Need For Crossover Research Articles

Short-Acting Oral Nifedipine versus Intravenous Labetalol for the Control of Severe Hypertension in the Postpartum Period: A Retrospective Cohort Study.

This study aimed to compare the effectiveness of oral short-acting (SA) nifedipine with intravenous (IV) labetalol for the treatment of postpartum (PP) severe hypertension. We conducted a retrospective cohort study of women who delivered at a tertiary care facility between January and December 2018, had not previously received antihypertensive medication, and required treatment for PP severe hypertension defined as systolic blood pressure (SBP) ≥ 160 mm Hg and/or diastolic blood pressure (DBP) ≥110 mm Hg. Exposure groups were defined by the receipt of either oral SA nifedipine or IV labetalol. The primary outcome was time (minutes) to BP control (SBP < 160 mm Hg and DBP <110 mm Hg). Secondary outcomes included number of doses required to achieve BP control, crossover to the alternative medication, and recurrence of severe range BP after the achievement of BP control. t-Tests and Wilcoxon-Mann-Whitney tests were used to analyze continuous variables and chi-square tests or Fisher's exact tests were used to analyze categorical variables. Multivariable linear regression models were conducted for the primary outcome, controlling for potential confounders in a sequential fashion across three models. A Kaplan-Meier plot was also created. Of the 99 women included, 74 received oral SA nifedipine and 25 received IV labetalol. There was no significant difference in minutes to initial BP control between groups (30.5 minutes [interquartile range, IQR: 20.0-45.0] vs. 25.0 minutes [IQR: 14.0-50.0]; p = 0.82) or in the rate of recurrent severe BP. However, patients who received nifedipine required fewer doses to achieve control (p < 0.01) and did not require crossover (0 vs. 12%, p = 0.01). Both oral SA nifedipine and IV labetalol are effective options for treating PP severe hypertension. An initial choice of nifedipine was associated with a lower requirement for subsequent doses of medication and no need for crossover to an alternative antihypertensive medication. · Nifedipine and labetalol effectively treat PP severe HTN.. · Nifedipine requires fewer doses to treat PP severe HTN.. · Both have low recurrence rates of severe HTN..

Comparison of Success Rates of Different Methods of Ultrasound-Guided Radial Artery Cannulation (Short-Axis and Long-Axis Methods) Against the Traditional Palpatory Method: A Prospective Randomized Study.

ObjectiveRecent meta-analysis comparing the success rates of various methods of arterial cannulation in adult patients found heterogeneity in the available data. Hence, we did this study to evaluate and compare the success rate of palpatory method with that of ultrasound guided methods of radial artery cannulation. The aim is to compare the first-attempt success rate of the palpatory method with that of ultrasound-guided radial artery cannulation techniques, namely, the short-axis out-of-plane and the long-axis in-plane methods.MethodsThis is a prospective, randomized, parallel-arm study. Ninety patients aged from 18 to 50 years (presenting for various surgeries requiring radial artery cannulation for invasive blood pressure monitoring or frequent arterial blood gas analysis) were divided into 3 groups. Each group had one of the 3 techniques of radial arterial cannulation, namely palpatory, short-axis ultrasound method, and long-axis ultrasound method. The parameters analyzed were first-attempt success rate, number of attempts needed, cannulation time, need for crossover of technique, and incidence of complications. Multivariate analysis was done with one-way ANOVA, with Tukey's post hoc test. For categorical data, the chi-square test was used. The probability value of .05 was considered as a significant level.ResultsThe first-attempt success rate was 76.7% in the long-axis method, 86.7% in the short-axis method, and 56.7% in the palpatory method. The short-axis method has been shown to have a shorter cannulation time, fewer attempts needed for successful cannulation, and lower need for crossover of techniques when the first 2 attempts fail.Conclusions: We conclude that the ultrasound-guided short-axis method of radial artery cannulation is associated with higher first-attempt success rate compared to the traditional palpatory method.

Safety of duplex ultrasound-assisted transulnar versus transradial arterial access for invasive coronary procedures: A search for safe alternative access

Background: Transulnar approach (TUA) was comparable to the transradial approach (TRA) in terms of efficacy and safety in the presence of extensive operator experience in the TUA. Without adequate experience, there was an increase in time, and number of punctures, to successful access. Objectives: The aim of the study was to compare the in-hospital safety of duplex ultrasound (DUS) assisted TUA to those of DUS-assisted TRA. Methods: All patients had preprocedural DUS assessment. Patients who needed urgent procedures (e.g., ST-elevation myocardial infarction) or had a history of upper extremity arterial disease were excluded. The patients were randomized into TUA or TRA arms. The primary endpoint was a composite of in-hospital vascular access complications (bleeding, limb ischemia, local pain, spasm, and need for crossover). The timing to successful puncture, total number of punctures, total procedural time, fluoroscopy time, amount of contrast, and radiation dose were compared between the two arms as well. Results: A total of 104 patients were randomized into TUA (n = 50) or TRA (n = 54) arms. There was no statistically significant difference between both arms in terms of the primary endpoint (TUA vs. TRA: 37.5% vs. 28.6% respectively, P = 0.33). Apart from an increase in the incidence of access site pain (28% vs. 7%, respectively, P = 0.006), there was no statistically significant difference between the two approaches in terms of time to successful access, number of punctures, total procedural time, fluoroscopy time, or contrast and radiation doses. There was no clinically detectable limb ischemia in both arms on 30-day follow-up. Conclusions: This study demonstrated that there was no difference in safety between DUS-assisted TRA and TUA. In the presence of DUS, TUA becomes a viable alternative arterial access even with the lack of previous TUA experience. More prolonged follow-up is needed to exclude late subclinical events related to the TUA.

P6522Overcoming anatomic challenges to transradial access in STEMI patients

Abstract Background Transradial access is associated with fewer access-related complications, earlier discharge and lower mortality, being the preferred route to perform coronary angiogram and interventions due to its safety and cost effectiveness in STEMI patients. However, the radial artery is smaller, more superficial and thinner than the femoral artery and a percentage of patients ranging from 14% to 27% have a radial artery that is smaller than a 6-French introducer, which sometimes makes angioplasty difficult. Purpose This study reports our initial experience with the 5F straight (STR) flush catheter, which can be used as a “child” type rapid exchange catheter inside the 6F guiding catheter, creating a distal tip transition, facilitating angioplasty in transradial coronary interventions when the radial artery is small, tortuous or as severe spasm that impedes advancement of guiding catheter after successful angiography with 5F catheter. Methods We analysed, retrospectively, 1510 STEMI patients (pts) admitted in our catheterization laboratory, from August of 2010 to October 2017. Of these patients, 95 (6.3%) pts with problems in advancing a 6F guiding catheter, were submitted to this technique and a direct crossover to a femoral approach was performed in 36 pts (2.4%). This technique consists in the use of longer 5F STR flush catheter in order to overcome the larger distal tip of the 6F guiding catheter through the radial access, employing a 5-in-6 F technique. Results In 89 of 95 patients (93.7%), this new technique was successful, with a mean reperfusion time since arrival to the catheterization laboratory of 24.5±9.9 minutes. Of the pts submitted to this technique the majority were female 51 (57.3%) and the mean age was 67±14.3 years. Angioplasties were performed in the left main (2; 2.3%), left anterior descending (36; 40.4%), left circumflex artery (8; 9.0%), right coronary artery (40; 44.9%), right posterior descending artery (1; 1.1%) and obtuse marginal branch (2; 2.3%). No complications in arterial access were seen. Throughout these years of study, the need for crossover to femoral approach has decreased with the learning of this technique. The time until reperfusion since catheterization laboratory arrival was 29.3±9.5 minutes when there was a crossover, being statistically higher than with the radial procedure with the STR technique (p&lt;0.017). Conclusion This new technique may be a simple and useful approach to perform primary PCI through transradial access in patients with small diameter radial arteries, allowing a reduction of crossover to femoral access, which translates into a lower risk of vascular complications and shorter reperfusion time, that may influence the prognosis of STEMI patients.

Comment

We congratulate the authors on their comments on innovative approaches to drug development that fall out of the traditional mold and may result in more quickly bringing safe and effective treatments to patients. Changes in the overall clinical development approach are most relevant to “breakthrough” therapies, which have generally yielded exceptional efficacy data in early clinical studies, motivating exploration of accelerated development and regulatory approaches, as well as a potential ethical need for crossover upon progression in randomized controlled studies (Horning et al.). As is clear from the article, it will be important to develop an understanding of what works well and where the pitfalls in new approaches are. We comment briefly on the four topics mentioned by the authors, combining comments on items 2 and 3: (1) nonproportional hazards, (2) interpretability of extended Phase I trials, (3) single-arm trials as a basis for approval, and (4) recent innovations in trial design.

TCT-424 Intraprocedural Ultrasound Evaluation of Both Radial and Ulnar Arteries and its Implication to Improve Success of Arterial Access from the Wrist: Anatomical Evaluation of a Consecutive Series of 566 Patients Undergoing Cardiac Catheterization and/or Percutaneous Coronary Intervention

Palpation-guided radial artery access is increasing as the primary access site for cardiac catheterization and/or intervention. However, the need for crossover to secondary access from the femoral artery was reported in up to 7.6%. The value of ultrasound to improve primary access from the wrist

Modified Veress needle decompression of tension pneumothorax

The current prehospital standard of care using a large bore intravenous catheter for tension pneumothorax (tPTX) decompression is associated with a high failure rate. We developed a modified Veress needle (mVN) for this condition. The purpose of this study was to evaluate the effectiveness and safety of the mVN as compared with a 14-gauge needle thoracostomy (NT) in a swine tPTX model. tPTX was created in 16 adult swine via thoracic CO2 insufflation to 15 mm Hg. After tension physiology was achieved, defined as a 50% reduction of cardiac output, the swine were randomized to undergo either mVN or NT decompression. Failure to restore 80% baseline systolic blood pressure within 5 minutes resulted in crossover to the alternate device. The success rate of each device, death, and need for crossover were analyzed using χ. Forty-three tension events were created in 16 swine (24 mVN, 19 NT) at 15 mm Hg of intrathoracic pressure with a mean CO2 volume of 3.8 L. tPTX resulted in a 48% decline of systolic blood pressure from baseline and 73% decline of cardiac output, and 42% had equalization of central venous pressure with pulmonary capillary wedge pressure. All tension events randomized to mVN were successfully rescued within a mean (SD) of 70 (86) seconds. NT resulted in four successful decompressions (21%) within a mean (SD) of 157 (96) seconds. Four swine (21%) died within 5 minutes of NT decompression. The persistent tension events where the swine survived past 5 minutes (11 of 19 NTs) underwent crossover mVN decompression, yielding 100% rescue. Neither the mVN nor the NT was associated with inadvertent injuries to the viscera. Thoracic insufflation produced a reliable and highly reproducible model of tPTX. The mVN is vastly superior to NT for effective and safe tPTX decompression and physiologic recovery. Further research should be invested in the mVN for device refinement and replacement of NT in the field.

El uso del acceso radial en la angioplastia primaria: resultados en 1.029 pacientes consecutivos y análisis en subgrupos desfavorables

Introduction and objectivesThe transradial approach is associated with a reduction in vascular access-related complications after primary percutaneous coronary interventions. The purpose of this study was to examine the feasibility of the routine use of transradial access in primary angioplasty and to evaluate how it affects subgroups with less favorable characteristics. MethodsWe analyzed 1029 consecutive patients with an ST-segment elevation acute coronary syndrome treated with primary angioplasty. ResultsTransradial access was the primary approach in 93.1% of the patients. The success rate of primary angioplasty was 95.9%, and 87.6% of the patients were event-free 30 days after the procedure. Crossover was required in 3.0% of the patients with primary transradial access, and this rate remained stable over the years. Predictors of the need for crossover were age older than 75 years (odds ratio=2.50, 95% confidence interval, 1.09–5.71; P=.03) and a history of ischemic heart disease (odds ratio=2.65; 95% confidence interval, 1.12–6.24; P=.02). Primary transfemoral access use was higher in women older than 75 years. Use of the transradial approach in this subgroup did not affect reperfusion time or the success of angioplasty, although there was a greater need for crossover (10.9% vs 2.6%; P=.006). Among patients in cardiogenic shock, the transradial approach was used in 51.5%; reperfusion times and angioplasty success rates were similar to those obtained with transfemoral access, but there was a greater need for crossover. ConclusionsTransradial access can be used safely and effectively in most primary angioplasty procedures. In older women and in patients in cardiogenic shock, there is a higher crossover requirement, with no detriment to reperfusion time.Full English text available from:www.revespcardiol.org/en

Use of the Radial Approach in Primary Angioplasty: Results in 1029 Consecutive Patients and Analyses in Unfavorable Subgroups

Introduction and objectivesThe transradial approach is associated with a reduction in vascular access-related complications after primary percutaneous coronary interventions. The purpose of this study was to examine the feasibility of the routine use of transradial access in primary angioplasty and to evaluate how it affects subgroups with less favorable characteristics. MethodsWe analyzed 1029 consecutive patients with an ST-segment elevation acute coronary syndrome treated with primary angioplasty. ResultsTransradial access was the primary approach in 93.1% of the patients. The success rate of primary angioplasty was 95.9%, and 87.6% of the patients were event-free 30 days after the procedure. Crossover was required in 3.0% of the patients with primary transradial access, and this rate remained stable over the years. Predictors of the need for crossover were age older than 75 years (odds ratio=2.50, 95% confidence interval, 1.09–5.71; P=.03) and a history of ischemic heart disease (odds ratio=2.65; 95% confidence interval, 1.12–6.24; P=.02). Primary transfemoral access use was higher in women older than 75 years. Use of the transradial approach in this subgroup did not affect reperfusion time or the success of angioplasty, although there was a greater need for crossover (10.9% vs 2.6%; P=.006). Among patients in cardiogenic shock, the transradial approach was used in 51.5%; reperfusion times and angioplasty success rates were similar to those obtained with transfemoral access, but there was a greater need for crossover. ConclusionsTransradial access can be used safely and effectively in most primary angioplasty procedures. In older women and in patients in cardiogenic shock, there is a higher crossover requirement, with no detriment to reperfusion time.

Influence and Critique of the INSTEAD Trial (TEVAR Versus Medical Treatment for Uncomplicated Type B Aortic Dissection)

Endovascular stent-grafting represents a novel nonsurgical therapeutic concept for type B aortic dissection in both the acute and subacute/chronic settings with unknown impact on outcomes. In a prospective trial, 140 patients with clinically stable type B dissection were randomly subjected to elective stent-graft placement in addition to optimal medical therapy (n = 72) or to optimal medical therapy (n = 68) with surveillance (arterial pressure according to World Health Organization guidelines, ≤120/80 mm Hg) and recurrent computed tomography imaging. Primary endpoint was 2-year all-cause mortality, while aorta-related mortality, progression of disease (with need for crossover to stent-graft or additional endovascular or open surgery), and aortic remodeling were secondary endpoints. There was no difference in all-cause mortality at 2 years, with cumulative survival of 95.6% ± 2.5% with optimal medical therapy versus 88.9% ± 3.7% with thoracic endovascular aortic repair (TEVAR) (P = .15). Considering, however, that only 40% of the expected events occurred within 2 years (based on registry data), the trial turned out to be underpowered for all-cause mortality. Moreover, aorta-related mortality was also not different (P = .44) within the first 2 years of follow-up, and risk for the combined endpoints of aorta-related death (rupture) and progression (including conversion or additional endovascular or open surgery) was similar (P = .65); three neurological adverse events occurred in the TEVAR group (one paraplegia, one stroke, and one transient paraparesis) versus one paraparesis with medical treatment. Finally, and as expected, aortic remodeling (with true lumen recovery and thoracic false lumen thrombosis) occurred in 91.3% with TEVAR, but only in 19.4%with medical treatment alone (P < .001), suggestive of continued remodeling with TEVAR and failure of medical treatment to induce remodeling and healing of dissection. In conclusion, the data in the INSTEAD (Investigation of Stentgrafts in Aortic Dissection) trial show that in the setting of clinically stable, so-called uncomplicated type B aortic dissection, elective stent-graft placement on top of optimized medical management fails to improve survival and adverse events within an observation period of 2 years, despite favorable aortic remodeling.

Routine use of the transradial approach in primary percutaneous coronary intervention: procedural aspects and outcomes in 2209 patients treated in a single high-volume centre

ObjectiveTo examine the feasibility of a routine transradial approach (TRA) in primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI).DesignA single-centre observational study with prospective data collection.SettingA...

Radiofrequency ablation of left-sided accessory pathways: Transaortic versus transseptal approach

The aim of this study was to compare the efficacy of transaortic ( n = 54) and transseptal ( n = 28) techniques during radiofrequency (RF) ablation of left accessory pathways ( n = 75) in both left posteroseptal and free-wall locations in 73 consecutive patients (mean age 32 ± 15 years). The transseptal approach included transseptal puncture and use of a retained long sheath in the left atrium ( n = 24) or direct insertion of the mapping/ablation catheter via a patent foramen ovale ( n = 4). Transseptal RF ablation was used as the primary method in 23 patients or at a separate session after the transaortic RF ablation failed in 5 patients. Transaortic RF ablation was used as primary method in 50 patients and after failed transseptal ablation in 4 patients. Transaortic ablation was successful in 47 (87%) of 54 procedures, transseptal ablation in 24 (86%) of 28 procedures, with total RF ablation success in 70 (96%) of 73 patients. The transseptal puncture/long sheath method was successful in 23 (96%) of 24 patients. This latter technique resulted in more stable positioning and easier manipulation of the ablation catheter. Switching from transseptal puncture/long sheath to transaortic technique was needed in 1 of 24 patients, from transseptal/patent foramen ovale approach to the transaortic route in 3 of 4 patients, and from the transaortic to the transseptal approach at a separate session in 5 patients. The age of patients and number of RF lesions were similar in the two groups. Fluoroscopy time was lower for the transseptal group (81 ± 57 vs 121 ± 81 min; p < 0.05). All complications (1 tamponade/3 vascular) occurred in the transaortic group. Recurrences over a period of 13 ± 9 months included 5 (11%) in the transaortic and 1 (4%) in the transseptal group. We conclude that, although the transaortic and transseptal methods appear to be complementary, the transseptal puncture/long sheath technique offers advantages that include high success rate, less need for crossover to the transaortic technique, shorter radiation exposure, and a lower complication rate.