Higher Rates Of Procedural Complications Research Articles

Outcomes of mitral valve transcatheter edge-to-edge repair for patients with hemodynamic instability: A systematic review and meta-analysis

BackgroundThe outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) for the patients with severe mitral regurgitation (MR) in hemodynamically unstable conditions, such as cardiogenic shock, still remain unclear. We aimed to integrate previous publications regarding M-TEER indicated for life-threatening conditions and indirectly particularly compared the short-term outcomes thereof, with that of other treatments. MethodsWe systematically searched the PubMed, Cochrane, and MEDLINE databases for studies from inception to June 2023, regarding M-TEER in patients with hemodynamic instability and severe MR. The primary outcomes analyzed included the in-hospital and 30-day mortality rates, and peri-procedural complications. ResultsOf the initial 820 publications, we conducted a meta-analysis of a total of 25 studies. The relative risk of moderate-to-severe or severe MR was 0.13 (95 % confidence interval [CI]: 0.10–0.18, I2 = 45.2 %). The pooled in-hospital and 30-day mortality rates were 11.8 % (95 % CI: 8.7–15.9, I2 = 96.4 %) and 14.1 % (95 % CI: 10.9–18.3, I2 = 35.5 %), respectively. The 30-day mortality rate was statistically significantly correlated with the residual moderate-to-severe or severe MR, as per the meta-regression analysis (coefficient β = 3.48 [95 % CI: 0.99–5.97], p = 0.006). Regarding peri-procedural complications, the pooled rates of a stroke or transient ischemic attack, life-threatening or major bleeding, acute kidney injury, and peri-procedural mitral valve surgery were 2.3 % (95 % CI: 1.9–2.6), 7.6 % (95 % CI: 6.8–8.5), 32.9 % (95 % CI: 31.6–34.3), and 1.0 % (95 % CI: 0.8–1.3), respectively. ConclusionsThis meta-analysis demonstrates that the relatively higher rates of procedural complications were observed, nevertheless, M-TEER can potentially provide favorable short-term outcomes even in hemodynamically unstable patients. PROSPERO registration numberCRD42023468946.

Current evidence for prognostic benefit of intravascular imaging-guided percutaneous coronary intervention in chronic total occlusion intervention.

Although percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has been increasing in recent years, CTO PCI is still one of the most challenging procedures with relatively higher rates of procedural complications and adverse clinical events after PCI. Due to the innate limitations of invasive coronary angiography, intravascular imaging (IVI) has been used as an adjunctive tool to complement PCI, especially in complex coronary artery disease. Considering the complexity of CTO lesions, the role of IVI is particularly important in CTO intervention. IVI has been a useful adjunctive tool in every step of CTO PCI including assisted wire crossing, confirmation of wire location within CTO segment, and stent optimization. The meticulous use of IVI has been one of the greatest contributors to recent progress of CTO PCI. Nevertheless, studies evaluating the role of IVI during CTO PCI are limited. The current review provides a comprehensive overview of the mechanistic advantages of IVI in CTO PCI, summarizes previous studies and trials, and presents future perspective of IVI in CTO PCI.

Coronary calcifications, the Achilles heel in coronary interventions.

Percutaneous coronary intervention in severely calcified coronaries has been associated with higher rates of procedural complications, including myocardial infarction and death in addition to increased frequency of coronary revascularization on an intermediate and long-term basis. The SYNTAX score, which is designed to assess the complexity of coronary artery disease and aids in choosing a revascularization method, allocates two points per lesion when there is heavy calcification present on fluoroscopy. With the advent of novel multimodality imaging technologies, the detection and evaluation of coronary calcifications improved significantly over the last decade. Several tools are now available for modifying calcified lesions including different types of dedicated balloons and atherectomy devices, which may create some degree of confusion regarding the suitable application of each instrument. The aim of this review is to cover this vital topic from different aspects. First, we tried to provide an overview on the pathophysiology and types of coronary calcification and its risk factors. Then, we outlined the available imaging modalities for the evaluation of calcified coronary lesions, highlighting the points of strength and weakness of each of them. A comprehensive discussion of calcium-modifying techniques was elaborated, summarizing their mechanism of action, pros and cons, and possible complications. Finally, an integrated algorithm was proposed for the best management of calcified coronary lesions.

Looking but not seeing the cap: The case for PROGRESS‐CTO

Key Points Chronic total occlusion (CTO) procedures are a well‐established treatment strategy for selected patients with chronic coronary disease. Proximal cap ambiguity is one of the key aspects impacting procedural success and final results. In this issue of CCI, data from a large multicenter prospective registry confirmed that proximal cap ambiguity is related to worse procedural outcomes, more aggressive procedural techniques, and higher rates of procedural complications. Proximal cap ambiguity should be considered for patients' selection and procedural planning. Further analysis will be needed to test different imaging modalities for a clearer cap visualization.

Efficacy and Safety of Contemporary PCI in the Elderly – A Prospective Two-Year Cohort Study From the Concord Hospital PCI Registry

A less invasive coronary revascularisation strategy is often preferred in the elderly (>80 years). Higher rates of procedural complications remain a concern in this group due to comorbidity and complex disease. We record in-hospital and longer-term outcomes in this group undergoing contemporary PCI.

Endovascular reperfusion of M2 occlusions in acute ischemic stroke reduced disability and mortality: ETIS Registry results

BackgroundThe predictors of successful reperfusion and the effect of reperfusion after endovascular treatment (EVT) for M2 occlusions have not been well studied. We aimed to identify predictors of successful reperfusion...

Risks and Benefits of Bronchoscopy during the First 100 Days Following Allogeneic Hematopoietic Cell Transplantation

BACKGROUND Pulmonary infiltrates are common after allogeneic hematopoietic cell transplantation (HCT) and can have infectious or non-infectious etiologies. Fiberoptic Bronchoscopy (FOB) with bronchoalveolar lavage (BAL) is frequently used to evaluate these patients. However, the diagnostic yield can be highly variable according to patient populations, and the impact on management is not well defined, especially in the era of modern antimicrobial therapies. The aim of this study was to investigate the diagnostic and therapeutic yield of FOB-BAL in adult patients with pulmonary infiltrates during the first 100 days following HCT. METHODS We retrospectively reviewed the medical records of adult HCT patients who underwent FOB-BAL during the first 100 days post HCT between January 2005 and December 2015 at Mayo Clinic, Rochester, MN. The interval from HCT to FOB was stratified into early (days 1-30) vs. late (days 31-100). The finding of progressively more hemorrhagic effluent and/or ≥ 20% hemosiderin-laden macrophages in BAL were considered diagnostic for diffuse alveolar hemorrhage (DAH). Univariate and multivariate logistic regression models were fit to identify clinical and transplant characteristics that may impact the diagnostic yield of FOB-BAL. RESULTS A total of 114 patients (median age 55 years), representing 12% of all HCT patients underwent FOB-BAL. Underlying diagnoses were AML in 36%, MDS in 16%, ALL in 16%, MPN in 12% , CLL in 7%, and other in 13%. Transplants were from matched related donor in 43%, matched unrelated donor in 40%, and other donor/matching status in 17%. FOB-BAL was performed during the early period in 61% and during the late period in 39% of patients. In the early period, FOB-BAL provided a specific diagnosis in 49% of patients (30% DAH and 19% infection). In the late period, FOB-BAL had a diagnostic yield of 55% (14% DAH and 36% infection) (Figure 1). The distribution of bacterial and viral infections identified via BAL were similar during the early period (39% and 38%, respectively), whereas more bacterial than viral infections were identified in the later period (56% vs. 19%, respectively) (Figure 2). Non-invasive testing for respiratory tract infection was performed in 34% of patients. These included nasopharyngeal swab for RSV/Influenza PCR in 16% (all negative), multiplex respiratory pathogen PCR in 5% (1 positive for coronavirus), and sputum culture in 21% (positive in 8 patients). This compares with the identification of an infectious pathogen via BAL in 36% of patients; bacterial in 16%, viral in 11%, and fungal in 10%. Transbronchoscopic lung biopsy biopsies were performed in 8 patients and provided diagnostic information in 3 patients (eosinophilic pneumonia, organizing pneumonia and diffuse alveolar damage each in 1 patient). Procedural complications occurred in 3 patients; 2 after transbronchoscopic lung biopsy (1 bleeding and 1 pneumothorax) and 1 during FOB-BAL (atrial fibrillation with rapid ventricular rate). In a multivariable logistic regression model, the underlying diagnosis, presence of acute respiratory failure, and early vs. later time period after HCT were independently affecting the diagnostic yield of FOB-BAL, with higher likelihood of DAH being diagnosed in patients with AML/MDS and during the early post-HCT period, and higher likelihood of DAH being diagnosed in patients with acute respiratory failure (Table 1). In 40% of patients, FOB-BAL findings lead to treatment changes. These included addition of antimicrobials in 24% and addition of corticosteroids in 22% (17% DAH, 2% idiopathic pneumonia syndrome, and 1% organizing pneumonia) (Figure 3). FOB findings lead to more antimicrobial modifications in the early than in the later period (32% vs. 18%, respectively). Overall survival was poor in all the three groups, although significantly better in patients with non-diagnostic FOB findings (median of 2, 3, and 11 months in patients with DAH, infection, or non-diagnostic FOB finings, respectively) (p = 0.03) (Figure 4). CONCLUSION FOB-BAL provides clinically useful information in the post-transplant period. BAL findings were diagnostic in 51% of patients, and led to management changes in 40% of patients. Transbronchoscopic lung biopsy is associated with higher rates of procedural complications. Further characterization of the underlying diagnosis in patients with non-diagnostic FOB-BAL findings remains an unmet clinical goal. Disclosures Sakemura: Humanigen: Patents & Royalties. Kenderian:Morphosys: Research Funding; Kite/Gilead: Research Funding; Lentigen: Research Funding; Humanigen: Other: Scientific advisory board , Patents & Royalties, Research Funding; Tolero: Research Funding; Novartis: Patents & Royalties, Research Funding. Patnaik:Stem Line Pharmaceuticals.: Membership on an entity's Board of Directors or advisory committees.

920 Efficacy and Safety of EUS-Guided Gastroenterostomy for Gastric Outlet Obstruction: A Systematic Review and Meta-Analysis

INTRODUCTION: For symptomatic gastric outlet obstruction (GOO), enteral stents or surgical gastroenterostomy (GE) are treatment options that are limited by short term efficacy or high procedural complication rates. With the advent of lumen apposing metal stents (LAMS) it is possible to use a minimally invasive EUS guided approach to create a gastro-enteric fistula. We conducted a systematic review and meta-analysis to evaluate and compare the efficacy and safety of EUS-guided gastroenterostomy for GOO. METHODS: MEDLINE, EMBASE, and SCOPUS were utilized to search for eligible studies that reported on technical success, clinical success and adverse events of this procedure from 2012-2019. Technical success was defined as the ability to create a GE with a LAMS and clinical success was defined as the ability to tolerate an oral diet. Patients with benign and malignant GOO were included. All studies were retrospective and the quality of eligible studies was assessed by the NHBLI tool. A sub-analysis was done to analyze the direct and balloon assisted techniques and procedural times. Figure 1 depicts the flow chart used for study screening. RESULTS: A total of 5 studies (n = 147 patients) were included in the analysis. The mean age of patients undergoing EUS guided GE was 64 years with 50% females. Most common etiology for GOO was malignancy with 77% of cases. Pooled technical success was 96% (95% CI 0.91-0.99) although 5 cases initially involved LAMS misdeployment requiring repositioning. Clinical success was 80% (95% CI 0.58-0.96) and a total of 6 adverse events (2% 95% CI 0.00 – 0.08) occurred including intra-procedural bleeding, peritonitis and perforation requiring surgery. Figures 2a–c highlights the technical success, clinical success and adverse events of EUS guided GE. On procedural sub-analysis, a total of 74 cases were done with the direct GE technique while 27 cases underwent balloon-assisted GE. Stent misdeployments occurred in 6.7% of cases of the direct technique and 9.1% of balloon assisted cases. Procedural time was comparatively lower with the direct technique averaging 35.6 mins compared to 84 mins for the balloon assisted technique. CONCLUSION: EUS guided gastroenterostomy is an efficacious and safe procedure for patients with gastric outlet obstruction. Although the direct GE technique appears to require less procedural time, more studies need to be done to assess the optimal procedural technique.

Outcomes of patients with heart failure after primary prevention ICD unit generator replacement

ObjectiveData describing outcomes after implantable cardioverter-defibrillator (ICD) unit generator replacement in patients with heart failure (HF) with primary prevention devices are limited.MethodData on patients with HF who underwent primary prevention...

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings

BackgroundLimited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. ObjectivesThis study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). MethodsFrom the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. ResultsA total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). ConclusionsThe TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

Past, Present and Future of Femoropopliteal Stenting

Endovascular stent implantation was introduced to femoropopliteal procedures almost 2 decades ago. Initial results with balloon-expandable stainless steel stents and self-expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were catastrophically high, in the range of 60% to 80% at 1 year. Also, attempts to resolve the problem of in-stent restenosis (ISR) using first-generation covered stent-grafts led to unsatisfactory results, high procedural complication rates due to large introducers, and a high incidence of graft thrombosis, which did not make these devices convincing alternatives to bare metal stents. After years of stagnation, however, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices; for the first time, stenting has been shown to be beneficial compared to balloon angioplasty in longer femoropopliteal lesions. Nevertheless, although superior to balloon angioplasty, nitinol stenting is still associated with a considerable restenosis rate, and treatment of ISR remains problematic. Future concepts to further improve long-term patency after femoropopliteal stenting therefore are under investigation, including drug-eluting stents, biodegradable stents, and coated stent-grafts. From a current perspective, femoropopliteal stenting remains the Achilles' heel of the interventionist.

Long‐Term Mortality, Cause of Death, and Temporal Trends in Complications after Percutaneous Aortic Balloon Valvuloplasty for Calcific Aortic Stenosis

We sought to assess survival, predictors of adverse outcomes, and complication rates in a more recent series of adults undergoing percutaneous aortic balloon valvuloplasty (PABV) for symptomatic calcific aortic stenosis. While aortic valve replacement is the treatment of choice for adults with symptomatic calcific aortic stenosis, PABV has been used in selected patients who are not good surgical candidates. Registries of patients who underwent PABV over 15 years ago have shown poor long-term survival and high procedural complication rates. This single-center cohort study enrolled consecutive adults undergoing PABV between 1989 and 2005 for calcific aortic stenosis. Demographic, hemodynamic, and procedural data, as well as vital status, were collected by chart review and query of the National Death Index. The study included 78 patients: mean age 78 +/- 11 years, 51% female, 90% heart failure, 61% coronary disease, and 8% end-stage renal disease. While 22% had a major procedural complication, this rate tended to decrease over time (P=0.068). In the cohort, 87% died with a median survival of 6.6 months. According to NDI records, the primary cause of death was cardiac in 54% of deaths. Survival was significantly higher in patients <or=70 years and those bridged to aortic valve replacement. PABV in patients who are elderly and not candidates for bridge to aortic valve replacement is associated with poor long-term survival. The decrease in the complication rate over the past 15 years has important implications regarding the morbidity associated with percutaneous aortic valve replacement techniques.

Complex emergencies in Indonesia.

Recently, Indonesia has experienced six major provincial, civil, armed conflicts. Underlying causes include the transmigration policy, sectarian disputes, the Asian economic crisis, fall of authoritarian rule, and a backlash against civil and military abuses. The public health impact involves the displacement nationwide of > 1.2 million persons. Violence in the Malukus, Timor, and Kalimantan has sparked the greatest population movements such that five provinces in Indonesia each now harbor > 100,000 internally displaced persons. With a background of government instability, hyperinflation, macroeconomic collapse, and elusive political solutions, these civil armed conflicts are ripe for persistence as complex emergencies. Indonesia has made substantial progress in domestic disaster management with the establishment of central administrative authority, strategic planning, and training programs. Nevertheless, the Indonesian experience reveals recurrent issues in international humanitarian health assistance. Clinical care remains complicated by absences of treatment protocols, inappropriate drug use, high procedural complication rates, and variable referral practices. Epidemiological surveillance remains complicated by unsettled clinical case definitions, non-standardized case management of diseases with epidemic potential, variable outbreak management protocols, and inadequate epidemiological analytic capacity. International donor support has been semi-selective, insufficient, and late. The militia murders of three UN staff in West Timor prompted the withdrawal of UN international staff from West Timor for nearly a year to date. Re-establishing rules of engagement for humanitarian health workers must address security, public health, and clinical threats.

Coronary artery stenting in the elderly: short-term outcome and long-term angiographic and clinical follow-up.

This study sought to compare the short- and long-term outcomes of elderly patients undergoing coronary artery stenting with those of younger patients and to determine the long-term clinical outcome and survival of elderly patients post stent implantation. Elderly patients undergoing coronary revascularization are considered a high-risk group. Few data exist that relate the results of stenting in treating coronary artery disease in the elderly population. All elderly patients >75 years of age who underwent coronary artery stenting between March 1993 and July 1997 (n=137) at our center were compared to the patients <75 who underwent coronary artery stenting during the same time period (n=2,551). Long-term clinical follow-up and survival were determined for the elderly group. Elderly patients presented with lower ejection fractions (54% vs. 58%, p=0.0001), more unstable angina (47% vs. 28%, p=0.0001), and more multivessel disease (78% vs. 62%, p= 0.0001) than younger patients. These older patients had higher rates of procedure related complications including procedural myocardial infarction (MI) (2.9% vs. 1.7%, p=0.2), emergency CABG (3.7% vs. 1.4%, p=0.04), and death (2.2% vs. 0.12%, p=0.0001). Angiographic follow-up, obtained in both groups, demonstrated significantly higher restenosis rates in the elderly versus younger patients (47% vs. 28%, p=0.0007). Longer term clinical follow-up, which was obtained only in the elderly group, showed that at a mean follow-up period of 12 months post coronary stenting, elderly survival free from death, MI, revascularization and angina was 54% and that their overall survival was 91%. Subanalysis of the elderly patients who died showed much higher incidence of combined unstable angina (80%), prior MI (60%), lower ejection fraction (46%), multivessel disease (100%) and complex lesions (100%) than the overall group. Elderly patients who undergo coronary artery stenting have significantly higher rates of procedural complications and worse six month outcomes than younger patients, especially those who present with combined unstable angina, history of MI, EF < 50%, multivessel disease and complex lesions. Overall survival in the elderly population at 12 months postcoronary artery stenting was 91% and event-free survival was 54%.