Mortality in Recipients of Durable Left Ventricular Assist Devices Undergoing Ventricular Tachycardia Ablation.

BACKGROUND: Left ventricular assist device (LVAD) recipients have a higher incidence of ventricular tachycardia (VT). However, the role of VT ablation in this population is not well-established. OBJECTIVES: This single-center retrospective cohort study sought to examine the impact of post-LVAD implant VT ablation on survival. METHODS: This retrospective study examined a cohort of patients that underwent LVAD implantation at Baylor St. Luke's Medical Center and Texas Heart Institute between January 2011 and January 2021. All-cause estimated mortality was compared across LVAD recipients based on the incidence of VT, timing of VT onset, and the occurrence and timing of VT ablation utilizing Kaplan-Meier survival analysis and Cox proportional hazards models. RESULTS: Post-implant VT occurred in 53% of 575 LVAD recipients. Higher mortality was seen among patients with post-implant VT within a year of implantation (HR: 1.62 [95% CI: 1.15-2.27]). Among this cohort, patients who were treated with a catheter ablation had superior survival compared with patients treated with medical therapy alone for the 45 months following VT onset (HR: 0.48 [95% CI: 0.26-0.89]). Moreover, performance of an ablation in this population aligned mortality rates with those who did not experience post-implant VT (HR: 1.18 [95% CI: 0.71-1.98]). CONCLUSIONS: VT occurrence within 1 year of LVAD implantation was associated with worse survival. However, performance of VT ablation in this population was correlated with improved survival compared with medical management alone. Among patients with refractory VT, catheter ablation aligned survival with other LVAD participants without post-implant VT. Catheter ablation of VT is associated with improved survival in LVAD recipients, but further prospective randomized studies are needed to compare VT ablation to medical management in LVAD recipients.

Morbidity and Mortality Associated With Heart Failure in Acute Coronary Syndrome: A Pooled Analysis of 4 Clinical Trials.

BACKGROUND: Heart failure (HF) may complicate acute coronary syndrome (ACS) and is associated with a high burden of short- and long-term morbidity and mortality. Only limited data regarding future ischemic events and rehospitalization are available for patients who suffer HF before or during ACS. METHODS: A secondary analysis of 4 large ACS trials (PLATO, APPRAISE-2, TRACER, and TRILOGY ACS) using Cox proportional hazards models was performed to investigate the association of HF status (no HF, chronic HF, de novo HF) at presentation for ACS with all-cause and cardiovascular death, major adverse cardiovascular event (MACE ), myocardial infarction, stroke, and hospitalization for heart failure (HHF) by 1 year. Cumulative incidence plots are presented at 30 days and 1 year. RESULTS: A total of 11.1% of the 47,474 patients presenting with ACS presented with evidence of acute HF, 55.0% of whom presented with de novo HF. Patients with chronic HF presented with evidence of acute HF at a higher rate than those with no previous HF (40.3% vs 6.9%). Compared to those without HF, those with chronic and de novo HF had higher rates of all-cause mortality (adjusted hazard ratio [aHR] 2.01, 95% confidence interval [CI] 1.72-2.34 and aHR 1.47, 95% CI1.15-1.88, respectively), MACE (aHR 1.47, 95% CI1.31-1-.66 and aHR 1.38, 95% CI1.12-1.69), and HHF (aHR 2.29, 95% CI2.02-2.61 and aHR 1.48, 95% CI 1.20-1.82) at 1 year. CONCLUSION: In this large cohort of patients with ACS, both prior and de novo HF complicating ACS were associated with significantly higher risk-adjusted rates of death, ischemic events and HHF at 30 days and 1 year. Further studies examining the association between HF and outcomes in this high-risk population are warranted, especially given the advent of more contemporary HF therapies.

Risk Stratification in Patients Who Underwent Percutaneous Left Atrial Appendage Occlusion.

Left atrial appendage occlusion (LAAO) is effective in preventing thromboembolism. Risk stratification tools could help identify patients at risk for early mortality after LAAO. In this study, we validated and recalibrated a clinical risk score (CRS) to predict risk of all-cause mortality after LAAO. This study used data from patients who underwent LAAO in a single-center, tertiary hospital. A previously developed CRS using 5 variables (age, body mass index [BMI], diabetes, heart failure, and estimated glomerular filtration rate) was applied to each patient to assess risk of all-cause mortality at 1 and 2 years. The CRS was recalibrated to the present study cohort and compared with established atrial fibrillation-specific (CHA2DS2-VASc and HAS-BLED) and generalized (Walter index) risk scores. Cox proportional hazard models were used to assess the risk of mortality and discrimination was assessed by Harrel C-index. Among 223 patients, the 1- and 2-year mortality rates were 6.7% and 11.2%, respectively. With the original CRS, only low BMI (<23 kg/m2) was a significant predictor of all-cause mortality (hazard ratio [HR] [95% CI] 2.76 [1.03 to 7.35]; p = 0.04). With recalibration, BMI <29 kg/m2 and estimated glomerular filtration rate <60 ml/min/1.73 m2 were significantly associated with an increased risk of death (HR [95% CI] 3.24 [1.29 to 8.13] and 2.48 [1.07 to 5.74], respectively), with a trend toward significance noted for history of heart failure (HR [95% CI] 2.13 [0.97 to 4.67], p = 0.06). Recalibration improved the discriminative ability of the CRS from 0.65 to 0.70 and significantly outperformed established risk scores (CHA2DS2-VASc = 0.58, HAS-BLED = 0.55, Walter index = 0.62). In this single-center, observational study, the recalibrated CRS accurately risk stratified patients who underwent LAAO and significantly outperformed established atrial fibrillation-specific and generalized risk scores. In conclusion, clinical risk scores should be considered as an adjunct to standard of care when evaluating a patient's candidacy for LAAO.

Genetic characterization and long-term management of severely affected siblings with intellectual developmental disorder with cardiac arrhythmia syndrome.

We report two brothers with severe global cognitive and motor delay, cortical visual impairment and sick sinus syndrome who were born to consanguineous parents. Standard genetic evaluations did not reveal the cause of their mental retardation. As expected, chromosomal microarray (CMA) revealed extensive regions of homozygosity. Exome sequencing revealed that both affected boys were homozygous for a nonsense mutation in the G-protein ß5 (GNB5) gene (NM_016194.3:c.1032C > G; Tyr344Ter), and that the parents were carriers of this mutation. No other DNA variants that were explanatory for the sick sinus or the developmental delay/intellectual disability were identified, and no other clinical parameters are likely to have contributed to this unusual combination of phenotypes. The neurologic features of our patients are more severe than those of most of the other patients previously reported with GNB5 variants, probably because of the homozygous, complete loss-of-function (nonsense/stop-gain) nature of their variant, and their clinical course has been monitored for longer duration.

Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial.

BACKGROUND: Recent trials have identified anti-diabetes mellitus agents that lower major adverse cardiovascular event (MACE) rates, although some increase rates of lower-extremity amputation (LEA). Patients with peripheral artery disease (PAD) have greater incidence of diabetes mellitus and risk for LEA, prompting this investigation of clinical outcomes in patients with diabetes mellitus and PAD in the EXSCEL trial (Exenatide Study of Cardiovascular Event Lowering). METHODS: EXSCEL evaluated the effects of once-weekly exenatide (a GLP-1 [glucagon-like peptide-1] receptor agonist) versus placebo on the rates of the primary composite MACE end point (cardiovascular death, myocardial infarction, or stroke) among patients with type 2 diabetes mellitus. In this post hoc analysis, we assessed the association of baseline PAD with rates of MACE, LEA, and the effects of exenatide versus placebo in patients with and without PAD. RESULTS: EXSCEL included 2800 patients with PAD (19% of the trial population). These individuals had higher unadjusted and adjusted rates of MACE compared with patients without PAD (13.6% versus 11.4%, respectively) as well as a higher adjusted hazard ratio (adjusted hazard ratio, 1.13 [95% CI, 1.00-1.27]; P=0.047). Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20-1.60]; P<0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16-7.22]; P<0.001). Patients treated with exenatide or placebo had similar rates of MACE and LEA, regardless of PAD status. CONCLUSIONS: EXSCEL participants with PAD had higher rates of all-cause mortality and LEA compared with those without PAD. There were no differences in MACE or LEA rates with exenatide versus placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01144338.

Advances in Antiplatelet and Anticoagulant Therapies for NSTE-ACS.

The treatment of patients requiring anticoagulation who develop acute coronary syndrome (ACS) and/or require percutaneous coronary intervention (PCI) must balance the reduction in major adverse cardiovascular events, stroke, and major bleeding. The development of direct oral anticoagulants (DOACs) for the treatment of atrial fibrillation has ushered in an era of potential treatment options for these complex patients. PURPOSE OF REVIEW: To review the clinical evidence underlying the use of DOACs for the treatment of patients with atrial fibrillation and ACS or PCI. RECENT FINDINGS: Three trials studied this particular patient population; WOEST showed that dual therapy with warfarin and clopidogrel decreased hemorrhage at 1 year compared with standard triple therapy (19.4 vs. 44.4% HR 0.36; 95% CI 0.26-0.50; P < 0.0001), without increasing thromboembolic events (11.1 vs. 17.6% HR 0.60; 95% CI 0.38-0.94; P = 0.025). PIONEER AF-PCI showed that 10-15 mg rivaroxaban plus P2Y12 inhibitor for 12 months significantly lowered bleeding rates than standard triple therapy (16.8 vs. 26.7% HR 0.59; 95% CI 0.47-0.76; P < 0.001) and had equivalent rates of MACE. Finally, REDUAL-PCI compared two different doses of dabigatran (110 mg twice daily and 150 mg twice daily) plus P2Y12 inhibitor with standard triple therapy and reported reduced ISTH bleeding with both doses; HR 0.52 with 110 mg dabigatran (95% CI 0.42-0.63, P < 0.001) and HR 0.72 with 150 mg dabigatran (95% CI 0.58-0.88; P = 0.002). The rate of the composite of thromboembolic events, death, or unplanned revascularizations was similar between pooled dabigatran dual therapy and triple therapy groups (13.7 vs 13.4% HR 1.04; 95% CI 0.84-1.29; P = 0.005). Recent evidence shows that DOACs plus one antiplatelet agent can decrease bleeding in patients with atrial fibrillation undergoing PCI for ACS. Although not powered to detect non-inferiority or superiority, large studies suggest rivaroxaban 10-15 mg plus P2Y12 inhibitor for 12 months or dabigatran 150 mg twice daily plus P2y12 inhibitor for 12 months will have similar rates of MACE and stent thrombosis as triple therapy. In patients who have contraindications to DOACs, the strategy of INR-adjusted warfarin plus clopidogrel appears to be safer than warfarin plus dual antiplatelet therapy.

Routine venous thromboembolism screening after pneumonectomy: The more you look, the more you see.

OBJECTIVES: Symptomatic venous thromboembolism (VTE) after pneumonectomy is associated with poor prognosis. We describe a new care pathway for patients undergoing pneumonectomy in which asymptomatic lower-extremity VTE screening was performed to determine if it increases VTE detection and potentially decreases sequelae. METHODS: 112 patients underwent pneumonectomy from 2006 to 2013 at Cleveland Clinic and were enrolled in a care pathway that included VTE prophylaxis and routine, predischarge, lower-extremity VTE screening. These data were contrasted with a previously published cohort of 336 patients (1990-2001) who underwent pneumonectomy without routine VTE screening. RESULTS: 10 of 112 patients (8.9%) had VTE detected by screening before discharge. An additional 4 patients (3.6%) with a negative predischarge screen developed symptomatic VTE within 30 days. Six patients (5.4%) developed VTE after pneumonectomy beyond the first 30 days. Prevalence of in-hospital VTE in the screened cohort was significantly higher than that of the non-screened cohort (3.0%; P = .008). Similarly, VTE within 30 days in the screened cohort (13%) was significantly higher than in the nonscreened cohort (5.0%; P = .007). In both cohorts, a peak was observed approximately 6 days after pneumonectomy and plateaued after 30 days. The presence of a VTE portended worse long-term survival: 66% at 1 year versus 85% for those not developing a VTE. CONCLUSIONS: Prevalence of VTE after pneumonectomy is higher than previously thought. The risk of developing a VTE peaks at 6 days after pneumonectomy, and remains increased until 30 days, suggesting a need for additional screening or longer prophylaxis.

Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series.

OBJECTIVE: Spinal cord stimulation (SCS) traditionally is thought to require paresthesia, but there is evidence that paresthesia-free stimulation using high-density (HD) parameters might also be effective. The purpose of this study is to evaluate relative effectiveness of conventional, subthreshold HD, and sham stimulation on pain intensity and quality of life. METHODS: Fifteen patients with response to conventional stimulation (60 Hz/350 µsec) were screened with a one-week trial of subthreshold HD (1200 Hz/200 µsec/amplitude 90% paresthesia threshold) and enrolled if there was at least 50% reduction on visual analog scale (VAS) for pain. Subjects were randomized into two groups and treated with four two-week periods of conventional, subthreshold HD, and sham stimulation in a randomized crossover design. RESULTS: Four of 15 patients responded to subthreshold HD stimulation. Mean VAS during conventional, subthreshold HD, and sham stimulation was 5.32 ± 0.63, 2.29 ± 0.41, and 6.31 ± 1.22, respectively. There was a significant difference in pain scores during the blinded crossover study of subthreshold HD vs. sham stimulation (p < 0.05, Student's t-test). Post hoc analysis revealed that subjects reported significantly greater attention to pain during conventional stimulation compared with subthreshold HD stimulation (p < 0.05, Student's t-test). All subjects reported a positive impression of change for subthreshold HD stimulation compared with conventional stimulation, and there was a trend toward greater likelihood for response to subthreshold HD stimulation in comparison with sham stimulation (p = 0.07, Fisher's exact test). At the end of the trial, all subjects elected to continue to receive subthreshold HD stimulation rather than conventional stimulation. CONCLUSIONS: Paresthesia are not necessary for pain relief using commercially available SCS devices, and may actually increase attention to pain. Subthreshold HD SCS represents a viable alternative to conventional stimulation among patients who are confirmed to have a clinical response to it.

Ultrasound Guided Local Endovascular Coiling of an Iatrogenic Superficial Temporal Artery Pseudoaneurysm.

Pseudoaneurysms of the superficial temporal artery are rare and may be treated by manual compression, surgical intervention, coil embolization, or percutaneous thrombin injection. We present a novel technique of local ultrasound guided low-profile coil embolization of the superficial temporal artery with both satisfactory cosmetic and surgical results.