Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience.

BACKGROUND: The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time. AIMS: This study aimed to examine whether these changes impacted clinical outcomes. METHODS: EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+ SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared. RESULTS: Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43). CONCLUSION: During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV.

Frequency of ventriculography during left heart catheterization for radial vs. femoral access.

BACKGROUND: Radial artery access has been used for left heart catheterization (LHC) and percutaneous coronary intervention (PCI) for over 30 years. This method has gained popularity among operators due to superficial vessel anatomy, allowing for easy accessibility and compressibility, resulting in effective hemostasis. METHODS: We conducted a retrospective analysis of patients who underwent PCI due to ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), and chest pain (stable angina) from November 2013 to February 2023. RESULTS: We analyzed validated registries and found 7714 PCIs. Of these, 1230 were STEMI patients, 5585 were NSTE-ACS patients, and 899 were stable angina patients, forming the basis of our final analysis. In STEMI patients, there was a trend toward a higher rate of ventriculography with femoral access compared to radial access (53.4 % vs. 47.5 %, p = 0.06), which was also observed in NSTE-ACS patients (34.2 % vs. 31.8 %, p = 0.07). The use of central venous access was more common with femoral access in all three diagnoses, with significantly higher rates seen in STEMI patients (36.2 % vs. 7.6 %, p < 0.001), NSTE-ACS patients (19.3 % vs. 2.8 %, p < 0.001), and chest pain patients (26.4 % vs. 2.7 %, p < 0.001). CONCLUSIONS: The analysis revealed that operators may perform fewer ventriculography and RHC procedures when using radial access as compared to femoral access. While there is discrepancy in performing left ventriculography and RHC when using a radial artery, it is essential to emphasize that routinely performing ventriculography and hemodynamic assessment has not proven to impact outcomes, despite their contributions to proper decision-making and treatment.

Computed tomography fractional flow reserve discrepancies with invasive angiography and physiology - Case series.

BACKGROUND: Computed tomography with fractional flow reserve (CT-FFR) is increasingly common in assessing coronary artery disease. CASE PRESENTATION: We report five cases of discrepancies that led to changes in treatment. CONCLUSIONS: This report highlights discordant findings between modalities, which should be considered during the diagnostic assessment of chest pain.

Aspirin Versus Warfarin after Transcatheter Aortic Valve Replacement in Low-Risk Patients: 2-Year Follow-Up.

Subclinical leaflet thrombosis occurs with transcatheter heart valves (THVs) and could be associated with structural valve deterioration. The current guidelines recommend the use of antiplatelet agents after transcatheter aortic valve replacement (TAVR) but not the routine use of oral anticoagulation. Our study examines the effects of short-term warfarin therapy on THV hemodynamics at 24 months after TAVR in low-risk patients. Low-risk patients who underwent TAVR were randomly allocated 1:1 to receive low-dose aspirin (n = 50) or low-dose aspirin plus warfarin (n = 44). After 30 days of treatment, ongoing medication regimens, including anticoagulation, were at the physicians' discretion. Follow-up after a period of 24 months was available for clinical and echocardiographic outcomes. At the 24-month mark, follow-up echocardiography of the randomly allocated patients revealed just 1 additional case of new structural valve deterioration in the aspirin group (compared with the occurrence within 30 days), based on the Valve Academic Research Consortium 3 definitions. There were also no differences in mean pressure gradients (11.5 ± 0.5 mm Hg vs 11.05 ± 4.0 mm Hg, p = 0.6) or peak velocity (2.2 ± 0.5 m/s vs 2.1 ± 0.4 m/s, p = 0.7) between the groups. A composite end point (mortality, stroke, and myocardial infarction) did not show any difference between the groups at long-term follow-up (p = 0.07). In conclusion, in low-risk patients who underwent TAVR, short-term anticoagulation with warfarin did not impact clinical outcomes or THV hemodynamics by echocardiography at 24 months.

Early experience with the Evolut FX self-expanding valve vs. Evolut PRO+ for patients with aortic stenosis undergoing TAVR.

BACKGROUND: The Evolut FX system is the most recent generation of self-expandable transcatheter heart valve (THV) technology. This study aims to report the early experience and outcomes associated with this system. METHODS: Our analysis included 200 consecutive patients who underwent transcatheter aortic valve replacement at our center from 2022 to 2023. The first cohort comprised the last 100 patients who received the Evolut PRO+ THV, while the second cohort included the first 100 patients who received the Evolut FX THV. The primary endpoints of the study were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, which included technical success (at exit from procedure), device success (at discharge or at 30 days), and early safety (at 30 days). RESULTS: The study groups demonstrated no significant differences in baseline characteristics, including co-morbidities, pre-procedural imaging, and echocardiography. VARC-3 technical success rate was 99 % for both valves. The VARC-3 device success rate for the Evolut FX was 92 % compared to 97 % for the Evolut PRO+ (p = 0.12), and VARC-3 early safety rate was 80.1 % for the Evolut PRO+ vs. 81.5 % for the Evolut FX (p = 0.82). The in-hospital permanent pacemaker implantation rate for the Evolut FX was 12 % compared to 9 % for the Evolut PRO+ (p = 0.21). There were no differences in clinical outcomes, such as mortality or stroke, between the two groups. CONCLUSIONS: The Evolut FX THV performed well when used for patients with severe aortic stenosis, demonstrating high success with low complication rates when compared to an earlier generation of self-expanding THV.

Impact of Thymectomy on Crisis Incidence and Quality of Life amongst Generalised Myasthenia Gravis Patients.

Background: Thymectomy, combined with corticosteroids, immunosuppressive agents, and cholinesterase inhibitors, has been accepted as the standard treatment for myasthenia gravis (MG) patients. Data on the effect of thymectomy on occurrence of myasthenic crisis are few. Objectives: To assess the long-term impact of thymectomy in patients with generalized Myasthenia gravis (GMG) in terms of occurrence of myasthenia crisis and quality of life. Methods: A retrospective analysis of 274 clinical records of patients diagnosed with myasthenia gravis (MG) in Nizam's institute of medical sciences (NIMS), a tertiary level teaching hospital between January 2000 and December 2015 was done. Severity of the disease was assessed using Myasthenia Gravis Foundation of America (MGFA) classification and quantitative myasthenia gravis (QMG) score. Myasthenia crisis was diagnosed in our patients when they required ventilator assistance due to respiratory failure caused by muscle weakness (MGFA class V). Quality of life (QoL) was assessed. Results: Of 230 cases included in the final analysis, 108 (46.9%) underwent thymectomy. Posttreatment crisis occurred in 53.3% of the nonthymectomy subjects, and 25.9% of thymectomy group (P < 0.001). In multivariate logistic regression analysis, after controlling for the effect of gender, age at diagnosis and grade of the disease, the odds ratio of myasthenic crisis in people with thymectomy was 0.186.(95% CI 0.087 to 0.387, P = 0.001). No statistically significant differences were observed in quality of life scores between thymectomy and nonthymectomy groups, either before (P = 0.86) or after surgery (P = 0.939). Conclusions: The odds of myasthenia crisis was lesser in people, who underwent thymectomy even after controlling for MGFA grade and other potential confounders but no significant differences in quality of life were found with thymectomy.

The Use of Bumper Wire Technique and Intravascular Ultrasound for Precise Aorto-Ostial Stenting.

Background: Aorto-ostial interventions are challenging due to the limitations of contemporary equipment, imprecise ostial demarcation, and problematic ostial lesion characteristics. Suboptimal stent placement is common and portends worse clinical outcomes. Procedural and long-term outcomes of the bumper wire technique with intravascular ultrasound (IVUS) assessment have not been investigated. Methods: A single-center retrospective study was conducted. Patients who underwent ostial lesion percutaneous coronary intervention (PCI) with the bumper wire technique between January 2019 and September 2020 were identified. The primary endpoint was to determine the geographic miss rate defined by inadequate ostial coverage or excess stent protrusion of > 2 mm by IVUS or angiography. The secondary endpoint was target lesion failure (TLF) at 6 months after PCI, defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization. Results: In total, 45 patients were identified. The average age was 71.7 years old, and 85.4% were men. Indication for PCI was acute coronary syndrome in about a third of patients. Twenty-six patients had left main ostial lesions and 19 patients had right coronary artery ostial lesions. Geographic miss was detected in two patients (4.4%): one patient (2.2%) had excess proximal stent protrusion and one patient (2.2%) had an ostial miss. Six patients were lost to follow-up. TLF, stroke, or major bleeding were not observed in any of the patients. Conclusion: The bumper wire technique is safe and efficient with low rates of geographic miss or adverse clinical outcomes. This is the first study to confirm precise aorto-ostial stent implantation with the bumper wire technique using IVUS confirmation.

Suction thrombectomy of a massive, hypermobile (type C) right atrial thrombus: a case report.

BACKGROUND: Right atrial thrombus (RAT) may be managed according to morphology and aetiology, i.e. Type A thrombi ('clot-in-transit', hypermobile) are managed with thrombolytics and surgical embolectomy due to high risk of embolization; Type B thrombi (broad-based, globular) may be managed medically as they will very likely maintain a benign course. Experience with management of a Type C thrombus (hypermobile but also broad-based) has not been explicitly described in the literature. CASE SUMMARY: A 25-year-old man with history of leukaemia with prior right subclavian vein chemoport is found to have massive RAT. Multimodal imaging shows a hypermobile mass attached to the right atrial lateral wall inferior to superior vena cava and prolapsing into right ventricle in diastole. Given the thrombus morphology and likely propagation from subclavian port, risk of catastrophic embolization was deemed high and as such, intervention was indicated. Systemic anticoagulation was considered but deferred due to theoretical risk of dissolving the thrombus stalk leading to embolization. Surgical thrombectomy was offered but the patient declined. Due to evidence for success in RAT, the AngioVac System: Generation 3 (Angiodynamics, Inc., Latham, NY, USA) was chosen for intervention. The RAT was successfully removed without any complication. DISCUSSION: AngioVac suction thrombectomy is a safe alternative option for removal of a Type C, massive, hypermobile RAT.

Basic Critical Care for Management of COVID-19 Patients: Position Paper of Indian Society of Critical Care Medicine, Part-I.

With more than 23 million infections and more than 814,000 deaths worldwide, the coronavirus disease-2019 (COVID-19) pandemic is still far from over. Several classes of drugs including antivirals, antiretrovirals, anti-inflammatory, immunomodulatory, and antibiotics have been tried with varying levels of success. Still, there is lack of any specific therapy to deal with this infection. Although less than 30% of these patients require intensive care unit admission, morbidity and mortality in this subgroup of patients remain high. Hence, it becomes imperative to have general principles to guide intensivists managing these patients. However, as the literature emerges, these recommendations may change and hence, frequent updates may be required. How to cite this article: Juneja D, Savio RD, Srinivasan S, Pandit RA, Ramasubban S, Reddy PK, et al. Basic Critical Care for Management of COVID-19 Patients: Position Paper of Indian Society of Critical Care Medicine, Part-I. Indian J Crit Care Med 2020;24(Suppl 5):S244-S253.

Basic Critical Care for Management of COVID-19 Patients: Position Paper of the Indian Society of Critical Care Medicine, Part II.

In a resource-limited country like India, rationing of scarce critical care resources might be required to ensure appropriate delivery of care to the critically ill patients suffering from COVID-19 infection. Most of these patients require critical care support because of respiratory failure or presence of multiorgan dysfunction syndrome. As there is no pharmacological therapy available, respiratory support in the form of supplemental oxygen, noninvasive ventilation, and invasive mechanical ventilation remains mainstay of care in intensive care units. As there is still dearth of direct evidence, most of the data are extrapolated from the experience gained from the management of general critical care patients. How to cite this article: Juneja D, Savio RD, Srinivasan S, Pandit RA, Ramasubban S, Reddy PK, et al. Basic Critical Care for Management of COVID-19 Patients: Position Paper of the Indian Society of Critical Care Medicine, Part II. Indian J Crit Care Med 2020;24(Suppl 5):S254-S262.

Comparison of Epidemiology and Outcomes of Acute Kidney Injury in Critically Ill Patients with and without Sepsis.

OBJECTIVES: In critically ill patients, acute kidney injury (AKI) and sepsis often coexist. This confounds the assessment of outcomes of both sepsis and AKI in these patients. Hence, in this study, we compare the outcomes of AKI with sepsis, AKI without sepsis, and sepsis without AKI against a control cohort comprising patients with neither AKI nor sepsis. MATERIALS AND METHODS: Prospective observational study conducted in our critical care unit (CCU) between January and July 2009. Data including demographic details, acute physiology and chronic health evaluation (APACHE) III score, presence of AKI, presence of sepsis, intensive care unit (ICU) length of stay (LOS), and outcomes were collected for all patients. Acute Kidney Injury Network (AKIN) criteria were used to define the presence of AKI and American College of Critical Care Medicine 2001 definition was used to define the presence of sepsis. RESULTS: A total of 250 patients were included in the study and 8 patients were excluded from analysis as they were discharged from hospital against medical advice. The remaining 242 patients (mean age 52.8 ± 17 years; 61.6% male; APACHE III score: 48.2 ± 24.1) were analyzed, and AKI was seen in 111 patients (45.8%). Among the patients with AKI, 55.8% (62/111) had sepsis and 44.2% (49/111) had nonseptic AKI. There was a higher need for renal replacement therapy (RRT) among patients with septic AKI in comparison to those with nonseptic AKI (19.3% vs 6.1%; p = 0.04), but no mortality difference was seen between the two groups (25.8% vs 20.4%, p = 0.5). Patients with sepsis and AKI had a significantly higher mortality (25.8%) compared to the patients with sepsis alone (5.6%; p < 0.01). CONCLUSION: Patients with septic AKI had a higher RRT requirement compared to patients with nonseptic AKI, but no significant differences in mortality were seen between the groups. Occurrence of AKI in septic patients substantially increases their mortality. HOW TO CITE THIS ARTICLE: Nandagopal N, Reddy PK, Ranganathan L, Ramakrishnan N, Annigeri R, Venkataraman R. Comparison of Epidemiology and Outcomes of Acute Kidney Injury in Critically Ill Patients with and without Sepsis. Indian J Crit Care Med 2020;24(4):258-262.

Clinical Characteristics and Management of Methamphetamine-Associated Cardiomyopathy: State-of-the-Art Review.

Methamphetamine-associated cardiomyopathy (MACM) is an increasingly recognized disease entity in the context of a rapidly spreading methamphetamine epidemic. MACM may afflict individuals with a wide range of ages and socioeconomic backgrounds. Presentations can vary greatly and may involve several complications unique to the disease. Given the public health significance of this disease, there is a relative dearth of consensus material to guide clinicians in understanding, diagnosing, and managing MACM. This review therefore aims to: (1) describe pathologic mechanisms of methamphetamine as they pertain to the development, progression, and prognosis of MACM, and the potential to recover cardiac function; (2) summarize existing data from epidemiologic studies and case series in an effort to improve recognition and diagnosis of the disease; (3) guide short- and long-term management of MACM with special attention to expected or potential sequelae of the disease; and (4) highlight pivotal unanswered questions in need of urgent investigation from a public health perspective.

Usefulness of Heart Rate Control in Atrial Fibrillation Patients With Obstructive Sleep Apnea.

In patients without atrial fibrillation and flutter (AF), obstructive sleep apnea (OSA) is associated with cyclic and often marked changes in heart rate (HR). We aimed to assess whether presence of OSA impacts optimal HR control in patients in AF. We retrospectively correlated diurnal HR patterns (recorded by 24-hour Holter monitoring) in patients with AF who independently also underwent diagnostic polysomnography. Exclusion criteria were paced rhythm or inadequate recordings from polysomnography and Holter monitoring. The relationship between the presence and severity of OSA and the mean, minimum, maximum HR, as well as pauses (>2 seconds) and their diurnal variation were studied. Of the 494 studied patients (age 69 ± 10 years; 26% women) mild-moderate OSA (apnea hypoxia index ≥5 and <20) was present in 171 (34%) and severe OSA (apnea hypoxia index ≥20) in 254 (51%). Mean 24-hour HR in patients with severe OSA and mild-moderate OSA was similar to those without OSA (78 vs 80 vs 79 beats per minute; p = 0.39), and there was no significant difference observed in minimum and maximum HR of these groups. However, the frequency of short pauses was greater in OSA patients (p = 0.009), with a prominent nocturnal distribution. In conclusion, OSA was not associated with increased HR in patients with AF suggesting that adequate HR control was similarly achievable in patients with and without OSA. The increased frequency of nocturnal pauses in OSA patients may function as a clinical hallmark, and the timing of pauses (during sleep vs wakefulness) should be noted before making therapeutic decisions regarding HR control.