Impact of calcification on percutaneous coronary intervention: MACE-Trial 1-year results.

OBJECTIVES: The Multi-center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE-Trial) was designed to provide further insight on the impact of calcification on procedural and long-term percutaneous coronary intervention outcomes. BACKGROUND: Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation. METHODS: The MACE-Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild [N = 133], moderate [N = 99], and severe [N = 114]). Endpoints were lesion success, procedural success, and 1-year major adverse cardiac events (MACEs). RESULTS: Presence of severe calcification had significant impact on lesion success ([83.3%] versus none/mild calcification [94.7%, P = 0.006]) and procedural success ([86.8%] versus moderate [95.0%, P = 0.028], and none/mild [97.7%, P = 0.001]). 1-year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P < 0.001) calcification; however, no difference was noted between none/mild and moderate (P = 0.237). The risk adjusted multivariable model identified severe calcification and decreasing eGFR as predictors of 30-day and 1-year MACE. CONCLUSIONS: In this prospective study, patients with severe calcification had significantly worse outcomes compared to those without; however, unlike previous retrospective studies, moderate calcium resulted in similar outcomes as none/mild calcium. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/ct2/show/NCT01930214. Unique Identifier: NCT01930214.

Median arcuate ligament syndrome: Use of fractional flow reserve in documentation of chronic mesenteric ischemia.

Median arcuate ligament syndrome (MALS) is a rare clinical entity. This condition typically affects women between the ages of 20 and 40 years and causes symptoms of abdominal pain, primarily post-prandial, as well as nausea, vomiting and weight loss. MALS is considered a diagnosis of exclusion. Typically, mesenteric arterial duplex ultrasonography, computed tomography (CT), and magnetic resonance (MR) are highly suggestive, and conventional contrast angiography confirmatory. We explore the role of fractional flow reserve and intravascular ultrasound in the evaluation of MALS. In order to illustrate the utility of these tools, we present the case of a 47-year-old symptomatic woman who underwent angiography, complemented by assessment of fractional flow reserve and intravascular ultrasound. These data convincingly demonstrated the dynamic nature of the obstructive characteristic of MALS.

Use of fractional flow reserve in the assessment of chronic mesenteric ischemia.

Chronic mesenteric ischemia (CMI) is a rare condition that is usually the result of atherosclerotic obstructive disease affecting the mesenteric arteries. The classic triad of post-prandial pain, food aversion and weight loss is not always present, often leading to low clinical suspicion for CMI and underdiagnosis. Non-invasive evaluation for CMI usually starts with mesenteric arterial duplex scanning, followed by computed tomography angiography, magnetic resonance angiography or conventional angiography, the latter being the gold standard for establishing its diagnosis. However, angiography alone has been demonstrated in coronary and other vascular beds to be inaccurate in predicting the physiologic and hemodynamic significance of a certain subset of atherosclerotic stenoses. We present the case of a patient with risk factors and symptoms suggestive of CMI who underwent angiography. However, angiography was equivocal and invasive physiologic testing was required to confirm the diagnosis and guide revascularization.

Sheath hemorrhage after percutaneous ventricular assist device implantation.

Technical advances in temporary ventricular assist devices (VADs) continue to progress, allowing for percutaneous implantation during times of hemodynamic instability. However, device delivery systems, i.e., sheaths, lag in their ability to sustain the mechanical demands of these VADs for extended periods. We propose both a novel technique and the implementation of an emergency preparedness plan to be enacted specifically during those times when delivery systems fail thereby leading to potentially catastrophic bleeding complications.

Left Ventricular Hypertrophy Regression Following Transcatheter Aortic Replacement: A Comparison of Self-Expanding Versus Balloon-Expandable Prostheses.

There are limited reports on the impact of prosthesis-patient mismatch (PPM) on the regression of left ventricular hypertrophy (LVH) after transcatheter aortic valve replacement (TAVR). We compared the relative effects of supra-annular, self-expanding (SE) versus intra-annular, balloon-expandable (BE) prostheses on TAVR LVH regression. Regression of left ventricular mass index (LVMi) was evaluated in 168 consecutive TAVR patients, including 60 treated with SE valves (Evolut series) and 108 treated with BE valves (Sapien 3). All patients had LVH determined at baseline by echocardiography and had repeat LVMi measurements at a mean follow-up time of 707 ± 528 days. SE patients were more likely female (68.3% vs 46.3%, p = 0.007), but otherwise, the 2 cohorts did not differ with respect to baseline demographics and Society of Thoracic Surgeons risk score. SE patients had a higher effective orifice area indexed to body surface area after TAVR (0.98 ± 0.29 vs 0.86 ± 0.25 cm²/m², p = 0.006), with lower mean aortic valve gradients (9.9 ± 6.5 vs 12.8 ± 5.8 mm Hg, p = 0.003) and a lower prevalence of moderate/severe PPM (33.3% vs 49.1%, p = 0.049). On follow-up, changes in LVMi were similar between the SE and BE groups, with similar absolute changes in LVMi (19.2 ± 26.8 vs 21.9 ± 31.7 g/m2, p = 0.578) and relative LVMi decrease (14.0 ± 19.5 vs 16.2% ± 24.2%, p = 0.547). No difference in LVMi regression was also noted comparing combined SE/BE patients with moderate/severe PPM versus those without PPM. In conclusion, despite differences in effective orifice area indexed to body surface area, mean aortic valve gradient, and PPM after TAVR, the degree of LVH regression during intermediate follow-up did not differ between patients receiving supra-annular SE and intra-annular BE prostheses.

Bailout antegrade coronary reentry with the stingray™ balloon and guidewire in the setting of an acute myocardial infarction and cardiogenic shock.

Emergent coronary artery bypass surgery for failed percutaneous coronary intervention (PCI) during acute myocardial infarction (MI) is a bailout strategy that is associated with a high in-hospital morbidity and mortality (7-10%). Innovative strategies to improve the probability of PCI success in this setting are needed. Antegrade coronary re-entry with the Stingray™ balloon and guidewire has been shown to facilitate recanalization of chronic total occlusions in stable patients. We report a case where the Stingray™ device was successfully used as a bailout strategy in the setting of an acute MI complicated by cardiogenic shock.

Vacuum assisted vegetation extraction for the management of large lead vegetations.

BACKGROUND: Complete device and lead removal is recommended for management of infected implantable cardiac device. Management of large lead vegetation (2 cm) is still in debate. METHODS: We report a series of patients involving percutaneous extraction of large vegetations (>2 cm) from ICD/pacing leads using the AngioVac Cannula in patients with infective endocarditis. This approach was used to debulk the ICD/pacing lead vegetations in order to minimize the risk of septic pulmonary embolism during lead explantation. CONCLUSION: AngioVac Cannula can be used safely and effectively as an adjunctive method for patients with large lead vegetation.

Prognostic impact of thyroid stimulating hormone levels in patients with cardiomyopathy.

BACKGROUND: Thyroid stimulating hormone (TSH) abnormalities have been associated with various cardiac arrhythmias. Effect of TSH abnormalities on mortality and implantable cardioverter defibrillators (ICD) behavior in patients with cardiomyopathy has not been investigated. METHODS: Our ICD database includes 1,445 patients between December 1997 and January 2008. TSH levels using the ultra sensitive assay were available in 371 patients. Patients were classified based on TSH levels as: High TSH (N = 102, TSH > 5) and Low TSH (N = 26, TSH < 0.4). TSH groups were compared for mortality, appropriate and inappropriate ICD therapies. RESULTS: A high or low TSH was an independent predictor of all-cause mortality: Hazard ratio (HR) 1.46 (95% CI 1.03-2.08), P = 0.033 and HR 1.76 (95% confidence interval 1.02-3.03), P = 0.043 respectively. TSH abnormalities were not associated with an increased incidence in appropriate or inappropriate ICD therapy. CONCLUSION: A low or high TSH was associated with a higher mortality; however, neither were associated with appropriate or inappropriate ICD therapy after multivariate analysis. Univariate analysis demonstrated an association of high TSH and appropriate ICD therapy. However, multivariate analysis did not show this association. Therefore, we are concluding that TSH levels are predictors of all-cause mortality but not ICD therapy.

Intermediate Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annuli.

The clinical impact of prosthesis-patient mismatch (PPM) in patients with small aortic annuli who underwent transcatheter aortic valve (AV) implantation with either balloon-expandable (BE) or self-expanding (SE) valves remains controversial. We assessed in-hospital and intermediate clinical outcomes in 573 patients with transfemoral transcatheter AV implantation with a small AV annulus, defined as an AV annulus area ≤430 mm2. A total of 337 patients treated with a 23-mm BE valve (SAPIEN 3, Ultra) were compared with 236 patients treated with a 26-mm SE valve (Evolut series). Valve-in-valve cases were excluded, and late echo follow-up (mean 674 ± 438 days) was assessed in a subset of 292 patients (51.0%). Well-matched BE and SE cohorts did not differ with respect to major in-hospital outcomes, other than a borderline increase in vascular complications and composite bleeding in patients with SE. Patients with BE had a higher incidence of severe PPM on discharge echocardiography (16.9% vs 6.8%, p <0.002). The mean AV gradient at 30 days was higher for patients with BE (12.2 ± 4.2 vs 6.2 ± 7.9 mm Hg, p <0.001) and at late follow-up (14.0 ± 8.2 vs 7.2 ± 3.5 mm Hg, p <0.001). The follow-up left ventricular ejection fraction and incidence of >mild aortic insufficiency were similar. All-cause mortality for the 2 cohorts was similar, with an overall mean (95% confidence interval) survival time of 61.2 months (57.8 to 64.5; p = 0.98). There were no significant survival differences between combined patients with BE and SE with no, moderate, or severe PPM, with an overall mean (95% confidence interval) survival time of 32.5 (30.5 to 34.5) months combining valve types (p = 0.23). In conclusion, despite an increased incidence of PPM with higher mean AV gradients that persist on late echocardiography in the BE cohort, patients with BE and SE with small aortic annuli have similar clinical outcomes at intermediate follow-up. Moderate and severe PPM had no impact on survival at a mean follow-up of 32.5 months.

Recovery From the Impact of COVID-19 on Treatment Times and Clinical Outcomes of Patients With ST-Segment Elevation Myocardial Infarction: An Interim Analysis.

BACKGROUND: Previous studies have documented a negative impact of the COVID-19 pandemic on emergent percutaneous treatment of patients with ST-segment elevation myocardial infarction (STEMI), but few have examined recovery of healthcare systems in restoring prepandemic STEMI care. METHODS: Retrospective analysis was performed of data from 789 patients with STEMI from a large tertiary medical center treated with percutaneous coronary intervention between January 1, 2019, and December 31, 2021. RESULTS: For patients with STEMI presenting to the emergency department, median time from door to balloon was 37 minutes in 2019, 53 minutes in 2020, and 48 minutes in 2021 (P < .001), whereas median time from first medical contact to device changed from 70 to 82 to 75 minutes, respectively (P = .002). Treatment time changes in 2020 and 2021 correlated with median emergency department evaluation time (30 to 41 to 22 minutes, respectively; P = .001) but not median catheterization laboratory revascularization time. For transfer patients, median time from first medical contact to device changed from 110 to 133 to 118 minutes, respectively (P = .005). In 2020 and 2021, patients with STEMI had greater late presentation (P = .028) and late mechanical complications (P = .021), with nonsignificant increases in yearly in-hospital mortality (3.6% to 5.2% to 6.4%; P = .352). CONCLUSION: COVID-19 was associated with worsening STEMI treatment times and outcomes in 2020. Despite improving treatment times in 2021, in-hospital mortality had not decreased in the setting of a persistent increase in late patient presentation and associated STEMI complications.

Electrocardiographic changes during vasodilator SPECT myocardial perfusion imaging: does it affect diagnosis or prognosis?

BACKGROUND: Significance of electrocardiographic (ECG) changes during vasodilator stress myocardial perfusion imaging (MPI) is controversial. We examined the diagnostic and prognostic significance of ECG changes during vasodilator single photon emission computerized tomography (SPECT) MPI. METHODS: We studied consecutive patients who underwent vasodilator SPECT MPI from 1995 to 2009. Patients with baseline ECG abnormalities, previous history of coronary artery bypass graft surgery or myocardial infarction (MI) were excluded. Significant coronary artery disease (CAD) was defined as >70% stenosis of any vessel or ≥50% stenosis of left main. Mean follow-up was 2.4 ± 1.5 years for cardiac events (cardiac death and non-fatal MI). RESULTS: Of patients in the diagnostic cohort, ST depression was associated with increased incidence of CAD with abnormal (P = .020 and P <.001) but not in those with normal perfusion (P = .342). Of 3,566 patients with follow-up in the prognostic cohort, including 130 (5.0%) with ST depression and normal perfusion, the presence of ST depression ≥1 mm did not affect the outcomes in any summed stress score category. CONCLUSIONS: ST depression ≥1 mm during vasodilator SPECT MPI is associated with CAD in patients with abnormal perfusion, but provides no additional risk stratification beyond concomitant perfusion imaging, including those with normal studies.

Ultrasound-assisted catheter-directed thrombolytic therapy for management of acute pulmonary embolism.

Acute pulmonary embolism (PE) is a common and potentially lethal condition. Anticoagulation is considered the mainstay therapy while systemic thrombolytic therapy is reserved only for patients who are hemodynamically unstable. However, therapy for PE with evidence of right ventricular strain is not well-defined. We report a case of PE treated successfully with an ultrasound-assisted catheter-directed thrombolytic therapy.

Transcarotid Versus Transfemoral Transcatheter Aortic Valve Replacement (from a Propensity-Matched Comparison).

Previous reports comparing transcarotid (TC) versus transfemoral (TF) approaches for patients undergoing transcatheter aortic valve replacement have had inconsistent conclusions. We compared in-hospital and 1-year clinical outcomes, changes in quality of life, and direct hospital costs for 138 TC versus 1,926 TF procedures. Propensity matching based on the Society of Thoracic Surgery Predicted Risk of Mortality was used to compare 130 patients who underwent TC with 813 patients who underwent TF. Matched TC versus TF cohorts did not differ with respect to in-hospital mortality (0.0% vs 1.4%, p = 0.380), stroke (2.3% vs 2.5%, p = 0.917), major vascular complications (0.8% vs 2.2%, p = 0.268), composite bleeding complications (4.6% vs 6.4%, p = 0.647), requirement for permanent pacemaker (14.6% vs 12.9%, p = 0.426), postoperative hospital length of stay (3.3 ± 3.4 vs 3.1 ± 3.3 days, p = 0.467), or direct hospital costs ($52,899 ± 9,560 vs $50,464 ± 10,997, p = 0.230). Similarly, at 1-year, patients who underwent TC versus patients who underwent TF did not differ with respect to all-cause mortality (7.6% vs 6.4%, p = 0.659), hospital readmission (20.0% vs 23.9%, p = 0.635), or quality of life as measured by the Kansas City Cardiomyopathy Questionnaire score (84.0 ± 17.1 vs 88.4 ± 13.9, p = 0.062). Patients who underwent TC and TF did not differ with respect to in-hospital complications, length of hospital stay, and direct hospital costs, as well as 1-year mortality, readmission, and quality of life. These data add to ongoing support for the TC approach as the optimal alternative access for patients with transcatheter aortic valve replacement deferred from a transfemoral approach.

Post-MI Ventricular Septal Defect During the COVID-19 Pandemic.

With the COVID-19 pandemic, the fear among patients of contracting it has made them reluctant to seek medical attention on a timely basis even for emergent conditions. We present a case of post infarction ventricular septal rupture due to delayed presentation as a consequence of the fear of COVID-19. (Level of Difficulty: Intermediate.).

Novel Cerebral Protection Technique During Right Transcarotid TAVR in Bicuspid Aortic Stenosis and Porcelain Aorta.

Periprocedural stroke related to transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. Cerebral embolic protection using the Sentinel device (Claret Medical) has demonstrated reduced rates of stroke during TAVR. However, alternative access such as a transcarotid approach precludes the use of the Sentinel device. We report a case using cerebral embolic protection during a right transcarotid TAVR.

Left atrial strain is reduced in patients with atrial fibrillation, stroke or TIA, and low risk CHADS(2) scores.

BACKGROUND: Left atrial (LA) strain as a marker for discrimination of risk for stroke and transient ischemic attack (TIA) in patients with atrial fibrillation and low-risk CHADS(2) scores (≤1) has yet to be examined. METHODS: Patients with atrial fibrillation, stroke or TIA, and CHADS(2) scores ≤ 1 before their events were identified retrospectively from a large single-center stroke registry and compared with age-matched and gender-matched controls. Antihypertensive use and echocardiographic parameters including chamber volumes and left ventricular mass and LA peak negative and positive strain and strain rate were compared between groups. RESULTS: Fifty-seven patients meeting entry criteria were identified. Patients demonstrated significantly lower left ventricular ejection fractions, larger LA dimensions, and larger LA volume indexes (24.4 ± 11.9 vs 32.3 ± 13.3 mL/m(2), P = .012) compared with controls. Both peak negative LA strain (-3.2 ± 1.2% vs -6.9 ± 4.2%, P < .001) and peak positive LA strain (14 ± 11% vs 25 ± 12%, P < .001) were significantly reduced in patients compared with controls. Peak negative LA strain was significantly associated with stroke by binary logistic regression (odds ratio, 2.15; P < .001). CONCLUSIONS: In patients with low-risk CHADS(2) scores, atrial fibrillation, and stroke or TIA, reduced LA strain is a potentially sensitive maker for increased risk for stroke or TIA. These results suggest that LA strain may have potential as a tool for helping guide the decision for or against oral anticoagulation in this group of patients.

Usefulness of stress gated technetium-99m single photon emission computed tomographic myocardial perfusion imaging for the prediction of cardiac death in patients with moderate to severe left ventricular systolic dysfunction and suspected coronary artery disease.

Although stress gated technetium-99m single-photon emission computed tomographic (SPECT) myocardial perfusion imaging (MPI) is useful in differentiating ischemic from nonischemic cardiomyopathy, its prognostic usefulness in this patient population is not well understood. Consecutive unique patients with suspected coronary artery disease who, for clinical indications, underwent technetium-99m rest and stress MPI demonstrating ejection fractions ≤40% by gated SPECT imaging were retrospectively identified. In addition to prescan variables, previously defined cutoffs for gated SPECT parameters using visual and standard 17-segment semiquantitative scoring were applied and related to the occurrence of cardiac death up to 5 years after MPI. Of the 475 patients fulfilling criteria for study inclusion, follow-up was complete in 444 (93%) over 3.7 ± 1.6 years. Of 393 patients without subsequent early (≤60 days) coronary revascularization, cardiac death occurred in 64 (16%). The summed stress score, an MPI measure of the extent and severity of coronary artery disease that also accounts for the ischemic burden, was the gated SPECT parameter most related to cardiac death with Kaplan-Meier 5-year cardiac death-free survival of 85.6% and 67.3% in patients with summed stress scores ≤8 and >8, respectively (p <0.001). In multivariate Cox regression analysis, a summed stress score >8 independently contributed to cardiac death (adjusted hazard ratio 2.20, 95% confidence interval 1.34 to 3.61), and its addition to the model significantly increased the global chi-square value over prescan variables (from 32.46 to 41.67, p = 0.002). In conclusion, stress MPI data from gated technetium-99m SPECT scans are useful for the prediction of cardiac death in patients with moderate to severe left ventricular systolic dysfunction in whom there is suspicion of underlying coronary artery disease.