On-site Surgical Backup Research Articles

SCAI Expert Consensus Statement on Percutaneous Coronary Intervention Without On-Site Surgical Backup.

Although once considered high-risk and below the standard of care, percutaneous coronary intervention (PCI) without on-site surgical backup has been performed with acceptable outcomes since the 1980s.1 An initial consensus document on PCI without surgery on site (no-SOS) was published by Society for Cardiovascular Angiography & Interventions (SCAI) in 2007 and updated in 2014.2,3 The 2014 document summarized new literature, reviewed existing guidelines and other publications related to PCI with no-SOS, and recommended best practices and requirements for facilities performing PCI with no-SOS.

Early experience with coronary debulking devices in a newcomer facility after introducing revised facility criteria in Japan.

Coronary debulking devices are essential in obtaining optimal results in percutaneous coronary intervention (PCI) for severely calcified lesions. However, since the introduction of these devices in Japan, the presence of full-time cardiovascular surgeons in their own facilities has been an essential condition (on-site surgical back-up) as the facility criteria for their use. The criteria were revised in April 2020, making their implementation possible at our hospital. Between May 2020 and January 2022, we administered PCIs using rotational atherectomy (RA) for 33 lesions in 28 patients and orbital atherectomy system (OAS) for 36 lesions in 27 patients. The most preferred strategy in our hospital is OAS via the distal radial approach using a 6Fr Glide sheath or RA via the femoral approach using a 7Fr sheath. The percentages of usable imaging modality as an initial device without lesion modification were 57.1 and 66.7% in the RA and OAS groups, respectively. In the RA procedure, 1.5- and 2.0-mm Rota burrs were more frequently adopted for the initial and second sessions, respectively. In the OAS procedure, the debulking was always initiated at a low speed. Nineteen of the 27 patients underwent additional high-speed debulking. Pre-procedural quantitative coronary angiographic analysis revealed that the minimal lumen diameter was significantly smaller in the RA than in the OAS group. Debulking procedures were successful in all patients excluding two instances of procedure-related complications in the RA group, one of which was coronary perforation safely treated via covered stent deployment without any resulting hemodynamic instability. Our early experience with coronary debulking devices with off-site surgical back-up clearly reveals the safety and feasibility of this procedure in a newcomer facility.

English

BACKGROUND Primary percutaneous coronary intervention is one of the treatment options for STelevation myocardial infarction and is relatively safer and superior to thrombolytic therapy. The decrease in time to reperfusion leads to decreased infarct size and hence incidence of major adverse cardiac events (MACE). This knowledge has led to the concept of off-site percutaneous coronary intervention centres (without surgical backup). However, performing primary percutaneous coronary intervention at centres without surgical backup has been controversial. Controversy arises regarding the safety and efficacy of primary percutaneous coronary intervention in centres without onsite surgical backup. No such studies have been available among Indian population regarding the outcome in patients undergoing primary coronary intervention in centres without surgical backup. Thus, our study focusses on one year clinical outcomes in Indian patients undergoing primary percutaneous coronary intervention without on-site surgical backup.1-8 METHODS It was done as an observational, single centre, retrospective study. It included 139 patients, who were diagnosed with ST elevation myocardial infarction (STEMI) who underwent primary PCI from February 2019 to June 2020 at Rajah Hospital, Thrissur, Kerala, India. The primary endpoint of the study was occurrence of major adverse cardiac events, a sum of target vessel revascularisation (TLR), cardiac death, and myocardial infarction at one year after procedure. RESULTS 83.45 % were males. 30.21% were hypertensives and 48.92 % were diabetics. There were four cardiac deaths at 30-day follow-up and 4 (2.87 %) events of TLR at one-year follow-up. And additionally, the mean age of population was 56.05 years. CONCLUSIONS Considering these results, it can be concluded that mainly in the developing countries like India; primary PCI can be performed safely at PCI centres which lack the facility of on-site surgical backup. KEY WORDS ST-Elevation Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Disease.

Supraventricular and Atrial Tachycardia Radiofrequency Catheter Ablation Without On-Site Surgical Backup – Single Centre Experience

Due to rapid advances in techniques and technology, electrophysiology services including radiofrequency catheter ablation (RFA) have been shown to be safely performed in centres with experienced staff, without on-site surgical backup. We report a single centre experience of performing RFA in supraventricular and atrial tachycardias.

Coronary Angiography and Angioplasty Without On-Site Surgical Backup: A Single-Centre 5-Year Experience

Coronary Angiography and Angioplasty Without On-Site Surgical Backup: A Single-Centre 5-Year Experience

Outcomes After Coronary Orbital Atherectomy at Centers Without On-Site Surgical Backup: Diabetics Versus Non-Diabetics and Impact of Access Site

Background/purposeThere is limited data available on atherectomy usage in hospitals or centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the in-hospital and 30-day outcomes of complex PCI patients (including diabetics) treated with coronary orbital atherectomy (OA) at centers without on-site surgical back-up. Methods/materialsAll comers treated with OA at two centers without on-site surgical backup were included. Baseline, procedure, and outcome data were compared in diabetic and non-diabetic patients. The impact of transfemoral (TFA) versus transradial (TRA) vascular access was also assessed. ResultsOf the 221 patients treated with OA, 43% were diabetics. The diabetes and no-diabetes groups had similar baseline demographic and lesion characteristics, except for the higher rate of chronic kidney disease seen in the diabetics. Overall, there was a high freedom from major adverse cardiac events (MACE; in-hospital: 99.5%; 30-day: 98.6%), as well as a high success in stent delivery (99.5%) and procedural success (97.3%). The rate of angiographic complications was low in both the diabetes and no-diabetes groups (3.1% vs. 1.6%, p = 0.450). TFA and TRA were used in 36% and 64% of the patients, respectively—resulting in low angiographic complications in both groups (3.8% vs. 1.4%, p = 0.263). ConclusionsDespite the complexity of patient co-morbidities and the presence of heavily calcified lesions, the results indicate that coronary OA can be used safely and effectively without on-site surgical back-up. OA treatment resulted in a high rate of successful stent delivery and procedural success, as well as low rates of angiographic complications and MACE, in diabetic and non-diabetic patients, regardless of access site. Table of contents summaryThere is limited data available on atherectomy usage in centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the outcomes of complex PCI patients (including diabetics) treated with coronary orbital atherectomy (OA) at centers without on-site surgical back-up. The impact of transfemoral (TFA) versus transradial (TRA) vascular access was also assessed. Despite the complexity of patient co-morbidities and the presence of heavily calcified lesions, the results indicate that coronary OA can be used safely and effectively without on-site surgical back-up. OA treatment resulted in a high rate of successful stent delivery and procedural success, as well as low rates of angiographic complications and major adverse cardiac events, in diabetic and non-diabetic patients, regardless of access site (TFA or TRA).

ACUTE OUTCOMES AFTER CORONARY ORBITAL ATHERECTOMY AT CENTERS WITHOUT ON-SITE SURGICAL BACKUP: DIABETICS VERSUS NON-DIABETICS AND IMPACT OF ACCESS SITE

There is limited data available on atherectomy usage in hospitals or centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the acute outcomes of complex percutaneous coronary intervention (PCI) patients (including diabetics)

Abstract 213: Percutaneous Coronary Intervention at Centers with and without On-Site Surgical Backup: A Meta-Analysis and Meta-Regression

Background: Guidelines recommend that Percutaneous coronary intervention (PCI) should be performed in hospitals with onsite cardiac surgery (CS). However, emerging data suggest that there is no significant difference in clinical outcomes following primary, or elective PCI between the two groups. We performed a meta-analysis and meta-regression to assess the safety and efficacy of performing PCI in centers with, and without on-site CS. Methods: We conducted electronic database searches in PubMed, CENTRAL, EMBASE. The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible studies. Risk ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I 2 )>25 was identified, effects were obtained with random models. Meta-regression analyses were performed to determine whether the effects of PCI without on-site CS were modulated by pre-specified study-level factors Results: Twenty-seven studies were included with total n=8,558,618 patients. No significant difference was observed for all-cause mortality (RR 1.02, 95% CI 0.86-1.21, p=0.82, I 2 =97.2%), cardiovascular mortality rates (RR 1.18, 95% CI 0.93-1.50, p=0.17, I 2 2.98%), myocardial infarction rates (RR 0.89, 95% CI 0.62-1.29, p=0.55, I2= 88.5%), repeat revascularization (RR 0.87, 95% CI 0.43-1.76, p=0.69, I 2 =98.8%), stroke (RR 1.28, 95% CI 0.56-2.91, p=0.55, I 2 98.8%), shock (RR 0.76, 95% CI 0.43-1.35, p=0.35, I 2 = 93.7%), mechanical circulatory support (RR 0.83, 95% CI 0.46-1.50, p=0.53, I 2 99.8%), bleeding (RR 0.88, 95% CI 0.43-1.81, p=0.73, I 2 =99.6%), and emergency CABG (RR 0.97, 95% CI 0.64-146, p= 0.87, I 2 =84.1%). In a meta-regression analysis, the effect of PCI without on-site CS, baseline clinical features did not affect the long-term all-cause mortality outcome. Conclusion: There was no significant difference in complications rates, and clinical outcomes for PCI performed at centers without on-site CS compared to centers with on-site CS.

Acute Coronary Artery Dissection: A Review of the Literature and Current Evidence.

Acute coronary artery dissection is a rare, complex disease occurring particularly in young women without traditional cardiovascular risk factors. The pathophysiology and treatment are different from acute coronary syndrome caused by plaque rupture or erosion. Its clinical presentation may vary from unstable angina to sudden cardiac death. Hence, early detection is crucial to manage the dissection and reduce the mortality and morbidity rates. Most coronary dissections will heal spontaneously, and conservative treatment is recommended for uncomplicated cases. In the acute phase, primary percutaneous coronary intervention remains the reperfusion strategy of choice; however, in small- and medium-sized arteries with normalized blood flow, conservative treatment is beneficial. Medical therapy should be tailored to the individual depending on the underlying severity of the condition. Percutaneous coronary intervention should be performed by experienced operators, with the use of intravascular imaging, and preferably with on-site surgical back-up due to the increased risk of complications. The prognosis is favorable; however, patients have a high risk of recurrent dissections in other arteries several weeks after the first event, suggesting a general weakness of the arteries. In the recent past, optical coherence tomography has played an important role in the diagnosis of acute coronary artery dissection; however, its therapeutic potential is underestimated. We recommend that long-term clinical trials should be conducted to fully determine the long-term mortality and morbidity rates of these patients.

Impact of On-Site Surgical Backup on Periprocedural Outcomes of Primary Percutaneous Interventions in Patients Presenting With ST-Segment Elevation Myocardial Infarction (From the ORPKI Polish National Registry)

Conflicting data exist regarding the associations between on-site surgical backup and outcomes after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Thus, we sought to assess the impact of such a backup on periprocedural outcomes of primary PCI using data from the Polish National Registry of PCI. From 2014 to 2016 data on 66,707 patients presenting with STEMI undergoing primary PCI from 154 centers were collected. Patients were divided into 2 groups based on the presence of on-site surgical backup. Of 66,707 patients, 15,040 (22.6%) patients were treated in 28 centers with on-site surgical backup. On-site surgical backup was associated with a higher center PCI annual volume (662.4 ± 301.8 vs 1098.7 ± 483.5; p <0.001), but a lower operator PCI annual volume (226.7 ± 126.0 vs 207.8 ± 96.6; p <0.001). The periprocedural mortality (1.60% vs 1.09%; p <0.001) was lower in patients from centers with on-site cardiac surgery and both on-site surgical backup (odds ratio [95% confidence interval], 0.618 [0.517; 0.738]; p <0.001) and the mean number of PCIs by operator per year (odds ratio per 10 [95% confidence interval], 0.990 [0.984; 0.996]; p = 0.001] were independent predictors of periprocedural death. In conclusion, results of our study suggest that periprocedural mortality in patients undergoing primary PCI for STEMI is lower in centers than without on-site cardiac surgical backup. Whether this effect on mortality is attributable to such backup itself and/or whether surgical backup is a marker ofoverall better medical care and adherence to professional guidelines, this needs clarification in further studies.

Structural Heart Interventions in Far North Queensland: Feasibility and Safety in a Regional Centre

Background: With advancements in device technology and procedural techniques, structural heart intervention is becoming increasingly common. However, this has been largely limited to metropolitan centres, usually with on-site surgical backup. This study sought to assess the safety and outcomes of structural heart interventions at Cairns Hospital.

Is a cardiac catheterization procedure at hospitals without on-site surgical backup safe?

Percutaneous cardiac catheterization procedures have now become an established and preferable method. Initially, these procedures were performed at clinical sites with surgical backup as complication rates and need of urgent surgery were high. With the improvement in catheter technique, experienced operators and the development of new devices, overall complication rates of catheterization are low and emergency cardiac surgery has become an increasingly rare event. The aim of the study was to evaluate the procedural outcomes for cardiac interventions in a tertiary-level hospital without onsite cardiac surgery backup. This was a prospective descriptive study. All consecutive patients who were admitted for percutaneous cardiac interventions, including both diagnostic as well as therapeutic interventions, between September 2013 and August 2015 were included in this study. Total 692 percutaneous cardiac interventions were performed. The mean age was 61.9 ± 18.3 years. 439(63.52%) procedures were carried out in men. PCI was done in 189(27 .31%). Percuteneous transvenous mitral comissurotomy was done in 49(7.08%) cases, coronary angiogram was done in 395(57.08%), permanent pacemaker insertion in 29(4.20%), peripheral angiogram in 16(2.30%), pericardiocentesis in 14(2 .02%).Primary PCI was done in 62(32.88%). The most frequent indication for PCI was STEMI 106(56.16%). Complications like Post-procedural cardiogenic shock in 4 (2.11%) cases, arrhythmias and minor complications in 7 (3.70%), and death in 4 (2.11%) patients was witnessed. Similarly, periprocedural MI and contrast induced nephropathy (CIN) requiring dialysis stroke or transient ischemic attack were not noted.Cardiac tamponade was observed in 1 (2.02%) patient during PTMC. There was no need of emergency cardiac surgery Percutaneous cardiac intervention was feasible with acceptable complications in a tertiary-level hospital without onsite cardiac surgery backup.

Is a cardiac catheterization procedure at hospitals without on-site surgical backup safe?

&lt;p&gt;Percutaneous cardiac catheterization procedures have now become an established and preferable method. Initially, these procedures were performed at clinical sites with surgical backup as complication rates and need of urgent surgery were high. With the improvement in catheter technique, experienced operators and the development of new devices, overall complication rates of catheterization are low and emergency cardiac surgery has become an increasingly rare event. The aim of the study was to evaluate the procedural outcomes for cardiac interventions in a tertiary-level hospital without onsite cardiac surgery backup. This was a prospective descriptive study. All consecutive patients who were admitted for percutaneous cardiac interventions, including both diagnostic as well as therapeutic interventions, between September 2013 and August 2015 were included in this study. Total 692 percutaneous cardiac interventions were performed. The mean age was 61.9 ± 18.3 years. 439(63.52%) procedures were carried out in men. PCI was done in 189(27 .31%). Percuteneous transvenous mitral comissurotomy was done in 49(7.08%) cases, coronary angiogram was done in 395(57.08%), permanent pacemaker insertion in 29(4.20%), peripheral angiogram in 16(2.30%), pericardiocentesis in 14(2 .02%).Primary PCI was done in 62(32.88%). The most frequent indication for PCI was STEMI 106(56.16%). Complications like Post-procedural cardiogenic shock in 4 (2.11%) cases, arrhythmias and minor complications in 7 (3.70%), and death in 4 (2.11%) patients was witnessed. Similarly, periprocedural MI and contrast induced nephropathy (CIN) requiring dialysis stroke or transient ischemic attack were not noted.Cardiac tamponade was observed in 1 (2.02%) patient during PTMC. There was no need of emergency cardiac surgery Percutaneous cardiac intervention was feasible with acceptable complications in a tertiary-level hospital without onsite cardiac surgery backup.&lt;/p&gt;

Balloon Mitral Valvuloplaty (BMV): An early experience in Chitwan Medical College

Balloon Mitral Valvotomy (BMV) is one the preferred modality of treatment for Rheumatic mitral stenosis. This is usually performed with onsite surgical backup to tackle the complications like cardiac tamponade needing surgical drainage and severe mitral regurgitation which requires emergency Mitral Valve Replacement. Our aim is to evaluate the pre and post procedural outcomes of the BMV, without onsite surgical backup. Total patients were 88 who underwent BMV in Chitwan Medical College, from Feb 2014 to Jan. 2016. All symptomatic patients (NYHA class II- IV) with their mitral valve area (MVA ) &lt;1.5cm2 were enrolled. Detail clinical evaluation and Echocardiography was done before and after the procedure. The procedure was performed under local anesthesia, using the step-wise Inoue balloon dilation with the ante grade transvenous approach. The successful procedure was 87 (98.8 %). The mean age was 38+13 yrs, mean pre BMV MVA= 0.85+0.18 cm2, mean Post BMV MVA =1.76+0.23 cm2, by plannimetry. Pre BMV mean left atrium pressure=23.10+6.79 mmHg and post BMV mean left atrium pressure=12.48+4.86mmHg.Minor complication like puncture site hematoma in 3 (3.44%) patients, vasovagal attack in 5 (5.74%) patients after intra atrial septal puncture, Ventricular arrhythmia in 3(3.44%) patients and supraventricular arrhythmia in 8 (9.19%) patients. Severe mitral regurgitation occurred in 4 (4.59%) patients and managed medically. Cardiac tamponade developed in 1(1.2%) patient, pericardiocentesis done. Balloon Mitral Valvotomy is safe and effective procedure for patient with severe and symptomatic patient with Rheumatic MS. It can be formed without onsite surgical backup with experience hand.

An Experience of “Antegrade Only” Chronic Total Occlusion Program Without Onsite Surgical Backup at Mackay Base Hospital, A Regional Hospital in Queensland and the Result of the First 20 Cases

Background: Chronic total occlusion (CTO) intervention requires specialised skill. While the risks of the retrograde approach require the procedure to be performed with onsite surgical backup, the antegrade approach is considered lower risk. In 2015 an “antegrade only” CTO program was established at Mackay Base Hospital (MBH). Methods: Specific guidelines have been implemented and are sub-divided into “Case Selection”, “Technical Considerations” and “Emergency Management”. Suitable case selection stipulates that only CTOs with a J-CTO score ≤ 3 are considered for intervention. A policy of “antegrade approach only” has been established. A time constraint of sixty minutes for wiring is allowed. Bilateral access is compulsory. The catheterisation laboratory must maintain stock of correct equipment including embolization devices and a pericardiocentesis kit. Results: Procedural success occurred in 15 of the 20 cases (75%). Mean age was 66.95 years (range 50 – 96 years). Mean J-CTO score was 1.73(range 0-3) for the successful cases and J-CTO score 3 for the rest. Mean procedure time was 133.85 ± 30.00 minutes. All cases required wire escalation. The complications were a branch dissection and a wire perforation, neither with consequences. There were no adverse events at one to six month follow-up. Of the five unsuccessful cases one required coronary bypass graft surgery, one underwent CTO intervention via a retrograde approach, one waiting for reattempt-CTO under general anaesthesia and two are for medical therapy. Conclusion: The CTO program established at MBH is feasible and safe without onsite surgical backup amid a success rate meeting the international standard.

Clinical outcomes of percutaneous coronary intervention in patients turned down for surgical revascularization.

We examined clinical outcomes following percutaneous coronary intervention (PCI) in patients turned down for surgical revascularization across a broad population. Prior studies suggest that surgical ineligibility is associated with increased mortality in patients with unprotected left main or multivessel coronary artery disease undergoing PCI. This study included consecutive patients who underwent PCI in a multicenter registry in Michigan from January 2010 to December 2014. Surgical ineligibility required documentation indicating that a cardiac surgeon deemed the patient ineligible for surgery. In-hospital outcomes included mortality (primary outcome), cardiogenic shock, cerebrovascular accident, contrast-induced nephropathy (CIN), and a new requirement for dialysis (NRD). Of 99,370 patients at 33 hospitals with on-site surgical backup, 1,922 (1.9%) were surgically ineligible. The rate of ineligibility did not vary by hospital (range: 1.5-2.5%; P = 0.79). Overall, there were no major differences in baseline characteristics or outcomes between surgically ineligible patients and the rest (i.e., nonineligible patients): mortality (0.52% vs. 0.52%; P > 0.5), cardiogenic shock (0.68% vs. 0.73%; P > 0.5), cerebrovascular accident (0.05% vs. 0.19%; P = 0.28), NRD (0.16% vs. 0.19%; P > 0.5), CIN (2.7% vs. 2.3%; P = 0.27). Among 1,074 patients who underwent unprotected left main PCI, 20 (1.9%) were surgically ineligible and experienced increased rates of mortality (20.0% vs. 5.3%; P = 0.022; adjusted OR = 7.38; P < 0.001) and other complications as compared to the remainder. PCI in a broad population of surgically ineligible patients is generally safe. However, among patients who underwent unprotected left main PCI, those deemed surgically ineligible experienced significantly worse outcomes as compared to the rest. © 2016 Wiley Periodicals, Inc.

Establishing an “Antegrade Only” Chronic Total Occlusion Intervention Program Without Onsite Surgical Backup at Mackay Base Hospital, Queensland and the Result of the First 8 Cases

Establishing an “Antegrade Only” Chronic Total Occlusion Intervention Program Without Onsite Surgical Backup at Mackay Base Hospital, Queensland and the Result of the First 8 Cases

Percutaneous Coronary Intervention: Relationship Between Procedural Volume and Outcomes.

Percutaneous coronary intervention (PCI) is an integral treatment modality for acute coronary syndromes (ACS) as well as chronic stable coronary artery disease (CAD) not responsive to optimal medical therapy. This coupled with studies on the feasibility and safety of performing PCI in centers without on-site surgical backup led to widespread growth of PCI centers. However, this has been accompanied by a recent steep decline in the volume of PCIs at both the operator and hospital level, which raises concerns regarding minimal procedural volumes required to maintain necessary skills and favorable clinical outcomes. The 2011 ACC/AHA/SCAI competency statement required PCI be performed by operators with a minimal procedural volume of >75 PCIs annually at high-volume centers with >400 PCIs per year, a number which was relaxed in the 2013 ACC/AHA/SCAI update to >50 PCIs/operator/year in hospitals with >200 PCIs annually to coincide with reduction in national PCI volume. Recent data suggests that many hospitals do not meet these thresholds. We review data on the importance of volume as a vital quality metric at both an operator and hospital level in determining procedural outcomes following PCI.

Predicting emergency coronary artery bypass graft following PCI: application of a computational model to refer patients to hospitals with and without onsite surgical backup

BackgroundClinical tools to stratify patients for emergency coronary artery bypass graft (ECABG) after percutaneous coronary intervention (PCI) create the opportunity to selectively assign patients undergoing procedures to hospitals with and...

TCT-449 Percutaneous Coronary Intervention at Centers With and Without On-Site Surgical Backup: An Updated Meta-analysis of 23 Studies

Emergency coronary artery bypass grafting (CABG) for unsuccessful percutaneous coronary intervention (PCI) is now rare. We aimed to evaluate the current safety and outcomes of primary PCI and non-primary PCI at centers with and without on-site surgical backup. We performed an updated systematic