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1.
Semin Thorac Cardiovasc Surg ; 35(1): 33-41, 2023.
Article in English | MEDLINE | ID: mdl-34718142

ABSTRACT

Del Nido cardioplegia offers equivalent myocardial protection and clinical outcomes to blood cardioplegia in adult isolated CABG and valve patients, but the safety and efficacy of del Nido in complex cases with prolonged aortic cross-clamp times is still unknown. 443 patients at our center underwent replacement of the ascending aorta using either del Nido (n = 182) or blood (n = 261) cardioplegia. Two surgeons used del Nido exclusively and 6 used blood exclusively over the study period. Propensity matching of preoperative characteristics yielded 172 well matched pairs. Emergency and reoperative cases were included. Clinical data were extracted from our local database. Troponin levels were drawn at 12 hours postop in all patients. Rates of perioperative mortality (4.7% vs 5.2%), stroke (5.8% vs 7.0%), renal failure (11.6% vs 12.2%), atrial fibrillation (36.0% vs 31.4%), intra-aortic balloon pump insertion (2.3% vs1.2%), and extra corporeal membrane oxygenation use (4.7% vs 4.1%) did not differ between blood and del Nido groups. Postop Troponin T levels were 0.50[0.35, 0.86] ng/mL and 0.40[0.20, 0.70] ng/mL for blood and del Nido, respectively (P < 0.0001). Postop echocardiography was available in 333 of 344 (96.8%) patients, and there was no difference in change in EF from pre- to postop between blood 0.0[-6.0, 5.0]% and del Nido 0.0 [-6.0, 3.5]% (P = 0.201). Subgroup analysis of patients with aortic cross-clamp time greater than 180 minutes (blood = 77, del Nido = 27) revealed no difference in troponins, ejection fraction, or clinical outcomes. Five-year survival was 85.9[76.8, 91.7]% and 79.8[71.2, 86.1]% for blood and del Nido, respectively (P = 0.151). In ascending aortic surgery with prolonged operative times, no differences were observed in myocardial protection or clinical outcomes with the use of del Nido cardioplegia compared to blood cardioplegia.


Subject(s)
Cardioplegic Solutions , Heart Arrest, Induced , Adult , Humans , Treatment Outcome , Heart Arrest, Induced/adverse effects , Coronary Artery Bypass/adverse effects , Troponin , Retrospective Studies
2.
Article in English | MEDLINE | ID: mdl-35660325

ABSTRACT

OBJECTIVE: Equivalent myocardial protection and clinical outcomes have been shown with the use of del Nido cardioplegia (DC) compared with blood cardioplegia (BC) in adult isolated coronary artery bypass grafting and valve patients. However, its safety and efficacy in cardiac procedures with aortic crossclamp times >90 minutes is still unknown. METHODS: From May 2014 to September 2019, 2506 adult patients at our center underwent cardiac surgery requiring prolonged aortic crossclamp time defined as 90 minutes or longer. Myocardial protection was achieved with BC in 1955 patients and DC in 551 patients. Two surgeons used DC exclusively and 5 used blood exclusively over the study period. BC was delivered anterograde and retrograde whereas DC was delivered anterograde only. Propensity score matching of several preoperative characteristics, including primary cardiac pathology, yielded 526 well matched pairs. Emergency and reoperative cases were included. Troponin T levels were drawn at 12 hours postoperative in all patients. Clinical data were extracted from our local Society of Thoracic Surgeons database. Subgroup analyses were performed on the basis of crossclamp time stratification. RESULTS: For the propensity score-matched cohort, the median crossclamp time was longer in the BC compared with the DC group (114 [interquartile range (IQR), 100-145] minutes for DC vs 153 [IQR, 122-200] minutes for BC; P < .0001) whereas intraoperative peak glucose was higher with BC (173 [IQR, 147-200] g/dL for DC vs 197 [IQR, 171-228] g/dL for BC; P < .001). In addition, perioperative mortality (3.4% vs 3.0%; P = .7273), stroke (3.2% vs 2.1%; P = .2504), renal failure (6.5% vs 4.6%; P = .1767), atrial fibrillation (34% vs 31.4%, P = .3575), intra-aortic balloon pump use (5.3% vs 4.6%, P = .5694), and extracorporeal membrane oxygenation use (3.0% vs 2.9%, P = .8596) did not differ between DC and BC. Postoperative troponin T levels were 0.53 (IQR, 0.30-0.96) ng/mL and 0.62 (IQR, 0.38-1.07) ng/mL for DC and BC, respectively (P = .0024). Subgroup analysis revealed higher troponin T levels with DC for crossclamp times between 150 and 180 minutes. Survival rates at 1, 2, and 5 years were 93.3%, 91.1%, and 78.7% for DC and 94.5%, 91.8%, and 81.5% for BC, respectively (P = .5140). CONCLUSIONS: In adult cardiac surgical procedures with aortic crossclamp times >90 minutes, comparable myocardial protection, perioperative mortality and morbidity, and distant survival were observed with the use of DC compared with BC. Higher troponin levels were seen in DC patients with crossclamp times between 150 and 180 minutes, but this was not associated with increased mortality.

3.
Clin Transplant ; 36(1): e14493, 2022 01.
Article in English | MEDLINE | ID: mdl-34689383

ABSTRACT

PURPOSE: To evaluate the effect of the new heart transplant (HT) allocation system in left ventricular assist device (LVAD) supported patients listed as bridge to transplantation (BTT). METHODS: Adult patients who were listed for HT between October 18, 2016 and October 17, 2019, and were supported with an LVAD, enrolled in the UNOS database were included in this study. Patients were classified in the old or new system if they were listed or transplanted before or after October 18, 2018, respectively. RESULTS: A total of 3261 LVAD patients were listed for transplant. Of these, 2257 were classified in the old and 1004 in the new system. The cumulative incidence of death or removal from the transplant list due to worsening clinical status at 360-days after listing was lower in the new system (4% vs. 7%, P = .011). LVAD Patients listed in the new system had a lower frequency of transplantation within 360-days of listing (52% vs. 61%, P < .001). A total of 1843 LVAD patients were transplanted, 1004 patients in the old system and 839 patients in the new system. The post-transplant survival at 360 days was similar between old and new systems (92.3% vs. 90%, P = .08). However, LVAD patients transplanted in the new system had lower frequency of the combined endpoint, freedom of death or re-transplantation at 360 days (92.2% vs. 89.6%, P = .046). CONCLUSION: The new HT allocation system has affected the LVAD-BTT population significantly. On the waitlist, LVAD patients have a decreased cumulative frequency of transplantation and a concomitant decrease in death or delisting due to worsening status. In the new system, LVAD patients have a decreased survival free of re-transplantation at 360 days post-transplant.


Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Adult , Graft Survival , Heart Failure/surgery , Humans , Retrospective Studies , Treatment Outcome , Waiting Lists
4.
Nat Commun ; 12(1): 5192, 2021 08 31.
Article in English | MEDLINE | ID: mdl-34465780

ABSTRACT

Despite progressive improvements over the decades, the rich temporally resolved data in an echocardiogram remain underutilized. Human assessments reduce the complex patterns of cardiac wall motion, to a small list of measurements of heart function. All modern echocardiography artificial intelligence (AI) systems are similarly limited by design - automating measurements of the same reductionist metrics rather than utilizing the embedded wealth of data. This underutilization is most evident where clinical decision making is guided by subjective assessments of disease acuity. Predicting the likelihood of developing post-operative right ventricular failure (RV failure) in the setting of mechanical circulatory support is one such example. Here we describe a video AI system trained to predict post-operative RV failure using the full spatiotemporal density of information in pre-operative echocardiography. We achieve an AUC of 0.729, and show that this ML system significantly outperforms a team of human experts at the same task on independent evaluation.


Subject(s)
Deep Learning , Heart Failure/diagnostic imaging , Ventricular Dysfunction, Right/surgery , Echocardiography , Heart/diagnostic imaging , Heart/physiopathology , Heart Failure/physiopathology , Humans , Postoperative Period , Preoperative Care , Retrospective Studies , Ventricular Dysfunction, Right/diagnostic imaging , Ventricular Dysfunction, Right/physiopathology , Video Recording
5.
J Heart Lung Transplant ; 40(8): 778-785, 2021 08.
Article in English | MEDLINE | ID: mdl-34167863

ABSTRACT

BACKGROUND: Multicenter data on long term survival following LVAD implantation that make use of contemporary definitions of RV failure are limited. Furthermore, traditional survival analyses censor patients who receive a bridge to heart transplant. Here we compare the outcomes of LVAD patients who develop post-operative RV failure accounting for the transitional probability of receiving an interim heart transplantation. METHODS: We use a retrospective cohort of LVAD patients sourced from multiple high-volume centers based in the United States. Five- and ten-year survival accounting for transition probabilities of receiving a heart transplant were calculated using a multi-state Aalen Johansen survival model. RESULTS: Of the 897 patients included in the study, 238 (26.5%) developed post-operative RV failure at index hospitalization. At 10 years the probability of death with post-op RV failure was 79.28% vs 61.70% in patients without (HR 2.10; 95% CI 1.72 - 2.57; p = < .001). Though not significant, patients with RV failure were less likely to be bridged to a heart transplant (HR 0.87, p = .4). Once transplanted the risk of death between both patient groups remained equivalent; the probability of death after a heart transplant was 3.97% in those with post-operative RV failure shortly after index LVAD implant, as compared to 14.71% in those without. CONCLUSIONS AND RELEVANCE: Long-term durable mechanical circulatory support is associated with significantly higher mortality in patients who develop post-operative RV failure. Improving outcomes may necessitate expeditious bridge to heart transplant wherever appropriate, along with critical reassessment of organ allocation policies.


Subject(s)
Heart Failure/mortality , Heart Transplantation , Heart Ventricles/diagnostic imaging , Heart-Assist Devices/adverse effects , Postoperative Complications/mortality , Ventricular Dysfunction, Right/surgery , Ventricular Function, Right/physiology , Equipment Failure , Female , Follow-Up Studies , Heart Failure/etiology , Heart Failure/surgery , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/surgery , Prognosis , Reoperation , Retrospective Studies , Survival Rate/trends , Time Factors , United States/epidemiology , Ventricular Dysfunction, Right/physiopathology
6.
Ann Cardiothorac Surg ; 10(1): 141-148, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33575184

ABSTRACT

BACKGROUND: Reductive annuloplasty repair of ischemic mitral regurgitation (IMR) is associated with high rates of recurrent MR, which may be improved with etiology-specific annuloplasty rings. METHODS: From October 2005 to May 2015, 128 consecutive patients underwent repair of IMR with the GeoForm ring. Clinical data was extracted from our local Society of Thoracic Surgeons database and electronic medical records. Mortality data was obtained from the Michigan State Social Security Death Index. RESULTS: The average age of patients was 65±11 years with mean pre-op left ventricular ejection fraction (LVEF) of 30%±10% and MR grade of 3.1±0.9 (0-4+). Thirty-day mortality was 4.7%, rate of renal failure 7.9%, rate of atrial fibrillation 27.3%, and no strokes were observed. Of the surviving patients, 89% (109/122) had a follow-up echocardiogram beyond 1 month with a mean echocardiographic follow-up of 59±39 months. LVEF improved from 30%±10% to 38%±14%, P<0.001) while end-diastolic (5.9±0.0 to 5.3±0.9 cm, P<0.001) and end-systolic (5.0±1.0 to 4.4±1.1 cm, P<0.001) left ventricular (LV) diameters decreased, as compared to pre-operative values. Seven patients were found to have recurrent moderate or greater IMR in follow-up to 10 years with three being due to ring dehiscence. One-, 5-, and 10-year freedom from recurrent moderate or severe IMR was 98%, 94%, and 80% respectively. One-, 5-, and 10-year survival was 91%, 77%, and 44%, respectively. CONCLUSIONS: Overall, etiology-specific ring repair of IMR was associated with low rates of recurrent MR on long-term follow-up, coupled with significant LV reverse remodeling and improvement in ejection fraction.

7.
Clin Transplant ; 35(4): e14205, 2021 04.
Article in English | MEDLINE | ID: mdl-33368608

ABSTRACT

Historically, adult congenital patients have longer waitlist time and worse outcomes on the heart transplant waitlist as well as poorer early post-transplant survival. A new heart transplantation allocation system was implemented in the United States on October 18, 2018. The effect of the new allocation system on adult congenital patients is unknown. Adult congenital patients listed for transplantation between November 1, 2015 and September 30, 2019 registered in the United Network for Organ Sharing were included in the study. October 18, 2018 was used as the limit to distribute listed and transplanted patients into old and new groups. A total of 399 patients were listed for heart transplant only, 284 in the old system and 115 in the new system. Clinical characteristics were similar between both groups. The cumulative incidence of poor outcome on the transplant list was similar in both groups (P = .23), but the cumulative incidence of transplant was higher in the new system group (P < .009) and was associated with a shorter waitlist time. The one-year post-transplant outcome was similar between old and new groups (P = .37). The new allocation system has benefited adult congenital patients with increased cumulative frequency of transplantation without worsening short-term survival after transplantation.


Subject(s)
Heart Defects, Congenital , Heart Failure , Heart Transplantation , Adult , Graft Survival , Heart Defects, Congenital/surgery , Humans , Retrospective Studies , United States/epidemiology , Waiting Lists
8.
Am J Transplant ; 21(3): 1255-1262, 2021 03.
Article in English | MEDLINE | ID: mdl-32978873

ABSTRACT

Historically, patients with restrictive (RCM) and hypertrophic cardiomyopathy (HCM) experienced longer wait-times for heart transplant (HT) and increased waitlist mortality. Recently, a new HT allocation system was implemented in the United States. We sought to determine the impact of the new HT system on RCM/HCM patients. Adult patients with RCM/HCM listed for HT between November 2015 and September 2019 were identified from the UNOS database. Patients were stratified into two groups: old system and new system. We identified 872 patients who met inclusion criteria. Of these, 608 and 264 were classified in the old and new system groups, respectively. The time in the waitlist was shorter (25 vs. 54 days, P < .001), with an increased frequency of HT in the new system (74% vs. 68%, P = .024). Patients who were transplanted in the new system had a longer ischemic time, increased use of temporary mechanical circulatory support and mechanical ventilation. There was no difference in posttransplant survival at 9 months (91.1% vs. 88.9%) (p = .4). We conclude that patients with RCM/HCM have benefited from the new HT allocation system, with increased access to HT without affecting short-term posttransplant survival.


Subject(s)
Cardiomyopathy, Hypertrophic , Heart Transplantation , Transplants , Adult , Cardiomyopathy, Hypertrophic/surgery , Databases, Factual , Heart Transplantation/adverse effects , Humans , Retrospective Studies , United States/epidemiology , Waiting Lists
9.
J Heart Lung Transplant ; 40(2): 149-157, 2021 02.
Article in English | MEDLINE | ID: mdl-33277169

ABSTRACT

BACKGROUND: Historically, patients bridged on extracorporeal membrane oxygenation (ECMO) to heart transplantation (HT) have very high post-transplant mortality. In the new heart transplant allocation system, ECMO-supported patients have the highest priority for HT. However, data are lacking on the outcomes of these critically ill patients. We compared the waitlist and post-transplant outcomes of ECMO-supported patients in the new and old allocation systems. METHODS: Adult patients supported by ECMO at the time of listing or transplantation who were registered in the United Network for Organ Sharing database between November 1, 2015 and September 30, 2019 were included. Clinical characteristics, outcomes in the waitlist, and post-transplant survival were compared between the old and new systems. Cox Proportional and subdistribution hazard regression models were used to evaluate the variables contributing to the post-transplant and waitlist outcomes RESULTS: A total of 296 ECMO-supported patients were listed for HT. Of these, 191 were distributed to the old system, and 105 were distributed to the new system. Patients listed in the new system had a higher cumulative incidence of HT (p < 0.001) and lower incidence of death or removal (p = 0.001) from the transplant list than patients listed in the old system. The 6-month survival after transplantation was 74.6% and 90.6% for the old- and new-era patients, respectively (p = 0.002). Among ECMO-supported patients, being listed or transplanted on the new system was independently associated with improved outcomes in the waitlist and after transplantation. CONCLUSIONS: With the implementation of the new heart transplant allocation system, ECMO-supported patients have a shorter waitlist time, improved frequency of HT, and improved short-term post-transplant survival.


Subject(s)
Extracorporeal Membrane Oxygenation/methods , Heart Transplantation/mortality , Postoperative Complications/epidemiology , Registries , Waiting Lists/mortality , Adult , Female , Follow-Up Studies , Graft Survival , Humans , Incidence , Male , Middle Aged , Postoperative Complications/therapy , Retrospective Studies , Risk Factors , Survival Rate/trends , Time Factors , Treatment Outcome , United States/epidemiology
11.
Ann Thorac Surg ; 110(5): 1512-1519, 2020 11.
Article in English | MEDLINE | ID: mdl-32224242

ABSTRACT

BACKGROUND: Less invasive techniques for left ventricular assist device implantation have been increasingly prevalent over past years and have been associated with improved clinical outcomes. The procedural economic impact of these techniques remains unknown. We sought to study and report economic outcomes associated with the thoracotomy implantation approach. METHODS: The LATERAL clinical trial evaluated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare centrifugal-flow ventricular assist device system (HVAD). We collected UB-04 forms in parallel to the trial, allowing analysis of index hospitalization costs. All charges were converted to costs using hospital-specific cost-to-charge ratios and were subsequently compared with Medicare cost data for the same period (2015-2016). Because thoracotomy implants were off-label for all left ventricular assist devices during that period, the Medicare cohort was assumed to consist predominately of traditional sternotomy patients. RESULTS: Thoracotomy patients demonstrated decreased costs compared with sternotomy patients during the index hospitalization. Mean total index hospitalization costs for thoracotomy were $204,107 per patient, corresponding to 21.6% reduction (P < .001) and $56,385 savings per procedure compared with sternotomy. Across almost all cost categories, thoracotomy implants were less costly. CONCLUSIONS: In LATERAL, a clinical trial evaluating the safety and efficacy of the thoracotomy approach for HVAD, costs were lower than those reported in Medicare patient claims occurring over the same period. Because Medicare data can be presumed to consist of predominately sternotomy procedures, thoracotomy appears less expensive than traditional sternotomy.


Subject(s)
Costs and Cost Analysis , Heart-Assist Devices , Prosthesis Implantation/economics , Prosthesis Implantation/methods , Sternotomy/economics , Thoracotomy/economics , Adult , Aged , Clinical Trials as Topic , Female , Humans , Male , Medicare , Middle Aged , Prospective Studies , Treatment Outcome , United States
12.
Circ Heart Fail ; 13(3): e006387, 2020 03.
Article in English | MEDLINE | ID: mdl-32164436

ABSTRACT

BACKGROUND: Limited data are available regarding the outcomes of patients supported by extracorporeal membrane oxygenation (ECMO) who undergo durable mechanical circulatory support implantation (dMCS). We analyzed the clinical characteristics, outcomes, and risk factors for mortality in patients who were bridged with ECMO to dMCS. METHODS: Adult patients who received dMCS between January 2008 and December 2017 (n=19 824), registered in the Society of Thoracic Surgeons-Interagency Registry for Mechanical Assisted Circulatory Support (STS-INTERMACS) database were included. Baseline characteristics, outcomes, risk factors, and adverse events were compared between ECMO-supported patients (n=933) and INTERMACS profile 1 (IP-1) patients not supported by ECMO (n=2362). A propensity match analysis was performed. RESULTS: ECMO patients had inferior survival at 12 months (66.1%) than non-ECMO patients (75.4%; P<0.0001). The proportion of patients transplanted at 2 years after dMCS was similar between the ECMO (30.8%) and non-ECMO (31.8%) groups (P=0.49). A multiphase parametric hazard model identified 2 different periods based on risk of death. ECMO patients had a high hazard for death in the first 6 months after implantation (hazard ratio, 2.18 [1.79-2.66]; P<0.001). Multivariable analysis showed that ECMO was an independent risk factor associated with poor outcome during the early phase after dMCS (hazard ratio, 1.69 [1.37-2.09]; P<0.0001) but not during the constant phase. ECMO patients had similar outcomes to non-ECMO patients when a propensity matched cohort was analyzed. CONCLUSIONS: ECMO-supported patients before dMCS have lower survival compared with other IP-1 patients. A multivariable analysis showed that ECMO is an independent risk factor of poor outcome after dMCS. However, a propensity matched analysis suggested that when important clinical variables are controlled the outcome of both groups is similar. These data support the implantation of dMCS in carefully selected ECMO patients.


Subject(s)
Extracorporeal Membrane Oxygenation , Heart-Assist Devices , Prosthesis Implantation/instrumentation , Shock, Cardiogenic/therapy , Stroke Volume , Ventricular Function, Left , Adult , Aged , Databases, Factual , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/mortality , Female , Heart Transplantation , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis Implantation/adverse effects , Prosthesis Implantation/mortality , Recovery of Function , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Time Factors , Treatment Outcome
13.
Ann Thorac Surg ; 110(2): 508-515, 2020 08.
Article in English | MEDLINE | ID: mdl-31866480

ABSTRACT

BACKGROUND: The objective of this study was to compare long-term outcomes of Mosaic (Medtronic, Minneapolis, MN) porcine mitral valves to Carpentier-Edwards (Edwards Lifesciences, Irving, CA) bovine pericardial mitral valves. METHODS: From 2001 through 2017 at a single institution, 940 patients received a mitral bioprosthesis, of which 463 (49.3%) were porcine and 477 (50.7%) were bovine pericardial. Retrospective review of the procedure and the postoperative clinical course, including echocardiography, through August 2018 were analyzed. All consecutive mitral valve replacements over the study period were included. Follow-up was 99% (929 patients) complete for a total of 6045 patient-years (mean, 6.4 ± 4.5 years). A propensity-matched cohort of 802 mitral bioprosthesis was used for outcome analyses. RESULTS: Operative mortality of the 940 patients was 5.4% (n = 51) and incidence of postoperative stroke was 2.1% (n = 20). Overall survival of the propensity-matched patients at 10 and 15 years was 49.7% (95% confidence interval [CI] 45.5%-53.7%) and 23.3% (95% CI 17.9%-29.3%), respectively. Survival at 15 years was 24.0% (95% CI 18.0%-30.5%) for porcine and 16.5% (95% CI 5.5%-32.6%) for bovine implants, which was not significantly different (P = .67). Overall cumulative incidence for reoperative structural valve deterioration at 15 years was 7.9% (95% CI 4.7%-12.3%) for porcine valves versus 13.2% (95% CI 8.1%-19.5%) for pericardial valves (P < .001). For patients age younger than 65 years, structural valve deterioration at 15 years was 15.8% (95% CI 7.4%-27.0%) versus 30.2% (95% CI 15.1%-46.8%) for porcine and pericardial valves, respectively (P = .009). Overall average time to reoperation for structural valve deterioration for porcine valves was 11.1 ± 2.3 years vs 6.8 ± 2.3 years for bovine pericardial valves (P < .001). CONCLUSIONS: In long-term follow-up, of patients younger than 65 years of age undergoing mitral valve replacement, bovine pericardial valves experienced earlier and more frequent structural valve deterioration than porcine valves.


Subject(s)
Bioprosthesis , Forecasting , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/methods , Mitral Valve/surgery , Postoperative Complications/mortality , Propensity Score , Aged , Animals , Echocardiography , Female , Follow-Up Studies , Heart Valve Diseases/diagnosis , Heart Valve Diseases/mortality , Humans , Male , Michigan/epidemiology , Mitral Valve/diagnostic imaging , Prosthesis Design , Reoperation , Retrospective Studies , Risk Factors , Swine
14.
J Heart Lung Transplant ; 38(4): 344-351, 2019 04.
Article in English | MEDLINE | ID: mdl-30945636

ABSTRACT

BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point-mean length of initial hospital stay -was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.


Subject(s)
Heart Failure/surgery , Heart-Assist Devices , Prosthesis Implantation/methods , Sternotomy , Thoracotomy , Adult , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Thoracotomy/methods
15.
Ann Thorac Surg ; 106(6): 1735-1741, 2018 12.
Article in English | MEDLINE | ID: mdl-30179625

ABSTRACT

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has increased in volume as an alternative to surgical aortic valve replacement (SAVR). Comparisons of total episode expenditures, although largely ignored thus far, will be key to the value proposition for payers. METHODS: We evaluated 6,359 Blue Cross Blue Shield of Michigan and Medicare fee-for-service beneficiaries undergoing TAVR (17 hospitals, n = 1,655) or SAVR (33 hospitals, n = 4,704) in Michigan between 2012 and 2016. Payments through 90 post-discharge days between TAVR and SAVR were price-standardized and risk-adjusted. Centers were divided into terciles of procedural volume separately for TAVR and SAVR, and payments were compared between lowest and highest terciles. RESULTS: Payments (± SD) were higher for TAVR than SAVR ($69,388 ± $22,259 versus $66,683 ± $27,377, p < 0.001), while mean hospital length of stay was shorter for TAVR (6.2 ± 5.6 versus 10.2 + 7.5 days, p < 0.001). Index hospitalization payments were $4,374 higher for TAVR (p < 0.001), whereas readmission and post-acute care payments were $1,150 (p = 0.001) and $739 (p = 0.004) lower, respectively, and professional payments were similar. For SAVR, high-volume centers had lower episode payments (difference: 5.0%, $3,255; p = 0.01) and shorter length of stay (10.0 ± 7.5 versus 11.1 ± 7.9 days, p = 0.002) than low volume centers. In contrast, we found no volume-payment relationship among TAVR centers. CONCLUSIONS: Episode payments were higher for TAVR, despite shorter length of stay. Although not a driver for TAVR, center SAVR volume was inversely associated with payments. These data will be increasingly important to address value-based reimbursement in valve replacement surgery.


Subject(s)
Aortic Valve/surgery , Health Expenditures , Heart Valve Prosthesis Implantation/economics , Heart Valve Prosthesis Implantation/statistics & numerical data , Heart Valve Prosthesis , Aged , Aged, 80 and over , Episode of Care , Female , Heart Valve Prosthesis Implantation/methods , Humans , Male , Transcatheter Aortic Valve Replacement/economics , Transcatheter Aortic Valve Replacement/statistics & numerical data
16.
J Card Surg ; 33(8): 424-430, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29911307

ABSTRACT

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


Subject(s)
Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/trends , Aged , Aged, 80 and over , Female , Heart Valve Prosthesis Implantation/statistics & numerical data , Humans , Male , Michigan , Risk , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/statistics & numerical data , Transcatheter Aortic Valve Replacement/trends
17.
Circ Cardiovasc Qual Outcomes ; 7(4): 567-73, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24987052

ABSTRACT

BACKGROUND: Health-care-acquired infections (HAIs) are a leading cause of morbidity and mortality after cardiac surgery. Prior work has identified several patient-related risk factors associated with HAIs. We hypothesized that rates of HAIs would differ across institutions, in part attributed to differences in case mix. METHODS AND RESULTS: We analyzed 20 896 patients undergoing isolated coronary artery bypass grafting surgery at 33 medical centers in Michigan between January 1, 2009, and June 30, 2012. Overall HAIs included pneumonia, sepsis/septicemia, and surgical site infections, including deep sternal wound, thoracotomy, and harvest/cannulation site infections. We excluded patients presenting with endocarditis. Predicted rates of HAIs were estimated using multivariable logistic regression. Overall rate of HAI was 5.1% (1071 of 20 896; isolated pneumonia, 3.1% [n=644]; isolated sepsis/septicemia, 0.5% [n=99]; isolated deep sternal wound infection, 0.5% [n=96]; isolated harvest/cannulation site, 0.5% [n=97]; isolated thoracotomy, 0.02% [n=5]; multiple infections, 0.6% [n=130]). HAI subtypes differed across strata of center-level HAI rates. Although predicted risk of HAI differed in absolute terms by 2.8% across centers (3.9-6.7%; min:max), observed rates varied by 18.2% (0.9-19.1%). CONCLUSIONS: There was a 18.2% difference in observed HAI rates across medical centers among patients undergoing isolated coronary artery bypass grafting surgery. This variability could not be explained by patient case mix. Future work should focus on the impact of other factors (eg, organizational and systems of clinical care) on risk of HAIs.


Subject(s)
Coronary Artery Bypass/adverse effects , Hospitals/statistics & numerical data , Myocardial Ischemia/surgery , Surgical Wound Infection/epidemiology , Aged , Aged, 80 and over , Female , Humans , Incidence , Male , Michigan/epidemiology , Middle Aged , Retrospective Studies , Risk Factors
18.
Ann Thorac Surg ; 94(3): 988-9, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22916754

ABSTRACT

Penetrating ascending aortic ulcers are rarely encountered, yet they present significant risk of hemorrhage and aortic dissection. Expedient recognition and repair is of vital importance. The current management of penetrating ulcer of the ascending aorta includes replacement of the ascending aorta with a prosthetic graft. We describe our technique of repairing a penetrating ulcer of the ascending aorta with localized ulcer resection and extracellular matrix patch aortoplasty.


Subject(s)
Aorta/surgery , Imaging, Three-Dimensional , Saphenous Vein/transplantation , Ulcer/surgery , Aorta/pathology , Aortic Diseases/diagnostic imaging , Aortic Diseases/surgery , Aortography/methods , Cardiopulmonary Bypass/methods , Female , Follow-Up Studies , Humans , Middle Aged , Recovery of Function , Risk Assessment , Severity of Illness Index , Sternotomy/methods , Suture Techniques , Sutures , Treatment Outcome , Ulcer/diagnostic imaging , Ulcer/pathology
19.
J Card Surg ; 27(1): 78-80, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22136258

ABSTRACT

Aortoesophageal fistula is a rare manifestation of thoracic aortic surgery or esophageal disease. We describe a patient who underwent emergent endovascular repair of an aortoesophageal fistula due to a ruptured penetrating ulcer of the descending thoracic aorta and review the literature on this subject.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Endovascular Procedures/methods , Esophageal Fistula/surgery , Aortic Diseases/diagnosis , Aortic Diseases/etiology , Aortic Rupture/complications , Aortic Rupture/diagnosis , Esophageal Fistula/diagnosis , Esophageal Fistula/etiology , Female , Humans , Middle Aged , Ulcer/complications , Ulcer/diagnosis
20.
Interact Cardiovasc Thorac Surg ; 14(2): 143-5, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22159235

ABSTRACT

Mitral valve annular calcification has long been a challenge in repairing posterior mitral valve prolapse. Folding valvuloplasty of the posterior leaflet without resection provides a means of circumventing common procedural complications. This report demonstrates the success of folding valvuloplasty without resection in the treatment of mitral valve prolapse and severe annular calcification.


Subject(s)
Calcinosis/therapy , Catheterization , Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Prolapse/therapy , Mitral Valve/surgery , Aged, 80 and over , Calcinosis/diagnosis , Calcinosis/surgery , Female , Humans , Mitral Valve Prolapse/diagnosis , Mitral Valve Prolapse/surgery , Severity of Illness Index , Treatment Outcome
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