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result(s) for
"Percutaneous treatment"
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Effects of percutaneous varicocele repair on testicular volume: results from a 12-month follow-up
2019
Varicocele is a common finding in men. Varicocele correction has been advocated for young patients with testicular hypotrophy, but there is a lack of morphofunctional follow-up data. We assessed whether percutaneous treatment of left varicocele is associated with testicular \"catch-up growth\" in the following 12 months by retrospectively reviewing data from an electronic database of 10 656 patients followed up in our clinic between 2006 and 2016. We selected all young adults (<35 years) with left varicocele who underwent percutaneous treatment, had a minimum of 12 months' ultrasound imaging follow-up, and had no other conditions affecting testicular volume. One hundred and fourteen men (mean±standard deviation [s.d.] of age: 22.8 ± 5.4 years) met the inclusion and exclusion criteria. Left testicular hypotrophy (LTH), defined as a ≥20% difference between left and right testicular volume at baseline, was observed in 26 (22.8%) men. Participants with LTH (mean±s.d.: 14.5 ± 2.7 ml) had lower baseline testicular volume compared to those without LTH (mean±s.d.: 15.7 ± 3.8 ml; P = 0.032). Repeated measures mixed models showed a significant interaction between LTH and time posttreatment when correcting for baseline left testicular volume (β = 0.114, 95% confidence interval [CI]: 0.018-0.210, P = 0.020), resulting in a catch-up growth of up to 1.37 ml per year (95% CI: 0.221-2.516). Age at intervention was also associated with reduced testicular volume (−0.072 ml per year, 95% CI: −0.135-−0.009; P = 0.024). Percutaneous treatment of left varicocele in young adults with LTH can result in catch-up growth over 1 year of follow-up. The reproductive and psychological implications of these findings need to be confirmed in longer and larger prospective studies.
Journal Article
Atrioventricular valve disease: challenges and achievements in percutaneous treatment
2018
Percutaneous treatment of atrioventricular (AV) valve disease has long been restricted to therapy of mitral stenosis, and was only lately expanded to mitral regurgitation. 15 years ago the MitraClip edge to edge repair was first applied to human pathology. In Europe, German centers were the first to widely adopt this technique in patients with mitral regurgitation and high or inappropriate risk for surgery. Given the exponential rise in implantation procedures, expertise of the operators and investigator initiated investigations substantially contributed to improvements in procedural processes and patient selection. Meanwhile, additional techniques to repair the mitral and tricuspid valve were introduced to German interventionalists, both reconstructive techniques as well as first experiences with transcatheter implantation of mitral valve bioprostheses. Of note, specialized Heart Valve referral Centers catalyzed the adoption of these techniques. This review summarizes the contributions of German Heart Centers to recent developments in percutaneous therapy of AV valve disease.
Journal Article
Trends in Intra-Aortic Balloon Pump Use in Cardiogenic Shock After the SHOCK-II Trial
by
Duffy, Stephen J.
,
Ajani, Andrew E.
,
Dagan, Misha
in
Aorta
,
Balloon treatment
,
Blood pressure
2023
Myocardial infarction complicated by cardiogenic shock (MI-CS) has a poor prognosis, even with early revascularization. Previously, intra-aortic balloon pump (IABP) use was thought to improve outcomes, but the IABP-SHOCK-II (Intra-aortic Balloon Pump in Cardiogenic Shock-II study) trial found no survival benefit. We aimed to determine the trends in IABP use in patients who underwent percutaneous intervention over time. Data were taken from patients in the Melbourne Interventional Group registry (2005 to 2018) with MI-CS who underwent percutaneous intervention. The primary outcome was the trend in IABP use over time. The secondary outcomes included 30-day mortality and major adverse cardiovascular and cerebrovascular events (MACCEs). Of the 1,110 patients with MI-CS, IABP was used in 478 patients (43%). IABP was used more in patients with left main/left anterior descending culprit lesions (62% vs 46%), lower ejection fraction (<35%; 18% vs 11%), and preprocedural inotrope use (81% vs 73%, all p <0.05). IABP use was associated with higher bleeding (18% vs 13%) and 30-day MACCE (58% vs 51%, both p <0.05). The rate of MI-CS per year increased over time; however, after 2012, there was a decrease in IABP use (p <0.001). IABP use was a predictor of 30-day MACCE (odds ratio 1.6, 95% confidence interval 1.18 to 2.29, p = 0.003). However, IABP was not associated with in-hospital, 30-day, or long-term mortality (45% vs 47%, p = 0.44; 46% vs 50%, p = 0.25; 60% vs 62%, p = 0.39). In conclusion, IABP was not associated with reduced short- or long-term mortality and was associated with increased short-term adverse events. IABP use is decreasing but is predominately used in sicker patients with greater myocardium at risk.
Journal Article
Current concepts in coronary artery revascularisation
2023
Coronary artery revascularisation can be performed surgically or percutaneously. Surgery is associated with higher procedural risk and longer recovery than percutaneous interventions, but with long-term reduction of recurrent cardiac events. For many patients with obstructive coronary artery disease in need of revascularisation, surgical or percutaneous intervention is indicated on the basis of clinical and anatomical reasons or personal preferences. Medical therapy is a crucial accompaniment to coronary revascularisation, and data suggest that, in some subsets of patients, medical therapy alone might achieve similar results to coronary revascularisation. Most revascularisation data are based on prevalently White, non-elderly, male populations in high-income countries; robust data in women, older adults, and racial and other minorities, and from low-income and middle-income countries, are urgently needed.
Journal Article
TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial
by
Malinowski, Krzysztof P
,
van Garsse, Leen
,
Postma, Sonja
in
Adenosine
,
Aged
,
Aged, 80 and over
2024
Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease.
This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed.
Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference –18·5 [90% CI –27·8 to –9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06–0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010).
The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment.
Isala Heart Centre and Medtronic.
Journal Article
Geographic variations and trends in percutaneous intervention for patients with and without acute myocardial infarction: A Japanese nationwide registry study
2025
A previous study demonstrated that the per capita volume of percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) was relatively uniform across the 47 prefectures in Japan, while elective PCIs for stable coronary artery disease showed wide regional variation. However, contemporary data remain limited.
The Japanese PCI (J-PCI) is a nationwide prospective registry covering most of the procedures performed within the country. PCI procedures in 2019 and 2023 were included and divided according to the indications: AMI versus non-AMI. The patterns of PCI procedures performed for AMI and non-AMI across all prefectures in Japan were evaluated. The associations of the non-AMI/AMI ratio with population, area, and the number of PCI-capable centers per prefecture were also assessed.
A total of 494,746 PCI procedures were analyzed. The ratios between the highest and lowest prefectures were 4.0-fold in non-AMI and 1.9-fold in AMI in 2019 and 4.2-fold in non-AMI and 2.0-fold in AMI in 2023. The non-AMI/AMI ratio was positively correlated with the ratios of the number of PCI-capable centers to population and area per prefecture.
Geographic disparity was observed in the relative volume of PCI performed for AMI compared to non-AMI across Japan, potentially reflecting variations in the density of PCI-capable centers relative to the area and population of each prefecture.
Journal Article
Characteristics and Outcomes of Young Patients With ST-Elevation Myocardial Infarction Without Standard Modifiable Risk Factors
2023
Patients with ST-elevation myocardial infarction (STEMI) with no standard modifiable risk factors (SMuRFs: hypertension, diabetes mellitus, hypercholesterolemia, and smoking) have worse short-term mortality than those with SMuRFs. Whether this association extends to younger patients is unclear. A retrospective cohort study was performed of patients aged 18 to 45 years with STEMI at 3 Australian hospitals between 2010 and 2020. Nonatherosclerotic causes of STEMI were excluded. The primary outcome was 30-day all-cause mortality. Secondary outcomes included 1 and 2-year mortality. Cox proportional hazards analysis was used. Of 597 patients, the median age was 42 (interquartile range 38 to 44) years, 85.1% were men and 8.4% were SMuRF-less. Patients who are SMuRF-less were >2 times more likely to have cardiac arrest (28.0% vs 12.6%, p = 0.003); require vasopressors (16.0% vs 6.8%, p = 0.018), mechanical support (10.0% vs 2.3%, p = 0.046), or intensive care admission (20.0% vs 5.7%, p <0.001); and have higher rate of left anterior descending artery infarcts than those with SMuRFs (62.0% vs 47.2%, p = 0.045). No significant differences in thrombolysis or percutaneous intervention were observed. Guideline-directed medical therapy at discharge was high (>90%), and not different in the SMuRF-less. 30-day mortality was almost fivefold higher in the SMuRF-less (hazard ratio 4.70, 95% confidence interval 1.66 to 13.35, p = 0.004), remaining significant at 1 and 2 years. In conclusion, young patients who are SMuRF-less have a higher 30-day mortality after STEMI than their counterparts with SMuRFs. This may be partially mediated by higher rates of cardiac arrest and left anterior descending artery territory events. These findings further highlight the need for improved prevention and management of SMuRF-less STEMI.
Journal Article
Pathophysiology, Diagnosis, and Management of the No-Reflow Phenomenon
2019
Successful reperfusion of an infarct-related coronary artery by primary percutaneous intervention or fibrinolysis during acute ST-elevation myocardial infarction (STEMI) does not always restore myocardial tissue perfusion, a phenomenon termed “no-reflow.” Herein we discuss the pathophysiology of this highly prevalent phenomenon and highlight the most salient aspects of its clinical diagnosis and management as well as the limitations of presently used methods. There is a great need for understanding the dynamic nature of no-reflow, as its occurrence is associated with poor cardiovascular outcomes. The no-reflow phenomenon may lend an explanation to the lack of further improvements in in-hospital mortality in STEMI patients despite decreases in door-to-balloon time. Hence, no-reflow potentially presents an important target for investigators interested in improving outcomes in STEMI.
Journal Article
Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial
by
Kessler, Thorsten
,
Rheude, Tobias
,
Xhepa, Erion
in
Angina pectoris
,
Balloon treatment
,
Calcification
2025
•The proportion of PCI for calcified CAD has increased over the years.•PCI for calcified CAD is associated with lower success rates and poor outcomes.•Intravascular lithotripsy could represent a breakthrough in this context.•Randomized trials investigating the clinical performance of IVL are not available.•ISAR-WAVE is the first randomized trial to address this unmet need.
Percutaneous coronary intervention of severely calcified lesions is limited by inadequate stent expansion and poor clinical outcomes. Over the past decade, several devices and techniques have been developed for calcium modification and lesion preparation. Intravascular lithotripsy (IVL) is a novel tool in this context. Although numerous observational studies have been reported on this technique, randomized trials powered for clinical outcomes on the relative merits of IVL in patients with severely calcified lesions are lacking.
The ISAR-WAVE trial is a multicenter, prospective, randomized, single-blind controlled trial. The aim is to test whether IVL is superior to other calcium-modifying techniques (modified or super high-pressure balloon and atheroablative devices) in de novo severely calcified coronary lesions. The study is planned to enroll 666 patients. The primary endpoint is the composite of major cardiac and cerebrovascular adverse events defined as death, nonfatal myocardial infarction, nonfatal stroke and clinically indicated target vessel revascularization at 12 months. In addition to the individual components of the primary endpoint, secondary endpoints include also safety, quality of life and cost-effectiveness measures.
ISAR-WAVE is a multicenter, randomized trial designed to test the hypothesis that a strategy of IVL confers superior clinical performance compared to other calcium-modifying techniques in patients undergoing percutaneous intervention for a de novo severely calcified coronary artery lesion.
ClilicalTrial.gov, NCT06369142.
Journal Article