Summary Background Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse ...cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. Methods In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25–3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm2 ), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov , number NCT02471586. Findings Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 35% to OCT, 146 32% to IVUS, and 146 32% to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 34% in the OCT group, 135 33% in the IVUS group, and 140 34% in the angiography group). The final median minimum stent area was 5·79 mm2 (IQR 4·54–7·34) with OCT guidance, 5·89 mm2 (4·67–7·80) with IVUS guidance, and 5·49 mm2 (4·39–6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI −0·70 mm2 ; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). Interpretation OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. Funding St Jude Medical.
Background
Transcatheter aortic valve replacement (TAVR) is the preferred option for high‐risk patients with severe aortic stenosis. The preferred access for TAVR is transfemoral (TF). Alternatives ...include the transapical (TA), trans‐subclavian (TS), and direct aortic (TAo) approaches.
Hypothesis
The TF approach is associated with lower in‐hospital outcomes as well as shorter length of stay and lower cost of hospitalization.
Methods
The National Inpatient Sample database from 2012 through 2014 was used to obtain the TAVR study population. International Classification of Diseases, 9th Revision, Clinical Modification procedure codes were utilized to identify the 2 groups. In‐hospital outcomes were compared in propensity‐score‐matched (1:3) cohorts, in which we took TA‐TAVR as a control.
Results
A total of 8210 (weighted N = 41 050) patients were identified. Of these, 1622 (weighted N = 8110) patients underwent TA‐TAVR and 6588 (weighted N = 32 940) patients underwent TF‐TAVR. In‐hospital mortality was lower with TF‐TAVR (4% vs 5.4%; P = 0.0355), along with a shorter length of stay (7.7 vs 9.7 days; P < 0.0001) and lower median hospitalization cost ($64 216 vs $74 735; P < 0.0001). Secondary outcomes of acute renal failure, transfusion, cardiogenic shock, and composite of all complications were lower with TF‐TAVR.
Conclusions
TF‐TAVR is safer and associated with lower in‐hospital outcomes compared with TA‐TAVR and should be the preferred approach. As TAVR is gaining popularity in intermediate‐ and low‐risk patients, we must not lose sight of the serious mortality and secondary outcomes associated with TA‐TAVR access.
Transcatheter aortic valve implantation (TAVI) is a rapidly emerging procedure for the treatment of intermediate and high-surgical-risk patients with severe aortic stenosis. The impact of gender on ...in-hospital outcomes has not been studied on a large scale. The aim of this study was to examine gender differences in in-hospital outcomes after TAVI. The National Inpatient Sample (2012 to 2014) using the International Classification of Diseases, 9th Revision, Clinical Modification procedure codes for TAVI (35.05 and 35.06) were used to form this database. Propensity score matching (1:1) was performed and in-hospital outcomes were compared. The primary outcome was in-hospital mortality. Statistical analysis was performed using SAS 9.4 (SAS Institute Inc., Cary, North Carolina). A total of 41,050 (weighted) patients were included in our study. Women accounted for 47.7% (n = 19,570) in our study and presented with older age (81.7 years vs 80.5 years, p ≤ 0.0001). The population was predominantly white (87.4%). After performing propensity score-matched analysis (1:1), no difference in the primary outcome was noted between men and women. The secondary outcomes including stroke, hemorrhage requiring transfusion, and pericardial complications were higher in women. The composite end point of death and stroke occurred more frequently in women than in men. Acute renal failure was higher in men. The post-TAVI length of stay was higher in women (8.3 days vs 7.7 days, p = 0.0007). In conclusion, this large, retrospective registry analysis of patients with severe aortic stenosis who underwent TAVI suggests women may experience higher rates of in-hospital morbidity compared with men.
Objective
To evaluate the impact of COVID‐19 pandemic migitation measures on of ST‐elevation myocardial infarction (STEMI) care.
Background
We previously reported a 38% decline in cardiac ...catheterization activations during the early phase of the COVID‐19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data.
Methods
Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019–February 2020 and March–April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC.
Results
Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18–38, p < .001), number of activations leading to angiography (34%, 95% CI: 12–50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11–27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (−0.2 to 44, p = .05).
Conclusions
The COVID‐19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI.
The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), is highly infectious, carries significant morbidity and mortality, and has rapidly resulted in strained health ...care system and hospital resources. In addition to patient‐related care concerns in infected individuals, focus must also relate to diminishing community spread, protection of staff, case selection, and concentration of resources. The current document based on available data and consensus opinion addresses appropriate catheterization laboratory preparedness for treating these patients, including procedure‐room readiness to minimize external contamination, safe donning and doffing of personal protective equipment (PPE) to eliminate risk to staff, and staffing algorithms to minimize exposure and maximize team availability. Case selection and management of both emergent and urgent procedures are discussed in detail, including procedures that may be safely deferred or performed bedside.
Objectives
To assess post‐procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention ...(PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS).
Background
Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized.
Methods
Thirty‐six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study.
Results
The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre‐PCI group (n = 20) and Post‐PCI group (n = 16). Non‐ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre‐PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan‐Meier 30‐day survival analysis showed very poor survival in Post‐PCI group (48.1% vs 12.5%, Log‐Rank P = 0.004).
Conclusions
Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days.
Background
Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). ...Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy.
Methods
A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end‐point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias.
Results
After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups.
Conclusion
In this non‐randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in‐hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.
Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, ...multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial.
Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were “PROTECT II-like” (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days.
Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048).
The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.
PDF
