Frequency of percutaneous coronary interventions at facilities without on-site cardiac surgical backup--a report from the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR)

The practice of performing percutaneous coronary intervention (PCI) in centers without on-site cardiac surgical backup is controversial. Using data from facilities that participated in the American College of Cardiology/National Cardiovascular Data Registry, the incidence of PCI without on-site surgical backup was evaluated. From January 1, 2001 through December 31, 2004, 39 of 449 (8.7%) centers were identified as sites that performed PCI without on-site surgical backup. By the end of 2005, 75 of 463 (16%) participating facilities were performing PCI without on-site backup. By using standardized data element definitions, it was possible to differentiate between patients who underwent elective PCI and those who had urgent nonelective PCI for acute ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction. This analysis showed that the number of elective and nonelective PCI procedures with or without on-site surgical backup per quarter had increased significantly (p <0.0001) from 2001 to 2004. The number of PCI procedures performed without on-site surgical backup continued to increase in 2005. In conclusion, the significant increase in elective PCIs performed at facilities without on-site surgical backup occurred despite national guidelines that state elective PCI should not be done in centers without on-site cardiac surgery.     

Elective and primary angioplasty at hospitals without on-site surgery versus with on-site surgery: results from a national registry

INTRODUCTION: Current European clinical guidelines do not restrict interventional cardiology at centers without on-site surgical backup, but disagreement still exists whether hospitals with cardiac catheterization laboratories, but without on-site cardiac surgery, should develop percutaneous coronary intervention (PCI) programs. Technical improvements in equipment and pharmacologic adjunctive therapy have increased the safety margins of diagnostic and therapeutic cardiac catheterization and more than half of the patients treated by PCI in Portugal are treated at hospitals without on-site cardiac surgery. OBJECTIVES: We set out to compare clinical outcomes of elective and primary PCI for ST-segment elevation myocardial infarction at centers without on-site cardiac surgery with those at centers with on-site cardiac surgery. METHODS: Based on the Portuguese Registry of Interventional Cardiology, we retrospectively reviewed a total of 13,235 PCI procedures performed from January 2002 to June 2006 and compared the results for 7,112 patients treated at hospitals without on-site cardiac surgery with 6,123 patients treated at hospitals with on-site cardiac surgery. RESULTS: Demographic data were similar, with a mean age of 64 (55-72) vs. 63 (54-71) years, 75% vs. 76% male and 25.0% vs. 24.2% with diabetes respectively at centers without and with on-site surgical backup. Hospital mortality at centers without and with on-site surgical backup respectively was: chronic angina: 0.3% vs. 0.3% (NS); acute coronary syndromes: 1.5% vs. 1.0% (NS); acute myocardial infarction with ST elevation and without cardiogenic shock: 4.0% vs. 5.0% (NS); cardiogenic shock: 50.9% vs. 53.4% (NS). CONCLUSIONS: Similar clinical outcomes for interventional cardiology were achieved at hospitals without on-site cardiac surgery and those with on-site cardiac surgery. In the era of coronary stents, adjunctive therapy and experienced operators, elective and primary PCI can safely be performed without on-site surgical backup.     

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial

ObjectivesThe aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundTRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging.MethodsFORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications.ResultsBetween 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose.COnclusionsTRA was noninferior to TFA for CTO PCI but had fewer access-site complications.     

Outcomes of Transradial Approach to Percutaneous Coronary Intervention in End-Stage Renal Disease Patients on Dialysis

BackgroundPercutaneous coronary intervention (PCI) is increasingly performed in patients with chronic kidney disease (CKD), including in end-stage renal disease (ESRD), however studies on vascular access are limited.ObjectiveWe sought to describe vascular access choice and outcomes of PCI from transfemoral (TFA) compared to transradial access (TRA) in ESRD patients on dialysis.MethodsPatients with ESRD on dialysis undergoing PCI from October 2010 to January 2017 at two hospitals in a health system reporting to the National Cardiovascular Data Registry (NCDR) CathPCI registry as well as their respective electronic medical records (Epic) were analyzed. Baseline characteristics, procedural and in-hospital outcomes were compared according to access site, TFA versus TRA.ResultsThere were 270 patients with ESRD on dialysis who underwent PCI, 234 via the TFA and 36 via the TRA. Mean age of the patients was 67 and 67.4% were male. The TFA patients had a lower body-mass-index (BMI) (P < 0.001) and were more likely to have prior coronary artery bypass graft (CABG) (P < 0.001) and PCI of the left main coronary artery (LM) (P = 0.04). Access site cross over only occurred in one patient in each group. Bleeding within 72 h was seen in 3.8% of the TFA group and in 2.8% of the TRA group (P = 0.75).ConclusionUse of TRA is uncommon in patients with ESRD on dialysis, but is feasible and associated with low complication rates, similar to TF.Summary for the annotated table of contentsWhile PCI is being increasingly performed in patients with end-stage renal disease, there are is a lack of data on vascular access for this group. This study shows that while a transradial approach TRA is less common than transfemoral (TFA), it is still a feasible option and is associated with low complications similar to TFA.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention

ObjectivesThe aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site–related bleeding or vascular complications.BackgroundThe femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.MethodsAn international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site–related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.ResultsThe primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.ConclusionsIn patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752)     

Percutaneous transluminal coronary angioplasty without on-site surgical facilities.

Percutaneous transluminal coronary angioplasty (PTCA) is associated with a low risk of serious complications, the most important of which is acute coronary occlusion needing emergency surgery. There is a consensus among many cardiologists and cardiac surgeons that all PTCA procedures need on-site surgical backup. A task force report on PTCA by the American College of Cardiology/American Heart Association mandates the presence of an on-site cardiovascular surgical team. Since 1981, we have performed PTCA without the benefit of on-site surgery but with backup surgery provided at a regional cardiac surgical center located 6 kilometers away. Up to the end of 1991, 762 patients have undergone 847 PTCAs. Most patients had 1-vessel angioplasty (94.6%). The primary success rate since 1981 was 76%, and from January 1990 to December 1991 it was 87% (n = 313). Complications included death in 7 patients (0.9%), myocardial infarction in 16 (2.1%) and emergency surgery in 12 (1.6%). Surgical backup was provided on a next available operating room basis. The average time from decision to transfer to onset of surgery was 164 minutes (range 75 to 320). All patients survived surgery, but 42% developed a new Q-wave myocardial infarction. These patients were followed up until the end of 1991, and are all alive. The results are similar to those reported from centers with and without on-site surgery. With careful selection of patients and a formal, coordinated plan for backup surgery, PTCA can be safely performed without on-site surgery.     

Impact of vascular approach (transradial vs. transfemoral) on the efficacy of thrombus aspiration in acute myocardial infarction patients

BackgroundManual thrombus aspiration improves the efficacy of percutaneous coronary interventions (PCIs) in ST-elevation acute myocardial infarction (STEMI). The transradial approach (TRA) is an emerging vascular approach for PCI but is associated with specific technical requirements. As data on the combination of thrombus aspiration and TRA are scarce, we sought to assess the feasibility of TRA manual thrombus aspiration in STEMI patients.MethodsAll consecutive patients treated with manual thrombectomy for acute STEMI in three Italian hospitals were considered. Patients were divided according to the vascular approach into two groups: TRA and transfemoral (TFA). Two primary end points were defined: thrombectomy feasibility (ability to cross the occlusion with the device) and thrombectomy efficacy (absolute thrombus score reduction after device crossing).ResultsFrom January 2008 to December 2009, 303 patients were included: 151 patients (63±13 years) were treated through TFA, and 152 patients (61±12 years, P=.25) were treated through TRA. There were no significant differences in thrombectomy feasibility (75% in the TRA compared to 74.8% in the TFA group, P=.97) or in thrombectomy efficacy (2.6±.8 for TRA and 2.9±2 for TFA, P=.15). In both groups, there was a significant reduction in thrombus score after manual thrombus aspiration. Angiographically evident distal embolization after device crossing was low and observed in seven cases (5%) either for TFA and TRA (P=.99).ConclusionsThe present study suggests that, in the setting of acute STEMI, manual thrombus aspiration through TRA is feasible, and its efficacy is comparable to the TFA.     

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Stenosis: A Systematic Review and Meta-Analysis

IntroductionPCI of ULMS is frequently performed through TFA because of technical complexity and safety concern. Studies have shown comparable efficacy and safety of TRA versus TFA, however, these studies are few in number. We intended to compare the clinical outcomes between transradial access (TRA) and transfemoral access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis (ULMS) by performing a meta-analysis.MethodA systematic search of database, including, PubMed, Web of Science, Google scholar and Cochrane Database were performed by two independent reviewers. Studies were included comparing “TRA” versus “TFA” in patients undergoing PCI in ULMS. The primary outcome was a procedural success rate. Secondary outcomes were major bleeding, access site complications, in-hospital and long term: major adverse cardiac events (MACE), myocardial infarction (MI) and cardiovascular mortality.ResultsEight studies were included in the analysis. The procedural success rate was 97.3% and there was no statistically significant difference between TRA and TFA groups (OR, 1.41 [CI 0.64, 3.12], I² = 26%). The rates of access site complications (OR, 0.17 [CI 0.07, 0.41], I² = 16%), major bleeding (OR, 0.39 [CI 0.17, 0.86], I² = 0%) and all-cause mortality (OR, 0.28 [CI 0.12, 0.64], I² = 0%) were lower in the TRA group. There were no significant differences in in-hospital and long term cardiovascular mortality, MI and MACE between the two groups.ConclusionIn contrast to TFA, TRA is associated with reduced bleeding and access site complications, with similar procedural success rate in patients undergoing PCI of ULMS.     

Radial vs Femoral Access in ACS Patients Undergoing Complex PCI Is Associated With Consistent Bleeding Benefit and No Excess of Risks

BackgroundThe comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear.MethodsAmong 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)—Access trial, 5233 underwent noncomplex (TRA: n = 2590; TFA: n = 2643) and 1491 complex (TRA: n = 777; TFA: n = 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days.ResultsRates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (P_int = 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR 0.18, 95% CI 0.05-0.63) and noncomplex (HR 0.41, 95% CI 0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) owing to their higher absolute risk.ConclusionsAmong ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.     

Transradial access in a cath lab with moderate procedural volume: a single operator's experience

AIM: The transradial access (TRA) for cardiovascular interventions has become increasingly popular and was shown to be effective in many clinical settings, including acute coronary syndromes. Despite offering many advantages, such as a striking reduction in access site complications, the penetration of TRA in routine practice is still low. One reason for this could be that many studies about TRA were performed in high-volume centers by expert operators, making their results not fully applicable to the real world. In order to assess the efficacy of TRA, we retrospectively reviewed the caseload of a single operator working in a community hospital with moderate procedural volume. METHODS: We considered 873 consecutive procedures, of which 406 percutaneous coronary interventions (PCI), performed by a single operator (S.R.) who had previously completed the learning curve in TRA at a high volume center. RESULTS: TRA was selected in 48.3% of patients, transfemoral approach (TFA) in 50.9% and transbrachial approach in 0.8%. TFA was used more frequently in PCI (62.5% vs 37.5%; P<0.001), largely because it was the access of choice in primary PCI. The overall procedural success rate was 94% in TRA and 98% in TFA (P=0.035); access failure was more frequent in TRA (5.9% vs 1.1%; P<0.001), whereas an increased rate of access-related vascular complications was observed in TFA as compared to TRA (1.1% vs 0%; P=0.029). CONCLUSION: After an adequate training period, the overall performance of TRA is good even in moderate-volume hospitals. Despite reducing access site complications, TRA is limited by a slightly higher rate of procedural failure as compared to TFA.     

Outcomes following elective percutaneous coronary intervention without on-site surgical backup in a community hospital

Despite guidelines to the contrary, limited numbers of elective percutaneous coronary intervention (PCI) procedures without on-site surgical backup are being performed, particularly in Europe and Canada. In the United States, many hospitals are considering establishing on-site surgical programs, in part to facilitate PCI. At a hospital with only off-site surgical backup, 562 elective PCI procedures were performed on 489 consecutive patients. Of these, 551 (98.0%) were successfully completed without major in-hospital complications; 5 patients (1.0%) had in-hospital complications, and 4 (0.8%) were urgently transferred. It is concluded that elective PCI with off-site surgical backup is feasible and safe for selected patients under specific conditions.     

Is percutaneous coronary intervention of unprotected left main coronary artery via transradial approach feasible for skilled transfemoral operators? Initial experience in an unselected population

BackgroundThe feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population.MethodsWe collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes.ResultsFrom January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p = 0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p = 0.008) and had a higher left ventricular ejection fraction (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p = 0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p = 0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p = 0.48). At a follow-up of 32 ± 13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p = 0.28).ConclusionsThe PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.     

Safety and feasibility of transradial coronary intervention in Chinese elderly patients

Objective To assess the feasibility and safety of transradial approach in Chinese elderly patients undergoing coronary intervention. Methods In this prospective study, 764 elderly patients with coronary artery disease received percutaneous coronary intervention via either a transradial approach (TRA group) or a transfemoral approach (TFA group). The procedural success rate, success rate of artery access, puncture time, fluoroscopy time, dose of contrast, local complications and post-procedural pulmonary embolism were recorded and compared between 2 groups. Results There was no significant difference of the procedural success rate between the TRA group and the TRF group (96.3% vs. 98.2%, P>0.05); there were also no differences of success rate of cannulation, mean fluoroscopy time and mean dose of contrast between the 2 groups. The mean puncture time was longer in the TRA group than in the TFA group (3.8±2.1 min vs. 2.0±3.4 min, P<0.05). However, there were fewer access site-related complications in the TRA group than in the TFA group. Post- procedural pulmonary embolism occurred in 2 patients in the TFA group but none in the TRA group. Conclusion Transradial coronary intervention was feasible and safe in most Chinese elderly patients when performed by experienced operators.     

Rationale for on-site cardiac surgery for primary angioplasty: a time for reappraisal

Since the early 1990s, with significant improvement in the procedural success of percutaneous coronary interventions (PCIs), there has been a concomitant reduction in the need for emergency coronary artery bypass graft surgery. This review article focuses on the need for on-site cardiac surgery in patients with acute myocardial infarction undergoing primary angioplasty at centers without on-site cardiac surgical backup. It gives an overview of the need for emergency bypass surgery in both the large trial setting and the community hospital setting. Special consideration is also given to the risks and benefits of primary angioplasty compared with thrombolytic therapy, transfer to an institution with an on-site cardiac surgical facility compared with primary PCI, the frequency and indications for emergency cardiac surgery related and unrelated to primary angioplasty and the requirements for primary angioplasty that must be met in hospitals without the capability of on-site cardiac surgery.     

Coronary stenting in diabetics: six months clinical and angiographic outcome

The aim of this study was to assess the clinical and angiographic outcome of coronary stenting in diabetics as compared to non-diabetic patients. A total of 114 patients undergoing coronary angioplasty with stenting were prospectively evaluated. There were 30 diabetic (group A) and 84 non-diabetic (group B) patients. There were no significant differences in both the groups with respect to other risk factors and clinical characteristics. Both the groups were also comparable in terms of lesion morphology and stent types. The clinical endpoints were recurrent angina, reinfarction, cardiac death and need for target vessel revascularisation. The angiographic endpoint was angiographic restenosis at six months. There were 70 males and 44 female patients with a mean age of 55 +/- 12 years. Angiographic follow-up was completed in 85 (74.7%) patients which included 25 (83.3%) patients in group A and 60 (71.4%) in group B. Among clinical events at 30 days, the incidence of recurrent angina was 10.0 percent versus 8.3 percent (group A and B; p = NS) and incidence of reinfarction was 6.6 percent versus 5.9 percent (group A and B; p = NS), respectively. At six months, recurrent angina was seen in 16.6 percent versus 15.4 percent (p = NS) and reinfarction was seen in 10.0 percent versus 8.3 percent (p = NS) in group A and B, respectively. There were no deaths in either group. The angiographic restenosis rate was significantly higher in diabetics compared to non-diabetics (40.0% vs 23.3%; p = 0.02). The need for target vessel revascularisation was higher in diabetics as compared to non-diabetics (16.0% vs 6.6%; p = 0.03). We conclude that in spite of using coronary stents, the diabetics have higher restenosis rate and higher target vessel revascularisation rate than the non-diabetic patients.     

A comparison of transradial and transfemoral approaches for primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients in a high volume percutaneous coronary intervention center

Background Large percutaneous coronary intervention （PCI） centers have shown statistically better prognosis with transradial approach （TRA） compared with transfemoral approach （TFA）. So we tried to compare the outcomes between TRA and TFA in one high volume PCI center in ST-segment elevation myocardial infarction （STEMI） patients undergoing primary PCI. Method Six hundred and sixty two STEMI patients who underwent primary PCI with stents implantation were retrospectively included from June 1, 2006 to April 30, 2011 in our hospital and prospectively followed for one year. The primary endpoint was defined as in-hospital net adverse clinical events （NACE） which included death, myocardial infarction （MI）, stroke, target vessel revascularization （TVR） and major bleeding. The secondary endpoint was defined as 1 year major adverse cardiovascular events （MACE） which included death, MI and TVR. Results The occurrence rates of NACE （8.0% vs. 17.0%, P = 0.0018）, access site complications （4.0% vs. 10.7% P = 0.0027） and access site-related major bleeding （2.4% vs. 6.3%, P = 0.0254） were all higher in the TFA group than in the TRA group. The incidence rate of 1 year MACE was similar between TRA and TFA （8.5% vs. 13.2%, P = 0.0932）. The inverse probabilities weighting matched multivariable Cox regression analysis showed TRA was an independent predictor of lower rates of in-hospital NACE （HR： 0.58, 95% CI： 0.34-0.99, P = 0.0477）, in-hospital death （HR： 0.31, 95% CI： 0.10-0.73, P = 0.0499） and access site complications （HR： 0.37, 95% CI： 0.19-0.73, P = 0.0040）. Conclusions TRA showed great efficacy and safety for STEMI patients undergoing primar-y PCI in high volume PCI centers. It should be recommended as routine practice in future, and especially in those patients with high risk of bleeding.     

Operator learning curve for transradial percutaneous coronary interventions: implications for the initiation of a transradial access program in contemporary US practice

ObjectivesOur study aimed to assess the characteristics and outcomes of transfemoral approach (TFA) versus the initial steps of a transradial approach (TRA) program and to assess the learning curve of TRA in contemporary, US practice.BackgroundWhen compared to TFA, TRA has been shown to lower bleeding and vascular complications during percutaneous coronary intervention (PCI). However, use of TRA is still low. There are limited data regarding the characteristics of TRA learning curve, especially in an era with designated TRA equipment.MethodsConsecutive patients undergoing PCI in a single US center were divided into two cohorts according to vascular access approach: the last 250 TFA patients prior to the establishment of a TRA program and the initial 239 TRA patients following the establishment of a TRA program. Subgroup analysis of the TRA group, which was divided into five sequential case groups of 50 cases per group, was performed in order to assess TRA learning curve.ResultsOverall, the baseline characteristics of TFA vs. TRA groups were comparable. Fluoroscopy time was significantly longer during TRA procedures (18 ± 11 vs. 15 ± 8 min, respectively, p = 0.002); however, contrast use was lower during TRA procedures (161 ± 72 vs. 180 ± 63 ml, respectively, p = 0.002). In-hospital outcomes were similar between the two groups, with low frequencies of mortality, myocardial infarction, and stent thrombosis. Subanalysis of TRA group for learning curve assessment showed no major differences in patient demographics among the five subgroups. In the initial cases, more PCI was performed among non-acute cases (62% in patients 1–50 vs. 8–27% in patients 51–239, p < 0.001). Despite these differences, characteristics of the treated vessels were similar between groups. There was no significant change in fluoroscopy time or in the amount of iodinated contrast volume delivered. Similarly, no differences in procedural, in-hospital, and long-term outcomes were documented.ConclusionsAdopting TRA as a default is feasible for high-volume operators without significant learning curve effects.     

Comparison of radial versus femoral access using hemostatic devices following percutaneous coronary intervention

Arterial access site complications are the important predictor of successful percutaneous coronary interventions (PCI). We prospectively studied 722 consecutive PCI patients for access site complications. A total of 303 trans-femoral access (TFA) patients who had suture based vascular closure devices (VCD) were compared with 419 transradial access (TRA) patients. Incidence of hematoma was more in TFA (2.3% vs 0.23%, p 0.01). Median ambulation time (4 h vs 1 h, p < 0.01) was significantly higher in TFA. In conclusion, TRA had fewer access site complications like haematoma, compared to TFA with VCD. TRA also resulted in earlier ambulation and discharge, compared to TFA with VCD.     

Outcomes in Diabetic Patients Undergoing Orbital Atherectomy System

Objectives

We evaluated the angiographic and clinical outcomes of orbital atherectomy to treat severely calcified coronary lesions in diabetic and non‐diabetic patients.

Background

Diabetics have increased risk for death, myocardial infarction, and target vessel revascularization after percutaneous coronary intervention. Severely calcified coronary lesions are associated with increased cardiac events. Orbital atherectomy facilitates stent delivery and optimizes stent expansion by modifying severely calcified plaque. Outcomes in diabetic patients who undergo orbital atherectomy have not been reported.

Methods

Our retrospective multicenter registry included 458 consecutive real‐world patients with severely calcified coronary arteries who underwent orbital atherectomy. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events at 30 days.

Results

Diabetics represented 42.1% (193/458) of the entire cohort. The primary endpoint was similar in diabetics and non‐diabetics (1.0% vs. 3.0%%, P = 0.20), as were 30‐day rates of death (0.5% vs. 1.9%, P = 0.41), myocardial infarction (0.5% vs. 1.5%, P = 0.40), target vessel revascularization (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P > 0.9). Angiographic complications and stent thrombosis rate were low and did not differ between the 2 groups.

Conclusion

Diabetics represented a sizeable portion of patients who underwent orbital atherectomy. Diabetics who had severely calcified coronary arteries and underwent orbital atherectomy had low event rates that were similar to non‐diabetics. Orbital atherectomy appears to be a viable treatment strategy for diabetic patients. Randomized trials with longer‐term follow‐up are needed to determine the ideal treatment strategy for diabetics.