CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
Original article
Balloon aortic valvuloplasty before noncardiac surgery in severe aortic stenosis: a single-center experience Francesca Calicchioa, Fabio Guarracinob, Cristina Gianninia, Francesco De Caroa, Rubia Baldassarrib, Marco De Carloa and Anna S. Petronioa Objectives The aim of this study is to investigate the role and short-term results of balloon aortic valvuloplasty (BAV) before noncardiac surgery in a high selected cohort of patients. Background Aortic stenosis is one of the most common valvular heart diseases and a well recognized risk factor for perioperative mortality. Methods Between May 2012 and July 2013 we enrolled 15 consecutive patients with severe aortic stenosis to allow urgent major noncardiac surgery. They had been excluded from surgical aortic valve replacement and transcatheter aortic valve implantation. Results Fifteen patients underwent BAV as a bridge to noncardiac surgery. They were elderly (mean age 81 W 5 years) and predominantly men (66%) with high surgery risk (mean logistic EuroSCORE: 31.1 W 18.2%). Three patients underwent vascular surgery, five underwent thoracic surgery, five were subjected to major abdominal surgery and in the last two patients orthopedic surgery and mastectomy were performed. No adverse events were observed in the perioperative period. Six patients (40%) were in New York Heart Association class III or IV. Mean aortic valve area was 0.52 W 0.1 cm2/m2; mean aortic pressure gradient was 55.6 W 10.8 mmHg. BAV was performed successfully in all patients. The mean
Introduction Perioperative evaluation and management of high-risk cardiac patients undergoing noncardiac surgery are complex and require careful teamwork between surgeon, anesthetist, cardiologist and the consultant. Despite advances in preoperative risk assessment, surgical and anesthetic techniques and the implementation of medical therapy, cardiovascular complications represent the most common adverse consequences of noncardiac surgery.1 Severe aortic stenosis constitutes a well established risk factor for perioperative mortality and myocardial infarction.2 In the case of elective noncardiac surgery the presence of symptoms is a key factor for decision making. In patients who have symptoms or objective consequences of left ventricular dysfunction, surgical aortic valve replacement (SAVR) is the treatment of choice prior to noncardiac surgery.3 However, as the surgical 1558-2027 Copyright ß 2016 Wolters Kluwer Health, Inc. All rights reserved.
peak-to-peak gradient assessed by catheterization significantly reduced after BAV (from 69.0 W 22.1 to 29.7 W 9.3 mmHg; P < 0.0001). The echocardiographic mean gradient was also significantly improved (from 55.6 W 10.8 to 33.8 W 7.9 mmHg; P < 0.0001). Survival at 30 days and at 6 months’ follow-up respectively was 100%. At 6 months’ follow-up clinical status according to New York Heart Association class was significantly improved (P < 0.0001). Conclusion BAV is well tolerated and effective in high-risk patients with severe aortic stenosis undergoing noncardiac surgery with good short-term survival. It could represent a valid choice of treatment prior to noncardiac surgery in these high-risk patients. J Cardiovasc Med 2016, 17:000–000 Keywords: aortic stenosis, balloon aortic valvuloplasty, transcatheter aortic valve implantation a Department of Cardiology and bDepartment of Anesthesiology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
Correspondence to Francesca Calicchio, MD, Department of Cardiology, Azienda Ospedaliero Universitaria Pisana, Via Paradisa 2 Cisanello, Pisa 56123, Italy Tel: +39050995321; fax: +39050995325; e-mail: [email protected] Received 14 December 2014 Revised 9 May 2015 Accepted 5 July 2015
risk is definitely higher in elderly patients, especially when significant comorbidities are present, many patients are not candidates for SAVR, and are left with a dismal prognosis. In these patients, considered at high risk for SAVR, transcatheter aortic valve implantation (TAVI) is the first option if life expectancy is more than 1 year and if logistics allow preprocedural screening. However, if patients have an uncertain life expectancy or have to undergo urgent noncardiac surgery, balloon aortic valvuloplasty (BAV) may offer a viable and ‘less invasive’ option.3 Therefore, the role of BAV in high-risk patients who require major noncardiac surgery still remains controversial. The aim of the present study is to investigate the role of BAV in a cohort of patients with severe symptomatic aortic stenosis who were not considered to be suitable for SAVR or for TAVI. DOI:10.2459/JCM.0000000000000331
Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
2 Journal of Cardiovascular Medicine 2016, Vol 00 No 00
Methods Patient population and study design
From May 2012 to July 2013, 150 consecutive patients with symptomatic severe aortic stenosis were referred to our department to undergo screening for TAVI. A detailed flow chart of the study population is given in Fig. 1. Of these, 15 patients underwent BAV as a bridge to major noncardiac surgery. They were included in a prospective registry. Detailed medical history, physical examination, electrocardiogram and coronary and peripheral angiography were performed. Surgical risk was estimated by means of the logistic EuroSCORE, calculated according to published guidelines (http:// www.euroscore.org/), and of clinical judgment. All patients enrolled underwent a transthoracic Doppler echocardiography (Philips IE33, Philips Ultrasound, Andover, Massachusetts, USA) at baseline and during the procedure. Echocardiographic measurements were performed according to current recommendations.4 Patients in this subgroup had a too high-risk profile for SAVR due to multiple comorbidities that would make surgical risk prohibitive as well as advanced age, general frailty, impaired ejection fraction and redo surgical procedure. Also, these patients were not considered eligible for TAVI because of uncertain life expectancy related to the outcomes after noncardiac surgery or the need to not postpone urgent surgery due to preimplantation screening timing.
BAV was performed during the same hospital admission for noncardiac surgery. The clinical follow-up was planned at 1 and 6 months by means of office visits. Patients’ clinical status was evaluated at baseline and during follow-up using the New York Heart Association (NYHA) classification. A signed informed consent was obtained for each patient. Balloon aortic valvuloplasty and postprocedural monitoring
The procedure was carried out under local anesthesia and mild systemic sedation, depending on patient collaboration. BAV was performed according to standard techniques using the retrograde femoral approach. Unfractionated heparin was administered (70 U/kg intravenous bolus) immediately after the femoral sheath (8–13F) insertion to achieve an activated clotting time of more than 200 s during the whole procedure. Arterial and ventricular pressures were recorded by means of pullback maneuver with a 6F pigtail catheter across the aortic valve. The valvuloplasty balloon inflation was performed under high-rate pacing (180 bpm) with a temporary catheter placed into the right ventricle, to stabilize the balloon position through the aortic valve. The procedural result was considered adequate if the peak-to-peak gradient decreased by 30 to 40%. When this goal was not achieved after the first attempt, additional BAV inflations were performed, and a larger balloon was employed in selected
Fig. 1
Patients referred for TAVI at our department n = 150
Eligible for SAVR n = 28 (19%)
Not eligible for SAVR n = 122 (81%)
Evaluated for TAVI
TAVI feasible n = 552 (43%)
TAVI feasible n = 70 (57%)
BAV
TAVI feasible n = 15 (29%)
Medical therapy n = 10 (19%)
Medical therapy n = 12 (23%)
Noncardiac srurgery n = 15 (29%)
Flow chart of patient population. BAV, balloon aortic valvuloplasty; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
Balloon aortic valvuloplasty Calicchio et al. 3
Table 1
Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient
Clinical and echocardiographic characteristics of study population (single patients)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Sex
Age (years)
Logistic EuroSCORE (%)
LVEF (%)
Mean aortic gradient (mmHg)
AVA (cm2)
Major noncardiac surgery
M F M M M F M F M F M M M F M
70 86 83 80 83 87 71 82 85 80 85 81 77 81 84
20.23 72.31 21.07 28.04 37.61 62.49 15.43 10.71 35.71 38.52 36.23 30.42 37.46 8.64 11.21
53 32 55 48 55 40 45 60 45 40 46 54 25 55 41
60 40 48 71 51 52 80 58 55 56 57 62 38 47 60
0.46 0.24 0.48 0.50 0.55 0.56 0.51 0.48 0.52 0.54 0.48 0.58 0.87 0.81 1.07
Colon cancer Breast cancer Lung cancer Liver cancer Lung cancer Orthopedic surgery Lung cancer Pancreatic cancer Abdominal aortic aneurysm Liver cancer Abdominal aortic aneurysm Iliac artery aneurysm Lung cancer Colon cancer Lung cancer
AVA, aortic valve area; LVEF, left ventricular ejection fraction.
cases. At the end of the procedure, transvalvular pressure gradient was again measured and an aortogram was performed to assess aortic regurgitation. All patients were monitored with electrocardiogram, pulse oximetry and invasive femoral artery blood pressure. During the procedure, aortic catheterization was recorded simultaneously with left ventricular catheterization immediately before and after BAV together with Doppler echocardiography measurement. Post BAV assessment for procedure-related complications [acute kidney injury (AKI), vascular access site and accessrelated complications, stroke and transient ischemic attack] was performed according to the Valve Academic Research Consortium-2 definitions.5 In our study group all patients were already in therapy with aspirin due to prior coronary revascularization, prior myocardial infarction and peripheral vascular disease, so aspirin was continued during and after BAV procedure. After the procedure all patients were transferred to intermediate care unit for continuous monitoring.
Statistical analysis
Categorical variables were presented as frequencies and percentages. Continuous variables were presented as mean standard deviation. The x2 test was used to show significant association between categorical variables. P < 0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 2007 (Chicago, SPSS Inc.).
Results Between May 2012 and July 2013, 150 consecutive patients with symptomatic aortic stenosis were referred to our department. Of these, 15 patients had to undergo necessary major noncardiac surgery and were included in a prospective cohort study. Indication for noncardiac surgery was cancer disease in 11 patients (lung cancer in five patients, liver cancer in two patients, breast cancer in one patient, pancreatic cancer in one patient, colon
cancer in two patients); three patients underwent vascular surgery and one patient was subjected to urgent major orthopedic surgery. Noncardiac surgery was successfully performed in all patients within 1 week after BAV without any postsurgical complications. All patients were symptomatic at baseline with six patients (40%) in III to IV NYHA class. The study population was elderly (mean age 81 5 years) and predominantly men (66%) with high risk for SAVR (mean logistic EuroSCORE was 31.1 18.2) because of the presence of several comorbidities. According to baseline echocardiography, all patients had severe aortic stenosis, with aortic valve area averaging 0.52 0.1 cm2/m2 and a mean aortic pressure gradient of 55.6 10.8 mmHg. Left ventricular ejection fraction averaged 46.3 9.6%, and systolic pulmonary artery pressure was 37.8 8.3 mmHg. Baseline characteristics are detailed in Tables 1 and 2. BAV was successful in all patients. Procedural details are defined in Table 3. During BAV procedure different sizes of balloon were used, according to annulus size measured by transthoracic echocardiography. The amount of contrast medium (iodixanol 320) administered during the procedures was 116.5 33.6 ml. None of the patients developed AKI according Table 2
Baseline characteristics of study population n ¼ 15
Diabetes mellitus Hypertension Severe chronic pulmonary disease Serum creatinine (mg/ml) Creatinine clearance (ml/min) Coronary artery disease Prior myocardial infarction Prior coronary revascularization Peripheral vascular disease Prior stroke NYHA functional class III/IV (%)
6 (40%) 12 (80%) 5 (33%) 1.2 0.3 50.8 8.7 6 (40%) 3 (20%) 6 (40%) 4 (26%) 3 (20%) 6 (40%)
Values are n (%), mean SD. NYHA, New York Heart Association.
Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
4 Journal of Cardiovascular Medicine 2016, Vol 00 No 00
Table 3
Procedural results n ¼ 15
Procedural success Procedural death Local anesthesia Fluoroscopy time (min) Procedural time (min) Conversion to surgery Acute kidney injury Periprocedural TIA/ictus Peak-to-peak aortic gradient (hemodynamic)
15 (100%) 0 (0%) 15 (100%) 20.2 3.4 90.2 18.7 0 (0%) 0 (0%) 0 (0%) 29.7 9.3
Values are n (%), mean SD. TIA, transient ischemic attack.
to Valve Academic Research Consortium-2 criteria. Moreover no vascular and cerebrovascular event (transient ischemic attack or stroke) occurred. There were two acute reductions in hemoglobin (>3 g/dl) treated by blood transfusion (2 units). The mean peak gradient assessed by catheterization significantly reduced after BAV (from 69 22.1 to 29.7 9.3 mmHg; P < 0.0001). The echocardiographic mean gradient was also significantly improved (from 55.6 10.8 to 33.8 7.9 mmHg; P < 0.0001) (Table 4). No patient developed significant hemodynamic aortic regurgitation after BAV. All patients were alive at 30 days and 6 months’ follow-up respectively, without any hospital readmission. At 6 months’ follow-up after noncardiac surgery, clinical status, according to NYHA class, was significantly improved (P < 0.0001).
Discussion Aortic stenosis is the most common valvular heart disease in Europe and it represents a well established risk factor for perioperative mortality, and its severity is predictive of these complications.6 According to the European Guidelines, severe valvular disease is one of the conditions that indicates major clinical risk and mandates intensive management and it may result in delay or cancellation of surgery if it is not emergent.3,7,8
cancelled. Such patients require valve replacement before elective but necessary noncardiac surgery. In patients who are not candidates for aortic valve replacement due to high cardiac risks or in those who refuse cardiac surgery, noncardiac surgery should be performed only if it is essential, with a mortality risk of approximately 10%.9,10 In these patients TAVI or BAV may be reasonable therapeutic options before surgery.8,11 When life expectancy is more than 1 year and logistics allow the procedure, TAVI should be considered as first-line strategy.12 With the introduction of TAVI, the precise role of BAV remains uncertain.13,14 There are studies of patients with severe aortic stenosis and high operative risk showing that BAV has the potential to facilitate TAVI (if technically suitable) and it is a well tolerated approach to be offered for temporary symptoms relief in selected patients.15–18 The hospital mortality for BAV ranges from 3 to 10%, with a hospital morbidity of 10 to 25%.19–21 In experienced hands BAV is an effective, low-cost lowrisk procedure and its improved technology makes it an attractive technique for elderly patients at high operative risk, especially as a bridge in major noncardiac surgery, when SAVR is not an option.22 Most of the study group patients (n ¼ 9), in addition to mild–moderate symptoms, had a reduced systolic ventricular function with increased perioperative risk. In this context BAV was the only viable alternative, even with the risk related to the procedure. We considered BAV not as a definitive intervention but as a tool to sufficiently reduce the mean aortic gradient so bridging the patients across noncardiac surgery. In our experience all patients underwent uncomplicated noncardiac surgery under general anesthesia and major complications related to BAV procedure were acceptable. Our limited experience confirms that BAV is a useful attempt to improve hemodynamics, reduce the risk associated with surgical procedures and palliate symptoms.
In the case of elective noncardiac surgery, the presence of symptoms is a key element for decision making.3 In patients with symptomatic severe aortic stenosis elective noncardiac surgery should generally be postponed or
Study limitations
Echocardiographic parameters before and after balloon aortic valvuloplasty
Conclusion
Table 4
Peak aortic gradient (mmHg) Mean aortic gradient (mmHg) Aortic valve area index (cm2/m2) Aortic valve regurgitation 2 Left ventricular ejection fraction (%) Pulmonary artery systolic pressure (mmHg) Values are n (%), mean SD.
Baseline n ¼ 12
Discharge n ¼ 12
P value
73.2 9.5 55.6 10.8 0.52 0.1 0 (0%) 46.3 9.6 37.8 8.3
50.9 6.5 33.8 7.9 1.48 0.4 1 (
JCM-D-14-00671
Original article
Balloon aortic valvuloplasty before noncardiac surgery in severe aortic stenosis: a single-center experience Francesca Calicchioa, Fabio Guarracinob, Cristina Gianninia, Francesco De Caroa, Rubia Baldassarrib, Marco De Carloa and Anna S. Petronioa Objectives The aim of this study is to investigate the role and short-term results of balloon aortic valvuloplasty (BAV) before noncardiac surgery in a high selected cohort of patients. Background Aortic stenosis is one of the most common valvular heart diseases and a well recognized risk factor for perioperative mortality. Methods Between May 2012 and July 2013 we enrolled 15 consecutive patients with severe aortic stenosis to allow urgent major noncardiac surgery. They had been excluded from surgical aortic valve replacement and transcatheter aortic valve implantation. Results Fifteen patients underwent BAV as a bridge to noncardiac surgery. They were elderly (mean age 81 W 5 years) and predominantly men (66%) with high surgery risk (mean logistic EuroSCORE: 31.1 W 18.2%). Three patients underwent vascular surgery, five underwent thoracic surgery, five were subjected to major abdominal surgery and in the last two patients orthopedic surgery and mastectomy were performed. No adverse events were observed in the perioperative period. Six patients (40%) were in New York Heart Association class III or IV. Mean aortic valve area was 0.52 W 0.1 cm2/m2; mean aortic pressure gradient was 55.6 W 10.8 mmHg. BAV was performed successfully in all patients. The mean
Introduction Perioperative evaluation and management of high-risk cardiac patients undergoing noncardiac surgery are complex and require careful teamwork between surgeon, anesthetist, cardiologist and the consultant. Despite advances in preoperative risk assessment, surgical and anesthetic techniques and the implementation of medical therapy, cardiovascular complications represent the most common adverse consequences of noncardiac surgery.1 Severe aortic stenosis constitutes a well established risk factor for perioperative mortality and myocardial infarction.2 In the case of elective noncardiac surgery the presence of symptoms is a key factor for decision making. In patients who have symptoms or objective consequences of left ventricular dysfunction, surgical aortic valve replacement (SAVR) is the treatment of choice prior to noncardiac surgery.3 However, as the surgical 1558-2027 Copyright ß 2016 Wolters Kluwer Health, Inc. All rights reserved.
peak-to-peak gradient assessed by catheterization significantly reduced after BAV (from 69.0 W 22.1 to 29.7 W 9.3 mmHg; P < 0.0001). The echocardiographic mean gradient was also significantly improved (from 55.6 W 10.8 to 33.8 W 7.9 mmHg; P < 0.0001). Survival at 30 days and at 6 months’ follow-up respectively was 100%. At 6 months’ follow-up clinical status according to New York Heart Association class was significantly improved (P < 0.0001). Conclusion BAV is well tolerated and effective in high-risk patients with severe aortic stenosis undergoing noncardiac surgery with good short-term survival. It could represent a valid choice of treatment prior to noncardiac surgery in these high-risk patients. J Cardiovasc Med 2016, 17:000–000 Keywords: aortic stenosis, balloon aortic valvuloplasty, transcatheter aortic valve implantation a Department of Cardiology and bDepartment of Anesthesiology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
Correspondence to Francesca Calicchio, MD, Department of Cardiology, Azienda Ospedaliero Universitaria Pisana, Via Paradisa 2 Cisanello, Pisa 56123, Italy Tel: +39050995321; fax: +39050995325; e-mail: [email protected] Received 14 December 2014 Revised 9 May 2015 Accepted 5 July 2015
risk is definitely higher in elderly patients, especially when significant comorbidities are present, many patients are not candidates for SAVR, and are left with a dismal prognosis. In these patients, considered at high risk for SAVR, transcatheter aortic valve implantation (TAVI) is the first option if life expectancy is more than 1 year and if logistics allow preprocedural screening. However, if patients have an uncertain life expectancy or have to undergo urgent noncardiac surgery, balloon aortic valvuloplasty (BAV) may offer a viable and ‘less invasive’ option.3 Therefore, the role of BAV in high-risk patients who require major noncardiac surgery still remains controversial. The aim of the present study is to investigate the role of BAV in a cohort of patients with severe symptomatic aortic stenosis who were not considered to be suitable for SAVR or for TAVI. DOI:10.2459/JCM.0000000000000331
Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
2 Journal of Cardiovascular Medicine 2016, Vol 00 No 00
Methods Patient population and study design
From May 2012 to July 2013, 150 consecutive patients with symptomatic severe aortic stenosis were referred to our department to undergo screening for TAVI. A detailed flow chart of the study population is given in Fig. 1. Of these, 15 patients underwent BAV as a bridge to major noncardiac surgery. They were included in a prospective registry. Detailed medical history, physical examination, electrocardiogram and coronary and peripheral angiography were performed. Surgical risk was estimated by means of the logistic EuroSCORE, calculated according to published guidelines (http:// www.euroscore.org/), and of clinical judgment. All patients enrolled underwent a transthoracic Doppler echocardiography (Philips IE33, Philips Ultrasound, Andover, Massachusetts, USA) at baseline and during the procedure. Echocardiographic measurements were performed according to current recommendations.4 Patients in this subgroup had a too high-risk profile for SAVR due to multiple comorbidities that would make surgical risk prohibitive as well as advanced age, general frailty, impaired ejection fraction and redo surgical procedure. Also, these patients were not considered eligible for TAVI because of uncertain life expectancy related to the outcomes after noncardiac surgery or the need to not postpone urgent surgery due to preimplantation screening timing.
BAV was performed during the same hospital admission for noncardiac surgery. The clinical follow-up was planned at 1 and 6 months by means of office visits. Patients’ clinical status was evaluated at baseline and during follow-up using the New York Heart Association (NYHA) classification. A signed informed consent was obtained for each patient. Balloon aortic valvuloplasty and postprocedural monitoring
The procedure was carried out under local anesthesia and mild systemic sedation, depending on patient collaboration. BAV was performed according to standard techniques using the retrograde femoral approach. Unfractionated heparin was administered (70 U/kg intravenous bolus) immediately after the femoral sheath (8–13F) insertion to achieve an activated clotting time of more than 200 s during the whole procedure. Arterial and ventricular pressures were recorded by means of pullback maneuver with a 6F pigtail catheter across the aortic valve. The valvuloplasty balloon inflation was performed under high-rate pacing (180 bpm) with a temporary catheter placed into the right ventricle, to stabilize the balloon position through the aortic valve. The procedural result was considered adequate if the peak-to-peak gradient decreased by 30 to 40%. When this goal was not achieved after the first attempt, additional BAV inflations were performed, and a larger balloon was employed in selected
Fig. 1
Patients referred for TAVI at our department n = 150
Eligible for SAVR n = 28 (19%)
Not eligible for SAVR n = 122 (81%)
Evaluated for TAVI
TAVI feasible n = 552 (43%)
TAVI feasible n = 70 (57%)
BAV
TAVI feasible n = 15 (29%)
Medical therapy n = 10 (19%)
Medical therapy n = 12 (23%)
Noncardiac srurgery n = 15 (29%)
Flow chart of patient population. BAV, balloon aortic valvuloplasty; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
Balloon aortic valvuloplasty Calicchio et al. 3
Table 1
Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient
Clinical and echocardiographic characteristics of study population (single patients)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Sex
Age (years)
Logistic EuroSCORE (%)
LVEF (%)
Mean aortic gradient (mmHg)
AVA (cm2)
Major noncardiac surgery
M F M M M F M F M F M M M F M
70 86 83 80 83 87 71 82 85 80 85 81 77 81 84
20.23 72.31 21.07 28.04 37.61 62.49 15.43 10.71 35.71 38.52 36.23 30.42 37.46 8.64 11.21
53 32 55 48 55 40 45 60 45 40 46 54 25 55 41
60 40 48 71 51 52 80 58 55 56 57 62 38 47 60
0.46 0.24 0.48 0.50 0.55 0.56 0.51 0.48 0.52 0.54 0.48 0.58 0.87 0.81 1.07
Colon cancer Breast cancer Lung cancer Liver cancer Lung cancer Orthopedic surgery Lung cancer Pancreatic cancer Abdominal aortic aneurysm Liver cancer Abdominal aortic aneurysm Iliac artery aneurysm Lung cancer Colon cancer Lung cancer
AVA, aortic valve area; LVEF, left ventricular ejection fraction.
cases. At the end of the procedure, transvalvular pressure gradient was again measured and an aortogram was performed to assess aortic regurgitation. All patients were monitored with electrocardiogram, pulse oximetry and invasive femoral artery blood pressure. During the procedure, aortic catheterization was recorded simultaneously with left ventricular catheterization immediately before and after BAV together with Doppler echocardiography measurement. Post BAV assessment for procedure-related complications [acute kidney injury (AKI), vascular access site and accessrelated complications, stroke and transient ischemic attack] was performed according to the Valve Academic Research Consortium-2 definitions.5 In our study group all patients were already in therapy with aspirin due to prior coronary revascularization, prior myocardial infarction and peripheral vascular disease, so aspirin was continued during and after BAV procedure. After the procedure all patients were transferred to intermediate care unit for continuous monitoring.
Statistical analysis
Categorical variables were presented as frequencies and percentages. Continuous variables were presented as mean standard deviation. The x2 test was used to show significant association between categorical variables. P < 0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 2007 (Chicago, SPSS Inc.).
Results Between May 2012 and July 2013, 150 consecutive patients with symptomatic aortic stenosis were referred to our department. Of these, 15 patients had to undergo necessary major noncardiac surgery and were included in a prospective cohort study. Indication for noncardiac surgery was cancer disease in 11 patients (lung cancer in five patients, liver cancer in two patients, breast cancer in one patient, pancreatic cancer in one patient, colon
cancer in two patients); three patients underwent vascular surgery and one patient was subjected to urgent major orthopedic surgery. Noncardiac surgery was successfully performed in all patients within 1 week after BAV without any postsurgical complications. All patients were symptomatic at baseline with six patients (40%) in III to IV NYHA class. The study population was elderly (mean age 81 5 years) and predominantly men (66%) with high risk for SAVR (mean logistic EuroSCORE was 31.1 18.2) because of the presence of several comorbidities. According to baseline echocardiography, all patients had severe aortic stenosis, with aortic valve area averaging 0.52 0.1 cm2/m2 and a mean aortic pressure gradient of 55.6 10.8 mmHg. Left ventricular ejection fraction averaged 46.3 9.6%, and systolic pulmonary artery pressure was 37.8 8.3 mmHg. Baseline characteristics are detailed in Tables 1 and 2. BAV was successful in all patients. Procedural details are defined in Table 3. During BAV procedure different sizes of balloon were used, according to annulus size measured by transthoracic echocardiography. The amount of contrast medium (iodixanol 320) administered during the procedures was 116.5 33.6 ml. None of the patients developed AKI according Table 2
Baseline characteristics of study population n ¼ 15
Diabetes mellitus Hypertension Severe chronic pulmonary disease Serum creatinine (mg/ml) Creatinine clearance (ml/min) Coronary artery disease Prior myocardial infarction Prior coronary revascularization Peripheral vascular disease Prior stroke NYHA functional class III/IV (%)
6 (40%) 12 (80%) 5 (33%) 1.2 0.3 50.8 8.7 6 (40%) 3 (20%) 6 (40%) 4 (26%) 3 (20%) 6 (40%)
Values are n (%), mean SD. NYHA, New York Heart Association.
Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CE: Tripti; JCM-D-14-00671; Total nos of Pages: 5;
JCM-D-14-00671
4 Journal of Cardiovascular Medicine 2016, Vol 00 No 00
Table 3
Procedural results n ¼ 15
Procedural success Procedural death Local anesthesia Fluoroscopy time (min) Procedural time (min) Conversion to surgery Acute kidney injury Periprocedural TIA/ictus Peak-to-peak aortic gradient (hemodynamic)
15 (100%) 0 (0%) 15 (100%) 20.2 3.4 90.2 18.7 0 (0%) 0 (0%) 0 (0%) 29.7 9.3
Values are n (%), mean SD. TIA, transient ischemic attack.
to Valve Academic Research Consortium-2 criteria. Moreover no vascular and cerebrovascular event (transient ischemic attack or stroke) occurred. There were two acute reductions in hemoglobin (>3 g/dl) treated by blood transfusion (2 units). The mean peak gradient assessed by catheterization significantly reduced after BAV (from 69 22.1 to 29.7 9.3 mmHg; P < 0.0001). The echocardiographic mean gradient was also significantly improved (from 55.6 10.8 to 33.8 7.9 mmHg; P < 0.0001) (Table 4). No patient developed significant hemodynamic aortic regurgitation after BAV. All patients were alive at 30 days and 6 months’ follow-up respectively, without any hospital readmission. At 6 months’ follow-up after noncardiac surgery, clinical status, according to NYHA class, was significantly improved (P < 0.0001).
Discussion Aortic stenosis is the most common valvular heart disease in Europe and it represents a well established risk factor for perioperative mortality, and its severity is predictive of these complications.6 According to the European Guidelines, severe valvular disease is one of the conditions that indicates major clinical risk and mandates intensive management and it may result in delay or cancellation of surgery if it is not emergent.3,7,8
cancelled. Such patients require valve replacement before elective but necessary noncardiac surgery. In patients who are not candidates for aortic valve replacement due to high cardiac risks or in those who refuse cardiac surgery, noncardiac surgery should be performed only if it is essential, with a mortality risk of approximately 10%.9,10 In these patients TAVI or BAV may be reasonable therapeutic options before surgery.8,11 When life expectancy is more than 1 year and logistics allow the procedure, TAVI should be considered as first-line strategy.12 With the introduction of TAVI, the precise role of BAV remains uncertain.13,14 There are studies of patients with severe aortic stenosis and high operative risk showing that BAV has the potential to facilitate TAVI (if technically suitable) and it is a well tolerated approach to be offered for temporary symptoms relief in selected patients.15–18 The hospital mortality for BAV ranges from 3 to 10%, with a hospital morbidity of 10 to 25%.19–21 In experienced hands BAV is an effective, low-cost lowrisk procedure and its improved technology makes it an attractive technique for elderly patients at high operative risk, especially as a bridge in major noncardiac surgery, when SAVR is not an option.22 Most of the study group patients (n ¼ 9), in addition to mild–moderate symptoms, had a reduced systolic ventricular function with increased perioperative risk. In this context BAV was the only viable alternative, even with the risk related to the procedure. We considered BAV not as a definitive intervention but as a tool to sufficiently reduce the mean aortic gradient so bridging the patients across noncardiac surgery. In our experience all patients underwent uncomplicated noncardiac surgery under general anesthesia and major complications related to BAV procedure were acceptable. Our limited experience confirms that BAV is a useful attempt to improve hemodynamics, reduce the risk associated with surgical procedures and palliate symptoms.
In the case of elective noncardiac surgery, the presence of symptoms is a key element for decision making.3 In patients with symptomatic severe aortic stenosis elective noncardiac surgery should generally be postponed or
Study limitations
Echocardiographic parameters before and after balloon aortic valvuloplasty
Conclusion
Table 4
Peak aortic gradient (mmHg) Mean aortic gradient (mmHg) Aortic valve area index (cm2/m2) Aortic valve regurgitation 2 Left ventricular ejection fraction (%) Pulmonary artery systolic pressure (mmHg) Values are n (%), mean SD.
Baseline n ¼ 12
Discharge n ¼ 12
P value
73.2 9.5 55.6 10.8 0.52 0.1 0 (0%) 46.3 9.6 37.8 8.3
50.9 6.5 33.8 7.9 1.48 0.4 1 (
