This qualitative research explored the lived experiences of patients who experienced postponement of elective cardiac and vascular surgery due to coronavirus disease 2019 (COVID-19). We know very ...little about patients during the novel coronavirus pandemic. Understanding the patient voice may play an important role in prioritization of postponed cases and triage moving forward.
Utilizing a hermeneutical phenomenological qualitative design, we interviewed 47 individuals who experienced a postponement of cardiac or vascular surgery due to the COVID-19 pandemic. Data were analyzed and informed by phenomenological research methods.
Patients in our study described 3 key issues around their postponement of elective surgery. Patients described robust narratives about the meanings of their elective surgeries as the chance to "return to normal" and alleviate symptoms that impacted everyday life. Second, because of the meanings most of our patients ascribed to their surgeries, postponement often took a toll on how patients managed physical health and emotional well-being. Finally, paradoxically, many patients in our study were demonstrative that they would "rather die from a heart attack" than be exposed to the coronavirus.
We identified several components of the patient experience, encompassing quality of life and other desired benefits of surgery, the risks of COVID, and difficulty reconciling the 2. Our study provides significant qualitative evidence to inform providers of important considerations when rescheduling the backlog of patients. The emotional and psychological distress that patients experienced due to postponement may also require additional considerations in postoperative recovery.
Although left ventricular assist device (LVAD) management strategies are undertaken to reduce the development of aortic insufficiency (AI), the effect of AI on patient morbidity and mortality is not ...known.
Patients undergoing HeartMate II (Thoratec, Pleasanton, CA) implant were prospectively monitored with serial echocardiograms. Kaplan-Meier methods and log-rank testing were used to estimate and compare mortality and freedom from moderate or worser right ventricular hypokinesis (RVHK), moderate or worse mitral regurgitation (MR), and hemolysis according to AI severity. Mixed modelling was used to examine for correlates of AI development in the pre-operative and post-operative setting and to investigate the effect of AI on post-operative MR and RVHK.
There were 930 echocardiograms completed in 166 patients. During 291 person-years of follow-up, mild-moderate or worse AI developed in 70 (0.38 persons per year PPY), moderate or worse AI in 36 (0.17 PPY), moderate-severe AI in 11 (0.039 PPY), and severe AI in 2 (0.0069 PPY). Overall 2-year survival and 2-year survival after onset of moderate or worse AI was 87% ± 6.2% and 65% ± 11%, respectively, compared with 76% ± 5.1% and 76% ± 5.1%, respectively, in those with less AI (p = 0.57). Patients with moderate AI were not more likely to develop MR, hemolysis events, or worsening RVHK, but patients with pre-existing RVHK appeared to be less tolerant of AI. Three of 35 deaths were directly attributed to AI. No reoperations were performed solely for AI.
AI is common after LVAD implant but did not affect survival in this cohort. Except in those with significant RV dysfunction, this calls into question need for echocardiogram-guided device settings to ensure aortic valve opening.
Aortic insufficiency (AI) following left ventricular assist device (LVAD) placement can affect device performance. The aim of this study was to examine AI development following LVAD implantation.
...Echocardiograms (n=315) from 78 subjects undergoing HeartMate-XVE (n=25 32%) or HeartMate-II (n=53 68%) implantations from 2004 to 2008 were reviewed. Studies were obtained preoperatively and at 1, 3, 6, 12, 18, and 24 months after surgery. AI was graded on an interval scale (0=none, 0.5=trivial, 1=mild, 1.5=mild-moderate, 2=moderate, 2.5=moderate-severe, 3=severe), and the change in AI at follow-up was analyzed with significance tests. Kaplan-Meier estimates for freedom from moderate or worse AI at follow-up were generated. Mixed-model linear regression was used to identify correlates of AI progression during LVAD support. The median (25th, 75th percentile) duration of LVAD support was 239 (112, 455) days, and preoperative AI grade was 0.0 (0.0, 0.0). At 6 months, 89±4% of subjects (n=49 at risk) were free from moderate or worse AI, but this was reduced to 74±7% (n=29 at risk) and 49±13% (n=13 at risk) by 12 and 18 months, respectively. Correlates (slope±SE) of AI progression included female sex (0.002±0.001; P=0.01), smaller body surface area (-0.003±0.001 per m(2); P=0.0017), and HeartMate-II model type (0.002±0.001; P=0.039). Correlates (β±SE) of progressive AI on postoperative echocardiogram included increasing aortic sinus diameter (0.04±0.01 per mm; P=0.001), an aortic valve that remained closed (0.42±0.06; P<0.001) or only intermittently opened (0.34±0.09; P<0.001), and lower left ventricular diastolic (-0.002±0.0004 per cm(3); P<0.001) and systolic (-0.002±0.0004 per cm(3); P<0.001) volumes.
AI progresses over time in LVAD-supported patients. As we move toward an era of long-term cardiac support, more studies are needed to determine the clinical significance of these findings.
Expandable, rapid deployment aortic valves may interfere with the cardiac conduction system, which can lead to permanent pacemaker implantation (PPI). We sought to characterize PPI after rapid ...deployment aortic valve replacement with the Edwards Intuity valve system (Edwards Lifesciences, Irvine, CA) and investigate associated factors.
We analyzed 708 patients from 29 centers in the Multicenter Experience With Rapid Deployment Edwards Intuity Valve System for Aortic Valve Replacement (TRANSFORM) trial undergoing rapid deployment aortic valve replacement with or without coronary artery bypass graft surgery without preexisting pacemakers. Intrinsic conduction status was recorded as well as PPI incidence through 1 year. The PPI indications were categorized based on expert review of patient PPI source documents. Multivariate analysis was conducted to identify characteristics associated with PPI.
After rapid deployment aortic valve replacement, the PPI incidence through 30 days (PPI30) was 13.6%, with 10.9% due to atrioventricular block. In the 423 of 708 patients (59.7%) without any baseline conduction abnormalities, all-cause PPI30 was 8%, 5% for atrioventricular block. For PPIs inserted before discharge, the median time to PPI was 5 days, with 22% placed within 48 hours. Independent predictors of PPI30 were baseline right bundle branch block (odds ratio 7.35, p < 0.0001), female gender (2.62, p = 0.004), larger valve size (1.20, p = 0.016), and atrioventricular block (1.80, p = 0.062). Subset analysis revealed a greater than twofold difference in PPI30 among the largest enrolling centers.
Patient factors associated with PPI after rapid deployment aortic valve replacement were right bundle branch block, atrioventricular block, female gender, and larger valve size. Interestingly, a strong center-level effect was associated with PPI. This effect may reflect differences in practice patterns, such as postoperative drug management or timing to PPI. These findings provide a deeper understanding of PPI after rapid deployment aortic valve replacement and help guide clinical practice and patient management.
Modern left ventricular assist devices (LVAD) require anti-coagulation (AC) with warfarin and anti-platelet therapy to prevent thromboembolic complications in patients. Gastrointestinal bleeding (GI) ...is a significant adverse event in these patients and treatment typically requires reduction or elimination of AC or anti-platelet therapy. It is not known whether alterations in AC to treat GI bleeding influence subsequent risk of thromboembolic (TE) events during LVAD support.
Between July 2003 and September 2011, 389 patients (308 male) underwent implantation of a continuous-flow LVAD at the University of Michigan Health System and the Mayo Clinic. Median age at implant was 60 years (range 18 to 79 years). Outcomes were analyzed for the association of GI bleeding events and subsequent TE events, defined as stroke, transient ischemic attack, hemolysis or suspected or confirmed pump thrombosis.
Median survival was 10 months (maximum 7.2 years, total 439 patient-years). TE events occurring within the first 30 days were not counted. Overall survival and freedom from an outcome event were assessed using the Kaplan-Meier method. Associations between GI bleeding and subsequent TE events and survival impact were analyzed as time-dependent covariates. One hundred ninety-nine GI bleeding episodes occurred in 116 of 389 patients (30%) for an event rate of 0.45 GI bleed/patient-year of support. One hundred thirty-eight TE events occurred in 97 of 389 patients (25%) for an event rate of 0.31 TE event/patient-year of support. Median time from LVAD implant to first GI bleed was 5 months (range 1 to 116 months) and to first TE event was 6 months (range 1 to 29 months). For patients who had a TE event after GI bleed, the median interval was 5 months (range 0.5 to 25 months). TE events were 7.4-fold more likely in patients who had a prior GI bleed (range 4.9- to 11.1-fold) (p < 0.001); however, neither the presence of GI bleeding (0.7 to 1.2) nor a TE event (0.8 to 2.0) portended a lower overall survival.
Patients who had GI bleeding were at significantly higher risk for a subsequent TE event. Although the exact cause of this relationship is unknown, it suggests that a reduction in anti-coagulation and anti-platelet management to treat GI bleeds may contribute to this risk.
The clinical relevance of elevated serum markers of hemolysis during left ventricular assist device (LVAD) support has not been fully ascertained.
Lactate dehydrogenase (LDH) and serum free ...hemoglobin (sfHg) values were tallied monthly in 182 patients on HeartMate II (Thoratec, Pleasanton, CA) LVAD support. Peak values for each marker were identified, and 2 hemolysis definitions were applied to the cohort: Hemolysis according to Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria (sfHg > 40 mg/dl with signs/symptoms) and/or hemolysis defined by an LDH ≥ 600 IU/liter (2.5-times the upper limit of laboratory normal). Kaplan-Meier survival free from death, urgent United Network of Organ Sharing 1A transplant for thrombosis, device exchange for thrombosis, and stroke/peripheral embolism was estimated, and Cox hazard ratios (HR) with the 95% confidence interval (95% CI) were calculated. Areas under the receiver-operating characteristic curves (AUCs) for predicting 1-year event-free survival were calculated.
Hemolysis occurred in 32 patients (18%) by INTERMACS criteria and in 68 (37%) patients by LDH criteria. Over a median (25(th), 75(th)) support of 427 days (245, 793 days), there were 78 events. One year event-free survival after the onset of INTERMACS-defined hemolysis was 16% ± 8.3% compared with 85% ± 3.2% in non-hemolyzers (HR, 14.7; 95% CI, 7.9-27; AUC 0.70 ± 0.05; p < 0.001; ). One year event-free survival after the onset of LDH-defined hemolysis was 32% ± 7.2% compared with 89% ± 3.2% in those with persistent LDH values < 600 IU/liter (HR, 8.0; 95% CI, 4.4-14; AUC 0.87 ± 0.04; p < 0.001). Patients who met the LDH hemolysis definition had longer times from hemolysis onset to clinical events and larger magnitudes of risk for embolism and device exchange for thrombosis than those with INTERMACS hemolysis.
Serum hemolysis marker elevations are associated with increased events in LVAD patients. LDH monitoring provides an earlier diagnosis of adverse events than sfHg, supporting need for a new INTERMACS definition of VAD-associated hemolysis.
Unicuspid aortic valves (Sievers type 2 bicuspid) are characterized by major fusion and clefting of the right-left coronary commissure, and minor fusion of the right-noncoronary commissure. Repair ...has been difficult because of two fusions, variable relative sinus sizes, and peripheral leaflet deficiencies or tears after balloon valvuloplasty.
Twenty unicuspid aortic valves patients underwent valve repair in nine institutions. Right-left major fusion and right-noncoronary minor fusion occurred in 17 of 20 (85%). Commissurotomy was performed on the minor fusion, and a bicuspid annuloplasty ring with circular base geometry and two 180-degree subcommissural posts was sutured beneath the annulus, equalizing the annular circumferences of the fused and nonfused cusps. The nonfused leaflet was plicated, and the cleft in the major fusion was closed linearly until leaflet effective heights and lengths became greater than 8 mm and equal, respectively.
Average age (mean ± SD) was 22.3 ± 12.3 years (range, 13 to 58), 12 of 20 (60%) were symptomatic, 10 of 20 (50%) required aortic aneurysm resection. Pre-repair hemodynamic data included mean systolic valve gradient 25.8 ± 12.9 mm Hg, aortic insufficiency grade 2.9 ± 1.2, and annular diameter 24.7 ± 3.3 mm. No mortality or major complications occurred. Post-repair annular (ring) size was 20.5 ± 1.3 mm, mean gradient fell to 16.2 ± 5.9 mm Hg, and aortic insufficiency grade decreased to 0.1 ± 0.3 (P < .001). At an average follow-up of 11 months (range, 1 to 22), all 20 patients were asymptomatic and had returned to full activity.
Aortic ring annuloplasty reduced annular diameter effectively, recruiting more leaflet to midline coaptation. Minor fusion commissurotomy and annular remodeling to 180-degree commissures converted UAV repair to a simple and reproducible procedure.
The effect of significant mitral regurgitation (MR) on outcomes after continuous flow left ventricular assist device (cfLVAD) implantation remains unclear.
We performed a retrospective review of ...prospectively collected data from 159 patients with preoperative severe MR who underwent cfLVAD implantation (2003-2017). Two-step cluster analysis using the log-likelihood distance for post-cfLVAD implantation parameters, which included right ventricular (RV) dysfunction, MR severity, and tricuspid regurgitation (TR) severity. Post-cfLVAD implantation echocardiographic parameters were obtained within the first month.
Cluster analysis resulted in 3 groups. Group 1 (n = 67) had mild or less MR with moderate-severe RV dysfunction (RVD). Group 2 (n = 43) had moderate-severe MR with moderate-severe RVD. Group 3 (n = 49) had moderate MR with mild RVD. Group 2 had the largest proportion with Interagency Registry for Mechanically Assisted Circulatory Support score of 1 (30.2%) and 2 (41.9%). They were more likely to undergo temporary mechanical circulatory support (18.6%) and tricuspid valve procedure (62.8%). Group 2 had the highest rate of stroke (30.2%; P = .02), hemolysis (39.5%; P = .01), device thrombosis (30%; P = .01), and worst survival (46.5%; P = .01). Survival at 5 years for groups 1, 2, and 3 were 56.0%, 17.6%, and 55.8%. Regression analysis of the entire population showed that greater MR severity after cfLVAD was associated with RV failure (P < .05; odds ratio, 1.6) and RV assist device use (P = .09; odds ratio, 1.6). After excluding tricuspid valve repairs, MR severity had a positive correlation with TR severity (R = 0.33; P < .01).
After cfLVAD implantation, moderate-severe MR and RVD predicted RV failure. Patients with preoperative moderate-severe MR and TR coupled with moderate-severe RVD might benefit the most from mitral and tricuspid valve intervention.
Post continuous flow left ventricular assist device implantation echocardiographic patterns in patients with preoperative severe mitral regurgitation. LVAD, Left ventricular assist device; RV, right ventricle; TR, tricuspid regurgitation; MR, mitral regurgitation; RVD, right ventricular dysfunction. Display omitted
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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