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Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device

Ramzy, Danny; Anderson, Mark; Batsides, George; Ono, Masahiro; Silvestry, Scott; D'Alessandro, David A; Funamoto, Masaki; Zias, Elias A; Lemaire, Anthony; Soltese, Edward
OBJECTIVE:, a temporary left ventricular assist device that provides up to 6.2 L/min forward flow, with recent FDA approval for up to 14 days. METHODS:From October 2019 to March 2020, 200 patients at 42 US centers received the Impella 5.5 and entered into the IQ registry, a manufacturer-maintained quality database that captures limited baseline/procedural characteristics and outcomes through device explant. Post hoc subgroup analyses were conducted to assess the role of baseline and procedural characteristics on survival, defined as successful device weaning or bridge to durable therapy. RESULTS:= 0.002). CONCLUSIONS:In the first 200 US patients treated with the Impella 5.5, we observed overall survival to explant of 74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly PCCS. Prospective studies assessing comparative performance of this device to conventional strategies are warranted in future.
PMID: 34101514
ISSN: 1559-0879
CID: 4899802

Unusual Cause of Severe Tricuspid Regurgitation: Tricuspid Leaflet Annular Tear Following Remote Motor Vehicle Accident [Case Report]

Bamira, Daniel G; Dwivedi, Aeshita; Bhatla, Puneet; Halpern, Dan; Vainrib, Alan F; Kim, Eugene; Zias, Elias; Saric, Muhamed
Tricuspid regurgitation (TR) is an uncommon and underdiagnosed complication of blunt chest trauma. Typical mechanisms include torn chordae, papillary muscle rupture, and radial leaflet tear. We describe an unusual case of traumatic TR due to circumferential avulsion of the anterior tricuspid leaflet from the tricuspid annulus and the crucial role of multimodality imaging in its diagnosis and treatment. (Level of Difficulty: Intermediate.).
PMCID:8299867
PMID: 34317128
ISSN: 2666-0849
CID: 4949442

Concomitant temporary mechanical support in high-risk coronary artery bypass surgery

Ranganath, Neel K; Nafday, Heidi B; Zias, Elias; Hisamoto, Kazuhiro; Chen, Stacey; Kon, Zachary N; Galloway, Aubrey C; Moazami, Nader; Smith, Deane E
OBJECTIVES/OBJECTIVE:Patients with low left ventricular ejection fraction (LVEF) undergoing high-risk coronary artery bypass grafting (CABG) are at increased risk for postcardiotomy cardiogenic shock. This report describes planned concomitant microaxial temporary mechanical support (MA-TMS) device placement as a viable bridge-to-recovery strategy for high-risk patients receiving surgical revascularization. METHODS:A retrospective review was performed for all patients from October 2017 to May 2019 with low LVEF (<30%), New York Heart Association Class III or IV symptoms, and myocardial viability who underwent CABG with prophylactic MA-TMS support at a single institution (n = 13). RESULTS:Mean patient age was 64.8 years, and 12 patients (92%) were male. Eight patients (62%) presented with acute coronary syndrome. Mean predicted risk of mortality was 4.6%, ranging from 0.6% to 15.6%. An average of 3.4 grafts were performed per patient. Greater than 60% of patients were extubated within 48 hours and out-of-bed within 72 hours, and the average duration of MA-TMS was 5.7 days. Mean postoperative length of stay was 16.7 days. There were no postoperative myocardial infarctions or deaths. CONCLUSIONS:Prophylactic MA-TMS may allow safe and effective surgical revascularization for patients with severe left ventricular dysfunction who may otherwise be offered a durable ventricular assist device.
PMID: 31654576
ISSN: 1540-8191
CID: 4161952

Ninety-Day Readmissions of Bundled Valve Patients: Implications for Healthcare Policy

Koeckert, Michael S; Grossi, Eugene A; Vining, Patrick F; Abdallah, Ramsey; Williams, Mathew R; Kalkut, Gary; Loulmet, Didier F; Zias, Elias A; Querijero, Michael; Galloway, Aubrey C
OBJECTIVE:Medicare's Bundle Payment for Care Improvement(BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care(EOC) which include operative costs, inpatient stay, physician fees, post-acute care, and readmissions up to 90 days post-procedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. METHODS:All BPCI valve patients from 10/2013 (start of risk-sharing phase) through 12/2015 were included. Readmissions were categorized as early (≤30 days) or late (31-90 days). Data were collected from institutional databases as well as Medicare claims. RESULTS:Analysis included 376 BPCI valve patients: 202 open and 174 transcatheter aortic valves (TAVR). TAVR patients were older (83.6 vs 73.8 years; p=0.001) and had higher STS predicted risk (7.1% vs 2.8%; p=0.001). Overall, 18.6% of patients (70/376) had one-or-more 90-day readmission, and total claims was on average 51% greater for these patients. Overall readmissions were more common among TAVR patients (22.4%(39/174) vs 15.3%(31/202),p=0.052) as was late readmission. TAVR patients had significantly higher late readmission claims, and early readmission was predictive of late readmission for TAVR patients only (p=0.04). CONCLUSION/CONCLUSIONS:Bundled claims for a 90-day episode of care are significantly increased in patients with readmissions. TAVR patients represent a high-risk group for late readmission, possibly a reflection of their chronic disease processes. Being able to identify patients at highest risk for 90-day readmission and the associated claims will be valuable as we enter into risk-bearing EOC agreements with Medicare.
PMID: 30102970
ISSN: 1532-9488
CID: 3236652

Del Nido cardioplegia for minimally invasive aortic valve replacement

Koeckert, Michael S; Smith, Deane E; Vining, Patrick F; Ranganath, Neel K; Beaulieu, Thomas; Loulmet, Didier F; Zias, Elias; Galloway, Aubrey C; Grossi, Eugene A
BACKGROUND:We analyzed the impact and safety of del Nido Cardioplegia (DNC) in patients undergoing minimally invasive aortic valve replacement (MIAVR). METHODS:We analyzed all isolated MIAVR replacements from 5/2013-6/2015 excluding re-operative patients. The approach was a hemi-median sternotomy in all patients. Patients were divided into two cohorts, those who received 4:1 crystalloid:blood DNC solution and those in whom standard 1:4 Buckberg-based cardioplegia (WBC) was used. One-to-one propensity case matching of DNC to WBC was performed based on standard risk factors and differences between groups were analyzed using chi-square and non-parametric methods. RESULTS:MIAVR was performed in 181 patients; DNC was used in 59 and WBC in 122. Case matching resulted in 59 patients per cohort. DNC was associated with reduced re-dosing (5/59 (8.5%) versus 39/59 (61.0%), P < 0.001) and less total cardioplegia volume (1290 ± 347 mL vs 2284 ± 828 mL, P < 0.001). Antegrade cardioplegia alone was used in 89.8% (53/59) of DNC patients versus 33.9% (20/59) of WBC patients (P < 0.001). Median bypass and aortic cross-clamp times were similar. Clinical outcomes were similar with respect to post-operative hematocrit, transfusion requirements, need for inotropic/pressor support, duration of intensive care unit stay, re-intubation, length of stay, new onset atrial fibrillation, and mortality. CONCLUSIONS:Del Nido cardioplegia usage during MIAVR minimized re-dosing and the need for retrograde delivery. Patient safety was not compromised with this technique in this group of low-risk patients undergoing MIAVR.
PMID: 29460374
ISSN: 1540-8191
CID: 2963242

Del nido cardioplegia simplifies myocardial protection strategy for minimally invasive aortic valve replacement [Meeting Abstract]

Koeckert, M S; Smith, D E; Beaulieu, T; Vining, P F; Loulmet, D F; Zias, E A; Williams, M R; Galloway, A C; Grossi, E A
Objective: The longer dosing interval afforded by Del Nido cardioplegia (DNC) may simplify myocardial protection strategies. We analyzed the impact and safety of DNC in patients undergoing minimally invasive aortic valve replacement. Methods: Institutional use of DNC began in May 2013; we analyzed all isolated minimally invasive aortic valve replacements during this transition (May 2013-June 2015), excluding reoperative sternotomy patients. The approach was hemi-median sternotomy in all patients. Prospectively collected local and Society of Thoracic Surgeons database data were used. Patients were divided into 2 cohorts: those who received 4:1 crystalloid:blood DNC solution and those in whom standard 1:4 Buckberg-based cardioplegia (BC) was used. One-to-one propensity case matching of DNC to Buckberg-based cardioplegia was performed based on standard risk factors, and differences between groups were analyzed using X2 and nonparametric methods. Results: Minimally invasive aortic valve replacement was performed in 181 patients; DNC was usedin 59 and Buckberg-based cardioplegia in 122. Case matching resulted in 59 patients per cohort. DNC was associated with reduced re-dosing [5/59 (8.5%) vs. 39/59 (61.0%), P<0.001] and less total cardioplegia volume (1290 ml+/-347 ml vs. 2284 ml+/-828 ml, P<0.001). Antegrade cardioplegia alone was used in 89.8% (53/59) of DNC patients versus 33.9% (20/59) of patients receiving Buckberg-based cardioplegia (P<0.001). Median bypass and aortic cross-clamp times were similar. Clinical outcomes were similar with respect to postoperative hematocrit, transfusion requirements, need for inotropic/pressor support, duration of stay in the intensive care unit, re-intubation, length of hospital stay, new onset atrial fibrillation, and mortality rate. Table SA15-1 contains demographics, cardioplegia delivery methods, and results. Conclusions: DNC usage markedly simplifies cardioplegia strategy for minimally invasive aortic valve replacement. Patient safety was not compromised with this technique. (Table pasented)
EMBASE:621290381
ISSN: 1559-0879
CID: 3005672

Reengineering valve patients' postdischarge management for adapting to bundled payment models

Koeckert, Michael S; Ursomanno, Patricia A; Williams, Mathew R; Querijero, Michael; Zias, Elias A; Loulmet, Didier F; Kirchen, Kevin; Grossi, Eugene A; Galloway, Aubrey C
BACKGROUND: Bundled Payments for Care Improvement (BPCI) initiatives were developed by Medicare in an effort to reduce expenditures while preserving quality of care. Payment model 2 reimburses based on a target price for 90-day episode of care postprocedure. The challenge for valve patients is the historically high (>35%) 90-day readmission rate. We analyzed our institutional cardiac surgical service line adaptation to this initiative. METHODS: On May 1, 2015, we instituted a readmission reduction initiative (RRI) that included presurgical risk stratification, comprehensive predischarge planning, and standardized postdischarge management led by cardiac nurse practitioners (CNPs) who attempt to guide any postdischarge encounters (PDEs). A prospective database also was developed, accruing data on all cardiac surgery patients discharged after RRI initiation. We analyzed detailed PDEs for all valve patients with complete 30-day follow-up through November 2015. RESULTS: Patients included 219 surgical patients and 126 transcatheter patients. Sixty-four patients had 79 PDEs. Of these 79 PDEs, 46 (58.2%) were guided by CNPs. PDEs were due to fluid overload/effusion (21, 27%), arrhythmia (17, 22%), bleeding/thromboembolic events (13, 16%), and falls/somatic complaints (12, 15%). Thirty-day readmission rate was 10.1% (35/345). Patients with transcatheter aortic valve replacement had a higher rate of readmission than surgical patients (15.0% vs 6.9%), but were older with more comorbidities. The median readmission length of stay was 2.0 days (interquartile range 1.0-5.0 days). Compared with 2014, the 30-day readmission rate for BPCI decreased from 18% (44/248) to 11% (20/175), P = .05. CONCLUSIONS: Our reengineering of pre/postdischarge management of BPCI valve patients under tight CNP control has significantly reduced costly 30-day readmissions in this high-risk population.
PMID: 28412109
ISSN: 1097-685x
CID: 2532462

A Contemporary Approach to Reoperative Aortic Valve Surgery: When is Less, More?

Smith, Deane E 3rd; Koeckert, Michael S; Vining, Patrick F; Zias, Elias A; Grossi, Eugene A; Galloway, Aubrey C
OBJECTIVE: Although the benefits of minimally invasive valvular surgery are well established, the applicability of extending these techniques to reoperative aortic valve surgery is unknown. We evaluated our experience with a minimally invasive approach to this patient population. METHODS: From January 2010 to September 2015, 21 patients underwent reoperative isolated aortic valve replacement via a minimally invasive approach by a single surgeon. All patients had preoperative evaluation with computerized tomography and coronary catheterization. Surgical approaches were right anterior thoracotomy (6/21) or upper hemisternotomy (15/21). Central aortic cannulation was preferred with femoral artery cannulation used in four patients (19%). In patients with left internal mammary artery (LIMA) grafts, no attempt to dissect or occlude the graft was made. Cold blood cardioplegia was administered antegrade (12/21) or retrograde (9/21); systemic cooling with a mean low temperature of 27.5 degrees C was employed. RESULTS: Mean age was 75.1 years with a range from 33 to 92 years, and 67% (14/21) were male. All procedures were completed with a minimally invasive approach. Mean +/- SD cross-clamp time was 51.5 +/- 9.2 minutes. Fourteen patients had patent LIMA grafts. No aortic, LIMA, or cardiac injuries occurred. There were no hospital deaths nor occurrences of perioperative myocardial infarction, stroke, wound infection, renal failure, or endocarditis/sepsis. One patient required a reoperation for bleeding. Sixty-two percent of patients were discharged to home; mean +/- SD length of stay was 6 +/- 3 days. CONCLUSIONS: With appropriate preoperative evaluation and careful surgical planning, a minimally invasive approach to reoperative aortic valve surgery can be performed in a safe and effective manner.
PMID: 28549029
ISSN: 1559-0879
CID: 2575002

Necessity for lifelong follow-up of patients with familial paraganglioma syndrome: A case report

Persky, Michael J; Adelman, Mark; Zias, Elias; Myssiorek, David
BACKGROUND: Patients with established familial paraganglioma (PGL) syndrome may have multiple metachronous lesions. This article illustrates, via imaging and findings, the need for lifetime follow-up of patients with familial PGL syndromes. METHODS: Patients' medical charts and radiological images were reviewed in a retrospective analysis. RESULTS: Over the course of 18 years, this patient developed 2 simultaneous carotid PGLs, a cardiac PGL, and a biochemically active interaortocaval PGL. CONCLUSION: PGLs do not necessarily occur simultaneously in patients with familial PGL syndrome. Lifelong observation is needed to detect these lesions before they become large and symptomatic. Lack of biochemical activity is not a predictor of future lesions being inactive. Cardiac PGLs are rare and require resection. (c) 2015 Wiley Periodicals, Inc. Head Neck 37: E174-E178, 2015.
PMID: 25783443
ISSN: 1097-0347
CID: 1920802

Long-term results of mitral valve repair with semi-rigid posterior band annuloplasty

Yaffee, David W; Loulmet, Didier F; Zias, Elias A; Ursomanno, Patricia A; Rabinovich, Annette E; Galloway, Aubrey C; Grossi, Eugene A
BACKGROUND AND AIM OF THE STUDY: Optimal repair of the mitral valve involves the implantation of an annuloplasty device to geometrically reshape and/or stabilize the annulus and improve long-term durability. It has been reported previously that trigone-to-trigone semi-rigid posterior band (PB) annuloplasty is associated with excellent short-term outcomes, physiologic motion of the anterior mitral annulus and leaflet, and lower postoperative transvalvular gradients compared to complete ring (CR) annuloplasty. The aim of this retrospective study was to compare the long-term effectiveness of PB and CR annuloplasty in patients with degenerative mitral valve regurgitation (MR). METHODS: Between 1993 and 2010, a total of 1,612 patients with degenerative MR underwent mitral valve repair (MVr) with either PB (n = 1,101) or CR (n = 511). Initially, CR was the annuloplasty device of choice, but after 2001 PB was preferred. A retrospective review of clinical and echocardiographic follow up was performed on these patients. The eight-year cumulative freedom from adverse events were determined by life-table analysis. RESULTS: Hospital mortality was 1.9% overall (n = 30/1612), but 1.3% (12/939) for isolated MVr, and 2.7% (18/673) for MVr with concomitant procedures (p = 0.04). Hospital mortality was similar for both PB (1.9%; 21/1101) and CR (1.8%; 9/511) (p = 0.8). The mean MR grade was reduced from 3.9 +/- 0.3 preoperatively to 0.6 +/- 0.9 at follow up using PB (p < 0.01), and from 3.9 +/- 0.4 to 0.9 +/- 0.9 using CR (p < 0.01). PB was associated with a similar long-term freedom from death (77 +/- 0.03% versus 83 +/- 0.02%; p = 0.4), reoperation (95 +/- 0.01% versus 92 +/- 0.01%; p = 0.06), and reoperation or recurrent severe MR (91 +/- 0.02% versus 92 +/- 0.01%; p = 0.7), and slightly greater freedom from valve-related complications compared to CR (91 +/- 0.02% versus 87 +/- 0.02%; p = 0.02). CONCLUSION: The long-term outcome of mitral valve annuloplasty with PB was comparable to that with CR for degenerative disease. Anterior annuloplasty was found to be unnecessary in this patient population.
PMID: 24779330
ISSN: 0966-8519
CID: 940942