Characteristics of strokes associated with centrifugal flow left ventricular assist devices.

Stroke is a devastating complication of left ventricular assist device (LVAD) therapy. Understanding the characteristics, risk factors and outcomes of strokes associated with the centrifugal flow LVADs is important to devise better strategies for management and prevention. This is a retrospective cohort study at a single US academic medical center. The cohort includes patients who received a first time Heartmate 3 (HM3) or Heartware (HVAD) LVAD between September 2009 through February 2018 and had a stroke while the LVAD was in place. Descriptive statistics were used when appropriate. A logistic regression analysis was used to determine predictors of poor outcome. Out of a total of 247 patients, 12.1% (N = 30, 24 HVAD and 6 HM3) had a stroke (63% ischemic) and 3 of these patients had pump thrombosis. Events per patient year (EPPY) were similar for HVAD and HM3 patients (0.3 ± 0.1). INR was subtherapeutic in 47.4% of ischemic stroke patients and supratherapeutic in 18.2% of hemorrhagic stroke patients. Concurrent infections were more common in the setting of hemorrhagic stroke than ischemic stroke (45.4% vs 5.3%, p = 0.008). Strokes were severe in most cases, with initial NIH stroke scale (NIHSS) higher in HM3 patients compared to HVAD patients (mean 24.6 vs 16) and associated with high in-patient mortality (21.1% of ischemic stroke vs. 88.8% of hemorrhagic stroke). Predictors of death within 30 days and disability at 90 days included creatinine at stroke onset, concurrent infection, hemorrhaghic stroke, and initial stroke severity (NIHSS). A score derived from these variables predicted with 100% certainty mortality at 30 days and mRS ≥ 4 at 90 days. For patients with centrifugal flow LVADs, ischemic strokes were more common but hemorrhagic strokes were associated with higher in-patient mortality and more frequently seen in the setting of concurrent infections. Infections, sub or supratherapeutic INR range, and comorbid cardiovascular risk factors may all be contributing to the stroke burden. These findings may inform future strategies for stroke prevention in this population.

Impact of Septal Myectomy Volume on Mitral-Valve Replacement Rate in Hypertrophic Cardiomyopathy Patients.

OBJECTIVE: Mitral regurgitation (MR) induced by systolic anterior motion in patients with hypertrophic cardiomyopathy (HCM) can frequently be abolished with a proficient septal myectomy (SM) without the need for mitral-valve replacement (MVR). ACC guidelines stress the importance of volume in improving outcomes after SM, but there is a lack of data measuring the impact of volume on the need for MVR during SM. This study was designed to assess the impact of institutional volume on MVR rates using national outcomes data. METHODS: The Nationwide Inpatient Sample was queried from 1998 to 2011 and a total of 6,207 patients had a diagnosis of HCM and a procedure code for SM. Outcomes were compared between patients who underwent SM (group I) and SM and MVR (group II). Furthermore, patients were stratified into 3 groups based on the number of SMs at the performing institution: low experience (1-24 cumulative SMs), medium experience (25-49 SMs), and high experience (>50 SMs). These patients underwent multivariable analysis to determine the impact of institutional volume on MVR rate. RESULTS: The total MVR rate was 26%. Perioperative outcomes were worse, i.e., there were higher rates of mortality, kidney injury, and urinary complications, in group II than in group I. Only 37.6% of patients were operated on at institutions meeting the guideline criteria of >50 cumulative SMs. When compared to patients in the high-experience group, patients in the low- (OR 2.7, 95% CI 2.3-3.2, p < 0.05) and medium-experience (OR 3.0, 95% CI 2.5-3.6, p < 0.05) groups were more likely to undergo MVR. CONCLUSION: Compared to reports from SM reference centers, national data suggest that MVR rates are quite high at SM. Patients undergoing SM at centers that do not meet the guideline standard have >2.5× the odds of undergoing MVR compared to those operated on at guideline-endorsed centers.

Stroke risk following implantation of current generation centrifugal flow left ventricular assist devices.

BACKGROUND AND AIM: Stroke remains a significant complication of left ventricular assist device (LVAD) therapy. We performed a single-center retrospective study evaluating patients undergoing first-time HeartWare HVAD (Medtronic Inc) or HeartMate 3 (Abbott Inc) implantation from September 2009-February 2018. METHODS: Exclusion criteria were age <18 and preoperative ECMO. The primary endpoint was stroke-free survival. Stroke was defined as new neurological deficits persisting >24 hours with corresponding radiographic evidence. Risk factors evaluated included demographics, medical comorbidities, heart failure etiology, LVAD indication, INTERMACS profile, and device type. Univariate predictors (P < .15) and variables clinically suspected to raise stroke risk were entered in a multivariate hazard regression model, specified using backward selection of covariates and accounting for competing risks of transplant/LVAD exchange. RESULTS: A total of 163 HVAD and 84 HM3 patients were analyzed. Median follow up (until death, censoring for transplant/LVAD removal, or end of follow up) was 1.2 years in HVAD patients and 1.4 years in HM3 patients. Stroke occurred in 24 HVAD patients (15 ischemic, 9 hemorrhagic) and 6 HM3 patients (4 ischemic, 2 hemorrhagic). One-year stroke-free survival was 76.8% for HVAD and 84.3% for HM3. Thirty-day mortality following stroke was 41.7% for HVAD and 66.7% for HM3; 54.2% of HVAD strokes were disabling compared to 83.3% of HM3 strokes. Age, LVAD indication, and device type were associated (P < .15) with stroke on univariate analysis. On multivariate analysis, the HVAD was associated with significantly higher stroke risk (hazard ratio, 2.57; 95% confidence interval, 1.02-6.44; P = .045). CONCLUSIONS: Different LVAD models appear to be associated with significantly different stroke risks.

Septal myectomy for hypertrophic cardiomyopathy: important surgical knowledge and technical tips in the era of increasing alcohol septal ablation.

Hypertrophic cardiomyopathy (HCM) is the most commonly inherited cardiac disease-recent studies suggest a prevalence as high as 1 in 200. For symptomatic patients with obstructive HCM who are refractory to medical therapy, septal reduction is indicated. Septal myectomy (SM) is considered the gold standard septal reduction technique. However, due to a shortage of surgeons who are experienced in this technique, alcohol septal ablation (ASA) has overtaken SM as the most commonly performed procedure for obstructive HCM. In this review, we summarize the existing literature comparing SM with ASA and describe recent innovations in operative technique, including a detailed description of the approach used at our institution.

Survival and recurrence after acute pulmonary embolism treated with pulmonary embolectomy or thrombolysis in New York State, 1999 to 2013.

BACKGROUND: Pulmonary embolism (PE) results in more than 250,000 hospitalizations annually in the United States, with high mortality. Outcome data are limited, and reperfusion strategies remain controversial. Here we evaluated the outcomes of thrombolysis and surgical embolectomy in patients with acute PE using a statewide database. METHODS: Among 174,322 patients hospitalized with PE in New York State between 1999 and 2013, we performed a retrospective comparison of 2111 adults with acute PE who underwent either thrombolysis (n = 1854; 88%) or surgical embolectomy (n = 257; 12%) as first-line therapy. Patients were identified using a mandatory database. The median follow-up was 4.2 years (range, 0-16.3 years). The primary study endpoint was all-cause mortality; secondary outcomes included recurrent PE, recurrent deep vein thrombosis, reintervention, and stroke. RESULTS: In 2111 patients who underwent reperfusion, there was no difference in 30-day mortality between those who underwent thrombolysis and those who underwent surgical embolectomy (15.2% vs 13.2%; odds ratio [OR], 1.12, 95% confidence interval [CI], 0.72-1.73). Thrombolysis was associated with higher risk of stroke (1.9% vs 0.8%; OR, 4.70; 95% CI, 1.08-20.42) and reintervention (3.8% vs 1.2%; OR, 7.16; 95% CI, 2.17-23.62) at 30 days. Five-year actuarial survival was similar in the 2 groups (72.4% [95% CI, 70.3%-74.5%] vs 76.1% [95% CI, 70.2%-81.0%]; hazard ratio (HR) for death, 1.11; 95% CI, 0.83-1.49). Thrombolysis was associated with a higher rate of recurrent PE necessitating inpatient readmission (7.9% [95% CI, 6.9%-9.4%] vs 2.8% [95% CI, 1.1%-5.8%]; HR, 3.38; 95% CI, 1.48-7.73). CONCLUSIONS: Pulmonary embolectomy and thrombolysis are associated with similar early and long-term survival, supporting guideline recommendations for embolectomy when thrombolysis is contraindicated.

Long-Term Risk for Aortic Complications After Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Versus Marfan Syndrome.

BACKGROUND: Bicuspid aortic valves are associated with valve dysfunction, ascending aortic aneurysm and dissection. Management of the ascending aorta at the time of aortic valve replacement (AVR) in these patients is controversial and has been extrapolated from experience with Marfan syndrome, despite the absence of comparative long-term outcome data. OBJECTIVES: This study sought to assess whether the natural history of thoracic aortopathy after AVR in patients with bicuspid aortic valve disease is substantially different from that seen in patients with Marfan syndrome. METHODS: In this retrospective comparison, outcomes of 13,205 adults (2,079 with bicuspid aortic valves, 73 with Marfan syndrome, and 11,053 control patients with acquired aortic valve disease) who underwent primary AVR without replacement of the ascending aorta in New York State between 1995 and 2010 were compared. The median follow-up time was 6.6 years. RESULTS: The long-term incidence of thoracic aortic dissection was significantly higher in patients with Marfan syndrome (5.5 ± 2.7%) compared with those with bicuspid valves (0.55 ± 0.21%) and control group patients (0.41 ± 0.08%, p < 0.001). Thoracic aortic aneurysms were significantly more likely to be diagnosed in late follow-up in patients with Marfan syndrome (10.8 ± 4.4%) compared with those with bicuspid valves (4.8 ± 0.8%) and control group patients (1.4 ± 0.2%) (p < 0.001). Patients with Marfan syndrome were significantly more likely to undergo thoracic aortic surgery in late follow-up (10.4 ± 4.3%) compared with those with bicuspid valves (2.5 ± 0.6%) and control group patients (0.50 ± 0.09%) (p < 0.001). CONCLUSIONS: The much higher long-term rates of aortic complications after AVR observed in patients with Marfan syndrome compared with those with bicuspid aortic valves confirm that operative management of patients with bicuspid aortic valves should not be extrapolated from Marfan syndrome and support discrete treatment algorithms for these different clinical entities.

Survival and outcomes following bioprosthetic vs mechanical mitral valve replacement in patients aged 50 to 69 years.

IMPORTANCE: In nonelderly patients with mitral disease requiring valve replacement, deciding between bioprosthetic and mechanical prosthetic valves is challenging because long-term survival and morbidity are not well defined. OBJECTIVE: To quantify survival and major morbidity after mitral valve replacement in patients aged 50 to 69 years. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort analysis of 3433 patients (aged 50-69 years) who underwent primary, isolated mitral valve replacement in New York State hospitals from 1997-2007. Follow-up ended November 30, 2013; median duration was 8.2 years (range, 0-16.8 years). Propensity score matching for 19 baseline characteristics yielded 664 patient pairs. EXPOSURES: Bioprosthetic vs mechanical prosthetic mitral valve replacement. MAIN OUTCOMES AND MEASURES: All-cause mortality, stroke, reoperation, and major bleeding events. RESULTS: No survival difference was observed between use of mechanical prosthetic and bioprosthetic mitral valves in patients aged 50 to 69 years matched by propensity score or in a subgroup analysis of age by decade. Among patients matched by propensity score, the incidences of stroke and bleeding events were both significantly higher in those who received mechanical prosthetic mitral valves compared with those who received bioprosthetic mitral valves; however, the incidence of reoperation was lower in the mechanical prosthesis group compared with the bioprosthesis group. [table: see text] CONCLUSIONS AND RELEVANCE: Among patients aged 50 to 69 years undergoing mitral valve replacement in New York State, there was no significant survival difference at 15 years in patients matched by propensity score who underwent mechanical prosthetic vs bioprosthetic mitral valve replacement. Mechanical prosthetic valves were associated with lower risk of reoperation but greater risk of bleeding and stroke. Even though these findings suggest bioprosthetic mitral valve replacement may be a reasonable alternative to mechanical prosthetic valve replacement in patients aged 50 to 69 years, the 15-year follow-up was insufficient to fully assess lifetime risks, particularly of reoperation.

Survival and long-term outcomes following bioprosthetic vs mechanical aortic valve replacement in patients aged 50 to 69 years.

IMPORTANCE: The choice between bioprosthetic and mechanical aortic valve replacement in younger patients is controversial because long-term survival and major morbidity are poorly characterized. OBJECTIVE: To quantify survival and major morbidity in patients aged 50 to 69 years undergoing aortic valve replacement. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort analysis of 4253 patients aged 50 to 69 years who underwent primary isolated aortic valve replacement using bioprosthetic vs mechanical valves in New York State from 1997 through 2004, identified using the Statewide Planning and Research Cooperative System. Median follow-up time was 10.8 years (range, 0 to 16.9 years); the last follow-up date for mortality was November 30, 2013. Propensity matching yielded 1001 patient pairs. MAIN OUTCOMES AND MEASURES: Primary outcome was all-cause mortality; secondary outcomes were stroke, reoperation, and major bleeding. RESULTS: No differences in survival or stroke rates were observed in patients with bioprosthetic compared with mechanical valves. Actuarial 15-year survival was 60.6% (95% CI, 56.3%-64.9%) in the bioprosthesis group compared with 62.1% (95% CI, 58.2%-66.0%) in the mechanical prosthesis group (hazard ratio, 0.97 [95% CI, 0.83-1.14]). The 15-year cumulative incidence of stroke was 7.7% (95% CI, 5.7%-9.7%) in the bioprosthesis group and 8.6% (95% CI, 6.2%-11.0%) in the mechanical prosthesis group (hazard ratio, 1.04 [95% CI, 0.75-1.43). The 15-year cumulative incidence of reoperation was higher in the bioprosthesis group (12.1% [95% CI, 8.8%-15.4%] vs 6.9% [95% CI, 4.2%-9.6%]; hazard ratio, 0.52 [95% CI, 0.36-0.75]). The 15-year cumulative incidence of major bleeding was higher in the mechanical prosthesis group (13.0% [95% CI, 9.9%-16.1%] vs 6.6% [95% CI, 4.8%-8.4%]; hazard ratio, 1.75 [95% CI, 1.27-2.43]). The 30-day mortality rate was 18.7% after stroke, 9.0% after reoperation, and 13.2% after major bleeding. CONCLUSIONS AND RELEVANCE: Among propensity-matched patients aged 50 to 69 years who underwent aortic valve replacement with bioprosthetic compared with mechanical valves, there was no significant difference in 15-year survival or stroke. Patients in the bioprosthetic valve group had a greater likelihood of reoperation but a lower likelihood of major bleeding. These findings suggest that bioprosthetic valves may be a reasonable choice in patients aged 50 to 69 years.