Clinical, paraclinical and recovery outlook for outpatient coronary angioplasty
Imane Oughazzou (imane dot oughazzou90 at gmail dot com), Fatima Ezzahra Amakha, Dounia Benzeroual, Mustapha El Hattaoui
Cardiology Department, Mohammed VI University Hospital Center, Marrakech, Morocco
DOI
//dx.doi.org/10.13070/rs.en.5.2667
Date
2018-11-17
Cite as
Research 2018;5:2667
License
Abstract

Same-day discharge after Percutaneous Coronary Intervention is an underutilized strategy due to concerns about the risk of hemorrhage and vascular injury. It does, however, represent an advantageous approach for the benefit of the patient and hospital staff; and for improved management of medical resources. Objective of the study: We seek to describe the clinical, paraclinical and recovery benefits for patients undergoing outpatient coronary angioplasty. Patients and methods: This study observed 100 cases with stable coronary artery disease with known coronary anatomy over the course of one year; these patients were admitted to the cardiology department at Mohammed VI University Hospital Center at Marrakech for outpatient coronary angioplasty. Results: The average age was 58.5±23.5 years. The sex ratio was 1.38 M:F. Coronarography was performed in 100% of these cases. Single-vessel damage was present in 44% of cases, two vessels in 32%, and three vessels in 24%. The ejection fraction (EF) for the left ventricle was preserved in 72% of cases. Outpatient angioplasty was performed for all 100 patients. Vascular access was obtained via the radial approach in 73% of cases. Drugs eluting stents (DES) were used in 90% of cases. The success of angioplasty was noted in all percutaneous coronary interventions (PCI). The average length-of-stay following PCI was 330 minutes ± 90min. Following the procedure, six of the patients had persistent chest pain and 6% developed hematoma at the puncture site. No serious clinical events were reported within 24 hours. For medium-term follow-up, recurrence of angina was observed in 6% of cases. Bruising and hematoma was noted at the access site in 16% and 18% respectively without thrombocytopenia. Conclusions: Outpatient coronary angioplasty is safe and less expensive than conventional angioplasty.

Introduction

Coronary artery disease is one of the most common cardiovascular diseases with immediate and long-term implications for patient health depending on clinical and at-home approaches for treatment. Coronary angioplasty was performed for the first time in 1977 by Andreas Gruentzig, who dilated the narrowed vessel with a balloon. The instrument was introduced and inflated in direct contact with stenosis of the anterior interventricular artery.

This major therapeutic revolution completely transformed the treatment coronary disease and the prognosis for affected individuals [1, 2]. The birth of the stent in 1990 and the drug-coated stent in 2000 dramatically advanced the scope and efficacy of coronary angioplasty. These advances allowed patients an outpatient angioplasty or same-day discharge.

The first outpatient angioplasty (ATL) pilot study was conducted in 1994. In the age of balloon angioplasty and at a time when the concept of outpatient coronary angiography was emerging, Laarman et al. [3] suggested that an outpatient angioplasty strategy could be safely performed in highly selected patients. The publication of two large randomized studies, the EASY study 2006 and the 2007 EPOS study [4], has given rise to a renewed interest in outpatient angioplasty, motivated in particular by economic considerations.

Methodology

This observational study was conducted in the cardiology department of the Mohammed VI University Hospital of Marrakech between March 2017 and March 2018. This project observed 100 patients with stable coronary artery disease with known coronary anatomy, admitted for coronary angioplasty on an outpatient basis. Case collection utilized coronarography and angioplasty intake and patient reports and phone interviews. Our patients were contacted by phone 24 hours after their release and interviewed during consultation on the 15th day and the 30th day post procedure. The objective of our work is to assess the feasibility of outpatient angioplasty as well as to describe the clinical, para-clinical and post-operative recovery trajectories of these cases.

Results

The average age of our patients was 58.5 ± 23.5 years, ranging from 35 to 82 years. The majority (47%) ranged between 56 and 65 years. Male predominance was noted (58%) with a sex ratio of 1.38. The majority of our patients were covered by the RAMED system numbering 87, 6 were mutualists and 7 patients were without social coverage. Of these patients, 52% were hypertensive, 31% were active smokers, 25% had dyslipidemia, 52% were overweight, 27% were obese. Diabetes was present in 53% of cases. 19% of patients had a ST segment elevation coronary syndrome in their antecedents and 2% a ST-segment free coronary syndrome. Angina chest pain was reported in the history of 43% of cases. A total of 91% of our patients consulted for chest pain and 5% for dyspnea. All patients had stable angina.

Of the 100, 53 patients had a normal ECG and of the remaining 47, 37% had a negative T wave or ST segment shift, and 10 patients had a necrosis Q wave. A lesion of the anterior interventricular artery was found in 43% of cases, right coronary in 26% of cases, and circumflex in 18% of cases. The results showed single ventricular involvement in 44 patients, bitroncular involvement in 32% of cases, and tritrocular lesion in 24% of cases. Regarding the types of lesion, this study showed a type B lesion in 76 patients, type C in 21 patients, and type A in 3 patients. All patients underwent transthoracic echocardiography before coronary angiography and angioplasty. Of these, 72 patients had left ventricular EF preserved. Angioplasty was performed in all patients with an indication of post-procedure ambulatory status. In cases with significant truncal lesions, 62% involved the anterior interventricular artery, 27% were in the right coronary artery, 13% were located in the circumflex artery, 7% occurred the marginal artery, and 1% were identified in the diagonal artery. The surgical approach was radial in 73% of cases and femoral in 27% of cases. Procedural medication administered in our patients was: unfractionated heparin, clopidogrel, aspirin, and intravenous nitrate derivatives. Drugs eluting stents were used in 90% of cases and bare stents constituted 10% of cases. The catheters used were 84% size 6 French and 16% were 5 French. Angioplasty was performed with direct stenting in 49% of cases and predilatation was performed in the remaining 51 patients. The average stent length was 15 ± 5 mm. The reference diameter was 3 mm in 75%; 2.5 mm in 11%; 3.5 mm in 7%; 2.75 mm in 6%, and 2 mm in 1%. Angioplasty successfully resolved stenosis in all 100 patients.

The average stay after angioplasty was 330 min ± 90 min (5 hours 30 min ± 90 min).

In our cohort, the post-angioplasty medical treatment included the clopidogrel ( 75 mg of Plavix daily) for 12 months. Additionally, aspirin (75-100 mg daily), statins, beta blockers, and angiotensin converting enzyme inhibitors were prescribed for life, especially if left ventricle dysfunction had been identified in the patient.

As for after the procedure, 15 patients required hospitalization in the hours following the intervention for the following reasons:

  • Persistence of chest pain in 6 patients (6%).
  • Complicated angioplasty of hematoma in 6 patients (6%).
  • Difficult outpatient surveillance in 3 patients for blood pressure peaks (3%).

The remaining 85 patients returned home the day of their surgery, after a maximum of 4 to 7 hours of inpatient surveillance.

The persistence of chest pain in 6 patients (6%), palpitations in 11 patients, and hematoma at the puncture site in 6 patients constitute the entirety of complications reported in the first 24 hours post-procedure. No serious clinical events were reported: no death, no cardiac arrest, and no major bleeding or severe thrombocytopenia. The recovery of patients in the outpatient group (n = 85) from day 15 to day 24 was marked by the appearance of pain in 5 patients (6%), palpitations in 6 patients (7%) , bruising and hematoma at the puncture site in 14 patients (16%) and 15 patients (18%) respectively without thrombocytopenia. The recovery of outpatients (n = 85) during day 16 to day 30 was marked by the recurrence of palpitations in 9 patients (11%), and 22 patients experienced chest pain. Additionally, 7% of cases (6 patients) had complications one month after their angioplasty:

  • One stroke in one patient (1.16%).
  • Heart failure in 2 patients (2.34%).
  • Myocardial infarction occurred in 3 patients (3.5%).

No cases of intrastent thrombosis, major bleeding, or death were noted.

Health and dietary measures have been recommended to our patients to improve their lifestyle and control or reduce the risk of future cardiovascular disease. In this study we emphasized the importance of rigorous adherence to treatment. All patients reported fastidious compliance with prescribed treatment, including Plavix.

Discussion

According to the latest international studies, the incidence of angina has decreased over time in many countries. This is coincident with the decline in cardiovascular mortality observed in the MONICA study [5, 6]. The emergence of these phenomena can be explained by an increase in the life expectancy of angina patients and improvement in the management of the disease. The annual mortality rate for coronary artery disease was 2% in the SAPAT study, it decreased to 1.1% in the APSIS study, the ACTION study cited 1.5%, the rate was 2.4% in the BARI 2D study and the IONA study reported 3% [7, 8].

In Morocco, the prevalence of coronary disease remains at the forefront of public health concerns. The morbidity for cardiovascular disease remains high. Indeed, once the positive diagnosis is made, immediate action must be taken to avoid complications and sometimes fatal outcome.

The average age in some studies is similar to that of our series, which was 58.5 ± 23.5 years. A male predominance is found in all cohorts with a sex ratio M:F ranging from 3.09 to 6.7 according to the work of Mehul Patel [9] and A.A.Ziakas [10]. As for this series, the sex ratio M:F was 1.38.

In this series, an ischemic cardiovascular history is found in 21% of cases. This number is consistent and unremarkable when compared with 45.1% in FADC, 2000 [11], 18% according to USIK 1995 [12-14], 18% according to the USIC 2000 register [12, 13], 30% according to the OSCAR register [15], and 10% % according to Ferrier et al [16]. Chest pain is the reason for initial consultation in 91% of our patients, consistent with 93.4% in the RICA 2000 study [11], and 94% according to OSCAR [15].

Normal ECGs accounted for 53% of intake ECGs, which seems disparate when compared to 13.8% according to the OSCAR registry [15]. This is explained by the stable nature of coronary heart disease in this study. In this series, 37% of the cases had a negative T wave or an ST-segment shift, and 10% had a Q wave, this is likely an indication of previously undiagnosed or undetected myocardial necrosis.

In our study, segmental kinetic disorders were detected in 36% of cases, of which 32% were represented by hypokinesia, and 4% by akinesia. In this work, the left ventricular EF was preserved in 72% of cases, compared to 54% for the 2000 ICUIS [12, 13] and 56% for the Benfadila H. study [17].

Clinical, paraclinical and recovery outlook for outpatient coronary angioplasty figure 1
Figure 1. Typical coronarography (OAD 84°): note the long subocclusive stenosis of the right coronary artery at the level of the 2nd segment.

The purpose of coronary angiography is to assess defects in vascularization and related coronary abnormalities. This procedure improves the ability of physicians to prescribe the most effective remedies. By diagnostic criteria, stenosis is significant when there is a relative change in endoluminal diameter of more than 50% (Figure 1).

The systematic analysis of the images must specify:The importance and topography of the lesions, their proximal or distal site, their number, their diffusion, and the quality of the downstream network [18, 19].

  • Collaterality of vascular tissue.
  • The distribution of homo- and contralateral anastomoses.
  • Myocardial perfusion.

These lesions are classified into 3 types: A, B and C according to ACC / AHA classification of coronary lesions. (Table I)

Our results showed a predominance of single-ventricular disease in 44% of cases; this is consistent with A.A. Ziakas and Klinke [10] in 84.5% of cases, and in 42.7% for Ferrier et al. [16]. A predominance of type B lesions is found in all series according to the work of Mehul Patel, et al. [9], A.A. Ziakas and Klinke [10]. As for this series, type B injury accounted for 76% of cases.

Type A lesions  Type B lesions (B1 : ≤ 1 criteria, B2 : > 2 criteria)       Type C lesions
Discrete <10mm
Concentric
Contours smooth
Little or no calcification
No accessibility problem
Angulation <45°
Not occlusive
Not ostial in location
No thrombus
No bifurcation
Tubular-Intermediate (10 to 20 mm)
Eccentric
Irregular contours
Calcifications moderate to heavy
Moderate tortuosity of the proximal segment
Moderate angulation between 45° and 90°
Total occlusion < 3 months old
Ostial location
Presence of some thrombosis
Bifurcation requiring double guidewires
Diffuse > 20 mm
Moderate tortuosities of the proximate segment
Extreme angulation > 90°
Total occlusion > 3 months
Inability to protect a major bifurcation
Degenerated vein graft with friable lesions
Success rate is high with angioplasty
Low risk
Success rate is average with angioplasty
Moderate risk
Low angioplasty success rate
High risk
Table 1. ACC / AHA classification of coronary lesion [20].

The therapeutic approaches are grouped into three categories:

  • Pharmacological treatment: Therapeutic decision tree of stable coronary disease according to ESC recommendations.
  • Coronary angioplasty.
  • Therapeutic education and control of cardiovascular risk factors.

We promote the adoption of first-line lifestyle modifications as the optimal treatment for the correction of risk factors in most low-symptomatic patients (CCS1 and 2) and reserve angioplasty for those with more severe symptoms (CCS3 and 4) and/or with signs of ischemia. A young patient wishing to maintain a recommended level of physical activity and adopt a healthy diet will be more likely to experience revascularization [21].

Clinical, paraclinical and recovery outlook for outpatient coronary angioplasty figure 2
Figure 2. The path of approach.

The arterial introducer is used to prepare the arterial approach and facilitate the passage of guides and catheters (Figure 2). Catheters are very thin flexible tubes sliding on metal guidewires during the approach phases, then allowing the passage of products and the handling of tools or implantable materials during the procedure. They include radio-opaque marks to help locate them angiographically. The diameters are expressed in French (F): 1 French = 1/3 mm. Most angioplasty can now be performed with new generation 6F catheters. The 5F guide catheter development addresses the concern of reducing the risk of vascular complications by reducing the size of the arterial puncture.

In this study, the catheters used were primarily size 6 French (84%) and the remainder (16%) consisted of size 5 French. The work of Refat Jabara [22] and of Mehul Patel [9] showed the prevalence of catheters measuring 6 French in 98% and 98.4% respectively.

The guidewire serves to facilitate the routing and advancement of catheters into the arterial network and to the injection site. Once the target area is reached, the guide is removed, leaving the catheter in place. The stent [23] is a tiny expandable tube made of medical-grade stainless steel or cobalt alloy. It is used to restore blood circulation in case of insufficient flow in the coronary artery. The stent effectively corrects occluded arteries by maintaining the shape and integrity of the arterial wall. It significantly reduces the elastic recoil of the arterial wall encountered in 30% of cases at six months following coronary angioplasty.

Clinical, paraclinical and recovery outlook for outpatient coronary angioplasty figure 3
Figure 3. Balloon angioplasty and stent placement simplified in 4 steps.

Percutaneous transluminal coronary angioplasty (Figure 3) is a method of restoring normal flow in coronary arteries that are narrowed by atherosclerotic lesions. The application of angioplasty for patients with stable angina pectoris is recommended, in addition to pharmaceutical treatment. The femoral or radial artery is punctured to insert a tube introducer and guidewires that will facilitate the introduction of the angioplasty tools into the artery. The radial approach has significantly reduced the local complications of angioplasty and is safer because it reduces the risk of hematoma at the puncture site. It also offers the possibility of an immediate lifting of the patient. In this series, the approach was radial in 73% of cases. Against 97.5% according to Juan G [24], 100% according to Corvoisier et al. 2013 [25] and 7% according to Shailesh Khatri et al. 2002 [26].

Since 2002, pharmaco-active stents are available. They are coated with an antiproliferative substance, which is released from the stent into the treated arterial wall during the first month after implantation. This procedure significantly reduced the rate of relapse for coronary stenosis from 25% to 7% as assessed by angiography.

In this series, 90 of our patients underwent implantation of drugs eluting stents. At the French national level, this approach constituted 45% of cases in 2008 [27] similar to the work of Puymirat et al. at the Georges-Pompidou European Hospital, where the percentage of active stents implanted was 35% [28], and 49.3% in the study of Arnaud Chaumeil [29].

According to Arnaud Chaumeil [29] and the 2017 study by Juan G [24], the anterior interventricular artery was the most commonly involved vessel in 47.8% and 54% respectively, compared with 62% in our population.

When the result of the angioplasty is judged satisfactory by the operator, the tube introducer is removed immediately in the catheterization room. Manual compression at the puncture point is performed. Then, a compression bandage is applied to the arterial puncture site to prevent bleeding.

Upon discharge, the following medications are prescribed to all our patients unless contraindicated,

  • Long-term aspirin at a dose of 75 to 100 mg per day.
  • Clopidogrel at a dose of 75 mg daily for 12 months in combination with aspirin.
  • Long-term beta-blockers starting immediately post-procedure if any cardiac dysfunction, rhythm dysfunction, or indications of heart failure is present.
  • Long-term statins to control the lipid balance starting 3 months post-procedure.
  • Life-long inhibitor conversion enzyme.

Therapeutic education programs are often coupled with cardiovascular rehabilitation via recommended changes in exercise routine and diet. They pursue the following objectives:

  • Educate the patient about coronary disease.
  • Explain the use of drug treatments (benefits and risks) to the patient.
  • Inform the patient about course of action in case of occurrence of an acute event.
  • Inform and motivate the patient about controlling risk factors
  • In the context of diabetes control, the DIGAMI study [30] has shown that three months of insulin therapy post-procedure reduces total mortality in the first year by 30% [31], in NIDDM.
  • Educate on the importance of maintaining blood pressure values below 140/90 mmHg for non-diabetic patients and 130/80 mmHg in patients with diabetes or chronic renal failure. Physical activity and weight loss play an important role in long term recovery and survival [32].

The success of angioplasty can be assessed by angiographic, surgical and clinical criteria [21].

The angiographic success of the stent corresponds to obtaining a result defined by a reduction in stenosis of at least 20% relative to a normal coronary flow (TIMI3 grade).

Operative success corresponds to an optimal angiographic result without clinical complications.

Short- and long-term clinical success requires the absence of a major complication in the hospital and during the outpatient surveillance period. The main cause of long-term clinical failure is restenosis, which is not considered a complication but rather an excessive physiological response associated with initial vascular trauma.

In the literature, the success rate is higher for type A and B1 lesions than for type B2 and type C lesions. For monotruncular stenosis, this rate is currently 90 to 95%. In this study, the success rate of angioplasty was 100%, similar to that of the study ''COURAGE'' which boasted a rate of 93%. The rate is dependent on the training of the team practicing the angioplasty and the severity of the lesions.

The rate of major haemorrhagic complications in this cohort at the puncture site after discharge was nil and minor haemorrhages were noted in 6% of cases (6 patients), which is remarkable when compared to 0.5 to 2% of cases in the Slagboom, et al. [33]. The rate of ischemic events in the first 24 hours was also lower; stent thrombosis occurred in only 1 out of 375 (0.3%) patients in the Slagboom, et al. [33] series, requiring an emergency redux angioplasty. In this series we noted no ischemic events immediately after angioplasty. Refat Jabara [22] and Juan G [24] also did not report the following:

  • Death, infarction, or new angioplasty within 24 hours of discharge
  • Major complications, as defined by the recommendations of the Academic Research Consortium (ARC)
  • IDM with or without Q wave
  • Stent thrombosis
  • Need for repeated revascularization of the target vessel guided or not
  • Need for repeated revascularization of another ischemic vessel
  • Major bleeding
  • Stroke: transient ischemic attack or ischemic/hemorrhagic stroke
  • Renal insufficiency caused by the contrast medium
  • Complications of vascular access requiring surgical treatment or involving major bleeding

Minor complications were those related to vascular access which required no admission or treatment.

The first outpatient angioplasty study reported by Kiemeneij et al. [34] clearly demonstrated the safety of same-day discharge after transradial PCI. This was followed by a study of 922 patients reported by Koch et al. [35], who showed that 4 hours surveillance was sufficient and safe for a same-day discharge after angioplasty. However, the latter was a highly selective study limited to those using 6F catheters and using stents in only 20% of cases.

The study by Juan G [24], published in 2017 is a multicenter Spanish study of 723 randomized patients. Of these, 533 patients (73.7%) were discharged after an interval ranging from 4 to 12 hours monitoring post transradial angioplasty for stable coronary artery disease affecting one or more vessels. A group of 190 patients (26.3%) were hospitalized for clinical instability post procedure. All patients received antiplatelet therapy combining at least aspirin and clopidogrel. Within 24 hours after angioplasty, detection of a major event in one patient (i.e. 0.19%) that required hospitalization for a decrease in hemoglobin due to rectal bleeding. On day 30, three major events (0.57%): subacute thrombosis of the stent, revascularization of another ischemic vessel, and stroke. Eight patients (1.5%) required rehospitalization on day 30.

This study has shown that outpatient angioplasty by radial approach in selected patients is a safe and feasible strategy.

Regarding the recovery after one month, installation of a myocardial inferction in 3.5% of cases, heart failure noted in two patients (2.34%), and a single case of stroke (1.16%). In addition to the high success rate, the after angioplasty event rate is low and the mortality rate is nil comparable to other series of outpatient angioplasty. So the main conclusion from this series is that outpatient angioplasty is an effective and low risk technique.

These results are consistent with data from the literature since Juan G [24], Muhel Patel [9], and other authors have significantly demonstrated the feasibility and safety of outpatient angioplasty, whatever the pathway. first (radial or femoral). The potential benefits of outpatient angioplasty:

  • Increasing the availability of beds, staff and other hospital resources.
  • Improving patient satisfaction by de-dramatization of procedures.
  • Heightening the quality and safety of care by reducing the incidence of nosocomial diseases.
  • Reducing the cost of the procedure.
  • Improving care for secondary prevention: consulting a nutritionist and including the explanation of the need for a double platelet anti-aggregation by the doctor during the after procedure monitoring period.

The main factors limiting the general acceptance of outpatient coronary angioplasty are the risk of stent thrombosis and complications at the point of puncture which have more serious consequences in case of occurrence in the home.

The adoption of the radial pathway for coronarography and angioplasty has been extensive, thanks to the miniaturization and improved reliability of angioplasty equipment. In comparison with the femoral approach, the radial approach has significantly reduced the frequency of bleeding and vascular complications at the puncture site [36]. In addition, it has been shown that radial angioplasty improves patient comfort and significantly reduces average length of stay and thus hospital costs [36].

Conclusion

Outpatient coronary angioplasty remains an unconventional approach to treatment due to concerns about the risk of post-procedural complications; however, the advantages of coronary angioplasty as an outpatient procedure are the reduction of the length of stay, the reduction of hospital costs, improved availability of hospital resources, increased availability of staff, and the reduction of the risk for nosocomial infections.

Declarations

All authors declare no conflict of interest.

This article is edited for English by Dr. Christie Taylor in New Hampshire, USA.

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