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1.
EuroIntervention ; 20(2): e135-e145, 2024 Jan 15.
Article in English | MEDLINE | ID: mdl-38224254

ABSTRACT

BACKGROUND: There are limited data on the clinical characteristics and outcomes of patients who require prolonged mechanical circulatory support (MCS) after Impella-supported high-risk percutaneous coronary intervention (HR-PCI). AIMS: The aim of this study is to describe the contemporary clinical characteristics, outcomes, and predictors associated with prolonged MCS support after assisted HR-PCI. METHODS: Patients enrolled in the prospective, multicentre, clinical endpoint-adjudicated PROTECT III study who had undergone HR-PCI using Impella were evaluated. Patient and procedural characteristics and outcomes for those who received prolonged MCS beyond the duration of their index procedure were compared to those in whom MCS was successfully weaned and explanted at the conclusion of the index PCI. RESULTS: Among 1,155 patients who underwent HR-PCI with Impella between 2017 and 2020 and had sufficient data to confirm the duration of Impella support, 16.5% received prolonged MCS (mean duration 25.2±31.1 hours compared with 1.8±5.8 hours for those who only received intraprocedural MCS). Patients receiving prolonged support presented with more urgent indications (e.g., acute coronary syndromes [ACS], lower ejection fraction [EF], elevated baseline heart rate and lower systolic blood pressure). Use of the Impella CP, intraprocedural complications, periprocedural complications and in-hospital mortality were all more common amongst the prolonged MCS group. Prolonged MCS was associated with increased rates of major adverse cardiovascular and cerebrovascular events, cardiovascular death, and all-cause mortality at 90-day follow-up. CONCLUSIONS: Patients receiving prolonged MCS after Impella-supported HR-PCI presented with more ACS, reduced EF and less favourable haemodynamics. Additionally, they were more likely to experience intraprocedural and periprocedural complications as well as increased in-hospital and post-discharge mortality.


Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Aftercare , Prospective Studies , Patient Discharge
2.
Am Heart J ; 248: 139-149, 2022 06.
Article in English | MEDLINE | ID: mdl-35192839

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.


Subject(s)
Coronary Artery Disease , Myocardial Infarction , Percutaneous Coronary Intervention , Coronary Artery Disease/therapy , Humans , Prospective Studies , Treatment Outcome
4.
Catheter Cardiovasc Interv ; 97(1): 41-46, 2021 01 01.
Article in English | MEDLINE | ID: mdl-31930652

ABSTRACT

OBJECTIVE: The purpose of this study is to report on safety, short-term and long-term clinical efficacy following intracoronary brachytherapy (ICBT) for restenosis (ISR) in patients with drug eluting stents (DES). BACKGROUND: ICBT is an effective treatment for ISR of bare metal stents (BMS) but its utilization has waned due to the advent of DES. ISR following DES occurs at a frequency of 8% or greater. METHOD: A retrospective analysis was performed on patients treated on an institutional review board (IRB) approved protocol using ICBT for DES ISR between January 2011 and October 2016. All patients were followed for 24 months for procedural complications, mortality, clinical ISR/target lesion revascularization (TLR) and stroke. RESULTS: A total of 290 patients were identified with a mean age of 66.6 years. All of them had high rates of typical coronary artery disease risk factors. Our primary outcome, composite of in-hospital mortality, myocardial infarction (MI), safety outcomes and procedural failure was noted in 1(0.3%) patient who had a MI. No other secondary outcome was noted in-hospital. At 1-year follow up, 12.4% patients had ISR, 1.7% patients died, and 1 (0.3%) had ischemic stroke. At 2-year, 14.7% had ISR, and total 6 (2.1%) patients had MI. CONCLUSION: ICBT demonstrates excellent technical success rates for treatment, safety, and reasonable efficacy over 2-years to be free from recurrent clinical ISR. This study represents the largest ICBT data for DES ISR to date among very complex lesion subsets, however, more prospective data will be needed to determine the optimal patient for treatment.


Subject(s)
Brachytherapy , Coronary Restenosis , Drug-Eluting Stents , Brachytherapy/adverse effects , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Humans , Prospective Studies , Retrospective Studies , Risk Factors , Stents , Treatment Outcome
5.
Catheter Cardiovasc Interv ; 98(2): 217-222, 2021 08 01.
Article in English | MEDLINE | ID: mdl-32767652

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon, Coronary/statistics & numerical data , COVID-19/epidemiology , Percutaneous Coronary Intervention/statistics & numerical data , Registries , SARS-CoV-2 , ST Elevation Myocardial Infarction/epidemiology , Comorbidity , Female , Follow-Up Studies , Humans , Male , Pandemics , Retrospective Studies , ST Elevation Myocardial Infarction/surgery , Time Factors , United States/epidemiology
7.
Catheter Cardiovasc Interv ; 96(3): 586-597, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32212409

ABSTRACT

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.


Subject(s)
Cardiac Catheterization/statistics & numerical data , Coronary Angiography/statistics & numerical data , Coronavirus Infections/prevention & control , Cross Infection/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Practice Guidelines as Topic/standards , COVID-19 , Cardiac Catheterization/standards , Cardiology , Coronary Angiography/methods , Coronavirus Infections/epidemiology , Female , Hospital Mortality , Humans , Laboratories, Hospital , Leadership , Male , Mentors , Pandemics/statistics & numerical data , Personal Protective Equipment/statistics & numerical data , Pneumonia, Viral/epidemiology , Societies, Medical , Survival Analysis , United States
8.
J Interv Cardiol ; 2019: 9691753, 2019.
Article in English | MEDLINE | ID: mdl-31772553

ABSTRACT

OBJECTIVES: We sought to assess if ineligibility to coronary artery bypass grafting (CABG) constitutes a risk factor in patients who underwent a nonemergent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with prophylactic Impella® heart pump support. BACKGROUND: ULMCA PCI in patients not deemed eligible for CABG is associated with significantly worse outcomes compared to ULMCA PCI in eligible patients. METHODS: Patients from the cVAD Registry and the PROTECT II trial who underwent a nonemergent ULMCA PCI were identified. We compared in-hospital mortality and major adverse cardiac and cerebrovascular event (MACCE) rates as well as 30-day survival and MACCE rates between CABG ineligible and CABG eligible patients. RESULTS: A total of 331 patients were included (293 Impella 2.5®, 38 Impella CP®); 227 were ineligible for CABG and 104 were eligible. Baseline characteristics were remarkable for a trend toward higher rate of chronic obstructive pulmonary disease in the ineligible patients. In-hospital mortality (3.52% vs. 5.77%; p=0.383) and MACCE (6.61% vs. 7.69%; p=0.816) rates as well as 30-day survival (92.0% vs. 93.4%; Log-Rank p-value =0.781) and MACCE (88.1% vs. 90.1%; Log-Rank p-value=0.648) rates were not different between the two groups. CONCLUSIONS: The results of our study suggest that prophylactic Impella support appears to mitigate the risks inherent to surgical ineligibility in patients undergoing a nonemergent ULMCA PCI. Our results require further investigation.


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease/surgery , Coronary Vessels/surgery , Heart-Assist Devices , Percutaneous Coronary Intervention , Aged , Contraindications, Procedure , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Vessels/diagnostic imaging , Coronary Vessels/pathology , Eligibility Determination , Female , Hospital Mortality , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Registries/statistics & numerical data , Risk Factors , Treatment Outcome , United States
9.
Eur Heart J Acute Cardiovasc Care ; 8(4): 369-378, 2019 Jun.
Article in English | MEDLINE | ID: mdl-29308660

ABSTRACT

BACKGROUND: The interventional treatment of complex high-risk indicated patients is technically difficult and can result in poor outcomes. Thus, percutaneous left ventricular assist devices are being increasingly used to provide hemodynamic support. No data is available comparing male and female for Complex High-risk Indicated Patients treated with percutaneous left ventricular assist devices. Our goal was to evaluate in-hospital as well as short term outcomes comparing males and females. METHODS: There were 160 complex high-risk indicated patients with percutaneous left ventricular assist device use who were not in cardiogenic shock. A total of 132 male and 28 female patients were included. Ejection fraction below 35% with one additional criterion such as use of atherectomy device or treatment on unprotected left main disease or multi-vessel disease were our inclusion criteria. An Impella 2.5 or Impella CP (Abiomed Inc.) device was used as a left ventricular support device. RESULTS: There was no difference in in-hospital mortality between the genders after performing a propensity score matched analysis (8.3% vs. 12.5%, p=0.54). Secondary outcomes of myocardial infarction, cardiogenic shock, congestive heart failure, dysrhythmia, major adverse cardiac events and composite of all complications were higher in males. Furthermore, 30-day survival was similar in males and females (88.9% vs. 87.5%, p=0.31). In addition, worse complications rates and survival were noted in patients with incomplete revascularization compared with those patients with complete revascularization in both gender. CONCLUSION: This study demonstrated no gender difference in clinical outcomes when using percutaneous left ventricular assist device support for the treatment of complex high-risk indicated patients. Overall, males had higher secondary outcomes compared with females with no difference in in-hospital mortality or 30-day survival rates.


Subject(s)
Coronary Artery Disease/surgery , Heart-Assist Devices , Percutaneous Coronary Intervention/methods , Risk Assessment , Stroke Volume/physiology , Aged , Coronary Artery Disease/epidemiology , Coronary Artery Disease/physiopathology , Female , Follow-Up Studies , Hospital Mortality/trends , Humans , Incidence , Male , Prognosis , Retrospective Studies , Sex Distribution , Sex Factors , Survival Rate/trends , United States/epidemiology
10.
Circulation ; 139(3): 337-346, 2019 01 15.
Article in English | MEDLINE | ID: mdl-30586728

ABSTRACT

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.


Subject(s)
Anterior Wall Myocardial Infarction/therapy , Heart-Assist Devices , Myocardial Reperfusion/methods , Prosthesis Implantation/instrumentation , ST Elevation Myocardial Infarction/therapy , Ventricular Function, Left , Adult , Aged , Aged, 80 and over , Anterior Wall Myocardial Infarction/diagnostic imaging , Anterior Wall Myocardial Infarction/physiopathology , Cerebrovascular Disorders/etiology , Cerebrovascular Disorders/physiopathology , Cerebrovascular Disorders/prevention & control , Feasibility Studies , Female , Humans , Magnetic Resonance Imaging, Cine , Male , Middle Aged , Myocardial Reperfusion/adverse effects , Myocardial Reperfusion Injury/etiology , Myocardial Reperfusion Injury/physiopathology , Myocardial Reperfusion Injury/prevention & control , Pilot Projects , Prospective Studies , Prosthesis Implantation/adverse effects , Recovery of Function , Recurrence , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/physiopathology , Time Factors , Treatment Outcome , United States , Young Adult
12.
J Interv Cardiol ; 31(4): 478-485, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29707807

ABSTRACT

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.


Subject(s)
Atherectomy, Coronary , Atherectomy/adverse effects , Coronary Artery Disease , Coronary Vessels , Vascular Calcification , Aged , Atherectomy/methods , Atherectomy, Coronary/adverse effects , Atherectomy, Coronary/methods , Coronary Artery Disease/pathology , Coronary Artery Disease/surgery , Coronary Vessels/pathology , Coronary Vessels/surgery , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Reoperation/methods , Treatment Outcome , United States , Vascular Calcification/pathology , Vascular Calcification/surgery
13.
Clin Cardiol ; 41(3): 326-332, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29573452

ABSTRACT

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.


Subject(s)
Aortic Valve Stenosis/surgery , Cardiac Catheterization/methods , Propensity Score , Risk Assessment , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/mortality , Cause of Death/trends , Female , Femoral Artery , Hospital Mortality/trends , Humans , Male , Retrospective Studies , Risk Factors , Severity of Illness Index , Time Factors , United States/epidemiology
16.
J Interv Cardiol ; 30(3): 256-263, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28419573

ABSTRACT

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.


Subject(s)
Assisted Circulation , Heart-Assist Devices , Myocardial Infarction , Percutaneous Coronary Intervention , Shock, Cardiogenic , Aged , Assisted Circulation/adverse effects , Assisted Circulation/instrumentation , Assisted Circulation/methods , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Registries/statistics & numerical data , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality , Treatment Outcome , United States/epidemiology
17.
Lancet ; 388(10060): 2618-2628, 2016 11 26.
Article in English | MEDLINE | ID: mdl-27806900

ABSTRACT

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.


Subject(s)
Coronary Angiography/methods , Coronary Artery Disease/surgery , Drug-Eluting Stents , Tomography, Optical Coherence , Ultrasonography, Interventional/methods , Aged , Coronary Vessels/pathology , Female , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Treatment Outcome
18.
Curr Treat Options Cardiovasc Med ; 17(8): 393, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26154294

ABSTRACT

OPINION STATEMENT: The development of bare metal stent (BMS) was a major advancement over plain old balloon angioplasty (POBA) in the management of symptomatic coronary artery disease. BMS prevented restenosis by attenuating early arterial recoil and contraction; both seen commonly after POBA. However, the rate of clinically indicated target lesion repeat revascularization due to a process of in-stent restenosis (ISR) at 1 year remained relatively high (10 to 20 %), often due to excessive neointimal growth (Fischman et al. N Engl J Med. 331:496, 1994; Serruys et al. N Engl J Med. 331:489, 1994; Cutlip et al. J Am Coll Cardiol 40:2082, 2002). Stents with drug elution technology (DES) were developed to reduce the relatively high rate of ISR and subsequent repeat revascularization seen with BMS. Clinical trials have confirmed a reduction of as much as 50 to 70 % in target lesion revascularization by DES compared to BMS. These findings have led to the preferential use of DES in the majority of percutaneous coronary intervention (PCI). However, as DES require a longer period of dual antiplatelet therapy (DAPT) to prevent stent thrombosis, DES are not appropriate for all patients.

19.
Cardiovasc Revasc Med ; 16(5): 294-8, 2015.
Article in English | MEDLINE | ID: mdl-26054718

ABSTRACT

INTRODUCTION: Percutaneous endovascular revascularization requires fluoroscopic guidance and radiopaque contrast use. This approach becomes problematic, especially in patients with advanced renal disease or allergies to iodinated contrast medium. The direct (exposure) and indirect (lead garment) burden of radiation affects patients and operators alike. PURPOSE: We propose a completely contrast-free, fluoroscopy-free approach to endovascular diagnostic arterial imaging and percutaneous intervention using available technologies, and outline a timeframe for its implementation. PROJECT DESCRIPTION/METHODOLOGY: Ultrasound imaging of the leg creates a roadmap of the vessel and identifies the lesion of interest. Device-based sensors using a low-powered electromagnetic field allow for wiring of the vessel. This is followed by the use of intravascular ultrasonography and near infrared spectroscopy to characterize the lesion dimensions and composition. After completion of the diagnostic phase of the process, the interventional portion with deployment of an angioplasty balloon and/or stent is performed using the electromagnetic field-guided sensors. FEASIBILITY: The project uses already available technologies. BENEFITS/ANTICIPATED OUTCOMES: This project demonstrates the real potential of performing endovascular peripheral intervention without fluoroscopy or contrast in a practical, user-friendly way with the currently available technology. The prospects in renal function preservation and radiation avoidance for both patients and operators are extremely attractive.


Subject(s)
Angioplasty, Balloon , Endovascular Procedures , Fluoroscopy , Peripheral Vascular Diseases/diagnosis , Stents , Angioplasty, Balloon/methods , Contrast Media , Endovascular Procedures/methods , Fluoroscopy/methods , Humans , Ultrasonography, Interventional/methods
20.
Am J Emerg Med ; 26(6): 716-20, 2008 Jul.
Article in English | MEDLINE | ID: mdl-18606329

ABSTRACT

T-wave inversions produced by myocardial infarction (MI) are classically narrow and symmetric. Electrocardiography T-wave changes including low-amplitude and abnormally inverted T waves may be the result of noncardiac path physiology. We present a series of cases that presented with different electrocardiography T-wave changes. The first case involved a 64-year-old woman who presented to the emergency department with diffuse splayed T-wave inversions and was found to have an MI in the context of an acute cerebrovascular accident. We contrasted this case with that of a 76-year-old man with hypercholesterolemia who presented with T-wave widening and a prolonged QT interval and was found to have a subarachnoid hemorrhage secondary to a basilar aneurysm and no MI. Several mechanisms have been suggested to explain the cardiac and cerebral injury, including microvascular spasm and increased levels of circulating catecholamines. Accurate interpretation of T-wave changes can assist the clinician toward a timely therapeutic intervention and accurate diagnosis.


Subject(s)
Electrocardiography , Intracranial Aneurysm/complications , Myocardial Infarction/etiology , Stroke/complications , Subarachnoid Hemorrhage/complications , Acute Disease , Aged , Basilar Artery , Female , Humans , Intracranial Aneurysm/diagnosis , Male , Middle Aged , Myocardial Infarction/diagnosis , Stroke/diagnosis , Subarachnoid Hemorrhage/diagnosis
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