, 1.23-2.16]; P = .001), elevated creatinine level (HR, 1.42 [95% CI, 1.17-1.72]; P < .001), elevated bilirubin level (HR, 1.39 [95% CI, 1.17-1.66]; P < .001), and low albumin or prealbumin level (HR, 1.18 [95% CI, 1.05-1.33]; P = .007). Conclusions and Relevance: These findings suggest that while treatment for patients who are ineligible for LVAD trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.


Subject(s)
Clinical Trials as Topic , Heart Failure/mortality , Heart Failure/therapy , Heart-Assist Devices , Patient Selection , Female , Humans , Male , Middle Aged , North America , Prognosis , Research Design
18.
Ann Thorac Surg ; 111(2): 479-486, 2021 02.
Article in English | MEDLINE | ID: mdl-32693045

ABSTRACT

BACKGROUND: Despite the superiority of mitral valve repair (MVr) over replacement for degenerative disease, repair rates vary widely across centers. Traveling to a mitral reference center (MRC) is 1 way to increase the odds of MVr. This study assessed the economic value (quality/cost) and long-term outcomes of distant referral to an MRC. METHODS: Among 746 mitral surgery patients between January 2011 and June 2013, low-risk patients with an ejection fraction greater than 40% undergoing isolated degenerative MVr were identified and included 26 out-of-state (DISTANT) and 104 in-state patients (LOCAL). Short- and long-term outcomes and institutional financial data (including travel expenses) were used to compare groups. National average and MRC-specific MVr rates, clinical outcomes, and marginal value of quality-adjusted life-years collected from The Society of Thoracic Surgeons database and Medicare estimates were used to perform a nationally representative cost-benefit analysis for distant referral. RESULTS: Age, ejection fraction, operative time, blood transfusions, and annuloplasty ring size did not differ between groups. Median charges were $76,022 for LOCAL and $74,171 for DISTANT (P = .35), whereas median payments (including travel expenses) were $57,795 for LOCAL and $58,477 for DISTANT (P = .70). Short- and long-term outcomes were similar between groups and median follow-up was 7.1 years. Estimated 5-year survival was 97% (96% for LOCAL and 100% for DISTANT; P = .24). Cost-benefit analysis showed a net benefit through distant referral to an MRC ranging from $436 to $6078 to the payer and $22,163 to $30,067 to the patient, combining for an estimated $22,599 to $32,528 societal benefit. CONCLUSIONS: These data suggest that distant referral to an MRC is achievable and reasonable.


Subject(s)
Heart Valve Prosthesis Implantation/economics , Medicare/economics , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Referral and Consultation/economics , Chronic Disease , Costs and Cost Analysis , Female , Follow-Up Studies , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve Insufficiency/economics , Retrospective Studies , Time Factors , Treatment Outcome , United States
20.
J Thorac Cardiovasc Surg ; 162(4): 1087-1096.e3, 2021 Oct.
Article in English | MEDLINE | ID: mdl-32305185

ABSTRACT

OBJECTIVE: Mitral valve repair is superior to replacement for degenerative disease, but long-term outcomes of anterior versus posterior leaflet repair remain poorly defined. We propensity matched anterior and posterior repairs to compare long-term outcomes. METHODS: Patients undergoing first-time degenerative mitral repair between 1992 and 2018 were identified. Primary outcome was overall survival. Secondary outcomes were postprocedural residual mitral regurgitation and reoperation. From 1025 patients, 1:1 propensity score matching was performed, yielding 309 anterior (isolated anterior = 85, bileaflet = 224) and 309 isolated posterior repairs. RESULTS: Age was 58 ± 15 years, ejection fraction was 57% ± 10%, and matched groups were well balanced. Anterior repairs had longer bypass (122 ± 53 vs 109 ± 43 minutes, P = .001) and crossclamp (94 ± 44 vs 85 ± 62 minutes, P = .033) times. Mean residual mitral regurgitation grade was 0.44 (95% confidence interval, 0.24-0.65) for anterior repair and 0.30 (95% confidence interval, 0.13-0.47) for posterior repair (P = .31). Overall, 92% (569/618) of matched patients had no residual mitral regurgitation, with no differences in mitral regurgitation grade between groups (P = .77). Survival did not differ between anterior (10 years: 72% ± 7%; 15 years: 63% ± 7%) and posterior (10 years: 74% ± 7%; 15 years: 60% ± 8%) groups (log-rank P = .93). Linearized incidence of reoperation was 0.62% per patient-year, including 0.74% for anterior and 0.48% for posterior repairs. Cumulative incidence of reoperation at 15 years was 7.5% after anterior repair and 4.9% after posterior repair (Gray's test P = .26). CONCLUSIONS: No long-term survival or reoperation difference was found between posterior and anterior repair. On the basis of these findings, surgeons at centers of excellence should aim for repair of both anterior and posterior leaflet pathology with the same decision-making threshold over valve replacement for degenerative mitral disease.


Subject(s)
Cardiac Surgical Procedures , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve , Postoperative Complications , Reoperation , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Clinical Decision-Making , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Humans , Male , Middle Aged , Mitral Valve/pathology , Mitral Valve/physiopathology , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnosis , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/physiopathology , Mitral Valve Insufficiency/surgery , Mitral Valve Prolapse/pathology , Mitral Valve Prolapse/surgery , Postoperative Complications/diagnosis , Postoperative Complications/physiopathology , Postoperative Complications/surgery , Reoperation/methods , Reoperation/statistics & numerical data , Treatment Outcome
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